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. 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 fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”. Asp-Arg-Val-Tyr-Ile-His-Pro must be included in a sequence listing. Required response - Applicant must provide: A "Sequence Listing" part of the disclosure; together with An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2) ; A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3). 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) c) or d) above, applicant must also provide: A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and A statement according to item 2) a) or b) above. 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 at pages 1-3 and in claim 1. 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. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claim s 1, 7-8 and 11- 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 7-8 and 12 recite crystalline polymorph, solvate, and crystalline forms of Angiotensin-(1-7). It is well established in the art that solid forms of pharmaceutical agents, including crystalline polymorphs, solvates, and crystalline forms, are highly unpredictable . It is not know whether for a particular pharmaceutical agent whether a crystalline polymorph, solvate, or crystalline form exists. In addition, the properties and characteristics of a crystalline polymorph, solvate, and crystalline form are unknowable prior to formation and experimentation characterization. Despite this general level of unpredictability in the art, the specification has not presented a single working example or reduction to practice of a crystalline polymorph, solvate, or crystalline form of Angiotensin-(1-7) . The specification does not provide guidance on how to make the crystalline polymorph, solvate, or crystalline forms of Angiotensin-(1-7) . The specification does not describe the identifying characteristics of crystalline polymorph, solvate, and crystalline forms of Angiotensin-(1-7) . For these reasons, the skilled artisan would not reasonably conclude that the inventor had possession of the full scope of the claimed invention at the time the application was filed . Claims 7-8 and 12, and claims 1 and 11 from which they depend, violate the written description provision of 35 U.S.C. 112(a). Claims 1, 7-8 and 11- 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for making pharmaceutical compositions comprising Angiotensin-(1-7) , does not reasonably provide enablement for making crystalline polymorph, solvate, or crystalline forms of Angiotensin-(1-7) . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims. Claims 7-8 and 12 recite crystalline polymorph, solvate, and crystalline forms of Angiotensin-(1-7). It is well established in the art that solid forms of pharmaceutical agents, including crystalline polymorphs, solvates, and crystalline forms, are highly unpredictable. It is not know n whether for a particular pharmaceutical agent whether a crystalline polymorph, solvate, or crystalline form exists. In addition, the properties and characteristics of a crystalline polymorph, solvate, and crystalline form are unknowable prior to formation and experimentation characterization. Despite this general level of unpredictability in the art, the specification has not presented a single working example or reduction to practice of a crystalline polymorph, solvate, or crystalline form of Angiotensin-(1-7). The specification does not provide guidance on how to make the crystalline polymorph, solvate, or crystalline forms of Angiotensin-(1-7). The specification does not describe the identifying characteristics of crystalline polymorph, solvate, and crystalline forms of Angiotensin-(1-7). For these reasons, the skilled artisan would be unable to make the claimed c rystalline polymorph, solvate, or crystalline form of Angiotensin-(1-7) without an undue burden of experimentation . Claims 7-8 and 12, and claims 1 and 11 from which they depend, violate the enablement provision of 35 U.S.C. 112(a). 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. Claim s 1 - 6, 10- 11, and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. Step 1: Claim 1 -3 , 5-6, 11 and 14 are to a composition of matter. Step 2A, Prong 1: Claims 1 -3 , 5-6, 11 and 14 are directed to a product of nature, the peptide Angiotensin-(1-7), which is a naturally-occurring peptide, as evidenced by Beringer (US 2015/0057216 A1), para. [0017] and a pharmaceutically acceptable carrier, which may be a nature-based product such as water , oil and/or hyaluronic acid. Because the peptide and water and/or hyaluronic acid as claimed are not found together in nature, the closest counterpart to the nature-based products is Angiotensin-(1-7) and water, oil and/or hyaluronic acid . There is no evidence on record that mixing the claimed peptide with water, oil and/or hyaluronic acid changes the structure, function, or other properties of either the peptide or water, oil and/or hyaluronic acid in a marked way. Thus, for at least one embodiment of the claim with the BRI (e.g. wherein the carrier is water, oil and/or hyaluronic acid ), the claimed mixture as whole does not display markedly different characteristics compared to the naturally-occurring counterparts. Instead, the peptide and water, oil and/or hyaluronic acid have the same characteristics in the mixture as the individual components, the same chemical structure and the same function of [ 1 ] and being a solvent. See Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) . Accordingly, each component, the peptide and the carrier, is a natural phenomenon exception. Step 2A, Prong 2: The claim only recites the peptide and the carrier, which are natural phenomenon exceptions. Because there are no additional claim elements besides the judicial exception s, the judicial exception s are not integrated into a practical application (MPEP § 2106.04(d)(III)) . In addition, because the limitation s “for use in treatment” and “pharmaceutical” do not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration (MPEP § 2106.04(d)(2)) . Step 2B: Prior to applicant’s invention and at the time of filing the application, using a carrier for a peptide was well-understood, routine, and conventional, as evidenced by Beringer (US 2015/0057216 A1) . Because mixing the peptide with a carrier at this high level of generality does not meaningfully limit the claim, the claim does not amount to significantly more than the judicial exception (MPEP § 2106.05) . In addition, because the limitation s “for use in treatment” and “pharmaceutical” do not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration (MPEP § 2106.04(d)(2)) . Therefore, claim s 1-3, 5 and 11 are patent ineligible. Regarding claims 4 and 10, there is no evidence on record that Angiotensin-(1-7) in a dry powder or freeze-dried form is markedly different from its naturally-occurring counterpart. Furthermore, p rior to applicant’s invention and at the time of filing the application, freeze-drying and powder forms were well-understood, routine, and conventional, as evidenced by Beringer (US 2015/0057216 A1). Regarding claims 6 and 14, nature-based Angiotensin-(1-7) is encapsulated in a cell membrane. Therefore, this limitation does not distinguish the Angiotensin-(1-7) from its naturally-occurring counterpart. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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. Claims 1 , 4, and 11 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Clinical Trial NCT0433266 (NPL 3, IDS 11/03/2023) . Clinical Trial NCT0433266 discloses a pharmaceutical composition comprising Angiotensin (1-7) and the pharmaceutically acceptable carrier 0.9% NaCl (page 4, Table “Arms and Interventions”). Clinical Trial NCT0433266 teaches administering the composition to patients suffering from SARS-CoV2 (COVID-19) by intravenous infusion in order to treat the condition (p. 4, Study Design). The composition satisfies all of the limitations of and anticipates instant claim 11 . Regarding the requirement for intramuscular, transdermal, pulmonary, lingual, buccal, and nasal administration in claim 1 , and sublingual administration in claim 4 , a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the composition disclosed by Clinical Trial NCT0433266 is capable of being used for intramuscular, transdermal, pulmonary, lingual, buccal, nasal, and sublingual administration. Therefore, the composition also satisfies all of the limitations of and anticipates instant claim s 1 and 4 . Claims 1-6, 9, and 11-15 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Souza Dos Santos et al. (US 2009/0221498 A1) . Souza Dos Santos et al. teach pharmaceutical compositions comprising the angiotensin-(1-7) peptide in a form suitable for administration example orally or rectally, in the form of pills, tablets, film-coated tablets, sugar-coated tablets, granules, hard and soft gelatin capsules, solutions such as aqueous, alcoholic, or oily solutions, juices, drops, syrups, emulsions, or suspensions. Souza Dos Santos et al. teach that administration can be intramuscular in the form of injection solutions or infusion solutions. Souza Dos Santos et al. teach that administration can be topical administration, in the form of ointments, creams, pastes, lotions, gels, sprays, powders, foams, aerosols, or solutions, or use in the form of implants. Souza Dos Santos et al. teach that the pharmaceutical formulation is orally administrable micro- and/or nanoparticulated device (para. [0058]). The composition satisfies all of the limitations of and anticipates instant claim 11 . Regarding claim 13, Souza Dos Santos et al. teach pharmaceutical compositions comprising the angiotensin-(1-7) peptide in a salt form (para. [0058]). Regarding claim 1 4 , Souza Dos Santos et al. teach pharmaceutical compositions comprising the angiotensin-(1-7) peptide in a n encapsulated form (para. [0058]). Regarding claim 1 5 , Souza Dos Santos et al. teach pharmaceutical compositions comprising the angiotensin-(1-7) peptide in a nanoparticulate form (para. [0058]). Regarding the requirement for treating coronavirus infection related diseases in claim s 1 -6 and 9 , a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the composition disclosed by Souza Dos Santos et al. is capable of being used for treating coronavirus infection related diseases because the chemical structure of the active agent, angiotensin-(1-7) peptide is the same as in the instant claims . The refore, the composition satisfies all of the limitations of and anticipates instant claim 1 . Regarding claim 2 , Souza Dos Santos et al. teach pharmaceutical compositions comprising the angiotensin-(1-7) peptide in an oily solutions and emulsion form s (para. [0058]). Regarding claim 3 , Souza Dos Santos et al. teach pharmaceutical compositions comprising the angiotensin-(1-7) peptide in liquid suspension and powder forms (para. [0058]). Regarding claim 4 , Souza Dos Santos et al. teach pharmaceutical compositions comprising the angiotensin-(1-7) peptide in liquid suspension and powder forms (para. [0058]). Regarding claim 5 , Souza Dos Santos et al. teach pharmaceutical compositions comprising the angiotensin-(1-7) peptide in nanoparticle and powder forms (para. [0058]). Regarding claim 6, Souza Dos Santos et al. teach pharmaceutical compositions comprising the angiotensin-(1-7) peptide in an encapsulated form (para. [0058]). Regarding claim 9 , Souza Dos Santos et al. teach pharmaceutical compositions comprising the angiotensin-(1-7) peptide in a salt form (para. [0058]). Claims 1-6, 9-11, and 13-14 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Beringer (US 20 15 /0 057216 A1) . Beringer teach es pharmaceutical compositions for and m ethod s of treating or preventing a fibrotic disease, disorder or condition by administering to a subject in need of treatment Angiotensin (1-7), Asp-Arg-Val-Tyr - Ile-His-Pro (para. [0006], [0018]). Beringer teaches that the Angiotensin (1-7) can be administered by any suitable route including, intravenous or intramuscular injection, intraventricular or intrathecal injection (for central nervous system administration), orally, topically, subcutaneously, mucocutaneously, intrapulmonary (e.g., inhalation), subconjunctivally, intraocularly, or via intranasal, intradermal, sublingual, vaginal, rectal or epidural routes (para. [0175], [0217]) . The composition satisfies all of the limitations of and anticipates instant claim 11 . Regarding claim 13, Beringer teaches pharmaceutical compositions comprising the angiotensin-(1-7) peptide in a salt form (para. [0 125 ] , [0209] ). Regarding claim 14, Beringer teaches pharmaceutical compositions comprising the angiotensin-(1-7) peptide in an encapsulated form (para. [ 021 8]). Regarding the requirement for treating coronavirus infection related diseases in claims , a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the composition disclosed by Beringer et al. is capable of being used for treating coronavirus infection related diseases because the chemical structure of the active agent, angiotensin-(1-7) peptide is the same as in the instant claims. Therefore, the composition satisfies all of the limitations of and anticipates instant claim 1 . Regarding claim 2, Beringer teaches pharmaceutical compositions comprising the angiotensin-(1-7) peptide in emulsion forms (para. [0 223 ]). Regarding claim 3, Beringer teaches pharmaceutical compositions comprising the angiotensin-(1-7) peptide in liquid suspension and powder forms (para. [0 223 ]). Regarding claim 4, Beringer teaches pharmaceutical compositions comprising the angiotensin-(1-7) peptide in sublingual (para. [0175]) and powder forms (para. [0058]). Regarding claim 5, Beringer teaches pharmaceutical compositions comprising the angiotensin-(1-7) peptide in powder forms (para. [0 223 ]). Regarding claim 6, Beringer teaches pharmaceutical compositions comprising the angiotensin-(1-7) peptide in an encapsulated form (para. [0 218 ]). Regarding claim 9, Beringer teaches pharmaceutical compositions comprising the angiotensin-(1-7) peptide in a salt form (para. [0125], [0209]). Regarding claim 10 , Beringer teaches that the Angiotensin-(1-7) is lyophilized (ie freeze-dried) (para. [0239] ). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT CHRISTINA MARCHETTI BRADLEY whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9044 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday, 7 am - 3 pm . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Lianko G Garyu can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-7367 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CHRISTINA BRADLEY/ Primary Examiner, Art Unit 1654