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 Claims
Claims 1-20 are currently amended, pending, and under examination.
Priority
This application is a 371 of PCT/US2022/080492, filed on 11/28/2022. It claims priority to parent U.S provisional application No. 63/286,029, filed on 12/04/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/05/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 7, 9, 17, and 19 are objected to because of the following informalities:
Claims 7 and 17 should say "further comprises" rather than merely “comprises’”.
Claims 9 and 19 repeats the statement "not more than" consecutively. Only one recitation of this is needed.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “room temperature” in claims 1, 8, 14, and 18 is a relative term which renders the claim indefinite. The term “room temperature” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purpose of examination, It will be assumed that the term “room temperature” refers to any temperature ranging from 25 ° C to 40 ° C (with 40° C referred to as the storage conditions in present claims 9 and 19).
Claims 2-7, 9-13, 15-17, and 19-20 are also indefinite for being dependent to claim 1 or 14.
The term “about” in claims 1-2, 4-5, 7-9, 14-15, 17-19 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purpose of examination, It will be assumed that the term “about” imposes a variability of ±10% to each of the values it refers to.
Claims 3, 6, 10-13, 16 and 20 are also indefinite for being dependent to claim 1 or 14.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
For the purposes of searching for and applying prior art, the term "consisting essentially of" will be construed as equivalent to "comprising”, as applicant has not demonstrated that adding additional excipients would materially affect the basic and novel characteristic of the claimed invention. If applicant contends that additional steps or materials in the prior art are excluded by the recitation of "consisting essentially of," applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of the claimed invention. See MPEP 2111.03.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Puri et al. (US20180214394A1) in view of Shao et al. (CN101053557A).
Puri et al. discloses compositions and methods for ready-to-inject norepinephrine compositions with improved stability [¶abstract]. Puri et al. provides non-limiting examples (embodiments) of the invention [¶30]. In some embodiments [¶33, table 4, Formulations I-IX], Puri et al. discuses compositions containing 0.016 mg/mL Norepinephrine Bitartrate, pH ranging from 3.0-3.8, sodium chloride, 10 mM of citrate buffer. This example does not include an aminopolycarboxylic acid and/or a sulfite. In another embodiment [¶35, table 7, formulation X], Puri et al. teaches such Norepinephrine Bitartrate formulations having a pH drift from 3.5 to 3.65 after 6 months of storage (25 ± 2° C. / 60 + 5 % RH), and a maximal pH drift from 3.5 to 3.66 after 6 months of storage (40 ± 2° C. / 75 + 5 % RH), both drifts being less than 0.3 pH units. Puri et al. teaches that with respect to stability of the composition, the storage condition can be at least three months at 40° C, and 75% (+/−5) relative humidity, and that equal or less than 6% of the R-isomer form will isomerize to the S-isomer, and/or that equal or less than 3.5% of the total norepinephrine will degrade to degradation products (i.e., impurities), with such degradation measured by HPLC [¶¶16, 19]. Puri et al. further reiterates that the composition may be stable for at least 3 months accelerated storage conditions such as 40° C. and 75% relative humidity [¶19], which obviates long-term stability at lower (and thus less destabilizing) storage temperatures (e.g., 20-25° C.) for periods such as 9 months or more. Puri et al. teaches the formulations contemplated herein can also be filtered through a 0.22-micron filter, and filled in to a polyethylene, polypropylene or low-density polyethylene (all being polyolefin) containers in a blow-fill-seal (BFS) process [¶28]. Puri et al. teaches that BFS is a form of advanced aseptic manufacturing wherein the container is formed, filled, and sealed in one continuous system [¶28]. Puri et al. teaches that the formulations may be filled in large volume polymeric, semi-permeable infusion containers (e.g., BFS container or flexible IV bags), the containers can optionally be additionally layered or covered with a secondary packaging system including an aluminum pouch and other oxygen scavengers/absorbers [¶29].
However, Puri et al. fails to teach the presence of arginine in such formulations.
Shao et al. discloses a medicine and preparation field, in detail, an injection of anti-shock blood vessel medicine combination bitartrate noradrenaline freeze-dry powder injection and its producing method [¶abstract]. Shao et al. teaches that the inventive bitartrate noradrenaline freeze-dry powder injection is composed of bitartrate noradrenaline and medical acceptable carrier component, wherein said medically acceptable carrier may be L-arginine [¶abstract]. In a single embodiment [embodiment 1], Shao et al. discloses a preparation of norepinephrine bitartrate composition lyophilized powder comprising: Noradrenaline (norepinephrine) bitartrate at 2g, Mannitol at 30g (an osmotic agent), L-arginine at 1g (i.e., 1 mg/mL), and water for injection at 1000ml.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the L-arginine taught by Shao et al. into the stable norepinephrine bitartrate formulations of Puri et al. This is because Shao et al. teaches L-arginine as a pharmaceutically acceptable carrier for norepinephrine bitartrate and demonstrates a formulation containing both components. Substituting or adding one known pharmaceutically acceptable excipient for another represents routine optimization of result-effective variables according to their established functions and would have led to no more than predictable results, with a reasonable expectation of success based on Shao et al.’s demonstrated compatibility of L-arginine and norepinephrine bitartrate for injectables.
Conclusions
No claim is found allowable.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/ Primary Examiner, Art Unit 1613
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