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 .
Election/Restrictions
Applicant’s election without traverse of the polypeptide comprising SEQ ID NO: 10 with the foldon trimer motif and the D614G, 6682A, R683G, R685G, K986P, and V987P mutations in the reply filed on 10/22/2025 is acknowledged.
Claim 17 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected polypeptide species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/22/2025.
Status of the Claims
Claim 17 is withdrawn for being directed to a non-elected species. Claims 1-16 and 18-20 are pending and examined here.
Priority
This application, filed 03/29/2022, claims benefit to PRO 63/167,773, filed 03/30/2021. This benefit is acknowledged and the claims examined herein are treated as having an effective filing date of 03/30/2021.
Information Disclosure Statement
The Information Disclosure Statement filed 10/22/2025 is acknowledged and has been considered.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4-9, 11-15, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US2024/0277831 A1, “POLYPEPTIDES, COMPOSITIONS, AND THEIR USE TO TREAT OR LIMIT DEVELOPMENT OF AN INFECTION” (priority date 08/11/2020, referred to herein as King).
King’s general disclosure relates to the use of spike protein polypeptides. In particular, King teaches the use of a spike protein polypeptide, “SARS-COV-2 S-2P Trimer” (King, SEQ. ID. 161, referred to as S-2P). Below is the sequence alignment of the S-2P amino acid sequence taught by King (top row) compared to elected SEQ. ID: 10 (bottom row) of this application:
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935
710
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Greyscale
Regarding claim 1, King teaches a method for detecting anti-SARS-CoV-2 antibody in a sample by ELISA assay (para. 0269, line 1) comprising contacting the sample with the S-2P polypeptide (para. 0269, lines 1-9) and detecting the presence of an anti-SARS-CoV-2 antibody bound to the peptide using HRP-conjugated secondary antibodies (para. 0269, lines 9-12). King teaches that the D614G mutation could be introduced into their polypeptides in order to study naturally occurring variant mutations (para. 0056, lines 1-10).
Regarding claim 2, King teaches that antibody titers are measured with the ELISA assay (para. 0267, lines 18-19).
Regarding claim 4, King teaches that the S-2P contains a 682-SGAG-685 substitution at the furin cleavage site (SEQ. ID NO: 161 as shown above, para. 0243, lines 14-16)
Regarding claim 6, King teaches that the S-2P polypeptide comprises the K986P and V987P mutations (King SEQ. ID NO: 161 as shown above).
Regarding claim 7, King teaches that the S-2P polypeptide comprises the spike protein sequence of SEQ ID NO: 3 (King SEQ. ID NO: 161 as shown above) and is further linked to the first 10 amino acids, i.e. ELGKYEQYIK, of SEQ ID NO: 24.
Regarding claims 8 and 9, King teaches the S-2P polypeptide which has greater than 95% sequence identity to SEQ ID NO: 4 (King SEQ. ID NO: 161 as shown above).
Regarding claims 11, 12, and 13, King teaches the S-2P polypeptide comprises the foldon trimer motif of SEQ ID NO: 16 (King SEQ. ID NO: 161 as shown above).
Regarding claim 14, King teaches the S-2P polypeptide is biotinylated and conjugated to streptavidin-APC detectable marker (para. 0274, lines 1-5).
Regarding claim 15, King teaches the S-2P polypeptide which has greater than 95% sequence identity to SEQ ID NO 10 (King SEQ. ID NO: 161 as shown above).
Regarding claim 18, King teaches that the S-2P polypeptide is a trimer (para. 0274, line 1).
Regarding claim 19, King teaches that the S-2P polypeptide is immobilized on a 384-well plate (para. 0269, lines 1-3).
However, King differs from the claimed invention in that it does not teach a specific polypeptide comprising the D614G.
Regarding the D614G mutation, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the S-2P polypeptide used by King by including the D614G mutation. Doing so would allow for the investigation of a mutation that occurs in naturally occurring variants, as taught by King (para. 0056, lines 1-10) with a reasonable expectation of success as a preferred embodiment of the S-2P polypeptide taught by King.
Claims 3, 5, 10, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over King as applied to claims 1, 4, 8, and 15 above, and further in view of US 2021/0246170, “COMPOSITIONS AND METHODS FOR PREVENTING AND TREATING CORONAVIRUS INFECTION – SARS-COV-2 VACCINES” (priority date 09/21/2020, referred to herein as Janssen).
Regarding claim 3, King teaches that the measuring mouse and human sera samples with the ELISA assay using the S-2P polypeptide (para. 0269, lines 6-9).
Regarding claim 5, King teaches the S-2P polypeptide comprises the R683G and R685G mutations (King SEQ. ID NO: 161 as shown above).
Regarding claims 10 and 16, King teaches the S-2P polypeptide which only differs from SEQ ID NOs: 7 and 10 at residues D614 and R682.
Regarding claim 20, King teaches the SARS-CoV-2 spike ectodomain S-2P polypeptide which comprises the R683G, R685G, K986P, and V987P mutations (King SEQ. ID NO: 161 as shown above).
However, King does not teach diagnosing an animal as having a SARS-CoV-2 infection when antibodies are detected or a polypeptide with the R682A mutation.
Regarding claim 3, Janssen teaches a method of diagnosing a subject with a coronavirus infection comprising measuring the level of an anti-coronavirus antibody in a sample (para. 0479, lines 1-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the ELISA assay with the S-2P polypeptide taught by King in order diagnose a subject as having a SARS-CoV-2 infection as taught by Janssen. An artisan would have been motivated to do so in order to effectively determine whether a subject would potentially benefit from treatment, such as the treatment methods taught by King (para. 0011, lines 1-7). An artisan would have a reasonable expectation of success because, as taught by Janssen, determining the antibody titer, like in the ELISA method taught by King, in a subject sample is sufficient to diagnose the subject with an infection (para. 0479, lines 1-6).
Regarding claims 5, 10, 16, and 20 Janssen teaches that the R682A (para. 1332, lines 11-15) or the R682S (para. 0260, lines 1-6) mutation can be used to make a SARS-CoV-2 spike protein polypeptide with furin cleavage resistance.
It would have been obvious to one of ordinary skill before the effective filing date to modify the S-2P polypeptide taught by King by substituting the R682S mutation for the R682A mutation as taught by Cheng. Doing so is considered to be a choice of preference by an artisan since both mutations are known in the art to enable furin cleavage resistance to a SARS-CoV-2 spike protein polypeptide. An artisan would have a reasonable expectation of success making this modification since introducing mutations is a well-known practice in the art of protein analysis and both mutations are well-known to be used for enabling furin cleavage resistance to SARS-CoV-2 spike protein polypeptides.
Conclusion
No claims are allowable.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 December 16, 2025
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