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 . Claims included in prosecution are claims 1, 3, 5, 7-9, 11, 13-15, 17, 24, 28, 35, 46, and 53-56.
Previous Rejections
Applicants' arguments, filed 6/17/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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.
1. Claim(s) 1, 3, 5, 7-9, 11, 13-15, 17, 24, 28, 35, 46, and 53-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (CN 109394699, Mar. 1, 2019) (hereinafter Yang) in view of Hancock et al., (Pharm Research, Apr. 2000, 17(4):397-404) (hereinafter Hancock) as evidenced by Fan (CN 1813683, Aug. 9, 2006) (hereinafter Fan).
Yang discloses an ibuprofen taste-masking dry suspension and a method of preparing thereof (¶ [0002]). The suspension comprises an ibuprofen solid dispersion and excipients. The ibuprofen solid dispersion is composed of ibuprofen and a polymeric carrier. Ibuprofen is contained in an amount of 1-25% and the polymeric carrier is contained in an amount of 58-95% (¶ [0010]). The polymeric carrier is a mixture of a stomach-soluble polymer carrier and a water-soluble polymer carrier, wherein the stomach-soluble polymer carrier is acrylic resin IV and the water-soluble polymer carrier may be poiyvinylpyrrolidone-vinyl acetate copolymer (¶ [0011]). The ratio of stomach-soluble polymer carrier to water-soluble polymer carrier is preferably 1 to 19 (¶ [0012]). Another object of the invention is to provide a method for preparing an ibuprofen taste-masking dry suspension (¶ [0015]). A preferred embodiment of the preparation method involves a hot melt extrusion method which comprises: Sieving and mixing the ibuprofen and the polymer carrier to obtain a mixture; setting the hot melt extruder to 70-150 ° C, and 10-100 rpm, and extruding. The extrudate was collected at the material exit of the melt extruder and cooled to obtain a solid dispersion of ibuprofen-polymer carrier (¶ [0019]). Testing showed that the mixture of acrylic resin IV and polyvinylpyrrolidone-vinyl acetate copolymer as the polymer carrier to prepare children's ibuprofen taste-masking dry suspension can effectively prevent the release of drugs in drinking water, improve the pungency caused by the dissolution of the drug during taking, and achieve a taste-masking effect (¶ [0153]). In a simulated gastric environment of hydrochloric acid solution with a pH of 1.0, the combination of acrylic resin IV and poiyvinylpyrrolidone-vinyl acetate copolymer had a release rate of more than 90% at 5 minutes performed better than acrylic resin IV only and the combination was found to significantly reduce the dissolution of ibuprofen in drinking water, achieve the taste masking effect, and significantly improve the dissolution rate of the drug in the simulated gastric juice environment. It is expected to achieve rapid limit dissolution in the gastric juice environment, eliminating children and even Infant and child differences between individuals (¶ [0158]).
As evidenced by Fan, acrylic resin IV is copolymer of dimethylaminoethyl methacrylate and methacrylate (Summary of the Invention, Pg. 1).
Yang differs from the instantly recited claims insofar as not explicitly disclosing wherein the Ibuprofen is in amorphous form.
However, Hancock discloses that amorphous pharmaceuticals are markedly more soluble than their crystalline counterparts (Abstract, Conclusions). The amorphous form of pharmacologically active materials has received considerable attention because in theory this form represents the most energetic solid state of a material and thus it should provide the biggest advantage in terms of solubility and bioavailability (Introduction, 1st Paragraph). In comparison with polymorphic crystal forms of drugs, the clinical relevance of the increase in solubility for amorphous drug forms is likely significant (Conclusions).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated Yang’s Ibuprofen to be in the amorphous form motivated by the desire to achieve improved drug solubility and bioavailability as taught by Hancock.
Regarding claim 1 reciting a method of taste masking, as discussed above, Yang discloses an ibuprofen taste-masking suspension and a method of preparing such a taste-masking suspension where the combination of polymers used improved the pungency caused by the dissolution of the drug during taking and achieve a taste-masking effect. Further, Yang’s method and suspension comprise the same steps as those instantly claimed. As such, Yang’s disclosure satisfies a method of taste masking as instantly claimed.
Regarding the “consisting essentially of” language recited in instant claim 1, as discussed above, the solidified hot melt extrudate of Yang only comprises Ibuprofen and the polymer carrier which is a mixture of a stomach-soluble polymer carrier and a water-soluble polymer carrier, wherein the stomach-soluble polymer carrier is acrylic resin IV (i.e., a dimethylaminoethyl methacrylate co-polymer) and the water-soluble polymer carrier may be poiyvinylpyrrolidone-vinyl acetate copolymer. As such, the extrudate does not contain any component not recited by the instant claim thereby meeting the limitations of the “consisting essentially of” language.
Regarding the NSAID recited in instant claims 1, 3, and 56, as discussed above, the methods/compositions of Yang comprise ibuprofen. Accordingly, methods and extrudates comprising such an NSAID would have been obvious.
Regarding the amounts of API recited in instant claims 5, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, the methods/compositions of Yang comprise ibuprofen in an amount of 1 to 25 %. Accordingly, because the amounts recited in the instant claims overlap with the range disclosed by Yang, the range disclosed by Yang meets the instantly recited limitations.
Regarding claims 7-9, 13-14, 17, 24, and 46, as discussed above, the extrudate of Yang comprises a polymeric carrier which is a mixture of a stomach-soluble polymer carrier and a water-soluble polymer carrier, wherein the stomach-soluble polymer carrier is acrylic resin IV (i.e., a dimethylaminoethyl methacrylate co-polymer) and the water-soluble polymer carrier may be poiyvinylpyrrolidone-vinyl acetate copolymer. Accordingly, an extrudate comprising such polymers with such properties would have been obvious.
Regarding claim 24, as discussed above, in a simulated gastric environment of hydrochloric acid solution with a pH of 1.0, the combination of acrylic resin IV (i.e., a dimethylaminoethyl methacrylate co-polymer) and poiyvinylpyrrolidone-vinyl acetate copolymer had a release rate of more than 90% at 5 minutes. Accordingly, a combination of polymers soluble at a pH of about 1 would have been obvious.
Regarding the amounts/ratios of polymers recited in instant claims 11, 15, 53, and 55, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, the extrudate of Yang comprises a polymeric carrier in an amount of 58-95% where the polymer carrier which is a mixture of a stomach-soluble polymer carrier and a water-soluble polymer carrier, wherein the stomach-soluble polymer carrier is acrylic resin IV (i.e., a dimethylaminoethyl methacrylate co-polymer) and the water-soluble polymer carrier may be poiyvinylpyrrolidone-vinyl acetate copolymer. Accordingly, it would have been obvious for one of ordinary skill in the art to have selected amounts of each of the components from within the above range and arriving at amounts and ratios of each component that overlaps with the claimed ranges.
Alternatively, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). As discussed above, the mixture of acrylic resin IV (i.e., dimethylaminoethyl methacrylate co-polymer) and polyvinylpyrrolidone-vinyl acetate copolymer as the polymer carrier to prepare children's ibuprofen taste-masking dry suspension can effectively prevent the release of drugs in drinking water, improve the pungency caused by the dissolution of the drug during taking, and achieve a taste-masking effect, which makes amounts and ratios thereof a result effective variable, since amounts/ratios directly impact the drug release and pungency/taste masking effects. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts and ratios of acrylic resin IV (i.e., dimethylaminoethyl methacrylate co-polymer) and polyvinylpyrrolidone-vinyl acetate copolymer to yield the desired drug release profile and pungency/taste masking effects.
Regarding the temperature recited in instant claim 28, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, the hot melt extruder is set to 70-150 ° C in the extrusion process of Yang. Accordingly, because the temperatures recited in the instant claims lie inside the range disclosed by Yang, the range disclosed by Yang meets the instantly recited limitations.
Regarding the screw speed recited in instant claim 35, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, the hot melt extruder is set to 10-100 rpm in the extrusion process of Yang. Accordingly, because the temperatures recited in the instant claims overlap with range disclosed by Yang, the range disclosed by Yang meets the instantly recited limitations.
Regarding the amounts of API recited in instant claims 46 and 55, 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 MPEP 2144.05(I). As discussed above, the methods/compositions of Yang comprise Ibuprofen in an amount of 1 to 25 %. As such, since the amounts disclosed by Yang are close to the claimed amounts (i.e., 30%), the claimed amounts would have been obvious and the amounts disclosed by Yang meet the instantly recited limitations.
Alternatively, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). As discussed above, Ibuprofen is an active agent that is commonly used to treat acute fever in children, which makes amounts/ratios thereof a result effective variable, since amounts directly impact the antipyretic effect. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts of Ibuprofen to yield the desired antipyretic effect.
Regarding the ratios recited in instant claim 54, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, the extrudate of Yang comprises Ibuprofen in an amount of 1 to 25 %. Further, it comprises a polymeric carrier in an amount of 58-95% where the polymer carrier which is a mixture of a stomach-soluble polymer carrier and a water-soluble polymer carrier, wherein the stomach-soluble polymer carrier is acrylic resin IV (i.e., a dimethylaminoethyl methacrylate co-polymer) and the water-soluble polymer carrier may be poiyvinylpyrrolidone-vinyl acetate copolymer. Accordingly, the claimed weight ratios would have been obvious from one selecting amounts of Ibuprofen, acrylic resin IV, and poiyvinylpyrrolidone-vinyl acetate copolymer from these ranges and arriving at a weight ratio that overlaps with the claimed ranges.
Alternatively, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). As discussed above, Ibuprofen is an active agent that is commonly used to treat acute fever in children, which makes ratios thereof a result effective variable, since ratios directly impact the antipyretic effect. Further, as discussed above, the mixture of acrylic resin IV (i.e., dimethylaminoethyl methacrylate co-polymer) and polyvinylpyrrolidone-vinyl acetate copolymer as the polymer carrier to prepare children's ibuprofen taste-masking dry suspension can effectively prevent the release of drugs in drinking water, improve the pungency caused by the dissolution of the drug during taking, and achieve a taste-masking effect, which makes ratios thereof a result effective variable, since ratios directly impact the drug release and pungency/taste masking effects. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed ratio of Ibuprofen to yield the desired antipyretic effect. It would have also taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed ratios of acrylic resin IV (i.e., dimethylaminoethyl methacrylate co-polymer) and polyvinylpyrrolidone-vinyl acetate copolymer to yield the desired drug release profile and pungency/taste masking effects.
Accordingly, the combined teachings of Yang and Hancock render obvious claims 1, 3, 5, 7-9, 11, 13-15, 17, 24, 28, 35, 46, and 53-56.
Response to Arguments
Applicant’s arguments with respect to claims 1, 3, 5, 7-9, 11, 13-15, 17, 24, 28, 35, 46, and 53-56 have been considered but are moot because new rejections necessitated by Applicant’s amendment have been made. The teachings of Yang in view of Hancock are applied to meet the requirements of the “extrudate consisting essentially of” limitations newly recited in instant claim 1.
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.
1. Claims 1, 3, 5, 7-9, 11, 13-15, 17, 24, 28, 35, 46, and 53-56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 11, 18, 21, 23, 34, 49-51, 53, and 63-65 of copending Application No. 18/548,645 in view of Yang et al. (CN 109394699, Mar. 1, 2019) (hereinafter Yang) and Hancock et al., (Pharm Research, Apr. 2000, 17(4):397-404) (hereinafter Hancock) as evidenced by Fan (CN 1813683, Aug. 9, 2006) (hereinafter Fan).
Although the claims at issue are not identical, they are not patentably distinct from each other because they both disclose a solidified melt extrudate comprising an NSAID and two polymers, namely dimethylaminoethyl methacrylate co-polymer and polyvinylpyrrolidone-vinyl acetate co-polymer {PVPVA64).
The difference between the instant claims and the copending claims lies in the fact that the instant claims further recite wherein the extrudate is used for taste masking.
However, Yang discloses an ibuprofen taste-masking dry suspension method of preparing thereof (¶ [0002]). The suspension comprises an ibuprofen solid dispersion and excipients. The ibuprofen solid dispersion is composed of ibuprofen and a polymeric carrier (¶ [0010]). The polymeric carrier is a mixture of a stomach-soluble polymer carrier and a water-soluble polymer carrier, wherein the stomach-soluble polymer carrier is acrylic resin IV and the water-soluble polymer carrier may be poiyvinylpyrrolidone-vinyl acetate copolymer (¶ [0011]). Another object of the invention is to provide a method for preparing an ibuprofen taste-masking dry suspension (¶ [0015]). A preferred embodiment of the preparation method involves a hot melt extrusion method which comprises: Sieving and mixing the ibuprofen and the polymer carrier to obtain a mixture; setting the hot melt extruder to 70-150 ° C, and 10-100 rpm, and extruding. The extrudate was collected at the material exit of the melt extruder and cooled to obtain a solid dispersion of ibuprofen-polymer carrier (¶ [0019]). Testing showed that the mixture of acrylic resin IV and polyvinylpyrrolidone-vinyl acetate copolymer as the polymer carrier to prepare children's ibuprofen taste-masking dry suspension can effectively prevent the release of drugs in drinking water, improve the pungency caused by the dissolution of the drug during taking, and achieve a taste-masking effect (¶ [0153]).
As evidenced by Fan, acrylic resin IV is copolymer of dimethylaminoethyl methacrylate and methacrylate (Summary of the Invention, Pg. 1).
Yang differs from the instantly recited claims insofar as not explicitly disclosing wherein the Ibuprofen is in amorphous form.
However, Hancock discloses that amorphous pharmaceuticals are markedly more soluble than their crystalline counterparts (Abstract, Conclusions). The amorphous form of pharmacologically active materials has received considerable attention because in theory this form represents the most energetic solid state of a material and thus it should provide the biggest advantage in terms of solubility and bioavailability (Introduction, 1st Paragraph). In comparison with polymorphic crystal forms of drugs, the clinical relevance of the increase in solubility for amorphous drug forms is likely significant (Conclusions).
As such, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated Yang’s Ibuprofen to be in the amorphous form motivated by the desire to achieve improved drug solubility and bioavailability as taught by Hancock.
Accordingly, it would have been obvious for one of ordinary skill in the art to have utilized the extrudate of the copending claims in an attempt to mask the bitter taste of ibuprofen since this is a known use of such extrudates containing such polymers as taught by Yang in view of Hancock as evidenced by Fan.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Regarding the rejection of claims 1, 3, 5, 7-9, 11, 13-15, 17, 24, 28, 35, 46, and 53-56 on the grounds of non-statutory double patenting, Applicants‘ arguments and the amendment have been fully considered and deemed unpersuasive for the reasons that follow.
Applicants have not submitted arguments and/or documentation (i.e. terminal disclaimer) in response to the double patenting rejection(s). Applicant requested that the double patenting rejection(s) recited above be held in abeyance until otherwise allowable subject matter is identified.
Further, new rejections necessitated by Applicant’s amendment have been made where the teachings of Yang in view of Hancock are applied to meet the requirements of the “extrudate consisting essentially of” limitations newly recited in instant claim 1.
Therefore, the previous rejection of non-statutory double patenting is maintained.
Conclusion
Claims 1, 3, 5, 7-9, 11, 13-15, 17, 24, 28, 35, 46, and 53-56 are rejected.
No claims 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 Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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/A.A./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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