DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 2/2/2026 has been entered.
Applicant has amended claims 21-22, 27, 29, 31-38 and 40, and canceled claim 39. Claims 21-38 and 40 are currently pending for examination. All the amendments and arguments have been thoroughly reviewed but are found insufficient to place the instantly examined claims in condition for allowance. In view of applicant’s amendment to claim 21, the rejection under 35 USC 102 has been withdrawn. However, new ground of rejection under 35 USC 112 is presented as set forth below.
Claim Rejections - 35 USC § 112
2. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
3. Claims 21-38 and 40 are rejected 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. 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. This is a new matter rejection.
In the amendment filed on 2/2/2026, applicant has amended claim 21 to recite two additional steps (i.e., the steps of “capturing” and “extending”), involving the use of “poly-T capture oligonucleotides comprising transcript barcodes and the cell barcodes” to capture mRNA of the cell. However, no support for the use of “poly-T capture oligonucleotides comprising transcript barcodes and the cell barcodes” to capture mRNA of a cell could be found in the disclosure as filed. Since claims 22-38 and 40 depend from claim 21, these claims also require the same newly added feature(s) that lacks support in the disclosure as filed.
Applicant submits that “[s]upport for the amendments may be found throughout the as-filed application including, for example, at least at [0015] on page 4; [0019] on page 5; [0029] on page 8; [0214] on page 36; [0305] on page 57; [0312]-[0313] on page 57; [0314]-[0315] on page 58; and [0320] on page 60” (see page 6 of applicant’s submission filed on 2/2/2026).
The as-filed application, in particular “[0015] on page 4; [0019] on page 5; [0029] on page 8; [0214] on page 36; [0305] on page 57; [0312]-[0313] on page 57; [0314]-[0315] on page 58; and [0320] on page 60”, has been thoroughly reviewed, but no support for the use of “poly-T capture oligonucleotides comprising transcript barcodes and the cell barcodes” to capture mRNA of the cell, as used in the method of instant claim 21, could be found.
Paragraph [0015] on page 4 of the as-filed application merely describes “a method of making a barcode library including obtaining a plurality of nucleic acid constructs in which each construct includes a unique N-mer and a functional N-mer.”
Paragraph [0019] on page 5 of the as-filed application mentions about “methods and materials for labeling a target material (e.g., protein or nucleic acid)”, stating that “[l]abeling can involve barcode-type labeling using nucleic acid constructs or a probe-type label (e.g., for digital PCR).”
Paragraph [0029] on page 8 of the as-filed application talks about “a barcode library”, and states that such a barcode library “can comprise a plurality of fluid compartments, each containing one or more copies of a unique construct, in which each construct includes a unique N-mer and a functional N-mer.”
Paragraph [0214] on page 36 of the as-filed application talks about “labels for target materials comprising a detectable barcode-type label”, indicating that “a barcode-type label is a nucleic acid construct such as a nucleic acid construct including a barcode-type sequence (e.g., a unique N-mer)” and “a barcode sequence generally refers to a nucleic acid construct that includes at least a unique N-mer portion and a functional N-mer portion.”
Paragraph [0305] on page 57 of the as-filed application merely mentions “methods for analyzing transcriptomes that include labeling transcriptomes with nucleic acid constructs comprising unique N-mers and functional N-mers.”
Paragraphs [0312]-[0313] on page 57 of the as-filed application are relating to biomarker counting using “a universal barcode droplet library (e.g., of a bind-and-ligate type)”, stating that “[a] barcode library can be used in combination with binding molecules that are also barcoded to provide target identification, linking information about the type and number of target molecules present in a sample with their co-incident presence in the same droplet.”
Paragraphs [0314]-[0315] on page 58 of the as-filed application describe how “barcoded binding reagents” are constructed and how such barcoded binders are used for determination of biomarker averages for a cell population, wherein the binding reagents as shown in FIGS. 27A-31D are “antibody binding reagents”.
Paragraph [0320] on page 60 of the as-filed application states the following: “FIG. 32A-C illustrates methods for linking and for releasing barcodes. FIG. 32, panel A, shows coupling barcodes by photoligation and releasing barcodes by photocleavage. FIG. 32, panel B, illustrates including restriction sites or binder-specific loops for cleavage enzymes for subsequent cleavage of barcodes (or for blocking of enzymes).”
Clearly, none of these paragraphs disclose the use of “poly-T capture oligonucleotides comprising transcript barcodes and the cell barcodes” to capture mRNA of a cell, let alone the use of “poly-T capture oligonucleotides comprising transcript barcodes and the cell barcodes” to capture mRNA of the cell in the context of the instantly claimed method.
Applicants are reminded that it is their burden to show where the specification supports any amendments to the disclosure. See MPEP 714.02, paragraph 5, last sentence and also MPEP 2163.06.I.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, inventor was in possession of the invention as now claimed…...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application.” MPEP 2163.06 further notes: When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicants should therefore specifically point out the support for any amendments made to the disclosure.
Response to Arguments
4. Applicant’s arguments filed 2/2/2026 have been considered but are moot because the arguments do not apply to the currently presented rejection.
Conclusion
5. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAIJIANG ZHANG whose telephone number is (571)272-5207. The examiner can normally be reached Monday - Friday, 8:30 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684
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