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 .
Continued Examination Under 37 CFR 1.114
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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 26th, 2026 has been entered.
Response to Amendment
The amendment filed March 26th, 2026 is acknowledged. Regarding the Office Action mailed October 27th, 2025:
The rejections set forth under 35 U.S.C. 103 are withdrawn in view of the amendments, arguments, and affidavit.
New grounds of rejection are set forth below, as necessitated by the amendments.
Claim Summary
Claim 178 has been amended. Claims 1-177 have been canceled. Claims 178-200 are pending. Claims 197-199 are withdrawn from consideration as being drawn to a non-elected invention/species. Claims 178-196 and 200 are under examination and discussed in this Office action.
Claim Rejections - 35 USC § 112(b)
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 178-196 and 200 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 178 recites the limitations “adding to the assay two or more detectors, wherein a first detector is a double-stranded nucleic acid configured for hybridization with the double-stranded nucleic acid formed in situ, and a second detector is configured for hybridization with the first detector to amplify the signal of the target molecule, wherein at least one of the two or more detectors comprises a double-stranded linear nucleic acid, and wherein at least one of the two or more detectors comprises a double-stranded branched nucleic acid comprising: (i) at least three single-stranded nucleic acids; and (ii) at least three overhangs, wherein one of the at least three overhangs is configured for hybridization with the first detector and/or the second detector.”
There are a few issues noted with these limitations:
It is unclear from these limitations how, if the double-stranded branched nucleic acid serves as the first detector, it is possible for the double-stranded branched nucleic acid to have three available overhangs as later described in (ii). One overhang would necessarily be occupied by hybridizing to the double-stranded nucleic acid formed in situ, and therefore is prohibited from being one of the three overhangs as claimed.
It is also unclear from these limitations how a signal is generated given that there is no aspect of the method claimed that would ultimately generate a signal. While a detection tag is introduced in claim 183, there is no detection tag claimed in claim 178, and therefore it is unclear what signal may be produced by the method detailed in claim 178. Also, given that there is no signal generating structure, it is further unclear how that signal may be amplified. Further, there is no active method step of either generating or detecting any signal in any claim.
Finally, it is unclear from these limitations how a signal is amplified when as few as two detectors are required by the claim, and further only two detectors are described. Amplification of a signal would suggest that multiple signals are added to produce a more prominent signal. However, given that as few as two detectors are described in claim 178, and only two specific detectors are described, it is unclear how signal from two detectors would serve to amplify the signal as claimed. This signal amplification is also reasonably affected by the issue noted immediately above regarding signal generation.
Overall, claim 178 is found indefinite. Claims 179-196 and 200 are also rejected here for their dependence on claim 178 and not fully clarifying the identified issues.
Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Todd (US 20140017669 A1) teaches on a double-stranded branched nucleic acid detector comprising at least three single-stranded nucleic acids and at least three overhangs (Figure 22; Page 26, paragraphs [0602]-[0604]). However, the method in which this double-stranded branched nucleic acid detector is used does not involve using overhangs to hybridize to other nucleic acid detectors. The structure of the double-stranded branched nucleic acid detector is cleaved by restriction enzymes to separate fluorophore/quencher pairs after hybridization of target nucleic acid fragments.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allison E Schloop whose telephone number is (703)756-4597. The examiner can normally be reached Monday-Friday 8:30-5 ET.
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/ALLISON E SCHLOOP/Examiner, Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
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