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 .
DETAILED ACTION
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 27 Jul 2026 has been entered.
Claims 1-10 remain pending in the application.
Claims 1, 5, and 6 are amended.
Claim 11 is cancelled.
Claims 1-4 and 7-10 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 5 and 6 are under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 14 Jul 2026 is in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Objections Withdrawn
Objections to the Claims
The claim objections set forth in the Non-Final Office Action mailed 05 May 2026 are hereby withdrawn in light of applicant’s amendments of the claims.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejection of claims 5 and 6 pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 05 May 2026 is hereby withdrawn in light of applicants amendment of the claims.
Rejections Pursuant to 35 USC § 103
The rejection of claims 5 and 6 under 35 U.S.C. 103 as being unpatentable over Takeshi et al. (JP2003-344406, published 03 Dec 2003, listed in IDS filed 05 Sep 2023) is withdrawn in light of applicant’s amendment of the claims, and the art is reapplied in the new grounds of rejection set forth below.
Rejections Pursuant to Double Patenting
The rejection of claims 5 and 6 under double patenting is withdrawn in light of applicant’s amendment of the claims, and the rejection reapplied in the new grounds of rejection set forth below to address the claim amendments.
New Grounds of Rejections
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.
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.
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.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Takeshi et al. (JP2003-344406, published 03 Dec 2003, listed in IDS filed 05 Sep 2023).
Takeshi teaches a developing solvent for an immunochromatography method ([0001]). Takeshi teaches that the developing solvent is for preventing non-specific aggregation and non-specific reaction at the time of measurement ([0008]). As part of the developing solvent Takeshi teaches a polymer having a phosphorylcholine group ([0009]). Takeshi teaches exemplary phosphorylcholine monomers including
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([0016]) and identifies 2-methacryloyloxyethyl ester phosphorylcholine or MPC as a particularly preferred monomer ([0015]). MPC has the structural form shown above where X is a methyl group, and Takeshi teaches that the phosphorylcholine monomer may be used alone as a homopolymer ([0013], [0017]) thus rendering obvious the structure of the sensitizer of formula [4] as claimed where n and p are 0. The examiner notes that the unit “m” being 100 to 30 in the claimed structure is in the context of the ratio of the individual monomers m:n:p and does not represent a range of monomer units. The only requirement is that “m” is a constitutional unit number, thus meaning that it can be present in any amount.
Takeshi teaches that the phosphorylcholine monomers may be used with two or more in combination ([0017]). Takeshi teaches copolymerizing the phosphorylcholine monomer with hydrophilic monomers including acrylic acids such as methacrylic acid ([0018-0021]). Methacrylic acid renders obvious the monomer unit enclosed by “q” in formula [5]. Takeshi teaches an MPC/methacrylic acid copolymer ([0052], Table 1) which renders obvious the formula [5] as claimed. Takeshi teaches that when the phosphorylcholine (PC) polymer is a copolymer of a PC monomer and another monomer, the content of the PC monomer in the PC polymer is from 2 to 98 mol% ([0028]), rendering obvious the ratio of m:q as claimed.
Takeshi teaches the developing solvent for use with an immunochromatographic test strip ([0040]). Takeshi teaches a test strip as in Figure 1 having an impregnation member, a sample addition member and a membrane carrier made of a nitrocellulose membrane filter in the form of an elongated strip ([0041-0042], Figure 1). Takeshi teaches that the developing solvent is mixed with a biological sample and injected onto the sample addition member of the test strip where it passes through to the impregnation member and then developed in the membrane carrier to reach a capture site ([0048]). Thus, the impregnation member, sample addition member and membrane carrier are understood to render obvious the conjugate pad, sample pad and development membrane of the instrument of claim 6. Takeshi teaches the invention is used for testing a variety of samples ([0038]) and that the analyte is not limited as long as it can be detected by immunochromatography, including viruses ([0039]).
The examiner notes that claims 5 and 6 further recite that the instrument is “for immunochromatographically assaying novel coronavirus (SARS-CoV-2) IgM antibodies and/or IgG antibodies as assay target substances.” This limitation is understood as an intended use of the claimed instrument and the examiner notes that the intended use of a product claim carries no patentable weight. See MPEP 2111.02. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"). The test strips with developing solvent comprising the polymer described above, as taught by Takeshi, render obvious the limitations as claimed for the instrument and is capable of immunochromatographic assays.
Takeshi does not expressly teach selecting the 2-methacryloyloxyethyl ester phosphorylcholine MPC polymer in combination with the MPC/methacrylic acid copolymer with the immunochromatographic test strips with sufficient specificity to rise to the level of anticipation.
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have formed an immunochromatographic test strip with a developing solvent comprising a polymer of MPC and a copolymer of MPC/methacrylic acid. One of ordinary skill in the art would have been motivated to do so as developing solvents with polymers are taught by Takeshi as for immunochromatography methods such as test strips and Takeshi teaches MPC polymer and MPC/methacrylic acid copolymer as polymers for the development solvent. Takeshi render obvious using combinations of PC monomers and further it is noted that "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One of ordinary skill in the art would have a reasonable expectation of successfully forming an immunochromatographic test strip with MPC polymer and MPC/methacrylic acid copolymer as taught by Takeshi since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Takeshi.
Response to Arguments
Applicant's arguments filed 27 Jul 2026 have been fully considered but they are not persuasive. Applicant states that they have unexpectedly discovered the advantageous effects of a sensitizer comprising a polymer represented by formula [4] and a copolymer represented by formula [5] (page 9 of remarks). Applicant argues that tables 1-6 of the specification show that sensitivity is improved when polymer 1, 3, or 4 is used in combination with polymer 6 (page 9 of remarks). Applicant argues that Takeshi does not disclose or suggest a sensitizer comprising a combination of polymer and copolymer as claimed (page 9 of remarks).
The examiner does not find this persuasive. Insofar as the applicant is arguing for unexpected results, the results pointed to are not sufficient to overcome the prima facie case of obviousness. As described, the combination of components from formula [4] and [5] is obvious for immunochromatographic analysis from Takeshi. While secondary considerations must be taken into account, they do not necessarily control the obviousness conclusion. The examiner notes that the combination of polymer 1, 3, or 4 with polymer 6 is not commensurate in scope with the claims as the variables for m, n, and p in formula [4] and m and q in formula [5] cover a much broader array of compounds than the limited selected tested. There is no evidence that the same sensitivity benefits asserted by the applicant would be present in the much broader scope of compounds as claimed.
Further, the results should demonstrate a difference in kind, rather than degree. See In re Huang, 100 F.3d 135, 139 (Fed.Cir.1996) (holding that claimed ranges must “produce a new and unexpected result which is different in kind and not merely in degree from results of the prior art”). The Court explained that a “32—43% increase in stress-rupture life, however, does not represent a ‘difference in kind’ that is required to show unexpected results.” Harris, 409 F.3d at 1344. Here, the applicant asserts “sensitivity is improved by using polymer 1, 3, or 4 in combination with polymer 6” but without any persuasive reason why improved sensitivity is unexpected, the asserted unexpected result data receives less persuasive weight.
Regarding the argument that Takeshi does not disclose or suggest a sensitizer comprising a combination of polymer and copolymer as claimed, the examiner does not find this persuasive as Takeshi teaches polymers that correspond the with claimed formulas [4] and [5] for immunochromatography and combinations and it would be obvious to use the formulas such as MPC and MPC/methacrylic acid copolymer as taught for their known use of immunochromatography.
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 5 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of copending Application No. 19/154,603 (reference application) in view of Takeshi et al. (JP2003-344406, published 03 Dec 2003, listed in IDS filed 05 Sep 2023).
Reference claim 4 recites an instrument for immunochromatographic assay of hepatitis virus as an assay target substance comprising a sensitizer of structure
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Thus, the reference claim renders obvious an instrument for immunochromatography comprising a sensitizer that renders obvious the sensitizer of formula [4] of the instant claims. It is noted that the instrument of the reference claim has an intended use for assay of hepatitis virus whereas the instant claims have an intended use of assay for novel coronavirus. The claims, however, are directed to an instrument and the intended use of a product claim carries no patentable weight. See MPEP 2111.02. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation").
The reference claim does not recite a copolymer of formula [5] and does not specifically recite a development membrane, a sample pad or a conjugate pad. These deficiencies are made up for in the teachings of Takeshi.
The teachings of Takeshi are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used the instrument for immunochromatography and the cited sensitizer and an MPC/methacrylic acid copolymer with an immunochromatographic test strip comprising an impregnation member, sample addition member and membrane carrier which are understood to render obvious the conjugate pad, sample pad and development membrane. Takeshi teaches similar polymers as the reference claims for use with immunochromatographic assays with test strips comprising an impregnation member, sample addition member and membrane carrier and teaches MPC/methacrylic acid copolymers. Takeshi renders obvious combination of monomers and, further, "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Thus, test strips with these components are known standard elements with test strips for immunochromatography and it would be obvious for the instrument to have these features for the purposes of immunochromatography.
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 27 Jul 2026 have been fully considered but they are not persuasive. Applicant argues that Takeshi does not disclose or suggest a sensitizer comprising a combination of polymer and copolymer as claimed (page 10 of remarks).
The examiner does not find this persuasive as Takeshi teaches polymers that correspond the with claimed formulas [4] and [5] for immunochromatography and combinations and it would be obvious to use the formulas such as MPC and MPC/methacrylic acid copolymer of Takeshi and the reference claims for their known use of immunochromatography.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.C.M./Examiner, Art Unit 1619 /ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
