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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 22, 2025 has been entered.
Priority
Support for the limitations of a projected treatment period of 36 month and stable eGFR over the projected treatment periods of at least 100 weeks or 36 months as recited in claims 1 and 29 is not found within Provisional Applications 63/245,779, 63/246,765, or 63/138,325. Should Applicant disagree with the analysis above, they must point to the location with the Provisional Applications where the limitations are presented.
Claim 1 and claims 24-26, 32, 34, 35, 37, and 38, which depend from claim 1, are given priority date of Jan 14, 2022.
Election/Restrictions
Applicant’s election without traverse of Group XI, corresponding to claims 1-5, 17, 20, 22, and 24-27, in the reply filed on Jan 22, 2024 is acknowledged.
Claim Objections
Claim 38 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 37. The two claims differ in that claim 38 lacks the phrase “after the start of the treatment period” following the limitation “about 12 months”. However, “the treatment period from about 12 months” in claim 38 is understood to mean from about 12 months from the start of the treatment period as recited in 37. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 1, 24-26, 32, 34, 35, 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over the AURORA2 Clinical Trial Listing (NCT03597464; Published: Aug 14, 2018), as evidenced by Rovin et al. (The Lancet. 397(10289): P2070-2080: Published: May 29, 2021; Non-Patent Literature Document #264 on the IDS dated 11/20/2023), in view of the Lupkynis Prescribing Information (Published: January 22, 2021).
Claim 1 recites treating lupus nephritis in a human by administering 23.7mg BID voclosporin over a treatment period of at least 100 weeks, the AURORA2 clinical trial listing teaches administering 23.7 mg BID voclosporin to lupus nephritis patients; see Arms and Interventions. Regarding the duration of the treatment period in claims 1 and 26, this long-term safety and tolerability study assessed the use of voclosporin enrolled patients from the 52-week long AURORA trial for an additional 24 months of treatment; see Study Description. In total, the patients were treated for 3 years or 156 weeks or 36 months. Regarding claims 24 and 25, the Study Description teaches that subjects will continue to receive MMF and a corticosteroid.
The AURORA2 Clinical trial listing does not teach assessing the eGFR every 3 months after the first 12 months.
The AURORA2 trial is an extension or continuation of the AURORA1 trial; see Study Description. The AURORA2 Clinical trial listing states the change in eGFR from AURORA1 baseline to up to 37 months and the proportion of subjects in renal response at months 12, 18, 24, 30, and 36 are secondary outcome measures. Because the AURORA2 trial is a two-year extension of the one-year AURORA1 trial, the months for renal response are from the AURORA1 baseline. Rovin et al. evidences that complete renal response is a composite which includes UPCR of 0.5 mg/mg or less and eGFR of 60 mL per min or more, or no confirmed eGFR decrease of more than 20% from baseline; see pages 2072-2073. Thus, the AURORA2 Clinical Trial Listing, as evidenced by Rovin et al., teaches measuring eGFR every 6 months.
The Lupkynis Prescribing Information teaches assessing eGFR every two weeks for the first month and every four weeks thereafter; see Dosage Recommendations.
It would have been obvious to one of ordinary skill in the art and one would have had a reasonable expectation of success to assess eGFR at any time in the interval of every one month, as taught by the Lupkynis Prescribing Information, to every six months, as taught by the AURORA2 Clinical Trial Listing. Claim 1, from which claims 32, 34, 35, 37, and 38 depend, requires only two steps – 1. assessing eGFR every 3 months after 12 months of treatment and 2. administering 23.7 mg BID voclosporin to a human with lupus nephritis for the treatment period duration. The limitations of eGFR during the treatment period as recited in claims 1, 32, 34, 35, 37, and 38 necessarily flow from the method of claim 1.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art
before the effective filing date of the application, as evidenced by the references.
Claims 1, 24-26, 32, 34, 35, 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Saxena et al. (ACR Convergence 2021 Abstract Number 1425; Published: November 8, 2021).
Regarding claims 1 and 24-26, Saxena et al. teaches that human patients with lupus nephritis were treated with 23.7 mg BID voclosporin in combination with MMF and low-dose steroids for 30 months with intent to treat for 36 months (12 months in AURORA1 and two years in AURORA2); see Methods. Regarding the step of assessing every 3 months after 12 months of treatment, Figure 2 demonstrates that eGFR remained stable at about 80 mL/min/1.73m2 for 30 months with data points at every 3-month interval.
Saxena et al. does not teach assessing eGFR every 3 months for a 36-month treatment period; instead the reference only teaches measuring eGFR for 30 months. However, it would have been obvious to one of ordinary skill in the art and one would have had a reasonable expectation of success to continue the 3 month eGFR assessment interval for two more assessments to reach the conclusion of the 36 month total treatment period. Claim 1, from which claims 32, 34, 35, 37, and 38 depend, requires only two steps – 1. assessing eGFR every 3 months after 12 months of treatment and 2. administering 23.7 mg BID voclosporin to a human with lupus nephritis for the treatment period duration. The limitations of eGFR during the treatment period as recited in claims 1, 32, 34, 35, 37, and 38 necessarily flow from the method of claim 1.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art
before the effective filing date of the application, as evidenced by the references.
Response to Arguments
Applicant’s amendments filed October 22, 2025 are acknowledged. Any rejection not repeated above is resolved by amendment.
The rejection under 35 U.S.C. 102(a)(1) has been overcome by amendment. The AURORA2 clinical trial does not teach assessing eGFR every 3 months after the first 12 months of the treatment period. New rejections under 35 U.S.C. 103 are set forth to address the amended claims.
Regarding the nonstatutory double patenting rejection over the claims of U.S. Patent Nos. 10,286,036 and 11,622,991, Applicant has amendments the claims such that all claims require a treatment period of at least 36 months. The declaration under 35 U.S.C. 1.132 from Gregory F. Keenan M.D. filed June 16, 2024 demonstrated that stable eGFR over a 36-month period is an unexpected result. No claims in U.S. Patent Nos. 10,286,036 and 11,622,991 teach treating for 36 months and the AURORA2 Clinical Trial listing was relied upon in an obviousness type nonstatutory double patenting rejection. Since Applicant has amended all claims to require stable eGFR over a treatment period of 36 months, for which Applicant has demonstrated unexpected results, the rejections of the claims of U.S. Patent Nos. 10,286,036 and 11,622,991 are withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Naughton (American Family Physician. 78(6): 743-750; Published: Sep 15, 2008) teaches clinical recommendations for managing drug-induced nephrotoxicity including calcineurin inhibitors and the use of the Cockcroft-Gault formula as a preventative measure for monitoring drug-induced nephrotoxicity; pages 744-745 and 748.
Lupus.net (Kidney Transplant; Published: Jan 2, 2020) teaches that a significant proportion of lupus nephritis patients will progress to end-stage kidney failure and require a kidney transplant.
Rovin et al. (Kidney International. 95: 219-223; Published: November 9, 2018) teaches measuring eGFR every 4 months during the first year of treatment; see Figure 5.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE ANN HOLTZMAN whose telephone number is (571)270-0252. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm MT.
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/KATHERINE ANN HOLTZMAN/Examiner, Art Unit 1646
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645
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