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 .
Information Disclosure Statement
The IDS received on November 27, 2024 and May 15, 2026 are acceptable.
Drawings
The drawings received on May 2, 2024 are acceptable.
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 306-325 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.
Claim 306 is indefinite for the following reasons.
Claim 306 recites, inter alia, the limitation, “generating an amplification product associated with the probe or probe set, wherein the amplification product comprises a plurality of stabilizing sequences complementary to a sequence of each of the plurality of stabilization agents.” Claim 306, however, does not provide any context on how the amplification product comprises the stabilizing sequences that are complementary to a sequence of each of the plurality of stabilization agents of the substrate. As of current, the claim does not recite any antecedent basis in the structure of the target nucleic acids, capture agent, nor probe/probe set for the amplification product to comprise the stabilizing sequences.
Claim 313 recites the limitation, “the common nucleic acid sequence”. There is an insufficient antecedent basis for this limitation in the claim. For the purpose of prosecution, claim 313 has been construed to depend from claim 311.
Claim 315 is indefinite because it is unclear when the removal of the captured target nucleic acid (or its portion) from the substrate occurs.
Claim 316 recites the limitation, “a complement of the complement of the captured target nucleic acid”. There is an insufficient basis for the “complement of the captured target nucleic acid.” While the parent claim 306 provides the step of providing a condition for capture probes anneal to the target nucleic acid, and a subsequent step of amplification product generated from a “probe or probe set,” this step does not provide an antecedent basis that the complement of the captured target nucleic acid has been produced.
Claims 307-325 are indefinite by way of their dependency on claim 306.
Conclusion
No claims are allowed.
Claims are free of prior art.
The prior art fails to teach or motivate a method of performing the method as presently claimed with the feature wherein a substrate comprising a plurality of capture agents and a plurality of stabilization agents are provided, and wherein the amplification product produced that are associated with a probe or probe set comprise a plurality of sequences complementary to a sequence of each of the plurality of stabilization agents. While the independent claim does not explicitly recite that the stabilization agent is nucleic acid, the fact that the amplification product comprises a plurality of sequences that are complementary to a sequence of each of the plurality of stabilization agents necessarily imply that the stabilization agents are comprised of at least nucleic acid sequences.
West et al. (US 2019/0262831 A1, published August 29, 2019) teach a method of performing an amplification of target nucleic acids from a sample, wherein the sample is applied to a first substrate, the target nucleic acids released therefrom, annealed to a plurality of oligonucleotides on a second substrate (see Figure 6). The captured target nucleic acids are amplified by the capture oligonucleotides of the second substrate, however, the artisans do not teach further annealing of a probe/probe set, wherein the amplification produced is associated with the probe/probe set with the amplification product comprising a plurality of stabilizing sequences complementary to a sequence of each of the plurality of stabilization agents, let alone the plurality of stabilization agents comprised on the substrate along with the capture probes.
Bava et al. (US 2021/0262018 A1, published August 26, 2021) teach a method of performing RCA in situ, wherein a sample is provided on a substrate, and RCA is performed thereon, wherein the RCA results in the amplification product which is then captured on a second substrate (see Fig. 1, and Fig. 2A, for example).
However, the substrate on which the amplification is performed does not comprise a capture agent that is a nucleic acid (as the amplification occurs on sample in vitro), nor do the artisans teach the substrate comprising a plurality of stabilizing agent, as well as the amplification product comprising a plurality of stabilization sequences complementary to the sequence of each of the plurality of stabilizing agents.
Inquiries
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7:30 a.m. to 4:00 p.m (M-F). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782.
Papers related to this application may be submitted to Art Unit 1681 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
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/YOUNG J KIM/Primary Examiner
Art Unit 1637 June 8, 2026
/YJK/
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