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 .
Response to Amendment
The response filed 03/16/2026 is acknowledged. Regarding the Office action mailed 12/16/2025, the rejection under 35 USC 102(a)(1) over Stoeckius is withdrawn in view of the amendment to incorporate the limitations from claim 30. The rejection under 35 USC 103 over Stoeckius in view of Van Eijk is withdrawn for the same reason.
New grounds of rejection are set forth below.
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 22-29, 32, 33 and 36-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,661,631 in view of Salathia (US 10,975,371, newly cited IDS reference).
The ‘631 claims disclose compositions and methods using such compositions, which compositions comprise a plurality (thus at least a first and a second) of cellular component-binding reagents each associated with a cellular component-binding reagent specific oligonucleotide comprising a unique identifier sequence for the cellular component-binding reagent, wherein the cellular component-binding reagent is capable of specifically binding to at least one of a plurality of cellular component targets, and wherein the cellular component-binding reagent specific oligonucleotide comprises an alignment sequence adjacent to a poly(dA) region, wherein the alignment sequence comprises a poly(dT) sequence, a poly(dG) sequence, a poly(dC) sequence, a poly(dU) sequence, or a combination thereof. The ‘631 claims disclose the cellular component-binding reagent specific oligonucleotide comprises one or more of: (a) a first molecular label sequence; (b) a linker, wherein the cellular component-binding reagent specific oligonucleotide is associated with the cellular component-binding reagent through the linker; and (c) the sequence of a first universal primer, a complementary sequence thereof, a partial sequence thereof, or a combination thereof. The ‘631 claims disclose the features of the compositions of the instant claims, except for the presence of a sample indexing sequence.
However, it was known in the art to incorporate sample indexing sequences for the purpose of determining the sample of origin of sequencing data. Salathia discloses the incorporation of sample barcodes; column 8, lines 52-62. Salathia discloses the use of sample barcodes allows sample multiplexing for sequencing analysis; column 7, lines 53-55.
It would have been obvious to modify the claims of the ‘631 patent to incorporate sample indexing sequences to allow sequencing libraries from different samples to be multiplexed, thus allowing for higher throughput and more efficient use of sequencing equipment.
Claims 34 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,661,631 in view of Salathia (US 10,975,371, newly cited IDS reference) and Regev (US 2021/0171938).
The disclosures of the ‘631 claims and Salathia have been discussed. The ‘631 claims did not disclose targeting any of the recited targets in claims 34 and 35.
Regev disclosed methods of multiplexing single cell sequencing. In particular, Regev disclosed targets including those recited in claims 34 and 35; paragraph [0077].
It would have been obvious to modify the compositions and methods of the ‘631 claims to incorporate sample barcodes as disclosed by Salathia for the reasons discussed above, and to further target the markers recited in claims 34 and 35 since Regev disclosed these as targets of interest in single cell sequencing methods.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 27-29 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 22 was amended to incorporate the limitations of previous claim 30. As such, claims 27-29 are no longer further limiting because the alignment sequence of claim 22 is necessarily two or more nucleotides in length, and necessarily comprises guanine, cytosine, thymine, uracil or a combination thereof (since if it only comprised adenine, it would not be distinguished from the adjacent polyA sequence). In addition, regarding claim 27, the alignment sequence cannot be only ONE nucleotide in length. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection under 35 USC 112(d) presented in this Office action.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 03/16/2026 prompted the new ground(s) of double-patenting rejection presented in this Office action.
Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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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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/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681
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