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 .
Claims 1-20 are pending and are under examination
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.
Claims 1-20 are rejected 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.
Claims 1 and 4 are indefinite in the recitation of amino acid substitutions M428L, N434S, L234A, L235A, and S131C. Since different Fc numbering systems have different amino acids, the scope of the specific amino acid positions cannot be established. It is noted that human IgG1 Fc has M428, N434, L234, L235 and S131, using EU numbering. However, other human IgGs differ in position L234 and S131. For example, human IgG4 has F234 and C131, using EU numbering. For the purposes of examination, the claims are being interpreted as referring to the EU numbering system for IgG1, and would encompass any human IgG Fc, such as an IgG4 Fc, wherein position 428 is L, 434 is S, 234 and 235 are A and 131 is C, using said EU numbering.
Claims 1 and 4 recite the limitation "the following human IgG Fc amino acid substitutions" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 is indefinite since it is not clear if the claim encompass variants of any of the recited AAV, i.e. a variant of AAV1, or whether the limitation of “variants thereof” applies only to AAVrh10
Claim 7 recites the limitation "the percentage of CCR5 receptors" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the period of time" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 9-14 are indefinite since they refer to the method of claim 1, however, claim 1 is directed to a product not a method. Furthermore, the claims recite the limitation "the period of time" and “the blood” or “the mesenteric lymph node” or “the spleen” in line 2. There is insufficient antecedent basis for these limitations in the claims.
Claims 15-20 recites the limitation "the period of time" and “the blood” “or “the mesenteric lymph node” or “the spleen” in line 2. There is insufficient antecedent basis for this limitation in the claims.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by WO2021/262632, as evidenced by Vidarsson, 2014 or, in the alternative, under 35 U.S.C. 103 as obvious over WO2021/262632, in view of Vidarsson, 2014.
WO2021/262632 teaches a humanized IgG4 antibody that binds CCR5 having a VH and VL in Fig1A and 1B, which has CDRs identical to SEQ ID NO: 9-13 of the instant application. WO2021/262632 teaches that the antibody is human IgG4 Fc with M428L/N434S terminal half-life extending mutations (using EU index numbering), and has F234A, L235A (see page 18-20 and 23, in particular). WO2021/262632 teaches a recombinant AAV vector comprising a nucleic acid sequence encoding said antibody (i.e. a heterologous nucleic acid, See page 25, in particular). WO2021/262632 teaches a method of treating HIV comprising administering to a subject said recombinant AAV vector (see page 26, in particular). WO2021/262632 teaches administration of the AAV in amounts 5 x 1912 or 1 x1013 viral genomes per kg (see page 14 and 18, in particular). WO2021/262632 teaches that the AAV has a capsid and has a serotype that can be AAV1 ((see page 26, in particular).
Regarding the limitation of S131C, human IgG4 has S131C mutation as compared to IgG1, using EU numbering (see Vidarsson, Fig. 3, IgG1 has S at position 131, while IgG4 has C at position 131). Thus, the IgG4 antibody of WO2021/262632 inherently has S131C substition. Alternatively., it would be obvious that an antibody with human IgG4 would have S131C as taught by Vidarsson.
Regarding claim 8, it is noted that this would be an inherent or latent property of performing the method of WO2021/262632 which employs an antibody with increased half-life. Furthermore, it would also be obvious, since WO2021/262632 teaches that the antibody has an increased half-life, and that the antibody binds to CCR5 on CD4+ T cells. It would thus be recognized that this would result in extended or increased occupancy of CCR5, due to the increased and extended half-life of the antibody in vivo.
Regarding claims 9-10, WO2021/262632 teaches administration of the same AAV particles/antibody in the same doses, and it would inherently result in the claimed levels of CCR5 occupancy. Alternatively, WO2021/262632 teaches administration of the AAV in two or more doses over a period of years, (See page10, in particular). It would be obvious to optimize the administered multiple doses over periods of years with the extended half-life antibody of WO2021/262632 such that CCR5 is fully occupied during the treatment period, i.e. for at least 38 weeks.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/527,061, in view of WO2020223279 and WO2021/262632.
The ‘061 application claims a method of preventing HIV infection and a method of conferring long-term CCR5 occupancy in a subject comprising administering to the subject a CCR5 antibody having the same IgG Fc substitutions and the same CDRs as the antibody of the instant claims. The ‘061 application claims that the half-life of the antibody is extended, and that CCR5 receptors are fully occupied on CCR5+CD4+ T cells in the blood.
The ’061 application does not claim that the antibody is encoded in an AAV vector.
WO2020223279 teaches that antibodies can be administered as a nucleic acid encoded in an AAV vector to provide for longer lasting efficacy and more consistent levels of the antibody throughout the treatment period (See paragraph 6, in particular). Additionally, WO2021/262632 (see above) teaches administration of the same antibody claimed in the ‘061 publication, as a nucleic acid in an AAV vector for treating HIV.
Therefore, the ordinary artisan would be motivated to administer the antibody in the method of the ’061 application, as a nucleic acid encoded by AAV as taught by WO2020223279 and WO2021/262632 to achieve longer lasting efficacy and more consistent levels of the antibody throughout the treatment period. It would be obvious to use AAV1, IgG4 and to achieve the claimed levels of CCR5 occupancy based on the teachings of WO2021/262632 for the same reasons set forth above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
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.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
Prosecution Insights