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
Election Restrictions
1. Applicant’s election without traverse of Group I in the reply filed on 11/20/2025 is acknowledged.
Claims 9-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/20/2025.
Claims 4-8 are under consideration.
Information Disclosure Statement
2. The information disclosure statements (IDS) were submitted on 3/10/2023; 4/25/2023; 4/10/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
3. Claim 4 is objected to because of the following informalities: for improved clarity, claim 4 should recite “contacting the sample with an epitope for binding to the SARS-CoV-2 antibody” or “contacting the sample with an epitope for binding the SARS-CoV-2 antibody”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
4. Claims 4, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. ("Validation of a SARS-CoV-2 spike protein ELISA for use in contact investigations and sero-surveillance,” Biorxiv (2020))(cited in applicant's IDS submitted 3/10/2023) in view of Lan et al. (Detection of protein biomarker using a blood glucose meter," Mobile Health Technologies: Methods and Protocols, 99-109 (2015))(cited in the IDS submitted on 3/10/2023).
See claims, 4, 7 as submitted 3/10/2023.
See also the 35 U.S.C. 112(b) rejection above.
Freeman et al. teaches: detection of SARS-CoV-2 specific antibodies (abstract)(as recited in claim 4); using SARS-CoV-2 specific ELISA using spike protein (interpreted as epitope as recited in claim 4)(abstract); using HRP conjugated goat anti human antibodies to produce binding complex (secondary antibodies (p. 5)); wherein secondary antibody maximized sensitivity and specificity of the assay (p. 7); wherein the HRP catalyzes substrate into detectable reagent, and detecting the detectable reagent (pp 3-4, 5-6); Freeman et al. also teaches use of sample (sera, p. 4; from patients (p. 7))(as recited in claim 7).
Freeman et al. does not teach: use of invertase linked antibodies or invertase-linked antigen binding domains; sucrose; detecting glucose.
Lan et al. teaches: a system that mimics ELISA (abstract); wherein the traditional ELISA
assay is replaced with an aptamer binding assay (abstract); detection using BGM (blood glucose
monitor); including use of invertase for converting sucrose into glucose (p. 2); wherein aptamers
possess similar ligand binding properties as antibody (p. 2); conjugation of thiol-modified DNA
to invertase; in addition to aptamers, antibodies have also been used as target recognition
elements in BGM based assays (p. 2); wherein instead of using reporter proteins to generate signal such as HRP, invertase is used to generate glucose for convenient detection (p. 3).
One of ordinary skill in the art would have been motivated to use invertase linking to antibodies and sucrose as taught by Lan et al. in the assay of Freeman et al. Freeman et al. teaches a binding assay such as ELISA and detection of bound antibody to SARS-CoV-2 using secondary antibodies with reporter protein such as HRP, and Lan et al., which also teaches a binding assay such as ELISA, teaches a known method for also detecting bound antibody using invertase instead of HRP and the advantage wherein use of invertase to generate glucose leads to convenient detection (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using invertase linking to antibodies and sucrose as taught by Lan et al. in the assay of Freeman et al. There would have been a reasonable expectation of success given the underlying materials and methods (use of ELISAs and detection of binding complex using reporter-linked antibodies as taught by Freeman et al. and Lan et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
5. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. in view of Lan et al. as applied to claims 4, 7 above, and further in view of Goldstein et al. (WO 2021262728 A1)(See PTO-892: Notice of References Cited).
See claim 8 as submitted 3/10/2023.
See the teachings of Freeman et al. in view of Lan et al. above.
Freeman et al. in view of Lan et al. does not teach: oral fluid sample.
Goldstein et al. teaches: compositions and methods for sample collection and testing for the presence of viral antibodies in a sample (p. 1); including for SARS-CoV-2 (p. 2); use of oral samples (p. 4); use of saliva samples and blood sample (Example 4).
One of ordinary skill in the art would have been motivated to test oral sample as taught by Goldstein et al. with the method as taught by Freeman et al. in view of Lan et al. Freeman et al. in view of Lan et al. teaches use of sample and detection of SARS-CoV-2 antibodies, and Goldstein et al., which also teaches use of sample and detection of antibodies, including for SARS-CoV-2, teaches samples known and used in the art such as blood sample and oral fluid sample (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for testing oral sample as taught by Goldstein et al. with the method as taught by Freeman et al. in view of Lan et al. There would have been a reasonable expectation of success given the underlying materials (samples as taught by Freeman et al. in view of Lan et al. and Goldstein et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie 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.
6. Claims 4, 7, 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 21 of copending Application No. 18/840190.
See claims 4, 7, 8 as submitted 3/10/2023.
Claims 1, 2, 21 of copending Application No. 18/840190 recite a method of detecting an antibody to an antigenic polypeptide in a sample, the method comprising: a) contacting the sample with the antigenic polypeptide under conditions sufficient for the antibody to bind the antigenic polypeptide to produce a bound antibody; b) contacting the bound antibody with at least one recombinant antibody fusion protein to produce a binding complex, wherein the at least one recombinant antibody fusion protein is capable of binding to a human immunoglobin (IgG) and has an invertase catalytic activity of converting at least one substrate into at least one detectable product; c) contacting the binding complex with the at least one substrate under conditions sufficient to convert the at least one substrate into the at least one detectable product; and d) detecting the presence or absence of the at least one detectable product in the sample, wherein detecting the presence of the at least one detectable product in the sample indicates that the sample contains the antibody to the antigenic polypeptide, optionally wherein the method further comprises obtaining the sample from the subject, and optionally wherein the sample is an oral fluid, nasal fluid, saliva, blood, plasma, or serum; wherein the antigenic polypeptide is: a) a polypeptide of an infectious pathogen; b) a polypeptide of a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2); or c) a polypeptide of human origin; substrate comprising sucrose and the at least one detectable product comprises glucose.
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 4, 7, 8 and claims 1, 2, 21 of copending Application No. 18/840190 recite a method of detecting a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) antibody in a sample, the method comprising: contacting the sample with an epitope of the SARS-CoV-2 antibody under conditions sufficient for the SARS-CoV-2 antibody to bind the epitope to produce bound SARS-CoV-2 antibody; contacting the bound antibody with one or more invertase-linked antibodies, or invertase-linked antigen binding portions thereof, that bind to the bound SARS-CoV-2 antibody under conditions sufficient for the one or more invertase-linked antibodies, or the invertase-linked antigen binding portions thereof, to bind to the bound SARS-CoV-2 antibody to produce a binding complex; contacting the binding complex with sucrose under conditions sufficient for the invertase to convert the sucrose to fructose and glucose; and, detecting the fructose and/or the glucose, thereby detecting the SARS-CoV-2 antibody in the sample.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
7. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
A. Dimitrov et al. (US 10822379 B1)(See PTO-892: Notice of References Cited) teaches: materials involved in binding a molecule to SARS-CoV-2 antigen (column 1, line 15); S protein containing receptor binding domain (RBD) as a target for antibodies (column 1, line 38); wherein RBD binds to ACE2 which serves as receptor (column 1, line 42); wherein RBD-ACE2 interaction is of high affinity and highly specific (column 1, line 45); using ELISA, binding fragments and recombinant soluble ACE2 receptor extracellular domain as competitor (Example 1).
B. Hu et al. (CN 111366525 A)(See PTO-892: Notice of References Cited)(See also the WIPO English translation of CN 111366525 A)(See PTO-892: Notice of References Cited) teaches: method for detecting SARS-CoV-2 virus infection (title); including primary antibody ACE2 and fluorescent secondary antibody (Fig. 3).
8. Claims 5, 6 are objected to for depending on rejected claims.
9. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672