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 .
Election/Restrictions
In view of amendments to claims filed on 7/22/26, the restriction requirement as set forth in the office action mailed on 6/5/26 is withdrawn.
Claims 1, 3-8, 10-16 and 18-20 are considered on the merits.
Claim Rejections - 35 USC § 112(b)
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.
Claims 3 and 18 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. Claim 3 further defines the terms C1-C4 alkyl for Ra, Rb and Rc “or” further defines the term C1-C4 alkoxy for R3. There are two issues in this claim that make it unclear what scope is being claimed.
The definitions provided for the terms C1-C4 alkoxy and C1-C4 alkyl include all possible alkoxy and alkyl groups with one to four carbon atoms. In this sense, the recitation of specific alkoxy and alkyl groups fails to further limit the terms “C1-C4 alkoxy” and “C1-C4 alkyl”.
It’s unclear if selection of Ra, Rb and Rc as, for example, methyl group, excludes selection of C1-C4 alkoxy as R3. The two definitions are recited as alternatives and can be read as “Ra, Rb, and Rc are alkyl OR R3 is alkoxy.
Claims 4-6 are 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.
Claim 4 recites X is N-Ra, or Ra is C1-C4 alkyl. The two recitations cannot be mutually exclusive because Ra is a substituent on N. In other words if Ra is an alkyl group, X has to be N.
Claims 5 and 6 recite:
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This recitation is unclear because a) since m can only be 2 or 3, the recited species do not further limit the group. b) the “or” makes this potion of the molecule an optional component, which is outside of the scope of claim 1. Same applies to the limitation directed to substituted phenyl.
Claim 7 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.
Claim 7 provides a compound where Rb and Rc are hydrogen; and Ra is C1-C4 alkyl. These definitions are mutually exclusive, they can’t both be present in the same compound because they come from different definitions of X and only one definition of X can be true for a given compound.
Claim 16 is directed to A 5-HT2A receptor agonist comprising the fused-piperidine compound of claim 1.
1) It’s unclear what structural elements the receptor agonist comprises other than the compound of claim 1. In this sense the claim does not further limit claim 1.
2) If the claim is to be interpreted as not all of the compounds within the scope of Formula (I) have receptor agonist activity, it’s not clear which compounds are within the scope of claim 16.
Claim 1 recites R1 and R2 are independently hydrogen. Since there are no options for R1 and R2 it is unclear what limitations the term “independently” imposes on the claim. Examiner will interpret R1 and R2 as hydrogen. Claim 1 also recites R3 is independently hydroxyl or C1-C4 alkyl. Here again the term “independently seems unnecessary because it suggests that more than one R3s are possible. However, n is 1, which means only one R3 is possible.
Claims 11, 12 and 14 are 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. Claims are directed to a method of treating or preventing a disease associated with the 5-HT2A receptor. It is unclear how the diseases are associated with the receptor in question and which diseases are within the scope of the claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claim(s) 1, 3-8, 10, 16 and 18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Peng et al (WO 2024/145659; priority date 12/30/22).
Peng et al disclose compound 89:
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Claim Rejections - 35 USC § 103
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.
Claim(s) 11-15, 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peng et al (WO 2024/145659; priority date 12/30/22).
Scope of prior art
Peng et al teach compound 89:
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And its utility in treatment of depression (paragraph [0001]).
Ascertaining the difference
With regards to structure, compound 89 has a hydroxy substituent on the benzene ring, while claimed compound has a methoxy substituent.
With regards to treatment, Peng suggests that the disclosed compounds have utility in treatment of depression, but do not actually administer the compound to a subject with depression.
Obviousness
Compound:
A skilled artisan would have found it obvious to substitute the hydrogen for a methyl group in the benzene ring substituent of compound 89. A Me vs H substitution would be expected to result in a compound with similar biological properties. Furthermore, examples in Peng provide numerous compounds that comprise a methoxy substituted benzene ring (see paragraph [000215]; compound 90). The art clearly sees the two as equivalents and substitution of H for Me is therefore obvious.
Method of treatment:
A skilled artisan would have found it obvious to utilize compound 90 of Peng in a method for which it is indicated. Since Peng teaches treatment of depression as one utility of the disclosed compounds, a skilled artisan would have found it obvious to try treating depression by administering to a subject an effective amount of compound 89.
Overcoming this rejection:
Applicants can overcome this rejection by providing a certified translation of the foreign priority document CN202210041795.5, which predated the priority date of Peng. Without a certified translation it is not possible to assess whether all of the claimed components are supported in the foreign priority document.
Conclusion
Claims 1, 3-8, 10-16 and 18-20 are pending
Claims 1, 3-8, 10-16 and 18-20 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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