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 .
Disposition of Claims
Claims 1-22 are pending.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2023/0146932 A1, Published 11 May 2023.
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.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The information disclosure statement filed 14 July 2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. Specifically, Foreign Patent Document WO 2022/071513 A1 is not in English, no English translation of the Abstract has been provided, and no English language equivalent has been identified. It has been placed in the application file, but the information referred to in the individual reference has not been considered.
The information disclosure statements (IDSes) submitted on 10 January 2023, 04 June 2024, 09 September 2024, 28 October 2024, 09 January 2025, 14 July 2025 have been considered, as a whole, by the examiner. Any individual references with strikethroughs, however, have not been considered.
Drawings
The Drawings are objected for containing references to colors. Specifically, Figures 2A, 5, 6A, 9, 10, 11A, 14, and 15A all contain references to colors (i.e., red, blue, green, brown) within the figures themselves, within the figure legends in the specification, and/or within other paragraphs within the specification, such as Paragraphs 0248 and 0255, at least. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification: “The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.”
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2). The objection to the drawings will not be held in abeyance. 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.
Drawings and Specification; Sequence Disclosure Requirements
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 drawings and specification are objected to because Figures 1, 5, 6A, 9, 10, 11A, 14, 15A, 17, 18, 19, 25, 32A, 32B, 32C, 32D, 34A, 34B, and 34C all comprise sequences that do not identify said sequences with corresponding SEQ ID NOs within the figures themselves or within the figure legends of the specification.
Also, Paragraphs 0058, 0060, 0156, 0231, and 0260 comprise sequences that do not identify said sequences with corresponding SEQ ID NOs.
These sequences in question have at least 4 specifically defined and enumerated amino acid residues or at least 10 specifically defined and enumerated nucleotide positions, as applicable. Therefore, they are required to have SEQ ID NOs. If these sequences correspond to existing sequences in the Sequence Listing, then each sequence should be associated with its corresponding SEQ ID NO each and every time it appears throughout the disclosure. If these sequences do not correspond to existing sequences in the Sequence Listing, then each one is required to have its own unique SEQ ID NO.
Additionally, SEQ ID NOs: 154 and 155 are 100% identical to each other and the exact same length (i.e., they are the same sequence). The same applies to SEQ ID NOs: 7 and 21; 35 and 49; and 204 and 224. These pairs of sequences are duplicates of each other. See attached sequence alignments.
The duplicate sequences must be removed from the Sequence Listing. Examiner also kindly requests that Applicant review the Sequence Listing and remove all instances of duplicate sequences.
The objection to the drawings will not be held in abeyance. Applicants must comply with sequence rules in order to be considered a complete response to this Office Action; a complete response would be to either submit corrected drawing sheets as noted below or to amend the specification to include the SEQ ID NO:s within the figure legend.
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.
Specification
The abstract of the disclosure is objected to because the first sentence is a sentence fragment. It is suggested that it say “Multi-epitope, pan-coronavirus recombinant vaccine compositions featuring a combination of highly conserved B cell epitopes, highly conserved CD4+ T cell epitopes, and highly conserved CD8+ T cell epitopes, at least one of which is derived from a non-spike protein[[.]], are provided” or “…are described”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// and/or www., or other browser-executable code. The hyperlinks in question are: www.ncbi.nlm.nih.gov/nuccore (Paragraph 0337); www.gisaid.org (Paragraph 0337); and www.atcc.org (Paragraph 0364). See MPEP § 608.01.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 4, 6-9, 11, 13-14, 16-18, and 20-22 are objected to because of the following informalities: In Claim 4, it is suggested that it say “…(BA.4); and sub-variant Omicron (BA.5)”.
In Claim 6, it is suggested that it say “…selected from [[a]] the group consisting of…”.
In Claim 7, it is suggested that it say “…or a combination thereof; and wherein the one or more coronavirus B cell…”.
In Claims 7, 21, and 22, all instances of “SEQ ID NO:” should be replaced with “SEQ ID NOs:”.
In Claims 8-9, it is suggested that they say “The composition of claim 1, further comprising…”. There should be a comma after the “1”.
In Claim 8, it is suggested that it say “…is CCL5, CXCL9, CXCL10, or CXCL11…
In Claim 11, it is suggested that it say “…coronavirus subvariants, and wherein the coronavirus variants comprise…”.
In Claim 13, it is suggested that it say “…protects against infection and reinfection [[of]] caused by coronavirus variants…”.
In Claim 14, it is suggested that it say “…coronavirus subvariants, and wherein the coronavirus variants comprise…”.
In Claim 16, it is suggested that it say “…one or more coronavirus variants or coronavirus subvariants”. It is also suggested that it say “…protects against infection or reinfection [[of]] caused by one or more…”.
In Claim 17, it is suggested that it say “…protects against infection or reinfection [[of]] caused by multiple coronavirus…”.
In Claim 18, it is suggested that it say “…one coronavirus variant[[s]] or coronavirus subvariant[[s]]”.
In Claim 20, it is suggested that it say “…SARS-CoV-1 or SARS-CoV-2”.
In Claim 21, the period is missing from the end of the claim. It is also suggested that it say “…derived from a non-spike protein, and wherein the composition…”.
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.
Claims 1 and 21, and dependent claims 2-20 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 “A universal multi-epitope, pan-coronavirus recombinant vaccine composition, the composition comprising at least two of: a) one or more conserved coronavirus B-cell target epitopes; b) one or more conserved coronavirus CD4' T cell target epitopes; c) one or more conserved coronavirus CD8' T cell target epitopes; wherein at least one epitope is derived from a non-spike protein”. Regarding Claim 21, it recites the limitation “A multi-epitope, pan-coronavirus recombinant vaccine composition, the composition comprising at least two of: a) one or more conserved coronavirus B-cell target epitopes selected from SEQ ID NO: 106- 116, SEQ ID NO: 117-138, SEQ ID NO: 263-270, SEQ ID NO: 271-284,or a combination thereof; b) one or more conserved coronavirus CD4+ T cell target epitopes selected from SEQ ID NO: 58-73, SEQ ID NO: 74-105, SEQ ID NO: 225-243, SEQ ID NO: 244-262, or a combination thereof; c) one or more conserved coronavirus CD8+ T cell target epitopes selected from SEQ ID NO: 2-29, SEQ ID NO: 30-57, SEQ ID NO: 184-203, SEQ ID NO: 204-224, or a combination thereof; wherein at least one epitope is derived from a non-spike protein, wherein the composition induces immunity to only the epitopes”. Both claims recite options a-c, but there is no connecting word between options b and c. As such, it is unclear if these options are being claimed in the alternative (i.e., “or”), all are required elements of the claims (i.e., “and”), or if only a subset is required (i.e., “and/or”). This lack of clarity renders the claims indefinite. It is suggested that the claims be amended by adding the appropriate connecting word, based on Applicant’s intention, 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 21 are rejected on the grounds of being indefinite. Claims 2-20 are also rejected since they depend upon Claim 1, but do not remedy the deficiencies of Claim 1.
Claims 1 and 21, and dependent claims 2-20 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 “A universal multi-epitope, pan-coronavirus recombinant vaccine composition, the composition comprising at least two of: a) one or more conserved coronavirus B-cell target epitopes; b) one or more conserved coronavirus CD4' T cell target epitopes; c) one or more conserved coronavirus CD8' T cell target epitopes; wherein at least one epitope is derived from a non-spike protein”. Regarding Claim 21, it recites the limitation “A multi-epitope, pan-coronavirus recombinant vaccine composition, the composition comprising at least two of: a) one or more conserved coronavirus B-cell target epitopes selected from SEQ ID NO: 106- 116, SEQ ID NO: 117-138, SEQ ID NO: 263-270, SEQ ID NO: 271-284,or a combination thereof; b) one or more conserved coronavirus CD4+ T cell target epitopes selected from SEQ ID NO: 58-73, SEQ ID NO: 74-105, SEQ ID NO: 225-243, SEQ ID NO: 244-262, or a combination thereof; c) one or more conserved coronavirus CD8+ T cell target epitopes selected from SEQ ID NO: 2-29, SEQ ID NO: 30-57, SEQ ID NO: 184-203, SEQ ID NO: 204-224, or a combination thereof; wherein at least one epitope is derived from a non-spike protein, wherein the composition induces immunity to only the epitopes”. As currently written, the claims can be reasonably interpreted in more than one way. One interpretation is that only two epitopes total are required and that both epitopes can be from the same group (i.e., only B-cell target epitopes, for instance). Another interpretation is that only two epitopes total are required and that they can be from different groups (i.e., one B-cell target epitope and one CD4+ T cell target epitope, for instance). Yet another interpretation is that at least two epitopes from each group are required, meaning a minimum of six epitopes total. This lack of clarity renders the claim indefinite. It is suggested that the claims be amended so as to clarify Applicant’s intention, 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 21 are rejected on the grounds of being indefinite. Claims 2-20 are also rejected since they depend upon Claim 1, but do not remedy the deficiencies of Claim 1.
Claims 1 and 21-22, and dependent claims 1-20 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 Claims 1 and 21-22, they all recite the limitation “pan-coronavirus recombinant vaccine composition”. It appears that the word “recombinant” is modifying the word “vaccine” and phrase “vaccine composition”, as currently written. It is unclear how a vaccine composition can be recombinant, rendering the claim indefinite. It is suggested that the claims be amended so that they recite “recombinant pan-coronavirus vaccine composition”, 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 21-22 are rejected on the grounds of being indefinite. Claims 2-20 are also rejected since they depend upon Claim 1, but do not remedy the deficiencies of Claim 1.
Claim 20 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 20, it recites the limitation “wherein the composition protects against Sarbecoviruses, wherein sarbecoviruses comprise SARS-CoV-1 or SARS-CoV-2”. The use of the word “comprise”, which is open-ended or inclusive, implies that there are other viruses encompassed by the claim language which are not listed. If Applicant’s intention, however, was to limit the claim to the two viruses recited, this would make the claim exclusive or closed-ended and thus conflict with the use of the word “comprise”. This lack of clarity renders the claim indefinite. It is suggested that the claim be amended so that it recites “wherein the composition protects against Sarbecoviruses selected from the group consisting of SARS-CoV-1 and SARS-CoV-2” or similar language, if the claim was meant to be closed-ended, 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 20 is rejected on the grounds of being indefinite.
Claims 21-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claims 21 and 22, as noted above, some of the claimed sequences are duplicates of each other. In Claim 21, SEQ ID NOs: 7/21, 35/49, and 204/224 are duplicates of each other. In Claim 22, SEQ ID NOs: 154/155 are duplicates of each other. As such, it is unclear which other sequences were meant to be referenced in place of the duplicate sequences, and this lack of clarity renders the claims indefinite. It is suggested that the claims be amended by removing all duplicate sequences, 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 Claims 21 and 22 are rejected on the grounds of being indefinite.
Claim Interpretation
In light of the issues raised above, the claims are being interpreted as reading upon the following:
Claim 1 is drawn to a universal multi-epitope, recombinant pan-coronavirus vaccine composition, the composition comprising at least two of: a) one or more conserved coronavirus B-cell target epitopes; b) one or more conserved coronavirus CD4+ T cell target epitopes; or c) one or more conserved coronavirus CD8+ T cell target epitopes; wherein at least one epitope is derived from a non-spike protein.
Claim 21 is drawn to a multi-epitope, recombinant pan-coronavirus vaccine composition, the composition comprising at least two of: a) one or more conserved coronavirus B-cell target epitopes selected from SEQ ID NOs: 106-116, SEQ ID NOs: 117-138, SEQ ID NOs: 263-270, SEQ ID NOs: 271-284,or a combination thereof; b) one or more conserved coronavirus CD4+ T cell target epitopes selected from SEQ ID NOs: 58-73, SEQ ID NOs: 74-105, SEQ ID NOs: 225-243, SEQ ID NOs: 244-262, or a combination thereof; or c) one or more conserved coronavirus CD8+ T cell target epitopes selected from SEQ ID NOs: 2-20, 22-29, SEQ ID NOs: 30-48, 50-57, SEQ ID NOs: 184-203, SEQ ID NOs: 204-223, or a combination thereof; wherein at least one epitope is derived from a non-spike protein, and wherein the composition induces immunity to only the epitopes.
Claim 22 is drawn to a multi-epitope, recombinant pan-coronavirus vaccine composition comprising one of SEQ ID NOs: 139-154.
Further limitations on the universal multi-epitope, pan-coronavirus recombinant vaccine composition according to Claim 1 are:
2. The composition of claim 1, wherein the non-spike proteins are encoded by ORF1ab, ORF3a, ORF6, ORF7a, ORF7b, ORF8, or ORF10, or derived from an Envelope protein, a Membrane protein, or a Nucleocapsid protein.
3. The composition of claim 1, wherein the one or more conserved epitopes are derived from one or more of: one or more SARS-CoV-2 human strains or variants in current circulation; one or more coronaviruses that has caused a previous human outbreak; one or more coronaviruses isolated from animals selected from a group consisting of bats, pangolins, civet cats, minks, camels, and other animal receptive to coronaviruses; or one or more coronaviruses that cause the common cold.
4. The composition of claim 3, wherein the one or more SARS-CoV-2 human strains or variants in current circulation are selected from: variant B.1.177; variant B.1.160, variant B.1.1.7 (UK), variant P.1 (Japan/Brazil), variant B.1.351 (South Africa), variant B.1.427 (California), variant B.1.429 (California), variant B.1.258; variant B.1.221; variant B.1.367; variant B.1.1.277; variant B.1.1.302; variant B.1.525; variant B.1.526, variant S:677H; variant S:677P; B.1.617.2-Delta, variant B.1.1.529-Omicron (BA.1); sub-variant Omicron (BA.1); sub-variant Omicron (BA.2); sub-variant Omicron (BA.3); sub-variant Omicron (BA.4); and sub-variant Omicron (BA.5).
5. The composition of claim 3, wherein the one or more coronaviruses that cause the common cold are selected from: 229E alpha coronavirus, NL63 alpha coronavirus, OC43 beta coronavirus, and HKU1 beta coronavirus.
6. The composition of claim 1, wherein target epitopes are derived from a SARS-CoV-2 protein selected from the group consisting of: ORF1ab protein, Spike glycoprotein, ORF3a protein, Envelope protein, Membrane glycoprotein, ORF6 protein, ORF7a protein, ORF7b protein, ORF8 protein, Nucleocapsid protein and ORF10 protein.
7. The composition of claim 1, wherein the one or more conserved coronavirus CD8+ T cell target epitopes are selected from SEQ ID NOs: 2-20, 22-29, SEQ ID NOs: 30-48, 50-57, SEQ ID NOs: 184-203, SEQ ID NOs: 204-223, or a combination thereof; wherein the one or more conserved coronavirus CD4+ T cell target epitopes are selected from SEQ ID NOs: 58-73, SEQ ID NOs: 74-105, SEQ ID NOs: 225- 243, SEQ ID NOs: 244-262, or a combination thereof; and wherein the one or more coronavirus B cell target epitopes are selected from SEQ ID NOs: 106-116, SEQ ID NOs: 117-138, SEQ ID NOs: 263- 270, SEQ ID NOs: 271-284, or a combination thereof.
8. The composition of claim 1, further comprising a T cell attracting chemokine, wherein the T cell attracting chemokine is CCL5, CXCL9, CXCL10, or CXCL11, or a combination thereof.
9. The composition of claim 1, further comprising a composition that promotes T cell proliferation, wherein the composition that promotes T cell proliferation is IL-7 or IL-15.
10. The composition of claim 1, wherein the vaccine composition protects against disease caused by one or more coronavirus variants or coronavirus subvariants.
11. The composition of claim 10, wherein the coronavirus variants or coronavirus subvariants comprise past or currently circulating coronavirus variants or coronavirus subvariants, and wherein the coronavirus variants comprise alpha, beta, gamma, delta, and omicron.
12. The composition of claim 10, wherein the coronavirus variants or coronavirus subvariants comprise future variants or future subvariants of human and animal coronavirus.
13. The composition of claim 1, wherein the vaccine composition protects against infection and reinfection caused by coronavirus variants or coronavirus subvariants.
14. The composition of claim 13, wherein the coronavirus variants or coronavirus subvariants comprise past or currently circulating coronavirus variants or coronavirus subvariants, and wherein the coronavirus variants comprise alpha, beta, gamma, delta, and omicron.
15. The composition of claim 13, wherein the coronavirus variants or coronavirus subvariants comprise future variants or future subvariants of human and animal coronavirus.
16. The composition of claim 13, wherein the vaccine composition protects against infection or reinfection caused by one or more coronavirus variants or coronavirus subvariants.
17. The composition of claim 16, wherein the vaccine composition protects against infection or reinfection caused by multiple coronavirus variants or coronavirus subvariants.
18. The composition of claim 16, wherein the vaccine composition protects against infection or re- infection caused by one coronavirus variant or coronavirus subvariant.
19. The composition of claim 1, wherein the vaccine composition induces strong and long-lasting protection mediated by antibodies (Abs), CD4+ T helper (Th1) cells, and/or CD8+ cytotoxic T-cells (CTL).
20. The composition of claim 1, wherein the composition protects against Sarbecoviruses selected from the group consisting of SARS-CoV-1 and SARS-CoV-2.
For the purposes of examining the claims on their merits, Claims 1 and 21 will be interpreted such that elements a-c are being claimed in the alternative and that the at least two epitopes can be selected from the same group of epitopes (i.e., only B-cell target epitopes, for instance). Regarding Claims 7 and 21, they will be interpreted such that the claimed sequences are limited only to the amino acids present (i.e., any prior art sequences must be 100% identical and the exact same length as the claimed sequences).
Claim Rejections - 35 USC § 112(d); Fourth Paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding Claim 16, it recites the limitation “The composition of claim 13, wherein the vaccine composition protects against infection or reinfection of one or more coronavirus variant or coronavirus subvariant”. Claim 13 recites the limitation “The composition of claim 1, wherein the vaccine composition protects against infection and reinfection of coronavirus variants or coronavirus subvariants.” Claim 13 recites “infection and reinfection” whereas Claim 16 recites “infection or reinfection”. The use of “and” in Claim 13 is more limiting than the use of “or” in Claim 16, which depends upon Claim 13. As such, Claim 16 does not further Claim 13 and instead broadens the scope. It also fails to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 and 10-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. While the claimed compositions do fall into one of the statutory categories (i.e., composition of matter), they recite a judicial exception, specifically a natural phenomenon. The claims recite a natural phenomenon because, as currently written, the claimed conserved epitopes can be found in nature in coronaviruses that infect a variety of species. For instance, the SARS-CoV-2 Wuhan-Hu-1 isolate would meet the limitations of Claims 1-3, 6-7, and 19-20. This judicial exception is not integrated into a practical application because, as written, the claims do not provide a particular treatment or prophylaxis for a disease or medical condition. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed invention, as written, recites a “vaccine”, but there are no additional elements comprised by said vaccine recited in the claims, such as an adjuvant. Additionally, the requirement that the composition be recombinant does not overcome this rejection because recombination happens naturally. As such, simply identifying something, the composition in this case, as recombinant is insufficient to differentiate it from the natural product as it still reads upon said natural product.
Applicant is free to amend the claims as they deem necessary or persuasively argue that they are patent eligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 and 9-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gaynor et al. (US 2023/0083931 A1) (cited on IDS filed on 09 September 2024)
Gaynor et al. teach an immunogenic composition that comprises conserved T cell and B cell epitopes from SARS-CoV-2 proteins, including ORF1ab, the Spike protein, the Membrane protein, Envelope protein, the Nucleocapsid protein, ORF3a, ORF6, ORF7a, ORF7b, ORF8, or ORF10 (see Abstract; Paragraphs 0005, 0009, 0059-0071, 1320-1321), as claimed in instant Claims 1-2 and 6.
Gaynor et al. also teach an immunogenic composition comprising conserved epitopes from a coronavirus that causes the common cold, such as 229E, NL63, OC43, and HKU1, as well as SARS-CoV-2 variants, such as B.1.1.7, alpha, beta, gamma, and delta (see Table A; Paragraphs 0114, 0115, 1044, 1075), as claimed in instant Claims 3-5, 10-12, and 14. While Gaynor et al. focus on SARS-CoV-2, they teach a method for selecting viral epitopes which can be applied to the genome sequence for any coronavirus disclosed (see Paragraphs 1079-1085). They disclose other coronaviruses such as SARS-CoV, MERS-CoV, the common cold coronaviruses, and coronaviruses infecting bats and camels (see Paragraphs 885, 1075), as claimed in instant Claims 3 and 5. Gaynor et al. teach a method of treating or preventing an infection by a virus in a subject who has at risk of getting infected by SARS-CoV-2, currently is infected with SARS-CoV-2, or has had a prior infection with SARS-CoV-2 by administering the disclosed immunogenic composition (see Claims 78 and 97), as claimed in instant Claims 13, 16-18, as well as an immunogenic composition which can be used to overcome SARS-CoV-2 variants that could reduce efficacy of other vaccines, which reads upon future variants or subvariants, as claimed in instant Claim 15.
Additionally, Gaynor et al. teach an immunogenic composition further comprising interleukins, such as IL-7 or IL-15 (see Paragraphs 1193-1194), as claimed in instant Claim 9, as well as an immunogenic composition comprising an immunogenic peptide or epitope that provides long-lasting protection through a cell-mediated immune response, such as helper T lymphocyte and/or cytotoxic T lymphocyte, or a humoral immune response, such as B lymphocyte, against SARS-CoV-2 (see Paragraphs 0005, 1002), as claimed in instant Claims 19 and 20.
Furthermore, Gaynor et al. teach an immunogenic composition comprising CD4+ T cell epitopes, CD8+ T cell epitopes, and/or B cell epitopes. Specifically, Gaynor et al. SEQ ID NOs: 11747, 11817, 11729, 9957, 1586, 11730, 11789, 8215, 11461, 9857, 11427, and 12681, which are 100% identical and the same length as instant SEQ ID NOs: 1-2, 13, 21-22, 24-29, and 106, respectively (see Paragraphs 0005, Sequence Listing), as claimed in instant Claims 7 and 21.
For at least these reasons, Gaynor et al. teach the limitations of instant Claims 1-7 and 9-21 and anticipate the invention encompassed by said 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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gaynor et al. (US 2023/0083931 A1) as applied to Claims 1-7 and 9-21 above, and further in view of Scholler et al. (US 2012/0258126 A1)
While Gaynor et al. teach the limitations of a majority of the instant claims, as summarized above, Gaynor et al. does not teach a coronavirus vaccine composition further comprising a T cell attracting chemokine, wherein the T cell attracting chemokine is CCL5, CXCL9, CXCL10, CXCL11, or a combination thereof.
Scholler et al. teach that vaccine compositions can further comprise additional immunologically active molecules (see Paragraph 0190), including chemokines, such as CCL5, CXCL9, CXCL10, and CXCL11 (see Paragraph 0216).
A person having ordinary skill in the art would have been motivated to modify the teachings of Gaynor et al. with those of Scholler et al. in order to develop a recombinant coronavirus vaccine composition. Adding the chemokines of Scholler et al. to the vaccine composition of Gaynor et al. would enhance the therapeutic effectiveness of the vaccine composition and lead to the development of a more protective vaccine.
Such modifications, combining prior art elements according to known methods in order 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 claimed invention. For at least these reasons, Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over the prior art.
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.
Claims 1-9 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 515-517, 520-522, and 532-533 of copending Application No. 18/046,462 (reference application) (cited on IDS on 14 July 2025 as US 2023/0226173 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets read upon each other, despite the differences in the claim language used. Both claim sets are drawn to a coronavirus vaccine composition comprising at least two of one or more coronavirus B-cell, CD4+ T cell, or CD8+ T cell target epitopes wherein at least one epitope is derived from a non-spike protein, wherein the non-spike protein is encoded by ORF1ab, ORF3a, ORF6, ORF7a, ORF7b, ORF8, ORF10, or the Envelope protein, the Membrane protein, or the Nucleocapsid protein, and wherein the target epitopes are derived from target epitopes are derived from a SARS-CoV-2 protein selected from a group consisting of: ORF1ab protein, Spike glycoprotein, ORF3a protein, Envelope protein, Membrane glycoprotein, ORF6 protein, ORF7a protein, ORF7b protein, ORF8 protein, Nucleocapsid protein and ORF10 protein. Both claim sets are also drawn to a composition wherein the epitopes are derived from one or more of: one or more SARS-CoV-2 human strains or variants in current circulation; one or more coronaviruses that has cause a previous human outbreak; one or more coronaviruses isolated from animals selected from the group consisting of bats, pangolins, civet cats, minks, camels, or other animals receptive to coronaviruses; or one or more coronaviruses that cause the common cold, wherein the one or more SARS-CoV-2 human strains or variants in current circulation are selected from: variant B.1.177; variant B.1.160, variant B.1.1.7 (UK), variant P.1 (Japan/Brazil), variant B.1.351 (South Africa), variant B.1.427 (California), variant B.1.429 (California), variant B.1.258; variant B.1.221; variant B.1.367; variant B.1.1.277; variant B.1.1.302; variant B.1.525; variant B.1.526, variant S:677H; variant S:677P; B.1.617.2-Delta, variant B.1.1.529-Omicron, (BA.1); sub-variant Omicron (BA.1); sub-variant Omicron (BA.2); sub-variant Omicron (BA.3); sub-variant Omicron (BA.4); and sub-variant Omicron (BA.5), and wherein the one or more coronaviruses that cause the common cold are selected from: 229E alpha coronavirus, NL63 alpha coronavirus, OC43 beta coronavirus, and HKU1 beta coronavirus. Both claim sets are also drawn to a composition further comprising a T cell attracting chemokine, such as CCL5, CXCL9, CXCL10, or CXCL11, and a composition further comprising a composition that promotes T cell proliferation and T-cell memory, such as IL-7, IL-2, or IL-15.
Additionally, instant SEQ ID NOs: 2-29 are 100% identical to reference SEQ ID NOs: 2-29, respectively; instant SEQ ID NOs: 30-57 are 100% identical to reference SEQ ID NOs: 30-57, respectively; instant SEQ ID NOs: 58-73 are 100% identical to reference SEQ ID NOs: 58-73, respectively; instant SEQ ID NOs: 74-105 are 100% identical to reference SEQ ID NOs: 74-105, respectively; instant SEQ ID NOs: 106-116 are 100% identical to reference SEQ ID NOs: 106-116, respectively; instant SEQ ID NOs: 117-138 are 100% identical to reference SEQ ID NOs: 117-138, respectively; and SEQ ID NOs: 173 and 178 are 100% identical to reference SEQ ID NOs: 108 and 114, respectively.
The main difference between the instant claims and the reference claims is that the reference claims are drawn to mutated epitopes, while the instant claims are drawn to conserved epitopes. The mutated epitopes of the reference application are in relation to the corresponding epitopes in the original SARS-CoV-2 Wuhan-Hu-1 isolate. The conserved epitopes of the instant application encompass epitopes of SARS-CoV-2 variants, which, by definition, have mutations when compared to the corresponding epitopes of the SARS-CoV-2 Wuhan-Hu-1 isolate. As such, the mutated epitopes of the reference application and the conserved epitopes of the instant application are overlapping in scope and are obvious variants of each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6 and 8-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9-10, and 12-22 of copending Application No. 18/046,875 (reference application) (cited on IDS filed on 14 July 2025 as US 2023/0173060 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets read upon each other, despite the differences in the claim language used. Both claim sets are drawn to a coronavirus vaccine composition comprising at least two of one or more conserved coronavirus B-cell, CD4+ T cell, or CD8+ T cell target epitopes wherein at least one epitope is derived from a non-spike protein, wherein the non-spike protein is encoded by ORF1ab, ORF3a, ORF6, ORF7a, ORF7b, ORF8, ORF10, or the Envelope protein, the Membrane protein, or the Nucleocapsid protein, and wherein the target epitopes are derived from target epitopes are derived from a SARS-CoV-2 protein selected from a group consisting of: ORF1ab protein, Spike glycoprotein, ORF3a protein, Envelope protein, Membrane glycoprotein, ORF6 protein, ORF7a protein, ORF7b protein, ORF8 protein, Nucleocapsid protein and ORF10 protein.
Both claim sets are also drawn to a composition wherein the epitopes are derived from one or more of: target epitopes are derived from a SARS-CoV-2 protein selected from a group consisting of: ORF1ab protein, Spike glycoprotein, ORF3a protein, Envelope protein, Membrane glycoprotein, ORF6 protein, ORF7a protein, ORF7b protein, ORF8 protein, Nucleocapsid protein and ORF10 protein, wherein the one or more SARS-CoV-2 human strains or variants in current circulation are selected from: variant B.1.177; variant B.1.160, variant B.1.1.7 (UK), variant P.1 (Japan/Brazil), variant B.1.351 (South Africa), variant B.1.427 (California), variant B.1.429 (California), variant B.1.258; variant B.1.221; variant B.1.367; variant B.1.1.277; variant B.1.1.302; variant B.1.525; variant B.1.526, variant S:677H; variant S:677P and wherein the one or more coronaviruses that cause the common cold are selected from: 229E alpha coronavirus, NL63 alpha coronavirus, OC43 beta coronavirus, and HKU1 beta coronavirus. Both claim sets are also drawn to a composition further comprising a T cell attracting chemokine, such as CCL5, CXCL9, CXCL10, or CXCL11, and a composition further comprising a composition that promotes T cell proliferation and T-cell memory, such as IL-7, IL-2, or IL-15.
Additionally, both claim sets are drawn to a vaccine composition that protects against disease caused by one or more coronavirus variants or coronavirus subvariants, protects against infection and re- infection of coronavirus variants or coronavirus subvariants, protects against infection or reinfection of one or more coronavirus variants or coronavirus subvariant, protects against infection or reinfection of multiple coronavirus variants or coronavirus subvariants, protects against infection or re- infection of one coronavirus variants or coronavirus subvariants, protects against Sarbecoviruses, wherein sarbecoviruses comprise SARS-CoV-1 or SARS-CoV-2, and induces strong and long-lasting protection mediated by antibodies (Abs), CD4+ T helper (Th1) cells, and/or CD8+ cytotoxic T-cells, wherein the coronavirus variants or coronavirus subvariants comprise past or currently circulating coronavirus variants or coronavirus subvariants and wherein the coronavirus variants comprise alpha, beta, gamma, delta, and omicron, and wherein the coronavirus variants or coronavirus subvariants comprise future variants or future subvariants of human and animal coronavirus.
The main differences between the instant claims and the reference claims are that the reference claims are drawn to conserved epitopes comprised in large sequences, where in at least one large sequence is highly conserved among human and animal coronaviruses, while the instant claims are generally drawn to conserved epitopes. The term “large” in the reference claims is a subjective term, however, and there is no size limitation, either minimum or maximum, recited in the reference claims. The instant claims are silent regarding large sequences, but such sequences are encompassed by the instant claims, as large sequences comprising the instantly claimed epitopes read on the instant claims. There is also no size limitation, either minimum or maximum, recited in the instant claims. As such, the conserved epitopes of the instant claims and the conserved epitopes comprised in large sequences of the reference claims are overlapping in scope and are obvious va