DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed March 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 (New, Necessitated by Amendment)
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.
Claim 12 is rejected under 35 U.S.C. 103 as being as being obvious over Cherukuri et al. (US 2013/0071476 A1) in view of Oberegger et al. (US 2007/0027213 A1)
Regarding claim 12, Cherukuri discloses a method of making a rapid melt tablet for oral administration where a pharmaceutical active ingredient is complexed with the resin, sodium polystyrene sulfonate [Abstract] [0069]-[0070]. The ratio of active ingredient to sodium polystyrene sulfonate is 1:1 [0069]-[0070]. Cherukuri discloses the active ingredient and resin are dispersed in water and stirred, then the drug-resin complex is separated from the supernatant by filtration to collect the complex and the drug-resin granules are dried and sifted [0070]-[0088]. The drug-resin-complexed articles are coated with coating agents such as ethyl cellulose [0008] [0087]-[0088] and are then blended with excipients and compressed into tablets [Abstract] [Claim 8] [0008] [0066] [0094]-[0096]. Cherukuri discloses the excipients include talc, sorbitol, maltodextrin, and mixtures thereof [Claim 14] [0123]-[0127]. Cherukuri discloses additional sweeteners and flavors may be included [Abstract] [0051].
Cherukuri does not disclose peach flavor or aspartame.
Oberegger discloses a tablet for oral administration [Abstract] [0025] where peach is taught as a flavorant [0313] and aspartame is taught as a sweetener [0314].
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, since Cherukuri generally taught flavors and sweeteners, it is prima facie obvious to include peach flavor and aspartame in a tablet for oral administration based on their recognized suitability for the intended use as a flavor and sweetener, respectively, as taught by Oberegger.
Further regarding claim 12, while Cherukuri does not explicitly disclose the dissolution time of a tablet with 1:1 active ingredient: sodium polystyrene sulfonate coated with ethyl cellulose, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art teaches a tablet with the same components (granule with 1:1 active ingredient: sodium polystyrene sulfonate and ethyl cellulose coating), the properties the applicant discloses and/or claims are necessarily present. It would be reasonably expected that the granules would begin to dissolve in the oral cavity within 15 seconds especially as Cherukuri teaches that that tablets are “rapid melt” (abstract) which is defined as “solid dosage forms containing medicinal substances which disintegrate rapidly, usually in a matter of seconds” (Cherukuri [0005]), and Cherukuri teaches dissolution times of tablets of the disclosure such as 10-12 seconds [0111] [0121].
Claims 13 and 15-18 are rejected under 35 U.S.C. 103 as being as being obvious over Cherukuri et al. (US 2013/0071476 A1).
Regarding claim 13, Cherukuri discloses a method of making a rapid melt tablet for oral administration where a pharmaceutical active ingredient is complexed with the resin, sodium polystyrene sulfonate [Abstract] [0070]. The ratio of active ingredient to sodium polystyrene sulfonate is 1:1 [0069]-[0070]. Cherukuri discloses the active ingredient and resin are dispersed in water and stirred, then the drug-resin complex is separated from the supernatant by filtration to collect the complex and the drug-resin granules are dried and sifted [0070]-[0088]. The drug-resin-complexed articles are coated with coating agents such as ethyl cellulose [0008] [0087]-[0088] and are then blended with excipients and compressed into tablets [Abstract] [Claim 8] [0008] [0066] [0094]-[0096]. Cherukuri discloses the excipients include xylitol, orange flavor, talc, fructose and mixtures thereof [Claim 14] [0093]-[0095].
Cherukuri is not believed to be anticipated because Cherukuri could be construed as not clearly and unequivocally disclosing the claimed invention or directing those skilled in the art to the claimed invention without any need for picking, choosing and combining various disclosures not directly related to each other by the teachings of the cited reference. Namely, one skilled in the art would need to choose ethyl cellulose as the coating ([0008] [0087]-[0088]) for the granule with the 1:1 active ingredient to sodium polystyrene sulfonate ratio ([0069]-[0070]).
Nevertheless, claim 13 is rendered prima facie obvious over the teachings of Cherukuri, because it is prima facie obvious to combine prior art elements according to known methods, to yield predictable results. In the instant case, all the claimed elements (e.g., granules with 1:1 ratio of active ingredient to sodium polystyrene sulfonate and ethyl cellulose coating) were known in the prior art (e.g., Cherukuri) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results (e.g., a rapid melt granule) to one of ordinary skill in the art. MPEP 2143.A.
Further regarding claim 13, while Cherukuri does not explicitly disclose the dissolution time of a tablet with 1:1 active ingredient: sodium polystyrene sulfonate coated with ethyl cellulose, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art teaches a tablet with the same components (granule with 1:1 active ingredient: sodium polystyrene sulfonate and ethyl cellulose coating), the properties the applicant discloses and/or claims are necessarily present. It would be reasonably expected that the granules would begin to dissolve in the oral cavity within 15 seconds especially as Cherukuri teaches that that tablets are “rapid melt” (abstract) defined as “solid dosage forms containing medicinal substances which disintegrate rapidly, usually in a matter of seconds” [0005], and Cherukuri teaches dissolution times of tablets of the disclosure such as 10-12 seconds [0111] [0121].
Claim 15 is rendered prima facie obvious because Cherukuri discloses the excipients include xylitol [Claim 14].
Claim 16 is rendered prima facie obvious because Cherukuri discloses the excipients include talc [Claim 14].
Claim 17 is rendered prima facie obvious because Cherukuri discloses the excipients include orange flavor [Claim 14] [0093]-[0095].
Claim 18 is rendered prima facie obvious because Cherukuri discloses the excipients include fructose [Claim 14].
Response to Arguments
Applicant's arguments filed 03/17/2026 have been fully considered but they are not persuasive.
Applicant argues at pg. 7, that Cherukuri does not teach “a ratio of the active ingredient to the sodium polystyrene sulfonate is 1:1” as set forth in amended claims 12 and 13.
The Examiner disagrees. Cherukuri discloses the amount of active ingredient (Dextromethorphan HBr) is 50 g and the amount of sodium polystyrene sulfonate is 50 g. [0069]-[0070]. This is a ratio of 1:1.
Conclusion
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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/ASHLEE E WERTZ/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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