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 .
Status of the Application
The Response filed March 20, 2026 is acknowledged.
Claims 1-6 are pending and are being examined on the merits.
Response to Arguments
Applicant’s arguments filed March 20, 2026 have been fully considered.
The following objections and rejections are WITHDRAWN In view of Applicant’s arguments and amendments to the claims:
Objections to the Specification
Objection to claim 5
Rejection of claims 2-4 and 6 under 35 USC § 112(b), indefiniteness
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.
Claim 4 is 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 4 has been amended to recite “the oligonucleotide and the anti-sense probe are
used with at least one internal probe nucleotide … separately or together”, the meaning of which is unclear. Specifically, it is unclear what “separately” refers to. For example, is it intended to mean a separate step of the isothermal amplification? Or is it intended to refer to separate embodiments of the claim 4 method, where one embodiment uses the oligonucleotide plus anti-sense probe, while another embodiment requires all three of the oligonucleotide, anti-sense probe and internal probe oligonucleotide? Further, it is unclear what “together” refers to. For example, is it intended to mean that all three of the oligonucleotide, anti-sense probe and internal probe oligonucleotide are used in the same reaction volume at the same time, or is it intended to mean that the internal probe oligonucleotide is ligated to one of the components so that they are “together”? Since the ordinary artisan would not be able to determine the metes and bounds of the claim, it is indefinite.
Allowable Subject Matter
Claims 1-3 and 5-6 are allowed. Claim 1 and its dependent claims are free of the art, at least, because SEQ ID NOs: 5-8 and 15-16 are free of the art. Specifically, the sequences of each of SEQ ID NOs: 5-8 and 15-16 are not found in the art, either as one continuous sequence, or as discontinuous parts. Additionally, each of SEQ ID NOs: 5-8 and 15-16 are not naturally occurring sequences and are not found as components of a larger, single genomic sequence.
Conclusion
Claims 1-6 are being examined. Claim 4 is rejected. Claims 1-3 and 5-6 are 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.
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/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
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