Changes to Information Disclosure Statement (IDS) Requirements Notice of Proposed Rulemaking (NPR)

Transcription

1 IP Innovations Class March 2008 Changes to Information Disclosure Statement (IDS) Requirements Notice of Proposed Rulemaking (NPR) 71 FR (2006) XX Off. Gaz. YY (2006) By: Jason Link, John McDonald, Larry Roberts and Chris Durkee

2 Attribution of Slides U.S. Patent and Trademark Office (PTO) published a slide presentation with its NPR The beginning portion of the presentation describing the rule changes borrows heavily from these slides 2

3 History of Proposed Changes The PTO published proposed IDS rule changes in July 2006 Proposed rules submitted to Office of Management and Budget (OMB) (White House) for review OMB approved proposed rules without change in December 2007 PTO could to issue final rules with implementation timeline in the near future, although implementation could be delayed pending resolution of the Tafas litigation [CON rule changes] 3

4 Stated PTO Objectives of Proposed Changes Three quality of examination objectives: 1. Get IDS(s) to examiner before initial examination 2. Reduce number of IDS cites in applications such that only the most pertinent are cited 3. Provide meaningful information to the examiner about large documents, foreign language documents, or a large volume of submitted documents 4th Objective: Help applicants avoid having to submit an IDS for documents served on them by 3rd parties 4

5 Current IDS Submission Requirements Current requirements for submitting an IDS: After 1st action: a timeliness certification or a fee After allowance: a timeliness certification and a fee After payment of issue fee: withdrawal from issue, admission of unpatentability of at least one claim, and an amendment with explanation giving reasons why claim(s) are patentable A citation does not have to be explained unless it is in a foreign language, and then the explanation is merely a concise explanation of relevance. Thus, there are essentially no explanation requirements for IDS cites. 5

6 Proposed Changes Concept: Impose additional disclosure requirements which encourage applicants to submit a limited number of citations, submit IDS before 1st Office action, and provide helpful information about cites in certain circumstances. 6

7 Proposed Changes Proposals: IDSs with a limited number of cites (20 or less) can be submitted before 1st Office action w/o any additional disclosure requirement, except for large cites (more than 25 pages) or foreign language documents. IDSs submitted after 1st Office action must meet increasing additional disclosure requirements. Completely eliminate IDS fee requirements. 7

8 Timeline - Time Periods 1-4 Application Prosecution Timeline Corresponding IDS requirements Application Filed First Office Action on the Merits (FAOM) Allowance of Application Payment of Issue Fee Time Sufficient for Consideration Patent First Period Up to 20 citations permitted w/o any explanation req d. Explanations req d for: each ref. >25 pages, or in non-english language, or for all refs when more than 20 Second Period Explanation, and Non-cumulative description Third Period Timeliness cert., and Patentability Justification which includes: Explanation, Non-cumulative description, and either: (A) Patentability reasons for unamended claims; or (B)(1) Statement of unpatentable claims, (B)(2) Amendment, and (B)(3) Patentability reasons for amended claim(s) Fourth Period Timeliness cert.; Patentability Justification which includes: Explanation, Non-cumulative description, Statement of unpatentable claims, Amendment, and Patentability reasons for amended claim(s); and Petition to w/d from allowance 8

9 Requirements for IDS Filed in 1st Period 1st period: Before a 1st Office action*: General rule: IDS may be submitted w/o any explanations Exceptions: An explanation would be required for: 1. Any English language document over 25 pages** 2. Any non-english language document** 3. All documents when cites exceed 20 (cumulatively)** * Or within three months of filing, whichever is later. **Exceptions: Sequence listings, computer program listings, cites from a foreign search report submitted with the report ( 1.97(e)(1) certification, including compliance with three month time period, not required), and cites responsive to an Office requirement for more information. 9

10 What is the Explanation if it is Required? A. An identification of: (1) the specific feature(s), showing(s), or teaching(s) that caused the document to be cited, with (2) a portion of the document where the specific, e.g., feature, may be found, and B. A correlation of, e.g., the feature, to corresponding specific claim language, or to a specific portion(s) of the supporting specification, where the document is cited for that purpose. 10

11 Explanation Example Compliance with the explanation requirement need not require an extensive submission. Facts: Patent A teaches a rotary pump, as element 32 in Figure 3; and Claim 1 of the application being examined recites a rotary pump (as taught in Patent A). Explanation: Patent A teaches a rotary pump as element 32 in Figure 3, which correlates to the recitation of a rotary pump in claim 1. 11

12 Requirements for IDS Filed in 2nd Period 2nd period: After 1st Office action; ends with allowance, or Notice of Intent to Issue a Reexamination Certificate (NIRC): General rule: an explanation as well as a non-cumulative description is required for all cites*. The current timeliness certification per 1.97(e)(1) or (2), or fee, would no longer be required What is the non-cumulative description requirement? A description of how each document is not merely cumulative of any other document, e.g., a description of a specific feature, showing or teaching in each cited document that is not found in any other citation in any (prior or current) IDS, or any information cited by the examiner. *Exceptions: Cites submitted with a 1.97(e)(1) timeliness certification and copy of foreign search report, or cites responsive to an Office requirement will not require an explanation or noncumulative description. 12

13 Requirements for IDS Filed in 3rd Period 3rd period: after allowance; ending with payment of the issue fee: An IDS requires a 1.97(e)(1) or (2) timeliness certification, and one of the 2 permitted patentability justifications. 13

14 14 Requirements for IDS Filed in 4th Period 4 th period: after payment of issue fee, or NIRC; but in sufficient time to be considered by the examiner prior to issuance: An IDS requires a 1.97(e)(1) or (2) timeliness certification; a patentability justification as defined in 1.98 (a)(3)(vi)(b) including: an unequivocal statement that one or more claims are unpatentable in view of the cited document(s), and an amendment to such unpatentable claims; and a petition to withdraw the application from issue pursuant to 1.313(c)(1).

15 What are the Two Types of Patentability Justification? Only for 3 rd period: (1) An explanation, (2) a non-cumulative description, and (3) reasons why the independent claims are patentable over the information in the IDS, considered together, and in view of any information already of record. ( 1.98 (a)(3)(vi)(a)) For 3 rd or 4 th periods: (1) and (2) above, (3) an unequivocal statement that one or more claims are unpatentable in view of the cited document(s) and in view of any information already of record, (4) an amendment to such unpatentable claims, and (5) reasons why an amendment causes the claims admitted to be unpatentable in the unequivocal statement to now be patentable over the IDS information when considered together. ( 1.98 (a)(3)(vi)(b)) 15

16 Meaningful Compliance (Rule 1.98(a)(1)(vii)) Compliance need not be extensive but must be meaningful : 1. The explanations provided must include a level of specificity commensurate with the specifics that caused the document to be cited. 2. The non-cumulative descriptions must be significantly different so as to point out why the cited document is not merely cumulative of other information. 3. The reasons for patentability must discuss specific claim language relative to specific feature(s), showing(s), or teaching(s) of specific documents. The Office may, in its discretion, decline to consider a noncompliant IDS and line through any cites not yet reviewed. 16

17 Updating of IDS Statements With each amendment that affects the scope of the claims (other than an examiner s amendment): Any previously submitted explanation must be reviewed and updated where necessary; or A statement must be supplied that updating is unnecessary (if asserted). 17

18 Addressing Some Very Large IDS Submissions Problem: Applicant sometimes receives very large numbers of references from a third party (e.g., from an opposing party in a litigation involving a patent related to the pending application. Applicant feels obligated to submit them.) Proposed Rule ( 1.291): applicants need not submit such information, as they can, instead, provide a consent to a protest by such third party, and thereby shift the burden back to the 3rd party to submit the information directly to the Office by complying with the protest rule requirements. 18

19 Third Party Submissions after Pre-Grant Publication The window of time for any 3rd party to file a submission under 1.99 would be extended to 6 months after pre-grant publication of an application, or until the notice of allowance, whichever occurs first. Only a 3rd party (not an applicant) could file a submission under

20 Reexamination Proceedings Proposed IDS rules would be applicable to reexamination proceedings. Compliant IDSs are needed to meet statutory requirement of "special dispatch" in reexamination Patent owner submissions of prior art in both ex parte and inter partes reexamination proceedings would have to comply with 1.97 and Third party submissions of prior art in inter partes reexamination proceedings would have to comply with IDS rules would not apply to requests for reexamination as and requirements are, at least, as comprehensive. 20

21 Addressing Practitioners Concerns Regarding Additional Disclosure Requirements PTO Objective: Address the bar s concern that the additional disclosure requirements, when triggered, may expose practitioners to inequitable conduct charges. Proposal: Add a safe harbor to 1.56 that applies to a party, when attempting to comply with the additional disclosure requirements of 1.98, who has made reasonable inquiry of the relationship of the documents to the claims, has acted in good faith, and has a reasonable basis for the statements provided. 21

22 Proposed Safe Harbor Proposed 1.56(f): The additional disclosure requirements for documents in 1.98(a)(3) would be deemed satisfied where a 1.56(c) individual has made reasonable inquiry of the relationship of the documents cited in an information disclosure statement to the claimed invention, including the supporting specification, and the individual has acted in good faith to comply with the disclosure requirements by having a reasonable basis for the statements made in such disclosure. 22

23 Increased Scrutiny of Current Rule (Duty to Review) An IDS is subject to the provisions of Section 10.18(b)(2) requires an inquiry reasonable under the circumstances. Thus, each item of information being contemplated for inclusion in an IDS must be reviewed before submission of the IDS to the Office to assure that the submission will not: (1) Cause unnecessary delay or needlessly increase the cost of examination, or (2) Result in the obscuring of material information 23

24 24 Duty to Review ( 10.18) WHEN: An IDS includes several documents of marginal relevance, and Other evidence suggests that the marginally relevant information was submitted with the intent to obscure material information. THEN: An inference that the applicant or their representative attempted to cover up or conceal a material reference could be drawn. See 10.18(b); and see Molins PLC v. Textron, Inc., 48 F.3d 1172, 1184, 33 USPQ2nd 1823, 1831 (Fed. Cir. 1995) ( burying a particularly material reference in a prior art statement containing a multiplicity of other references can be probative of bad faith )

25 Unanswered Questions Retroactivity? Updating previously filed IDSs if threshold number of references is reached? 25

26 Practical Implications and Strategic Considerations 26

27 Practical Implications and Strategic Considerations Roadmap for 102/103 Rejections by Examiner Estoppel implications of Explanation, Non- Cumulative Description and Patentability Justification Increased awareness of timeliness of IDS submissions 27

28 Practitioners Making Relevance Determinations Burden to make relevance determinations shifts to practitioners In view of some obviousness combinations we see, how can you exclude any reference as irrelevant? Changes come at a time when McKesson encourages applicants to err on side of disclosure. How strong will 37 C.F.R Safe Harbor be? 28

29 Increased Costs Additional up-front cost to applicants as practitioners will need to: Review Narrow Explain/characterize Update Walk-through of hypothetical example 29

30 Searches/Prior Art Implications for searches: Do we still do them? Do we ask searchers to narrow results (e.g., provide only the 10 most relevant results)? Biotechnology and chemical searches (e.g., sequences; generic formulae) Do rules encourage see nothing know nothing approach to prior art? Effect on prosecution Effect on issued patents Is this even practical? 30

31 Other Impacts Explanation, Non-cumulative description and Patentability justification requirements encourages increased continuation practice Effect of proposed continuation rules may block this. Increased scrutiny by litigators for potential validity attacks and inequitable conduct charges Consider filing continuing application and IDSs now? Others? 31

32 Questions? Comments? 32