1 New PTO Claims and Continuation Practice: Working with the Rules Bruce D. Sunstein Bromberg & Sunstein LLP © 2007 Bromberg & Sunstein LLP

2 New Rules of the Patent and Trademark Office create a new patent environment The new patent environment compresses patent prosecution The new patent environment calls for new strategies Many of the rules apply retroactively to applications filed before the November 1 effective date of the new rules New strategies are required for this environment

3 The New Rules Establish: Limitations on filing of continuation applications Special prior art search requirements when application has more than 25 claims or more than 5 independent claims  All claims must be subject to a prior art search of specified dimensions  Prior art search results must be reported in an “examination support document” of specified content

4 Limitations on Continuations Only two continuations, divisionals or CIP applications, plus one RCE, per application family, absent a special showing by petition  Unless due to a restriction requirement  All patentably indistinct claims must be in the same application (and if not, are still integrated for purposes of claim number limitations discussed below)  PTO can require elimination of patentably indistinct claims from all but a single application ( § 1.78(f)(3))  RCEs filed on or after 11/1/07 must comply with the “one RCE per family” limitation, so cannot file RCE if there had already been an RCE in the family

5 Limitations on continuations--II A divisional application prompted by a restriction requirement (which is defined as a “divisional application” in the rules) is treated as the start of a new family and therefore may itself be followed by two continuations and an RCE Cannot file a CIP off of a DIV. § 1.78(d)(1)(iii) Rules are implemented as revisions to, and reorganization of, 37 C.F.R. § 1.78

6 Special prior art search requirement Applicable when application has more than 25 claims or more than 5 independent claims Claims withdrawn from consideration as a result of a restriction requirement do not count for the purposes of these limitations. § 1.75(b) Applicable to reissue applications when claims are being amended or added to.

7 Search requirement manifested in the examination support document Examination support document absolutely required before the first office action on the merits (§ 1.75(b)(1)) Must cover each claim, even dependent claims Failure to file examination support document before first office action on the merits precludes amendment to include more than 25 claims or more than 5 independent claims

8 The prior art search (§ 1.265(b)) Must involve U.S. patents and patent application publications, foreign patent documents, and non- patent literature.  Exception: if applicant can justify with reasonable certainty (and so state in the examination support document) that no references more pertinent than those already identified are likely to be found in the eliminated source. Must encompass all limitations of the dependent claims separately from the claims from which they depend. Claims must be given the broadest reasonable interpretation (making foreign patent office searches of only qualified benefit).

9 The examination support document (§ 1.265(a))—I Must include a statement that a prior art search was conducted in compliance with § 1.265(b). Must identify (in the manner set forth in MPEP § ) the field of search by class and subclass and the date of the search, where applicable. For database searches, must identify the search logic or chemical structure or sequence used as a query, the name of the file or files searched and the database service, and the date of the search.

10 The examination support document (§ 1.265(a)) —II Must include a listing, in compliance with § 1.265(c), of the references deemed most closely related to the subject matter of each of the claims. For each listed reference, must identify all of the limitations of each of the claims (whether in independent or dependent form) that are disclosed by the reference.  Small entities exempt from this requirement. § 1.265(f).  However, “small entity” is as defined by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), and not exactly the same as for purposes of reduced filing fees. See 72 FR

11 The examination support document (§ 1.265(a))—III Must include a detailed explanation particularly pointing out (by reference to one or more specific claim limitations) how each of the independent claims is patentable over the references cited in the listing. Must include a showing of where each limitation of the claims finds support under 35 U.S.C. 112, ¶ 1, in the written description of the specification (making reference to all priority documents where applicable)

12 ESD in two different environments Regular Exam 25 claims or 5 indep. claims are a trigger If a restriction, incentive to accept because increase in no. of permissible continuations Can be triggered by reissue app. with amended or added claims Accelerated Exam 20 claims or 3 indep. claims are maximum If a restriction, must elect without traverse Not for reissue app. Dependent claims grouped with indep. claims for examination Pre-exam interview required

13 ESD in two different environments (cont’d) Regular Exam Must identify all limitations of each of the claims that are disclosed by the reference and at least one appearance of each limitation in the reference. Need not identify any cited refs. that may be disqualified as prior art under 35 U.S.C. § 103(c) as amended by the Cooperative Research and Technology Act (although encouraged to do so). If claim amendment is not covered by the ESD, then ESD must be updated. (Small entities exempt.) § 1.265(e). Accelerated Exam Must also specify where the limitation is disclosed in the cited reference. Must identify any cited references that may be disqualified as prior art under 35 U.S.C. § 103(c) as amended by the Cooperative Research and Technology Act. Pre-exam search must cover disclosed features that may be claimed; any claim amendment must be encompassed by ESD or ESD must be updated.

14 Disclosure burdens associated with continuation applications—I For a given application (to help the PTO deal with claim number limitations), the applicant must disclose (§ 1.78(f)(1)(i)) all other applications that:  Are commonly owned;  Have a common inventor; and  Have a claimed filing date or priority date at least within two months of that of the given application. But two months is not a safe harbor—related applications outside the two months must also be disclosed.

15 Disclosure burdens associated with continuation applications—II In connection with a given continuation-in- part application, the applicant must identify all claims directed to subject matter having a priority date earlier than the filing date of the given application (§ 1.78(d)(3)).  Should be before the examiner’s prior art search  Providing this information after a rejection does not prevent the next action from being made final

16 Disclosure burdens III: need to rebut presumption (§ 1.78(f)(2)) that an application includes a claim that is not patentably distinct from a claim in another application or patent if: (1) the application has a filing date that is the same as the filing date of another pending application or patent, taking into account any filing date for which a benefit is sought; (2) the application names at least one inventor in common with the other pending application or patent; (3) the application is owned by the same person, or subject to an obligation of assignment to the same person, as the other pending application or patent; and (4) the application contains substantially overlapping disclosure as the other pending application or patent.

17 Transition Rules Rules effective November 1, 2007 Pending applications having claims that exceed the numerical limitations and that have not had a first office action on the merits before November 1, 2007 will receive a notice (§ 1.75) giving an extendable two-month period within which to  (a) Provide an examination support document; or  (b) Amend the claims to avoid exceeding the numerical limitations.  The notice may include a restriction requirement; otherwise the applicant may optionally provide a suggested restriction requirement in lieu of (a) or (b). Applications filed before November 1, 2007 have until February 1, 2008 to comply if rules would otherwise specify a shorter time Applications pending as of August 21, 2007 entitled to at least one more continuation but still subject to the one RCE per family limit (counting RCEs filed before the effective date)

18 Shorter Prosecution, Fewer Choices Fewer continuations means prosecution can be over sooner Numerical limitations on claims necessitate early decisions on claim strategy Longer pendency in the near term complicates matters further

19 Strategic Considerations: stringent requirements for the prior art search and the examination support document Require a substantial and costly effort by patent counsel Create a serious risk of an error, and—given the required statement that a prior art search was conducted in compliance with § 1.265(b)—a serious risk of a downstream inequitable conduct allegation (but cf. PTO responses to comments 233 and 234: if no intent to deceive, there can be no inequitable conduct) Give an attacker of the issued patent a roadmap to invalidating the patent Provide strong motivation to avoid exceeding the numerical limitations on claims that trigger these requirements—hence now fewer claims per application

20 Strategic Considerations (cont’d) Continuation-in-part applications are more burdensome, owing to the duty of identifying claims directed to subject matter in a previously filed application The rules have the ultimate effect of compressing patent prosecution Patent strategy must therefore seek to preserve opportunities for claiming subject matter despite the compression

21 Typical Strategies in the New Environment Lengthen prosecution (to defer date for filing continuation)  Leverage appellate strategies ―Continuation application can be filed in a late stage of appeal process ―If some claims are allowed, appeal of disallowed claims maintains pendency of the application, during which a continuation application can be filed  File first regular application as national phase application following PCT filing based on provisional  Or, after filing a first regular application based on provisional, use PCT filing based on provisional to establish a second regular application  Request, under § 1.103(d), deferral of examination of an original application for up to three years from the earliest filing date claimed (but not much benefit, given current PTO backlog)

22 Typical Strategies in the New Environment (cont’d) Generate right to more continuation applications by making conditions ripe for a restriction requirement on the first regular application  Can propose a restriction requirement if two or more independent and distinct inventions are claimed 1.142(c). Suggested requirement for restriction must be filed before the earlier of the first Office action on the merits or a requirement for restriction (including an election of species)  If the claims exceed threshold numbers, and the proposed restriction requirement is not accepted and another suitable restriction requirement is not established, then within a non- extendable two-month period, applicant must cancel claims or provide an examination support document Broadening reissue application (filed within 2 years after issue) may become more important, although also subject to potential requirement of prior art search and examination support document when numerical claim limitations are exceeded

23 More Compact Applications, More of them Limited continuations make more challenging the use of broad applications to cover an area of innovation having diverse topics Easier, instead, to make applications that are more focused The narrower scope of a focused application will likely prompt use of multiple applications to cover a single area of innovation

24 US Strategy Meets European Strategy The significance of 18 months: publication Reduced availability of continuations makes publication a more important event One may file a new application without priority within 18 months after filing of the predecessor application  Predecessor application is not prior art  But there can be intervening art!

25 Things to do now Evaluate each pending application with more than 25 claims or more than 5 independent claims  Propose a restriction requirement  The restriction requirement should break the claims into groups, with each group within these numerical limits Develop a good collection of prior art to assess patentability of each pending claim Evaluate each claim in view of prior art and amend where appropriate to shorten prosecution

26 More things to do now Scour each pending patent application for additional subject matter to claim and claim it ASAP to maximize chances for claiming it at all  Add claims to that subject matter now if the application is not under final rejection  Otherwise, add in the next continuation Any application under final rejection for which a request for continued examination (RCE) has already been used:  Before November 1, request a further RCE  Because after November 1, no RCE will be available

27 More effort up front The new patent environment compresses patent prosecution. Hence more effort up front, at greater up front cost to patent owners. No longer wise to file a major non- provisional application without first performing a prior art search

28 New filings (cont’d) When claims are over the threshold numbers, always provide a basis for generation of a restriction requirement that places each claim group below the threshold numbers  Remember aggregation rules!  Claims of related applications may be aggregated. Where possible, use the fact of a restriction requirement to make a continuation filing not count against the continuation filing limits

29 New filings Warning: when the restriction is entered, cancel the non-elected claims!  Otherwise the examiner could change his mind about the restriction. If the non-elected claims are canceled in reliance on the restriction, it would be more difficult (at least) for the examiner to withdraw the restriction. Cancel them before the first office action on the merits and claim a refund under § within two months after canceling the claims  Otherwise the refund is forfeited.  But without Congressional approval of new funding legislation for the PTO, no refund! See, e.g., 72 F.R

30 Conclusion A new patent environment is emerging to compress patent prosecution New strategies are required for the new environment New strategies seek to preserve claiming opportunities in face of the compressed prosecution

31 Challenges ahead Mastering patent prosecution in the new compact environment Contending with “patent reform”  Threat to the value of patents ―Diminished damages recovery  Threat to the cost of patents ―Can small businesses and inventors afford post-grant procedures?

32 Bromberg & Sunstein has an outstanding record of important wins for our technology and life sciences clients through litigation, patent prosecution, IP portfolio development and business transactions. Bromberg & Sunstein LLP Attorneys at Law 125 Summer Street Boston, MA Tel: (617) Fax: (617)