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 .
RESPONSE TO APPLICANT’S AMENDMENT
1. Applicants amendment filed on 11/12/25 is acknowledged.
2. Claims 1-16, 20-23 are pending.
3. Claims 7,8,10-12,14-16, 20-23 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1-6, 9, 13 are drawn to a method for identifying neoantigen sequences under consideration in the instant application.
4. 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.
5. Claims 1-6,9,13 stand rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by US Patent Application 20220349010 for the same reasons set forth in the previous Office Action, mailed on 08/13/25.
Applicant’s arguments filed on 11/12/25 have been fully considered but have not been found convincing.
Applicant asserts that : (i) the structural rearmament recited in the instant claim 1 yield fundamentally different transcript products than the simple frameshift mutation taught by US Patent’010. (ii) US Patent’010 does not teach or suggest long-read RNA sequence as recited in the instant claims.
As initial matter it is noted that performing a long read whole genome sequence was recited as an optional step in claim 1. Accordingly the term “optionally” is was interpreted as that in claim 1 said step was not performed.
With regards to Applicant’s statement that “the structural rearmament recited in the instant claim 1 yield fundamentally different transcript products than the simple frameshift mutation taught by US Patent’010”
The arguments of counsel cannot take the place of evidence in the record. In re Schulze , 145 USPQ 716, 718 (CCPA 1965). See MPEP 716.01© Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long - felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant.
As has been stated previously, US Patent ‘010 teaches a method of identifying neoantigen encoded by tumor-specific frameshift mutation in a genes of a subject comprising identifying somatic DNA rearrangement in a tumor sample, determining the sequence of the full-length RNA transcripts encoding by nucleic acid sequences and selecting neoantigen sequences comprising 8-10 contiguous amino acids. US Patent ‘010 teaches performing sequencing of mRNA ( see entire document, paragraphs 0008, 0045, 0047, 0059,0072, 0091 in particular).
The reference teaching anticipates the claimed invention.
6. 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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.131(c). 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. 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 filing date of the application will determine what form 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 https://www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer
7. The claims 1-6,9,13 stand provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application No. 18/703444 and US Patent Application 17/261,997. Although the conflicting claims are not identical, they are not patentably distinct from each other because claims of copending Application No. 18/703444 and US Patent Application 17/261,997 each recited a method for identifying neoantigen sequences comprising similar method steps as instantly claimed.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
It is noted that Applicant requested that said rejection be held in abeyance until allowable subject matter is identified.
8. No claim is allowed.
9. THIS ACTION IS MADE FINAL. See MPEP § 609(B)(2)(i). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel Kolker can be reached on 571/ 272-3181
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644