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Re: PyroStocks post# 8889

Wednesday, 11/16/2022 12:34:09 PM

Wednesday, November 16, 2022 12:34:09 PM

Post# of 8968

Claims 1-33 remain in the application. Only claim 23 is in independent form.

Applicant wishes to express appreciation for the courtesies extended Applicant's representative, Laura S. Dellal, during a telephonic interview conducted on October 6, 2022. The obviousness rejection was discussed. Claim 23 has been amended without prejudice to clarify that the individual has taken the psychedelic drug for a medical treatment, and the psychedelic experience is shortened by the duration shortening and/or effect reducing agent. Support for this amendment can be found in paragraphs [00029] and [00044], no new matter has been added. Peters, et al. does not disclose or suggest stopping or shortening an intentional medical treatment but only treating psychosis with 5HT2A inverse agonists or antagonists. In view of the unexpected results detailed below, the invention is patentable over the combined references of Kraehenmann, et al. and Peters, et al.

Claims 23-33 stand rejected under 35 U.S.C. §103(a) as being unpatentable over Kraehenmann, et al. in combination with U.S. Patent No. 9,050,343 to Peters, et al. Specifically, the Office Action holds that Kraehenmann, et al. teaches treating healthy subjects with LSD and with LSD and ketanserin orally, LSD-induced increase in cognitive bizarreness and changes in state of consciousness were fully blocked by ketanserin. The Office Action holds that Kraehenmann, et al. does not teach administering ketanserin after the individual has taken a psychedelic drug, but Peters, et al. discloses that 5HT2A inverse agonists or antagonists such as ketanserin are useful in treating psychosis caused by psychoactive drug intoxication, and therefore it would have been prima facie obvious to administer ketanserin after the administration of LSD. Reconsideration of the rejection under 35 U.S.C. §103(a), as being unpatentable over Kraehenmann, et al. and Peters, et al. is respectfully requested.

"Any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed"; however, that reason must be present for the combination to be obvious. KSR Intern Co. v. Teleflex, 127 S. Ct. 1727, 1742, U.S. (2007). This requirement was confirmed in Takeda Chem. lndust., et al. v. Alphapharm, No. 06-

1329 (Fed. Cir. 2007).

"The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385, 1396 (2007) noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit." MPEP Section 2143.

"The rationale to support a conclusion that the claim would have been obvious is that 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 International Co. v. Teleflex Inc., 83 UDPQ2d 1385, 1395 (2007) and MPEP Section 2143.

Applicant acknowledges that Kraehenmann, et al. teaches that LSD-induced increases in cognitive bizarreness and changes in the state of consciousness were fully blocked by ketanserin. Peters, et al. discloses that a 5-HT2A inverse agonist or antagonist (which can be ketanserin) can be administered with an antipsychotic by co-administration to treat psychosis. Neither reference discloses or suggests that ketanserin (i.e., a duration shortening and/or effect reducing agent) is administered after an individual has taken a psychedelic drug as in the presently pending claims.

In addition, the present invention shows unexpected results, supported by the Declaration submitted herein. The present invention is not obvious because only administration of ketanserin prior to LSD has been shown to prevent the LSD response but administration after LSD has never been investigated and was considered not effective by several experts. There was significant controversy about whether simple binding of LSD to its target receptor is sufficient to explain its duration of action and therefore it is not obvious that administering a receptor antagonist such as ketanserin would attenuate and shorten the action of LSD in humans. Thus, it is not obvious that the LSD experience can be blocked with a treatment performed after administration based on the known information that ketanserin can prevent an LSD response when ketanserin was administered 1 hour before the LSD. Specifically, leading experts argued that the receptor for LSD forms a lid over the compound thus locking it in and preventing its release and resulting in the long duration of action of the molecule (Kim et al., 2020;

Wacker et al., 2017). Based on this argumentation it was expected that LSD effects cannot be reversed once established and once the receptor down-stream effects have been initiated. Thus, it was not considered obvious or clear at all that the LSD effect can be reversed with ketanserin as set forth in the present invention. Additionally, Applicant performed a human experiment within this invention to demonstrate that this is the case contrary to expectations in the field.

Wacker, et al. 2017 (Wacker et al., 2017) suggested that LSD's slow binding kinetics may be due to a "lid" formed by an extracellular loop of the receptor. The publication also showed "exceptionally slow dissociation of LSD from the receptor". Thus, the view among scientists was, that LSD binds very tightly to the receptor and is even trapped explaining its long action and making it impossible to antagonize its effects. Kim, et al. 2020 (Kim et al., 2020) also described the structure of LSD bound to the 5-HT2 receptor and stated that presence of a "lid" over LSD, prolonging LSD's residence time.

Based on these high-impact publications the view was that LSD effects cannot be antagonized and it was therefore not obvious that this can be done with ketanserin. Based on pharmacokinetic-pharmacodynamic modeling data and the present human study the present patent application showed an unexpected effect of ketanserin to reverse the LSD response. The fact that ketanserin has been used in preclinical experiments and in humans to prevent the response to LSD is not an obvious indication of antagonism when used after LSD in the light of the scientific published data. There was no preclinical or clinical data using ketanserin to reverse LSD responses in vivo prior to the present patent application.

Therefore, the combination of Kraehenmann, et al. and Peters, et al. does not disclose or suggest the present invention, and the unexpected results overcome the prima facie obvious rejection.

Since neither the cited references alone or in combination with knowledge in the art suggest the currently claimed invention, it is consequently respectfully submitted that the claims are clearly patentable over the combination, even if the combination were to be applied in opposition to applicable law, and reconsideration of the rejection is respectfully requested.

The remaining dependent claims not specifically discussed herein are ultimately dependent upon the independent claims. References as applied against these dependent claims do not make up for the deficiencies of those references as discussed above, and the prior art references do not disclose the characterizing features of the independent claims discussed above. Hence, it is respectfully submitted that all of the pending claims are patentable over the prior art.

In conclusion, it is respectfully requested that the present amendment be entered in order to place the application in condition for allowance, which allowance is respectfully requested.

The Commissioner is authorized to charge any fee or credit any overpayment in connection with this communication to our Deposit Account No. 11-1449.

Respectfully submitted,


Kenneth I. Kohn, Reg. No. 30955 Customer No. 48924

Dated: October 14, 2022

Date of Electronic Filing: October 14, 2022

I hereby certify that this correspondence is being electronically filed with the United States Patent & Trademark Office on the above date.

Kimberly Saperstein

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