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/Disposition of Claims
Applicant’s Amendment filed on 03 December 2025 has been received and entered. Claims 1-2, 4-10, 12-16, 21, 24-27, 30, and 61 were pending. Claims 1, 5-6, 8-10, 14-15, 21, 24, 27, and 30 have been amended. Claims 2-4, 7, 11-13, 17-20, 22-23, 26, 28-29, and 31-70 have been cancelled. New Claim 71 has been added.
Accordingly, Claims 1, 5-6, 8-10, 14-16, 21, 24-25, 27, 30, and 71 are currently pending and will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2023/0241202 A1, Published 03 August 2023. Applicant’s amended Specifications as presented on 03 December 2025 and 23 November 2022 are acknowledged and entered.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Response to Arguments
Applicant's arguments filed 03 December 2025 regarding the previous Office action dated 04 September 2025 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Specification; Sequence Disclosure Requirements
(Objection withdrawn) – The objection to the Specification for failing to comply with Sequence Disclosure Requirements is withdrawn in light of the amendments to the Specification and the Sequence Listing.
(Objection withdrawn) – The objection to Claim 7 for reciting duplicate sequences is withdrawn in light of the cancellation of the claim.
(New Objection) – This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below or on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures.
The specification is objected to because Paragraph 0085 (PGPub; 0086 of the Substitute Specification filed on 03 December 2025) comprises a sequence that does not identify said sequence with a corresponding SEQ ID NO within the figure itself or within the figure legend of the specification. The sequence in question is EPEA, the C-terminal affinity tag identified in Figures 5A and 5B. While this sequence is part of SEQ ID NOs: 9 and 10 in Figures 5A and 5B, respectively, it is explicitly recited by itself in the figure legend within the Specification as a standalone sequence. As such, it must meet the Sequence Disclosure Requirements in this instance as it has at least 4 specifically defined and enumerated amino acid residues. It is therefore required to correspond to a sequence identifier in the instant Sequence Listing. If it corresponds to a sequence in the Sequence Listing, then it should be associated with said SEQ ID NO each and every time it appears throughout the disclosure. If it does not correspond to a sequence in the Sequence Listing, then it is required to have its own unique SEQ ID NO.
Additionally, the amended Sequence Listing filed on 03 December 2025 still contains duplicate sequences. Specifically, SEQ ID NOs: 8, 56, and 60 are all 100% identical to each other and the exact same length. In other words, they are all the same sequence. The full sequence alignments have been attached to this Office Action.
Examiner kindly requests that Applicant thoroughly review the Sequence Listing and remove all instances of duplicate sequences.
Applicants must comply with sequence rules in order to be considered a complete response to this Office Action.
Specification
(Objection withdrawn) – The objection to the disclosure for containing embedder hyperlinks and/or other forms of browser-executable code is withdrawn in light of the amendments to the Specification.
(Objection withdrawn) – The objection to the disclosure for containing possible minor errors is withdrawn in light of the amendments to the Specification.
Claim Objections
(Objection withdrawn) – The objection to Claims 1, 15, 24, 26, 30, and 61 for containing minor informalities is withdrawn in light of the cancellation of two of the claims and the amendments to the remainder of the claims.
(Potential Objection obviated) – The potential objection to Claim 26 as being a substantial duplicate thereof of Claim 24 has been obviated by the cancellation of Claim 26.
(New Objection) – Claims 30 and 71 are objected to because of the following informalities: It is suggested that they say “…has at least 99% sequence identity with the amino acid sequence of any one of SEQ ID NOS:…” or “has at least 99% sequence identity with an amino acid sequence selected from the group consisting of SEQ ID NOS:…” instead of “…has at least 99% sequence identity with an amino acid sequence of any one of SEQ ID NOS:…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b); Second Paragraph
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.
(Rejection withdrawn) – The rejection of Claims 1 and 61, and dependent claims 2, 4-10, 12-16, 21, and 24-27 thereof under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to one of the claims and the cancellation of the other claim.
(Rejection withdrawn) – The rejection of Claim 4 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the cancellation of the claim.
(Rejection withdrawn) – The rejection of Claim 7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the cancellation of the claim.
(Rejection withdrawn) – The rejection of Claim 7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the cancellation of the claim.
(Rejection withdrawn) – The rejection of Claim 26, and dependent claim 27 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the cancellation of the claim.
(Rejection withdrawn) – The rejection of Claim 30 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the use of indefinite articles is withdrawn in light of the amendments to the claim.
(Rejection withdrawn) – The rejection of Claim 30 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for not being complete in itself is withdrawn in light of the amendments to the claim.
(New Rejection – necessitated by amendment) – Claims 1 and 30, and dependent claims 5-6, 8-10, 14-16, 21, 24, and 27 thereof, 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 Claim 1, it recites the limitation of “a nucleic acid encoding a polypeptide comprising, in frame, a coronavirus S1 protein amino acid sequence and at least one epitope string, wherein the epitopes string comprises two of more of the following amino acid sequences…separated by spacer amino acid sequences”. Regarding Claim 30, it recites the limitation of “a nucleic acid encoding an immunogenic polypeptide comprising a coronavirus S1 protein amino acid sequence and one or both of: an epitope string, wherein two or more epitopes of the epitope string comprise one or more of the following amino acid sequences:…, separated by spacer amino acids,…”. While the claim limitation reciting the epitopes of the epitope string and the spacer amino acids was presented previously, it was done so as a separate dependent claim and thus was definite on its own. Now that this claim limitation has been incorporated into two independent claims which recite other amino acid sequences, the phrase “separate by spacer amino acids” now renders these claims indefinite because it is now unclear if this claim language still only applies to the epitopes comprising the epitope string. It is believed that this is still Applicant’s intention, but the amended claim language can now be reasonably interpreted such that the epitope string is separated from the coronavirus S1 protein amino acid sequence by spacer amino acids while the epitopes of the epitope string are not separated from each other by spacer amino acids. Yet another interpretation is that the coronavirus S1 protein amino acid sequence is separated from the first epitope of the epitope string by spacer amino acids and that the first and second epitopes of the epitope string are in turn also separated by spacer amino acids. The multiple reasonable interpretations of these claims render them indefinite. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite."). It is suggested that the claims be amended to clarify which sequences are being separated by the spacer amino acids, such as by reciting the limitation “wherein the epitopes of the epitope string are each separated by spacer amino acids”, or similar language, as long as said amendment is supported by the originally-filed disclosure, but Applicant is free to amend the claims as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 1 and 30 are rejected on the grounds of being indefinite. Claims 5-6, 8-10, 14-16, 21, 24, and 27 are also rejected, since they depend upon Claim 1 but do not remedy the deficiencies of Claim 1.
(New Rejection – necessitated by amendment) – Claim 71 is 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 Claim 71, it recites the limitation “wherein said amino acid sequence ranges from 90% to 110% of the length of and has at least 99% sequence identity with an amino acid sequence of…”. The use of the phrase “said amino acid sequence” renders the claim indefinite because two different amino acid sequences are introduced earlier in the claim. As such, it is unclear if “said amino acid sequence” refers to the “coronavirus S1 protein amino acid sequence” or the “at least one amino acid sequence” introduced in Lines 2-3 of the claim. It is suggested that the claim be amended by clarifying which amino acid sequence is being reference in the wherein clause, but Applicant is free to amend the claim as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 71 is rejected on the grounds of being indefinite.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Note: for the purposes of examining the claims on their merits, the proteins recited in Claim 5 will be interpreted as reading upon any coronavirus M, N, ORF1ab, and ORF3 proteins. The element of an “epitope” will be interpreted as defined by Applicant, i.e., “an antigenic determinant capable of inducing humoral and/or cell-mediated immune response or immunity” (see Paragraph 0130 of the instant Specification). Claims 1 and 30 will be interpreted such that the at least two epitopes in the epitope string can either be two different epitopes or the same epitope repeated, as defined by Applicant (see Paragraph 0132 of the instant Specification).
Claim Rejections - 35 USC § 112(a); First Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
(Rejection maintained in part and extended) – The rejection of Claims 1-2, 4-10, 12-16, 21, 24-27, 30, and 61 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for failing to comply with the written description requirement is maintained in part and extended.
Response to Arguments
Applicant's arguments filed 03 December 2025 with respect to the rejection of Claims 1-2, 4-10, 12-16, 21, 24-27, 30, and 61 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for failing to comply with the written description requirement have been fully considered but they are not persuasive.
In their Response, Applicant argues that “Applicant has amended claim 1, to remove the phrase ‘at least 90% sequence identity’, cancelled claims 7 and 61, amended claims 5 and 30 to recite ‘at least 99% sequence identity’, and drafted new claim 71 similarly” (see Page 2 of Remarks, Paragraph 2). Applicant also argues that conservative “substitution of an amino acid sequence is provided in paragraph [00125]] of the amended specification”, that paragraphs “[00140] and [00141] of the amended specification further provide general rules for conservative substitutions and what aspects of the sequence should not be altered in a manner understandable to one of ordinary skill in the art”, and that paragraph “[00142] of the amended specification provides a number of substitutions which would not be conservative, limiting the set of potential substitutions that would be considered conservative” (see Page 2, Paragraph 2). Applicant then argues that “the current amendment increases the threshold of sequence identity to at least 99%, thus reducing the overall number of substitutions that could occur in a sequence” (see Page 2, Paragraph 2). While Examiner agrees with what the instant Specification states, Examiner disagrees with the conclusion that the claims are adequately described and supported by the as-filed specification. First, Examiner cited some of the same paragraphs in the rejection that Applicant cited, including the paragraphs regarding conservative amino acid substitutions. As stated in the rejection, while this information is helpful, Applicant still fails to provide details about specific nucleotides/residues or regions which can tolerate such changes. Applicant discusses in the Specification that conservative substitutions are those that “least interfere with the properties of the original protein, that is, the structure and especially the function of the protein is conserved and no significantly changed” (see Paragraph 00141 of the 12/03/25 Specification). While important, the instant claims are more concerned with the immunogenicity of the claimed epitopes and polypeptides. For instance, a conservative substitution could potentially alter the immunogenicity of one of the claimed epitopes or polypeptides. For example, SEQ ID NO: 13, which is claimed, is 1313 amino acids long. A sequence having 99% sequence identity to it would have 13 amino acid changes. If those changes are present in a site normally bound by a neutralizing antibody, for instance, then said neutralizing antibody might not be generated if a patient was immunized with a construct expressing a polypeptide with 99% sequence identity to instant SEQ ID NO: 13. Additionally, the claims, as currently written, also read on variant sequences with insertions and/or deletions present relative to the claimed sequences. The Arguments presented by Applicant appear to contemplate substitutions as the only changes which can be made. As also stated in the previous Office Action, it does not appear Applicant tested any of the claimed variants to determine if they function as effectively as the complete sequences and there is no information regarding the essential characteristics of the genus Applicant is claiming. For at least these reasons, Examiner does not find Applicant’s Arguments persuasive. As such, the rejection of Claims 1-2, 4-10, 12-16, 21, 24-27, 30, and 61 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for failing to comply with the written description requirement is withdrawn as it relates to Claims 1-2, 4, 6-10, 12-16, 21, 24-27, and 61, in light of the amendments to the claims and the cancellation of some of the claims, is maintained as it related to Claims 5 and 30, and is extended to include new Claim 71.
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.
(Rejection withdrawn) – The rejection of Claims 1-2, 4-6, 10, and 61 under 35 U.S.C. 101 for being directed to a product of nature without significantly more is withdrawn in light of the amendments to some of the claims and the cancellation of some of the claims.
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.
(Rejection withdrawn) – The rejection of Claims 1-2, 4-6, 10, and 61 under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al. (Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. A new coronavirus associated with human respiratory disease in China. Nature. 2020 Mar;579(7798):265-269) is withdrawn in light of the amendments to some of the claims and the cancellation of some of the claims.
(Rejection withdrawn) – The rejection of Claims 1-2, 5-6, 10, 12-14, 16, 24-27, 30, and 61 under 35 U.S.C. 102(a)(2) as being anticipated by Rauch et al. (US 2023/0302122 A1, earliest Priority Date 04 February 2020) is withdrawn in light of the amendments to some of the claims and the cancellation of some of the claims.
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.
(Rejection withdrawn) – The rejection of Claims 4, 7-9, 15, and 21 under 35 U.S.C. 103 as being unpatentable over Rauch et al. (US 2023/0302122 A1, earliest Priority Date 04 February 2020) as applied to claims 1-2, 5-6, 10, 12-14, 16, 24-27, 30, and 61 previously, and further in view of Li et al. (US 2023/0310581 A1, earliest Priority Date 27 April 2020), Georges et al. (US 2021/0260181 A1, earliest Priority Date 14 February 2020), Falo, Jr. et al. (US 2015/0126923, Published 07 May 2015), Akinc et al. (US 2022/0127615 A1, earliest Priority Date 26 March 2020), and Gaynor et al. (US 2023/0083931 A1, earliest Priority Date 20 March 2020) is withdrawn in light of the amendments to some of the claims and the cancellation of some of the claims.
(New Rejection – necessitated by amendment) – Claims 1, 5-6, 8-10, 14-16, 21, 24-25, 27, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Rauch et al. (US 2023/0302122 A1, earliest Priority Date 04 February 2020) (cited in the previous Office Action), Georges et al. (US 2021/0260181 A1, earliest Priority Date 14 February 2020) (cited in the previous Office Action), Falo, Jr. et al. (US 2015/0126923, Published 07 May 2015) (cited in the previous Office Action), Akinc et al. (US 2022/0127615 A1, earliest Priority Date 26 March 2020) (cited in the previous Office Action), and Gaynor et al. (US 2023/0083931 A1, earliest Priority Date 20 March 2020) (cited in the previous Office Action).
Rauch et al. teach a nucleic acid encoding a polypeptide comprising a coronavirus S1 protein fragment and/or a coronavirus S2 protein fragment (see Paragraphs 0259-0263). Rauch et al. also teach that said nucleic acid expresses epitopes of one or more of a coronavirus M protein or N protein (see Paragraph 0101). As such, Rauch et al. teach a nucleic acid encoding an S protein and additional epitopes including one or more of a coronavirus M protein or N protein. Rauch et al. teach that the polypeptide encoded by the nucleic acid can further comprise a signal peptide, a self-cleaving sequence, or a multimerization sequence (see Paragraphs 0108, 0263, 0328-0331), as well as an ACE2 RBD of the SARS-CoV-2 S protein (see Paragraphs 0251-0254).
Rauch et al. also teach a nucleic acid encoding a polypeptide wherein said nucleic acid is a DNA expression vector, such as a replication-deficient Adenovirus, and an Adenovirus comprising said nucleic acid (see Paragraphs 0551, 0554-0556). Rauch et al. teach delivering the nucleic acid encoding the polypeptide using a microneedle patch (see Paragraph 0995).
Additionally, Rauch et al. teach a method of treating or preventing a coronavirus infection, wherein the coronavirus is SARS-CoV-2 (see Abstract; Paragraphs 0003, 0072), wherein a composition comprising an Adenovirus comprising the nucleic acid encoding the polypeptide is administered using a delivery device (see Paragraphs 0551, 0554-0556, 0995).
Furthermore, Rauch et al. teach a method of treating or preventing a coronavirus infection and generating an immune response against a coronavirus, wherein the coronavirus is SARS-CoV-2 (see Abstract; Paragraphs 0003, 0072, 0051, 0554-0556, 0721-0723, 0977, 0979-0985), wherein a composition comprising an Adenovirus comprising the nucleic acid encoding the polypeptide is administered (see Paragraphs 0551, 0554-0556) and wherein said polypeptide comprises a coronavirus S1 protein fragment and/or a coronavirus S2 protein fragment (see Paragraphs 0259-0263).
Georges et al. teach a nucleic acid, specifically a replication-defective Adenoviral vector, encoding a SARS-CoV-2 polypeptide, wherein the nucleic acid also encodes a molecular adjuvant, such as a TLR agonist domain, specifically an RS09 domain (see Paragraphs 0009, 0206-0207).
Falo, Jr. et al. teach microneedle arrays for delivering compositions comprising Adenovirus particles, located in the microneedle tips, and adjuvants (see Paragraphs 0061, 0112-0116), wherein the microneedles comprise trehalose (see Paragraphs 0117-0118).
Akinc et al. teach delivering a composition comprising an Adenovirus comprising a heterologous nucleic acid, wherein the delivery device includes a nebulizer, an inhaler, a nasal sprayer, or an aerosol device (see Paragraphs 0643-0645, 0653-0654, 0660, 0663).
Gaynor et al. teach a nucleic acid wherein two or more epitopes of an epitope string comprise one or more specific epitope amino acid sequences selected from instant SEQ ID NOs: 16-44. Specifically Gaynor et al. teach SEQ ID NOs: 10513 and 11379, which are 100% identical to instant SEQ ID NOs: 18 and 19, respectively (see Sequence Listing). Gaynor et al. teach immunogenic compositions for SARS-CoV-2 wherein said compositions comprise one or more polynucleotides encoding a polypeptide encoded by a string construct comprising SARS-CoV-2 epitopes wherein the viral epitopes can be administered by a viral vector, such as an Adenovirus vector (see Abstract; Paragraphs 1071, 1233-1234). Instant SEQ ID NOs: 18 and 19 correspond to CD8+ T cell epitopes derived from the ORF1ab and N proteins, respectively. Gaynor et al. teach immunogenic compositions for SARS-CoV-2 that specifically target T cell responses, including CD4+ T cell responses and/or CD8+ T cell responses, and/or leverage long-term persistence of T cell immunity and that the compositions specifically target one or more T cell responses to a polypeptide antigen of SARS-CoV-2, including the N protein and the ORF1ab protein (see Paragraphs 0005, 0009-0014). Therefore, the Gaynor et al. sequences, SEQ ID NOs: 10513 and 11379, correspond to CD8+ T cell epitopes derived from the ORF1ab and N proteins, respectively.
A person having ordinary skill in the art would have been motivated to combine the teachings of Rauch et al., Georges et al., Falo, Jr. et al., Akinc et al., and Gaynor et al. in order to develop an effective Adenovirus-based SARS-CoV-2 vaccine. It would be obvious to a skilled artisan to use a replication-deficient Adenovirus which cannot proliferate in human cells, as taught by Rauch et al., to make a vaccine using said Adenovirus safer for administration to human subjects. The delivery device disclosed by Falo, Jr. et al. would enable the delivery of the Adenovirus vector disclosed by Rauch et al., along with an adjuvant, and provide an efficient delivery mechanism for a vaccine and an adjuvant to stimulate a more robust immune response. The adjuvant in question could be the RS09 domain, which is a TLR agonist domain, disclosed by Georges et al., which can be encoded by the nucleic acid encoding the polypeptide, disclosed by Rauch et al., allowing for the simultaneous administration and expression of both the viral antigen/epitopes and the RS09 domain. Alternatively, the delivery devices of Akinc et al. would allow for other methods to deliver an Adenovirus vector, which would enable the administration of said vector in a variety of settings, depending on the form of the vector and the conditions under which the vector would need to be administered. While the teachings of Akinc et al. are primarily drawn to treatments, such as using an Adenovirus as the vector for the therapeutic agents, they disclose the use of their delivery systems for the administration of a vaccine (see Paragraphs 0184-0185), such as the vaccine disclosed by Rauch et al. The specific epitope sequences taught by Gaynor et al. would allow for the Adenovirus-based SARS-CoV-2 vaccine disclosed by Rauch et al. to elicit an immune response against specific antigenic sequences. The combination of these traits would allow for the development of a more effective Adenovirus-based SARS-CoV-2 vaccine and the combined teachings of these prior art references render obvious the invention encompassed by the instant claims.
Such modifications, combining prior art elements according to known methods to yield predictable results, would have had a reasonable expectation of success and arrived at the claimed invention prior to the effective filing date of the instant application. For at least these reasons, instant Claims 1, 5-6, 8-10, 14-16, 21, 24-25, 27, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over the prior art.
Response to Arguments
Applicant's arguments filed on 03 December 2025 have been fully considered but they are not persuasive. While the original rejection has been withdrawn in light of the amendments to the claims, a new rejection was warranted that utilizes the teachings of Rauch et al., Georges et al., Falo, Jr. et al., Akinc et al., and Gaynor et al., and the arguments presented regarding these teachings will be addressed as applicable herein in the interest of compact prosecution.
In their Response, Applicant argues that “claim 1, which has been amended to incorporate claim 4 therein, has also been amended to incorporate elements of claim 12, which is not rejected under 35 U.S.C. 103 over this combination of references” (see Page 3 of Remarks, Last Paragraph). Applicant also argues that “claims 8, 9, 15 and 21 depend from claim 1 and define over the cited combination of art for at least the same reasons” (see Page 3, Last Paragraph). Examiner disagrees with Applicant’s Arguments. Amended independent claim 1 has been rendered obvious over the same combination of references, despite the incorporation of limitations from dependent claims, as the new claim limitations in amended claim 1 are still met by the prior art of record, as noted in the rejection above. The same is true for amended independent Claim 30, also as noted in the rejection above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(Rejection withdrawn) – The rejection of Claims 1-2, 4-10, 12-14, 16, 21, 24-27, 30, and 61 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-7, 10, 12, and 16-18 of U.S. Patent No. 11,213,482 B1 in view of Rauch et al. (US 2023/0302122 A1, earliest Priority Date 04 February 2020), Georges et al. (US 2021/0260181 A1, earliest Priority Date 14 February 2020), and Gaynor et al. (US 2023/0083931 A1, earliest Priority Date 20 March 2020) is withdrawn in light of the amendments to some of the claims and the cancellation of some of the claims.
(Rejection withdrawn) – The rejection of Claims 1-2, 5-6, 8-10, 12-16, 21, 24-27, 30, and 61 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7 of U.S. Patent No. 11,737,974 B2 in view of Rauch et al. (US 2023/0302122 A1, earliest Priority Date 04 February 2020), Georges et al. (US 2021/0260181 A1, earliest Priority Date 14 February 2020), Falo, Jr. et al. (US 2015/0126923, Published 07 May 2015), and Akinc et al. (US 2022/0127615 A1, earliest Priority Date 26 March 2020) is withdrawn in light of the amendments to some of the claims and the cancellation of some of the claims.
(Rejection withdrawn) – The provisional rejection of Claims 1-2, 5-6, 8-10, 12-14, 16, 21, 24-27, 30, and 61 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6-7, 19, 25-26, and 32-33 of copending Application No. 17/917,873 in view of Rauch et al. (US 2023/0302122 A1, earliest Priority Date 04 February 2020) and Georges et al. (US 2021/0260181 A1, earliest Priority Date 14 February 2020) is withdrawn in light of the amendments to some of the claims and the cancellation of some of the claims.
(New Rejection – necessitated by amendment) – Claims 1, 5-6, 8-10, 14-16, 21, 24-25, 27, 30, and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-8, 10-12, and 16-18 of U.S. Patent No. 11,213,482 B1 (cited in the previous Office Action) in view of Rauch et al. (US 2023/0302122 A1, earliest Priority Date 04 February 2020) (cited in the previous Office Action), Georges et al. (US 2021/0260181 A1, earliest Priority Date 14 February 2020) (cited in the previous Office Action), Falo, Jr. et al. (US 2015/0126923, Published 07 May 2015) (cited in the previous Office Action), Akinc et al. (US 2022/0127615 A1, earliest Priority Date 26 March 2020) (cited in the previous Office Action), and Gaynor et al. (US 2023/0083931 A1, earliest Priority Date 20 March 2020) (cited in the previous Office Action).
Both the instant claims and the patented claims are drawn to a polypeptide comprising a coronavirus S1 protein amino acid sequence wherein said polypeptide further comprises a multimerization sequence and/or a TLR agonist domain. Both claim sets are also drawn to a delivery device, specifically a microneedle array comprising a plurality of microneedles, for delivering said polypeptide or a composition comprising said polypeptide, wherein each of the plurality of microneedles comprises trehalose. Both claim sets are also drawn to a method of generating an immune response against SARS-CoV-2 in a patient comprising administering to the patient an immunogenic polypeptide comprising a coronavirus S1 protein amino acid sequence. Additionally, amino acids 1-661 of instant SEQ ID NO: 60 are 100% identical to amino acids 1-661 of patented SEQ ID NO: 2, which is 663 amino acids long, amino acids 1-663 of instant SEQ ID NO: 60 are 100% identical to the entirety of patented SEQ ID NO: 2, and patented SEQ ID NO: 16 is 100% identical to and the exact same length as instant SEQ ID NO: 58 and thus amino acids 664-1082 of instant SEQ ID NO: 58 are also 100% identical to amino acids 664-1082 of patented SEQ ID NO: 16.
The main differences between the instant claims and the patented claims are that the instant claims are drawn to a replication-defective Adenovirus comprising a nucleic acid encoding said polypeptide, wherein said polypeptide comprises an amino acid sequence having at least 99% sequence identity with an amino acid sequence of a coronavirus M, N, ORF1ab, or ORF3 protein, and/or an epitope thereof, wherein the TLR agonist domain is an RS09 domain, and wherein the polypeptide further comprises an ACE2 RBD of the SARS-CoV-2 S protein. The instant claims are also drawn to a composition comprising said replication-defective Adenovirus as well as a microneedle array comprising said Adenovirus and a compound with adjuvant or immune stimulation effect. The patented claims are drawn to a pharmaceutical composition comprising said polypeptide and a microneedle array comprising said polypeptide. The patented pharmaceutical composition comprises the instant polypeptide encoded by the instant nucleic acid comprised within the replication-defective Adenovirus. Thus, it would have been obvious to a skilled artisan to use the instant polypeptide in the patented pharmaceutical composition.
The previous teachings of Rauch et al., Georges et al., Falo, Jr. et al., Akinc et al., and Gaynor et al. have been summarized above.
A person having ordinary skill in the art would have been motivated to modify the teachings of the patented claims with those of Rauch et al., Georges et al., Falo, Jr. et al., Akinc et al., and Gaynor et al. in order to arrive at the claimed instant invention. A skill artisan would have been able to generate a nucleic acid which encoded the patented polypeptide and to insert said nucleic acid in a vector, such as a viral vector, specifically a replication-defective Adenovirus, as disclosed by Rauch et al. The delivery device disclosed by Falo, Jr. et al. would enable the delivery of the Adenovirus of Rauch et al., along with an adjuvant, providing an efficient delivery mechanism for a vaccine and an adjuvant to stimulate a more robust immune response. The adjuvant in question could be the RS09 domain disclosed by Georges et al., which can also be encoded by the nucleic acid encoding the polypeptide, disclosed by Rauch et al., which can further comprise said RS09 domain, which is a TLR agonist domain, allowing for simultaneous administration and expression of both the viral antigen/epitopes and the RS09 domain. The specific antigenic sequence and/or epitope sequences disclosed by the patented claims and Gaynor et al. would allow for the Adenovirus-based SARS-CoV-2 vaccine disclosed by Rauch et al. to elicit an immune response against specific antigens and/or antigenic sequences. The combination of these traits would allow for the development of a more effective Adenovirus-based SARS-CoV-2 vaccine.
Such modification, combining prior art elements according to known methods to yield predictable results, would have had a reasonable expectation of success and arrived at the claimed invention. For at least these reasons, Claims 1, 5-6, 8-10, 14-16, 21, 24-25, 27, 30, and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-8, 10-12, and 16-18 of U.S. Patent No. 11,213,482 B1 in view of Rauch et al., Georges et al., Falo, Jr. et al., Akinc et al., and Gaynor et al.
(New Rejection – necessitated by amendment) – Claims 1, 5-6, 8-10, 14-16, 21, 24-25, 27, and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7 of U.S. Patent No. 11,737,974 B2 (cited in the previous Office Action) in view of Rauch et al. (US 2023/0302122 A1, earliest Priority Date 04 February 2020) (cited in the previous Office Action), Georges et al. (US 2021/0260181 A1, earliest Priority Date 14 February 2020) (cited in the previous Office Action), Falo, Jr. et al. (US 2015/0126923, Published 07 May 2015) (cited in the previous Office Action), Akinc et al. (US 2022/0127615 A1, earliest Priority Date 26 March 2020) (cited in the previous Office Action), and Gaynor et al. (US 2023/0083931 A1, earliest Priority Date 20 March 2020) (cited in the previous Office Action).
Both the instant claims and the patented claims are drawn to a polypeptide comprising an immunogenic amino acid sequence of a SARS-CoV-2 spike protein, wherein the polypeptide further comprises a TLR agonist domain, specifically a TLR4 agonist domain. Both claim sets are also drawn to a method of vaccinating a patient against SARS-CoV-2, wherein the method comprises administering a composition comprising said polypeptide to a patient by inhalation, intranasally, or into or through the skin.
The main differences between the instant claims and the patented claims are that the instant claims are drawn to a replication-defective Adenovirus comprising a nucleic acid encoding said polypeptide, wherein said polypeptide comprises an amino acid sequence having at least 99% sequence identity with an amino acid sequence of a coronavirus M, N, ORF1ab, or ORF3 protein, and/or an epitope thereof, wherein the TLR agonist domain is an RS09 domain, and wherein the polypeptide further comprises an ACE2 RBD of the SARS-CoV-2 S protein. The instant claims are also drawn to a composition comprising said replication-defective Adenovirus as well as a microneedle array comprising said Adenovirus and a compound with adjuvant or immune stimulation effect. The patented claims are drawn to a method of vaccinating a patient against SARS-CoV-2 comprising administering a composition parentally and wherein said composition further comprises a pharmaceutically acceptable excipient. While the patented claims are method claims, they comprise the instant polypeptide encoded by the instant nucleic acid comprised within the replication-defective Adenovirus. Thus, it would have been obvious to a skilled artisan to use the instant polypeptide in the patented method.
The previous teachings of Rauch et al., Georges et al., Falo, Jr. et al., Akinc et al., and Gaynor et al. have been summarized above.
A person having ordinary skill in the art would have been motivated to modify the teachings of the patented claims with those of Rauch et al., Georges et al., Falo, Jr. et al., Akinc et al., and Gaynor et al. in order to arrive at the claimed instant invention. A skill artisan would have been able to generate a nucleic acid which encoded the patented polypeptide and to insert said nucleic acid in a vector, such as a viral vector, specifically a replication-defective Adenovirus, as disclosed by Rauch et al. The delivery device disclosed by Falo, Jr. et al. would enable the delivery of the Adenovirus of Rauch et al., along with an adjuvant, providing an efficient delivery mechanism for a vaccine and an adjuvant to stimulate a more robust immune response. Alternatively, the delivery devices of Akinc et al. would allow for other methods to deliver an Adenovirus vector, which would enable the administration of said vector in a variety of settings, depending on the form of the vector and the conditions under which the vector would need to be administered. While the teachings of Akinc et al. are primarily drawn to treatments, such as using an Adenovirus as the vector for the therapeutic agents, they disclose the use of their delivery systems for the administration of a vaccine (see Paragraphs 0184-0185), such as the vaccine disclosed by Rauch et al. As such, it would have been obvious to a skilled artisan to try delivering the Adenovirus vector of Rauch et al. using the delivery devices of Akinc et al. The adjuvant in question could be the RS09 domain disclosed by Georges et al., which can also be encoded by the nucleic acid encoding the polypeptide, disclosed by Rauch et al., which can further comprise said RS09 domain, which is a TLR agonist domain, allowing for simultaneous administration and expression of both the viral antigen/epitopes and the RS09 domain. The specific epitope sequences disclosed by Gaynor et al. would allow for the Adenovirus-based SARS-CoV-2 vaccine disclosed by Rauch et al. to elicit an immune response against specific antigens and/or antigenic sequences. The combination of these traits would allow for the development of a more effective Adenovirus-based SARS-CoV-2 vaccine.
Such modification, combining prior art elements according to known methods to yield predictable results, would have had a reasonable expectation of success and arrived at the claimed invention. For at least these reasons, Claims 1, 5-6, 8-10, 14-16, 21, 24-25, 27, and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7 of U.S. Patent No. 11,737,974 B2 in view of Rauch et al., Georges et al., Falo, Jr. et al., Akinc et al., and Gaynor et al.
(New Rejection – necessitated by amendment) – Claims 1, 5-6, 8-10, 14-16, 21, 24-25, 27, and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6-7, 19, 25-26, and 32-33 of copending Application No. 17/917,873 (reference application) (cited in the previous Office Action) in view of Rauch et al. (US 2023/0302122 A1, earliest Priority Date 04 February 2020) (cited in the previous Office Action), Georges et al. (US 2021/0260181 A1, earliest Priority Date 14 February 2020) (cited in the previous Office Action), Falo, Jr. et al. (US 2015/0126923, Published 07 May 2015) (cited in the previous Office Action), Akinc et al. (US 2022/0127615 A1, earliest Priority Date 26 March 2020) (cited in the previous Office Action), and Gaynor et al. (US 2023/0083931 A1, earliest Priority Date 20 March 2020) (cited in the previous Office Action).
Both the instant claims and the reference claims are drawn to a delivery device, specifically a microneedle array comprising a plurality of microneedles, for delivering a recombinant Adenovirus particle comprising a gene for expressing a polypeptide, wherein the gene expresses an immunogen. Both claim sets are also drawn to a microneedle device further comprising a compound with adjuvant or immune stimulation effect, wherein said compound is a TLR agonist and wherein the plurality of microneedles comprise trehalose. Both claim sets are drawn to a method of eliciting a therapeutic effect in a patient comprising administering said recombinant Adenovirus to said patient using said microneedle device.
The main differences between the instant claims and the patented claims are that the instant claims are drawn to a replication-defective Adenovirus comprising a nucleic acid encoding a polypeptide, wherein said polypeptide is an immunogenic polypeptide from a coronavirus, namely SARS-CoV-2, and comprises an amino acid sequence having at least 99% sequence identity with an amino acid sequence of a coronavirus M, N, ORF1ab, or ORF3 protein, and/or an epitope thereof, wherein the TLR agonist domain is an RS09 domain, and wherein the polypeptide further comprises an ACE2 RBD of the SARS-CoV-2 S protein. The reference claims are drawn to a microneedle device comprising a recombinant Adenovirus comprising a gene expressing a generic immunogenic polypeptide.
The previous teachings of Rauch et al., Georges et al., Falo, Jr. et al., Akinc et al., and Gaynor et al. have been summarized above.
A person having ordinary skill in the art would have been motivated to modify the teachings of the patented claims with those of Rauch et al., Georges et al., Falo, Jr. et al., Akinc et al., and Gaynor et al. in order to arrive at the claimed instant invention. A skill artisan would have been able to generate a nucleic acid which encoded the patented polypeptide and to insert said nucleic acid in a vector, such as a viral vector, specifically a replication-defective Adenovirus, as disclosed by Rauch et al. The delivery device disclosed by Falo, Jr. et al. would enable the delivery of the Adenovirus of Rauch et al., along with an adjuvant, providing an efficient delivery mechanism for a vaccine and an adjuvant to stimulate a more robust immune response. Alternatively, the delivery devices of Akinc et al. would allow for other methods to deliver an Adenovirus vector, which would enable the administration of said vector in a variety of settings, depending on the form of the vector and the conditions under which the vector would need to be administered. While the teachings of Akinc et al. are primarily drawn to treatments, such as using an Adenovirus as the vector for the therapeutic agents, they disclose the use of their delivery systems for the administration of a vaccine (see Paragraphs 0184-0185), such as the vaccine disclosed by Rauch et al. As such, it would have been obvious to a skilled artisan to try delivering the Adenovirus vector of Rauch et al. using the delivery devices of Akinc et al. The adjuvant in question could be the RS09 domain disclosed by Georges et al., which can also be encoded by the nucleic acid encoding the polypeptide, disclosed by Rauch et al., which can further comprise said RS09 domain, which is a TLR agonist domain, allowing for simultaneous administration and expression of both the viral antigen/epitopes and the RS09 domain. The specific epitope sequences disclosed by Gaynor et al. would allow for the Adenovirus-based SARS-CoV-2 vaccine disclosed by Rauch et al. to elicit an immune response against specific antigens and/or antigenic sequences. The combination of these traits would allow for the development of a more effective Adenovirus-based SARS-CoV-2 vaccine.
Such modification, combining prior art elements according to known methods to yield predictable results, would have had a reasonable expectation of success and arrived at the claimed invention. For at least these reasons, Claims 1, 5-6, 8-10, 14-16, 21, 24-25, 27, and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6-7, 19, 25-26, and 32-33 of the reference application in view of Rauch et al., Georges et al., Falo, Jr. et al., Akinc et al., and Gaynor et al.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed on 03 December 2025 with respect to the rejection of the claims on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,213,482 B1 in view of Rauch et al., Georges et al., Falo, Jr., et al., and Gaynor et al. have been fully considered but they are not persuasive. While the original rejection has been withdrawn in light of the amendments to some of the claims and the cancellation of some of the claims, a new rejection was warranted that utilizes the teachings of Rauch et al., Georges et al., Falo, Jr., et al., and Gaynor et al., and the arguments presented regarding these teachings will be addressed as applicable herein in the interest of compact prosecution.
In their Response, Applicant states that they “will file a Terminal Disclaimer, if appropriate, to address the remaining rejection upon withdrawal of the statutory rejections” (see Page 4 of Remarks, Paragraph 2). As this response does not actually address the prior art used or the patented claims, no rebuttal is required by the Examiner at this time regarding the new double patenting rejection raised above over U.S. Patent No. 11,213,482 B1.
Applicant's arguments filed on 03 December 2025 with respect to the rejection of the claims on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,737,974 B2 in view of Rauch et al., Georges et al., Falo, Jr. et al., and Akinc et al. have been fully considered but they are not persuasive. While the original rejection has been withdrawn in light of the amendments to some of the claims and the cancellation of some of the claims, a new rejection was warranted that utilizes the teachings of Rauch et al., Georges et al., Falo, Jr. et al., and Akinc et al., and the arguments presented regarding these teachings will be addressed as applicable herein in the interest of compact prosecution.
In their Response, Applicant argues “that claims 4 and 7 are not rejected over the ‘974 Patent or the ‘873 Application and have been introduced into claim 1 and new claim 71, respectively” and that these rejections should be withdrawn (see Page 4 of Remarks, Paragraph 2). Examiner disagrees with Applicant’s Arguments. Amended independent claim 1 has been rendered obvious over the same combination of references, despite the incorporation of limitations from dependent claims, as the new claim limitations in amended claim 1 are still met by the patented claims and the prior art of record, as noted in the rejection above. The same is true for amended independent Claim 30, also as noted in the rejection above.
Applicant's arguments filed on 03 December 2025 with respect to the provisional rejection of the claims on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/917,873 in view of Rauch et al. and Georges et al. have been fully considered but they are not persuasive. While the original rejection has been withdrawn in light of the amendments to some of the claims and the cancellation of some of the claims, a new rejection was warranted that utilizes the teachings of Rauch et al. and Georges et al., and the arguments presented regarding these teachings will be addressed as applicable herein in the interest of compact prosecution.
In their Response, Applicant argues “that claims 4 and 7 are not rejected over the ‘974 Patent or the ‘873 Application and have been introduced into claim 1 and new claim 71, respectively” and that these rejections should be withdrawn (see Page 4 of Remarks, Paragraph 2). Examiner disagrees with Applicant’s Arguments. Amended independent claim 1 has been rendered obvious over the same combination of references, despite the incorporation of limitations from dependent claims, as the new claim limitations in amended claim 1 are still met by the reference claims and the prior art of record, as noted in the rejection above. The same is true for amended independent Claim 30, also as noted in the rejection above.
Conclusion
No claims are allowed.
The prior art made of record, but not relied upon, and considered pertinent to applicant's disclosure are listed below:
Georges and Roberts (US 2021/0260180 A1, earliest Priority Date 14 February 2020)
Georges and Roberts teach immunogenic compounds, pharmaceutical formulations thereof, and their use for inducing a protective immune response against SARS-CoV-2. This reference has not been utilized, as rejection would have been redundant to those set forth above.
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 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.
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/CAREY ALEXANDER STUART/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671