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 of Group I, claims 1-11, 13, 14, drawn to a vaccine polypeptide, the species of SEQ ID NO: 12 in claims 3, 4, 5, 10 and 11, and the species of (S1)-LFRK(-S1)SNLK(- S1) PFERDISTEIYQAGSTPCNGVEGFNCYFPLQSY GFQPTNGVGYQPY (SEQ ID NO: 12) in claim 8, in the reply filed on 10/20/2025 is acknowledged.
Further, Applicant’s amendment filed 10/20/2025 in which claims 1-4, 10-13, and 17, were canceled amended has been entered.
Claims 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-11, 13 and 14 are under examination on the merits.
Priority
Applicant’s claim for foreign priority of prior-filed Chinese application No. CN- 202010514683.8 filed on 06/08/2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 12/07/2022. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 12/07/2022. The drawings are objected to because Figs. 1, 4 contains amino acid sequences which are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Further, the resolution of Fig. 8 is so low as to render the data unascertainable.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/patents-application- process/filing-online/legal-framework-efs-web), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings (Figs. 1, 4) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
It is noted that the Specification is missing a paragraph indicating cross-references to related applications.
Claim Objections
Claims 1, 2, 8, 9, 11 are objected to because of the following informalities:
On claim 1, the recitation of “a vaccine polypeptide of coronavirus SARS-CoV-2” should read “a vaccine polypeptide against a SARS-CoV-2 coronavirus”. Appropriate correction is required.
Claim 1 recites “RBM”, “S”, “RBD”, “TLR7”, “ACE2”. It is recommended that such abbreviations be defined at first mention to improve clarity of the claim.
On claim 2, the recitation of “block the binding of RDB to ACE2” should read “block the binding of the RDB to the ACE2 receptor”. Appropriate correction is required.
On claim 8, the recitations of “the U is site-specifically linked to Z” and “wherein, SZU-101 is attached” should read “the U is site-specifically linked to the Z” and “wherein, the SZU-101 is attached”, respectively. Appropriate correction is required. Further, the recitations of “L” and “K” should read “leucine” and “lysine” respectively. Appropriate correction is required.
Claims 9 is objected to because it contains sequence disclosures (“P-37”, “P-67-F1”, etc.) that are encompassed by the definitions for amino acid sequences set forth in 37 CFR § 1.821(a)(1) and (a)(2) and it fails to make reference to the amino acid sequences by use of sequence identifiers (“SEQ ID NO:” or the like) in accordance to 37 CFR § 1.823(a)(5). See MPEP 2422. Appropriate correction is required.
On claim 11, the recitation of “vaccine polypeptide of coronavirus” on line 2 should read ““vaccine polypeptide of the coronavirus”. 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 1-11, 13 and 14 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.
See claims 1-11, 13, 14 as submitted on 10/20/2025.
On claim 1 the recitations of “the antigenic polypeptide has an amino acid sequence derived from the RMB region of the S protein” on lines 7 and 8; and “wherein the sequence of the core fragment is selected from one or more of SEQ ID NO: 1-12” on lines 20 and 21, are not clear because they do not define the scope of the claim in relation to the sequences. Specifically, it is not clear if Applicant intended to recite “comprising”, “consisting essentially of” or “consisting of” to define the scope of a claim in relation to the sequences. See MPEP 2111.03. Further, it is unclear what the term “derived” means because the Specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the claim is indefinite. The dependent claims do not add additional clarity and, therefore, are also indefinite. For purposes of compact prosecution and applying prior art, claim 1 was interpreted herein as reciting the open-ended language of comprising an amino acid sequence of the RMB region of the S protein on lines 7 and 8, and wherein the sequence of the core fragment comprises SEQ ID NO: 12 (elected species).
On claim 3 the recitation of “the antigenic polypeptide is a polypeptide having any one of the amino acid sequences shown in SEQ ID NO: 1-12” is not clear because it does not define the scope of the claim in relation to the sequences. Specifically, it is not clear if Applicant intended to recite “comprising”, “consisting essentially of” or “consisting of” to define the scope of a claim in relation to the sequences. See MPEP 2111.03. Therefore, the claim is indefinite. For purposes of compact prosecution and applying prior art, claim 3 was interpreted herein as reciting the open-ended language of comprising SEQ ID NO: 12 (elected species).
On claim 5 the recitation of “the antigenic polypeptide is selected from Table A” is not clear because it does not define the scope of the claim in relation to the sequences. Specifically, it is not clear if Applicant intended to recite “comprising”, “consisting essentially of” or “consisting of” to define the scope of a claim in relation to the sequences. See MPEP 2111.03. Therefore, the claim is indefinite. The dependent claims do not add additional clarity and, therefore, are also indefinite. For purposes of compact prosecution and applying prior art, claim 5 was interpreted herein as reciting the open-ended language of comprising SEQ ID NO: 12 (elected species).
Claim 7 recites "the amino group" on line 2, and “the sulfhydryl group” on line 4. There is insufficient antecedent basis for these recitations in the claim because neither claim 6 nor claim 1 mention such amino group nor such sulfhydryl group. Therefore, the claim is indefinite. The dependent claims do not add additional clarity and, therefore, are also indefinite. For purposes of compact prosecution and applying prior art, claim 7 was interpreted herein as referring to an amino group and a sulfhydryl group, respectively.
Claim 8 recites the term “preferably” which renders the claims indefinite because it is unclear whether the limitations following this term are part of the claimed invention or not. See MPEP § 2173.05(d). Further, it is noted that claim 8 recites “(S1)-LFRK(-S1)SNLK(-S1) PFERDISTEIYQAGSTP CNGVEGFNCYFPLQSYGFQPTNGVGYQPY (SEQ ID No: 12) wherein, SZU-101 is attached to the N-terminal amino group of L and the side chain amino group of K in the amino acid sequence through the S1 structure” This recitation is unclear because it is missing the indefinite articles (“a” or “an”) before the recitations of “L” and “K” to indicate the scope of the claim. Further, it is not clear if the ‘wherein’ clause refers to the lysine residue number 4 or lysine residue number 8, or both as indicated in the sequence representation. A clear indication of which amino acid residues in SEQ ID NO:12 bear the conjugation of the SZU-101 molecule is lacking. Therefore, the claim is indefinite. For purposes of compact prosecution and applying prior art, claim 8 was interpreted herein as referring to the vaccine polypeptide of claim 7, wherein the U is site-specifically linked to the Z.
Claim 9 recites “wherein the vaccine polypeptide is selected from the group consisting of: P-37 or its conjugate with TLR7 agonist, P-67-F1 or its agonist with TLR7, P-71 or its conjugate with TLR7 agonist, LV54 or its conjugate with TLR7 agonist, and combinations thereof”. This recitation is unclear because it seemingly refers to the amino acid sequences listed in Table A in claim 5 (see also Objections above) but does not define the scope of the claim in relation to the sequences. Specifically, it is not clear if Applicant intended to recite “comprising”, “consisting essentially of” or “consisting of” to define the scope of a claim in relation to the sequences. See MPEP 2111.03. Further, the recitation of “LV54” seems to bear a typographical error, given that claim 5 recites “LY54” corresponding to SEQ ID NO:12. For purposes of compact prosecution and applying prior art, claim 9 was interpreted herein as reciting the open-ended language of comprising SEQ ID NO: 12 (elected species).
Claims 10, 11 and 13 recite "the peptide set comprises at least two vaccine polypeptides" or “comprising at least two vaccine polypeptides”. It is unclear if these recitations refer to at least two distinct species of polypeptides or to a polymer comprising at least two polypeptides of a single species. For purposes of compact prosecution and applying prior art, claims 10, 11 and 13 were interpreted herein as referring to at least two distinct species of polypeptides or to a polymer comprising at least two polypeptides of a single species.
Claims 11 and 13 recite "the peptide set" on line 2 and line 3 respectively. There is insufficient antecedent basis for these recitations in the claims because claim 1, which claims 11 and 13 depend on, does not mention such peptide set. Therefore, the claims are indefinite. The dependent claims do not add additional clarity and, therefore, are also indefinite. For purposes of compact prosecution and applying prior art, claims 11 and 13 were interpreted herein as referring to a peptide set.
It is noted that any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this Office Action. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office Action.
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 1-5, 9-11, 13, 14 are rejected under 35 U.S.C. 103 as being unpatentable over US PG Pub 20230172869 to Nel et al., filed on 04/20/2020, in view of US PG Pub 20210332085 to Chen, filed on 03/05/2020 (See PTO-892: Notice of References Cited).
See claims 1-5, 9-11, 13, 14 as submitted on 10/20/2025.
Regarding claim 1, Nel et al. teach a vaccine composition comprising a SARS-CoV-2 polypeptide wherein the SARS-CoV-2 polypeptide comprises an antigenic fragment of the SARS-CoV-2 Spike protein comprising the receptor binding motif (RBM) conjugated via a linker to a toll-like receptor (TLR) 7 agonist (Abstract, ¶¶ [0006]-[0012], [0089], [0212]-[0214], [0241]). Nel et al. further teach the SARS-CoV-2 Spike protein comprising the receptor binding motif (RBM) comprises a T cell epitope, a B cell epitope or both and is capable of inducing an immunogenic response against the SARS-CoV-2 virus (¶ [0238]).
Nel et al. do not teach a SARS-CoV-2 Spike polypeptide sequence 8-100 amino acid residues in length, wherein the fragment comprises SEQ ID NO: 12.
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However, Chen teaches SARS-CoV-2 Spike polypeptide sequences comprising the RBD region which bear B cell epitopes and T cell epitopes and are capable of
eliciting enhanced antibody responses in a mammalian subject and block viral entry (Abstract, ¶¶ [0022]-[0023]). One such sequence taught by Chen (SEQ ID NO: 281) is 69 amino acid residues in length, it comprises the SARS-CoV-2 RBD and shares 100% sequence identity with instant SEQ ID NO: 12. See alignment above (Qy is instant SEQ ID NO: 12; Db is instant Chen’s SEQ ID NO: 281). It is noted that Chen further teaches 1 and/or 2 amino acid residues flanking at both ends of the sequence shown above which are connected to the sequence shown below by peptide bonds.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the SARS-CoV-2 Spike polypeptide sequence as taught by Chen into the vaccine composition comprising a TLR7 agonist as taught by Nel et al. for the benefit of eliciting an enhanced antibody response capable of blocking viral entry. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in incorporating the sequence of Chen into the vaccine formulation of Nel et al. given that the methods of formulating polypeptide vaccines comprising TLR7 agonists are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claim 2, the claim recites “wherein the vaccine polypeptide stimulates primates to produce neutralizing antibodies that block the binding of RDB to ACE2”. Nel et al. teach demonstrate effective disease prevention and reduction of viral load with their vaccine composition in nonhuman primates (¶ [0241]). Further, it is noted that such recitation is does not impart any additional structural features to the vaccine polypeptide as recited in claim 1, therefore this recitation is considered to flow from the features already present in the vaccine polypeptide as recited in claim 1. Further, given that instant claims are directed to a vaccine polypeptide and not to a method of using the vaccine polypeptide, the recitations with respect to the manner in which the claimed vaccine polypeptide is indented to be employed do not differentiate the claimed vaccine polypeptide from any prior art vaccine polypeptides that meet the structural limitations as recited in claim 1. See also MPEP 2111.04 (II). Therefore, any vaccine polypeptide in the prior art having the all of the structural limitations recited in claim 1 would be capable of stimulating primates to produce neutralizing antibodies that block the binding of RDB to ACE2.
Regarding claims 3-5, 9 as indicated above Chen teaches a SARS-CoV-2 RBD sequence that shares 100% sequence identity with instant SEQ ID NO: 12. See alignment above. Further, the sequence taught by Chen and shown above meets the limitation of “wherein the total number of amino acids of X1 and X2 is 0 or 1”, as recited in claim 4, because Chen teaches 0 and/or 1 amino acid residues flanking at both ends of the sequence as shown above which are connected to the sequence shown below by peptide bonds.
Regarding claim 10, Nel et al. further teach vaccine compositions comprising biocompatible polymer comprising one or more viral proteins or fragments thereof (Abstract, ¶¶ [0031], [0201], [0207]).
Regarding claim 11, Nel et al. further teach pharmaceutical compositions comprising a pharmaceutical acceptable carrier (¶¶ [0357]-[0377]).
Regarding claims 13 and 14, Nel et al. teach in vitro administration of the vaccine polypeptide to immune cells, wherein the immune cells comprise antigen presenting cells (APC) such as dendritic cells (Example 1, ¶ [0412]). As indicated above, Nel et al. further teach pharmaceutical acceptable carriers suitable for pharmaceutical compositions (¶¶ [0357]-[0377]).
Accordingly, claims 1-5, 9-11, 13 and 14 were prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Nel et al., and Chen (previously cited), as applied to claims 1-5, 9-11 above, further in view of WO-2018214699-A1 to Jin et al., filed on 04/27/2018 (See PTO-892: Notice of References Cited).
See claims 6-8 as submitted on 10/20/2025.
Regarding claims 6-8, Nel et al. and Chen in combination teach the vaccine polypeptide of claim 1.
Neither Nel et al. nor Chen teach the TLR7 agonist SZU-101, nor attachment of the SZU-101 at a specific site as recited in claims 7 and 8.
However, Jin et al. teach a viral vaccine comprising a TLR7 agonist such as SZU-101 to elicit an enhanced cytokine induction and higher production of protective antibodies (Abstract, pages 2, 5, 6). Jin et al. further teach the structure of the SZU-101 molecule as well as other closely related molecules SZU-103, SZU-117, SZU-114, etc. (Figs. 1, 3, 5, 7) Jin et al. further teach that the α, β-unsaturated carbonyl group present in the SZU-101 molecule has adsorptive properties that allow covalent bonding to an amino group of an antigenic protein at that specific site (page 4, Fig. 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the teaches of Jin et al. about the TLR7 agonist SZU-101 covalently bonded to the amino group of an antigenic protein at the specific site of the α, β-unsaturated carbonyl group into the vaccine polypeptide of Nel et al. in view of Chen for the benefit of eliciting an enhanced cytokine induction and higher production of protective antibodies. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in incorporating the TLR7 agonist SZU-101 of Jin et al. and covalently bond it to the amino group of the polypeptide of Nel et al. in view of Chen at the specific site of the SZU-101 α, β-unsaturated carbonyl group given that the methods of conjugating polypeptides to immune agonists such as the TLR7 agonist SZU-101 are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Accordingly, the limitations of claims 6-8 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-F 8-5.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672