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 .
According to paper filed on Jan. 30, 2026, the applicants have elected compound 1A-6 as specific species for further prosecution. The applicants have also amended claim 32.
Claims 1-7, 20-24, 26, 28-29, 32, 35 and 40-42 are pending in the application. Claim 42 is withdrawn from further consideration as being directed to non-elected subject matter.
Claim Rejections - 35 USC § 112
4. 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 1 and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for preparing compounds, does not reasonably provide enablement for preparing solvates and prodrugs of instant compounds. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. The following eight different factors (see Ex parte Foreman, 230 USPQ at 547; Wands, In re, 858.F. 2d 731, 8 USPQ 2d 1400, Fed. Cir. 1988) must be considered in order for the specification to be enabling for what is being claimed:
Quantity of experimentation necessary, the amount of direction or guidance provided, presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability and the breadth of claims. In the instant case, the specification is not enabling based on atleast four of the above mentioned eight different factors such as quantity of experimentation necessary, the amount of direction or guidance provided, presence of working examples, state of the prior art, unpredictability and the breadth of claims.
In regard to lack of enablement issue of independent claim 1 and claim 24 for solvates or prodrugs of instant compounds, there is no teaching or guidance present in the specification for preparing any specific solvates or prodrugs. Preparation of specific solvates of any compound is a very specialized field and involves their characterization using different techniques such as infrared spectrum, XRD powder diffraction etc. There is no teaching or guidance present in the specification regarding any specific solvents used for preparing specific solvates and their characterization using any techniques such as XRD powder diffraction or infrared spectrum etc. There is not even a single example present for preparing any specific solvate of instant compounds. Healy (Adv. Drug Deliv. Rev.) teaches that differences in solid forms (hydrates, solvates or polymorphic forms) often leads to differences in thermodynamic parameters and physiochemical properties such as solubility, dissolution rate, stability and mechanical properties (see abstract and table 1 on page 28). Therefore, in absence of such teachings, guidance, presence of working examples and unpredictability, it would require undue experimentation to select specific solvates of instant compounds with enhanced stability properties.
In regard to prodrugs, there is no teaching or guidance present in the specification for preparing specific types of prodrug such as carboxylic acid esters, amino acid or amide esters, phosphate esters, phosphono esters, sulfate esters etc. There is not even a single working example present in the specification for preparing any type of specific prodrug of instant compounds. Kumar (J. of Drug Deliv. Sci. & Technol.) teaches that various pharmacokinetic reasons are consi9dered to be responsible for developing the prodrugs such as improving drug solubility, reducing pre-systemic metabolism and increasing bioavailability, penetration to blood brain barrier, site specific drug delivery, improving time of onset action, masking taste and odor, reducing pain at injection site, enhancing the chemical stability and reduction of toxicity (see pages 2-9). Therefore, in absence of such teachings, guidance, presence of working examples and unpredictability, it would require undue experimentation to select specific types of prodrugs of instant compounds which will be effective following in vivo administration.
Claims 28-29, 32 and 35 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention. The following eight different factors (see Ex parte Foreman, 230 USPQ at 547; Wands, In re, 858.F. 2d 731, 8 USPQ 2d 1400, Fed. Cir. 1988) must be considered in order for the specification to be enabling for what is being claimed:
Quantity of experimentation necessary, the amount of direction or guidance provided, presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability and the breadth of claims. In the instant case, the specification is not enabling based on atleast four of the above mentioned eight different factors such as quantity of experimentation necessary, the amount of direction or guidance provided, presence of working examples, state of the prior art, unpredictability and the breadth of claims.
The specification teaches agonist activity of instant compounds on 5-HT2A receptors as shown in table 1 on page 77. Based on these teachings, the instant compounds are enabled for activating 5-HT2 receptors only and furthermore, for treating specific disease conditions where 5-HT2 receptor agonists are well known in the art to have therapeutic utility. However, there is no teaching either in the specification or prior art references provided showing well established utility of 5-HT2 receptor agonists for treating all these diverse disease conditions listed in instant claims 32 and 35 including anxiety, depression, sexual disorders, Parkinson’s disease, multiple sclerosis etc. There are no working examples present showing efficacy of instant compounds in animal models of all these diverse disease conditions listed in instant claims 32 and 35 including anxiety, depression, sexual disorders, Parkinson’s disease, multiple sclerosis etc. According to Suarez-Trujillo (Journal of Dairy Sci.) the serotonin receptors are divided into 7 classes and these classes are divided into 14 subtypes (see page 2703, 2nd column, last paragraph). Also, in the prior art, Zmudzka (Life Sci.) teaches that 5-HT2A receptor antagonists (not 5-HT2 agonists) possess antidepressant effect (see page 111, 1st column, 2nd paragraph) and antianxiety effect (see page 111, 2nd column, 1st paragraph). Therefore, in absence of such teachings or guidance in the specification, prior art, working examples and unpredictability, it would require undue experimentation to demonstrate efficacy of instant compounds in animal models of diverse disease conditions listed in instant claims 32 and 35 including anxiety, depression, sexual disorders, Parkinson’s disease, multiple sclerosis etc. and hence their utility for treating these disease conditions.
8. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 32 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 32 recites the broad recitation addiction disorder, and the claim also recites drug addiction which is the narrower statement of the range/limitation.
Similarly, claim 32 recites the broad recitation mood disorder, and the claim also recites depression and anxiety disorder which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 20-24, 26, 28-29, 32, 35 and 40-41are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nivorozhkin (WO 2021/ 234608 A1, cited on applicant’s form 1449).
Nivorozhkin discloses Deuterated tryptamine derivatives for treating various diseases (see claims 81-91). The compounds (see 1st compound and 4th compound) disclosed on page 98 by Nivorozhkin anticipate the instant claims when the instant compounds are represented by the elected species (compound 1A-6).
Claims 1-7, 20-24, 26, 28-29, 32, 35 and 40-41are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nivorozhkin (U.S. Patent 11,242,318 B2).
Nivorozhkin discloses Deuterated tryptamine derivatives for treating various diseases (see claims 52-53). The compounds (see 1st compound and 4th compound) in column 110 in claim 50) disclosed by Nivorozhkin anticipate the instant claims when the instant compounds are represented by the elected species (compound 1A-6).
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621