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 November 24, 2025.
Restrictions/Elections.
Applicant’s election without traverse of Group III (Claims 9 and 11-13) in the reply filed on November 24, 2025, is acknowledged.
Applicant election of the following species:
1- treatment of atopic dermatitis, and
2-
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(formula 2) as the compound of Formula 1,
is acknowledged.
Status of Claims
Claims 1-9 and 11-13 are currently pending and are the subject of this office action.
Claims 1-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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.
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.
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) 9 and 11-13 is/are 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, Tamakwala 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.
NOTE: although the species “prevention of atopic dermatitis” is not under examination, it is strongly suggested that Applicant amends the claims by removing the word “prevention”, since prevention of a disease can be the subject of enablement rejections.
Conclusion
No claims are allowed.
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
December 12, 2025.