ETAILED 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 .
Priority
This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/US2021/059641, filed 11/17/2021, which claims the priority benefit of PRO Application No. 63/114,760, filed 11/17/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/17/2023, and 09/13/2023 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant's election without traverse of Group I, claims 1-14 and 34-36, drawn to a compound of Formula I in the reply filed 01/07/2026 is acknowledged. Applicant further elects N-(3-fluoro-4-(trifluoromethyl)benzyl)-1-(3-fluorophenyl)-4-phenyl-lH-imidazol-2-amine, without traverse, as the species (Below).
PNG
media_image1.png
251
321
media_image1.png
Greyscale
As per MPEP 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species makes a contribution over the prior art of record. Therefore, according to MPEP 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. The Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examiner has selected 5-(4-Bromophenyl)-1-phenyl-2-[(phenylmethyl)thio]-1H-imidazole, CAS RN 1207038-21-8 as the new species. It has been determined that the entire scope claimed is not patentable.
Status of the Application
Claims 1-15, 19, 33-36 are pending. Claims 15, 19 and 33 have been withdrawn from further consideration as being drawn to a non-elected species. Claims 1-14 and 34-36 read on the elected group and species and are currently under examination.
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)(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 1-14 and 34-36 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by CAplus Registry Number: RN 1207038-21-8. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 1207038-21-8, Entered STN: 22 Feb 2010].
PNG
media_image2.png
599
789
media_image2.png
Greyscale
RN 1207038-21-8 anticipates the instant claims wherein R1-2, R4-5, and R12 are absent, R3 is H, Z1-4 and Y are CH, X is S, A1-2 are N, A3 is C, (D2)n is 0, R11, R13 is the aryl phenyl, R6-7, and R9-10 are H, D1 is C, and R8 is Br. The prior art compound anticipates formula I in claim 1.
PNG
media_image3.png
389
663
media_image3.png
Greyscale
Registry number 1207038-21-8 is available as prior art as of 22 Feb 2010, the day it was indexed into the CAplus database. Regarding the compositions of claim 14, comprising the anticipatory compounds and a pharmaceutically acceptable carrier, the Registry entry for Registry no. 1207038-21-8 discloses a mass solubility of 0.000019 g/L, in unbuffered water at pH 7.00. This teaching of water anticipates the claimed composition, wherein the compounds are present with an pharmaceutically acceptable carrier (i.e., water).
PNG
media_image4.png
120
507
media_image4.png
Greyscale
See MPEP § 2128 “Printed Publications” as prior art. An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. § 102 (a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981): since this date represents the date that each compound entered the REGISTRY database on STN, this represents the date that each compound was made accessible to the public.
It is further noted that for the purposes of determining if a reference is a “printed publication,” MPEP § 2128 (I) states the following:
A reference is proven to be a "printed publication" "upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it." In re Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA 1981) (quoting I.C.E. Corp. v. Armco Steel Corp., 250 F. Supp. 738, 743, 148 USPQ 537, 540 (SDNY 1966)) ("We agree that ‘printed publication’ should be approached as a unitary concept.
where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation.
Conclusion
All claims are rejected, no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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, Adam C Milligan can be reached at 571-270-7674. 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.
/E.V./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
Prosecution Insights