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 .
Status of the Application
Claims 82-93, 95-97, and 100-107 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 10/29/2025 are acknowledged. Claims 82, 95, 100, and 102 are amended and new claims 103-107 is added. Claims under consideration in the instant office action are claims 82-93, 95-97, and 100-107.
Applicants' arguments, filed 10/29/2025, have been fully considered but they are not deemed to be persuasive. The rejection of claim 102 under 35 USC 112 is withdrawn due to Applicant’s amendments. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Claims 82-90, 92-93, 95-97, and 100-107 are rejected under 35 U.S.C. 103 as being unpatentable over Gullapalli (WO 01/15688, as disclosed in IDS) as applied to claims 82, 86, and 92-93 above, and further in view of Singla (WO 2005/123133, as disclosed in IDS).
Gullapalli teaches “softgel capsules comprised of a gelatin sheath enclosing such fill formulations, are prepared by dissolving more than 30 % of ibuprofen in free acid form in polyethylene glycol and at least 10 % by weight of a polyvinylpyrrolidone having an average molecular weight of from about 2,000 to about 54,000.” (see abstract). Gullapalli teaches polyethylene glycol present in an amount of 30 to about 60% (pg. 3, lines 4-7). Gullapalli teaches a composition comprising ibuprofen in an amount of 35%, PEG 600 in an amount of 35%, Kollidon 30 (i.e. polyvinyl pyrrolidone) in an amount of 15%, Cremophor RH 60 in an amount of 10%, and propylene glycol in an amount of 5% (pg. 10, Example 7). Such a composition results in a ratio of ibuprofen to a polyvinyl pyrrolidone of 2.3:1, a ratio of ibuprofen to polyethylene glycol of 1:1, and a ratio of polyethylene glycol to polyvinyl pyrrolidone of 2.3:1. Gullapalli teaches water present in an amount of 5% (pg. 9, Example 2). Gullapalli teaches “Upon mixing under the conditions described by Yu et al., the polyethylene glycol acts to dissolve the free form of the ibuprofen; the hydroxyl ions source, e.g., sodium hydroxide or potassium hydroxide, partially forms an ibuprofen salt, and the water forms a solvation sphere around the acid salt permitting it to go into solution in the polyethylene glycol.” (pg. 2, lines 13-17). Gullapalli teaches “Preferably, the polyethylene glycol has an average molecular weight of at least about 200, with an average molecular weight of from about 400 to about 1,000 being preferred.” (pg. 5, lines 5-9).
Gullapalli does not teach wherein the composition further comprises a base in an amount of from 5% w/w to 10% w/w. Gullapalli does not teach a composition further comprising polyoxysorbitan esters such as polysorbate 80. Gullapalli does not teach the weight percentages and ratios recited.
Singla is drawn towards soft gelatin capsules comprising ibuprofen and a solvent system for filling into soft gelatin capsules (see abstract). Singla teaches the addition of alkalizing agents, such as bases to the composition in an amount of 1 to about 10% (pg. 6, lines 19-28). Singla teaches capsules further comprising “from about 1 to about 20% by weight ofpolysorbate-80” (pg. 7, lines 27-29).
It would have been obvious to one of ordinary skill in the art to formulate a composition further comprising a base in an amount of from 5% w/w to 10% w/w and polyoxysorbitan esters such as polysorbate 80, as suggested by Singla, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so in order to improve the solubility and dispersion of ibuprofen during formulation of the composition as taught by Singla (pg. 5, lines 3-5; pg. 6, lines 19-28).
Even though the range for weight percentages and ratios as taught by Gullapalli and Singla are not the same as the claimed ratios, Gullapalli and Singla do teach an overlapping range of weight percentages and ratios, and it has been held that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. 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). See MPEP § 2144.05(I). Furthermore, the determination of concentrations is well within the purview of those skilled in the art through routine experimentation, and it has been held that “it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05(II). It would have been obvious to one of ordinary skill in the art to optimize the component amounts in order to increase the amount and bioavailability of the active agent of the composition.
The amounts of active agents to be used, the pharmaceutical forms, e.g., tablets, etc; mode of administration, flavors, surfactant are all deemed obvious since they are all within the knowledge of the skilled pharmacologist and represent conventional formulations and modes of administration.
Furthermore, no unobviousness is seen in the ratio claimed because once the usefulness of a compound is known to treat a condition, it is within the skill of the artisan to determine the optimum ratio.
Response to Arguments
Applicant argues that “A skilled artisan would not be motivated to make a modification, as proposed by the Examiner, that results in ibuprofen being in the form of a salt when Gullapalli specifies ibuprofen being in a free acid form and is directed to forming compositions with high concentrations of ibuprofen in its free acid form.” The Examiner respectfully disagrees since although Gullapalli teaches ibuprofen in its free acid form, Gullapalli does teach “softgel capsules comprised of a gelatin sheath enclosing such fill formulations, are prepared by dissolving more than 30 % of ibuprofen in free acid form in polyethylene glycol and at least 10 % by weight of a polyvinylpyrrolidone having an average molecular weight of from about 2,000 to about 54,000.” (see abstract), which reads on the recited components of the claimed invention as broadly recited.
Applicant also argues that “This section of Gullapalli describes what is done in the prior art, e.g., in "Yu et al." As explained above, Gullapalli's compositions include ibuprofen in its free acid form, and teaches away from the use of a base in its composition. Adding a base would result in at least some of the ibuprofen being in the form of a salt, i.e., not in its free acid form as desired by Gullapalli. Potassium hydroxide is a base.” The Examiner respectfully disagrees since although Gullapalli teaches ibuprofen in its free acid form, both Gullapalli and Singla are both drawn towards gelatin capsules that provide higher concentrations of ibuprofen, and Gullapalli does not teach against the use of a base in the overall formulation.
Applicant also argues that “Singla is directed to improved systems for solubilising certain pharmaceutically active ingredients. There is no data in Sing la about the dissolution properties of the compositions described therein. There is no teaching or disclosure which would lead the person of ordinary skill in the art to consider that the compositions of Singla are faster than the existing commercial composition whose dissolution data is included in the present application. In contrast, as shown by the Examples in the specification, the compositions of the present invention exhibit improved release properties compared to existing commercial compositions.” The Examiner respectfully disagrees since the prior art is not required to disclose data to provide teachings that read on the claimed invention. Additionally, it is unclear what the formulation is that represents the commercial example, and if it is representative of the prior art.
Conclusion
Claims 82-102 are rejected.
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 ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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