DETAILED ACTION
This Action is in response to the amendment filed on 04/29/2026.
Claims 10, 15-18 are pending.
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 .
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.
Claims 10, 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ZHENG et al. Chinese Journal of New Drugs 2009 vol 18(5) (hereinafter “ZHENG”; original article and English translation provided), as evidenced by LIU et al. Food Chemistry 2009 vol 112 (hereinafter “LIU”).
Claim 10 is drawn to a method for treating an ADP-ribosyl cyclase-mediated disease, comprising administering an inhibitor against the activation of an ADP-ribosyl cyclase comprising an amino acid sequence of SEQ ID NO 1 or a naturally occurring variant thereof as an active ingredient to a subject in need thereof, wherein the inhibitor is a compound selected from the group consisting of 2-(1,3-benzoxazol-2-ylamino)-1-methylquinazolin-4(1H)-one and dicaffeoylquinic acid.
Claim 15 is drawn to the method according to claim 10, wherein the ADP-ribosyl cyclase-mediated disease is a renal disease.
Claim 16 is drawn to the method according to claim 15, wherein the renal disease is renal failure, nephropathy, nephritis, renal fibrosis or nephrosclerosis.
ZHENG teaches that total saponins from Kuding tea (Ilex kudingcha C.J. Tseng) protects against kidney injury induced by hypercholesterolemia in apolipoprotein E knockout mice (e.g., see Title, Abstract, etc.). Zheng teaches that Kuding tea saponins reduced plasma cholesterol and alleviated renal interstitial hyperplasia caused by hypercholesterolemia and decreased the concentration of oxidative products in the blood and kidneys, providing a protective effect on lipid-induced kidney damage (e.g., see abstract). ZHENG explicitly teaches that renal fibrosis was significantly reduced (see page 432, top of right column). ZHENG teaches that Ilex kudingcha saponins have an effect similar to atorvastatin on lowering plasma total cholesterol, but is superior to atorvastatin in its anti-lipid peroxidation function, thus making Ilex kudincha saponins superior to atorvastatin at improving renal damage (see page 433, right column).
Although AHENG does not teach that Ilex kudingcha tea comprises dicaffeoylquinic acid, LIU provides evidence that Ilex kudingcha D.J. Tseng contains large amounts of caffeoylquinic acid, including dicaffeoylquinic acid (e.g., see abstract).
Therefore, ZHENG teaches a method of treating an ADP-ribosyl cyclase mediated disease comprising administering dicaffeoylquinic acid to a subject in need of treatment, wherein the ADP-ribosyl cyclase-mediated disease is a renal disease, including renal fibrosis.
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.
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.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over ZHENG et al. Chinese Journal of New Drugs 2009 vol 18(5) (hereinafter “ZHENG”; original article and English translation provided), as evidenced by LIU et al. Food Chemistry 2009 vol 112 (hereinafter “LIU”) as applied in the rejection above, in view of MORADI et al. Semin. Dial. 2018 July vol 31(4) (hereinafter “MORADI”).
ZHENG teaches that saponins from Ilex kudincha (which comprises dicaffeoylquinic acid as evidenced by LIU) reduces renal fibrosis, and has an effect similar to atorvastatin on lowering plasma total cholesterol, but is superior to atorvastatin in its anti-lipid peroxidation function, thus making Ilex kudincha saponins superior to atorvastatin at improving renal damage, as indicated in the rejection above. LIU provides evidence that Ilex kundincha comprises saponins, including dicaffeoylquinic acid, as indicated in the rejection above.
ZHENG does not teach using saponins from Ilex kudincha to treat other renal diseases including chronic renal failure and nephropathy syndrome.
However, MORADI teach saponins from Ilex kudincha
“In contrast to patients being treated with hemodialysis, there is accumulating evidence that statin therapy in patients with non-dialysis dependent CKD [Chronic Kidney disease] and those with ESRD [End Stage Renal Disorder] treated with PD [peritoneal dialysis] may result in improved outcomes. The SHARP study as well as various meta-analyses have found that statin therapy in patients with mild to moderate CKD can be associated with reduced major cardiovascular events, cardiovascular death and all-cause mortality. Based on these findings, major dialysis guidelines have recommended lipid lowering therapy with statins in patients with predialysis CKD. In addition, as described earlier, patients with ESRD being treated with PD have been noted to have increased levels of serum cholesterol and cholesterol-rich lipoproteins (LDL-c) in a pattern of dyslipidemia similar to that observed in patients with nephrotic syndrome. There are observational studies which have found that the use of lipid-modifying medications including statins is associated with improved mortality in PD patients.” (See page 8, second full paragraph, references omitted, emphasis added).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the date the claimed invention was filed to treat chronic renal failure as well as nephrotic syndrome with saponins from Ilex kudincha which includes dicaffeoylquinic acid, with a reasonable expectation of success. The fact that MORADI teaches major dialysis guidelines have recommended lipid lowering therapy with statins in patients with predialysis CKD and that patients with ESRD being treated with PD have been noted to have increased levels of serum cholesterol and cholesterol-rich lipoproteins (LDL-c) in a pattern of dyslipidemia similar to that observed in patients with nephrotic syndrome provides explicit teaching to use statins to treat predialysis CKD and nephropathy and ZHENG’s teaching that Ilex kudincha saponins treatment is superior to atorvastatin treatment in improving renal damage provides the motivation to substitute saponins from Ilex kundincha for statin treatment. Furthermore, the positive results demonstrated/reported by ZHENG and MORADI also provide the basis for a reasonable expectation of success.
Response to Arguments
Applicant’s arguments with respect to the rejection of claims under 35 U.S.C. 102 have been fully considered and in view of the amendment to the claims are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration of the amended claims, a new ground(s) of rejection is made under 35 USC 102 and 35 USC 103 as indicated above.
Conclusion
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 J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/ Primary Examiner, Art Unit 1637 2026
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