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 .
Applicant's amendments to the claims filed on 11-25-2024 have been received and entered. Claims 4, 7-8, 11, 14 have been amended. Claims 1-3, 5-6 have been canceled. Claims 16-24 have been added. Claims 4, 7-24 are pending in the instant application.
Priority
This application is a DIV of 17/791,261 filed on 07/07/2022 (PAT 11981705 17/791,261) which is a 371 of PCT/US2021/012746 filed on 01/08/2021 which has a provisional application 62/959,625 filed on 01/10/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05-02-2024; 11-25-2024; 03-17-2025; 06-03-2025; 07-07-2025; 10-10-2025; 01-26-2026; 03-25-2026 are in compliance with the provisions of 37 CPR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
All references have been considered; however, due to the voluminous number of references in the IDS they have been only briefly considered. It is noted that the cloaking of a relevant reference by inclusion in a long list of citations may not comply with the Applicant' s duty of disclosure. Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948 (S.D. Fla. 1972). Therefore, the applicant is encouraged to present a concise statement as to the relevance of any particular documents known to be material for patentability as defined by 37 C.F.R. § 1.56.
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 4, 7-24 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.
SEQ ID NO: 80 (TV[S/p][A/m/t/]L) was correctly marked as “000” (skipped) in the sequence listing under 37 CFR 1.831(a). Under WIPO ST.26 rules, positions with ambiguous or alternative residues like [S/p] and [A/m/t/] are not considered “specifically defined.” When represented in ST.26 format, these would be shown as “X,” giving the sequence TVXXL—only 3 specifically defined amino acids. Since ST.26 requires sequences to contain at least 4 specifically defined amino acids (for peptides) or 10 specifically defined nucleotides, this sequence properly does not appear in the listing.
However, claim 4 references “SEQ ID NO: 80,” which creates an indefiniteness issue under 35 U.S.C. 112(b). A claim cannot reference a sequence identifier that does not exist in the sequence listing. It would be remedial to amend claim 4 to either: Remove the SEQ ID NO: 80 reference and describe the targeting sequence using only the amino acid notation: TV[S/p][A/m/t/]L, or list each specific variant separately in the sequence listing (e.g., TVSAL, TVPAL, etc. as separate SEQ ID NOs) and reference all of them in the claim.
Claim 13 depending from claim 12 recites the limitation “intrathecal delivery” in line 1; however, there is no “intrathecal delivery” in claim 12. There is insufficient antecedent basis for this limitation in the claim.
Claims 7-24 are included in the rejection because they directly or indirectly depend from base claim. Appropriate correction is required.
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 4, 8, 9, 10, 11, 12, 14, 15, 16, 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, 12, 13, 16, 17, 18 of U.S. Patent No. US 11,981,705 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because
Pending claim 4 is directed to a method of delivering an immunotherapy agent to treat a cancer in a subject, the method comprising administering to the subject an adeno-associated virus (AAV) vector comprising (i) a capsid protein comprising a targeting sequence that comprises TV[S/p][A/m/t/]L (SEQ ID NO:80) and (ii) a transgene encoding the[[an]] immunotherapy agent. Pending claim 16 is directed to the immunotherapy agent is an immune checkpoint inhibitor. Pending claim 17 is directed to the immune checkpoint inhibitor is an antibody or antigen binding fragment which binds PD-1, PD-L1, CLTA-4, or CD137.
Issued claim 1 is directed to a method of delivering an antibody or antigen binding fragment thereof that binds PD-L1 to treat a glioblastoma in a subject, the method comprising systemically administering to the subject an adeno-associated virus (AAV) vector comprising (i) an AAV capsid, wherein the AAV capsid comprises a peptide insert of TVSALFK (SEQ ID NO: 8) or TVSALK (SEQ ID NO: 4), and (ii) a transgene encoding an antibody or antigen binding fragment thereof that binds PD-L1.
Since TV[S/p][A/m/t/]L of pending claim 4 encompasses TVSAL, TVSML, TVSTL, TVPAL, TVPML, TVPTL (see instant disclosure page 12), Pending claim 4, 16, 17 are anticipated by Issued claim 1.
Pending claim 8 is directed to the AAV is AAV9.
Issued claim 2 is directed to the AAV vector is AAV9.
Pending claim 9 is directed to the AAV9 comprises AAV9 VP1
Issued claim 3 is directed to the AAV9 comprises AAV9 VP1.
Pending claim 10 is directed to the targeting sequence is inserted in a position corresponding to amino acids 588 and 589 ofAAV9 VP1 comprising SEQ ID NO:85.
Issued claim 4 is directed to the peptide insert is located in a position corresponding to amino acids 588 and 589 of AAV9 VP1 comprising SEQ ID NO:85.
Pending claim 11 is directed to the AAV is administered by parenteral delivery, intracerebral delivery, or intrathecal delivery. Pending claim 12 is directed to the parenteral delivery is via intravenous, intraarterial, subcutaneous, intraperitoneal, or intramuscular delivery.
Issued claim 16 is directed to the administration is intravenous. Issued claim 17 is directed to the administration is intraarterial. Issued claim 18 is directed to the administration is intraperitoneal.
Pending claim 14 is directed to further comprising administering chemotherapy, radiation, and/or surgical resection to the subject.
Issued claim 6 is directed to further comprising administering chemotherapy, radiation, and/or surgical resection to the subject. Issued claim 8 is directed to the method comprises administering radiation to the subject. Issued claim 9 is directed to the method comprises administering surgical resection to the subject. Issued claim 10 is directed to the method comprises administering chemotherapy to the subject.
Pending claim 15 is directed to the chemotherapy comprises temozolamide, lomustine, or a combination thereof.
Issued claim 7 is directed to the chemotherapy comprises temozolamide, lomustine, or a combination thereof. Issued claim 11 is directed to the chemotherapy comprises temozolamide. Issued claim 12 is directed to the chemotherapy comprises lomustine. Issued claim 13 is directed to the chemotherapy comprises a combination of temozolamide and lomustine.
Therefore, pending claims 4, 8, 9, 10, 11, 12, 14, 15, 16, 17 are anticipated by claims 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, 12, 13, 16, 17, 18 of the issued U.S. Patent No. US 11,981,705 B2.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA NHAT TRAN whose telephone number is (571)270-0201. The examiner can normally be reached M-F (9-5).
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/KHOA NHAT TRAN/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
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