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 .
Election/Restrictions
Applicant’s election without traverse of Group I and SNV in the reply filed on 5/05/2026 is acknowledged.
Claims 1-4,19,47,57,60,73-75,81,84-85,91,94-95,97,99 are pending. Claims 5-18,20-46,48-56,58-59,61-72,76-80,82-83,86-90,92-93,96,98,100-106 have been cancelled.
An action on the merits is set forth below.
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.
Claims 1-4,19,47,57,60,73-75,81,84-85,91,94-95,97,99 are 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.
Claims 1-4,19, 47,57,60,73-75,81,84-85,91,94-95,97, 99 are indefinite over “or a complement” as the conjugate does not have a complement, but rather requires an antibody-oligonucleotide in claims 1, 19 and 99. Further the claims are unclear as the claims encompass “optionally” however, it is not clear which steps after the term is optional in claims 1, 19 and 99.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-4,19,73,74,75,81,84,94,95,97 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stoeckius et al. (Nature Methods September 2017 Vol 14 p. 865).
With regard to claim 1, Stoeckius et al. teaches providing an antibody-oligonucleotide conjugate to a permeabilized cell such that the analyte is internal in the cell (p. 867, figure 1). Stoeckius et al. teaches a method of performing a single cell analysis using droplet assay techniques for sequencing (p 867).
With regard to claim 2, Stoeckius et al. teaches a method of obtaining a permeabilized cell that comprises fixing, quenching and permeabilization of the cell (p. 867).
With regard to claims 3-4, Stoeckius et al. teaches incubating the permeabilized ell with the conjugate and washing and as Stoeckius et al. teaches washing, Stoeckius et al. teaches washing one time (p. 865 2nd column).
With regard to claim 19, Stoeckius et al. teaches providing an antibody-oligonucleotide conjugate to a permeabilized cell such that the analyte is internal in the cell (p. 867, figure 1). Stoeckius et al. teaches a method of performing a single cell analysis using droplet assay techniques for sequencing (p 867). Stoeckius et al. teaches multiple antibody-oligonucleotide conjugates and sequencing (figure 2).
With regard to claim 73, Stoeckius et al. teaches a single cell analysis that is capable of performing the workflow of million of cells (Online methods antibody oligo sequences).
With regard to claims 74-75, Stoeckius et al. teaches a method of antibody tag primers of at least 10 (online methods CITE seq and antibody oligo sequences).
With regard to claim 81, Stoeckius et al. teaches a method of PCR (online methods Antibody oligo sequences).
With regard to claim 84, Stoeckius et al. teaches genomic DNA or RNA (figure 1, p 866).
With regard to claim 94, Stoeckius et al. teaches application to cell lines (figure 3).
With regard to claim 95, Stoeckius et al. teaches a method wherein the analyte is a surface protein (p. 866 last paragraph).
With regard to claim 97, Stoeckius et al. teaches generating cDNA (p. 866).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 47,57,60,91,99 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stoeckius et al. (Nature Methods September 2017 Vol 14 p. 865) in view of Schwartz et al. (US Patent Application 2013/0344508 December 26, 2013).
Stoeckius et al. teaches providing an antibody-oligonucleotide conjugate to a permeabilized cell such that the analyte is internal in the cell (p. 867, figure 1). Stoeckius et al. teaches a method of performing a single cell analysis using droplet assay techniques for sequencing (p 867).
However, Stoeckius et al. does not teach the fixing requirements.
With regard to claim 47, Schwartz et al. teaches use of antibody oligonucleotide conjugates (para 506). Schwartz et al teaches fixative with DPBS for two hours (para 577).
With regard to claims 57 and 60, Schwartz et al. teaches .5 ml of DPBS (para 580).
With regard to claim 91, Schwartz et al teaches lysing the permeabilized with reagents (para 580). It is noted that the claims do not limit the claims to DTT, but rather extra reagent.
With regard to claim 99, Stoeckius et al. teaches providing an antibody-oligonucleotide conjugate to a permeabilized cell such that the analyte is internal in the cell (p. 867, figure 1). Stoeckius et al. teaches a method of performing a single cell analysis using droplet assay techniques for sequencing (p 867). Schwartz et al. teaches that nuclei can be isolated from the cell (para 588-589).
Therefore it would be prima facie obvious at the time of the effective filing date to modify the method of Stoeckius et al. to use the known samples and reagents of Schwartz et al. who further teaches methods of use of antibody oligonucleotide conjugates. The ordinary artisan would be motivated to use known finite types of samples and reagents in order to detect in the nuclei using an antibody oligonucleotide conjugate.
Claim(s) 85 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stoeckius et al. (Nature Methods September 2017 Vol 14 p. 865) in view of West et al (US Patent Application Publication 20180051338 Feb 22, 2018).
Stoeckius et al. teaches providing an antibody-oligonucleotide conjugate to a permeabilized cell such that the analyte is internal in the cell (p. 867, figure 1). Stoeckius et al. teaches a method of performing a single cell analysis using droplet assay techniques for sequencing (p 867).
However, Stoeckius et al. does not teach measuring SNPs.
With regard to claim 85, West et al. teaches methods of using oligonucleotide antibody conjugates (para 74-75). West et al. teaches that the sequencing is used to detect SNPs, insertions, deletions or copy number variations (para 96-118).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Stoeckius et al to use the method step of sequencing to detect SNPs, insertions, deletions or copy number variations as taught by West et al. The ordinary artisan would have a reasonable expectation of success as West et al. teaches use of oligonucleotide antibody conjugates to detect differences in sequences.
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 1-3,19,,99 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21-40 of copending Application No. 19299158(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each binds to a protein-oligonucleotide tag to permeabilize cells and using to detect amplificant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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