DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-19 of record 7/09/24 are pending and subject to prosecution. Prosecution on the merits commences for claims 1-19.
PRIORITY
The instant application, filed 7/09/24 is a CONTINUATION of US Patent Application No. 18/052,735, now abandoned, filed 11/04/2022, is a CONTINUATION of US Patent No. 11,524,081, filed 05/09/2022, which is a CONTINUATION of US Patent No. 11,357,870, filed 08/31/2021, which claims priority to US Provisional Application No. 63/073,837, filed 09/02/2020. Thus, the earliest possible priority for the instant application is 09/02/2020.
SEQUENCE COMPLIANCE- CLAIMS
The claims are objected to because they contain sequences that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821 (a)(1) and (a)(2), wherein strands of four or more amino acids or ten or more nucleotides are required to be identified by a sequence identifier. See, claims 1 and 17.
If the sequences are already present in the sequence listing, it would be remedial to amend the claims to include the appropriate sequence identifiers. Applicants are required to comply with all of the requirements of 37 CFR 1.821 - 1.825. 9. Any response to this office action that fails to meet all of these requirements will be considered non-responsive. The nature of the noncompliance with the requirements of 37 C.F.R. 1.821 through 1.825 did not preclude the examination of the application on the merits, the results of which are communicated below.
CLAIMS
Claims 1 and 17 are drawn to methods of administering a recombinant adeno-associated virus comprising a variant capsid and encoding a heterologous gene (Claim 1), wherein the heterologous gene is REP1 (Claim 17).
PNG
media_image1.png
200
400
media_image1.png
Greyscale
PNG
media_image2.png
200
400
media_image2.png
Greyscale
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.
Claims 1-19 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 17 require an insertion consisting of the amino acid sequence of LAISDQTKHA “at amino acid position 588 relative to native AAV2 VP1 capsid” which renders the claims indefinite because the position is not associated with a SEQ ID NO. As claimed, the positions are relative to an unclaimed, unknown “native AAV2 VP1 capsid.” Not all native VP1 proteins will have the same amino acid at the same position. Further, the comprising claim language allows for additional variations within the coding sequence, for example deletions and insertions, and thus, adding or subtracting amino acids from a “native” VP1. Thus, the skilled artisan would not know the metes and bounds of the claimed invention.
Claims 2 and 17, which require wherein the AAV capsid comprises a P34A substation is indefinite for the same reasons.
Claims 3-16, and 18-19 are included in the rejection because they depend from rejected claims.
Claim 17 at section (ii) is unclear. Administering the rAAV of part (i), and (ii)” a heterologous nucleic acid comprising a nucleotide sequence encoding REP 1, or administering a pharmaceutical composition comprising the rAAV and a pharmaceutically acceptable carrier.” If one administers the AAV encoding REP1, is the composition formulated as a pharmaceutical composition? Is REP1 only an one option?
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)(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.
Claims 1-7 and 12-19 are rejected under 35 U.S.C. 102(a)(1)(a)(2) as being WO2017/197355 to Kirn. The publication dated of Kirn is 11/16/2017.
With regard to claims 1, 2, 6, 7, 12, and 17, Kirn discloses methods of treating eye disorders, including choroideremia, comprising the administration of recombinant AAV vectors comprising variant capsids, wherein the AAV vectors encode a therapeutic gene (abstract, [004]-[005], [010], [0015], [00168]). The AAV capsid comprises an AAV2 capsid comprising the insertion of a the peptide “LAISDQTKHA” encoded by SEQ ID NO: 28 therein, inserted at position 588, and further wherein the AAV2 capsid comprises a P34A substitution, and formulated as a pharmaceutical composition ([0018], [0020], [00132], [00187]). The heterologous gene encoded on the AAV2 vector is Rab escort protein 1 ([00172]Kirn disclose the recombinant AAV2 vector is injected intravitreally, into both eyes of a primate at the same time, which reads on “sequential bilateral ocular administration” absent evidence to the contrary ([0029], [0034]-[0036], [00184]). Thus, Kirn anticipates claims 1, 2, 6, 7, 12, and 17.
With regard to claims 3-5 and 18, the AAV2 vector encoded by SEQ ID NO: 42 in Kirn is 100% identical to instant SEQ ID NO: 9:
PNG
media_image3.png
589
562
media_image3.png
Greyscale
PNG
media_image4.png
438
552
media_image4.png
Greyscale
With regard to claims 13-14 and 18, Kirn discloses the patient treated is a human [0081],[0082], [00187], the rAAV vector is formulated as a pharmaceutical composition with carrier and is injected intravitreally, into both eyes of a primate at the same time, which reads on “sequential bilateral ocular administration” absent evidence to the contrary ([0029], [0034]-[0036], [00184], [00204]).
With regard to claims 15-16, Kirn discloses the pharmaceutical composition comprises about 109 to 1011 vg and 109 to 1011 vg of the AAV [00183].
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,357,870. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious variants over the patented claims. The instant application is related to the ‘870 patent, share the same specification and effective filing date.
Claim 1 of the ‘870 patent is drawn to a nucleic acid encoding a human REP1 gene encoded by SEQ ID NO: 1, and dependent claims 10-12 are drawn to AAV2 vectors encoded by SEQ ID NO: 9 therein, and used in a method of treating choroideremia in a human.
Thus, the patented claim, drawn to methods of treating choroideremia in a human by administering the same virus are obvious variants of instant claims 1 and 17.
Instant claims 2-16 and 18-19 are obvious variants of patented claims 2-25.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,524,081. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious variants over the patented claims. The instant application is related to the ‘081 patent, share the same specification and effective filing date.
Claim 1 of the ‘081 patent is drawn to a nucleic acid encoding a human REP1 gene encoded by SEQ ID NO: 1, and dependent claims 8-10 and 13 are drawn to AAV2 vectors encoded by SEQ ID NO: 9 therein, and used in a method of treating choroideremia in a human.
Thus, the patented claim, drawn to methods of treating choroideremia in a human by administering the same virus are obvious variants of instant claims 1 and 17.
Instant claims 2-16 and 18-19 are obvious variants of patented claims 2-20.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY A ARON whose telephone number is (571)272-2789. The examiner can normally be reached Monday-Friday 9AM-5PM.
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
KAA
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
