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 claims benefit of the provisional application: 63/358,411 with a filing date 07/05/2022.
2. Amendment of claims 2 and 15, and cancelation of claims 5, 9-11, 13-14, 24-25 and 27-30 in the amendment filed on 5/18/2026 is acknowledged. Claims 2-4, 6-8, 12, 15-23, 26 and 31 are pending in the application.
Responses to Amendments/Arguments
3. The rejection of claims 2-3, 6-8, 12 and 15-17 under 35 U.S.C. 112 (a) has been overcome in the amendment filed on 5/18/2026. Since claims 11 and 14 have been canceled, therefore the rejection of claims 11 and 14 under 35 U.S.C. 112 (a) has been
obviated herein. However, claim 4 still has limitation “WNK kinase pathway inhibitor” without limitation (i.e., no named compounds), therefore the rejection of claim 4 under 35 U.S.C. 112 (a) is maintained.
4. The rejection of claim 15 under 35 U.S.C. 112 (b) has been overcome in the amendment filed on 5/18/2026.
5. Applicant's arguments regarding the rejection of claims 2 and 15 under 35 U.S.C. 103 (a) over Yang et al. and He et al. ‘205 have been fully considered but they are not persuasive.
Applicants state “Without agreeing with the Office, claim 2 has been amended to recite the administration of the WNK kinase pathway inhibitor increases pH of airway surface liquid (ASL) and/or increases secretion of HCO3 ions in the ASL in the subject. The Yang and He references do not disclose or suggest increasing pH or secretion of HCO3- ions in ASL by administering an effective amount of the select WNK kinase pathway inhibitors required in claim 2, for treating one or more signs or
symptoms of cystic fibrosis. In addition, increasing pH of ASL and/or increasing secretion of HCO3 ions in the ASL are elements of claims 4 and 6 respectively, which are not asserted to be obvious.”, see page 6.
However, 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),
PNG
media_image1.png
470
314
media_image1.png
Greyscale
, ad a specific WNK kinase inhibitor is WNK 463, see claim 1 and 5 on
pages 2-3.
Additionally, the discovery of a new property or use, i.e., WNK kinase pathway inhibitor increases pH of airway surface liquid (ASL) and/or increases secretion of HCO3- ions in the ASL in the subject, for treating cystic fibrosis of Yang et al. and He et al. ‘205, even when that property and use are unobvious from the prior art, cannot impart patentability to claims to the known compounds of, see In re Spada, 15 USPQ2d 1655 (Fed. Cir. 1990), and MPEP 2112.01. Therefore Yang et al. and He et al. ‘205 still render obviousness over the instant invention. The rejection of claims 2 and 15 under 35 U.S.C. 103 (a) over Yang et al. and He et al. ‘205 is maintained. Since claim 11 has been canceled, therefore the rejection of claim 11 under 35 U.S.C. 103(a) has been obviated herein.
Claim Objections
6. Claims 3, 6-8 and 16-17 are objected to as being dependent on rejected claim 2.
7. 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 extension fee 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.
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.
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, Renee Claytor can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
June 15, 2026
Prosecution Insights