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 1-14 are 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 2025/0000967 A1, Published 02 January 2025. Applicant’s amended Specification as presented on 09 July 2024 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 applications filed in Korea on 29 December 2021 and 10 November 2021. It is noted, however, that applicant has not filed certified copies of the English translations of the KR10-2021-0191702 and KR10-2021-0154283 applications 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.
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 (IDS) submitted on 09 May 2024 has been considered by the examiner.
Drawings
The drawings are objected to because some of the figures are blurry and difficult to read. Specifically, the shading in Figure 2 makes it extremely difficult to read the sequence being highlighted. The same issue, to a lesser extent, is present in Figure 3. The lack of clarity of both Figures 3 and 4 make it difficult to read the sequences being highlighted, especially the S1/S2 cleavage site in Figure 4. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings. Specifically, Figures 2-4 all display sequences without any accompanying SEQ ID NOs being present either in the Figures themselves or in the figure legends within the Specification. If these sequences are part of the Sequence Listing, then the SEQ ID NOs must be included each and every time the sequences are displayed, even if they are already described elsewhere in the disclosure. If these sequences are not part of the Sequence Listing, then they must each be assigned their own unique SEQ ID NO.
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834. The examiner has noted that the Sequence Listing filed on 09 July 2024 does not have a sequence for SEQ ID NO: 1, but SEQ ID NO: 1 is referenced in the Specification. The Sequence Listing which was filed on 09 May 2024 does display a sequence for SEQ ID NO: 1. Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2., as well as
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency - The “Sequence Listing XML” has not been entered into the application because the required statement of no new matter, in accordance with 37 CFR 1.835(a)(4) or 1.835(b)(5), is missing. A Sequence Listing was initially filed on 09 May 2024. A new Sequence Listing was then filed on 09 July 2024, but the required statement of no new matter was not included.
Required response - Applicant must submit a statement that the “Sequence Listing XML,” identified by the date the “Sequence Listing XML” was filed, includes no new matter.
Specification
The abstract of the disclosure is objected to because it contains typographical errors, such as inconsistent punctuation, which lead to incomplete and/or run-on sentences. It is suggested that it instead say “The present invention relates to an exosome platform-based antiviral vaccine[[.]] with the ability to induce a strong immune response to viruses and induce a stable and long-term immune response even to viruses with frequent mutations[[,]]. T[[t]]he exosome platform-based antiviral vaccine can be utilized effectively for use as an antiviral vaccine.” 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 Abcam, Lipofectamine, DMEM, Invitrogen, Santa Cruz Biotechnology, Pierce, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term, as applicable.
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 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:// or other browser-executable code. See MPEP § 608.01. The hyperlink in question is www.ncbi.nlm.nih.gov/genbank/ (Paragraph 0046).
The disclosure is objected to because of the following informalities: In Paragraph 0058 of the PGPub of the instant application, it should say “COVID-19” instead of “COVID19”.
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 5-7 and 9 are objected to because of the following informalities: In Claim 5, it should say “TNF-α” instead of “TNF-a”.
In Claim 6, it is suggested that only one of DFNA5 and GSDME be used, as they both refer to the same gene.
In Claim 7, it is suggested that it say “fetal cells,
In Claim 9, it is suggested that it say “wherein the viral structural protein is at least one protein selected from the group consisting of a SARS-CoV-2 membrane protein, a SARS-CoV-2 envelope protein, a SARS-CoV-2 nucleocapsid protein, and a SARS-CoV-2 spike protein.
Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the definitions of the abbreviations GSDMA, GSDMB, GSDMC, GSDMD, DFNA5, GSDME, DFNB59 are not provided. For clarity, it is requested that the first recitation of an abbreviation within a claim set be preceded by its full-length name.
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 2, and dependent claims 3-4 and 6 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 2, it recites the limitation “wherein the exosome is a normal exosome and an apoptotic exosome”. It is unclear how the exosome can be both “normal” and “apoptotic” and there is nothing in the instant Specification to clarify what this phrase means or to delineate between the two terms. This lack of clarity renders the claim indefinite.
The term “normal” also renders the claim indefinite because it is unclear exactly what this terms means in the context of the claim language. For instance, is it referring to the shape and/or size of the exosome? This lack of clarity renders the claim indefinite.
Additionally, it is unclear if “an apoptotic exosome” is one which causes, or induces, apoptosis or if it is an exosome caused by, or the by-product of, apoptosis. This lack of clarity also renders the claim indefinite. It is suggested that the claim be amended to clarify the problematic claim language, 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 2 is rejected on the grounds of being indefinite. Claims 3-4 and 6 are also rejected, since they depend upon Claim 2 but fail to remedy the deficiencies of Claim 2.
Claim 5 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.
Claim 5 recites the limitation "the culture medium" in Line 1. There is insufficient antecedent basis for this limitation in the claim as no other claim mentions a culture medium, including Claim 1, upon which Claim 5 depends. As such, it is unclear which culture medium is being referenced, rendering the claim indefinite. It is suggested that Claim 5 be amended to properly introduce the limitation of a culture medium, 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 5 is rejected on the grounds of being indefinite.
Claim 6 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 6, it recites the limitation “wherein the Gasdermin family protein is at least one protein selected from the group consisting of GSDMA, GSDMB, GSDMC, GSDMD, DFNA5 (GSDME) and DFNB59”. The claim language indicates that the options listed are proteins, but the literature indicates that these are actually the gene names (see Table 1 of Kovacs and Miao, 2017, attached to this Office Action). This conflicting claim language renders the claim indefinite. It is suggested that the actual protein names be used instead or that the claim be amended to recite “wherein the Gasdermin family protein is at least one protein encoded by a gene selected from the group consisting of GSDMA, GSDMB, GSDMC, GSDMD, DFNA5 (GSDME) and DFNB59”, or similar language, 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 6 is rejected on the grounds of being indefinite.
Claim 6 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.
Claim 6 recites the limitation "the Gasdermin family protein" in Line 1. There is insufficient antecedent basis for this limitation in the claim as neither Claim 2, upon which Claim 6 depends, nor Claim 1 introduce the limitation of a Gasdermin family protein, making it unclear which protein is being referenced. This limitation is introduced in Claim 3. It is suggested that Claim 6 be amended to be dependent on Claim 3, 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 6 is rejected on the ground of being indefinite.
Claims 10-11, and dependent claims 12-13 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.
Claim 10 recites the limitation "the virus" in Line 1. There is insufficient antecedent basis for this limitation in the claim as the limitation of “a virus” is not introduced earlier in Claim 10 or in Claim 1, upon which Claim 10 depends. Similarly, Claim 11 recites the limitation “the virus” in Line 1. There is insufficient antecedent basis for this limitation in the claim as the limitation of “a virus” is not introduced earlier in Claim 11 or in Claim 1, upon which Claim 11 depends. As such, it is unclear which virus is being referenced. It is suggested that each claim be amended to properly introduce the limitation of “a virus” or that Claim 1 be amended to introduce the limitation of “a virus”, 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 10-11 are rejected on the grounds of being indefinite. Claims 12-13 are also rejected, since they depend upon Claim 11 but do not remedy the deficiencies of Claim 11.
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, Claim 6 is being interpreted as being dependent on Claim 3.
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 6 and 9 are 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 6, it recites the limitation “wherein the Gasdermin family protein is at least one protein selected from the group consisting of GSDMA, GSDMB, GSDMC, GSDMD, DFNA5 (GSDME) and DFNB59”. Claim 3 introduces the limitation of “a Gasdermin family protein” (emphasis added). Claim 3 is limited to a single protein, but the use of “at least one” in Claim 6 encompasses embodiments with multiple Gasdermin family proteins, which broadens the scope of Claim 3, upon which Claim 6 depends. Similarly, Claim 9 recites the limitation “wherein the structural protein is at least one protein selected from the group consisting of membrane, envelope, nucleocapsid and spike”. Claim 1, upon which Claim 9 depends, introduces the limitation of “a viral structural protein” (emphasis added). Claim 1 is limited to a single protein, but the use of “at least one” in Claim 9 encompasses embodiments with multiple structural viral structural proteins, which broadens the scope of Claim 1.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply 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 and 7-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature/natural phenomena without significantly more. The claims, Claim 1 in particular, recite an exosome comprising a viral structural protein. Claims 1 and 10 are ineligible because they recite an exosome comprising a viral structural protein wherein the virus is SARS-CoV-2. This reads on the virus particle itself and a natural exosome comprising a viral particle. As noted by Fehr and Perlman (2015, attached to this Office Action), coronavirus virions, following their assembly, are transported to the cell surface in vesicles and released by exocytosis (see Page 10, Paragraph 2). Borowiec et al. (2021, attached to this Office Action) note that exosomes are also called small extracellular vesicles (see Abstract) and that they share structural similarities to viruses, such as small size, common mechanisms of biogenesis and mechanisms for cell entry (see Abstract; Page 8, Paragraph 4) and that viruses “exit the cell by ‘budding’ through the cell membrane” (see Page 8, Paragraph 4). Borowiec et al. also note that viral particles can be contained within exosomes and then released, causing delayed reinfection (see Figure 4). Claims 7-8 are ineligible because they recite exosomes derived from cells or cell lines, which occur naturally. As noted by Borowiec et al., exosomes can be derived from lung cells (see Page 11, Paragraph 2), which are one type of cell that SARS-CoV-2 can infect. Claims 1, 7-8, and 10 do not recite any additional components to distinguish the claimed exosome from its naturally-occurring counterpart. Claims 11-13 are ineligible because, while they recite a “viral vaccine composition”, the claimed composition is only required to have the claimed exosome of Claim 1. As such, the composition, at a minimum, can be the exosome itself, which reads on a natural product, as discussed above.
This judicial exception is not integrated into a practical application because, as currently written, the claimed invention is not used to 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, simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. It is suggested that the claims be amended to recite limitations which would markedly distinguish the claimed exosome from its naturally occurring counterpart, such as a heterologous element or tag. It is suggested that the claimed vaccine composition recite additional required components which would markedly distinguish it from the naturally-occurring exosome, such as an adjuvant. Applicant is free to amend the claims as they deem necessary, as long as said amendments do not introduce new matter, or persuasively argue that the claims 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 1-2 and 7-14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sathyanarayanan et al. (WO 2021/189047 A2, Published 23 September 2021) (cited on IDS filed on 09 May 2024).
Sathyanarayanan et al. teach extracellular vesicles (EVs) comprising one or more antigens from a coronavirus, such as SARS-CoV-1 or SARS-CoV-2 (see Abstract), wherein these EVs, or exosomes (see Paragraph 0003), comprise an antigen derived from SARS-CoV-2, wherein said antigen is the spike protein, envelope protein, the membrane protein, or the nucleocapsid protein (see Paragraphs 0007-0013, 0220, 0423), which reads on instant Claims 1 and 8-9. Sathyanarayanan et al. also teach wherein said EVs include apoptotic bodies (see Paragraph 0122), which reads on instant Claim 2. Additionally, Sathyanarayanan et al. teach a method of producing EVs via a producer cell, wherein said producer cell can be a mammalian cell line, such HEK-293 cells, stem cells, such as adipose mesenchymal stem cells, an epithelial cell line, or immune cells (see Paragraphs 0436-0437), which reads on instant Claims 7-8 and 14. Furthermore, Sathyanarayanan et al. teach that the EVs can be used as a vaccine to treat and/or prevent diseases (see Paragraph 0003), wherein said EV further comprises an adjuvant (see Paragraphs 0057-0059) and wherein said EVs are part of a pharmaceutical composition comprising at least one carrier or excipient (see Paragraphs 0043, 0169), which reads on instant Claims 11-13.
For at least these reasons, Sathyanarayanan et al. teach the limitations of instant Claims 1-2 and 7-14 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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Sathyanarayanan et al. (WO 2021/189047 A2, Published 23 September 2021) (cited on IDS filed on 09 May 2024) and Baxter (Baxter, A. A. (2020). Stoking the Fire: How Dying Cells Propagate Inflammatory Signalling through Extracellular Vesicle Trafficking. International Journal of Molecular Sciences, 21(19), 7256.).
Sathyanarayanan et al. teach extracellular vesicles (EVs) comprising one or more antigens from a coronavirus, such as SARS-CoV-1 or SARS-CoV-2 (see Abstract), wherein these EVs, or exosomes (see Paragraph 0003), comprise an antigen derived from SARS-CoV-2, wherein said antigen is the spike protein, envelope protein, the membrane protein, or the nucleocapsid protein (see Paragraphs 0007-0013, 0220, 0423), which reads on instant Claims 1 and 8-9. Sathyanarayanan et al. also teach wherein said EVs include apoptotic bodies (see Paragraph 0122), which reads on instant Claim 2. Additionally, Sathyanarayanan et al. teach a method of producing EVs via a producer cell, wherein said producer cell can be a mammalian cell line, such as HEK-293 cells or HeLa cells, stem cells, such as adipose mesenchymal stem cells, an epithelial cell line, or immune cells (see Paragraphs 0436-0437), which reads on instant Claims 7-8 and 14. Furthermore, Sathyanarayanan et al. teach that the EVs can be used as a vaccine to treat and/or prevent diseases (see Paragraph 0003), wherein said EV further comprises an adjuvant (see Paragraphs 0057-0059) and wherein said EVs are part of a pharmaceutical composition comprising at least one carrier or excipient (see Paragraphs 0043, 0169), which reads on instant Claims 11-13.
Sathyanarayanan et al. does not teach an exosome, specifically an apoptotic exosome wherein the apoptosis is induced by cleavage of a Gasdermin family protein using staurosporine and wherein the culture medium for obtaining the exosome comprises at least one substance selected from the group consisting of tumor necrosis factor alpha (TNF-a), Cycloheximide, Anisomycin, Aurintricarboxylic acid, Diphtheria toxin, Edeine, Fusidic acid, Pactamycin, Puromycin, Ricin, Sodium fluoride, Sparsomycin, Tetracycline, Trichoderma and staurosporine.
Baxter teaches extracellular vesicles (EVs), such as exosomes (see Page 2, Paragraphs 2-3; Table 1), being released from cells after cleavage of gasdermin D (see Page 8, Paragraphs 2-3) and the derivation of exosome-like EVs from apoptotic HeLa cells following staurosporine treatment (see Page 6, Paragraph 2). Specifically, Baxter teaches that the exosome-like EVs derived from the apoptotic HeLa cells following staurosporine treatment were shown to activate the NF-κB signalling pathway and induce IL-1β expression in THP-1 macrophages via uptake of sphingosine-1 phosphate 3 receptor expression on EV membranes (see Page 6, Paragraph 2) and that, during inflammasome activation, cleavage of caspase 1 into its active form is responsible for both the activation of proinflammatory cytokines IL-1β and IL-18, as well as the N-terminal cleavage of gasdermin D, which then forms membrane pores leading to cell lysis (see Page 8, Paragraph 2), which reads on instant Claims 2-6.
A person having ordinary skill in the art would have been motivated to modify the teachings of Sathyanarayanan et al. with those of Baxter in order to develop of exosome-based viral vaccine. The teachings of Baxter would provide a skilled artisan with a routine method to produce exosomes via the gasdermin D pathway using a staurosporine treatment in the producer cell line being used for generating the exosomes of Sathyanarayanan et al. Sathyanarayanan et al. and Baxter both contemplate the same cell line, HeLa cells, for generating the exosomes, it would have been obvious to use this cell line to generate the exosomes of Sathyanarayanan et al. and to add staurosporine to the culture medium to induce the formation of the exosomes. The teachings of Sathyanarayanan et al. would enable a skilled artisan to generate the exosomes of Baxter and engineer them to display viral antigens and use them as part of an immunogenic composition against infectious agents, such as SARS-CoV-2, due to their enhanced ability to induce certain types of immune responses and display an array of antigens and other moieties of interest, such as adjuvants (see Paragraph 0182-0185 of Sathyanarayanan et al.). The combination of these teachings would have led to the development of a therapeutically effective exosome-based composition. The combination of these teachings also renders the instant invention obvious.
Such modifications, combining prior art element 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 instant application. For at least these reasons, instant Claims 1-14 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:
Hur et al. (Hur, J., Kim, Y. J., Choi, D. A., Kang, D. W., Kim, J., Yoo, H. S., Shahriyar, S. A., Mustajab, T., Kim, D. Y., & Chwae, Y.-J. (2021). Role of Gasdermins in the Biogenesis of Apoptotic Cell–Derived Exosomes. bioRxiv.)
Hur et al. teach gasdermins play an important role in the biogenesis of apoptotic cell-derived exosomes. This reference has not been utilized, as rejection would have been redundant to those set forth above.
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 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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