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, 17-19, 23, 28, 31, 33-36, 38, 40 and 42 are pending in the present application file.
AMENDMENTS
The amendments filed September 15, 2026 have been acknowledged and entered in the present application file.
Response to Arguments
Applicant’s amendments submitted September 15, 2026, have overcome all previous objections and rejections from the Office Action mailed June 23, 2025. Therefore, Applicant’s arguments from September 15, 2026 will not be addressed.
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, 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: 7/01/2010; International Filing Date: 07/23/2009).
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 compound 420 on page 114, which corresponds to N-Methyl-4-[4-(phenylmethoxy)phenyl]-N-[1-(phenylmethyl)-4-piperidinyl]-1H-imidazole-1-carboxamide having the structure shown below.
PNG
media_image1.png
183
295
media_image1.png
Greyscale
Compound 420 of Kiss is encompassed by a compound of present formula (I) wherein,
L1 is unsubstituted alkylene (CH2; see claims 18-19)
Ring A is unsubstituted arylene (phenyl; see claim 7 and 17)
Z1 is 0
R2 is H
R3 is H
R4 is unsubstituted CH3 (see claim 23)
L2 – L2A-L2B-L2C
L2A is a bond
L2B is unsubstituted heterocycloalkylene (piperidine)
L2C is unsubstituted alkylene (CH2)
R5 is unsubstituted arylene (phenyl; see claim 34)
Compound 420 of Kiss is encompassed by Formula (Ia) of claim 2 and formula (IIa) of claim 5, where ring A is aryl, and z6 is 0 (see also claim 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.
Claims 1-2, 5, 7, 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 2012/015324 (Learmonth et al.; Publication Date: 02/02/2012; International Filing Date: 07/28/2011).
Learmonth et al teach compound of Example 5.12 on page 69, which corresponds to N-Methyl-4-[4-(phenylmethoxy)phenyl]-N-[1-(phenylmethyl)-4-piperidinyl]-1H-imidazole-1-carboxamide having the structure shown below.
PNG
media_image2.png
210
291
media_image2.png
Greyscale
The compound of Example 5.12 is encompassed by a compound of present formula (I) wherein,
L1 is unsubstituted alkylene (CH2; see claims 18-19)
Ring A is unsubstituted arylene (phenyl; see claim 7 and 17)
Z1 is 0
R2 is H
R3 is H
R4 is unsubstituted CH3 (see claim 23)
L2 – L2A-L2B-L2C
L2A is a bond
L2B is unsubstituted heterocycloalkylene (piperidine)
L2C is unsubstituted alkylene (CH2)
R5 is unsubstituted arylene (phenyl; see claim 34)
Compound 420 of Kiss is encompassed by Formula (Ia) of claim 2 and formula (IIa) of claim 5, where ring A is aryl, and z6 is 0 (see also claim 14).
Regarding present claim 36, the prior art discloses where the process for preparing compounds of the invention comprises preparing and obtaining a reaction mixture comprising the compound of the invention and water (see Example 4 on page 60 of Learmonth), which is a pharmaceutically acceptable excipient.
Allowable Subject Matter
Claims 8, 13, 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 8, 13, 28, 31, 35 and 42 are objected to.
Claims 38 and 40 are withdrawn.
Claims 1-2, 5, 7, 14, 17-19, 23, 33-34 and 36 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
