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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Applications 63/157,682 and 63/184,691, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In particular, Applications ‘682 and ‘691 do not disclose the X-ray powder diffraction data recited in the instant claims. Accordingly, claims 35-53 are not entitled to the benefit of Applications ‘682 and ‘691.
The disclosure of prior-filed Application No. 17/687,568 is sufficient to comply with the requirements of 35 U.S.C. 112(a). Accordingly, the priority date of instant claims 35-53 is the filing date of Application ‘568, 4 March 2022.
Claim Interpretation
The instant claims recite the modifier “about”. As “about” is not defined in the specification, it is interpreted as meaning the claimed value ±10% e.g., about 19.42° would mean between 17.48° and 21.36°.
Claim Rejections - 35 USC § 112(a)
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 35-38, 42-43, 46-47, and 50-51 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.
Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention. The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? The factors to be considered when determining whether any necessary experimentation is undue have been set forth by the courts in the Wands factors (see MPEP 2164.01(a)) and In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
These factors are:
(1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of working examples; and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
(1) The breadth of the claims:
Claims 35-38 are drawn to a crystalline form of psilocin displaying a specific set of X-ray diffraction signals. Claims 42-43 are drawn to compositions comprising this crystalline form of psilocin. Claims 46-47 and 50-51 are drawn to methods of treating anxiety and depression by administering the crystalline form of psilocin.
(2) Nature of the invention; (3) State of the prior art; and (5) Level of predictability in the art:
It is evidenced by the instant specification that the use of different solvents can lead to different crystal forms of psilocin (Par. [139]). This crystalline form dependence on solvent is further evidenced by Nivorozhkin et al. (WO 2022/195011 effectively filed 18 March 2021), demonstrating that form 1 of psilocin tartrate is made from acetonitrile or THF, whereas form 2 of psilocin tartrate is made from 1,4-dioxane (Pg. 107 last paragraph).
As such, the level of predictability in the art is low as to what solvents lead to crystalline forms having specific X-ray diffraction signals.
(4) Level of one of ordinary skill:
The level of skill to practice the art of the instantly claimed invention is high and requires a variety of skills usually found in institutions and companies that employ highly trained and skilled scientists to carry out these tasks.
(6) Amount of direction provided by the inventor; (7) Existence of working examples:
While the instant specification discloses a working example of a crystalline form of psilocin having the instantly claimed X-ray diffraction signals, there is no discussion of how this crystal form was made. Further, there is no direction present in the specification as to how solvent choice changes the angles of the X-ray diffraction signals of the crystalline form.
(8) Quantity of experimentation needed to make the invention:
Based on the level of predictability in the art and the lack of direction provided in the specification, a prohibitively large number of experiments would be required to determine how to make the invention of instant claim 35. Accordingly, a prohibitively large number of experiments would be required to determine how to make or use the invention of instant claims 36-38, 42-43, 46-47, and 50-51 due to their dependence from claim 35.
As such, claims 35-38, 42-43, 46-47, and 50-51 are rejected as non-enabled.
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 35-41 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nivorozhkin et al. (WO 2022/195011 effectively filed 18 March 2021).
Claims 35-38 are drawn to a crystalline form of psilocin having X-ray powder diffraction signals at about 8.35°2θ, about 12.59°2θ, about 16.73°2θ, about 17.63°2θ, about 19.42°2θ, about 19.62°2θ, about 20.87°2θ, about 21.08°2θ, about 23.65°2θ, and about 26.77°2θ.
Nivorozhkin et al. teach psilocin compounds (Abstract), further teaching psilocin (compound I-7 in Table 1 on pg. 38) having X-ray powder diffraction signals of 8.375°2θ, 12.626°2θ, 16.753°2θ, 17.671°2θ, 19.668°2θ, 21.112°2θ, 21.863°2θ, 22.201°2θ, 23.711°2θ, and 26.820°2θ (Table 11 on pg. 103), corresponding to the instantly claimed signals based on the interpretation of “about” discussed above.
As such, claims 35-38 are anticipated.
Claims 39-41 are drawn to a crystalline form of psilocin tartrate having X-ray powder diffractions signals at about 16.26°2θ, about 17.54°2θ, about 19.46°2θ, about 20.54°2θ, about 23.46°2θ, about 24.46°2θ, and about 27.96°2θ.
Nivorozhkin et al. further teach pharmaceutically acceptable salts of psilocin (Abstract) including psilocin tartrate (Pg. 107) having X-ray powder diffraction signals of 16.351°2θ, 17.367°2θ, 18.937°2θ, 22.594°2θ, 25.806°2θ, 21.112°2θ, and 26.820°2θ (Table 13 on pg. 108), corresponding to the instantly claimed signals based on the interpretation of “about” discussed above.
As such, claims 39-41 are anticipated.
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 42-53 are rejected under 35 U.S.C. 103 as being unpatentable over Nivorozhkin et al. as applied to claims 35-41 above.
Claims 42-43 is drawn to a pharmaceutical composition comprising the crystalline form of claim 35 and at least one agent that provides enhanced stability, wherein the agent that provides enhanced stability is an antioxidant.
Claims 44-45 are drawn to a pharmaceutical composition comprising the crystalline form of claim 39 and at least one agent that provides enhanced stability, wherein the agent that provides enhanced stability is an antioxidant.
Nivorozhkin et al. teach the crystal structures of claims 35 and 39 as discussed above. Nivorozhkin et al. further teach pharmaceutical compositions comprising the crystalline structures and an excipient such as an antioxidant (Pg. 61 second and third paragraphs).
As such, claims 42-45 are rejected as prima facie obvious.
Claims 46, 48, 50, and 52 are drawn to a method of treating anxiety, comprising administering to a subject one of the compositions of claims 35, 39, 42, or 44.
Claims 47, 49, 51, and 53 are drawn to a method of treating depression, comprising administering to a subject one of the compositions of claims 35, 39, 42, or 44.
Nivorozhkin et al. teach the compositions of claims 35, 39, 42, and 44 as discussed above. Nivorozhkin et al. further teach the psilocin compositions as being appropriate for treating mental health disorders including depression and anxiety (Pg. 92-93 bridging paragraph).
As such, claims 46-53 are rejected as prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paul Hoerner whose telephone number is (571)270-0259. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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