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 September 17, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 103 - Obviousness
Claims 1-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Tao (US 20180289606) in view of List (BE 1020399) and Tangri et al. (2017).
Tao discloses a multi-film delivery system for a multi-component tooth whitening, desensitization and remineralization. The system comprises a first orally dissolvable film made of a liquid-soluble or liquid dispersible polymer system containing an activation compound or complex and desensitizing agents and/or remineralizing agents and/or anti-inflammatory agents; and a separate second orally dissolvable film made of an inert hydrophilic polymer system containing a tooth whitening compound, such as hydrogen peroxide, stabilizers and thickeners, and/or desensitizing agents and/or remineralizing agents and/or anti-inflammatory agents. When the two strips are applied together onto the teeth surfaces, the activation compound/complex on the first film activates the tooth whitening compound in the second film, and accelerates the release of active bleaching radicals for accelerated whitening action (Abstract). The compositions encompass films and strips. The oral thin films or orally dissolvable films (ODFs) are films that contain film-forming polymers such as natural, semi-synthetic and synthetic polymers, including but not limited to guar gum, karya gum, xanthan gum, pectin, starch, gelatin, pullulan, maltodextrins, chitosan derivatives, sodium alginate, polyethylene glycol (PEG), polyvinylpyrrolidone (PVP), polyvinyl alcohol, polyacrylic acid, salts of polyacrylic acid including sodium salt, potassium salt and ammonium salt, poly(meth)acrylic acid and its derivatives, hydroxypropylmethyl cellulose (HPMC), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), carboxymethyl cellulose (CMC), sodium carboxymethyl cellulose (Na—CMC), alone or mixtures thereof (paragraph 0015). The film-forming polymers comprise about 20% to 95% by weight of the film, meeting greater than 35%. The whitening agent includes hydrogen peroxide in an amount ranging from 1% to 20% by weight (paragraph 0058). Preferably, whitening compound compounds are stabilized by adding into the whitening compound stabilizers, selected from the group of EDTA and its salt, potassium stannate, sodium stannate, etidronic acid, phosphoric acid, sodium pyrophosphate (a polyphosphate). Thickening agents are critical to obtain ideal viscosity so that the second film can adhere onto teeth surfaces and the first film when applied. The thickening agents are selected from crosslinked polyacrylic acid, polyvinylpyrrolidone (PVP), copolymer of polyethylene oxide and polypropylene oxide, and the mixture of thereof (paragraph 0059). The remineralizing agents and the desensitizing agents may be added to the film comprising the whitening compound. Remineralizing agents include nano-hydroxyapatite (meeting pentacalcium hydroxide triphosphate) in an amount of 5% (examples). The thickness of the films range from 50 micrometers to 1 mm (paragraph 0042). An example of the second ODF comprises hydrogen peroxide, polyvinyl pyrrolidone, polyacrylic acid, glycerin water, sodium pyrophosphate (a polyphosphate), disodium EDTA and polyethylene glycol 400 (EXAMPLE 1). The compositions are made by mixing the components together and then drying the films to remove some water and ethanol.
Tao differs from the instant claims insofar as it does not disclose the films comprise phthalimido peroxy caproic acid (PAP) as the whitening agent or polycabophil as the crosslinked polyacrylic acid.
List discloses teeth whitening compositions comprising at least on source of microcrystalline calcium and a tooth whitening agent in a thixotropic gel carrier. The source of microcrystalline calcium includes an amorphous calcium phosphate complex, which is released by liquefaction of the thixotropic gel support material and fulfills a dual function. This source causes a substantial increase in the calcium concentration in the saliva, thereby reducing and even reversing demineralization of the tooth enamel and dentin. In the presence of saliva, this calcium source transforms into a more thermostable form, in particular the microcrystalline calcium hydroxyapatite. The hydroxyapatite is substantially insoluble in the saliva, restores lesions, adheres to the tooth enamel as a microcrystalline film and thus has a bleaching effect. Dental bleaches in the composition include peroxyacids such as peroxycapronic acids, hydrogen peroxide, carbamide peroxide and urea peroxide. Favorable results were established by the use of peroxycaproic acid, and in particular phthalimido peroxycaproic acid as a tooth whitening agent. The bleaching effect is enhanced by the beneficial effect of the peroxycaproic acid on the dental plaque, which causes a microcrystalline calcium film to form faster and fasten to the tooth enamel faster and more firmly. Phthalimido peroxycaproic acid is a fairly unstable tooth bleach that can be stabilized with butyl hydroxy toluene (BHT) or other chelating compounds such as ethylenediamine tetraacetic (EDTA) or trimethoxybenzoic acid (page 4). The thixotropic gel carrier material can be any gel capable of retaining the active ingredients in its structure in a reversible manner and forming a film on the tooth enamel. Examples thereof are polyvinylpyrrolidone, polyvinyl alcohols such as polyethylene and polypropylene glycols, cellulose polymers, polyvinyl acrylates and mixtures thereof to the extent that they are capable of forming a tight film on the teeth. Polyvinylpyrrolidone is a particularly favorable thixotropic gel carrier material because it is soluble in water and in polar solvents such as alcohols, harmless because it is not absorbed by the body, admitted as an additive in foodstuffs and frequently used as an adjuvant in the cosmetic and pharmaceutical industry (page 5, paragraph 2). The compositions may further contain one or more flavors, chelating agents such as EDTA, anti-dental adhesives such as pyrophosphates, polyphosphates, polyphosphates, polyphosphates polyphosphonates and mixtures thereof, one or more sources of fluoride ions, antimicrobial and / or anti-inflammatory agents and enzymes.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used phthalimido peroxycaproic acid in an amount of 1% as a tooth whitening agent in place of or in combination with hydrogen peroxide motivated by the desire to use a tooth whitening agent that has favorable results and where the bleaching effect is enhanced due to the beneficial effect of the peroxycaproic acid on the dental plaque, which causes a microcrystalline calcium film to form faster fasten to the tooth enamel faster and more firmly.
In regards to the amounts of phthalimido peroxycaproic acid, when mixed with hydrogen peroxide, it would have been in the relative skill of one ordinary skill in the art through routine optimization to have adjusted the amounts of phthalimido peroxycaproic acid to about 1% in combination with hydrogen peroxide 10 to 20% to arrive at the desired tooth whitening effect. See MPEP 2144.05.
Tao in view of List differs from the instant claims insofar as it does not disclose that the crosslinked polyacrylic acid used in Tao is polycarbophil.
Tangri et al. disclose drug delivery systems. Polymers used in drug delivery systems include mucoadhesive polymers such as polyacrylic acids. Polyacrylic acids include polycarbophil (page 117, col. 2 paragraph 5).
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 used a polycarbophil as the polyacrylic acid polymer of Tao because it is a suitable mucoadhesive polyacrylic acid polymer.
In regards to the form of the hydroxyapatite, Tao discloses the hydroxyapatite are nanohydroxyapatites. Hydroxyapatite are particles and when added to water to make the formulation of Tao in view of List, it would become a paste. In regards to the high amount of hydroxyapatite, hydroxyapatite is used as remineralization component making it a result effective variable. It would have taken no more than the relative skill of one of ordinary skill in the art through routine optimization to have adjusted the amount of hydroxyapatite to obtain the desired therapeutic effect.
Response to Arguments
The Examiner submits a slower releases of the PAP would not necessarily result in lesser whitening performance. It would result in a prolonged whitening time. In regards to the PAP being a much bigger molecule and not suitable for the strips of Tao, Tao discloses other peroxide actives other than hydrogen peroxide. One such active is persilicate perphosphate, which is bigger than PAP. Therefore one would reasonably conclude that the size of PAP would not inhibit it from being suitable for the films of Tao. In regards to the strips of the instant claims being fundamentally distinct from the that of Tao, there appears to be no recitation in the instant claims that the strips have an extended dissolution time. There is no recitation in regards to time at all. The motivation to use PAP in the films of Tao is because it is a suitable peroxide compound for whitening compositions. Tao discloses a list of peroxide providing compounds that are suitable for the disclosed invention. Therefore it would be obvious to use other peroxide sources from the art. In regards to the dissolution time, Tao does not specifically disclose “polycarbophils” but does disclose crosslinked polyacrylic acid. Polycarbophils are crosslinked polyacrylic acids. Therefore, it would be reasonable to use polycarbophils in the compositions of Tao as the crosslinked polyacrylic acid. Therefore adding polycarbophils to Tao as a substitution would not contradict the objective. In regard to the final sentence, Tao discloses crosslinked polyacrylic acid, which would include polycarbophils. Therefore, this would not greatly affect the films of Tao. In regards to PAP, one would only need to adjust the amount to determine the amount of peroxide released. It is noted that Tao does disclose other whitening agents besides hydrogen peroxide. Therefore one would reasonably conclude that PAP was also suitable, absence of evidence to the contrary. In regards to the stability of PAP, the motivation to replace peroxide with PAP because it results has favorable results and the bleaching effect is enhanced due to the beneficial effect of the peroxycaproic acid on the dental plaque. In regards with replacing polyacrylic acid with polycarbophils, it would have been obvious because polycarbophils are used in whitening compositions. In regards to the amount of polycarbophil, it would only require routine experimentation to find the appropriate amount. In regards to the functions of the components of the instant claims, these are not recited by the instant claims. Therefore, the rejection is maintained.
Conclusion
Claims 1-17 and 19 are rejected.
No claims allowed.
THIS ACTION IS MADE FINAL. 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.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612