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 .
Claim Status
Claims 1, 3-16 and 18-20 are pending. Claims 7-16 and 18-20 are withdrawn. Claims 1 and 3-6 are rejected.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1 and 3-6, drawn to compounds and compositions in the reply filed on March 23rd, 2026 is acknowledged.
Claims 7-16 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 23rd, 2026.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by PubChem SID 440792516 deposited on March 16th, 2021 (cited in the IDS filed 09/13/2023).
PubChem SID 440792516 is drawn to 2-chloro-N-(2,2-dimethylpropyl)-N-[(3R)-1,1-dioxo-1lambda~6~-thiolan-3-yl]acetamide, which has the following structure:
PNG
media_image1.png
228
258
media_image1.png
Greyscale
.
The compound is a mixture of the isomers of PIN1-3 P1 and PIN1-3 P2 of instant claim 1.
Claims 1, 3 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 2451481-08-4, which entered Registry on July 30th, 2020.
CAS Registry No. 2451481-08-4 is drawn to 2-Chloro-N-(2,2-dimethylpropyl)-N-(tetrahydro-1,1-dioxido-3-thienyl)acetamide, which has the following structure:
PNG
media_image1.png
228
258
media_image1.png
Greyscale
.
The compound is a mixture of the isomers of PIN1-3 P1 and PIN1-3 P2 of instant claim 1.
Regarding instant claim(s) 3 and 6, which are drawn to a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier, the CAS Registry entry includes predicted properties including mass and molar solubilities at varying pH values. MPEP 2131.02 states:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015)
In this situation, a person having ordinary skill in the art in viewing the properties of the Registry entry would envisage a liquid composition with the compound and water, which is a pharmaceutically acceptable carrier.
Claim(s) 1 and 3-6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2020/144695 A1 filed January 9th, 2020 (cited in the IDS filed 09/13/2023).
The applied reference has a common joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding instant claim 1, the prior art discloses the following compound which is a mixture of the isomers of PIN1-3 P1 and PIN1-3 P2 (page 81):
PNG
media_image2.png
214
156
media_image2.png
Greyscale
.
Regarding instant claims 3-6, the prior art discloses pharmaceutical compositions comprising the prior art compound and a pharmaceutically acceptable carrier in formulations including tablets, capsules and liquid forms (page 46, lines 16-19).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 3-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8-11, 13-14, 20, 26-28, 33-34, 36-37, 43 and 45-46 of copending Application No. 18694557 in view of Trucillo, P. (2021). Drug Carriers: Classification, Administration, Release Profiles, and Industrial Approach. Processes, 9(3), 470.
Copending claim 33 discloses a pharmaceutical composition in the form of a liquid or solid comprising a Pin1 inhibitor such as sulfopin which is identical to the following compound disclosed by London et al. (page 81 of WO):
PNG
media_image2.png
214
156
media_image2.png
Greyscale
.
The claim does not require a pharmaceutically acceptable carrier however Trucillo describes considerations for selecting drug carriers for pharmaceuticals. Trucillo teaches that drug carriers can be classified according to their properties such as shape, application, and drug delivery and reports that oral delivery is the most used method for drugs (page 2). The prior art further teaches that drugs delivered orally may be in solid or liquid form and discusses various types of carriers such as hydrogel nanoparticles, nanocapsules, liposomes, etc. (pages 2 and 4). A person of ordinary skill seeking to prepare the copending pharmaceutical compositions would have been motivated to explore known carriers in order to prepare the tablet, capsule or liquid of the copending claims and optimize drug delivery (copending claims 34 and 36).
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 3-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 7, 9, 17-21, 24-25, and 28-35 of copending Application No. 18572972 in view of Trucillo, P. (2021). Drug Carriers: Classification, Administration, Release Profiles, and Industrial Approach. Processes, 9(3), 470.
Copending claim 25 discloses a pharmaceutical composition in the form of a liquid or solid comprising a Pin1 inhibitor such as sulfopin (Pin1i-2) which is identical to the following compound disclosed by London et al. (page 81 of WO):
PNG
media_image2.png
214
156
media_image2.png
Greyscale
.
The claim does not require a pharmaceutically acceptable carrier however Trucillo describes considerations for selecting drug carriers for pharmaceuticals. Trucillo teaches that drug carriers can be classified according to their properties such as shape, application, and drug delivery and reports that oral delivery is the most used method for drugs (page 2). The prior art further teaches that drugs delivered orally may be in solid or liquid form and discusses various types of carriers such as hydrogel nanoparticles, nanocapsules, liposomes, etc. (pages 2 and 4). A person of ordinary skill seeking to prepare the copending pharmaceutical compositions would have been motivated to explore known carriers in order to prepare the tablet, capsule or liquid of the copending claims and optimize drug delivery (copending claim 28).
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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, James H Alstrum-Acevedo can be reached at (571)272-5548. 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.
/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
Prosecution Insights