double patenting simplified as much as possible anyway! robert j. hill, jr. quality assurance...
TRANSCRIPT
Double Patenting Simplified
As much as possible anyway!
Robert J. Hill, Jr.Quality Assurance Specialist
Technology Center 1600
Double Patenting in General
The Basics
What is a Double Patenting Rejection? Rejection of Claims Of common Applicant or Assignee Not Entitled to a Patent Because:
You already have a patent to the same invention
Your claimed invention is an obvious variation of the claimed invention in the patent you already have
The Purpose Behind the Policy The Constitution
Promote the progress of science and useful arts Limited exclusive right in exchange for disclosure Benefits the public
Double Patenting Prevents unjustified extension of exclusive rights After expiration, public should be able to:
Freely use the claimed invention Freely use obvious modifications of the claimed
invention
A Graphical Representation of the Problem
FilingDate
IssueDate
Patent ExpirationDate Free Public Use of the
Invention and ObviousModifications Thereof
SecondApplication
By ApplicantOr Assignee
FilingDate
IssueDate
Patent ExpirationDate
Free Public Use of theInvention and ObviousModifications ThereofOriginal
ApplicationPossible Unjust ExtensionOf Original Patent Term
Focus on the Claims Claims of the Potentially
Conflicting Patent or Application vs. Examined Claims
Use of Specification of the Potentially Conflicting Patent or Application is Generally Prohibited Limited exception – to be discussed
more fully later
Types of Double Patenting Rejections Statutory (35 U.S.C. 101) Double
Patenting Non-Statutory Double Patenting
Obviousness-Type Double Patenting Rejection based on obviousness analysis Rejection based on anticipation analysis
Non-Statutory Double Patenting Based Solely on Improper Timewise Extension of Patent Rights
Possible Double Patenting Situations Examined Application vs. Another
Copending Application (Provisional Rejection)
Examined Application vs. Issued Patent
Examined Application vs. Published Application (Provisional Rejection) No need to apply this last one in an
Office action
Double Patenting and 35 U.S.C. 121 The Third Sentence of 35 U.S.C. 121
Provides: A patent issuing on an application with respect
to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application.
Double Patenting and 35 U.S.C. 121 MPEP § 804.01
This apparent nullification of double patenting as a ground of rejection or invalidity in such cases imposes a heavy burden on the Office to guard against erroneous requirements for restrictions where the claims define essentially the same invention in different language and which, if acquiesced in, might result in the issuance of several patents for the same invention.
When Prohibition Under 35 U.S.C. 121 Does Not Apply Two or More Applications Filed – No
Restriction Requirement Made Claims Amended Such That They
Are Not Commensurate With the Restriction Requirement
Linking Claim Practice Followed and Generic Claim Allowed Restriction Withdrawn
When Prohibition Under 35 U.S.C. 121 Does Not Apply Restriction (Lack of Unity) Only
Made in PCT Application Examiner Withdraws Restriction
Before Patent Issues Claims are Directed to Identical
Subject Matter
General Analysis Double Patenting Rejection
Prohibited by 35 U.S.C. 121? Statutory Basis Exists (35 U.S.C.
101)? Nonstatutory Basis Exists?
Domination and Double Patenting Domination: Broad or Generic Claims
in One Patent Fully Encompass Narrower Claims in Another Patent
Domination by Itself Cannot Support a Double Patenting Rejection
Domination Does Not Preclude a Double Patenting Rejection
Statutory Double Patenting
35 U.S.C. 101
The Statute 35 U.S.C. 101 Whoever invents or discovers any new
and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. (Emphasis added)
Same Invention Is the Same Invention Being
Claimed Twice? Identical Subject Matter
A Reliable Test Is There an Embodiment That Falls
Within the Scope of One Claim, but Not the Other?
Could One Claim be Literally Infringed Without Literally Infringing the Other Claim?
Statutory (35 U.S.C. 101) Double Patenting Venn Diagram
Examined claim
Examined claim and claim of potentially conflicting patent or
application exactly match in scope – statutory (35 U.S.C.
101) double patenting appropriate.
Claim of potentially conflicting patent or application
Statutory (35 U.S.C. 101) Double Patenting Venn Diagram
Examined claim
Examined claim and claim of potentially conflicting patent or application DO NOT exactly match in
scope – DO NOT make a statutory (35 U.S.C. 101) double patenting rejection. Perform further
analysis to determine whether a rejection on non-statutory double patenting grounds is appropriate.
Claim of potentially conflicting patent or application
Non-Statutory Obviousness-Type Double Patenting: Rejection Based on Obviousness Analysis
ODP-Obviousness
ODP-Obviousness Analysis Analogous to 35 U.S.C. 103 Analysis Determine the Scope and Content of the
“Prior Art” Ascertain the Differences Between the
“Prior Art” and the Claim in Issue Resolve the Level of Ordinary Skill in the
Art Evaluate Evidence of Secondary
Considerations
Written Rejection Any Obviousness-Type Double Patenting
Rejection Based on an Obviousness Analysis Should Make Clear: The differences between a claim in the
examined application compared to a claim in the reference patent (or copending application)
The reasons for concluding that the invention defined in the claim at issue would have been an obvious variation of the invention defined in a claim in the patent (or copending application)
Differences Between 35 U.S.C. 103 and ODP-Obviousness Analysis
“Prior Art” 35 U.S.C. 103 Analysis
Prior art within the meaning of 35 U.S.C. 102 ODP-Obviousness Analysis
Claims of a potentially conflicting patent or application
Alone or with prior art within the meaning of 35 U.S.C. 102
Reliance on specification of a potentially conflicting patent or application is generally prohibited
Limited exceptions
Proper Uses of Disclosure Exceptions to the General
Prohibition of Using the Disclosure of a Potentially Conflicting Patent or Application Dictionary for claim terminology Portions of the disclosure which
provide support for the claims in the potentially conflicting patent or application
ODP-Obviousness Venn Diagram
Examined claim
ODP-Obviousness Rejection Appropriate.
Claim of potentially conflicting patent or application
X
X X O
X
Obvious
Specifically disclosed embodiments in potentially conflicting patent or application
ODP-Obviousness Venn Diagram
Examined claim
ODP-Obviousness Rejection Appropriate.
Claim of potentially conflicting patent or application
X
Specifically disclosed embodiment in potentially conflicting patent or application
ODP-Obviousness Venn Diagram
Examined claim
ODP-Obviousness Rejection Appropriate.
Claim of potentially conflicting patent or application
OObvious
ODP-Obviousness Venn Diagram
Examined claim
O
ODP-Obviousness Rejection Appropriate.
Claim of potentially conflicting patent or application
Obvious
ODP-Obviousness Venn Diagram
Examined claim
ODP-Obviousness Rejection NOT Appropriate.
Claim of potentially conflicting patent or application
X
X X
X
Not Obvious
Specifically disclosed embodiments in potentially conflicting patent or application
ODP-Obviousness Venn Diagram
Examined claim
ODP-Obviousness Rejection NOT Appropriate.
Claim of potentially conflicting patent or application
Not Obvious
ODP-Obviousness Venn Diagram
Examined claim
ODP-Obviousness Rejection NOT Appropriate.
Claim of potentially conflicting patent or application
Not Obvious
Non-Statutory Obviousness-Type Double Patenting: Rejection Based on Anticipation Analysis
ODP-Anticipation
ODP-Anticipation Situation Examined Claims
Generic to (fully encompasses) a claim in the potentially conflicting patent or application
Anticipated by the claim in the potentially conflicting patent or application
Written Rejection No Graham v. Deere analysis needed Explain how the examined claim is
anticipated
ODP-Anticipation - !!CAUTION!! NOT for These Situations
Examined claim – species/subgenus of generic claim in potentially conflicting patent or application
Mere overlap without anticipation ODP-Obviousness analysis required
ODP-Anticipation Venn Diagram
Examined claim
ODP-Anticipation Rejection Appropriate.
Claim of potentially conflicting patent or application
One-Way Obviousness Claim A – Examined Application Claim B – Potentially Conflicting
Patent or Application Would Claim A Have Been Obvious
Given Claim B?
Two-Way Obviousness Claim A – Examined Application Claim B – Potentially Conflicting
Patent or Application Would Claim A Have Been Obvious
Given Claim B? Would Claim B Have Been Obvious
Given Claim A?
General Rule – One-Way vs. Two-Way Apply One-Way Test Unless All Three
Apply The examined application has an effective U.S.
filing date before that of a potentially conflicting patent
There is sufficient evidence of record that the claims could not have been filed in the same application
There is sufficient evidence of record that there was administrative delay on the part of the Office in the application being examined
Obviousness-Type Double Patenting: Eli Lilly v. Barr
An Unusual Situation
Obviousness-Type Double Patenting: Eli Lilly v. Barr Facts:
ODP rejection over examined claims in view of a patent
Patent was statutorily disclaimed Patent owner cannot avoid double patenting by
disclaiming earlier patent Should be Rare Must be Approved by TC Director
Go to SPE first Then QAS Then TC Director
Terminal Disclaimers
One Avenue for Overcoming ODP Rejections
What is a Terminal Disclaimer? Legal Document
Ensures that the term for a patent granted on the examined application will not extend past the expiration of the term of the conflicting patent or a patent granted on a conflicting application
Ensures common ownership between the examined application and the conflicting patent or a patent granted on the conflicting application
Some Interesting Things about Terminal Disclaimers It “must operate with respect to all
claims in the patent.” It “is not an admission of the propriety
of the rejection.” It is “effective only with respect to the
application identified in the disclaimer, unless by its terms it extends to continuing applications.” Effective with respect to each application
having the identified application number
Some Interesting Things about Terminal Disclaimers A terminal disclaimer fee is required for
each terminal disclaimer filed. A terminal disclaimer is required even in
applications filed on or after June 8, 1995 as a result of patent term adjustment
provisions patents and conflicting claims would not necessarily expire on the same day
even if patents with conflicting claims would expire on the same day, ensuring enforceability only as long as they are commonly owned is still required
How to Overcome a Proper Double Patenting Rejection Statutory (35 U.S.C. 101) Double
Patenting Amend the claim(s) Cancel the claim(s) A terminal disclaimer is NOT sufficient to
overcome such a rejection Declarations under 37 CFR 1.131 are
NOT sufficient to overcome such a rejection
How to Overcome a Proper Double Patenting Rejection Non-Statutory Double Patenting
(All Types) Amend the claim(s) Cancel the claim(s) File a proper terminal disclaimer Declarations under 37 CFR 1.131 are
NOT sufficient to overcome such a rejection
Double Patenting vs. Art Rejection Double Patenting
Compares claims With limited use of the disclosure of the
potentially conflicting patent or application
Can be overcome by a terminal disclaimer (ODP only)
TD removes potential harm to public
Double Patenting vs. Art Rejection Art Rejection
Reference used for all it fairly teaches Cannot be overcome with a terminal
disclaimer
Form Paragraphs See Pages 19-30 of the Training Materials
See also the section “Suggested Language for Clarifying Basis for Rejection” on page 12
See the examples for sample rejections Do Not Forget to Read the Examiner Notes
for the Form Paragraphs The “Examiner Notes” may provide information
as to other appropriate rejections
Flow Chart Page 32 of the Training Materials
Example 1 09/123,123, Filed 01/01/02
Claim 1 – Protein Claim 2 – DNA encoding the protein Restricted between claims 1-2 Elected claim 2, cancelled claim 1 Issued 6/1/02
09/234,234, Filed 4/1/02 Divisional of 09/123,123 Claim 1 – Protein (same as original claim 1 of
09/123,123) Claim 1 rejected under ODP over the DNA claim of
issued parent
Example 1 ODP Rejection – NOT PROPER
35 U.S.C. 121 prohibits the rejection because of the restriction in the parent application
Example 2 Examined Application (Inventor A)
Claim 1. A shampoo composition comprising water, a moisturizer, a surface-active agent, and a dye.
Patent 8,500,000 (Inventors A and B) Issued less than one before the examined
application Claim 37. A composition comprising water, a
surfactant, a dye, and a moisturizer wherein the composition is useful as a shampoo.
No Claimed Benefit to Patent No Restriction Made
Example 2 Statutory (35 U.S.C. 101) Double
Patenting is Appropriate Rejection Under 35 U.S.C. 102(e)
Would Also Be Appropriate
Example 2 (Modifications) Patent Issued More Than One Year
Before the Effective Filing Date of the Application Statutory double patenting still
appropriate 102(b) rejection would also be
appropriate No Common Inventor or Assignee
102(e) rejection would be appropriate If overcome - interference
Example 3 Examined Application (Inventors A and B)
Claim 1. A compound having the following formula:R1-(CH2CH2)n-R2
wherein R1 is alky, alkyoxy, or hydroxy, R2 is cycloalkyl, unsubstituted phenyl, or substituted phenyl, and n is 1-10.
Patent 8,500,000 (Inventors A and B) Filed before but issued after the effective filing date of the
examined application Claim 10. A compound having the following formula:
CH3OCH2CH2CH2CH2CH2CH2-Phenyl or CH3OCH2CH2CH2CH2-Phenyl.
Benefit to Patent Claimed No Restriction Made
Example 3 Obviousness-Type Double
Patenting – Anticipation Analysis Appropriate
Example 4 Examined Application (Inventors A and B)
Claim 1. A method of treating high blood pressure in a patient in need thereof comprising administering to the patient an aqueous solution of compound X wherein the aqueous solution includes a thickener in an amount such that the aqueous solution has a viscosity of 50-80 centipoise at 37 oC.
Patent 8,500,000 (Inventors A and B) Filed before but issued after the effective filing date of the
examined application Claim 20. A method of treating high blood pressure in a patient in
need thereof comprising administering to the patient an aqueous solution of compound X.
CIP Benefit to Patent Claimed No Restriction Made
Example 4 Specification of 8,500,000
The aqueous solution of compound X can be administered by various routes including, subcutaneous, intravenous, and oral.
Hill et al More than one year before the effective filing date
of the application Better results are obtained from drugs that are
administered subcutaneously When the viscosity of the composition is 50-60 centipoise
at 37oC Better drug availability at the disclosed viscosity Viscosity can be adjusted using thickening agents.
Example 4 Examined Application (Inventors A and B)
Claim 1. A method of treating high blood pressure in a patient in need thereof comprising administering to the patient an aqueous solution of compound X wherein the aqueous solution includes a thickener in an amount such that the aqueous solution has a viscosity of 50-80 centipoise at 37 oC.
Patent 8,500,000 (Inventors A and B) Claim 20. A method of treating high blood pressure in a patient in
need thereof comprising administering to the patient an aqueous solution of compound X.
Obviousness-Type Double Patenting – Obviousness Analysis Appropriate
Example 4 (Modifications) Patent and Hill et al Issued More Than
One Year Before the Effective Filing Date of the Application 103 rejection would also be appropriate Obviousness-type double patenting still
appropriate Not necessary – overcoming 103 rejection would
overcome ODP rejection No Common Inventor or Assignee
102(e)/103 rejection would be appropriate If overcome - interference
Example 6 Examined Application (Inventors A and B)
Claim 1. A method of making compound C comprising reacting compound A with compound B in aqueous solution at a temperature from 50oC to 90oC.
Patent 8,500,000 (Inventors A and B) Filed before but issued after the effective filing date of the
examined application Claim 70. A method of making compound C comprising reacting
compound A with compound B in aqueous solution at a temperature from 80oC to 150oC.
Discloses several examples wherein the reaction is carried out at 80oC, 90oC, 100oC, 110oC, 120oC, 130oC, 140oC, and 150oC
CIP Benefit to Patent Claimed No Restriction Made
Example 6 Obviousness-Type Double
Patenting – Obviousness Analysis Appropriate
Example 6 (Modification) Examined Application (Inventors A and B)
Claim 1. A method of making compound C comprising reacting compound A with compound B in aqueous solution at a temperature from 50oC to 90oC.
Patent 8,500,000 (Inventors A and B) Claim 70. A method of making compound C comprising reacting
compound A with compound B in aqueous solution at a temperature from 40oC to 150oC.
Discloses several examples wherein the reaction is carried out at 80oC, 90oC, 100oC, 110oC, 120oC, 130oC, 140oC, and 150oC
Obviousness-Type Double Patenting – Obviousness Analysis Appropriate
Using specifically disclosed embodiments (80oC and 90oC) that support the temperature range in claim 70
The End