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 1-3, 6-9 and 11-13 are presented for examination.
The amendments and remarks filed on February 26, 2026 have been received and entered.
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) 1-3, 6-9 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pergolizzi et al. (WO 2012054831).
Regarding claim 1, Pergolizzi teaches a pharmaceutical composition for parenteral administration comprising: an aqueous solution comprising ketorolac or a pharmaceutically acceptable salt thereof in an amount from about 0.1 mg/mL to about 10 mg/mL; and a pharmaceutically acceptable excipient; wherein the formulation is substantially free of alcohol. See the abstract. Pergolizzi in Para [0004] teaches that Ketorolac tromethamine salt for intramuscular and intravenous administration is available at concentrations ranging from 1.5% (15 mg in 1 ml) to 3% (60 mg in 2 mis). The concentrations taught by Pergolizzi overlap and/or are very close to the claimed concentrations. The use of a liquid carrier is taught in claim 50. The use of ketorolac tromethamine is taught in Para [0028]. The use of arginine is taught in claim 63. The use of hydrochloric acid, acetic acid, citric acid, phosphoric acid, sulphuric acid, sodium hydroxide and sodium bicarbonate as pH regulators. See Para [0040]. The pH of 6.0-7.5, which is within the scope of the claimed pH of 6.0-9.0 is taught in Paras [0025], [0036] and claims 103- 104. The use of sodium chloride ad glucose as tonicity adjusting agent. See claim 17. Pergolizzi teaches the concentration of ketorolac tromethamine being 10 mg/ml, which is very close to the concentration of 11.25 mg/ml of the claimed composition. Pergolizzi also teaches the concentrations ranging from 1.5% (15 mg in 1 ml) to 3% (60 mg in 2 mis). Furthermore, the determination of optimum proportions or amounts are considered to be within the skill of artisan. Applicant's attention is drawn to In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), wherein the court stated "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."
Regarding claim 2, Pergolizzi teaches the use of arginine in general, which is the combination of D and L arginine.
Regarding claim 3, the determination of optimum proportions or amounts is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding, claim 6, Pergolizzi teaches the use of hydrochloric acid, acetic acid, citric acid, phosphoric acid, sulphuric acid, sodium hydroxide and sodium bicarbonate.
Regarding claim 7, Pergolizzi teach he osmolality of 270-330 mOsmol/kg, which is within the scope of the claimed osmolality of 200-500 mOsmol/kg. See Para [0062].
Regarding claim 8, Pergolizzi et al. teach the use of ketorolac, sodium chloride, ammonium acetate, , sodium phosphate, hydrochloric acid, sodium hydroxide and water. See Para 0078] and table 4. The injection is taught in Para [0004]. The parenteral administration is taught in Para [0009].
Regarding claim 9, Pergolizzi teaches all the components of the claimed invention being used in combination. Mixing the ingredients in order to obtain ketorolac liquid solution is the inherent property of Pergolizzi et al.
Regarding claim 11, the determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 12, Pergolizzi teaches the injection in Para [0004]. The parenteral administration is taught in Para [0009].
Regarding claim 13, Pergolizzi teaches Ketorolac has considerably higher analgesic and anti-inflammatory activity than many other non-steroid anti-inflammatory drugs. See Paras {0002] and [0003].
Response to Arguments
Applicant’s arguments and remarks have been noted. Applicant in his remarks argues that “First, Pergolizzi discloses formulations comprising ketorolac tromethamine, sodium chloride and other components, namely ammonium acetate, citric acid, disodium hydrogen phosphate, hydrochloric acid, sodium hydroxide, ethanol, trehalose and glucose. Pergolizzi does not disclose arginine or meglumine as the stabilizer.
Further, Pergolizzi discloses a concentration of ketorolac tromethamine ranging from 0.1 mg/mL to 10 mg/mL, and does not disclose the range of 30 mmol/L to 160.00 mmol/L (i.e., 11.25 mg/mL to 60 mg/mL). Pergolizzi provides a skilled artisan no rationale to increase the concentration of ketorolac tromethamine to the claimed range of 30 mmol/L to 160.00 mmol/L for the specific reasons set forth below.” It is the examiner’s position that Pergolizzi teaches the use of arginine as well. Although Pergolizzi teaches the concentration of 0.1 mg to10 mg/ml in one section of the document it also teaches in the background it teaches that injectable ketorolac can have the concentration of 15 mg/ml to 30 mg/ml. Applicant in his remarks further argues that “Examples 6 and 7 are within the scope of claim 1 and are in compliance with the requirements of the Chinese Pharmacopoeia (ChP) 2020 Edition and have good stability, which a person skilled in the art would not have expected based on the disclosure of Pergolizzi”. It is the examiner’s position that the composition of Pergolizzi also comprises arginine and the other components of the claimed invention. Therefore, it is expected that the composition of Pergolizzi to be clear and have the acceptable number of particles in the absence of evidence to the contrary. Additionally, the presented data are not commensurate in scope with the claimed language. The data uses one concentration of each component and a few components within the scope of the claimed. However, the claims are not limited to one component of each group and one concentration. Finally, there is no side by side comparison between the claimed composition and Pergolizzi’s composition.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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