DETAILED ACTION
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 .
Application Status
The amendment filed on 4/20/2026 in response to the Non-Final rejection of 11/20/2026 is acknowledged and has been entered. Claims 1, 3 and 5-6 are currently pending and under consideration.
Rejections Withdrawn:
The rejection of Claim(s) 1, 3-6, 8-11, 13-14 and 16-17 under 35 U.S.C. 102(a)(1) as being anticipated by Benbrook, Dennis (US20060281806A1, 2006-12-14) referred to herein as Benbrook 1 as evidenced by Colt et al. (Epidemiology 2011; 22(6): 797-804) and Takagi et al. (Annals of Vascular Surgery 2017; 39: 74-89) is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 1, 3-6, 8-11, 13-14 and 16-17 under 35 U.S.C. 102(a)(1) as being anticipated by Benbrook and Hays (US20130184323A1, 2013-07-18) referred to herein as Benbrook and Hays is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 18-21 under 35 U.S.C. 103 as being unpatentable over Benbrook and Hays (US20130184323A1, 2013-07-18) referred to herein as Benbrook and Hays, as applied to claims 1, 3-6, 8-11, 13-14 and 16-17 above, in view of Ajay Gupta (US20100249081A1, 2010-09-30) is withdrawn in view of Applicants amendments.
The rejection of Claims 1, 3-6, 8-11, 13-14 and 16-17 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 7,612,107B2 as evidenced by the Kennefick et al. (Kidney International, 1999; 56(6): 2181-2190) is withdrawn in view of Applicants amendment.
The rejection of Claims 18-21 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 7,612,107B2 in view of Ajay Gupta (US20100249081A1, 2010-09-30) is withdrawn in view of Applicants amendment.
Rejections Maintained, but modified in view of Applicants amendments:
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1, 3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Benbrook and Hays (US20130184323A1, 2013-07-18) referred to herein as Benbrook and Hays, as applied to claims 1, 3-6, 8-11, 13-14 and 16-17 above, in view of Wang et al. (Hypertension 2017; 69:879-891). (Please note: The instant rejection addresses a subject in need).
Benbrook and Hays teach a method of treating a disease or condition involving defective protein folding, in particular those associated with endoplasmic reticulum stress (ERS), by administering to a subject having such disease or condition, one or more flexible heteroarotinoids, wherein the disease or condition include, but are not limited to, cancer (renal cancer), kidney disease, ischemia, heart diseases and inflammation (paragraph 0084). With regards to the inflammatory condition, Benbrook and Hays teach non-infectious inflammatory condition include, but are not limited to, diabetic nephropathy (paragraph 0088). With regards to the flexible heteroarotinoid, Benbrook and Hays teach that flexible heteroarotinoids include, but are not limited to, SHetA2 (paragraph 0061).
Benbrook and Hays do not specifically teach that the disease or condition associated with endoplasmic reticulum stress (ERS) is hypertension induced nephropathy.
Wang et al. teach that diabetes mellitus and hypertension interact synergistically to promote kidney dysfunction and injury via endoplasmic reticulum (ER) stress (abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Benbrook and Hays to treat a patient suffering from hypertension induced nephropathy in view of the teachings of Wang et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Wang et al. teach that diabetes mellitus and hypertension interact synergistically to promote kidney dysfunction and injury via endoplasmic reticulum (ER) stress (abstract).
Regarding the limitations of claims 3 and 5-6, it is noted that the limitations appear to be a result of following the method which contains the active step of administering the SHetA2. Accordingly, since the prior art teaches the same patient population and administering the same compound, the "results" would appear to be necessarily present. Applicants are reminded that the office does not have the facility and resources to determine whether the claim results actually occur. The burden is on applicants to provide evidence that the result of following the same active steps to the same patient population would not necessarily be present.
In response to this rejection, Applicants contend that the animals tested in Wang were (1) control rats (Wistar) and (2) diabetic rats (Goto-Kakizaki, (GK)), wherein both the control and GK rats were subjected to unilateral aortic constriction leading to hypertensive right kidneys and normotensive left kidney. Moreover, Applicants contend that Wang is silent as to the role in ER stress in the control rats (without diabetes) and provides no data suggesting that treating with the ER stress inhibitor tauroursodeoxycholic acid (TUDCA) would have any effect on hypertensive kidneys. Thus, Applicants contend that a person of ordinary skill in the art would not have had a reasonable expectation of success in treating hypertension-induced nephropathy in a subject in need thereof with any ER stress inhibitor.
These arguments have been carefully considered, but are not found persuasive.
The Examiner acknowledged and does not dispute Applicants contention that Wang is silent as to the role of ER stress in the control rats (without diabetes). However, the examiner recognizes that Wang specifically teaches that hypertension and diabetes mellitus interact synergistically to promote renal dysfunction and that inhibition of ER stress markedly attenuates dysfunction and injury in kidneys exposed to hypertension and diabetes mellitus (page 889, Perspective). It is important to note that the instant claims do not limit the patient population to be only hypertension induced nephropathy without other complications.
Applicants further contend that Figure 18 demonstrates that SHetA2 restores renal microvascular responses in hypertensive rats, wherein no therapeutics capable of restoring renal microvascular responses in hypertensive subjects were known at the time of filing. As such, Applicants contend that there is no indication in any of the cited references that SHet2A could restore renal microvascular responses in hypertensive subjects.
These arguments have been carefully considered but are not found persuasive.
In the instant case, the Examiner acknowledges the data presented in Figure 19. However, the examiner recognizes that "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004) see MPEP 2112. Accordingly, since the prior art combination teaches the same patient population and administering the same compound, the "results" would appear to be necessarily present. Applicants are reminded that the office does not have the facility and resources to determine whether the claim results actually occur. The burden is on applicants to provide evidence that the result of following the same active steps to the same patient population would not necessarily be present.
Conclusion
Therefore, No claim is allowed.
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 BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 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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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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