DETAILED ACTION The preliminary amendment submitted on May 3, 2024 has been entered. Claims 18-38 are pending in the application and are rejected for the reasons set forth below. No claim is allowed. 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. 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. 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)(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 18-21 and 23-25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2018 / 0344748 A1 by Barbut et al. Barbut discloses a method of treating multiple system atrophy (MSA) (para. 0002 and 0035) comprising administering an aminosterol (para. 0015-16 and 0028). The administration may be oral, nasal, and so forth (para. 0033), which meets the limitations of claims 19-20. The reference also discloses dosage amounts (para. 0115) within the meaning of instant claim 21. The aminosterol is formulated with a buffer (para. 0109) and is administered to a human (para. 0136), which meets the limitations of claims 23-24. An example aminosterol is squalamine (para. 0016), which meets the limitations of claim 25. The applied reference has a t least one common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a state ment pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. Claim Rejections – 35 USC § 112(b) 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. Claim 35 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 35 contains several the trademark s or trade name s . Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b). See Ex parte Simpson , 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trade mark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe certain commercially available drugs and, accordingly, the identification/description is indefinite. Claim Rejections – 35 USC § 112 (a) The following is a quotation 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. Claim s 18-38 are rejected under 35 U.S.C. 112(a) as failing to comply with the enable ment requirement. The claims contain subject matter which was not described in the specifica tion in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The claimed invention is in the pharmaceutical arts. The broadest independent claim is drawn to a method of treating, preventing, and/or slowing the onset or progression of multiple system atrophy (MSA) and/or a related symptom in a subject in need comprising administering to the subject a therapeutically effective amount of at least one aminosterol or a pharmaceuti cally acceptable salt thereof. Dependent claims 25 and 38 are drawn to squalamine or other compounds as the aminosterol. Other dependent claims are drawn to various routes of admin istration, dosage amounts, diagnostic criteria for MSA, and so forth. The state of the prior art as it relates to MSA is summarized in the following references: Heras-Garvin et al., Parkinsonism Relat . Disord. 2020;73:94-104. Kim et al., Parkinsonism Relat . Disord. 2016;22 Suppl 1:S12-5. Krismer et al., Lancet Neurol. 2024;23(12):1252-66. Meissner et al., Mov . Disord. 2019;34(11):1629-42. Heras-Garvin discloses (see Abstract) that “[m]ultiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder characterized by rapidly progressive autonomic and motor dysfunction. … At present, there is no treatment that can halt or reverse its progression.” Because the prior art acknowledges that “ there is no treatment ” for MSA, one would have been skeptical of the premise of the instant application. Heras-Garvin further cautions that “ etiology of MSA remains unclear and may be multifactorial , caused by a combination of genetic predispo sition and environmental factors” (p. 94). This reference states that “most of the clinical trials have failed or did not find changes in disease progression or symptoms in MSA patients, in contrast with their preclinical findings” (p. 97), which further casts doubt on whether applicant has truly invented a treatment for this disease. Heras-Garvin concludes that “strategies targeting α-syn aggregation, such as α-syn immunotherapy and small molecules, hold, however, promising therapeutic potential that still have to be evaluated in human trials” (p. 99). Substantial work remains to be conducted and research into treatments for this disease “may be successful only if preclinical and clinical researchers work side by side to solve actual problems and to design future approaches” (p. 99). One of skill in the art would therefore understand that the treatment of MSA remains a substantial technical challenge. Kim discloses that MSA “ is a relentless progressive disorder without effective treatment ” (see Abstract) and “ there still is no disease-modifying therapy ” (p. S12) for MSA. The fact that this reference cautions that this disease is “without effective treatment” and that there is no existing therapy raises further questions about whether applicant has indeed solved the technical problems associated with providing a treatment for MSA. Krismer similarly discloses that “the exact causative mechanisms underlying multiple system atrophy pathology still remain elusive and require further investigation” (p. 1263). This reference further discloses (p. 1260) that “[a] characteristic of multiple system atrophy and other neurodegenerative diseases is the continuous spread of disease pathology, which corresponds clinically to the disease stage. Disease prevention, disease-modifying therapies, and restorative therapies remain a major unmet need in the management of the disease. At present, prevention of multiple system atrophy in particular appears to be unattainable, because of an absence of established risk factors or biomarkers that can reliably predict multiple system atrophy in healthy people or individuals in the prodromal stage of [α] synucleinopathy. ” Note that the instant claims are drawn to a method of preventing MSA, but this Krismer states that “ prevention of multiple system atrophy in particular appears to be unattainable ,” which is evidence that one would not find “preventing” MSA to be credible. Meissner similarly discloses that “underlying pathogenesis [of MSA] is still not well under stood” (p. 1629). Advances in the treatment of MSA have not come from pharmacological inter ventions. Instead, “[t]he major care innovation of the last decade has been the establishment of a multidisciplinary care team approach, bringing together complementary health care expertise in neurology, urology, cardiology, gastroenterology, speech therapy, physiotherapy, occupa tional therapy, palliative care, and others that are necessary to optimize the management of the complex spectrum of motor and nonmotor symptoms endured by patients with MSA” (p. 1635). Given the number of medical specialties involved in the treatment of a patient with MSA, one would understand that this disease requires a high level of expertise with a wide range of prob lem-solving skills. The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. The amount of guidance or direction refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpre dictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See MPEP 2 164.03 (r elationship of p redictability of the a rt and the e nable ment r equirement ). It is implicit that one of ordinary skill in the art is a person who can read and understand these references, as well as applicant’s own specification. Such a person would have advanced education or substantial professional experience in pharmacology, clinical medicine, or a related technical discipline. As outlined above, the prior art recognizes that the technical problems that remain to be solved in this technology area are significant . One of skill in the art would therefore look to applicant’s specification for information about how the invention is practiced in actual fact. The specification includes data about the pharmacokinetics of an aminosterol after administration to laboratory animals. See Examples 2, 3, and 4 at pp. 208-14. It also includes a study on the effect of aminosterol administration on the gastrointestinal physiology of laboratory animals. See Examples 5, 6, and 8 at pp. 214-22 and 226-27. The specification also includes a number of prophetic examples, including Example 13 (pp. 229-30), which is a prophetic example that relates to MSA. “ A prophetic example describes an embodiment of the invention based on predicted results rather than work actually conducted or results actually achieved. ” See MPEP 2164.02 (w orking and p rophetic e xamples ). There are no working examples in the specification, or any evidence whatsoever, that the claimed invention has actually been reduced to practice. In light of the numerous technical challenges taught in the prior art, and the lack of evidence of efficacy, the examiner concludes that one of skill in the art would be burdened with undue experimentation when attempting to determine whether or not an aminosterol would actually be useful for treating, preventing, or slowing the onset or progression of MSA or a related symptom. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possi ble harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provi sions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompa nied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer . Claim s 18-21 and 23-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-8 of U.S. Patent No. 11 , 066 , 438 B2 . Although the claims at issue are not identical, they are not patentably distinct from each other . Claim 1 of the ‘438 Patent is directed to squalamine phosphate, which is a salt form within the scope of instant claim 18. The ‘438 Patent (col. 7, l. 35) explains that this compound is useful for treating multiple system atrophy. It also discloses (col. 15, ll. 3-23) oral and intravenous administration within the scope of instant claims 19-20, as well as dosage amounts (col. 15, ll. 60-67) within the meaning of instant claim 21. Claim s 18-21 and 23-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-10 of U.S. Patent No. 12 , 503 , 485 B2 . Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above . Claim s 18-21 and 23-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1 and 4-33 of copending Application No. 17/912 , 025 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim s 18-21 and 23-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1, 3, 9, 11, 13-17, 19-20, 22, 26-27, 29, 31, 36, and 38 of copending Application No. 18/832 , 100 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Theodore R. Howell whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-5993 . The exam iner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time) . Exam iner 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 Amy L. Clark can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)272-1310 . 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. FILLIN "Examiner Stamp" \* MERGEFORMAT THEODORE R. HOWELL Primary Examiner Art Unit 1628 /THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628 March 24, 2026