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 .
Status of the Claims
Claims 1-9 and 12-19 are pending. Claims 1-7 and 12-19 are withdrawn. Claims 8 and 9 are rejected.
Information Disclosure Statement
The Information Disclosure Statements (IDS’s) submitted on 5/17/2024 and 6/24/2024 were considered by the Examiner.
Priority
This is a 35 U.S.C. 371 National Stage Filing of International Application No.
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, which claims priority under 35 U.S.C. 119(a-d) to
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. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d).
Election/Restrictions
Applicant’s election without traverse of a compound of Formula 157:
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, in the reply filed on 8/10/2026 is acknowledged.
Claims 8 and 9 embrace Applicant’s elected species and are therefore under examination. Applicant’s elected species is not allowable. Search and examination have been limited to the elected species which is rejected below under 35 USC 102.
Claims 1-7 and 12-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Regarding instant claim 1, the R1 definition is drawn to “cyclic C5 or C6 alkyl”, wherein one of ordinary skill would not assume that definition embraces the elected species aromatic phenyl at the R1 location. Additionally, the instant specification does not provide an enhanced definition to allow aromatic compounds to be part of the cyclic “alkyl”. Therefore, claim 1 and any dependent claims do not embrace Applicant’s elected species.
Claim Objections
Claim 8 is objected to because of the following informalities:
On p. 10, line 5: Delete “following” and replace with “group consisting of”.
There should be an “and” between the last two compounds.
Appropriate correction is required.
Claim 9 is objected to because of the following informalities:
On p. 21, line 5: Delete “following” and replace with “group consisting of”.
There should be an “and” between the last two compounds.
Appropriate correction is required.
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 8 and 9 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.
Claims 8 and 9 allow for “a polymorph of the compound”, wherein the instant disclosure does not provide data for any specific polymorph of the instant compounds, let alone all polymorphs. Claiming all polymorphs for all compounds is not supported by the instant disclosure. The instant disclosure is not sufficiently detailed to show that the Applicant was in possession of the full scope of the claimed invention at the time of filing. Namely, all polymorphs of all claimed compounds, are not sufficiently detailed in order to stand on their own as being adequately described. Therefore, the instant claims lack written description and are properly rejected under 35 USC 112(a).
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 1593538-05-6 (which entered the STN database on 4/30/2014).
Regarding instant claims 8 and 9, which are drawn to a pharmaceutical composition which may comprise a physiologically acceptable salt of a compound (no other ingredients specifically required), CAS Registry No. 1593538-05-6 is drawn to the following structure:
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, which is identical to Applicant’s elected species and a physiologically acceptable salt (HCl) of a compound of instant Formula 157.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy 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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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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