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
This application is a 371 of PCT/US2022/016813 (02/17/2022)
PCT/US2022/016813 has PRO 63/151,479 (02/19/2021).
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-12, in the reply filed on 1/20/26 is acknowledged. The traversal is on the ground(s) that unity of invention exists. This is not found persuasive because as detailed in the following prior art rejection unity of invention does not exist as the feature linking the claims of the compound is not a contribution over the art.
The requirement is still deemed proper and is therefore made FINAL.
Applicant also elected the following species:
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stated as reading on claims 1-3, 5, 7, 9, 10-12.
As detailed in the following rejections, the generic claim encompassing the elected species was not found patentable. Therefore, the provisional election of species is given effect, the examination is restricted to the elected species only, and claims not reading on the elected species are held withdrawn. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987). Accordingly, claims 4, 6, 8 are hereby withdrawn.
Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection through amendment, the amended Markush-type claim will be reexamined to the extent necessary to determine patentability of the Markush-type claim. See MPEP 803.02.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-3, 5, 7, 9, 10, 12 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 has the language “R3 is C2-12 alkyl or phenyl optionally substituted …” which is ambiguous as to whether both R3 alternatives “C2-12 alkyl or phenyl” can be substituted. Claim 1 also has the language “wherein the C1-6 alkyl and C3-6 cycloalkyl can be substituted …” which lacks a clear antecedent basis due to there being more than one occurrence of each of the alky and cycloalkyl. Thus, the claim and those that depend therefrom are rejected as indefinite.
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.
Claims 1-2, 9, 10, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Labadie et al. (WO2017174757) in view of Patani et al. (Chem. Rev., 1996, Vol. 96, No. 8, p. 3147-3176).
Labadie teaches estrogen receptor alpha (ERa) modulator compounds of Formula (I) (p. 22-23, claim 1) including the following compounds 104 and 116 (Tables 1-2, p. 31-51) showing high levels of ERa activity:
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Compound 104 Corresponding to claim 1’s formula (I) where R1 is H, R2 is H (not methyl), R3 is 2-fluoro-isopropyl (C3-alkyl substituted by halo), X1 and X2 are O, n is 2, R4 is azetidine (C3 heterocycloalkyl), R5 is C1 alkyl substituted by halo. Labadie’s claim 1 genus of formula (I) encompasses instant claim 1.
Thus, compound 104 differs from the scope of claim 1 by R2 is H vs. methyl. Alternatively, compound 116 differs from the scope of claim 1 by -S(O)2- vs. -C(O)-.
One of ordinary skill in the art would have considered modifying Labadie’s compound 104 to incorporate a methyl group as was demonstrated as successful in compound 116. Alternatively, one of ordinary skill in the art would have considered modifying Labadie’s compound 116 to replace S(O)2 with C(O) due to the success of compound 104. One of ordinary skill in the art would have considered such a modification because of the successful experimental demonstration of the compounds as modulators of ERa and because Labadie’s genus teaches the modification as within the scope of ERa modulator compounds. In addition, the level of skill in the art is very high and such modifications are routine in the art as taught by Patani wherein is demonstrated that H and methyl, as well as C(O) and S(O)2 are known as bioisosteres (p. 3152, 3166-67). One of ordinary skill in the art would have had a reasonable expectation of success because of the experimental demonstrations reported by Labadie as well as the well-known bioisosterism relationship.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Claim Objections
Claim 11 is objected to for being dependent on a rejected base claim and reading on non-elected subject matter as a result of the restriction to the elected species ONLY.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626