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 .
DETAILED ACTION
Claims 1-2, 5, 7-8, 13-14, 18-19, 23, 33, 36, 38, 40 and 42 are pending in the present application file.
Election/Restrictions
Applicant’s election of Group I (claims 1-2, 5, 7-8, 13-14, 18-19, 23, 33, and 36; directed a compound, or a pharmaceutically acceptable salt thereof, having the formula (I)) and a species of present formula (I) without traverse in the reply filed May 14, 2026 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species of present formula (I) appears free of the prior art. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the species cited below under 35 U.S.C. 102, which are not allowable, as well as the species encompassed by present claims 28, 31, 35 and 42, which are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As a non-elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 1-2, 5, 7-8, 13-14, 18-19, 23, 33, 36 and 42 have been examined to the extent that they embrace and are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 38 and 40 do not read on the presently searched and examined subject matter. Therefore, claims 38 and 40 are withdrawn from consideration by the Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Priority
The following continuity data is acknowledged in the present application file:
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Information Disclosure Statement
The Information Disclosure Statement(s) filed 05/29/2024 and 10/08/2025 have been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to for repeating information given in the title, the use of phrases which can be implied and because the nature of the compound or composition should be given as well as its use should be given. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
(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 1-2, 5, 7-8, 13-14, 17-19, 23, 33-34 and 36 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2010/074588 A2 (Kiss et al.; Publication Date: 07/01/2010; International Filing Date: 12/23/2009).
Kiss has disclosed compounds and compositions for inhibiting the enzyme fatty acid amide hydrolase (FAAH), the use of the compounds in therapy and, in particular, for treating or preventing conditions whose development or symptoms are linked to substrates of the FAAH enzyme, and methods of treatment or prevention using the compounds and compositions. See abstract.
Kiss discloses specific compound examples which are encompassed by formula (I) of the instant claims. See compound 230 on page 108, which corresponds to N-methyl-4-[4-(2-morpholin-4-ylethoxy)phenyl]-N-phenylimidazole-1-carboxamide hydrochloride.
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Compound 203 of Kiss is encompassed by a compound of present formula (I) wherein,
L1 is a C2 alkylene (see present claims 18-19)
Ring A is unsubstituted heterocycloalkyl (morpholinyl)
z1 is 0
R2 is hydrogen
R3 is hydrogen
R4 is unsubstituted C1 alkyl
L2 is L2A-L2B-L2C
L2A is unsubstituted arylene (phenyl)
L2B is a bond
L2C is a bond
R5 is hydrogen (see present claims 33-34).
Compound 203 is encompassed by a compound of formula (Ia) of present claim 2 and formula (IIa) of present claim 5, where z6 is 0. See also present claim 14. Compound 203 is encompassed by a compound of present claim 17 where
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is
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.
Kiss also discloses compound 363 on page 108, which corresponds to 4-[3-(4-cyanophenoxy)phenyl]-N-cyclohexyl-N-methylimidazole-1-carboxamide.
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230
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Compound 363 of Kiss is encompassed by a compound of present formula (I) wherein,
L1 is a bond (see present claims 18-19)
Ring A is substituted phenyl
z1 is 0
R2 is hydrogen
R3 is hydrogen
R4 is unsubstituted C1 alkyl
L2 is L2A-L2B-L2C
L2A is cyclohexyl
L2B is a bond
L2C is a bond
R5 is hydrogen (see present claims 33-34).
Compound 363 is encompassed by a compound of formula (Ia) of present claim 2 and formula (IIa) of present claim 5, where R6 is -CN and z6 is 1. See also present claims 8 and 13-14.
Kiss discloses a pharmaceutical composition comprising a compound of the invention, together with one or more pharmaceutically acceptable excipients. See pages 48-50 as well as claim 62 of Kiss and present claim 36.
Allowable Subject Matter
Claims 28, 31, 35 and 42 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 28, 31, 35 and 42 are objected to.
Claims 38 and 40 are withdrawn.
Claims 1-2, 5, 7-8, 13-14, 17-19, 23, 33-34 and 36 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/ Primary Examiner, Art Unit 1626