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 .
Applicant’s response filed on December 11, 2025 and the supplemental response filed on January 14, 2026 have been fully considered.
The previous claim rejection made under 35 U.S.C. 103 over Ochoa (MX 2013005378 A) as indicated in the Office action dated August 13, 2025 has been withdrawn in view of the amendment made to claim 1.
New rejections have been made to address the amended claim(s).
Claim Rejections - 35 USC § 112
§ 112 (a)
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.
Claims 1 and 7 are 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 sufficient to deliver 0.316 mg/kg; ii) pregabalin or its pharmaceutically acceptable salt in an amount sufficient to deliver 10 mg/kg; and iii) a pharmaceutically acceptable carrier and/or excipient.
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). While applicant point to paragraph [0099] for support, that disclosure pertains exclusively to rat dosages, which implies that the use of liquid formulations, the standard for such laboratory models. As such, the specification provides no clear written description for the solid dosages form currently claimed.
Claim 7 is rejected for depending on the base claim which fails to comply with the written description requirement.
Claim 7 is also rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 7 depends on claim 1, and requires that the pregabalin or a pharmaceutically acceptable salt thereof is present in the composition in an amount that is 3 times greater than the amount of the S-ketorolac in base form or a pharmaceutically acceptable salt thereof. Such is not feasible as claim 1 explicitly requires that 0.316 mg/kg of S-ketorolac and 10 mg/kg of pregabalin, which is 31.6 times greater than the amount of the S-ketorolac, are to be delivered from a single solid dosage form.
One of ordinary skill in the art would not know how to make and use the presently claimed invention.
§ 112 (b)
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.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 7 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.
As indicated above, the amended claim 1 is directed to a solid oral composition comprising i) S-ketorolac or a pharmaceutically acceptable salt thereof in an amount of sufficient to deliver 0.316 mg/kg and ii) pregabalin or its pharmaceutically acceptable salt in an amount sufficient to deliver 10 mg/kg. The amounts of the drugs to be delivered are expressed as a dose rather than a concentration, which defines how much of the composition should be administered, rather than the structure of the composition per se.
Claim 7 is rejected as the claim depends on the indefinite base claim.
§ 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 depends on claim 1, and requires that the pregabalin or a pharmaceutically acceptable salt thereof is present in the composition in an amount that is 3 times greater than the amount of the S-ketorolac in base form or a pharmaceutically acceptable salt thereof. Such is not feasible as claim 1 explicitly requires that only 0.316 mg/kg of S-ketorolac and 10 mg/kg of pregabalin are to be delivered from a single solid dosage form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Ochoa (MX 2013005378 A, published on November 21, 2014, previously cited).
Ochoa discloses a solid oral dosage form which delivers S-ketorolac tromethamine and pregabalin at the concentrations of 10 mg and 300 mg, respectively. For a patient weighing about 31.6 kg, the composition delivers about 0.316mg/kg of K-ketorolac and 9.5 mg/kg of pregabalin.
It is well settled in patent law, that 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 MPEP2144.05, I, second full paragraph; 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."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0).
In this case, a solid dosage form providing 0.316 mg/kg of S-ketorolac and 9.5 mg/kg of pregabalin or its salts is very close to the present solid composition which is said to provide 0.316 mg/kg S-ketorolac and 10 mg/kg of the pregabalin and one of ordinary skill in the art would have expected these two solid oral compositions to have the same properties.
Oath and Declaration
The declaration under 37 C.F.R. § 1.132 filed on January 14, 2026 has been fully considered but does not place the application in allowable condition. Pointing out to a clinical study submitted as an attachment on December 11, 2025, the declarant/co-inventor states that co-administration of S-ketorolac 0.316 mg/kg and pregabalin 10 mg/kg produces 50 % reduction of GI damage compared to the administration of S-ketorolac alone. However, as indicated in the rejection under 35 U.S.C. 103 above, the solid oral composition disclosed in Ochoa is very similar to the presently claimed composition, and one of ordinary skill in the art would have expected that these two compositions have the same properties, unless shown otherwise.
Response to Arguments
Applicant's arguments filed on December 11, 2025 have been fully considered but they are moot in view of the new ground of rejection.
Conclusion
No clams are allowed.
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 GINA JUSTICE whose telephone number is (571)272-8605. The examiner can normally be reached M-F 9:00 AM - 5 PM.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617