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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 11th, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because Figure 2D (on the Drawing sheet submitted October 2nd, 2025) doesn’t have the image of the peptide shown in the Drawings submitted January 11th, 2023, and also lacks the “Figure 2D” label. Similarly, replacement Figure 1G (submitted October 2nd, 2025) doesn’t have the “Figure 1G” label. Furthermore, some figures are missing from the sheet submitted October 2nd, 2025.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-2, 4, 7, 9, 13, 15, 22-23, 25-26, 42, and 43) drawn to the compounds of Formula I, in the reply filed on October 2nd, 2025 is acknowledged.
Upon election of Group I, Applicant was further required to elect a single compound of Formula I with all variables defined. Applicant elected the compound below:
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The elected compound was found to be free of the art, thus the search was expanded to include the compounds of Formula I wherein R1 is H or halogen; m is 2-4; R2 is H or Me; and R3 is Me or –(CH)p-Ar2, wherein p is 1 or 2 and Ar2 is phenyl or indole.
Claims 22-23, 25, 27, 52, 55, 57-58, and 65-66 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 2nd, 2025.
Status of the Claims
Claims 1-2, 4, 7, 9, 13, 15, 22-23, 25-27, 42-43, 52, 55, 57-58, and 65-66 are pending in this application. Claims 3, 5-6, 8, 10-12, 14, 16-21, 24, 28-41, 44-51, 53-54, 56, 59-64, and 67-127 have been cancelled by Applicant. Claims 1-2, 4, 7, 9, 13, 15, 26, and 42-43 are under examination herein. Claims 22-23, 25, 27, 52, 55, 57-58, and 65-66 are withdrawn from consideration.
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, 4, 7, 9, 13, 15, 26, and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Opsenica et al. (J. Med. Chem. 2013, 56, 5860−5871).
Regarding claim 1-2, 4, 7, 9, 13, 15, Opsenica discloses a reaction for the preparation of compounds 6-15 below from 4 and 5 (Scheme 1, page 5864), which anticipate the instant compounds when R1 is a halogen; m = 2-3; R2 is H; and R3 is –(CH2)-phenyl, substituted or unsubstituted.
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Regarding claim 26, Opsenica discloses the compounds below:
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Regarding claim 42, Opsenica discloses pharmaceutical composition of their compounds (Table 1, page 5862) and discloses that their compounds were dissolved in DMSO for in vitro toxicity studies (page 5869, col. 2, last 6 lines).
Claims 1-2, 4, 7, 9, 13, 15, 26, and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Markovic et al. (Molecular and Biomolecular Spectroscopy, 192, 2018, 128–139).
Regarding claim 1-2, 4, 7, 9, 13, 15, and 26, Markovic discloses compounds 4-6 (Figure 2, page 129), shown below, which anticipate the instant compounds when R1 is a halogen; m = 2-3; R2 is H; and R3 is –(CH2)-phenyl, substituted or unsubstituted.
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Regarding claim 42, Markovic discloses a composition comprising an amount of their compound 6 in DMSO (page 130, col. 1, section 2.2).
Claims 1-2 and 9 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Matsuo et al. (US 9,120,749 B2).
Regarding claims 1-2 and 9, Matsuo discloses compd. 11 below (col. 65, line 11), which anticipates the instant compounds when instant R1 is H; m = 3; and R2, 3 are Me (C1 alkyl).
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(compd. 11)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Matsuo et al. (US 9,120,749 B2); as applied to claims 1-2 and 9; in view of Bayat et al. (Oncotarget, 2017, 8, 38022-38043).
The teachings of Matsuo et al. are disclosed in the 102-section above and incorporated herein.
Regarding claim 42, Matsuo discloses a pharmaceutical composition comprising their compounds of pharmaceutically acceptable salts thereof (col. 50, lines 58-60).
Regarding claim 43, Matsuo discloses a therapeutic agent comprising their compounds for the treatment of cancer (col. 51, lines 9-10).
While Matsuo doesn’t specifically teach coadministration with another anticancer agent, the teachings of Bayat et al. are relied upon for these disclosures.
Bayat teaches that combination therapy is a cornerstone of cancer therapy and that the amalgamation of anticancer drugs enhances efficacy compared to the mono-therapy approach because it targets key pathways in a characteristically synergistic or an additive manner (abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to prepare a pharmaceutical composition comprising Matsuo’s anticancer agents in combination with an additional anticancer agent in view of Bayat. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Matsuo’s disclosure of their compounds and pharmaceutical compositions thereof for the treatment of cancer; and Bayat’s disclosure that combination therapy is a cornerstone of cancer therapy due to the resulting synergism and additive effects of drug combinations.
Applicant is advised with respect to a mixture of the two claimed reagents, the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art (In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).” See MPEP2144.06. It is therefore obvious to provide a mixture of the two agents.
Response to Arguments
Claims
Claim amendments are acknowledged. No new matter has been added.
Specification/ Sequence Listing
Amendments to the specification are acknowledged and have been entered. No new matter has been added.
Drawings
Replacement drawings are acknowledged. See new ground of objections in this Office Action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627