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 .
Information Disclosure Statement
The Information Disclosure Statements (IDSs) submitted on 4/16/2026, 3/5/2026, and 1/5/2026, are in compliance with 37 CFR 1.97. Accordingly, the references listed in the previously submitted and those IDSs are being considered by the examiner.
Examiner’s Note
Examination of the instant application has been transferred to Examiner Jeff Sifford of Art Unit 1671. The examiner may be contacted at 571-272-7289 or jeffrey.sifford@uspto.gov.
Withdrawn Objections
The previous objections are hereby withdrawn due to Applicant’s amendment submitted on 3/5/2026:
Claim objections: claim 1.
Maintained Rejections
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) Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Oyamada, et al. (US 8043866 B2; issued 10/25/2011) in further view of Akihide, et al. (JP 2017145246; published 8/24/20217), Kang, et al. (Acta Pharmaceutica Sinica B, 10(7), 1228-1238, published 4/20/2020, cited in Applicant’s IDS submitted on 7/11/2024), and Jones, et al. (J. Imm. Methods, 275 (1-2), 239-250, published 1/16/2003).
After careful consideration, Applicant’s arguments submitted on 3/5/2026 are found to be unpersuasive.
Applicant submits the following arguments:
The cited reference fail to disclose each and every element of the pending claims for the following reasons. The amino acid sequence of the SARS-CoV-2 nucleocapsid protein is around 50% identical to MERS-CoV, and it is not self-evident that an antibody having comparable high binding affinity for each antigen can be obtained. Therefore, one of ordinary skill in the art would not expect that SARS-CoV-2 nucleocapsid protein can be detected with high sensitivity based on findings regarding MERS.
One of ordinary skill in the art would not expect, based on the cited references, that the SARS-CoV-2 nucleocapsid protein could detect with high sensitivity in the claimed invention. In the claimed invention, the detection system achieved remarkably high sensitivity as a result of satisfying the following two factors: (1) the antibody itself has high binding affinity and (2) the antibody can enhance sensitivity when combined with silver amplification (for example, an antibody having high non-specific adsorption, which causes noise, often do not show an improved sensitivity with silver amplification). Considering that the amino acid sequence homology between the nucleocapsid proteins of MERS and SARS-CoV-2 is approximately 50%, one of ordinary skill in the art would infer that sensitivity will differ based on antigen differences (differences between MERS and SARS-CoV-2).
To establish a prima facie case of obviousness of a claimed invention, all of the claim limitations must be disclosed by the cited references. The cited references fail to disclose all of the claim limitations of independent claims 1 and 9, and those claims dependent thereon. Accordingly, the combination of references does not render the claimed invention obvious.
Furthermore, the cited references or the knowledge in the art provide no proper reason or rationale that would allow one of ordinary skill in the art to arrive at the claimed invention, therefore a prima facie case of obviousness has not been established, and withdrawal of the outstanding rejection is respectfully requested.
Applicant’s arguments are not persuasive because:
Contrary to Applicant’s assertion, each of the limitations of the claimed invention is rendered obvious by the cited references, as discussed in the rejection under 35 U.S.C. §103. Further, Applicant did not specifically point out which limitations were not disclosed by the cited references.
The sequence variation between MERS-CoV and SARS-CoV-2 nucleocapsid proteins is acknowledged, however, that is not persuasive as a reason why one of ordinary skill in the art would expect difficulty with detecting SARS-CoV-2 nucleocapsid protein at high sensitivity. Additionally, the argument is not commensurate in scope with the claims, as the claims do not require high sensitivity. Further, even if the argument were commensurate in scope, it would still not be convincing, because the skill in the art of producing antibodies is high, and a person having ordinary skill in the art would be capable of making an antibody with high sensitivity for SARS-CoV-2 nucleocapsid protein. There are a number of strategies, such as making multivalent Fabs, which can increase antibody sensitivity.
The Examiner wishes to inform applicants of the following guidelines pertaining to arguments that mirror supported claims or facts but are not founded on a factual basis.
In the MPEP:
MPEP §2145 Consideration of Applicant's Rebuttal Arguments:
(I) ARGUMENT DOES NOT REPLACE EVIDENCE WHERE EVIDENCE IS NECESSARY
Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See MPEP § 2129 and§ 2144.03 for a discussion of admissions as prior art.
The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602,145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.”). See MPEP § 716.01(c) for examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration.
MPEP §716.01 (c) Probative Value of Objective Evidence
I. TO BE OF PROBATIVE VALUE, ANY OBJECTIVE EVIDENCE SHOULD BE SUPPORTED BY ACTUAL PROOF
Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ191, 196 (Fed. Cir. 1984) (“It is well settled that unexpected results must be established by factual evidence.” “[A]ppellants have not presented any experimental data showing that prior heat-shrinkable articles split. Due to the absence of tests comparing appellant’s heat shrinkable articles with those of the closest prior art, we conclude that appellant’s assertions of unexpected results constitute mere argument.”). See also In re Lindner, 457 F.2d 506, 508, 173 USPQ 356,358 (CCPA 1972); Ex parte George, 21 USPQ2d 1058(Bd. Pat. App. & Inter. 1991).
II. ATTORNEY ARGUMENTS CANNOT TAKE THE PLACE OF EVIDENCE
The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602,145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant.
See MPEP § 2145 generally for case law pertinent to the consideration of applicant’s rebuttal arguments.
III. OPINION EVIDENCE
Although factual evidence is preferable to opinion testimony, such testimony is entitled to consideration and some weight so long as the opinion is not on the ultimate legal conclusion at issue. While an opinion as to a legal conclusion is not entitled to any weight, the underlying basis for the opinion may be persuasive. In re Chilowsky,306 F.2d 908, 134 USPQ 515 (CCPA 1962) (expert opinion that an application meets the requirements of 35U.S.C. 112 is not entitled to any weight; however, facts supporting a basis for deciding that the specification complies with 35 U.S.C. 112 are entitled to some weight); In re Lindell, 385 F.2d 453, 155 USPQ 521 (CCPA 1967)(Although an affiant’s or declarant’s opinion on the ultimate legal issue is not evidence in the case, “some weight ought to be given to a persuasively supported statement of one skilled in the art on what was not obvious to him.” 385 F.2d at 456, 155 USPQ at 524 (emphasis in original)).
Presently and in view of the guidance from MPEP §2145 and §716 above, Applicants statements regarding the cited references or the knowledge in the art provide no proper reason or rationale that would allow one of ordinary skill in the art to arrive at the claimed invention and that a prima facie case of obviousness has not been established have not been found convincing.
Based on the cited references and state of the art, which teaches how to make antibodies, this type of assay, silver amplification, etc., a person having ordinary skill in the art is well enabled to make and use the obvious kit and perform its obvious method.
Double Patenting
(Previous Rejection Maintained) Claims 1, 4-6, 8, 9, and 12-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8043866 B1, in view of Akihide, et al. (JP 2017145246; published 8/24/20217), Kang, et al. (Acta Pharmaceutica Sinica B, 10(7), 1228-1238, published 4/20/2020, cited in Applicant’s IDS submitted on 7/11/2024), and Jones, et al. (J. Imm. Methods, 275 (1-2), 239-250, published 1/16/2003).
After careful consideration, Applicant’s arguments submitted on 3/5/2026 are found to be unpersuasive.
Applicant submits the following arguments:
Applicants respectfully request that the Examiner reconsider this rejection in view of the claim amendments and remarks against the obviousness rejection since the same references are being used in this rejection.
Applicant’s arguments are not persuasive because:
Applicant’s arguments against the rejection under 35 U.S.C. §103 above are found to be unpersuasive (see above). Accordingly, the obviousness-type double patenting rejection of Claims 1, 4-6, 8, 9, and 12-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8043866 B1, in view of Akihide, et al. (JP 2017145246; published 8/24/20217), Kang, et al. (Acta Pharmaceutica Sinica B, 10(7), 1228-1238, published 4/20/2020, cited in Applicant’s IDS submitted on 7/11/2024), and Jones, et al. (J. Imm. Methods, 275 (1-2), 239-250, published 1/16/2003) is still appropriate, and thus is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY MARK SIFFORD whose telephone number is (571)272-7289. The examiner can normally be reached 8:30 a.m. - 5:30 p.m. ET with alternating Fridays off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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