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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/13/2024 is objected to because it contains illegible copies of the following documents; "GC Unifast III Instructions for Use (IFU)" and "Hexagonal Boron Nitride (hBN) - Applications from Metallurgy to Cosmetics" by Engler. Further, Engler and "GC Unifast III Powder Material Safety Data Sheet" are not in English and do not contain at least an English abstract. The documents described above are not considered.
Specification
The disclosure is objected to because of the following informalities:
The paragraph numbers in the instant specification have inconsistent formatting. Paragraphs from [0001] to [0099] have four digits, however after paragraph [0099], the paragraph number then has five digits, being paragraphs [00100] to [00114). The paragraphs should instead be enumerated as follows; [0100], [0101] and so on.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nuran (EP 2712656 A2).
Regarding claims 1 and 4, Nuran teaches a dental material composition for preventing dental calculus formation comprising nano-sized hexagonal boron nitride (abstract, paragraphs [0010-0012] .
Claims 23-25 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oh (WO 2020262814 A1) .
Regarding claims 23-25 and 27, Oh teaches a dental composition comprising zirconium oxide (ZrO2) as an inorganic reinforcing filler with a particle size of 0.01-0.1 micrometers, which is equivalent to 10-100 nm and in an amount of 1-15 wt.% (paragraphs [0053] and [0054]). Oh also teaches that the dental composition (the dental composite blank which comprises zirconium oxide) may have a flexural strength between 210-300 MPa (paragraph [0098]).
Oh, as referenced above, teaches a particle size range from 10-100 nm whereas the claimed range is between about 20-800 nm. The instant specification paragraph [00113] states that the use of the term “about” in the disclosure means within 20% of the numerical amount cited, so the claimed range of particle size could read as between 15-960 nm in light of the specification. The range as taught by Oh regarding zirconium oxide particle size has substantial and significant overlap with the claimed range and is disclosed with sufficient specificity so as to anticipate the claimed range. See MPEP 2131.03.
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.
Claims 1-2 and 4-31 are rejected under 35 U.S.C. 103 as being unpatentable over GC Asia Dental Pte Ltd. (UNIFAST III Brochure) in view of Oh (WO 2020262814 A1) and further in view of Zhang (Enhancing the thermal and mechanical properties of polyvinyl alcohol (PVA) with boron nitride nanosheets and cellulose nanocrystals).
Regarding claims 1-2, 4-31, GC Asia Dental Pte Ltd. (herein after referred to as GC) teaches a two-part, self-curing dental resin material UNIFAST III comprising a powder and solvent (liquid) component (page 8, kit contents). The examiner notes that the instant specification paragraph [0041] describes UNIFAST III as comprising:
A resin powder comprising about >70% Ethyl-methyl methacrylate polymer and about <30% Polymethylmethacrylate; and
A solvent comprising about 92.0% Methyl methacrylate, about 4.0% N,N-dimethyl-p-toluidine, about 2.0% Ethyleneglycol dimethacrylate and about 1.8% Trimethylolpropane trimethacrylate.
The examiner notes that the above components of UNIFAST III are the exemplified resin components in the instant specification, and it is expected that the solvent (liquid) component of UNIFAST III is a solvent being a liquid monomer as claimed.
GC further teaches that the ratio of powder to solvent is 2 grams of powder to 1 mL of liquid or 2 grams of powder to 1.5 mL of liquid (page 6, Q&A section) and that the cured composition has a flexural strength of 76.30 MPa and a modulus of elasticity of 2.46 GPa, which is equivalent to 2,460 MPa (page 7, Table: UNIFAST Trad vs. UNIFAST III). The examiner notes that the “modulus of elasticity” is the “Young's modulus”, as described in instant specification paragraph [0075].
However, GC does not teach boron nitride and zirconia as components of the dental resin composition.
Oh applies as referenced above and further teaches that zirconia gives excellent mechanical properties like flexural strength (paragraph [0005]). However, Oh does not teach boron nitride.
Zhang teaches a polyvinyl alcohol (PVA) composition with the addition of hexagonal boron nitride nanosheets (measuring 60-80nm wide by 10nm thick) as an inorganic filler. The hexagonal boron nitride is in concentrations of 0.8 and 1.6 wt.% and gives the composite an effect of increased tensile strength and Young’s modulus (abstract, section 3.1.; section 3.2.; and Figure 2). Zhang further teaches that hexagonal boron nitride has excellent mechanical strength and chemical stability (introduction). Zhang is analogous to the instant application in that both pertain to reinforcing inorganic fillers for resin compositions.
A person of ordinary skill in the art as of the effective filing date of the instant application would have found it obvious to see the usefulness of zirconium oxide and hexagonal boron nitride as a filler intended to increase resin mechanical properties, and, using methods known in the art, add the fillers in the disclosed amounts and with the disclosed particle sizes to the two-part dental material of GC and the results would have been predictable.
Further regarding claims 9-14 and 26-28, which are claims directed towards the properties of the dental material. The dental material of GC in view of Oh and further in view of Zhang uses UNIFAST III which is the applicant’s preferred resin, zirconium oxide and hexagonal boron nitride nanoparticles which are the applicant’s exemplified fillers, where the nanoparticles have both a particle size and concentration in the ranges exemplified in the instant specification. Since UNIFAST III, as referenced above, has a flexural strength of 76.30 MPa and a modulus of elasticity (Young’s Modulus) of 2.46 GPa, which is equivalent to 2,460 MPa before the addition of zirconia and boron nitride, it is expected that the dental material of GC in view of Oh and further in view of Zhang would have a Vickers hardness within the claimed range upon the addition of the fillers as well as a Young’s modulus and flexural strength within the claimed range.
Further regarding claims 7 and 25, the particle size disclosed by Oh, as referenced above, range from 10-100 nm whereas the claimed range is between about 20-800 nm. The instant specification paragraph [00113] states that the use of the term “about” in the disclosure means within 20% of the numerical amount cited, so the claimed range of particle size could read as between 15-960 nm in light of the specification. The range as taught by Oh regarding zirconium oxide particle size has substantial and significant overlap with the claimed range and is disclosed with sufficient specificity so as to anticipate the claimed range. See MPEP 2131.03.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over GC Asia Dental Pte Ltd. (UNIFAST III Brochure) in view of Oh (WO 2020262814 A1) further in view of Zhang (Enhancing the thermal and mechanical properties of polyvinyl alcohol (PVA) with boron nitride nanosheets and cellulose nanocrystals) and further in view of Zhou (CN 101851378 A).
Regarding claims 1 and 3, GC in view of Oh and further in view of Zhang applies as described above with respect to the dental material. However, all the aforementioned references fail to mention a dental material comprising boron nitride in wurtzite form.
Zhou teaches a resin compositions comprising boron nitride in hexagonal and wurtzite forms (paragraph [0015]), and further, a resin composition comprising a total of 113 parts by weight comprising 0.6 parts by weight of wurtzite boron nitride which has a particle size of 0.8 micrometers (800 nm), which is equivalent to 0.53 wt.% of the composition (Example 9, paragraph [0052]). Zhou further teaches that the addition of boron nitride yields a composition with better workability (paragraph [0023]).
Boron nitride in hexagonal and wurtzite forms and their functions were known in the art, so one of ordinary skill as of the effective filing date of the instant application would have found it obvious to substitute the hexagonal boron nitride of Zhang with the wurtzite boron nitride of Zhou and the results would have been predictable.
The examiner further notes that the applicant considers boron nitride in wurtzite form to be hexagonal according to instant paragraph [0010].
Conclusion
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/KOLTON JONES/Examiner, Art Unit 1763 /JOSEPH S DEL SOLE/Supervisory Patent Examiner, Art Unit 1763
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