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 5/8/2026 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 21-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21 and 24-30 of copending Application No. 19/361,770 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 21 and 24-30 of copending Application No. 19/361,770 teach or render obvious all the steps and elements as recited in instant claims 21-34. Specifically, claim 21 of copending Application No. 19/361,770 teaches all the steps and elements as required by instant claim 21. In addition, the features as recited in dependent claims 22-34 are also taught or rendered obvious by claims 21 and 24-30 of copending Application No. 19/361,770.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
4. Claims 21-34 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 21-34. Specifically, claims 21 and 29 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 22-34 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
5. 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.
6. Claims 21-34 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”).
Regarding claim 21
Larsson et al. teach, throughout the whole document, a method comprising: incubating a plurality of target analytes with a plurality of binding agents (e.g., padlock probes), thereby forming one or more complexes comprising a binding agent bound to a target analyte, wherein the one or more complexes include at least a first complex comprising a first binding agent of the plurality of binding agents bound to a first target analyte of the plurality of target analytes (see Figure 1a for schematic representation, and see page 396, column 1, paragraph 3 – page 397, column 1, paragraph 1 for specific examples); amplifying the first binding agent by rolling circle amplification (RCA) to produce a first concatamer (e.g., rolling circle product (RCP)) comprising multiple copies of a first target identifying sequence (e.g., multiple copies of a target-specific tag sequence for detection through hybridization of fluorescently-labeled detection probe) (see Figure 1a, and also see Supplementary Table 1 for sequences used in each of the specific examples); and detecting the first concatamer comprising the multiple copies of the first target identifying sequence, thereby detecting the first target analyte of the plurality of target analytes (see Figure 1).
Regarding claim 22
The method according to Larsson et al., further comprising separating unbound binding agents from the one or more complexes (see Figure 1a; the section under “In situ cDNA detection procedure” in the 2 pages of “Online Methods”).
Regarding claims 23-24
The method according to Larsson et al., wherein a plurality of target identifying sequences are amplified, wherein the plurality of target identifying sequences are amplified by rolling circle amplification (RCA) (see Figure 1a).
Regarding claim 25
The method according to Larsson et al., wherein the plurality of binding agents (e.g., padlock probes) are oligonucleotides (see Figure 1a; Supplementary Table 1).
Regarding claim 26
The method according to Larsson et al., wherein detecting the first concatamer comprises hybridization from a library of probes (see Figure 1a; Supplementary Table 1).
Regarding claims 27-28
The method according to Larsson et al., wherein one or more target analytes are labeled with an optically detectable label, wherein the optically detectable label comprises a fluorescent label (see Figures 1-2).
Regarding claim 29
The method according to Larsson et al., wherein detecting the first concatamer comprises obtaining sequence information of at least a portion of the first target identifying sequence (see Figure 1a).
Regarding claims 30-32
The method according to Larsson et al., wherein the target analytes of the plurality of target analytes comprise nucleic acids, wherein the nucleic acids comprise RNA (e.g., mRNA), and wherein the method further comprises converting the RNA to cDNA (see Figure 1a).
Regarding claims 33-34
The method according to Larsson et al., wherein the plurality of target analytes are target analytes of a sample, wherein the sample is a tissue sample (see Abstract; Figure 1; page 396, column 1, paragraph 4 – page 397, column 1, paragraph 2).
Conclusion
7. 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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