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 .
Election/Restrictions
Applicant’s election of the particular species that are: (I) a nucleic acid label that comprises a PCR handle (claim 4); and (II) a capture sequence that is a poly T nucleotide sequence (claim 18, in part) in the reply filed on 05/11/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 3 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (i.e.: requiring a nucleic acid label that comprises a unique molecular identifier (UMI)), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/11/2026.
Claim Objections
Claim 1 is objected to because of the following informalities: the claims recites, in lines 5 and 16, the term “tragetspecifc” where the term “target-specific” is likely intended. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 2, 4-11 and 18-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peterson et al (2017).
Relevant to claim 1, Peterson et al teaches (e.g.: Online Methods - REAP-seq assay; Supplementary Figure 1; Supp Discussion - REAP-seq method overview) a method of analyzing protein and mRNA in cells using REAP-seq, including incubating target specific, nucleic-acid-labeled, antibodies with cells to bind the antibodies to target proteins expressed by the cells; washing the antibody-bound cells to remove unbound antibodies, and combining the washed cells with template particles which comprise capture probes with a universal primer sequence, a barcode, and a capture sequence that binds to mRNA present in the cells. Peterson et al further teaches addition of a second fluid and encapsulation of a single particle and a single cells inside droplets using the 10x Genomics Chromium Controller instrument (i.e.: shear forces generated droplets), and amplifying and sequencing nucleic acid labels to identify cellular proteins.
Relevant to claim 2, Peterson et al teaches quantification of proteins (e.g.: p. 936 – Abstract).
Relevant to claim 4, Peterson et al teaches a nucleic-acid-labeled antibodies where the label includes a PCR handle (e.g.: Supp Fig 1).
Relevant to claims 5, 8 and 9, Peterson et al teaches lysing cells to release mRNA and reverse transcribe the mRNA in the droplet, and quantifying the mRNA to create an mRNA profile of each cell (e.g.: Supp Fig 1).
Relevant to claim 6 and 7, Peterson et al teaches a nucleic-acid-labeled antibodies where the label includes a poly A sequence (e.g.: Supp Fig 1).
Relevant to claim 10 and 11, Peterson et al teaches a first fluid that is PBS (i.e.: an aqueous fluid) and a second fluid that is an oil (e.g.: Online Methods - REAP-seq PBMC preparation; Supp Fig 1).
Relevant to claims 18 and 19, Peterson et al teaches a poly T nucleotide sequence that is a capture sequence (e.g.: Supp Fig 1) that hybridizes to a poly A sequence on the nucleic acid label (e.g.: Supp Fig 2).
Relevant to claims 20 and 21, Peterson et al teaches reverse transcription of capture mRNA using the capture oligo thus adding a barcode sequence to the cDNA, and amplification of the resulting cDNA (e.g.: Online Methods - REAP-seq assay; Supplementary Figure 1; Supp Discussion - REAP-seq method overview).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al (2017) in view of Schutze et al (2011).
As detailed earlier in this Office Action Peterson teaches a method of analyzing protein and mRNA in cells using REAP-seq, which provides all of the limitations of claims 1 and 11, from which instantly rejected claim 12 depends.
Peterson et al does not teach shearing fluids using a vortexer. But the creation of emulsions of droplets for amplification of one or a few templates per drop by vortexing was known in the prior art and is taught but Schutze et al (e.g.: Fig 1).
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have used the vertexing methods of Schutze et al to make droplet for analysis using the methods of Peterson et al. The use of the droplet forming methods of Schutze et al would have been the simple substitution of one know element for another with predictable results.
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.
Claims 1, 2, 4-12, and 18-21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,866,782. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to the analysis of proteins and nucleic acids is cells comprising the use nucleic-acid-labeled antibodies, and template particles with capture probes where the conflicting claims (e.g.: claim 16) include elements of the capture probe comprising a universal primer sequence; at least one barcode; and a capture sequence that hybridizes to one or more of the plurality of distinct mRNA, and the claim include that capture portion of the nucleic-acid-labeled antibodies may be poly A (claim 9) and that the capture sequence may be poly T (claim 17).
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US PG Pub 2018/0208975 A1 (Jul 26, 2018) teaches methods of analyzing protein and mRNA in cells using nucleic acid labeled antibodies and capture probes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN THOMAS KAPUSHOC whose telephone number is (571)272-3312. The examiner can normally be reached M-F, 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
Prosecution Insights