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 11 December 2025 has been received and entered. Claims 1-22 were pending. Applicant’s election with traverse of Group III, Claims 15-18, in the reply filed on 21 July 2025 was acknowledged. Claims 1-14 and 19-22 were withdrawn from further consideration as being drawn to nonelected inventions, there being no allowable generic or linking claims. Claims 15-18 were examined on their merits.
Of the claims currently under examination, Claims 15-16 and 18 have been amended, no claims were cancelled, and new Claims 25 and 26 have been added.
Of the withdrawn claims, Claims 1, 10, and 13-14 have been amended, Claims 4-9 and 19-22 have been cancelled, and new Claims 23-24 have been added.
Accordingly, Claims 1-3, 10-18, and 23-26 are currently pending, with Claims 1-3, 10-14, and 23-24 being withdrawn from further consideration as being drawn to nonelected inventions, there being no allowable generic or linking claims, and Claims 15-18 and 25-26 being 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 2023/0152318 A1, Published 18 May 2023. Applicant’s amended Specifications as presented on 11 December 2025 and 07 October 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 11 December 2025 regarding the previous Office action dated 15 September 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 If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn.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arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.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
(Objection withdrawn) – The objection to the Abstract of the disclosure for containing language which can be implied is withdrawn in light of the amendments to the Abstract.
(Objection withdrawn) – The objection to the disclosure for containing possible minor errors is withdrawn in light of the amendments to the Specification.
Claim Objections
(Objection withdrawn) – The objection to Claims 15 and 18 for containing informalities is withdrawn in light of the amendments to the claims.
(New Objection) – Claim 17 and 25 are objected to because of the following informalities: In Claim 17, it is suggested that it say “…an anti-human IgG antibody, an anti-human IgM antibody, an anti-human IgA antibody,…” instead of “…an anti-human IgG, an anti-human IgM, an anti-human IgA,…”.
In Claim 25, it is suggested that it say “…wherein the composition of (b) comprises…” instead of “…the composition of (b) comprises…”.
Appropriate correction is required.
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 16 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.
Maintained Rejections
(Rejection maintained and extended) – The rejection of Claim 15, and dependent claims 16-18 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is maintained as it relates to instant Claims 15-18 and is extended to include new Claims 25-26, as these new claims depend upon instant Claim 15 but do not remedy the deficiencies of instant Claim 15.
Response to Arguments
Applicant's arguments with respect to rejection of Claim 15, and dependent claims 16-18 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been fully considered but they are not persuasive. The rejection of Claim 15, and dependent claims 16-18 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is maintained as it relates to instant Claims 15-18 and is extended to include new Claims 25-26, as these new claims depend upon instant Claim 15 but do not remedy the deficiencies of instant Claim 15.
In their Response, Applicant argues that “Claim 15 recites that three elements are combined ‘either simultaneously or wholly or partially sequentially’” and that when “the limitation is considered in the full context of the claim, it is unambiguously clear that the three reagents may be added at exactly the same time (i.e., simultaneously), at three completely separate times (i.e., wholly sequentially), or at two or more times that may at least partially overlap with one another (i.e., partially sequentially)” (see Page 2 of Remarks, Paragraph 4). Examiner does not find this argument persuasive. The components recited are either combined simultaneously or sequentially. “Partially sequentially” is still sequentially. There is no special definition provided in the instant Specification for this phrase. Paragraph 0081 of the instant Specification states, in part, that “the various components of the method are provided in combination (either simultaneously or sequentially). When the various components of the method are added sequentially, the order of addition of the components may be varied; a person having ordinary skill in the art can determine the particular desired order of addition of the different components of the assay. The simplest order of addition, of course, is to add all the materials simultaneously and determine the signal produced therefrom. Alternatively, each of the components, or groups of components, can be combined sequentially.” This paragraph does not distinguish between wholly and partially sequentially. It only recites simultaneously or sequentially, which supports the argument that the components can only be combined either simultaneously or sequentially.
As such, the rejection of Claim 15, and dependent claims 16-18 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is maintained as it relates to instant Claims 15-18 and is extended to include new Claims 25-26, as these new claims depend upon instant Claim 15 but do not remedy the deficiencies of Claim 15.
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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Withdrawn Rejections
(Rejection withdrawn) – The rejection of Claims 15-18 under 35 U.S.C. 102(a)(2) as being anticipated by Loomis (US 2023/0145699 A1, earliest Priority Date 03 April 2020) is withdrawn in light of the amendments to the claims.
New Rejections
(New Rejection – necessitated by amendment) – Claims 15-18 and 25-26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lipkin et al. (US 2023/0184764 A1, earliest Priority Date 06 April 2020).
Lipkin et al. teach methods for detecting the exposure to and infection by certain viruses, namely coronaviruses, including SARS-CoV-2 (see Abstract; Paragraph 0010). Specifically, Lipkin et al. teach detection of the antibody response to SARS-CoV-2 using peptides that are specific for SARS-CoV-2 (see Paragraphs 0003, 0011), wherein detection entails contacting a sample with one or more disclosed peptides and detecting the formation of an antibody-peptide complex comprising said peptide, wherein formation of said complex is indicative of the presence of an antibody to an epitope of a SARS-CoV-2 antigen in said sample (see Paragraph 0026), which reads on instant Claims 15-16 and 26.
Lipkin et al. teach a detection method wherein said sample used is a human biological sample obtained from blood, serum, plasma, urine, saliva, sputum, cerebrospinal fluid, nasopharyngeal aspirate, or feces (see Paragraph 0115), which reads on instant Claim 18. Lipkin et al. also teach a detection method wherein the method comprises obtaining or receiving a patient sample likely to contain antibodies, contacting the sample with a peptide or peptides under conditions effective for the formation of a specific peptide-antibody complex, and assaying the contacted sample for the presence of an antibody-peptide reaction (see Paragraph 0111), which reads on instant Claim 15.
Additionally, Lipkin et al. teach a detection method wherein the peptides are attached to or immobilized on a solid support, wherein said solid support is a latex bead (see Paragraph 0023), wherein the detecting step comprises performing an agglutination assay (see Paragraph 0036), which reads on instant Claims 15 and 25.
Furthermore, Lipkin et al. teach a detection method comprising reacting the peptide and the sample containing antibodies, forming a peptide-antibody complex, and detecting the amount of antibody bound to the peptide by adding by adding a binding partner which specifically recognizes the sample antibodies, such as anti-human antibodies, specifically anti-human IgG antibodies or anti-human IgM antibodies, (see Paragraphs 0087-0088), and detecting the formation of these complexes via an agglutination assay (see Paragraph 0084), which reads on instant Claims 15 and 17.
For at least these reasons, Lipkin et al. teach the limitations of instant Claims 15-18 and 25-26 and anticipate the invention encompassed by said claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Maintained Rejections
(Rejection maintained and extended) – The provisional rejection of Claims 15-16 and 18 on the ground of nonstatutory double patenting as being unpatentable over claims 60, 62-63, and 65 of copending Application No. 18/552,167 (reference application) is maintained and extended. The provisional rejection of Claims 15-16 and 18 on the ground of nonstatutory double patenting as being unpatentable over claims 60, 62-63, and 65 of copending Application No. 18/552,167 (reference application) is maintained as it relates to instant Claims 15-16 and 18 and is extended to include new Claim 26.
Response to Arguments
Applicant's arguments with respect to the provisional rejection of Claims 15-16 and 18 on the ground of nonstatutory double patenting as being unpatentable over claims 60, 62-63, and 65 of copending Application No. 18/552,167 (reference application) have been fully considered but they are not persuasive. The provisional rejection of Claims 15-16 and 18 on the ground of nonstatutory double patenting as being unpatentable over claims 60, 62-63, and 65 of copending Application No. 18/552,167 (reference application) is maintained as it relates to instant Claims 15-16 and 18 and is extended to include new Claim 26, as the reference claims teach detection of antibodies against SARS-CoV-2, which is a virus. As such, the reference claims recite a species of the genus recited by instant Claim 26 and thus anticipate this claim limitation.
In their Response, Applicant argues that “the claims of the subject application are fully described and enabled in the ‘239 provisional application, and thus the claims of the subject application have a priority date of April 24, 2020”, that the “earliest priority date for the ‘167 application is April 21, 2021, and the earliest priority date for the ‘351 application is September 30, 20021” and that the “earliest filing date of the subject application is at least one year earlier than the earliest filing dates of the two applications utilized in the provisional double patenting rejections” (see Page 5 of Remarks, Paragraph 5). Applicant then argues that “all other rejections of the claims in the subject application have been overcome, and that the provisional ODP rejections are the only remaining rejections in the subject application” and “that the provisional ODP rejections should be withdrawn and this application allowed to issue as a patent without requiring a terminal disclaimer, in accordance with Section 804(I)(B)(1) of the Manual of Patent Examining Procedure” (see Page 5, Paragraph 6). While Examiner agrees with Applicant’s rationale, this conclusion is based on the assumption that all of the previously raised rejections have been overcome and that no new rejections have been raised that were necessitated by Applicant’s Amendments. This is not the case. As such, this provisional double patenting rejection will not be withdrawn based on that line of reasoning.
Applicant did not present any additional arguments regarding this rejection. As such, this provisional double patenting rejection will be maintained for reasons of record. Therefore, the provisional rejection of Claims 15-16 and 18 on the ground of nonstatutory double patenting as being unpatentable over claims 60, 62-63, and 65 of copending Application No. 18/552,167 (reference application) is maintained as it relates to instant Claims 15-16 and 18 and is extended to include new Claim 26.
(Rejection maintained and extended) – The provisional rejection of Claims 15-16 and 18 on the ground of nonstatutory double patenting as being unpatentable over claims 37-44 of copending Application No. 18/691,351 (reference application) is maintained and extended. The provisional rejection of Claims 15-16 and 18 on the ground of nonstatutory double patenting as being unpatentable over claims 37-44 of copending Application No. 18691351 (reference application) is maintained as it relates to instant Claims 15-16 and 18 and is extended to include new Claim 26.
Response to Arguments
Applicant's arguments with respect to the provisional rejection of Claims 15-16 and 18 on the ground of nonstatutory double patenting as being unpatentable over claims 37-44 of copending Application No. 18/691,351 (reference application) have been fully considered but they are not persuasive. The provisional rejection of Claims 15-16 and 18 on the ground of nonstatutory double patenting as being unpatentable over claims 37-44 of copending Application No. 18/691,351 (reference application) is maintained as it relates to instant Claims 15-16 and 18 and is extended to include new Claim 26, as the reference claims teach detection of antibodies against SARS-CoV-2, which is a virus. As such, the reference claims recite a species of the genus recited by instant Claim 26 and thus anticipate this claim limitation.
In their Response, Applicant grouped together the provisional double patenting rejections and presented the same arguments for both provisional double patenting rejections, as noted above. Examiner has already rebutted those arguments, as noted above, for the first provisional double patenting rejection. As such, this second provisional double patenting rejection also will not be withdrawn. Therefore, the provisional rejection of Claims 15-16 and 18 on the ground of nonstatutory double patenting as being unpatentable over claims 37-44 of copending Application No. 18/691,351 (reference application) is maintained as it relates to instant Claims 15-16 and 18 and is extended to include new Claim 26.
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:
Huo (US 2013/0052661 A1, Published 28 February 2013)
Huo teaches methods for detecting biomolecules in a biological sample and for detecting complexes comprising said biomolecules. 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