DETAILED ACTION
Notice of Pre-AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
The amendments filed 12/17/2025 have been entered.
Response to Arguments
Applicant’s arguments, filed 12/17/2025, have been fully considered.
The objections to the claims, as well as the rejections of claims under 35 U.S.C. 112, fourth paragraph, and 102(b) are WITHDRAWN in view of Applicant’s amendments to the claims.
Claims 1, 3-12 and 14-15 are NEWLY REJECTED under 35 U.S.C. 103(a) and MAINTAINED rejected on the grounds of non-statutory double patenting, which Applicant does not traverse.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1, 3-12 and 14-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Lee et al (US 2003/0191187).
As amended, claim 1 is drawn to a pharmaceutical composition for parenteral administration comprising:
(a) an aqueous solution comprising ketorolac or a pharmaceutically acceptable salt thereof (more specifically, ketorolac tromethamine (claim 15)) in an amount from about 0.1 mg/mL to about 10 mg/mL (more specifically, from about 0.1 to about 1 mg/mL (claims 11-12)); and
(b) a pharmaceutically acceptable excipient selected from sodium chloride, dextrose, sucrose, xylitol, fructose, glycerol, sorbitol, mannitol, potassium chloride, mannose, calcium chloride, and magnesium chloride;
wherein the composition:
is free of alcohol;
has a pH from about 4.5 to about 8.5 (more specifically, about 6.9 to about 7.5 (claim 14)); and
maintains at least 90% of the amount of ketorolac or a pharmaceutically acceptable salt thereof after storage for 6 months at 25oC (more specifically, at least 98% after storage for 2 years (claims 3-10)); and
wherein the composition is contained in a pharmaceutically acceptable container selected from the group consisting of intravenous bags and intravenous bottles.
Lee et al teach “a stable pharmaceutical composition... particularly suitable for parenteral injection such as intravenous... injection” (Abstract), specifically disclosing a “Pharmaceutical Composition of the Present Invention” at Paragraph 0057, Example 1 comprising:
(a) an aqueous solution comprising 1800 g ketorolac tromethamine in 60 L water (i.e., 30 mg/mL ketorolac tromethamine); and
(b) 261 g NaCl;
wherein the composition:
is free of alcohol (see also Paragraph 0020: “[t]he stable pharmaceutical composition does not contain alcohol”); and
“the pH of the solution [is] 6.9 ~ 7.9” (Paragraph 0061); and
wherein the composition is contained in “a sterile container, such as an ampoule or vial” (Paragraph 0065) and “sterilize[d]” (Paragraph 0066).
As such, the pharmaceutical composition of Lee et al differs from the instantly claimed pharmaceutical composition in that:
(i) Example 1 comprises 30 mg/mL ketorolac tromethamine as opposed to about 0.1 mg/mL to about 10 mg/mL; and
(ii) Lee et al does not specify that the stable pharmaceutical composition maintains at least 90% of the amount of ketorolac or a pharmaceutically acceptable salt thereof after storage for 6 months at 25oC (and, more specifically, at least 98% after storage for 2 years).
Yet, as to (i): as generically taught by Lee et al, the “stable pharmaceutical composition... contains... about 0.1 to 15% by weight of an acetic acid class of a non-steroidal anti-inflammatory drug (NSAID)” (Paragraph 0018) wherein “[t]he preferred NSAID is ketorolac, particularly ketorolac tromethamine” (Paragraph 0019), which is equivalent to about 1 mg/mL to 150 mg/mL.
As discussed by MPEP 2144.05, “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” (citing In re Wertheim, 541 F.2d 257 (CCPA 1976); In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465 (Fed. Cir. 1997)).
And, as to (ii): although it is recognized that “[i]nherency may not be established by probabilities or possibilities” (In re Robertson, 169 F.3d 743 (Fed. Cir. 1999)), Applicant is also reminded that the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent Applicant may present previously unmeasured characteristics. When, as here, the prior art appears to contain the exact same elements as those instantly claimed, the burden is properly shifted to Applicant to show otherwise. As stated in In re Best, Bolton, and Shaw, “[w]here… the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product" 562 F2d 1252 (CCPA 1977). In the instant case, the claimed and prior art products are substantially identical. As such, absent evidence to the contrary, it is asserted that the “stable” pharmaceutical composition comprising an aqueous solution comprising ketorolac tromethamine in the recited amount and a pharmaceutically acceptable excipient (i.e., sodium chloride) taught by Lee et al would necessarily maintain at least 98% of the amount of ketorolac tromethamine after storage for 2 years at 25oC, as instantly claimed. See also In re Fitzgerald 619 F2d 67 (CCPA 1980): the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on.”
In view of all of the foregoing, claims 1, 3-12 and 14-15 are rejected as prima facie obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-12 and 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 9,421,191.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘191 claims are similarly drawn to a pharmaceutical composition for parenteral administration comprising ketorolac, which are recited to be free of alcohol.
Claims 1, 3-12 and 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,116,750.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘750 claims are similarly drawn to a pharmaceutical composition for parenteral administration comprising ketorolac, which are recited to be free of ethanol.
Conclusion
The new ground(s) of rejection presented in this Office action are necessitated by Applicant’s amendments to the claims. 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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