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 Claims
1. This application is a 371 of PCT/CN2023/086583 04/06/2023, which claims benefit of the foreign application: CHINA CN202210380702.1 04/08/2022 and
CHINA CN202310326245.2 03/22/2022.
2. Claims 1-20 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 1-20 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 of the instant “a JAK inhibitor” without limitation (i.e., no named
compounds or formula). 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.
ln 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 Iack 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 composition comprising “a JAK inhibitor” without limitation (i.e., no named compounds or formula), see claim 1.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Xu et al. US 9,745,320, it discloses a similar compound of
formula (I) in column 3.
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 “a JAK inhibitor” on pages 2-5 of the specification. There is no data present in the instant specification for the “a JAK inhibitor” without limitation (i.e., no named compound or formula).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure,
specifically, the instant “a JAK inhibitor” is without limitation (i.e., no named compound or formula).
The quantity or experimentation needed and the Ievel 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 “a JAK inhibitor” without limitation. There is no guidance or working examples present for constitutional any “a JAK inhibitor” without limitation for the instant invention. Incorporation of the limitation of “a JAK inhibitor” supported by specification into claim 1 would overcome this rejection.
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION-The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 14 recites a limitation “preferably” which is indefinite and ambiguous. Deletion of the limitation ‘preferably” would obviate the rejection.
5. 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
6. The following is a quotation of 35 U.S.C. 103(a) 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 1-20 are rejected under 35 U.S.C. 103(a) as being obvious over Xu et al.
US 9,745,320.
Applicants claim a pharmaceutical composition comprising a JAK inhibitor, wherein the pharmaceutical composition comprises the following components in mass fraction: 0.1% to 3% of a compound of formula I or a compound of formula II or a pharmaceutically acceptable salt thereof, 35% to 93% of a solvent, and 5% to 63% of a transdermal enhancer; the solvent is selected from one or more of water, glycerol, polyethylene glycol 400, dimethyl sulfoxide, ethyl acetate, propylene glycol, or ethanol; the transdermal enhancer is selected from one or more of diethylene glycol monoethyl ether, azone, urea, oleic acid, diisopropyl adipate, menthol, N-methylpyrrolidone, imidurea, propyl gallate, isopropyl myristate, cyclodextrin, sodium dodecyl sulfate, polyoxyethylene lauryl ether, polyethylene glycol hexadecyl ether, Tween 20, Tween 40, Tween 60, Tween 80, Span 20, Span 40, Span 60, Span 80, Span 85, deoxycholate, glycocholate, glyceryl monocaprylate, caprylic/capric mono- and diglycerides, propylene glycol monolaurate, propylene glycol monocaprylate, or glyceryl behenate;
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370
620
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, see claim 1. Dependent claims 2-20 further limit the scope of compositions, i.e., specific amount of compound of formula I or II, solvent,
formulations, preparation methods, and methods of use for treating diseases.
Determination of the scope and content of the prior art (MPEP §2141.01)
Xu et al. ‘320 discloses a compound/composition comprising a JAK inhibitor
of a compound of formula (I), i.e.,
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168
262
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, wherein X is S, Y and V are C or CR5, W is N, ring A is
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132
184
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, L1 is a bond or alkyl substituted with alkyl, cyano, or heterocycloalkyl (i..e, azetidinyl) which substituted with
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76
130
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, R1 or R2 is hydrogen or alkyl, L2 is
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168
122
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, M is alkyl, variable m is 0-2, p is 0-5 and n is 1-4. A specific compound T-15 has been examplified, i.e.,
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262
284
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, which reads on the instant compound of formula (II), see columns 3-15. Xu et al. ‘320 compounds/compositions are used for inflammation and autoimmune diseases, see column 3-4. Preparation of compositions has been disclosed in columns 175-176.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Xu et al. ‘320 is that the instant claims are embraced within the scope of Xu et al. ‘320.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the 1-20 prima facie obvious because one would be motivated to employ the compositions and methods of use of Xu et al. ‘320 to obtain instant invention.
The motivation to claim instant compositions and methods of use derived from the known compositions and methods of use of Xu et al. ‘320 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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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
July 17, 2026
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