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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on April 9, 2026 is acknowledged.
Claim 58 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 9, 2026.
Applicants’ remark regarding the rejoinder of claim 58 based on its dependence on the elected group (i.e., method claims) is noted. However, a product can be used in a materially distinct process unrelated to a particular method of its use (of Group I), and therefore, are not entitled to a rejoinder. The right to rejoinder is only present when applicants elect a product, and all withdrawn process of using said product amended as provided under the In re Ochiai guidance.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS received on September 14, 2023; December 31, 2024; and November 4, 2025 are proper and are being considered by the Examiner.
Drawings
The drawings received on September 14, 2023 are acceptable.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 27, lines 35-36; page 28, line 1, for example). Applicant is required to delete all such embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 30-57 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 30 recites the phrase, “one or more anti-signal oligonucleotide” but the claim does not recite any mechanism or elements which would result in the generation of the anti-signal oligonucleotide(s) and therefore, lacks a proper antecedent basis.
Claim 30 is also indefinite because the claim is missing a conjunction between steps (b) and (c). For the purpose of prosecution, the conjunction, “and” is assumed.
Claim 35 is indefinite for reciting the phrase, “the activator oligonucleotide” and the phrase, “the repressor oligonucleotide” because it is unclear which of the “at least one” activator oligonucleotide (or repressor oligonucleotide) from claim 30, “the” subject-oligonucleotide is referring to. The Office suggest referring to these oligonucleotides with the word, “the at least one,” respectively.
Claim 36 is indefinite for reciting the term, “anti-signal oligonucleotide(s)”. The term, “oligonucleotide(s)” embodies both the single oligonucleotide and multiple oligonucleotides as an alternative. Because the parent claim (i.e., claim 30) does not provide an antecedent basis for a single anti-signal oligonucleotide embodiment, the subject term does not find a proper antecedent basis.
Claim 37 is indefinite for reciting the phrase, “the compartment” because it is unclear which of the plurality of compartments, the phrase is referring to. For the purpose of prosecution, the phrase has been construed to mean, “said each compartment”.
Claim 38 recite phrase, “the signal oligonucleotide”. The phrase is indefinite for the same reasons discussed above. The Office suggest amending the phrase to recite, “the one or more signal oligonucleotides”.
Claim 47 is indefinite the claim recites that the cellular or organelle nucleic acids and/or labeling nucleic acid comprise a compartment-specific barcode sequence further to extension of a cDNA on a barcoded primer, extension of a cDNA on a barcoded template switching oligonucleotide …”. Preliminarily, the phrase doesn’t make grammatical sense. Additionally, the claim appears to be lacking a nexus between the steps of the parent claim and the subject claim as there is no prior step or rationale of cDNAs being generated, for the extension of the cDNA to occur. No interpretation could be made for this claim.
Claims 48, 49, 51, and 52 are also indefinite by way of their dependencies on claim 47.
Claim 50 recites the phrase, “wherein in step (c), the binding … of the signal oligonucleotide.” Step (c) of the parent claims do not recite such a step. Therefore, a proper antecedent basis is lacking.
Claim 53 is indefinite for missing a conjunction between the two descriptions of step c’s. For the purpose of prosecution, the conjunction, “and” is assumed.
Claims 31-57 are indefinite by way of their dependencies on claim 30 (directly or via an intervening claim).
Conclusion
No claims are allowed.
Claims are free of prior art. The prior art does not teach or reasonably suggest for a method of utilizing a marker-specific ligand coupled to at least one activator oligonucleotide (or repressor oligonucleotide) with a DNA toolbox mixture comprising at least one polymerase, at least one restriction or nicking enzyme, and at least one amplification oligonucleotide, wherein a single generated oligonucleotide binds to the amplification oligonucleotide, which results in signal propagation.
While marker-specific ligand coupled to an oligonucleotide has been employed in the art of molecular diagnostics, such as in situ RCA, there is no motivation to combine such a method with a polymerase and a restriction/nicking enzyme, and at least one oligonucleotide that binds to a generated signal oligonucleotide.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YOUNG J KIM/Primary Examiner
Art Unit 1637 June 26, 2026
/YJK/
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