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 .
The claims dated 1/8/2026 are under consideration.
The amendments and arguments presented in the papers filed 1/8/2026 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 9/12/2025 listed below have been reconsidered as indicated.
a) Any rejections of claims 13-15 and 47 are rendered moot by the cancellation of the claims.
b) The rejections of: claim(s) 1, 2, 8, 10, 12, 17, 18, 19, 20, 21, 52 and 53 under 35 U.S.C. 103 as being unpatentable over Cai (US 2021/0017587 A1); and claim(s) 3, 4, 5 and 45 under 35 U.S.C. 103 as being unpatentable over Cai (US 2021/0017587 A1) as applied to claim 1 above and in further view of Desai (US 2020/0224243 A1), are withdrawn in view of the amendments to the claims.
The Examiner’s responses to the Remarks regarding issues not listed above are detailed below in this Office action.
New and modified grounds of rejection necessitated by amendment are detailed below and this action is made FINAL.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on a submitted IDS, they have not been considered.
Drawings
High resolution copies of the drawings may be accessed via PAIR/Patent Center Retrieval using the Supplemental Content tab.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 8, 10, 12, 17-21, 45, 52-53 and 61-63 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luo (US 2020/0399689 A1).
Claim 1 has been narrowed to an embodiment of claim 15 in which both signals associated with the first and second spot-calling regions are detected. The following are new rejections necessitated by the amendments to claim 1.
It is noted the “barcode region” has no signal that is directly associated with it. Thus, any signal derived from an “intermediated probe” hybridized with the “barcode region” is “associated” with the “barcode region”.
Regarding claims 1 and 17, Luo teaches contacting a biological sample with a “plurality of primary probes” in the form of probes comprising: L1a and T1a; L2a and T2a; L3a and T3a; L4a and T4a; L1b and T1b; L2b and T2b; L3b and T3b; and L4b and T4b. See Fig. 7C; para. 112 and 372; and Fig. 1.
The probes include a region that binds the “analyte” in the form of target binding regions “T” and a “barcode region” in the form of label probe binding region “L”. See Fig. 7C; and paras. 112 and 372.
Luo further teaches contacting the biological sample with a “library of intermediate probes” comprising LP1a, LP2a, LP1b and LP2b, where each probe has a “hybridization region” that hybridizes with the label probe binding region “L” and a “spot-calling region” in the form of “SGP” elements. As depicted in Fig. 7C, the “spot-calling regions” are different and are divided into sub-libraries for analytes within Target A or within Target B. See also, para. 112 and 372.
Luo teaches detecting the signals from the different “SGPs” (Fig. 1; and Fig. 7C), which are associated with the different “L” regions (Fig. 7C).
Regarding claim 2, Luo teaches the region “L” directly hybridizes with the “hybridization region” of a “LP” (Fig. 7C).
Regarding claims 8 and 10, Luo teaches the “SGP” element may be a single-stranded polynucleotide that hybridizes to a nucleic acid that is in turn hybridized to the target nucleic acid (para. 188).
Regarding claim 12, Luo teaches detecting a signal associated with a “decoding region” of the “intermediate probes”, such as the segment between the “L” and “T” regions (Fig. 7C).
It is noted the “decoding regions” have no signals that is directly associated with them nor is the location of the “decoding region” defined. Thus, any signal derived from an “intermediated probe” hybridized with the “barcode region” is “associated” with any region that is reasonably a “decoding region”.
Regarding claims 18 and 19, Luo teaches the sub-libraries include “intermediate probes” for multiple different “analytes” within Target A or within Target B (Fig. 7C).
Regarding claim 20, Luo teaches an alternative embodiment in which a “decoding probe” is in the form of a “PreAMP” (para. 613; and Fig. 11D).
Regarding claim 21, Luo teaches using detectable probes that hybridize with the decoding regions in the form of an “AMP” (para. 614; and Fig. 11D).
Regarding claims 3-5 and 45, Luo teaches contacting a biological sample with a “plurality of primary probes” that includes a “barcode” and a region that indirectly binds with an analyte in the form of regions that hybridize with L1 or L2. See Fig. 9; and para. 114 and 379.
Luo teaches using RCA to amplify the primary probe (Fig. 9).
Luo further teaches contacting the biological sample with a “library of intermediate probes” comprising labeling probes that bind to the RCA product and to a label as “spot-calling region” (para. 379; Fig. 9).
Luo further teaches within multiplex assays, distinct capture probes, rolling circles, and label probes will be designed and used (para. 379)
Luo teaches detecting the signals from the different “SGPs” (Fig. 1; and Fig. 7C), which are associated with the different “L” regions (Fig. 7C).
Regarding claims 52 and 53, Luo teaches aligning and “registering” signals from different analytes of targets (para. 618; and Fig. 13).
Regarding claims 61, 62 and 63, Luo teaches aligning and “registering” signals from different analytes of targets (para. 618; and Fig. 13).
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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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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/JOSEPH G. DAUNER/Primary Examiner, Art Unit 1682
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