DETAILED ACTION
Applicants amended claims filed on 4/5/2024 are acknowledged and entered into the record.
Accordingly, Claims 43-53, 55-56, and 58-64 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 43-53, 55-56, and 58-64 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Belk et al. (WO2021207597) in view of Adler et al. (US PgPub20110158987).
The applied reference, Belk et al., has a common assignee (Invivyd) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The claims are drawn to a pharmaceutical formulation comprising an isolated antibody or antigen binding fragment thereof, which binds to the spike protein of a coronavirus (CoV-S) wherein the antibody comprising VH CDR1-3 having SEQ ID NOs: 52, 54, and 56 and VL CDR1-3 having SEQ ID NOs: 252, 254, and 256 and VH having at least 90% identity to SEQ ID NO: 258 and a VL having at least 90% identity to SEQ ID NO: 58. The claims are further drawn to wherein the formulation comprising a histidine buffer, sucrose, arginine hydrochloride and polysorbate 80 at specific concentrations. The claims are drawn to methods of treatment comprising administering said pharmaceutical formulations to a human subject.
Belk et al. teach antibodies and antigen binding fragments thereof that specifically bind to the S protein of coronaviruses (CoV-S) and therapeutic and diagnostic uses of said antibodies. Belk et al. teach, with 100% identity, the instantly claimed antibody sequences. Belk et al. teaches intramuscularly, intravenously, or subcutaneous administration at varying monthly administrations. Belk et al. disclose pharmaceutical formulations comprising said antibody with appropriate buffers and reagents, however does not explicitly disclose the instantly claimed reagents. This deficiency is made up for by Adler et al.
Adler et al. teach pharmaceutical formulations for a therapeutic antibody comprising 15-30mM of a buffering agent such as histidine, a 0.05% w/v surfactant such as polysorbate 80, sucrose and arginine hydrochloride. Alder et al. teach 1 to 200 mg/ml of antibody and the pH range of 4.0-7.0. Adler et al. disclose the formulation is stable at refrigerator temperatures (2-8 degrees) for more than 1 year.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the anti-CoV-S antibody pharmaceutical formulation using the buffer and reagents taught by Alder et al. for a stable therapeutic antibody formulation. One of skill in the art would have had a reasonable expectation of success based on the teachings of Alder et al. of a stable antibody pharmaceutical formulation for methods of treatment.
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 43-53, 55-56, and 58-64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,192,940 in view of Adler et al. (US PgPub20110158987).
The instant claims and those of US Patent 11,192,940 are both drawn to the same antibody which binds to CoV-S spike protein having the same CDR/VH/VL sequences in a pharmaceutical formulation. The claims of US Patent 11,192,940 do not recite the instantly claimed buffers or reagents. This deficiency is made up for by Adler et al. The teachings of Adler et al. are presented in the 103(a) rejection set forth above. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the anti-CoV-S antibody pharmaceutical formulation using the buffer and reagents taught by Alder et al. for a stable therapeutic antibody formulation. One of skill in the art would have had a reasonable expectation of success based on the teachings of Alder et al. of a stable antibody pharmaceutical formulation for methods of treatment.
Conclusion
Claims 43-53, 55-56, 58-64 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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