DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Applicant’s amendment filed 11/19/2025 is acknowledged. Claims 32, 34, 45, 54, 67, 218 and 219 are amended. Claims 32, 34, 45, 65, 67 and 212-228 are under examination.
Objections/Rejections Withdrawn
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Specification
The objection to the disclosure for informalities is withdrawn in response to Applicant’s amendment to the specification to remove identifiers for sequences having fewer than 10 nucleotides or fewer than 4 amino acids.
Claim Objections
The objection to claims 32, 65, 218 and 219 for minor informalities is withdrawn in response to Applicant’s amendment of the claims. Specifically, the repeated word “comprises” was deleted in claims 32 and 65. In addition, Applicant has removed redundancies from claims 218 and 219.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 32, 34, 45, 65, 67 and 212-228 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in response to Applicant’s amendment. Specifically, Applicant has removed the sequence identifier for the sequence having fewer than 4 amino acids and removed the exemplary claim language from claims 34 and 67.
Rejections Maintained
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
The rejection of claim 34 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 maintained for reasons of record and the following.
Response to Arguments
Applicant argues at p. 12 of the Office action mailed 11/14/2025 that the recitation of an analgesic biologic apart from the recited anti-CGRP and that this is no different from use with another therapeutic agent which may take the forms of anti-histamines, anti-inflammatory agents, analgesics, or antibiotics, which were not rejected.
This argument has been fully considered, but is not found persuasive. The other recited therapeutic agents were well-known and described in the prior art and information which is well known in the art need not be described in detail in the specification. See MPEP 2163(II)(A)(3)(a), which states:
What is conventional or well known to one of ordinary skill in the art need not be disclosed in detail. See Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d at 1384, 231 USPQ at 94. See also Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1085 (Fed. Cir. 2005) (“The ‘written description’ requirement must be applied in the context of the particular invention and the state of the knowledge…As each field evolves, the balance also evolves between what is known and what is added by each inventive contribution.”).
In contrast, an analgesic comprising an antibody or another analgesic biologic encompasses a broad genus of antibodies/biologics with the required function of acting as an analgesic that was not well described or known in the art at the time of the filing of the invention. From the specification, it is clear that Applicant has possession of the antibody, Ab2, which is disclosed as having analgesic properties (see specification at paragraphs [0057]-[0059]). At the time of the filing of the invention (around 2011), some analgesic antibodies were known, for instance, Lane et al. (N Engl J Med 2010;363:1521-31—of record) taught the NGF antibody, tanezumab, acted as an analgesic (see abstract). In addition, Ugolini et al. (PNAS, 2007; 104: 2985-2990—of record) disclosed an anti-TrkA antibody (MNAC13) with analgesic effects (see abstract). While there were some examples of analgesic antibodies having varied structures before 2011, neither the specification nor the art adequately described a sufficient number of species of analgesic antibodies/biologics that are representative of the entire genus. Particularly in light of the fact that there is a substantial structural variation within the genus of analgesic antibodies and biologics, one must describe a sufficient variety of species to reflect the variation within the genus (see MPEP 2163.05(I)(B).
The MPEP 2163(A) states “‘[a]n invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function.’” For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable to one of ordinary skill in the art, more evidence is required to show possession. (See MPEP 2163(II)(A)(3)(a)(i)). In this case, neither the specification nor the prior art provides sufficient description of the encompassed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
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.
The following rejections on the ground of nonstatutory double patenting are maintained.
The rejection of claims 32, 34, 45, 65, 67 and 212-228 as being unpatentable over claims 1-42 of U.S. Patent No. 9,708,393.
The rejection of claims 32, 34, 45, 65, 67 and 212-228 as being unpatentable over claims 1-10 of U.S. Patent No. 11,325,967.
The rejection of claims 32, 34, 45, 65, 67 and 212-228 as being unpatentable over claims 1-30 of U.S. Patent No. 10,066,009 in view of Latham (WO2008/144757—on IDS filed 06/11/2024).
The rejection of claims 32, 34, 45, 65, 67 and 212-228 as being unpatentable over claims 1-30 of U.S. Patent No. 10,179,809 in view of Latham (WO2008/144757—on IDS filed 06/11/2024).
The rejection of claims 32, 34, 45, 65, 67 and 212-228 as being unpatentable over claims 1-30 of U.S. Patent No. 10,214,582 in view of Latham (WO2008/144757—on IDS filed 06/11/2024).
The rejection of claims 32, 34, 45, 65, 67 and 212-228 as being unpatentable over claims 1-30 of U.S. Patent No. 10,533,048 in view of Latham (WO2008/144757—on IDS filed 06/11/2024).
The rejection of claims 32, 34, 45, 65, 67 and 212-228 as being unpatentable over claims 1-30 of U.S. Patent No. 12,122,821 in view of Latham (WO2008/144757—on IDS filed 06/11/2024).
The provisional rejection of claims 32, 34, 45, 65, 67 and 212-228 as being unpatentable over claims 1, 2, 8, 25, 65-73, 76, 77 and 80 of copending Application No. 18/733,949 (reference application).
The rejection of claims 32, 34, 45, 65, 67 and 212-228 as being unpatentable over claim 30 of U.S. Patent No. 9,855,332 in view of Seidler et al. (Ann. N.Y. Acad. Sci. 1072: 262–275 (2006)).
The rejection of claims 32, 34, 45, 65, 67 and 212-228 as being unpatentable over claims 1-29 of U.S. Patent No. 10,765,746 in view of Seidler et al. (Ann. N.Y. Acad. Sci. 1072: 262–275 (2006)) and Latham (WO2008/144757—on IDS filed 06/11/2024).
Response to Arguments
Applicants’ request for deferral of this issue until other issues of patentability are resolved in their response filed 11/14/2025 at p. 13 of the Remarks is noted. However, deferral of arguments is not proper; an argument after the claims have been found otherwise allowable that obviousness type double patenting does not exist will not be considered timely. Accordingly, the rejections are maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675