DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's amendment and remarks filed on 12/30/2025 are acknowledged.
Claims 1-2, 12-20 and 28-36 are pending.
Claims 1-2 and 12-18 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 07/07/2025.
Claims 19-20 and 28-36 are presently under consideration.
3. The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
4. Claims 19-20 and 28-36 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. This is a New Matter rejection.
The disclosure as-filed does not provide adequate written description of the following newly added limitation of claim 19: “wherein the protease substrate does not inhibit activity of the therapeutic agent by a statistically significant amount.”
Applicant asserts that no New Matter has been added and points to the specification at Example 1, Example 2, Figs. 2A-2E, and Figs. 3A-3E for support for the newly added limitation.
Example 1 describes experiments wherein an unspecified anti-PD-1 antibody functionalized with a granzyme B protease sensing biomarker retained the ability to bind PD-1 protein and tumor infiltrating CD8+ cells (Figs. 2A-2D). Example 2 describes experiments wherein CTLA-4-Ig fusion protein abatacept functionalized with a granzyme B substrate retained the ability to competitively inhibit binding of anti-CD80 and anti-CD86 antibodies, and to suppress T cell activation and proliferation (Figs. 3A-3D).
This disclosed examples of two therapeutic agents, each conjugated to one specific protease substrate, does not provide adequate support under 35 U.S.C. 112(a) a generic limitation encompassing any therapeutic agent and any protease substrate.
The amended claims now recite limitations which were not clearly disclosed in the specification or claims as filed, and change the scope of the instant disclosure as filed. These limitations introduce new concepts and violate the description requirement of 35 U.S.C. 112(a).
Applicant is required to cancel the New Matter in the response to this Office Action. Alternatively, Applicant is invited to clearly point out the written support for the newly added limitations.
5. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
6. Claims 19-20 and 28-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 17/276711, published as US 20220249369 (of record).
Applicant does not appear to have substantively addressed the grounds of rejection presented in section 8 of the previous Office action; accordingly, the grounds of rejection are maintained for the reasons of record, and are incorporated by reference herein as if reiterated in full.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
7. Conclusion: no claim is allowed.
8. 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.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644