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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group II (an immunogen comprising an amino acid sequence), which is encompassed by claims 1-8, 22, and 32-34, in the reply filed on 1/12/2026 is acknowledged.
Status of Claims
Claims 1-8, 22, 24-25, 27-30, and 32-34 are pending.
Claims 1-8, 22, and 24 were amended without concession or disclaimer by the applicant.
Claims 9-21, 23, 26 and 31 are canceled without concession or disclaimer.
Claims 24-25 and 27-30 are withdrawn.
Claims 32-34 were added as new claims.
Claims 1-8, 22, 32-34 are examined on their merits.
Priority
For examination purposes, the earliest effective filing date for the instant claims is 10/14/2020 based on the filing date of the provisional application 63/091,676.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/21/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6, 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more that the judicial exception for the reasons set forth below. See MPEP § 2106 for analysis framework.
The instant claims are drawn to a polypeptide immunogen that induces an immune response against a coronavirus. With broadest reasonable interpretation, the instant claims can read broadly on the polyprotein coronavirus itself as the immunogen that induces an immune response against a coronavirus, e.g., post-infection and when taking into account the dependent claims, more specifically on SARS-CoV-2 (COVID-19) and further, with respect to specific polypeptides, nonstructural proteins and the envelope (E) protein. In addition, the broadest reasonable interpretation of a pharmaceutically acceptable carrier, as recited in claim 22, can include water. As such, the instant claims are drawn to a composition of matter, which is a statutory category of invention (Step 1: YES).
In the May 2020 article, The Proteins of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS CoV-2 or n-COV19), the cause of COVID-19 (See PTO 892 – Notice of References Cited), Yoshimoto reviews the genome of naturally occurring SARS-CoV-2 providing in Table 1 the genes expressed by SARS-CoV-2 (NC_045512.2), (e.g., the 11 genes with 11 different open reading frames), and in Table 2, the nonstructural proteins (NSPs) found in the polyprotein of SARS-Cov-2. Pertinent to the instant claims, Yoshimoto teaches ORF4 (E) and the envelope protein (E protein) as well as ORF1ab and the NSPs 7-10, and 12-13. For instant claim 22, water is naturally occurring. Accordingly the instant claims recite a natural phenomenon which is a judicial exception (JE) (Step 2A, Prong One: YES).
The instant claims are drawn solely to the JE(Step 2A, Prong Two: NO).
Since the claims are limited to only the JE, the instant claims do not recite any additional elements that amount to significantly more than the JE (Step 2B: NO).
In view of the foregoing, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. § 101.
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Safavi et al. (Safavi)(2020)(cited in the IDS submitted on 8/21/2023).
Safavi teaches the immunodominant epitopes from SARS-CoV-2 proteins S glycoprotein and Orf1ab polyprotein were selected for designing the candidate vaccine using prediction, modeling and simulation software (p. 7613, 2.2 Collection of Proteins; 17614; 2.10 Assemblage of multi-epitope vaccine candidate sequence) that induces an immune response against SARS-CoV-2. The immunodominant fragment of the functional region of SARS-CoV-2 spike (400-510 residues) was selected for inducing neutralizing antibodies production. And, the immunodominant regions of six non-structural proteins (nsp7, nsp 8, nsp 9, nsp 10, nsp 12 and nsp 14) of SARS-CoV-2 were selected by multiple immunoinformatic tools to provoke a T-cell immune response (p. 7612, Abstract).
Accordingly, Safavi teaches each and every aspect of claims 1-4.
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.
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 5-8 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Safavi, above (see § 102) as applied to claims 1-4 above, and further in view of Dong et al. (Dong)(2020)(cited in the IDS submitted on 8/21/2023).
Claims 5-8, 22 as submitted 1/12/2026.
Safavi teaches claim 1.
Safavi also teaches the immunodominant regions of six non-structural proteins (nsp7, nsp8, nsp9, nsp10, nsp12, and nsp14) of SARS-CoV-2 were selected…to provoke T cell immune response (as recited in claim 5 for NSP 7, 8, 9; as recited in claim 6 for NSP 7, 8, 19, 10, 12).
Safavi, however, does not teach NSP 13, the envelope (E) protein, or pharmaceutically acceptable carriers.
Dong, however, teaches “Apart from the S protein, other proteins, such as the N protein, M protein, non-structural proteins (nsps), and accessory proteins, may have the potential to serve as antigens…Recent studies found that nsp13 of SARS-CoV-2 targeted the IFN pathway by associating with TBK1” (p.2). Dong also teaches eight immunodominant CD4+ T-cell epitopes have been suggested for use in a subunit vaccine, to potentially elicit effective T- and B-cell responses and that they are distributed across the S protein, E protein, and M protein (p. 3). Furthermore, for claim 22, which also recites a pharmaceutically acceptable carrier which can broadly be interpreted from pharmacy grade vials, to water, to more commonly adjuvant formulations with a more advanced example being vaccine adjuvant delivery systems (VADS), Dong teaches adjuvants (p. 9).
One of ordinary skill in the art would have been motivated to add both the SARS-CoV-2 nsp13, the E protein, and a pharmaceutically acceptable carrier to a polypeptide immunogen construct with their noted immunogenic properties as taught by Dong in order to improve the overall immunogenicity of the polypeptide immunogen construct and to boost the immune response against SARS-CoV-2 as part of a vaccination strategy (See MPEP 2143 Rationale A: Combining prior art elements according to known methods to yield predictable results).
For claims 7 and 8, which recite an order of NSPs and an E protein insertion between select NSPs, not commonly found in nature, it would be obvious to select specific NSPs and the E protein (based on their projected desirable epitopes ascertained by immunoinformatics) and arrange in different ways to arrive at the orders as recited in claims 7 and 8 with strong predictive immunogenicity absent unexpected results (in view of Safavi and Dong) (See MPEP 2144.04: IV C.: C. Changes in Sequence of Adding Ingredients. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious).
One of ordinary skill in the art would have had a reasonable expectation of success for incorporating both the SARS-CoV-2 nsp13, the E protein, and pharmaceutically acceptable carrier as taught by Dong into a polypeptide immunogen construct in order to improve the overall immunogenicity of the polypeptide immunogen construct and to boost the immune response against SARS-CoV-2. There would have been a reasonable expectation of success given the underlying materials and methods are known in recombinant protein production, vector vaccine construction, and coronavirus vaccinology fields, successfully demonstrated, and commonly used as evidenced by the applied prior art
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Allowable Subject Matter
Claims 32, 33, and 34 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Claire Cornelius whose telephone number is (571) 272-0860. The examiner can normally be reached M-F, 0930-1700.
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/C.C./Examiner, Art Unit 1672
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672