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New USPTO Guidelines and the Obviousness New USPTO Guidelines and the Obviousness Standard for PatentsStrategies to Withstand Obviousness Rejections and Attacks on Patent Validity

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WEDNESDAY, JANUARY 12, 2011

Today’s faculty features:

Paul Davis, Partner, Goodwin Procter, Menlo Park, Calif.

Karen Canaan, Attorney, CanaanLaw, Menlo Park, Calif.

Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

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New USPTO Guidelines and the Obviousness Standard for Patents

Strategies to Withstand Obviousness Rejections and Attacks on Patent Validity

Paul DavisPaul DavisPartner, Goodwin Procter [email protected] @g p650.752.3106858.202.2700

©2011. Goodwin Procter LLP

Determining Obviousness Under 35 U.S.C. § 103After the Supreme Court Decision in

KSR I t ti l C T l fl IKSR International Co. v. Teleflex Inc.,550 U.S.—, 82 USPQ2d 1385 (2007)

Th USPTO h tl t i d d i d id li f i• The USPTO has recently trained and issued guidelines for examiners relative to 35 U.S.C. § 103 rejections in view of KSR International Co. v. Teleflex Inc..

• These guidelines/rationales are discussed herein.

Recognize the following:

• When you traverse an obviousness rejection under § 103, consider providing a reasoned statement explaining why the applicant believes the Office has erred substantively as to the factual findings or the conclusion of obviousness. 37 CFR 1.111(b).

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GENERAL STRATEGIES AND RECOMMENDATIONS

• Did the examiner articulate a competent rational to support the obviousness rejection.• Challenge the examiner on what is the state of the art.• Can provide evidence refuting the examiner’s view as to what is the state of the artCan provide evidence refuting the examiner s view as to what is the state of the art.• Who is a person or ordinary skill.• Refute what a person of ordinary skill would have known at the time of the invention.• If the person of ordinary skill would have known, why was it never done? • What did the inventor need to do to come up with the invention• What did the inventor need to do to come up with the invention.• What was going on in the industry.• What was the industry doing?• What were competitors doing?

D t h it t t f t d id id H k th id t• Do not hesitate to refute and provide evidence. However, make sure the evidence can not be used as an estoppel later on.

• Challenge the examiner’s knowledge as to his/her level of skill as to the state of the art.• Focus on the Interdependency of Features in a Claim.

E t bli h th t l i d bi ti i t di t bl f i t l t di• Establish that a claimed combination is not a predictable use of prior art elements according to their established functions.

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Graham v. John Deere

Examiners must:

• Resolve the Graham inquiries.

• Articulate the appropriate findings as identified by the Examination Guidelines.

• Explain how the rationale leads to a conclusion of obviousness under § 103.p §

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PTO’s POSITION

• Determining the scope and content of the prior art;

• Ascertaining the differences between the claimed invention and the prior art; andg p

• Resolving the level of ordinary skill in the pertinent art.

• Objective evidence sometimes referred to as “secondary considerations” when timelyObjective evidence, sometimes referred to as secondary considerations when timely presented by applicants must be evaluated.

• The examiner need not always include an explicit indication of the level of ordinary skill in the art in the statement of the rejection, because the level of ordinary skill in the art may be j , y yimplicit in view of the prior art applied.

• However, in certain situations it may be necessary to explain the level of ordinary skill in order to support the examiner's conclusion of obviousness.

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RECOMMENDATIONS

• Do not accept the examiner’s view of level or ordinary skill in the art.

• Look for objective evidence Challenge the examiner on objective evidenceLook for objective evidence. Challenge the examiner on objective evidence.

• Is the examiner correct in what is implicit? Provide contrasting evidence.

• Make the examiner show what the level of ordinary skill in the art is by evidence of what it is• Make the examiner show what the level of ordinary skill in the art is by evidence of what it is. Argue for references.

• Refute what the level of ordinary skill is.

• Focus/Present Unexpected Results or Commercial Success

• These secondary considerations under Graham v. Deere remain relevant. Presenting evidence of unexpected results or commercial success remains a good possible strategy forevidence of unexpected results or commercial success remains a good possible strategy for rebutting an obviousness rejection. Be careful of what you say, make sure it will not limit claim interpretation later on.

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THE EXAMINER AS FACT FINDER

PTO’s Position• Examiners act as fact finders when resolving the Graham inquiries.• Examiners must articulate findings as to the scope and content of the prior art as

necessary to support the obviousness rejection being made.• The examiner must articulate a reason or rationale to support the obviousness rejection. • In formulating a rejection under 35 U.S.C. § 103, the rationale should be based on the

state of the art and not impermissible hindsight, e.g. applicant’s disclosure.

RATIONALES• Examiners need to account for all claim limitations in their rejections.• Examiners must either indicate how each limitation is shown by the reference(s) applied,

or provide an explanation.• Prior art is not limited to the references being applied. • Prior art includes both the specialized understanding of one of ordinary skill in the art,

and the common understanding of the layman. • Examiners may rely on, for example, official notice, common sense, design choice, and

ordinary ingenuity.

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THE EXAMINER AS FACT FINDER (cont)

RECOMMENDATIONS

• Did the examiner pick the best rationale.• Determine if any of the findings under the various independent rationales cannot be

made, then that particular rationale cannot be used to support a conclusion of obviousness.

• Did the examiner articulate an appropriate reason or rationale?• What is the state of the art? • Is the examiner correct in the state of the art?• Establish the state of the art through the inventor, third parties, etc.

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Rationale A. Combining prior art elements according to known methods to yield predictable results.

Examiners must articulate the following:• a finding that the prior art included each element claimed although not necessarily in a single

reference;• a finding that one of ordinary skill in the art could have combined the elements as claimed by

known methods and that in combination, each element merely would have performed theknown methods and that in combination, each element merely would have performed the same function as it did separately; and

• a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable.

RECOMMENDATIONS• Do the references provide all of the claim elements?• Would one of ordinary skill in the art combine the elements as claimed.• Would each element perform the same function as it did separately?

W ld th bi ti b di t bl t kill d i th t?• Would the combination be predictable to one skilled in the art?• Are there secondary considerations or other arguments. • Did the examiner explain why it would have been obvious to one of ordinary skill in the art to

combine the elements.• Were all of the elements known in the prior art?• Were all of the elements known in the prior art?• If so, would one skilled in the art have combined the elements as claimed by known methods

with no change in their respective functions.• If so, would the combination would have yielded predictable results to one of ordinary skill in

the art at the time of the invention.

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Rationale B. Simple substitution of one known, equivalent element for another to obtain predictable results

RECOMMENDATIONS

Did the examiner articulate the following:• A finding that the prior art contained a device which differed from the claimed device the substitution• A finding that the prior art contained a device which differed from the claimed device the substitution

of some components with other components;• A finding that the substituted components and their functions were known in the art;• A finding that one of ordinary skill in the art could have substituted one known element for another

and the results of the substitution would have been predictable.• Advocate that the claim would not have been obvious because the substitution of one known

element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.

• Advocate that combining known prior art elements is not sufficient to render the claimed invention obvious if the results would not have been predictable to one of ordinary skill in the art.

• What is the level of ordinary skill in the art?• Refute combining• Refute combining.• Do you get the same results?• Present evidence to the contrary.• Remember, invention is combining known elements. How is the invention different? Why did

others not do this. What is going on in the industry.

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Rationale C. Use of known technique to improve similar devices (methods, or products) in the same way.

Examiners must articulate the following:• a finding that the prior art contained a “base” device upon which the claimed invention is an improvement;• a finding that the prior art contained a comparable device that was improved in the same way as the claimed

invention; and• a finding that one of ordinary skill could have applied the known “improvement” technique in the same way to the g y pp p q y

“base” device and the results would have been predictable.

Sample Rejection: The claim is rejected under 35 U.S.C. 103 as being unpatentable over Reference A in view of Reference B. Reference A teaches a device for protecting an inverter circuit in an undisclosed manner via a control means. The device indicates the high-load condition by way of the control means, but does not indicate the specific manner of overload protection. Reference B discloses disabling an inverter in the event of a high-load current p g gcondition in order to protect the inverter circuit. That is, the overload protection was achieved by disabling the inverter by means of a cutoff switch. It would have been obvious to one of ordinary skill in the art to use the threshold signal produced in the device of Reference A to actuate a cutoff switch to render the inverter inoperative as taught by Reference B. Using the known technique of a cutoff switch for protecting a circuit to provide the protection desired in the inverter circuit of Reference A would have been obvious to one of ordinary skill.

RECOMMENDATIONS• Did the examiner articulate 1-3?• Make rebuttal arguments to items 1-3 if they are completely articulated.• Challenge that the claim would have been obvious because the technique for improving a particular class of devices

was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.p

• Note that in KSR noted that if the actual application of the technique would have been beyond the skill of one of ordinary skill in the art, then the resulting invention would not have been obvious because one of ordinary skill could not have been expected to achieve it.

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Rationale D. Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results.Examiners must articulate the following:• a finding that the prior art contained a “base” device;• a finding that the prior art contained a known technique that is applicable to the base device; and• a finding that one of ordinary skill in the art would have recognized that applying the known technique would have

yielded predictable results.

Sample Rejection: The claim is rejected under 35 U.S.C. 103 as being unpatentable over Reference A in view of Reference B. Reference A teaches the general state of the art in banking, specifically that banks are routinely known to use data processing equipment and computer software to do much of their record-keeping automatically. Reference A specifically teaches that data processing systems are used to read the amount of a check and then print that value in a designated area of the check. The check is then sent through a further data processing step which uses magnetic ink information to generate the appropriate records for transactions and for posting towhich uses magnetic ink information to generate the appropriate records for transactions and for posting to appropriate accounts. These systems include generating periodic statements for each account, such as the monthly statements sent to checking account customers. Reference A does not teach applying the technique of adding further digits designating categories to account numbers. Reference B teaches a system of tracking transactions of individual business units within a larger organization by associating an account number code with each business unit with further digits added to designate subunits. The additional code applied to all transactions allows the tracking sorting and generation of reports at any level of granularity as desired Thus it would haveallows the tracking, sorting and generation of reports at any level of granularity as desired. Thus, it would have been obvious to one of ordinary skill in the art to apply the technique of adding further digits designating categories to account numbers as taught in reference B, to improve the banking system of Reference A for the predictable result of enabling standard sorting, searching, and reporting by category.

RECOMMENDATIONS• Did the examiner articulate items 1-3?• Make rebuttal arguments to items 1-3 if they are completely articulated.• Challenge that the claim would have been obvious because a particular known technique was recognized as part

of the ordinary capabilities of one skilled in the art.

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Rationale E. “Obvious to try” – choosing from a finite number of predictable solutions.

Examiners must articulate the following:• a finding that there had been a recognized problem or need in the art including a design need or market pressure to

solve a problem;• a finding that there had been a finite number of identified predictable potential solutions;

fi di th t f di kill i th t ld h d th k t ti l ti ith bl• a finding that one of ordinary skill in the art could have pursued the known potential options with a reasonable expectation of success.

Sample Rejection: The claim is rejected under 35 U.S.C. 103 as being unpatentable over Reference A in view of Reference B. Reference A teaches that the uncombined form of the drug X is known to be useful for a particular therapeutic purpose. A person of ordinary skill in the art, upon reading the reference, would also have recognized the desirability of improved methods of formulating drug X. Reference B teaches that Y is one of a finite number of y p g ganions known to be useful for formulation of salts of drugs. Furthermore, Reference B teaches methods of making salts of drugs that would reasonably have been expected to be applicable to drug X. Reference B also inherently discloses to one of ordinary skill in the art that combining a known drug with one of the anions disclosed in order to make a salt does not affect the therapeutic properties of the drug. Thus, it would have been obvious to a person of ordinary skill in the art to try the anions of Reference B in an attempt to provide an improved formulation of drug X, as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp. In turn, because drug product X-Y as claimed has the properties predicted by the prior art, it would have been obvious to

k d d t X Ymake drug product X-Y.

RECOMMENDATIONS• Did the examiner articulate items 1-3?• If not, make rebuttal arguments to items 1-3.• Challenge that the claim would have been obvious because a person of ordinary skill has good reason to pursue the

known options within his or her technical grasp If this leads to the anticipated success it is likely the product not ofknown options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.

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Rationale F. Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations would have been predictable to one of ordinary skill in the art.

Examiners must articulate the following:Examiners must articulate the following:• a finding that the scope and content of the prior art, whether in the same or different field of endeavor, included a similar

or analogous device.• a finding that there were design incentives or market forces which would have prompted adaptation of the known

device.• a finding that the differences between the claimed invention and the prior art were encompassed in known variations or

in a principle known in the prior art.• a finding that one of ordinary skill in the art, in view of the design incentives or market forces, could have implemented

the claimed variation of the prior art, and the claimed variation would have been predictable.

Sample Rejection: The claim is rejected under 35 U.S.C. 103 as being unpatentable over Reference A in view of Reference B Reference A teaches an electro-mechanical toy for phonetic learning Reference A does not teachReference B. Reference A teaches an electro mechanical toy for phonetic learning. Reference A does not teach electronic components within the toy responsive to the child’s actions. Reference B teaches an electronic reading toy that generates sounds corresponding to the first letter of a word using electronic means. Since the marketplace reflects the reality that applying modern electronics to older mechanical devices is commonplace, it would have been obvious to one of ordinary skill in art of children’s learning toys to update older mechanical devices such as shown in Reference A with modern electronic components that are commonly available and understood in the art as shown in Reference B, in order to gain the commonly understood benefits of such adaptation such as decreased size increased reliabilityin order to gain the commonly understood benefits of such adaptation, such as decreased size, increased reliability, simplified operation, and reduced cost.

RECOMMENDATIONS• Did the examiner articulate items 1-3?• If not, make rebuttal arguments to items 1-3.g• Challenge that the claim would have been obvious because the design incentives or market forces provided a reason

to make an adaptation, and the invention resulted from application of the prior knowledge in a predictable manner.• What are the market forces? Are they as the examiner believes them to be? Present evidence that they are not.

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Rationale G. TSM Test

Examiners must articulate the following:• a finding that there was some teaching, suggestion, or motivation, either in the references themselves or in the

knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; AND

• a finding that there was reasonable expectation of success• a finding that there was reasonable expectation of success.

Sample rejection: The claim is rejected under 35 U.S.C. 103 as being unpatentable over Reference A in view of Reference B. Reference A teaches a portable audio player. Reference A does not teach the audio player having mp3 capability. Reference B teaches an mp3 player, and discloses that mp3 player capability increases the listening options of the user and provides a simple way to receive audio content from other sources, such as computers. It would have thus been obvious to one of ordinary skill in the art to include the mp3-playing capability disclosed in Reference B in the portable audio player of Reference A to achieve the claimed invention As disclosed in ReferenceReference B in the portable audio player of Reference A to achieve the claimed invention. As disclosed in Reference B, the motivation for the combination would be to increase the listening options of the user.

RECOMMENDATIONS• Were items 1-2 articulated?• If not, make rebuttal arguments.• Challenge that the claim would have been obvious because a person of ordinary skill in the art would have been• Challenge that the claim would have been obvious because a person of ordinary skill in the art would have been

motivated to combine the prior art to achieve the claimed invention and that there would have been a reasonable expectation of success.

• Refute the examiner’s assertion as to what would be obvious to one skilled in the art. • Consider submitting rebuttal evidence that can include evidence of secondary considerations such as commercial

success, long felt but unsolved needs, failure of others, and unexpected results.

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New USPTO Guidelines and the Obviousness Standard for Patents

Strategies to Withstand Obviousness Rejections and Attacks on Patent Validity

Paul DavisPartner Goodwin Procter LLPPartner, Goodwin Procter [email protected]

©2011. Goodwin Procter LLP

Applying KSR & the E i ti G id li tExamination Guidelines to

Patent Prosecution

Karen Canaan, CanaanLaw, P.C.Strafford Seminar, January 12, 2011

CanaanLaw, P.C. ® 2011

KSR v. Teleflex21

Pre-KSR the TSM test controlled obviousness Pre KSR, the TSM test controlled obviousness determinations.

Post-KSR obviousness determinations are Post KSR, obviousness determinations are based upon the predictability of the invention and whether the ordinary artisan would have a yreasonable expectation of successfully arriving at the claimed invention based upon the teachings of the cited references.

KSR v. Teleflex & Examination22

Changes to Obviousness Examinations post-KSR TSM no longer the standard for obviousness examinations. The problem that the inventor was trying to solve no longer

controls the scope of the prior art search. Obviousness examinations are now based upon 7

examination guidelines promulgated by the USPTO in response to KSR. C ti it & f t i th b i Creativity & common sense are factors in the obvious determinations (leading Examiners to sometimes use their own knowledge to fill in missing elements).

“Obvious-to-try” is now a valid ground for a rejection Obvious to try is now a valid ground for a rejection. Citations of non-analogous art in other fields is now

sanctioned.

KSR v. Teleflex & Rebuttals23

Changes to Obviousness Rebuttals post-KSR TSM is no longer the standard for obviousness rebuttals. The unpredictability of the invention and the assertion that

the ordinary artisan would not have a reasonable t ti f i i t th l i d i ti f thexpectation of arriving at the claimed invention from the

teachings of the references now controls the rebuttal arguments.

Arguing that a reference “teaches away” is now a viable Arguing that a reference teaches away is now a viable rebuttal argument.

Evidence of unexpected results remains a strong option for rebuttal argumentsoption for rebuttal arguments.

Rebuttal arguments of hindsight reconstruction and extraordinary skill in the art remain valid rebuttals.

Setting up the OA Responseg p p24

1 Refer to Examination Guidelines to determine1. Refer to Examination Guidelines to determine which of the seven Guidelines the Examiner is using for the basis of the obviousness grejection.

Exam Guideline A: CombinationsCombinations

25

A. Combining prior art elements according to known methods to yield predictable resultsto yield predictable results.

1. The prior art includes each element as claimed, although not in a single reference.

2. One of ordinary skill in the art could have combined the elements as claimed by known methods & in combination, each element would have performed the same function as it did separatelywould have performed the same function as it did separately.

3. One of ordinary skill in the art would have recognized that the results of the combination were predictable.

4. Graham factors. The first examination guideline addresses rejections where The first examination guideline addresses rejections where

elements from one or more references are combined to arrive at the claimed invention.

The Examination Guidelines provide that a reason should be articulated as to why the ordinary artisan would combine the l t i th th t th l i d i ti d

y yelements in the way that the claimed new invention does.

Combining a collection of old elements into a single device is not obvious if the art teaches away from doing so.

Exam Guideline B: Substitution26

B. Simple substitution of one known element for another to obtain predictable resultsobtain predictable results.

1. The prior art contained a device (method, product, etc.), which differed from the claimed device by the substitution of some components (step, element, etc.) with other components.

2. The substituted components & their functions were known in the artart.

3. One of ordinary skill in the art could have substituted one known element for another and the results of the substitution would have been predictable.

4. Graham factors. The second examination guideline addresses rejections

where an element from a secondary reference is substituted into the teaching from the primary reference.

The Examination Guidelines provide that at least the primary f h ld t th t th difi ti ld b

p p yreference should suggest that the modification could be successful.

Even in an unpredictable field, a reasonable expectation of success may justify the rejection.

Exam Guideline C: Skill Level27

C. Use of known technique to improve similar devices (methods or products) in the same way(methods, or products) in the same way.

1. The prior art contained a “base” device (method, or product) upon which the claimed invention can be seen as an “improvement.”

2 The prior art contained a “comparable” device (method, or2. The prior art contained a comparable device (method, or product that is not the same as the base device) that was improved in the same way as the claimed invention.

3. One of ordinary skill in the art could have applied the known “improvement” technique in the same way to the “base” device (method or product) and the results would have beendevice (method, or product) and the results would have been predictable to one of ordinary skill in the art.

4. Graham factors. The third examination guideline addresses rejections

where the improvement relating to the invention is withinwhere the improvement relating to the invention is within the skill level of the ordinary artisan.

The Examination Guidelines provide that if the application of the technique is beyond the skill level of the ordinary artisan then the technique is not obvious.artisan then the technique is not obvious.

Exam Guideline D:Common KnowledgeKnowledge

28

D. Applying a known technique to a known device (method or product) ready for improvement to yield(method, or product) ready for improvement to yield predictable results.

1. The prior art contained a “base” device (method, or product) upon which the claimed invention can be seen as an “improvement.”p

2. The prior art contained a “known technique” that is applicable to the base device (method, or product).

3. One of ordinary skill in the art would have recognized that applying the known technique would have yielded predictable results and resulted in an improved systemresults and resulted in an improved system.

4. Graham factors. The fourth examination guideline addresses rejections

where the Examiner has the opportunity to apply common knowledge to the rejectionknowledge to the rejection.

The Examination Guidelines provide that a claim is obvious if a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art.

Exam Guideline E: Obvious to TryTry

29

E. “Obvious to Try” - Choosing from a finite number of identified predictable solutions with a reasonableidentified, predictable solutions, with a reasonable expectation of success.

1. At the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem. p p

2. There had been a finite number of identified, predictable potential solutions to the recognized need or problem.

3. One of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success.G h f t4. Graham factors.

The fifth “obvious to try” examination guideline addresses another rejection where the Examiner has the opportunity to apply common knowledge to the rejection.

The Examination Guidelines emphasize that the unpredictability of a procedure may be obviated when there are only a “finite” number of solutions to solve a problem and the testing of the solutions is within the skill level of the ordinary artisanlevel of the ordinary artisan.

Exam Guideline F: Analogous ElementsElements

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F. Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if thesame field or a different one based on design incentives or other market forces if the variations would have been predictable to one of ordinary skill in the art.

1. The scope and content of the prior art, whether in the same field of endeavor as that of the applicant’s invention or a different field of endeavor, included a similar or analogous device (method, or product).

2. There were design incentives or market forces that would have prompted adaptation of the known2. There were design incentives or market forces that would have prompted adaptation of the known device (method, or product).

3. The differences between the claimed invention and the prior art were encompassed in known variations or in a principle known in the art.

4. One of ordinary skill in the art, in view of the identified design incentives or other market forces, could have implemented the claimed variation of the prior art, and the claimed variation would p phave been predictable to one of ordinary skill in the art.

5. Graham factors. The sixth examination guideline includes rejections that cite non-analogous art. The Examination Guidelines cite Leapfrog & KSR as a representative of rejections

b ht d thi G id librought under this Guideline. LeapFrog combined electrical & mechanical elements to arrive at the claimed electronic toy. KSR combined two mechanical elements to arrive at the claimed adjustable pedal assembly.

Exam Guideline G: TSM31

G. Some teaching, suggestion, or motivation in the prior g, gg , part that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (TSM)teachings to arrive at the claimed invention (TSM).

1. There was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally

il bl t f di kill i th t t dif thavailable to one of ordinary skill in the art, to modify the references or to combine reference teachings.

2. There was a reasonable expectation of success.3. Graham factors.

The seventh examination guideline addresses rejections that use the TSM testthat use the TSM test.

Setting up the OA Responseg p p32

1. Review the law cited in the Examination Guidelines d i if h E i h l li d hto determine if the Examiner has properly applied the

law and/or applied the appropriate Examination Guideline.

2. Use the law, rather than the Examiner’s arguments, as your guideline for preparing the response.

3. Set up the Office Action by citing the appropriate p y g pp pholding from KSR.

4. Use additional case law to support arguments within the text of the response, e.g., case law relating to p , g , gnon known problem, teaching away, unexpected results, hindsight reconstruction, common knowledge, etc.

Citing KSRg33

A rationale to support a conclusion that a claim would have b b i i th t ll th l i d l t k ibeen obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have p ,yielded nothing more than predictable results to one of ordinary skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 401 (2007); see also, KSR 550 U.S. at 415-417 (2007) citing Great Atlantic & P Tea Co v Supermarket(2007) citing Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152 (1950), Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63 (1969), and Sakraida v. AG Pro, Inc., 425 U.S. 273, 282 (1976)(1976).

Unknown Problem – Exam Guideline A34

From the 2010 Updated KSR Guidelines: Example 4.1. In re Omeprazole Patent Litigation 536 F 3d 1361 (Fed Cir 2008)Omeprazole Patent Litigation, 536 F.3d 1361 (Fed. Cir. 2008). Even where a general method that could have been applied to make the claimed product was known and within the skill level of the ordinary artisan, the claim may nonetheless be nonobvious if the problem which had suggested use of the method had beenthe problem which had suggested use of the method had been previously unknown.

Invention: Applying two layers of enteric coating to a the drug omeprazol.p

Modification: Enteric coatings were known, but the reason for adding it was that the prior art coating was interfering with the action of the drug.Nonobviousness: The D Ct & Fed Cir found the patent Nonobviousness: The D. Ct. & Fed. Cir. found the patent nonobvious because the problem that the invention addressed was not previously known so there was no reason for one of skill in the art to add the enteric layer.

Teaching Away 1 – Exam Guideline AA

35

From the 2010 Updated KSR Guidelines: Example 4.2. Crocs, Inc. v U S International Trade Commission 598 F 3d 1294 (Fed Cirv. U.S. International Trade Commission, 598 F.3d 1294 (Fed. Cir. 2010). A claimed combination of prior art elements may be nonobvious where the prior art teaches away from the claimed combination and the combination yields no more than predictable results. I ti C f t h i i ld d f b f Invention: Crocs footwear having a one-piece molded foam base for the top part of the shoe (upper) & and sole with a strap also made of foam attached to the foot opening of the upper, such that the strap could provide support to the Achilles portion of the wearer’s foot.

Modification: The strap was connected via connectors that allow it to be in contact with the base section & pivot; the foam strap did not fall under the force of gravity to a position adjacent to the heel of the base section.sect o

Nonobviousness: The Fed. Cir. found that the prior art taught against using foam as a material for the heel strap, so the results were not predictable.

Teaching Away 2 – Exam Guideline AA

36

From the 2010 Updated KSR Guidelines: Example 4.6. DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314 (Fed. Cir. 2009). Predictability as di d i KSR th t ti th i t l t bl f

( ) ydiscussed in KSR encompasses the expectation the prior art elements are capable of being combined, as well as the expectation that the combination would have worked for its intended purpose. An inference that a claimed combination would not have been obvious is especially strong where the prior art’s teachings undermine the very reason being proffered as to why a person of ordinary skill would have combined the known elements.

Invention: A polyaxial pedicle screw used in spinal surgeries that included a compression Invention: A polyaxial pedicle screw used in spinal surgeries that included a compression member for pressing a screw head against a receiver member.

Modification: The primary prior art reference (Puno) disclosed all the elements except the compression member, which was discussed in a secondary reference (Anderson).

Nonobviousness: The Fed. Cir. found that Puno taught away from the combination b P t ht th t i id i th lik lih d th t th ill f ilbecause Puno taught that a rigid screw increases the likelihood that the screw will fail within the human body rendering the device inoperative. Secondary considerations relating to the failure of others and copying also supported the finding that the combination was not obvious.

Teaching Away 1 – Exam Guideline BB

37

From the 2010 Updated KSR Guidelines: Example 4.11. Eisai Co. Ltd. v. Dr. Reddy’s Labs (Fed. Cir. 2008). A claimed compound would notv. Dr. Reddy s Labs (Fed. Cir. 2008). A claimed compound would not have obvious where there was no reason to modify the closest prior art lead compound to obtain the claimed compound and the prior art taught that modifying the lead compound would destroy its advantageous property. Any known compound may serve as a lead compound when there is some reason for starting with that lead compound and modifying it to obtain thereason for starting with that lead compound and modifying it to obtain the claimed compound.

Invention: Rabeprazole, a proton pump inhibitor for treating stomach ulcers and related disorders.

Modification: The prior art lansoprazole, useful for the same indications p p ,as rabeprazole, has a trifluoroethoxy substituent at the 4-position of the pyridine ring, while rabeprazole has a methoxypropoxy substituent. The trifluoro substituent of lansoprazole was known to be a beneficial feature because it conferred lipophilicity to the compound.

Nonobviousness: The Fed. Cir. found that despite the structural similarities, there was no reason to modify the lead compound; a skilled artisan would have expected that replacing the trifluoroethoxy substituent with a methoxypropoxy substituent would reduce the lipophilicity of the compoundcompound.

Teaching Away 2 – Exam Guideline BB

38

From the 2010 Updated KSR Guidelines: Example 4.12. Proctor & Gamble Co v Teva Pharmaceuticals USA Inc 566Proctor & Gamble Co. v. Teva Pharmaceuticals USA, Inc., 566 F.3d 989 (Fed. Cir. 2009). It is not necessary to select a single compound as a “lead compound” in order to support an obviousness rejection; however, where there was a reason to select and modify the lead compound to obtain the claimed compound, but

bl t ti f th l i d dno reasonable expectation of success, the claimed compound would not have been obvious.

Invention: Risedronate, the active ingredient of P&G’s osteoporosis drug Actonel, which inhibits bone resorption.

Modification: P&G’s prior art patents did not teach risedronate, but disclosed 36 similar compounds, including 2-pyr EHDP, as potentially useful with regard to osteoporosis.

Nonobviousness: The Fed Cir found that despite the disclosure Nonobviousness: The Fed. Cir. found that despite the disclosure of 2-pyr EHDP, there was no evidence that the necessary modifications to 2-pyr EHDP to obtain risedronate would have been routine and therefore, there was no reasonable expectation of success The Court also noted the unpredictable nature of the artsuccess. The Court also noted the unpredictable nature of the art.

Ordinary, not Extraordinary Skill –Exam Guideline CExam Guideline C

39

Factors pertinent to the level of skill element of the Grahamb i l i i l d (1) d ti l l l f thobviousness analysis include (1) educational level of the

inventor, (2) type of problems encountered in the art, (3) prior art solutions to those problems, (4) rapidity with which innovations are made, (5) sophistication of the technology, , ( ) p gy,and (6) education level of workers active in the field. Environmental Design, Ltd. v. Union Oil Co. of Calif., 713 F2d 693 (Fed. Cir. 1983).A f di kill i th t i “ h thi k l A person of ordinary skill in the art is “one who thinks along the line of conventional wisdom in the art and is not one who undertakes to innovate…” Standard Oil Co. v. American Cyanamid Co., 774 F.2d 448 (Fed. Cir. 1985). y , ( )

“A person of ordinary skill is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. 398, 421 (2007).

Common Knowledge Assertions –Exam Guideline DExam Guideline D

40

Useful for responding to Examination Guideline D. Where an Examiner chooses to take notice of facts beyond the

record for the prima facie case, those facts must be “capable of such instant and unquestionable demonstration as to defy dispute.” In re Alhert, 424 F.2d 1088, 1091 (CCPA 1970). It is not( )appropriate for an Examiner to take official notice of facts without citing a prior art reference where the facts asserted to be well-known are not capable of instant and unquestionable demonstration as being well-known. Id. For example, assertions of technical facts g pin esoteric technology or specific knowledge of the prior art must always be supported by citation to some reference work recognized as standard in the pertinent art. Id.; see also, MPEP § 2144.03, 8th

ed., Aug. 2001, Rev. Feb. 2003, pp. 2100-131-2100-132; In re g ppGrose, 592 F.2d 1161, 1167-1168 (CCPA 1979) (“[W]hen the PTO seeks to rely upon a chemical theory, in establishing a prima facie case of obviousness, it must provide evidentiary support for the existence and meaning of the theory.”). g y )

Not Obvious to Try1 – Exam Guideline EGuideline E

41

Useful for responding to Examination Guideline E.F th 2010 U d t d KSR G id li E l 4 15 T k d From the 2010 Updated KSR Guidelines: Example 4.15. Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed. Cir. 2007). A claimed compound would not have been obvious where it was not obvious to try to obtain it from a broad range of compounds, any one of which could have been selected as the lead compound for further in estigation and the prior art ta ght a a from sing a partic lar leadinvestigation, and the prior art taught away from using a particular lead compound, and there was no predictability or reasonable expectation of success in making the particular modifications necessary to transform the lead compound into the claimed compound.

Invention: Pioglitazone, a member of a class of drugs known as e t o og ta o e, a e be o a c ass o d ugs o asthiazolidinediones (TZDs) for treatment of type 2 diabetes.

Modification: A two-step modification of compound b; specifically, homologation & ring-walking.

Nonobviousness: The Fed Cir found that there was no reason to select Nonobviousness: The Fed. Cir. found that there was no reason to select compound b as the lead compound from the 54 compounds identified in Takeda’s prior patent and the 100-million other compounds generally disclosed. Although compound b was the closest prior art, one reference taught disadvantages associated with compound b.

Not Obvious to Try 2 – Exam Guideline EGuideline E

42

Useful for responding to Examination Guideline E.F th 2010 U d t d KSR G id li E l 4 19 R ll From the 2010 Updated KSR Guidelines: Example 4.19. Rolls-Royce, PLC v. United Technologies Corp., 603 F.3d 1325 (Fed. Cir. 2010). An obvious to try rationale may be proper when the possible options for solving a problem were known and finite; however if the possible options were not either known or finite thenhowever, if the possible options were not either known or finite, then an obvious to try rationale cannot be used to support a conclusion of obviousness.

Invention: A fan blade for jet engines. Modification: The sweep angle in the outer region was reversed Modification: The sweep angle in the outer region was reversed

as compared with prior art fan blades from rearward to forward sweep, in order to reduce endwall shock.

Nonobviousness: The Fed. Cir. found the fan blade not obvious to try because the possible options for solving a problem must have been “known and finite.” In this case, there was no suggestion in the prior art that changing the sweep angle would have addressed the issue of endwall shock.

TSM:No Reasonable Expectation of Success Exam Guideline G43

The Court of Appeals for the Federal Circuit has explained that the rationale to support a conclusion that a claim would have beenrationale to support a conclusion that a claim would have been obvious is that ‘‘a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and that there would have been a reasonable expectation of success ’’ USPTO Examination Guidelines 72 Fed Reg 195success. USPTO Examination Guidelines, 72 Fed. Reg. 195 (2007) quoting DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006).

A showing of obviousness requires a motivation or suggestion to combine or modify prior art references, coupled with a reasonable expectation of success…“While absolute certainty is not necessary to establish a reasonable expectation of success, [citations omitted] p [ ]there can be little better evidence negating an expectation of success than actual reports of failure.” Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339 (Fed. Cir. 2003). )

Unexpected Results –All Exam GuidelinesAll Exam Guidelines

44

Most commonly used in chemical/biotech cases. Rebuttal of a case of prima facie obviousness based on structural

similarity can consist of a comparison of test data showing that the claimed compositions possess unexpectedly improved properties or properties that the prior art does not have. In re Dillon, 919 F.2d p p p688 (Fed. Cir. 1990) (en banc), cert. denied, 500 U.S. 904 (1991).

That a claimed combination (e.g., of A and B) showed an additive result when a diminished result would have been expected is persuasive of nonobviousness even though the result may be equalpersuasive of nonobviousness even though the result may be equal to that of one component alone. In re Corkill, 771 F.2d 1496 (Fed. Cir. 1985). (Helpful if rebuttal arguments of unexpected results are based on the unexpected synergistic effect of the claimed combination )combination.)

“Given a presumption of similar properties for similar compositions, substantially improved properties are ipso facto unexpected.” In re Soni, 54 F.3d 746 (Fed. Cir. 1995).

Hindsight Reconstruction 1 –All Exam GuidelinesAll Exam Guidelines

45

It is well-established that an obviousness analysis that relies upon the applicant’s disclosure rather than the prior art reference isthe applicant s disclosure rather than the prior art reference is improper as being based upon an impermissible hindsight reconstruction. In re Deuel, 51 F.3d 1551, 1558 (Fed. Cir. 1995).

A single line in a prior art reference should not be taken out of g pcontext and relied upon with the benefit of hindsight. Bausch & Lomb, Inc. v. Barnes-Hind/Hydrocurve, Inc., 796 F.2d 443 (Fed. Cir. 1986).

Using the inventor’s success as evidence that one or ordinary skill Using the inventor s success as evidence that one or ordinary skill in the art would have reasonably expected success represents an impermissible use of hindsight. Life Technologies, Inc. v. Clontech Laboratories, Inc., 224 F.3d 1320 (Fed. Cir. 2000). “The invention must be viewed not with the blueprint drawn by the “The invention must be viewed not with the blueprint drawn by the inventor, but in the state of the art that existed at the time.” Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1138 (Fed. Cir. 1985).

Hindsight Reconstruction 2 –All Exam GuidelinesAll Exam Guidelines

46

One cannot use hindsight reconstruction to pick and choose among isolated disclosures in the prior art to deprecate the claimed invention In re Fine 837 F 2ddisclosures in the prior art to deprecate the claimed invention. In re Fine, 837 F.2d 1071 (Fed. Cir. 1988); In re Fritch, 972 F.2d 1260 (Fed. Cir. 1992). (Exam Guidelines A)

It is impermissible to engage in a hindsight reconstruction of the claimed invention by using the applicant’s structure as a template and selecting elements from references t fill i th I G 933 F 2d 892 (F d Ci 1991) (E G id li B)to fill in the gaps. In re Gorman, 933 F.2d 892 (Fed. Cir. 1991). (Exam Guideline B)

The combination of elements from nonanalogous sources, in a manner that reconstructs the applicants invention only with the benefit of hindsight, is insufficient to present a prima facie case of obviousness. In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). (Exam Guideline F)USPQ2d 1443 (Fed. Cir. 1992). (Exam Guideline F)

A retrospective view of inherency is not a substitute for some teaching or suggestion that supports the selection and use of the various elements in the particular claimed combination. In re Newell, 891 F.2d 899 (Fed. Cir. 1989). (Exam Guideline G)

Both the suggestion and the reasonable expectation of success “must be founded in gg pthe prior art, not in the applicant’s disclosure.” In re Vaeck, 947 F.2d 488, 473 (Fed. Cir. 1991). (Exam Guideline G)

Conclusion47

Review the Examination Guidelines to determine which line of reasoning the Examiner used to organize the OAthe Examiner used to organize the OA.

Determine the legal framework for the OA response based upon the Examination Guideline or Guidelines used by the Examiner.

Review the application to see if it addresses a problem that was not known. Review prior art references for discussions that teach away from the

invention. Request verification of all common knowledge or judicial notice assertions. If appropriate present evidence of unexpected results & argue hindsight If appropriate, present evidence of unexpected results & argue hindsight

reconstruction. With TSM arguments, emphasize that the ordinary artisan would have no

reasonable expectation of success of arriving at the claimed invention from a reading of the cited referencesa reading of the cited references.

If the inventor’s own work is being cited against the application, argue that the art being cited represents the efforts of an extraordinary artisan.

Karen Canaan

48

Karen CanaanCanaanLaw, P.C.

[email protected]

lwww.canaanlaw.com

Obviousness Standard for Patents and New USPTO GuidelinesNew USPTO Guidelines

Strategies to Withstand Obviousness Rejections and Attacks on ValidityRejections and Attacks on Validity

TOM IRVING STACY LEWIS

JANUARY 12 , 2011

©Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, 2011

The US PTO Is Not Las Vegas!

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You can improve your odds!!

How?

Study the post-KSR “lead compound” cases from theStudy the post KSR lead compound cases from the Federal Circuit, and use the rationale to argue against obviousness arguments from the US PTO (or opposing parties in litigation!) in all technologies.

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Let’s Have A Look

Example: the US PTO examines the claims then by Example: the US PTO examines the claims, then, by hindsight, picks the closest prior art. The examiner states that a prima facie case of obviousness hasstates that a prima facie case of obviousness has been made, and you now have to show unexpected results to overcome the rejection.

What do you do?

Use the Federal Circuit “no lead compound” case

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law, no matter what technology !

“Lead Compound” Case Law

The “lead compound” cases have strong origins in The “lead compound” cases have strong origins in drug patent litigations involving patent claims covering active ingredients of drug productscovering active ingredients of drug products approved by US FDA.

Let us examine those cases.

Why do those cases have to be limited to drug active ingredient claims?

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Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075 (Fed. Cir. 2008)2008) Was clopidogrel bisulfate (brand name Plavix®) obvious in view of its

known racemate (mixture of the approved clopidogrel and its mirror image)?image)?

District court bench trial: patent valid and enforceable. “the wide range of possible outcomes and the relative unlikelihood that

the resulting compound would exhibit the maximal increase in anti-platelet aggregation activity and the absence of neurotoxicity makes clopidogrel bisulfate non-obvious.”

Federal Circuit: Affirmed. Federal Circuit: Affirmed. Unexpected and unpredictable properties of clopidogrel.

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Multiple choices faced inventors (80 acids as candidates for forming salts with basic drug g gcompounds) Mechanical? Electrical?

Unpredictable result when combining elements (whether a pharmaceutically suitable crystalline salt will form from a particular acid-base combination is unpredictable)combination is unpredictable)

Properties do not teach process (“recognition that stereoisomers may exhibit different propertiesthat stereoisomers may exhibit different properties does not teach which results may ensue or how to separate any given enantiomers.”)p y g )

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Post-KSR Cases: Prior Art Did Not Indicate Lead Compound

•Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed Cir 2007) cert denied 128 S Ct 1739 (March 31 2008)

o t d ot d cate ead Co pou d

(Fed. Cir. 2007), cert. denied, 128 S.Ct. 1739 (March 31, 2008)

• Prior art: A patent describing genus of millions of compounds

• Situation was not one with “a finite number of identified, predictable solutions”

•“Rather than identify predictable solutions for antidiabetic treatment, h i di l d b d l i f d f hi hthe prior art disclosed a broad selection of compounds any one of which

could have been selected as a lead compound for further investigation.”

• Basis for obviousness prior art “compound b” was not suggested to• Basis for obviousness, prior art compound b , was not suggested to be best, and in fact, exhibited negative properties that would have directed one skilled in the art away from that compound.

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Mechanical? Electrical?


Procter & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989


(Fed. Cir. 2009)

Claim: risedronate (osteoporosis drug Actonel®).( p g )

P&G’s expired patent listed 36 polyphosphonate molecules as osteoporosistreatment candidates and 8 preferred compounds for intermittent dosing,p p g,including X (positional isomer of claimed risedronate).

District court: No evidence that the expired patent would “have District court: No evidence that the expired patent would haveled a person of ordinary skill in the art to identify [X] as thelead compound.” Skilled artisan would not have been motivated to make the specificp

molecular modifications to X to make risedronate.

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What Did P&G Show?

P&G (con’t)Unpredictable nature (“extremely unpredictable nature of Unpredictable nature (“extremely unpredictable nature ofbisphosphonates at the time of the invention”; “properties ofbisphosphonates could not be anticipated based on their structure.”)

Unique nature (“every compound, while remaining abisphosphonate, exhibits its own physical-chemical, biological andtherapeutic characteristics, so that each bisphosphonate has to beconside ed on its o n To infe f om one compo nd the effects inconsidered on its own. To infer from one compound the effects inanother is dangerous and can be misleading.”

No reasonable expectation [at time of the invention] that No reasonable expectation [at time of the invention] thatrisedronate would be a successful compound.

Unexpected results of risedronate's potency and toxicity andsecondary considerations of non-obviousness.

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P&G (con’t)


Federal Circuit: Affirmed nonobviousness.

T-S-M test still useful if not rigidly applied.

“under KSR, ‘it remains necessary to identify somereason that would have led a chemist to modifya known compound in a particular manner toa known compound in a particular manner toestablish prima facie obviousness of a new claimedcompound.’ Takeda Chem. Indus., Ltd. v. Alphapharm

d 92 3d 3 0 3 ( d C 200 ) ”Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007).”

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P&G (con’t)


P&G (con t)Federal Circuit: (con’t)

“An obviousness argument based on structural An obviousness argument based on structuralsimilarity between claimed and prior art compounds‘clearly depends on a preliminary finding that one of

di kill i th t ld h l t dordinary skill in the art would have selected[the prior art compound] as a lead compound.’”

Teva argued prior art patent identified X as the mostpromising compound; District court had disagreed.

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P&G (con’t)


P&G (con t)Federal Circuit: (con’t)

Declined to address whether X was most promising:Declined to address whether X was most promising: “even if [X] was a lead compound, the evidence

does not establish that it would have been obviousf di kill h i f hto a person of ordinary skill at the time of the

invention to modify [X] to create risedronate.”

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Daiichi Sankyo Co Ltd v Matrix Laboratories


Daiichi Sankyo Co., Ltd. v. Matrix Laboratories, Ltd., 619 F.3d 1346 (Fed. Cir. 2010) Federal Circuit: Affirmed nonobviousness.Federal Circuit: Affirmed nonobviousness.

“We agree with Daiichi that the district court did not err in holding that Mylan failed to establish a prima facie case of obviousness. Specifically, we agree that Mylan failed toobviousness. Specifically, we agree that Mylan failed to show that one of ordinary skill in the art would have been motivated to select the '902 ARBs as lead compounds or, even if they had, that the skilled artisan p , y ,would have been motivated to modify the '902 compounds to synthesize olmesartan medoxomil, the claimed invention.”

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Prior Art Suggested Lead Compound OTHER THAN Structurally Closest Compound

Daiichi (con’t)

THAN Structurally Closest Compound

Daiichi (con t) Federal Circuit: “Nevertheless, the court found that a

medicinal chemist of ordinary skill would not have beenmedicinal chemist of ordinary skill would not have been motivated to select the '902 compounds over other second-generation ARBs, including L-158,809, DuP 532,second generation ARBs, including L 158,809, DuP 532, the Eisai compounds, and valsartan, because many of the latter ARBs demonstrated greater potency and all had been more thoroughly studied than the '902 ARBs.” (emphasis added)

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Prior Art Suggested Lead Compound OTHER THAN Structurally Closest Compound

Daiichi (con’t)

THAN Structurally Closest Compound

Daiichi (con t) Federal Circuit: “Specifically, the court found that L-158,809

had 180 times, Example 7 of the Eisai compounds had 100 times, and DuP 532 had seven times the potency of losartan. … The court also found that while the [prior art patent] disclosed in vivo oral activity the prior art included not only data ondisclosed in vivo oral activity, the prior art included not only data on oral activity for all but the Eisai compounds, but also data on the binding affinity and intravenous activity for L-158,809, the Eisai

d D P 532 d l t ll l ti it d t f Lcompounds, DuP 532, and valsartan as well as selectivity data for L-158,809 and DuP 532. …Finally, the court found that DuP 532, which shared losartan's imidazole-biphenyltetrazole backbone, could also

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benefit from the ‘069 patent’s SAR data.”


Daiichi (con’t)


Daiichi (con t) Federal Circuit: “Mylan argues that because the '902

ARBs are undisputedly the closest prior art, that ‘should have been dispositive of the lead compound issue.’ …That argument runs contrary to our case law. In Takeda we upheld a co a y o ou case a a eda e up e d adistrict court's finding that one of skill in the art would not have chosen the structurally closest prior art compound compound b as the lead compound incompound, compound b, as the lead compound in light of other compounds with more favorable characteristics.”

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Cannot Pick Lead Compound in Hindsight

Daiichi (con’t)( ) Federal Circuit: “These cases illustrate that it is the

possession of promising useful properties in a lead compo nd that moti ates a chemist to makecompound that motivates a chemist to make structurally similar compounds. Yet the attribution of a compound as a lead compound after the fact must avoid hindsight bias; it must look at the state of the art at the time the invention was made to find a motivation to select and thenwas made to find a motivation to select and then modify a lead compound to arrive at the claimed invention.”

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Must Prove Reason To Select Lead Compound

Daiichi (con’t) Federal Circuit: Federal Circuit:

“Accordingly, proving a reason to select a compound as a lead compound depends on more than just structural similarity, but also knowledge in the art of the functionalbut also knowledge in the art of the functional properties and limitations of the prior art compounds. See Eli Lilly, 471 F.3d at 1377-79. Potent and promising activity in the prior art trumps mere structural relationships.”

“While the lead compound analysis must, in keeping with KSR, not rigidly focus on the selection of a single, best lead compound, …the analysis still requires the challenger to demonstrate by clear and convincing evidence that one of ordinary skill in the art would have had a reason to select a proposed lead compound or compounds over other compounds

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proposed lead compound or compounds over other compounds in the prior art. ”

Petition for certiorari filed: more later…

KSR Framework To Analyze Prior Art

Ei i C Ltd D R dd ’ L b Ltd 533 Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd., 533F.3d 1353 (Fed. Cir. 2008)

Eisai patent claims rabeprazole and its salts, soldas ACIPHEX®

DC: Patents valid enforceable and infringedDC: Patents valid, enforceable, and infringed.

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KSR Framework To Analyze Prior Art

Eisai (con’t) Federal Circuit: Affirmed.

KSR framework: Are there starting reference points “in the art, prior to the time of Are there starting reference points in the art, prior to the time of

invention, from which a skilled artisan might identify a problem and pursue potential solutions”

Does “the record up to the time of invention . . . give some reasons, available within the knowledge of one of skill in the art, to make particular modifications to achieve the claimed compound”?

“ f i th i t i t ‘fi it• “reasons for narrowing the prior art universe to a ‘finite number of identified, predictable solutions’”

“this ‘easily traversed small and finite number of alternatives this easily traversed, small and finite number of alternatives . . . might support an inference of obviousness.’”

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No Lead Compound

Eisai (con’t)( )

Federal Circuit (con’t):

“In other words, post-KSR, a prima facie case of obviousness for a chemical compound still, in general, begins with the reasoned identification of a lead compound.”

Teva cannot create a genuine issue of material fact on obviousness through the unsupported assertion that compounds other than lansoprazole might have served as lead compounds.

“The record contains no reasons a skilled artisan would have considered modification of lansoprazole … as an identifiable, predictable solution.”

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Post-KSR Cases: Inventors Faced Multiple Choices

•Ortho-McNeil Pharms. Inc. v. Mylan Labs., Inc., 520 F.3d 1358 (Fed. Cir. 2008)

e to s aced u t p e C o ces

2008)

• Patent claims the anticonvulsive drug topiramate nonobvious. • Federal Circuit:

•“even if an ordinarily skilled artisan sought an FBPase inhibitor, that person would not have chosen topiramate. Moreover this invention, … does not present a finite (and small in the context of the art) number of options easily traversed to show obviousness.”

• Record shows that a person of ordinary skill would not even be likely to start with the compound that the inventor did.

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Post-KSR Cases: Inventors Faced Multiple Choicese to s aced u t p e C o ces

•Ortho-McNeil Pharms (con’t)

• Federal Circuit (con’t):• Beyond that, “the ordinarily skilled artisan would have to have some reason to select (among several unpredictable alternatives) the exact route that produced topiramate as an intermediate. Even beyond that, the ordinary artisan in this field would have had to (at the time f i ti ith t l f t ti l tilit f t i t ) tof invention without any clue of potential utility of topiramate) stop

at that intermediate and test it for properties far afield from the purpose for the development in the first place (epilepsy rather than diabetes) ”rather than diabetes).

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Hindsight Reasoning “Always Inappropriate”

•Ortho-McNeil (con’t)

•Federal Circuit:• “In sum, this clearly is not the easily traversed, small and finite number of alternatives that KSR suggested might support an inference of obviousness.”gg g pp

•“Mylan's expert… simply retraced the path of the inventor with hindsight, discounted the number and complexity of the alternatives, and concluded that the invention of topiramate was obvious Of course this reasoning isthat the invention of topiramate was obvious. Of course, this reasoning is always inappropriate for an obviousness test based on the language of Title 35 that requires the analysis to examine “the subject matter as a whole” to ascertain if it “ would have been obvious at the time the invention was made.” 35 U.S.C. § 103(a) (emphasis added). In retrospect, Dr. Maryanoff's pathway to the invention, of course, seems to follow the logical steps to produce these properties, but at the time of invention, the inventor's insights willingness to confront and overcome obstacles and yes even

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insights, willingness to confront and overcome obstacles, and yes, even serendipity, cannot be discounted.” (emphasis added)

Post-KSR Cases: Lead Compound and Obviousness

•Altana Pharma v Teva 566 F 3d 999 (Fed Cir 2009)•Altana Pharma v. Teva, 566 F.3d 999 (Fed. Cir. 2009)

• Affirm denial of preliminary injunction.

• The patent in suit is directed to the compound pantoprazole, the active ingredient in Altana's antiulcer drug Protonix®.

•The compound pantoprazole belongs to a class of compounds known as proton pump inhibitors (“PPIs”) that are used to treat gastric acid disorders in the stomach.

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•Altana (con’t)Altana (con t)• The operation of the gastric acid pump was known at the time of the invention at issue.

• The mechanism by which PPIs inhibit the gastric acid pump was not understood in the art until after the effective filing date of the ′ 579 patent.

•Part of the uncertainty surrounding the method of action for PPIs is attributable to the fact that PPIs are prodrugs, which are drugs that con e t to thei acti e fo m afte the a e deli e ed ithin a patient'sconvert to their active form after they are delivered within a patient's body.

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•Altana (con’t)•Altana (con t)

• The first commercialized PPI compound was omeprazole, sold as Prilosec®.Prilosec .

• Prior art developing new PPIs disclosed 18 compounds and tested them against 4 prior art compounds.

•Pantoprazole, the compound at issue in the litigation, exhibits a structure that is very similar to one of those 18 prior art compounds.

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•Altana (con’t)( )

• The only structural difference between one of those 18 prior art compounds and pantoprazole is the presence of a bridging oxygen atom

lin pantoprazole

• The defendants urged that that prior art compound (compound 12) was the lead compound and pieced together a scientific12) was the lead compound and pieced together a scientific story to modify that compound to achieve Pantoprazole.

•The court found that one of skill in the art would have selected•The court found that one of skill in the art would have selected compound 12 as a lead compound for modification.

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•Altana (con’t)( )

• Altana argued that the prior art suggested the availability of numerous other compounds that were at least as promising to modify as compound 12.

• But the prior art claimed that its compounds, including 12, were improvements over the prior artwere improvements over the prior art

•Compound 12 was disclosed as one of the more potent of the 18 compounds in the prior art and the patent examiner relied on18 compounds in the prior art, and the patent examiner relied on those prior art compounds during prosecution of the patent-in-suit.

78



• An expert testified that the prior art with compound 12 was on the cutting edge of PPI at the relevant time.the cutting edge of PPI at the relevant time.

• The expert testified that one skilled in the art would have picked those 18 compounds over Omeprazole® for further development of PPIs.

•District court accepted that testimony over Altana’s expert, who said further PPI development would focus on Omeprazole®.

79



• Compound 12 was found to be a natural choice for further development efforts because it was one of the more potent prior art PPI compounds,efforts because it was one of the more potent prior art PPI compounds, and Altana itself had selected compound 12 for further development efforts.

•Altana suggests that the prior art must point to only a single lead compound for further development but that would present a rigid test similar to the teaching-suggestion-motivation test h h S C li i l j d i Sthat the Supreme Court explicitly rejected in KSR.

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•Abbott Labs v Sandoz Inc 544 F 3d 1341 (Fed Cir 2008) reh’g denied•Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341 (Fed. Cir. 2008), reh g denied(2009)

• Drug delivery invention.Drug delivery invention. • Abbott’s choice of components not shown or suggested by the prior art.

•“Abbott stressed the difference between new biological compositions whose f d ff ti i bi ti t b fid tl di t dperformance and effectiveness in combination cannot be confidently predicted

but must be made and evaluated[.]”

•Prior art showed “’scores’” of possible formulations” and “more than a pdozen possible classes of delivery devices” .

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•In re Omeprazole Patent Litigation, 536 F.3d 1361 (Fed. Cir. 2008)

• Formulation invention.

•“The district court gave lengthy consideration to the multiple paths that would have faced a person of ordinary skill in the art who recognized the stability problem resulting from a directly applied enteric coating.”

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KSR USPTO Guidelines

Example 4.14 from the September 1 2010 Guidelines: In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009): “Kubin stated that KSR ‘resurrects’ the Federal Circuit’s own wisdom in O’Farrell, in

which ‘to differentiate between proper and improper applications of ‘obvious to try,’ ’ the Federal Circuit ‘outlined two classes of situations where ‘obvious to try’ isthe Federal Circuit ‘outlined two classes of situations where ‘obvious to try’ is erroneously equated with obviousness under § 103.’ Kubin, 561 F.3d at 1359. These two classes of situations are: (1) When what would have been ‘obvious to try’ would have been to vary

ll h f ibl h i ilall parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful; and

(2) when what was ‘obvious to try’ was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it. Id. (citing O’Farrell, 853 F.2d at 903).” 75 Fed. Reg. 53643, 53653 (Sept. 1, 2010).

83

U.S. PTO AFTER KSR

Ex Parte SUBRAMANYAM (BPAI March 29 Ex Parte SUBRAMANYAM (BPAI March 29, 2010)

Rejected claim: toothpaste with Rejected claim: toothpaste with antibacterial effective amount of compound I.p

Would an ordinary artisan have chosen tetrahydrohonokiol out of all of the polyols found in the plant extracts disclosed by the prior art?

84

U.S. PTO AFTER KSR

Ex Parte SUBRAMANYAM (BPAI March 29, 2010)

BPAI: “While the analysis under 35 U.S.C. § 103 allows flexibility in determining whether a claimed invention would have been obvious KSR it stillinvention would have been obvious, KSR …it still requires showing that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” Id. “We must still be careful not to allow hindsight reconstruction of references to reach the claimed invention without any explanation as to how or why the references would be combined to produce the claimed invention ”combined to produce the claimed invention.

85

U.S. PTO AFTER KSR

Ex Parte SUBRAMANYAM (con’t)Ex Parte SUBRAMANYAM (con t)

Board: Reversed.

For prima facie case, “not only must the structural i il it i t b h i l idsimilarity exist, but the prior art must also provide

reason or motivation to make the claimed compound.”

86

U.S. PTO AFTER KSR

Ex Parte SUBRAMANYAM (con’t)

Board: Reversed.

Claimed compound is structurally similar to a polyol disclosed by Ning Claimed compound is structurally similar to a polyol disclosed by Ning, which is one polyol among many other polyols disclosed by Ning to be found in the plant extracts taught by that reference.

“Such structural similarity, alone, however, is insufficient to establish a prima facie case of obviousness, as there must be some reason that would have led the ordinary artisan to the compound required by the l i Th E i h h t id d idclaims. The Examiner, however, has not provided any evidence or any

reason as to why the ordinary artisan would have picked tetrahydrohonokiol out of all of the polyols found in the plant extracts disclosed by Ning as a lead compound.”y g p

87

U.S. PTO AFTER KSR

Ex Parte SUBRAMANYAM ( ’t) Ex Parte SUBRAMANYAM (con’t)

Board: “We conclude that the Examiner has not established a Board: We conclude that the Examiner has not established a prima facie case that the ordinary artisan would have chosen tetrahydrohonokiol out of all of the polyols found in the plant extracts disclosed by Ning as a leadfound in the plant extracts disclosed by Ning as a lead compound to arrive at the claimed compositing requiring an antibacterial effective amount of a compound of structure (I).”

88

Use Rationale

Is there a reasoned identification of a lead Is there a reasoned identification of a leadcandidate in the prior art? Or might multiplecandidates be possible?candidates be possible? Must be more than an unsupported assertion.

Any reason a skilled artisan would haveconsidered modification of the prior art andexpected the invention as an identifiable,predictable solution?

89

Think Back to The Example…

Example: the US PTO examines the claims Example: the US PTO examines the claims, then, by hindsight, picks the closest prior art The examiner states that a prima facieart. The examiner states that a prima facie case of obviousness has been made, and you now have to show unexpected results toyou now have to show unexpected results to overcome the rejection.

90

Use Your Ammunition!

Conclusion: It is unacceptable for USPTO to pick closest prior t i hi d i htart in hindsight.

Use “no lead compound” rationale to attack rejection.

No acceptable reasoning for picking applied prior art out of “scope and content of the prior art.” Graham v. John Deere.

Not “lead prior art.”

Th f t l t t ll t h l i “ l d” f l ti Therefore, extrapolate to all technologies, “no lead” formulation, device, circuit . . . .

91

Opposition?

Mylan v Daiichi pet for cert filed Dec 8 2010 Mylan v. Daiichi, pet. for cert. filed Dec. 8, 2010

Petition: “Whether, contrary to this Court’s decision in , yKSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Federal Circuit has erred in applying a "lead compound test" as the exclusive standard for pdetermining whether a patent claim directed to a new chemical compound is "obvious" and therefore invalid under 35 U.S.C. § 103(a).” (emphasis added)§ ( ) ( p )

Note the attempt to shoe horn Daiichi into KSR’s T-S-M issue

92

issue.

“Lead Compound” Test

Mylan (con’t) Mylan (con’t) “the lead compound test requires a challenger to

establish that one of ordinary skill in the art would haveestablish that one of ordinary skill in the art would have been motivated in two specific ways: (1) to select the lead compound and (2) to modify the lead compound to arrive at the claimed compound ”arrive at the claimed compound.

“The two parts are not alternatives; a challenger must The two parts are not alternatives; a challenger must satisfy both prongs to establish a prima facie case of obviousness.”

93

“Lead Compound Test Too Rigid and Sets Impossibly High Standard”p y g

M l ( ’t) Mylan (con’t) “[The Federal Circuit] has rejected every structural

ob io sness challenge to a patent claiming a ne chemicalobviousness challenge to a patent claiming a new chemical compound since Congress passed the Act in 1984. This long-standing pattern has crystallized more recently withlong standing pattern has crystallized more recently with the Federal Circuit’s consistent application of a "lead compound" test as the exclusive, rigid standard for determining obviousness of chemical compound patent claims.”

94

“Lead Compound Test Too Rigid and Sets Impossibly High Standard”p y g

M l ( ’t) Mylan (con’t) “This analysis was not initially intended to be a specialized

ob io sness test b t o e time it became canoni ed bobviousness test, but over time it became canonized by mechanical application in the district courts and the Federal Circuit. As applied after KSR, the lead compound test nowCircuit. As applied after KSR, the lead compound test now stands in defiance of this Court’s holding in KSR that the question of obviousness should be addressed with an expansive and flexible approach.” (footnote omitted)

95

Higher Standard for Compound Cases

Mylan (con’t)Mylan (con t) “Applying the lead compound test rigidly, the Federal Circuit has found

nonobviousness in each and every chemical compound patent case since KSR In contrast for example the court has found two out of threeKSR. In contrast, for example, the court has found two out of three pharmaceutical method-of-treatment patents obvious over the same time period. As the following table demonstrates, the Federal Circuit is effectively applying a much higher standard to chemical compounds thanis effectively applying a much higher standard to chemical compounds than it does to other inventions, even within the chemical arts.”

Compound cases Outcome Method of treatment cases Outcome

Takeda Non-obvious Daiichi (2007) Obvious

Eisai Non-obvious PharmStem Obvious

Ortho-McNeil Non-obvious Eli Lilly Non-obvious

Procter & Gamble Non-obvious

96

Procter & Gamble Non-obvious

Daiichi (2010) Non-obvious

Argue For “Case-By-Case” Approach

M l ( ’t) Mylan (con’t) “Instead of using the lead compound test, chemical compound

patent claims should be evaluated on a case-by-case basis withpatent claims should be evaluated on a case by case basis, with less focus on ‘predictability’ per se of the claimed compound and greater focus on whether the claimed compound was ‘obvious to try’ to a chemist of ordinary skill. Such an approach is consistent with the flexible analysis KSR requires, and it is especially vital in the chemical arts where, to chemists of ordinary skill, structurethe chemical arts where, to chemists of ordinary skill, structure and activity may not be entirely predictable, but the claimed structure is obvious to try in a methodical trial-and-error process.”

97

“Rigid Application of the Lead Compound Test Undermines Fundamental Policies of the Patent and Drug Laws”

M l ( ’t) Mylan (con’t) “The Federal Circuit is imposing an obviousness standard for new

chemical compounds that is analytically inflexible and practicallychemical compounds that is analytically inflexible and practically impossible to meet. This standard indicates a disconnect between how a chemist creates new compounds and the obviousness standard used by the courts and the Patent and Trademark Office ("PTO") to determine whether that chemist’s work was truly non-obvious and, thus, patent-worthy. If the standard for obviousnessobvious and, thus, patent worthy. If the standard for obviousness in these cases is overly rigid and impracticable, then the validity of every patent claim reciting the active ingredient of a branded d ill b j ifi bl il bl d § 103( ) ”

98

drug will be unjustifiably unassailable under § 103(a).”

Criticism of US PTO Guidelines

Mylan (con’t) Mylan (con’t) “This trend is further perpetuated by the PTO’s adoption of

the lead compound analysis in its 2010 PTO Guidelines forthe lead compound analysis in its 2010 PTO Guidelines for patent examiners. … Although the PTO mentions that six rationales in addition to the TSM test can be used to support an obviousness determination, most of the chemical compound cases appear under the lead compound analysis. Without direction from Congress or this Court toanalysis. Without direction from Congress or this Court to refrain from an overly rigid lead compound analysis, the infection that pervades the courts will continue to spread h h h PTO ll ”

99

through the PTO as well.”

What Did Daiichi Say?

D ii hi (2010) Daiichi (2010) “Yet the attribution of a compound as a lead compound

ft th f t t id hi d i ht bi it t l k tafter the fact must avoid hindsight bias; it must look at the state of the art at the time the invention was made to find a motivation to select and then modify a leadfind a motivation to select and then modify a lead compound to arrive at the claimed invention. ”

100

What Did Daiichi Say?

D ii hi (2010) Daiichi (2010) “While the lead compound analysis must, in keeping with

KSR t i idl f th l ti f i l b tKSR, not rigidly focus on the selection of a single, best lead compound, see Altana Pharma, 566 F.3d at 1008,the analysis still requires the challenger to demonstratethe analysis still requires the challenger to demonstrate by clear and convincing evidence that one of ordinary skill in the art would have had a reason to select a proposed lead compound or compounds over other compounds in the prior art.”

101

Use the post-KSRUse the post KSRpharma/med device rationales torationales to establish non-

obviousness at theobviousness at the USPTO and

establish “no establish no demonstration of obviousness” in litigation.

102

obviousness in litigation.

Which Chart Do You Prefer?

8/31 5/17

23/31 12/17

Court of Appeals for the Federal Circuit post KSR published decisions Current to Nov 18 2010

103

Court of Appeals for the Federal Circuit post-KSR published decisions. Current to Nov. 18, 2010.

Thank you.T I iTom Irving

[email protected]

104

Appendix to SlidesT I iTom Irving

[email protected]

105

New Guidelines: Combining Prior Art Elements

post-KSR cases have held such combinations to be nonobvious “when the combination requires a greater expenditure of time effort orthe combination requires a greater expenditure of time, effort, or resources than the prior art teachings.”

Case Cite Notes

h l h d h ld h b li d k h l i d d kIn re Omeprazole Patent Litigation

536 F.3d 1361 (Fed. Cir. 2008)

Even where a general method that could have been applied to make the claimed product was known and within the level of skill of the ordinary artisan, the claim may nevertheless be nonobvious if the problem which had suggested use of the method had been previously unknown.

Crocs Inc. v. International Trade Commission

598 F.3d 1294 (Fed. Cir. 2010)

“[M]erely pointing to the presence of all claim elements in the prior art is not a complete statement of a rejection for obviousness.”

Sundance Inc. v. DeMonte Fabricating Ltd.

550 F.3d 1356 (Fed. Cir. 2008)

A claimed combination of prior art elements may be nonobvious where the prior art teaches away from the claimed combination and the combination yields more than predictable results.

Ecolab Inc. v. FMC Corp.

569 F.3d 1335 (Fed Cir. 2009)

A combination of known elements would have been prima facie obvious if an ordinarily skilled artisan would have recognized an apparent reason to combine those elements and would have known how to do sodo so.

Wyers v. Master Lock Co.

No. 2009-1412—F.3d-- (Fed. Cir. July 22, 2010)

The scope of analogous art is to be construed broadly and includes references that are reasonably pertinent to the problem that the inventor was trying to solve. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning.

DePuy Spine Inc. v. Medtronic Sofamor

567 F.3d 1314 (Fed. Cir 2009)

Predictability as discussed in KSR encompasses the expectation that prior art elements are capable of being combined, as well as the expectation that the combination would have worked for its intended Medtronic Sofamor

Danek Inc.Cir. 2009) being combined, as well as the expectation that the combination would have worked for its intended

purpose. An inference that a claimed combination would not have been obvious is especially strong where the prior art’s teachings undermine the very reason being proffered as to why a person of ordinary skill would have combined the known elements.

106

New Guidelines: Substituting One Known Element for AnotherElement for Another

“applies when the claimed invention can be viewed as resulting from substituting a known element for an element of a prior art invention”element for an element of a prior art invention

Case Cite Notes

In re ICON Health & Fitness Inc.,

496 F.3d 1374(Fed. Cir. 2007)

When determining whether a reference in a different field of endeavor may be used to support a case of obviousness (i.e., is analogous), it is necessary to consider the problem to be solved.

Agrizap v. W d t

520 F.3d 1337(F d Ci 8)

Analogous art is not limited to references in the field of endeavor of the invention, but also includes references that ld h b i d b th f di kill i th t f l f li t’ Woodstream (Fed. Cir. 2008) would have been recognized by those of ordinary skill in the art as useful for applicant’s purpose.

Muniauction Inc. v. Thomson Corp.

532 F.3d 1318 (Fed. Cir. 2008)

Because Internet and Web browser technologies had become commonplace for communicating and displaying information, it would have been obvious to adapt existing processes to incorporate them for those functions.

Aventis Pharma 499 F.3d 1293 A chemical compound would have been obvious over a mixture containing that compound as well as other Aventis Pharma Deutschland v. Lupin Ltd.

499 F.3d 1293(Fed. Cir. 2007)

A chemical compound would have been obvious over a mixture containing that compound as well as other compounds where it was known or the skilled artisan had reason to believe that some desirable property of the mixture was derived in whole or in part from the claimed compound, and separating the claimed compound from the mixture was routine in the art.

Eisai Co. Ltd. v. Dr. Reddy's Laboratories Ltd.

533 F.3d 1353(Fed. Cir. 2008)

A claimed compound would not have been obvious where there was no reason to modify the closest prior art lead compound to obtain the claimed compound and the prior art taught that modifying the lead compound would destroy its advantageous property. Any known compound may serve as a lead compound when there is some reason for

i i h h l d d d dif i i b i h l i d dstarting with that lead compound and modifying it to obtain the claimed compound.

Procter & Gamble Co. v. Teva Pharmaceuticals USA Inc.

566 F.3d 989 (Fed. Cir. 2009)

It is not necessary to select a single compound as a ‘‘lead compound’’ in order to support an obviousness rejection. However, where there was reason to select and modify the lead compound to obtain the claimed compound, but no reasonable expectation of success, the claimed compound would not have been obvious.

Altana Pharma AG 566 F.3d 999 (Fed. Obviousness of a chemical compound in view of its structural similarity to a prior art compound may be shown by v. Teva Pharmaceuticals USA Inc.

Cir. 2009) identifying some line of reasoning that would have led one of ordinary skill in the art to select and modify a prior art lead compound in a particular way to produce the claimed compound. It is not necessary for the reasoning to be explicitly found in the prior art of record, nor is it necessary for the prior art to point to only a single lead compound.

107

New Guidelines: Obvious To Try

Applies when “there is a recognized problem or need in the art; there are a finite number of identified, predictable solutions to the recognized need or problem; and one of ordinary , p g p ; yskill in the art could have pursued these known potential solutions with a reasonable expectation of success.”

Case Cite Notes

In re Kubin 561 F.3d 1351 (Fed. A claimed polynucleotide would have been obvious over the known protein that it encodes where the skilled artisan would Cir. 2009) have had a reasonable expectation of success in deriving the claimed polynucleotide using standard biochemical

techniques, and the skilled artisan would have had a reason to try to isolate the claimed polynucleotide. KSR applies to all technologies, rather than just the ‘‘predictable’’ arts.

Takeda Chemical Industries Ltd. v. Alphapharm Pty. Ltd.

492 F.3d 1350(Fed. Cir. 2007)

A claimed compound would not have been obvious where it was not obvious to try to obtain it from a broad range of compounds, any one of which could have been selected as the lead compound for further investigation, and the prior art taught away from using a particular lead compound, and there was no predictability or reasonable expectation of success in making the particular modifications necessary to transform the lead compound into the claimed compound.

Ortho-McNeil Pharmaceutical Inc. v. Mylan Laboratories Inc.,

520 F.3d 1358(Fed. Cir. 2008)

Where the claimed anti-convulsant drug had been discovered somewhat serendipitously in the course of research aimed at finding a new anti-diabetic drug, it would not have been obvious to try to obtain a claimed compound where the prior art did not present a finite and easily traversed number of potential starting compounds, and there was no apparent reason for selecting a particular starting compound from among a number of unpredictable alternatives.

Bayer Schering Pharma A.G. v. Barr Laboratories Inc.

575 F.3d 1341 (Fed. Cir. 2009)

A claimed compound would have been obvious where it was obvious to try to obtain it from a finite and easily traversed number of options that was narrowed down from a larger set of possibilities by the prior art, and the outcome of obtaining the claimed compound was reasonably predictable.p y p

Sanofi-Synthelabo v. Apotex Inc. 550 F.3d 1075(Fed. Cir. 2008)

A claimed isolated stereoisomer would not have been obvious where the claimed stereoisomer exhibits unexpectedly strong therapeutic advantages over the prior art racemic mixture without the correspondingly expected toxicity, and the resulting properties of the enantiomers separated from the racemic mixture were unpredictable.

Rolls-Royce PLC v. United Technologies Corp.

603 F.3d 1325 (Fed. Cir. 2010)

An obvious to try rationale may be proper when the possible options for solving a problem were known and finite. However, if the possible options were not either known or finite, then an obvious to try rationale cannot be used to support a conclusion of obviousness.

Perfect Web Technologies Inc. v. InfoUSA Inc.

587 F.3d 1324, 1328-29 (Fed. Cir. 2009)

Where there were a finite number of identified, predictable solutions and there is no evidence of unexpected results, an obvious to try inquiry may properly lead to a legal conclusion of obviousness. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning.

108

New Guidelines: Consideration of Evidence

C Cit N tCase Cite NotesPharmaStem Therapeutics Inc. v. Viacell Inc.

491 F.3d 1342(Fed. Cir. 2007)

Even though all evidence must be considered in an obviousness analysis, evidence of nonobviousnessmay be outweighed by contradictory evidence in the record or by what is in the specification. Although a reasonable expectation of at s t e spec cat o . t oug a easo ab e e pectat o o success is needed to support a case of obviousness, absolute predictability is not required.

In re Sullivan 498 F.3d 1345 (Fed. Cir. 2007)

All evidence, including evidence rebutting a prima facie case of obviousness, must be considered when properly presented.

Hearing Components Inc. v. Shure Inc.

600 F.3d 1357(Fed. Cir. 2010)

Evidence that has been properly presented in a timely manner must be considered on the record. Evidence of commercial success is pertinent where a nexus between the success of the product and the claimed invention has been demonstrated.

Asyst Technologies 544 F 3d 1310 Evidence of secondary considerations of obviousness such as Asyst Technologies Inc. v. Emtrak Inc.

544 F.3d 1310(Fed. Cir. 2008)

Evidence of secondary considerations of obviousness such as commercial success and long-felt need may be insufficient to overcome a prima facie case of obviousness if the prima facie case is strong. An argument for nonobviousness based on commercial success or long-felt need is undermined when there is a failure to link the commercial success or long-felt need to a claimed feature that distinguishes over the prior art.

109

Post KSR Fed Cir Cases as of Dec 2010

In re DBC, 545 F.3d 1373 (Fed. Cir. 2008)In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009)In re Trans Texas Holdings Corp., 498 F.3d 1290 (Fed. Cir. 2007)

Leapfrog Enterprises Inc. v. Fischer-Price Inc., 485 F.3d 1157 (Fed. Cir. 2008)Geo M. Martin Co. v. Alliance Machine Systems Intern. LLC, 618 F.3d 1294 (Fed. Cir. 2010)Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc., 617 F 3d 1296 (Fed Cir 2010)

Muniauction v. Thomson Corp., 532 F.3d 1318 (Fed. Cir. 2008)Dow Jones & Co., Inc. v. Ablaise Ltd., 606 F.3d 1338 (Fed. Cir. 2010)Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (Fed. Cir. 2009)Ritchie v. Vast Resources, Inc., 563 F.3d 1334 (Fed. Cir. 2009)In re Mettke, 570 F.3d 1356 (Fed. Cir. 2009)Monolithic Power Systems, Inc. v. O2 Micro Intern. Ltd., 558 F.3d 1341 (Fed. Cir 2009)

F.3d 1296 (Fed. Cir. 2010)Wyers v. Master Lock Co., 616 F.3d 1231 (Fed. Cir. 2010)

Fresenius USA, Inc. v. Baxter Intern., Inc., 582 F.3d 1288 (Fed. Cir. 2009)Kinetic Concepts, Inc. v. Blue Sky Medical Group, Inc., 554 F.3d 1010 (Fed. Cir. 2009)Hearing Components, Inc. v. Shure Inc., 600 F.3d 1357 (Fed. Cir. 2010)Spine Solutions, Inc. v. Medtronic Sofamor Danek USA, Inc., 620 F.3d 1305 (Fed.

Cir. 2009)In re Translogic Technology, Inc., 504 F.3d 1249 (Fed. Cir. 2007)Ricoh Co., Ltd. v. Quanta Computer Inc., 550 F.3d 1325 (Fed. Cir. 2008)Lucent Technologies, Inc. v. Gateway, Inc., 580 F.3d 1301 (Fed. Cir. 2009)Perfect Web Technologies, Inc. v. Infousa, Inc., 587 F.3d 1324 (Fed. Cir. 2009)i4i Ltd. Partnership v. Microsoft Corp., 598 F.3d 831 (Fed. Cir. 2010)

Cir. 2010)TriMed, Inc. v. Stryker Corp., 608 F.3d 1333 (Fed. Cir. 2010)

Bayer Schering Pharma AG v. Barr Laboratories, Inc., 575 F.3d 1341 (Fed. Cir. 2009)Proctor & Gamble Co. v. Teva Pharmaceuticals USA, Inc., 566 F.3d 989 (Fed. Cir. 2009)Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075 (Fed. Cir. 2008)p p , ( )

Power-One, Inc. v. Artesyn Technologies, Inc., 599 F.3d 1343 (Fed. Cir. 2010)Scanner Technologies Corp. v. ICOS Vision Systems Corp. N.V., 528 F.3d 1365 (Fed. Cir. 2008)Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337 (Fed. Cir. 2008)

Gemtron Corp. v. Saint-Gobain Corp., 572 F.3d 1371 (Fed. Cir. 2009), reh'g

In re Omeprazole Patent Litigation, 536 F.3d 1361 (Fed. Cir. 2008)Eisai Co. Ltd. v. Dr. Reddy's Laboratories, Ltd., 533 F.3d 1353 (Fed. Cir. 2008)Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc., 520 F.3d 1358 (Fed. Cir. 2008)Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293 (Fed. Cir. 2007)

PharmaStem Therapeutics Inc v ViaCell Inc 491 F 3d 1342 (Fed Cir 2007)denied (Oct. 2, 2009)Rothman v. Target Corp., 556 F.3d 1310 (Fed. Cir. 2009)Ball Aerosol and Specialty Container, Inc. v. Limited Brands, Inc., 555 F.3d 984 (Fed. Cir. 2009)Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356 (Fed. Cir. 2008)Asyst Technologies, Inc. v. Emtrak, Inc., 544 F.3d 1310 (Fed. Cir. 2008)In re ICON Health and Fitness, Inc., 496 F.3d 1374 (Fed. Cir. 2007)

PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342 (Fed. Cir. 2007)

Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed. Cir. 2007)Daiichi Sankyo Co., Ltd. v. Matrix Laboratories, Ltd., 619 F.3d 1346 (Fed. Cir. 2010)Eli Lilly and Co. v. Teva Pharmaceuticals USA, Inc.619 F.3d 1329 (Fed. Cir. 2010)King Pharmaceuticals, Inc. v. Eon Labs, Inc., 616 F.3d 1267 (Fed. Cir. 2010), , ( )

Honeywell Intern., Inc. v. U.S., 609 F.3d 1292 (Fed. Cir. May 25, 2010)Rolls-Royce, PLC v. United Technologies Corp., 603 F.3d 1325 (Fed. Cir. 2010)

110

g , , , ( )Media Technologies Licensing, LLC v. Upper Deck Co., 596 F.3d 1334 (Fed. Cir. 2010)Crocs, Inc. v. International Trade Com'n, 598 F.3d 1294 (Fed. Cir. 2010)

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