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/Disposition of Claims
Applicant’s Amendment filed on 13 February 2026 has been received and entered. Claims 1-22 were pending. Claims 1, 3-4, 9, 16-19, and 22 have been amended. Claim 2 has been cancelled. New Claims 23-24 have been added.
Accordingly, Claims 1 and 3-24 are currently pending and will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2023/0176057 A1, Published 08 June 2023. Applicant’s amended Specifications as presented on 13 February 2026 and 03 November 2022 are acknowledged and entered.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Response to Arguments
Applicant's arguments filed 13 February 2025 regarding the previous Office action dated 17 November 2025 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Specification; Sequence Disclosure Requirements
Withdrawn Objections
(Objection withdrawn) – The objection to the Specification for containing an incorrect incorporation by reference statement of the Sequence Listing is withdrawn in light of the amendments to the Specification.
New Objections
(New Objection) – The disclosure is objected to because of the following informalities: the Specification is objection to for referencing an NCBI Reference Sequence, specifically NP_001358344.1, and a UniProtKB Reference Sequence, specifically Q9BYF1 (see Paragraph 0064), rather than sequences set forth in the Specification. These reference sequences are subject to change. This constitutes an improper incorporation by reference, since the information required to describe and enable the required sequences is found in their respective databases, extraneous to the application. Furthermore, since these sequences are not irrevocably fixed but are corrected and updated as additional sequence information becomes available, these accession numbers may refer to sequences which change after the application filing date. Thus, the disclosure is objected to for this improper incorporation by reference.
Applicants must comply with sequence rules in order to be considered a complete response to this Office Action.
Specification
Withdrawn Objections
(Objection withdrawn) – The objection to the disclosure for containing possible minor errors is withdrawn in light of the amendments to the Specification.
New Objections
(New Objection) – The title of the invention is objected to due to the presence of the word “virus”. Its use is redundant since “CoV” stands for “coronavirus”. The following title is suggested: “Detection Assay for SARS-CoV-2”.
(New Objection) – The use of the terms AviTag (Paragraph 0016, at least); NanoLuc (Paragraph 0116, at least); iDimerize (Paragraph 0129, at least); TWEEN (Paragraph 0203, at least); 3M (Paragraph 0210, at least); Clean-Trace (Paragraph 0210); Tecan Infinite 200 Pro (Paragraph 0210, at least); Promega (Paragraph 0210, at least); GloMax (Paragraph 0210, at least); ExpiFectamine (Paragraph 0215, at least); and BinaxNOW (Paragraph 0241, at least), which are trade names or marks used in commerce, has been noted in this application. These terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Examiner kindly requests that Applicant thoroughly review the entire disclosure for the presence of any additional trademarks or trade names which the Examiner might have missed.
(New Objection) – the “clean” copy of the Specification filed on 13 February 2026 contains edit markups, specifically at least in the section title “REFERENCE TO AN ELECTRONIC SEQUENCE LISTING”. There is underlining present in the title. A new clean copy must be submitted.
(New Objection) – The disclosure is objected to because of the following informalities: all instances of “SARS-CoV-2 virus” or “SARS-CoV virus” should be replaced with “SARS-CoV-2” and “SARS-CoV”, respectively. The addition of the word “virus” in those phrases is redundant since “CoV stands for “coronavirus”.
Appropriate correction is required.
Claim Objections
(Objection withdrawn) – The objection to Claims 1-3, 9, 16-17, and 19 for containing minor informalities is withdrawn in light of the amendments to the claims and the cancellation of one of the claims.
Claim Rejections - 35 USC § 112(b); Second Paragraph
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.
Withdrawn Rejections
(Rejection withdrawn) – The rejection of Claim 17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claim.
(Rejection withdrawn) – The rejection of Claim 22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claim.
New Rejections
(New Rejection – necessitated by amendment) – Claims 23, and dependent claim 24 thereof, 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.
Regarding Claim 23, it recites the limitation “wherein the first peptide fragment of a split reporter protein or a first reporter moiety is fused to an N-terminus of the first viral protein-binding domain, or the second peptide fragment of a split reporter protein or the second reporter moiety is fused to an N-terminus of the second viral protein-binding domain”. The use of the article “an” in the phrases “an N-terminus of the first viral protein-binding domain” and “an N-terminus of the second viral protein-binding domain” renders the claim indefinite. The use of “an” implies that there are multiple N-termini to choose from and that only one is being selected from the multiple options available when in fact the proteins in question only have one N-termini each. It is suggested that the claim be amended by replacing “an” with “the”, but Applicant is free to amend the claim as they deem necessary.
Additionally, the use of the article “a” in the phrases “the first peptide fragment of a split reporter protein or a first reporter moiety” and “the second peptide fragment of a split reporter protein or the second reporter moiety” also render the claim indefinite. The use of “a” makes it unclear if the split reporter protein and first reporter moiety being referenced are the same as those referenced in Claim 1, which Claim 23 depends on, or if they are different molecules. “A/An” is an indefinite article, while “the” is a definite article. “The” refers back to a specific molecule from Claim 1, while “A” can refer back to any non-specific molecule and is not clear that it is only referencing the molecule of Claim 1. It is suggested that the claim be amended by replacing “a” with “the”, but Applicant is free to amend the claim as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 23 is rejected on the grounds of being indefinite. Claim 24 is also rejected, since it depends upon Claim 23 but does not remedy the deficiencies of Claim 23.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim Rejections - 35 USC § 112(d); Fourth Paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(Rejection withdrawn) – The rejection of Claim 22 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn in light of the amendments to 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.
(Rejection maintained and extended) – The rejection of Claims 1-22 under 35 U.S.C. 103 as being unpatentable over Ter Meulen et al. (US 2010/0172917 A1, Published 08 July 2010), Hall et al. (US 2020/0270586 A1, earliest Priority Date 12 June 2018), Tsai et al. (US 2023/0250410 A1, earliest Priority Date 13 February 2020), and Wohlstadter et al. (2025/0237661 A1, earliest Priority Date 01 May 2020) is maintained as it relates to Claims 1 and 3-22, withdrawn as it relates to Claim 2 in light of the cancellation of the claim, and extended to include new Claims 23-24.
Response to Arguments
Applicant's arguments with respect to the rejection of Claims 1-22 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
In their Response, Applicant argues that “none of the cited references teach the claimed subject matter in the configuration set forth in amended claim 1” “either independently or in combination” (see Page 4 of Remarks, Last Paragraph and Page 5, First Paragraph). Applicant also argues that there “is no indication in Wohlstadter or any of the other cited references as to why the teachings of Wohlstadter should be combined with the enzymatic activity detection assays of Hall, the ACE2-Fc fusion molecules of Tsai, or the binding molecules of Ter Meulen” (see Page 5, Paragraph 2). Additionally, Applicant argues that “the rejections of record are erroneous and rely on improper hindsight (see Page 5, Last Paragraph). Furthermore, Applicant argues that the cited references and the Examiner “take for granted that SARS-CoV-1 and SARS-CoV-2 can be treated as functional equivalents” (see Page 6, Paragraph 2) and states that “the instant application, however, explicitly cautions against the examiner’s position and discloses that ‘caution should be exercised when comparing ACE2-binding datasets and conformational states between SARS-CoV-1 and SARS-CoV-2” (see Page 6, Paragraph 2). Finally, Applicant argues that the working examples demonstrate unexpected results, such as the claimed system being able to “bind to Spike protein on a live virus, as well as to a full-length Spike protein, and pseudotyped lentivirus” (see Page 6, Last Paragraph), and that “the N-terminal fusion reporter pair showed surprisingly higher sensitivity compared to the C-terminal fusion reporter pair” (see Page 7, Last Paragraph and Page 8, First Paragraph).
With regard to the arguments that the limitations of the claimed invention are not met by the cited references either individually or in combination and that there is no motivation to combine the teachings of said references, Examiner restates that, as noted in the Non-Final Rejection, the multipartite luciferase system disclosed by Hall et al., though not specific to virus detection, is contemplated for the detection of viruses and the discrimination between different viruses. Also, the fusion molecules of Tsai were taught for prevention or treatment of COVID-19 through specific binding of SARS-CoV-2. A skilled artisan would have recognized that any molecules capable of such interactions could also be used for detection of the virus in a sample. Additionally, Ter Meulen et al., Hall et al., and Tsai et al. all taught the use of fusion molecules comprising an antibody or an antigen/analyte-binding fragment thereof which specifically binds to an antigen or analyte of interest in a sample, thereby allowing for detection of said antigen or analyte of interest in said sample. Wohlstadter et al. taught methods for detecting a coronavirus in a sample, comprising, in part, contacting a biological sample with a binding reagent that specifically binds to the coronavirus, such as the fusion molecules of Tsai et al. Furthermore, Wohlstadter et al. also teach that their disclosed method can be used for detecting viruses using luminescence, chemiluminescence, or even enzymatic activity which causes changes in optical absorbance or fluorescence (see Paragraph 0274).
In response to Applicant's Argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
With regard to Applicant’s Argument that SARS-CoV-1 and SARS-CoV-2 cannot be treated as functional equivalents in the context of the instant invention, the arguments presented are not commensurate in scope with the instant claims. While Applicant’s assertion may be true, instant Claim 1 does not only read on SARS-CoV-2. It recites “A method for detecting SARS-CoV”, which reads on any SARS-CoV, not just SARS-CoV-2. In fact, the claims do not specify “SARS-CoV-2” until dependent Claims 16 and 17. If Applicant wishes the claims to only read on SARS-CoV-2, then independent Claim 1 should be amended to explicitly recite “SARS-CoV-2”.
With regard to arguments that the working examples demonstrate unexpected results, including that the N-terminal fusion performed surprisingly better than the C-terminal fusion, this argument is unpersuasive. First, Hall et al. teach their multipartite luciferase system using either terminus. Also, with a split reporter system, there are only 4 possibilities with regard to where the fusion can occur and thus there are a finite number of options for a skilled artisan to try. The claimed invention in Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 82 USPQ2d 1321 (Fed. Cir. 2007), was directed to the amlodipine besylate drug product, which was sold in tablet form in the United States under the trademark Norvasc®. Amlodipine and the use of besylate anions were both known at the time of the invention. Amlodipine was known to have the same therapeutic properties as were being claimed for the amlodipine besylate, but Pfizer discovered that the besylate form had better manufacturing properties (e.g., reduced "stickiness"). Pfizer argued that the results of forming amlodipine besylate would have been unpredictable and therefore nonobvious. The court rejected the notion that unpredictability could be equated with nonobviousness here, because there were only a finite number (53) of pharmaceutically acceptable salts to be tested for improved properties. The court found that one of ordinary skill in the art having problems with the machinability of amlodipine would have looked to forming a salt of the compound and would have been able to narrow the group of potential salt-formers to a group of 53 anions known to form pharmaceutically acceptable salts, which would be an acceptable number to form "a reasonable expectation of success." Additionally, Wohlstadter et al. teach that their method can detect virus-like particles (VLPs), while Tsai et al. teach that their methods can detect pseudovirus, so it is not unexpected that Applicant’s invention can also detect live virus as well as pseudotyped lentivirus. Applicant cites Figures 5 and 6 regarding the superiority of the N-terminal fusion over the C-terminal fusion, but those figures do not show any data. These differences are not depicted in those figures, as suggested. As such, these figures do not provide the data being referenced and which would be needed to validate the claims made by Applicant. Even if the data is present somewhere else, the Examiner will not hunt for it in the application. Furthermore, in the assay depicted in Figure 5, if virus is present, the signal is lost as there is more virus. In the assay depicted in Figure 6, however, you get more signal the more virus is present. Thus, Figures 5 and 6 depict different assays. The claims must be commensurate in scope with the assay/drawings/arguments/data provided. Claims 1 and 23 cannot be allowed because there is no data provided and no specific binding proteins listed and Claim 23 is not commensurate in scope with either Figure 5 or Figure 6.
As such, for at least these reasons, the rejection of Claims 1-22 under 35 U.S.C. 103 as being unpatentable over Ter Meulen et al. (US 2010/0172917 A1, Published 08 July 2010), Hall et al. (US 2020/0270586 A1, earliest Priority Date 12 June 2018), Tsai et al. (US 2023/0250410 A1, earliest Priority Date 13 February 2020), and Wohlstadter et al. (2025/0237661 A1, earliest Priority Date 01 May 2020) is maintained as it relates to Claims 1 and 3-22, withdrawn as it relates to Claim 2 in light of the cancellation of the claim, and extended to include new Claims 23-24.
Conclusion
No claims are allowed.
The prior art made of record, but not relied upon, and considered pertinent to applicant's disclosure is listed below:
Russell et al. (US 2023/0184765 A1, earliest Priority Date 17 April 2020)
Russell et al. teach methods for determining the presence of coronavirus neutralizing antibodies in a sample. This reference has not been utilized, as rejection would have been redundant to those set forth above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAREY A STUART whose telephone number is (703)756-4668. The examiner can normally be reached Monday - Friday, 7:30 AM - 4:30 PM EST.
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/CAREY ALEXANDER STUART/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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