Securing Innovation Michael D. Stein Stein, McEwen & Bui LLP 1400 Eye Street, NW Suite 300 Washington, DC 20005 (202) 216-9505

Securing Innovation Michael D. Stein Stein, McEwen & Bui LLP 1400 Eye Street, NW Suite 300 Washington, DC 20005 (202) 216-9505 mstein@smbiplaw.com www.smbiplaw.com Changes To USPTO Continuation and Examination Practice: Final Rules Michael D. Stein October 2007

Securing Innovation 1 Introduction On Jan. 3, 2006, USPTO proposed sweeping changes to patent prosecution: – Proposed Change #1: Proposal §1.78(d)  changes to continuation practice – Proposed Change #2: Proposal §1.75(b)(1)(ii)  maximum of ten (10) examined claims – Proposed Change #3: Proposal §1.78(f)(2)  rebuttable presumption similar, commonly-owned applications are patentably indistinct – All rules are retroactive Reason: Need “to bring ‘finality’ to patent process” to prevent backlog and provide “certainty in a timely manner” (USPTO 2007-2012 Strategic Plan, p11) – Backlog awaiting examination could approach 1.4 million cases by 2012. – Assuming 8% growth per year – Current backlog is 31 months to first office action.

Securing Innovation 2 PROPOSED CHANGE 1: Total Continuation Filing Rates *Straight Continuations 37 CFR §1.53 (b)(1) – No Divisionals or CIPs – as of 1/17/06

Securing Innovation 3 Reasons For Proposed Change #1 Reduce the Backlog at the USPTO – Current practice allows an applicant to generate an unlimited string of continued examination filings, causing delay – More than 900,000 cases currently pending Backlog awaiting examination could approach 1.4 million cases by 2012. Current backlog is 31 months to first office action. – For multiple applications Consolidate indistinct applications into single applications Shifts burden to applicant to explain why multiple applications are patentably distinct If patentably indistinct, why should multiple indistinct applications should be maintained Improves quality of issued patents – Makes exchange between examiners and applicants more efficient – Requires applicants to file 2 nd or subsequent continued examination filings in good faith

Securing Innovation 4 PROPOSED CHANGE 2: Distribution of Total Claims at Filing 0% 10% 20% 30% 40% 1~10 11~20 21~2526~3031~4041~5051~60 61~100 101+ FY 2004FY 2005

Securing Innovation 5 Reasons for Proposed Change #2 Increases efficiency – Currently, effort is wasted examining every claim in an application for every Office Action, even if patentability of dependent claims stand or fall together with independent claims which they depend on. – Examiners can focus on claims which applicant designates as “representative” Does not have a negative impact on examination quality – In 2005, only 1.2% of applications included more than 10 independent claims – thus, even with proposed change #2, examiners still required to examine vast majority of independent claims Consistent with BPAI practice – BPAI provides that if applicant desires BPAI to consider patentability of a claim separately from other claims also subject to same ground of rejection, applicant must include section in brief arguing for separate patentability.

Securing Innovation 6 Reasons for Proposed Change #3 Ease the burden on Examiners – When applicant chooses to file substantially similar applications, applicant shares burden of resolving potential double patenting rejections Does not adversely impact most applicants – In FY 2004, only 17,600 out of 310,000 (i.e., 5.7%) of applicants filed terminal disclaimers – Does not disproportionately impact small entities (only 4.1% of terminal disclaimers filed in FY 2004 filed by small entities) – No new fees associated with proposed rule change

Securing Innovation 7 FINAL RULES HAVE BEEN PUBLISHED On August 21, 2007, the U.S. Patent and Trademark Office Published the Final Rules in the Federal Register The Final Rules make sweeping changes to the following areas: – Examination of Claims – Continued Examination Filings (Continuations, CIPS, RCEs) – Patent Applications Containing Patentably Indistinct Claims The Final Rules were implemented to allow the USPTO “…to conduct a better and more thorough and reliable examination of patent applications.” 72 Fed. Reg. No. 161, Pg. 46716 (August 21, 2007) The Final Rules are different from the proposed rules

Securing Innovation 8 FINAL RULES HAVE BEEN PUBLISHED The Final Rules represent the most significant change to U.S. patent prosecution law in at least the last decade Various provisions of the Final Rules “interlock” with each other The Final Rules are effective NOVEMBER 1, 2007 – Retroactive in nature

Securing Innovation 9 Table of Contents Part 1: Examination of Claims · · · · · · · · · · · · · · · · · · 10 Part 2: Continued Examination Filings · · · · · · · · · · · ·35 Part 3: Patent Applications Containing Patentably Indistinct Claims · · · · · · · · · · · · · · · · · · · · · · · · · · ·72 Part 4: Practical Prosecution Strategies · · · · · · · · · · 90 Specific Strategies before November 1, 2007· · · · · · · · · · · 93 General Strategies before or after November 1, 2007· · · · 102 Part 5: Recent Developments · · · · · · · · · · · · · · · · · 123

Securing Innovation 10 PART 1: EXAMINATION OF CLAIMS

Securing Innovation 11 Claim Rules: Text 37 C.F.R. §1.75(b)(1): “An applicant must file an examination support document in compliance with §1.265 that covers each claim (whether in independent or dependent form) before the issuance of a first Office action on the merits of the application if the application contains or is amended to contain more than five independent claims or more than twenty-five total claims. An application may not contain or be amended to contain more than five independent claims or more than twenty-five total claims if an examination support document in compliance with §1.265 has not been filed before the issuance of a first Office action on the merits of the application.”

Securing Innovation 12 Claim Rules: Text (cont) 37 C.F.R. §1.75(b)(2): – “A claim that refers to another claim but does not incorporate by reference all of the limitations of the claim to which such claim refers will be treated as an independent claim for fee calculation purposes under §1.16 (or §1.492) and for purposes of paragraph (b) of this section. A claim that refers to a claim of a different statutory class of invention will also be treated as an independent claim for fee calculation purposes under §1.16 (or §1.492) and for purposes of paragraph (b) of this section.

Securing Innovation 13 Claim Rules: Text (cont) 37 C.F.R. 1.75(b)(3): – “The applicant will be notified if the application contains or is amended to contain more than five independent claims or more than twenty-five total claims but the applicant has not complied with the requirements set forth in paragraph (b)(1) or (b)(4) of this section. If the non-compliance appears to have been inadvertent, the notice will set a two-month time period that is not extendable under §1.136(a) within which, to avoid abandonment of the application, the applicant must comply with the requirements set forth in paragraph (b) of this section.”

Securing Innovation 14 Claim Rules: Text (cont) 37 C.F.R. §1.75(b)(4): – “If a nonprovisional application contains at least one claim that is patentably indistinct from at least one claim in one or more other pending nonprovisional applications, and if such one or more other nonprovisional applications and the first nonprovisional application are owned by the same person, the Office will treat the claims (whether in independent or dependent form) in the first nonprovisional application and in each of the nonprovisional applications for purposes of paragraph (b) of this section.”

Securing Innovation 15 Claim Rules: Text (cont) 37 C.F.R. §1.75(b)(5): – “Claims withdrawn from consideration under §§1.141 through 1.146 or §1.499 as drawn to a non-elected invention or inventions will not, unless they are reinstated or rejoined, be taken into account in determining whether an application exceeds the five independent claim and twenty- five total claim threshold set forth in paragraphs (b)(1), (b)(3), and (b)(4) of this section.”

Securing Innovation 16 Claim Rules: 5/25 Rule Rule- “5/25”  37 C.F.R. §1.75(b)(1) limits an application to five independent claims and twenty-five total claims (the “5/25” Rule) if the application is filed after November 1, 2007, or if the application is filed before November 1, 2007 but the first Office Action on the merits (FAOM) is issued after November 1, 2007, unless an examination support document (“ESD”) is filed with the application Non-compliance  If an ESD is required and the applicant has not submitted same, the U.S.P.T.O. will notify the applicant that an ESD is required pursuant to 37 C.F.R. §1.75(b)(3) – Notice sets a two-month time period within which, to avoid abandonment, applicant must comply with the requirements of 37 C.F.R. §1.75(b). – Notice may include a restriction requirement – Notice is extendable for up to 4 months for applications filed before November 1, 2007 which have not received an FAOM, but is not extendable for applications filed after November 1, 2007.

Securing Innovation 17 Claim Rules: 5/25 Rule (cont) How to Respond to Notice Indicating Non-Compliance of 5/25 Rule  – For applications filed on or after November 1, 2007: File an ESD; or Amend the application to comply with the 5/25 rule – Note: Applicant cannot file Suggested Restriction Requirement (SRR) in this case once Notice issues – For applications filed before November 1, 2007, which have not yet received an FAOM by November 1, 2007: File an ESD; or File a new set of claims which comply with the 5/25 rule; or File an SRR under §1.142(c)

Securing Innovation 18 Claim Rules: 5/25 Rule (cont) Hypo: Applicant files an application with 6 independent claims and 10 total claims on December 1, 2007. – Applicant must do one of the following to avoid abandonment: file an ESD; or Amend the application to comply with the 5/25 rule Hypo: Applicant files an application with 6 independent claims and 10 total claims on August 1, 2007, which has not yet received an FAOM by November 1, 2007. – Applicant must do one of the following to avoid abandonment: File an ESD; File a new set of claims which comply with the 5/25 rule; or File an SRR under §1.142(c)

Securing Innovation 19 Claim Rules: Co-pending Applications Rule – 5/25 applies to co-pending apps  37 C.F.R. §1.75(b)(4) states that the 5/25 rule also applies to co-pending applications which are: – (1) commonly owned; and – (2) contain at least one patentably indistinct claim Purpose: prevents applicants from by-passing 5/25 rule by filing a number of applications (whether continuations are not) which each comply with the 5/25 rule Definition: “patentably distinct”  claims are patentably distinct where “the inventions as claimed are not connected in at least one of design, operation, or effect (e.g., can be made by, or used in, a materially different process) and wherein at least one invention is PATENTABLE (novel and nonobvious) OVER THE OTHER (though they may each be unpatentable over the prior art).” MPEP 802.01 (II). – NOTE: FILING DATES ARE NOT CONSIDERED FOR PURPOSES OF OBVIOUSNESS TYPE DOUBLE PATENTING Conventionally, a later filed species claim may be distinct over an earlier filed genus claim, whereas a later filed genus claim may be indistinct over an earlier filed species claim

Securing Innovation 20 Claim Rules: Co-pending Applications (Cont) If commonly owned applications violate 5/25 rule as set forth in 37 C.F.R. §1.75(b)(4), applicant must: – Cancel patentably indistinct claims from all but one application; – File an ESD before FAOM; or – Amend the application(s) to contain no more than 5/25 claims Hypo: Applications “A” and “B” are commonly owned and each contain 4/15 (independent/total) claims. Claim 3 in application “A” is patentably indistinct over claim 12 in application “B.” – Both Applications “A” and “B” are considered to have 8/30 claims. Applicant must: Cancel claim 3 or claim 12; File an ESD before FAOM; or Amend applications “A” and/or “B” to collectively have no more than 5/25 claims

Securing Innovation 21 Claim Rules: Co-pending Applications (Cont) The U.S.P.T.O. will treat an application as no longer pending for purposes of §1.75(b)(4) if: – A notice of allowance is issued; – The application is recognized as abandoned; – A notice of appeal to the U.S. Court of appeals for the Federal Circuit under 35 U.S.C. §141 is filed; or – A civil action under 35 U.S.C. §146 is commenced. Thus, §1.75(b)(4) provides an incentive to file commonly owned applications serially instead of in parallel. Hypo: Application “A” and “B” are commonly owned and each contain 4/15 claims. A notice of allowance has been issued for application “A.” – The 5/25 rule does NOT apply to Applications “A” and “B,” because at the moment the notice of allowance issues for application “A,” the two applications are no longer co-pending for purposes of 37 C.F.R. §1.75(b)(4).

Securing Innovation 22 Claim Rules: Exceptions 5 exceptions to the 5/25 Rule: (1) Filing Examination Support Document (ESD) (2) Filing Suggested Restriction Requirement (SRR) (3) Demonstrating distinctiveness between co- pending application claims (4) Cancelling claims in co-pending application (5) Applications having FAOM before November 1, 2007

Securing Innovation 23 Claim Rules: Exceptions (cont) (1) Filing an ESD (37 C.F.R. §1.265) – Requirements: Pre-examination search Listing of most relevant references Analysis as to which claim elements are described in which references Explanation of the patentability of the independent claims over the most relevant references Identification of where the claims are supported under 35 U.S.C. §112. – A supplemental ESD required if claims amended beyond scope of original ESD

Securing Innovation 24 Claim Rules: Exceptions (cont) (1) Filing an ESD (cont) – The Preexamination search must encompass a search for each and every claim limitation For example, independent claim 1 recites elements “A” and “B,” and dependent claim 2 recites element “C.” Applicant must search for “C” even if applicant does not find “A” or “B.” – Preexamination search must involve: U.S. Patents and patent application publications; Foreign patent document; and Non-patent literature

Securing Innovation 25 Claim Rules: Exceptions (cont) (1) Filing an ESD (cont) – The ESD is similar to an Accelerated Examination Support Document (AESD), with a few differences: AESD must be submitted at filing, whereas ESD can be submitted any time before FAOM AESD requires explanation of patentability of each claim, whereas ESD requires explanation of patentability of independent claims only AESD requires a statement of utility for each claim, n/a to ESD AESD requires search for all disclosed features that may be claimed, n/a to ESD

Securing Innovation 26 Claim Rules: Exceptions (cont) (1) Filing an ESD (cont) – On September 6, 2007, the U.S.P.T.O. published a comprehensive 16-pg set of Guidelines for ESDs Guidelines available at: http://www.uspto.gov/web/offices/pac/dapp/opla/presentation/e sdguidelines090607.pdf http://www.uspto.gov/web/offices/pac/dapp/opla/presentation/e sdguidelines090607.pdf – Guidelines explain the specific search templates which applicants must use – The bottom line: ESDs will require a lot of time and effort to prepare and should cost more than $10,000 per application. Thus, applicants should rely on prosecution strategies which avoid ESDs if at all possible, except in cases involving very valuable inventions.

Securing Innovation 27 Claim Rules: Exceptions (cont) (2) Filing an SRR (37 C.F.R. §1.142(c)) – Requirements: Suggestion of how claims can be separated into separate inventions Applicant must elect without traverse one of the suggested claim sets and withdraw the remaining claim sets Filed before the earlier of FAOM or restriction requirement – Once U.S.P.T.O. issues RR, applicant cannot submit an alternative SRR – Examiner not required to adopt SRR – Benefits: 5/25 rule does not apply to withdrawn claims If Examiner adopts the SRR, withdrawn claims can be used in a divisional application – Note: withdrawn claims which are reinstated (e.g., as a result of a request for reconsideration) or rejoined (e.g., upon allowance of a generic claim) are taken into account for purposes of the 5/25 rule.

Securing Innovation 28 Claim Rules: Exceptions (cont) Hypo: An application contains 3/25 claims directed to a product and 3/25 claims directed to a process of making the product. Process claims are withdrawn in response to a RR or SRR. Product claims allowed, and applicant requests withdrawn claims to be rejoined. – If the withdrawn claims are rejoined, the new claim total is 6/50, which violates the 5/25 rule. Thus, unless applicant submitted an ESD before the FAOM of the elected claims, applicant cannot rejoin claims unless applicant amends new total to comply with 5/25 rule.

Securing Innovation 29 Claim Rules: Exceptions (cont) (3) Demonstrating distinctiveness between co-pending application claims – Distinctiveness is essentially an obviousness inquiry: “Would the differences between the claims in these separate applications have been obvious to one of ordinary skill in the art?” – Applicant must use a Petition instead of an Appeal U.S.P.T.O. views 5/25 rule as purely procedural, and petitions are used to make procedural changes

Securing Innovation 30 Claim Rules: Exceptions (cont) (4) Cancelling claims in co-pending application – When applicant receives Notice that claims are patentably indistinct between two or more applications and therefore violate the 5/25 rule, applicant may cancel patentably indistinct claims from all but one application – Cancelling claims is encouraged because 37 C.F.R. §1.117 specifically allows for refunds of claims cancelled prior to examination – Deadline  Only applies to fees paid on or after December 8, 2004

Securing Innovation 31 Claim Rules: Exceptions (cont) (5) Applications having FAOM before November 1, 2007 – The 5/25 rule does not apply to pending applications which have received an FAOM before November 1, 2007. (72 Fed. Reg. No. 161, Pg. 46716 (August 21, 2007)). – Thus, applicants can move patentably indistinct claims from an application which does not have an FAOM by November 1, 2007 to another commonly owned application having an FAOM before November 1, 2007 to avoid the 5/25 rule.

Securing Innovation 32 Claim Rules: Exceptions (cont) Hypo: Applicant files application “A” which has 3/20 claims. Application “A” receives an FAOM before November 1, 2007. Applicant then files commonly owned application “B” which has 3/20 claims and which has 1 patentably indistinct dependent claim from application “A.” Application “B” receives an FAOM after November 1, 2007. – Scenario #1  applicant does NOTHING: application “A” is not subject to 5/25 rule because application “A” has received FAOM before November 1, 2007. However, application “B” is subject to 5/25 rule because application “B” is commonly owned with application “A,” has at least one patentably indistinct claim with application “A,” and has received an FAOM after November 1, 2007. Thus, application “B” is considered to have 6/40 claims. – Scenario #2  applicant CANCELS PATENTABLY INDISTINCT CLAIM FROM APPLICATION “B” and ADDS THIS CLAIM TO APPLICATION “A”: application “A” is not subject to 5/25 rule. Application “B” no longer has patentably indistinct claims with application “A.” Thus, application “B” is considered to have 2/19 claims.

Securing Innovation 33 Claim Rules: Patent Term Adjustment A failure to comply with §1.75(b) in an application will cause a reduction of any PTA – Example #1: In an application that contains more than 5/25 claims and no ESD (and no SRR), applicant did not file an ESD until after four months from the filing date of the application. – Example #2: In an application in which an ESD was not filed before FAOM, applicant filed an amendment resulting in the application containing more than 5/25 claims Any PTA will be reduced by the number of days beginning on the day after the date that is the later of: – The filing date of the amendment resulting in the noncompliance with §1.75(b); – Four months from the filing date of the application; or – Four months from the date on which the national stage commenced

Securing Innovation 34 Claim Rules: Patent Term Adjustment (cont) Any PTA will be reduced by the number of days ending on the filing date of: – An ESD in compliance with §1.265; – An election of an invention in response to a restriction requirement that is drawn to no more than 5/25 claims; – An amendment resulting in the application containing no more than 5/25 claims; or – An SRR accompanied by an election of an invention that is drawn to no more than 5/25 claims.

Securing Innovation 35 PART 2: CONTINUED EXAMINATION FILINGS

Securing Innovation 36 Continued Examination Filings: Index to Text §1.78(d)(1)(i) – conditions for 2 CONs or CIPs of an intial application §1.78(d)(1)(ii) – conditions for divisional applications §1.78(d)(1)(iii) – conditions for 2 CONs of a divisional application §1.78(d)(1)(iv) – conditions for “one more” CON or CIP of an international application in which a Demand and the basic national fee have not been filed §1.78(d)(1)(v) – conditions for “one more” CON or CIP for a nonprovisional application abandoned in preexamination §1.78(d)(1)(vi) – conditions for a third or subsequent CON or CIP filed with a petition and showing §1.114(f) – conditions for first RCE §1.114(g) – conditions for second or subsequent RCE

Securing Innovation 37 Continued Examination Filings: Text 37 C.F.R. 1.78(d)(1)(i): “(A) The nonprovisional application is either a continuation application as defined in paragraph (a)(3) of this section or a continuation-in-part application as defined in paragraph (a)(4) of this section that the benefit under 35 U.S.C. 120, 121, or 365(c) of no more than two prior-filed applications; and (B) Any application whose benefit is claimed under 35 U.S.C. 120, 121, or 365(c) in such nonprovisional application has its benefit claimed in no more than one other nonprovisional application, not including any nonprovisional application that satisfies the conditions set forth in paragraph (d)(1)(ii), (d)(1)(iii) or (d)(1)(vi) of this section.”

Securing Innovation 38 Continued Examination Filings: Text (cont) 37 C.F.R. §1.78(d)(1)(ii): “(A) The nonprovisional application is a divisional application as defined in paragraph (a)(2) of this section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of a prior-filed application that was subject to a requirement to comply with the requirement of unity of invention under PCT Rule 13 or a requirement for restriction under 35 U.S.C. 121; and (B) The divisional application contains only claims directed to an invention or inventions that were identified in such requirement to comply with the requirement of unity of invention or requirement for restriction but were not elected for examination and were not examined the prior-filed application or in any other nonprovisional application, except for a nonprovisional application that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of such divisional application and satisfies the conditions set forth in paragraph (d)(1)(iii) or (d)(1)(vi) of this section.”

Securing Innovation 39 Continued Examination Filings: Text (cont) 37 C.F.R. §1.78(d)(1)(iii): “(A) The nonprovisional application is a continuation application as defined in paragraph (a)(3) of this section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of a divisional application that satisfies the conditions set forth in paragraph (d)(1)(ii) of this section; (B) The nonprovisional application discloses and claims only an invention or inventions that were disclosed and claimed in such divisional application; (C) The nonprovisional application claims the benefits under 35 U.S.C. 120, 121, or 365(c) of only the divisional application, any application to which such divisional application claims benefit under 35 U.S.C. 120, 121, or 365(c) in compliance with the conditions set forth in paragraph (d)(1)(ii) of this section, and no more than one intervening prior-filed nonprovisional application; and (D) The divisional application whose benefit is claimed under 35 U.S.C. 120, 121, or 365(c) in such nonprovisional application has its benefit claimed in no more than one other nonprovisional application, not including any other divisional application that satisfies the conditions set forth in paragraph (d)(1)(ii) or any nonprovisional application that claims the benefit under 35 U.S.C. 120 or 365(c) of such other divisional application and satisfies the conditions set forth in paragraph (d)(1)(iii) or (d)(1)(vi) of this section.”

Securing Innovation 40 Continued Examination Filings: Text (cont) 37 C.F.R. §1.78(d)(1)(iv): “(A) The nonprovisional application claims benefit under 35 U.S.C. 120 or 365(c) of a prior-filed international application designating the United States of America, and a Demand has not been filed and the basic national fee (§1.492(a)) has not been paid in the prior-filed international application and the prior-filed international application does not claim the benefit of any other nonprovisional application or international application designating the United States of America; (B) The nonprovisional application is either a continuation application as defined in paragraph (a)(3) of this sectin or a continuation-in-part application as defined in paragraph (a)(4) of this section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of no more than three prior-filed applications; and (C) Any application whose benefit is claimed under 35 U.S.C. 120, 121, or 365(c) in such nonprovisional application has its benefit claimed in no more than two other nonprovisional applications, not including any nonprovisional application that satisfies the conditions set forth in paragraph (d)(1)(ii), (d)(1)(iii) or (d)(1)(vi) of this section.”

Securing Innovation 41 Continued Examination Filings: Text (cont) 37 C.F.R. §1.78(d)(1)(v): “(A) The nonprovisional application claims benefit under 35 U.S.C. 120 or 365(c) of a prior-filed nonprovisional application filed under 35 U.S.C. 111(a), and such nonprovisional application became abandoned due to the failure to timely reply to an Office notice issued under §1.53(f) and does not claim the benefit of any other nonprovisional application or international application designating the United States of America; (B) The nonprovisional application is either a continuation application as defined in paragraph (a)(3) of this section or a continuation-in-part application as defined in paragraph (a)(4) of this section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of no more than three prior- filed applications; and (C) Any application whose benefit is claimed under 35 U.S.C. 120, 121, or 365(c) in such nonprovisional application has its benefit claimed in no more than two other nonprovisional applications, not including any nonprovisional application that satisfies the conditions set forth in paragraph (d)(1)(ii), (d)(1)(iii) or (d)(1)(vi) of this section.”

Securing Innovation 42 Continued Examination Filings: Text (cont) 37 C.F.R. §1.78(d)(1)(vi): – “The nonprovisional application is a continuing application as defined in paragraph (a)(1) of this section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of a prior-filed application, is filed to obtain consideration of an amendment, argument, or evidence that could not have been submitted during the prosecution of the prior-filed application, and does not satisfy the conditions set forth in any of paragraphs (d)(1)(i) through (d)(1)(v) of this section. A petition must be filed in such nonprovisional application that is accompanied by the fee set forth in §1.17(f) and 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. If the continuing application is an application filed under 35 U.S.C. 111(a), this petition must be submitted within four months from the actual filing date of the continuing application. If the continuing application is a nonprovisional application which entered the national from an international application after compliance with 35 U.S.C. 371, this petition must be submitted within four months from the date on which the national state commenced under 35 U.S.C. 371(b) or (f) in the international application.”

Securing Innovation 43 Continued Examination Filings: Text (cont) 37 C.F.R. §1.114(f): – “An applicant may file a request for continued examination under this section in an application without a petition under paragraph (g) of this section if the conditions set forth in at least one of paragraphs (f)(1), (f)(2), or (f)(3) of this section are satisfied: – (1) A request for continued examination under this section has not been previously filed in any of: (i) the application; (ii) any application whose benefit is claimed under 35 U.S.C. 120, 121, or 365(c) in such application; and (iii) any application that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of such application, not including any nonprovisional application that satisfies the conditions set forth in §1.78(d)(1)(ii), (d)(1)(iii) or (d)(1)(vi). – (2) The application is a divisional application that satisfies the conditions set forth in §1.78(d)(1)(ii), and a request for continued examination under this section has not previously been filed in any of: (i) the divisional application; and (ii) any application that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of such divisional application, not including any nonprovisional application that satisfies the conditions set forth in §1.78(d)(1)(ii), (d)(1)(iii), or (d)(1)(vi). – (3)The application is a continuation application that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of a divisional application and satisfies the conditions set forth in §1.78(d)(1)(iii), and a request for continued examination under this section has not been filed in any of: (i) the continuation application; (ii) the divisional application; and (iii) and other application that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of such divisional application, not including any nonprovisional application that satisfies the conditions set forth in §1.78(d)(1)(ii), (d)(1)(iii) or (d)(1)(vi).

Securing Innovation 44 Continued Examination Filings: Text (cont) 37 C.F.R. §1.114(g): – “A request for continued examination must include a petition accompanied by the fee set forth in §1.17(f) and a showing that the amendment, argument, or evidence sought to be entered could not have been submitted prior to the close of prosecution in the application, except as otherwise provided in paragraph (f) of this section.”

Securing Innovation 45 Continued Examination Filings: Definitions Definitions: – “Continuing application”  a nonprovisional application (or an international application designating the U.S.) that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of a prior- filed nonprovisional application (or international application designating the U.S.) – A continuing application can be: A divisional application; A continuation application; or A continuation-in-part (CIP) application

Securing Innovation 46 Continued Examination Filings: Definitions (cont) “Divisional” application: – Discloses and claims only an invention(s) that was disclosed and claimed in a prior-filed application, but – Was subject to a requirement for restriction in the prior-filed application, and – Was not elected for examination and was not examined in any prior-filed application. §1.78(d)(1)(i). “Continuation” application: – Discloses and claims only an invention(s) that was disclosed in the prior- filed application. “CIP” application: – Discloses subject matter that was not disclosed in the prior-filed application. “Application family”: – An initial application and its continuation or CIP applications.

Securing Innovation 47 Continued Examination Filings: 2 + 1 Rule Rule- 2 +1  Effective November 1, 2007, applicants may file 2 continuations or 2 CIP applications plus one RCE (the “2 + 1” rule) in an application family without a petition and showing. §1.78(d)(1)(i). Petition to Exceed the 2 + 1 Rule  An applicant may file a third or subsequent continuation or CIP or a second or subsequent RCE with a petition showing why the amendment, argument, or evidence sought to be entered could not have been previously submitted. §1.78(d)(1)(vi). – Note: The U.S.P.T.O. has indicated that these petitions will have a high standard, i.e., will rarely be granted.

Securing Innovation 48 Continued Examination Filings: 2 + 1 Rule (cont) Retroactive in nature  The 2 + 1 Rule is retroactive in the sense that any application family which already has at least 2 continuations/CIPS + 1 RCE before November 1, 2007, cannot file any more continuations, CIPS or RCEs after November 1, 2007. – Exceptions: Petition showing why amendment, argument, evidence could not have been made “one more” exception “bypass” exception “Voluntary” divisionals, i.e., divisionals not filed in response to a restriction requirement, count as a continuation – Conversely, divisionals filed in response to a restriction requirement do not count as a continuation

Securing Innovation 49 Continued Examination Filings: 2 + 1 Rule (cont) After November 1, 2007, applicant may file two continuation or CIP applications (parallel or serial) without a petition and showing I C I C C C Initial Application “A” Continuation or CIP “B” Continuation or CIP “C”

Securing Innovation 50 Continued Examination Filings: 2 + 1 Rule (cont) After November 1, 2007, Applicant may file a third or subsequent continuation or CIP application with a petition and showing I C I C C C P P Initial Application “A” CON or CIP “B” CON or CIP “C” Continuation or CIP with a petition and showing

Securing Innovation 51 Continued Examination Filings: 2 + 1 Rule (cont) After November 1, 2007, applicant may file a single RCE in an application family, without a petition or showing. I C I CC C I C C R R R RCE CON or CIP “B” CON or CIP “C”

Securing Innovation 52 Continued Examination Filings: 2 + 1 Rule (cont) After November 1, 2007, applicant may file a second or subsequent RCE with a petition and showing I C I C C C R RP P CON or CIP “B” CON or CIP “C” First RCE RCE with a petition and showing Initial Application “A”

Securing Innovation 53 Continued Examination Filings: 2 + 1 Rule (cont) Hypo: Applicant files application “A” before November 1, 2007. Applicant files 2 continuations and one RCE based on application “A” before November 1, 2007. – Applicant cannot file any continuations or RCEs after November 1, 2007, without a petition and showing. Hypo: Applicant files application “A” before November 1, 2007. Applicant files 2 continuations and no RCEs before November 1, 2007. – Applicant can file one more RCE after November 1, 2007 without a petition and showing. Hypo: Applicant files application “A” before November 1, 2007. Then, after November 1, 2007, applicant wants to switch the “2 +1” rule to the “1 + 2” rule by filing 2 RCEs and one continuation. – Applicant cannot substitute continuations for RCEs or vice versa in the “2 + 1” rule. Applicant is limited to 2 continuations and one RCE without filing a petition and a showing.

Securing Innovation 54 Continued Examination Filings: 2 + 1 Rule (cont) Second Action Final Practice  A second or subsequent Office action may be made final when: – Necessitated by an amendment of the claims, including an amendment to eliminate unpatentably alternatives; – Based upon an IDS filed after a FAOM with the fee; – Based upon a double patenting rejection; – Necessitated by an identification of claims in a CIP application that is supported by a prior-filed application; – Necessitated by a showing that a claim element is a means- (or step-) plus-function claim element

Securing Innovation 55 Continued Examination Filings: Divisional Applications A divisional application is not required to be filed during the pendency of the initial application, as long as the copendency requirement of 35 U.S.C. 120 is met I C C D R Initial application “A” w/ restriction requirement CON or CIP “C” RCE Divisional application “D” CON or CIP “B”

Securing Innovation 56 Continued Examination Filings: Divisional Applications (cont) Applicant may file the divisional applications in parallel or series I C C I C D D DD D

Securing Innovation 57 Continued Examination Filings: Divisional Applications (cont) Applicant may file two continuation applications (but not CIPs) of a divisional application, without a petition and showing. I C C C C D I C C D Initial application “A” Continuation “F” Continuation “E” Continuation or CIP “C” Continuation or CIP “B” Divisional “D” CC

Securing Innovation 58 Continued Examination Filings: Divisional Applications (cont) Hypo: Applicant files application “A.” Applicant then files 2 continuations C1 and C2 and one RCE based on application “A,” each filed after November 1, 2007. The Examiner restricts both C1 and C2, and the applicant withdraws the non-elected claims for C1 and C2. – The applicant can file separate divisional applications D1 and D2 directed to the withdrawn claims in C1 and C2, as long as D1 and D2 are co- pending. Then, applicant can file 2 more continuations and one RCE for each divisional D1 and D2. Under §1.78(d)(1)(ii), divisional applications are “new” applications for the 2 + 1 rule. Hypo: Applicant files application “A.” Applicant then files three divisional D1, D2, and D3 based on application “A,” which are not in response to a restriction requirement, each divisional filed after November 1, 2007. – Divisional applications which are not in response to a restriction requirement count as continuations for purposes of the 2 + 1 rule. Thus, applicant is violating the 2 + 1 rule in this case.

Securing Innovation 59 Continued Examination Filings: Reissues Reissue applications do not count as a continuation or an RCE – Thus, every reissue gets 2 new continuations and one new RCE without a petition and showing However, the 5/25 Rule does apply to reissues – Thus, any claims in any co-pending applications from the original family may count towards the 5/25 rule as applied to the reissue – If the reissue violates the 5/25 rule, an ESD is only required in a reissue application if the reissue application changes the claims in the patent being reissued I Reissue CC R C C R

Securing Innovation 60 Continued Examination Filings: Optional Streamlined Continuation Application Procedure Basically converts a continuation into an RCE Applicant may request to have a continuation application placed on an Examiner’s amended docket under the Optional Streamlined Continuation Application Procedure if: – Continuation is complete including a specification, at least one claim, and drawings – Filed on or after November 1, 2007 – Application discloses and claims only an invention that was disclosed and claimed in the prior-filed application – Applicant agrees that any election in response to a restriction requirement carries over to the continuation – Prior-filed application has been finally rejected or appealed; and – Prior-filed application is expressly abandoned upon filing of the continuation application

Securing Innovation 61 Continued Examination Filings: Exceptions (1) Petition under §1.78(d)(1)(vi) showing “that the amendment, argument, or evidence sought to be entered could not have been submitted during the prosecution of the prior- filed application.” (2) “One more” exception (3) “Bypass” exception

Securing Innovation 62 Continued Examination Filings: Exceptions (cont) (1) Petition – Must include: Petition in compliance with §1.78(d)(1)(vi) Fee set forth in 37 C.F.R. §1.17(f) (=$400.00) An amendment, argument, or evidence 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 – Factors in deciding whether showing is sufficient: Whether an applicant should file an appeal or a petition under 37 C.F.R. under §1.181 (e.g., to withdraw the finality of an Office Action) instead of a continuation or RCE The number of applications filed in parallel or serially with substantially identical disclosures; and Whether the evidence, amendments, or arguments are being submitted with reasonable diligence

Securing Innovation 63 Continued Examination Filings: Exceptions (cont) (1) Petition – 3 factors – First factor (type of petition/appeal) If the showing relates to an issue that is procedural in nature, e.g., an objection, a request to withdraw the finality of an Office action, or a request to review the examiner’s refusal to enter an after-final amendment, U.S.P.T.O. not likely to grant petition under §1.78(d)(1)(vi) If the issue goes to the merits of a rejection, applicant should file an appeal to the BPAI under 35 U.S.C. 134 and 37 C.F.R. 41.31. – Second factor (number of similar applications) The higher the number of applications with identical or substantially similar disclosure, the more opportunities applicant already had to present the amendment, argument, or evidence, and the less likely the U.S.P.T.O. will be to grant the petition under §1.78(d)(1)(vi). – Third factor (reasonable diligence) Takes into account: (a) condition of application at time of examination (e.g., whether initial application was in proper form or required 35 U.S.C. §112 rejections); (b) consistency of U.S.P.T.O.’s position during prosecution ; and (c) earnestness of applicant’s efforts to overcome rejections (e.g., whether applicant fully addresses all the grounds of rejection)

Securing Innovation 64 Continued Examination Filings: Exceptions (cont) (1) Petition – There are no situations where the U.S.P.T.O. will automatically grant a petition – The mere fact that an Examiner made new arguments or a new ground or rejection is not a sufficient showing under §1.78(d)(1)(vi) – Filing an IDS alone does not count as a sufficient showing to file a second or subsequent RCE – petitions under §1.78(d)(1)(vi) have a HIGH STANDARD which must be met to be granted

Securing Innovation 65 Continued Examination Filings: Exceptions (cont) (2) “One-more” Exception – Rule – “one-more”  If an applicant has filed two or more continuations before August 21, 2007 (i.e., publication date of Final Rules), and no continuations between August 21, 2007, and November 1, 2007 (i.e., effective date of rules), the U.S.P.T.O. will grant the applicant one more continuation or CIP after November 1, 2007 – Purpose: After November 1, 2007, applicants which already have 2 continuations in an application family will not be able to file any more continuations in that family without a petition and showing. However, U.S.P.T.O. does not want a flood of continuations. Thus, the U.S.P.T.O. grants this group of people “one more” continuation after November 1, 2007. – 2 types: 2 or more continuations filed prior to August 21, 2007 2 or more continuations filed prior to August 21, 2007 and one of the continuations goes abandoned due to failure to timely reply to an Office notice issued under §1.53 (e.g., a notice to file missing parts)

Securing Innovation 66 Continued Examination Filings: Exceptions (cont) (2) “One – more” exception – an applicant with 2 or more continuations before August 21, 2007 may file “one more” after November 1, 2007, if applicant does not file a third or subsequent continuation in between August 21, 2007 and November 1, 2007 I CCC August 21, 2007 November 1, 2007

Securing Innovation 67 Continued Examination Filings: Exceptions (cont) (2) “One – more” exception – If applicant files one or more continuations before August 21, 2007, and then files another continuation between August 21, 2007 and November 1, 2007, “one-more” exception does not apply, and applicant must petition under §1.78(d)(1)(vi) to file a third or subsequent continuation after November 1, 2007 I C August 21, 2007 November 1, 2007 PC I C CC P

Securing Innovation 68 Continued Examination Filings: Exceptions (cont) (2) “One – more” exception – abandonment  an applicant files 2 or more continuations before August 21, 2007. One of the continuations goes abandoned due to failure to timely reply to an Office notice issued under §1.53 (e.g., a notice to file missing parts). Applicant may file “one more” after November 1, 2007, if applicant does not file a third or subsequent continuation in between August 21, 2007 and November 1, 2007. I C C C August 21, 2007 November 1, 2007 abandon

Securing Innovation 69 Continued Examination Filings: Exceptions (cont) (3) “Bypass” exception – Rule – bypass  An applicant may file “one more” continuation or CIP application after November 1, 2007 without a petition and showing, if the prior-filed application is an international application designating the U.S., a Demand has not been filed and the basic national fee has not been paid in the prior-filed application, and the prior-filed application does not claim any benefit of any other nonprovisional application or international application designating the U.S. – Purpose: Recognizing that some applicants will file a continuation off of a PCT application instead of entering the National Phase, the rules create an exception to the two continuation rule by giving such bypass application an extra continuation. §1.78(d)(1)(iv). However, this exception only applies where the PCT application itself does not enter the national stage.

Securing Innovation 70 Continued Examination Filings: Exceptions (cont) (3) Bypass exception – If I is international application which designates the U.S., a Demand has not been filed and a basic national fee has not been paid for I, and I does not claim the benefit of any other nonprovisional application or international application designating the U.S., then C3 can be filed after November 1, 2007 without petition and showing I C1C2C3 November 1, 2007 Demand not filed and basic national fee not paid

Securing Innovation 71 Continued Examination Filings: Consequences If applicant presents a benefit claim that is not permitted by §1.78(d)(1)  The U.S.P.T.O. will refuse to enter the improper benefit claim and refuse the benefit of the filing date of the prior-filed application – The application will be treated as entitled only to the actual filing date and will be subject to prior art based on the actual filing date, such as previous applications being §102 prior art I C1C2C3 Filing date 1Filing date 2 I = Filing date 1 C1 = Filing date 1 C2 = Filing date 1 C3 = Filing date 2

Securing Innovation 72 PART 3: PATENT APPLICATIONS CONTAINING PATENTABLY INDISTINCT CLAIMS

Securing Innovation 73 Patent Applications Containing Patentably Indistinct Claims: Text 37 C.F.R. §1.78(f)(1): – “(i) The applicant in a nonprovisional application that has not been allowed (§1.311) must identify by application number (i.e., series code and serial number) and patent number (if applicable) each other pending or patented nonprovisional application, in a separate paper, for which the following conditions are met; (A) The nonprovisional application has a filing date that is the same as or within two months of the filing date of the other pending or patented nonprovisional application, taking account any filing date for which a benefit is sought under title 35, United States Code; (B) The nonprovisional application names at least one inventor in common with the other pending or patented nonprovisional application; and (C) The nonprovisional application is owned by the same person, or subject to an obligation of assignment to the same person, as the other pending or patented nonprovisional application.”

Securing Innovation 74 Patent Applications Containing Patentably Indistinct Claims (cont) 37 C.F.R. §1.78(f)(1): – “(ii) The identification of such one or more other pending or patented nonprovisional applications if required by paragraph (f)(1)(i) of this section must be submitted within the later of: (A) Four months from the actual filing date in a nonprovisional application filed under 35 U.S.C. 111(a); (B) Four months from the date on which the national stage commenced under 35 U.S.C. 371(b) or (f) in a nonprovisional application entering the national stage from an international application under 35 U.S.C. 371; or (c) Two months from the mailing date of the initial filing receipt in such other nonprovisional application for which identification is required by paragraph (f)(1)(i) of this section.”

Securing Innovation 75 Patent Applications Containing Patentably Indistinct Claims (cont) 37 C.F.R. §1.78(f)(2): – “(i) A rebuttable presumption shall exist that a nonprovisional application contains at least one claim that is not patentably distinct from at least one of the claims in another pending or patented nonprovisional application if the following conditions are met: (A) The nonprovisional application has a filing date that is the same as the filing date of the other pending or patented nonprovisional application, taking into account any filing date for which a benefit is sought under title 35, United States Code; (B) The nonprovisional application names at least one inventor in common with the other pending or patented nonprovisional application; (C) The nonprovisional application is owned by the same person, or subject to an obligation of assignment to the same person, as the other pending or patented nonprovisional application; and (D) The nonprovisional application and the other pending or patented nonprovisional application contain substantial overlapping disclosure. Substantial overlapping disclosure exists if the other pending or patented nonprovisional application has written description support under the first paragraph of 35 U.S.C. §112 for at least one claim in the nonprovisional application.

Securing Innovation 76 Patent Applications Containing Patentably Indistinct Claims (cont) §1.78(f)(2): – “(ii) If the conditions specified in paragraph (f)(2)(i) of this section exist, the applicant in the nonprovisional application must, unless the nonprovisional application has been allowed (§1.311), take one of the following actions within the time period specified in paragraph (f)(2)(iii) of this section: (A) Rebut this presumption by explaining how the application contains only claims that are patentably distinct from the claims in each of such other pending nonprovisional applications or patents; or (B) Submit a terminal disclaimer in accordance with §1.321(c). In addition, where one or more other pending nonprovisional applications have been identified, the applicant must explain why there are two or more pending nonprovisional applications naming at least one inventor in common and owned by the same person, or subject to an obligation of assignment to the same person, which contain patentably indistinct claims.

Securing Innovation 77 Patent Applications Containing Patentably Indistinct Claims (cont) §1.78(f)(2): – “(iii) If the conditions specified in paragraph (f)(2)(i) of this section exit, the applicant in the nonprovisional application must, unless the nonprovisional application has been allowed (§1.311), take one of the actions specified in paragraph (f)(2)(ii) of this section within the later of: (A) Four months from the actual filing date of a nonprovisional application filed under 35 U.S.C. 111(a); (B) Four months from the date on which the national stage commenced under 35 U.S.C. 371(b) or (f) in a nonprovisional application entering the national stage from an international application under 35 U.S.C. 371; (C) The date on which a claim that is not patentably distinct from at least one of the claims in the one or more other pending or patented nonprovisional applications is presented; or (D) Two months from the mailing date of the initial filing receipt in the one or more other pending or patented nonprovisional applications.

Securing Innovation 78 Patent Applications Containing Patentably Indistinct Claims (cont) §1.78(f)(3): – “In the absence of good and sufficient reason for there being two or more pending nonprovisional applications owned by the same person, or subject to an assignment to the same person, which contain patentably indistinct claims, the Office may require elimination of the patentably indistinct claims from all but one of the applications.”

Securing Innovation 79 Patent Applications Containing Patentably Indistinct Claims: Identification Rule Rule- Identification  Effective November 1, 2007, an applicant must identify other commonly owned application(s) or patent(s) that has: – An inventor in common with the application; and – A claimed filing or priority date within two months of the claimed filing or priority date of the application. The filing and priority dates take into account the actual filing date, any foreign priority date, and any filing date of a prior-filed provisional or nonprovisional application for which a benefit is claimed. Note: This Identification Rule places a heavy burden on the owner of the co-pending applications, because the owner is in the best (and possibly the only) position to know the information required to identify co-pending applications under §1.78(f).

Securing Innovation 80 Patent Applications Containing Patentably Indistinct Claims: Identification Rule (cont) Hypo: Application “A” and application “B” are commonly owned, have at least one common inventor, and claim the benefit of the same prior-filed nonprovisional application. – Applicant for application “A” must identify application “B,” and Applicant for application “B” must identify application “A” Hypo: Application “A” and application “B” are commonly owned, have at least one common inventor, and claim the benefit of the same prior-filed application. The owner sends application “A” to law firm 1 and application “B” to law firm 2. Law firm 1 does not communicate with law firm 2. – The burden here is on the owner to inform law firm 1 about application “B” and law firm 2 about application “A,” because the owner is in the best (and possibly the only) position to know filing information about application “A” and application “B.”

Securing Innovation 81 Patent Applications Containing Patentably Indistinct Claims: Identification Rule (cont) Identification Rule – In the below example, if application “A” and application “B” are commonly owned and have at least one inventor in common, applicant for application “A” has to identify application “B” because the foreign filing dates are within 2 months of each other. 81 Application “A” Application “B” Actual FD 4 months FD of a prior-filed provisional app. Foreign FD FD of a prior-filed nonprovisional app. 2 months

Securing Innovation 82 Patent Applications Containing Patentably Indistinct Claims: Identification Rule (cont) Under 37 C.F.R. §1.78(f)(1)(ii), applicant must submit the identification of other commonly owned applications or patents within the later of: – Four months from the actual filing date of the application or from the date on which national stage commenced; or – Two months from the mailing date of the initial filing receipt in the other application. Exception  For applications filed before November 1, 2007, applicants have until the later of February 1, 2008 or the above deadlines under 37 C.F.R. §1.78(f)(1)(ii) to submit identification

Securing Innovation 83 Patent Applications Containing Patentably Indistinct Claims: Rebuttable Presumption A rebuttable presumption will exist that the application and the other commonly owned application(s) or patent(s) contain at least one patentably indistinct claim if the other application or patent has: – An inventor in common with the application; – A claimed filing or priority date that is the same as the claimed filing or priority date of the application; and – Substantial overlapping disclosure  Substantial overlapping disclosure exists if the other application or patent has written description support under 35 U.S.C. 112 for at least one claim in the application. 37 C.F.R. §1.78(f)(2)(i)(D). Note: the rebuttable presumption under 37 C.F.R. §1.78(f)(2) only applies to two applications having the same filing or priority date.

Securing Innovation 84 Patent Applications Containing Patentably Indistinct Claims: Rebuttable Presumption (cont) Rebuttable Presumption – In the below example, if application “A” and application “B” are commonly owned, have at least one inventor in common, and have substantial overlapping disclosure, 37 C.F.R. §1.78(f)(2) imposes a rebuttable presumption that application “A” and application “B” have at least one patentably indistinct claim. Application “A” Application “B” Actual FD 4 months Foreign FD FD of a prior-filed nonprovisional app. Same day

Securing Innovation 85 Patent Applications Containing Patentably Indistinct Claims: Rebuttable Presumption (cont) If the rebuttable presumption under §1.78(f)(2) exists, applicant must either: – Rebut the presumption by explaining how the application contains only patentably distinct claims; or – submit a terminal disclaimer. If the terminal disclaimer is submitted, applicant must also explain why there are two or more pending applications which contain patentably indistinct claims. Examples of sufficient explanations: – An applicant filed a continuation application after the mailing of a notice of allowance in the prior-filed application, but the allowance was subsequently withdrawn; or – An interference was declared in an application that contains both claims corresponding to the count and claims not corresponding to the count, the BPAI suggests that the claims not corresponding to the count be cancelled, and the applicant filed a continuation application to present the claims not corresponding to the count.

Securing Innovation 86 Patent Applications Containing Patentably Indistinct Claims: Rebuttable Presumption (cont) If the applicant does not sufficiently explain why there are two or more pending applications which contain patentably indistinct claims, the U.S.P.T.O may require elimination of all but one of the patentably indistinct claims. 37 C.F.R. §1.78(f)(3).

Securing Innovation 87 Patent Applications Containing Patentably Indistinct Claims: Rebuttable Presumption (cont) If the rebuttable presumption under §1.78(f)(2) exists, applicant must submit a rebuttal or a terminal disclaimer within the later of: – Four months from the actual filing date of the application or from the date on which the national stage commenced; – The date on which a patentably indistinct claim is presented; or – Two months from the mailing date of the initial filing receipt in the other application.

Securing Innovation 88 Patent Applications Containing Patentably Indistinct Claims: Consequences Consequence #1 – failing to identify applications with similar (i.e., within 2 months) dates  – If applicant inadvertently fails to identify the other commonly owned applications or patents in compliance with 37 C.F.R. §1.78(f)(1) in a timely manner, applicant should submit the identification to the U.S.P.T.O. as soon as practical. – If the submission necessitates a new ground of rejection based upon double patenting in a second or subsequent Office Action on the merits, the examiner may make such an action final – The U.S.P.T.O. may also refer any registered practitioner who repeatedly fails to comply with the rule requirements to the Office of Enrollment and Discipline. Consequence #2 – failing to rebut the presumption for applications with the same filing or priority date  – The U.S.P.T.O. will apply the 5/25 rule and determine whether the applications violate the 5/25 rule. – The U.S.P.T.O. will also require the applicant to file a terminal disclaimer. – The U.S.P.T.O. will also require an explanation as to why there are two or more co- pending applications that contain patentably indistinct claims, and if the explanation is insufficient, the U.S.P.T.O. will cancel all but one of the patentably indistinct claims.

Securing Innovation 89 Patent Applications Containing Patentably Indistinct Claims: Consequences (cont) Consequence #3- intentionally filing a related application outside the 2-month window to avoid the identification requirement  applicant may be violating the duty to bring other applications that are “material to patentability” to an examiner’s attention. MPEP §2001.06(b). Application “A” Application “B” Actual FD DO NOT INTENTIONALLY DELAY HERE!!! Foreign FD FD of a prior-filed nonprovisional app. 4 months

Securing Innovation 90 PART 4: PRACTICAL PROSECUTION STRATEGIES

Securing Innovation 91 Practical Prosecution Strategies: Road Map (Specific Strategies to be used before November 1, 2007) (A)SPECIFIC STRATEGIES to be used before November 1, 2007 – Pending applications (1)File an RCE prior to November 1 if a family or a single application already has an RCE filed (2)File an RCE prior to November 1 if multiple applications in a family have final office actions (3)Establish a Docketing System (4)File an SRR if application violates 5/25 rule (5)Cancel claims prior to examination and request refund (6)Move claims in pending application to applications under active examination – New applications (1)File new applications before November 1, 2007 (2)File new continuation applications where family includes more than two continuation applications before November 1, 2007

Securing Innovation 92 Practical Prosecution Strategies: Road Map (General Strategies to be used before or after November 1, 2007) (B) GENERAL STRATEGIES to be used before or after November 1, 2007 – Pending applications which have not received an FAOM by November 1, 2007 (1)Conserve RCEs and continuations (2)Conduct Examiner Interviews Prior to Final Office Action (3)Cancel claims prior to examination and request refund (4)Cancel claims subject to Restriction Requirement (5)Move claims in pending application to applications under active examination in response to obviousness type double patenting (6)Add claims to applications under active examination to provoke restriction (7)Conduct Examiner Interview to agree that Claims are patentably distinct – New applications (1)File SRR with the new application (2)If more than 5/25 claims necessary, use accelerated examination (3)File continuations serially (4)File ESD in last continuation application (5)File SRR even where no problem exists for the 5/25 rule (6)Use reissue applications after last continuation application (7)Break applications for systems into component pieces

Securing Innovation 93 Practical Prosecution Strategies: Specific Strategies to be used before November 1, 2007

Securing Innovation 94 Practical Prosecution Strategies: Specific Strategies: Pending Applications (cont) (1) File an RCE prior to November 1 if: (a) a family or (b) a single application already has an RCE filed  If a family or a single application already has an RCE filed prior to November 1, 2007, additional RCEs should be filed prior to November 1, 2007 for any applications in the family which already have final office actions, since this is the last chance to file RCEs without a petition and showing. I R R C November 1, 2007 C R (a) family (b) single application I RR

Securing Innovation 95 Practical Prosecution Strategies: Specific Strategies: Pending Applications (cont) (2) File an RCE prior to November 1 if multiple applications in a family have separate final office actions  Regardless of whether a family already has an RCE filed, if multiple applications in the family have separate final office actions, file an RCE in each case prior to November 1, 2007. I R C November 1, 2007 C R FAOM Final OA FAOM Final OA R

Securing Innovation 96 Practical Prosecution Strategies: Specific Strategies: Pending Applications (cont) (3) Establish a Docketing System  The Identification Rule requires an applicant filing an application to identify every other commonly owned application which has at least one common inventor and is filed within 2 months of the application. Other Applications (Inventor X) U.S. filing date Foreign filing date Within 2 months? If same day, substantially overlapping disclosure? A2/7/072/7/06Non/a B7/18/07 Non/a C9/1/079/1/06YESn/a Search Results: Inventor X, application Y, U.S. filing date 9/27/07, foreign filing date 9/27/06

Securing Innovation 97 Practical Prosecution Strategies: Specific Strategies: Pending Applications (4) File an SRR in new applications exceeding the 5/25 rule where an ESD is not to be filed  If an application is already filed with claims that exceed the 5/25 rule, file an SRR to determine whether the Examiner will restrict claims to an elected set consistent with the 5/25 rule. In the below example, I has claims that exceed the 5/25 rule. An SRR is filed, and the elected claims and divisional do not individually have claims that exceed the 5/25 rule, thereby complying with the 5/25 rule. I FILE SRR Elected claims D

Securing Innovation 98 Practical Prosecution Strategies: Specific Strategies: Pending Applications (cont) (5) Cancel claims prior to examination and request refund  If claims are cancelled prior to examination, a refund can be obtained. For applications with more than 5/25 claims which are filed before November 1, 2007 and which do not receive an FAOM by November 1, 2007, the applicant can cancel claims at any time before the FAOM, or can wait to receive a Notice from the U.S.P.T.O. I FAOM CANCEL CLAIMS AND REQUEST REFUND

Securing Innovation 99 Practical Prosecution Strategies: Specific Strategies: Pending Applications (cont) (6) Move claims in pending applications to applications under active examination as of Nov. 1, 2007  The 5/25 rule does not apply to applications which receive an FAOM before November 1, 2007. Thus, if two applications are commonly owned, co-pending and have patentably indistinct claims, and one application has received an FAOM, move the patentably indistinct claims from the other application to the one application. Additionally, this movement of claims may also provoke a restriction requirement. In the below example, I 1 and I 2 are commonly owned, have 3/20 claims, and have patentably indistinct claims. I1I1 FAOM I2I2 Cancel and move to I 1 Patentably indistinct claims Final OA November 1, 2007 FAOM

Securing Innovation 100 Practical Prosecution Strategies: Specific Strategies: New Applications (1) File new applications before November 1, 2007  Applicants should ensure that applications which are substantially completed are filed before November 1, 2007. Advantages: For applications filed before November 1, 2007 which exceed 5/25, applicants can wait until receiving a Notice to make a decision to file SRR; Notice will likely occur when examiner takes up the case for consideration rather than promptly upon filing; and the response to Notice is extendable for up to 4 months (no extensions for applications filed after November 1, 2007), during which claims in similar applications may be allowed. Applicant November 1, 2007 I I I

Securing Innovation 101 Practical Prosecution Strategies: Specific Strategies: New Applications (2) File new continuation applications where family includes more than two continuation applications before November 1, 2007  Applicants can file as many continuation applications as they deem necessary by November 1, 2007. Advantages: The applicant may wish to file more than two continuations in an application family. Disadvantages: the Final Rules are retroactive, so the 5/25 rule and the identification rule may still apply to continuations filed before November 1, 2007 which are co-pending after November 1, 2007. I November 1, 2007 C C C

Securing Innovation 102 Practical Prosecution Strategies: General Strategies to be used before or after November 1, 2007

Securing Innovation 103 Practical Prosecution Strategies: General Strategies: Pending Applications (1) Conserve RCEs and continuations with petitions  The 2 + 1 rule makes filing multiple RCEs and three or more continuations very difficult. Thus, in pending applications where there is a final Office Action, the applicants should be more aggressive in petitioning the finality of the Office Action or non-entry of amendments after final. Furthermore, the 2 + 1 rule should increase the number of appeals. Thus, try to reserve at least one RCE and/or continuation to correct a defect with any applications which are appealed. Otherwise, if all the RCEs and continuations have been used, an expensive Petition under 37 C.F.R. §1.78(d)(vi) is needed, and this Petition is not guaranteed to be granted. – NOTE: Petitioning finality should be done within 1 month of receipt of FINAL OA, because if petition is denied, response period is not delayed. I FAOM Amendment FINAL OA PETITION FINALITY WITHIN ONE MONTH

Securing Innovation 104 Practical Prosecution Strategies: General Strategies: Pending Applications (cont) (2) Conduct Examiner Interviews prior to Final Office Action  traditionally, examiner interviews are conducted after a final office action or after an RCE had been filed. However, since the Final Rules limit an applicant to one RCE as a matter of right, consider examiner interviews right after FAOM to narrow and simplify issues. I FAOM FINAL OA EXAMINER INTERVIEW

Securing Innovation 105 Practical Prosecution Strategies: General Strategies: Pending Applications (cont) (3) Cancel claims prior to examination and request refund  If claims are cancelled prior to examination, a refund can be obtained under 37 C.F.R. §1.117. These cancelled claims can be reserved for filing in a continuation application at the conclusion of prosecution of the instant application. In the below example, if I has more than 5/25 claims, cancel a sufficient number of claims to comply with the 5/25 rule before the FAOM, and request a refund of the remaining claims. I FAOM CANCEL CLAIMS AND REQUEST REFUND

Securing Innovation 106 Practical Prosecution Strategies: General Strategies: Pending Applications (cont) (4) Cancel claims subject to restriction requirement  Under the Final rules, where non- elected claims depend from (or otherwise require all the limitations of) an elected claim and the elected claim becomes allowable, two problems occur: 1. The rejoinder can result in violation of the 5/25 rule. Since the ESD cannot be filed after an FAOM, if the rejoinder of the non-elected claims would result in the claims exceeding the 5/25 rule, it is likely applicant will have to cancel the non-elected claims. 2. The rejoinder is technically a withdrawal of the original restriction requirement, so applicant cannot file a divisional for claims needing to be cancelled, and must instead use any remaining continuations to cover these claims. I Elected claims RR Non-Elected claims CANCEL

Securing Innovation 107 Practical Prosecution Strategies: General Strategies: Pending Applications (cont) (5) Move claims in pending applications to applications under active examination as of November 1, 2007 in response to obviousness type double patenting rejections  Currently, terminal disclaimers are typically filed in applications under active examination where a provisional obviousness type double patenting rejection is issued. However, effective November 1, 2007, 37 C.F.R. §1.78 requires a Statement showing “good and sufficient reasons” to allow patentably indistinct claims to exist in multiple applications, and otherwise, the Examiner can cancel all but one of the patentably indistinct claims. Thus, to avoid submitting this Statement, cancel the patentably indistinct claims from a pending application and move these claims to an application under active examination as of November 1, 2007. I1I1 FAOM I2I2 Cancel and move to I 1 Patentably indistinct claims Final OA OTDP rejection FAOM November 1, 2007

Securing Innovation 108 Practical Prosecution Strategies: General Strategies: Pending Applications (cont) (6) Add claims to applications under active examination to provoke restriction  Under 37 C.F.R. §1.145, the Examiner can restrict newly presented claims after an FAOM. By including an SRR with the newly added claims, it may be possible to provoke a divisional application. The 2 continuations or CIPS + 1 RCE rule does not apply to divisionals, and thus, provoking a divisional may allow for greater flexibility in ensuring adequate patent coverage. I FAOM ADD CLAIMS AND INCLUDE SRR Elected claims D

Securing Innovation 109 Practical Prosecution Strategies: General Strategies: Pending Applications (cont) (7) Conduct Examiner Interview to agree that claims are patentably distinct  when a new continuation application is to be filed or where multiple copending applications already exist, it might be possible to obtain an agreement from the Examiner that the new claims, if added in a pending application before the Examiner, would be restricted as patentably distinct. Applicants could contact the Examiner and see if the Examiner would agree, in an interview, to a restriction for a pending application. I EXAMINER INTERVIEW Elected claims D

Securing Innovation 110 Practical Prosecution Strategies: General Strategies: New Applications (1) File an SRR in new applications exceeding the 5/25 rule where an ESD is not to be filed  If an application is already filed with claims that exceed the 5/25 rule, file an SRR to determine whether the Examiner will restrict claims to an elected set consistent with the 5/25 rule. By filing an SRR, it may be possible to provoke a divisional application. The 2 continuations or CIPS + 1 RCE rule does not apply to divisionals, and thus, provoking a divisional may allow for greater flexibility in ensuring adequate patent coverage. In the below example, I has claims that exceed the 5/25 rule. An SRR is filed, and the elected claims and divisional do not individually have claims that exceed the 5/25 rule, thereby complying with the 5/25 rule. I FILE SRR Elected claims D

Securing Innovation 111 Practical Prosecution Strategies: General Strategies: New Applications (cont) (2) If more than 5/25 claims are necessary in an application, consider filing some claims in an accelerated application using an Accelerated Examination Support Document (AESD) and the remaining claims in another application. 3 different ways to file remaining claims: 1. Continuation in series 2. U.S. application based on same foreign or provisional application which accelerated application is based on 3. PCT application based on same foreign or provisional application which accelerated application is based on

Securing Innovation 112 Practical Prosecution Strategies: General Strategies: New Applications (cont) (2) 1. accelerated application (continuation in series)  File some claims in accelerated application, remaining claims in continuation application in series with accelerated application. Advantages: Accelerated application results in faster issuance of claims; by filing continuation serially, 5/25 rule and Identification rule does not apply to later-filed application because later-filed application not co-pending. Disadvantage: Uses one of the 2 continuations allowed by the 2 + 1 rule; later filing date of continuation delays claim issuance. In the below example, I is the accelerated application, and C is the continuation. I One year after Filing Date ALLOW C Filing Date Accelerated examination C filed in series with I

Securing Innovation 113 Practical Prosecution Strategies: General Strategies: New Applications (cont) (2)(cont) 2. accelerated application (U.S. application based on foreign or provisional)  File some claims in accelerated application based on a foreign or provisional, remaining claims in a U.S. application based on the same foreign or provisional. Advantages: if accelerated application issues within one year, file U.S. application under 35 U.S.C. §119 and get foreign priority without using up a continuation. Disadvantages: Applicant must file foreign and accelerated application simultaneously. Below, I f is the foreign or provisional application and I 1 and I 2 are based on I f. I1I1 One year after Filing Date ALLOW I2I2 IfIf Filing Date of I f (foreign or provisional) and I 1 (1 st application) Accelerated examination C C I 2 gets foreign priority date of I f

Securing Innovation 114 Practical Prosecution Strategies: General Strategies: New Applications (cont) (2)(cont) 3. accelerated application (PCT)  File some claims in accelerated application based on a foreign or provisional, remaining claims in a PCT based on the same foreign or provisional. Advantages: if accelerated examination not going to issue within 12 months from foreign priority, then file a PCT application based on the foreign priority before 12 month deadline. PCT allows applicant 30 months from foreign priority to enter national stage. Once accelerated application issues (presumably within 30 months), enter national stage with PCT. Now, national stage receives foreign priority date without using up a continuation. I1I1 One year after FFD ALLOW PCT IfIf Foreign Filing Date Accelerated examination C C 30 months after FFD NS

Securing Innovation 115 Practical Prosecution Strategies: General Strategies: New Applications (cont) (3) File continuations serially  Instead of filing multiple pending applications, the continuation applications should be filed serially (i.e., one after the other). Advantage: avoids 37 C.F.R. §1.78(f) (Identification Rule) and 37 C.F.R. §1.75(b) (5/25 rule), because these rules only apply to co-pending applications. Disadvantage: delay in issuance of the desired claims. I ALLOW C1C1 C2C2

Securing Innovation 116 Practical Prosecution Strategies: General Strategies: New Applications (cont) (4) File an ESD in last continuation application  File an ESD in last possible continuation allowed under 37 C.F.R. §1.78. Advantages: since the ESD is filed, the last possible continuation can have more than 5/25 claims, thereby functioning as a “catchall” application which can be directed towards many different embodiments; statements in ESD not as likely to create estoppel for earlier-filed related applications. I ALLOW C1C1 C2C2 ESD

Securing Innovation 117 Practical Prosecution Strategies: General Strategies: New Applications (cont) (5) File an SRR even where no problem exists for the 5/25 rule  In order to ensure that the maximum flexibility is allowed for prosecution of important cases, file an SRR in each case. Advantages: increases likelihood of getting divisionals, which each get 2 new continuations plus one new RCE, and do not count towards the 5/25 limit of the parent. In the below example, I has less than 5/25 claims. I FILE SRR Elected claims D

Securing Innovation 118 Practical Prosecution Strategies: General Strategies: New Applications (cont) (6) Use reissue applications after last continuation application  Reissue applications are considered new applications for purposes of the 2 + 1 Rule. Advantage: a reissue is entitled to 2 new continuations and one new RCE without a petition and showing. Disadvantage: reissues applications are subject to the 5/25 rule. I Reissue C C R C C R

Securing Innovation 119 Practical Prosecution Strategies: General Strategies: New Applications (cont) (7) Break applications for systems into component pieces  Assuming you have a system having multiple novel components, instead of filing a single application for the entire system, file one of the following three: 1. separate applications for each component; 2. single provisional for entire system, and claim priority to the single provisional for each component specific application; or 3. PCT application for system claims and claiming the benefit of a provisional application and enter national stage at the 30 month mark.

Securing Innovation 120 Practical Prosecution Strategies: General Strategies: New Applications (cont) (7) 1. file separate applications for each component  File a separate application for each component and remove the descriptions of the non-claimed components. Advantages: provides better evidence of distinctiveness of claims to avoid the 5/25 rule and the identification rule. In the below example, if a system has components A, B, and C, file separate initial applications A, B, and C to each component and remove the descriptions of the non-claimed components. A ABCABC SYSTEM FILE 3 SEPARATE APPS B C

Securing Innovation 121 Practical Prosecution Strategies: General Strategies: New Applications (cont) (7)(cont) 2. file single provisional or foreign application for entire system and claim priority to the single provisional for each component  File a single provisional or foreign application for entire system. File separate nonprovisional applications for each component, each one claiming priority and incorporating by reference. After all but one of the component applications are allowed, amend the final application to claim the system. Advantages: component applications each get priority date of provisional or foreign; since component applications are allowed, they are not “copending” with system application. A ABCABC PROVISIONAL OR FOREIGN B C Allow Amend to claim system Allow

Securing Innovation 122 Practical Prosecution Strategies: General Strategies: New Applications (cont) (7)(cont) 3. file PCT application for system claims and claiming the benefit of the provisional  File a single provisional for entire system and separate nonprovisionals to each component claiming priority to the provisional. File a PCT application with system claims by 12 month deadline. Enter national stage by 30 month deadline from provisional filing date, at which point the component applications may have already issued. Advantages: For each component application allowed within 30 months of provisional filing date, these component applications will not be co-pending with the national stage application. A ABC B C Allow PCT (A + B + C) Allow National Stage 12 months 30 months

Securing Innovation 123 PART 5: RECENT DEVELOPMENTS

Securing Innovation 124 Recent Developments: Road Map Legal Challenges to the Final Rules Patent Reform Act Sample Forms

Securing Innovation 125 Recent Developments: Legal Challenges to the Final Rules On September 7, 2007, Plaintiff Dr. Triantafyllos Tafas (“Plaintiff”), through his law firm Kelley Frye & Warren LLP, filed an amended complaint against Defendants Jon W. Dudas and the U.S.P.T.O. (“Defendants”) to: – prevent the Defendants from implementing sections 1.75, 1.78, 1.114, 1.265 and 1.704 of the Final Rules; – have the Final Rules declared null, void and without legal effect, inter alia, as being beyond the rule making power of the U.S.P.T.O. and as inconsistent with various federal statutes and Article I, Section 8, cl. 8, and the Fifth Amendment to the United States Constitution; and – vacate and remand the Final Rules, including requiring Defendants to comply with the requirements of the APA, 5 U.S.C. §533, and the RFA, 5 U.S.C. §601 et seq., in promulgating any regulations in the future concerning the subject matter of the Final Rules. General Argument: the Plaintiffs argue that the U.S.P.T.O. does not have the power to implement the Final Rules.

Securing Innovation 126 Recent Developments: Legal Challenges to the Final Rules (cont) Specifically, Plaintiffs argue that the U.S.P.T.O. does not have the power to implement the final rules because: – Count 1  The Director and the U.S.P.T.O. can establish regulations that facilitate and expedite the processing of patents (i.e., procedural regulations), but cannot create substantive changes to the law (i.e., substantive changes). The Final Rules are substantive changes. – Counts 2 and 3  the Administrative Procedure Act prohibits agency action which is “contrary to constitutional right, power, privilege, or immunity,” and the U.S.P.T.O. is violating the APA by implementing the Final Rules in light of the established Patent Laws. – Count 4  The Regulatory Flexibility Act provides that “the agency shall prepare and make available for public comment an initial regulatory flexibility analysis,” unless the head of the Agency certifies that proposed Rules will not have a significant economic impact on a substantial number of small entities. Here, Director Dudas made this certification, but the Rules will have a significant economic impact on small entities.

Securing Innovation 127 Recent Developments: Legal Challenges to the Final Rules (cont) Briefing Schedule Deadlines: Tafas v. Dudas 1. Oct. 4, 2007  Defendant’s motion to dismiss 2. Oct. 5, 2007  Defendants provide plaintiffs with PTO administrative record 3. Oct. 18, 2007  Plaintiff’s opposition to motion to dismiss 4. Oct. 25, 2007  Plaintiff’s motion for summary judgment 5. Oct. 26, 2007  Defendant’s reply to opposition to motion to dismiss 6. Nov. 2, 2007  Court hears Defendant’s motion to dismiss 7. Nov. 20, 2007  Defendant’s opposition to summary judgment and cross-motion for summary judgment 8. Dec. 6, 2007  Plaintiff’s reply to Defendant’s opposition to summary judgment and cross- motion for summary judgment 9. Dec. 17, 2007  Defendant’s reply in support of Defendant’s cross-motion 10. Dec. 21, 2007  Court hears Plaintiff’s and Defendant’s summary judgment motions 10/1/07 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 1/1/08

Securing Innovation 128 Recent Developments: Legal Challenges to the Final Rules (cont) It is unlikely, although possible, that the Courts will invalidate the Final Rules In any event, assume that the Final Rules will be upheld and learn practical prosecution strategies to adapt to these Final Rules

Securing Innovation 129 Recent Developments: Sample Forms Sample 1.78(f) form:

Securing Innovation 130 Recent Developments: Sample Forms (cont) The U.S.P.T.O. website will have sample forms in October 2007 for the following: – EDS transmittal – EDS listing of references – Request for Streamlined Docketing Procedure Website (forms): http://www.uspto.gov/web/offices/pac/dapp/o pla/presentation/clmcontfinalrule.html http://www.uspto.gov/web/offices/pac/dapp/o pla/presentation/clmcontfinalrule.html

Securing Innovation 131 THE END

Securing Innovation Michael D. Stein Stein, McEwen & Bui LLP 1400 Eye Street, NW Suite 300 Washington, DC 20005 (202) 216-9505

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Securing Innovation Michael D. Stein Stein, McEwen & Bui LLP 1400 Eye Street, NW Suite 300 Washington, DC 20005 (202) 216-9505

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Presentation on theme: "Securing Innovation Michael D. Stein Stein, McEwen & Bui LLP 1400 Eye Street, NW Suite 300 Washington, DC 20005 (202) 216-9505"— Presentation transcript:

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