CTFR 17/690,101 CTFR 73403 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority This application, Serial No. 17/690,101 was filed on 03/09/2022 and is a Continuation of PCT Application No. PCT/JP2020/033152 filed 09/01/2020, and claims benefit under 35 U.S.C. 119 to JP Application number JP2019-178682, filed on 30 September 2019, JP 2020-005325, filed on 16 January 2020 and JP 2020-096898 filed on 03 June 2020. Status of the Claims Claims 5 and 6 have been canceled. Claims 1-4 and 7-20 are pending. Claims 16-20 are withdrawn. Claims 1-4 and 7-15 are examined herein. Withdrawn Rejections All rejections not reiterate herein below are withdrawn in view of Applicant’s arguments and/or claim amendments. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claim 15 is 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 has been amended to include all limitations from claim 15. Thus, claim 15 does not further limit claim 1 from which it ultimately depends. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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.. 07-21-aia AIA Claim s 1-4 and 7-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wada (US 2014/0087367) in view of Lea et al (WO2006007711) as evidenced by Darnett (US6270873) . Wada teaches an immunochromatography method and kit for the detection of biological analytes including influenza virus antigen. Regarding claims 1 and 15 , Wada teaches chromatography techniques and device comprising a labeling substance holding area and a labeling substance replenishing area, a color developing area (i.e. a reaction site) located downstream of the labeling area. See [0063] – [0066]. Wada teaches a method where a test sample, such as blood, serum, sweat, urine, etc., containing analytes such as toxin, pesticides, viruses and other antigens are pre-treated to obtain a concentrated solution containing the antigen. See [0061] – [0062]. Wada teaches labeling substances comprising an antibody conjugated to metal colloidal particles such as gold. See [0065] and [0068]. Wada further teaches amplification methods to enhance detection signal and to avoid a problem (risk) that the antigen is not detected due to the low sensitivity. Amplification increases the sensitivity of detection using a compound containing silver and a reductant for silver ions for a label selected from a group consisting of a metallic colloid label and a metallic sulfide label (silver amplification) [0005]. Wada teaches silver ion as an amplification solution [0054] and [0102]. Wada teaches the selection of appropriate amplification solutions in [0089]. Wada discloses the use of amplification solution in order to reduce background signals yet at the time same, the test is simple, convenient and can be carried out rapidly [0008]. Wada further teaches monoclonal antibodies for use as labeling and capture reagent. See [0076] and [0128]. Wada differs from the instant invention in failing to teach the use of superabsorbent polymer with a swelling ratio of 0.2 g/g to 800 g/g to concentrate the antigens prior to applying the concentrated sample to a gold pad. Lea, however, teaches throughout the publication a method and device to process, label and concentrate analytes (abstract), comprising: mixing a sample containing an antigen with a polyacrylic acid-based superabsorbent polymer (page 8, lines 14-29, Favor-Pac 100), to concentrate and increase the number of analyte particles to a level that may be reliably detected. The fluid sample may then be transferred to a container for mixing with detection reagents (page 2, lines 22-26.) Lea teaches superabsorbent polymer having a swelling ration between 0.2 g/g and 800 g/g, as evidenced by Darnett who teaches in their use of the same polymer, Favor-Pac 100, in a pouch that contains 4 0.75g pads of Favor-Pac 100 that absorbs a total of 120g of biofluids, or 40g/g (col. 6, lines 36-38). Lea also teaches the concentrating step may be done without the reagents, i.e. the analyte is labeled in the assay device after concentrating (page 9, lines21-24.) Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing to modify the method taught by Wada by concentrating the antigen using the superabsorbent polymers taught by Lea because Wada specifically recognizes the needs for amplification of the antigen prior to detection to increase sensitivity and accuracy and Lea teaches the advantages of using superabsorbent polymers for the same purpose, mainly, to increase the concentration of the analyte in the fluid sample leading to better detection. A skilled artisan would have had a reasonable expectation of success in modifying the method of Wada by using the polymers taught by Lea to concentrate the analyte prior to applying the mixture to a gold pad because both Wada and Lea teaches the needs to concentrate analytes before mixing with labeled reagents in the case where the level of antigen in a fluid sample may be low. The use of superabsorbent polymers for this purpose is well known in the art. See Lea. Regarding claim 2, Lea teaches polyacrylic acid-based superabsorbent polymer. See page 8, lines 14-31. Regarding claims 3 and 4, Wada teaches sample fluids including urine. See ]0060]. Regarding claims 7-12 , Lea teaches superabsorbent polymers having particles size from 100-850 microns which falls inside the claimed range. See page 9, lines 1-7. Regarding claim 13, Lea teaches on pg. 5 line 25 – pg. 6 line 3, 350µl of sample fluid is exposed to concentrating material, 30mg of Favor-Pac 100 (pg. 9, lines 8-10), for up to 20 minutes which would at a minimum of 0.583 g/min of pure water (times vary based on solution makeup) absorbed per 1g of superabsorbent polymer, meeting limitations in claim 13 wherein a water absorption rate of the superabsorbent polymer is 0.01 g/min or more and 40 g/min or less per 1 g of the superabsorbent polymer. It would have been obvious to modify the method taught by Wada by using the antigen concentration techniques taught by Lea and to further select polymers with specific characteristic because Lea teaches that these polymers are well known in the art and are commercially available for the same intended purpose. Lea further discloses that polymers such as Favor-Pac 100 provides the advantage of being solvated when brought into contact with a water-based liquid and 30mg of polymer increases analyte concentration by a factor of three. Regarding claim 14 , Wada teaches immunological test method comprising immunochromatography. [0056] - [0057] . Double Patenting 08-33 AIA 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 1-4 and 7-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 13, 15-16 and 18-20 of co-pending Application No. 17/859,292 for reasons of record. Although the claims at issue are not identical, they are not patently distinct from each other because they are all directed to a method for detecting an analyte comprising a concentrating step using a superabsorbent polymer, contacting the concentrated mixture with a test pad comprising labeled reagent and capturing and detecting the complex. This is a provisional nonstatutory double patenting rejection. Response to Arguments Applicant’s arguments with respect to all pending claims have been considered but are moot because the new ground of rejection does not rely on any applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Conclusion No claims are allowed. 07-40 AIA 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. 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Oyama et al. A sensitive point of care testing chip utilizing superabsorbent polymer for the early diagnosis of infectious disease. Sensors and Actuators B: Chemical. 240 (2017) 881-886. Any inquiry concerning this communication or earlier communications from the examiner should be directed to /BAO-THUY L NGUYEN/ whose telephone number is (571)272-0824. The examiner can normally be reached M-Th 8:00 am - 4:00 pm (ET); Alternate Friday 9:00 am - 12:00 Noon. 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, Yvone (Bonnie) Eyler can be reached at 571.272.1200. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 May 27, 2026 Application/Control Number: 17/690,101 Page 2 Art Unit: 1677 Application/Control Number: 17/690,101 Page 3 Art Unit: 1677 Application/Control Number: 17/690,101 Page 4 Art Unit: 1677 Application/Control Number: 17/690,101 Page 5 Art Unit: 1677 Application/Control Number: 17/690,101 Page 6 Art Unit: 1677 Application/Control Number: 17/690,101 Page 7 Art Unit: 1677 Application/Control Number: 17/690,101 Page 8 Art Unit: 1677 Application/Control Number: 17/690,101 Page 9 Art Unit: 1677 Application/Control Number: 17/690,101 Page 10 Art Unit: 1677 Application/Control Number: 17/690,101 Page 11 Art Unit: 1677
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