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 23-38.
Applicants' arguments, filed 11/21/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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 25-32 and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Lee, Jr. et al. (US 4,150,485, Apr. 24, 1979) (hereinafter Lee, Jr.) in view of Pearson et al. (US 2003/0162864, Aug. 28, 2003) (hereinafter Pearson), Jia (US 2006/0241205, Oct. 26, 2006), Wang et al. (US 6,262,142, Jul. 17, 2001) (hereinafter Wang), and Shahid et al. (Flake Glass Dental Composites, 2011) (hereinafter Shahid).
Lee, Jr. discloses a low viscosity dental restorative coating composition for application to natural and to artificial teeth, useful in covering surface imperfections. As ready to use, the coating composition will contain from about 30% to about 70% filler by weight of the composition, in a resinous, curable liquid vehicle. The composition is formulated to be sufficiently fluid so that it can be applied to a dental surface easily and conveniently, as by brushing on a previous prepared surface. The filler is a blend of glass or silica and a fluorescent pigment (abstract). The composition offers mechanical, chemical, biological, and thermal protection to the tooth on which it is coated (col. 1, lines 62-63). The coating composition is also useful for restoring small Class I and III cavities primarily in enamel (col. 2, lines 5-6). The use of such an enamel coating eliminates the need to prepare the tooth for a cap (col. 3, lines 47-49). The enamel coating is wear resistance (col. 4, line 29). The dental coating can be formulated to match the appearance of the surface on which it is placed and of adjacent teeth, and to match and retain its appearance in all kinds of light (col. 3, lines 50-54). The filler is a mixture of finely divided particulate inorganic materials, including 80% or more of the filler of conventional filler materials, together with 20% or less of a finely divided fluorescent material. (col. 4, lines 3-6). The filler mixture ordinarily forms from 30% to 70% by weight of the total composition, with the curable liquid and the other ingredients forming the balance (col. 4, lines 10-13). The filler is a blend of at least 2 filler materials (col. 6, lines 1-2). The curable liquid may be a blend of an aromatic or hydrogenated aromatic diacrylate or dimethacrylate with an aliphatic di- or mono-acrylate or methacrylate in a weight ratio of not more than 90% of the former to 10% of the later (col. 5, lines 35-39). It is possible to use more than one aromatic or hydrogenated aromatic diacrylate or dimethacrylate, and to dilute this material with one or more different aliphatic di- or mono-acrylates or methacrylates (col. 5, lines 43-46). The curable liquid may be cured by admixture with curing agents such as an activator and an initiator (i.e., photoinitiator system) (col. 7, lines 28-29). The composition will cure relatively fast. A room temperature set in about ½ minute to about 10 minutes is desirable (col. 7, lines 30-32).
Lee, Jr. differs from the instant claims insofar as not disclosing wherein the composition comprises glass flakes, UDMA, and HEMA.
However, Pearson discloses a polymerizable dental filling and sealing composition which comprises a mixture of at least one resin containing on average at least two acrylate or methacrylate groups and a copolymerizable methacrylate or acrylate monomer, which has a low viscosity compared with said resin (abstract). The composition may be used to coat dentine surfaces to provide a seal (¶ [0006]). Suitable resins include urethane dimethacrylate (UDMA) and hydroxyethyl methacrylate (HEMA) (¶ [0009]). The composition may optionally contain some inert material to vary the viscosity to the appropriate level for the proposed use and to improve the strength. This may be from using flake glasses (¶ [0010]). Flake glass is a particularly preferred filler since sufficient flake glass can be added to the resin composition to provide occlusal surface without increasing the viscosity above a level which would preclude syringing (¶ [0011]).
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. Lee, Jr. discloses wherein the composition comprises conventional filler materials and one or more different aliphatic di- or mono-acrylates or methacrylates. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated glass flakes into the composition of Lee, Jr. since it is a known and effective filler material as taught by Pearson. It would have been obvious to one of ordinary skill in the art to have incorporated UDMA and HEMA (i.e., hydrophilic monomer) into the composition of Lee, Jr. since they are known and effective aliphatic di- or mono methacrylates as taught by Pearson.
The combined teachings of Lee, Jr. and Pearson do not disclose wherein the glass flakes have a thickness in the range of between 0.5 and 10 microns and are coated with a silane.
However, Jia discloses a dental composite comprising a reinforcing material in the form of glass flakes and a polymeric matrix material (¶ [0004]). The resulting filler material can be used in dental composites and dental restorations (¶ [0005]). The glass flakes can be any standard size and preferably are between about 5 to about 1000 microns in length/width. The average thickness of the glass flakes can be any standard thickness. It is preferable that the thickness of the flakes is from about 1 to about 10 microns (¶ [0008]). The glass flakes are surface silane treated to enhance the property of the composition (¶ [0028]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated glass flakes that are surface silane treated and have a thickness from about 1 to about 10 microns into the composition of Lee, Jr. since, as discussed above, it would have been obvious to one of ordinary skill in the art to have incorporated glass flakes, and this is a known and effective glass flake for dental compositions as taught by Jia.
The combined teachings of Lee, Jr., Pearson, and Jia do not disclose wherein the glass flakes and resin have a refractive index difference of less than 0.04.
However, Wang discloses a dental material useful in making artificial tooth enamel, inlays, onlays and veneers. The dental material preferably has an opacity less than 50 percent (col. 1, lines 16-19). Preferably the refractive index of the resin matrix material used to make artificial tooth enamel is within 5 percent of the refractive index of the filler material (col. 1, lines 22-25). The translucency of composite material is dependent on the difference in refractive indices between the glass filler and the resin matrix in which the glass powders are located. The substantially perfect match (effective equality) in the refractive indices between inorganic glass filler and organic resin matrix results in improved translucency of the dental enamel material (col. 2, lines 56-64). Example 1 discloses a polymerizable monomeric resin matrix forming material having a refractive index of 1.52.
Lee, Jr. discloses wherein the composition can be formulated to match the appearance of the surface on which it is placed and of adjacent teeth. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the curable liquid to have a refractive index of 1.52 and the glass flakes to have a refractive index within 5 percent of the refractive index of the curable liquid motivated by the desire to have the composition match the appearance of artificial tooth since this is a known refractive index for artificial tooth as taught by Wang. Therefore, it would have been obvious to have incorporated a glass flake with a refractive index of 1.51 since such refractive index is within 5 percent of the refractive index of the polymeric matrix material.
The combined teachings of Lee, Jr., Pearson, Jia, and Wang, do not disclose wherein upon application of the composition to a tooth surface the glass flakes align substantially parallel to the surface.
However, Shahid discloses wherein aligned flake glass composites based on thin plates of glass have potential for use as dental composites. The purpose of the study was to analyze the alignment of the flakes and the water uptake. SEM micrographs showed that of the three flake glasses used, 1.0 and 0.1 micron flakes aligned almost parallel to the composite surface. The alignment of the flakes was found to be related to their aspect ratios (ratio of flake length to flake thickness). Thin flakes with higher aspect ratios had a higher tendency to align than thick flakes with lower aspect ratio. It was expected that diffusion of water would be impeded by the aligned glass flake particles. However, there was an increase in the uptake of water. It was concluded that flake thickness and aspect ratio are critically important for obtaining a self-aligning flake composite. The high degree of alignment of flakes to the surface should give rise to excellent wear properties and anisotropic shrinkage (abstract).
Lee, Jr. disclose wherein the coating is wear resistant. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the composition of Lee, Jr. such that the glass flakes align almost parallel to a tooth surface since a high degree of alignment of flakes to the surface give rise to advantageous properties such as excellent wear properties as taught by Shahid.
In regards to instant claims 25 and 26 reciting wherein the glass flakes have an aspect ratio in the range of between 20:1 and 90:1 and between 20:1 and 40:1, respectively, Shahid discloses wherein the flake aspect ratio is critically important for obtaining a self-aligning flake composite. As such, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed aspect ratio based on obtaining a self-aligning flake composite. Furthermore, Jia discloses wherein glass flakes have a length/width between about 5 to about 1000 microns and a thickness from about 1 to about 10 microns. Therefore, the glass flakes may be a length/width of, for example, 30 microns and a thickness of, for example, 1 micron and thus an aspect ratio of 30:1 would have been obvious.
In regards to instant claim 25 reciting a dental sealant coating, the composition of Lee, Jr. offers thermal protection to the tooth on which it is coated. Thus, the composition of Lee, Jr. is a sealant.
In regards to instant claims 25 and 27 reciting 10% to 40% and between 20% and 40% glass flakes, respectively, Lee, Jr. discloses about 30% to about 70% fillers of which 80% or more of the filler is conventional filler materials. Since glass flakes is a conventional filler material, the claimed amount of glass flakes would have been obvious from these ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
In regards to instant claim 25 reciting 50% to 90% resin, Lee, Jr. discloses about 30% to about 70% filler with the curable liquid forming the balance and wherein the curable liquid comprises at least 10% by weight of the aliphatic di- or mono—acrylate or methacrylate (i.e., resins). The amount of resin would have been obvious from these ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
2. Claims 23, 24, 33 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Lee, Jr. et al. (US 4,150,485, Apr. 24, 1979) (hereinafter Lee, Jr.) in view of Pearson et al. (US 2003/0162864, Aug. 28, 2003) (hereinafter Pearson), Jia (US 2006/0241205, Oct. 26, 2006), Wang et al. (US 6,262,142, Jul. 17, 2001) (hereinafter Wang), Shahid et al. (Flake Glass Dental Composites, 2011) (hereinafter Shahid), and further in view of Xu et al. (US 2016/0228335, Feb. 5, 2015 priority date) (hereinafter Xu).
The teachings of Lee, Jr., Pearson, Jia, Wang, and Shahid are discussed above. Lee, Jr., Pearson, Jia, Wang, and Shahid do not disclose wherein the composition comprises 2-hydroxyethyl methacrylate phosphate.
However, Xu discloses a rechargeable dental material. The rechargeable dental material may be included in dental sealants (abstract). Rechargeable monomers include HEMA and UDMA (¶ [0010]). In addition to the one or more rechargeable monomers, the rechargeable dental material may include one or more acidic methacrylate and acrylate-based monomers that have the potential for calcium and phosphate recharge (¶ [0058]). Suitable monomers include 2-hydroxyethyl methacrylate phosphate (¶ [0060]).
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. Lee, Jr. discloses wherein the composition comprises one or more different aliphatic di- or mono-acrylates or methacrylates. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 2-hydroxyethyl methacrylate phosphate into the composition of Lee, Jr. since it is a known and effective aliphatic di- or mono methacrylates as taught by Xu.
3. Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Lee, Jr. et al. (US 4,150,485, Apr. 24, 1979) (hereinafter Lee, Jr.) in view of Pearson et al. (US 2003/0162864, Aug. 28, 2003) (hereinafter Pearson), Jia (US 2006/0241205, Oct. 26, 2006) (hereinafter Jia 1), Wang et al. (US 6,262,142, Jul. 17, 2001) (hereinafter Wang), Shahid et al. (Flake Glass Dental Composites, 2011) (hereinafter Shahid), and further in view of Jia (US 2008/0020353, Jan. 24, 2008) (hereinafter Jia 2).
The teachings of Lee, Jr., Pearson, Jia 1, Wang, and Shahid are discussed above. Lee, Jr., Pearson, Jia, Wang, and Shahid do not disclose wherein the composition comprises fluoride releasing agent.
However, Jia 2 discloses a dental filling material comprising fillers (abstract). Suitable fillers include ytterbium fluoride and bismuth fluoride (¶ [0032]).
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. Lee, Jr. disclose wherein the composition comprises at least two filler materials. Accordingly, it would have been obvious to have incorporated ytterbium fluoride or bismuth fluoride into the composition of Lee, Jr. since they are known and effective fillers as taught by Jia 2.
Response to Arguments
Applicant argues that one skilled in the art starting from Jia would not contemplate preparing a low-viscosity dental restoration composite.
The Examiner does not find Applicant’s argument to be persuasive. The rejection states wherein Lee is the primary reference. Applicant has not explained why would one of ordinary skill in the art starting from Lee would not contemplate preparing a low-viscosity dental restoration composite. As such, Applicant’s argument is unpersuasive and the rejection is maintained.
Applicant argues that the office states that one skilled in the art would combine Jia I with Wang. However, Wang also relates to dental restoration composites, not dental sealant coatings.
The Examiner does not find Applicant’s argument to be persuasive. The rejection states wherein Lee is the primary reference. As discussed in the rejection, the composition of Lee, Jr. offers thermal protection to the tooth on which it is coated. Thus, the composition of Lee, Jr. is a sealant. As such, a dental sealant coating is taught and Applicant’s argument is unpersuasive.
Applicant argues that Shahid teaches away from Applicant’s claimed dental sealant coatings because it states that water diffusion through the resin was increased by incorporating the aligned glass flakes. This was thought to be a result of water wicking along glass flake-air interfaces, since the resin failed to completely wet the flake particles. This demonstrates that glass flake alignment alone is insufficient to provide a sealant coating.
The Examiner does not find Applicant’s argument to be persuasive. Shahid disclosing wherein their glass flakes allow water diffusion does not mean the glass flakes of the prior art would allow water diffusion. The rejection states wherein the glass flakes of the prior art are modified. The rejection states wherein it would have been obvious to have formulated the glass flakes to align almost parallel to a tooth surface and to have surface silane treated the glass flakes. Applicant has not shown wherein the surface silane treated glass flakes of the prior art when aligned substantially parallel would allow water diffusion. As such, since Applicant has not shown wherein the composition of the prior art would allow water diffusion, Applicant’s argument is unpersuasive.
Applicant argues that the addition of Lee does not cure any of the deficiencies set forth above.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, Lee is the primary reference of the rejection and teaches dental sealant coatings, which Applicant argues the other references do not. As such, Applicant’s argument is unpersuasive.
Applicant argues that Lee is not relevant to Applicant’s field of endeavor.
The Examiner does not find Applicant’s argument to be persuasive. Applicant’s field of endeavor is in oral care since the claimed invention is a dental sealant composition applied on tooth. Lee is in the same field of endeavor of oral care since Lee discloses a low viscosity dental restorative coating composition for application to natural and to artificial teeth. The prior art does not need to disclose the entire claimed invention or intended use to be in the same field of endeavor as the claimed invention. For example, for a patent application claiming a hair brush having a specific bristle configuration, the Board affirmed the examiner’s rejection of the claims as being obvious in view of prior art patents disclosing toothbrushes. The court upheld the Board’s interpretation of the claim term "hair brush" to encompass any brush that may be used for any bodily hair, including facial hair. The court applied the "field of endeavor test" for analogous art and determined that the references were within the field of the inventor’s endeavor and hence were analogous art because toothbrushes are structurally similar to small brushes for hair, and a toothbrush could be used to brush facial hair. See MPEP 2141.01(a)(IV). As such, Applicant’s argument is unpersuasive.
Applicant argues that Lee is not reasonably pertinent to the problem face by Applicant.
The Examiner does not find Applicant’s argument to be persuasive. A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See MPEP 2141.01(a). Therefore, since Lee is from the same field of endeavor as the claimed invention as discussed above, Lee is analogous art to the claimed invention despite not being reasonably pertinent to the problem faced by the inventor. As such, Applicant’s argument is unpersuasive.
Conclusion
Claims 23-38 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