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 1-10 are pending and will be examined on the merits.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102(a)(1) 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.
Claim(s) 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hochrein (Hochrein, et al., WO 2019/038388A1; Published 2/28/2019; Priority to 8/24/2017 via EP 17187824.2) as evidenced by UnitProt (UniProt; ERBB2_Human-P04626 Sequence entry; File available: https://rest.uniprot.org/uniprotkb/P04626.fasta; Last Update: 08/13/1987; v1).
Hochrein discloses a synthetic HER2 polypeptide comprising Hochrein’s SEQ ID NO: 1 (Hochrein, claim 44). UnitProt entry P04626 provides the wild type sequence for ERBB2 (same as HER2) (UniProt, 1987). The following image displays a sequence-to-sequence comparison comparing the amino acid sequence of wild type HER2 (UniProt, p 1; Top sequence) with Hochrein’s SEQ ID NO: 1 (Bottom sequence) with claimed mutation loci identified by arrows and text:
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Regarding claim 2, Hochrein’s SEQ ID NO: 1 comprises an E580 (loop1) mutation, a F595 (loop 2) mutation and a K615 (loop 3) mutation. Regarding claims 2 and 7, Hochrein’s SEQ ID NO: 1 comprises the following mutations: E580, F595 and K615. Regarding claims 2 and 7, Hochrein’s SEQ ID NO: 1 comprises the following mutations: E580, F595 and K615. Regarding claims 4, 5 and 8, Hochrein’s SEQ ID NO: 1 comprises the following mutations: L317 and H318. Regarding claim 6, Hochrein s SEQ ID NO 1: comprises the following group (a), (b), and (c) mutations: (a)- D277, E280, L317 and H318, (b) K753, and (c) Y1023A. Regarding claims 9 and 10, Hochrein’s SEQ ID NO: 1 is a 100% match for instant SEQ ID NO: 1 (see DAV).
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.
Claim 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,723,964 B2 as evidenced by UnitProt (UniProt; ERBB2_Human-P04626 Sequence entry; File available: https://rest.uniprot.org/uniprotkb/P04626.fasta; Last Update: 08/13/1987; v1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to a method requiring a vaccina virus comprising a nucleic acid encoding a tumor associated antigen (Claim 1), that a nucleic acid encoding HER2 (Claim 2) and with the resulting polypeptide having a sequence of SEQ ID NO: 1 of the reference patent (Claim 6). The nucleic acid encoding SEQ ID NO: 1 of the ‘964 patent and the synthetic HER2 polypeptide of instant SEQ ID NO: 1 are not patentably distinct because the nucleic acid is present within a viral vector and will invariably produce a polypeptide having instant SEQ ID NO: 1. UnitProt entry P04626 provides the wild type sequence for ERBB2 (same as HER2) (UniProt, 1987).
The following image displays a sequence-to-sequence comparison comparing the amino acid sequence of wild type HER2 (UniProt, p 1; Top sequence) with the ‘964 patent’s SEQ ID NO: 1 (Bottom sequence) with claimed mutation loci identified by arrows and text:
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Regarding claim 2, the reference patent’s SEQ ID NO: 1 comprises an E580 (loop1) mutation, a F595 (loop 2) mutation and a K615 (loop 3) mutation. Regarding claims 2 and 7, the reference patent’s SEQ ID NO: 1 comprises the following mutations: E580, F595 and K615. Regarding claims 2 and 7, the reference patent’s SEQ ID NO: 1 comprises the following mutations: E580, F595 and K615. Regarding claims 4, 5 and 8, the reference patent’s SEQ ID NO: 1 comprises the following mutations: L317 and H318. Regarding claim 6, reference patent’s SEQ ID NO 1: comprises the following group (a), (b), and (c) mutations: (a)- D277, E280, L317 and H318, (b) K753, and (c) Y1023A. Regarding claims 9 and 10, reference patent’s SEQ ID NO: 1 is a 100% match for instant SEQ ID NO: 1 (see DAV).
Claim 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,273,211 B2 as evidenced by UnitProt (UniProt; ERBB2_Human-P04626 Sequence entry; File available: https://rest.uniprot.org/uniprotkb/P04626.fasta; Last Update: 08/13/1987; v1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to a pharmaceutical composition comprising a vaccina virus comprising a nucleic acid encoding a tumor associated antigen (Claim 1), that a nucleic acid encoding HER2 (Claim 2) and with the resulting polypeptide having a sequence of SEQ ID NO: 1 of the reference patent (Claim 6). The nucleic acid encoding SEQ ID NO: 1 of the ‘211 patent and the synthetic HER2 polypeptide of instant SEQ ID NO: 1 are not patentably distinct because the nucleic acid is present within a viral vector and will invariably produce a polypeptide having instant SEQ ID NO: 1. UnitProt entry P04626 provides the wild type sequence for ERBB2 (same as HER2) (UniProt, 1987).
The following image displays a sequence-to-sequence comparison comparing the amino acid sequence of wild type HER2 (UniProt, p 1; Top sequence) with the ‘211 patent’s SEQ ID NO: 1 (Bottom sequence) with claimed mutation loci identified by arrows and text:
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Regarding claim 2, the reference patent’s SEQ ID NO: 1 comprises an E580 (loop1) mutation, a F595 (loop 2) mutation and a K615 (loop 3) mutation. Regarding claims 2 and 7, the reference patent’s SEQ ID NO: 1 comprises the following mutations: E580, F595 and K615. Regarding claims 2 and 7, the reference patent’s SEQ ID NO: 1 comprises the following mutations: E580, F595 and K615. Regarding claims 4, 5 and 8, the reference patent’s SEQ ID NO: 1 comprises the following mutations: L317 and H318. Regarding claim 6, reference patent’s SEQ ID NO 1: comprises the following group (a), (b), and (c) mutations: (a)- D277, E280, L317 and H318, (b) K753, and (c) Y1023A. Regarding claims 9 and 10, reference patent’s SEQ ID NO: 1 is a 100% match for instant SEQ ID NO: 1 (see DAV).
Conclusion
Claims 1-10 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sydney Van Druff whose telephone number is (571)272-2085. The examiner can normally be reached 10 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SYDNEY VAN DRUFF/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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