DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification and claims as well as applicant arguments/remarks, filed 10/28/2025, is acknowledged. Amendments to the specification have been entered.
Claims 1-10, 12-22 are pending in this action. Claim 11 has been cancelled. Claims 1, 9-10, 12, 14-17, 20-22 have been amended. Claims 1-10, 12-22 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Priority
This application was filed 06/29/2023. No provisional U.S. Application is associated with this application.
Claim Rejections - 35 USC § 112(b)
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 1-10, 12-22 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 pre-AIA the applicant, regards as the invention.
Newly amended claim 1 recites the limitation “the intragranular portion constituting a plurality of granules” that is not reasonably clear. In the present case, it is noted that the instant specification teaches “The intragranular portion comprises a plurality of granules” (see Para. 0016), i.e., may include additional components/compounds even in large amounts (see MPEP 2111.03). Further, neither the claims nor the instant specification provides a definition for the term “constitute” with respect to the disclosed structure. Therefore, the scope of the claim is not clear. Similar is applied to newly amended claims 20, 21. Clarification is required.
As stated previously, claim 1 recites the limitation “sweetener in an amount of at least 20 wt% by weight of the plurality of granules” that is unclear, because the claimed amounts are not clearly delineated. Similar is applied to claims 3, 4, 6, 9, 18. Clarification is required.
In response to applicant’s argument that one skilled in the art would understand what concentrations/amounts can be used, it is noted that newly amended independent claim 1 does not clearly set forth the metes and bounds of the patent protection desired, because the concentration/amount of constituent (i.e., a sweetener) is not clearly delineated. Clarification is required.
As stated previously, claim 12 recites the term “low substituted hydroxypropyl cellulose” that is not reasonably clear. In the present case, it is noted that the term “low substituted” is not defined by the claim, the specification does not provide a definition and/or examples for this term. Therefore, one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Clarification is required.
In response to applicant’s argument that the term “low-substitute hydroxypropyl cellulose” is well known in the field, it is noted that neither the claim nor the specification provides the definition for the term “low-substituted”. Therefore, one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Clarification is required.
Claims 2, 5, 7-8, 10, 13-17, 19, 22 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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.
Claims 1-10, 12-22 are rejected under 35 U.S.C. 103 as being unpatentable over Wittorff, US 2021/0169808 A1.
Wittorff teaches oral tablets for buccal absorption of active ingredients, wherein said tablets comprise a population of particles and an active ingredient to be released in the oral cavity for absorption through the oral mucosa, wherein said population of particles comprises directly compressible (DC) sugar alcohol particles (e.g., obtained by granulation) and non-directly compressible (non-DC) sugar alcohol particles (Abstract; Para. 0003, 0158, 0262, 0263, 0266, 0292 as applied to claims 1, 8), and wherein said tablets are chewable tablet (Para. 0129 as applied to claim 2).
Wittorff teaches that the active ingredient can be present in an amount of 0.05-12% by weight of the tablet as both DC and non-DC particles, and further teaches the use of such active agents as loratadine, diphenhydramine, famotidine, fexofenadine, cetirizine, caffein (Para. 0008, 0014, 0375 as applied to claims 1, 9-10, 14-17).
Wittorff teaches that both DC and non-DC sugar alcohol particles (i) include such sugar alcohols as erythritol, xylitol, maltitol, mannitol, lactitol, isomalt, or a combination thereof (Claims 142, 144; Para. 0012, 0140-0149, 0158 as applied to claims 1, 7, 13); and (ii) DC sugar alcohol particles may include a binder and can be present in an amount of at least 10 wt% of the tablet (Para. 0161, 0321 as applied to claims 1, 4); and (iii) non-DC sugar alcohol particles can be present in an amount of at least 10 wt% of the tablet (Para. 00153-157 as applied to claims 3, 6).
Wittorff teaches the use of such binders as hydroxypropyl cellulose, hydroxyethyl cellulose, hypromellose/hydroxypropyl methylcellulose (Para. 0126, 0127 as applied to claim 12).
Wittorff teaches that said tablets may comprise at least two modules (Para. 0078, 0079, 0082 as applied to claim 20).
Therefore, the examiner maintains the position that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made/filed, because every element of the invention has been taught by the teaching of the reference cited. Regarding the properties of the disclosed tablets (claims 5, 22), it is noted that the cited prior art teaches formulations comprising the same components. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided.
With regard to the concentrations instantly claimed (claims 14, 16), it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. 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. Claims 18, 19 are rejected as being depended on rejected base claim.
Response to Arguments
Applicant's arguments, filed 10/28/2025, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New rejections and/or arguments have been added to the record to address newly introduced amendments and/or to clarify the position of the examiner. Additional examiner’s comments are set forth next.
In response to applicant’s argument that Wittorff does not teach the use of binders in a plurality of granules, it is noted that Wittorff teaches the use of DC particles, wherein said DC particles are obtained by processing non-DC particles by granulating with a binder (Para. 0158, 0159, 0292). Further, Wittorff teaches the use of such binders as hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, polyvinylpyrrolidone, copovidone alone or in combination (Para. 0177-0181).
In response to applicant’s argument that Wittorff does not teach that active agents/ingredients can be present in both DC and non-DC particles, it is noted that Wittorff teaches that active agents/ingredients may be present as both DC and non-DC particles as long as the active ingredient as such does not interfere significantly with other compounds (Para. 0375).
Applicant is advised to clarify the structure of the claimed tablets and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the reference cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
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 OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615