DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s response and amendments received November 21, 2025 are acknowledged.
Claims 1-9, 11-19, 21-26, 28, 30, 31, 33, 34, and 38-46 have been canceled.
Claim 10 has been amended.
Claims 47-56 have been added.
Claims 10, 20, 27, 29, 32, 35-37, and 47-56 are pending in the instant application.
As part of the 11/21/2025 response, applicant has added new claims 47-56. Claims 48-50 are properly part of group II, while claim 47 is part of withdrawn group III (polynucleotides) and claims 51-56 are part of group IV drawn to administration methods to treat disease. Given that applicant has already received an action on the merits for the invention of group II drawn to antibody polypeptides claims 47 and 51-56 are withdrawn from prosecution at this time, although they have the possibility of rejoinder as set forth in the 3/26/2025 restriction requirement. See also 37 CFR 1.142(b) and MPEP § 821.03.
Claims 10, 20, and 48-50 are under examination as they read upon the elected anti-HIV Env antibody species comprising the six CDRs of SEQ ID NOs:61-64, GDT, and SEQ ID NO:66. It should be noted that as per Table 3 of the instant specification, these sequences are the CDRs of NC-Cow7 (VH of SEQ ID NO: 67, VL of SEQ ID NO:68, see Table 1), and this antibody clone appears to be free of the prior art as was communicated in the prior office action. It should also be noted that all 10 species as presently recited in independent claim 10 (i.e. embodiments a-j which recite the six CDRs of antibodies NC-Cow1-NC-Cow10 respectively) also appear to be free of the prior art.
Specification
Applicant’s amendments to the specification to correct formal matters are acknowledged.
Claim Objections
The objection to claim 6 is moot as it has bene canceled.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejection of claims 10, 12, 20, 21, and 23 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite has been withdrawn in view of applicant’s claim amendments received November 21, 2025.
The rejection of claims 6 and 8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is moot as said clams were canceled as part of the November 21, 2025 response.
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 claims 6, 8, 10, 12, 20, 21, and 23 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 has been withdrawn in view of applicant’s claim amendments received November 21, 2025.
Specifically, all of the claimed anti-HIV Env antibodies are defined by specific combinations of six, non-degenerate CDR sequences and this level of sequence information is generally accepted in the art as being sufficient to make antibodies recombinantly that maintain the recited functional properties.
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 10, 20, and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,795,211. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate what has been presently claimed.
Specifically, the issued claims are drawn to the bovine HIV Env neutralizing antibody NC-Cow1 (i.e. CDRs of SEQ ID NOs:1-4, GDT, and SEQ ID NO:6, VH or SEQ ID NO:7, VL of SEQ ID NO:8) whereas the instant claims encompass multiple genera of anti-Env antibodies. Notably, the breadth of antibodies encompassed by the instant claims encompasses NC-Cow1 itself (see most particularly embodiment (a) of instant claims 10 and 49 and compare to issued claims 2 and 4). It should also be pointed out that the issued claims recite chimeric, humanized, bispecific and trispecific antibodies (compare instant claim 20 and issued claim 3) Given that the issued claims recite one of the ten anti-Env species instantly claimed, the issued claims anticipate the breadth of what is presently claimed.
Claim Objections
Claims 48 and 50 are objected to as being dependent upon a rejected independent claim, but would be allowable if rewritten in independent form including all of the limitations of the independent claim and any intervening claims.
No claims are allowable.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/ Primary Examiner, Art Unit 1644