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 .
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 18-25 are rejected under 35 U.S.C. 103 as being unpatentable over Eckert et al. (WO 2015126862 A1).
Regarding claim 18, Eckert et al. discloses a process for producing a shaped dental part, including:
i) providing a flowable, photopolymerizable composite resin composition having a dynamic viscosity of less than 5 Pa:s at 23°C (see page 25, lines 21-24 – “free radical-generating photoinitiators”, page 9, lines 3-4 – “viscosity from about 0.5 to about 200 Pa*s or from about 1 to about 100 Pa*s measured at 23°C”; therefore, the range of less than 5 Pa:s is included in both ranges), including the following components:
a) free-radically photopolymerizable monomers (see abstract – “dental composition comprising polymerizable monomer”, and page 25, lines 21-24 – “resin matrix which contain free radically active functional groups includes free radical-generating photoinitiators”),
b) an organically surface-modified and partially aggregated nanosize filler particles incorporated in the flowable, photopolymerizable composite resin composition (see page 3, lines 18-19 – “filler component(s) in an amount of more than about 20 wt.-%, wt.-% with respect to the whole weight of the composition”), wherein the partially aggregated nanosize filler particles include:
(1) dispersed primary particles having a primary particle size, measured by means of transmission electron microscopy, of less than 100 nm (see page 57, line 7 – “Non agglomerated silanized silica nano filler, (50 nm)”; furthermore, in page 36, lines 15-17 – “Besides an inorganic material the filler(s) can also be based on an organic material. Examples of suitable organic filler particles include filled or unfilled pulverized polycarbonates, poly(meth)acrylates, polyepoxides, and the like”; therefore, the compound can include fillers made of organic or inorganic material having the same particle size), and
(2) dispersed filler aggregates having a diameter, measured by means of dynamic light scattering (see page 57, line 8 – “Aggregated Zr/Si nanoclusters”, in page 36, lines 15-17 – “Besides an inorganic material the filler(s) can also be based on an organic material”, e.g., shown above; therefore, the material can include fillers made of organic or inorganic material having the same dispersion characteristics), and
c) at least one photoinitiator (see page 25, lines 21-24 – “free radical-generating photoinitiators”),
and
ii) performing a stereolithographic layer-by-layer buildup of the shaped dental part from the flowable, photopolymerizable composite resin composition in a bath filled with said flowable, photopolymerizable composite resin composition (see page 41, lines 11-12).
However, Eckert et al. does not disclose that dynamic viscosity is measured using a plate-plate rheometer having an upper plate diameter of 25 mm at a shear stress of 50 Pa, and the range from 40 to 1000 nm of the dispersed filler aggregates diameters.
The document of Rheology teaches the use parallel plates for measuring viscosity of a material by applying a range of shear deformations. Where the upper plate ranges from 4-60 mm in diameter as standard, where smaller diameters (<25 mm) are suited to highly viscous materials samples (>10 Pa-s) (see page 2, Parallel Plates paragraph under Size section). Examiners Note — the Office provided with the last Office action, as evidence page 3 of the TA Instruments document, under Peltier Plate Geometries section, indicating that the plates described in the above document of Rheology has been used before the effective filling day of the present application. Therefore, in order to be described in the document of Rheology, it is understood that the plates have been in the public knowledge before the effective filling day of the present application and that are well known in the art.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the size of the plate of Eckert, with the 25 mm diameter upper plate taught in the Rheology document/TA Instrument, in order to better measure highly viscous samples of over 10 Pa-s.
Furthermore, with respect to the diameter range of the dispersed filler aggregates. Eckert et al. discloses that the preferred general method for measuring the particle diameter is by placing samples having approximately 80nm thick over a 200 mesh grids, and in a population size of about 50-100 particles for measuring the average diameter (see page 35, lines 21-29). Due to the measurement in Eckert is done using a 200-mesh grid, it is understood that the measurement of the shape, particle size, etc. of is for materials having nano size particles. Therefore, the fillers used in Eckert et al. is in the nano size range.
However, Eckert/Rheology does not disclose that the diameter of the dispersed filler aggregates is in the range from 40 to 1000 nm.
On the other hand, it would have been obvious to one having ordinary skill in the art at the time the invention was made to define the range to be 40 to 1000 nm of the dispersed filler aggregates, since this parameter is considered a deemed matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
Regarding claim 19, Eckert / Rheology discloses the claimed invention substantially as claimed, as set forth above for claim 18, and where Uttereodt discloses it is characterized in that the nanosize filler particles have at least one feature selected from among the following:
— the nanosize filler particles consists essentially of aggregates of primary particles (see page 34, line 3- “Filler(s) which can also be used include nano-sized fillers such as nano-sized silica”, page 57, line 7 – “Non agglomerated silanized silica nano filler”, “aggregated silica particles”);
— the shape of the nanosize filler particles is not perfectly spherical but is irregular (see page 7, lines 6-8 – “Particles may be amorphous or crystalline”);
— the nanosize filler particles are present in dispersion in unagglomerated form (see page 34, lines 19-20 – “Surface-treating the nano-sized silica particles before loading into the dental material can provide a more stable dispersion in the resin”);
— the nanosize filler particles in dispersion are distributed over a continuous size range from at least about 40 nm to not more than 1000 nm (see page 34, lines 4-5 – providing that the nano-seized silica particles can have a range between 5-80nm, where the range between 40-80 nm is included in the claimed range; furthermore, due to the filler can be organic, it understood that the same particle size is maintained).
Regarding claim 20, Eckert /Rheology discloses the claimed invention substantially as claimed, as set forth above for claim 18, and where Uttereodt discloses that the flowable, photopolymerizable composite resin composition includes 20-95% by weight of microfillers (see page 38, lines 15-16 –“20-95 wt.-%”).
However, Eckert /Rheology photopolymerizable composite resin composition comprises less than 5% by weight of microfillers.
On the other hand, Eckert further discloses that any measurement indicated to be “about” that quantity can be modified (see page 8, lines 13-16).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include less than 5% by weight of microfillers, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Regarding claim 21, Eckert /Rheology discloses the claimed invention substantially as claimed, as set forth above for claim 20, and where Uttereodt discloses that the microfillers are milled fillers (see page 68, lines 15-17 – “ceramic three-roller mill”), and wherein said microfillers differ in shape and size from the nanosize filler particles of component b) (see page 7, lines 6-8 – “Particles may be amorphous or crystalline”).
Regarding claim 22, Eckert /Rheology discloses the claimed invention substantially as claimed, as set forth above for claim 18, and where Eckert discloses that it is characterized in that the organically surface-modified and partially aggregated nanosize filler particles are obtained by a process including:
i) providing a mixture of said free-radically photopolymerizable monomers and/or oligomers as per component a) of the flowable, photopolymerizable composite resin composition (see abstract – “dental composition comprising polymerizable monomer”),
ii) adding a silane hydrolysate to said mixture (see page 34, lines 28-29), and
iii) dispersing partially aggregated nanosize filler particles in said mixture (see page 34, lines 19-20 – “Surface-treating the nano-sized silica particles before loading into the dental material can provide a more stable dispersion in the resin),
However, Eckert /Rheology does not disclose a ratio of silane hydrolysate to particle surface area of agglomerated particles in step iii) is from 0.005 mmol/m2 to 0.08 mmol/m2, based on a molar amount of silanes used per unit surface area of the nanosize filler particles.
On the other hand, the subject matter is related to the agglomerated particles, that it is claimed in an “and/or” statement, and said agglomerated particle option was not selected. Therefore, not included in the analysis.
Regarding claim 23, Eckert /Rheology discloses the claimed invention substantially as claimed, as set forth above for claim 18, and where Uttereodt discloses that it is characterized in that the flowable, photopolymerizable composite resin composition further includes
— less than 0.5% by weight of thixotropy-inducing agents (see page 20, lines 12-14 – “Using (meth)acrylate functionalized polyalkenoic acids… improve properties like viscosity), page 33, lines 10-12 – “Adding a filler can be beneficial e.g. for adjusting the rheological properties like viscosity”).
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Eckert et al. (WO 2015126862 A1) as applied to claim 18 above, and further in view of Herrmann et al. (WO 2017155692 A1).
Regarding claims 24 and 25, Eckert /Rheology discloses the claimed invention substantially as claimed, as set forth above for claim 18, and where Eckert discloses that the added filler can adjust the physical properties of the composition after hardening, like hardness or the flexural strength (see page 33, lines 11-13).
However, Eckert/Rheology does not disclose that the shaped dental part has a bending strength of at least 100 MPa (for claim 24), and a bending modulus of at least 4 GPa (for claim 25), measured in accordance with ISO 4049:2009.
Herrmann et al. teaches a dental composite crown including nanofillers having a flexural strength of 50-200 MPa or 80-150 MPa, and an E-Modulus from 1,000-4,000 MPa, according to ISO 4049:2009 (see page 15, lines 4-25).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the mechanical properties of the composite of the dental part of Eckert/Rheology, with the shaped dental part having the bending strength of at least 100 MPa to 200 MPa and the E-Modulus from 4,000 MPa (4 GPa) of Hermann, in order for a dental part to have sufficient flexibility and to avoid easily breakage during its normal use.
Response to Arguments
Applicant’s arguments with respect to claims 18-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The amendments to the claims changed the interpretation of the process, specifically the section b) of the claim 18. It is understood that the previous prior art of Mayr used in the last Office action of 13 March 2025 does not disclose the claimed subject matter.
However, after a further search, it was found the prior arts of Eckert, that in combination with the prior art of Rheology, includes the subject matter as it is described in the claims.
Therefore, the Office understands that the claims are not ready for allowance.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIRAYDA ARLENE APONTE whose telephone number is (571)270-1933. The examiner can normally be reached M-F 8-5.
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/MIRAYDA A APONTE/Examiner, Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772