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 preliminary amendment filed on 8/16/2023 is acknowledged. Claims 1, 3-6, 8-11, 13-14 and 16-21 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statements filed on 4/30/2025 and 5/28/2025 have been considered except where lined through.
Claim Objections
Claim 4 is objected to because of the following informalities: Claim 4 recites “… the hypertension-linked disease comprises hypertension-induced nephropathy.” In the instant case, it is unclear how to interpret “comprise” since this is open language. It is suggested that Applicants amend the claim to replace “comprise” with “is”. Appropriate correction is required.
Claim Interpretation
Claim 1 recites the phrase “hypertension-linked disease”. A review of the specification does not appear to provide a definition as to what this encompasses. While it is recognized that there needs to be some type of correlation with hypertension, it is unclear of whether hypertension induces the disease or whether hypertension can be a risk factor for the disease. For example, a review of the state of the art indicates that hypertension is a risk factor for renal cancer (see as evidenced by article below). As such, while hypertension does not appear to induce renal cancer, one of skill in the art could interpret that hypertension and renal cancer are linked. As such, a “hypertension-linked disease” will be interpreted as both a hypertension induced disease, as well as, one in which hypertension has been shown to be a risk factor.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 3-6, 8-11, 13-14 and 16-17 is/are rejected 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).
Benbrook 1 teach a method of treating tumor growth or development in a subject comprising administering a therapeutically effective amount of a flexible heteroarotinoid, wherein the tumor growth is related to renal cancer (Claim 1). In addition to inhibition of tumor growth, Benbrook 1 teaches a method of inhibiting or regulating angiogenesis in a subject an effective amount of a flexible heteroarotinoid (Claim 5). With regards to the inhibition or regulation of angiogenesis, Benbrook 1 teaches that conditions in need of regulation or inhibition of angiogenesis include, but are not limited to, aneurysms (paragraph 0089). With regards to the flexible heteroarotinoid, Benbrook 1 teaches flexible heteroarotinoids include, but are not limited to SHetA2 (paragraph 0094, for example). Thus, while the prior art does not specifically teach that renal cancer is a “hypertension-linked disease”, hypertension is a risk factor for renal cancer among both blacks and whites as evidenced by Colt et al. (conclusions). Moreover, while the prior art does not specifically teach that an aneurysm is a “hypertension-linked or induced disease”, hypertension is positively associated with abdominal aortic aneurysm (AAA) presence as evidenced by Takagi et al. (see background). Regarding the limitations of claims 3, 5-6, 10-11, 13-14, 16-17, 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. Note: The claims recite “prevention” which encompasses any subject including those which do not yet have the disease or condition yet. Accordingly, the prior art reads on 1(a)-1(e), since the recitation of “prevention” in the claims do not specifically require that the subject have the disease.
Claim(s) 1, 3-6, 8-11, 13-14 and 16-17 is/are rejected 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.
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). Regarding the limitations of claims 3, 5-6, 10-11, 13-14, 16-17, 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. Note: The claims recite “prevention” which encompasses any subject including those which do not yet have the disease or condition yet. Accordingly, the prior art reads on 1(a)-1(e), since the recitation of “prevention” in the claims do not specifically require that the subject have the disease.
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.
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) 18-21 is/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 Ajay Gupta (US20100249081A1, 2010-09-30).
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 SHetA2 is in a kit, wherein the kit further comprises an additional drug such as an aldosterone agonist.
Ajay Gupta teaches a method and compositions for the treatment of proteinuria and/or hypertension secondary to other conditions such as diabetic nephropathy, wherein the method and compositions involve a combination of an indoline and an anti-aldosterone agent (Abstract). In particular, Ajay Gupta teaches that the combination therapy can be packaged into a kit with instructions for administering said compounds to the subject (paragraph 0043).
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 package SHetA2 taught by Benbrook and Hays into a kit and further include another agent for the treatment of diabetic neuropathy in view of the teachings of Ajay Gupta. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Anjay Gupta teaches that combination therapies can be packaged as a kit with instructions for administering said compounds to the subject.
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
Claim(s) 1, 3-6, 8-11, 13-14 and 16-17 is/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).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-6, 8-11, 13-14 and 16-17 are rejected 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). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting patent claims a method of treating or inhibiting polycystic fibrosis in a subject comprising administering a composition comprising SHetA2. While the prior art does not specifically teach that polycystic fibrosis is a hypertension linked disease, as evidenced by Kennefick et al., hypertension accelerates renal failure in autosomal dominant polycystic kidney disease (Background). As such, the claimed patient populations appear to be the same.
Claims 18-21 are rejected 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).
The conflicting patent claims a method of treating or inhibiting polycystic fibrosis in a subject comprising administering a composition comprising SHetA2.
The conflicting patent does not specifically claim that the SHetA2 is in a kit, wherein the kit further comprises an additional drug such as an aldosterone agonist.
Ajay Gupta teaches a method and compositions for the treatment of proteinuria and/or hypertension secondary to other conditions such as diabetic nephropathy, wherein the method and compositions involve a combination of an indoline and an anti-aldosterone agent (Abstract). In particular, Ajay Gupta teaches that the combination therapy can be packaged into a kit with instructions for administering said compounds to the subject (paragraph 0043).
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 package SHetA2 as claimed by the conflicting patent into a kit and further include another agent for the treatment of polycystic fibrosis in view of the teachings of Ajay Gupta. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Anjay Gupta teaches that combination therapies can be packaged as a kit with instructions for administering said compounds to the subject.
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
Conclusion
Therefore, No claim is allowed.
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BRANDON J. FETTEROLF
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626