DETAILED ACTION
This office action is in response to the Applicant’s filing dated October 17th, 2025.
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 .
Status of Claims
Claims 1, 8-9, 13 and 15-18 are pending in the instant application. Acknowledgement is made of
Applicant's remarks and amendments filed on October 17th, 2025. Acknowledgement is made of
Applicant's amendment of claims 1, 9, and 13; and cancelation of claims 2-7, 14 and 19-23. Claims 13 and 15-18 remain withdrawn as they do not read on the elected invention.
Priority
This application is a 371 of PCT/KR2020/013418 filed on September 29th, 2020; a PRO of 62/910,537 filed on October 4th, 2019; and claims benefit of foreign priority of KR10-2020-0127176 filed on September 29th, 2020.
Objections and/or Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
New Objections and/or Rejections Necessitated by Claim Amendment
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.
Claims 1 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Gardner et al (Bioorganic & Medicinal Chemistry, (2012), 20(23), 6877-6884), cited in a previous Office Action; in view of Pino-Lagos et al (Ann N Y Acad Sci., (2008), 1143, 1-19); further in view of Rowe et al (Dimethyl Sulfoxide. Handbook of Pharmaceutical Excipients. (2009), 6th Edition, Pharmaceutical Press, 238-240), cited for evidentiary purposes only in a previous Office Action.
Regarding claim 1, Gardner teaches Compound 10b shown below (page 6883, right column, 4.1.45):
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Compound 10b is a benzothiazole-indole amide compound of Scheme 3 (page 6789, right column) wherein R is Cl and n is 1. Gardner discloses that compounds of this family were developed as RARß2 agonists and retinoid pathway enhancers (page 6878, left column, paragraphs 1-2). Gardner demonstrates that compounds of this family exhibit RARß2 dependent biological activity, including differential effects in RARß2 overexpressing cells and induction of RARß2 expression, establishing their function as RARß2 agonists rather than inhibitors; measuring their effects against RARß2 overexpressing cells compared to empty vector controls, demonstrating that observed biological effects are RARß2 dependent (page 6880, right column, Figure 4).
This compound has an identical core scaffold as the compound of instant claim 1. The only structural distinction is the placement of the Cl substituent on the aromatic scaffold; wherein Compound 10b bears Cl at the R15 position, while in the instantly claimed compound bears Cl at the R2 position.
MPEP § 2144.09(II) 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). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978).”
Pino-Lagos teaches that retinoid signaling exerts immunosuppressive and anti-inflammatory effects, including reduced leukocyte infiltration into sites of inflammation and decreased production of pro-inflammatory cytokines. Pino-Lagos further teaches that retinoids have been considered as therapeutic agents for autoimmune diseases, including multiple sclerosis and Crohn’s disease (page 12, paragraphs 4-5). In experimental mouse models of multiple sclerosis, retinoid treatment was shown to delay disease onset and reduce disease severity; establishing therapeutic benefit of retinoid receptor activation in autoimmune and inflammatory disease contexts (page 12, last paragraph).
“[T]he rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
It would have been prima facie obvious to a person of ordinary skill in the art to apply the RARß2 agonist Compound 10b of Gardner to treat autoimmune and inflammatory diseases such as multiple sclerosis and irritable bowel syndrome as taught by Pino-Lagos; because Gardner demonstrates that Compound 10b, and compounds sharing its core scaffold, function as RARß2 agonists exhibiting RARß2-dependent biological activity. Furthermore, modifying the position of a Cl substituent on an otherwise identical scaffold is a routine structural optimization. One of ordinary skill in the art would have had a reasonable expectation of success in producing a positional isomer with predictable properties and retaining similar retinoid receptor activity.
Regarding claims 8-9, It is respectfully pointed out that a recitation of an intended use of the claimed invention, as recited in instant claim 9, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Thus, the intended use recited in instant claim 9, namely that the composition is used for treating autoimmune diseases, is not afforded patentable weight.
Gardner and Pino-Lagos render Compound 10b obvious as discussed in the above rejection. Gardner further demonstrates the potential for the benzothiazole-indole amide compounds of 10a-10d for RARß2 activation (page 6879, right column, last paragraph; page 6880 whole page); where BE(2)-C cells were exposed to a DMSO solvent control, and Compound 10b at a concentration of 20µM. A 20µM concentration of Compound 10b reads on a composition comprising Compound 10b and a solvent, DMSO, which reads on a pharmaceutical excipient (carrier) as evidenced by Rowe, cited for evidentiary purposes only, in the Handbook of Pharmaceutical Excipients (page 238, section 7).
Taken together, all of this would result in the compound and composition of instant claims 1 and 8-9 with a reasonable expectation of success.
Conclusion
Claims 1 and 8-9 are rejected.
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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/C.L.J./Examiner, Art Unit 1691
/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691