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 present application claims foreign priority of PCT/CN2022/109155 filed 07/29/2022 which claims priority of CN 202110875927.X filed 07/30/2021.
Election/Restriction
Applicant’s election of Group 1, claims 1, 3, 6, 7, 11, 12, 18, 19, 23, 25, 29, 31, 32, 33, 45, and 46, in the reply filed on 05/05/2026 is acknowledged. Applicant’s species election of compound 110 as a compound of claim 1 is acknowledged. Examiner notes that Applicant did not expressly state whether the election/restriction was made with or without traverse. MPEP 818.01 states “[t]he absence of any statement indicating whether the requirement to restrict is traversed or the failure to provide reasons for traverse will be treated as an election without traverse.” Therefore, the instant Election/Restriction is entered onto the record as without traverse. The requirement for species election is withdrawn and the search was expanded to encompass the entire scope of claim 1.
Status of the claims
The claims filed on 05/05/2024, election of Group I and species election accordingly with the response filed on 05/05/2026 are entered onto the record. Claims 1, 3, 6, 7, 11, 12, 18, 19, 23, 25, 29, 31, 32, 33, 34, 40, 43, 44, 45, and 46 are pending. claims 1, 6, 7, 11, 12, 18, 19, 23, 25, 29, 31, 32, 33, and 45 are currently examined. Claims 34, 40, 43, 44 are withdrawn according to Applicant’s response filed on 05/05/2026. Additionally, claims 3 and 46 are withdrawn from further consideration pursuant to 37 CFR 1.42 (b) as being drawn to a nonelected species (i.e., compound 110). Claim 3 recites “characterized in that… G1 and G2 are not absent”, however, the elected species does not have both G1 and G2 present in the A subunit of the TB moiety. Claim 46 recites a list of compounds of which compound 110 is not included.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/29/2024 complies with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6, 7, 11, 18, 19, 23, 29, 31, 43 and 45 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Several claims depend from claims which were previously cancelled. For example, claim 6 depends from claim 5 which was cancelled. Examiner notes that the above listed claims all have improper claim dependencies for the same reason. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 1 and 33 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andersen et al., (WO 2020/198711 A1, published 01/10/2020; see IDS filed 01/29/2024).
Regarding claim 1, Andersen et al., teach compounds of formula PLM-LI-PTC(Q), which reads on the compound of formula 1 of instant claim (i.e., “TB-L-U”), wherein PLM is a “E3 ligase binding group” which reads on the U moiety, ubiquitin protease recognition/binding moiety of instant claim 1, LI is a linker which reads on the L moiety of instant claim 1, and PTC is an androgen receptor modulator which reads on the TB moiety of instant claim 1 (see para. [187]-[191]). Further, Andersen teach specific compounds of formula PLM-LI-PTC(Q), including N-(4-((4-(2-(3-chloro-5-cyano-4-(3-(4-(((2-(2,6-dioxopiperidin-3-y1)-1,3-dioxoisoindolin-4-yl)amino)methyl)-1H-1,2,3-triazol-1-yl)propoxy)phenyl)propan-2-yl)phenoxy)methyl)pyrimidin-2-yl)methanesulfonamide (see para. [199],
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Table P; Example 51; shown below).
This compound reads on instant claim 1 wherein:
the TB moiety is the structure of formula I-A and is disclosed in ‘289 (see pg. 36, lines 11-13), wherein A is a hetero aromatic ring, R1 is NR3-SO2-R4, R3 is H, R4 is C1 alkyl, and R2 is absent, B is an unsubstituted benzene ring, and B1 and B2 are H; C is an unsubstituted benzene ring, L1 is a halogen, and L2 is an amino group, Z is C, T1 and T2 are C1 alkyl, and X is O;
the L moiety is the structure of formula I-L, wherein Q is O, n1 is 2, Y is an aromatic heterocycle, n2 is 1, W is NRq1 and Rq1 is H, n3 is 0, V is absent, n4 is 0, and J is absent;
the U moiety is the structure of formula I-U, wherein M is NRm and Rm is H, Y1 and Y2 are O, E1 and E2 are O, and U1, U2, U3, and U4 are CH.
Regarding claim 33, Andersen et al., further teach that the compounds disclosed therein “can be useful for treating various diseases and conditions including, but not limited to, cancer” (see pg. 32, para. [183]) and “[i]n some embodiments, the cancer is prostate or breast cancer” (see pg. 51, para. [226]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 32 is rejected under 35 U.S.C. 103 as being unpatentable over Andersen et al., (WO 2020/198711 A1, published 01/10/2020; see IDS filed 01/29/2024) as applied to claims 1 and 33 above and in further view of Crew et al., (US 2017/0327469 A1, published 11/16/2017).
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Regarding claim 32, which depends from claim 1, , Andersen et al., teach a compound that reads on claim 1, as discussed above, however it differs from compounds of claim 32, wherein the compound of Andersen et al. comprise a 5-membered triazole ring as part of the linker moiety. However, in the same field of endeavor of androgen receptor targeting compounds Crew et al., teach compounds bifunctional or proteolysis targeting chimeric (PROTAC) compounds, which find utility as modulators of targeting ubiquitination and degradation of androgen receptor (see para. [0006]). Specifically, compounds taught by Crew have a general structure “ABD-L-VLM wherein ABM is an AR [androgen receptor] binding moiety, VLM is a VHL E3 ligase binding moiety and L is a bond or a linker moiety which links the ABM and VLM” (see pg. 1, para. [0008]-[0009]), which is also taught by Andersen, as discussed above. More specifically, Crew et al., teach linkers according to the structure “-A1 … Aq-“ wherein q is an integer greater than or equal to 0 (see pg. 16 para. [0191]) and wherein A1 and Aq are, for example, each independently “a bond, CRL1RL2, O…, wherein RL1, RL2… are, each independently, H, halo, C1-8alkyl…” (see pgs. 17-18, para. [0196]-[0197]) which read on linkers of the instantly claimed invention. For example, instantly claimed compound 9 (see claim 32) comprises a linker moiety that comprises only carbons and two oxygens which is encompassed by linkers taught by Crew (e.g., linker shown below, see pg. 18, left col.).
Notably, the teachings of Crew also meet the particular linker of instantly claimed compounds 156, 157, 158… etc that comprise an -O-cyclobutyl ring-NH-. Specifically, the “-A1 … Aq- linker of Crew can comprise -A1-A2-A3-A4-A5-wherein -A1 is a bond, A2 is an oxygen, A3 is a C4cycloalkyl, A4 is NRL3 wherein RL3 can be an H, and A5 can be a bond.
Thus a skilled artisan would be motivated to substitute the linkers taught by Andersen with the other suitable linkers taught by Crew to maintain the bifunctional androgen binding and degradation activity of the whole structure. Accordingly, since both Andersen and Crew teach that the structures are similar and have the same utility (i.e., to bind an androgen receptor), it would be obvious to modify the compound of Andersen according to the teachings of Crew to make the instantly claimed compound with an expectation that they will have similar properties (see MPEP§ 2144.09 (I)). Additionally, one of skill in the art at the time of filing of the instant application would know of methods to create PROTACs that target androgen receptors that may include different and similar structural motifs for the target binding, linker, and ubiquitination moieties and would be motivated to optimize the compounds by mixing and matching and combining the chemical structure motifs taught by Andersen and Crew with an expectation of success for use as a bifunctional androgen receptor targeting compound. (see MPEP §2143 (I)(B)).
Thus claim 32 is obvious in view of the teachings of Andersen and Crew.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN JEROME FOWLER whose telephone number is (571)272-0195. The examiner can normally be reached Monday - Friday 9-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALAN J FOWLER/ Examiner, Art Unit 1691
/RENEE CLAYTOR/ Supervisory Patent Examiner, Art Unit 1691
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