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 .
Response to Arguments
Applicant’s arguments, see p. 4, filed 02/20/2026, with respect to the rejection of claims 7-8 and 11-12 under 35 U.S.C. 112(b) have been fully considered and are persuasive in part. The amendments partially clarify the claims but “structural analog or derivative” remains indefinite. See rejection under 35 U.S.C. 112(b) below for further explanation.
Applicant’s arguments, see pp. 4-6, filed 02/26/2026, with respect to the rejection(s) of claim(s) 7-8 and 11-12 under 35 U.S.C. 103 have been fully considered and are persuasive. Amendments exclude the administration of secretin from the claims, mooting the rejection(s). The rejection(s) of 08/20/2026 have been withdrawn.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-8 and 11-14 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 7-8 and 11-14 encompass the administration of KSD179019 structural analogs and derivatives. The specification provides no guidance to these terms and it is therefore unclear to what extent a compound must have structural similarity to KSD179019 in order to be considered a structural analog or derivative. For example, it is unclear whether a compound merely having a purine ring system may be considered a structural analog or derivative. Accordingly, the metes and bounds of the terms are unclear and the claims are indefinite. Because the degree of structural similarity necessary to be considered encompassed by the terms is unclear, the terms are given their broadest reasonable interpretation to include compounds which share at least two functional groups and corresponding points of attachment in common with KSD179019.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 7-8 and 13-14 is/are rejected under 35 U.S.C. 102(a)(1)/(a)/(2) as being anticipated by WO2006076595A1 to Albers et al.
Albers et al. teaches compounds such as
PNG
media_image1.png
146
249
media_image1.png
Greyscale
(p.31). The prior art compound can be considered encompassed by KSD179019 structural analogs/derivatives as it shares a 9N-cyclohexyl purine moiety with KSD179019. The compounds of the disclosure are useful for treating pulmonary hypertension (Para. [0026]) and asthma (Para. [00202]). While the arrangement of claims 8 and 14 wherein the subject has both hypertension and asthma is not explicitly recited, said arrangement can be at once envisaged by a PHOSITA given that the compound is taught as useful for treating both hypertension and asthma.
Claims 13 and 14 each recite parameters regarding biological activity. The identical compound (i.e., a KSD179019 structural analog or derivative) applied to an identical subject (e.g., a subject in need of hypertension treatment of claim 13 or a subject in need of hypertension treatment and having a further condition of disease of claim 14) must inherently have the same claimed effect, even if not recognized in the art. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the claimed chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. Consequently, a “a method for treating hypertension, the method comprising administering to a subject in need of hypertension treatment” of claim 13 and “a method for treating hypertension and a further condition of disease, the method comprising administering to a subject in need of hypertension treatment” of claim 14 would inherently fulfill the limitations regarding parameters of biological activity recited in claims 13-14.
Claim Rejections - 35 USC § 103
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 for establishing a background for determining obviousness under 35 U.S.C. 103 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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7-8 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2006076595A1 to Albers et al. in view of Cheng "Azilsartan/chlorthalidone combination therapy for blood pressure control" Integrated Blood Pressure Control 2013:6 39–48.
Albers et al. teaches compounds such as
PNG
media_image1.png
146
249
media_image1.png
Greyscale
(p.31). The prior art compound can be considered encompassed by KSD179019 structural analogs/derivatives as it shares a 9N-cyclohexyl purine moiety with KSD179019. The compounds of the disclosure are useful for treating pulmonary hypertension (Para. [0026]) and asthma (Para. [00202]). While the arrangement of claims 8 and 14 wherein the subject has both hypertension and asthma is not explicitly recited, said arrangement can be at once envisaged by a PHOSITA given that the compound is taught as useful for treating both hypertension and asthma.
Claims 13 and 14 each recite parameters regarding biological activity. The identical compound (i.e., a KSD179019 structural analog or derivative) applied to an identical subject (e.g., a subject in need of hypertension treatment of claim 13 or a subject in need of hypertension treatment and having a further condition of disease of claim 14) must inherently have the same claimed effect, even if not recognized in the art. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the claimed chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. Consequently, a “a method for treating hypertension, the method comprising administering to a subject in need of hypertension treatment” of claim 13 and “a method for treating hypertension and a further condition of disease, the method comprising administering to a subject in need of hypertension treatment” of claim 14 would inherently fulfill the limitations regarding parameters of biological activity recited in claims 13-14.
Alsers et al. does not teach co-administration with an an additional therapeutic agent such as a diuretic or angiotension II receptor blocker.
Cheng teaches Azilsartan/chlorthalidone as an antihypertensive combination therapy. Azilsartan is an angiotensin II receptor blocker and chlorthalidone is a diuretic (see Background, Conclusions, pp. 39). It would have been prima facie obvious to combine the secretin composition taught by Hashimoto et al. with the Azilsartan/chlorthalidone which are taught by the prior art to be useful for the same purpose of lowering blood pressure and thereby treating hypertension. See MPEP 2144.06(I). Accordingly, claims 7-8 and 11-14 are obvious.
Conclusion
Claims 7-8 and 11-14 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JED A KUCHARCZK/Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621 06/26/2026
Prosecution Insights