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 .
Restriction/Election of Species
In their Response to the restriction and election of species requirement mailed on 09 April 2026, Applicant elected Group 2, Claims 23-37, without traverse.
In their Response to the restriction and election of species requirement mailed on 09 April 2026, Applicant elected the following species without traverse:
Species of specific coronavirus: SARS-CoV-2; Species of spike protein: S1; Species of CD1d ligand: α-GalCer; Species of additional antigen: claims 3 and 4 have been cancelled, thereby rendering the election moot; Species of infection status of the subject: the subject is infected; Species of cancer status of the subject: no cancer; Species of mRNA vaccine: refractory to the vaccine; Species of chemotherapy status: the subject has not received chemotherapy. The elected species read on instant Claims 23-30, 33-34, and 37.
Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09 June 2026. Claims 31-32, 35, and 36 are also withdrawn from further consideration as being drawn to nonelected species. Election was made without traverse in the reply filed on 09 June 2026. Additionally, Claims 25-28 and 34 are also withdrawn from further consideration due to these claims not reading on the elected species. Examiner would like to note, for the record, that Applicant has elected at least one species that is not actually claimed. Namely, the species of specific coronavirus, SARS-CoV-2, is not recited in the claims as currently written. This also applies to the species of CD1d ligand which was elected, α-GalCer, as well as the species of spike protein, S1.
Response to Amendment/Disposition of Claims
Applicant’s Amendment filed on 09 June 2026 has been received and entered. Claims 1-5 and 23-37 were pending. Claim 23 has been amended. Claims 6-22 have been cancelled. No new claims have been added. Claims 1-2, 5, and 23-37 are currently pending.
Of the withdrawn claims, Claims 1-2, 25-28, 31-32, and 34-36, no claims have been amended. Claims 3-4 have been cancelled. No new claims have been added.
Of the claims under examination, Claims 23-24, 29-30, 33, and 37, Claim 23 has been amended. No claims have been cancelled. No new claims have been added.
Accordingly, Claims 23-24, 29-30, 33, and 37 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 2024/0226278 A1, Published 11 July 2024. Applicant’s amended Specification as presented on 15 December 2023 is 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.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 30 April 2021. It is noted, however, that applicant has not filed a certified copy of the English translation of that JP2021-077785 application as required by 37 CFR 1.55.
Should applicant desire to obtain the full benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). While an English translation is not required unless an interference has been raised, it is suggested that one be filed of record to perfect the foreign priority effective filing date. Applicant is reminded that in the event that intervening art is found that falls between the foreign priority filing date and the 371-filing date, a prior art rejection may be raised since the certified copy of the foreign priority documents is not in English and an English translation of said documents has not been provided.
Failure to provide a certified translation may result in no benefit being accorded for the non-English application. Until a certified English translation of the foreign application has been provided, the Effective Filing Date of the claims under examination will be 28 April 2022, the 371-filing date.
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 statements (IDSes) submitted on 25 February 2025 and 27 October 2023 have been considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application contains sequence disclosures in accordance with 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 - 1.825.
The sequence disclosures are located in Paragraph 0096 of the PGPub of the instant application. The sequences in question are “RARR” and “RVRR”. These sequences have at least 4 specifically defined and enumerated amino acid residues and are therefore required to have their own unique SEQ ID NOs.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because of language which can be implied, specifically “The present disclosure provides” and “According to the present disclosure” [emphasis added]. 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 use of the terms FreeStyle, NEPA21, FACS Calibur, MACS Beads, and PepTivator, which are trade names or a marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include proper symbols indicating use in commerce such as ™, SM , or ® following the respective terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities: In Paragraphs 0077, 0078, and 0098, sequences are described by reference to GenBank Accession Nos., which are subject to change, rather than to sequences set forth in the specification. This is an improper incorporation by reference, since the information required to describe and enable the required sequences is found in the NCBI database, extraneous to the application. Furthermore, since the NCBI sequences are not irrevocably fixed but are corrected and updated as additional sequence information becomes available, the NCBI accession numbers may refer to sequences which change after the application filing date. Thus, the disclosure is objected to for this improper incorporation by reference.
Furthermore, essential material such as that which provides written description or enablement, as here since the antigen is needed for functional antibody identification, should not come from NPLs. See 37 CFR 1.57d.
Appropriate correction is required.
The disclosure is objected to because of the following informalities: In Paragraph 0094, it should say “SEQ ID NO: 2” instead of “SEQ ID NO: 4”.
In Paragraph 0096, there is an extra set of parentheses around the sequence and SEQ ID NO for F2A.
Appropriate correction is required.
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 23 and 37 are objected to because of the following informalities: In Claim 23, it is suggested that it say “…expressing [[a]] CD1d…and expressing an antigen…”.
In Claim 37, it is suggested that it say “…is a human patient of age or older”.
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 23, and dependent claims 24, 29-30, 33, and 37 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 23, it recites the limitation “A method for inducing antigen-specific immunity in a subject, comprising: administering to the subject a cell expressing a CD1d on a cell surface, wherein the CD1d is bound by a CD1d ligand, and the cell further expresses an antigen, wherein the antigen is a spike protein of a coronavirus or a fragment thereof, thereby capable of inducing spike protein-specific immunity”. The use of “a” in the phrase “a cell surface” renders the claim indefinite because it implies that there a multiple cell surfaces and that only one of these surfaces has CD1d present and that any of the cell surfaces present can be chosen for having the CD1d being present. There is only one cell surface, however. The same fact pattern is present for the use of “a” in the phrase “a spike protein”. Its use implies that there are multiple possible spike proteins to choose from and that only one is being selected. It is suggested that the claims be amended by replacing “a” with “the” in both phrases, 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 23 is rejected on the grounds of being indefinite. Claims 24, 29-30, 33, and 37 are also rejected, since they depend upon Claim 23 but do not remedy the deficiencies of Claim 23.
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.
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 23-24 and 29-30 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Fujii and Shimizu (US 2010/0233215 A1, Published 16 September 2010) (cited on IDS filed by Applicant on 27 October 2023).
Fujii and Shimizu teach a method for inducing antigen-specific immunity in a subject, comprising administering to said subject a cell co-expressing a target antigen and CD1d, wherein said target antigen is the SARS-CoV spike protein (see Paragraphs 0025, 0045) and wherein the CD1d is bound by a CD1d ligand (see Paragraphs 0025, 0034-0035), which is capable of generating an immune response against said target antigen (see Paragraph 0060), such as the SARS-CoV spike protein (see Paragraph 0045). Fujii and Shimizu also teach a method wherein the CD1d ligand is α-GalCer, wherein the cell is administered intravenously (see Paragraph 0113), and wherein the subject is infected with a pathogenic virus, such as SARS-CoV (see Paragraphs 0042-0047), which reads on instant Claims 23-24 and 29-30. Note: the prior art reference teaches the same composition being administered intravenously to a subject. This identical composition would have the same properties as the instant composition. Therefore, it would also induce antigen-specific immunity to the Betacoronavirus S protein in the lung tissue of said subject, and thus meets the limitations of instant Claim 24.
For at least these reasons, Fujii and Shimizu teach the limitations of instant Claims 23-24 and 29-30 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.
Claims 33 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Fujii and Shimizu (US 2010/0233215 A1, Published 16 September 2010) (cited on IDS filed by Applicant on 27 October 2023), as applied to claims 23-24 and 29-30 above, in view of Yan et al. (US 2021/0268102 A1, earliest Priority Date 25 February 2020), Hao et al. (US 2022/0401477 A1, earliest Priority Date 18 May 2021), and Kalkanli Tas et al. (Kalkanli Taş S, Uzunoğlu MS, Uzunoğlu AS, Kirkik D, Altunkanat D, Kalkanli N. Adoptive T-cell therapies to overcome T cell-dependent immune dysregulations in COVID-19. Turk J Biol. 2021 Dec 20;46(2):105-117.).
As summarized above, Fujii and Shimizu teach a method for inducing antigen-specific immunity in a subject, comprising administering to said subject a cell co-expressing a target antigen and CD1d, wherein said target antigen is the SARS-CoV spike protein (see Paragraphs 0025, 0045) and wherein the CD1d is bound by a CD1d ligand (see Paragraphs 0025, 0034-0035), which is capable of generating an immune response against said target antigen (see Paragraph 0060), such as the SARS-CoV spike protein (see Paragraph 0045). Fujii and Shimizu also teach a method wherein the CD1d ligand is α-GalCer, wherein the cell is administered intravenously (see Paragraph 0113), and wherein the subject is infected with a pathogenic virus, such as SARS-CoV (see Paragraphs 0042-0047), which reads on instant Claims 23-24 and 29-30. Note: the prior art reference teaches the same composition being administered intravenously to a subject. This identical composition would have the same properties as the instant composition. Therefore, it would also induce antigen-specific immunity to the Betacoronavirus S protein in the lung tissue of said subject, and thus meets the limitations of instant Claim 24.
Fujii and Shimizu do not teach a method for inducing antigen-specific immunity against SARS-CoV-2 in a subject or a method wherein said subject is refractory to an mRNA vaccine against a SARS-related coronavirus or wherein said subject is 60 years of age or older.
Yan et al. teach immunogenic compositions comprising SARS-CoV-2 spike antigens for inducing an immune response, protecting against, or treating SARS-CoV-2 infection in a subject (see Abstract). Yan et al. teach that the SARS-CoV-2 antigen can comprise a SARS-CoV-2 spike protein, the S1 subunit of the spike protein, or the S2 subunit of the spike protein (see Paragraph 0117). Yan et al. also teach methods of inducing an immune response against SARS-CoV-2 as well as methods of treating SARS-CoV-2 infection in a subject (see Paragraph 0012), wherein the immunogenic composition can be administered intravenously (see Paragraph 0168).
Hao et al. teach a method for treating a viral infection in a recipient subject comprising administering to the recipient subject a pharmaceutical composition comprising a therapeutic amount of superactivated cytokine killer T cells pulsed with monocyte-derived dendritic cells (DCs) loaded with α-GalCer (see Abstract). Hao et al. teach that the viral infection can be caused by a coronavirus, such as SARS-CoV-2 (see Paragraphs 0021-0027). Hao et al. also teach a method wherein the recipient subject is a human, such as a geriatric human, wherein the human is 60 years of age or older (see Paragraphs 0693-0696).
Kalkanli Taş et al. teach adoptive T-cell therapies to overcome T cell-dependent immune dysregulations such as inadequate T cell-dependent immune responses or lymphopenia for people who are immunocompromised (see Abstract).
A person having ordinary skill in the art would have been motivated the modify the teachings of Fujii and Shimizu with those of Yan et al., Hao et al., and Kalkanli Taş et al. in order to develop a cell-based immunotherapy to treat SARS-CoV-2 infections and induce an anti-SARS-CoV-2 immune response in subjects. Yan et al. teach that the S1 subunit facilitates binding of the coronavirus to cell surface protein and thus controls which cells are infected, while the S2 subunit comprises a transmembrane domain that facilitates viral and cellular membrane fusion (see Paragraph 0117). It would have been obvious to one of ordinary skill in the art to only use the S1 subunit as the antigen in the artificial adjuvant cell of Fujii and Shimizu so as to avoid the potential fusion of the artificial adjuvant cell with the target cells if the S2 subunit was present in the spike protein antigen. This would make the composition safer for administration to subjects. Hao et al. teach that the capacity to induce protective antibody at a sufficient titer to prevent infection declines significantly with age (see Paragraph 0058), while Kalkanli Taş et al. teach that vaccine-induced neutralization antibody titers against SARS-CoV-2 decreased in an age-dependent manner for people who received two doses of BNT162b2 (see Page 109, Right Column, First Paragraph). The combination of the artificial adjuvant cell of Fujii and Shimizu with the S1 subunit antigen of Yan et al. would have made the composition effective at inducing an immune response against the SARS-CoV-2 spike protein in subjects who are immune-compromised, such as geriatric subjects, and are unable to generate a proper immune response after administration of a SARS-CoV-2 mRNA vaccine. This combination of prior art references is being interpreted to teach the instant limitation of a subject who is refractory to an SARS-related coronavirus mRNA vaccine. Thus, the combination of these teachings renders the instant claims obvious.
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 33 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over the prior art.
Note: The Hao et al. and Kalkanli Taş et al. references constitute prior art due to the Foreign Priority not being perfected.
Claims 33 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Fujii and Shimizu (US 2010/0233215 A1, Published 16 September 2010) (cited on IDS filed by Applicant on 27 October 2023), as applied to claims 23-24 and 29-30 above, in view of Yan et al. (US 2021/0268102 A1, earliest Priority Date 25 February 2020), and Connors et al. (Connors J, Bell MR, Marcy J, Kutzler M, Haddad EK. The impact of immuno-aging on SARS-CoV-2 vaccine development. Geroscience. 2021 Feb;43(1):31-51.).
As summarized above, Fujii and Shimizu teach a method for inducing antigen-specific immunity in a subject, comprising administering to said subject a cell co-expressing a target antigen and CD1d, wherein said target antigen is the SARS-CoV spike protein (see Paragraphs 0025, 0045) and wherein the CD1d is bound by a CD1d ligand (see Paragraphs 0025, 0034-0035), which is capable of generating an immune response against said target antigen (see Paragraph 0060), such as the SARS-CoV spike protein (see Paragraph 0045). Fujii and Shimizu also teach a method wherein the CD1d ligand is α-GalCer, wherein the cell is administered intravenously (see Paragraph 0113), and wherein the subject is infected with a pathogenic virus, such as SARS-CoV (see Paragraphs 0042-0047), which reads on instant Claims 23-24 and 29-30. Note: the prior art reference teaches the same composition being administered intravenously to a subject. This identical composition would have the same properties as the instant composition. Therefore, it would also induce antigen-specific immunity to the Betacoronavirus S protein in the lung tissue of said subject, and thus meets the limitations of instant Claim 24. .
Fujii and Shimizu do not teach a method for inducing antigen-specific immunity against SARS-CoV-2 in a subject or a method wherein said subject is refractory to an mRNA vaccine against a SARS-related coronavirus or wherein said subject is 60 years of age or older. These deficiencies are remedied by the addition of Yan et al. and Connors et al.
Yan et al. teach immunogenic compositions comprising SARS-CoV-2 spike antigens for inducing an immune response, protecting against, or treating SARS-CoV-2 infection in a subject (see Abstract). Yan et al. teach that the SARS-CoV-2 antigen can comprise a SARS-CoV-2 spike protein, the S1 subunit of the spike protein, or the S2 subunit of the spike protein (see Paragraph 0117). Yan et al. also teach methods of inducing an immune response against SARS-CoV-2 as well as methods of treating SARS-CoV-2 infection in a subject (see Paragraph 0012), wherein the immunogenic composition can be administered intravenously (see Paragraph 0168). Additionally, Yan et al. teach that the elderly and those with comorbidities are at more serious risk of complications from SARS-CoV-2 infection (see Paragraph 0406).
Connors et al. teach that aging is associated with a decline in immune function and chronic activation of inflammation that contributes to enhanced viral susceptibility and reduced responses to vaccination (see Abstract) and that SARS-CoV-2 infection is deadlier to those individuals over the age of 65 and/or those with immunocompromising conditions (see Abstract). Connors et al. also teach that older subjects suffer from ineffective recall immunity responses and that older adults have significantly reduced antigen-specific antibody responses in response to vaccination in the context of Influenza A virus, another respiratory virus (see Page 35, Left Column, Last Paragraph).
A person having ordinary skill in the art would have been motivated the modify the teachings of Fujii and Shimizu with those of Yan et al. and Connors et al. in order to develop a cell-based immunotherapy to treat SARS-CoV-2 infections and induce an anti-SARS-CoV-2 immune response in subjects. Yan et al. teach that the S1 subunit facilitates binding of the coronavirus to cell surface protein and thus controls which cells are infected, while the S2 subunit comprises a transmembrane domain that facilitates viral and cellular membrane fusion (see Paragraph 0117). It would have been obvious to one of ordinary skill in the art to only use the S1 subunit as the antigen in the artificial adjuvant cell of Fujii and Shimizu so as to avoid the potential fusion of the artificial adjuvant cell with the target cells if the S2 subunit was present in the spike protein antigen. This would make the composition safer for administration to subjects. Connors et al. teach that individuals 65 years of age or older and/or those with immunocompromising conditions often fail to generate the same level of immune response when exposed to a pathogen and/or vaccinated against an infectious agent. The combination of the artificial adjuvant cell of Fujii and Shimizu with the S1 subunit antigen of Yan et al. would have made the composition effective at inducing an immune response against the SARS-CoV-2 spike protein in subjects who are immune-compromised, such as geriatric subjects, and are unable to generate a proper and robust immune response after administration of any kind of SARS-CoV-2 vaccine, including a SARS-CoV-2 mRNA vaccine. This combination of prior art references is being interpreted to teach the instant limitation of a subject who is refractory to an SARS-related coronavirus mRNA vaccine. Thus, the combination of these teachings renders the instant claims obvious.
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 33 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over the prior art.
Conclusion
No claims are allowed.
The prior art made of record, but not relied upon, and considered pertinent to applicant's disclosure is listed below:
Panikkar et al. (2022)
Panikkar et al. teach SARS-CoV-2-specific T cells generated for adoptive immunotherapy in the treatment of viral infections in immunocompromised patients. This reference has not been utilized, as rejection would have been redundant to those set forth above. Note: the reference constitutes prior art due to the Foreign Priority not being perfected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAREY A STUART whose telephone number is (703)756-4668. The examiner can normally be reached Monday - Friday, 7:30 AM - 4:30 PM EST.
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/CAREY ALEXANDER STUART/Examiner, Art Unit 1671
/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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