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, 13-16 and 25-30.
Applicants' arguments, filed 02/03/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Objections
Claim 30 is objected to because of the following informalities: the term “retain” should be removed. Appropriate correction is required.
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, 13-16, 25 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Lees et al. (US 2022/0226218, Filing date: Apr. 22, 2020) (hereinafter Lees) in view of Chen (US 2013/0078195, Mar. 28, 2013).
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]). Certain water-soluble film-forming polymers may also function as adhesives, aiding attachment of the tooth whitening film to one or more teeth (¶ [0150]). The tooth whitening film may further comprise water. The water may be present in the film in an amount of less than 15% by weight, particularly from 0.1% (i.e., meeting substantially free) to 15% by weight (¶ [0099]). The tooth whitening film dissolves in the oral cavity during bleaching such that subsequent removal of the film by the subject is not required. Adhesion may occur by the action of saliva on the PVP component of the film, rendering it tacky or may be as a result of the presence of an adhesive water-soluble polymer (¶ [0209]). The tooth whitening film can be applied to one or more teeth of a subject for a period of more than 5 minutes (i.e., meeting about 5 minutes) (¶ [0210]).
Lees differs from the instant claims insofar as not disclosing wherein the tooth whitening film 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. Lees discloses wherein the tooth whitening film comprises PVP as a water-soluble polymer and wherein the water-soluble polymer functions as an adhesive. 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 tooth whitening film of Lees since this is a known and effective PVP for providing adhesion as taught by Chen.
In regards to instant claim 16 reciting wherein the oral care composition is free or substantially free of menthol, betaine, fluoride containing components, or a combination thereof, Lees does not disclose wherein any of these compounds are required (see claim 1 of Lees). Therefore, it would have been obvious to one of ordinary skill in the art to have formulated the tooth whitening film without these compounds.
2. Claims 4 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Lees et al. (US 2022/0226218, Filing date: Apr. 22, 2020) (hereinafter Lees) 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 Lees and Chen are discussed above. Lees and Chen do not teach wherein the dental bleaching 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 dental bleaching agent of Lees to provide greater than 0.0 weight % to less than or equal to 35.0 weight % free hydrogen peroxide since Lees 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. Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Lees et al. (US 2022/0226218, Filing date: Apr. 22, 2020) (hereinafter Lees) 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 Lees and Chen are discussed above. Lees 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 tooth whitening film of Lees 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.
Conclusion
Claims 1, 4, 13-16 and 25-30 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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