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 reply filed on July 6, 2026.
Status of Claims
Amendment of claim 9 is acknowledged.
Claims 1-9 and 11-13 are currently pending and are the subject of this office action.
Claims 1-8 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 24, 2025.
Claims 9 and 11-13 are presently under examination.
The following species is under examination:
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(instant Formula 2) as the compound of Formula 1.
Priority
The present application is a 371 of PCT/KR2021/013097 filed on 09/27/2021 and claims priority to foreign application KOREA, REPUBLIC OF KR10-2020-0125583 filed on 09/28/2020.
Rejections and/or Objections 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Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 103 (Maintained Rejection).
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) 9 and 11-13 stand rejected under 35 U.S.C. 103 as being unpatentable over Tamakuwala et. al. (JPP (2016) 68:1268-1277), Elliot et. al. (WO 2021/138525, July 8, 2021), Crosby et. al. (BJD (April 2020) 183: e103-e104, P18), Komori et, al. (FASEB (April 2020) 34 Issue S1 p.1) in view of Paek et. al. (WO 2014/129796, August 28, 2014, cited by Applicant).
For claims 9 and 11-12, Tamakuwala teaches a method of treating atopic dermatitis comprising the administration of the sphingosine-1-phosphate (S1P) receptor agonist Fingolimod (FTY-720, Gilenya) (see abstract under Conclusion, and see conclusion on page 1275). Elliot, like Tamakwala, also teaches a method of treating atopic dermatitis comprising the administration of the S1P receptor agonist Fingolimod (FTY-720, Gilenya) (see abstract for example, see [0010]).
Crosby teaches a method of treating atopic dermatitis comprising the administration of a composition comprising the S1P receptor agonist Etrasimod (APD334, Velsipity). Komori, like Crosby, teaches that the S1P receptor agonist Etrasimod is in development for the treatment of atopic dermatitis (see background).
The above references do not teach the treatment of atopic dermatitis comprising the administration of compounds of formula 1 as in instant claims 9 and 11 and more specifically the compound of formula 2:
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.
However, Paek teaches that compounds of formula:
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wherein Q represents -CH2-O-, and
S is:
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wherein R7, R8, R9 and R10 can be H or halogen (see [11] through [22]) are S1P receptor agonists (see for example abstract). In particular, they disclose compound 153:
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(see {2177]-[2178]), which is identical to the instantly claimed structure of instant claim 12 (Formula 2) and anticipates the general structures of instant claims 9 and 11. Paek further teaches that these compounds are S1P agonists like Fingolimod (FTY-720) (see for example [2303] through [2310]).
Since the prior art (Tamakuwala, Elliot, Crosby and Komori) teach a method of treating atopic dermatitis comprising the administration of a S1P receptor agonist (Fingolimod or Etrasimod), and since Paek teaches that the compound 153 (instant formula 2) is a S1P receptor agonist like for example Fingolimod, before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any S1P receptor agonist like Fingolimod or Etrasimod) for another (compound 153 (instant formula 2)) with an expectation of success, since the prior art establishes that both function in similar manner, thus resulting in the practice of claims 9 and 11-12, with a reasonable expectation of success.
For claim 13, Paek further teaches pharmaceutically acceptable salts like: hydrochloric acid, sulfuric acid, etc. (see [39]), thus resulting in the practice of claim 13 with a reasonable expectation of success.
Response to Applicant’s arguments related to the above rejection
Applicants’ arguments have been fully considered but are not persuasive.
Examiner’s response:
First: The fact that Paek does not teach the treatment of atopic dermatitis is completely irrelevant. The fact is that Paek teaches that the compound 153 (identical to instantly claimed compound of Formula 2) is a S1P agonist like Fingolimod or Etrasimod, both of which are known to be effective against atopic dermatitis due to their S1P agonism, as such it will be expected that the S1P agonist 153 disclosed by Paek to also be effective against atopic dermatitis. If Peak had taught atopic dermatitis, then the rejection would have been a 102 anticipatory rejection instead of a 103-obviousness rejection.
Second: The fact that compound 153 is one of 161 compounds disclosed by Paek is also irrelevant, since all 161 compounds share a common structural core:
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. So, the skilled in the art would have been motivated to replace the S1P agonist Fingolimod or Etrasimod with any of the 161 S1P agonists, including compound 153, disclosed by Paek, and expect any of these 161 compounds to be active against atopic dermatitis.
Third, the differences between compound 153 and Fingolimod on Tables 1, 2 and 3 (see pages 12 and 13 of the response dated 07/06/26) would not have discouraged the skilled in the art to select compound 153 because the differences are not dramatic (much less than 10-fold).
Fourth: there is nothing unexpected about compound 153 (Instant compound of Formula 2) to be superior to Etrasimod. Again, differences in efficacy, side effects, etc. are expected. The differences between Etrasimod and compound 153 shown in Table 4 of the specification at 1 mg/kg, even though they show superior activity for compound 153, cannot be considered unexpected.
Conclusion
No claims are 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
July 21, 2026.
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