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 .
Non-Final Rejection
The Status of Claims:
Claims 1-18 are pending.
Claims 1-18 are rejected.
DETAILED ACTION
1. Claims 1-18 are under consideration in this Office Action.
Priority
2. It is noted that this application is a continuation of 18264538 08/07/2023 PAT 12134598 , which is a 371 of PCT/US2022/013622 01/25/2022 PCT/US2022/013622 has a priority of 63147355 02/09/2021.
Drawings
3. The drawings filed on 9/27/24 are accepted by the examiner.
IDS
4. The IDS filed on 9/27/24 were reviewed by the examiner.
Claim Rejections - 35 USC § 112
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 3, 5, 8-9, 12, 14 and 17-18 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 pre-AIA the applicant regards as the invention.
In claim 1, the phrases “a purified psilocybin derivative “ and “ substantially similar to” is recited. Theses expressions are vague and indefinite because the term” derivative “ and the phrase“ substantially similar to” are undefined in the claims; the claim does not elaborate what is meant by the derivative for a purified psilocybin . Also, the claims do not explain how substantially the an X-ray powder diffraction pattern is similar to the figures 4 or 5. The examiner recommends to remove them from the claims.
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.
Claims 1-18 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treating specific diseases or disorders, does not reasonably provide enablement for preventing a brain disorder, or a disorder selected from a developmental disorder; delirium; an amnestic disorder; a cognitive disorder; a psychiatric disorder due to a somatic condition; a drug-related disorder; a mood disorder; an anxiety disorder; a somatoform disorder; a factitious disorder; a dissociative disorder; an eating disorder; a sleep disorder; an impulse control disorder; an adjustment disorder; and a personality disorder. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Applicants are not enabled for preventing any of these disorders. The only established prophylactics are vaccines not the claimed drug such as present here. In addition, it is presumed that “prevention” of the claimed disorders would require a method of identifying those individuals who will develop the claimed disorders before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted.
“The factors to be considered [in making an enablement rejection have been summarized as the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art, and the breadth of the claims”, In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. 1) As discussed above, preventing disorders requires identifying those patients who will acquire the disorders before psoriasis occurs. This would require extensive and potentially opened ended clinical research on healthy subjects. 2) There is no working example of such a preventive procedure in man or animal in the specification. 3) The claims rejected are drawn to clinical preventative medicine and are therefore physiological in nature. 4) The state of the art is that no general procedure is art-recognized for determining which patients generally will become the patients with any disorder or condition response to an immune system before the fact. 6) The artisan using Applicants invention would be a Board Certified physician in the disorders or conditions response to the immune system with an MD degree and several years of experience. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of a disorder or condition response to an immune system generally. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable to any agent to be able to prevent any brain disorder or other disorders generally. That is, the skill is so low that no compound effective generally against the disease or disorders or conditions response to an immune system has ever been found let alone one that can prevent such conditions. 7) It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved", and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). 8) The claims broadly read on all patients, not just those undergoing therapy for the claimed disorders.
The Examiner suggests deletion of the word “preventing” from the claims.
Claims 1-5 and 10-14 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification 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 specification mentions that it is possible to treat various brain disorders, such as Huntington’s disease, Alzheimer’s disease, dementia, and Parkinson’s disease.
by using crystalline form 1 of [2-(5-methoxy-1H-indol-3-yl)ethyl]dipropylamine (5-MeO-DPT) or (5-MeO-DPT fumarate).
However, enablement for “ the treatment of Alzheimer’s disease “by using (5-MeO-DPT) or (5-MeO-DPT fumarate) is not present in the specification. The specification merely mention the use of (5-MeO-DPT) or (5-MeO-DPT fumarate) in the treatment of Alzheimer’s disease without any sufficient examples and tests. Alzheimer's disease (AD), also referred to simply as Alzheimer's, is a chronic neurodegenerative disease that usually starts slowly and gradually worsens over time. It is the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in remembering recent events. As the disease advances, symptoms can include problems with language, disorientation (including easily getting lost), mood swings, loss of motivation, not managing self care, and behavioral issues. As a person's condition declines, they often withdraw from family and society. Gradually, bodily functions are lost, ultimately leading to death. Although the speed of progression can vary, the typical life expectancy following diagnosis is three to nine years. The cause of Alzheimer's disease is poorly understood. About 70% of the risk is believed to be inherited from a person's parents with many genes usually involved. Other risk factors include a history of head injuries, depression, and hypertension The disease process is associated with plaques and neurofibrillary tangles in the brain. A probable diagnosis is based on the history of the illness and cognitive testing with medical imaging and blood tests to rule out other possible causes. Initial symptoms are often mistaken for normal ageing. Examination of brain tissue is needed for a definite diagnosis. Mental and physical exercise, and avoiding obesity may decrease the risk of AD; however, evidence to support these recommendations is weak. There are no medications or supplements that have been shown to decrease risk. Affected people increasingly rely on others for assistance, often placing a burden on the caregiver. The pressures can include social, psychological, physical, and economic elements. Exercise programs may be beneficial with respect to activities of daily living and can potentially improve outcomes. Behavioral problems or psychosis due to dementia are often treated with antipsychotics, but this is not usually recommended, as there is little benefit with an increased risk of early death. No treatments stop or reverse its progression, though some may temporarily improve symptoms. The above list is by no means complete, but demonstrates the extraordinary breadth of causes, mechanisms and treatment (or lack thereof) for Alzheimer ‘s Disease. It establishes that it is not reasonable to any agent to be able to treat Alzheimer‘s Disease successfully. Therefore, an appropriate correction is required.
Furthermore, another mental disease called Parkinson's disease, which is a progressive neurodegenerative disorder (synucleopathy) diagnosed on the basis of characteristic motor disturbances, asymmetry of symptoms onset and response to levodopa (Litvan et al., 2003). Lewy bodies, neurofibrillary tangles and plaques are observed in nigral, limbic and neocortical regions. These degenerations are supposed to affect catecholaminergic (dopamine and norepinephrine) and cholinergic neurotransmission. In particular, an important part of cognitive deficits (executive function and working memory) have been related to a decreased prefrontal dopaminergic signaling in non demented patients (Nandakumar et al., 2013). However, the specification does not show any treatment of Parkinson's disease in view of any sufficient examples, evidence and tests by using (5-MeO-DPT) or (5-MeO-DPT fumarate) at all.
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. § 112, first paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The Nature of the Invention
The nature of the invention in claims 1 and 10 is as followed:
A method of preventing or treating a brain disorder comprising the step of: administering to a subject in need thereof a therapeutically effective amount of.
crystalline form 1 of [2-(5-methoxy-1H-indol-3-yl)ethyl]dipropylamine (5-MeO-DPT).
10. A method of preventing or treating a brain disorder comprising the step of: administering to a subject in need thereof a therapeutically effective amount of crystalline form 1 of bis([2-(5-methoxy-1H-indol-3-yl)ethyl]dipropylazanium) (2E)-but-2-enedioate (5-MeO-DPT fumarate).
The State of the Prior art
Chadeayne et al (Psychedel Sci. Rev. , 2019) discloses that psychedelic agents produce mood-altering effects which can be used to treat mood disorders such as depression and post-traumatic stress disorder (PTSD).
Carhart-Harris et al (Neuropsychopharmacol., 42, 2105-2113) discloses that
psilocybin can be used to treat depression.
Jefferson et al. (Neuropsychopharmacology 2023, 48:1257-1266) discloses
that 5-methoxy tryptamine analog, 5-MeO-DMT, has been associated with improvement in depression and anxiety symptoms in early phase clinical studies.
However, there are no conclusive data which allow the approval for treating all kinds of brain disorders comprising administering the compounds similar to the claimed compound of 5-MeO-DPT or 5-MeO-DPT fumarate.
The presence or absence of working examples
In the specification, there are no examples for the treatment for various brain disorders including Huntington’s disease, Alzheimer’s disease, dementia, and Parkinson’s disease and others using the claimed compounds in the specification. Also, the specification does not contain any pharmacological data regarding the treatments for all kinds of brain disoders while using the claimed compounds. Thus, the specification fails to provide sufficient working examples as to how the treatment of all kinds of brain disorders can be treated successfully by the claimed compounds without any unexpected negative effects of using the claimed compounds.
The level of the skill in the art
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine whether or not the claimed compounds can be led to exhibit the desired pharmacological activity for treating all the neurological or cardiovascular diseases or disorders.
Thus, the specification fails to provide sufficient support for the treatment of all brain disorders. As a result, it necessitates one of the skilled artisans in the art to perform an exhaustive search for selecting claimed brain disorders suitable for the claimed compounds in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001 (3/13/1997), states that “ a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test whether or not all the claimed brain disorders can be treated by the claimed compounds, which is encompassed in the instant claims, with no assurance of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 6 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 and 15 of U.S. Patent No.12,134,598 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of some difference between the scope of the claimed invention with respect to the treatment of a various types of disorders vs. a few of disorders.
The claims 1, 6 ,10 , and 15 of U.S. Patent No. describe the followings:
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, whereas the instant claims 6 and 15 do disclose the following method as shown below:
6. A method of preventing or treating a disorder selected from the group consisting of: a developmental disorder; delirium; an amnestic disorder; a cognitive disorder; a psychiatric disorder due to a somatic condition; a drug-related disorder; a mood disorder; an anxiety disorder; a somatoform disorder; a factitious disorder; a dissociative disorder; an eating disorder; a sleep disorder; an impulse control disorder; an adjustment disorder; and a personality disorder, the method comprising the step of: administering to a subject in need thereof a therapeutically effective amount of crystalline form 1 of [2-(5-methoxy-1H-indol-3-yl)ethyl]dipropylamine (5-MeO-DPT).
15. A method of preventing or treating a disorder selected from the group consisting of: a developmental disorder; delirium; an amnestic disorder; a cognitive disorder; a psychiatric disorder due to a somatic condition; a drug-related disorder; a mood disorder; an anxiety disorder; a somatoform disorder; a factitious disorder; a dissociative disorder; an eating disorder; a sleep disorder; an impulse control disorder; an adjustment disorder; and a personality disorder, the method comprising the step of: administering to a subject in need thereof a therapeutically effective amount of crystalline form 1 of bis([2-(5-methoxy-1H-indol-3-yl)ethyl]dipropylazanium) (2E)-but-2-enedioate (5-MeO-DPT fumarate).
However, the instant claims differ from the U.S. Patent No. in that the claimed limitations of a developmental disorder; delirium; an amnestic disorder; a cognitive disorder; a psychiatric disorder due to a somatic condition; a drug-related disorder; a mood disorder; a somatoform disorder; a factitious disorder; a dissociative disorder; an eating disorder; a sleep disorder; an impulse control disorder; an adjustment disorder; and a personality disorder are unspecified.
Even so, the speciation does disclose that crystalline form 1 of 5-MeO-DPT or crystalline form 1 of 5-MeO-DPT fumarate may also be used to prevent and/or
treat developmental disorders, delirium, dementia, amnestic disorders and other cognitive disorders, psychiatric disor-ders due to a somatic condition, drug-related disorders, mood disorders somatoform disorders, factitious disorders, dissociative disorders, eating disorders, sleep disorders, impulse control disorders, adjustment disorders, or personality disorders (see col. 5, lines 43-52).
From these, it seems reasonable for the skilled artisan in the art to incorporate those limitations into the claims in order to expand the treatment for the mental health issues. Moreover, such limitations can be anticipated; there is very little difference as to the patentable distinction.
So, it would have been obvious to the skilled artisan to be motivated to add those limitations to the claims in order to broaden up the scope of the claimed method. This is because the skilled artisan in the art would expect such a manipulation to be feasible and successful as guidance shown in the U.S. Patent No..
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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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
5. Claims 1-4, 6-8, 10-13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Stamets (US 2021/0069170A1), filed on Nov. 18, 2020.
Applicant claims the followings:
1. A method of preventing or treating a brain disorder comprising the step of: administering to a subject in need thereof a therapeutically effective amount of crystalline form 1 of [2-(5-methoxy-1H-indol-3-yl)ethyl]dipropylamine (5-MeO-DPT).
2. The method of claim 1, wherein the crystalline form 1 of 5-MeO-DPT is administered in a composition comprising the crystalline form 1 of 5-MeO-DPT and at least one excipient.
3. The method of claim 2, wherein the composition further comprises a second component selected from (a) a serotonergic drug, (b) a purified psilocybin derivative, (c) one or two purified cannabinoids, and (d) a purified terpene.
4. The method of claim 1, wherein the brain disorder is selected from the group consisting of Huntington’s disease, Alzheimer’s disease, dementia, and Parkinson’s disease.
6. A method of preventing or treating a disorder selected from the group consisting of: a developmental disorder; delirium; an amnestic disorder; a cognitive disorder; a psychiatric disorder due to a somatic condition; a drug-related disorder; a mood disorder; an anxiety disorder; a somatoform disorder; a factitious disorder; a dissociative disorder; an eating disorder; a sleep disorder; an impulse control disorder; an adjustment disorder; and a personality disorder, the method comprising the step of: administering to a subject in need thereof a therapeutically effective amount of crystalline form 1 of [2-(5-methoxy-1H-indol-3-yl)ethyl]dipropylamine (5-MeO-DPT).
7. The method of claim 6, wherein the crystalline form 1 of 5-MeO-DPT is administered in a composition comprising the crystalline form 1 of 5-MeO-DPT and at least one excipient.
8. The method of claim 7, wherein the composition further comprises a second component selected from (a) a serotonergic drug, (b) a purified psilocybin derivative, (c) one or two purified cannabinoids and (d) a purified terpene.
10. A method of preventing or treating a brain disorder comprising the step of: administering to a subject in need thereof a therapeutically effective amount of crystalline form 1 of bis([2-(5-methoxy-1H-indol-3-yl)ethyl]dipropylazanium) (2E)-but-2-enedioate (5-MeO-DPT fumarate).
11. The method of claim 10, wherein the crystalline form 1 of 5-MeO-DPT fumarate is administered in a composition comprising the crystalline form 1 of 5-MeO-DPT fumarate and at least one excipient.
12. The method of claim 11, wherein the composition further comprises a second component selected from (a) a serotonergic drug, (b) a purified psilocybin derivative, (c) one or two purified cannabinoids, and (d) a purified terpene.
13. The method of claim 10, wherein the brain disorder is selected from the group consisting of Huntington’s disease, Alzheimer’s disease, dementia, and Parkinson’s disease.
15. A method of preventing or treating a disorder selected from the group consisting of: a developmental disorder; delirium; an amnestic disorder; a cognitive disorder; a psychiatric disorder due to a somatic condition; a drug-related disorder; a mood disorder; an anxiety disorder; a somatoform disorder; a factitious disorder; a dissociative disorder; an eating disorder; a sleep disorder; an impulse control disorder; an adjustment disorder; and a personality disorder, the method comprising the step of: administering to a subject in need thereof a therapeutically effective amount of crystalline form 1 of bis([2-(5-methoxy-1H-indol-3-yl)ethyl]dipropylazanium) (2E)-but-2-enedioate (5-MeO-DPT fumarate).
16. The method of claim 15, wherein the crystalline form 1 of 5-MeO-DPT fumarate is administered in a composition comprising the crystalline form 1 of 5-MeO-DPT fumarate and at least one excipient.
17. The method of claim 16, wherein the composition further comprises a second component selected from (a) a serotonergic drug, (b) a purified psilocybin derivative, (c) one or two purified cannabinoids and (d) a purified terpene.
Determination of the scope and content of the prior art
Stamets discloses a method of treating various disorders including neurodegeneration diseases such as Alzheimer’s disease , Parkinson’s disease, mood disorders as in claims 1, 4, 6, 10 , 13, 15 (see page 20 ,a paragraph#0161) by using 5-methoxy- N,N-diethyltrptamine in the followings:
A method of treating or preventing serotonin (5-hy-droxytryptamine, 5-HT) receptor disorders, neuronal injuries, neurodegeneration, neurological diseases, congenital or organic cognitive impairment, learning disabilities, autism spectrum disorder, psychiatric and mood disorders, cognitive enhancement, physical or motor neuron enhancement, or general improvement of mental health in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a composition com-prising one or more tryptamines or in pure form or phar-maceutically acceptable salts, hydrates, solvates, prodrugs, stereoisomers, tautomers thereof or combinations thereof. or extracts or isolates from psilocybin containing mushrooms, or combinations thereof combined with one or more erina-cines or hericenones in pure form or pharmaceutically acceptable salts, hydrates, solvates, prodrugs, stereoisomers, or tautomer thereof. or combinations thereof, extracts or isolates from Hericium mushroom species, combinations thereof; one or more cannabinoids in pure form as in claims 3, 8 , 12, 17 or pharmaceutically acceptable salts, hydrates, solvates, prodrugs, stereoisomers, tautomers thereof, or combinations thereof, and one or more pharmaceutically acceptable excipients.as in claims 2, 7,11, 16 (see page 50, claim 27).
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(see page 30)
Furthermore, it teaches that any resulting mixtures of isomers can be separated based on the physicochemical differences of the constituents, into the pure or substantially pure geometric or optical isomers, diastereomers, racemates, for example, by chromatography and/or fractional crystallization (see page 11, a paragraph#0093).
Moreover, pharmaceutically acceptable acid addition salts can be formed with inorganic acids and organic acids. In addition, organic acids from which salts can be derived include, for example, acetic acid, propionic acid, glycolic acid, oxalic acid, maleic acid, malonic acid, succinic acid, fumaric acid, tartaric acid, citric acid, benzoic acid, mandelic acid, methanesulfonic acid, ethanesulfonic acid, toluenesulfonic acid, sulfosalicylic acid, and the like (see page 11, paragraphs# 0098, 0100)
The instant invention, however, differs from the prior art in that the claimed crystalline form 1 of bis([2-(5-methoxy-1H-indol-3-yl)ethyl]dipropylazanium) (2E)-but-2-enedioate (5-MeO-DPT fumarate) is unspecified in the prior art.
Ascertainment of the difference between the prior art and the claims
The difference between the instant application and the applied Stamets art is that the Stamets does not expressly teach the claimed crystalline form 1 of bis([2-(5-methoxy-1H-indol-3-yl)ethyl]dipropylazanium) (2E)-but-2-enedioate (5-MeO-DPT fumarate).
Resolving the level of ordinary skill in the pertinent art.
Regarding the instant Claims 10-13, 15-17, with respect to the lack of disclosing the formation of crystalline form 1 of 5-MeO-DPT fumarate, the prior art does teach that pharmaceutically acceptable acid addition salts can be formed with inorganic acids and organic acids from which salts can be derived include, for example, fumaric acid (see page 11 paragraphs#0098 &0100). Also, the prior art does give a guidance a that any resulting mixtures of isomers can be separated based on the physicochemical differences of the constituents, into the pure or substantially pure geometric or optical isomers, diastereomers, racemates, for example, by chromatography and/or fractional crystallization (see page 11 ,a paragraph#0093).
From these teachings, if the skilled artisan in the art had desired to form a crystalline form 1 of 5-MeO-DPT fumarate for treating various disorders including brain disorders and mood disorders, it would have been obvious to the skilled artisan in the art to be motivated to do so. This is because such a manipulation would expect to be within the purview of the skilled artisan in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Stamets expressly discloses a method of treating various disorders including neurodegeneration diseases such as Alzheimer’s disease , mood disorders by using 5-methoxy- N,N-diethyltrptamine.
Although the prior art does not exemplify the formation of form 1 of 5-MeO-DPT fumarate for treating various disorders including brain disorders and mood disorders, the prior art does give a guidance that pharmaceutically acceptable acid addition salts can be formed with fumaric acid and any resulting mixtures of isomers can be separated and purified by fractional crystallization.
So, if the skilled artisan in the art had desired to form a crystalline form 1 of 5-MeO-DPT fumarate for treating various disorders including brain disorders and mood disorders, it would have been obvious to the skilled artisan in the art to be motivated to use the well-known fumaric acid as s pharmaceutically acceptable acid addition salt and apply the crystallization process. This is because such a manipulation would expect to be be successful and feasible as guidance shown in the prior art.
Conclusion
Claims 1-18 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 7/10/2026
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