1. Double Patenting Simplified
As much as possible anyway!
Robert J. Hill, Jr.
Quality Assurance Specialist
Technology Center 1600

2. Double Patenting in General
The Basics

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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.

10. Double Patenting and 35 U.S.C. 121
MPEP §
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.

11. 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

12. 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

13. General Analysis
Double Patenting Rejection Prohibited by 35 U.S.C. 121?
Statutory Basis Exists (35 U.S.C. 101)?
Nonstatutory Basis Exists?

14. 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

15. Statutory Double Patenting
35 U.S.C. 101

16. 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)

17. Same Invention Is the Same Invention Being Claimed Twice?
Identical Subject Matter

18. 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?

19. 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

20. 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

21. Non-Statutory Obviousness-Type Double Patenting: Rejection Based on Obviousness Analysis
ODP-Obviousness

22. 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

23. 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)

24. 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

25. 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

26. 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

27. 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

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

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

30. 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

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

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

33. Non-Statutory Obviousness-Type Double Patenting: Rejection Based on Anticipation Analysis
ODP-Anticipation

34. 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

35. 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

36. ODP-Anticipation Rejection Appropriate.
Venn Diagram
Examined claim
ODP-Anticipation Rejection Appropriate.
Claim of potentially conflicting patent or application

37. One-Way Obviousness Claim A – Examined Application
Claim B – Potentially Conflicting Patent or Application
Would Claim A Have Been Obvious Given Claim B?

38. 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?

39. 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

40. Obviousness-Type Double Patenting: Eli Lilly v. Barr
An Unusual Situation

41. 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

42. One Avenue for Overcoming ODP Rejections
Terminal Disclaimers
One Avenue for Overcoming ODP Rejections

43. 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

44. 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

45. 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

46. 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 are NOT sufficient to overcome such a rejection

47. 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 are NOT sufficient to overcome such a rejection

48. 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

49. Double Patenting vs. Art Rejection
Reference used for all it fairly teaches
Cannot be overcome with a terminal disclaimer

50. 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

51. Flow Chart
Page 32 of the Training Materials

52. 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

53. Example 1 ODP Rejection – NOT PROPER
35 U.S.C. 121 prohibits the rejection because of the restriction in the parent application

54. 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

55. Example 2 Statutory (35 U.S.C. 101) Double Patenting is Appropriate
Rejection Under 35 U.S.C. 102(e) Would Also Be Appropriate

56. 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

57. 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

58. Example 3
Obviousness-Type Double Patenting – Anticipation Analysis Appropriate

59. 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 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

60. 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 centipoise at 37oC
Better drug availability at the disclosed viscosity
Viscosity can be adjusted using thickening agents.

61. 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 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

62. 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

63. 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

64. Example 6
Obviousness-Type Double Patenting – Obviousness Analysis Appropriate

65. 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

66. The End