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 .
Response to Amendment
The amendment filed 26 May 2026 in which claims 1, 7, and 8 were amended and claim 6 was cancelled has been entered.
Claims 1-5 and 7-9 are under examination on the merits.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, maintained for claims 1-9). 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.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn for claims 1-5 due to amendment to claim 1). Claims 1-5 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lo.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(New rejection, as to claims 1-5, necessitated by amendment, maintained for claim 7, and withdrawn as to claims 6, due to cancellation, and 8 due to amendment). Claims 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Lo and further in view of Aydin.
Regarding claims 1 and 7, Lo teaches 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). 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.
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 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.
(New rejection, as to claim 8 necessitated by amendment). Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lo and Aydin and further in view of Promega (Protease Inhibitor Cocktail, available at https://www.promega.com/products/protein-purification/protein-purification-kits/protease-inhibitor-cocktail/ and accessed on 08/04/2026 using the WayBack Machine for publication date 08/03/2020 at https://web.archive.org/web/20200803172734/https://www.promega.com/products/protein-purification/protein-purification-kits/protease-inhibitor-cocktail/?catNum=G6521).
As discussed above, claims 1-5 and 7 were rendered prima facie obvious over Lo and Aydin.
Regarding claim 8, Lo and Aydin teach combining the culture fluid with a protease inhibitor (pg. 10 column 2). Lo and Aydin do not teach adding a second protease inhibitor. However, Promega teaches a protease inhibitor cocktail containing 6 different inhibitors (Overview).
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 Lo and Aydin for a method of producing a positive antigen-based control for detecting a pathogen and the teachings of Promega for protease inhibitor cocktail. Promega provides motivation by teaching that the cocktail includes 6 different inhibitors that cover a wide range of proteases (Overview). One of skill in the art would have had a reasonable expectation of success in combining the teachings of Lo, Aydin, and Promega because they all teach protein 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.
(Previous rejection withdrawn, as to claim 9 due to amendment). Claim 9 was rejected under 35 U.S.C. 103 as being unpatentable over Lo and further in view of Goodrich.
(New rejection, as to claim 9 as necessitated by amendment). Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lo and Aydin, as applied to claims 1-5 and 7 above, and further in view of Goodrich.
As discussed above, claims 1-5 and 7 were rendered prima facie obvious over Lo and Aydin.
Lo teaches that total inactivation of SARS-CoV-2 occurs after 30 seconds (Figure 2). Lo and Aydin do 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).
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.
Response to Arguments
Applicant contends on pages 5-6 of the Remarks submitted on 26 May 2026 that the term “about” is defined in the Specification (¶0033 and 0037) and that one of skill in the art would understand the approximation for concentration and time as there is natural imprecision in measuring these parameters.
In response: The definitions given for time periods are not definitive. In 0033, the time frame is given a 1-20, 1-14, and 5-15, and then about all minutes between 1 and 15. This is not a definitive definition of about 1-15 minutes. In 0037, the “about” difference is defined by listing all percentages between 1 and 50%. This is not a definitive definition of “about 50%”.
Applicant contends on pages 6-8 of the Remarks submitted on 26 May 2026 that Aydin’s teachings on protease inhibitors are not relevant to Lo’s method. Aydin is measuring peptide/protein concentration in biological fluids while Lo is measuring SARS-CoV-2 in a laboratory setting, not using biological fluids and that the instant application uses proteases to minimize the deleterious effects on proteins and reduce or eliminate their breakdown while the reference, Lo is concerned with the opposite.
In response: The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The protease inhibitor taught by Aydin can be used in the method taught by Lo. Even though the two references may not have the same aim that does not mean that the protease inhibitor has a different function, inhibiting proteases.
Lo may be concerned with the degradation of SARS-CoV-2 proteins by disinfection but one of skill in the art would still use a protease inhibitor in Lo’s assays to ensure when testing for disinfection that the results occurred from true disinfection rather than proteases. A protease inhibitor in Lo would make objective sense to one of skill in the art to ensure accuracy of results.
Conclusion
NO CLAIMS ARE ALLOWED
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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