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 the applicant arguments/remarks, filed 12/09/2025, is acknowledged. Amendments to the specification have been entered.
Claims 1-17, 19-25 are pending in this action. Claims 26 has been cancelled. Claims 18, 27 have been cancelled previously. Claims 1-2, 10, 12, 15-16, 19, 25 have been amended. Claims 1-17, 19-25 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Any rejection or objection not reiterated in this action is withdrawn.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 .
Priority
This application is a 371 of PCT/US2022/011795, filed January 10, 2022, which claims benefit of provisional U.S. Application No. 63/135,931, filed January 11, 2021.
Claim Objections
Claims 1, 13, 14 are objected to because of the following informalities:
Newly amended claim 1 comprises the typographic error “by weight isomalt particles” that needs to be corrected to “by weight of isomalt particles”.
Claim 13 comprises the typographic error “hydroxypropylmethylcellulose” that needs to be corrected to “hydroxypropyl methylcellulose” (see claims 12, 19).
Claim 14 recites the limitation “plasticizer being present in the range of” should be corrected to “plasticizer being present in an amount of” for clarity (see claim 19).
Appropriate correction is required.
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 1-17, 19-25 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 “less than 15 wt% of the isomalt particles are less than about 60 microns” that is unclear. First, it is unclear what particle size should be measured – radius, diameter. Second, as stated previously, where a claimed value (i.e., particle size) varies with its method of measurement and several alternative methods of measurement are available, the value is indefinite when the claim fails to concurrently recite the method of measurement used to obtain it. Honeywell Intl. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). It is well known in the field that there is no a comprehensive standard for particle size measurements, and different methods of particle size analysis yield different estimates of particle size for the same sample (see Wikipedia and references cited wherein; “Interpretation of Particle Size Reported by Different Analytical Techniques” on labmanager.com; “Comparison of particle characterization methods” on microtrac.com), i.e., experimental estimates of particle sizes depend on methods of measurements used to obtain it. Third, claim 1 recites the term "about” that is a relative term which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claim 2. Clarification is required.
In response to applicant’s argument that one skilled in the art would understand said particle-size limitation, it is noted that in the present case, the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. MPEP § 2173.05(c). Furthermore, “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims.” See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, clarification is required.
Claim 2 recites the limitation “99 % of the particles” that is not reasonably clear. In the present case, it is unclear if “99%” is measure by the number of particles, OR by “wt%” (see claim 1). Clarification is required.
Newly amended claim 12 recites the limitation “the water-soluble polymer comprises a member of the group consisting of polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, hydroxypropyl methylcellulose and hydroxypropyl cellulose” that is unclear, because the structure of the water-soluble polymer is not clearly delineated. Does this limitation define the water-soluble polymer as a mixture that may include other compounds even in large amounts (i.e., comprising)? This limitation was interpreted as best understood as “the water-soluble polymer is selected from the group consisting of polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, hydroxypropyl methylcellulose and hydroxypropyl cellulose”. Similar is applied to claim 16. Clarification is required.
Claim 16 recites the limitation "medium chain glyceride" that is not clear. As stated previously, although the instant specification teaches the use of median chain triglyceride (see Para. 0012, 0035), it does not provide a definition and/or a standard for ascertaining the requisite degree (i.e., medium chain). Therefore, one of ordinary skills in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
Claim 3-11, 13-15, 17, 19-25 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
Response to Arguments
Applicant's arguments, filed 12/09/2025, have been fully considered. Any rejection or objection not reiterated in this action is withdrawn. New objections and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Applicant is advised to clarify the claim language, the structure of the claimed compositions 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 references cited, to place the application in condition for allowance. As best understood, the applicant discloses dry film coating compositions comprising compounds as instantly claimed, wherein claimed opacifying agents is present in a form of particles having a size of less than 45 microns; and wherein 85 % of isomalt particles have a particle size of greater than or equal to 60 microns. Applicant teaches that said approach allows controlling interactions of isomalt and opacifying agent, i.e., isomalt tightly binds and orients the opacifying agent particles during the film formation process on the surface of an orally-ingestible substrate such that the opacity of the coating is higher than when isomalt is not included.
Conclusion
Claims 1-17, 19-25 are rejected, but would be allowable if rewritten to overcome objections and the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
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.
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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