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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/14/2026 has been entered.
Status of Claims
Claims 1 and 3 have been amended. Claims 2, 5, 8 and 14 have been cancelled. Claims 1, 3-4, 6-7, 9-13 and 15-20 remain pending and examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11 and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 11 and 17 are dependent upon cancelled claim 5.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 6-7, 9-13 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi (US 2017/0322202, Pub Date: 11/09/2017) in view of Wada (US 2014/0087367, Pub Date: 03/27/2014, IDS).
Regarding claims 1 and 3, Kobayashi teaches throughout the publication an immunological test device and method (paragraph 0160), comprising: a concentration step (paragraphs 0093 and 0100) which is a step of mixing a solution capable of containing an antigen (paragraphs 0091 and 0154), a superabsorbent polymer (paragraph 0103), 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 (paragraph 0160), and a detection step which is a step of detecting the composite bodies in the concentrated and mixed solution using an antigen-antibody reaction (paragraph 0156-0160), wherein a swelling ratio of the superabsorbent polymer is 20 g/g or more and less than 800 g/g (paragraph 0201, Aqualic CA – as evidenced by Nippon) and whereby detection sensitivity is improved through use of the superabsorbent polymer (paragraph 0100).
While Kobayashi 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 Kobayashi to incorporate a urine sample as taught by Wada because Kobayashi is generic regarding the type of samples that can be incorporated in the immunological method (paragraph 0154) and one skilled in the art would have been motivated to choose the appropriate sample based on the desired analytes to be detected. While Kobayashi 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. Kobayashi teaches a superabsorbent polymer having the claimed swelling ratio and absorption characteristics as the polymer claimed and thus the polymer of Kobayashi in view of Wada would have inherent capabilities to absorb urea in urine and thus suppress inhibition of the antigen-antibody reaction.
While Kobayashi in view of Wada 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 as recited in claim 3, 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 claims 4 and 6, while Kobayashi teaches that the absorbent member has a very high water absorptivity per unit mass (paragraph 0093), the reference does not explicitly teach that the absorption rate is 0.01 g/min or more and 40 g/min or less per 1 g of the superabsorbent polymer. However, 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 4 and 6 are for any particular purpose or solve any stated problem, and the prior art teaches the benefits of a high absorption rate, 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 absorbent material art.
Regarding claims 7 and 9-12, Kobayashi teaches the method wherein the immunological test method is immunochromatography (paragraphs 0160 and 0242-0244).
Regarding claims 13 and 15-17, Kobayashi teaches the method wherein the labeled antibody is an antibody-modified gold colloid particle which is a monoclonal antibody capable of binding to the antigen, the monoclonal antibody is labeled with a gold colloid particle (paragraph 0160).
Regarding claim 18, Kobayashi teaches the method wherein the superabsorbent polymer is a polyacrylic acid-based polymer (paragraph 0105).
Regarding claim 19, Kobayashi teaches the method wherein a particle diameter of the superabsorbent polymer is 5 mm or less and 0.001 mm or more (paragraph 0108 and 0201, Aqualic – as evidenced by Nippon, diameter of 300-450 micrometer).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi (US 2017/0322202, Pub Date: 11/09/2017) in view of Wada (US 2014/0087367, Pub Date: 03/27/2014, IDS), as applied to claim 1 above (hereinafter “Modified Kobayashi”) and further in view of Lee (WO 2008/143406, Pub Date: 11/27/2008).
Regarding claim 20, while Modified Kobayashi 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 Kobayashi, 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, including: by adding dropwise the antigen-concentrated solution onto a gold colloid holding pad, which is a pad that holds modified gold particles which are gold particles modified with a first binding substance capable of binding to an antigen in the antigen- concentrated solution, of an insoluble carrier having the gold colloid holding pad and a reaction site at which a second binding substance capable of binding to the antigen has been immobilized, spreading gold particle composite bodies on the insoluble carrier, in a state where the gold particle composite bodies which are composite bodies of the antigen and the modified gold particles are formed: capturing the gold particle composite bodies at the reaction site of the insoluble carrier: and silver-amplifying the captured gold particle composite body, wherein the antigen is lipoarabinomannan or influenza virus, wherein a swelling ratio of the superabsorbent polymer is more than 0.2 g/g and less than 800 g/g, and both the first binding substance and the second binding substance are a monoclonal antibody (see reference claim 1).
Additionally, reference claim 2 reads on instant claim 18, reference claim 3 reads on instant claim 1, 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 12/15/2025 have been considered but are found to be moot in view of the new grounds of rejection applied to the newly amended claims. The rejections are drawn to the deficiencies of Lea, which is no longer being replied upon to teach the claimed invention. Kobayashi teaches an immunochromatography method and device incorporating the claimed swelling properties and thus the claims remain unpatentable based on the teachings of Kobayashi in view of Wada, as described above. While Kobayashi 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. Kobayashi teaches a superabsorbent polymer having the claimed swelling ratio and absorption characteristics as the polymer claimed and thus the polymer of Kobayashi in view of Wada would have inherent capabilities to absorb urea in urine and thus suppress inhibition of the antigen-antibody reaction.
Conclusion
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