DETAILED ACTION
Election/Restrictions
Applicant’s election of species c) metal salt and cationic polymer, in the reply filed on June 18, 2026 is acknowledged.
Claims Summary
Claims 1-12 and 22
Claim 1 is directed to an immunoassay method, immunochromatography (claim 7), for detecting a protein with an isoelectric point of 9.5 or higher. The method comprises bringing a sample containing the protein into contact with a glass material in the presence of a cationic substance, specifically, wherein the sample is contacted with the cationic substance, followed by bringing the protein into contact with the glass material (claim 2). In another embodiment, prior to the step of bringing the sample into contact with the glass material, the sample is contacted with a specimen diluent that contains the cationic substance (claim 4). In another embodiment, the protein complexed with a first binding partner to which a labeling substance is directly or indirectly bound, thereby forming a first complex, followed by contacting the first complex with a second binding partner to form a second complex, and then detecting a signal derived from the labeling substance (claim 9).
The protein is derived from a respiratory infection virus (claim 10), specifically coronavirus (claim 11), more specifically SARS-CoV-2 (claim 12).
The glass material is a specimen filtration filter containing glass fibers (claim 3). The specification teaches that the term “glass” means glass having silicon dioxide (SiO2) as a constituent component (see paragraph [0051] of the published application US 2024/0377396). The glass material is a sample pad, a third pad, or a conjugate pad of an immunochromatography test strip (claim 8). A third pad refers to a pad positioned between a sample supply part and an insoluble membrane carrier, different from the sample pad and the conjugate pad (see paragraph [0056] of the published application).
The cationic substance comprises a mixture of a metal salt and a cationic polymer (claims 5 and 6, elected species). According to the specification, the term “cationic polymer” means a polymer having a cationic functional group as a side chain (see paragraph [0063] of the published application). Claim 22, a product claim, is directed to a specimen diluent containing a cationic substance for use in the immunoassay method of claim 1.
Claims 13-21
Claim 13 is directed to an immunochromatography kit for detecting a protein with an isoelectric point of 9.5 or higher, comprising:
A specimen diluent;
An immunochromatography test strip;
A cationic substance; the cationic substance is contained within the specimen diluent (claim 16); the cationic substance comprises a mixture of a metal salt and a cationic polymer (claims 17 and 18, elected species) and
A glass material; the glass material is within a specimen filtration filter (claim 14), within a sample pad in the test strip (claim 15), within a conjugate pad in the test strip (claim 15), or within a conjugate pad in the test strip (claim 15)
The protein is derived from a respiratory infection virus (claim 19), specifically coronavirus (claim 20), more specifically SARS-CoV-2 (claim 21).
Claim 23
Claim 23 is directed to a filtration method for a sample containing a protein with an isoelectric point of 9.5 or higher. The method comprises:
Contacting a sample containing the protein with a specimen diluent that comprises a cationic substance; and
Filtering the sample diluted with the specimen diluent using a specimen filtration filter containing a glass material
Claim 24
Claim 24 is directed to an immunoassay method for detecting a protein with an isoelectric point of 9.5 or higher. The method comprises suppressing adsorption of the protein to a glass material. The method comprises bringing a sample containing the protein into contact with a glass material in the presence of a cationic substance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 and 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshida et al. (US 2015/0086974 A1, “Yoshida”). The claims are outlined above and correlated with the teachings of the prior art in bold font below.
Yoshida discloses a method of immunochromatography comprising a step of supplying a sample to a test strip comprising a membrane having a sample-supply portion (sample pad), a spreading portion (conjugate pad), and a detecting portion (see paragraphs [0125]-[0126]) (claims 7 and 8). The spreading portion comprises a colloidal-gold-labeled antibody conjugated to an analyte (conjugate pad) (see paragraph [0127]). The sample comprises blood and is contacted with hexadimethrine bromide (a cationic polymer) in the sample-supply portion or in the upstream of the sample-supply portion, in order to agglutinate red blood cells (see paragraphs [0046], [0076]-[0078] and [0128]) (claims 1-4, 23 and 24, aspects of cationic polymer, glass, glass fibers, sample contacted with cationic substance before glass material). Aggregates are separated and removed from the sample, and the remaining sample is contacted with the colloidal-gold-labeled antibody conjugated to an analyte (see paragraph [0129]), which is then contacted with an immobilized antibody in the detecting portion (see paragraph [0039] (claim 9). The resulting complex is detected via signals from the colloidal gold (see paragraphs [0123] and [0131]) (claim 9). Yoshida also discloses the use of a third pad to remove unnecessary components (see paragraphs [0090]-[0093]) (claim 8). The sample pad, the third pad and the conjugate pad are comprised of glass, such as glass fibers (see paragraphs [0084], [0088], [0092]) (claims 5 and 6).
Additionally, Yoshida discloses a diluting solution comprising a mixture of saline (sodium chloride, a metal salt, plus water) and hexadimethrine bromide (a cationic polymer) (see paragraphs [0046] and [0075]-[0078]) (claim 22). Although Yoshida does not explicitly teach that the solution is capable of use in an immunoassay to detect a protein with an isoelectric point of 9.5 or higher, the fact is that Yoshida’s diluting solution comprises a cationic substance, hexadimethrine bromide, which is one of the cationic polymers that Applicant discloses in the specification (see paragraph [0063] and Table 6 of the published application). Thus, Yoshida’s product is expected to be capable of use in the claimed method.
Yoshida does not characterize the isoelectric point of any of the target analytes, but teaches that the analyte is a substance found in blood, RBCs, serum, plasma, urine, saliva or sputum (see paragraph [0112]). Examples of analytes include various types of proteins, including the viruses HBV and HCV (see paragraph [0012]). Since Yoshida discloses a method and reagents that meet the limitations of the instant claims, Yoshida’s method would necessarily detect proteins having an isoelectric point of 9.5 or higher, and filter a sample containing proteins having an isoelectric point of 9.5 or higher (claims 1 and 23). Although Yoshida does not appreciate that the cationic substance suppresses adsorption of proteins having an electric point of 9.5 or higher to a glass material, such is a necessary outcome given the same reagents and method steps (claim 24). Therefore, the claimed embodiments are anticipated by the prior art.
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.
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 10, 11 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida et al. (US 2015/0086974 A1, “Yoshida”) as applied to claims 1-8 above, and further in view of Rappouli et al. (US 2006/0257852 A1, “Rappouli”). The claims are outlined above and correlated with the teachings of the prior art in bold font below.
The teachings of Yoshida are outlined above, however, Yoshida does not disclose kits nor proteins derived from respiratory infection virus, specifically coronavirus. Rappouli discloses diagnostic kits comprising diagnostic reagents such as antibodies and antigens (see paragraph [0023]). It would have been obvious to have packaged Yoshida’s immunoassay test strips into a kit for storage, transportation and marketing purposes with a reasonable expectation of success (claims 13-18).
It would have been obvious to have chosen a SARS antigen for Yoshida’s immunoassay given its global significance (see Rappouli, abstract). Rappouli discloses an ELISA for detecting SARS spike protein (see paragraph [0755]), thus one would have had a reasonable expectation of success that the spike protein would have been detectable in the immunoassay of Yoshida (claims 10, 11, 19 and 20). Therefore, the claimed embodiments would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 12 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida et al. (US 2015/0086974 A1, “Yoshida”) in view of Rappouli et al. (US 2006/0257852 A1, “Rappouli”) as applied to claims 1, 10, 11, 13, 19 and 20 above, and further in view of Deeks et al. (Cochrane Database of Systematic Reviews, June 25, 2020, 6:CD013652, 306 pages, “Deeks”).
Claims 12 and 21 are directed to embodiments wherein the protein is from SARS-CoV-2. The teachings of Yoshida and Rappouli are outlined above, neither of which disclose SARS-CoV-2 protein since it was not known yet. Deeks discloses antibody tests for SARS-CoV-2 infection (see page 7, left column, last paragraph, right column, top paragraph). It would been obvious to have applied Yoshida’s and Rappouli’s teachings to a SARS-CoV-2 protein given the global significance of SARS-CoV-2 (see page 1, abstract, background), with a reasonable expectation of success given the immunoassays disclosed by Deeks. Therefore, the claimed embodiments would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of copending Application No. 18/862,623 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Co-pending claims 1-31 are directed to a method and reagents to detect a substance having an isoelectric point of 10.0 or more, brought into contact with a glass-made member in the presence of a cationic substance, such as a cationic polymer and metal salt. The co-pending claims are essentially a species of the instantly claimed genus of claims 1-23. A species anticipates a genus. Regarding instant claim 24, directed to an immunoassay method wherein adsorption of the protein to glass is suppressed due to the presence of a cationic substance, while the co-pending claims do not have a limitation about suppression of adsorption of the protein to glass, such is a necessary outcome given the same reagents and method steps the co-pending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
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