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 .
Applicants' arguments Request for Continued Examination, filed June 29, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims
Claim Rejections - 35 USC § 103 – Obviousness (Maintained Rejection)
Claims 61-62, 65-66, 68, 70 and 72-79 are rejected under 35 U.S.C. 103 as being unpatentable over Boyd et al. (WO 2005058265).
Boyd et al. disclose oral and personal care composition. A composition comprising a film or a plurality of film fragments entrained in a carrier is disclosed (Abstract). The films comprise a function material. The films comprises clays, waxes and polymers (paragraph 0016). Water soluble polymers among those useful herein include cellulose ethers, methacrylates, polyvinylpyrrolidone, and mixtures thereof. In one embodiment, the polymer is a cellulose ether, including those selected from the group consisting of hydroxyalkyl cellulose polymers such as hydroxypropyl methyl cellulose (HPMC), hydroxypropyl cellulose, hydroxyethyl cellulose, methyl cellulose, carboxymethyl cellulose, and mixtures thereof. The hydroxypropyl methyl cellulose that may be used includes methylcellulose E5 and methyl cellulose E50 (Example 8, meeting instant claim 65). Methyl cellulose comprises 40% by weight of a film (Example 1). Other polymers among those useful herein include polyvinylpyrrolidone, cross-linked polyvinyl pyrrolidone, polyvinylpyrrolidone-vinyl acetate copolymer, polyvinyl alcohol, polyacrylic acid, poly acrylate polymer, cross-linked polyacrylate polymer, cross-linked polyacrylic acid (e.g., Carbopol®), polyethylene oxide, polyethylene glycol, poly vinyl alkyl ether-maleic acid copolymer (such as Gantrez®) and carboxy vinyl polymer; natural gums such as sodium alginate, carrageenan, xanthan gum, gum acacia, arabic gum, guar gum, pullulan, agar, chitin, chitosan, pectin, karaya gum, zein, hordein, gliadin, locust bean gum, tragacanth and other polysaccharides; starches such as maltodextrin, amylose, high amylose starch, corn starch, potato starch, rice starch, tapioca starch, pea starch and sweet potato starch (paragraph 0018). The film comprises functional materials such as calcium pyrophosphate (paragraph 0047) and zinc citrate (paragraph 0048). The carrier includes toothpaste (paragraph 0032). The film fragments have a thickness of from about 1 mil (thousandth of an inch, 25.4 microns) to about 3 mils (76.2 microns) (paragraph 0028). A film comprises 9.55% methylcellulose E5, 4% cornstarch, carrageenan and solids (Example 8). The amount of titanium dioxide meet substantially free.
The reference is not anticipatory insofar as it does not exemplify all the components recited by the instant claims. However, 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. It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added calcium pyrophosphate or a zinc salt to the films of Boyd et al. as a particulate, and polyacrylic acid as a polymer because it is suggested by Boyd and for their recognized suitability and therapeutic functions.
In regards to claim 75-76, the film of Boyd et al. comprises substantially the same components as that of the instant claims, and therefore one would reasonably conclude that the composition of the reference would have substantially the same properties of the breaking strength and; remaining substantially undissolved after about 2 months at 40 degrees C and after about 1 month at 60 degrees C as that of the instant claims.
Response to Arguments
The Examiner submits that Boyd discloses calcium salts such as calcium pyrophosphate may be added to the films as a polishing agent. The refractive index would be a property of the component. Therefore, when calcium pyrophosphate is added to the film, it would have substantially the same refractive index. One would further conclude that when using calcium pyrophosphate, the film would take on an opaque appearance. In regard to the titanium dioxide and titanium dioxide coated mica being the colorant, these components are not essential or required to be incorporated into the disclosed film. Therefore, although Boyd does not specifically say that the polishing agent causes opacity, incorporation of calcium pyrophosphate would cause the film to be opaque due to their appearance. In regards to omitting the titanium dioxide, the films would be opaque if an opaque powder, such as calcium pyrophosphate, was added to the films. Therefore, the function in the film would be retained. In regards to the alleged unexpected results, Boyd discloses ratios that touch that of the instant claims. Therefore, one would reasonably conclude that they would have substantially the same properties. Further, even if the results were indeed unexpected, the claims are not commensurate in scope with the results. The claims recite natural gums and the examples in the instant specification disclose starch, calcium pyrophosphate and a specific ratio of 2.5. It would appear the components and their mixtures are critical to achieving a film. Therefore, it is not clear if varying the type of components outside those disclosed in the examples would lead to similar results. Therefore the rejection is maintained.
Obvious-Type Double Patenting
Claims 61-62, 65-66, 68, 70 and 72-79 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 66-85 of copending Application No. 18/250,421 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as both sets of claims recite a film comprising a polymer, a gum and a particulate, wherein the film does not comprise titanium dioxide. The instant claims differ the copending claims insofar as the copending claims recite polymer and not clays or wax a long with polymers as an option. However, the instant claims are obvious over the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants respectfully defer these issues until the application is otherwise in condition for allowance. Since this has not occurred, the rejection is maintained.
Conclusion
Claims 61-62, 65-66, 68, 70 and 72-79 are rejected.
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612
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