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 .
Applicant’s response filed on 7/16/2026 is acknowledged and fully considered.
Status of Application, Amendments, And/Or Claims
The amendments to claim 1 have been made of record.
Claims 1-41 are pending.
Claims 14-41 remain withdrawn for being drawn for the reasons of record at pg. 2 of the office action of 5/6/2026.
Claims 1-13 are under consideration.
Response to Arguments
Claim Rejections - 35 USC § 103-maintained
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.
Claim(s) 1-13 remain rejected under 35 U.S.C. 103 as being unpatentable over Lovell et al. (IDS, US Pub. No. 2018/0085473) in view of Babb et al. (IDS, US Patent No. 10,787,501) for the reasons of record at pg. 3-8 of the office action of 5/6/2026 and as discussed below.
Applicants argue that Babb et al. does not teach or suggest use of any portion of the SARS-CoV-2 spike protein as a vaccine agent to raise antibodies rather Babb et al uses the SARS-CoV-2-S receptor binding with 1273 amino acid residues (col. 54, lines 34-57). They argue that using a sequence disclosed in one reference for an entirely different purpose, such as vaccine antigen rather than antibody binding domain characterization requires a motivation rooted in the prior art. They argue that the instant amino acid sequence of SEQ ID NO: 1 is from Arg391-Phe541 is used solely to coat plate in a binding assay to screen and characterize antibody supernatant and that they do not suggest using RBD as a vaccine agent.
Applicants’ arguments have been fully considered but they are not persuasive because Babb et al tach that “Because this virus uses its spike glycoprotein for interaction with the cellular receptor ACE2 and the serine protease TMPRSS2 for entry into a target cell, this spike protein represents an attractive target for antibody therapeutics. In particular, fully human antibodies that specifically bind to the SARS-CoV-2-Spike protein (SARS-CoV-2-S) with high affinity and that inhibit virus infectivity could be important in the prevention and treatment of COVID-19.” (see col.1, lines53+). Applicants’ arguments are focused on examples of Babb’s teachings (Example 1, col. 54). It is noted to applicants that the whole patent is considered enabled if its specification meets the statutory enablement requirement under 35 U.S.C. § 112(a) (pre-AIA ) or § 112, first paragraph, meaning it must describe how to make and use the claimed invention so that a person of ordinary skill in the art can do so without undue experimentation. The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In reBorkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970). Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1310, 115 USPQ2d 2012, 2023 (Fed. Cir. 2015) ( “Only a sufficient description enabling a person of ordinary skill in the art to carry out an invention is needed.”). The reference discloses that the amino acid sequence of full-length SARS-CoV-2 spike protein is exemplified by the amino acid sequence provided in SEQ ID NO: 832. The term “CoV-S” includes protein variants of CoV spike protein isolated from different CoV isolates as well as recombinant CoV spike protein or a fragment thereof (col. 9, lines 54+). They also disclose amino acid sequence of SEQ ID NO: 829 which is 100% identical to the instantly claimed SEQ ID NO: 1 and it is a fragment of amino acid sequence of the instantly claimed amino acid sequence of SEQ ID NO: 1. They teach immunizeing a subject using CoV-2-S of SARS. Additionally, antibodies generated against CoV2-S would bind RBD of spike protein of SARS-CoV-2 and therefore, one could use this fragment in a vaccine. Therefore, one skill in the art using the teaching of Babb would be able to make antibodies from a fragment from the spike protein or could use in a vaccine (including using amino acid sequence of SEQ ID NO: 829) that would bind with high affinity to its cognate receptors. Claim 1 does not recite the limitation of a receptor binding domain consisting of amino acid sequence of SEQ ID NO: 1. Therefore, claim 1 is broad and the combined teachings of Lovell et al. in view of Babb et al make the instantly claimed invention obvious.
Conclusion
No claim is allowed.
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 GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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