DETAILED ACTION
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/13/2025 has been entered.
Previous Rejections
Applicant’s arguments, filed November 13, 2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 112, Second Paragraph
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 12-13 and 15-18 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.
Claims 12-13 are indefinite because they recite the limitation “rapid”. The term “rapid” is indefinite because it is not clear how fast the granules must dissolve in order to be considered “rapid melt granules” and the term “rapid” is not explicitly defined in the specification.
Claim Rejections - 35 USC § 112 (New Matter)
The following is a quotation 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 12-13 and 15-18 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 12 and 13 introduce new matter as the claims recite the limitation: " the active ingredient having rapid release of more than 50% within 5 minutes”. There is no support in the specification for this limitation. The limitation of: " the active ingredient having rapid release of more than 50% within 5 minutes" was not described in the specification as filed and a person skilled in the art would not recognize in the applicant’s disclosure a description of the invention as presently claimed.
Claim 18 introduces new matter as the claims recite the limitation: " said natural or artificial sweeteners are selected from… sodium salt” There is no support in the specification for this limitation. The limitation of the sweetener being sodium salt was not described in the specification as filed and a person skilled in the art would not recognize in the applicant’s disclosure a description of the invention as presently claimed. The specification discloses the sodium salt of saccharin as a sweetener (pg. 17, lines 3-4) but does not describe the instantly claimed limitation.
From MPEP 2163.06: “Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Applicant has not directed the Examiner to the support in the specification for the amendments. Therefore, it is the Examiner’s position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of filing of 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.
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) and Villarroel et al. (J Pharma Investig, 2018;8:7-13).
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] [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 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 discloses that a variety of drugs can be used in the rapid melt tablet [0041] and that the resins are used to mask the taste of drugs which have a bitter taste, such as dextromethorphan [0040] [abstract].
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.
Additionally, Cherukuri does not disclose that the active ingredient has rapid release of more than 50% within 5 minutes.
Villarroel teaches a complex of metformin hydrochloride with Indion-254 (a brand of sodium polystyrene sulfonate, pg. 7, left column) for the purposes of preparation of a dispersible tablet (abstract). The complex of metformin hydrochloride with sodium polystyrene sulfonate demonstrates release of more than 50% within 5 minutes (pg. 11, Figure 4 b,c). Villarroel teaches that metformin is a drug with a bitter taste and both dextromethorphan and metformin are known to be complexed with resin polymers for the purpose of taste masking (pg. 7). Villarroel also teaches that metformin has use in treating type 2 diabetes and polycystic ovarian syndrome (pg. 7, left column).
Since Cherukuri generally teaches a method to prepare an oral dosage form where it is taught that a variety of bitter drugs can be complexed with the resin [0041] (and hence different diseases/disorders can be treated), it would have been prima facie obvious to one of ordinary skill in the art to include metformin, within the teachings of Cherukuri, because Villarroel teaches that metformin hydrochloride is an additional drug to dextromethorphan that can be complexed with sodium polystyrene sulfonate. An ordinarily skilled artisan would be motivated to use metformin hydrochloride within the teachings of Cherukuri to mask the bitter taste of the drug and treat disorders such as type 2 diabetes and polycystic ovarian syndrome (pg. 7, left column).
Furthermore, 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 were known in the prior art, that is, a method of preparing granules where a bitter drug is complexed with sodium polystyrene sulfonate (Cherukuri) and the bitter drug, metformin hydrochloride, being complexed with sodium polystyrene sulfonate which demonstrates release of more than 50% within 5 minutes (Villarroel). One skilled in the art could have combined the elements as claimed by known methods (i.e., using the bitter drug, metformin hydrochloride, within the teachings of Cherukuri) with no change in their respective functions (an active ingredient and masking bitter taste), and the combination yielding nothing more than predictable results (the active ingredient having release of more than 50% within 5 minutes) to one of ordinary skill in the art. MPEP 2143.A.
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) in view of Villarroel et al. (J Pharma Investig, 2018;8:7-13).
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]. 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 discloses that a variety of drugs can be used in the rapid melt tablet [0041] and that the resins are used to mask the taste of drugs which have a bitter taste, such as dextromethorphan [0040] [abstract].
Cherukuri does not disclose that the active ingredient has rapid release of more than 50% within 5 minutes.
Villarroel teaches a complex of metformin hydrochloride with Indion-254 (a brand of sodium polystyrene sulfonate, pg. 7, left column) for the purposes of preparation of a dispersible tablet (abstract). The complex of metformin hydrochloride with sodium polystyrene sulfonate demonstrates release of more than 50% within 5 minutes (pg. 11, Figure 4 b,c). Villarroel teaches that metformin is a drug with a bitter taste and both dextromethorphan and metformin are known to be complexed with resin polymers for the purpose of taste masking (pg. 7). Villarroel also teaches that metformin has use in treating type 2 diabetes and polycystic ovarian syndrome (pg. 7, left column).
Since Cherukuri generally teaches a method to prepare an oral dosage form where it is taught that a variety of bitter drugs can be complexed with the resin [0041] (and hence different diseases/disorders can be treated), it would have been prima facie obvious to one of ordinary skill in the art to include metformin, within the teachings of Cherukuri, because Villarroel teaches that metformin hydrochloride is an additional drug to dextromethorphan that can be complexed with sodium polystyrene sulfonate. An ordinarily skilled artisan would be motivated to use metformin hydrochloride within the teachings of Cherukuri, to mask the bitter taste of the drug and treat disorders such as type 2 diabetes and polycystic ovarian syndrome (pg. 7, left column).
Furthermore, 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 were known in the prior art, that is, a method of preparing granules where a bitter drug is complexed with sodium polystyrene sulfonate (Cherukuri) and the bitter drug, metformin hydrochloride, being complexed with sodium polystyrene sulfonate which demonstrates release of more than 50% within 5 minutes (Villarroel). One skilled in the art could have combined the elements as claimed by known methods (i.e., using the bitter drug, metformin hydrochloride, within the teachings of Cherukuri) with no change in their respective functions (an active ingredient and masking bitter taste), and the combination yielding nothing more than predictable results (the active ingredient having release of more than 50% within 5 minutes) to one of ordinary skill in the art. MPEP 2143.A.
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 11/13/2025 have been fully considered but they are not persuasive and will be discussed insofar as they apply to the new grounds of rejection.
Applicants argue that the prior art fails to teach the limitation that “the active ingredient has rapid release of more than 50% within 5 minutes”.
First, the Examiner notes that this limitation is new matter not found in the originally filed disclosure (see above 112 rejection).
Second, while the applicant has provided data in the remarks to show the % release of metformin HCl of the instant application (remarks, pg. 16) this data is not found in the specification and has not been submitted in a proper affidavit or declaration. Any evidence submitted to traverse the rejection or objection on a basis not otherwise provided for must be by way of an oath or declaration under MPEP 716.
Finally, while Cherukuri does not disclose that the active ingredient has release of more than 50% within 5 minutes, this property is not unexpected over the prior art. Cherukuri teaches a method of preparing a rapid melt tablet for oral administration with the drug, dextromethorphan HBr. The data of the applicant instead uses the drug, metformin HCl. It would have been prima facie obvious to include metformin HCl, within the teachings of Cherukuri as discussed above, and the release time, as claimed, of the metformin hydrochloride/sodium polystyrene sulfonate complex is known in the art to occur with this drug (Villarroel; pg. 11, Figure 4 b,c).
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHLEE E WERTZ/Examiner , Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612