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
Claims 1-6 and 13-22 are pending.
Response to Amendments/Arguments
Applicant’s 5/22/2026 amendments have overcome objections to drawings, objections to claims and 112b (claim 25 was cancelled) rejections. Therefore, arguments related to such will not be addressed.
Examiner acknowledges that claims 7-12 and 23-25 were cancelled in the 5/22/2026 claim set and consequently, all objections and rejections to such claims are moot.
The 102 rejection of claims 1, 5, and 13-18 is amended (as necessitated by amendment) and ultimately maintained below. The use of the transitional phrase “consisting essentially of” does not overcome the previous 102 rejection by Examiner. According to MPEP 2111.03(III): ‘The transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463’. There is no indication in the instant disclosure that the basic and novel characteristic of the claimed invention (administering PPARy agonist) is materially affected by the additional administration of a glucocorticoid. Therefore, the co-administration of a glucocorticoid is not limited by the instant claims.
The 103 rejections over claims 2-4, 6, and 19-22 have been amended (as necessitated by amendment) and ultimately maintained, as described below. Regarding Applicant’s arguments on p. 7 of the response, the instant claims use of the transitional phrase “consisting essentially of” is not solely drawn to monotherapy. Additionally, items may be included that do not clearly affect the basic and novel characteristic of the claimed invention (see argument in paragraph directly supra).
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.
Claim(s) 1, 5, 13, 14, 15, 16, 17, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Agrawal et al. (Scientific Reports, 2016, 6:24392, p. 1-9).
Regarding instant claims 1 and 13-15, Agrawal teaches that pioglitazone (a PPARy agonist and thiazolidinedione) can be used to treat nephrotic syndrome and enhances the beneficial effects of glucocorticoids (see title). “Glucocorticoids are the primary therapy for nephrotic syndrome (NS), but have serious side effects and are ineffective in ~20-50% of patients. Thiazolidinediones have recently been suggested to be renoprotective, and to modulate podocyte glucocorticoid-mediated nuclear receptor signaling” (see abstract). Specifically, regarding instant claim 9, Agrawal teaches the GC used in Animal Study Design was methylprednisolone (see Methods: Animal Study Design p. 7). Specifically, regarding instant claim 12, Agrawal discloses Pio [pioglitazone] with low dose GC in Figure 4B:
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.
Regarding instant claim 5, Agrawal explains the following: “While a single case report certainly cannot imply cause and effect, the addition of pioglitazone to the treatment regimen of the child [with glucocorticoids] with refractory NS was associated with clinically important improvements in his condition” (see p. 7, 3rd para.).
Regarding instant claim 16, Agrawal teaches administering 10 mg/kg of Pio, which would equate to 30 mg (within the instantly claimed range) for a 3 kg child.
Regarding claim 17, Agrawal teaches pioglitazone was found to significantly reduce puromycin aminonucleoside-induced proteinuria, a type of proteinuria (see abstract).
Regarding claim 18, Agrawal discloses the following table:
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, wherein all the levels treated with “Pio” were lower on Day 11 than the “PAN”. Additionally, “Pio +high dose GC” is almost to control levels at Day 11. Eleven days is within 5-7 months, as instantly claimed and claim 1 uses the transitional phrase “consisting essentially of”. According to MPEP 2111.03(III): ‘The transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463’. There is no indication in the instant disclosure that the basic and novel characteristic of the claimed invention (administering PPARy agonist) is materially affected by the additional administration of a glucocorticoid. Therefore, the co-administration of a glucocorticoid is not limited by the instant claims.
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 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) 6 and 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agrawal et al. (Scientific Reports, 2016, 6:24392, p. 1-9).
**The 102 rejection of claims 1, 5, 13, 14, 15, 16, 17, and 18 over Agrawal supra is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Agrawal teaches the treatment of a child with Pio + GC. Additionally, Agrawal fails to specifically disclose the following:
Wherein administering the PPARy agonist increases the level of serum albumin in the subject;
Wherein administering the PPARy agonist produces an immunosuppressive medication/glucocorticoid sparing effect;
Wherein NS is treated without any consequential adverse effects.
Regarding albumin levels, Agrawal teaches that after the treatment (Pio + GC), the need for albumin infusions was eliminated (see p. 6, third para.).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Agrawal fails to disclose the age of the child. Additional dependent limitations will be addressed below.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claim 6, it would have been obvious to a PHOSITA to explore the age range of 1-12 with a reasonable expectation of success because a “child” was successfully treated. The total age range of being a child is 1-17, with 1-12 falling within that range. “In the case where the claimed ranges ’overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I). As a result of routine optimization, a PHOSITA would have been motivated to treat a pediatric subject that has an age from 1-12 years, as needed.
Regarding instant claim 19, it would have been obvious to a PHOSITA that serum albumin was increased in the subject post PPARy agonist. Additionally, claim 1, from which claim 19 depends uses the transitional phrase “consisting essentially of” which does not eliminate the administration of another agent (including GC) because there is no indication that this materially affects the invention. If the need for albumin infusions was eliminated by the prior art treatment, a skilled artisan would have been motivated to investigate the successful replenishment of serum albumin in the subject.
Regarding instant claims 20-21, it would have been obvious to a PHOSITA that there was an immunosuppressive medication/glucocorticoid sparing effect because treatment was effect with Pio + lower than standard therapy GC (see Table 1 supra). The effectiveness of treatment while being able to lower GC (immunosuppressive medication) would imply to a skilled artisan that the GC was being spared in the subject. Additionally, regarding instant claim 22, Agrawal does not teach consequential adverse effects of the treatment of claim 1. Therefore, a skilled artisan would have a reasonable expectation of success that such a treatment would result without any consequential adverse effects.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agrawal et al. (Scientific Reports, 2016, 6:24392, p. 1-9), in view of Dakshayani et al. (Turk Pediatri Ars, 2018; 53: 24-30—disclosed on 4/12/2024 IDS).
**The 102 rejection of claims 1, 5, 13, 14, 15, 16, 17, and 18 over Agrawal supra is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Agrawal fails to disclose treatment of nephrotic syndrome that is steroid-dependent nephrotic syndrome (SDNS) or frequent relapsing nephrotic syndrome (FRNS).
Dakshayani discloses steroid-dependent nephrotic syndrome and frequent relapsing nephrotic syndrome (NS is steroid-dependent; NS with frequent relapses—see p. 24, 1st column, 1st para.) “The majority of children have steroid-sensitive nephrotic syndrome (SSNS). Although SSNS has a favorable long-term outcome, about half of all patients with SSNS become frequent relapsers and or steroid dependent and may experience several adverse effects secondary to the disease or its treatment” (p. 24, 1st column).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
There is not a single embodiment in the art of treating SDNS or FRNS with a PPARy agonist.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 2-3, it would have been obvious to a PHOSITA to explore treatment of both SDNS and/or FRNS with a PPARy agonist as both types of nephrotic syndrome are common and disruptive to patients. A skilled artisan would have been motivated to explore a successful nephrotic syndrome treatment on both the specific types: SDNS and FRNS, with a reasonable expectation of success in treatment efficacy.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agrawal et al. (Scientific Reports, 2016, 6:24392, p. 1-9), in view of Troost et al. (Clinical Kidney Journal, 2020, vol. 13, no. 4, 597-606—disclosed on 4/12/2024 IDS).
**The 102 rejection of claims 1, 5, 13, 14, 15, 16, 17, and 18 over Agrawal supra is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Agrawal fails to disclose treatment of nephrotic syndrome wherein the subject has focal segmental glomerulosclerosis. Agrawal also fails to disclose wherein administering the PPARy agonist produces an improvement in PROs in the subject or an improvement in edema.
Troost teaches: “Focal segmental glomerulosclerosis (FSGS) is a common cause of nephrotic syndrome, frequently chronic and progressive in nature, and accounts for ~12% of children and 3% of adults with incident end-stage kidney disease in the USA” (see p. 599, left column).
Troost discloses an improvement in PROs including physical, mental, social and global health with NS treatment (see p. 599, 2nd column, 3rd para. Table 2). Troost additionally teaches the following regarding edema: “children with edema had significantly worse mobility, fatigue, pain interference and anxiety when compared to children with no edema” (see p. 603, 2nd column, 4th para.).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
There is not a single embodiment in the art of treating nephrotic syndrome with a PPARy agonist, wherein the subject has focal segmental glomerulosclerosis. Additional dependent limitations will be addressed below.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claim 4, it would have been obvious to a PHOSITA to explore successfully demonstrated nephrotic syndrome treatment to a subject who has focal segmental glomerulosclerosis because focal segmental glomerulosclerosis is a known common cause of NS. A skilled artisan would have been motivated to explore treatment of NS for a patient who already has the cause of focal segmental glomerulosclerosis with a reasonable expectation of success in treatment efficacy.
Conclusion
Applicant’s amendments necessitated the new ground(s) of rejection presented in this Office Action. Accordingly, THIS ACTION IS MADE FINAL. 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 extension fee 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 MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
/KAMAL A SAEED/ Primary Examiner, Art Unit 1626
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