DETAILED ACTION
Applicant’s response filed on 04/24/2026 has been fully considered. Claims 1-5 and 7-18 are canceled. Claim 6 is pending and is amended.
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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Irino et al. (JP 2020-051928 A, machine translation in English used for citation).
Regarding claim 6, Irino teaches that a biological sample is diluted with a solution obtained by dissolving a blocking agent in an aqueous medium [0024], wherein the block agent is a 2-methacryloyloxyethyl phosphorylcholine polymer that is a homopolymer of 2-methacryloyloxyethyl phosphorylcholine [0024], which reads on a composition comprising water and a sensitizer, wherein the sensitizer is a homopolymer having constitutional units derived from the monomer represented by formula (1) wherein X1 is a (meth)acryloyloxy group, L1 is an alkylene group having 2 carbon atoms, and R1 to R3 are each independently an alkyl group having 1 carbon atom, and wherein the sensitizer is dissolved in water as claimed. Irino teaches that the biological sample is diluted in the presence of the blocking agent to prevent nonspecific adsorption of labeled sterols [0024], that the diluted biological sample is mixed with a labeled sterol [0020], that labeled sterols are sterols that contain a labeling substance [0026], that the labeling substance present in labeled sterols will also be referred to as the first label [0026], that the first label may be, for example, a tag that is itself the object to be detected [0029], and that the tags may be either naturally occurring or synthetically produced substances, such as nucleic acids [0042], which optionally reads on the composition further comprising nucleic acid as claimed.
Irino does not teach a specific embodiment of the composition further comprising nucleic acid. Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to select Irino’s labeling substance in Irino’s labeled sterols that are mixed with Irino’s diluted biological sample to be nucleic acids. The proposed modification would read on the composition further comprising nucleic acid as claimed. One of ordinary skill in the art would have been motivated to do so because it would have been beneficial for making nucleic acids detectable in Irino’s biological sample because Irino teaches that that the biological sample is diluted in the presence of the blocking agent to prevent nonspecific adsorption of labeled sterols [0024], that the diluted biological sample is mixed with a labeled sterol [0020], that labeled sterols are sterols that contain a labeling substance [0026], that the labeling substance present in labeled sterols will also be referred to as the first label [0026], that the first label may be, for example, a tag that is itself the object to be detected, or a substance that generates a detectable signal [0029], that the first label is a labeling substance that makes the labeled sterol incorporated into the lipoprotein detectable [0029], that the tags may be either naturally occurring or synthetically produced substances, such as nucleic acids [0042], that the ability to measure sterol uptake is performed by detecting signals derived from labeled sterols incorporated into lipoproteins [0092], and that signals can be detected, for example, when a labeled sterol having a signal-generating substance is used as the first label [0094].
Irino satisfies the limitation that the sensitizer is for nucleic acid amplification as claimed because this limitation is an intended use, Irino teaches all of the claimed ingredients, amounts, process steps, and process conditions of the sensitizer, and Irino renders obvious all of the claimed ingredients, amounts, process steps, and process conditions of the composition, including the claimed nucleic acid. The sensitizer in the composition that is rendered obvious by Irino therefore would have been capable of performing as a sensitizer for nucleic acid amplification. To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim (MPEP 2111.02(II)). Also, the sensitizer in the composition that is rendered obvious by Irino therefore would have had the property of being a sensitizer for nucleic acid amplification. "Products of identical chemical composition can not have mutually exclusive properties (MPEP 2112.01(II))." A chemical composition and its properties are inseparable (MPEP 2112.01(II)). Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (MPEP 2112.01(II)).
Response to Arguments
Applicant’s arguments, see p. 4, filed 04/24/2026, with respect to the rejection of claims 7 and 8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been considered but are moot because claims 7 and 8 are canceled in the amendments field on 04/24/2026.
Applicant’s arguments, see p. 5-8, filed 04/24/2026, with respect to the rejection of claim 6 under 35 U.S.C. 102(a)(1) as being anticipated by Ko et al. (US 2019/0360021 A1, cited in IDS) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see p. 5-8, filed 04/24/2026, with respect to the rejection of claim 6 under 35 U.S.C. 102(a)(1) as being anticipated by Kaneko (US 2018/0369804 A1) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see p. 5-8, filed 04/24/2026, with respect to the rejection of claim 6 under 35 U.S.C. 102(a)(1) as being anticipated by Sakaki et al. (JP 2006-305401 A, machine translation in English used for citation) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see p. 9, filed 04/24/2026, with respect to the provisional rejection of claim 6 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, and 7 of copending Application No. 19/130,695 (reference application) have been fully considered and are persuasive. The provisional rejection of claim 6 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, and 7 of copending Application No. 19/130,695 (reference application) has been withdrawn.
Applicant’s arguments, see p. 9, filed 04/24/2026, with respect to the provisional rejection of claim 6 on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/697,245 (reference application) have been fully considered and are persuasive. The provisional rejection of claim 6 on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/697,245 (reference application) has been withdrawn.
Applicant’s arguments, see p. 9, filed 04/24/2026, with respect to the provisional rejection of claim 6 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/458,354 (reference application) have been fully considered and are persuasive. The provisional rejection of claim 6 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/458,354 (reference application) has been withdrawn.
Applicant’s arguments, see p. 9, filed 04/24/2026, with respect to the rejection of claim 6 on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 8,252,531 B2 have been fully considered and are persuasive. The rejection of claim 6 on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 8,252,531 B2 has been withdrawn.
Conclusion
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID KARST whose telephone number is (571)270-7732. The examiner can normally be reached Monday-Friday 8:00 AM-5:00 PM.
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/DAVID T KARST/Primary Examiner, Art Unit 1767
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