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 .
DETAILED ACTION
Priority and Status of the Claims
1. This application is a 371 PCT/EP2022/058483 03/30/2022, which claims benefit of the provisional application: 63168055 03/30/2021.
2. Claims 1, 39 and 53- 72 are pending in the application.
3. 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 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 § 103
4. The following is a quotation of 35 U.S.C. 103(a) 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(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1, 39, 53 and 65 are rejected under 35 U.S.C. 103(a) as being obvious
over Loudesbrough et al. US 2019/0119310 A1
Applicants claim a pharmaceutical composition comprising: a therapeutically effective amount of psilocybin; and one or more pharmaceutically acceptable excipients, wherein, after storage of the composition at 40°C and 75% relative humidity for one month, the potency of the psilocybin in the composition decreases by less than 5% and the mass balance of psilocybin and related substances is greater than 97%, see claim 1.
Applicants claim a method of making a pharmaceutical composition comprising: a) direct mixing psilocybin and one or more pharmaceutically acceptable excipients to provide a blend, and b) filling a capsule with the blend to provide the pharmaceutical composition, wherein the content uniformity of the composition complies with the European Pharmacopeia 2.96. or USP <905>, see claim 39.
Applicants claim a pharmaceutical composition comprising: a therapeutically effective amount of psilocybin; and about 85% to about 99%, by weight, partially pregelatinized starch, see claim 53.
Applicants claim a pharmaceutical composition comprising: about 1% to about 10%, by weight, psilocybin; about 85% to about 99%, by weight, partially pregelatinized starch; and about 0.5% to about 2.0%, by weight, sodium stearyl fumarate, see claim 65.
Determination of the scope and content of the prior art (MPEP §2141.01)
Loudesbrough et al. ‘310 discloses a pharmaceutical composition comprising
psilocybin, excipient and lubricant, wherein the excipient is pregelatinized starch or sodium stearyl fumarate, see Table 36 in column 36, section [102] in column 10-11.
Loudesbrough et al. ‘310 compositions have been tested for potency for one month at a condition 400C and 75 relative humidity, and the mass balance of psilocybin in two batch is 99.23 %, 99.17 % respectively, see Table 27 and 29 in columns 31-32.
A process of making composition has been disclosed in sections [103]- [112] and Example 12 in column 36.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Loudesbrough et al. ‘310 is that the instant claims are embraced within the scope of Loudesbrough et al. ‘310. Loudesbrough et al. ‘310 compositions and processes of making read on the instant claims 1, 39, 53 and 65.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1, 39, 53 and 65 prima facie obvious because one would be motivated to employ the composition and processes making of Loudesbrough et al. ‘310 to obtain instant invention.
The motivation to make the claimed compositions and processes derived from the known composition and processes of Loudesbrough et al. ‘310 would possess similar activity to that which is claimed in the reference.
Double Patenting
5. 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. See 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1 and 53 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 of Loudesbrough et al. US 10,519,175, and over claim 1 of Loudesbrough et al. US 12,447,164. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a pharmaceutical composition comprising:a therapeutically effective amount of psilocybin; and one or more pharmaceutically acceptable excipients, wherein, after storage of the composition at 40°C and 75% relative humidity for one month, the potency of the psilocybin in the composition decreases by less than 5% and the mass balance of psilocybin and related substances is greater than 97%, see claim 1.
Applicants claim a pharmaceutical composition comprising: a therapeutically effective amount of psilocybin; and about 85% to about 99%, by weight, partially pregelatinized starch, see claim 53.
Loudesbrough et al. ‘175 claims a method of treating drug resistant depression comprising orally administering to a subject in need thereof a therapeutically effective amount of an oral dosage form (i.e., composition) , wherein, the oral dosage form comprises: crystalline psilocybin in the form Polymorph A characterized by peaks in an XRPD diffractogram at 11.5, 12.0, 14.5, 17.5, and 19.7°2θ±0.1°2θ, wherein the crystalline psilocybin has a chemical purity of greater than 97% by HPLC, and no single impurity of greater than 1%; and silicified microcrystalline cellulose, see column 69.
Loudesbrough et al. ‘175 compositions have been tested for potency for one month at a condition 400C and 75 relative humidity, and the mass balance of psilocybin in two batch is 99.23 %, 99.17 % respectively, see Table 27 and 29 in columns 57-60.
Loudesbrough et al. ‘175 compositions comprise psilocybin and pregelatinized starch, see Table 36 in column 67.
Loudesbrough et al. ‘164 claims a method for treating an eating disorder in a subject in need thereof, the method comprising orally administering to the subject a therapeutically effective amount of an oral dosage form comprising: crystalline psilocybin characterized by XRPD peaks at 11.5±0.1, 12.0±0.1, 14.5±0.1, 17.5±0.1 and 19.7±0.1° 2θ, wherein the crystalline psilocybin has a chemical purity of greater than 97% as determined by HPLC analysis; and a pharmaceutically acceptable excipient, wherein the eating disorder is pica, bulimia nervosa, rumination disorder, avoidant/restrictive food intake disorder, binge-eating disorder, or a combination thereof, see column 187. A pharmarceutical composition has been disclose in Table 9 and 10, see columns 116-117.
The difference between instant claims and Loudesbrough et al. ‘175 and ‘164 is that the instant claims are embraced within the scope of Loudesbrough et al. ‘175 and ‘164. Loudesbrough et al. ‘175 compositions read on the instant compositions in claim 1 and 53.
One having ordinary skill in the art would find the claims 1 and 53 prima facie obvious because one would be motivated to employ the composition of Loudesbrough et al. ‘175 and ‘164 to obtain instant invention.
The motivation to make the claimed compositions derived from the known composition ad methods of use of Loudesbrough et al. ‘175 and ‘164 would possess similar activity to that which is claimed in the reference.
Claim Objections
6. Claims 54-64 and 66-72 are objected to as being dependent on rejected claims 53 and 65.
Conclusion
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examiner should be directed to REI TSANG SHIAO whose telephone number is
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
December 15, 2025