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
Claim Status
Claims 1-11 are pending.
Election/Restrictions
Applicant’s election without traverse of Group 3, claims 5 and 6, directed to an instrument for immunochromatographically assaying novel coronavirus IgM and/or IgG antibodies, in the reply filed on 15 Apr 2026 is acknowledged.
Claims 1-4 and 7-11 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.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.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05 Sep 2023 and 28 Oct 2024 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 5 and 6 are objected to for improperly referring to a withdrawn claim (i.e., claim 1). Claim 1 is withdrawn from consideration as being directed to a non-elected product of a sensitizer, whereas the elected invention is directed to the product of an instrument. Claims 5 and 6 would need to be written in independent form prior to allowance.
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 5 and 6 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.
Claims 5 and 6 recite “novel coronavirus (SARS-CoV-2).” The parenthetical statement renders the claims indefinite as it is not clear if the claims require that the novel coronavirus is SARS-CoV-2 or if this is merely exemplary and the claims are open to any novel coronavirus.
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 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 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 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. 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 as a polymer for the development solvent. One of ordinary skill in the art would have a reasonable expectation of successfully forming an immunochromatographic test strip with MPC polymer 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.
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 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 specifically recite a development membrane, a sample pad or a conjugate pad. This deficiency is 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 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. 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.
Conclusion
No claim is allowed.
Correspondence
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
Prosecution Insights