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 . Preliminary amendment filed on 02/27/2023 has been entered. Claims 3 and 8 are cancelled. Claims 1, 2, 4-7, and 9-12 are pending in this application. Claims 1, 2, 4-6, and 12 are withdrawn. Claims 7 and 9-11 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.
Election/Restrictions
Applicant's election with traverse of Group I invention (claims 7 and 9-11) in the reply filed on 01/23/2026 is acknowledged. The traversal is on the ground(s) that “both Groups I and III, which are directed to methods of use of the elected group and are commensurate with respect to the kit of Group II” (p. 1). This is not found persuasive because "Groups I/II/III are directed to a technical feature: porous plastic film containing skin surface lipids, an ethanol aqueous solution, and guanidine hydrochloride (and/or guanidine thiocyanate). This technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Inoue et al. (WO 2020/091044, published on May 07, 2020 and cited as US 2022/0002782 for English, also listed in IDS filed on 02/27/2023) … Therefore, the technical feature of Groups I/II/III cannot be a special technical feature over the prior art”, as set forth no pages 5 to 6 of the Restriction/Election Requirement mailed on 10/23/2025. “Lack of unity of invention may be directly evident “ a priori ,” that is, before considering the claims in relation to any prior art, or may only become apparent “ a posteriori ,” that is, after taking the prior art into consideration. For example, independent claims to A + X, A + Y, X + Y can be said to lack unity a priori as there is no subject matter common to all claims. In the case of independent claims to A + X and A + Y, unity of invention is present a priori as A is common to both claims. However, if it can be established that A is known, there is lack of unity a posteriori, since A (be it a single feature or a group of features) is not a technical feature that defines a contribution over the prior art.“ (see MPEP § 1850 [R-01.2024], 37 CFR 1.475, II). Furthermore, as indicated in MPEP, only independent claims are considered.
Claims 1, 2, 4-6, and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Thus, claims 7 and 9-11 are currently under examination.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
Three information disclosure statement (IDS) filed on 02/27/2023, 02/12/2024, and 08/23/2024 have been considered.
Claim Objections
Claims 7, 10, and 11 are objected to because of the following informalities: In claim 7, change the incorrect recitation “porous plastic film which comprises at least one selected from” (lines 3 to 4) to “porous plastic film, wherein the ethanol aqueous solution comprises at least one agent selected from” because the solution, not the film, comprises the agent; and replace the incorrect recitation “film containing skin surface lipids treated with the ethanol” (lines 6 to 7) with “film for containing skin surface lipids and to be treated with the ethanol” because the film in the kit has not yet contained skin surface lipid or has not yet been treated with the ethanol aqueous solution. In claim 10, change the incorrect recitation “has an alcohol” (line 2) to “has the alcohol” to comply with the preceding “the ethanol alcohol”. In claim 11, insert the missing word “agent” immediately after the recitation “at least one” to provide a noun. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(I) Claims 7 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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 guanidine thiocyanate (or has the alcohol concentration of 20% to 70% by volume; or a concentration of 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 9-11):
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).
Thus, these teachings of Kolluri ‘2020 anticipate Applicant’s claims 7 and 9-11 because the SNAPflex RNA capture and recovery include chromatography paper, capture membrane, customer lysis buffer comprising 5.8 M (= 0.686 g/mL, calculated from 5.8 mol x 118.2 gmol-1/L) guanidine thiocyanate, initial “pre-wash” buffer (70% ethanol, 12.5% custom lysis buffer, 17.5% nuclease free water), a zip-top Mylar bag, and a silica packet desiccant, which 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.
(II) Claims 7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pugia et al. (US 2017/0137805, May 18, 2017, hereinafter referred to as Pugia ‘805).
With regard to structural limitations “a kit comprising: a porous plastic film, an ethanol aqueous solution comprising 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):
Pugia ‘805 disclosed Separation of Circulating Rare Cell Nucleic Acids from Non-Rare Cell Nucleic Acid: diluted sample was placed into a filtration station and was filtered through the membrane of the filtration station that the filtration membrane pore sizes ranged from 0.1 μm to 10 μm. Following the filtration, the membrane was incubated and washed with an aqueous media such as PBS or other buffer capable of releasing nucleic acids from non-rare cells, such as those containing buffered guanidine thiocyanate, ethanol, detergents and 0.05% proclin-300 (Siemens Healthcare Diagnostics, VERSANT® Sample Preparation Reagents). The buffer lyses cells and denatures nuclei while releasing RNA and DNA. The membranes were either immediately processed to extract and purify nucleic acids according to a method or were stored at -20° C on pieces of tinfoil in plastic bags with desiccant (page 12/13, [0110-0115]). Filtration includes contacting the aqueous medium with a porous matrix. Materials for fabricating a porous matrix include cellulose (including paper), nitrocellulose, cellulose acetate, polycarbonate, poly(vinyl chloride), polyacrylamide, polyacrylate, polyethylene, polypropylene, polystyrene, nylon, and poly(vinyl butyrate). Ethanol was added to the flow-through material from the gDNA Eliminator spin column to provide appropriate binding conditions for RNA, where the total RNA binds to the membrane and contaminants are efficiently washed away. (pages 5/13 to 6/13, [0040-0042]; page 11/13, [0098]). Extraction of nucleic acids from the rare cells may involve one or more of the following processes: cell lysis; denaturation of DNA and proteins using denaturation agents, removal of cellular membrane lipids; removal of cellular proteins; treatment with chaotropic agents such as, guanidinium chloride and guanidinium isothiocyanate (pages 7/13 to 8/13, [0056]).
Thus, these teachings of Pugia ‘805 anticipate Applicant’s claims 7 and 9 because a porous membrane, a buffer capable of releasing nucleic acids from non-rare cells, such as those containing buffered guanidine thiocyanate and ethanol, and membrane storage at -20° C on pieces of tinfoil in plastic bags with desiccant are required by Pugia ‘805, 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.
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691