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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/20/2025 has been entered.
Status of the Claims
Claims 17-27 are pending in a Response of 11/20/2025.
Claim Rejections - 35 USC § 103
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.
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 17-27 are rejected under 35 USC 103 as being obvious over Russ et al. (WO2018/195455A1, citation is obtained from its corresponding US2020/0147038A1. Both references are found in IDS of 09/15/2023) in view of Hutchinson et al. (US5,817,323); Young et al. (US2015/0018275A1); and Chadeayne (US2018/0221396A1, IDS of 09/15/2023).
Applicant claims the below claim 17 filed on 11/20/2025:
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Determination of the scope and content of the prior art
(MPEP 2141.01)
Russ teaches treating psychedelic-responsive subjects (title) comprising orally administering a soft gelatin capsules for the treatment of anxiety, panic disorder, social anxiety, obsessive compulsive disorder ([0016], claims 42 and 43 of prior art) wherein the psychedelic agent such as psilocybin is mixed with water or oil such as olive oil or peanut oil ([0004], [0017], [0026], [0031], [0152], etc.) in which psilocybin reads on the claimed ingredient (ii) that would be compatible with and contained within capsule shell and the water or oil reads on the claimed ingredient (iii) and the capsule formulation further comprises excipients such as sorbitol, starches including potato starch, gelatin, hydrogenated vegetable oils, coloring agents, flavoring agents, plasticizers, polyethylene glycol, etc. ([0149]), lecithin ([0154]); for oral sue, the composition is presented as soft gelatin capsule wherein the psychedelic compound is mixed with an oil medium ([0152]) which reads on the claimed liquid vehicle compatible with the capsule shell and which would effectively dissolved and/or suspends the psychedelic compound, and are present within the shell (instant claim 17 (in part)). The composition further comprises preservatives ([0154]) (instant claim 23); other excipients such as magnesium aluminum silicate, talc which reads on the claimed opacifier, flavoring agents, colorants, etc. ([0149]) (instant claim 24-26).
However, Russ fails to teach soft shell formed from (i) of instant claim 17 and liquid vehicle beeswax of instant claim 17. The deficiency is cured by Hutchinson.
Hutchinson discloses soft gelatin capsule shell compositions comprising gelatin, plasticizer such as glycerol, water, and potato starch which reads on the claimed capsule shell materials (see col. 3, lines 20-33) wherein the soft capsule shell made from the below composition advantageously shortens disintegration time in the mouth (abstract and Examples S1 on col. 3):
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Further, Hutchinson discloses beeswax as suspending agent (col. 5, line 58) which reads on the claimed liquid vehicle.
However, Russ in view of Hutchinson does not expressly teach the amount of psychedelic compound including psilocybin of instant claim 17; and liquid vehicle PEG-PPG copolymer (=poloxamer) of instant claim 17. The deficiency is cured by Young.
Young teaches methods of improving behavioral therapies (title) comprising oxytocin- release compound as an active substance to treat or reduce the severity of psychotherapeutic or social disorders including anxiety disorders (see entire document including claim 3 of prior art); the oxytocin release compounds include psilocybin ([0025]-[0026] and claim 13 or prior art) in the form of soft shell gelatin capsule wherein the compound in an amount of about 0.001 mg to about 7 g per day which overlaps the instant range of 0.01 to 5mg or 0.05 to 2.5mg or 0.05 to 1mg or 0.1 to 1mg (instant claims 17-20: amount of psychedelic compound); the multiple administration per day can be done ([0081], [0084],[0087] [0092] and [0098]); the capsules further comprises surfactant, sorbitol, lecithin ([0089]), peanut oil and olive oil and water ([0091]), glycols, oils, alcohols, flavoring agents, preservatives, coloring agent, starches, etc. ([0092]); the oxytocin releasing compound as the active substance may be incorporated with excipients in the form of ingestible capsules and in soft-gelatin capsules, the active substance is preferably dissolved or suspended in suitable liquids, such as vegetable oils or liquid polyethylene glycols ([0098]); and to enhance absorption of the composition, nonionic surfactant such as poloxamer 124 ([0107]) which reads on the claimed PEG-PPG ([0107]) (instant claim 17 – liquid vehicle).
However, Russ/Hutchinson/Young fails to teach e.g., the psilocybin is obtained from e.g., Psilocybe of instant claim 17. The deficiency is cured by Chadeayne.
Chadeayne teaches psilocybin containing composition for the treatment of anxiety where psilocybin is a psychoactive prodrug often found in mushrooms of genus Psilocybe ([0087]) (instant claim 17 – source of active agent).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
1. The difference between the instant application and Russ is that Russ fails to teach soft shell formed of (i) of instant claim 17; and liquid vehicle beeswax of instant claim 17. The deficiencies are cured by Hutchinson.
2. The difference between the instant application and Russ/Hutchinson is that Russ/Hutchinson fails to teach the properties of instant claims 22 and 27. The deficiencies are cured by Hutchinson.
3. The difference between the instant application and Russ/Hutchinson is that Russ/Hutchinson does not expressly teach the amount of psychedelic compound of instant claim 17 and liquid vehicle PEG-PPG copolymer of instant claim 17. The deficiency is cured by Young.
4. The difference between the instant application and the applied art is that the applied art fails to teach purity (at least 99%) of the psychedelic compound of instant claim 17.
5. The difference between the instant application and Russ/Hutchinson/Young is that Russ/Hutchinson/Young fails to teach e.g., the psilocybin is obtained from e.g., Psilocybe of instant claim 17. The deficiency is cured by Chadeayne.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The examiner must ascertain what would have been obvious to one of ordinary skill in the art at the time the invention was made, and not to the inventor, a judge, a layman, those skilled in remote arts, or to geniuses in the art at hand. Environmental Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 218 USPQ 865 (Fed. Cir. 1983), cert. denied, 464 U.S. 1043 (1984).
The level of ordinary skill will often predetermine whether an implicit suggestion exists to modify the prior art. Persons of varying degrees of skill not only possess varying bases of knowledge, they also possess varying levels of imagination and ingenuity in the relevant field, particularly with respect to problem-solving abilities. If the level of skill is low, for example that of a mere technician, then it may be rational to assume that such an artisan would not think to combine references absent explicit direction in a prior art reference. If, however, the level of skill is that of a relevant research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
Indeed, MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). This is because “The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the time of the invention.” (MPEP 2141.03(1)) and an artisan must be presumed to know something about the art apart from what the references disclose. See In re Jacoby, 309 F.2d 513, 516 (CCPA 1962). “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418, 82 USPQ2d at 1396. (MPEP 2141.03 (I)). “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07). In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(11)).
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
1. It would have been prima facie obvious to one of the skilled in the art before the effective filing date of the claimed invention to modify the soft gel capsule of Russ with a capsule shell of Hutchinson in order to provide faster disintegration time advantage of the soft gel capsule shell containing glycerin plasticizer, gelatin, potato starch and water, as taught by Hutchinson.
Russ teaches the psychedelic compound is dissolved or suspended in a parenterally acceptable liquid vehicle such as water and/or solubilizing agent such as propylene glycol ([0004] and [0158]) and Hutchinson teaches beeswax as a suspending agent. Thus, it would have been prima facie obvious to one of the skilled in the art before the effective filing date of the claimed invention to modify liquid vehicle for the soft gel capsule of Russ with beeswax of Hutchinson as a matter of choice or design in order to dissolve or suspend the active ingredient in the shell.
2. Although the applied art does not expressly teach the properties of instant claims 22 and 27, it would be implicit because such properties are naturally flow from the combination of elements as taught by the applied art. In this context, please see are a natural result of the combination of elements. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). (inherency is limited when applied to obviousness and is present only when the limitation at issue is the “natural result” of the combination of prior art elements; quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)).
3. It would have been prima facie obvious to one of the skilled in the art before the effective filing date of the claimed invention to further define the psychedelic compound of Russ/ Hutchinson with the amount of Young disclosing overlapping amount of the psychedelic compound. In this context, see MPEP 2144.05 stating that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Russ teaches the psychedelic compound is dissolved or suspended in a parenterally acceptable liquid vehicle such as water and/or solubilizing agent such as propylene glycol ([0004] and [0158]), and Young teaches PEG-PPG poloxamer can be used to enhance adsorption of active drug. Thus, it would have been prima facie obvious to one of the skilled in the art before the effective filing date of the claimed invention to modify the liquid vehicle of the soft gel capsule of Russ with poloxamer of Young as a matter of choice or design in order to dissolve or suspend the active ingredient in the shell.
4. It would have been a prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the composition of the applied art to have high purity of psilocybin in order to minimize volume required to get effective amount.
5. It would have been prima facie obvious to one of the skilled in the art before the effective filing date of the claimed invention to further define the source of psilocybin of Russ with Psilocybe as taught by Chadeayne. Such definition would have yielded no more than the predictable results, devoid of evidence to the contrary.
This rejection is based on the well-established proposition of patent law that no invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients, In re Sussman, 1943 C.D. 518. From MPEP 2143 A: “…all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).”
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that none of the art does not teach the claimed liquid vehicle.
The Examiner responds that as noted in the body of action, the applied art of Hutchinson and Young teach the claimed liquid vehicle beeswax and PEG-PPG poloxamer. Thus, unless there is evidence to show that the claimed vehicle selection leads to unexpected results compared to other liquid vehicle, applicant’s arguments are not persuasive
Conclusion
All the examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613