Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 32 and 34-42 are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement filed 12/5/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Withdrawn Rejections
The objections to the specification are withdrawn in view of the new specification amendment submitted on 11/20/2024.
The rejection of claims 32-42 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of the newly amended claims.
The rejection of 32-41 under 35 U.S.C. 102(a)(1) as being anticipated by Lu et al., US2016/0031977 is withdrawn in view of the newly amended claims which now require SEQ ID NOs: 24 and 51 which are not taught by the reference.
The rejection of 32-42 under 35 U.S.C. 103 as being unpatentable over Lu et al., US2016/0031977in view of Yoshiyama et al., 2010 is withdrawn in view of the newly amended claims which now require SEQ ID NOs: 24 and 51 which are not taught by the reference.
New Rejection Necessitated by Amendment
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 32 and 34-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,591,385. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘385 claims the same antibody now required in newly amened claim 32. In the parent application 16/762,141 now U.S. Patent No. 11,591,385, in the notice of allowance on 10/20/2022, the restriction requirement was withdrawn as to any claim that required all the limitations of the allowable claim. At the time of allowance, the method claims 10-20 did not require the same antibody. Those claims came to be the proper divisional application of the instant claims but the instant claims, on 11/20/2025, were amended to require the specific antibody that was allowed in the U.S. Patent No. 11,591,385. The newly amended claims would have been allowed with the original patent since the newly amended claims of 18/155,230 now require all the limitations of the allowed claim of ‘385. Therefore, the instant claims are rejected over the claims of ‘385 patent.
The courts have held that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use," which extend to any and all such uses disclosed in the specification of the earlier patent. Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d at 1363 (Fed. Cir. 2008), and Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d at 1385-86 (Fed. Cir. 2003). Indeed, as both cases recognized,
[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, … and then prevent the public from making an beneficial use of such product by securing patents upon each of the uses to which it may be adapted.
Sun Pharmaceuticals Industries, Ltd. v. Eli Lilly and Co., 611 F.3d 1381 (Fed, Cir. 2010), citing Pfizer, 518 F.3d at 1363 n.8 (emphases added); and Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 (CCPA 1931)).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Advisory Information
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURORA M. FONTAINHAS whose telephone number is 571-272-2952. The examiner can normally be reached on Monday - Friday (8AM - 4PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached on (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675