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 10 October 2025 has been received and entered. Claims 1, 4, 6, 8, 11-12, and 14-17 were pending. Claims 1, 6, 11-12, and 16 have been amended. Claims 2-3, 5, 7, 9-10, and 13 have been cancelled. No new claims have been added.
Accordingly, Claims 1, 4, 6, 8, 11-12, and 14-17 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 2022/0065857 A1, Published 03 March 2022. Applicant’s amended Specifications as presented on 10 October 2025, 24 April 2025, 23 August 2024, and 10 June 2021 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 10 October 2025 regarding the previous Office action dated 11 June 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 If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn.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arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Priority
As Applicant has submitted a corrected Applicant Data Sheet (ADS) on 19 September 2025 along with a petition regarding the unintentional delay in submitting a priority claim and the requisite fee. Said petition was granted by the Office on 22 January 2026 and a corrected Filing Receipt was mailed out on 23 January 2026 containing the correct Provisional Application number, 62/778,342, for claiming Domestic Benefit. As such, the Effective Filing Date of the instant application is now considered to be 12 December 2018.
Drawings
Withdrawn Objections
(Objection withdrawn) – The objection to the Drawings is withdrawn in light of the amendments to the figure legend for Figure 12 within the Specification.
New Objections
(New Objection) – The drawings are objected to because Figure 11 shows that SEQ ID NO: 180 supposedly came from the “Pro” HIV protein. It is believed that it should say “Pol” instead. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
(Objection withdrawn) – The objection to the disclosure for containing minor informalities is withdrawn in light of the amendments to the Specification.
Claim Objections
Withdrawn Objections
(Objection withdrawn) – The objection to Claims 1, 11-12, and 16 for containing minor informalities is withdrawn in light of the amendments to the claims.
New Objections
(New Objection) – Claim 1 is objected to because of the following informalities: it is suggested that it say “…are indicative of cross-sectional incidence…” instead of “…are indicative of cross-section incidence” in Line 13.
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.
(Rejection withdrawn) – The rejection of Claims 1, and dependent claims 4, 6, 8, 11-12, and 14-17 thereof, 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 claims.
(Rejection withdrawn) – The rejection of Claim 6 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.
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 § 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) – The rejection of Claims 1, 4, 6, 8, 11-12, and 14-17 under 35 U.S.C. 103 as being unpatentable over Tomaras et al. (WO 2018/009561 A2, Published 11 January 2018), and further in view of Parekh et al. (Parekh, B. S., Kennedy, M. S., Dobbs, T., Pau, C. P., Byers, R., Green, T., Hu, D. J., Vanichseni, S., Young, N. L., Choopanya, K., Mastro, T. D., & McDougal, J. S. (2002). Quantitative detection of increasing HIV type 1 antibodies after seroconversion: a simple assay for detecting recent HIV infection and estimating incidence. AIDS research and human retroviruses, 18(4), 295–307.), Elledge et al. (US 2016/0320406 A1, Published 03 November 2016), and Baker et al. (US 2007/0054262 A1) is maintained.
Response to Arguments
Applicant's arguments with respect to the rejection of Claims 1, 4, 6, 8, 11-12, and 14-17 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
In their Response, Applicant argues that “Tomaras discloses a set of four antigen/antibody biomarkers, that are derived from a Discriminant Function Analysis of a training sample set, that can be used in a method to classify samples, of known or unknown status, as recent or long standing infection, wherein the set comprises four antigen/antibody biomarkers selected from the list of antigen-antibody pairs listed in Figure 61 or Figure 62” and that “Tomaras discusses at length the use of its discriminant function analysis model and its application to all possible combinations of 2-8 measurement to arrive at a set of measurements (or antibody/antigen (epitopes) combination) with an optimum predictive power, or the ‘best’ measurements” (see Page 5 of Remarks, Paragraph 2). Applicant then argues that “Tomaras clearly emphasizes the identification of a combination of four antibody/antigen comprising BF1266 gp140-IgG3 binding, CH505 TF gp140-IgG4 avidity magnitude, SC42261 gp140-IgG4 avidity magnitude, and gp41 ID-IgG epitope” (see Page 5, Paragraph 2) and that “one of skill in the art would find no motivation in Tomaras to select epitopes comprising the amino acid sequences of SEQ ID NOs: 3, 22, 159, and 180 among the 2,000 epitopes as provided by Baker, knowing that Tomaras entire specification revolves around the identification of its own combination of antigens/antibodies” (see Page 5, Paragraph 3). Additionally, Applicant argues that “Tomaras describes said combination as the most powerful for their prediction model, which does not provide any motivation” or “guidance to look for an alternative combination”, and that there is “no motivation and no guidance in Tomaras, even in combination with Parekh, Elledge and Baker to specifically selected epitopes having the amino acid sequences of SEQ ID NOs: 3, 22, 159, and 180 among the 2,000 epitopes as provided by Baker, and that therefore, Tomaras, Parekh, Elledge and Baker do not disclose or suggest the specific combination of those four epitopes, let alone for the claimed application.
With regard to Applicant’s assertions regarding the importance of the claimed sequences recited in instant Claim 1, Applicant’s arguments appear to imply that only those four sequences are sufficient and is limited to just those four. This is not the case, however, as the use of the transitional phrase “comprises”/”comprising” in instant Claim 1 means that the claim is not just limited to those four epitopes. The use of the phrase “at least” also opens the claim up to a scope broader than just the four recited sequences. Additionally, Applicant calls out the transitional phrase “comprises”/”comprising” in instant Claim 1 in dependent Claim 8, which specifically demonstrates that the invention is not just limited to those four epitopes. As such, instant Claim 1 is not commensurate in scope with the arguments presented by Applicant.
Furthermore, Applicant’s claim that the optimal embodiment disclosed by Tomaras does not provide any motivation or guidance to look for alternative combinations ignores the fact that the prior art serves as a reference for all that it teaches, not just it’s preferred or most preferred embodiment(s). See MPEP 2123. Applicant is reminded that preferred embodiments are not the only teaching of a reference. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also > Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)(reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); < Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. “The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.”). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
As such, the rejection of Claims 1, 4, 6, 8, 11-12, and 14-17 under 35 U.S.C. 103 as being unpatentable over the prior art is maintained.
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:
Tomaras et al. (US 2013/0217002 A1, Published 22 August 2013)
Tomaras et al. teach methods of detecting incident HIV-1 infection. This reference has not been utilized, as rejection would have been redundant to those set forth above.
Mason et al. (US 2020/0166511 A1, Published 28 May 2020)
Mason et al. teach methods for determination of risk, previous history, and/or presence of a betaretrovirus infection in a subject. This reference has not been utilized, as rejection would have been redundant to those set forth above.
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.
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