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 .
Claims 1-20 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/13/2025 has been considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “a method of for inducing…” It is suggested to amend the claim to “a method for inducing...” for clarity. Claims 3-21 are objected to for same reason because they depend on claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 4, 5, 11-13, 15 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 4, 5, 11-13, the recitation of “wherein the amino acid residue sequence within RBD of SARS-CoV-2 spike protein is amino acid residue 319-545” and “N331, N334 and N343” renders the claim indefinite because it is unclear whether the residue number is referring to the entire SARS-CoV-2 sequence, the S protein, or only RBD sequence. Without a reference sequence, the numbering of the aa residue does not establish the metes and bounds of the claimed polypeptide sequence.
Regarding claims 15 and 16, the claims are indefinite because it is unclear whether the limitation in parenthesis are part of the claim limitation.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-6, 10, 14-20 is/are rejected under 35 U.S.C. 102 (a2) as being anticipated by Chen (US 2021/0244811).
Claim 1 is drawn to a method of inducing an immune response against SARS-CoV-2 in a primate comprising administering an immunogenetically effective amount of recombinant polypeptide, wherein the at least a portion of the recombinant polypeptide corresponds to an amino acid residue sequence within the RBD of SARS-CoV-2 spike protein capable of forming a binding interface that interacts with a viral receptor of the primate. The claimed polypeptide read on a polypeptide that comprises a full length SARS-CoV-2 spike protein, or fragments thereof, that comprises the RBD domain sequence.
Chen teaches live attenuated chimeric virus that comprises antigenic portion that comprises nCoV(2019) RBD (paragraph [0011]), which is RBD of SARS-CoV-2. Chen teaches said chimeric virus may be administered directly to a mammal to elicit an immune response (paragraph [0101]). Chen teaches the mammal may be a child or elderly human, which meets the limitation of a primate. The teaching from Chen anticipates the claimed invention of claim 1.
Claim 2 is drawn to a method of preventing, inhibiting, reducing, eliminating, protecting or delaying the onset of an infection caused by SARS-CoV-2 comprising the same step as claim 1. Chen teaches the immunogenic composition may be used as vaccine (page 5, paragraph [0055]), which meets the limitation of “preventing, inhibiting or protecting” infection caused by SARS-CoV-2.
Regarding claim 3, Chen teaches a method for increasing immune response to SARS-CoV-2 (paragraph [0139]), which is responsible for clinical condition COVID-19.
Regarding claim 4, the RBD within SARS-CoV-2 spike protein inherently comprises amino acid residue 319-545.
Regarding claim 5, Chen teaches use of RBD as antigen minimizes potential antibody-dependent enhancement pathology caused by using full-length spike protein or whole virus (paragraph [0054]). The RBD of SARS-CoV-2 encoded by a polypeptide that comprises 238 amino acid residues (paragraph [0019], and page 14, SEQ ID NO: 2). Although claim 5 recites amino acid residue 319-545 within the RBD of SARS-CoV-2 S protein (226 aa residue), the claim recites the polypeptide “consists essentially,” which means there may be additional amino acid residue(s) in the polypeptide. Therefore, the RBD taught by Chen meets the claim limitation.
Regarding claim 6, it is inherent that S1 SARS-CoV-2 spike protein comprises RBD that interacts with ACE2 receptor.
Regarding claim 10, the sequence of SARS-CoV-2 RBD comprises multiple N-glycosylation sites, for example, Asparagine at aa. 12, 29, 38, as shown in SEQ ID NO: 2 (page 14, SEQ ID NO: 2).
Regarding claim 14-16, SARS-CoV-2 RBD comprises multiple O-glycosylation sites, for example, serine at aa. 11, 44, 54, 61, 68, 70, 78, or threonine at aa. 10, 28, 40, as shown in SEQ ID NO: 2 (page 14, SEQ ID NO: 2).
Regarding claim 17, Chen teaches administering additional adjuvant with the viral RBD antigenic portion (paragraph [0137]).
Regarding claim 18, Chen teaches aluminum salts is an example of adjuvant (paragraph [0058]), oil in water emulsion and saponin (paragraph [0059] and paragraph [0062]).
Regarding claim 19, Chen teaches the aluminum salt is aluminum hydroxides (paragraph [0058]).
Regarding claim 20, the wherein clause is not given patentable weight because it simply expresses the intended result of a process step positively recited. The recitation that “wherein the immune response against SARS-CoV-2 induced by the effective amount of the recombinant polypeptide blocks SARS-CoV-2 infection in the primate by at least about 65%...” does not require any additional steps besides the single step in claim 1, that is administering an effective amount of a recombinant polypeptide comprises a least a portion of RBD of SARS-CoV-2 spike protein. Moreover, it recited percentage is not a meaningful limitation because it is unclear what it is compared to.
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.
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.
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen, in view of Viktorovich (RU 2723008 C1).
The teaching from Chen has been discussed above.
However, Chen does not teach the molecular weight of the RBD from SARS-CoV-2.
Viktorovich teaches a method of producing recombinant SARS-CoV-2 recombinant protein RBD in Chinese hamster ovary cells (CHO-S-RBD) (abstract). Viktorovich teaches that the recombinant SARS-CoV-2 RBD protein produced in CHO cells has a molecular weight of 31 kDa, which is verified by both mass spectral analysis and gel electrophoresis (Example 3, 6th paragraph, and Figure 3, and Example 4, no.3). Viktorovich teaches that the mass of the RBD including glycosylation is about 30 kDa, and excluding glycosylation is 25 kDa (Example 3, 6th paragraph).
It would have been obvious to an ordinary skilled in the art at the time of filing to recognize that recombinantly produced SARS-CoV-2 RBD protein would have glycosylation depending on the specific type of host cell. The ordinary skilled in the art would recognize that SARS-CoV-2 RBD produced in CHO cells, a commonly used cell line for producing recombinant eukaryotic protein, would result in a recombinant polypeptide having about 31 kDa as shown by Viktorovich (claim 7: more than 28 kDa, claim 8: between 28-40 kDa, claim 9: about 34 kDa). The ordinary skilled in the art would recognize that recombinant RBD produced by CHO cells as taught by Viktorovich would have larger molecular weight including glycosylation. The ordinary skilled in the art would have reasonable expectation of success to use said eukaryotic expressed RBD (including glycosylation) in the method of inducing an immune response as taught by Chen following combined teaching from Chen and Viktorovich. Therefore, the claimed invention of claims 7-9 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen, in view of Shajahan (Glycobiology, 2020, vol.30, no.12, pages 981-988).
The teaching from Chen has been discussed above. Chen also teaches administering the immunogenic composition to a mammal in need of protective immunity (paragraph [0015]). Chen teaches the term “mammal” includes both human and non-humans including non-human primates, canines, felines, murines, bovines, equines, and porcines (paragraph [0043]).
However, Chen does not teach the number of glycan moieties on N331, N334 and N343.
Shajahan et al. teach and demonstrate a method of deducing the N- and O-glycosylation profile of the spike protein of novel coronavirus SARS-CoV-2. Shajahan et al. teach each monomer of S protein is highly glycosylated with 22 predicted N-linked glycosylation sites and three O-glycosylation sites, and elucidating the glycosylation of the viral S protein can aid in understanding viral binding with receptors, fusion, replication and design suitable vaccine development (page 982, 1st col., 2nd paragraph).
It would have been obvious to an ordinary skilled in the art at the time of filing that S protein of SARS-CoV-2 is highly glycosylated, and a map of N-glycosylation and O-glycosylation on S protein is provided by Shajahan (Figure 2 and legend). An ordinary skilled in the art would recognize that the glycosylation pattern is highly dependent on the protein structure and the cell the protein being expressed in (the glycosylation map taught by Shajahan was produced by HEK293, a human cell line). Since the structure of the RBD from the S protein of SARS-CoV-2 is already known in the art, the number of glycan moieties on an amino acid produced in a particular cell type may be determined for using the method taught by Shajahan for design suitable vaccine in a particular mammal including human and non-human primate. Therefore, the claimed invention of claims 11-13 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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/CELINE X QIAN/ Primary Examiner, Art Unit 1637
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