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 .
The amended claims dated 6/15/2026 are under consideration.
Election/Restrictions
Applicant’s election of Group II, claims 3 and 4, in the reply filed on 6/15/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Upon consideration of elected Group II, the restriction between Groups II, III and IV is withdrawn. Claims 5 and 6 are included with the election of Group II.
In view of the above noted withdrawal of the restriction requirement between Groups II, III and IV, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 7-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6/15/2026.
Priority
The present application claims priority to JAPAN 2022-176209 (filed 11/2/2022).
Priority is recognized.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or on a submitted IDS, they have not been considered.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sai (“Study On Catalytic Properties of FLAP Structure – Specific Endonuclease 1 And Establishment of New Platforms For Screening Its Inhibitors”. Thesis – Nanyang Technological University. 2015, 154 pages).
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Regarding claims 3 and 4, Sai teaches a single-stranded oligonucleotide having a sequence that is complementary to a target nucleic acid (Scheme 1.8). Sai further teaches the single-stranded oligonucleotide has a “structure” in the form of a phosphothioate/phosphorothioate bond either upstream or downstream of a flap endonuclease cleavage site (Scheme 1.8).
The structure is depicted in Scheme 1.8 (p. 16), which is reproduced below:
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Similar structures are depicted in Fig. 3.2 (p. 65), which is reproduced below with AS2Dn and AS4Dn being particularly relevant:
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On p. 65, in section 3.1.2 DNA sequences, DNA sequences having phosphorothioate modifications are described, and are reproduced below:
Additional sequences continue onto p. 66, but are not reproduced in this action.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lyamichev (US 7,122,364 B1) in view of Sai (“Study On Catalytic Properties of FLAP Structure – Specific Endonuclease 1 And Establishment of New Platforms For Screening Its Inhibitors”. Thesis – Nanyang Technological University. 2015, 154 pages).
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Claims 5 and 6 are drawn to “kits”. The term “kit” is not limited by the claim nor is it specifically defined in the specification. The term “kit” is broadly interpreted as a collection of elements used together.
Regarding claims 5 and 6, Lyamichev teaches a collection of the following structural reagents:
The structures include:
“WT Probe” as a flap probe;
“INVADER Oligo” as an invasive probe as claimed;
“FRET Cassette” as a fluorescent probe as claimed.
The cleavage is via a flap endonuclease, which is part of an INVADER assay.
Lyamichev further teaches the stacker oligonucleotides include phosphorothioates and such modifications may also serve to make these flanking oligonucleotides resistant to contaminating nucleases. This feature further ensures their continued presence on the target strand during the course of the reaction.
While Lyamichev suggests incorporating phosphorothioate bonds, Lyamichev does not specifically teach the structure of claim 3 or claim 4 as required by claims 5 and 6.
However, Sai teaches a single-stranded oligonucleotide having a sequence that is complementary to a target nucleic acid and includes phosphorothioate bonds at the claimed positions, as described in the 102 rejections above.
It would have been prima facie obvious to the ordinary artisan at the time of invention to have modified the reagent set of Lyamichev by replacing the “WT Probe” with the single-stranded oligonucleotide of Sai. One would have been motivated to do so because it renders the probe resistant to nucleases, yet also allowing for cleavage by a FLAP endonuclease.
Conclusion
No claims allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH G. DAUNER/ Primary Examiner, Art Unit 1682
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