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
The instant application, is a continuation of 16/960,541, filed 07/07/2020, which is a national stage entry of PCT/US19/36860, filed 06/12/2019, which claims domestic priority to provisional U.S. application numbers 62/714,436, filed 08/03/2018, and 62/683,953, filed 06/12/2018.
Amendments and Claim Status
The following amendment filed on 01/26/2026 is acknowledged and entered.
Claim 1 is amended;
Claims 2-4 are cancelled;
Claims 21-23 are added;
Claims 13 -20 and 23 remain withdrawn according to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species;
Claims 1 and 5-23 are pending and are under prosecution.
Response to arguments
Applicant’s arguments filed 01/26/2026 with respect to the drawing objections and claim rejections under 35 U.S.C. §§ 112(a), 103, and double patenting have been fully considered.
With respect to the objection to the drawings, the amendment to the drawings filed 01/26/2026 with regard to the inclusion of shaped data points to clarify Figures 3 A-D, 4, 5 A-D, 6 and 19 as well as the inclusion of a legend for Figures 16 and 26 are sufficient to overcome the objection. Accordingly, the objection is hereby withdrawn.
With respect to the rejection of claims 1 and 5-12 under U.S.C. § 112(a) scope of enablement, the amendment to claim 1, striking the cancers which are not enabled is sufficient to overcome the rejection. Accordingly, the rejection is hereby withdrawn.
With respect to the rejection of claims 1 and 5-12 under 35 U.S.C. § 103 as being unpatentable over Stella and Diaz (WO 2013106460 A2, published July 18, 2013, included on applicant IDS filed 07/18/2022), in view of Rocheblave et al (Journal of Medicinal Chemistry, Vol 45, Iss 15, published June 20, 2002), hereinafter Rocheblave, Applicant’s arguments filed 01/26/2026, have been fully considered and are found to be persuasive for several reasons.
Regarding the lack of motivation to combine the teachings of Stella and Rocheblave in applying the ketone reduction, the argument is found to be persuasive because the ketone reduction is taught to be simply a synthetic step within a distinct structural context, directed to compounds within a different chemical class, such that a person of ordinary skill in the art would not reasonably apply said teachings to the structurally and functionally distinct anticancer compounds taught by Stella.
Regarding the lack of motivation to disrupt known advantageous ketone binding interactions, the argument is found to be persuasive because the instant specification establishes that the ketone is critical for target binding (e.g., hydrogen bonding through electropositive functional group, i.e., the carbonyl) and modifying it to a hydroxide would change said functional group to an electron donating action binding partner. On its face, the person of ordinary skill in the art would consider this modification to worsen the binding activity of the compound.
Regarding unexpected properties of the instantly claimed compounds, the argument is found to be persuasive because the evidence shows significantly improved activity across multiple cancer lines relative to the ketone-containing analog.
As such, Applicant’s arguments are found to be convincing. Further searches of the instantly claimed compounds comprising the method of treatment, beyond the elected species, have revealed structurally distinct compounds, and also suggest that said compounds are novel with respect to the use of a method of treatment and glioma and colorectal cancer. The only remaining art on the record, sufficient for the rejection of the instant claims, the applicant’s own art (see nonstatutory double patenting rejection, below). It has been determined that the compounds comprising the instant claims, as well as the diseases being treated by the instantly claimed method are distinguishable over the prior art. Accordingly, the rejection is hereby withdrawn.
With respect to the rejection of claims 1 and 5-12 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. US 11420967 B2, the amendment of claim 1 to now include colorectal cancer has necessitated the amendment of the double patenting rejection to include the new claim limitations as well as patented claim 20 and the rejection rationale. Patented claim 21 was inadvertently omitted from the claim listing, although being listed in the rationale for the rejection, and is hereinafter included. A terminal disclaimer has not been filed. Accordingly, the rejection is hereby maintained.
Specification
The amendments to the specification, filed 01/26/2026 as a result of the amendments to the drawings are also hereby entered.
Drawings
The drawings filed on 01/26/2026 are found to be in compliance with 37 CFR §§ 1.121 and 1.84, and are hereby accepted.
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, 5-12, 21, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18, 20, and 21 of U.S. Patent No. US 11420967 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims as written encompass elected species, as well as the methods claimed.
The elected species
PNG
media_image1.png
215
349
media_image1.png
Greyscale
is directly anticipated by the patent document and can be found in claim 14 of the reference patent
PNG
media_image2.png
127
187
media_image2.png
Greyscale
. Furthermore, the patent is drawn to a method of treatment of colorectal cancer (claim 20) and glioblastoma (claim 21) using the claimed compounds. Therefore, the instant claims and the referenced patent overlap in scope and the claims are rejected.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new grounds 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 Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
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 on +1 (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is +1 (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 +1 (800) 786-9199 (IN USA OR CANADA) or +1 (571) 272-1000.
/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623