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 .
DETAILED ACTION
Claims 23-39 are pending in the present application file.
Election/Restrictions
Applicant’s election of Group I (claims 23-33; drawn to a compound comprising the chemical structure: PTM-L-CLM) and a species of a compound of Group I as pictured below without traverse in the reply filed August 03, 2026 is acknowledged by the Examiner.
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As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species is not allowable over the prior art as indicated in the rejection under 35 U.S.C 102(a)(1) and 102(a)(2).
As the Applicant’s elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 23-33 have been examined to the extent that they embrace and are readable on the elected embodiment. Claims 23-33 have been found to be not allowable over the prior art.
Claims 34-39, as well as non-elected embodiments of claims 23-33, are withdrawn from consideration by the Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Priority
The following continuity data is acknowledged in the instant application file:
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Information Disclosure Statement
The Information Disclosure Statement(s) filed 09/25/2023 have been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
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 23-33 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2016/197032 A1 (Crews et al.; Publication Date: December 8, 2016; International Filing Date: June 3, 2016), alone and as evidenced by US 9,907,807 (Evers et al.).
Crews discloses bifunctional or proteolysis targeting chimeric (PROTAC) compounds having chemical structure PTM-L-CLM, which find utility as modulators of targeted ubiquitination of a variety of polypeptides and other proteins, which are then degraded and/or otherwise inhibited by the bifunctional compounds (see abstract, paragraphs 12-24 and claims 1-3).
Crews discloses compound Example 1 in paragraph 402 and Table 1, page 163:
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Compound 1 corresponds to Applicant’s elected species.
Crews discloses a method for the preparation of Compound 1 in paragraphs 402-422.
Regarding instant claim 33, the prior art discloses generation in dimethylformamide (DMF; see paragraph 422 of Crews) which is deemed to anticipate the instant claim 33 since the evidentiary reference by Evers teaches that DMF is a penetration enhancing agent for topical pharmaceutical compositions (column 9, lines 56-58 of Evers).
Claims 23-33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 10,584,101 B2 (Crew et al.; priority to 62/406,888, filed October 11, 2016), alone and as evidenced by US 9,907,807 (Evers et al.).
Crew discloses compounds having the general formula ABM-L-CLM, which contain on one end a cereblon ligand which binds to the E3 ubiquitin ligase and on the other end a moiety which binds Androgen Receptor, such that Androgen Receptor is placed in proximity to the ubiquitin ligase to effect degradation (and inhibition) of Androgen Receptor (see abstract and columns 3-4).
Crew discloses compound Example 7 in Fig. 2, Sheet 4 of 266 (see paragraph 213, page 63 and claim 23, page 163 of PRO 62/496,888 for compound 7):
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Compound 7 corresponds to Applicant’s elected species. Crew discloses where Compound 7 is prepared by general scheme 1A (see column 357-358) has a DC50 of 1-10 nM and a Dmax of >50% (see column 536, lines 26-34).
Regarding instant claim 33, the prior art discloses compound testing in AR degradation assays where compositions comprising compounds of the invention and DMSO (see column 536, lines 35-54), which is deemed to anticipate the instant claim 33 since the evidentiary reference by Evers teaches that DMSO is a penetration enhancing agent for topical pharmaceutical compositions (see column 9, lines 56-58 of Evers).
Conclusion
Claims 23-33 are rejected.
Claims 34-39 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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, Jeffrey Murray can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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