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, 27, 29, 31, 33, 35, 37 and 39.
Applicants' arguments, filed 07/08/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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, 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 1 reciting wherein the composition is capable of an isothermal gel-sol-gel transformation, the claimed recitation “capable of” is merely a functional recitation requiring the ability to fulfill that function; the claim does not require, however, that isothermal gel-sol-sol- transformation actually occurs. 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 is capable of 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.
In regards to instant claims 35, 37 and 39 reciting wherein the composition undergoes a gel to sol conversion during application and reforms as a gel after application, 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 is thixotropic, the composition of Pekovic would necessarily undergo a gel to sol conversion during application and reform as a gel after application.
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 the rejection supplies no articulated, evidence-backed reason a person of ordinary skill would have arrived at the claimed thixotropic/viscosity profile, for the claimed purpose, with a reasonable expectation of success.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, Pekovic discloses wherein the composition is thixotropic. As for the claimed viscosity, as discussed in the rejection, 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. Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant. See MPEP 2112(V). Applicant has not shown wherein the composition of Pekovic would not have the claimed viscosity when it comprises substantially the same amount and type of thickening agents. Also, it is not required for the Examiner to provide evidence to show inherency since reasoning may be used. As such, Applicant’s argument is unpersuasive.
Applicant argues that if the equivalence of a high-viscosity gel to a low-viscosity liquid is said to have been predictable, the premise is unsupported by any citation.
The Examiner does not find Applicant’s argument to be persuasive. Applicant had argued previously that it was unexpected to find that the dentinal tubule penetration and occlusion were indistinguishable for both the SDF liquid with SDF gel compositions. As discussed previously, 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, instant claim 1 is not limited to an SDF gel composition. Instant claim 1 does not recite wherein the composition is required to be a gel. Instant claim 1 merely recites wherein the composition is capable of being a gel. Thus, Applicant’s argument is unpersuasive and the rejection is maintained since Applicant has not addressed this argument.
Applicant argues that Lokken teaches that thickening an oral active-delivery composition impedes the active.
The Examiner does not find Applicant’s argument to be persuasive. Pekovic teaches wherein the composition reduces dentinal hypersensitivity and that it comprises thickening agents. Thus, one of ordinary skill in the art would reasonably expect that the thickening agent of Pekovic would not negatively affect dentinal tubule penetration and occlusion. Applicant has not shown with objective evidence that the thickening agent of Pekovic would negatively affect dentinal tubule penetration and occlusion. Although Lokken discloses in paragraph [0004] that use of such thickeners prevents the active from migrating to the tooth surface which is referred to as gel blocking, Lokken does not disclose an amount of thickening agents. One of ordinary skill in the art would not reasonably expect all amounts of thickening agent (which includes very small to negligible amounts) to gel block since different amounts of thickening agents affects viscosity which affects how well an active can migrate. As such, Applicant’s argument is unpersuasive.
Applicant argues that one would not borrow Swanson’s mucosal-moisturization purpose and graft it onto a tooth-targeted mucosa-avoiding SDF composition.
The Examiner does not find Applicant’s argument to be persuasive. Pekovic does not disclose wherein the composition is mucosa-avoiding. Therefore, one of ordinary skill in the art would not be not motivated to use the teachings of Swanson. As such, Applicant’s argument is unpersuasive.
Applicant argues that the claimed values are not taught,
The Examiner does not find Applicant’s argument to be persuasive. As discussed above and in the rejection, the composition of Pekovic necessarily has substantially the same viscosity as claimed. Applicant has not shown otherwise. As such, Applicant’s argument is unpersuasive.
Applicant argues that no motivation to teach the claimed values come from the art.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above and in the rejection, the composition of Pekovic necessarily has substantially the same viscosity as claimed. Applicant has not shown otherwise. As such, Applicant’s argument is unpersuasive.
Applicant argues that known-ness does not fill the gap.
The Examiner does not find Applicant’s argument to be persuasive. The rejection does not state wherein the claimed amount is obvious from “known-ness.” As such, Applicant’s argument is unpersuasive.
Applicant argues that the cited art gives no direction to the particular claimed form – the shear-reversible thixotropic gel – and identifies no critical parameters and no finite set of predictable solutions leading to the claimed profile.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, Pekovic teaches, like the claimed invention, a composition comprising SDF, which is thixotropic and comprises substantially the same thickening agent and amount thereof as claimed. Thus, it is not clear why the composition of Pekovic would not have substantially the same properties as claimed. As such, Applicant’s argument is unpersuasive.
Applicant argues that the considerable time that SDF liquid has been in clinical use with its handling and staining drawbacks recognized and unaddressed confirms that the claimed solution was not obvious to try.
The Examiner does not find Applicant’s argument to be persuasive. Applicant’s argument is merely speculative and not factual. Also, Applicant has not shown wherein the claimed invention is not obvious over the teachings of Pekovic and wherein Pekovic would not have claimed properties. As such, Applicant’s argument is unpersuasive.
Applicant argues that that viscosity depends on the amount of thickening agent does not mean it is solely determined by that amount; dependence on one variable does not exclude dependence on others.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown wherein the amount of thickening agent disclosed by Pekovic would not lead to the claimed viscosity. Also, neither the instant specification nor the instant claims disclose/recite wherein another agent is required to achieve the claimed viscosity. As such, Applicant has not shown wherein the composition of Pekovic would not have the claimed viscosity with the amount of thickening agent disclosed and Applicant’s argument is unpersuasive.
Applicant argues that xanthan gum typically does not impart thixotropic properties when added to compositions.
The Examiner does not find Applicant’s argument to be persuasive. The thickening agent of Pekovic is not limited to xanthan gum. Applicant has not shown wherein none of the thickening agents of Pekovic would not arrive at a composition with the claimed properties. Additionally, instant claim 9 recites wherein the thickening agent comprises xanthan. Thus, it is not clear how the claimed invention is thixotropic with xanthan gum as the thickening agent if xanthan gum does not impart thixotropic properties. As such, Applicant’s argument is unpersuasive.
Applicant argues that Niederman states that the quantity depends on among other things its chain length and molecular weight and thus on the viscosity formed in the solution. Weight percent alone does not fix viscosity even in the cited art.
The Examiner does not find Applicant’s argument to be persuasive. Pekovic discloses wherein the composition is thixotropic. Thus, one of ordinary skill in the art would use a CMC with a molecular weight that will achieve this property. Applicant has not shown wherein such CMC would not lead to the claimed viscosity. Additionally, instant claim 9 recites wherein the thickening agent may be silica. Pekovic discloses in paragraph [0124] wherein the thickener may be silica. Silica has a fixed molecular weight. Applicant has not shown wherein the amount of silica in Pekovic would not lead to a composition with the claimed viscosity. As such, Applicant’s argument is unpersuasive.
Applicant argues that a generic, unspecified CMC of the kind Pekovic discloses cannot be presumed to reach the claimed thixotropic, gelled state at any given weight percent, some grades gel and some do not.
The Examiner does not find Applicant’s argument to be persuasive. Pekovic discloses wherein the composition is thixotropic and wherein the CMC is a thickening agent. Therefore, it would have been obvious to one of ordinary skill in the art that the CMC of Pekovic gels. As such, Applicant’s argument is unpersuasive.
Applicant argues that concentration is a steep, state-changing variable – not a proxy for a single viscosity.
The Examiner does not find Applicant’s argument to be persuasive. Pekovic teaches an amount of thickening agents that is encompassed by the entire claimed range. Thus, it is not clear why the amount of thickening agents disclosed by Pekoic would not lead to a composition with the claimed viscosity. As such, Applicant’s argument is unpersuasive.
Applicant argues that the governing rule is multivariate. Thixotropy is influenced by several factors like pH, temperature, polymer concentrations, polymer modification or combinations, addition of cations or anions….
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, Pekovic teaches a thixotropic composition. As such, Applicant’s argument is unpersuasive.
Applicant argues that the difficulty is compounded in a real formulation.
The Examiner does not find Applicant’s argument to be persuasive. The only required ingredient in Pekovic that is not claimed is sodium chloride-free sea water. Applicant has not shown wherein this ingredient would affect the composition from arriving at the claimed viscosity. As such, Applicant’s argument is unpersuasive.
Applicant argues that the examiner’s theory would render the separately recited viscosity range and the separate thixotropy limitation mere surplusage.
The Examiner does not find Applicant’s argument to be persuasive. It is not clear what theory Applicant is referencing to and Applicant has not explained why. As such, Applicant’s argument is unpersuasive.
Applicant argues that there is no reason a skilled person would have optimized Pekovic’s thickener toward the claimed thixotropic/viscosity profile.
The Examiner does not find Applicant’s argument to be persuasive. Nowhere in the rejection does it say that the claimed thixotropic/viscosity profile would have been optimized. As such, Applicant’s argument is unpersuasive.
Applicant argues that the rejection rests the combination on nothing more than predictable results and reasons that one of ordinary skill in the art would expect that adding a thickening agent would not negatively affect dentinal tubule penetration and occlusion.
The Examiner does not find Applicant’s argument to be persuasive. The rejection does not state that one of ordinary skill in the art would expect that adding a thickening agent would not negatively affect dentinal tubule penetration and occlusion. Also, the instant claims as currently recited do not require dentinal tubule penetration and occlusion. Such statement by the examiner was made two office actions ago in response to one of Applicant’s argument. It is not clear how such a response applies to currently. As such, Applicant’s argument is unpersuasive.
Applicant argues that if viscosity determines whether the material spreads on and is retained at the tissue surface, the rejection has itself supplied the viscosity-dependent transport expectation – the very expected barrier to penetration due to the higher viscosity.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown wherein the amount of thickening agents in Pekovic would lead to a high viscosity that would negatively affect the composition. As such, Applicant’s argument is unpersuasive.
Applicant argues the rejection concludes an assertion of identity, which is the province of anticipation. Yet the rejection is maintained under 103.
The Examiner does not find Applicant’s argument to be persuasive. An inherency argument may be made in a 103 obviousness rejection. The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness. See MPEP 2112. As such, Applicant’s argument is unpersuasive.
Applicant argues that a possibility cannot be converted into a certainty.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown wherein undergoing isothermal gel-sol-gel transformation is necessary to arrive at the claimed viscosity. Also, even if it is necessary, Applicant has not shown wherein the composition of Pekovic won’t undergo such transformation when it is a thixotropic composition. As such, Applicant’s argument is unpersuasive.
Applicant argues that the rejection treats the result as requiring nothing more than predictable results, while faulting Applicant for not comparing the claimed range against compositions outside it.
The Examiner does not find Applicant’s argument to be persuasive. Applicant is mentioning something that was said two office actions ago and is not addressing the most recent office action prior to this office action. Applicant had argued that the claimed viscosity is important. Thus, burden is on Applicant to show that the claimed viscosity is important. As such, Applicant’s argument is unpersuasive.
Applicant argues that the rational of Swanson and Niederman contradict.
The Examiner does not find Applicant’s argument to be persuasive. Niederman was not used in the rejection. Therefore, Niederman does not affect the motivation to use the teachings of Swanson. As such, Applicant’s argument is unpersuasive.
Applicant argues that that the evidentiary references were needed at all and were added only in response to Applicant’s arguments and in no statement of rejection is an implicit concession that Pekovic alone teaches neither the SDF-gel embodiment nor the claimed viscosity.
The Examiner does not find Applicant’s argument to be persuasive. This is merely Applicant’s opinion. The evidentiary references were to support the Examiner’s argument when addressing Applicant’s argument. The evidentiary references were not needed to make the rejection and Applicant has not shown how they were needed. As such, Applicant’s argument is unpersuasive.
Applicant argues that a skilled person would expect a higher viscosity SDF gel to reach and penetrate the tubules worse than a low viscosity liquid. That it penetrated and occluded equivalently is the unexpected result.
The Examiner does not find Applicant’s argument to be persuasive. The claimed subject matter must be compared with the closest prior art to be effective to rebut a prima facie case of obviousness. See MPEP 716.02(e). The composition of Pekovic appears to be the closest prior art since it comprises SDF and the same thickening agents in the same amount as claimed. Applicant has not shown wherein the claimed composition is unexpected over Pekovic. As such, the rejection is maintained and Applicant’s argument is unpersuasive.
Applicant argues that there was long-felt need and failure of others.
The Examiner does not find Applicant’s argument to be persuasive. As discussed previously, Applicant’s solution was to create an SDF gel and Pekovic discloses wherein SDF may be incorporated into a gel. As such, Pekovic teaches the solution to the SDF liquid problem and Applicant’s argument of long-felt need is unpersuasive. As such, Applicant’s argument is unpersuasive.
Applicant argues that the examiner has not considered or articulately rebutted the four declarations of record.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not identified which arguments in the declarations were not addressed. As such, Applicant’s argument is unpersuasive.
Applicant argues that the declarations state facts not opinions.
The Examiner does not find Applicant’s argument to be persuasive. Declarant’s argument that a skilled person would expect a higher viscosity SDF gel to reach and penetrate the tubules worse than a low viscosity liquid and that it penetrated and occluded equivalently is the unexpected result has been addressed above and in the previous office and is unpersuasive. As such, Applicant’s argument is unpersuasive.
Applicant argues that the merely Dr. Milgrom’s opinion label cannot reach the evidence it purports to dispose of.
The Examiner does not find Applicant’s argument to be persuasive. Declarant’s argument that a skilled person would expect a higher viscosity SDF gel to reach and penetrate the tubules worse than a low viscosity liquid and that it penetrated and occluded equivalently is the unexpected result has been addressed above and in the previous office and is unpersuasive. As such, Applicant’s argument is unpersuasive.
Applicant argues that the examiner’s contrary premise is itself unsupported.
The Examiner does not find Applicant’s argument to be persuasive. Applicant’s argument has been addressed above with regards to Lokken. Also, as discussed above, the claimed invention does not appear to be unexpected. As such, Applicant’s argument is unpersuasive.
Applicant argues that Lokken criticizes and discourages precisely what the claimed invention does – thicken an oral active delivery composition with a water-soluble agent.
The Examiner does not find Applicant’s argument to be persuasive and submits that this argument has been addressed above.
Applicant argues that Pekovic discloses a difference of three to nearly five orders of magnitude in the very species responsible for the staining.
The Examiner does not find Applicant’s argument to be persuasive. A prior art is evaluated for all that it reasonably suggests. Pekovic is not limited to 5 to 20 ppm of silver ions since Pekovic discloses up to 70.00 wt. % of the silver ions solution. As such, Applicant’s argument is unpersuasive.
Applicant argues that raising the fluoride concentration to the claimed content 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 the directions of Advantage Arrest are the opposite of a mouthwash.
The Examiner does not find Applicant’s argument to be persuasive. The composition of Pekovic is not limited to a mouthwash. Also, Advantage Arrest states that it does not normally stain enamel or burnished dentin. As such, Advantage Arrest can be used for the mucosa. As such, Applicant’s argument is unpersuasive.
Applicant argues that Pekovic discloses no silver diamine fluoride above 5-20 ppm silver in any form – rinse or gel.
The Examiner does not find Applicant’s argument to be persuasive. A prior art is evaluated for all that it reasonably suggests. Pekovic is not limited to 5 to 20 ppm of silver ions since Pekovic discloses up to 70.00 wt. % of the silver ions solution. As such, Applicant’s argument is unpersuasive.
Applicant argues that Pekovic’s thickened form is disclosed for tube-dispensing and toothbrushing and not as the placement-controlled high silver spot gel of the claims.
The Examiner does not find Applicant’s argument to be persuasive. A placement-controlled high-silver spot gel is not claimed. Therefore, the prior art does not need to teach it and Applicant’s argument is unpersuasive.
Applicant argues that Pekovic names no specific stain reducing agent and nowhere suggests that one would counteract silver discoloration.
The Examiner does not find Applicant’s argument to be persuasive. The instant claims as currently recited do not recite wherein the composition does not stain. Thus, even if the composition of Pekovic stains, the composition of Pekovic does not teach away from the claimed invention. As such, Applicant’s argument is unpersuasive.
Applicant argues that a person of ordinary skill would not have modified Pekovic’s dilute whole-mouth preparation into a 10-40 wt. % silver diamine fluoride composition because doing so destroys the safe whole mouth contact on which Pekovic depends.
The Examiner does not find Applicant’s argument to be persuasive. Pekovic discloses up to 70.00 wt. % of the silver ions solution and wherein the silver ions solution is obtained from silver diamine fluoride (SDF). As such, Applicant’s argument of is unpersuasive since Pekovic teaches otherwise.
Applicant argues that Applicant’s specification wants the composition not to reach gums, other mucosal surfaces, tongue, lips, and face.
The Examiner does not find Applicant’s argument to be persuasive since this is not recited in the claims. Therefore, the prior art is not required to teach it. As such, Applicant’s argument is unpersuasive.
Applicant argues that the very feature Swanson is cited for is defeated when its clathrate is placed in a composition engineered to adhere to the tooth and avoid the mucosa.
The Examiner does not find Applicant’s argument to be persuasive. Neither the instant claims nor Pekovic requires the composition to adhere to the tooth only. As such, Applicant’s argument is unpersuasive.
Applicant argues that Swanson is non-analogous art.
The Examiner does not find Applicant’s argument to be persuasive. Swanson is analogous art since it is in the same field of endeavor as the claimed composition, which is the field of oral care. Nowhere does the MPEP mention that the field of endeavor has to be very specific. As such, Applicant’s argument is unpersuasive.
Applicant argues that a person of ordinary skill would not have had a reasonable expectation of success in arresting caries or reducing dentinal hypersensitivity by increasing Pekovic’s content by several orders of magnitude; doing so would fundamentally alter Pekovic’s dilute, near-neutral, isotonic system and render it unsatisfactory for its disclosed purpose.
The Examiner does not find Applicant’s argument to be persuasive. This is merely Applicant’s speculation. Without objective evidence supporting Applicant’s allegation, Applicant’s allegation is unpersuasive.
Applicant argues that the claimed range and Pekovic’s disclosure do not overlap.
The Examiner does not find Applicant’s argument to be persuasive. As this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. The claimed amount of fluoride is taught by Dimensions of Dental Hygiene, as evidenced by Soares-Yoshikawa. As such, Applicant’s argument is unpersuasive.
Applicant argues that nothing in Pekovic would have led a skilled person to raise Pekovic’s fluoride and silver content by three to four orders of magnitude, and doing so would fundamentally alter Pekovic’s dilute, near-neutral, isotonic whole-mouth system and render is unsatisfactory for its disclosed purpose.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, the silver content disclosed by Pekovic overlaps with the claimed range. With regards to fluoride, Pekovic does not disclose an amount of fluoride. Therefore, there is nothing indicating that the amount of fluoride provided by Advantage Arrest would be unsuitable. Also, Applicant has not shown with objective evidence wherein such modification would make Pekovic’s composition unsatisfactory. Applicant’s argument is merely speculative. As such, Applicant’s argument is unpersuasive.
Conclusion
Claims 1, 9, 11, 13, 15, 17, 19, 21, 23, 27, 29, 31, 33, 35, 37 and 39 are rejected.
No claims are 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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/TRACY LIU/Primary Examiner, Art Unit 1614
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