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
Claims 1, 5-7, 8, 12-14, 16-18 and 20-22 are pending and are under consideration in the instant office action.
Priority
This is a US national phase application of PCT application no. PCT/US2021/024125, filed on 25 March 2021.
Election/Restrictions
Applicant's election with traverse of Group 2 (claims 14-22) in the reply filed on 02/27/2026 is acknowledged. The argue that the newly amended claims render the Group I and Group II to be technically related . Examiner finds applicants argument persuasive
. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/27/2026 and the restriction requirement set forth on 12/29/2025 is hereby withdrawn.
Claims 1, 5-7, 8, 12-14, 16-18 and 20-22 are under consideration in the instant action.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 5-7, 8, 12-14, 16-18 and 20-22 are rejected under 35 U.S.C. 103(a) as being unpatentable over by Gopi et al (US 10,639,285) in view of Buyuklu et al. (European review of Medical and Pharmacological science, 2014;18; 461-470) further in view of Majeed et al (US 2010/0034762, Majeed 762 hereinafter) and Majeed et al. (WO 2020/050914 (Majeed 914 hereinafter).
Independent claims 1 and 8 are drawn to a method for the therapeutic management of nephropathy in mammals and a method for maintaining normal kidney function in mammals, said method comprising step of administering a composition comprising 70%- 80% w/w tetrahydrocurcuminoids, 10%-20% w/w hexahydrocurcuminoids and 5%-10% w/w octahydrocurcuminoids, said composition further comprising at least 10% w/w 1-0- galloyl-3-D-glucose ((-glucogallin) and at least 10% w/w total mucic acid gallates and ellagic acid, isolated from Emblica officinalis, and said composition still further comprising Pterocarpus marsupium extract standardized to contain tannins and C- glycosides containing not less than 0.5% w/w Pterocarposide, not less than 0.5% w/w Sabioside, to mammals in need of such therapeutic management
Independent claims 14 and 18 method for the therapeutic management of nephropathy in mammals or the maintaining normal kidney function in mammals, said method comprising step of administering a composition comprising at least 10% w/w 1-O-galloyl-3-D-glucose ((3-glucogallin) and at least 10% w/w total mucic acid gallates and ellagic acid, isolated from Emblica officinalis and Pterocarpus marsupium extract standardized to contain tannins and C-glycosides containing not less than 0.5% w/w Pterocarposide, not less than 0.5% w/w Sabioside, to mammals in need of such therapeutic management
Gopi et al. teaches a method in mammals (col 5, In 4-6 The bio-equivalent studies showed that the recommended dosage of encapsulated white curcumin is 250 mg per day in human...), said method comprising step of administering a composition comprising 70%-80% w/w tetrahydrocurcuminoids, 10%-20% w/w hexahydrocurcuminoids and octahydrocurcuminoids (col 4, In 9-12 White curcumin is a mixture of tetrahydrocurcuminoids 101, hexahydrocurcuminoids 102 and octahydrocurcuminoids 103 at the concentrations of 75-80 % 15-20 % and 3-5 % respectively...) to mammals in need of such therapeutic management (col 1, In 14-16 The present invention also discloses white curcumin with its biological properties useful in treatment of various disease...), Gopi et al teaches that tetrahydrocurcuminoid is a colorless hydrogenated phenolic compound derived from curcuminoids and is known for its anti-oxidant activities, skin protection and inhibition of tyrosinase (col.1, lines 44-51)
Gopi et al. does not teach (i) wherein for the therapeutic management of nephropathy or in maintaining the normal kidney function of the said mammal (ii) wherein the composition further comprises at least 10% w/w- 1-O-galloyl-beta-D-glucose (beta-glucogallin) and at least 10% w/w total mucic acid gallates and ellagic acid, isolated from Emblica officinalis. (iii) wherein the composition further comprises of Pterocarpus marsupinin extract standardized to contain tannins and C-glycosides containing not less than 0.5% w/w Pterocarposide, not less than 0.5% w/w Sabioside . (iv) wherein it is 5-10% w/w octahydrocurcuminoids.
However, Buyuklu et al., teaches that curcuminoids can be used to reduce nephropathy. They disclose biochemical measurements showed a significant increase (p < 0.001) in urea, creatinine and malondialdehyde (MDA) but a significant decrease (p < 0.001) in glutathione (GSH), superoxide dismutase (SOD), catalase (CAT) and glutathione peroxidase (GSH-Px) levels in the contrast-induced nephropathy (CIN) group compared with the control group. The immunohistochemical examination revealed a significant increase in autophagic and apoptotic cell death ratios and in the inflammatory signal (p < 0.05). Compared with the CIN group, a significant improvement in these unfavorable parameters was observed with CC therapy CC therapy is those that were fed curcumin (abstract). It would have been obvious to one of skill in the art to use the tetra-, hexa-, and octahydrocurcuminoids for reducing nephropathy or in the maintinence of normal kidney function , by routine experimentation motivated by the teachings of Buyuklu et al. It also would have been obvious to one skilled in the art to vary the amount of octahydrocucuminoids in order to vary the treatment of nephropathy by inhibiting the release of cytokines
Majeed 762 teaches that diabetic mellitus is a leading cause of many complications such as atherosclerosis, cardiac dysfunction, retinopathy and nephropathy...) teaches wherein the composition further comprises at least 10% w/w 1-O-galloyl-beta-D-glucose (beta-glucogallin) and at least 10% w/w total mucic acid gallates and ellagic acid (para[0074] Extract enriched in >than 40% w/w of gallic acid esters including 1-O-galloyl-B-D-glucose and other mucic acid gallates...), isolated from Emblica officinalis (para[0043] In another preferred embodiment, the present invention relates to the use of standardized Emblica officinalis extracts enriched in greater than 40% w/w of gallic acid ester...). (para[0085]. . Majeed 762 further teaches wherein nephropathy is induced by conditions selected from the group consisting of hyperglycemia, hypercholesterolemia, elevated blood pressure and renal hypertension, drugs, autoimmune diseases, oxidative stress and inflammation (para[0075] hyperglycemia in diabetes mellitus type 2 para[0085] Diabetic mellitus is a leading cause of many complications such as atherosclerosis, cardiac dysfunction, retinopathy and nephropathy...
Majeed 914 discloses (para[0023] use in activating AMPK in mammalian cells teaches wherein the composition further comprises of Pterocarpus marsupinin extract standardized to contain tannins and C-glycosides (para[0017] In a most preferred embodiment, the invention discloses a process for isolating C-glycosides from Pterocarpus marsupium since the plant is used tannins are inherently in the formulation as said in para[002] Pterocarpus marsupium is a deciduous tree that is native to the parts of India, Nepal and Sri Lanka. It contains many flavonoids, glycosides, catechins, stilbenoids and tannins that exhibit therapeutic properties...) containing not less than 0.5% w/w Pterocarposide, not less than 0.5% w/w Sabioside (para[0023] comprising not less than 5% w/w Pterocarpus marsupium extract standardized to contain not less than 0.5% w/w Pterocarposide (STR#1) and not less than 0.5% w/w Sabioside.
As such it would have been prima facia obvious to a person of ordinary skill in the art to combine the teachings of the references above to develop a method for treating nephropathy and maintaining normal kidney function in mammals by administering the instantly claimed composition to the mammal. Use of curcuminoids to treat nephropathy is well known in the art as taught by It would have been obvious to one ordinary skilled in the art to combine Gopi et al. and Majeed 762 to increase the amount of components that can also increase the positive effects on nephropathy. Therefore, it would have been obvious to one ordinary skilled in the art to combine Gopi et al. and Majeed 914 in order to lower the effects of diabetes on the progression of nephropathy and for maintaining normal kidney function, absence of evidence to the contrary. A person of ordinary skill in the art has a reasonable expectation of success in developing such a method motivated by the prior art.
With regards to the amounts of the components instantly claimed, the above references teaches the base line dosages for each of these components and it would have been obvious to a person of ordinary skill in the art to arrive at the instantly claimed amounts by routine optimization to get the most positive effects on nephropathy and kidney function. . It is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regards to instant claims 6, 13, 17 and 21 agents used in this combination is already known to be useful in reducing inflammation and are known in the art in the as antioxidants and as such reads on these claims.
Conclusion
Claims 1, 5-7, 8, 12-14, 16-18 and 20-22 are rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
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.
/SAVITHA M RAO/Primary Examiner, Art Unit 1691
Prosecution Insights