IDS NPR

1. IDS NPR Changes to Information Disclosure Statement (IDS) Requirements Notice of Proposed Rulemaking (NPR) 71 FR 38808 (2006) XX Off. Gaz. YY (2006)

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

3. Results to be Achieved by Proposed Changes in IDS NPR Quality results achieved if objectives are met: 1. Less wasted time by examiner on unrelated, cumulative or not understood cites in IDSs 2. Most relevant prior art known by applicant will be appropriately considered by examiner in preparing 1st Office action, so search and examination process can be better focused 3. IDSs will be meaningful, add early value to the examination process, help examiner to issue a high quality 1st Office action, and avoid wasting time.

4. Current IDS Submission Requirements and Problems 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) 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. Problems: Many IDSs are submitted late in examination process; contain large individual cites, or large submissions with unrelated and cumulative cites, which not only waste an examiner’s (and the Office’s) time, but they are not effectively considered. Thus, many IDSs add little value to, or even, hinder the examination process; not help it. They’re often meaningless, not meaningful.

5. Proposed Changes in IDS NPR 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. 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 (more than 25 pages) or foreign language documents. IDSs submitted after 1st Office action must meet increasing “additional disclosure” requirements. This would permit, but discourage, later filed IDSs, while providing helpful information if submitted. Eliminate fee requirements in toto, as they are inconsistent with quality and timeliness objectives of proposals.

6. Proposed Changes In IDS NPRTime Periods 1- 4 Application Prosecution Timeline and corresponding IDS requirements Application Filed First Office Action on the Merits (FAOM) Allowance of Application Payment of Issue Fee Time Sufficient for Consideration Patent • 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 • 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

7. Proposed Changes in IDS NPR 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 § 1.105 requirement.

8. Proposed Changes in IDS NPR 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.

9. Proposed Changes in IDS NPR Requirements for IDS filed in 2nd period 2nd period: After 1st Office action; ends with allowance, or 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 § 1.105 requirement will not require an explanation or non-cumulative description.

10. Proposed Changes in IDS NPRRequirements for IDS filed in 3rd and 4th periods 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.” (See slide 11) 4th 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).

11. Proposed Changes in IDS NPRRequirements for IDS filed in 3rd and 4th periods What are the two types of “patentability justification?” Only for 3rd 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 3rd or 4th 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 to now be patentable over the IDS information when considered together. (§ 1.98 (a)(3)(vi)(B))

12. Proposed Changes in IDS NPRIDS With Submission That Does Not Comply With the Additional Disclosure Requirements • For any IDS that does not comply with the additional disclosure requirements, the examiner may choose not to consider the non-complaint IDS. If documents are considered during the determination of non-compliance, the examiner should initial each considered reference and place a line through the non-considered references. • This is applicable to IDSs filed during any time period

13. Proposed Changes In IDS NPRAddressing Some Very Large IDS Submissions Problem: Applicants sometimes receive very large numbers of references from a third party, e.g., from litigation in a patent related to the application under examination, and they feel they must submit them whether or not they believe they are relevant. Such large submissions impose significant burdens on applicants, and the Office, provide little if any useful information to the examiner, while wasting his/her limited amount of examining time. Proposal: Indicate in protest rule, § 1.291, that 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.

14. Proposed Changes In IDS NPRReexamination 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 1.98. • Third party submissions of prior art in inter partes reexamination proceedings would have to comply with § 1.98. • IDS rules would not apply to requests for reexamination as §§ 1.510 and 1.915 requirements are, at least, as comprehensive.

15. Proposed Changes In IDS NPRThird 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. • It would be clarified that only a 3rd party (not an applicant) could file a submission under § 1.99.

16. Proposed Changes In IDS NPREntry of Certain Amendments After Allowance • To decrease the need to file a RCE or a continuation, amendments affecting the following items would be entered after allowance and before (or with) issue fee payment: Bibliographic data; Reference to a joint research agreement; Change in the order of inventors; and Correction of inventorship • These formality amendments would be entered after payment of the issue fee, if submitted in sufficient time to permit the patent to be printed with the amended information.

17. Proposed Changes In IDS NPRAddressing Practitioner’s Concerns Regarding “Additional Disclosure” Requirements 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.

18. Duty to Review (§10.18) • An IDS, like any other paper filed in the Office, is subject to the provisions of § 10.18. • 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. • Failure to review an IDS can also implicate obligations of registered practitioners under §§ 10.23(b) and (c), and § 10.77(b) (handle a legal matter w/o preparation adequate in the circumstances).

19. 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 seeMolins 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”)

20. More Information • The below listed documents may be accessed via the “More Information” hyperlink associated with the Notice’s title at the following USPTO webpage: http://www.uspto.gov/web/offices/pac/dapp/ogsheet.html • Executive Summary – IDS NPR, • Detailed Summary – IDS NPR, • Charts of: “The Four Time Periods for Submitting an IDS and Their Corresponding Requirements,” and • Application Prosecution Timeline. • For more information, please contact the Office of Patent Legal Administration at (571) 272-7701 or e-mail to PatentPractice@USPTO.gov, or contact one of the following: • Hiram Bernstein 571-272-7707 • Brian Hanlon 571-272-5407 • Robert J. Spar 571-272-7700

21. Public Comments Public Comments on this proposed rulemaking must be received on or before September 10, 2006. Comments can be sent to or via: • AB95Comments@USPTO.gov • Mail Stop Comments-Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450 • Please include a DOS formatted 3.5 inch disk accompanied by a paper copy of the comments. • Facsimile to (571) 273-7707 • Federal eRulemaking Portal at www.regulations.gov Because comments will be made available for public inspection, information that is not desired to be made public should not be included.

22. Proposed Changes In IDS NPRAppendix 1: §§ 1.97(e)(1) & (2) Timeliness Certifications(No changes are being proposed) 37 CFR 1.97(e)(1): That each item of information contained in the information disclosure statement was first cited in any communication from a foreign patent office in a counterpart foreign application not more than three months prior to filing of the information disclosure statement. 37 CFR 1.97(e)(2): That no item of information contained in the information disclosure statement was cited in a communication from a foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification after making reasonable inquiry, no item of information contained in the information disclosure statement was known to any individual designated in § 1.56(c) more than three months prior to filing of the information disclosure statement.

23. Proposed Changes In IDS NPRAppendix 2: Safe Harbor proposed to be added to § 1.56 Section 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.

24. Proposed Changes In IDS NPRAppendix 3: “Explanation” Example Compliance with the “explanation” requirement need not require an extensive submission. Example: 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.

25. Proposed Changes In IDS NPR Appendix 4: Meaningful Compliance While compliance with the additional disclosure requirements need not be extensive, it 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. If compliance with the requirements is not found to be present after some cites in the IDS are reviewed, the Office may decline to further consider the IDS and line through the remaining cites. §1.98(a)(3)(vii).

26. Proposed Changes In IDS NPRAppendix 5: Updating Updating of additional disclosure required: 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 supplied that updating is unnecessary.