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 .
This is a Non-Final Office Action.
Election/Restrictions
Applicant's election without traverse of Group I in the reply filed on February 1, 2024 is acknowledged. Group I, drawn to compounds of formula (IA) and compositions thereof, embraced by claims 1-60 was elected by Applicant. Applicant has not pointed to any errors in the Examiner’s analysis of the classification of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
The elected Markush group based on the elected species was removed by amendment and the claims which read on the elected species and under examination were claims 1-3, 5, 7-9, 13, 25, 26, 32-39, 45, 50, 55-57, and 59.
The claims are currently drawn to the following formula:
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. Based on the search and the current amendments to the claims, all product claims are rejoined and the species election is withdrawn.
Claims 1-3, 6-23, 27, 33-57 and 59-60 are pending and under examination.
Claim Objections
The objection to claims 11, 12, 16, 17, 20, 21, 36, 37, 41, 42, 46, 47, 51 and 52 because the claims should have the term “unsubstituted” prior to the terms “alkyl” or “alkoxy” in said claims, is withdrawn based on the amendments.
Claims 15-23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
The rejection of claim 6 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the term “heteroaryl (C<12)” in the definition of R1-R4, is withdrawn based on the amendments.
The rejection of claim 6 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the variable R9 is withdrawn based on the amendments.
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-3, 6-14, 27, 33-57, 59 and 60 are rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Kreugel et al. (WO 2020037136).
The present application claims compounds of formula (I), wherein R1= OCH3, R2= H, R3= H, R4= H, R5= OCH3, R6= OCH3, R8= H and R7= vinyl in the R stereochemistry:
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.
The ‘136 publication teaches the following species, wherein R1= OCH3, R2= H, R3= H, R4= H, R5= OCH3, R6= OCH3, R8= H and R7= vinyl in the S stereochemistry:
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, see page 65, Scheme 9.
The only difference between the claimed compound and the cited compound above is the stereochemistry at the R7, S versus Applicant’s R. Applicants are requested to note that MPEP § 2144.09 teaches that stereoisomers are prima facie obvious, see also In re May, 574 f.2d 1082, 197 USPQ 601 (CCPA 1978).
Since a methyl group is considered a homolog of hydrogen these compounds are considered equivalent. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Further, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 373, 203 USP 245, 254 (COCPA 1979). In re Papesch, 315 F.2d 381, 137 USPO 43 (CCPA 1963) and In re Dillon, 919 F.2d 688, 16 USPO2d 1997 (Fed. Cir, 1990). See also MPEP § 2144.09.
The compositions are taught spanning pages 47-51, with unit dosage and route of administration on page 47.
Thus, said claims are obvious over Kreugel et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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