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 .
Claims 1 and 4-8 have undergone amendments. Claims 9-11, 15-18, 20, and 23 have been cancelled. Claims 24 and 25 are newly added. Thus, Claims 1, 4-8, 12-14, and 24-25, submitted on 29 January 2026, represent all claims currently under consideration.
Information Disclosure Statement
One Information Disclosure Statement (IDS), submitted on 29 January 2026, is acknowledged and has been considered.
Response to Amendment
The objection to Claim 8 is withdrawn. Applicant has amended claim 8 to incorporate the word “inhibitor” following “intracellular calcium”.
The 35 U.S.C. § 112(a) rejection of Claims 9-11 and 23 is withdrawn. Applicant has cancelled Claims 9-11 and 23, rendering the rejection moot.
The 35 U.S.C. § 112(a) rejection of Claims 15-17 is withdrawn. Applicant has cancelled Claims 15-17, rendering the rejection moot.
The 35 U.S.C. § 112(a) rejection of Claim 18 is withdrawn. Applicant has cancelled claim 18, rendering the rejection moot.
The 35 U.S.C § 102(a)(1) rejections of Claims 1, 4-10, 12-14, and 20 and 1, 4-10, 12-14, 16, 18, and 20 over Miller and Basile are each withdrawn. Applicant has amended Claim 1 to include the limitations of “once daily” and “formulated as a unit dosage form”, which is not taught by either Miller or Basile. However, a new grounds of rejection is made over Miller in view of Loftsson as applicant has amended the claims to incorporate a new treatment regimen not found in the previous set of claims.
The 35 U.S.C. § 102(a)(1) rejection of Claim 20 over Velicelbi is withdrawn. Applicant has cancelled Claim 20, rendering the rejection moot.
The 35 U.S.C. § 103 rejection of Claims 1, 4-18, 20, and 23 over Velicelbi in view of Cao, Basile, Greenberg, and Noel is withdrawn. Applicant has amended Claim 1 to incorporate the limitations of Claim 10 into Claim 1, which is not taught by these references.
Claim Rejections - 35 USC § 103- NEW GROUNDS OF REJECTION
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4-8, 12-14, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (Annals of Emergency Medicine, Vol. 74, No. 4, 1 October 2019) in view of Loftsson (Essential Pharmacokinetics, Chapter 5-Pharmacologic Response and Drug Dosage Adjustments, Pages 119-130, Volume 1, 2015).
Miller (See IDS, 9 March 2023) discloses the intracellular calcium signaling inhibitor CM4620 (also known as auxora, the compound of examined Claim 1) in the form of an injectable emulsion (a unit dosage form) which reduces the development of acute kidney injury in patients with acute pancreatitis (Table 1). The drug is administered 1.0 mg/kg on day 1 and 1.4 mg/kg on Days 2-4 in phase 1. In phase 2, females received the same dosages as in phase 1, while males received 2.08 mg/kg on days 1-2 and 1.6 mg/kg on days 3-4 of the injectable emulsion. These data are identical to those presented in Example 2 of the specification of the examined application (Paragraph 00186). The data of Miller (Table 1), and of the specification, show that within the sub-group which received the placebo, 20% of patients developed acute kidney injury, while the sub-group receiving injectable emulsions of auxora only had 8% of patients develop acute kidney injury.
Miller does not explicitly state that the injectable emulsion is administered once daily.
Loftsson teaches dosing of pharmaceuticals and that drugs are administered on the basis of their average pharmacokinetic parameters in normal patient populations (Page 119). Many drugs have a wide therapeutic window and can easily remain within their therapeutic window (Page 119). Pharmacodynamics describes the relationship between drug concentration at the receptor and the drug effect, with the receptor being a well-defined place within the body, or on or within the surface of a microorganism within the body (Section 5.3, Pharmacodynamics). The relationship between drug concentration and drug effect is shown in Figure 5.2A; at high drug concentrations, the drug effect approaches a maximum value where 100% drug response is obtained. At this concentration, virtually all receptors have formed a drug-receptor complex. This relationship is sigmoidal (Section 5.3, Pharmacodynamics).
Miller and Loftsson are considered analogous to the claimed invention as all are involved in the field of pharmaceutics and administration of pharmaceuticals to patients in need of treatment. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to modify the method of treating acute kidney injury disclosed by Miller by administering the injectable emulsion of CM4620 once daily as dosage adjustments are routine in the pharmaceutical arts. The skilled artisan, a medical doctor, would have extensive training in pharmacokinetics, pharmacodynamics, and the use of therapeutics in the treatment of disease, and would recognize that Miller demonstrates that CM4620 is effective in both the treatment and prevention of acute kidney injury, and would be motivated to adjust dosages to require a single daily dose to increase patient compliance, leading to improved outcomes.
Regarding Claims 4-8, CM4620 inherently possesses these properties and as such, when administered through the method of Miller, will inhibit each of these channels.
Regarding Claims 24 and 25, the data presented by Miller demonstrate a reduction in acute kidney injury, and thus, provide a reasonable expectation of success that using this method would be effective in the treatment of different stages of acute kidney injury. This reduction also provides a motivation and reasonable expectation of success in applying this method in patients who are at risk of developing chronic kidney disease, or end-stage renal disease due to the demonstrated efficacy in preventing acute kidney injury.
Conclusion
Claims 1, 4-8, 12-14, and 24-25 are rejected.
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 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 PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625