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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 7/23/2026 has been entered.
Double Patenting
2. 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.
3. Claims 21 and 24-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-40 of copending Application No. 19/644,591 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 21-40 of copending Application No. 19/644,591 teach or render obvious all the steps and elements as recited in instant claims 21 and 24-30. Specifically, claims 21 and 29-30 of copending Application No. 19/644,591 teach all the steps and elements as required by instant claim 21. In addition, the features as recited in dependent claims 24-30 are also taught or rendered obvious by claims 21-40 of copending Application No. 19/644,591.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
4. The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
5. Claims 21 and 24-30 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Larsson et al. (Nat. Methods 2010, 7(5):395-397, published online 11 April 2010, with 2 pages of “Online Methods” and 18 pages of “Supplementary Information”; cited in the IDS filed 7/23/2026).
Regarding claim 21
Larsson et al. teach, throughout the whole document, a method for analyte detection, the method comprising the steps of: exposing a plurality of binding agents (e.g., padlock probes) to a plurality of target molecules of a sample, wherein binding agents of the plurality of binding agents comprise an oligonucleotide that includes at least one target-binding portion and a target barcode, thereby binding one or more of the plurality of binding agents to target molecules of the plurality of target molecules and forming at least a first complex comprising a first target molecule bound to a first binding agent that comprises at least a first target-binding portion and a first target barcode (e.g., target-specific tag sequence included in the non-target-complementary segment of the padlock probe that is designed for detection through hybridization of fluorescently-labeled detection probe after rolling circle amplification (RCA)) (see Figure 1a for schematic representation, see page 396, column 1, paragraph 3 – page 397, column 1, paragraph 1 for specific examples, and also see Supplementary Table 1 for sequences used in each of the specific examples); conducting a rolling circle amplification (RCA) with at least the first binding agent to generate a first RCA product (e.g., rolling circle product (RCP)) comprising a plurality of copies of the first target barcode (see Figure 1a); hybridizing one or more fluorescently labeled detection probes to one or more of the copies of the first target barcode in the first RCA product (see Figure 1a); and identifying the first target molecule in the sample by detecting the one or more fluorescently labeled detection probes hybridized to the one or more of the copies of the first target barcode in the first RCA product (see Figure 1, as well as the various examples described throughout the whole document).
Regarding claim 24
The method according to Larsson et al., wherein the sample is a tissue sample (see Abstract; Figure 1; page 396, column 1, paragraph 4 – page 397, column 1, paragraph 2).
Regarding claim 25
The method according to Larsson et al., wherein the tissue sample comprises cells from a tissue biopsy (see page 396, column 1, paragraph 4 – page 397, column 1, paragraph 2).
Regarding claim 26
The method according to Larsson et al., wherein the tissue sample comprises a plurality of different target molecules (see Abstract; Figure 1; page 396, column 1, paragraph 4 – page 397, column 1, paragraph 2).
Regarding claim 27
The method according to Larsson et al., wherein target molecules of the plurality of target molecules are associated with a unique nucleic acid sequence of a binding agent (see Figure 1; page 396, column 1, paragraph 4 – page 397, column 1, paragraph 2; the section under “Oligonucleotide sequences” in the 2 pages of “Online Methods”; Supplementary Table 1).
Regarding claims 28-29
The method according to Larsson et al., wherein the binding agents comprise oligonucleotide probes, wherein the oligonucleotide probes comprise padlock probes (see Abstract; Figure 1a; page 395, column 2, last paragraph – page 396, column 2, paragraph 2; Supplementary Table 1).
Regarding claim 30
The method according to Larsson et al., wherein the padlock probes hybridize to their targets and ligase produces a circular DNA (see Figure 1a).
Conclusion
6. 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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/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684
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