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 .
Applicants' arguments, filed March 5, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Applicant’s arguments with respect to the pending claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 35, 38 – 41, 45 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Zhi et al. (US 2015/0099720) in view of Allott et al. (Mol Imaging, 2015).
Zhi et al. discloses compounds such as those formula (V)
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that are androgen receptor modulators and/or androgen receptor being agents (whole document, e.g., abstract and claim 1). Compounds of formula (V) with n = 0; R22 is an optionally substituted C1-C4 haloalkyl; R23 and R24 are each independently a hydrogen, optionally substituted C1-C8 alkyl, an optionally substituted C2-C8 alkenyl, an optionally substituted C2-C8 alkynyl or an optionally substituted aryl; and X = O or S fall within the scope of the instant claims when R3 and R4 of are linked to form a benzene ring. The compounds that selectively bind androgen receptors can be radio- or isotopically-labeled to determine the presence of such receptors in a sample (¶ [0473]). A pharmaceutical composition containing: i) a physiologically acceptable carrier, diluent, and/or excipient; and ii) one or more compounds provided herein is also disclosed (¶ [0044]).
The presence of 18F in a compound such as those of formula (V) that bind to androgen receptors is not specifically disclosed.
Allott et al. discloses steroid hormone receptors (SHRs) are frequently overexpressed in tumors and are at the forefront of targeted cancer therapy, with widespread targeting in endocrine-related treatments (p 534, col 1, ¶ 1). The androgen receptor (AR) is an important target in prostate cancer (p 534, col 1, ¶ 1). Positron emission tomography (PET) is a sensitive, minimally invasive imaging modality with the potential to be used for functional imaging where not only receptor expression but also receptor function can be determined in heterogenous tissue (p 523, col 2, ¶ 2). 18F labeled compounds are discussed in sections on each of the different SHRs including AR (p 540 – 543 including the figures therein). Exemplary clinical investigation into the utility of [18F]FES ([18F]fluoro-17ß-estradiol) PET for imaging ER expression in both primary and metastatic disease as well as identifying response to treatment has demonstrated not only the rigor by which new radiotracers should be evaluated but also the advantage of using PET in a standard clinical workup in patients presenting a clinical dilemma (p 543, col 2, ¶ 2).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prepare an 18F containing C1-C4 haloalkyl for R22 in formula (V) of Zhi et al. for use as a PET imageable compound for imaging of androgen receptor expression and/or function. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because compounds of formula (V) in Zhi et all would reasonably be expected to bind to the androgen receptor and can be isotopically labeled. Allott et al. discloses that AR binding compounds labeled with 18F are suitable for PET imaging that provides a sensitive, minimally invasive imaging modality for receptor expression and/or function in tissue. The preparation of pharmaceutically acceptable compositions is also disclosed by Zhi et al. and would readily enable the use of such compounds for PET imaging.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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