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New Patent Office Rules 1 New Patent Office Rules 1

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

Introduction to Rules • Limited No. of Continuations - 2 + 1 Rule • 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 3

Themes to Rules • More front end work required – Searching – Filing strategy 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 4

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

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

2 + 1 Continuation/RCE Rules Generally: • Limited to 2 CONs (or CIPs) of 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 7

2 + 1 Continuation/RCE Rules • Although described together in the 2 +1 rule, 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. 8

Continuation and CIP Applications • Continuation application – Discloses and claims only inventions that 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) 9

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

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

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

Divisional Applications • • Divisional application – Discloses and claims only inventions that were: 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. 13

Divisional & COD Examples Utility Claims: A, B Disclose: A, B Restriction Elect: A 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 14

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

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

1. Not a proper COD because does not only claim the invention claimed in 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. Divisional & COD Examples Permitted Not Permitted w/o Petition Utility Claims: A, B, C Disclose: A, B, C Restriction Elect: A DIV Claims: B Disclose: A, B, C CON Claims: A Disclose: A, B, C 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. CON Claims: A Disclose: A, B, C 17

Continuing Application Requirements for Priority Claim Without Petition • Continuation of PCT (COP) (Bypass 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) 18

“One more CON” for COP Of a 120 bypass nationalization of an international application “One more CON” for COP Of a 120 bypass nationalization of an international application – Demand 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. 19

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

“One more CON” for CAMP Can file 3 rd CON without petition U. S. “One more CON” for CAMP Can file 3 rd 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. 21

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

Summary Number of Parent Applications that Can be Claimed (Serial Aspect) Number of Other Summary Number of Parent Applications that Can be Claimed (Serial Aspect) Number of Other Children for Parent Applications (Parallel Aspect) Examination of Claims Continuation 2 1 Continuation-in-part (CIP) 2 1 N/A 2 (1 Intervening application between COD and parent DIV plus all parent applications of DIV) 1, Except Unlimited DIV’s Continuation of PCT (COP) 3 2 No demand & no national stage (claims unexamined) Continuation of Abandoned Missing Parts App. (CAMP) 3 2 Claims unexamined DIV Continuation of Divisional (COD) Claims unexamined 23

“One more CON” For Applications Filed Before Nov. 1 st • Can file 1 “One more CON” For Applications Filed Before Nov. 1 st • 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. 24

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

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

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

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

Summary of 2 CONs Rule Number of Con/CIPs Filed Before Aug. 21, 2007 Number Summary of 2 CONs Rule Number of Con/CIPs Filed Before Aug. 21, 2007 Number of Con/CIP Filed Between Aug. 21, 2007 and Oct. 31, 2007 Number of Con/CIP Filed On or After Nov. 1, 2007 Without a Petition Initial + 0 Con/CIP 2 Con/CIPs 1 Con/CIP 2 or more Con/CIPs 0 Con/CIP 1 Con/CIP 0 Con/CIP 2 or more Con/CIPs 0 Con/CIP Initial + ≥ 1 Con/CIPs 29

RCE • Can file an RCE without petition if an RCE has not been 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). 30

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

Summary of 1 RCE Rule Number of RCEs Filed Before Aug. 21, 2007 Number Summary of 1 RCE Rule Number of RCEs Filed Before Aug. 21, 2007 Number of RCEs Filed Between Aug. 21, 2007 and Oct. 31, 2007 Number of RCEs Filed On or After Nov. 1, 2007 Without a Petition 0 RCEs 1 RCE 1 or more RCEs 0 RCEs 1 or more RCEs 32

Petitions to exceed CON/RCE limit 1. 2. 3. 4. Petition $400 fee (1. 17(f)) Petitions to exceed CON/RCE limit 1. 2. 3. 4. 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. 33

Petition Factors considered: • Whether applicant should file an appeal or a petition under Petition 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. 34

Petitions to exceed CON/RCE limit • Sufficient showing: – In a CON, an interference 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. 35

Petitions to exceed CON/RCE limit • The following are NOT sufficient showings to grant 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) 36

Petitions to exceed CON/RCE limit • More examples of what are NOT sufficient showings 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 37

CIP • Must identify the claims that are supported by the parent application. – 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 38

Streamlined Continuation • Placed on examiner’s Regular Amended docket; not the New Special docket. 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 39

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

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

5/25 Claim Limitation Rules • Applicant may present, without an ESD, up to 5 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 42

5/25 Claim Limitation Rules • 5/25 limitation applies collectively to claims in commonly owned 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. 43

5/25 Claim Limitation Rules • What is a patentably indistinct claim? – “The standard 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, J 19, J 26. – “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. 3 d 1438, 46 USPQ 2 d 1226 (Fed. Cir. 1998) (the court applied a one-way test where both applications were filed the same day). ” 44

5/25 Claim Limitation Rules • What will count as an independent claim? – A 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 45

5/25 Claim Limitation Rules • FAOM = first action on the merits = does 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 46

ESD (Examination Support Document) • Requirements – Preexamination search statement – Listing of most 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/clm contfinalrule. html • Consider Accelerated Examination if already preparing ESD • If later amend claims out of ESD scope, must supplement ESD 47

ESD Forms ESD Transmittal PTO/SB/216 48 ESD Forms ESD Transmittal PTO/SB/216 48

ESD Forms ESD Listing of References PTO/SB/211 49 ESD Forms ESD Listing of References PTO/SB/211 49

SRR (Suggested Restriction Requirement) • Requirements – Election of no more than 5/25 claims 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 50

Patent Term Adjustment (PTA) Consequences for Failure to Comply with 5/25 Rule • PTA Patent Term Adjustment (PTA) Consequences for Failure to Comply with 5/25 Rule • PTA (in this context) only applies to applications filed or nationalized on or after November 1, 2007 (see Applicability Date section) – “The changes to 37 CFR 1. 78(a) [CON, CIP, DIV Definitions], 1. 78(d)(1) [Limiting to 2 CONs/CIPs, etc. ], 1. 495 [Default to treat PCT’s entering national stage via 371] and 1. 704(c)(11) [PTA failure to comply with 5/25 claim limit] are applicable only to any application, including any continuing application, filed under 35 U. S. C. 111(a) on or after November 1, 2007, or any application entering the national stage after compliance with 35 U. S. C. 371 on or after November 1, 2007. – Note: The existing PTA rules carryover, such that PTA will exist in applications filed before 11/1/07 in situations where applicant fails to respond to 5/25 Notice within 3 months 51

Patent Term Adjustment (PTA) Consequences for Failure to Comply with 5/25 Rule • PTA Patent Term Adjustment (PTA) Consequences for Failure to Comply with 5/25 Rule • PTA (in this context) only applies to applications filed or nationalized on or after November 1, 2007 (see Applicability Date for Rule 1. 704(c)(11)). – Note: The existing PTA rules carryover, such that PTA will exist in applications filed before 11/1/07 in situations where applicant fails to respond to 5/25 Notice within 3 months • Application filed with more than 5/25 claims – no ESD & no SRR within 4 months – PTA will exist – Time begins to run after 4 months and runs until compliance with 5/25 limitation 52

How to Calculate PTA For Failure to Comply with 5/25 Rule • Any PTA How to Calculate PTA For Failure to Comply with 5/25 Rule • Any PTA will be reduced by the number of days – Beginning on the day after the later of: • Four months from filing/nationalization date; or • Filing date of amendment that created the 5/25 non-compliance. – Ending on : • Filing date of amendment satisfying 5/25 Rule; • Filing date of response to restriction requirement in which 5/25 Rule satisfied; • Filing date of SRR complying with 5/25 Rule; or • Filing date of compliant ESD. 53

Refunds for claims fees • Applies to fees paid after 12/8/04 • Applies to Refunds for claims fees • Applies to fees paid after 12/8/04 • Applies to amendments canceling (not just withdrawing) claims filed before FAOM (no certificates to get date) • Request must be filed within 2 mo. of amendment, and on or after 11/1/07 • Result of the Consolidated Appropriations Act, was set to expire 9/30/07. Congress passed a continuing resolution to continue the Act until 10/19/07. At that time, they will either pass another continuing resolution or enact a new Act. 54

Disclosure of “Related” Patents and Applications 55 Disclosure of “Related” Patents and Applications 55

Disclosure of “Related” Patents and Applications • Applicant must, without PTO prompting, identify all Disclosure of “Related” Patents and Applications • Applicant must, without PTO prompting, identify all “related” patents and applications. • “Related” patent(s) and application(s) have: – One common inventor, and – A filing or priority date(s) within 2 months of one another, and – A common assignee or obligation to assign 56

Disclosure of “Related” Patents and Applications Filing or Priority Dates • This includes: foreign Disclosure of “Related” Patents and Applications Filing or Priority Dates • This includes: foreign priority date, actual filing date, and any prior-filed provisional or non-provisional application that is the basis of priority. • All priority/filing dates for an application or patent must be considered. • Exceptions - do not need to report – PCT application not nationalized in US. • PCT Applications - International filing date (and not 371 national stage date) is used to determine same filing date or 2 -month window. 57

Disclosure of “Related” Patents and Applications Common Ownership • In the case of more Disclosure of “Related” Patents and Applications Common Ownership • In the case of more than one assignee, application(s) and/or patent(s) are “commonly owned” if wholly owned by same (identical) person(s), organization(s)/business entity(ies) at the time the invention was made. • Inventions of two, separate, wholly-owned subsidiaries are commonly owned by the parent company. • Mergers & acquisitions – determine owner of each, related document at time the invention was made. • Parties to a joint research agreement under the CREATE act are considered an owner (§ 1. 78(h)). 58

Disclosure of “Related” Patents and Applications Common Ownership Example • Companies A and B Disclosure of “Related” Patents and Applications Common Ownership Example • Companies A and B have a joint development agreement in place when invention X is made (as analyzed under the CREATE Act) – The invention is considered to be owned by AB. – Any other pending applications and patents owned by AB (jointly) satisfying the common inventor and filing/priority date window requirements must be reported. – Pending applications and patents owned solely by A, solely by B or by another entity (e. g. , ABC) do NOT need to be reported by AB. 59

Disclosure of “Related” Patents and Applications • Submit “Listing of Commonly Owned Applications and Disclosure of “Related” Patents and Applications • Submit “Listing of Commonly Owned Applications and Patents” to PTO • (at least by the LATER of): – 4 months from filing date of application (or beginning of national stage) – 2 months from mailing date of filing receipt in another, related application. – Applications filed before Nov. 1, 2007, have until Feb. 1, 2008, or time periods above. 60

Disclosure of “Related” Patents and Applications • Exception: Applications filed before Nov. 1, 2007 Disclosure of “Related” Patents and Applications • Exception: Applications filed before Nov. 1, 2007 – The two-month window does not apply. – Only need to identify if have identical filing/priority date. • Exception: Application filed on or after Nov. 1, 2007 claiming priority to applications/patents filed before Nov. 1, 2007 – The two-month window does not apply to the priority applications filed before Nov. 1, 2007. – Only need to identify applications/patents if they have identical filing/priority date before Nov. 1, 2007. • Note: Applications filed on or after Nov. 1, 2007 or claiming priority to applications filed on or after Nov. 1, 2007 still need to identify related applications/patents within the 2 month window. 61

Failure to identify “Related” Documents • Second or subsequent Office Action made final, even Failure to identify “Related” Documents • Second or subsequent Office Action made final, even when double patenting rejection is new. • Possible grounds for making the patent unenforceable due to inequitable conduct. • Multiple violations - practitioners may be referred to the Office of Enrollment and Discipline. 62

Listing Of Commonly Owned Applications And Patents PTO/SB/206 63 Listing Of Commonly Owned Applications And Patents PTO/SB/206 63

Rebuttable Presumption of Patentably Indistinct Claims 64 Rebuttable Presumption of Patentably Indistinct Claims 64

Rebuttable Presumption of Patentably Indistinct Claims 37 C. F. R. § 1. 78(2)-(3) Rebuttable Rebuttable Presumption of Patentably Indistinct Claims 37 C. F. R. § 1. 78(2)-(3) Rebuttable presumption that there is at least one patentably indistinct claim if: • One common inventor, and • Common assignee or obligation to assign to common assignee, and • Same priority/filing date(s), and • Substantial, overlapping disclosure. 65

Rebuttable Presumption of Patentably Indistinct Claims Substantial overlapping disclosure • Occurs when one patent/application Rebuttable Presumption of Patentably Indistinct Claims Substantial overlapping disclosure • Occurs when one patent/application provides written description support (35 U. S. C. 112, para. 1) for at least one claim in the other patent/application. • Expressly or incorporation by reference • Single common sentence or disclosed element most likely not enough • Drawing(s) in common probably enough 66

Rebuttable Presumption of Patentably Indistinct Claims I have a rebuttable presumption, what now? • Rebuttable Presumption of Patentably Indistinct Claims I have a rebuttable presumption, what now? • Applicant must take action on own initiative • Appropriate action depends on disposition of cases – Pending application + issued patent / allowed application – Pending application + non-allowed application 67

Rebuttable Presumption of Patentably Indistinct Claims Pending application + issued patent / allowed application Rebuttable Presumption of Patentably Indistinct Claims Pending application + issued patent / allowed application • Rebut the presumption (one-way obviousness test: M. P. E. P. § 804(II)(B)(1)(a)); OR • File a terminal disclaimer. “Good and sufficient” reason not required. Deadline for acting: 4 months from the filing date (or beginning of national stage) of pending application. 68

Rebuttable Presumption of Patentably Indistinct Claims Pending application + non-allowed application • Possible actions: Rebuttable Presumption of Patentably Indistinct Claims Pending application + non-allowed application • Possible actions: 1. Rebut the presumption; OR 2. Amend/cancel claims (and then rebut); OR 3. File terminal disclaimer; And i. Show “good and sufficient” reason for multiple applications with patentably indistinct claims; AND ii. Meet 5/25 limitation for combined total claims 69

Rebuttable Presumption of Patentably Indistinct Claims “good and sufficient” reason • Exceptional cases (subjective) Rebuttable Presumption of Patentably Indistinct Claims “good and sufficient” reason • Exceptional cases (subjective) • Examples: – allowance in prior-filed application was withdrawn by PTO; – Interference declared in prior-filed application. Later-filed application claims embodiment not involved in interference. 70

Rebuttable Presumption of Patentably Indistinct Claims Pending application + non-allowed application • Must take Rebuttable Presumption of Patentably Indistinct Claims Pending application + non-allowed application • Must take action in both cases • Deadline for acting: (the later of) – 4 months from the filing date (or beginning of national stage); OR – 2 months from mailing of filing receipt in nonallowed application 71

Rebuttable Presumption of Patentably Indistinct Claims Pending application + non-allowed application • If amending Rebuttable Presumption of Patentably Indistinct Claims Pending application + non-allowed application • If amending claims, determine if amended claim has written description support in related application. • Deadline for acting: – Date amendment is filed. 72

Comparison of Rules – When Implicated Ownership Inventorship Filing/Priority Date(s) Disclosure Claims Reporting: Identification Comparison of Rules – When Implicated Ownership Inventorship Filing/Priority Date(s) Disclosure Claims Reporting: Identification of Pending Applications and Patents 1. 78(f)(1) Owned by same person At least one common inventor Look at filing date: If after 11/1/07, 2 month window applies unless priority before 11/1/07; If before 11/1/07, only ID if same date. Rebuttable Presumption of Patentably Indistinct Claims 1. 78(f)(2) Owned by same person At least one common inventor Same as other pending Substantially non-provisional Overlapping applications or patents Eliminate Patentably Indistinct Claims From All but One Application w/o Good Reason 1. 78(f)(3) Owned by same person At least one claim patentably indistinct Group Applications Together for 5/25 Claim Totals 1. 75(b)(4) Owned by same person At least one claim patentably indistinct 73

Comparison of Rules - Actions Required Action From Filing or National Stage Entry Date Comparison of Rules - Actions Required Action From Filing or National Stage Entry Date From Mailing Date of Filing Receipt Reporting: Identification of Pending Applications and Patents 1. 78(f)(1) Submit form 4 Months identifying other pending nonprovisional applications and patents with filling/priority dates within 2 months (after 11/1/07 unless priority before 11/1/07) or same (before 11/1/07). 2 Months Rebuttable Presumption of Patentably Indistinct Claims 1. 78(f)(2) Submit rebuttal or terminal disclaimer (with explanation, if required) 2 Months Other 4 Months Date Patentably Indistinct Claim Presented 74

Scenarios, Actions & Considerations 75 Scenarios, Actions & Considerations 75

Scenario 1 • Scenario: How to satisfy the reporting requirement in large portfolios being Scenario 1 • Scenario: How to satisfy the reporting requirement in large portfolios being handled by both inside and outside counsel? • Possible Actions: – Maintain database with all patents and applications • Internally or • Outside Counsel – Use Private PAIR • Each firm has a client specific customer number • Each firm (and client) reviews Private PAIR • Considerations: – Segregating work between outside counsel based on inventor(s) / subject matter. – Even if consolidating outside counsel will not solve problems if still filing in house. 76

Satisfy Reporting Requirements • Solution Generally Needs to Address – Output - How to Satisfy Reporting Requirements • Solution Generally Needs to Address – Output - How to Easily Check if You Need to Report Other Applications – Where to Store Application Data For Reporting Purposes – How to Maintain Application Data • Main issue: communication about applications not yet published 77

How to Easily Check if You Need to Report Other Applications • Consider Web How to Easily Check if You Need to Report Other Applications • Consider Web Access Solution to Provide Universal Availability • Reporting rule requirements are generally divided between – Applications Filed Before Nov. 1 st • Common inventor • Same Filing/Priority Date – Applications Filed On or After Nov. 1 st • Common inventor • Filing/Priority Date within 2 -month window 78

Sample Online Database Access 79 Sample Online Database Access 79

How to Easily Check if You Need to Report Other Applications • Applications Filed How to Easily Check if You Need to Report Other Applications • Applications Filed Before Nov. 1 st – Common inventor – Same Filing/Priority Date • Use Computer Power to Generate Report – Use a database to generate reports – If certain data complete, base report on filing date and check family information to supplement report – Simpler solution is to incorporate priority data when generating report 80

How to Satisfy the Reporting Requirement • Applications Filed Before Nov. 1 st - How to Satisfy the Reporting Requirement • Applications Filed Before Nov. 1 st - Sample Matching Filing Date and Common Inventor Report 81

How to Easily Check if You Need to Report Other Applications • Applications Filed How to Easily Check if You Need to Report Other Applications • Applications Filed On or After Nov. 1 st – Common inventor – Filing/Priority Date within 2 -month window • Again Use Computer Power to Generate Report – If certain data complete, base report on filing date and check family information to supplement report – Simpler solution is to incorporate priority data when generating report 82

How to Satisfy the Reporting Requirement • Applications Filed On or After Nov. 1 How to Satisfy the Reporting Requirement • Applications Filed On or After Nov. 1 st - Sample “ 2 Month Window” and Common Inventor Report 83

How to Satisfy the Reporting Requirement • Where to Store Application Data For Reporting How to Satisfy the Reporting Requirement • Where to Store Application Data For Reporting Purposes – Options • Privately maintain database • Access public/semi-publicly available records – No Cookie Cutter Solution • • Budgetary Factors Past Practices for Maintaining Application Data Information Technology Support Degree of risk willing to bear • How to Maintain Application Data – Main issue: communication about applications not yet published 84

“Private Records” Option • Variation - Centralize Application Data – In House; or – “Private Records” Option • Variation - Centralize Application Data – In House; or – Outside Counsel • Require Reporting Application Data in Standard Format (e. g. , Excel spreadsheet) – When Application Filed – Inventorship, Assignment, and/or Priority Changes – Consider using e-Office Action Pilot Program - email cc: to primary data holder • • Requests are sent to primary data holder before reporting deadline Data accessed through web portal App. Data In House OR Outside #1 Outside #2 App. Data Outside #1 Outside #2 85

How to Satisfy the Reporting Requirement • Consider Double Checking Internal Data with Public How to Satisfy the Reporting Requirement • Consider Double Checking Internal Data with Public Data 86

“Public Records” Option • File All Applications via EFS With Unique Customer Numbers for “Public Records” Option • File All Applications via EFS With Unique Customer Numbers for the Client. For Example: – – – • • For Each Customer Number Keep Standard Address, but Add All Attorneys/Agents That Work for the Client as Having Power of Attorney In House and Outside Counsel will Obtain Application Reporting Data Via Public Records Using Standard Search Criteria – – – • • In House For Client A - Customer No. 123 Outside Counsel #1 For Client A - Customer No. 456 Outside Counsel #2 For Client A - Customer No. 789 Private PAIR USPTO Search Public Databases (if desired) - Delphion, etc. For a Limited Window of Time - Will Need to Communicate List of Unpublished Applications Pending Applications Not Associated with the Client Specific Customer Number Will Need to Report to Other Counsel When Inventorship, Priority, and/or Inventorship Change Creates an Issue for Other Counsel PAIR, USPTO, Delphion Outside #1 In House Outside #2 87

Reporting Requirements - General • Always Cite Family Members – Forwards and Backwards • Reporting Requirements - General • Always Cite Family Members – Forwards and Backwards • Use USPTO form PTO/SB/206 • Consider Preparing Report Prior to 4 Month Deadline and not when filed – Reduces duplicate effort 88

Scenario 2 • Scenario: Application currently (before 11/1/07) under final rejection • Considerations: – Scenario 2 • Scenario: Application currently (before 11/1/07) under final rejection • Considerations: – Any unclaimed subject matter? • Possible Actions: – Search family’s prosecution history to determine if an RCE has already been filed for the claimed invention. If yes, file an RCE to add claims before 11/1/07 – Consider filing CONs or amend to add claims before 11/1/07 89

 • • Scenario 3 Scenario: What is the best way to add unclaimed • • Scenario 3 Scenario: What is the best way to add unclaimed subject matter ad/or new claims before Nov. 1, 2007? Option #1: File multiple continuation applications in parallel before Nov. 1 st: – Positives • Do not need to file SRR’s. • Assuming an RCE was not filed in parent case(s) you will be able to file an RCE in each line of continuation applications. – Negatives • • Limited continuations - lose “one more” continuation. High risk of 5/25 claim violations. Increase reporting requirements. Increase chance for a terminal disclaimer. Expensive. Need to file before Nov. 1 st. Option #2: Add claims to a single case and file SRR – Positives • Chance to receive restriction requirement – Increases the number of continuation application opportunities. – Eliminates need for terminal disclaimer. – Eliminates some 5/25 claim limit issues. • Reduces reporting burden. • Filing fees are less. • Not necessary to file before Nov. 1 st – Negatives • Restriction requirement not certain. • Option #3: Combine Option #1 and Option #2 90

Scenario 4 • Scenario: – Invention family with multiple inventions disclosed (e. g. , Scenario 4 • Scenario: – Invention family with multiple inventions disclosed (e. g. , inventions A, B & C), and – At least one invention does not have claims currently pending • E. g. , only one DIV (claims to invention B) currently pending (before 11/1/07) • Considerations: After 11/1/07, all continuing applications claiming priority to DIV may only have claims to invention claimed in DIV (invention B) • Possible Actions: – Amend currently pending DIV to add claims covering unclaimed invention (and change priority as a CON) – File CON to unclaimed invention before 11/1/07 91

Scenario 5 • Scenario: FAOM received in one application before Nov. 1 st, but Scenario 5 • Scenario: FAOM received in one application before Nov. 1 st, but not in another invention family application • Considerations: 5/25 limitation will apply to case in which FAOM not received (both individually and collectively with all invention family applications) • Possible Actions: Determine if claims are patentably distinct – Distinct: rebut presumption in both cases • Must still meet 5/25 limitation individually in case not having FAOM – Not Distinct: amend to patentably distinct (and rebut presumption) • Must still meet 5/25 limitation individually in case not having FAOM – Not Distinct: consolidate into 1 application • Avoid more than one application justification (§ 1. 78(f)(2)-(3)) • If over 5/25, file SRR or wait for Rest. Req. ; could file ESD 92

Scenario 6 • Scenario: Family contains a large number of non-allowed applications • Considerations: Scenario 6 • Scenario: Family contains a large number of non-allowed applications • Considerations: Rebuttable presumption of patentably indistinct claims • Possible Actions: – Get cases allowed before Nov. 1 st – If distinct, rebut presumption of patentably indistinct claims – Consolidate Claims into 1 Case or a CIP • If over 5/25, submit SRR or wait for possible Rest. Req. ; could submit ESD • Avoid more than one application justification (§ 1. 78(f)(2)-(3)) – Amend so each non-allowed application presents distinct claims (and rebut presumption) • Must still meet 5/25 limitation in individual applications • Avoid more than one application justification (§ 1. 78(f)(2)-(3)) – File terminal disclaimer 93

Scenario 7 • Scenario: How to claim previously unclaimed subject matter after 11/1 if Scenario 7 • Scenario: How to claim previously unclaimed subject matter after 11/1 if application has exhausted 2 CONs + 1 RCE? • Possible Actions: – If < 2 years from issuance, file a broadening reissue with claims to previously unclaimed matter. – If > 2 years from issuance, possibility to file narrowing reissue – With the reissue, you will be able to file 2 CONs + 1 RCE. – Consider 1 more CON. 94

Scenario 8 • Scenario: Received foreign search report with new references and already exceeded Scenario 8 • Scenario: Received foreign search report with new references and already exceeded 2+1. The search report was mailed over 3 months ago so you cannot make a certification under 1. 97(e). • Considerations: – RCE NOT possible (see comments to Rules) • Possible Actions: – Consider if “one more” rule applies – Petition to suspend the rules – Consider Reexamination /Reissue of parent patent – Memo analyzing relevance 95

Scenario 9 • Scenario: – – – Application filed after Nov. 1 st has Scenario 9 • Scenario: – – – Application filed after Nov. 1 st has claims directed to Inventions A, B, C and D. Receive 1 st Restriction to Group I - A, B & C and Group II - D. Respond by electing Group I (A, B & C). Receive and respond to 1 st Non-final OA. Receive 2 nd Restriction Requirement requiring to elect A, B or C. Respond by electing C • Problem: According to rules cannot file divisional applications to Inventions A & B because A & B already examined. • Possible Actions: PTO Less Draconian in FAQ – 2 nd restrictions will now be rare - need to be authorized by head of Technology Center. – PTO will consider A & B as not being examined if second restriction issued. 96

Scenario 10 • Scenario: – Received restriction and elected invention A – Filed divisional Scenario 10 • Scenario: – Received restriction and elected invention A – Filed divisional to unexamined invention B • Problem: Can you file 2 CONs for invention A claiming the benefit of divisional B? • Answer: NO, according FAQ C 12, see Rule 1, 78(d)(1)(iii). Only can file 2 CONs of divisional B directed to invention B • Possible Actions: – Incorporate claims directed to invention A into the “divisional” B application and change priority claim from the “divisional” application to a “continuation” application. • No petition required to merely change application type after 4 months • There is an unresolved question as to whether you can do this after an Office Action. Not sure questions as to whether Rule 1. 145 “Subsequent presentation of claims for different invention” will be treated as a restriction requirement. – File another divisional to invention B. 97

Scenario 11 • Scenario: How to increase the certainty of having multiple divisional applications Scenario 11 • Scenario: How to increase the certainty of having multiple divisional applications for applications filed after Nov 1, 2007. • Possible Actions: – File the application as a PCT application • If possible, designate EP searching authority. • Can pay additional search fees & file Article 19 amendments 98

Scenario 12 • Scenario: How do you maximize potential to cover future products for Scenario 12 • Scenario: How do you maximize potential to cover future products for applications filed after November 1, 2007? • Possible Actions: – File provisional application – File PCT application claiming benefit of provisional • Nationalize or file bypass CON & prosecute with small claim set. • Appeal often. • At second continuation (after using RCE) file a large number of claims with an SRR and hope for restriction so that can file multiple divisional applications. • Delays having the restriction requirement set too early before products are developed. • Must remain aware of “not examined” requirement for divisionals because one of the early CONs might hide a similar claim that was examined – For Utility applications use a similar tactic – To reduce SRR risk of not being accepted, instead file large claim set and SRR in 1 st CON so 2 nd CON acts as an insurance policy. 99

Scenario 13 • Scenario: How to reduce the risk that a non-US patent office Scenario 13 • Scenario: How to reduce the risk that a non-US patent office will cite prior art too late during prosecution (i. e. , after final or allowance)? • Possible Actions: – File in countries outside the US (OUS) that will likely contain the best prior art or where you will likely foreign file. • Obtain foreign filing license from USPTO, if needed. • Request expedited examination (e. g. , EPO - no charge & no reason needed to expedite examination). – File provisional application to avoid intervening 102(b) prior art issue • As a practical matter, you might want to file the provisional application first because it makes obtaining an expedited foreign filing license a little easier. – File PCT application claiming benefit of provisional and foreign applications • Pay additional search fees & do not file a demand – Nationalize in US close to Chapter II deadline to extend time to receive foreign search results – Possible added benefit: might be able to expedite US examination through patent prosecution highway program (Japan and United Kingdom Patent Offices are participants). 100

Scenario 14 • Scenario: How do you reduce the chance of being required by Scenario 14 • Scenario: How do you reduce the chance of being required by the USPTO to file a terminal disclaimer? • Possible Actions: – Remove the rebuttable presumption of patentably indistinct claim of rule 78(f)(2) • File applications 1 day apart (e. g. , file applications directed to the molecule/apparatus, method of treatment/use, and method of manufacturing on different days). • Do not share common specification and/or drawings. • Do not incorporate by reference. 101

Scenario 15 • Scenario: You want to maximize the number of claims for both Scenario 15 • Scenario: You want to maximize the number of claims for both a Genus and Species and want to minimize impact of 5/25 Rule, reporting requirements, and patentably indistinct presumption • Possible Actions: – Consider Dual PCT and Utility approach claiming benefit of common provisional (file 1 day apart to avoid rebuttable presumption) – File at or near the same time • US utility applications with Broader (Genus) Claims & • PCT with narrower (Species) claims - large number of independent species claims to get unity of invention rejection so can file multiple divisionals & may strengthen patentably distinct argument for genus. – Try to get utility allowed before PCT’s Chap II deadline – Delays 2+1, 5/25, reporting, and presumption issues 102

Scenario 16 • Scenario: How to address the 5/25 limitation, as well as others, Scenario 16 • Scenario: How to address the 5/25 limitation, as well as others, in large portfolios being handled by multiple firms? • Possible Actions: – Maintain claims/subject matter database per invention family • Internally or • Outside Counsel – Coordinate so that prosecution is serial – Segregating work between outside counsel based on subject matter – Avoid justification (§ 1. 78(f)(2)-(3)) and 5/25 limitation 103

Scenario 17 • Scenario: How can you use the new rules against competitors? • Scenario 17 • Scenario: How can you use the new rules against competitors? • Possible Actions: – Send competitor prior art just after allowance/issue fee payment so that they waste RCEs or CONs. • Note: New IDS rules will allow applicant to consent to 3 rd party protest for unsolicited documents – Litigation-new grounds for inequitable conduct and estoppel - ESDs, reporting, etc. 104

What To Do 105 What To Do 105

What You Need to Do Now (Before Nov. 1 st) • Review all applications What You Need to Do Now (Before Nov. 1 st) • Review all applications under final to determine if you can/should file RCE. • Submit all IDS’s requiring a second RCE. • Review all divisional applications to determine if to add claims and change to CON to incorporate unclaimed or previously claimed inventions. 106

What Would be Nice to Do Now • Create policy for firms handling work What Would be Nice to Do Now • Create policy for firms handling work & update data – Reporting requirements – 5/25 claim limits • Create Docket Entries – February 1, 2008 Deadline • File related application/patent reports (for cases having the same filing/priority date) in applications filed before November 1, 2007. • CIPs filed before Nov. 1, 2007 to determine if claim support report needed (FAOM received? ). – 4 Month from filing/national stage date • Submit identification of commonly owned applications and patents • Check 5/25 - cancel, submit rebuttal of patentably indistinct claims or terminal disclaimer – 2 Month from amendment canceling claims • Request refund • Review CIPs to determine if you should remove priority - avoid limiting number of continuations off parent case and CIP. 107

What You Do NOT Need To Do Now • Don’t worry about the 5/25 What You Do NOT Need To Do Now • Don’t worry about the 5/25 claim limits before Nov. 1 st – Although 5/25 rule applies to all applications without FAOM before Nov. 1 st, PTA is NOT a concern because the PTA rule (Rule 1. 704(c)(11)) is only applicable to applications filed on or after Nov. 1 st. – You will receive a Notice that you exceed 5/25 • 2 month time to reply is extendable • Applicant must: (1) Amend, (2) file SRR, or (3) file ESD • Note may lose opportunity to file SRR if notice is combined with Restriction Requirement – Note PTA rules will apply if you file a late response to the Notice. 108

What You Need to Do Before Feb. 1, 2008 • Applications Filed Before Nov. What You Need to Do Before Feb. 1, 2008 • Applications Filed Before Nov. 1 st – Submit report identifying applications with same filing/priority date. – CIPs • If FAOM before Nov. 1 st, no action required. • If FAOM not before Nov. 1 st, file claim support document. • Applications filed After Nov. 1 st – Submit report identifying applications with filing/priority date within 2 month window (note exceptions to priority claim before Nov. 1 st) within 4 months of filing. – File SRRs even if under 5/25 limit. – Limit claims to 5/25 limit. • If over 5/25, file an (1) SRR, (2) wait for possible Rest. Req. (unattractive option – if don’t receive Rest. Req. , must use a CON), or (3) ESD (consider filing an SRR along with ESD to preserve PTA if ESD is non-compliant). • Get applications allowed to take them out of the reporting requirements. 109

What to Consider After Nov. 1 st 110 What to Consider After Nov. 1 st 110

Invention Disclosures • Try to segregate invention disclosures to individual inventions – Long term Invention Disclosures • Try to segregate invention disclosures to individual inventions – Long term will help with reporting requirements by limiting the number of inventors on an application – Granular Invention Disclosures will help with divisional or separate application decision – Will help limit the number of references found during search which might help with future IDS rules • Requires more detailed invention disclosures – No surprises when application drafted (new embodiments) can create unclaimed subject matter and claim limit problems • Prioritize Invention Disclosures – How much searching – How the application is drafted – How the application is prosecuted 111

Patent Search • Patent Searches are more important – Need a better idea of Patent Search • Patent Searches are more important – Need a better idea of art for drafting claims, so know weaknesses before the first Office Action (2+1 Rule) • When available, follow USPTO Search Templates for ESD purposes – Available at http: //www. uspto. gov/web/patents/searchtemplates/ • If IDS Rules Finalized – Keep inventions (disclosures) compartmentalized to limit number of references from each search • Maintain a list of classes and subclasses from search because can be helpful in drafting an SRR to show that the claims cover different classes and subclasses. 112

Patent Search – Types • Standard Approach – Quick Search to Find Knockout art Patent Search – Types • Standard Approach – Quick Search to Find Knockout art • ESD or ESD Like Approach – Quick search to find knockout art – Decision to file • Draft rough claim with all dependent features • Search all claims - Use USPTO search templates – Consider using different searchers for each search – Leaves option open for ESD • Consider Filing PCT to Further Gain Benefit of Search Report 113

Patent Application Drafting • General – Need to understand overall strategy of the case Patent Application Drafting • General – Need to understand overall strategy of the case – Consider if ESD appropriate case (if ever) • Specification – Consider limiting incorporation by reference to reduce the chance of patentably indistinct presumption – Limit subject matter described to the invention to avoid describing overlapping subject matter that would support claims in other case(s) that would create patentably indistinct presumption – Cross reference to other related applications where benefit is not claimed needs to be in a separate paragraph (Rule 1. 78(d)(6)) • Claims – – – Limit 5/25 Draft Claims to provoke restriction & consider SRR Do not leave unclaimed subject matter Use Markush claims to reduce claim totals Claim order more important in PCT applications because will dictate the order in which inventions are prosecuted once nationalized – Consider interference like omnibus claim (e. g. , A or B) • Drawings – Recycling drawings from other applications may invoke presumption of patentably indistinct claims 114

1 st Filed U. S. Applications • Provisional Applications – Consider filing a series 1 st Filed U. S. Applications • Provisional Applications – Consider filing a series of provisional applications where product is being developed because provisionals not subject to 2+1 Rule, 5/25 Rule, and reporting rules – Consider provisional to delay examination in order to cover future products • Utility – Conduct search for cases that might create presumption – Foreign Priority - Need to Track Dates for Reporting – Rule problem discovered - consider converting to provisional to give time to fix problem (e. g. , 5/25 notice - 2 month no EOT) 115

PCT Applications • Might be more desirable now – subject to delaying US patent PCT Applications • Might be more desirable now – subject to delaying US patent issuance – – – • • 5/25 Rule does not apply during international phase Search might provide art which will help decide how to prosecute in the US Can amend claims without wasting an office action Not subject to reporting requirements until nationalized Not subject to rebuttable presumption of patentably indistinct until nationalized Issue: New PCT rules increased filing costs cost more Nationalization - which way is better – 371 Route - PCT restriction rules apply • • Claims subject to unity of invention rejection can file separate divisionals at nationalization. Filing a demand does not cause problem with divisional applications. – 120 Bypass Route & 371 Route - get generally the same number of CONs (120 Bypass – one more rule), but must NOT file a Demand, so limited in amendments and arguments • • Can pay additional search fees without causing problems for divisionals Make standard practice to not file a demand to keep nationalization options open – Note impact of not filing demand: Will lose opportunity to directly nationalize in a few countries (e. g. , Switzerland, etc. ) if not nationalized by Chap. 1 deadline, but can nationalize through regional office (e. g. , EPO, etc. ) • Consider Dual PCT and Utility approach claiming benefit to common provisional – US Broader (Genus) Claims & PCT Narrower Claims – Try to get allowance before PCT’s Chap II deadline – Avoids 2+1, 5/25, reporting, and presumption issues 116

Design Applications • Only have a 2 Rule and not 2+1 Rule – Only Design Applications • Only have a 2 Rule and not 2+1 Rule – Only can file two continuations/CIPs – RCEs not permitted in Design Applications • Reporting requirement applies • Rules not clear about patentably indistinct presumption – If common drawing with utility application will likely create presumption, but easy to rebut. • Rules not clear how or if 5/25 Rule would apply to Design Applications 117

Continuing Applications • General – – – • Track number of applications in invention Continuing Applications • General – – – • Track number of applications in invention family Track number of RCE’s in invention family Prosecute Serially Exhaust CON before filing divisionals Consider SRR at filing File Family report when filed & supplement at 4 month from filing Continuation – File rebuttal or terminal disclaimer at filing • Continuation-in-part – Avoid due to support reporting requirements – Must identify the claims that are supported by the parent application. – The examiner may require the location in the specification (page and line number) that support those claims. 37 C. F. R. 1. 105 – File rebuttal or terminal disclaimer at filing – Cannot File CIP of a divisional • Divisional – Still must rebut presumption of indistinct claims - Consider submitting paper at filing indicating that subject to restriction and presumption should not apply – Restarts 2+1 Rule – CIPs of divisionals not permitted 118

Patent Application Filing • Identify related applications • Consider Terminal Disclaimer, ESD, etc. • Patent Application Filing • Identify related applications • Consider Terminal Disclaimer, ESD, etc. • File SRR even below 5/25 limit so as to create opportunity of more divisional applications • When possible, file non-publication request to avoid creating 102(b) art that could be used to invalidate a continuing application that was not granted a priority date 119

Docket Dates • Docket 4 month to identify related cases • Docket 4 month Docket Dates • Docket 4 month to identify related cases • Docket 4 month to take action on rebuttable presumption • If over 5/25, docket 2 weeks to file SRR, amend, or ESD. (No set date in Rules for this docket entry, but need to address quickly before the notice. ) • Feb 1, 2008 – Submit related cases reports in cases where filing/priority date is identical for applications filed before Nov. 1 st. – Identify claim support in CIPs filed before Nov. 1 st, that did not receive a FAOM before Nov. 1 st. 120

Post Filing Notices • Receive Notice that application is over 5/25 – Docket 2 Post Filing Notices • Receive Notice that application is over 5/25 – Docket 2 months – Appl. filed before 11/1/07 • Time is extendable • File SRR, Amend, or ESD – Appl. filed after 11/1/07 • Time is not extendable • File Amend or ESD 121

Patent Application Assignment • “Common Ownership” – Mergers & acquisitions – key is ownership Patent Application Assignment • “Common Ownership” – Mergers & acquisitions – key is ownership (for all related documents) at the time the invention was made. – Parties to a joint research agreement under the CREATE act are considered an owner (§ 1. 78(h)). – Inventions of two separate, wholly-owned subsidiaries are commonly owned by the parent company. 122

Foreign Filing • Need to Track Prior Foreign Application Filing Dates for Reporting Purposes Foreign Filing • Need to Track Prior Foreign Application Filing Dates for Reporting Purposes • Alternative #1: Consider foreign filing first in countries that typically have relevant prior art so that art is available before US examination. – File counterpart US provisional to avoid 102(b) issues – EPO consider requesting expedited examination • Alternative #2: Consider Delaying Examination in Foreign Cases until after US Prosecution concludes for the first case – Avoid burning RCE/CON on an IDS – Might help with limits under new IDS Rules – Request Foreign Associates to promptly report Search/Examination Reports so IDS is timely filed • Might Not Foreign File so can file non-publication request to avoid creating 102(b) art. 123

Publication • If possible, consider Non-Publication Requests when application is filed to avoid creating Publication • If possible, consider Non-Publication Requests when application is filed to avoid creating 102(b) art where lose priority because of violating 2 CON limit or where want to capture unclaimed subject matter that is disclosed in the application. • Consider Filing Application Data Sheet to Identify Current Owner in Published Applications - easier tracking and searching for reporting requirements. • If added new claims, consider filing a request for republication so that damages toll. 124

IDS • Consider Delaying Examination in Foreign Cases until after US Prosecution concludes – IDS • Consider Delaying Examination in Foreign Cases until after US Prosecution concludes – Avoid burning RCE/CON on an IDS – Might help with limits in proposed IDS Rules – Request Foreign Associates to promptly report Search Reports so IDS is timely filed • Consider limiting number of search results from patent searches (in view of proposed IDS rules) • Be selective in dependent claims so as to eliminate irrelevant art 125

Restriction • Never Traverse because a restriction requirement creates a new “Invention family” which Restriction • Never Traverse because a restriction requirement creates a new “Invention family” which is entitled to 2 CONs/1 RCE • Consider filing an SRR in every case where may have more than 1 invention, even if claims are less that 5/25. • PCT Applications might help for restrictions 126

Prosecution Practices First Office Action • Under New Rules 2 nd Final Office Actions Prosecution Practices First Office Action • Under New Rules 2 nd Final Office Actions will be more common so prosecution will be more compact – Conduct Interviews – Prepare 1 st response like an Appeal Brief – Submit affidavits or other evidence in 1 st response • • Make Claims in Condition for Allowance - know number of independent claims available Obviousness Type Double Patenting will be more common – Be careful – more terminal disclaimers greater risk of not being commonly assigned • New/Amended Claims - Check for rebuttable presumption – Patentably Distinct: Rebut Presumption – Patentably Indistinct: • Other case is allowed application/patent, file Terminal Disclaimer • Other case is non-allowed application – Make claims distinct: re-amend or delete – Exceptional circumstances: provide “good and sufficient” reason for addt’l app & don’t exceed 5/25 limit • Remove Any Claim Interpretation Issues – Aids acceptance into Pre-Appeal Brief Review Program 127

Second / Final Office Action • Try to Interview (again) if Examiner Receptive • Second / Final Office Action • Try to Interview (again) if Examiner Receptive • File Response by 2 month deadline • Prepare Response like appeal brief • Remove Claim Interpretation Issues – So you can use Pre-Appeal Brief Program 128

RCE • Final Office Action Before Nov. 1 – File RCE - if one RCE • Final Office Action Before Nov. 1 – File RCE - if one or more RCE’s already in Family • Use RCE 1 st – want to file petitions off CONS (conservative approach) • If a petition filed off an RCE is denied, the application can be abandoned before you receive a decision on the petition. • If a petition filed off a CON is denied, the application only loses the priority date • Track RCE’s in Family – Note RCE on File – Track Electronically 129

Appeal • Consider Pre-Appeal Brief Review Pilot Program – – Allows to address “bad” Appeal • Consider Pre-Appeal Brief Review Pilot Program – – Allows to address “bad” final Office Actions without the need to prepare a full appeal brief Panel of Examiners (including the Examiner for the case) will reconsider grounds for rejection. Must file request with Notice of Appeal (No EOT) and cannot file with Appeal Brief. Proper Grounds to Use Program • • Clear errors in fact or law in the examiner's rejections; or The examiner's omission of one or more essential elements needed for a prima facie rejection. – Improper Grounds to Use Program - Use Full Appeal • Claim interpretation issues – Filing Requirements • • Notice of Appeal along with any EOTs Pre-Appeal Brief Request for Review Form PTO/SB/33 Arguments - 5 pages or less DO NOT file an Appeal Brief with Request - will remove from program – Decision from Panel • • Appeal process continues - 1 issue remains for appeal Application allowed Prosecution Reopened Request denied (improper) – Time period for filing an appeal brief will be reset to later of: • • • One-month from mailing of the decision on the request, or Two-month time period running from the receipt of the Notice of Appeal. Proposed Appeals Rules Considerations – Stricter requirements (e. g. , brief require claim charts, limited extensions, etc. ) 130

Allowance • Want Notice of Allowance as soon as possible – Authorize Examiner Amendments Allowance • Want Notice of Allowance as soon as possible – Authorize Examiner Amendments • For Patentably Indistinct Claims, file Continuation after Notice of Allowance – Avoid “good and sufficient” reason justification – Avoid 5/25 (multiple applications) limitation • Get Applications Allowed Before Nov. 1 – Avoid 5/25 problems (single or multiple applications) – Eliminate multiple, non-allowed applications having patentably indistinct claims (requiring “good and sufficient” reason) • Check Inventorship at allowance to eliminate any “non”inventors (reduce reporting load) • Consider filing Comments on Reasons for Allowance to preserve Broadening Reissue rights 131

Issuance and Maintenance Fees • Issue Fee Payment – Pay issue fee as soon Issuance and Maintenance Fees • Issue Fee Payment – Pay issue fee as soon as you receive a Notice of Allowance to window of competitor “game playing” that will cause you to submit additional CON/RCE • • – Place assignee on Patent for tracking Issue Notification – Check Patent Term Adjustment Issues Maintenance Fees – Must identify and, when necessary, rebut presumption when a common inventor / common owner situation exists with an application and a patent that has expired due to failure to pay maintenance fees. 132

Reissue • Reissues • Same standard to file reissue: – Error which causes the Reissue • Reissues • Same standard to file reissue: – Error which causes the patent to be "deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent. “ • An attorney's failure to appreciate the full scope of the invention was held to be an error correctable through reissue. MPEP 1402 • Applicants may file a reissue application under 35 U. S. C. 251, if appropriate, to submit claims with a different scope. • 2+1 Rule Applies to reissue – Can file 2 reissue continuation app’s + 1 RCE, w/out justification. Even if app for original patent was a 2 nd continuation app. 133

Reissue • Disclosure of “Related” Documents and Rebuttable Presumption Applies to Reissue • 5/25 Reissue • Disclosure of “Related” Documents and Rebuttable Presumption Applies to Reissue • 5/25 Rule Applies to Reissue – Changes apply to reissue app’s filed on or after Nov. 1, 2007 and any reissue app in which a FAOM was not mailed before Nov. 1, 2007. • ESD not req’d if reissue app does not seek to change claims in patent being reissued. – Change in claims is sought either by addition of a claim, or amendment to claim or spec which changes a claim. 134

Other Proceedings • Reexamination – Consider if unable to file IDS due to 2+1 Other Proceedings • Reexamination – Consider if unable to file IDS due to 2+1 limit • Interference – Less likely to copy claims due to 5/25 limit 135

Litigation • ESD - creates estoppel. • Obviousness type double patenting issues magnified by Litigation • ESD - creates estoppel. • Obviousness type double patenting issues magnified by increased number of terminal disclaimer – Common assignee issue • Grounds for inequitable conduct if fail to correct improper priority claim (see, Nilssen v. Osram Sylvania (Fed. Cir. 2007)). 136

Other Proposed Rules to Consider • • PCT Rules - Increased Search Fee IDS Other Proposed Rules to Consider • • PCT Rules - Increased Search Fee IDS - Limit to 20 References More Stringent Appeals Formalities Markush Limits … We’ll be back 137

New Final PCT Rules • Restoration of priority rights - does not yet apply New Final PCT Rules • Restoration of priority rights - does not yet apply in the US, but the earliest priority date, including restored dates, will be used as a basis to calculate PCT time limits/deadlines • Permits the insertion of a missing portion of the application without the loss of a filing date via incorporation by reference on PCT Request • PCT Rule changes directed to clarifying the circumstances and procedures under which the correction of an obvious mistake may be made in an international application - No change needed in the US • Increased search fee to $1, 800. The search fee is applicable, regardless of whethere is a corresponding US prior nonprovisional application (i. e. , no reduced fees if previously filed counterpart US application) 138

Proposed IDS Rules • Requirements for each period has changed – 1 st Period Proposed IDS Rules • Requirements for each period has changed – 1 st Period - IDS filed within 3 month or before FAOM - just submit IDS (exceptions below). – 2 nd Period - IDS filed after FAOM - explanation and non-cumulative description. – 3 rd Period - IDS between allowance and issue fee payment - Timeliness certification and patentability justification (including, explanation and non-cumulative description). – 4 th Period - IDS after issue fee payment - includes 3 rd Period requirements plus petition to withdraw from allowance, statement of unpatentable claims, amendment, & patentability reasons for amended claims. – IDS fees eliminated • Explanation required before FAOM (1 st Period) – Cite over 20 references - explanation for all references. – References over 25 pages. – Non-English language documents. • Exceptions – 1 st Period Explanation - Not required if submit foreign search report citing the references – 2 nd Period Explanation and Non-Cumulative Description - Not required if submit foreign search report and certification submitting within 3 months of first cited. • Amendments - re-explanation for IDS or indicate nothing changed. • Consent to protest by 3 rd party of unsolicited documents received from 3 rd party. 139

Proposed IDS Rules Time Periods 1 - 4 From USPTO Presentation Application Prosecution Timeline Proposed IDS Rules Time Periods 1 - 4 From USPTO Presentation Application Prosecution Timeline and corresponding IDS requirements Application Filed First Office Action on the Merits (FAOM) Allowance of Application Payment of Issue Fee Time Sufficient for Consideration Patent First Period Up to 20 citations permitted w/o any explanation req’d. • Explanations req’d for: each ref. >25 pages, or in non-English language, or for all refs when more than 20 Second Period • Explanation, and • Non-cumulative description Third Period • Timeliness cert. , and • Patentability Justification which includes: Explanation, Non-cumulative description, and either: (A) Patentability reasons for unamended claims; or (B)(1) Statement of unpatentable claims, (B)(2) Amendment, and (B)(3) Patentability reasons for amended claim(s) Fourth Period • Timeliness cert. ; • Patentability Justification which includes: Explanation, Non-cumulative description, Statement of unpatentable claims, Amendment, and Patentability reasons for amended claim(s); and • Petition to w/d from allowance 140

Proposed Appeals Rules • Additional format requirements and sections (e. g. , claim support, Proposed Appeals Rules • Additional format requirements and sections (e. g. , claim support, drawing analysis, etc. ) • Page limits - 25 pages for Appeal Briefs and 15 pages for Reply Briefs • Limits Extensions of Times after Appeal Brief Filed • Further limits arguments that can be presented • Limits amendments that can be made and evidence presented • Makes it easier to abandon applications without notice • Examiner Makes a New Rejection - the applicant must within 2 months (to avoid abandonment) request appeal to continue (file reply brief) or request reopening of prosecution (file response). 141

Proposed Markush Claims Rules • An intra-claim restriction is proper unless all species share Proposed Markush Claims Rules • An intra-claim restriction is proper unless all species share a substantial feature essential for common utility or species prima facie obvious over each other. – Can file an explanation why claim limited to a single invention • A claim may not incorporate part of the specification by reference unless absolutely necessary. • Markush alternatives: – – must be substitutable; may not encompass other alternatives; may not be a set of further alternatives; and must not make the claim difficult to construe. 142

Want to know more? Woodard, Emhardt, Moriarty, Mc. Nett & Henry LLP Chase Tower Want to know more? Woodard, Emhardt, Moriarty, Mc. Nett & Henry LLP Chase Tower 111 Monument Circle, Suite 3700 Indianapolis, IN 46204 317. 634. 3456 www. uspatent. com 143