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 dated 5/13/24 are acknowledged. Claim 1 is cancelled. Claims 2-18 are new. Prosecution on the merits commences for claims 2-18.
PRIORITY
The instant application, filed 11/27/2023, is a CONTINUATION of US Patent No. 11,865,187, filed 8/06/2020, which is a CONTINUATION of US Patent No. 10,780,182, filed 10/24/2016, which is a 371 of PCT/US2015/027491, filed 04/24/2015, which claims priority to US Provisional Application No. 61/984,686, filed 4/25/2014. Thus, the earliest possible priority for the instant application is 4/25/2014.
INFORMATION DISCLOSURE STATEMENT
The information disclosure statements (IDS) of 5/13/24 and 8/28/24 have been considered by the examiner. An initialed copy of each IDS is included with the mailing of this action.
The listing of references throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
CLAIMS
Independent claim 2 is directed to a nucleic acid composition comprising an AAV vector genome, wherein the AAV vector encodes, at least, (i) an anti-Her2 heavy chain variable sequence and heavy chain constant sequence; (ii) a linker; and (iii) an anti-Her2 light chain variable sequence and a light chain constant sequence; and wherein each of the anti-Her2 chain sequences are operably linked to an IL-2 leader sequence:
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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 2-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,865,187. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious variants of the patented claims.
The instant application is a CONTINUATION of U.S. Patent No. 11,865,187, and thus share the same effective filing date and specification.
Independent claim 1 of the ‘187 Patent is directed to a nucleic acid composition comprising an AAV vector genome, wherein the AAV vector encodes, at least, an anti-Her2 heavy chain sequence having an amino acid sequence of SEQ ID NO: 18, and an anti-Her2 light chain sequence having an amino acid sequence of SEQ ID NO: 20, wherein each of the anti-Her2 chain sequences are operably linked to an IL-2 leader sequence, and regulatory sequences which direct the expression of the heavy chain and light chain, and wherein the heavy chain and light chain sequences form an anti-Her2 antibody when expressed in a cell.
Independent claim 2 is directed to a nucleic acid composition comprising an AAV vector genome, wherein the AAV vector encodes, at least, (i) an anti-Her2 heavy chain variable sequence having an amino acid sequence of SEQ ID NO: 18, and heavy chain constant sequence; (ii) a linker; and (iii) an anti-Her2 light chain variable sequence having an amino acid sequence of SEQ ID NO: 20, and a light chain constant sequence; wherein each of the anti-Her2 chain sequences are operably linked to an IL-2 leader sequence, and regulatory sequences operably linked to the heavy chain and light chain sequences.
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Patent Claim 1 Instant Claim 2
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Thus, it would have been obvious to amend the claims of the ‘187 patent to arrive at the pending claims.
Instant claims 3-18 are similar in scope and/or obvious variants of patented claims 2-16.
Claims 2-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,780,182. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious variants of the patented claims.
The instant application is a CONTINUATION of U.S. Patent No. 11,865,187, which is a CONTINUATION of U.S. Patent No. 10,780,182, and thus share the same effective filing date and specification.
Independent claims 1, 10 and 20 of the ‘182 Patent are directed to a nucleic acid composition comprising an AAV vector, wherein the AAV vector encodes, at least, an anti-Her2 heavy chain sequence having an amino acid sequence at of SEQ ID NO: 12, and an anti-Her2 light chain sequence having an amino acid sequence of SEQ ID NO: 14, wherein the composition is formulated with a pharmaceutically acceptable carrier, and/or and regulatory sequences operably linked to the heavy chain and light chain sequences.
Dependent claim 21 of the ‘182 Patent is directed to an embodiment wherein the heterologous leader is an IL-2 leader.
Independent claim 2 is directed to a nucleic acid composition comprising an AAV vector genome, wherein the AAV vector encodes, at least, (i) an anti-Her2 heavy chain variable sequence having an amino acid sequence of SEQ ID NO: 18, and heavy chain constant sequence; (ii) a linker; and (iii) an anti-Her2 light chain variable sequence having an amino acid sequence of SEQ ID NO: 20, and a light chain constant sequence; wherein each of the anti-Her2 chain sequences are operably linked to an IL-2 leader sequence, and regulatory sequences operably linked to the heavy chain and light chain sequences.
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Instantly claimed SEQ ID NO: 18 is 100% identical to SEQ ID NO: 12 of Patent ‘182:
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Instantly SEQ ID NO: 20 is 100% identical to nucleotides 1-102 of SEQ ID NO: 14 of Patent ‘182:
Thus, it would have been obvious to amend the claims of the ‘187 patent to arrive at the pending claims.
Instant claims 3-18 are similar in scope and/or obvious variants of patented claims 2-9, 11-19 and 21-28.
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.
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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.
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KAA
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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