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
This office action is in response to applicant’s communication filed on 2/6/26. Claims 409-432 are pending.
Applicant’s election without traverse of Group I, claims 409-413 in the reply filed on 2/6/26 is acknowledged. Thus Claims 414-432 are withdrawn from further consideration being drawn to the nonelected invention.
Applicant’s election of the following compound is acknowledged herewith:
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638
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As a result, claims 409-413 are being examined in this Office Action.
Priority
The applicant claims benefit as follows:
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458
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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 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 of this title, 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.
Claims 409-413 are rejected under 35 U.S.C. 103 as being unpatentable over Jarman et al. (Anti-Cancer Drug Design, 1986, 1, 259-268).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Jarman et al. teaches the following tamoxifen analogue in both the trans and cis configurations, in particular the trans configuration as shown below. Jarman et al. teaches the equivalency of both methyl and hydrogen substitution (H and Me equivalency for R1 substitution) for the phenol ring (R2 = OH). For another similar tamoxifen analogue (7b), Jarman et al. teaches that the trans isomer binds 10-fold more strongly than the cis counterpart. (abstract; page 260, second column, see Figures and Table, specifically Compound No. 6; page 264, first column, last line of the first paragraph)
Compound No. 6
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This reads on applicant’s claims when
R4 = C2 alkyl (ethyl)
n = 2
R1 = R2 = R3 = C1 alkyl (methyl)
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Jarman et al. is deficient in the sense that the phenol ring includes methyl substitution, instead of hydrogen substitution at the R1 position.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
However, it would be prima facie obvious to one of ordinary skill in the art at the time of the invention, to substitute a hydrogen for the methyl group at the R1 position of Jarman et al.’s Compound No. 6, since Jarman et al. teaches the equivalency of hydrogen and methyl at the R1 position of Jarman et al.’s Compound No. 6.
Note that an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
Thus with regard to applicant’s particular elected species, it is the position of the examiner that one of ordinary skill in the art, at the time of the invention, would through routine and normal experimentation determine the appropriate R1 substitution on the phenol ring of Jarman et al.’s Compound No. 6. The applicant does not show any unusual and/or unexpected results for the limitations stated. It would be reasonable to expect that Jarman et al.’s Compound No. 6, a tamoxifen analogue, with a hydrogen at the R1 position instead of a methyl, would have similar tamoxifen activity.
With regard to applicant’s limitation for at least 75% of the compound of Formula (IIa), in claim 412, the examiner interprets this to mean at least 75% of applicant’s compound of Formula (IIa) contains the trans isomer. It would be obvious to form at least 75% of the trans isomer for applicant’s compound of Formula (IIa), since Jarman et al. teaches that for another tamoxifen analogue, the trans isomer binds 10-fold more strongly than the cis counterpart, a beneficial property of the trans isomer.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer Cho Sawyer whose telephone number is (571) 270 1690. The examiner can normally be reached on Monday-Friday 9 AM - 6 PM PST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Renee Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-274-1690.
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Jennifer Cho Sawyer
Patent Examiner
Art Unit: 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691