0Notice 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 claims benefit of the provisional application: 63/358,411 with a filing date 07/05/2022.
2. Applicant’s remarks filed on 11/20/2025 are acknowledged. Claims 2-4, 6-8, 11-12, 14-23, 26 and 31 are pending in the application.
Responses to Election/Restriction
3. Applicant’s election without traverse of Group I claims 2-4, 6-8, 11-12 and 14-17 in the reply filed on November 20, 2025 is acknowledged. Election of a compound WNK 463 as a single species is also acknowledged.
Claims 2-4, 6-8, 11-12, 14-23, 26 and 31 are pending in the application.
Claims 2-4, 6-8, 11-12 and 14-17 drawn to methods of use, and are prosecuted
in the case.
Claims 18-23, 26 and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
The requirement is still deemed proper and therefore is made FINAL.
Claim Rejections - 35 USC § 112
4. 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, 6-8, 11-12 and 14-17 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 “WNK kinase pathway 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 a method of use using “WNK kinase pathway inhibitor” without limitation (i.e., no named compounds or formula), see claim 2.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is He et al. CAS: 172: 194396, 2019, it discloses a compound
of formula (I) as a WNK kinase pathway inhibitor.
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 “WNK kinase pathway inhibitor or formula” on pages 14-16 of the specification. There is no data present in the instant specification for the “WNK kinase pathway 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 “WNK kinase pathway inhibitor” are 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 “WNK kinase pathway inhibitor” without limitation. There is no guidance or working examples present for constitutional any “WNK kinase pathway inhibitor” without limitation for the instant invention. Incorporation of the limitation of “WNK kinase pathway inhibitor” supported by specification (i.e., the compounds with formulae on pages 14-16 of specification) into claim 2 would overcome this rejection.
5. 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 15 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 15, line 2, recites the limitation “comprises” is ambiguous and indefinite. A compound claim cannot use open-ended language when defining the parameters of the gene or compound, see M.P.E.P. 2111.03. Replacement of the limitation “comprises” with a limitation “is” would overcome this rejection.
6. 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
7. 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 2, 11 and 15 are rejected under 35 U.S.C. 103(a) as being obvious over
Yang et al. Biochemical and Biophysical Research Communication, 2007, 353(3): 535-
540, and He et al. CN 110585205.
Applicants claim a method of treating one or more signs or symptoms of cystic fibrosis in a subject in need thereof, the method comprising: administering to the subject an effective amount of a WNK kinase pathway inhibitor to the subject to treat the one or more signs or symptoms of cystic fibrosis, see claim 2. Dependent claims 11 and 15 further limit the scope of methods, i.e., the inhibitor is WNK 1 or WNK 463.
Determination of the scope and content of the prior art (MPEP §2141.01)
Yang et al. disclose that WMK1 and WNK 4 kinase are widely expressed
modulator cystic fibrosis. Therefore WMK1 and WNK 4 kinase inhibitors can be used
for treating cystic fibrosis.
He et al. ‘205 discloses a WNK kinase inhibitor or a pharmaceutical composition
comprising a WNK kinase inhibitor in the preparation of a product for the prevention
and/or treatment of pulmonary arterial hypertension and its complications (e.g. cystic
fibrosis), wherein the WNK kinase inhibitor has the structure of general formula (I),
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470
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, ad a specific WNK kinase inhibitor is WNK 463, see claim 1 and 5 on
pages 2-3.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Yang et al. and He et al. ‘205 is that the instant claims are embraced within the scope of Yang et al. He et al. ‘205. Yang et al. He et al. ‘205 read on the instant claims 2, 11 ad 15. It is noted that the instant claim is silent the scope of WNK kinase pathway inhibitor.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 2, 11 and 15 prima facie obvious because one would be motivated to employ the methods of use of Yang et al. and He et al. ‘205 to obtain instant invention.
The motivation to make the claimed methods of use derived from the known methods of use of Yang et al. and He et al. ‘205 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
January 12, 2026