DETAILED ACTION
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 .
Priority
Applicant does not claim priority to any foreign and U.S. Provisional applications, as such, for the purposes of applying prior art, the effective filing date is 06 September 2023.
Election/Restrictions
Applicant’s election without traverse of Group I, corresponding to claims 1-11 in the reply filed on 04 June 2026 is acknowledged. Claims 12-19 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04 June 2026.
Claim Objections
Claims 10-11 are objected to because of the following informalities: “SARS-Cov-2” should read “SARS-CoV-2”. Appropriate correction is required.
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.
Claim 3 is 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.
Claim 3 recites the limitation "the infectious agent" in line 2, but there is no mention of an infectious agent in claim 1 for which it depends. There is insufficient antecedent basis for this limitation in the claim.
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 1-5 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Faizo, et al. (Diagnostics (Basel). 2021 May 2;11(5):825., hereinafter Faizo) and further in view of Neumair, et al. (Anticancer Res. 1999 Jan-Feb;19(1A):13-21., hereinafter “Neumair”) and Surmodics ELISA Troubleshooting (https://shop.surmodics.com/elisa-test-results-troubleshooting, accessed via the WayBack Machine at https://web.archive.org/web/20220819073020/https://shop.surmodics.com/elisa-test-results-troubleshooting published 19 August 2022, hereinafter “Surmodics”) as evidenced by Sensi, et al. ( Bio Protoc. 2022 Dec 5;12(23):e4562., hereinafter ‘Sensi”) and Pan, et al. (FASEB J. 1995 Jan;9(1):43-9. , hereinafter “Pan”).
Regarding claim 1-2, 8-9, and 11, Faizo teaches a method for conducting an indirect ELISA to detect human IgG antibodies to SARS-CoV-2 antigens in biological samples (Title). Faizo does not teach pre-treating the biological sample with an anti-idiotypic antibody to remove antibodies that cross react with the desired antigen from the sample. However, Neumair teaches removing antibodies from a sample using an anti-idiotypic antibody affinity column (abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have combined the teachings of Faizo for a SARS-CoV-2 indirect ELISA and the teachings of Neumair for an anti-idiotypic antibody affinity column because Surmodics teaches that cross-reactive antibodies are known in the art to cause high background (pg. 2 high background) and false positives (pg. 3 false positives) when testing samples with an indirect ELISA. One of skill in the art when faced with this problem of cross-reactive antibodies causing false positives and high background during indirect ELISA would have been motivated to select a known way to remove the unwanted antibodies from the sample, including anti-idiotypic antibody affinity columns. Using these columns would lead to a predictable outcome of removing the undesired, cross-reactive antibodies from the sample, leaving, in the flow-through, only the antibodies that bind to the target antigen, therefore reducing false positives and lowering the background. One of skill in the art would have had a reasonable expectation of success in combining the teachings of Faizo, Neumair, and Surmodics because they all teach antibodies.
Regarding claim 3, Faizo teaches antibodies against SARS-CoV-2 antigens. As evidenced by Pan, anti-idiotypic antibodies are antibodies that are elicited against the variable region of other antibody molecules, meaning they are variable and manipulatable (abstract). Therefore, an anti-idiotypic antibody against a SARS-CoV-2 antigen would be a mirror image of the SARS-CoV-2 antigen.
Regarding claim 4-5, Neumair teaches the anti-idiotypic antibody affinity column and as evidenced by Sensi affinity purification columns contain beads on which the proteins are immobilized (Abstract).
Regarding claim 10, Faizo teaches that antibodies raised against HKU1 are cross-reactive with SARS-CoV-2 antigens (abstract) and that the indirect ELISA detects antibodies against SARS-CoV-2 antigens (Title). As evidenced by Pan, anti-idiotypic antibodies can be raised against any antibody (abstract). Therefore, the antibody can be against HKU1 which cross-reacts with SARS-CoV-2.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Faizo, Neumair, and Surmodics as evidenced by Sensi and Pan as applied to claims 1-5 and 8-11 above, and further in view of Wesselhoeft, et al. (KR 20230069042, hereinafter “Wesselhoeft”) as evidenced by Leinco Technologies Immunoprecipitation protocol (https://www.leinco.com/immunoprecipitation/ and available at the WayBack Machine at https://web.archive.org/web/20110214183739/http://www.leinco.com/immunoprecipitation published on 14 February 2011, hereinafter “Leinco”)
As discussed above, claim 1-5 and 8-11 were rendered prima facie obvious over Faizo, Neumair, and Surmodics as evidenced by Sensi and Pan.
Regarding claim 6, Faizo, Neumair, and Surmodics do not teach adding the anti-idiotypic antibody to a liquid phase without immobilization on a support and then removing the precipitate by centrifugation. However, Wesselhoeft teaches using anti-idiotypic antibodies for immunoprecipitation to purify antigen-binding proteins from cell cultures (¶2049). As evidenced by Leinco, immunoprecipitation involves adding an antibody to a liquid phase to bind with the desired antigen with immobilizing the antibody to a support and then centrifuging the sample to remove the precipitate (Immunoprecipitation image).
It would have been prima facie obvious to one of ordinary skill in the art to have substituted the affinity column taught by Neumair for the immunoprecipitation taught by Wesselhoeft. Both affinity columns and immunoprecipitation are methods of purifying antibodies and are functionally equivalent methods of purification to yield an identical, predicable, result. One of skill in the art would have had a reasonable expectation of success in substituting the affinity column taught by Neumair for the immunoprecipitation taught by Wesselhoeft because they are both methods of antibody purification.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Faizo, Neumair, and Surmodics as evidenced by Sensi and Pan as applied to claims 1-5 and 8-11 above, and further in view of Liu, et al. (Ecotoxicol Environ Saf. 2009 Sep;72(6):1673-9., hereinafter “Liu”).
As discussed above, claim 1-5 and 8-11 were rendered prima facie obvious over Faizo, Neumair, and Surmodics as evidenced by Sensi and Pan.
Regarding claim 7, Faizo teaches an indirect ELISA where the antigen is from SARS-CoV-2. Faizo and Neumair do not teach that the antigen is from an environmental sample. Liu teaches an indirect ELISA where the antigen is from an environmental sample (pg. 1678).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the SARS-CoV-2 antigen taught by Faizo for the environmental sample antigen taught by Liu. Indirect ELISAs can use a variety of different antigens based on the desired assay and desired measurement (materials 2.) One of skill in the art would have had a reasonable expectation of success of substituting the SARS-CoV-2 antigen taught by Faizo for the environmental sample antigens taught by Liu because they are both antigens used in indirect ELISAs.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cassandra Senn Grizer whose telephone number is (571)272-2292. The examiner can normally be reached M-Th 0630 - 1700 ET.
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/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
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