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 Free Public Use of the Invention and Obvious Modifications Thereof Filing Date Issue Date Patent Expiration Date Original Application Possible Unjust Extension Of Original Patent Term Second Application By Applicant Or Assignee Filing Date Issue Date Patent Expiration Date Free Public Use of the Invention and Obvious Modifications Thereof

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 Rejection Appropriate. Venn Diagram Examined claim ODP-Obviousness Rejection Appropriate. Claim of potentially conflicting patent or application X X X O Obvious Specifically disclosed embodiments in potentially conflicting patent or application

ODP-Obviousness Rejection Appropriate. 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 Rejection Appropriate. Venn Diagram Examined claim ODP-Obviousness Rejection Appropriate. Claim of potentially conflicting patent or application O Obvious

ODP-Obviousness Rejection Appropriate. Venn Diagram Examined claim O ODP-Obviousness Rejection Appropriate. Claim of potentially conflicting patent or application Obvious

ODP-Obviousness Rejection NOT Appropriate. Venn Diagram Examined claim ODP-Obviousness Rejection NOT Appropriate. Claim of potentially conflicting patent or application X X X Not Obvious Specifically disclosed embodiments in potentially conflicting patent or application

ODP-Obviousness Rejection NOT Appropriate. Venn Diagram Examined claim ODP-Obviousness Rejection NOT Appropriate. Claim of potentially conflicting patent or application Not Obvious

ODP-Obviousness Rejection NOT Appropriate. 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 Rejection Appropriate. 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

One Avenue for Overcoming ODP Rejections 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 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 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 09/234,234, Filed 4/1/02 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 Hill et al 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

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