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 .
Election/Restrictions
Applicant's election with traverse of T4GP32 and SEQ ID NO 1 in the reply filed on 02/17/2026 is acknowledged. The traversal is on the ground(s) that additional species would not constitute undue burden on the Office. This is not found persuasive because the species requirement was because the species do not share a special technical over the prior art, as taught by Piche (2005, cited on IDS).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-5, 8, 12-16 are under examination with regard to T4GP32, SEQ ID NO 1.
Priority
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. In the instant case, a certified copy of Japan 2021-020853 has been received however there is no certified translation.
Drawings
The drawings are accepted.
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.
Claims 1-5, 8, 12-16 are 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 1 recites the limitation "water soluble alcohol aqueous solution" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not require any water soluble alcohol aqueous solution. Claim 1 requires an ethanol aqueous solution but does not require a water soluble alcohol.
Claim 1 recites a concentration of ethanol in ethanol aqueous solution is 40 to 46 vol %. Claim 15 recites 42 to 45 vol%. This recitation renders the claim indefinite. Is it unclear what concentration of ethanol is required for the claim. Is the vol % the final alcohol concentration, such as 40% of the final alcohol concentration or is concentration 40% (v/v)? The claim is vague and indefinite because it is unclear the concentration requirement for the ethanol as the recitation of vol % is not an art recognized nomenclature to describe volume concentration. One of skill in the art cannot determine the metes and bounds of the claimed subject matter.
Claims 2-5, 8, 12-16 depend from claim 1 and are indefinite for the reasons applied to claim 1.
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.
Claims 1-4, 8, 12-16 are rejected under 35 U.S.C. 103 as being obvious over Uehara (WO20211411108A1, published 7/15/2018, filed 01/8/2021, translation provided and citations reference translation) in view of Schlumpberger (US20150232831A1)
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Uehara teaches a method of extracting RNA from a sample from the surface of skin (see pg. 2) (within a depth of 5µm from skin surface). Uehara teaches extracting RNA from epidermis (stratum corneum, outermost layer of epidermis, claim 2-3). Uehara teaches the surface of the skin is isolated, this encompasses the outermost layer of epidermis including within four stratum corneum layers, as this comprises the outermost layer of epidermis. Uehara teaches isolating skin using adhesive material including tape (claim 4, tape stripping) (see pg. 3). Uehara teaches RT-multiplex PCR of the extracted RNA. Uehara teaches RT-multiplex PCR is performed in the presence of single stranded nucleic acid binding protein (see pg. 3) and teaches T4GP32 (see pg. 3). Uehara teaches T4GP32 comprises the amino acid sequence of SEQ ID NO 1 and the concentration used is 5 to 200 µg/ml (claim 8, 12) (see pg. 3). Uehara teaches using RNeasy extraction kit to isolate RNA (see pg. 5, example 1) (claim 13, silica-based solid phase material) Uehara teaches the nucleic acid amplification is applied for gene expression analysis and sequence analysis (see pg. 4) (claims 14 and 16). Uehara does not teach RNeasy protocol and does not teach the concentration of ethanol used in the assay.
However it was known in the art to use varying concentration of ethanol in the ethanol aqueous solution for contacting silica-based solid phase material (RNeasy). Schlumpberger teaches isolating RNA and small RNA from samples using silica-based solid phase materials. Schlumpberger teaches alcohol is added to aqueous solution and teaches the alcohol is added to assist in binding conditions for binding the RNA to solid phase. Schlumpberger teaches ethanol is well suited and teaches final concentration of alcohol used for binding include 41% to 47% (see para 46).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have used a final concentration of ethanol between 42 to 45% as taught by Schlumpberger in the method of Uehara to allow for extracting small RNA from samples. One would have been motivated to do so based on the teaching of Schlumpberger to extract RNA from samples using RNeasy protocols (see para 144) because Uehara teaches isolating RNA from sample using RNeasy protocols.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claims 1-5, 8, 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Benson (US20130296185 A1) in view of Olivia (2001, cited on IDS) and Schlumpberger (US20150232831A1).
Benson teaches a method of extracting nucleic acids, including RNA from the surface of skin via tape stripping (see para 9). Benson teaches isolating an epidermal sample adhering to tape by tape stripping. Benson teaches a tape stripped sample comprises the surface of skin and includes structures associated with stratum corneum and epidermis (within 5um of skin surface, within four stratum corenum layers) (see para 36). Benson further teaches that following skin stripping, cells isolated from stratum corneum can be lysed (see para 130) (claims 2-4). Benson teaches isolating mRNA from surface of skin via tape stripping. Benson teaches comparing acrylic based adhesive to rubber based adhesive to RNA yield. It is noted that, with regard to claim 5, Benson teaches rubber based adhesive has a higher yield than acrylic tape, however the claims do not require amount of RNA yield and Benson demonstrates that acrylic tape can be used to isolate RNA, which is the limitation required for claim 5. Benson teaches Benson teaches extracting RNA using RNeasy RNA extract kit (silica based solid phase material to separate RNA) (see para 168). Benson teaches multiplex RT-PCR of mRNA (see para 176). Benson teaches determining gene expression (see ex 2). Benson does not teach the concentration of ethanol prior to contact of silica based solid phase material. Benson does not teach adding T4GP32.
Oliva teaches use of T4 gene 32 protein in RT-PCR to increase yield from 90% to 150%. Oliva teaches yield is increased in both long mRNA templates and low concentration of total RNA (see abstract and discussion).
Additionally, it was known in the art to use varying concentration of ethanol in the ethanol aqueous solution for contacting silica-based solid phase material (RNeasy). Schlumpberger teaches isolating RNA and small RNA from samples using silica-based solid phase materials. Schlumpberger teaches alcohol is added to aqueous solution and teaches the alcohol is added to assist in binding conditions for binding the RNA to solid phase. Schlumpberger teaches ethanol is well suited and teaches final concentration of alcohol used for binding include 41% to 47% (see para 46).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have included T4 gene 32 protein in the RT-PCR reaction of Benson to increase the yield of RNA because Oliva teaches T4 gene 32 protein increases the yield of low concentration of total RNA and Benson teaches acrylic adhesives provide low concentration of total RNA. Even with using the rubber adhesive, one of ordinary skill in the art would have included T4 gene 32 protein to increase the yield of amplification product of RNA in RT-PCR reactions. Additionally the ordinary artisan would have used a final concentration of ethanol between 42 to 45% as taught by Schlumpberger in the method of Benson to allow for extracting RNA from samples. One would have been motivated to do so based on the teaching of Schlumpberger to extract RNA from samples using RNeasy protocols (see para 144) because Uehara teaches isolating RNA from sample using RNeasy protocols. Additionally one would have been motivated to include T4 gene 32 protein in the RT-PCR multiplex assay for the expected benefit of increased yield of the amplification product as taught by Oliva.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8, 12-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 5 of copending Application No. 17791709 in view of Benson (US20130296185 A1) and Schlumpberger (US20150232831A1).
Claims 1-2 and 5 of ‘709 encompass amplifying a nucleic acid from a sample RNA derived from skin surface lipid by RT and multiplex PCR. The claims of ‘709 include the use of T4GP32 in the RT and multiplex PCR. Instant claims 1-5, 8, 12-15 require extracting RNA from surface stratum corneum followed by RT-PCR multiplex with T4GP32. Although the claims at issue are not identical, they are not patentably distinct from each other because the teachings of Benson and Schlumpberger.
Benson teaches a method of extracting nucleic acids, including RNA from the surface of skin via tape stripping (see para 9). Benson teaches isolating an epidermal sample adhering to tape by tape stripping. Benson teaches a tape stripped sample comprises the surface of skin and includes structures associated with stratum corneum and epidermis (within 5um of skin surface, within four stratum corenum layers) (see para 36). Benson further teaches that following skin stripping, cells isolated from stratum corneum can be lysed (see para 130) (claims 2-4). Benson teaches isolating mRNA from surface of skin via tape stripping. Benson teaches comparing acrylic based adhesive to rubber based adhesive to RNA yield. It is noted that, with regard to claim 5, Benson teaches rubber based adhesive has a higher yield than acrylic tape, however the claims do not require amount of RNA yield and Benson demonstrates that acrylic tape can be used to isolate RNA, which is the limitation required for claim 5. Benson teaches Benson teaches extracting RNA using RNeasy RNA extract kit (silica based solid phase material to separate RNA) (see para 168). Benson teaches multiplex RT-PCR of mRNA (see para 176). Benson teaches determining gene expression (see ex 2). Benson does not teach the concentration of ethanol prior to contact of silica based solid phase material. Benson does not teach adding T4GP32.
Additionally, it was known in the art to use varying concentration of ethanol in the ethanol aqueous solution for contacting silica-based solid phase material (RNeasy). Schlumpberger teaches isolating RNA and small RNA from samples using silica-based solid phase materials. Schlumpberger teaches alcohol is added to aqueous solution and teaches the alcohol is added to assist in binding conditions for binding the RNA to solid phase. Schlumpberger teaches ethanol is well suited and teaches final concentration of alcohol used for binding include 41% to 47% (see para 46).
Therefore based on the teaching of Benson and Schlumpberger, the claims of ‘791 are not patentable distinct from the instant claims because it would have been obvious to include extracting RNA using tape stripping and use a well-known commercial method of RNeasy as taught by Benson and include a final concentration of ethanol between 42 to 45% as taught by Schlumpberger to allow for extracting RNA from samples. One would have been motivated to do so based on the teaching of Schlumpberger to extract RNA from samples using RNeasy protocols (see para 144) and the teaching of Benson to extract RNA from skin surface samples using RNeasy for RT-PCR assays.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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/SARAE L BAUSCH/Primary Examiner, Art Unit 1699
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