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 and species (SARS-CoV-2; SARS-CoV-2; NP; oral fluid) in the reply filed on 9/22/2025 is acknowledged.
Claims 75, 79, 86, 92, 97, 101, 106, 122, 125, 127, 134-136, 144 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 9/22/2025.
Claims 51-54, 57, 73 are under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) was submitted on 9/22/2025. 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 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.
3. Claims 52, 53 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.
See claims 52, 53 as submitted 3/16/2023.
Claims 52, 53 recite “capable of binding to at least one coronavirus”. However, claim 51 on which the claims depend recites “capable of binding to a coronavirus antigen”. It is not clear if the claims intend to recite antigen or virus or not.
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 51, 54, 57, 73 are rejected under 35 U.S.C. 103 as being unpatentable over Mertens et al. (CN101326441A)(See PTO-892: Notice of References Cited)(See also the WIPO English translation of CN101326441A)(2008))(See PTO-892: Notice of References Cited) in view of Fujimoto et al. (CN101283093A)(See PTO-892: Notice of References Cited)(See also the WIPO English translation of CN101283093A)(2008))(See PTO-892: Notice of References Cited).
See claims 51, 54, 57, 73 as submitted 3/16/2023.
Mertens et al. teaches: detecting analytes in biological samples [0002]; wherein samples are oral (saliva [0096])(as recited in claim 57); detecting virus [0099]; with solid support [0039].
Further, Merten et al. teaches: test strips [0002]; pad [0068]; device with first region containing porous material [0006](as recited in claim 51a); detection zone [0007]; absorption region [0008]; wherein three zones are in contact with one another to allow liquid to move [0010]; including for immunoassay and includes immunoassay reagent as capture reagent [0019]; wherein area 2 includes at least one analyte specific conjugate [0027]; forming at least one complex [0028]; wherein embodiments include sample application area, sample detection area, and optional intermediate area arranged adjacent to the detection area, wherein the detection area optionally includes a control area [0040].
Merten et al. teaches: conjugate pads [0088](as recited in claim 51b)); wherein conjugate pad includes compounds to form analytic specific conjugates; these compounds will react specifically with analyte [0111].
Merten et al. teaches: intermediate region includes one or more absorbent membranes and may contain one or more specific conjugates and/or control conjugates [0057](as recited in claim 51c)); some reagents should react with the reagent complex labeled with the analyte; this second zone may also include a control zone [0007](as recited in claim 51c)); each test strip will have a test zone for binding the analyte (to indicate a positive test result indicating the presence of the analyte in the analyte sample) and a control zone for binding the tracer (to indicate the correct operation of the test) [0130](as recited in claim 51c)); detection zone can be sensitized with one or more reagents (analytic specific capture reagents); and migration control capture reagents [0077]; wherein migration control capture reagent is conjugate unrelated to analyte [0077](as recited in claim 51c)).
Merten et al. also teaches wherein: capture reagent and conjugate reagent may be antibodies [0078, 0086]; control antibodies in control area of detection area [0086]; test and control conjugates can be antibodies, or antigens recognized by IgG [0086](as recited in claim 51 c)); advantageously, signal at location in control capture reagent (control antibody) is independent of the presence or absence of the analyte to be detected [0095] (as recited in claim 51c)).
Thus, in view of such teachings or suggestions of pads, materials, zones including test and control as well as use of antibodies and immunoglobulins for capturing analyte and migration control (independent of analyte to be detected), the system as recited in claim 51 is an obvious embodiment in view of Merten et al.
Merten et al. does not teach first coronavirus antibody; second coronavirus antibody for detecting antigen complex; NP.
Fujimoto et al. teaches: methods, kits, antibodies against SARS virus nucleocapsid protein (description); detection kit, apparatus; allowing method to be applied to ELISA in assays for SARS-NP detection as well as immunochromatographic method [0012]; using first antibody that binds to SARS-NP and a second antibody that binds to SARS-NP [0014]; including kits composed of solid phase immobilizing first antibody and reagent containing second antibody labeled with marker [0015]; first and second antibody that specifically bind SARS-NP [0015]; immobilizing antibodies on vector [0048]; as well as antibodies immobilized on carrier [0184].
One of ordinary skill in the art would have been motivated to use antibodies and target as taught by Fujimoto et al. with the method as taught by Mertens et al. Mertens et al. teaches use of immunoassays and antibodies for detection, and Fujimoto et al., which also teaches use of immunoassays and antibodies for detection, including for virus, teaches such antibodies and such a viral target (See MPEP 2144.06: Substituting equivalents known for the same purpose).
As to claim 73, Mertens et al. teaches quantification of amount in test sample [0106]. Absent unexpected results, such a recitation is considered to be that determined by routine optimization to one of ordinary skill in in the art in view of Mertens et al. in view of Fujimoto et al. (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: 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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
One of ordinary skill in the art would have had a reasonable expectation of success for using antibodies and target as taught by Fujimoto et al. with the method as taught by Mertens et al. There would have been a reasonable expectation of success given the underlying materials and methods (using immunoassays for detection as taught by Mertens et al. and Fujimoto 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. Claims 52, 53 are rejected under 35 U.S.C. 103 as being unpatentable over Mertens et al. in view of as Fujimoto et al. applied to claims 51, 54, 57, 73 above, and further in view of Wu et al. (“A new coronavirus associated with human respiratory diseases in China,” Nature, Vol. 579: 265-271 (2020))(See PTO-892: Notice of References Cited).
See claims 52, 53 as submitted 3/16/2023.
See also the 35 U.S.C. 112(b) rejection above.
See the teachings of Mertens et al. in view of as Fujimoto et al. above.
Mertens et al. in view of as Fujimoto et al. does not teach SARS-CoV-2.
Wu et al. teaches: RNA virus strain 2019-nCoV (known in the art as SARS-CoV-2)(p. 265).
One of ordinary skill in the art would have been motivated to use coronavirus strain as taught by Wu et al. with the method as taught by Mertens et al. in view of as Fujimoto et al. Mertens et al. in view of as Fujimoto et al. teaches use of a coronavirus strain, and Wu et al., which also teaches a coronavirus strain, teaches such a known coronavirus strain (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 coronavirus strain as taught by Wu et al. with the method as taught by Mertens et al. in view of as Fujimoto et al. There would have been a reasonable expectation of success given the underlying materials (coronavirus strains as taught by Wu et al. and Mertens et al. in view of as Fujimoto 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.
Conclusion
6. 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