DETAILED ACTION
Claims 1, 2, and 4-12 are currently pending in the instant application. Claims 1, 2, 4, 6 and 10 are rejected. Claims 7 is objected. Claim 9 is allowed. Claims 5, 8, 11 and 12 are withdrawn from consideration as being for non-elected subject matter.
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 .
Election/Restrictions
Applicant’s election of group I and the species of compound 40:
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in the reply filed on 14 October 2025 has been previously acknowledged.
According to MPEP 803.02, the examiner has determined whether the elected species is allowable. Applicants’ elected species appears allowable. Therefore, the search and examination has been extended to the compounds of claims 7 and 9 which also appear allowable, and now further to the compounds
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and
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which are not allowable.
Claims 1, 2, 4, 6, 7, 9 and 10 have been examined to the extent that they are readable on the elected embodiment, the elected species and the above mentioned compounds.
Response to Amendment and Arguments
Applicant's amendment and arguments filed 2 February 2026 have been fully considered and entered into the instant application. As the structures in claim 9 are clear, claim 9 is now allowable. The objection to claim 7 is maintained as claim 7 is still dependent upon a rejected base claim. Applicant’s amendment of claim 1 to define variables R1 and R2 more specifically ahs overcome the 35 USC 102(a)(1) rejection for at least the reason that R1 cannot be the heteroaryl thienyl.
Terminal Disclaimer
The terminal disclaimer filed on 2 February 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on pending Application Number 18/926,885 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claim 7 is 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 § 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 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, 2, 4, 6, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 7,524,853.
US Patent No. 7,524,853 discloses compounds of the formula (I) wherein the hydrocarbon chain -C(R3)-C(R4)-C(R5)-C(R6)- of the six-membered ring is saturated or contains one or two double bonds between the carbon atoms:
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on column 7. R2 is disclosed on column 7 to include substituted arylalkyl as a substituent. Preferred embodiments are disclosed on column 17 to include R2 as aryl-C1-C12-alkyl wherein the aryl is preferably phenyl and wherein the aryl moiety can be substituted with C1-C12 alkoxy. Especially preferred compounds are those where the six-membered ring comprising the hydrocarbon chain -C(R3)-C(R4)-C(R5)-C(R6)- is aromatic, column 18, and particularly preferable compounds of formula () are those where R2 is aryl-C1-C8-alkyl which aryl is phenyl which can be substituted with C1-C8 alkoxy, column 18. Most preferred compounds are disclosed on column 19 wherein even more preferred R2 is (iii) phenyl-C1-C4alkyl wherein the phenyl group is optionally substituted with one or two C1-C4 alkoxy groups. A specific compound disclosed is the
compound No. 83 on column 82:
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which corresponds to homologs of the instant claim 1. Specifically, the compound No. 83 is a homolog of the compounds:
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and
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which are encompassed by applicant’s instant claims. The compound 83 corresponds to instant claims 1 and 2, formula (I):
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wherein M is S; R6 is OH; R3, R4, and R5 are hydrogen; R2 is:
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. The difference being that compound No. 83 of the ‘853 patent is a homolog at applicant’s position R1 wherein R1 is
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or
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. The compound No. 83 corresponds to homologs of instant claim 4 formula (IV). The compound No. 83 corresponds to homologs of instant claim 6 formula (X). Instant claim 10 is drawn to a pharmaceutical composition comprising a compound according to claim 1 and a pharmaceutical acceptable carrier or excipient. The ‘853 patent discloses pharmaceutical compositions on column 35.
In the instant case, the prior ‘853 patent discloses compounds of the formula (I) with direction and preferences towards the variable R2 (which corresponds to applicant’s instant R1 variable) of the ‘853 patent as phenyl-C1-C4alkyl wherein the phenyl group is optionally substituted with one or two C1-C4 alkoxy groups, disclosing the specific compound No. 83, which differs only by homology from the instantly claimed invention. To those skilled in chemical art, one homologue is not such an advance over adjacent members of a series as requires invention because chemists knowing properties of one member of the series would in general know what to expect in adjacent members. In re Henze, 85 USPQ 261 (1950). The instant claimed compounds would have been obvious because one skilled in the art would have been motivated to prepare homologs of the compounds taught in the reference with the expectation of obtaining compounds which could be used in the treatment of steroid hormone dependent diseases or disorders, such as steroid hormone dependent diseases or disorders requiring inhibition of 17B-hydroxysteroid dehydrogenase enzymes as seen on column 1 of the ‘853 patent for the treatment of diseases such as rheumatoid arthritis and Alzheimer’s disease, column 34. Therefore, the instant claimed compounds would have been suggested to one skilled in the art. Additionally, nothing unobvious is seen in substituting the known claimed homolog for the structurally similar homolog, as taught by the ‘853 patent, since such structurally related compounds suggest one another and would be expected to share common properties absent a showing of unexpected results. Please see MPEP 2144.09 II:
II. HOMOLOGY AND ISOMERISM ARE FACTS WHICH MUST BE CONSIDERED WITH ALL OTHER RELEVANT FACTS IN DETERMINING OBVIOUSNESS
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 reWilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In reMay, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.).
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 REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 4 June 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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