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 .
Priority
This Application filed on 12/09/2022 is a 371 of PCT/IB2021/055041 filed on 06/08/2021 which has PRO 63/037,483 filed on 06/10/2020.
DETAILED ACTION
The Office Action is in response to the Applicant's reply filed September 29, 2025 to the restriction requirement made on July 30, 2025.
Applicant's election without traverse of Group I claims 1-2, 15-18, 25-29, 35-39, and 41-43 in the reply filed on 9/29/25 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claim 40 is withdrawn. Claims 1-2, 15-18, 25-29, 35-39, and 41-43 are herein acted on the merits.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 11/26/2025, is in compliance with the provisions of S7 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
The rejections are as below:
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 1-2, 15-18, 29, 35-39, and 41-42 is rejected under 35 U.S.C. 103(a) as being unpatentable over Reiner1 et al. (WO 2018/138690 A1).
Reiner1 et al. teach a liquid pharmaceutical composition for oral use, characterized by comprising: a) diclofenac potassium salt in an amount from 3.5 to 20% (w/v) with respect to the volume of the composition; b) potassium bicarbonate in an amount from 2.0 to 10.0% (w/v) with respect to the volume of the composition; wherein the sodium is absent or present in an amount of up to 0.05% by weight with respect to the volume of the composition. The composition further comprises a sweetener selected from the group consisting of sucralose, aspartame, thaumatin, isomalt (reads on polyol), maltitol (reads on polyol), lactitol (reads on polyol), and xylitol (claim 8). Exemplified are formulations containing about 5 weight parts diclofenac, sucralose, potassium hydrogen carbonate, 100-150 weight parts water, etc. The composition has a density of between 1.0 and 1.1 g/ml, or between 1.0 and 1.05 g/ml.
The reference fails to teach the parts by weight of xylitol, amounts of claim 2, 15-17, a combination of flavoring agents and additional ingredients.
It would have been obvious to one of ordinary skill in the art at the time of filing to use combinations of the ingredients taught in Reiner1 et al., such as xylitol and sucralose and modify amounts of xylitol, water, or diclofenac and. The motivation to combine xylitol and sucralose is because Reiner et al. teaches both as a selective sweetener. The skilled artisan would have reasonably concluded, in light of the shared efficacy as sweeteners, that the concomitant administration of xylitol and sucralose would have been reasonably expected to achieve, at minimum, additive, if not synergistic, effects when combined. It is further noted that in the absence of evidence to the contrary, it is generally prima facie obvious to use in combination two or more agents that have previously been used separately for the same purpose. See In re Kerkhoven, 205 USPQ 1069 (CCPA). With respect to the amounts of xylitol, water, or diclofenac, since the general conditions of the claim are taught in the prior art, discovering optimum or workable ranges involves only routine skill in the art (In re Aller).
Claims 25-28 and 43 are rejected under 35 U.S.C. 103(a) as being unpatentable over Reiner1 et al. (WO 2018/138690 A1), as applied to claims 1-2, 15-18, 29, 35-39, and 41-42 above, further in view of Reiner2 (WO 03/043600 A1 – IDS ‘FP20’).
Reiner1 et al. is as discussed above.
The reference fails to teach sorbitol or specify the pH of the composition.
Reiner2 teaches NSAID formulations selected from diclofenac, wherein the pH of the aqueous solution of the composition is in the range from 7.0 to 8.5. The final pH of the aqueous solution cannot reach extreme values in that it is known that, at acidic values, the acid form of the NSATD could precipitate while, at basic values, damaging effects on the mucosae could occur. Furthermore, the reference teaches “the aim to make the administration of the product even more pleasant, may comprise additional non flavoring pharmaceutically acceptable excipients are sweeteners, i.e. saccharin, aspartame, cyclamate, acesulfame, saccharose, sorbitol, fructose and mixtures thereof, in such amount as to appropriately sweet the final solution.”
It would have been obvious to one of ordinary skill in the art at the time of filing to adjust the pH and use sweeteners taught in Reiner2 et al. The motivation to adjust the pH is because Reiner2 et al. teaches the pH should not precipitate or have damaging effects on the mucosae. The motivation to use sorbitol is because Reiner2 et al. teaches the sweeteners make the administration of the product even more pleasant. A skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Reference of relevance:
Pifferi (US Patent No. 7,250,428) teaches a mouthwash formulation comprising 10 g of xylitol, 0.2 g diclofenac, natural flavorings and 100 g of purified water (Examples)
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 15-18, 25-29, 35-39, 41-42, and 43 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-22 of Reiner3 et al. US Patent No.12,036,317.
Reiner3 et al. teaches an “oral liquid diclofenac formulation comprising: a) a therapeutically effective amount of diclofenac or a pharmaceutically acceptable salt thereof; b) from about 0.05% to about 9% of an alkalizing agent; and c) a sugar-based aqueous means for solubilizing and stabilizing the formulation, wherein the pH is from about 7 to about 10. The sugar alcohols selected from the group consisting of ethylene, propylene glycol, glycerol, erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fucitol, iditol, inositol, volemitol, isomalt, maltitol, lactitol, maltotriitol, maltotetraitol and polyglycitol. The xylitol is used in about 25- 75%. Flavoring agents include sucralose. The alkalizing agents, are ammonia solution, ammonium carbonate, diethanolamine, monoethanolamine, potassium hydroxide, sodium borate, sodium carbonate, sodium bicarbonate, sodium hydroxide, triethanolamine, and trolamine and others known. The density is from about 1.02 to about 1.5 g/ml.
With respect to the part by weight of xylitol, water, or diclofenac, since the general conditions of the claim are taught in the prior art, discovering optimum or workable ranges involves only routine skill in the art (In re Aller).
Claims 1-2, 15-18, 25-29, 35-39, 41-42, and 43 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of Reiner4 et al. US Patent No. 11,260,026.
Reiner4 et al. teaches a “liquid diclofenac formulation in a ready to use stick pack comprising: a) about 0.47% diclofenac potassium; b) about 0.21% potassium hydrogen carbonate; c) about 20% xylitol; d) about 0.06% sucralose; and e) water. Flavoring agents include sucralose, and sorbitol. The density is from about 1.02 to about 1.5 g/ml. The alkalizing agent imparts a pH of from about 7 to about 10 to the formulation;
With respect to the part by weight of xylitol, water, or diclofenac, since the general conditions of the claim are taught in the prior art, discovering optimum or workable ranges involves only routine skill in the art (In re Aller).
Conclusion
No claims allowed.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622