DETAILED ACTION
Claims 47-51 and 65-66, submitted 08 April 2026, are pending in the application. Claims 1-46 and 52-64 have been cancelled. Claims 47-51 and 65-66 are under examination in the instant Office 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 .
Election/Restrictions
Applicant’s election of Group I, claims 47-51 and now 65-66, and the elected species of Major Depressive Disorder and microcrystalline cellulose, in the reply filed on 08 April 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The Examiner did not find prior art on the elected species, therefore, the elected species is free of the art. As such, the scope of the search was expanded to include the broader genus.
Claim Rejections - 35 USC § 112
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 47-51 and 65-66 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 47 recites the limitation of “a method of treating depression comprising or consisting of administering to a subject an amount of 2-Bromo-LSD or a derivative or salt thereof at least once per day…” for which the specification does not provide adequate written description to convey that the inventors were in possession of the full scope of the claimed invention.
The Applicant has provided adequate written description for certain aspects of the instantly claimed invention. Applicant has provided guidance with respect to the method of making the claimed invention by teaching the methods of preparation of 2-Bromo-LSD for oral dosing in a capsule and a tablet found on page 19 of the specification. Additionally, the Applicant has provided evidence of written description with regards to the disintegration time of the oral dissolving tablet and the 2-Bromo-LSD compound in a solution of distilled water, found on pages 19-20 of the specification.
However, the Applicant has not provided adequate written description with regards to the treatment of general depression, much less Major Depressive Disorder (MDD), through experimentation in vitro. As mentioned above, the instant specification provides examples for the preparation of the compound in a capsule or tablet form but does not teach the compositions being administered in the treatment of any form of depression but instead relies on the assertation of the compounds being useful in the treatment of the claimed disorders and conditions.
The Applicant has submitted a non-patent literature reference, Lewis, Vern, et al. "A non-hallucinogenic LSD analog with therapeutic potential for mood disorders." Cell reports 42.3 (2023)., which teaches that “LSD and other psychedelics have been shown to relieve depressive symptoms in treatment-resistant MDD and induce behavioral effects in rodents comparable with first-line antidepressants and rapidly acting treatments such as ketamine” (pg. 8, Section “2-Br-LSD promotes exploration of stressogenic environments…”, Left Col., 1st paragraph). This reference also teaches the use of a mouse model to determine the effectiveness of the 2-Br-LSD compound in treating the symptoms of Major Depressive Disorder (MDD) by stating “Exposure to chronic stress in rodents leads to behavioral, structural, and molecular adaptations relevant to MDD and other psychiatric disorders” (pg. 8, Section “2-Br-LSD reverses the behavioral effects of chronic stress in mice”, Right Col., 1st paragraph). However, the prior art also teaches uncertainty in the above-mentioned model by reciting “The failure of preclinical research to translate to the clinic could be due to poor validity of the animal situations used to model MDD. Our first example concerns poor homological validity relating to insufficient relevance of the species and of the strain chosen to construct the animal model (Belzung and Lemoine, 2011)” taught by Belzung ("Innovative drugs to treat depression: did animal models fail to be predictive or did clinical trials fail to detect effects?." Neuropsychopharmacology 39.5 (2014): 1041-1051.) (pg. 1043, Section “Did Animal Models Fail to be Predictive”, Right Col., 2nd paragraph).
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plain for obtaining the claimed chemical invention.” Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the 35 U.S.C. 112.1 "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter aria, "functional characteristics when coupled with a known or disclosed correlation between function and structure..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)).
For the reasons expressed above, the recitation of “a method of treating depression comprising or consisting of administering to a subject an amount of 2-Bromo-LSD or a derivative or salt thereof at least once per day…” is not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the instantly claimed invention.
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 (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 47, 49-51, and 65-66 are rejected under 35 U.S.C. 103 as being unpatentable over Olson (WO 2018/064465 A1) in view of Walker et al. ("Selective and nonselective serotonin antagonists block the aversive stimulus properties of MK212 and m-chlorophenylpiperazine (mCPP) in mice." Neuropharmacology 49.8 (2005): 1210-1219.) as evidenced by Kraus et al. ("Prognosis and improved outcomes in major depression: a review." Translational psychiatry 9.1 (2019): 127.).
Olson teaches a method of administering a non-hallucinogenic analog of LSD, 2-Bromo-LSD (BOL-148) in the form of a tablet, capsule, or an oral dosing solution in the treatment of a psychiatric disorder, wherein the psychiatric disorder is depression, anxiety, and/or PTSD (paragraphs 134-135; paragraph 176; paragraphs 202-203). Olson does not teach wherein the depression is Major Depressive Disorder (MDD) or any other subcategory of depression, however, it’s known in the art that MDD “is the most common psychiatric disease and a worldwide leading cause of years lived with disability” as evidenced by Kraus (pg. 1, Section “Depression: a major relentless burden”, Left Col., 1st paragraph). Therefore, it would have been prima facie obvious for a person having ordinary skill in the art to modify the teachings of Olson to treat depression in a subject in need thereof. A person having ordinary skill would have had an expectation of success because Olson teaches “ The non-hallucinogenic analogs of psychedelic compounds can have optimized physical properties giving them direct access to the brain. These compounds can increase endogenous brain levels of neurotrophic factors, thereby promoting neural plasticity in a brain region” (paragraph 113). Thus, it would have been prima facie obvious for a person having ordinary skill in the art, prior to the effective filing date of the instant application, to modify the teachings of Olson as evidenced by Kraus to arrive at the instantly claimed invention. This also reads on the limitations of instant claim 51, which recites “…wherein the pharmaceutical composition is formulated in a tablet, capsule, or an oral dosing solution.”
With regards to claim 49, Olson does not teach the dosage administered, however, Walker cures this deficiency by teaching “Serotonin2C (5-HT2C) receptors have been implicated to treat mood disorders such as depression and anxiety.” (pg. 1210, Section “Abstract”, 1st paragraph). Walker also teaches the administration of bromo-LSD at a dose of 32 µg/kg in a mouse model, which is within the range of the instant claim which recites a range from about 12µg/kg body weight to about 36 µg/kg body weight.
With respect to claim 50, Olson teaches the compound of the invention in combination with a pharmaceutically acceptable carrier and excipients and further specifies wherein the excipient can be magnesium stearate, which reads on the limitation of instant claim 65 (paragraph 169; paragraph 179).
Regarding claim 66, Olson teaches the above limitations of the instantly claimed pharmaceutical composition. While Olson nor Walker teaches a tablet hardness similar to that of the Applicant’s, the composition of said tablet is substantially identical and thus, the physical properties cannot be mutually exclusive. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01(II). Consequently, the instant claim is rejected upon the inherent properties of identical compositions.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN CHRISTOPHER SANCHEZ whose telephone number is (703)756-5336. The examiner can normally be reached Monday -Friday (0730-1700).
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JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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