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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/4/25 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-6,8,9 are rejected under 35 U.S.C. 103 as being unpatentable over Sadoun 20190091110 in view of Velamakanni et al 20130137065 and Shi et al 20160202137.
With regard to claim 1, Sadoun 20190091110 discloses a dental prosthesis with a structure similar to that of a natural tooth, the dental prosthesis being a cured product (see paragraph 224) comprising ceramic particles dispersed in a polymer (resin, see paragraph 224 as well as throughout the disclosure) matrix, the dental prosthesis comprises: a first cured product layer (enamel layer, see paragraph 24) comprising ceramic particles having an average particle diameter of 100 nm to 1,000 nm (see paragraph 17 which discloses particles greater than 0.5 microns, which is greater than 500nm, which falls within applicant’s claimed range); a second cured product layer (dentin layer, see paragraph positioned adjacent to an inner surface of the first cured product layer, and comprising ceramic particles having an average particle size greater than the average particle size of the enamel layer.
With regard to applicant’s newly presented limitation, note that the first and second cured product layers are distinct adjacent layers, defining a bilayer structure. See below annotated figure.
[AltContent: arrow][AltContent: arrow][AltContent: textbox (Distinct layer)][AltContent: textbox (Distinct layer)]
PNG
media_image1.png
176
147
media_image1.png
Greyscale
Sadoun does not disclose the first layer (enamel layer) comprising 70-90% by weight of the disclosed ceramic particles. Sadoun does not disclose the second layer (dentin layer) comprising 40-60% by weight of the disclosed ceramic particles.
Velamakanni et al disclose a similar multilayer prosthesis in which a layer may have particles 36 therein (see fig. 3), the particles may be ceramic (see paragraph 65), and the particles may comprise 3- 90% by weight of the layer, which includes both weight percentage ranges claimed by applicant. See paragraph 59.
It would have been obvious to one skilled in the art to include the ceramic particles in the first enamel layer of Sadoun to be 70-90% weight, and to include the ceramic particles in the second dentin layer of Sadoun to be 40-60% weight, in view of the teaching of Velamakanni et al that suspended ceramic particles in a layer of a dental tooth prosthesis maybe anywhere between 3-90% by weight.
Furthermore, Sadoun does not disclose the second layer of ceramic particles to have an average particle diameter of 10 microns to 500 microns, although Sadoun does note that the particles of the second layer are larger than in the first layer. See paragraph 17 of Sadoun.
Velamakanni et al disclose that the average ceramic particle diameter of 50 to 70 microns, which falls within applicant’s claimed range of 10 microns to 500 microns.
It would have been obvious to one skilled in the art to size the ceramic particles in the second layer of Sadoun to have an average size of 50-70 microns, which values fall within applicant’s claimed range, in view of the teaching of Sadoun that a layer of a dental tooth prosthesis may have ceramic particles therein with an average size of 50-70 microns.
With further regard to claim 1, although Sadoun discloses that the first cured product layer has a dense structure simulating enamel (a resin is considered to be “dense”, and the second cured product layer has a pore structure (see paragraph 226), Sadoun/Velamakanni et al does not disclose the second cured product layer including a tubular pore structure simulating dentin, wherein the tubular pore structure is disposed inside the second cured product layer.
Shi et al discloses a dental prosthesis in which simulated dentin in characterized by tubular pore structures. See tubules described in paragraph 3 and figure 1.
It would have been obvious to one skilled in the art to include tubular pore structures in the second cured product layer of the prosthesis of Sadoun/Velamakanni et al, in view of the teaching of Shi et al that dentin may be simulated by inclusion of tubular pore structures (tubules).
With regard to claims 2 and 3, Sadoun/Velamakanni et al/Shi et al does not disclose the that first cured product layer has a biaxial flexural strength of 300 to 500 MPa, an elastic modulus of 50 GPa to 110 GPa, and a hardness of 3 GPa (305 Vickers) to 6 GPa (611 Vickers), and the second cured product layer having a biaxial flexural strength of 100 MPa to 300 MPa, an elastic modulus of 5 GPa to 20 GPa, and a hardness of 0.5 GPa (50.98 Vickers) to 1.5 GPa (153 Vickers). It is noted, however, that Sadoun discloses the first layer to have an elastic modulus of greater than 30 GPa anda hardness of greater than 240 Vickers, while the second layer has an elastic modulus of greater than 15 GPa and less than 30 Gpa, along with a hardness of greater than 60 and less than180 Vickers. See paragraph 59.
It would have been obvious to one skilled in the art to form the first and second layers of the Sadoun/Velamakanni et al/Shi et al prosthesis having the flexural strength ranges, elastic modulus ranges and hardness ranges as recited in instant claims 2 and 3 as a matter of routine optimization, as one skilled in the art would recognize that such parameters result in different overall hardness of the first and second layers (see paragraph 59 of Sadoun which discloses how one layer is “very hard” and the other layer is “hard”. It has been held that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA1955).
With regard to claim 4, note that Sadoun discloses that the ceramic particles are particles of at least one material selected from the group consisting of barium silicate -based crystallized glass, leucite- based crystallized glass, alumina, zirconia, and glass. See paragraphs 230-233 which disclose the use of alumina particles.
With regard to claim 5, note that Sadoun discloses wherein the ceramic particles have a Silane- treated surface. See paragraphs 226-227.
With regard to claim 6, note that Sadoun discloses that the polymer matrix is a cured product of at least one polymerizable organic compound selected from the group consisting of hydroxy ethyl methacrylate (HEMA), 2,2-bis [4- (2-hydroxy-3-methacryloyloxy propoxy)phenyl]propane (Bis-GMA), triethylene glycol dimethacrylate (TEGDMA), diurethane dimethacrylate (UDMA), urethane dimethacrylate (UDM), biphenyldimethacrylate (BPDM), n-tolylglycine-glycidylmethacrylate (NTGE) , polyethylene glycol dimethacrylate (PEG-DMA), and oligocarbonate dimethacrylic esters. See paragraph 179.
With regard to claims 8 and 9, these claims recite method steps of forming the prosthesis. Such method steps in an apparatus claim are considered to be product -by-process limitations and are only given patentable weight with respect to the final product required by the claims. In this case, since the final product required by claims 8 and 9 is either a “cured” or “manufactured” product, the product of Sadoun/Velamakanni et al/Shi et al is considered to meet the final product required by these claims.
Response to Arguments
Applicant's arguments filed 11/4/25 have been fully considered but they are not persuasive.
Applicant argues (page 7 of response) that the “open dentin tubules” cannot teach or suggest the “pore structure”, because the pore structures are not open like Shi’s open tubules. Applicant also argues that the term “pore” means a “space” located inside the layer by it’s plain meaning and thus is not exposed outside the layer.
This is not found persuasive. Claim 1 requires a “tubular pore structure”. This is exactly what Shi discloses. A “pore” is simply and opening through which a liquid or gas can pass, and it is clear that this is what Shi discloses.
Applicant also argues (page 8 of response) that Sadoun does not disclose the newly presented limitation of the first and second cured product layers being distinct adjacent layers, thereby defining a bilayer structure because Sadoun’s gradient approach teaches away from such and does not disclose a bilayer structure.
This is not found persuasive. As seen in the annotated figure above, Sadoun shows two distinct layers, as indicated by the arrows. These two layers are clearly distinct, and are also clearly adjacent.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS D LUCCHESI whose telephone number is (571)272-4977. The examiner can normally be reached M-F 800-430.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached at 571-270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICHOLAS D LUCCHESI/ Primary Examiner, Art Unit 3772