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 .
Claim Status
Applicant’s remarks and amendments, filed 16 April 2026 in response to the non-final rejection mailed 20 October 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 16 April 2026 replaces all prior versions and listings of the claims.
Claims 1, 3, 4, 7, 8, 25, and 26 are pending. Claims 2, 5, 6, and 9-20 are canceled by Applicant’s amendment. Claims 25 and 26 are newly added. Claims 1, 3, 4, 7, and 8 are amended. Claims 1, 3, 4, 7, 8, 25, and 26 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s arguments and amendments with respect to the rejection of Claims 1-8 under 35 USC § 102(a)(1) as being anticipated by Teles et al. (US 2015/0366815 A1) have been fully considered. The rejections of Claims 1-8 are withdrawn due to amendment of Claim 1.
Applicant’s arguments and amendments with respect to the rejection of Claim 1 under 35 USC § 102(a)(1) as being anticipated by Krotzer (US 2001/0008641 A1) have been fully considered. The rejection of Claim 1 is withdrawn due to amendment of the claim.
Applicant’s arguments and amendments with respect to the rejection of Claims 1-7 under 35 USC § 103 as being unpatentable over Krotzer (US 2001/0008641 A1) have been fully considered. The rejections of Claims 1-7 are withdrawn due to amendment of Claim 1.
Claim Objections
Claim 3 and 4 objected to because, in Claim 3, L-arginine is listed twice. Claim 4 depends directly or indirectly from rejected claims and are, therefore, also objected to for the reasons set forth above. Appropriate correction is required.
Claims 7 and 8 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim results from the inclusion of “or 4” in instant Claim 7 and “4 or 7” in instant Claim 8. See MPEP § 608.01(n).
Please note for clarity of the record that Claims 21-24 of the original claim set are being treated as canceled claims. However, in response to this Office Action, applicant is required to submit a complete claim set indicating Claims 21-24 having such canceled status, and any new claims numbered starting with Claim 25 (see 37 CFR 1.121(c)).
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not). Accordingly: misnumbered Claim 21 has been renumbered as Claim 25; and misnumbered Claim 22 has been renumbered as Claim 26.
Claim Rejections - 35 USC § 103
(grounds modified as necessitated by amendment)
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.
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 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.
Claims 1, 3, 4, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Teles et al. (US 2015/0366815 A1) in view of Romm (Adaptogens: Ancient Medicine for 21st Century Stress, 2014, 29 pages).
The instant claims are as of record, drawn to a composition comprising a psychoactive compound selected from psilocybin, psilocin, and combinations thereof; a supplement selected from an amino acid, Vitamin B6, piracetam, GABA, theobromine, caffeine, resveratrol, and combinations thereof; and a plant herb selected from the group consisting of rhodiola, ashwagandha, and combinations thereof; wherein the composition comprises from 15-25 wt% of the psychoactive compound.
Teles et al. teach enteric soft capsules containing a matrix fill (composition; Teles et al., [0075], page 8) comprising psilocybine or psilocine ([0123], page 15, col 2; as required for instant Claim 1) as an active drug substance (psychoactive compound) which may be present in an amount from 5-80% of the matrix fill mass (total weight of the composition; [0142], page 16, col. 2; as required for instant Claim 1). The composition may additionally include:
the amino acids 5-hydroxytryptophan, tryptophan (L-tryptophan; [0102], page 12, col. 1), and arginine (L-arginine; [0080], page 8, col. 1; as required for instant Claims 1, 3, and 7);
vitamins B1 (thiamine), B6, C, choline, and niacin ([0105], page 12, col. 2; as required for instant Claims 1, 4, 7, and 8);
piracetam ([0118], page 14, col. 1; as required for instant Claims 1 and 7);
caffeine ([0102], page 12, col. 1; as required for instant Claims 1 and 7);
resveratrol ([0102], page 12, col. 1; as required for instant Claims 1 and 7);
creatine ([0102], page 12, col. 1; as required for instant Claims 4 and 8); and
glutathione ([0102], page 12, col. 1; as required for instant Claims 4 and 8).
Teles et al. do not teach wherein the composition comprises a plant herb selected from the group consisting of rhodiola, ashwagandha, and combinations thereof.
Romm, however, teaches that ashwagandha and rhodiola are adaptogens with many benefits (Romm, whole document, as required for instant Claim 1).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to include the ashwagandha and/or rhodiola of Romm in the composition of Teles et al. A skilled artisan could include these nutraceutical ingredients with a reasonable expectation of success because the composition of Teles et al. includes nutraceutical ingredients (Teles et al., [0102], page 12). A skilled artisan would be motivated to include these specific ingredients because ashwagandha provides the benefits of improving energy, memory, and learning, promoting libido, preventing premature aging, acts as a calming agent, antioxidant, and anti-inflammatory, improves sleep, reduces anxiety, boosts the immune system, is used to treat arthritis, and is beneficial for treating fertility challenges (Romm, page 4). Rhodiola provides the benefits of promoting a calm emotional state, supports strong mental performance, optimal immune function, hormonal balance, reduces anxiety, improves mental and physical stamina, improves sleep, reduces stress and irritability, boosts the immune system, decreases frequency of colds and infections, reduces inflammation and can be used to help treat chronic fatigue syndrome, fibromyalgia, poor appetite, and chronic stress headaches (Romm, page 4).
Claims 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Teles et al. (US 2015/0366815 A1) in view of Brain Tropic (Sulbutiamine, 2015, 9 pages) and Romm (Adaptogens: Ancient Medicine for 21st Century Stress, 2014, 29 pages).
The instant claims are as of record, drawn to a composition comprising a psychoactive compound selected from psilocybin, psilocin, and combinations thereof; a supplement selected from an amino acid, Vitamin B6, piracetam, GABA, theobromine, caffeine, resveratrol, and combinations thereof; and an additive selected from the group consisting of nattokinase, sulbutiamine, agmatine, and combinations thereof; wherein the composition comprises from 15-25 wt% of the psychoactive compound.
Teles et al. teaches enteric soft capsules containing a matrix fill (composition; Teles et al., [0075], page 8) comprising psilocybine or psilocine ([0123], page 15, col 2; as required for instant Claim 25) as an active drug substance (psychoactive compound) which may be present in an amount from 5-80% of the matrix fill mass (total weight of the composition; [0142], page 16, col. 2; as required for instant Claim 25). The composition may additionally include:
the amino acids 5-hydroxytryptophan, tryptophan (L-tryptophan; [0102], page 12, col. 1), and arginine (L-arginine; [0080], page 8, col. 1; as required for instant Claim 25);
vitamin B6 ([0105], page 12, col. 2; as required for instant Claim 25);
piracetam ([0118], page 14, col. 1; as required for instant Claim 25);
caffeine ([0102], page 12, col. 1; as required for instant Claim 25); and
resveratrol ([0102], page 12, col. 1; as required for instant Claim 25).
Teles et al. do not teach wherein the composition comprises an additive selected from the group consisting of nattokinase, sulbutiamine, agmatine, and combinations thereof or a plant herb selected from the group consisting of rhodiola, ashwagandha, and combinations thereof.
Brain Tropic teaches that sulbutiamine is a synthetic derivative of Vitamin B1 which is often used as a supplement for reversing chronic Vitamin B1 deficiency and is known for its ability to improve memory (Brain Tropic, pages 1-2).
Romm teaches that ashwagandha and rhodiola are adaptogens with many benefits (Romm, whole document, as required for instant Claim 26).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to include the sulbutiamine of Brain Tropic and the ashwagandha and/or rhodiola of Romm in the composition of Teles et al. A skilled artisan could include the sulbutiamine of Brain Tropic the nutraceutical ingredients of ashwagandha and/or rhodiola with a reasonable expectation of success because the composition of Teles et al. includes Vitamin B1 (Teles et al., [0105], page 2) and nutraceutical ingredients (Teles et al., [0102], page 12). A skilled artisan would be motivated to include these specific ingredients because sulbitiamine improve memory (Brain Tropic, pages 1-2); ashwagandha provides the benefits of improving energy, memory, and learning, promoting libido, preventing premature aging, acts as a calming agent, antioxidant, and anti-inflammatory, improves sleep, reduces anxiety, boosts the immune system, is used to treat arthritis, and is beneficial for treating fertility challenges (Romm, page 4); rhodiola provides the benefits of promoting a calm emotional state, supports strong mental performance, optimal immune function, hormonal balance, reduces anxiety, improves mental and physical stamina, improves sleep, reduces stress and irritability, boosts the immune system, decreases frequency of colds and infections, reduces inflammation and can be used to help treat chronic fatigue syndrome, fibromyalgia, poor appetite, and chronic stress headaches (Romm, page 4).
From the 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 references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Response to Arguments
Applicant's arguments filed 16 April 2026 have been fully considered but they are not persuasive.
Applicant argues that the prior art fails to teach all elements of the invention recited in the pending claims, including specific amounts of the psychoactive compound. Teles et al., however, teach enteric soft capsules containing a matrix fill (composition; Teles et al., [0075], page 8) comprising psilocybine or psilocine as an active drug substance (psychoactive compound) which may be present in an amount from 5-80% of the matrix fill mass (total weight of the composition; [0142], page 16, col. 2). This range overlaps the 15-25 wt% of instant Claims 1 and 25.
Additionally, it is noted that generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical (see MPEP § 2144.05). In the instant case, applicant notes that the claimed invention provides advantages and solves problems not recognized by Krotzer, however this argument is moot because the rejection above does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments with respect to the rejection of Claims 1-8 under 35 USC § 102(a)(1) as being anticipated by Teles et al. (US 2015/0366815 A1) have been considered but are moot because the new ground of rejection relies on the combination of references (Teles/Romm and Teles/BrainTropic/Romm) not relied upon in the prior rejection of record, for any teaching or matter specifically challenged (e.g., the specific constellation of ingredients) in the argument.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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