Patent Application 17635852 - TREATMENT OF IDIOPATHIC HYPOHIDROSIS

Title: TREATMENT OF IDIOPATHIC HYPOHIDROSIS

Application Information

Invention Title: TREATMENT OF IDIOPATHIC HYPOHIDROSIS
Application Number: 17635852
Submission Date: 2025-04-08T00:00:00.000Z
Effective Filing Date: 2022-02-16T00:00:00.000Z
Filing Date: 2022-02-16T00:00:00.000Z
National Class: 514
National Sub-Class: 559000
Examiner Employee Number: 79521
Art Unit: 1691
Tech Center: 1600

Rejection Summary

102 Rejections: 0
103 Rejections: 1

Cited Patents

No patents were cited in this rejection.

Office Action Text

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
Priority and Status of the Claims
1. This application is a 371 of PCT/SG2020/050476 8/17/2020, which claims benefit of the foreign application SIGAPORE with a filing date 8/19/2019.
2. Claims 1-10 are pending in the application.
Claim Rejections - 35 USC § 112
3. 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.

Claims 2-4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph (pre-AIA ), because the specification does not reasonably provide enablement for the instant “derivative” without limitation (i.e., no named compound or moiety), see line 2 in claim 2. 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 the invention commensurate in scope with these claims.
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case:
The nature of the invention
The nature of the invention is methods of use using isotretinoin and its “derivative”, wherein the “derivative” is without limitation, see claims 2-4.
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is Garattini et al., ScienceDirect, 2001. Garattini et al. discloses retinol as retinoid derivative.
The amount of direction or guidance present and the presence or absence of working examples
The only direction or guidance present in the instant specification is the description of a number of retinoid analog or derivative of on pages 6-10 of the specification. There is no data present in the instant specification for the instant “derivative” without limitation (i.e., no named compounds or moiety).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure, specifically, the instant “derivative” are without limitation (i.e., no named compound or moiety).
The quantity or experimentation needed and the level of skill in the art
While the level of the skill in the chemical arts is high, it would require undue experimentation of one of ordinary skill in the art to resolve any instant “derivative” without limitation. There is no guidance or working examples present for constitutional any instant “derivative” without limitation for the instant invention. Incorporation of the limitation of the instant “derivative” supported by the specification into claims 2-4 respectively would overcome this rejection.
4. 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 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.
Claim Rejections - 35 USC § 103

5. 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-10 are rejected under 35 U.S.C. 103(a) as being obvious over Kakizaki et al. Australasian Journal of Dermatology, 2013, 54(4): e82-e84.
Applicants claim a method comprising utilizing a retinoid in the manufacture of a medicament for the treatment of idiopathic hypohidrosis, see claim 1. Dependent claims 2-08 further limit the scope of methods, i.e., specific retinoid acitretin or isotretinoin, administration strategy, formulation, and dose.

Determination of the scope and content of the prior art (MPEP §2141.01)
Kakizaki et al. disclose a method for treating hypohidrosis using retinoid compound.

Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Kakizaki et al. is that the instant claims are embraced within the scope of Kakizaki et al.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1-10 prima facie obvious because one would be motivated to employ the methods of use of Kakizaki et al. to obtain instant invention.
The motivation to make the claimed methods of use derived from the known and methods of use of Kakizaki et al. would possess similar activity to that which is claimed in the reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is (571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 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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/REI TSANG SHIAO/

Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691

April 03, 2025