New Patent Office Rules

1. New Patent Office Rules

2. Overview • Introduction to Rules • Examples of Rule Scenarios • Best Practices and Suggestions

3. Introduction to Rules • Limited No. of Continuations - 2 + 1 Rule • Limited No. of Claims - 5/25 Rule • Disclosure of “Related” Patents and Applications • Rebuttable Presumption of Patentably Indistinct Claims

4. Themes to Rules • More front end work required • Searching • Filing strategy • Know the invention better before you file the application • Know what problem(s) it solves and how it differs from what was done before. • Focus on maximizing claim potential not on the number of applications • Allowance of the application takes the application out of the rules

5. Rules Being Challenged • Tafas vs. Dudas • Filed Aug. 22, 2007 (Eastern District of VA) • GlaxoSmithKline vs. Dudas • Filed Oct. 10, 2007 (Eastern District of VA) • AIPLA, IBM, etc. supporting GlaxoSmithKline • Hearing October 31st

6. Limited Number of Continuations 2 + 1 Continuation/RCE Rules

7. 2 + 1 Continuation/RCE Rules Generally: • Limited to 2 CONs (or CIPs) of an Initial Application. These are considered an “Invention Family”. • Limited to 1 RCE in an Invention Family. • Restriction Requirement creates a new Invention Family. • If limits are exceeded: • RCE is abandoned • CONs or CIPs do not get the priority date of the Initial Application

8. 2 + 1 Continuation/RCE Rules • Although described together in the 2 +1 rule, continuing applications and RCEs are controlled by different rules, which apply differently. • Continuing Applications - Rule 1.78 “Claiming benefit of earlier filing date and cross-reference to other applications” (Fail to follow - lose earlier priority claim) • RCEs - Rule 1.114 “Request for continued examination” (Fail to follow - RCE not granted, so still have to respond) • As applied, the new rules generally have different applicability dates. • Continuing Applications- • Applications filed on or after November 1, 2007 must • Meet the requirements limiting the number of continuing applications under the new rules OR • File a Petition. • One More Exception: Applications only claiming priority to applications filed before August 21, 2007 do not need to meet the new requirements if: • The continuing application only claims priority to nonprovisional applications filed before August 21, 2007 AND • No other applications filed on or after August 21, 2007 claim priority to the continuing application. • RCEs - Rules only apply to RCEs filed on or after November 1, 2007 • No August 21, 2007 “One More” Exception.

9. Continuation and CIP Applications • Continuation application • Discloses and claims only inventions that were: • Disclosed in a prior-filed application (does not need to be claimed). • Continuation-in-part • Discloses subject matter that was not disclosed in prior-filed application. • Continuation or Continuation-in-part (CIP) Priority Claim (w/o Petition) • Continuation or CIP applications can claim benefit of no more than 2 parent applications (Serial aspect) • Parent applications can only provide priority to one other application (Parallel aspect)

10. CON and CIP Examples Utility Utility Parallel CIP Serial CIP CON Family CON Family Petition Petition Petition

11. CON and CIP Examples Provisional/ Foreign Application(s) Provisional/ Foreign Application(s) Provisional and Outside US (OUS) (i.e., Foreign) Applications Do Not Count Utility Utility Parallel CIP Serial CIP CON Family CON Family Petition Petition Petition

12. CON and CIP Examples Utility Exceeds the 2 Parent (Serial) Requirement CIP CON CON Family Petition

13. Divisional Applications • Divisional application • Discloses and claims only inventions that were: • Disclosed in a prior-filed application and • Claimed in the prior-filed application. • Required to comply with a PCT unity of invention or US restriction requirement in the prior-filed application. • Inventions were: • Not elected for examination and • Not examined in any prior-filed application. • Note “examined” does not include PCT examination after filing Demand. “Examined” only applies to US national stage examination. • Continuation of a Divisional (COD) • COD claims the benefit of a Divisional. • COD discloses and claims only the invention(s) disclosed and claimed in the divisional application. • COD claims benefit of divisional and divisional’s parents. • COD claims benefit of at most one intervening application between it and the divisional. (Serial aspect) • Divisional parent application can only provide priority to one other application, not including other divisional applications satisfying the above-mentioned conditions (Parallel aspect) • No CIP of Divisional allowed.

14. Divisional & COD Examples Utility Claims: A, B Disclose: A, B Restriction Elect: A CON/CIP Claims: A Disclose: A, B DIV Claims: B Disclose: A, B CON/CIP Claims: A Disclose: A, B COD Claims: B Disclose: A, B Petition COD Claims: B Disclose: A, B Petition

15. Divisional & COD Examples Utility Claims: A, B Disclose: A, B, C Restriction Elect: A Number of Applications to Originally Unclaimed Invention C is Limited CON/CIP Claims: A, C Disclose: A, B, C DIV Claims: B Disclose: A, B, C CON/CIP Claims: C Disclose: A, B, C COD Claims: B Disclose: A, B, C Petition COD Claims: B Disclose: A, B, C Petition

16. Divisional & COD Examples Utility Claims: A, B Disclose: A, B, C Restriction Elect: A DIV Claims: B Disclose: A, B, C CON Claims: A, C Disclose: A, B, C COD Claims: B Disclose: A, B, C CON Claims: A, C Disclose: A, B, C COD Claims: B Disclose: A, B, C Petition

17. Divisional & COD Examples 1. Not a proper COD because does not only claim the invention claimed in the divisional application. BUT 2. Permitted under CON/CIP portion of the Rules. Not Permitted w/o Petition Permitted Utility Claims: A, B, C Disclose: A, B, C Restriction Elect: A Utility Claims: A, B, C Disclose: A, B, C Restriction Elect: A 1. Not a proper COD because does not only claim the invention claimed in the divisional application. 2. Not a proper CON because has more than 2 parent applications. DIV Claims: B Disclose: A, B, C DIV Claims: B Disclose: A, B, C CON Claims: A Disclose: A, B, C CON Claims: A Disclose: A, B, C CON Claims: A Disclose: A, B, C

18. Continuing Application Requirements for Priority Claim Without Petition • Continuation of PCT (COP) (Bypass Nationalization) • COP claims benefit under 35 U.S.C. 120 to PCT application in which: • PCT application designated US; • Demand has not been filed in PCT application; • Basic national application fee for PCT has not been paid; AND • PCT does not claim benefit of other non-provisional or other PCT application designating US. • COP is a continuation or CIP of no more than 3 parent applications. (Serial aspect) • Parent applications can only provide priority to 2 other applications (Parallel aspect) • Continuation of Abandoned Application Due to Failure to Respond to Missing Parts (CAMP) • CAMP claims benefit of a parent non-provisional application • Parent non-provisional abandoned due to failure to respond to notice to file missing parts • Parent non-provisional application does not claim the benefit of any other non-provisional or US designated PCT applications. • CAMP is a continuation or CIP of no more than 3 parent applications. (Serial aspect) • Parent applications can only provide priority to 2 other applications. (Parallel aspect)

19. “One more CON” for COP Of a 120 bypass nationalization of an international application • Demand and the basic national fee have not been filed in the international application • The international application does not claim the benefit of any other nonprovisional application or international application designating the U.S.

20. “One more CON” for 120 Bypass Nationalization (COP) PCT Designate US No Demand No 371 Nat’l PCT Designate US No Demand No 371 Nat’l CON/CIP 120 Bypass “COP” CON/CIP 120 Bypass “COP” CON/CIP “COP” CON/CIP “COP” CON/CIP “COP” CON/CIP “COP” Petition Petition Petition

21. “One more CON” for CAMP Can file 3rd CON without petition U.S. Application • The initial nonprovisional application abandoned for failure to timely reply to a Notice of Missing Parts 37 CFR 1.53(f) • The initial nonprovisional application does not claim benefit of either a U.S. application or international application designating the U.S.

22. “One more CON” for Failure to Respond to Missing Parts (CAMP) Utility BUT Abandoned Fail Respond to Missing Parts Utility BUT Abandoned Fail Respond to Missing Parts CON/CIP “CAMP” CON/CIP “CAMP” CON/CIP “CAMP” CON/CIP “CAMP” CON/CIP “CAMP” CON/CIP “CAMP” Petition Petition Petition

23. Summary

24. “One more CON” For Applications Filed Before Nov. 1st • Can file 1 more CON/CIP after November 1, 2007 in Invention Families meeting or exceeding the two CONs/CIP limit if no CONs/CIPs were filed after August 21, 2007. • Patent Office has clarified that Divisional applications and Continuations of Divisional applications (CODs) do not count against the “one more CON/CIP” Rule. • Note: There is no limit to the number of CONs filed before Nov. 1. The 5/25 rule and the rebuttable presumption of indistinct claims will apply.

25. “One more CON” For Applications Filed Before Nov. 1st Aug. 21, 2007 Nov. 1, 2007 Utility Utility CON/CIP CON/CIP CON/CIP CON/CIP Petition Petition Petition

26. “One more CON” For Applications Filed Before Nov. 1st Aug. 21, 2007 Nov. 1, 2007 Utility Utility CON/CIP CON/CIP CON/CIP CON/CIP CON/CIP CON/CIP CON/CIP Petition Petition CON/CIP Petition

27. “One more CON” For Applications Filed Before Nov. 1st Aug. 21, 2007 Nov. 1, 2007 Utility Utility CON/CIP CON/CIP CON/CIP CON/CIP CON/CIP CON/CIP CON/CIP CON/CIP Petition Petition Petition Petition

28. “One more CON” For Applications Filed Before Nov. 1st Aug. 21, 2007 Nov. 1, 2007 Utility Claims: A, B Disclose: A, B Restriction Elect: A CON/CIP Claims: A Disclose: A, B DIV Claims: B Disclose: A, B CON/CIP Claims: A Disclose: A, B COD Claims: B Disclose: A, B Note: Can file more than one if fall under DIV and COD Rules COD Claims: B Disclose: A, B Petition Petition

29. Summary of 2 CONs Rule

30. RCE • Can file an RCE without petition if an RCE has not been previously filed in: • The application; • Any parent application (backward priority); or • Any child application (forward priority). • Divisional applications - can file an RCE without petition if an RCE has not been previously filed in: • The divisional application; or • Any child application (forward priority). • Continuation of Divisional (COD) - can file an RCE without petition if an RCE has not been previously filed in: • The COD; • Any parent application (backward priority); or • Any child application (forward priority).

31. RCE • Contrary to the USPTO’s initial slide show, you can file RCEs in parallel cases without petition

32. Summary of 1 RCE Rule

33. Petitions to exceed CON/RCE limit • Petition • $400 fee (1.17(f)) • Amendment, argument, or evidence • Provide a showing that the amendment, argument, or evidence sought to be entered could not have been submitted during the prosecution of the prior-filed application.

34. Petition Factors Factors considered: • Whether applicant should file an appeal or a petition under 1.181 rather than a CON/RCE • The number of applications filed in parallel or serially with substantially identical disclosures • Whether evidence, amendments, or arguments are being submitted with reasonable diligence.

35. Petitions to exceed CON/RCE limit • Sufficient showing: • In a CON, an interference is declared in an application containing both claims corresponding to the counts and claims not corresponding to the counts and an APJ (Admin Patent Judge) suggests that the claims not corresponding to the counts be canceled from the continuing application in the interference and pursued in a separate application.

36. Petitions to exceed CON/RCE limit • The following are NOT sufficient showings to grant petitions for one more CON/RCE: • Inadequate examination – file petition under 1.181 • Examiner made new arguments or new ground of rejection in a final Office action • Independent claims of a second CON in which the dependent claims contain allowable subject matter and rewriting the dependent claims as independent claims would result in the application containing more than five independent claims • To include subject matter that was not present at the time of filing the prior-filed application • To submit newly discovered references (IDS)

37. Petitions to exceed CON/RCE limit • More examples of what are NOT sufficient showings to grant petitions for one more CON/RCE: • Product becomes commercially viable • A competing product is newly discovered • New information is discovered that could have been provided in the prior application • Applicant discovers new inherent properties to claim • Applicant acquires financial resources to file previously unclaimed inventions • When clinical trials indicate the previously unclaimed subject matter may be useful • When a court determined that the format of a patented claim is improper and applicant wishes to file a continuing application to seek proper protection

38. CIP • Must identify the claims that are supported by the parent application. • Does not apply to CIP applications that received a FAOM before Nov. 1, 2007. • CIP applications filed before Nov. 1, 2007 that did not receive a FAOM before Nov. 1, 2007 have a February 1, 2008 deadline to identify claim support. • The examiner may require the location in the specification (page and line number) that support those claims. 37 C.F.R. 1.105

39. Streamlined Continuation • Placed on examiner’s Regular Amended docket; not the New Special docket. • Requirements • File complete CON application • App must disclose and claim only invention disclosed and claimed in prior-app • Applicant agrees that any election in response to restriction/unity of invention in prior app carries over to the CON • Prior-filed app under final Office action or appeal • Prior-filed app must be expressly abandoned upon filing of CON. • Must request that CON be placed on examiner’s Regular Amended Docket

40. Streamlined Continuation • Request for Streamlined Docketing Procedure PTO/SB/201

41. Limits to Number of Claims 5/25 Claim Rule

42. 5/25 Claim Limitation Rules • Applicant may present, without an ESD, up to 5 independent claims and 25 total claims • Does not include withdrawn claims, but does include reinstated and rejoined claims • Later amendments sending claims over 5/25 without an ESD are non-responsive (Notice will be mailed) • 15/75 limitation considering 2 continuations in invention family • If over 5/25, PTO will mail Notice • Applicant must: (1) Amend, (2) file ESD, or (3) file SRR (appl. filed before 11/1/07) • Consider PTA, will exist in certain situations

43. 5/25 Claim Limitation Rules • 5/25 limitation applies collectively to claims in commonly owned pending applications with at least one patentably indistinct claim • If total combined is over 5/25, each application will be deemed to be over 5/25 • Must (1) cancel patentably indistinct claim from all but 1 appl, (2) file ESD before FAOM, or (3) amend to meet 5/25 limitation • 5/25 limitation does not apply to a PCT application during international phase.

44. 5/25 Claim Limitation Rules • What is a patentably indistinct claim? • “The standard for ‘patentably indistinct’ as the term appears in 37 CFR 1.75(b)(4), 1.78 is the same as one-way distinctness in an obviousness-type double patenting analysis. See MPEP 804(II)(B)(1)(a).” PTO Questions and Answers, J19, J26. • “If the application at issue is the later filed application or both are filed on the same day, only a one-way determination of obviousness is needed in resolving the issue of double patenting, i.e., whether the invention defined in a claim in the application would have been >anticipated by, or< an obvious variation of >,< the invention defined in a claim in the patent. See, e.g., In re Berg, 140 F.3d 1438, 46 USPQ2d 1226 (Fed. Cir. 1998) (the court applied a one-way test where both applications were filed the same day).”

45. 5/25 Claim Limitation Rules • What will count as an independent claim? • A claim that refers to another claim but does not incorporate by reference all the limitations of the claim to which such claim refers • Ex: A method using the apparatus of claim 1, comprising …. • Will be counted as an independent claim • Dependent claim • A claim which incorporates by reference all the limitations of the previous claim to which it refers and specifies a further limitation of the subject matter of the previous claim

46. 5/25 Claim Limitation Rules • FAOM = first action on the merits = does not include restriction requirements and requirements for information • FAOM received before 11/1/07 • 5/25 limitation does not apply (but would apply to CON of app) • FAOM not received before 11/1/07 • 5/25 limitation does apply • Notice (2 mo. is extendable), Applicant must: (1) Amend, (2) file ESD, or (3) file SRR • Notice may be combined with Rest. Req., if so, can’t file SRR • Applications filed on or after 11/1/07 • 5/25 limitation does apply • Notice (2 mo. not extendable), Applicant must: (1) Amend, or (2) file ESD • No SRR option after Notice, must be filed earlier

47. ESD (Examination Support Document) • Requirements • Preexamination search statement • Listing of most closely related references • Identification of claim limitations disclosed by each reference (exempt if small entity) • Detailed explanation of patentability • Showing of support under 112 • ESD Guidelines Available at: • http://www.uspto.gov/web/offices/pac/dapp/opla/presentation/clmcontfinalrule.html • Consider Accelerated Examination if already preparing ESD • If later amend claims out of ESD scope, must supplement ESD

48. ESD FormsESD Transmittal PTO/SB/216

49. ESD FormsESD Listing of References PTO/SB/211

50. SRR (Suggested Restriction Requirement) • Requirements • Election of no more than 5/25 claims and explanation of why the inventions are independent or distinct • Identification of the elected claims • Must be filed before the earlier of a FAOM or Rest. Req. • Best practice tip: file with application • If accepted, Examiner will set out the restriction in the FAOM • Note: it is now too late to get refund for cancelled claims • If not accepted: • Examiner makes Rest. Req.: Applicant must make election (if over 5/25 must further file ESD or amend) • Examiner makes no Rest. Req.: Notice will be mailed, Applicant must either file ESD or amend