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 .
Priority
This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/US2020/054347, filed on October 6, 2020, which claims the priority benefit and priority to U.S. Application Serial No. 62/911,670, filed on October 7, 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on dates 09/16/2024, 03/11/2025, 10/30/2025, 11/03/2025, and 11/13/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restriction
Claims 1-38, 42-54 and 58-82 are pending. Claim 1 has been amended. Claims 39-41 and 55-57 are cancelled without prejudice or disclaimer. The requirement for restriction between group I (claims 1-69) and group II (claims 70-82) in the restriction requirement dated 04/24/2024 remains in effect. Applicants' species election dated 11/21/2024 of compound 115 named (2R,4S)-rel-2-[4-(2,3-dichloro-6-hydroxyphenyl) piperidin-2-yl]-N-methylacetamide with the structure shown below, makes a contribution over the prior art.
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Examiner elected new species of formula I for further examination of 1-(2-ethoxyphenyl) piperazine, CAS RN 35386-24-4 in which Claims 1, 2, 4, 9, 15, 19, 25-26, 39-40, 42-49, 58-61, and 69 were rejected under 35 U.S.C. 102(a)(l) in the Nonfinal office action dated 03/11/2025.
Applicant amended claim 1 to exclude examiners elected compound in applicants response dated 08/20/2025.
The Examiner now selects a new species from within the structural limitations of formula I for further examination, the new species is Compound 1-(4,5-Difluoro-2- hydroxyphenyl) cyclopentane carbonitrile, CAS RN 2091366-92-4.
Claims 3, 5, 7-8, 10-11, 13-14, 16-18, 21-23, 27-28, 33-38, 51-54, 63, 67 and 70-82 have been withdrawn. Claims 1, 2, 4, 6, 9, 12, 15, 19-20, 24-26, 29-32, 42-50, 58-62, 64-66, and 68-69 are examined herein insofar as they read on the elected invention and species.
Applicant’s arguments, filed August 20, 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. They constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments, see pages 14-15, filed 08/20/2025, with respect to the rejections of claims 1, 2, 4, 9, 15, 19, 25-26, 39-40, 42-49, 58-61, and 69 under 35 U.S.C. 102(a)(l) over RN 35386-24-4 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of CAplus Registry Number: RN 2091366-92-4. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 2091366-92-4, Entered STN: 18 Apr 2017].
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.
Claims 1-38, 42-54 and 58-82 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAplus Registry Number: RN 2091366-92-4. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 2091366-92-4, Entered STN: 18 Apr 2017].
Compound 1-(4,5-Difluoro-2-hydroxyphenyl) cyclopentane carbonitrile CAS RN: 2091366-92-4 anticipates the limitations of formula I of the instant claims where Z is OH, R3 is H, X1 and X2 are halogen (F), X3 is H, X is CR4 wherein R4 is CN, Y is C(R4)2 wherein R4 is H, and n4, n5 and (R4)n1 are 1. Regarding the compositions of claim 69, comprising the anticipatory compounds and an excipient, the Registry entry for Registry no. 2091366-92-4 discloses a molar solubility of 0.00022 mol/L, in unbuffered water at pH 6.41. This teaching of water anticipates the claimed composition, wherein the compounds are present with an acceptable carrier or diluent (i.e. water).
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See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed
Publication" 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.
See 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 CAPlus database on STN, this represents the date that
each compound was made accessible to the public.
The aforementioned compounds anticipate the instantly claimed compounds: It is further
noted that for the purposes of determining if a reference is a "printed publication" for the
purposes of 102(b), MPEP 2128 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))".
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, and the claims are anticipated.
Conclusion
All claims are rejected, no claims are allowed.
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.
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.
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/E.V./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623