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 .
Claim Status
Claims 1-30 are currently pending and under examination. Claims 1 and 16 are independent claims. Claims 2-15 are dependent upon claim 1, while claims 17-30 are dependent upon claim 16.
Response to Arguments
The rejection of claims 1-30 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is maintained.
Applicant's arguments filed 6/18/2026 have been fully considered but they are not persuasive. The applicant’s arguments in the remarks are conclusory and do not address the rejection, included again here for reference;
“The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
With respect to the limitation in claim 1 reciting “(ii) a labeling agent, wherein said labeling agent comprises an MHC-peptide complex comprising a peptide, an MHC molecule, and a reporter barcode molecule, wherein said reporter barcode molecule comprises a reporter barcode sequence that identifies said peptide,”, and claim 16 reciting “(ii) a labeling agent, wherein said labeling agent comprises a T-cell receptor molecule and a reporter barcode molecule, wherein said reporter barcode molecule comprises a reporter barcode sequence that identifies said T-cell receptor molecule,” the specification describes labeling agents that coupled to reporter oligonucleotide containing a nucleic-acid barcode. The barcode is copied/extended and read by sequencing via hybridization to an anchor oligonucleotide in the partition. The figures likewise depict nucleic-acid barcodes rather than protein/peptide barcodes.
Although the specification broadly states that “barcodes can include polynucleotide barcodes… and/or amino-acid sequences,” (see [0120]), the application does not provide any representative examples, constructs, or instructions for a reporter barcode molecule that is not a nucleic acid (e.g. peptide-based barcode) being coupled to an MHC-peptide complex nor a T-cell receptor and then detected according to the disclosed nucleic-acid sequencing workflow. The disclosure therefore does not reasonably convey possession of the full scope or “reporter barcode molecule” as claimed, nor does describe practicing non-nucleic-acid embodiments without undue experimentation.
Accordingly, to the extent the claim reads on non-nucleic-acid “reporter barcode molecules” (e.g. peptide barcodes), the specification fails to provide adequate written description and enablement for such embodiments. See MPEP §2163 and §2164
Suggested amendment to overcome: replace “reporter barcode molecule” with “reporter oligonucleotide comprising a nucleic-acid barcode sequence that identifies said peptide /T-cell receptor molecule),” aligning the claim with the disclosed and enabled embodiments.
Claims 2-15, and 17-30 are likewise rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on their dependence on claims 1 and 16 respectively.”
The inclusion of a line that says possible alternate components, does not convey to one of reasonable skill how to make or use the invention, and does not convey that the inventor were in possession of such invention. As stated previously, the specification fails to provide adequate written description and enablement for such embodiments and the rejection is maintained.
The rejection of Claims 1-30 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 is maintained.
Applicant's arguments filed 6/18/2026 have been fully considered but they are not persuasive. The applicant’s remarks are conclusory and do not address the rejection, included again here for reference;
“Claims 1 and 16 recite “an mRNA molecule comprising a sequence encoding for a B-cell receptor or a portion thereof”. The phrase “portion thereof” renders the scope of the claim as indefinite under 35 U.S.C. 112(b) because the specification fails to provide any objective standard for determining what constitutes a “portion” of the B-cell receptor that would fall within the claim’s coverage.
The specification generically refers to nucleic acids “encoding at least a portion of VDJ sequence of an immune cell receptor” but it does not define what size, region, or functional domain qualifies as such a portion (see [0040], [0048]). A B-Cell receptor contains multiple subunits (e.g. VH, VL, CH, CL regions, transmembrane domains, and signal peptides), any of which could be considered a portion. Because the term is purely relative and the disclosure provides no measurable parameters, such as length, sequence identity, or functional limitation, a person of ordinary skill in the art cannot determine, with reasonable certainty, the boundaries of the claimed subject matter.
Absent clear guidance, “portion thereof” could encompass anything from the start codon methionine of any protein, to a short CDR motif of only a few codons, to nearly the entire B-cell receptor transcript, leading to multiple plausible interpretations. As a result, the metes and bounds of the claim cannot be ascertained with reasonable certainty, contrary to MPEP 2173.02 and Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910, 110 USPQ2d 1688, 1693 (2014).
Claims 2-15, and 17-30 are likewise rejected as they are dependent upon claims 1 and 16, respectively, and do not rectify the deficiencies above. While claims 4 and 19 attempt to limit the “portion thereof” by stating that the sequence “comprises a CDR1 sequence, a CDR2 sequence, and a CDR3 sequence” this does little to provide clarity as the complementarity determining regions (CDRs) are short hypervariable loops within the variable domain of an antibody and do not have any conserved sequence to enable identification of these sequences as CDR1, CDR2, or CDR3. These domains are defined by their position relative to conserved framework regions flanking the CDRs. Antibody structure reviewed by Chiu et al. (Antibodies 2019 Dec. 3;8(4):55).”
The Applicant argues that “the skilled artisan would readily appreciate what “a portion of” entails with respect to B-cell receptor, a VDJ sequence of an immune cell receptor and or that such a sequence could comprise a CDR1 sequence, CDR2 sequence, or CDR3 sequence.” However, this argument does not explain how the claim language provides objective boundaries for determining what constitutes the claimed “portion.” The face that a claimed portion may comprise one of several examples does not resolve the ambiguity regarding the full scope of the term. Neither the claims nor the specification identify any minimum length, required region, or other objective criteria that distinguish claimed portions from unclaimed portions. Accordingly, the rejection under 35 USC 112(b) is maintained.
The rejection of claim(s) 1-30 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Abate et al. is maintained.
Applicant's arguments filed 6/18/2026 have been fully considered but they are not persuasive. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Applicant merely asserts that Abate does not disclose the limitations of claims 1 and 16 but does not identify any specific limitation allegedly absent from Abate, nor does Applicant address the Examiner’s findings set forth in the Office Action. Accordingly, Applicant has not identified reversible error in the rejection, and the rejection under 35 USC 102(a)(2) is maintained.
The rejection of claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over: Claims 1-31 of U.S. Patent No. 10,011,872, Claims 1-34 of U.S. Patent No. 10,480,029, Claims 1-34 of U.S. Patent No. 10,550,429, Claims 1-12 of U.S. Patent No. 10,954,562, Claims 1-36 of U.S. Patent No. 11,248,267, and Claims 1-23 of U.S. Patent No. 11,732,302, is maintained.
Applicant's arguments filed 6/18/2026 have been fully considered but they are not persuasive. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Applicant merely asserts that the present application is patentably distinct but does not disclose any reasoning and the nonstatutory double patenting rejection is maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 Matthew H Raymonda whose telephone number is (703)756-5807. The examiner can normally be reached Monday - Friday 10:00 am - 4:00 pm.
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/MATTHEW HAROLD RAYMONDA/Examiner, Art Unit 1684
/AARON A PRIEST/ Primary Examiner, Art Unit 1681
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