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
Per Applicant’s amendment to the claims, submitted on 02/25/2026, claims 6-7 and 15-16 are amended. Currently, claims 1-20 are pending in the instant application.
Terminal Disclaimer
Applicant has filed Terminal Disclaimer over the claims of applications 18/437,931, 18/999,662, and 19/202,994. Further Terminal Disclaimer has been filed over the claims of commonly owned patents 12,133,837, 11,207,280, 10,653,646, and 11,071,719.
Claim Objections
Claims 6-9, and 11-20 are objected to as being dependent upon previously rejected claims (Claims 1 and 10), but would be in allowable condition pending allowability of the parent claims.
Claim Rejections - 35 USC § 112 Second Paragraph - Withdrawn
Rejections of claims 6-7 and 15-16:
In light of Applicant’s amendment to the claims, the rejections are hereby withdrawn.
Claim Rejections - 35 USC § 112 Second Paragraph - Maintained
Rejections of claims 1-5, and 10:
Applicant’s arguments are not persuasive, the rejections are hereby maintained. Applicant contends that the functional language as recited in the instant claims is acceptable per MPEP 2173.05(g) (Remarks page 5, paragraph 2). Examiner respectfully disagrees. Applicant indicates that the citation in re barr regarding a radical on a chemical compound as "incapable of forming a dye with said oxidizing developing agent" is exemplary as to why the recitation of the instant claim would be acceptable functional language. However, the citation cannot be held as analogous to the recitation of the instant claims “wherein sterilization increases S-isomer content to no more than” or “wherein sterilization increases total impurities content to no more than”. The reason being that the recitation in claims 1-5 and 10 are drawn explicitly to the result of the sterilization process rather than the structure of the composition. In the provided citation of re barr, the compound in question is described by a functional description of an attached radical. By implicating the autoclaving/sterilization process with a claimed result, Applicant has created an ambiguity in said process wherein a person of ordinary skill in the art would not reasonably be able to understand how the desired result is achieved. This rejection may be overcome by amending the claim language to a form more similar to claims 6-7 and 15-16 wherein the property is applied to the structure of the composition rather than the process, and/or amending the claims such that the autoclaving process is specified for temperature and time.
The maintained rejections will be reiterated below for the purpose of record and clarity.
Claim Rejections - 35 USC § 112 First Paragraph - Withdrawn
Rejections of claims 1, 10, and 20:
Applicant’s arguments are persuasive. The rejections are hereby withdrawn. The disclosure at least provides that suitable chelators are at least linked structurally to compounds containing bicarboxylic, tricarboxylic, and aminopolycarboxylic acids (specification [0031])1.
Double Patenting - Withdrawn
Rejections of claims 1-17:
In light of Applicant’s submission of Terminal Disclaimer, the rejections are hereby withdrawn. Applicant has overcome the outstanding rejections by submission of terminal disclaimer over the indicated copending applications and commonly owned and issued patents.
Allowable Subject Matter
The prior art does not teach or reasonably suggest the compositions of the instant claims. The closest prior art is Sanghvi (US 20170189352 A1). While the claims contain allowable subject matter, they are not currently in allowable form (see 112(b) rejections and claim objections above).
Sanghvi teaches epinephrine compositions, and methods of making such compositions. Of particular relevance to the instant claims is the following exemplary formulation 2 (specification [0219]):
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As can be seen from the above table, the formulation of Sanghvi comprises epinephrine which is indicated as L-epinephrine (i.e., R-epinephrine), and the metal ion chelator disodium edetate (EDTA). Epinephrine is present in the formulation at 0.114 mg/ml, while EDTA is present at 0.02 mg/ml (20 ug/ml). While the amount of EDTA in formulation meets the limitations of claims 1 and 10 (1-50 ug/ml of chelator), Sanghvi does not appear to provide any suggestion or rationale to decrease the epinephrine concentration to 0.07 mg/ml or lower. Sanghvi provides six exemplary formulations (specification [0219]) such as the above, with differing excipient amounts, but each having the same 0.114 mg/ml epinephrine concentration. Furthermore, Sanghvi is silent with regards to autoclave sterilization of compositions, or controlling the dissolved oxygen content of the formulations.
Conclusion
Claims 1-5 and 10 are rejected.
Claims 6-9, and 11-20 are objected to.
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.
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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 “Moreover, in further contemplated aspects, the ready-to-administer epinephrine composition will also include one or more chelating agents, and particularly metal ion chelators to slow down the baseline and metal ion-stimulated autoxidation of epinephrine. For example, suitable chelators include various bicarboxylic acids, tricarboxylic acids, and aminopolycarboxylic acids such as ethylenediaminetetraacetic acid (EDTA), ethylene glycol- bis(P-aminoethyl ether)-N,N,N',N'-tetraacetic acid (EGTA), and penta(carboxymethyl)diethylenetriamine (DTPA), and salts and hydrates thereof.”