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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/29/2026 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 63/040,578, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim 1 recites “multilayer dental restoration, comprising an outer layer formed of a first polymeric material, an inner layer formed of a second polymeric material”. However, the provisional application fails to provide adequate support or enablement for these limitations.
Accordingly, the prior-filed application fails to provide support for claims 1-13 and 18-20 and the filling date for these claims is therefore June 18th, 2021, which is the filling date of PCT/US2021/038035, which does support the limitations of claim 1.
Response to Arguments
Applicant’s arguments, see Remarks filed on 05/29/2026, have been fully considered. Upon careful consideration the Examiner finds that the claims are not patentable over the prior art of record. Applicant’s arguments against the rejections in view of the prior art of record have been fully considered, but are not persuasive, as they do not address the new grounds of rejection and/or interpretation below necessitated by Applicant’s amendments and clarifications.
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 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.
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.
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.
Claim(s) 1-13, 18-20 and 118-119 is/are rejected under 35 U.S.C. 103 as being unpatentable over Billet (US 6010337 A) in view of Kim (WO 2021194327 A1, see the translation attached to this Office Action).
Regarding claim 1, Billet discloses a multilayer dental restoration (Abstract and Figure 1), comprising an outer layer formed of a first polymeric material (layer 3 e.g. made of methacrylate resin, Bis-GMA; see col 4, line 43 to col 5, line 25), an inner layer formed of a second polymeric material that is different from the first polymeric material (layer/matrix 5 formed of e.g. a triethylene-glycol-dimethacrylate, TEDMA; see col 5, lines 5-15). The Examiner notes that Billet recites that the inner and outer layer can be made of similar materials; therefore not the same exact material (col 4, line 54) and that said material could be from the same chemical family (col 4, lines 47). Therefore, the inner layer could be made of TEDMA while the outer layer could be made of Bis-GMA, which are similar materials, but have different properties.
Wherein the inner layer is arranged to form an interior region to contact a tooth so that the inner layer is located between the outer layer and the tooth (Figure 1 and col 4, lines 29-42), wherein the multilayer dental restoration is adapted to conform to an underlying tooth shape (Figure 1 and col 4, lines 30-42).
Billet fails to specifically discloses “wherein the inner layer has a hardness that is lower than a hardness for the outer layer” and “wherein the inner layer has a modulus of elasticity of about 1,500 MPa to about 2,500 MPa and wherein the outer layer has a modulus of elasticity of about 2,500 MPa to about 6,000 MPa”.
Kim discloses a multilayer dental restoration (at least two layers, see Abstract), comprising an outer layer formed of a first polymeric material (first cured layer formed of ceramic particles dispersed in a polymerizable organic compound), an inner layer formed of a second polymeric material that is different from the first polymeric material (second cured layer, also ceramic particles dispersed in a polymerizable organic compound, but with difference concentration of ceramic particles) (see [0029] and [0047]). Kim’s invention can present structures and properties similar to those of natural teeth, in which the surface is enamel and the inside is dentin ([0025]). Wherein the inner layer (second cured layer) has a lower elastic modulus than the outer layer (first cured layer) (see [0012]-[0013]). Wherein the inner layer (second cured layer) has a hardness that is lower than a hardness for the outer layer (first cured layer) (see [0012]-[0013]). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Billet’s inner and outer layers in order to make the inner layer having a lower modulus of elasticity and being less hard, since such modification would create a prosthesis that is similar to the structures of natural teeth, in which the surface is enamel (harder) and the inside is dentin (less hard).
Billet and Kim disclose the invention substantially as claimed, as combined above; specifically Billet discloses the same material recited in the immediate Specification ([0025] and [0032]. The immediate specification discloses the rages regarding the modulus of elasticity as being merely preferable ([00160] and [00168]) and does not describe then as contributing an unexpected result to the dental restoration. As such, these parameters, are deemed matters of design choice (lacking in any criticality), well within the skills of the ordinary artisan, obtained through routine experimentation in determining optimum results. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the inner and outer layer modulus of elasticity to include a particular range of e.g. about 1,500 MPa to about 2,500 MPa and about 2,500 MPa to about 6,000 MPa, since such modification would merely involve the optimization of a result effective variable (more or less elastic layers), obtained through routine experimentation in determining optimum results (such as the optimum elasticity to achieve comfort and durability) which has been held to be within the skill of the ordinary artisan (see MPEP 2144.05 (II)).
Regarding claims 2-10, Billet and Kim, as combined above, fail to disclose “wherein the inner layer has a flexural modulus of about 1500 to about 2500 MPa”, “wherein the outer layer has a flexural modulus of about 2500 MPa to about 6000 MPa”, “wherein the inner layer has a flexural strength of about 35 to about 50 MPa”, “wherein the outer layer has a flexural strength of about 65 MPa to about 150 MPa”, “wherein the inner layer has an elongation at break of more than about 20%”, “wherein the outer layer has an elongation of break of about 5% to about 20%” and “wherein the inner layer is about 10% to about 75% by volume of the multilayer dental restoration”.
However, the Examiner notes that Billet discloses the invention substantially as claimed as discussed above; specifically Billet discloses the same material recited in the immediate Specification ([0025] and [0032]). The immediate specification discloses these parameters as being merely preferable ([00158], [00166], [00159], [00167], [00161] and [00154]) and does not describe it as contributing an unexpected result to the dental restoration. As such, these parameters, are deemed matters of design choice (lacking in any criticality), well within the skills of the ordinary artisan, obtained through routine experimentation in determining optimum results. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the inner and outer layer flexural modulus, flexural strength, elongation at break and the percentage by volume of the two material in the overall dental restoration, in order to make these parameters optimum for e.g. comfort and durability; since such modification would merely involve the optimization of a result effective variable (e.g. more or less e flexural strength in the layers), obtained through routine experimentation in determining optimum results (such as the optimum elongation at break to achieve comfort and durability) which has been held to be within the skill of the ordinary artisan (see MPEP 2144.05 (II)).
Regarding claim 11, Billet and Kim, as combined above, disclose the invention substantially as claimed. Billet discloses wherein the first polymeric material is a composite (since it could be Bis-GMA mixed with fillers to form a composite; see col 4, lines 63-67).
Regarding claim 12, Billet and Kim, as combined above, disclose the invention substantially as claimed. Billet discloses wherein the first polymeric material comprises triethylene glycol dimethacrylate (TEGDMA), Bis-GMA, Urethane dimethacrylate, or poly methylmethacrylate (i.e. Bis-GMA; see col 6, lines 15-20).
Regarding claim 13, Billet and Kim, as combined above, disclose the invention substantially as claimed. Billet discloses wherein the first polymeric material comprises a filler (since it is a charged polymeric material; see col 6, lines 15-20).
Regarding claim 18, Billet and Kim, as combined above, disclose the invention substantially as claimed. Billet discloses wherein the second polymeric material is a composite (since it could be TEGDMA mixed with fillers to form a composite; see col 4, lines 63-67).
Regarding claim 19 Billet and Kim, as combined above, disclose the invention substantially as claimed. Billet discloses wherein the second polymeric material comprises triethylene glycol dimethacrylate (TEGDMA), Bis-GMA, Urethane dimethacrylate, or poly methylmethacrylate (i.e. Bis-GMA; see 5, lies 5-15).
Regarding claim 20, Billet and Kim, as combined above, disclose the invention substantially as claimed. Billet discloses wherein the second polymeric material comprises a filler (see light-curing organic charges in col 6, lines 7-14).
Regarding claim 118, Billet and Kim, as combined above, disclose the invention substantially as claimed. Billet discloses wherein the filler comprises a glass filler, a ceramic, or a combination thereof (col 3, lines 28-32).
Regarding claim 119, Billet and Kim, as combined above, disclose the invention substantially as claimed. Billet discloses wherein the multilayer dental restoration consists of two layers (since as shown in Figure 1, a dental prosthesis has been fitted on a natural stump 1 of dentin trimmed in the mouth to receive the prosthesis; this prosthesis is formed by a support shell 2 covering the natural stump 1 and an external finishing coating 3 covering the support shell 2, col 4, lines 30-35).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUIS MIGUEL RUIZ MARTIN whose telephone number is (571)270-0839. The examiner can normally be reached M-F 8 Am - 5 PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached on (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUIS RUIZ MARTIN/
Examiner, Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772
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