DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment filed on 08/05/2026 has been entered. Claims 3, 8, 10, and 11 are cancelled. Claims 1, 2, 4-7, 9 and 12 are pending in this application. Claims 1, 2, 4-6, and 12 are withdrawn. Claims 7 and 9 are currently under examination.
Priority
This application is a 371 of PCT/JP2021/031568 filed on 08/27/2021 and claims foreign priority of JAPAN 2020-144317 filed on 08/28/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 03/18/2026 has been considered.
Withdrawn Claim Objections/Rejections
The objection of claims 7, 10, and 11 because of incorrect recitation, as set forth on pages 3 to 4 of the Non-Final Rejection mailed on 03/06/2026, is withdrawn in view of amended claim 7 and cancelled claims 10 and 11.
The rejection of claims 7 and 9-11 under 35 U.S.C. 102(a)(1) as being anticipated by Kolluri et al., as set forth on pages 4-6 of the Non-Final Rejection mailed on 03/06/2026, is withdrawn in view of amended claim 7 and cancelled claims 10 and 11. Claim 9 depends from claim 7.
The rejection of claims 7 and 9 under 35 U.S.C. 102(a)(1) as being anticipated by Pugia et al., as set forth on pages 6 to 7 of the Non-Final Rejection mailed on 03/06/2026, is withdrawn in view of amended claim 7. Claim 9 depends from claim 7.
New (necessitated by amendment) Claim Rejections - 35 USC § 103
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.
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kolluri et al. (Lab Chip, 2020, 20, 3386–3398, Accepted 31st July 2020, hereinafter referred to as Kolluri ‘2020).
With regard to structural limitations “a kit comprising: a porous plastic film, an ethanol aqueous solution comprising (a) 20% by volume or more and 70% by volume or less of ethanol and (b) 0.50 g/mL guanidine thiocyanate, a container for storing the porous plastic film, and a desiccant (or held in the container), wherein the amount of the ethanol aqueous solution is such an amount that the solution permeates 80% or more of an area of the porous plastic film” (claims 7 and 9):
Kolluri ‘2020 disclosed a SNAPflex device consisting of layers of laminating plastic, adhesive plastic, a chromatography paper waste pad, and a paper capture membrane. The main components of the SNAPflex device are a glass fiber capture membrane to collect purified nucleic acids and a chromatography paper waste pad to provide capillary force for passive wicking of fluid through the glass fiber capture membrane. To prepare the custom lysis buffer, 5.8 M guanidine thiocyanate supplemented with 0.1 M MOPS (pH 7.0) was dissolved in nuclease-free water. Prior to sample lysis, a complete lysis buffer was prepared containing 68% (v/v) custom lysis buffer, 29% (v/v) 10% nonyl phenoxypolyethoxylethanol (NP-40), and 3% (v/v) GlycoBlue co-precipitant (15 mg mL−1 blue glycogen). After lysis, 35% (v/v) 1-butanol was added to the solution as a precipitating agent. After the addition of precipitating buffer, the lysed blood solution was inverted to mix and immediately applied to the capture membrane on the device in 40 μL increments to capture precipitated nucleic acid–glycogen particles (Fig. 2A). An initial “pre-wash” buffer (70% ethanol, 12.5% custom lysis buffer, 17.5% nuclease free water) was applied to the capture membrane. The final wash was 100 μL 95% ethanol to enable rapid drying of the preserved nucleic acids on the membrane. The center circle of the capture membrane was removed for drying (Fig. 2E). Once the capture membrane was completely dry, the sample was either stored in a zip-top Mylar bag with a silica packet (Fig. 2F) or immediately eluted.
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. The eluted sample was collected from the membrane and stored at the appropriate storage temperature prior to analysis by RT-qPCR (HIV RNA studies) (page 3387, right col., para. 3 and 4; page 3388, left col., para. 4; right col., para. 2 to 4; page 3389, Fig. 2; left col., para. 1 and 2). The “pre-wash” step which includes 12.5% of lysis buffer is akin to a similar “pre-wash” buffer that is used in commercial silica-based nucleic acid extraction columns, where traces of guanidine-thiocyanate are added to a 70% ethanol mixture to minimize the chance of protein aggregates clogging the silica. The lysis buffer contains guanidine thiocyanate and 2-mercaptoethanol, which aggressively denature proteins in the solution (including RNases, which usually contain numerous disulphide bonds) thereby preventing degradation of RNA in solution (page 3395, left col., para. 5, right col., para. 5).
Kolluri ‘2020 did not explicitly disclosed the limitation “an ethanol aqueous solution comprising (a) 20% by volume or more and 70% by volume or less of ethanol and (b) 0.50 g/mL guanidine thiocyanate”, required by claim 7.
However, skilled artisan would follow the teachings of Kolluri ‘2020 to optimize and to increase the concentration of guanidine thiocyanate in 70% ethanol to aggressively denature proteins, including RNase, in the solution thereby preventing degradation of RNA, as described above. Thus, one of skill in the art would have a reasonable expectation that by optimizing and incresing concentration of guanidine thiocyanate in 70% ethanol to aggressively denature proteins, including RNase, in the solution, one would achieve Applicant’s claims 7 and 9, and would carry the same properties or would achieve the same intended purpose, including “for collecting skin surface lipid-derived RNA”, “porous plastic film for containing skin surface lipids and to be treated with the ethanol aqueous solution”, and “the solution permeates 80% or more of an area of the porous plastic film”, required by claim 7. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 [R-01.2024] [II.A].
To overcome the obviousness rejection, Applicant may insert the clause “and prevents degradation of RNA superior to the ethanol or guanidine alone at ambient or higher temperature” at the end of claim 7, which is supported by Table 1, Table 3, Table 4, and Table 5 in the Specification and constitutes unexpected results. Any amendment After-Final may not be entered if new issue arises and/or extensive search is required.
Conclusion
No claims 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YIH-HORNG SHIAO whose telephone number is (571)272-7135. The examiner can normally be reached Mon-Thur, 08:30 am to 07:00 pm EST.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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