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 .
DETAILED ACTION
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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/18/2026 has been entered.
2. Claims 1-23, 26, 28, 30-33, 35, 38-41, 43, 44 are canceled. Claims 24, 27, 29, 34, 36, 37, 47 are amended. Claims 24, 25, 27, 29, 34, 36, 37, 42, 45-47 are under consideration.
Claim Rejections - 35 USC § 112
3. (previous rejection, withdrawn) Claims 24, 25, 27, 29, 34, 36, 37, 42, 45-47 were
rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply
with the written description requirement.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
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.
4. (previous rejection, maintained; new rejection to claim 24 as indicated below) Claims 24, 25, 27, 29, 34, 36, 37, 42, 45-47 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.
See claims 24, 25, 27, 29, 34, 36, 37, 42, 45-47 as submitted 2/18/2026.
Applicant contends: the claims have been amended.
Applicant’s arguments are considered and found persuasive as to previous rejections not included below, but maintained and newly rejected as also indicated below.
As to claim 24, the claim still recites “a get index, ratio, percentages, visual or other value”. It is unclear what “get index” refers to or what the metes and bounds of “visual or other value” are. Further, the claim still recites "qualitative determination". It is not clear what the metes and bounds of such a term are. Claims 25, 27, 29, 34, 36, 37, 42, 45-47 depend on this claim.
Further, the claim recites “the target sequence is the target primers are capable of hybridizing”. It is not clear what such language means, or if the claim intends to recite “capable of hybridizing to”.
Further, it is not clear “what” “is capable of hybridizing resulting in the formation of the nucleic acid hybridization complexes…”.
Further, the claim recites “produce highly selective assays”. The term “highly selective” is a relative term which renders the claim indefinite. The term “highly selective” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Further, the claim still recites "SEQ ID NO: 5 with mutation A23403C". SEQ ID NO: 5 is 10 nucleotides long, It is not clear what the position numbers (23,404) are in reference to.
As to claim 36, it is still not clear what "further processing to conduct the multiplex assay comprising the RT-PCR are extracted from said biological sample" means. It is not clear what the metes and bounds of such a term are.
Conclusion
5. As indicated in Item #12 of the Non-Final Rejection issued 6/6/2024, SEQ ID NO: 5 (as now recited in instant claim 24) is free of the prior art of record. Further, amended and examined SEQ ID NO: 37 is also free of the prior art of record. Thus, claim 24 with respect to the combination of SEQ ID NOs: 5, 13, 14, 17, 18, 23-25, 29, 30, 37, 38 is free of the prior art of record.
6. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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