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 .
Status of the Application
The Reply filed January 12, 2026 is acknowledged.
Claims 1-19 and 21-27 were pending. Claims 1-5, 7-8, 10-19 and 21-27 are being examined on the merits. Previously withdrawn claim 6 is rejoined and is also being examined on the merits. Claim 9 is canceled.
Response to Arguments
Applicant’s arguments filed January 12, 2026 have been fully considered.
All of the previously made rejections are WITHDRAWN in view of Applicant’s arguments, and in view of the filing of a terminal disclaimer.
Election/Restrictions
Claims 1-5, 7-8, 10, 12-19 and 21-27 are allowable. The election of species requirement between the species of claims 5/7, and the species of claim 6, as set forth in the Office action mailed on January 29, 2025, has been reconsidered in view of the allowability of claims to the elected species pursuant to MPEP § 821.04(a). The election of species requirement is hereby withdrawn and claim 6 is rejoined.
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.
Claim 11 is 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.
Claim 11 depends from now-canceled claim 9. Thus, the meaning of claim 11 cannot be
ascertained. Since the ordinary artisan would not be able to determine the metes and bounds of the claim, it is indefinite.
Allowable Subject Matter
The following claims are allowed: 1-8, 10, 12-19 and 21-27.
The closest art is Vigneault1 (US Patent App. Pub. No. 2016/0032282), Agresti2 (US Patent App. Pub. No. 2016/0060621) and Brown3 (Profiling tissue-resident T cell repertoires by RNA sequencing, Genome Medicine, 7:125, 1-8, 2015), the teachings of each of which are discussed, at least, in the Non-Final Office Action mailed September 12, 2025. However, the references do not teach or suggest, at least, the instant claim 1 limitations requiring that the barcoded nucleic acid molecules created in steps (a) and (b) are amplified to create both the immune receptor-enriched sequencing library of step (c) and the whole-transcriptome sequencing library of step (d). Vigneault teaches various embodiments comprising amplification of the barcoded nucleic acid molecules (e.g., paras. 620-623) and teaches the use of a target-specific primer for amplification (paras. 245, 259, 266, 488-489, 500-501, 555, 586). Agresti additionally teaches various amplification and sequencing steps, while Brown teaches analyzing enriched and unenriched sequencing libraries. Thus, Vigneault combined with the secondary references teach or suggest barcoding and sequencing transcripts from a single cell, but do not teach or suggest using the barcoded nucleic acid molecules of steps (a) and (b) to generate immune receptor-enriched sequencing library of step (c) and the whole-transcriptome sequencing library of step (d). Further, there would not appear to be any reason to modify the Vigneault method in such a manner. For example, Brown teaches analyzing sequencing data from unenriched RNA sequencing libraries and from T cell specific libraries, but does not teach creating such libraries with barcode sequences such that the whole transcriptome data and the immune receptor-enriched data can be mapped back to the same individual cell source. Nor is it clear that there would be an expectation of success if the ordinary artisan made such a modification. Thus, independent claim 1 and its dependent claims are free of the art.
Conclusion
Claims 1-8, 10-19 and 21-27 are being examined. Claims 1-8, 10, 12-19 and 21-27 are allowed. Claim 11 is rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN GREENE whose telephone number is (571)272-3240. The examiner can normally be reached M-Th 7:30-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
1 Vigneault was cited in the Information Disclosure Statement submitted August 4, 2023.
2 Agresti was cited in the Information Disclosure Statement submitted August 4, 2023.
3 Brown was cited in the Information Disclosure Statement submitted March 12, 2024.
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