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 .
Status of the Claims
This Office Action is in response to Applicant's Restriction Requirement remarks filed on April 23, 2026. Claim(s) 1-13 and 34-40 are pending. Claim(s) 7-14 and 18-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant's election of species of nephrotic syndrome(disease) and lobeglitazone (thiazolidinedione) without traverse of the restriction requirement in the reply is acknowledged. The requirement is deemed proper and is therefore made FINAL. The elected species was found free of the art, therefore the search was expanded to a genus encompassing the elected specie. The specie requirement is hereby withdrawn. Claim(s) 1-13 and 34-40 are examined herein insofar as they read on the elected invention.
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.
Claims 1, 4-6, 8, 10, 11, 36, and 37 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Liu (Nephrology, 2010) of record.
Liu teaches thiazolidinedione (TZD) reduces proteinuria and glomerulosclerosis in focal segmental glomerulosclerosis (FSGS) by preserving the structure and function of SD (abstract; Figures 1-3).
Liu teaches glomerular SI and podocyte foot PFR were significantly attenuated by rosiglitazone treatment. Rosiglitazone prevented the reduction of nephrin, podocin and CD2AP protein expression induced by Adriamycin, however, the mRNA expression levels of these SD-related markers did not change significantly (abstract).
Liu concludes the study data suggest that TZD are promising therapeutic agents on FSGS (abstract; page 77, column 2, Results).
Based on the foregoing reasons, the instant claims are deemed unpatentable over the cited art.
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.
Claims 1, 4-12 and 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over Ranganathan (US 10,953,049).
Ranganathan teaches a method for maintaining or improving kidney function and improving quality of life in a patient with reduced renal function comprising (a) administering to a patient suffering from a disease that results in reduced renal function an effective amount of a composition comprising xylooligosaccharide, inulin and 45 billion colony-forming units of probiotic bacteria consisting of Streptococcus thermophilus, Lactobacillus acidophilus, and Bifidobacterium longum, in combination with (b) standard of care treatment selected from the group consisting of insulin, metformin, pioglitazone, rosiglitazone, glipizide, sitagliptin, dapagliflozin, an anti-hypertensive agent, an anti-inflammatory agent, an antibacterial agent, hemodialysis, peritoneal dialysis or a combination thereof; thereby maintaining or improving kidney function and improving quality of life in the patient, wherein kidney function improvement comprises at least a 2 mL/min increase in glomerular filtration rate and quality of life improvement is selected from the group consisting of increased energy level, increased social interactions, increased vigor, improved appetite, improved cognitive function, improved ability to work, or a combination thereof.
Ranganathan teaches diseases contemplated for combination treatment with RENADYL™ and the standard of care include but would not be limited to those with diabetic nephropathy, hypertensive nephrosclerosis, glomerulonephritis, interstitial nephritis, or polycystic kidney disease wherein nephron function is impaired thereby decreasing glomerular filtration rate (column 4, lines 15-20).
The difference between Ranganathan and the claimed invention is that it does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831,15 USPQ2d 1566 (Fed. Cir. 1990)).
However, based on the above, Ranganathan teaches the elements of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Therefore, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited art.
Claims 1-13 and 34-39 are rejected under 35 U.S.C. 103 as being unpatentable over Sporn (WO 2009089545).
Sporn teaches a method for treating renal/kidney disease (RKD), insulin resistance, diabetes, endothelial dysfunction, fatty liver disease, or cardiovascular disease (CVD) in a subject comprising, administering to said subject a pharmaceutically effective amount of a compound as recited in claim 1 and a second drug (claim 1), wherein the RKD is diabetic nephropathy (DN) (claim3).
Sporn teaches a method for improving glomerular filtration rate administering to said subject a pharmaceutically effective amount of a compound as recited in claim 36 and a second drug (claim 67).
Sporn teaches wherein the second drug is a thiazolidinedione (TZD) (claim 78), selected from pioglitazone, rosiglitazone or troglitazone (claim 79).
The difference between Sporn and the claimed invention is that it does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831,15 USPQ2d 1566 (Fed. Cir. 1990)).
However, based on the above, Sporn teaches the elements of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Regarding claims 2, 38 and 40, Sporn does not teach the TZD as lobeglitazone.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the TZDs as taught by Sporn in the treatment of improving glomerular filtration and substituted another TZD, such as lobeglitazone. The skilled artisan would have found a reasonable expectation of success with the substitution of one TZD over another, absent secondary considerations.
Therefore, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited art.
Conclusion
Claims 1-13 and 34-40 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
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/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
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