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, filed December 11, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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 § 112 – Indefiniteness (New Rejections)
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 61-62, 65-66 and 68-76 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.
The claim recites the film comprises a polymer, a clay, a waxy or a combination thereof and then further recites “wherein the polymer, clay, wax or the combination thereof comprises hydroxypropyl methyl cellulose”. Hydroxypropyl methyl cellulose is a polymer. Therefore it would appear that a polymer must be present and is not optional, as inferred by the recitation of “or”.
In regards to claim 62, the claim recites the polymer, the clay, the wax or the combination is from about 30% to about 70, and the starch is from about 5% to about 30. The claim is indefinite insofar as when the natural gum is 5%, it is not clear how the ratio of hydroxypropyl methyl cellulose to starch is met.
In regards to claim 66, the claim recites wherein the polymer comprises polyvinylpyrrolidone polymer. However, claim 61 recites “wherein the polymer, clay, wax or the combination thereof comprises hydroxypropyl methyl cellulose”. Hydroxypropyl methyl cellulose is a polymer and therefore, it is not clear if the PVP polymers are in addition to or are in place of hydroxypropyl methyl cellulose.
Claim Rejections - 35 USC § 102 – Anticipation (Maintained Rejection)
Claims 61-66, 68 and 71-78 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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.
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 should 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. .
Boyd et al. anticipate the instant claims.
Response to Arguments
The Examiner submits that the claims recite “about” 2.4:1 to “about” 3:1 hydroxypropyl methyl cellulose to starch. The instant specification discloses that the term “about” encompasses 10% of the recited number. Applicant acknowledges that Boyd discloses a ratio of 3.25:1, which is within 10% of 3:1, and a ratio of 2.3:1, which is within 10% of 2.4:1. Therefore the ratio of Boyd are encompassed by the instant claims and the rejection is maintained.
Claim Rejections - 35 USC § 103 – Obviousness (Maintained Rejection)
Claims 67, 69-70 and 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.
Response to Arguments
The Examiner submits that as discussed above, Boyd meets the limitation of the ratio of the instant claims. In regards to the ratio HPMC to starch, it would appear 3.3 forms a film, even though it is not a smooth film. Therefore the 3.25 of Boyd would also form a film. Further the film formation may be affected by the addition of other components such as calcium pyrophosphate in a specific amount, which is not recited by the instant claims. Therefore, the claims are not commensurate in scope with the examples in the instant specification. Further, Boyd discloses that the examples therein form films. Therefore one of ordinary skill in the art would reasonably conclude that the compositions of Boyd forms films and therefore would meet the limitations of the instant claims. In regards to forming films with the proper characteristics, there appears to be no characteristics recited in the instant claims. One of ordinary skill in the art would reasonably conclude that the composition of Boyd would form films because Boyd discloses the compositions form films. In regards to the instantly claimed ratio, the claims recite “about” and at least two of the examples of Boyd meet this limitation based on the definition of “about”. Therefore the rejection is maintained.
Obvious-Type Double Patenting
Claims 61-80 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 and 68-79 are rejected.
No claims allowed.
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.
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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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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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612
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