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 .
Claims 1-3, 5, 9-11 and 15-17 are presented for examination.
Applicants’ amendment and response filed November 6, 2025 have been received and entered.
Accordingly, the rejection made under non-statutory double patenting as being unpatentable over claims 1, 39, 63, 70, 94 and 95 of U.S. Patent No. 8,609,647 B2 as set forth in the previous Office action dated May 6, 2026 at pages 2-4 as applied to claims 1 and 4 is hereby WITHDRAWN due applicants’ amendment to claim 1 to delete the phrase “eczema”.
Claims 9-11 are withdrawn from consideration as being drawn to the non-elected invention (37 CFR 1.142(b)).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5 and 15-17 are again rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating a skin disease is selected from the group consisting of senile xerosis, asteatosis, contact dermatitis, ichthyosis vulgaris, Netherton syndrome, and type B peeling skin syndrome with the JAK inhibitor, does not reasonably, does not reasonably provide enablement for preventing a skin disease is selected from the group consisting of senile xerosis, asteatosis, contact dermatitis, ichthyosis vulgaris, Netherton syndrome, and type B peeling skin syndrome with the JAK inhibitor. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
In this regard, the application disclosure and claims have been compared per factors indicated in the decision In re Wands, 8 USPQ2d 1400 (Fed. Cir., 1988) as to undue experimentation.
The factors include:
1) the quantity of experimentation necessary
2) the amount of direction or guidance provided
3) the presence or absence of working examples
4) the nature of the invention
5) the state of the art
6) the relative skill of those in the art
7) the predictability of the art and
8) the breadth of the claims.
Because of record, for reason of record as set forth in the previous Office action dated May 6, 2025 at pages 4-8 as applied to claims 1-5 and 15-17 is hereby MAINTAINED.
Applicants’ remarks regarding the specification teaches and discloses examples of the administration of a JAK inhibitor to prevent a skin disease selected from a group consisting of senile xerosis, asteatosis, contact dermatitis, ichthyosis vulgaris, Netherton syndrome, and type B peeling skin syndrome are not persuasive since the specification do not teach the instant JAK inhibitor can be administered to a subject not having the instant skin disease, and this subject can purchase the instant JAK inhibitor, and apply to the its skin and never have the instant skin disease during its lifetime.
To overcome this rejection, the applicants need to insert the phrase “in need thereof”, in claim 1.
Claims 1-3, 5 and 15-17 are not allowed.
The rejection made under 35 USC 112(a) or 35 USC 112 (pre-AIA ), first paragraph (Scope of Enablement) is adhered to.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/ Primary Examiner, Art Unit 1629
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