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 .
Response to Amendment
The Amendment filed 04/14/2026 in which claims 1-3, 4, 7-11, 13 were amended, and claim 5 was canceled, has been entered. Claims 15-17 were previously withdrawn.
Claims 1-4, 6-11, 13-14 are under examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 04/14/2026 after the Nonfinal Office Action mailed on 01/14/2026. 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
(Previous objection, withdrawn) Applicant’s amendments to the Drawings submitted on 04/14/2026 have overcome the objection previously set forth in the Non-Final Office Action mailed 01/14/2026.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on 04/14/2026 have overcome the objection previously set forth in the Non-Final Office Action mailed 01/14/2026.
Nucleotide and/or Amino Acid Sequence Disclosures
(Previous objection, withdrawn) Applicant’s amendments to the Specification concerning nucleotide and/or amino acid sequence disclosures submitted on 04/14/2026 have overcome the objection previously set forth in the Non-Final Office Action mailed 01/14/2026.
Claim Objections
(Previous objections, withdrawn as to claims 1, 2, 8, 9, 11). Applicant’s amendments to the instant claims have overcome previous objections to claims 1, 2, 8, 9, 11.
(New objections, necessitated by amendment as to claim 9) Claim 9 is objected to because of the following informalities:
On claim 9, the recitation of “wherein, SZU-101 is attached…” should read “wherein, the SZU-101 is attached…”.
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.
(Previous rejection, withdrawn as to claim 5, maintained and modified as necessitated by amendment at to claims 1-4, 6-11, 13-14) Claims 1-4, 6-11, 13-14 are rejected under 35 U.S.C. 112(b)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 1-4, 6-11, 13-14 as submitted on 04/14/2026.
The previous rejection of claim 5 is moot in view of Applicant’s cancelation of this claim.
On claim 1 the recitation of “the antigenic polypeptide has an amino acid sequence derived from the Receptor-Binding Domain (RMB) region of the S protein” on lines 7 and 8 is unclear because it is not indicated what the term “derived” means or how it is to be understood. 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.
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.
(Previous rejection, withdrawn as to claims 5 and 9, maintained and modified as necessitated by amendment as to claims 1-4, 10-11, 13-14) Claims 1-4, 10-11, 13, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Nel et al., in view of Chen (prior art of record).
See claims 1-4, 10-11, 13, 14 as submitted on 04/14/2026.
The previous rejection of claim 5 is moot in view of Applicant’s cancelation of this claim.
Applicant’s amendments to claim 9 submitted have overcome the rejection previously set forth in the Non-Final Office Action mailed 01/14/2026.
Regarding claim 1, it is noted that all of the amendments were made to overcome the previous rejections under 35 U.S.C. 112(b), second paragraph set forth in the Non-Final Office Action mailed on 01/14/2026. No new limitations were introduced in the amendment filed on 04/14/2026. Accordingly, the rejection under 35 U.S.C. § 103 set forth in the previous Non-Final Office Action still applies to amended claim 1. As previously explained, 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, it is noted that no new limitations were introduced to claim 2 in the amendment filed on 04/14/2026. As previously explained, the claim recites “wherein the vaccine polypeptide stimulates primates to produce neutralizing antibodies that block the binding of the RDB to the ACE2 receptor”. 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 the RDB to the ACE2 receptor.
Regarding claims 3-4, it is noted that no new limitations were introduced to claims 3 and 4 in the amendment filed on 04/14/2026. As previously explained, 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, it is noted that amended claim 10 recites “at least two distinct vaccine polypeptides”. However, as previously explained, Nel et al. already teach this limitation. Specifically, Nel et al. teach vaccine compositions comprising biocompatible polymers comprising one or more viral proteins or fragments thereof (Abstract, ¶¶ [0031], [0201], [0207]).
Regarding claim 11, it is noted that amended claim 11 recites “at least two distinct vaccine polypeptides”. However, as previously explained, Nel et al. already teach this limitation. Specifically, Nel et al. teach pharmaceutical compositions comprising one or more viral proteins or fragments thereof and a pharmaceutical acceptable carrier (¶¶ [0357]-[0377]).
Regarding claims 13 and 14, it is noted that amended claim 13 recites “at least two distinct vaccine polypeptides”. However, as previously explained, 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 compositions comprising one or more viral proteins or fragments thereof and a pharmaceutical acceptable carrier wherein the pharmaceutical acceptable carrier is suitable for pharmaceutical compositions (¶¶ [0357]-[0377]).
Accordingly, claims 1-4, 10-11, 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.
(Previous rejection, maintained as at to claims 6-8, expanded as to claim 9) Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Nel et al., and Chen (previously cited), as applied to claims 1-4, 10-11, 13 and 14 above, further in view of Jin et al.
See claims 6-9 as submitted on 04/14/2026.
Regarding claims 6-8, it is noted that no new limitations were introduced to claims 6-8 in the amendment filed on 04/14/2026. As previously explained, 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.
Regarding amended claim 9, as noted above Nel et al., Chen and Jin et al. in combination teach the polypeptide vaccine in SEQ ID NO: 12. With respect to the recitation of “wherein SZU-101 is attached to the N-terminal amino group of the first L and the side chain amino group of the 4th and 8th K in the amino sequence through the S1 structure”. Nel et al. teach conjugation of a SARS-CoV-2 Spike protein comprising the receptor binding motif (RBM) to a toll-like receptor (TLR) 7 agonist (Abstract, ¶¶ [0006]-[0012], [0089], [0212]-[0214], [0241]) using standard laboratory techniques well known in the art including simple adsorption, native ligation, etc. (¶¶ [0350], [0351]). As evidenced by Liu, et al. “Synthetic MUC1 breast cancer vaccine containing a Toll-like receptor 7 agonist exerts antitumor effects.” Oncology letters vol. 20,3 (2020): 2369-2377 (see 892-Notice of References Cited), an SZU-101 molecule can be conjugated onto a viral sequence by attachment to the N-terminus and to lysine (K) residues which are available for linkage. Further, it is noted that it is well within the purview of one of ordinary skill in the art to determine the sites of conjugation within a viral sequence and such sites of conjugation of for example, a TLR7 agonist molecule, are considered to be those determined by routine optimization according to one of skill in the art in view of the teachings of the cited references See MPEP 2144.05. Therefore, the embodiment of claim 9 represents an obvious embodiment of the teachings of the cited references.
Accordingly, the limitations of claims 6-9 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.
Response to Arguments
Applicant's arguments filed 04/14/2026 have been fully considered but they are not persuasive.
Applicant contends on page 12 of the Remarks submitted on 04/14/2026:
“Nel et al. teach an immunogenic nanoparticle comprising a biocompatible polymer where one or more proteins or fragments are conjugated to, or co-encapsulated with an adjuvant. However, Nel et al. only disclose that SARS-CoV-2 antigenic fragment were co-encapsulated with STING agonist (adjuvant) to form a nanoparticle in the Examples. Nel et al. do not disclose any adjuvant conjugated SARS-CoV-2 antigenic fragment. It is difficult to anticipate the effect of adjuvant (such as TLR7 agonist) conjugated SARS-CoV-2 antigenic fragment based on the Nel et al.'s disclosure.”
In response:
The instant rejection is in view of instant claim language. Although the claims are interpreted in light of the Specification, limitations from the Specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The instant claims do not mention nor require any limitation in regards to conjugation specifically. The instant claims merely recite “a chemical bond or linker” which encompasses a wider range of combining two elements into a single embodiment. Further, it is noted that the disclosure of Nel et al. specifically includes conjugation which is the exact claimed embodiment, as noted above in detail. Examples of every possible embodiment are not required in patent applications. See MPEP 2164.
Applicant contends on page 13 of the Remarks submitted on 04/14/2026:
“In fact, no prior art has disclosed or hinted the vaccine polypeptide as claimed in the present application. More importantly, the vaccine polypeptide as claimed in the present application has achieved surprisingly excellent technical effects…”
In response:
To reiterate, the instant rejection is in view of instant claim language. Although the claims are interpreted in light of the Specification, limitations from the Specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is noted that the instant claims do not require nor recite limitations with respect to technical effects. Further, in view of the teachings of the cited prior art explained in detail above, such a result of an enhanced humoral and cellular immune response would be considered entirely expected and consistent with the prior art. Therefore, Applicant’s arguments in reference to the alleged surprisingly excellent technical effects of the claimed vaccine polypeptide are neither surprising nor of any relevance to overcome the rejections of record.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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-R 8:00 AM - 5:00 PM.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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