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 . Claims included in the prosecution are claims 1, 4, 14-16 and 25-32.
Applicants' arguments, filed 08/10/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
1. Claims 1, 14, 16, 27, 28 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Buch et al. (US 2007/0178055, Aug. 2, 2007) (hereinafter Buch) in view of Chen (US 2013/0078195, Mar. 28, 2013).
Buch discloses a dissolvable strip for whitening teeth. The strip, which is preferably a single layer, has a whitening agent and a water-soluble or water-dispersible polymer system (abstract). The whitening strip is a film (¶ [0027]). The whitening strip has a polymer system that includes a first polymer, namely water-soluble or water dispersible poly(vinylpyrrolidone) (PVP) or any of its derivatives, and at least one second polymer. The polymer system has adhesive properties, such that when it is bought to the teeth, the strip will adhere to the teeth (¶ [0033]). The water-soluble or water dispersible polymer system is present up to about 99.9 wt. % based on the total weight of the weighting strip (¶ [0038]). The time frame of the dissolution of the strip can be adjusted based on the end benefit desired (¶ [0029]). The whitening strip can be targeted to deliver the whitening agent to a desired area at a desired delivery rate, for example, within about 1 minute to about 360 minutes, to whiten the teeth (¶ [0030]). Suitable whitening agents include PVP-hydrogen peroxide complex (¶ [0041]). The whitening agent is present from about 0.5 wt. % to about 99 wt. % based on the total weight of the whitening strip (¶ [0042]). The whitening strip may have a plasticizer (¶ [0043]). The dry film does not contain water (Example 2).
Buch differs from the instant claims insofar as not disclosing wherein the whitening strip comprises a high molecular weight PVP and a low molecular weight PVP.
However, Chen discloses an adhesive one-part dental bleaching composition comprising a dental bleaching agent, a liquid component, and at least one tooth adhesion agent, the tooth adhesion agent comprising polyvinylpyrrolidone (claim 23). Example 8 discloses an embodiment comprising about 10% PVP with a molecular weight of 1,000,000 to 1,500,000 and about 10% PVP with a molecular weight of 44,000 to 54,000 (¶ [0068]).
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. Buch discloses wherein the whitening strip comprises a polymer system that includes PVP and at least one second polymer, and wherein the polymer system has adhesive properties. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated about 10% PVP with a molecular weight of 1,000,000 to 1,500,000 and about 10% PVP with a molecular weight of 44,000 to 54,000 into the whitening strip of Buch since this is a known and effective polymer system comprising PVP and another polymer and which has adhesive properties as taught by Chen.
Regarding instant claim 16 reciting wherein the oral care composition is free or substantially free of menthol, betaine, and fluoride containing components, Buch does not disclose wherein any of these compounds are required (see claim 1 and abstract of Buch). Therefore, it would have been obvious to one of ordinary skill in the art to have formulated the whitening strip without these compounds.
2. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Buch et al. (US 2007/0178055, Aug. 2, 2007) (hereinafter Buch) in view of Chen (US 2013/0078195, Mar. 28, 2013), and further in view of Yuan et al. (US 2020/0206101, Jul. 2, 2020) (hereinafter Yuan).
The teachings of Buch and Chen are discussed above. Buch and Chen do not teach wherein the whitening agent provides free hydrogen peroxide in an amount of from about 0.01 weight % to about 25 weight %.
However, Yuan discloses an oral care composition for whitening teeth comprising a source of hydrogen peroxide (abstract). The source of hydrogen peroxide may include a cross-linked polyvinylpyrrolidone (PVP) hydrogen peroxide complex (¶ [0012]). The amount or concentration of the source of hydrogen peroxide may vary widely, and may depend upon the amount or a desired amount of hydrogen peroxide provided or otherwise delivered by the source of hydrogen peroxide. In at least one implementation, the source of hydrogen peroxide may be present in an amount that provides from greater than 0.0 weight % to less than or equal to 35.0 weight % free hydrogen peroxide (¶ [0031]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the whitening agent of Buch to provide greater than 0.0 weight % to less than or equal to 35.0 weight % free hydrogen peroxide since Buch does not disclose an amount of free hydrogen peroxide and this is a known and effective amount of free hydrogen peroxide for whitening teeth as taught by Yuan.
3. Claims 15, 25, 26, 29 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Buch et al. (US 2007/0178055, Aug. 2, 2007) (hereinafter Buch) in view of Chen (US 2013/0078195, Mar. 28, 2013), and further in view of Lees et al. (US 2022/0226218, Filing date: Apr. 22, 2020) (hereinafter Lees).
The teachings of Buch and Chen are discussed above. Buch and Chen do not teach wherein the whitening strip comprises about 4 wt. % to about 20 wt. % polyethylene glycol and a cross-linked polyvinylpyrrolidone (PVP) hydrogen peroxide complex.
However, Lees discloses a tooth whitening film comprising a dental bleaching agent comprising one or both of a non-hydrogen peroxide bleaching agent and hydrogen peroxide in a hydrogen peroxide-polymer complex; one or more water soluble film-forming polymers; and one or more plasticizers in a total amount of about 0.1% to about 15% by weight (claim 1). The tooth whitening film may be a single layer (¶ [0052]). In one embodiment the dental bleaching agent comprises a hydrogen peroxide-polymer complex (¶ [0019]). Preferably, the polymer in the polymer complex may be a polyvinyl pyrrolidone. Thus, the hydrogen peroxide-polymer complex may be a hydrogen peroxide-polyvinyl pyrrolidone complex (¶ [0020]). The polyvinyl pyrrolidone polymer in the complex may be uncrosslinked polyvinyl pyrrolidone or crosslinked polyvinyl pyrrolidone (¶ [0118]). The one or more plasticizers may be a polyalkylene glycol. Preferred polyalkylene glycols include polyethylene glycol (¶ [0036]). The one or more water soluble film-forming polymers may comprise polyvinyl pyrrolidone (¶ [0031]).
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. Buch discloses wherein the whitening strip comprises a plasticizer. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated about 0.1% to about 15% polyethylene glycol into the whitening strip of Buch since it is a known and effective plasticizer and amount thereof for a whitening strip as taught by Lees.
Additionally, Buch discloses wherein the whitening strip comprises a PVP-hydrogen peroxide complex as a whitening agent. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated crosslinked polyvinyl pyrrolidone-hydrogen peroxide complex into the whitening strip of Buch since it is a known and effective PVP-hydrogen peroxide complex whitening agent as taught by Lees.
Regarding instant claim 25 reciting wherein polyethylene glycol is the sole plasticizer, neither Buch nor Lee discloses wherein more than one plasticizer is required to formulate a whitening strip. Therefore, it would have been obvious to one of ordinary skill in the art to have used only polyethylene glycol as the plasticizer.
4. Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Buch et al. (US 2007/0178055, Aug. 2, 2007) (hereinafter Buch) in view of Chen (US 2013/0078195, Mar. 28, 2013), and further in view of JP 4613339 B2. Jan. 19, 2011) (hereinafter JP).
The teachings of Buch and Chen are discussed above. Buch and Chen do not teach wherein the tooth whitening film retains active oxygen in an amount of at least 50% after 3 months at 40°C.
However, JP discloses a whitening agent for bleaching teeth discolored by pigmentation with active oxygen (abstract). Hydrogen peroxide is an active oxygen species (¶ [0023]). It is necessary to retain hydrogen peroxide generated for a long period of time or to continuously generate active oxygen. Whether it is consumed in a short time or stays for a long time depends on the pH conditions in the system, and the higher the pH, the longer the stay (¶ [0016]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the whitening strip of Buch to retain active oxygen in the highest amount possible for a long period of time since active oxygen contributes to teeth whitening as taught by JP. One of ordinary skill in the art would have had a reasonable expectation of success since adjusting the pH conditions of a composition with hydrogen peroxide affects active oxygen retention as taught by JP.
Response to Arguments
Applicant’s arguments have been considered but are moot because new rejections necessitated by Applicant’s amendment have been made.
Applicant argues that after years of development work testing numerous ingredients, the present inventors identified a unique balance between high molecular weight PVP and low molecular weight PVP that ensures peroxide stability, ease of consumer use and remarkable whitening performance. The data in the Examples objectively evidences these attributes.
The Examiner does not find Applicant’s argument to be persuasive. The Examples in the specification do not compare various combinations of PVPs with different molecular weights or compare various amounts of the different PVPs with different molecular weights. Therefore, Applicant has not shown wherein the claimed high molecular weight PVP and low molecular weight PVP is unexpected. As such, Applicant’s argument is unpersuasive.
Conclusion
Claims 1, 4, 14-16 and 25-32 are rejected.
No claims are 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 TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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