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, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37 and 39.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/11/2026 has been entered.
Applicants' arguments, filed 02/11/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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, 9, 11, 13, 19, 23, 25, 27, 29, 35, 37 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Pekovic (CA 3,050,693 A1, Oct. 5, 2020).
Pekovic discloses an oral care composition comprising sodium chloride free sea water, a silver ions solution and optionally a pharmaceutically acceptable carrier or excipient (abstract). The silver ions solution is obtained from silver diamine fluoride (SDF) (claim 22). SDF is known in prevention and stopping dental decay (¶ [0064]). The oral care composition comprises up to 70.00 wt. % of the silver ions solution (¶ [0078]). The oral care composition may comprise at least one thickening agent (¶ [0138]). The thickening agent may be in proportion of 0.1 wt. % to 10 wt.% with respect to the total weight of the oral care composition (¶ [0139]). Suitable thickening agents include carboxymethyl cellulose (CMC) (¶ [0140]). The pharmaceutically acceptable carrier or excipient may be a liquid. The liquid can be a thixotropic liquid (¶ [0120]). The oral care composition may further comprise flavorings, colorings, and mixtures thereof (¶ [0084]). The oral care composition may have a pH generally in the range of from 7 to 8 (¶ [0136]). The oral composition prevents the etiology of dental caries (¶ [0052]) and reduces dentinal hypersensitivity (¶ [0100]).
The prior art discloses an oral composition (abstract) containing silver diamine fluoride (claim 22) up to 70.00 wt. % (¶ [0078]) and 0.1 wt. % to 10 wt. % thickening agent (¶ [0138] and [0139]), wherein the composition is thixotropic (¶ [0120]). Together these would provide a composition as claimed instantly.
The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
In regards to the viscosity recited in claims 1 and 29, as noted in the instant specification on page 8, the thickening agent is present in an amount such that the composition for oral application has a viscosity of from 0.01 to 500 Pa·s as measured by a TA AR-G2 rheometer with a 40 mm cone and plate, carried out at room temperature (about 23°C), and a shear rate of 0.1/second to 100/second. Accordingly, since viscosity appears to be dependent on the amount of thickening agent, and Pekovic discloses an amount of thickening agent (i.e., 0.1 wt. % to 10 wt.%) that overlaps with the claimed amount of thickening agents (i.e., 0.1 wt. % to 15 wt.%), the oral care composition of Pekovic necessarily has the same viscosity as the claimed composition.
In regards to instant claim 13 reciting mixing silver diamine fluoride with the thickening agent, this is a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113. Accordingly, since the claimed product is obvious from Pekovic, the claim is unpatentable.
In regards to instant claim 25 reciting wherein the composition can undergo an isothermal gel-sol-gel transformation, as noted in the instant specification on page 9, the claimed composition may be thixotropic and thus capable of undergoing an isothermal gel-sol-gel transformation. Accordingly, since the composition of Pekovic may be thixotropic, the composition of Pekovic can undergo an isothermal gel-sol-gel transformation.
In regards to instant claim 35 reciting applying the composition to a decayed portion of tooth, this method step would have been obvious since Pekovic discloses wherein the composition comprises SDF and wherein SDF stops dental decay.
In regards to instant claim 37 reciting preventing caries in high-risk teeth and applying the composition to a surface of the tooth at a high risk of forming a carious lesion, Pekovic discloses wherein the composition prevents the etiology of dental caries. Therefore, it would have been obvious to one of ordinary skill in the art to have applied the composition to any individual concerned with dental caries, which would include individuals with a tooth at a high risk of forming a carious lesion.
2. Claims 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Pekovic (CA 3,050,693 A1, Oct. 5, 2020) in view of Swanson (US 2017/0354676, Dec. 14, 2017).
The teachings of Pekovic are discussed above. Pekovic does not teach wherein the composition comprises a clathrate.
However, Swanson discloses a mucoadhesive formulation containing a clathate host that encloses water molecules for providing moisture to and maintaining moisture on a mucosal surface (abstract). An example of a clathrate host is cyclodextrin (¶ [0020]). The clathrate host may also be a clathrate of glycerin and polyacrylate (claim 4). In one embodiment the clathrate host is LUBRAJEL® BA (¶ [0043]). The composition may comprise 7 wt. % LUBRAJEL® BA (Table 2).
Accordingly, it would have prima facie obvious to one of ordinary skill in the art to have incorporated 7 wt. % clathrate, such as LUBRAJEL® BA, into the composition of Pekovic motivated by the desire to formulate the composition to provide moisture to a mucosal surface as taught by Swanson.
3. Claims 21, 31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Pekovic (CA 3,050,693 A1, Oct. 5, 2020) in view of Dimensions of Dental Hygiene (Advantage ArrestTM Silver Diamine Fluoride 38% is Now Available in the U.S., Exclusively from Elevate Oral Care, Apr. 28, 2015), as evidenced by Soares-Yoshikawa et al. (Fluoride Concentration in SDF Commercial Products and their Bioavailability with Demineralized Dentine, 2020) (hereinafter Soares-Yoshikawa) and Elevate Oral Care (Advantage Arrest, 2018).
The teachings of Pekovic are discussed above. Pekovic does not disclose wherein the composition comprises triarylmethane dye and wherein the silver diamine fluoride provides 10,000 to 100,000 ppm or 50,000 ppm fluoride.
However, Dimensions of Dental Hygiene discloses wherein Advantage Arrest™ Silver Diamine Fluoride 38% is Now Available in the U.S., Exclusively from Elevate Oral Care.
As evidenced by Soares-Yoshikawa, Advantage Arrest comprises 45,283 to 51,013 ppm F (Table 1).
As evidenced by Elevate Oral Care, Advantage Arrest comprises FD&C Blue 1 (i.e., a triarylmethane dye) as an inactive ingredient.
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. Pekovic discloses wherein the silver ions solution is obtained from silver diamine fluoride (SDF). Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated Advantage Arrest into the composition of Pekovic since it is a known and effective SDF as taught by Dimensions of Dental Hygiene.
Response to Arguments
Applicant argues that even taking into consideration the teachings of Pekovic, it was unexpected to find that the dentinal tubule penetration and occlusion were indistinguishable for both the SDF liquid with SDF gel compositions. The present invention is not made obvious by Pekovic.
The Examiner does not find Applicant’s argument to be persuasive. It appears that Applicant is arguing that using an SDF gel is unexpected. However, the Examiner does not agree. SDF gels were known in the art. As evidenced by Niederman et al. (US 2010/0247456, Sep. 30, 2010), they disclose a method for arresting caries or reducing the number of new or active caries lesions in an individual by administering silver diamine fluoride (SDF) in a sustained release composition. The steps of the method include applying a SDF gel composition to the tooth surface of the individual for a period of between about 1 and 5 minutes (¶ [0006]). Thus, an SDF gel was known in the art and using an SDF gel is not unexpected.
Additionally, the claims are not limited to an SDF gel composition. Instant claim 1 does not recite wherein the composition is a gel and instant claim 25 recites wherein the composition is a thixotropic fluid. As discussed in the rejection, Pekovic discloses wherein the composition is a thixotropic fluid in paragraph [0120]). Thus, the claimed invention is made obvious by Pekovic and Applicant’s argument is unpersuasive.
Applicant argues that the low concentration of silver used by Pekovi would not be expected to reduce sensitivity.
The Examiner does not find Applicant’s argument to be persuasive. Pekovic specifically discloses in paragraph [0100] wherein the composition reduces dentinal hypersensitivity. Thus, one of ordinary skill in the art would have reasonably expected the composition of Pekovic with its amount of silver to reduce sensitivity. Applicant has not shown wherein the composition of Pekovic does not reduce dentinal hypersensitivity. Although Applicant compared a commercial formulation with an experimental formulation, this comparison does not show wherein concentration of silver affects sensitivity reduction since both formulations comprise the same amount of silver. Also, the commercial formulation is not representative of Pekovic’s composition since the commercial formulation is not thixotropic like Pekovic’s composition. Additionally, even if the commercial formulation is representative of Pekovic’s composition, Applicant’s argument would still be unpersuasive. Applicant found that both the commercial and experimental formulation occluded the top part of dentinal tubules. Thus, both the commercial and experimental formulations are effective at reducing sensitivity. The instant claims do not recite to what degree the composition reduces sensitivity. As such, Applicant’s argument is unpersuasive.
Applicant argues that the skilled person would reasonably conclude that increasing the fluoride concentration 4 orders of magnitude would render the low fluoride composition of Pekovic to be inoperable for its intended use.
The Examiner does not find Applicant’s argument to be persuasive. Although Applicant has provided statements from Dr. Milgrom, this is merely Dr. Milgrom’s opinion. Given the totality of evidence, Applicant’s argument is unpersuasive. Pevokic discloses wherein the composition may be in the form of a gel instead of a mouthwash. Applicant has not shown wherein a gel should not contain large amounts of silver or wherein a gel formulation would risk ingestion of silver. As such, Applicant’s argument is unpersuasive.
Applicant argues that Horst discloses that if you accidentally apply SDF liquid to the skin or gums, a brown or white stain may appear that causes no harm, cannot be washed off and will disappear in one to three weeks.
The Examiner does not find Applicant’s argument to be persuasive. Pekovic discloses in paragraph [0069] wherein the composition may comprise stain reducing agents. Thus, even if SDF liquid causes staining, one of ordinary skill in the art would have still been motivated to use the composition of Pekovic since such staining may be reduce or eliminated with the stain reducing agents. As such, Applicant’s argument is unpersuasive.
Response to Declarations
Declarant’s arguments in both declarations have been addressed above and are unpersuasive.
Conclusion
Claims 1, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37 and 39 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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