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 .
Status of Claims
Claim 1 has been amended. Claims 7, 9-12 and 17 have been cancelled. Claims 1, 3-4, 6, 13, 15-16 and 18-20 are examined.
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.
Claim(s) 1, 3-4, 6, 13, 15-16 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lea et al. (WO 2006/007711, Pub Date: 01/26/2006, IDS, hereinafter “Lea”, previously cited), as evidenced by Darnett (US 6,270,873), in view of Eisinger et al. (US 4,943,522) and Wada (US 2014/0087367, Pub Date: 03/27/2014, IDS, previously cited).
Regarding claims 1 and 18-19, Lea teaches throughout the publication an immunological test method (page 4, lines 4-21), comprising: mixing a solution capable of containing an antigen, a polyacrylic acid-based superabsorbent polymer (page 8, lines 14-29, Favor-Pac 100), and a labeled antibody against the antigen, to obtain a concentrated and mixed solution which is a concentrated mixed solution containing composite bodies of the antigen and the labeled antibody; and detecting the composite bodies in the concentrated and mixed solution using an antigen-antibody reaction (page 5, line18 – page 7, line 7), wherein a swelling ratio of the superabsorbent polymer is more than 20g/g and less than 800 g/g and the particle diameter of the superabsorbent polymer is 0.80mm (page 9, lines 8-18), the claimed swelling ratio teaching being 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).
While Lea teaches that the sampling device is utilized to expel a sufficient amount of the concentrated fluid sample into an assay device (page 6, lines 9-14), the reference does not specifically teach that the concentrated sample is added onto an addition pad of an insoluble carrier having the addition pad and a reaction site at which a binding substance capable of binding to the antigen is immobilized and further capturing the concentrated sample at the reaction site of the carrier.
Eisinger teaches throughout the publication a standard immunoassay device for conducting specific binding assays (abstract). The device has an application zone (claimed addition pad) that is adapted to receive a liquid sample as well as indicator zones 106 (claimed reaction site) that contain the complementary member of a specific binding pair where the other member is the analyte of interest within the sample (column 10, line 62 – column 11, line 6; see Figure 1) that is captured at the indicator zone if present in the sample (column 5, lines 19-36).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the method of Lea, an assay device as taught by Eisinger because Lea is generic regarding the type of assay device that the concentrated sample can be expelled onto and one skilled in the art would have been motivated to choose the appropriate assay device based on the desired assay conditions.
While Lea in view of Eisinger does not explicitly teach that the solution capable of containing an antigen is urine, Wada teaches throughout the publication a chromatography method (abstract). More specifically, Wada teaches that the chromatography method can be conducted with samples such as urine, which inherently include urea (paragraph 0060).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the sample fluid of Lea in view of Eisinger to incorporate a urine sample as taught by Wada because Lea is generic regarding the type of samples that can be incorporated in the immunological method and one skilled in the art would have been motivated to choose the appropriate sample based on the desired analytes to be detected. While Lea and Eisinger in view of Wada do not specifically teach wherein urea in the urine is, together with water in the urine, absorbed by the superabsorbent polymer in the concentration step, whereby inhibition of the antigen-antibody reaction is suppressed in the detection step, such limitations are drawn to inherent properties and abilities of the superabsorbent polymer. Lea teaches a superabsorbent polymer having the claimed swelling ratio and absorption characteristics as the polymer claimed and thus the polymer of Lea and Eisinger in view of Wada would have inherent capabilities to absorb urea in urine and thus suppress inhibition of the antigen-antibody reaction.
Regarding claim 3, as described above, Wada teaches that the chromatography method can be conducted with samples such as urine, which inherently include urea (paragraph 0060). While Wada in view of Lea do not specifically teach the method wherein a concentration of urea in the concentrated and mixed solution is 5 times or less with respect to a concentration of urea in the solution capable of containing an antigen, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 3 are for any particular purpose or solve any stated problem, and the prior art teaches the use of urine samples, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the immunological methods art.
Regarding claim 4, Lea teaches the method 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 (page 8, lines 14-29, Favor-Pac 100).
Regarding claim 6, Lea teaches the method 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 (page 8, lines 14-29, Favor-Pac 100).
Regarding claims 13 and 15-16, Lea teaches that the reagents may be include monoclonal antibodies (page 4, line 17-18) that can be labeled with a colloidal particle (page 6, line 31- page 7, line 2). However the reference fails to specifically teach that the monoclonal antibody is labeled with a gold colloidal particle. Wada teaches the use of monoclonal antibodies labeled with colloid gold particles (paragraph 0128). It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the monoclonal antibody-labeled colloidal particle in the method Lea with a colloidal gold particle as taught by Wada because Lea is generic regarding the type of colloidal particle that can be used to label the monoclonal antibody and one would have been motivated to choose the appropriate colloidal particle based on the desired detection signal.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lea et al. (WO 2006/007711, Pub Date: 01/26/2006, IDS, hereinafter “Lea”, previously cited) in view of Eisinger et al. (US 4,943,522) and Wada (US 2014/0087367), as applied to claim 1 above (hereinafter “Modified Lea”), and further in view of Lee (WO 2008/143406, Pub Date: 11/27/2008).
Regarding claim 20, while Modified Lea does not specifically teach the method wherein casein and tricine are mixed in addition to the solution capable of containing an antigen, the superabsorbent polymer, and the labeled antibody, Lee teaches an assay diagnostic kit (abstract) wherein an extraction solution is used to obtain and preserve the reagents, wherein the solution contains both Tricine and casein (page 3, i7).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the method of Modified Lea, a solution containing both Tricine and casein as taught by Lee because it would have been desirable to preserve the reagents during the reaction.
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 1-3, 7 and 13-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 7 and 18-19 of copending Application No. 17/690101 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because regarding instant claim 1, reference application 101 recites an immunological test method comprising: concentrating an antigen-containable solution by mixing the antigen-containable solution with a superabsorbent polymer to obtain an antigen-concentrated solution; and detecting an antigen in the antigen-concentrated solution using an antigen-antibody reaction, wherein a swelling ratio of the superabsorbent polymer is more than 0.2 g/g and less than 800 g/g, and an antibody that is used in the antigen-antibody reaction is a monoclonal antibody (reference claim 1).
Additionally, reference claim 2 reads on instant claim 18, reference claim 3 reads on instant claim 2, reference claim 7 reads on instant claim 19, reference claim 13 reads on instant claim 5 and reference claim 14 reads on claim 7.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed 04/28/2026 have been considered but are found to be moot in view of the new grounds of rejection applied to the newly amended claims. While Applicants persuasively argued against the teachings of Kobayashi, the claims remain unpatentable based on the teachings of Lea, as evidenced by Darnett, in view of Eisinger and Wada, as described above. While Lea was cited in previous office actions to reject the claims, the reference has been reintroduced as deemed necessary by claim amendments and in combination with evidence from Darnett.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/ Primary Examiner, Art Unit 1677
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