DETAILED NOTICE
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
Acknowledgement is made of Applicants’ claim for benefit to prior filed US Provisional applications 63/357,415 (filed on 06/30/2022), 63/378,735 (filed on 10/07/2022) and 63/490,886 (filed on 03/17/2023).
Election/Restrictions
Applicant's election with traverse of Group I drawn to claims 1-9 in the reply filed on 04 February, 2026 is acknowledged. The traversal is on the ground(s) that no undue search burden is evident between the two groups. However, this is not found persuasive at least because Groups I-II are written independently from each other and the Groups have acquired a separate status in the art at least because of their different classifications.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04 February, 2026.
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 1-9 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.
The term “about” in claims 1 and 9 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “about" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The difference in concentrations between the first and second concentrations and the time period of electromagnetic irradiation are rendered indefinite by the use of the term “about”.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lo, et al. (Sci Rep 11, 13804 (2021), NPL-IDS, filed, 10/20/2023, hereinafter “Lo”).
Lo discloses a method of inactivating SARS-CoV-2 with UV-C, while maintaining the protein concentration and structure (Abstracta and Figure 3B). While using the inactivated virus as a positive-antigen based control is not explicitly disclosed by Lo, the instant Specification defines a the positive-antigen based control as “a culture fluid containing an inactivated pathogen” (¶00036), which is disclosed by Lo (Figures 1-3).
Regarding claim 1, Lo discloses a method for producing an inactivated pathogen, the method comprising (Abstract, Figure 3B): (1) the viral particles in media (Figure 1, Figure 3B), (2) exposing the media to UV for long enough to inactivate the particles (Figure 2, Figure 3B), and (3) after UV, the amount of protein detectable does not decrease more than 50% from the original protein concentration (Figure 3B).
Regarding claims 2-3, Lo discloses that that the pathogen is the virus SARS-CoV-2 (Abstract, Figures 1-3).
Regarding claim 4, Lo discloses that the detectable antigen is the SARS-CoV-2 nucleocapsid (Figure 3B).
Regarding claim 5, Lo discloses that the UV irradiation is provided by UV-C (Abstract, Figure 3B).
Accordingly, the claimed invention was anticipated by Lo.
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 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lo as applied to claims 1-5 above, and further in view of Aydin (Peptides. 2015 Oct;72:4-15.).
As discussed above, claims 1-5 were anticipated by Lo.
Regarding claims 6-8, Lo teaches a culture fluid with viral particles and inactivated viral particles (see claim 1 above). Lo does not teach combining the culture fluid or the inactivated virus with a protease inhibitor. However, Aydin teaches that a protease inhibitor is necessary in all steps of peptide analyses as it protects the target peptides against proteases, protease inhibitors are essential to maintain protein levels in samples to maintain consistency and confirmation that any changes are due to experimental methods and not proteases (pg. 10, column 2).
It would have been prima facie obvious before the effective filing date of the invention for one of ordinary skill in the art to have combined the teachings of Lo for a culture fluid with viral particles and inactivated viruses with the teachings of Aydin for a protease inhibitor. Aydin provides motivation by teaching teaches that a protease inhibitor is necessary in all steps of peptide analyses as it protects the target peptides against proteases, protease inhibitors are essential to maintain protein levels in samples to maintain consistency and confirmation that any changes are due to experimental methods and not proteases (pg. 10, column 2). One of skill in the art would have had reasonable expectation of success at combining Lo and Aydin because they both teach antigens for immunological assays.
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lo, as applied to claims 1-5 above, and further in view of Goodrich, et al. (WO 2021/178877, hereinafter “Goodrich”).
As discussed above, claims 1-5 were anticipated by Lo.
Regarding claim 9, Lo teaches that total inactivation of SARS-CoV-2 occurs after 30 seconds (Figure 2). Lo does not teach that inactivation by UV-C occurs for 1-15 minutes. However, Goodrich teaches that inactivation of viruses for use in vaccines and as positive antigen-based controls can occur with UV-C light from 1-60 minutes (¶0116).
Routine optimization of Lo’s inactivation time period would have led to the claimed range of a time period between 1 to 15 minutes because Goodrich teaches that the dose of UV light may vary depending on the volume of media, with pathogen, being treated (¶0114) and that the time period is 1 to 60 minutes to inactivate a pathogen for use in a vaccine or as a positive control for assays (¶0116 and 0151). The person of ordinary skill in the art would have found it obvious to optimize the time period of pathogen inactivation for a vaccine or positive control by starting optimization from the time period taught by Goodrich because Goodrich teaches that the dose of UV light may vary depending on the volume of media, with pathogen, being treated (¶0114)
It would have been further be obvious that the time period for viral inactivation for use in a vaccine or positive antigen-based control is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal time period of UV-C needed to achieve the desired results. The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 2.
Accordingly, the claimed inventions were 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