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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 27, 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amended claim 1 is directed to a solid oral composition comprising a synergistic combination of i) S-ketorolac or a pharmaceutically acceptable salt thereof in an amount of about 10 mg; ii) pregabalin or its pharmaceutically acceptable salt in an amount of about 316 10 mg; and iii) a pharmaceutically acceptable carrier and/or excipient, wherein the weight ratio of the pregabalin or a pharmaceutically acceptable salt thereof to the S-ketorolac in base form or salt thereof is approximately 31.6: 1. .
The originally filed specification generally provides a solid oral composition comprising i) S-keratolac or a pharmaceutically acceptable salt thereof and ii) pregabalin or its pharmaceutically acceptable salt thereof and iii) a pharmaceutically acceptable carrier and/or excipient. The concentrations of the drugs are provided in approximate ranges in mg (e.g., approximately 0.001 to approximately 5000 mg). Although specification discloses the ratio of the weight amount of S-keratolac or its salt to pregabalin or its salt to be 31.6:1, there is no support for the range “approximately 31.6 : 1. Thus, the specification provides no clear written description for the solid dosages form currently claimed.
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.
Claims 1, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Ochoa (MX 2013005378 A, published on November 21, 2014, cited in IDS).
Claim 1 is directed to a solid oral administration pharmaceutical composition comprising a synergic combination of:
S-ketorolac in base form or a pharmaceutically acceptable salt thereof in an amount of about 10 mg;
ii. pregabalin or a pharmaceutically acceptable salt thereof in an amount of about 316 mg; and
iii. a pharmaceutically acceptable carrier and/or excipient; wherein the weight ratio of the pregabalin or a pharmaceutically acceptable salt thereof to the S-ketorolac in base form or a pharmaceutically acceptable salt thereof is approximately 31.6:1.
Ochoa discloses an oral capsule for human use, the pharmaceutical composition comprising S-ketorolac tromethamine and pregabalin at the concentrations of 10 mg and 300 mg. See Translation, Example 8. The ratio Pregelatinized starch and talc added in the formulation meets the limitation for a pharmaceutically acceptable carrier and/or excipient in present claim 1, iii. The reference teaches that the composition is useful in improving analgesic response speed for sever pain. See abstract. The reference specifically teaches that combining S-ketorolac with pregabalin produces more effective analgesia and longer duration. See translation, 4, second full paragraph.
Regarding the disclosed amount of pregabalin at 300 mg, it is well settled in patent law that where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The amount 300 mg is well within the range of “about 316 mg”,
Regarding the weight ratio of S-ketorolac tromethamine and pregabalin, the disclosed ratio of 30:1 is also well within the presently claimed range of approximately 31.6:1.
Regarding claim 7, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). In this case, since the disclosed weight ratio between the drugs is so close to the claimed ratio of 31.6:1, it is viewed that the prior art composition is expected to have the same properties.
Similarly, regarding claim 8, the disclosed amount of 300 mg of pregabalin is so close to the claimed amount of 316 mg, that one of ordinary skill in the art would have expected the two compositions to have same properties.
Response to Arguments
Applicant’s arguments filed on May 27, 2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that the experimental evidence in the 1.132 declaration dated January 14, 2026 demonstrates the claimed composition exhibits unexpected results. However, an affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. See In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979); MPEP 716.02 (e). In this case, the declaration merely compares the therapeutic effects of and the reduced damages by the combination of S-ketorolac and pregabalin as compared to the individual components. No comparative data are present to show that the claimed composition produces different effects from the disclosed composition.
Applicant’ further argues that Ochoa is silent to the synergistic properties of the claimed composition, but the reference clearly teaches and suggests a solid oral dosage form which is very close to the presently claimed composition. In view of the court decision Titanium Metals Corp. of America v. Banner, the Ochoa composition is expected to have the same, synergistic properties, unless shown otherwise.
Conclusion
No claims are allowed.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617
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