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Chapter 12 Chinese Herb-Related Invention

1. Foreword…………………………………………….2-12-1

2. Subject matter of the patent application…………….2-12-2

2.1 Types of subject matter of the patent application……….2-12-2

2.1.1 Product invention…………………………………………..2-12-2

2.1.2 Process invention…………………………………………..2-12-3

2.1.3 Use invention………………………………………………2-12-4

2.2 Non-invention-related types……….……………………2-12-4

2.2.1 Rules of nature……………………………………………..2-12-4

2.2.2 Simple discovery…………………………………………..2-12-6

2.2.3 Those against rules of nature………………………………2-12-7

2.2.4 Those not utilizing rules of nature…………………………2-12-7

2.2.5 Those not based on technical concepts…………………….2-12-9

2.3 Statutorily Unpatentable Inventions…………………..2-12-10

2.3.1 Animals, plants, and essentially biological processes for

production of animals or plants…………………………..2-12-11

2.3.2 Diagnostic, therapeutic or surgical operation methods for the

treatment of diseases in humans or animals………………2-12-11

2.3.2.1 Diagnostic methods for the treatment of diseases in humans or

animals………………………………………………………….2-12-11

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2.3.2.2 Therapeutic method for the treatment of diseases in humans or

animals………………………………………….…………….2-12-12

2.3.2.3 Surgical operation methods for the treatment of diseases in humans or

animals………………………………………….…………….2-12-13

2.3.3 Inventions detrimental to public order, morality or

hygiene………………………………………..………….2-12-14

3. Specification………………………………………..2-12-14

3.1 Title of the invention…………………………..………2-12-15

3.2 Abstract of the invention………………………..……...2-12-15

3.3 Description of the invention……………………………2-12-15

3.3.1 Disclosure of description of the invention………………..2-12-15

3.3.1.1 Names………………………………………………………….2-12-16

3.3.1.2 Production area, harvest season, and part to use……………….2-12-17

3.3.1.3 Extracts…………………………………………………………2-12-18

3.3.1.4 Ingredients and proportions of compositions…………………...2-12-19

3.3.1.5 Preparation method……………………………………………..2-12-19

3.3.1.6 Concocting method of medicinal materials…………………….2-12-20

3.3.1.7 Curative effects…………………………………………………2-12-20

3.3.1.7.1 Determination of curative effects in terms of the diseases or

pharmacological action defined in the Western medicine...2-12-21

3.3.1.7.2 Determination of curative effects in terms of the syndromes or

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diseases defined in the Chinese medicine……..…………2-12-28

3.3.2 Principles for examining the description of the invention..2-12-33

3.3.2.1 Principles for examining extracts………………………………2-12-33

3.3.2.2 Principles for examining curative effects………………….……2-12-34

3.3.2.2.1 Curative effects of compositions…………………………..2-12-34

3.3.2.2.1.1 Determination of curative effects by syndromes or

diseases defined in Chinese medicine…………..2-12-34

3.3.2.2.1.2 Determination of curative effects by diseases or

pharmacological actions defined in Western

medicine………………………………………...2-12-36

3.3.2.2.2 Curative effects of extracts……………………………....2-12-37

3.3.2.2.2.1 Determination of curative effects by syndromes or

diseases defined in Chinese medicine…………...2-12-38

3.3.2.2.2.2 Determination of curative effects by diseases or

pharmacological actions defined in Western

medicine………………………………………....2-12-39

4. Claims………………………………………………2-12-40

4.1 Definition of claims…………………………………….2-12-40

4.1.1 Product claims……………………………………….……2-12-40

4.1.1.1 Compositions……………………………………………..……..2-12-40

4.1.1.2 Extracts…………………………………………………….……2-12-42

4.1.1.3 Dosage Form……………………………………………………2-12-45

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4.1.2 Process claim……………………………………….……..2-12-47

4.1.3 Use claim………………………………………………….2-12-50

4.1.3.1 Medical uses…………………………………………………….2-12-50

4.1.3.2 Non-medical uses……………………………………………….2-12-52

5. Requirements for patentability……………………...2-12-52

5.1 Industrial applicability………………………………....2-12-52

5.1.1 Uses of products…………………………………………..2-12-53

5.1.2 Toxicity of products and dosage of medicinal materials…2-12-53

5.2 Novelty………………………………………………....2-12-54

5.2.1 Proven formulas spread by word-of-mouth…………..….2-12-54

5.2.2 Addition, subtraction, or substitution of components of

conventional formulas…………………………………….2-12-55

5.2.3 Inventions about extracts………………………………….2-12-56

5.2.3.1 Defining extracts………………………………………………..2-12-57

5.2.3.2 Defining extracts with preparation methods……………………2-12-57

5.2.4 Using part invention………………………………………2-12-58

5.2.5 Use invention……………………………………………...2-12-58

5.2.5.1 Determination of novelty of a use invention……………..…….2-12-58

5.2.5.2 Uses not specifically disclosed in citations…………………….2-12-59

5.2.6 Comparison of syndromes or diseases defined in Chinese

medicine and diseases defined in Western medicine……...2-12-59

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5.3 Inventive step………………………………………..…2-12-61


conventional formulas…………………………………….2-12-61

5.3.2 Selection Invention………………………………………..2-12-65

5.3.3 Use invention……………………………………………...2-12-66

5.3.3.1 Uses not specifically disclosed in citations……………………..2-12-66

5.3.3.2 Uses utilizing known properties………………………………...2-12-67

Appendix

1. Differential treatment based on differentiation of symptoms and

signs used in Chinese medicine……………….…………….2-12-68

1.1 Differentiation of symptoms and signs………………..…....2-12-68

1.2 Differential treatment……………………………………..…..2-12-69

2. Basic theory and content of formula………………………...2-12-70

2.1 Seven relations in medicine combination……………………...2-12-70

2.2 Principles of Medicine Combination in Formulas……………2-12-73

2.2.1 Sovereign, Minister, Assistant and Courier…………… ……………2-12-74

2.2.2 Other principles of medicine combination in formulas… ………..…2-12-78

2.2.3 Lost principles of medicine combination………………… ………...2-12-78

Section II. Substantive examination for invention patent Chapter 12 Chinese herb related Inventions

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Chapter 12 Chinese Herb-Related Invention 1. Foreword

In contrast to Western medicinal inventions, which can identify a chemical

substance as an effective ingredient, the active ingredients in Chinese

herb-related inventions are mostly unknown and difficult to be separated and

purified into a single active substance with a specific chemical structure. The

basic theory of Chinese herbs differs from that of Western medicine, and the

features of single or compound formulae seen in Chinese herbal medicine are

not common in Western medicine inventions. Thus it is not entirely

appropriate to apply the same criteria and practice adopted in the examination of

pharmaceutical patent applications to the definition and examination of the

claims of Chinese herb patent applications.

In view of the above characteristics of Chinese herbs, the Examination

Guidelines for Chinese Herb-Related Invention Patents is hereby constituted as

the basis for examination of Chinese herb-related invention patent applications.

The term “Chinese herbs” mentioned in the Guidelines covers plants, animals,

minerals, algae, fungi, and other natural substances or the extracts or

compositions thereof, excluding a single compound or the compositions thereof.

The term “Chinese herb related invention” mentioned in the Guidelines includes

the inventions relating to Chinese herbs as well as applications thereof.

In addition to the general provisions and special provisions for pharmaceutical

inventions and biological inventions discussed in relevant chapters of the

Guidelines, other provisions specific for examination of Chinese herb related

invention that must be considered independently are discussed in this chapter.

The examples provided in the chapter are used for explicating the Guidelines

only and should not be relied upon as the form for drafting a specification. The

examples are only meaningful in explaining specific issues and cannot be

regarded as meeting other prerequisites for a patent.

The contents and examples of the chapter relate to the basic theory of

"differential treatment based on differentiation of symptoms and signs" and

Chinese medicine formulae (see Appendix).


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2. Subject matter of the patent application

2.1 Types of subject matter of the patent application

The subject matter of the Chinese herb-related invention is generally

classified into product invention, process invention, and use invention.

2.1.1 Product invention

(1) Chinese herbal compositions, for example: “a Chinese herbal

composition for the treatment of hepatitis C,” “a Chinese herbal

preparation for the treatment of leukemia,” “a Chinese herbal

plant pesticide” or “a herbal bath gel.”

(2) Chinese herbal extracts, for example: “a propolis extract” or “an

asiatic moonseed rhizome extract.”

(3) Chinese herbal dosage forms, for example: “a body contour gel”

or “a wound dressing.”

(4) Food, beverages, and cosmetics containing Chinese herbs, for

example: “a Chinese herbal nutritional oral solution” or “a skin

cosmetic containing ginkgo extracts.”

(5) Medical materials containing Chinese herbs, for example: “a pit

and fissure sealant containing Chinese herbs” or “an artificial

skin material containing ganoderma lucidum extracts.”

(6) Medical instruments or apparatuses containing Chinese herbs, for

example: “an acupuncture instrument using Chinese herbal

steam” or “a cupping instrument containing a Chinese herbal

preparation.”

2.1.2 Process invention

(1) Preparation methods of Chinese herbs, for example: “a

preparation method of a Chinese herbal composition for the

treatment of hepatitis,” “a manufacturing method of Xiaoyao

Powder,” “a preparation method of a Chinese herbal plant

pesticide,” or “a manufacturing method of herbal bath gel.”

(2) Extraction methods of Chinese herbs, for example: “an extraction

method of the extract with high baicalein content,” “a method of


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extracting effective fractions ofred sage root” or “a

manufacturing method of ginkgo leaf extract.”

(3) Concocting methods of Chinese herbs, for example: “a method

for concocting fresh rehmannia root” or “a method for concocting

Chinese angelica root.”

(4) Preparation methods of Chinese herbal dosage forms, for

example: “a preparation method of Chinese formula hard

capsules having contents with fine disintegration,” “a preparation

method of Chinese formula tablets having fine disintegration” or

“a preparation method of Chinese herbal aerosol for the treatment

of cardio-cerebral diseases.”

(5) Preparation methods of food, beverage and cosmetics containing

Chinese herbs, for example: “a preparation method of Chinese

herbal nutritional oral solution” or “a preparation method of skin

cosmetics containing ginkgo extracts.”

(6) Preparation method of medical materials containing Chinese

herbs, for example: “a preparation method of a pit and fissure

sealant containing Chinese herbs” or “a preparation method of an

artificial skin material containing ganoderma lucidum extracts.”

(7) Preparation methods of medical instruments or apparatuses

containing Chinese herbs, for example: “a preparation method of

a cupping instrument containing a Chinese medicine preparation”

or “a preparation method of a acupuncture instrument using

Chinese herbal steam.”

(8) Quality control methods of Chinese herbs, for example: “a

method of determining purity of the Cordyceps” or “a method of

identifying maturity level of ginseng.”

2.1.3 Use invention

(1) Medical uses of Chinese herbs, for example: “a use of juniper

extracts in the manufacture of a medicament for the treatment of

skin chap.”


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(2) Non-medical uses of Chinese herbs, for example: “a use of

arsenic sulphide as pesticide.”

2.2 Non-invention-related types

The non-invention-related types mainly include the following.

2.2.1 Rules of nature

If an invention patent application relates to a principle or theory of

Chinese medicine, since the principle or theory is not a technical means

for solving a technical problem but a rule of nature, it does not have a

technical nature and does not satisfy the definition of an invention.

Example 1

[Claim]

A Chinese medicine theory of five primary elements, consisting of five basic

elements comprising wood, fire, earth, metal, and water, characterized in that it

explains the human physiology and pathology, and the relationship between the

human body and the external environment, so as to provide a basis for disease

diagnosis and therapy.

[Explanation]

The theory of five primary elements is an ancient philosophical concept in

China which describes the attributes and relations of things on the basis of the

classification of five elements and the rules of generation, restriction,

subjugation, and counter restriction. The theory of five primary elements in

the Chinese medicine is to make five elements correspond to five internal

organs (i.e., liver pertains to wood, heart pertains to fire, spleen pertains to earth,

lung pertains to metal, kidney pertains to water), and describes the physiological

and pathological relations between viscera in terms of generation, restriction,

subjugation, and counter restriction. For example, lung (metal) promotes

kidney (water), and liver (wood) restrains spleen (earth). Therefore, such

invention patent application is a basic principle of the Chinese medicine and

does not meet the definition of an invention.

Example 2

[Claim]


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A Chinese medicine theory about visera, characterized by the study of

physiological function and pathological variation of human viscera and

relationship thereof, so as to provides basis for clinical "differential treatment

based on differentiation of symptoms and signs."

[Explanation]

The viscera referred to in the Chinese medicine include five "zang" (liver, heart,

spleen, lung, and kidney), six "fu" (gallbladder, stomach, small intestine, large

intestine, urinary bladder, and triple warmer), and extraordinary "fu"

(encephalon, marrow, bone, pulse, gallbladder, and uterus). The viscera theory

is characterized in that it centers on the five "zang," and connects the six "fu,"

five body constituents, five sense organs and nine orifices, and five emotions to

form a whole system. Although the five "zang" have the same names as the

organs in Western medicine, they are not all the same or are completely

different in physiology and pathology, and belong to a different theory system.

Such invention patent application relates to a kernel of theory system of the

Chinese medicine and a basis for clinical "differential treatment based on

differentiation of symptoms and signs," and is a basic principle of the Chinese

medicine, so it does not meet the definition of an invention.

2.2.2 Simple discovery

If an invention patent application relates to a plant, an animal, or a

mineral in a natural form, the plant, animal, or mineral does not meet

the definition of an invention even if it is unknown before, because the

plant, animal, or mineral is a natural occurrence and discovering it

cannot be deemed a creation using technical concepts of rules of

nature.

Example 1

[Claim]

A wild ginseng discovered in the high mountains in Taiwan.

[Explanation]

It is quite obvious that the invention patent application relates to a wild ginseng

in a natural form, so it is simply a discovery instead of an invention, and does

not meet the definition of an invention.


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However, if the invention patent application relates to a wild ginseng extract

which is obtained through specific separation steps, even if the extract is a

mixture with some indefinite ingredients, the extract can satisfy the definition of

an invention for some technologies are involved and having technicality.

2.2.3 Those against rules of nature

If an invention patent application is against rules of nature, it does not

meet the definition of an invention. Since such an invention cannot

be implemented, it is not an industrially applicable invention, either.

Example 1

[Claims]

A Chinese herbal composition for immortality, comprising rhubarb, scutellaria

root, amur cork-tree bark, gypsum, and anemarrhena rhizome.

[Explanation]

The invention patent application relates to a Chinese herbal composition for

immortality. Such composition is determined to be obviously impossible

according to academic theories, and thus is against rules of nature and does not

meet the definition of an invention.

2.2.4 Those not utilizing rules of nature

If an invention patent application utilizes any other laws than rules of

nature, or the rules, methods, and plans which should be executed

through mental activities, such as deduction and memory (for example,

health-promoting sport rules or methods deduced from the Chinese

medicine theories are merely conventional rules or methods to be

obeyed by participants), the invention does not meet the definition of

an invention for it lacks a technical nature.

Example 1

[Claim]

A ch’i kung theory for extending life and improving health, comprising a pithy

formula of six actions: Xu, He, Hu, Xie, Chui, and Xi.

[Explanation]

The invention patent application relates to a ch’i kung theory of six actions,


2 - 12 - 7 Revision 2008

which is a sport method obeyed by followers, not a technical creation, and thus

does not meet the definition of an invention.

Example 2

[Claim]

A fist principle of five primary elements capable of coordinating body functions,

comprising the following steps:

1. the first gesture: breaks through liver channel;

2. the second gesture: breaks through heart channel;

3. the third gesture: breaks through spleen channel;

4. the fourth gesture: breaks through lung channel; and

5. the fifth gesture: breaks through kidney channel.

[Explanation]

The invention patent application relates to a sport method in a fist sequence, not

a technical creation, and thus does not meet the definition of an invention.

Example 3

[Claim]

A easy-to-remember verse describing the Sijunzi decoction addition/subtraction

formula, which is:

Sijunzi decoction has roughly equal proportions of ginseng, white atractylodes

rhizome, indian bread, and glycyrrhiza. The decoction is named Liujunzi if

pinellia tuber and dried tangerine peel (Pericarpium Citri Reticulatae) are added.

The Liujunzi decoction expels phlegm, invigorates vital energy and is suitable

for persons suffering from asthenia of Yang. The Liujunzi decoction is named

Yigong decoction if the pinellia tuber is removed. The Liujunzi decoction

added with costus root and villous amomum fruit are suitable for persons having

stomach-cold.

[Explanation]

A Chinese herbal formula involves multitudinous medicinal materials.

Therefore, in order to help memorize the medicinal materials, the medicinal

materials are often recorded in verses. Memorzing the medicinal materials by

means of verses is not regarded as a technical creation and does not meet the

definition of an invention.


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The verse in the patent application is directed to the method of formulating the

Liujunzi decoction, Yigong decoction, and Xiangsha Liujunzi decoction by

adding medicinal materials to or subtracting medicinal materials from the

formulation of the Sijunzi decoction. Such a recordation method itself is to

express a change in formulae, not a technical creation, and does not meet the


2.2.5 Those not based on technical concepts

If an invention patent application is an abstract idea or a concept

lacking a specific technical means, and is merely a wish or a though

intended to solve a problem, it does not meet the definition of an

invention.

Example 1

[Claim]

A Chinese herbal composition for treating diseases, characterized in that the

medicine formula thereof is constituted by “sovereign, minister, assistant and

courier herbs.”

[Explanation]

The Chinese herbal composition of the patent application merely defines the

medicine formula as being constituted by “sovereign, minister, assistant and

courier herbs,” but does not specifically define which medicinal material does

“sovereign” refers to, which medicinal material does “minister” refers to, which

medicinal materials “assistant” and “courier” refer to respectively. Therefore,

the composition lacks a specific technical means and cannot satisfy the


Example 2

[Claim]

A Chinese herbal composition for treating stroke, characterized in that the

medicine formula thereof is capable of invigorating liver and kidney,

suppressing yang and nausea, calming liver and endogenous wind, diminishing

inflammation and dispersing phlegm, and promoting blood circulation and

dredging meridian.

[Explanation]


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Such Chinese herbal composition does not specifically define the medicinal

materials used, but merely relates to principles of treatment of stroke. It is an

abstract thought or a concept lacking a specific technical means and does not

meet the definition of an invention.

2.3 Statutorily Unpatentable Inventions

An invention relating to statutorily unpatentable subject matter cannot

be granted an invention patent even if it satisfies the definition of an

invention.

2.3.1 Animals, plants, and essentially biological processes for production

of animals or plants

If the subject matter of a Chinese herb-related invention is an animal,

plant, or an essentially biological process for the production of animals

or plants, it falls within the scope of statutorily unpatentable subject

matter.

Example 1

[Claim]

A new species of radix gentianae.

[Explanation]

The invention patent application is a new species of plants and cannot be

patented.

2.3.2 Diagnostic, therapeutic or surgical operation methods for the

treatment of diseases in humans or animals

In consideration of ethics and morality, if the subject matter of a

Chinese herb-related invention is a diagnostic, therapeutic or surgical

operation method for the treatment of disease in living humans or

animals, it falls within the scope of the statutorily unpatentable subject

matter.

2.3.2.1 Diagnostic methods for the treatment of diseases in humans or

animals


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Example 1

[Claim]

A method for diagnosing visceral diseases through examination of ears,

comprising the following steps.

[Explanation]

The invention patent application relates to a method of examining ears in the

Chinese medicine by means of visual examination, level of tenderness,

tenderness impression, touch, and electrometer, so as to indicate diseases and

their locations. Therefore, it is a diagnostic method for diseases and shall not

be patented.

Example 2

[Claim]

A pulse diagnosis method used in the Chinese medicine, comprising the

following steps:

1. letting a patient sit still or lie down on his/her back with arms placed at the

same level of the heart, wrists straight and palms up, and placing a pillow

under the wrists for the convenience of taking the pulse; the doctor sitting

at one side of the patient and using the left hand/right hand to take the

patient's right hand/left hand; and

2. the doctor pressing the patient's styloid process of radius with the middle

finger to take the pulse, putting the index finger and the ring finger on the

radial artery after finding the pulse, keeping the three fingers in a

rectangular shape with the tips of the fingers aligned, and using the finger

pads to press the radial artery, so as to learn of the physiological function

and pathology through the pulse of each part of the patient.

[Explanation]

The invention patent application is a pulse diagnosis method used in the

Chinese medicine, and shall not be patented for it is a diagnostic method of

diseases.

2.3.2.2 Therapeutic method for the treatment of diseases in humans or

animals


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Example 1

[Claim]

A method for the treatment of hepatocellular carcinoma, comprising

administering Chinese herbs containing ganoderma lucidum extracts to patients.

[Explanation]

The invention patent application is a method for the treatment of hepatocellular

carcinoma by using Chinese herbs containing ganoderma lucidum extracts, and

shall not be patented for it is a diagnostic method of diseases.

Example 2

[Claim]

A method for the treatment of cholecystitis, characterized in using filiform

needle to stab at the gallbladder point between the peroneus longus muscle and

the extensor digitorum longus muscle beneath the knee.

[Explanation]

The invention patent application relates to a method for treatment of

cholecystitis with acupuncture, which uses a filiform needle to stab at the

gallbladder point, and shall not be patented for it is a therapeutic method of

diseases.

Example 3

[Claim]

A method for the treatment of fracture or dislocation, characterized in using the

technique of pulling, rotation flexion and extension to put the fractured or

dislocated bone back into place.

[Explanation]

The invention patent application relates to a method for the treatment of fracture

and dislocation through massage, and shall not be patented for it is a therapeutic

method of diseases.

2.3.2.3 Surgical operation methods for the treatment of diseases in

humans or animals


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Example 1

[Claim]

A method for expelling pus so as to eliminate focus, characterized in incising

the ulcer and sore and neoplasm to expel pus and eliminate focus.

[Explanation]

The invention patent application relates to a method of ablating abscess by

surgery so as to expel pus and eliminate focus, and shall not be patented for it is

a surgical operation method of diseases.

2.3.3 Inventions detrimental to public order, morality or hygiene

If a commercial use of the subject matter of a Chinese herb related

invention described in the description of invention, claims, or drawings

is detrimental to public order, morality, or hygiene, it falls within the

scope of statutorily unpatentable subject matter.

Example 1

[Claim]

A suicide method, characterized in taking arsenic.

[Explanation]

The invention patent application teaches a suicide method of taking arsenic, and

shall not be patented as it is detrimental to public order and morality.

3. Specification

The specification shall contain the title of the invention, description of the

invention, abstract, and claims.

The disclosure of the specification of a Chinese herb-related invention is special

in some aspects, as will be explained below.

3.1 Title of the invention

The title of the invention shall conform to the following provisions.

(1) The title of an invention shall recite the subject matter of a patent

application clearly and concisely and reflect the scope of the

invention claimed. For example, “a Chinese herbal composition

for the treatment of acquired immunodeficiency syndrome


2 - 12 - 13 Revision 2008

(AIDS)” or “a Chinese herb for the treatment of liver cancer and

the method of preparing the same.”

(2) The title of an invention shall not include non-technical terms,

such as person names, place names, company names, codes, and

trademarks. For example, “Stomachin ‘CHANG KUO

CHOU’,” “Yunnan Baiyao,” and “Tiger Balm.”

(3) The title of an invention shall not use ambiguous and general

words. For example, “a herbal medicine,” “a device,” and “and

the like.”

3.2 Abstract of the invention

The abstract of the invention shall summarize the disclosure of an

invention, technical problems to be solved, technical means for solving

the problems, and main uses, and shall not include commercial

advertisement.

3.3 Description of the invention

The description of the invention shall include technical field of the

invention, prior art, detailed description of invention, embodiments of

the invention, and brief description of the figures.

3.3.1 Disclosure of description of the invention

For an invention relating to a Chinese herbal composition, the

description of the invention shall disclose the ingredients and the

proportions thereof, preparation steps and conditions, and efficacies

and usages of the composition, and provide concrete data to prove the

efficacies and usages.

For an invention relating to a Chinese herbal preparation method, the

description of the invention shall disclose the types and quantities of

the raw materials used and the procedures for carrying out the method,

such as steps and conditions.

For an invention relating to the use of Chinese herbs, the description of

the invention shall disclose the use (for example, the diseases to be

treated or the pharmacological mechanism), the effective dosage, and


2 - 12 - 14 Revision 2008

the application method, and provide concrete data to prove the use.

Attention shall be paid to the following items regarding the disclosure

of the invention in the specification of a Chinese herb-related

invention.

3.3.1.1 Names

The use of Chinese herbs began a very long time ago has been recorded

in many ancient books and widely spread. Thus, a Chinese herb

usually has more than one name. For example, indian bread is the

sclerotium of fungi Tuckahoe Poria cocos (Schw.) Wolf , classified

under Polyporaceae, and is also called Yunling. Ginkgo seed is the

mature seed of Ginkgo biloba L., classified under Ginkgoaceae, and is

also called ginkgo. Radix trichosanthis is the root of Trichosanthes

kirilowii Maxim or T. japonica Regel, classified under Cucurbitaceae,

and is also called Huafen, trichosanthes root, mongolian snakegourd

root and so on.

There is also the situation where the same name refers to different

herbs. For example, malabar spinach, commonly called Chuanqi, is

the leaves of an edible climbing vine, while the Chuanqi recorded in

ancient books of the Chinese medicine is the dried root of Panax

notoginseng（Burk.）F. H. Chen., classified under Araliaceae; the two

are totally different. The former does not have the function of

dispersing blood stasis, stopping bleeding, promoting blood circulation

and eliminating ache. Likewise, airpotato yam rhizome, also called

Taiwanese fleeceflower root, can be used to treat enlarged thyroid

gland, while the fleeceflower root recorded in ancient books of the

Chinese medicine is the root tuber of Polygonum multiflorum Thumb,

classified under Polygonaceae, and has the curative effects of

supplementing the liver, nourishing the kidney, enriching the blood and

dispelling the wind. The two are different. The most significant

example is the yacon (Smallanthus sonchifolius), which is similar in

shape to the commonly used root tuber of sweet potato. Its

pharmacological effects cannot be more different from those of the


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saussurea laniceps (Saussyrea lanicep Hand-Mazz) recorded in the

ancient books of the Chinese medicine, whose flower can be used as

medicine.

The names of Chinese herbs can be the formal scientific names used in

taxology or the names given in ancient books. The byname, popular

name, or informal name is acceptable only when it has been recorded

in ancient books and the books are clearly identified in the

specification, so as to avoid misuse medicinal materials due to the same

name referring to different materials or the same material with different

names. If the specification uses a name which is not recorded in

ancient books, the ancient books where the Chinese herb's name is

given or the formal scientific name of the medicinal material used in

taxology shall be indicated.

3.3.1.2 Production area, harvest season, and part to use

The production area, harvest season, and part to use of Chinese herbs

generally have considerable influences on the contents and efficacy of

the active ingredients of the product, and are important factors that

affect the quality of the product. If the medicinal material is

commonly known to persons of ordinary skills in the art, in principle,

the specification does not need to disclose the production area, harvest

season, and part to use of the medicinal material unless such conditions

affect the efficacies or uses claimed in the invention. For example, if

the ingredients or effects of different parts of the same plant are

different, thus affecting the claimed efficacies or uses, the specific part

of the plant shall be indicated.

3.3.1.3 Extracts

If an invention patent application relates to a Chinese herbal extract,

the description of the invention shall disclose the preparation method,

properties, or characteristics.

Regarding a preparation method of an extract, the description of the

invention shall disclose the types and quantities of raw materials and

the preparation steps and parameters (such as temperature, duration,


2 - 12 - 16 Revision 2008

and pH value), as well as at least one embodiment for illustration.

Regarding properties or characteristics of extracts, the description of

the invention shall properly disclose the characteristics of the invention,

and shall provide at least one characteristic sufficient for identifying

the claimed extract which can be one or more physical properties,

chemical properties, or other characteristics (such as biological

activity). For example, molecular weight, melting point, specific

rotation, UV absorption spectrum, IR absorption spectrum, NMR

spectrum, mass spectrograph spectrum, solubility, color reaction,

acid-alkalinity, color and luster, physical state (such as solid, liquid,

gas), etc. The data or information provided must be sufficient for

identifying the claimed extract. Therefore, it is advisable to provide

more complete data or information, for example, the fingerprint

chromatogram or the biological activity data.

3.3.1.4 Ingredients and proportions of compositions

For an invention patent application relating to a Chinese herbal

composition and methods thereof, if it is characterized by the

ingredients and proportions of the composition, the ingredients and

proportions shall be clearly described in the specification. For

example, a Chinese herbal compound formula composition for the

treatment of headache contains specific amounts of medicinal materials,

such as gastrodia tuber, dahurian angelica root, ligusticum chuanqiong

hort, schizonepeta herb, Chinese angelica root, and olibanum. The

type and proportion of each medicinal material shall be indicated in the

specification.

The proportion can be recorded by specific amount or ratio, such as

weight, weight part, weight ratio, weight percentage, or ranges thereof.

The weight shall be represented according to the metric system instead

of qian or fen.

3.3.1.5 Preparation method

For an invention patent application relating to a preparation method of

Chinese herbs, no matter whether the subject matter of the patent


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application is a product, a process or a use, the specification shall

specifically disclose the technical contents for practicing the invention

including the raw materials, processes, and products. The raw

materials include the components (types or ingredients) and

proportions thereof (amount or ratio). The processes include

preparation steps or parameters (such as temperature, time, humidity,

and pH value). The product refers to a dosage form. If the technical

features of the invention relate to a dosage form, it is necessary to

disclose a definite dosage form. If the dosage form in the invention is

commonly known to persons of ordinary skills in the art, it shall be

described as “medicaments” or “preparations.”

3.3.1.6 Concocting method of medicinal materials

Medicinal materials of the Chinese medicine usually need to be

concocted in order to change the properties of the original medicinal

materials (for example, concocting fresh rehamnnia root into prepared

rehmannia root, or concocting white peony root into parched white

peony root), clear toxicity (for example, prepared pinellia tuber,

concocted aconite root), and to make them more easily reserved or

transported.

If an invention patent application relates to a concocting method, the

description of the invention shall disclose the steps and conditions of

the method. If the invention is characterized by the achievement of

the same purpose as a conventional concocting method, the means for

achieving the purpose shall be sufficiently described, and appropriate

embodiments shall be disclosed for illustration.

3.3.1.7 Curative effects

The curative effects of a Chinese herb related invention refer a

medicament's ability to treat a specific disease or improve the status of

a human body. The curative effects can be defined by not only

diseases or pharmacological actions in the Western medicine, but also

syndromes or diseases treated with the Chinese medicine.

The number of samples to be tested to validate or evaluate the curative


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effects depends on whether the test results have a significant meaning

to persons of ordinary skills in the art on the basis of their recognition

and understanding in the field of the invention. For example, if an

invention can provide the curative effects for a disease in the Western

medicine or a syndrome or disease in the Chinese medicine which has a

unclear pathogenic mechanism and treatment mechanism in both

Chinese and Western medical fields, or can provide curative effects for

a disease in the Western medicine or a syndrome or disease in the

Chinese medicine which has few medical records, the invention may be

considered to have a significant meaning to the artisans in the Chinese

and Western medicines although only few samples are tested to

validate or evaluate the curative effects.

3.3.1.7.1 Determination of curative effects in terms of the diseases or

pharmacological action defined in the Western medicine

If curative effects are defined according to the diseases or

pharmacological action in the Western medicine, the curative effects

shall be proved by scientific data obtained from the scientific methods

in the art such as in vitro tests, animal tests, or clinical trials.

Alternatively, it is also acceptable to illustrate the relation,

pharmacological action, or mechanism between the active ingredients

and curative effects, provided that the relevant references are listed.

Example 1

[Claim]

A neuronal differentiation promoter, comprising minor bupleurum decoction

and cassia twig and peony decoction of certain weight proportions……

[Evidence of Curative Effects]

Experiments on the neuron cells of the murine prove the curative effects:

Neuron cells were taken from an 18-day-old murine embryo and placed in 5 ml

culture medium containing 200 ug/ml of the medicament of the present

invention. After 48 hours, elongated neurites were observed under the

microscope. The above procedures were performed on the control group,


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without the medicament of the present invention. The results showed that the

neurite of the control group did not extend which indicated that the medicament

of the invention had neurite elongation effect. Therefore, the present invention

has the effect of promoting neuronal differentiation.

[Explanation]

The specification of the invention specifically illustrates the principle of making

the medicine formula and proves that the new medicine formula of the invention

has the effect of elongating the neurite with the experiment on animal cells, so

the present invention has the effect of promoting differentiation of neuron cells.

The data provided in the specification is sufficient to prove the curative effects

of the medicament of the invention.

Example 2

[Claim]

A Chinese herbal oral preparation for the treatment of plaque psoriasis,

characterized in being prepared by a common method with the following

ingredients as raw materials: 10-20 weight parts ofcoptis rhizome, 10-20 weight

parts of scutellaria root, 10-20 weight parts of amur cork-tree bark, 10-20

weight parts of indigowoad root, 10-20 weight parts of safflower, 10-20 weight

parts of snake slough, 10-20 weight parts of cicada slough, 10-30 weight parts

of Chinese angelica root, 10-30 weight parts of astragalus root, 10-20 weight

parts of fresh rehmannia root, 10-30 weight parts of rhubarb, 10-40 weight parts

of zaocys, 10-30 weight parts of smooth greenbrier rhizome, 10-20 weight parts

of honeycomb, and 5-10 weight parts of glycyrrhiza.


Human test (after years of clinical observation and follow-up on the treatment,

effective rate reaches 92%, and cure rate reaches 78.5%). The comparison of

the curative effects is illustrated as follows:

1. Case data

Treatment group: 500 patients, including 400 male and 100 female

patients, aged 6 to 58 years, with courses of disease

lasting 10 days to 20 years.


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Control group: 160 patients, including 80 male and 80 female

patients, aged 8 to 60, with courses of disease lasting

1 month to 25 years.

2. Treatment method

Treatment group: oral delivery of capsules of the present invention

twice a day, ten pills per dose, one month as a course

of treatment, with an average 1-3 courses of

treatment.

Control group: taking bimolane capsules.

3. Treatment standard

Cured: over 90% of skin lesion or pruritus symptom

disappears.

Effective: 50-90% of skin lesion or pruritus symptom

disappears.

Ineffective: Less than 50% skin lesion or pruritus symptom

disappears.

4. Treatment results

Treatment group: 380 patients cured, 80 patients effective, 40 patients

ineffective, effective rate 92%.

Control group: 20 patients cured, 60 patients effective, 80 patients

ineffective, effective rate 50%.

Significant difference between the two groups (X2＝8%, p＜0.01).

Significant difference before and after the treatment (t＝4.97, p＜0.01).

After the treatment, the preparation of the present invention has no

apparent influence blood, urine, excrement, liver function and kidney

function, IgG, IgM, IgA and lymphocyte conversion.

[Explanation]

The specification of the invention provides a human test to prove the curative

effects. The test includes a treatment group of 500 patients and a control group


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of 160 patients and defines the standard of cured, effective, and ineffective.

The experiment results show that the effective rate of the treatment group is

92%, while that of the control group is merely 50%. Apparently, the present

invention provides preferable efficacies which are sufficient to prove the

curative effect of the preparation of the invention.

Example 3

[Claim]

A pharmaceutical composition for the treatment and prevention of premature

ejaculation, comprising the alcohols and/or aqueous extracts of ginseng,

Chinese angelica root, broomrape, cassia seed, asarum herb, and toad venom of

certain weight proportions……


1. Human experiment

30 male patients, aged 32 to 57, having sexual dysfunction for 3 months to

30 years.

The patients were divided into 2 groups, including one group of 15

patients suffering from simple premature ejaculation, and the other group

of 15 patients suffering from simple premature ejaculation and erection

difficulty.

0.2 g ointment was smeared on the glans penis, and washed away with

water after 20 to 30 minutes. The patients had sexual intercourse within

2 to 8 hours, and the changes of their ejaculation ability were checked four

times a week.

Results:

In the group of simple premature ejaculation, the duration of erection was

2 minutes before using the ointment and was extended to 15 to 20 minutes

after using the ointment. In the group of premature ejaculation

accompanied with erection difficulty, the erection is improved after using

the ointment.

After a week's use, the pre-ejaculation period was 2-5 minutes for 2


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patients, 10 minutes for 2 patients, 15 minutes for 13 patients, and over 20

minutes for 13 patients.

The pre-ejaculation period in the third report: 15 minutes for 2 patients, 20

minutes for 26 patients, and no obvious improvement for the other 2

patients.

After that, 11 patients declared that they had satisfactory sexual

performance without using the ointment, and the others were not checked.

2. The comparison of the effects of the treatment of premature ejaculation by

using the ointment of the present invention and the commercially

available ointment A:

50 patients with an average age of 41.4 years, suffering from premature

ejaculation caused by genitalia sensitivity.

The following five medicines were tested: the ointment of the present invention,

1.5% ointment A, 5% ointment A, 10% ointment A, and a placebo. Ointment

A and the placebo were smeared 30 minutes before sexual intercourse, and the

ointment of the present invention was smear 1 to 8 hours before sexual

intercourse and washed with water after 30 minutes. After one month, the

patients reported the duration of the sexual intercourse and the satisfaction……

which indicated improvement.

[Explanation]

The specification of the invention provides a clinical trial and compares the

invention with the commercially available ointment A to prove the curative

effects of the composition of the invention. The data provided in the

specification is sufficient to prove the curative effects of the claimed invention.

Example 4

[Claim]

A Chinese herbal composition for the treatment of oral ulceration,

comprisingcoptis rhizome, indigowoad root, lonicera japonica, asian puccoon,

fresh rehmannia root, phyllostachys nigra, viola yedoensis, turmeric, lily, and

snake gallbladder in certain weight proportions:…...


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[Evidence of curative effect]

1. Animal test

The Chinese herbal composition of the present invention was made into

tablets and tested on rabbits by pharmacological experiment.The rabbits in

the placebo control group are only administered to with water, …....,

exhibiting the effect of improvement.

2. Human test

The evaluation was made on the basis of the diagnosis standards of both

the Chinese medicine and Western medicine. 30 patients (including 7

males and 23 females) participated in the experiment and took medicine 3

times a day, 3 pills per dose. A course of treatment was half a month,

and 2 courses were conducted. Four months later, 10 cases showed

significant improvement, and 10 cases showed improvement.

[Explanation]

The specification of the invention provides data of animal tests and human tests

as evidence of the curative effects. It is sufficient to prove the curative effects

of the claimed invention.

Example 5

[Claim]

A herbal medicament for regulating unhealthy or sub-healthy smooth

muscle-containing organs, characterized in comprising peony extracts or

compositions containing peony extracts.

[Evidence of Curative Effect]

The following animal tests show the regulating function of the medicament of

the present invention on smooth muscle-containing organs:

Gained pigs were used to test the effect of promoting the tensile force of ileum;

Pot-bellied pigs were used to test the effect of improving the stomach and

intestines' peristalsis;

Gained pigs were used to test the effect of relieving the convulsion of the ileum.


2 - 12 - 24 Revision 2008

[Explanation]

The specification of the invention provides several animal experiments to prove

that the medicament of present invention has the function of regulating smooth

muscle-containing organs. It is sufficient to prove the curative effects of the

claimed invention.

3.3.1.7.2 Determination of curative effects in terms of the syndromes or

diseases defined in the Chinese medicine

If the curative effects are determined by the syndromes or diseases

defined in the Chinese medicine, the curative effects can be proved by

the treating methods used in the Western medicine, such as in vitro

trials, animal trials, or human trials. Furthermore, it is also acceptable

to deduce the curative effects of the claimed medicament on the basis

of the principle of "differential treatment based on differentiation of

symptoms and signs" used in the Chinese medicine, provided that

objective measurement indexes for validation and evaluation and/or

examples sufficient to prove the curative effects are given.

When an invention patent application is described with the Chinese

medical theory, in order not to be too broad or general, the applicant

can describe the abstract syndrome or disease with specific symptoms

and then provide evidence of efficacy for verification. As the

measurement indexes for evaluating the curative effects, data or

evidences shall be provided.

Historically, the diseases mentioned in the Chinese medicine often had

different definitions in different dynasties. The definitions in the

Chinese medicine are also different from those in the Western medicine,

and even the same disease name may indicate different diseases.

Therefore, when the curative effects are determined in terms of the

diseases in the Chinese medicine, the disease should be clearly

described and defined. For example, “hernia” defined in the Chinese

medicine refers to a series of symptoms including swelling and pains of

the spermary and scrotum or pains at lower abdomen caused thereby,

which is distinct from the “hernia” defined in the Western medicine as


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a condition wherein the rectum falls into the scrotum or labium due to a

thin abdominal wall.

Example 1

[Claim]

A Chinese herbal composition for the treatment of syndrome of cold extremities,

comprising gypsum, anemarrhena rhizome, scutellaria root, amur cork-tree bark,

american ginseng, indigowoad leaf, and glycyrrhiza of certain weight

proportions, ......., wherein the syndrome of cold extremities comprises the

symptoms of cold limbs, fantod, thirst, sore throat, or excessive heat with

eruption.


25 patients with the syndrome of cold extremities were selected and divided into

two groups; the experiment group was given 4g of concentrated powder of the

medicine of the present invention, and the control group was supplied with a

placebo, 3 times a day for 8 weeks. The blood perfusion on the volar fingertip

of the right middle finger of patients in the two groups was measured with a

laser blood flowmetery before and after taking the medicine. The average flow

volume was recorded, and the difference between the two groups before and

after taking medicine was analyzed on the basis of the non-parametric statistics.

The results showed that, after taking the medicine for 8 weeks, the experiment

group had a reduced baseline perfusion(P=0.033), and no significant change in

the recovery rate of perfusion. The control group showed no significant

difference in the baseline perfusion and recovery rate of perfusion.

The patients in the experiment group had cold limbs less frequently, and the

symptoms of facial red spots, thirst and excessive heat were alleviated. The

control group showed no difference. This proves that this medicine has a certain

curative effect on “the syndrome of cold extremities.”

[Explanation]

The specification of the invention explains the symptoms of “the syndrome of

cold extremities.” The human trial proves the efficacies of the medicine of the

present invention in alleviating the symptoms listed by comparing the


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experiment group with the control group. Since objective and believable

evaluating methods and results as well as the evidence have been provided, the

curative effects as claimed can be supported.

Example 2

[Claim]

A Chinese herbal composition for the treatment of wetness-heat, comprising

virgate wormwood herb, sweet wormwood herba, scutellaria root, Chinese

brake herb, umbellate pore fungus, talcum, glycyrrhiza, radix gentianae,

roughhaired holly root of certain weight proportions........

[Evidence of Curative Effect]

20 patients diagnosed as having “wetness-heat” according to the Chinese

medicine were selected, and the Chinese herbal composition of the present

invention was administered. The severity of illness in all of the patients was

moderated and objective evidence was provided as support. A typical case is

described by way of an example as follows.

A 53-year-old male patient complained of fatigue, soft and loose stool, and

brown urine for years. After the four diagnostic procedures adapted in the

Chinese medicine, i.e., inspection, listening and smelling, inquiry, and

palpation , the following results were obtained.

(1) Inspection

The patient appeared to lack energy and the white of the eyes was

yellowish and bloodshot. Tongue image analysis showed that the toungh

was dark red with a thick yellow coating.

(2) Listening and smelling

No special odor, voice low and weak. After examination with the voice

diagnosis instrument, the following data were obtained.

Time-domain axis analysis

Zero-crossing number (A1): 0.76807 (normal:1.000±0.404)


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Peak floating (A2): 3.64482 (normal:1.000±0.633)

Frequency-domain axis analysis

Resonant peak variation (A3): 1.09 (normal:1.000±0.289)

High-frequency energy ratio (A4): 1.20647 (normal:1.000±0.499)

Low-frequency energy ratio (A5): 0.77983 (normal:1.000±0.497)

In combination, the data indicated deficiency of Qi (vital energy).

(3) Inquiry

The patient had heaviness of head, fatigue, detention in abdomen and solar

plexus area, appetite loss, unsmooth urination, loose stool, low heat or no

heat, and bitter taste in mouth.

(4) Palpation

After measurement with a pulse diagnosis instrument, it showed that

there was more obvious thready pulse at the right Guan than the left Guan.

When pressed, both pulses were tense. The pause of the left Guan was

less taut than that of the right Guan. The pulses at both Guan were slow

and unsmooth.

Based on the results obtained from the four diagnostic procedures, the patient

was diagnosed as “wetness-heat stagnating in the middle warmer.” The Chinese

herbal compound formulation powder was administered for 4 weeks, 3 times a

day, 4 g per dose. After 4 weeks, the results of subsequent consultation of this

patient were listed as follows.

(1) Inspection

Fatigue was alleviated and the white of the eyes was no longer yellowish

and bloodshot. Tongue image analysis showed that the tongue was pink


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with thin yellow coating.

(2) Listening and smelling

No special odor. Fluent voice. After examination with the voice

diagnosis instrument, the following data were obtained.

Time-domain axis analysis

Zero-crossing Number (A1): 1.86069(normal:1.000±0.404)

Peak floating(A2): 0.82483 (normal:1.000±0.633)

Frequency-domain axis analysis

Resonant peak variation(A3): 1.03 (normal:1.000±0.289)

High-frequency energy ratio(A4): 0.76891 (normal:1.000±0.499)

Low-frequency energy ratio(A5): 1.69808 (normal:1.000±0.497)

The comprehensive data reports the significant improvement of Qi

deficiency.

(3) Inquiry

Good appetite, clear and smooth urine, moderate and smooth stool. The

feeling of heaviness and fatigue disappeared, and the bitter taste in mouth

is greatly alleviated. No fever. Good sleep.

(4) Palpation

After measurement with the pulse diagnosis instrument, the right

Cun-Guan-Chi pulse was alleviated, and platform-like pulse at left Guan

was obviously reduced.

The medicine of the present invention has an obvious curative effect on

the “wetness-heat.”


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[Explanation]

The specification of the invention specifically provides specific examples of

verification methods, including a typical case and objective measurement data,

to illustrate the curative effects, including the responses before and after taking

the medicine. The analysis results obtained from the four diagnostic

procedures of inspection, listening and smelling, inquiry, and palpation in the

Chinese medicine and from the voice diagnosis instrument prove that the

symptoms as listed may be alleviated after the medicine of the present invention

is taken. Since objective and credible evaluating methods and results as well

as evidence have been provided, the declared curative effects can be supported.

3.3.2 Principles for examining the description of the invention

3.3.2.1 Principles for examining extracts

For a patent application relating to an extract, whether it be a simple

formula extract or a compound formula extract, the examination should

focus on whether the disclosure of the specification is sufficient to

distinguish the extract from conventional ones. If the examiner finds

that the disclosure about the extract cannot render the invention

distinguishable from prior art, or the requirements for patentability

cannot be examined due to insufficient disclosure of the specification,

the examiner shall state the reasons and evidence and notify the

applicant to provide supplementary illustrations, information, or data.

Take for example, a patent application defining an extract using only a

preparation method, the description of which provides no relevant

physicochemical or biological activity data. Under these

circumstances, if the examiner finds a reference which has disclosed an

extract prepared from the same medicinal materials, but he/she cannot

determine whether the two are the same invention because the

reference merely provides biological activity data without mentioning

the preparation method, the examiner shall state the detailed reasons

regarding the doubt of the distinguishability of the invention from the

prior art and notify the applicant to further clarify the distinguishing

characteristics of the claimed extract.


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3.3.2.2 Principles for examining curative effects

For the claims of a Chinese herb-related invention, the subject matter

under the category of medicine includes mainly Chinese herbal

compositions and Chinese herbal extracts.

3.3.2.2.1 Curative effects of compositions

For the subject matter directed to Chinese herbal compositions

consist of simple formula compositions or compound formula

compositions, the curative effects claimed by an invention shall be

determined by syndromes or diseases defined in Chinese medicine,

or diseases or pharmacological actions defined in Western medicine.

3.3.2.2.1.1 Determination of curative effects by syndromes or diseases

defined in Chinese medicine

If curative effects are determined by syndromes or diseases defined

in the Chinese medicine, the description of the invention should

contain sufficient disclosure regarding the methods used to deduce

or verify the curative effects of the composition. For example, the

description of the invention can provide relevant Chinese medical

theories or reasons explicating the curative effects, cite suitable

references, or provide relevant evidence to explain and prove the

curative effects of the claimed medical materials and the

composition. Examples are illustrated as follows:

(1) For a patent application relating to a Chinese herbal

composition for treating a syndrome or a disease defined in

Chinese medicine, if the description of the invention does not

disclose relevant Chinese medical theories, reasons

explicating the curative effects, or evidence to prove the

curative effects of the claimed composition or each medicine

material contained thereof, persons of ordinary skill in the art

will not be able to understand the curative effects of the

composition on the basis of the description of the invention or

general knowledge available on the filing date. Under such

circumstance, the disclosure of the invention is deemed


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insufficient.

(2) If the patent application relates to a Chinese herbal

composition for treating a syndrome defined in Chinese

medicine, but the description of the invention merely discloses

that the composition can treat a disease, the disclosure may be

insufficient. This is because the same syndrome may include

a set of different diseases, and different medicines may be

adopted to treat a syndrome. If persons of ordinary skill in

the art cannot determine whether the claimed composition is

suitable for treating all diseases of the syndrome on the basis

of the disclosure of the invention or general knowledgein the

art, the disclosure will be deemed insufficient. For example,

for persons have ordinary skills in the art, it is known that the

"wetness-heat" syndrome includes diseases of vomit, diarrhea,

dysentery, dropsy, icterus, eczema, arthralgia, abnormal

vaginal discharge, dermatophytosis, and so on. The Chinese

herbs, such asdensefruit pittany root-bark, fructus cnidii, and

rice paperiant pith, useful for the treatment of eczema of the

"wetness-heat" syndrome are not always suitable for the

treatment of vomit of the "wetness-heat" syndrome.

Likewise, the Chinese herbs, such as kansui root, phytolacca

acinosa, and pepperweed seed, for the treatment of dropsy of

the "wetness-heat" syndrome cannot be used to treat icterus of

the "wetness-heat" syndrome. Therefore, for an invention

relating to a Chinese herbal composition for treating the

"wetness-heat" syndrome, if the disclosure of the specification

cannot enable persons of ordinary skill in the art to know that

the claimed Chinese herbal composition can be used to treat

all the medical conditions of the syndrome, the disclosure is

deemed insufficient.

3.3.2.2.1.2 Determination of curative effects by diseases or pharmacological

actions defined in Western medicine

If curative effects are determined by diseases or pharmacological


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actions defined in the Western medicine, the description of the

invention should disclose the correlation between the syndromes or

diseases defined in Chinese medicine that can be treated with the

composition and the diseases or the pharmacological actions defined

in Western medicine, or provide relevant evidence to prove the

curative effects. The examples are illustrated as follows:

(1) For a patent application relating to a conventional formula of

Chinese herbs for the treatment of a disease or with a

pharmacological action defined in Western medicine, if the

description of the invention neither discloses the correlation

between the syndromes or diseases defined in Chinese

medicine that can be treated with the formula and the diseases

or pharmacological actions defined in Western medicine, nor

provides any evidence for proving the curative effects so as to

enable persons of ordinary skill in the art to know that the

formula has the curative effects for the treatment of the

diseases on the basis of the disclosures or general knowledge

available on the filing date, the disclosures of the specification

is insufficient.

(2) If the description for a patent application relating to a known

Chinese herbal formula for treating a disease or

pharmacological action defined in Western medicine merely

discloses the pharmacological property of each Chinese herb

of the formula, but does not provide any evidence for proving

the curative effects so as to enable persons of ordinary skill in

the art to determine whether the formula has the curative

effects on the basis of the disclosure or general knowledge

available on the filing date, the disclosure of the invention is

insufficient.

(3) If the description for a patent application relating to a novel

Chinese herbal formula for treating a disease or

pharmacological action defined in Western medicine neither

discloses each Chinese herb of the formula, the relevant


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Chinese medical and pharmacological theories, and the

reasons explicating the curative effects, nor provides any

evidence proving the curative effects so as to enable persons

of ordinary skill in the art to determine whether the formula

has the curative effects on the basis of the disclosure of the

specification or general knowledge available on the filing date,

the disclosure of the specification is insufficient.

3.3.2.2.2 Curative effects of extracts

A patent application for a Chinese herbal extract, whether the

extract is from a conventional or unconventional Chinese herbal

formula, the curative effects claimed by the invention can be

determined by syndromes or diseases defined in Chinese medicine

or diseases or pharmacological actions defined in Western medicine.

The examination principles are as follows.

3.3.2.2.2.1 Determination of curative effects by syndromes or diseases

defined in Chinese medicine

If the curative effects are determined by syndromes or diseases

defined in Chinese medicine, the description of the invention should

disclose the pharmacological explanations or reference documents

or provide relevant evidence, so as to prove that the extract has such

curative effects. The examples are described as follows.

(1) If a patent application relates to an extract of a conventional

Chinese herbal formula and claims the curative effects as the

original formula for treating the syndromes or diseases defined

in Chinese medicine, but the description of the invention does

not disclose the pharmacological explanations or reference

documents or provide evidence, so as to prove the curative

effects of the extract, the disclosure may be insufficient. It is

known that after the medicinal materials of the original

conventional formula are extracted and purified, the curative

effects of the extract may not correspond to those of the

original formula. Therefore, if persons of ordinary skill in


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the art cannot determine the curative effects of the extract by

quoting relevant traditional Chinese medical and

pharmaceutical theories, such as combination principle on the

basis of the disclosure of the description of invention or

general knowledge available on the filing date, the disclosure

is insufficient.

(2) If a patent application relates to an extract of an

unconventional Chinese herbal formula and claims the

curative effects of treating the syndromes or diseases defined

in Chinese medicine, but the description of the invention does

not disclose the pharmacological explanations, reference

documents, or provide evidence, so as to prove the curative

effects of the extract, the disclosure may be insufficient.

Under such circumstances, if persons of ordinary skill in the

art cannot determine the curative effects of the extract on the

basis of the disclosure of the description of the invention or

general knowledge available on the filing date, the description

is insufficient.

3.3.2.2.2.2 Determination of curative effects by diseases or pharmacological

actions defined in Western medicine

If the curative effects are determined by the diseases or

pharmacological actions defined in Western medicine, the

description of the invention should disclose the pharmacological

explanations or reference documents or provide relevant evidence,

so as to prove the curative effects of the extract. The examples are

described as follows.

(1) A patent application relating to an extract of a conventional

formula and claims the curative effects or pharmacological

action of treating the diseases defined in Western medicine.

The description of the invention has disclosed the relation

between the syndromes or diseases defined in Chinese

medicine that are treatable with the conventional formula and

the diseases or pharmacological actions defined in Western


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medicine. However, since the curative effects of the original

formula do not indicate that the extract is certain of such

curative effects, and without further data or evidence to prove

the curative effects of the extract so as to enable persons of

ordinary skill in the art to determine the curative effects on the

basis of the disclosure of description of the invention or

general knowledge available on the filing date, the disclosure

is insufficient.

(2) If a patent application relates to an extract of an

unconventional formula and claims the curative effects or

pharmacological actions of treating the diseases defined in

Western medicine, but the description of the invention does

not disclose the pharmacological explanations, reference

documents, or provide any evidence to prove the curative

effect of the extract, the description may be insufficient.

Under such circumstances, if persons of ordinary skill in the

art cannot determine the curative effects on the basis of the

disclosure of the description of the invention or general

knowledge available on the filing date, the description is

insufficient.

4. Claims

4.1 Definition of claims

Claims may be divided into product claims, process claims, and use

claims.

4.1.1 Product claims

If the subject matter is a product of Chinese herbs, the claims should

clearly define the product so as to enable persons of ordinary skills in

the art to distinguish it from prior art. If the product possesses

specific functions or uses sufficient to show its characteristics, the

functions or uses can be recited in the claims for definition of the

product.

4.1.1.1 Compositions


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Subject matter regarding a Chinese herbal composition may be a

simple formula composition containing an individual medicinal

material or a compound formula composition containing multiple

medicinal materials.

If the technical features of an invention reside in components of a

composition, the types or ingredients of the raw medicinal materials

should be defined. If the technical features also involve the

proportions of components, it is required to further define dosages or

proportions of the raw medicinal materials which are expressed by

weights, weight parts, weight proportions, weight percentages, or

ranges thereof. The weight shall be represented in the metric system

instead of qian or fen.

Example 1

[Claims]

A Chinese herbal composition for supplementing the kidney, strengthening the

spleen and vitalizing blood, comprised of 5-30 weight parts of colla corii asini,

5-30 weight parts of colla cornus cervi, 5-30 weight parts of testudinis plastrum,

5-30 weight parts of ginseng, 10-50 weight parts ofred sage root, 10-50 weight

parts of wolfberry fruit, 10-100 weight parts ofepimedium herb, 10-30 weight

parts of malaytea scurfpea fruit, 10-50 weight parts of schizandra fruit, 5-30

weight parts of white atractylodes rhizome, 5-30 weight parts of

preparedglycyrrhiza, 10-100 weight parts of astragalus root, 5-30 weight parts

of Chinese angelica root, 5-30 weight parts of indian bread, 30-100 weight parts

of suberect spatholobus stem, and 5-30 weight parts of costus root.

[Explanation]

The Chinese herbal composition in the patent application is defined by types

and weight proportions of the medicinal materials included therein, so as to be

distinguished from the conventional ones.

Example 2

[Claims]

A Chinese herbal composition for treating drug addicts, comprising 70-80


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weight parts of crystal sulfur, 5-7 weight parts of mica, 0.8-1.12 weight parts of

burnt alum, and 0.7-0.9 weight parts of non-toxic, processed aconite root.

[Explanation]

The Chinese herbal composition of the invention patent application is defined

by types and weight proportions of medicinal materials with specific

physicochemical properties. The claims clearly specify the physicochemical

properties of the medicinal materials suitable for the present invention, such as

“crystal" sulfur, "burnt" alum, and "non-toxic" processed aconite root, so as to

be distinguished from the conventional ones

4.1.1.2 Extracts

Subject matter regarding a Chinese herbal extract is usually defined by

a preparation method so as to be distinguish from prior art, since an

extract is usually not a pure substance but contains a plurality of

ingredients and cannot be defined with a chemical name, molecular

formula, structure formula, or physicochemical properties.

When the product is defined by a preparation method, it is necessary to

recite the essential technical features of the preparation method such as

the raw materials and processes. The patent application is directed to

the final product per se but not the preparation method specified in the

claims. For example, for a claim “an extract X, obtained from a raw

material A through extraction steps P1, P2, and P3…,” the invention

patent application should be directed to the “extract X” but not to the

raw material A or to the extraction steps P1, P2, or P3.

Example 1

[Claims]

An aqueous extract of amur cork-tree bark and whiteflower patrinia herb,

prepared by the method containing the following steps:

(1) grinding a dried mixture of amur cork-tree bark and whiteflower patrinia

herb;

(2) heating and extracting the mixture which is dissolved in water and

filtering it to form a filtrate;


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(3) extracting the filtrate with an organic solvent and separating it into an

organic layer and a aqueous layer; and

(4) collecting and lyophilizing the water layer to obtain an aqueous extract.

[Explanation]

The aqueous extract of amur cork-tree bark and whiteflower patrinia herb of the

patent application is defined through "product by process," that is, the product is

defined with raw medicinal materials and the extraction steps, so as to be


Example 2

[Claims]

A partially separated extract ofmulberry twig, preapred through the following

steps:

(1) extracting the mulberry twig with water or an organic solvent, and

evaporating the solvent to form a solid phase;

(2) adding water in an amount of 1-10 times of the dry weight of the solid

phase into the solid phase, so as to form a suspension;

(3) adding chloroform in an amount equivalent to the water added into the

suspension, so as to separate the suspension into two phases;

(4) separating the aqueous layer from the two phases;

(5) adding ethyl acetate in an amount equivalent to the water added into the

aqueous layer, so as to separate the layer into two phases;

(6) separating the layer containing ethyl acetate; and

(7) evaporating the separated layer.

[Explanation]

The partially separated extract of mulberry twig of the invention patent

application is defined with "product by process," that is, the product is defined

with raw medicinal materials and the extraction steps, so as to be distinguished

from the conventional ones.

Example 3


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[Claims]

An antiviral pharmaceutical composition, prepared through the following steps:

1. contacting Ligustrum lucidum fruit powder, Ligustrum japonicum fruit

powder, or a mixture thereof with water to form an aqueous suspension;

2. separating insoluble substances from the aqueous suspension;

3. acidificating the aqueous solution to the pH of about 4 or lower, so as to

form acid deposits;

4. separating the acid deposits from the solution; and

5. purifying the acid deposits to obtain the pharmaceutical composition.

[Explanation]

The antiviral pharmaceutical composition of the patent application is defined

with "product by process," that is, the product is defined with raw medicinal

materials, separation steps, and deposition steps, so as to be distinguished from

the conventional ones.

Example 4

[Claims]

A glycoprotein extracted from curcuma root, wherein the sugar moiety of the

glycoprotein mainly contains glucose, arabinose, xylose, and rhamnose with a

weight proportion of 45-55 : 2-4 : 4-6 : 4-6, and wherein the protein moiety

consists of a large amount of aspartic acid, glutamic acid, leucine, valine, and

glycine and a small amount of other amino acids.

[Explanation]

The curcuma root extract of the patent application is defined with the different

saccharides and amino acids having certain weight proportions, so as to be


Example 5

[Claims]

A neutral fat extracted from endosperm of coix seed, having the following

physicochemical indexes: acid value < 0.20, iodine value of 95.00-107.00,


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saponification value of 185.00-195.00, relative density of 0.915-0.918 (20°C),

and refractive index of 1.470-1.475 (20°C).

[Explanation]

The endosperm extract of coix seed of the patent application is defined by its

physicochemical properties, so as to be distinguished from the conventional

ones.

4.1.1.3 Dosage Form

Regarding the subject matter directed to a specific dosage form of

Chinese herbs, the claims should specify the type of dosage form.

Example 1

[Claims]

A wound dressing characterized in consisting of compositions of 4-5 wt% of

ethanol extractum liquidum of common bletilla tuber, 4-5 wt% of ethanol

extractum liquidum of great burnet root, 1-2 wt% of ethanol extractum liquidum

of tree peony bark, 3-4 wt% of ethanol extractum liquidum of giant knotweed

rhizome, 2-3 wt% of colophony, 10-12 wt% of film forming agent, 3-4 wt% of

plasticizing agent, and 65-73 wt% of ethanol.

[Explanation]

The wound dressing of the patent application is defined by the components and

weight percentages of the raw medicinal materials and by the bandage dosage

form, so as to be distinguished from the conventional ones.

Example 2

[Claims]

A Chinese herbal tablet for the treatment of coronary heart disease, prepared by

the raw material of red sage root through the following steps:

(1) mixing red sage root with water in an amount of 2-3 times of the weight

of salvia miltiorrhiza bunge, decocting the mixture for 0.5-2 hours, then

filtering the mixture and collecting the filtrate; (2) adding water in an

amount of 2 times of the weight of dregs of the decoction into the dregs of

the decoction and decocting it for 0.5-1 hour, then filtering the mixture


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and collecting the filtrate; (3) combining the two filtrates and

concentrating them into extractum with relative density of 1.25-1.28,

adding excipient into the extractum in an amount of one fifth of the weight

of the extractum, and making it into pills and tablets.

[Explanation]

The Chinese herbal tablet of the invention patent application is defined by

"product by process," i.e., the product is defined by the raw medicinal materials,

the preparation process and conditions, and the dosage form of the tablet, so as

to be distinguished from the conventional ones.

Example 3

[Claims]

An external-use ointment for the treatment of chilblain prepared by using raw

materials of certain weight percentages through the following steps:

1-3 wt% of cortex cinnamomi, 1-2 wt% of aconite root, 1-2 wt% of common

bletilla tuber, 1-2 wt% of Chinese angelica root, 3-5 wt% of trogopterus dung,

1-3 wt% of ligusticum chuanxiong hort, 1-3 wt% of rhubarb, 50-70 wt% of

balsam, 12-18 wt% of bees wax, 3-7 wt% of suet, 1-3 wt% of olibanum, 1-3

wt% of myrrh, 3-5 wt% of musk,

adding the cortex cinnamomi, aconite root, common bletilla tuber, Chinese

angelica root, trogopterus dung, ligusticum chuanxiong hort, rhubarb into

balsam according to the above proportions, decocting them into liquid, filtering

and mixing the liquid oil with the bees wax and suet to form an ointment, then

adding grinded olibanum, myrrh, and musk and stirring them to form the

ointment.

[Explanation]

The external-use ointment of the patent application is defined by "product by

process," that is, the product is defined by the components and weight

percentages of the raw medicinal materials, the preparation process, and the

dosage form of the ointment, so as to be distinguished from the conventional

ones.

4.1.2 Process claim


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A process claim generally relates to a manufacturing method and a

treatment method.

The technical features for a patent application directed to a preparation

method of a product of Chinese herbs, such as a preparation method of

a Chinese herbal composition, an extract, or a dosage form, including

raw materials, processes, and products. The features for raw materials

should include the components (types or ingredients) of medicinal

materials or should further include the proportions (amounts or

proportions) of the medicinal materials. The features for processes

should include necessary preparation steps or parameter conditions

(such as temperature, time, humidity, or pH values). The features for

products usually refer to a dosage form, which should be clearly

defined if the technical feature of an invention relates to a dosage form.

If the dosage form disclosed in the invention is a general and

conventional one known to persons of ordinary skill in the art, the

dosage form can be recited as “medicament” or “preparation.”

For a patent application directed to a treatment method using a product

of Chinese herbs, the claims can be drafted as “a method of treating X,

using a product A of Chinese herbs”. The technical features include

the use of the treatment and the product of Chinese herbs. However,

such a recitation method is merely adapted to non-medical uses. If a

treatment method is for medical uses, since it involves diagnostic,

therapeutic or surgical operation methods for the treatment of diseases

in humans or animals, it is unpatentable subject matter.

Example 1

[Claims]

A method for preparing hypericum perforatum extract, extracting all parts of the

plant with a diluted solution of low molecular aliphatic alcohol or ketone,

respectively, or in combination, through the following steps:

1. concentrating and removing the solvent at a temperature below 40°C;

2. after removing the organic solvent, removing any unexpected gummy

residues by filteration or centrifugation;


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3. completely extracting extractable substances with ethyl acetate and

discarding raffinate;

4. using resin column and water phase chromatography, and eluting with

water-diluted low molecular aliphatic alcoholor or ketone;

5. partially concentrating the elution obtained from the column at or below

60°C in a vacuum;

6. drying the concentrated solution in vacuum;

7. dissolving the residue in a small amount of methanol; and

8. processing the solution with dichloro ethane in an amount capable of

depositing the active ingredients and obtaining the red deposits that are

soluble in water but insoluble in aprotic solvent.

[Explanation]

The method for preparing the extract in the patent application is defined by the

part of the raw plant material, the extract solvent, and the extracting steps and

conditions, so as to be distinguished from the conventional ones.

Example 2

[Claims]

A method of concoting fresh rehmannia root, characterized in cutting a fresh

rehmannia root into 2-5 mm slices and baking the slices on a baking tray,

wherein the slices are 5-10 mm high on the baking tray, the baking temperature

set between 30°C-95°C, and the baking duration between 4-12 hours.

[Explanation]

The method of concocting fresh rehmannia root in the patent application is

defined by parameters, such as the slice thickness, baking temperature, and

baking duration, so as to be distinguished from the conventional ones.

Example 3

[Claims]

A method for killing aphids on fruit trees, characterized in using a composition

ofartemisia argyi extract.


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[Explanation]

The method for killing aphids in the patent application is defined by the use of

killing aphids and the adopted Chinese herbs, so as to be distinguished from the

conventional ones.

4.1.3 Use claim

The subject matter of the use claim can be directed to uses and is

equivalent to a process claim.

4.1.3.1 Medical uses

For subject matter directed to a medical use of Chinese herbs, the claim

can be drafted as “Use of substance A in the manufacture of a

medicament for the treatment of disease X (or pharmacological action

Y)” or “Use of substance A, for manufacturing a medicament for the

treatment of disease X (or pharmacological action Y),” which is

equivalent to “a method of using substance A to prepare a medicament

for the treatment of disease X (or pharmacological action Y).” The

claims are all interpreted as a method of preparing a medicament. It

should be noted that no diagnostic, therapeutic or surgical operation

method for the treatment of diseases in humans or animals are allowed

in a claim. For example, “Use of a substance A in the treatment of

disease X (or pharmacological action Y)” or “a method of using

substance A for the treatment of disease X (or pharmacological action

Y),” which relates to a treatment method is unpatentable subject matter.

Example 1

[Claims]

A use of ginseng extract to manufacture a medicament for the treatment of

hepatocellular carcinoma (HCC).

[Explanation]

The use of ginseng extract to manufacture a medicament for the treatment of

hepatocellular carcinoma (HCC) of the invention patent application is defined

by the use of manufacturing a medicament and the adopted Chinese herbal

extracts, so as to be distinguished from the conventional ones.


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Example 2

[Claims]

A use of a Chinese herbal composition in the manufacture of a medicament for

getting rid of opiate addiction, comprised of 230-270 weight parts of shinyleaf

pricklyash root, 130-170 weight parts of flos daturae stramonii jimsonweed

flower, 80-120 weight parts of prepared rhizome of Chinese monkshood, 80-120

weight parts of long-noded pit viper, 60-70 weight parts of centipede, 40-60

weight parts of scorpion, 40-50 weight parts of rhubarb, 10-30 weight parts of

Chinese angelica root, 5-15 weight parts of oriental bezoar.

[Explanation]

The use of the Chinese herbal composition in the manufacture of a medicament

for getting rid of opiate addiction in the patent application is defined by the use

of manufacturing medicaments and the adopted Chinese herbal composition, so

as to be distinguished from the conventional ones.

4.1.3.2 Non-medical uses

For subject matter directed to a non-medical use of Chinese herbs, the

claims can be drafted as “Use of substance A in treating X” or “Use of

substance A, for treating X,” which is equivalent to “a method of using

substance A to treat X.” The claims are all interpreted as a treatment

method. For example, “Use of substance A for killing insects” is

equivalent to “a method of killing insects by using substance A,” but

not to “a pesticide containing substance A” or “a method of preparing a

pesticide using substance A.”

Example 1

[Claims]

A use of artemisia argyi extract for killing aphids on fruit trees, characterized in

using a composition containing artemisia argyi extracts to kill aphids of fruit

trees.

[Explanation]

The use of artemisia argyi extract for killing aphids in the patent application is


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defined by the use of killing aphids and the adopted Chinese herbal extracts, so

as to be distinguished from the conventional ones.

5. Requirements for patentability

5.1 Industrial applicability

For details on the examination of industrial applicability, refer to

“Industrial Applicability” in Section 1 of Chapter 3. The following

merely illustrates the examination of industrial applicability of Chinese

herb related inventions with specific aspects.

5.1.1 Uses of products

For an invention regarding a product of Chinese herbs, the uses shall be

specifically described in the description of the invention. If the uses

of the invention are known to persons of ordinary skill in the art, and

the invention can be industrially manufactured or used, the invention

has industrial applicability.

If the description of the invention states that the invention has the same

or similar medicinal materials or physicochemical properties as a

known product, and the uses of the known product are known to

persons of ordinary skill in the art, it can be deduced that the invention

has the same or similar uses.

If the description of the invention does not indicate the relation

between the invention and a known product with specific uses, but

provides theories or evidence proving that the invention has practical

uses, the patent application has the claimed use.

5.1.2 Toxicity of products and dosage of medicinal materials

If an invention achieves the curative effects through a substance

containing heavy metals or toxic medicinal materials of Chinese herbs

which may do harm to human bodies, whether the invention has

industrial applicability shall be determined on the basis of the

description of the invention or the data and evidence provided therein.

If the toxicity is caused by a high dosage or a high concentration, the

application is required to illustrate suitable dosages of medicinal


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materials when necessary. If the toxicity may be alleviated, reduced,

or eliminated through a concocting method or through the effects of

other medicinal materials in the compound formula, the application is

required to illustrate the principles behind the process(es) or provide

relevant data or evidence to indicate the changes of toxicity before and

after the treatment when necessary.

A single formula of traditional Chinese herbs has its own reasonable

dosage range. This so-called “reasonable dosage” is based on

traditional experiences and is not absolutely fixed. If the formula of

an patent application adopts a usage or dosage different from those of

traditional experiences, it is required to state the reasons or provide

data and evidence to notify the applicant to make responses if

necessary.

5.2 Novelty

For details on examination regarding novelty, refer to “Novelty” in

Section 2 of Chapter 3. The following merely illustrates the

examination on novelty of Chinese herb related inventions with

specific aspects.

5.2.1 Proven formulas spread by word-of-mouth

For traditionally or culturally proven formulas merely spread by word

of mouth that cannot be found in publications such as documents and

ancient books. The following items should be taken into

consideration when examining whether such proven formulas have

novelty.

(1) Whether a formula has been put to public use

If the contents of a formula become known to the public after the

formula is used, the formula is considered to have been put to public

use. On the other hand, if a user or a third party cannot know the

contents of the formula after using it, the formula is not considered to

have been put to public use. For example, if one only gives the

medicament to others and keeps the formula secret, and others cannot

know the components and proportions of the formula when using the


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medicament, the formula is not considered to have been put to public

use. On the contrary, if others can easily determine the components

and proportions of the formula from the medicament, the formula is

considered to have been put to public use.

(2) Date of public use

Date of public use is the date on which a formula is put to public use

and becomes known to the public. It is often difficult to determine the

actual date of public use. If the fact of public use or a publication date

has been recorded in a publication, the date recorded in the publications

is presumed to be the date of public use. If the publication does not

record the publication date, the issuance date of the publication is

presumed to be the date of public use.


conventional formulas

Conventional formulas of Chinese medicine always have specific

components and formulation principles and are formed according to the

main syndrome to be treated. Therefore, if the main syndrome to be

treated and the main herbs of the formula are not changed, the

components can be added, subtracted, or substituted.

[Examples]

Addition/subtraction formula: Four Agents decoction is a formula used in

Chinese medicine for the treatment of blood deficiency. The main syndrome

to be treated is blood deficiency and the medicinal materials include rehmannia

root, Chinese angelica root, ligusticum chuanxiong hort, and peony, with

rehmannia root and Chinese angelica root being the main herbs. Clinically, for

a patient having the syndrome of blood deficiency and Qi stagnation (in which

blood deficiency is the main syndrome, and Qi stagnation is the accompanied

syndrome), he/she can be treated with the Four Agents decoction added with

magnolia bark and immature bitter orange which is also known as Pushi Liuhe

decoction. For a patient having the syndrome of blood deficiency and cold

spleen and stomach, he/she can be treated with the Four Agents decoction where

rehmannia root is subtracted and dried ginger is added which is also known as


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Sishen decoction.

Substitution formula: Chinese taxillus twig in Duhuo Jisheng decoction was

once substituted bydipsacus, astragalus root, and fresh ginger due to a shortage

of supply, and the substitution formula was called Sanbi decoction. In addition,

medicinal materials with similar efficacies can always be substituted by one

another. For example, rehmannia root in Four Agents decoction can be

substituted by fleeceflower root because both of them have the efficacy of

nourishing blood.

If a patent application relates to an addition, subtraction, or substitution of

components of conventional formulas of Chinese medicine, and the addition,

subtraction, or substitution has been published, put into public use, or known to

the public before the filing date, the invention does not have novelty. When

searching for relevant prior art regarding the components and proportions of a

claimed formula, the relation between the claimed formula and the conventional

formulas published in the documents, as well as relevant records of the addition,

subtraction, or substitution of the components of the conventional formulas

should be noted.

5.2.3 Inventions about extracts

5.2.3.1 Defining extracts

Regarding a patent application relating to an extract of medicinal

materials of a Chinese herbal simple formula or compound formula, the

extract is not necessarily equivalent to the original medicinal material

before extraction. The narrower the extracted scope, the less the

correlation between the extract and the original medicinal materials.

If the extract is defined by one or more features such as ingredients

(active ingredients or marker ingredients), proportions,

physicochemical properties, or preparation method, and after

examination, it is found that the patent application is similar to the

prior art, the novelty requirement shall be examined carefully. If

necessary, the applicant should provide evidence showing the

differences between the invention and the prior art, such as providing a

mass spectrometry analysis or comparing relations between the main


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ingredients of the extract and the prior art.

5.2.3.2 Defining extracts with preparation methods

Most inventions regarding extracts of Chinese herbs are defined by a

preparation method. The claims should be interpreted as final

products with the properties being the preparation methods. The

novelty of such inventions should be examined on the basis of the

extract itself instead of merely comparing whether the preparation

methods involved are the same as those disclosed in citations.

Different preparation methods will not necessarily result in different

extracts.

If it is determined that the extract of an invention is the same as a

known product after comparing the invention with a citation, the

product defined by the preparation method of the invention lacks

novelty. For example, if the starting materials and extraction methods

of the invention and the prior art are the same, or the extraction

methods are different but the known product also has the properties

from the preparation method described in the claims, the product

defined by the preparation method of the invention lacks novelty.

If the difference between the extract of the invention and known

products resides only in the preparation method and the applicant does

not indicate the changes of the extract in function and properties due to

the difference of the preparation method, or if the application does not

provide parameters for comparing the extract of the invention with the

known product to distinguish between the two, it is presumed that the

product defined by the preparation method of the invention lacks

novelty.

5.2.4 Using part invention

A patent application characterized by a using parts of Chinese herbs

differing from conventional ones has novelty, even if the given

efficacies are the same as those of the prior art. For example, the

fruits of ginkgo are conventionally used in Chinese medicine. If an

invention adopts the leaves of ginkgo as a new medical part, the


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invention has novelty because the used part is different from that of the

prior art.

5.2.5 Use invention

5.2.5.1 Determination of Novelty of a Use invention

Methods for determining novelty of use inventions differ from those of

product inventions.

Even if a use invention relating to a specific use of a known product is

based on the inherent properties of the product, the use invention still

has novelty as long as the use is unknown to the public. Take for

example, a patent application relating to anti-cancer efficacies of a

known product A, and the claim is “a use of product A for preparing a

pharmaceutical composition with anti-cancer efficacies.” When

determining the novelty of the invention, it is essential to examine

whether the anti-cancer efficacies of product A have been disclosed in

previous citations. If the efficacies have been disclosed in previous

citations, the invention lacks novelty. If the citations merely disclose

product A but not the anti-cancer efficacies, the invention has novelty.

5.2.5.2 Use not specifically disclosed in citations

If an invention relates to a use of Chinese herbs for treating new

indications and the use is not specifically disclosed in previous

citations, even though the use is correlated with the disclosure of the

citations, the citations should not be used as a basis to negate the

novelty of the invention since the citations do not clearly disclose the

use. The citations may, however, be used as a basis for the

determination of the inventive step. For example, an invention

relating to a use of product A for the treatment of diabetes, and

previous citations merely disclose that product A may promote the

production of insulin. Although persons of ordinary skill in the art

have known that some products for promoting the production of insulin

have the efficacy of treating diabetes, the citations shall not be used as

a basis to negate the novelty of the invention because the citations do

not clearly disclose that product A is useful in treating diabetes.


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However, the citations may be used as a basis for the determination of

the inventive step of the invention.

5.2.6 Comparison of syndromes or diseases defined in Chinese medicine

and diseases defined in Western medicine

If an invention relates to a novel medical use of a conventional formula

and the new indications are defined by name of disease in Western

medicine, not only shall the components and proportions of the

medicinal materials be compared with those of the conventional

formulas to determine whether they are the same, but also the functions,

curative effects, and indications, so as to determine whether the

claimed new indications have novelty.

Because the ideologies are very different from each other, names or

types of syndroms or diseases defined in Chinese medicine have no

direct relation to the diseases defined in Western medicine. Even if

the names of the diseases are identical, the diseases are not necessarily

equivalent. A diagnosis of some patents in Chinese medicine may be

consistent with Western medicine. However, this cannot be

interpreted to mean that the definitions of the disease in Chinese

medicine and Western medicine are identical. There is no

corresponding relation or superordinate and subordinate relation

between the two. For example, hypertension in Western medicine is

generally divided into secondary hypertension and primary

hypertension. Secondary hypertension is always related to kidney

diseases, endocrine, and intracranial lesions, and it is a symptom

caused by such diseases, but not an independent disease. The

etiopathogenesis of primary hypertension is not well understood, and

the primary hypertension is always related to nervousness, external

stimulus, or inheritance. In the theory of Chinese medicine, on the

other hand, does not include the term "blood pressure." Although it

may be found that some symptoms such as "vertigo," "headache," "Yin

deficiency leading to Yang hyperactivity," and " sthenia of liver Yang"

recorded in Chinese medicine relate to clinical symptoms of

hypertension, since the syndromes or diseases defined in Chinese


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medicine and the diseases defined in the Western medicine belong to

two different systems, they are not comparable.

When searching for prior art, it should be noted whether the technical

terms for the syndroms or diseases defined in Chinese medicine and the

diseases defined in Western medicine in Chinese medicine system are

consistent. Furthermore, even when the name of syndromes or

diseases in Chinese medicine is the same as that in Western medicine,

they do not necessarily have any corresponding relationship.

When examining novelty, if it is found that the corresponding

relationship between syndromes or diseases in Chinese medicine and

diseases in Western medicine has been disclosed in prior art, and the

medicament components and proportions used in the invention and the

prior art are the same, the invention does not have novelty.

5.3 Inventive step

For details on the examination of an inventive step refer to “Inventive

Step” in Section 3 of Chapter 3. The following merely illustrates

examination of an inventive step of a Chinese herb related invention

with specific aspects.


conventional formulas

If an invention relates to addition, subtraction, or substitution of

components of a conventional Chinese herbal formula, and the addition,

subtraction, or substitution has not been published, put to public use, or

made known to the public, the invention has novelty. However, if the

addition, subtraction, or substitution can be easily achieved by persons

of ordinary skill in the art on the basis of the prior art published before

the filing date, the invention lacks an inventive step.

If it is difficult to determine whether an addition, subtraction, or

substitution of components of a conventional Chinese herbal formula

can be easily achieved by persons of ordinary skill in the art, examiners

can compare the Chinese herbs after addition, subtraction, or

substitution with the original formula to determine whether they have


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non-obvious efficacies.

Some medicinal materials of Chinese herbs are difficult to obtain, and

thus are often substituted with other common medicinal materials.

For example, rhinoceros horn can be substituted with buffalo horn or

sheep horn, and pangolin scales can be substituted by Chinese

honeylocust spine. Furthermore, the origins of Chinese herbs are

complicated; the same Chinese herbal name may include a plurality of

medicinal materials. For example, the Chinese herb fortune's drynaria

rhizome includes at least 13 plants with different scientific names.

The 13 medicinal materials may be used in place of one another in

prior art, but in traditional use, the curative effects are not considered to

be quite different from one another. Therefore, if one or more

medicinal materials in conventional formulas are substituted by other

medicinal materials that are easily obtained or have the same origins,

but no non-obvious efficacy is produced, the substitution is not

considered to be an inventive step.

Example 1

Xiaoyao Powder is a common formula which includes the powder of Chinese

angelica root, indian bread, white peony root, white atractylodes rhizome,

bupleurum root, and prepared glycyrrhiza and ginger andpeppermint. To drink

the formula, simmer the powder with ginger and peppermintin water. Xiaoyao

Powder is used for treatment of hypochondriac pain, headache and dizziness,

dry mouth and throat, poor spirit, and minimal food intake caused by liver

depression and blood deficiency. Thus, it is a conventional formula and lacks

novelty.

For treating a patient having the symptom of liver-heat, tree peony bark and

gardeniae fructus are added into the above-mentioned formula to obtain Added

Xiaoyao Powder (also referred to as Danzhi Xiaoyao Powder or

Eight-Ingredient Xiaoyao Powder) The Added Xiaoyao Powder is an

addition formula of a conventional formula recorded in ancient books and does

not have novelty.

For treating a patient having the symptom of poor appetite, massa medicata


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fermentata and chicken's gizzard-membrane are added into the above-mentioned

formula to obtain an addition formula of Xiaoyao Powder. Although the

addition formula is not recorded in ancient books, it is known that massa

medicata fermentata has the functions of promoting digestion, relieving

dyspepsia, strengthening spleen, and moderating stomach, and chicken's

gizzard-membrane has the functions of activating spleen, promoting digestion,

and stopping nocturnal emission. Therefore, the addition and subtraction of

the formula can be easily achieved by persons having ordinary skill in the art

and lack an inventive step.

Example 2

Prepared Glycyrrhiza decoction is a formula recorded in the Treatise on

Exogenous Febrile Diseases, and is used for the treatment of palpitation

resulting from deficiency of both qi and yin. It contains the medicinal

materials prepared glycyrrhiza, ginseng, jujube, cassia twig, fresh ginger, fresh

rehmannia root, colla corii asini, dwarf lilyturf tuber, hemp seed and Japanese

sake.

In addition to the above mentioned medicinal materials, if astragalus root,

Chinese angelica root, prepared rehmannia root, jujube seed, polygala root, and

poria cum pini radice are added to the formula, improved curative effects of

supplementing Qi and blood as well as a tranquilizing effect are achieved as

compared with the conventional formula. Although the new formula is

different from the conventional one, and the addition and subtraction have not

been recorded in ancient books, it is known that astragalus root is a herb for

supplementing Qi, Chinese angelica root and prepared rehmannia root are herbs

for supplementing blood, and jujube seed, polygala root, and poria cum pini

radice are herbs for tranquilizing. The addition formula of the Prepared

Glycyrrhiza decoction can be easily obtained by persons of ordinary skill in the

art and thus lacks an inventive step.

Example 3

Four Agents decoction is a formula in Chinese medicine usually used for

supplementing blood and is also a widely-used conventional formula. This

invention relates to an Addition Four Agents decoction which contains, in


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addition to the original medicinal materials, three additional medicinal materials

X, Y, and Z and claims that the Addition Four Agents decoction has better

efficacy of nourishing blood. The formula is different from the conventional

Four Agents decoction, and the addition and subtraction have not been recorded

in ancient books. The added X has a function of supplementing blood, and Y

is a herb for supplementing Qi; when Qi is replenished, blood is generated. Z

is capable of softening liver and supplementing kidney and promoting the

generation of essence and blood.

Although the efficacies of the Addition Four Agents decoction of the invention

are understandable to persons of general knowledge in pharmacological

mechanisms of Chinese medicine, the originality of the invention must not be

easily discarded by deduction. In principle, the invention has an inventive step.

However, the generation of blood is mainly dependent on the appropriate

operation of Qi, and it is more complex than merely the matter of supplementing

blood. In this case, most medicinal materials in the Addition Four Agents

decoction are for supplementation. However, if a composition contains too

many medicinal materials for supplementing blood or Qi, it may not necessarily

increase the generation of blood. Instead, it may cause blood stasis and

damage the normal operation of Qi. As a result, the generation of blood may

be blocked. Therefore, relevant explanation of curative effects shall be

provided to validate whether the declared improved efficacy of nourishing blood

is true and whether the invention has an inventive step.

5.3.2 Selection Invention

For an invention relating to specifically limiting the dosage range of

some or all of the medicinal materials of a known Chinese herbal

formula of which each medicinal material has a known dosage range, if

the limited range cannot be easily accomplished by persons of ordinary

skill in the art or if the new dosage range renders the formula to possess

non-obvious efficacies over the original one, the invention has an

inventive step.

For an invention relating to the selection of a specific type of medicinal

material from a known medicinal material, if the selection cannot be

easily accomplished by persons of ordinary skill in the art or if the


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selected medicinal material has non-obvious efficacies to known

medicinal materials, the invention has an inventive step. For example,

the Chinese herb “akebia stem” includes at least four plants with totally

different scientific names, namely, “Guan Mutong” (Aristolochiae

manshuriensis), “Huai Mutong” (Aristolochia kaempferi Willd.),

“Chuan Mutong” (Clematis armandi Franch), and “Bai Mutong”

(Akebia trifoliata Thunb.). An invention discovers that “Guan

Mutong” and “Huai Mutong” contain aristolochic acid that may cause

serious nephropathy or cancer and thus selects “Chuan Mutong” and

“Bai Mutong” The selection is specified in the claims. Furthermore,

the specification discloses the relevant ancient books or notes, the

scientific names of the medicinal materials, and that the toxicity and

side effects are reduced significantly when compared to the original

formulas. In light of the above, the invention possesses a non-obvious

efficacy and thus has an inventive step.

Example 1

An invention relates to a method of extracting andrographolide. It specially

specifies the conditions such as the type and amount of a basifier, heating time,

and heating temperature of a conventional extraction method of andrographolide,

so as to reduce the impurities and the toxicity of the end product and improve

the extraction ratio of the active components. Therefore, the invention has an

inventive step.

5.3.3 Use invention

5.3.3.1 Uses not specifically disclosed in citations

For an invention relating to a use of Chinese herbs for new indications,

if the use can be easily achieved by persons of ordinary skill in the art

on the basis of the pathogenesis or pharmacological mechanism of the

indications stated in the prior art, the invention lacks an inventive step.

Take for example, an invention relating to a use of product A for

treating diabetes. Although the citations merely disclose that product

A may promote the production of insulin, persons of ordinary skill in

the art have known that substances promoting the production of insulin


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would have the efficacies of treating diabetes. Therefore, on the basis

of the disclosure of previous citations and general knowledge available

on the filing date, it can be determined that product A should have the

efficacy of treating diabetes. The invention lacks an inventive step.

5.3.3.2 Uses utilizing known properties

For an invention relating to a use of a known product, if the properties

of the product have been disclosed in prior art, and persons of ordinary

skill in the art can easily accomplish the use of the product on the basis

of the disclosed properties and general knowledge available on the

filing date, the invention lacks an inventive step. Take for example,

an invention relating to a detergent composition comprising a known

Chinese herbal extract A as the main ingredient. If prior art has

disclosed that extract A has the property of reducing surface tension of

water, since reducing surface tension is a known essential property of a

detergent, persons of ordinary skill in the art can easily know that the

Chinese herbal extract A can be used as a detergent on the basis of the

prior art. Therefore, the invention lacks an inventive step.


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Appendix

1. Differential treatment based on differentiation of symptoms and signs used

in Chinese medicine

The differences between Chinese herb related inventions and other kinds of

medical inventions arise mainly out of the differences between the theory of

curative effects of Chinese herbs of modern medicines. For example, the

theory of curative effects of modern medicine focuses on the mechanism of the

medicine on human tissues or cells, while thought process of "differential

treatment based on differentiation of symptoms and signs" and the

corresponding treatment methods are the focus in the theory of curative effects

of Chinese medicine and predominate the curative effects of Chinese herbs.

This so-called "differential treatment based on differentiation of symptoms and

signs" is actually a method of thinking and a mold for diagnosis and treatment

of diseases in Chinese medicine that mainly includes "differentiation of

symptoms and signs" and "differential treatment" which are described as

follows.

1.1 Differentiation of symptoms and signs

"Differentiation of symptoms and signs" refers to a system of diagnosing

patients under the guidance of the basic theory of Chinese medicine (such

as yin and yang, five elements, bowels and viscera, channels and

collaterals, blood and Qi, body fluids, six exogenous factors which cause

diseases, seven modes of emotion). This system summarizes and

analyzes various clinical information (known as syndrome in Chinese

medicine) such as medical history, living environment, emotional factors,

symptoms, signs, pulse manifestations, and tongue coating obtained by the

four diagnostic procedures (inspection, listening and smelling, inquiry,

and palpation) to identify the interrelationships among the various clinical

information and the relationships among each disease and symptom,

thereby summarizing the cause, nature, site, tendency and relation

between good and evil of the disease, so as to judue the “syndrome” to

which the disease relates. “Syndrome” is the summary of

pathomechanism.


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In general, eight principles predominate in the procedure of differentiation

of symptoms and signs. The eight principles are yin and yang,

superficies and interior, cold and heat, asthenia and sthenia. The eight

principles summarize the most abstract and simplest relations in

pathomechanism. Therefore, after the establishment of the eight

principles, the basic understanding of the sites, natures, tendency, and

causes of the disease were obtained. Further understanding of the

disease, which is called “syndrome,” is obtained through the identifying

methods of bowels and viscera, channels and collaterals, blood and Qi and

body fluids, defense, Qi, Ying and blood, six channels, triple

warmer, and so on. “Syndrome” in Chinese medicine is the integration

of various situations of causes, sites, natures, tendencies and relations

between the good and evil of a disease which is obtained by analyzing

clinical informations. The meaning of "syndrome" in Chinese medicine

is completely different from the concept of a “symptom” which is an

individual and exterior manifestation appearing during the course of a

disease.

1.2 Differential treatment

Differential treatment refers to concluding and analyzing many different

symptoms and further exploring the causes, natures, sites, tendencies,

relations between good and evil of a disease to find out the definite

“syndrome,” creating a proper treatment principle, and choosing a proper

treatment method (including herbal medicines and formulas, acupuncture,

moxibustion, massage, bloodletting, cupping, breathing exercise,

regulation and nourishing through diet and the like recorded in the ancient

books of Chinese medicine, among which herbal medicines and

acupuncture and moxibustion predominate and are the most developed) to

treat diverse diseases and achieve curative effects.

Differentiation of symptoms and signs is the precondition and basis for

differential treatment, and differential treatment is the purpose for the

differentiation of symptoms and signs as well as the method and approach

to treating a disease. Differential treatment based on differentiation of

symptoms and signs is not only the principle guiding the Chinese


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medicine clinic but also the practical method for diagnosis, treatment and

the like. The process of differential treatment based on differentiation of

symptoms and signs is the process of recognizing and treating diseases in

Chinese medicine.

2. Basic theory and content of formula

2.1 Seven relations in medicine combination

Using more than one kind of medicine in combination on the basis of

different disease situations and the properties of different medicines is

referred to as medicine combination. There is a systematic theory of

medicine combination in the real of Chinese medicine. The theory of

medicine combination mainly refers to seven relations between medicines.

The complex mutual combination between various kinds of medicines in a

formula, known as sovereign, minister, assistant and courier, will be

illustrated in the following section "Principles of Medicine Combination

in Foumulas."

The seven relations are acting singly, mutual promotion, assisting, fearing,

killing, antagonizing, and clashing. These are descriptions of the

relations between medicines. The description of each relation is as

follows.

(1) Acting singly: Individual action of a single medicine. The so-called

singly-acting medicine" is able to independently and effectively

attack and supplement without combining with other medicines.

Although acting singly is one of the seven relations of medicine

combination, it actually does not involve combination. Acting

singly is usually used for diseases with simple conditions. Since in

this relation only a single medicine is used, the effect of the

medicine is often intense, and thus is often used in urgent situations.

For example, one ingredient of ginseng is used in Pure Ginseng

decoction to treat a sudden exhaustion of energy, and trogopterus

dung is used in Single Acting Powder to disperse blood stasis so as

to treat postpartum dizziness casued by blood stasis.

(2) Mutual promotion: After the combination of two medicines with


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similar functions, a synergistic effect is generated and increased

curative effects are obtained. For example, the combination of

schizonepeta herb and saposhnikovia root can enhance the effect of

expelling wind and promoting sweating to expel exogenous evils

from the body surface. The combination of scorpion and centipede

will enhance the effect of suppressing the liver and calming the

endogenous wind as well as stopping tetany and convulsions.

(3) Assisting: Taking one medicine as the main component and another

medicine as the assisting component to improve the curative effect

of the main component. The functions of these two medicines may

be and are often different; this is the difference between assisting

and mutual promotion. For example, atractylodes rhizome in

combination with amur cork-tree bark can enhance the effect of

clearing wetness-heat of amur cork-tree bark, and astragalus root in

combination with Chinese angelica root can enhance

blood-supplementing effect of Chinese angelica root.

(4) Fearing: Toxicities or side effects of one medicine can be eliminated

or alleviated by the use of another medicine. A typical example of

fearing is recorded in Variorum of Materia Medica : “Pinellia tuber

is toxic so it must be used with fresh ginger. This is based on

pinellia tuber's fear of fresh ginger so as to inhibit its toxin.” In

addition, in Ten Jujubes decoction, jujube is used in combination

with kansui root to alleviate the side effect of excessive diuresis of

kansui root and alleviate damage to the spleen and stomach.

(5) Killing: This is the reverse relation to the medicine combination of

fearing. Pinellia tuber fears fresh ginger; this is known as fearing.

Fresh ginger kills pinellia tuber; this is known as killing. The

difference between fearing and killing only lies in the different

position of being the inhibiting or inhibited medicine.

(6) Antagonizing: It means one medicine interact with another medicine

so as to weaken each other's effect. Since curative effects of the

medicine will be inhibited, this combination should be avoided.

Antagonizing is a negative example of medicine combination. For


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example, if fresh ginger is used in combination with scutellaria root,

the cold of scutellaria root will decrease the stomach-warming effect

of fresh ginger. If center-warming and cold-dissipating effect is

required, the combination of scutellaria root and fresh ginger should

be avoided.

(7) Clashing: when the combination of two medicines produces toxicity

and side effects. There is a saying that “those medicines with

hatred toward each other can not be combined.” This kind of

combination, just as antagonizing combinations, should be avoided.

In conclusion, mutual promotion and assisting combinations can enhance

the curative effects and are the most common combinations; fearing and

killing combinations can inhibit toxicity and side effects and are the

common combination for medicines with high toxicities; antagonizing and

clashing combinations can decrease medicinal curative effects or enhance

toxicity and are incompatible combinations. The above is the common

methodology according to the seven relations of medicine combination.

However, there are always exceptions. Therefore, one should know not

only the general rule but also the exceptions. In Compendium of Materia

Medica, Li Shizhen said “Li Dongyuan used a Peaceful Interaction Pill

containing ginseng and Chinese honeylocust fruit to regulate spleen and

stomach and purge sthenic yin fire. The combination of ginseng and

Chinese honeylocust fruit is an antagonizing combination but does not

have disadvantages of the antagonizing combination. The ancients

treated amenorrhea by Four Agents decoction further added with ginseng

and trogopterus dung. The combination of ginseng and trogopterus dung

is a fearing combination but does not have disadvantages of the fearing

combination. Also, ginseng and veratrum can be used together to obtain

an upwelling effect so as to treat phlegm in chest and diaphragm. The

combination of ginseng and veratrum is to encourage their extreme effect.

These are all profound teachings, that persons without good judgement

cannot possibly understand.” The above-mentioned curative effects are

achieved by formulas adopting the fearing, antagonizing and clashing

combination. However, in Chinese medicine, these kinds of applications


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are relatively rare and should be used carefully.

2.2 Principles of Medicine Combination in Formulas

Treatment methods of the Chinese medicine, using singly-acting

medicines to obtain acurative effect is relatively rare, while using

formulas containing multiple medicines to obtain curative effect is more

frequent. The treatment method used in the Chinese medicine is

achieved by differentiation of symptoms and signs on the basis of theory

of physiology and pathology, determineing principle of forming formulas

according to the syndromes, and formulating the formulas on the basis of

the princle and theory of Chinese medicine. In view of the above,

Chinese medicine is an academic medicine in which curative effects are

produced by the treatment method rather than an experiential medicine in

which curative effect is produced by the medicine. The method of

creating a formula is based on the principle of medicine combination.

The difference between the principle of medicine combination in formulas

and the seven relations of medicine combination is that the seven relations

of medicine combination mainly discuss the interaction of only two

medicines, while the principle of medicine combination in formulas is the

mutual effects among many various medicines in a formula.

2.2.1 Sovereign, Minister, Assistant and Courier

The principle of "sovereign, minister, assistant and courier" is the most

frequently used and most widely accepted principle of medicine

combination in formulas. It is influenced by past forms of

administrative organization, and is a clear, deducible, but debatable

principle of creating formulas. The details are described as follows.

(1) Sovereign medicine: Sovereign medicine is the most important

medicine in a formula. It is like the sovereign who leads a country.

The sovereign medicine is directed to the main syndrome and plays

the leading role in a formula. Taking Ephedra decoction as an

example, Ephedra decoction is mainly used for treating an externally

contracted wind-cold, in which wind-cold is the main syndrome

Ephedra can promote sweating and dissipate cold, and usually, upon


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sweating the syndrome can be expelled. Therefore, ephedra is the

sovereign medicine in Ephedra decoction.

(2) Minister medicine: The minister medicine is the medicine for

enhancing the effect of the sovereign medicine. Generally, the

combination of the sovereign medicine and the minister medicine

can increase their respective effects, so as to achieve higher curative

effects on the main syndrome. For example, cassia twig is used as

the minister medicine in Ephedra decoction. Cassia twig is sweet,

acrid, effusing and dissipating and can dissipate wind-cold and free

the channel and Qi so it can assist the effect of sweating, dissipating

cold and expelling exogenous evils from the body surface of

ephedra. The effect of of the combination of cassia twig and

ephedra in eliminating wind-cold is much higher than that a

large-amount of ephedra alone.

(3) Assistant medicine: An assistant medicine has two functions. The

first is assisting the sovereign and minister medicines to treat the

main syndrome. The assisting effect of assistant medicine is not as

significant as that of the minister medicine to the sovereign herb, but

to a certain extent, it plays a promoting role. For example, apricot

kernel is used as the assistant medicine in Ephedra decoction

because of its effect of opening the inhibited lung energy. The

effect is used to promote the dissipating effect of ephedra and cassia

twig. The second function of an assistant medicine is treating the

symptoms or signs caused by the pathomechanism of the main

syndrome. For example, in Ephedra decoction, apricot kernel is

used to treat the symptom of cough and panting in the wind-cold

syndrome because of its effect of lowering the adverse-rising

energy.

Another form of an “assistant” is a “ counter assistant.” It is very

similar to fearing in the seven relations of medicine combination

and is used to alleviate the side effects of the sovereign or minister

medicines. For example, in Four Agents decoction, ligusticum

chuanxiong hort is used to alleviate the rich and slimy feature or to


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alleviate Qi stagnation of prepared rehmannia root because of its

effect of promoting circulation of Qi and blood.

(4) Courier medicine: Courier medicine has two functions, “channel

direction” and “harmonizing various medicines.” One focus of

differentiation of symptoms and signs in Chinese medicine is to

identify the site of the disease; once the site is identified, the

medicines can be directed to the disease site by the courier medicine.

For example, the disease site of forehead headache belongs to

Yangming channel so dahurian angelica root is used in Tea-Blended

Chuanxiong powder to conduct the medicines to the Yangming

channel. The disease site of bilateral headache belongs to the

Shaoyang channel so bupleurum root is used in Clear Sky paste to

conduct the medicines to the Shaoyang channel. The above are all

examples of channel directing medicines used as courier medicines.

As for the function of harmonizing various medicines, glycyrrhiza is

the most commonly used in Chinese medicine formulas. For

example, in Pinellia tuber Heart-Draining decoction, the cold and

hot medicines are used in combination, and glycyrrhiza is used to

harmonize them.

In order to illustrate the meaning of sovereign, minister, assistant

and courier, an example of Ephedra decoction is analyzed as

follows.

Ephedra decoction:

Sovereign medicine: ephedra, which is warm and acrid, promotes

sweating, dissipates cold, opens the inhibited

lung energy, and calms panting.

Minister medicine: cassia twig, which is sweet, acrid and warm,

warms the channels, regulates Ying, expels

evil factors from the muscles, dissipate cold

so it can assist ephedra in sweating,

dissipating cold and expelling exogenous

evils from the body surface.


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Assistant medicine: apricot kernel. It can assist ephedra in

calming panting due to its characteristics of

warmth, bitterness, and lowering the

adverse-rising lung energy, and it can assist

ephedra and cassia twig in promoting

sweating and and expelling exogenous evils

from the body surface due to its effect of

dissipateing wind-cold .

Courier medicine: preparedglycyrrhiza, which is warm and

sweet, harmonizes each medicine, and

counter assists ephedra and cassia twig to

prevent them from excessive effusing and

dissipating.

Channel conducting: ephedra is the special medicine for the lung

channel. Since apricot kernel belongs to lung and large intestine

channels, courier medicines for channel directing is not needed.

The entire structure of a formula, sovereign, minister, assistant and

courier can be used to classify the functions of each medicine in the

formula and can also guide the medicine combination in the formula.

It must be noted that the principle of sovereign, minister, assistant,

and courier is not necessarily fixed. In some formulas (especially

formulas with less medicines), certain medicines can have two roles.

For example, Platycodon and Glycyrrhiza decoction is made up of

two medicines, i.e., platycodon and glycyrrhiza. Platycodon has

the effect of opening the inhibited lung energy and promoting the

throat and is the sovereign medicine. Furthermore, it can also

conduct the medicines to upper warmer and lung channels so it also

plays the role of courier medicine. On the other hand, complex

formulas containing more than ten medicines are not necessarily

limited to the medicine combination principle of sovereign, minister,

assistant and courier.

2.2.2 Other principles of medicine combination in formulas


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In the history of Chinese medicine, the composition of some formulas are

very complex and are hard to analyze or explain by the principle of

sovereign, minister, assistant and courier. For example, there are more

than fifty kinds of medicine in the Renewal Pill. Major

Network-Quickening Elixir is also a complex formula. Yun Tieqiao

named these kinds of formulas “Thousand Gold Pieces Formula” and said

“the principle of medicine combination in complex formulas is totally

different from the principle of sovereign, minister, assistant and courier

taught in Treatise On Cold Damage and Essential Prescriptions of the

Golden Coffer. The complex formulas is the combination of forty or

fifty medicines which conteract and assist each other.” In these formulas,

the medicines can only be identified as major and minor parts according to

the different functions, and the combination principle of sovereign,

minister, assistant and courier becomes inapplicable.

2.2.3 Lost principles of medicine combination

The Divine Husbandman’s Herbal Foundation Canon: “there is a

combination of yin and yang of herbs.”

The preface to The Divine Husbandman’s Herbal Foundation Canon:

“combination of the medicines of son, mother, elder brother and younger

brother.”

The above are lost principles of medicine combination which have not been

mentioned or applied in existing literature.

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