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 .
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 10/27/2025, 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-5, 8-13, 18-20 and 116-117 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 116-117 recite respectively: “wherein the multilayer dental restoration can compensate up to about 25%and the patient tooth”; it is unclear what is meant by these limitations and how the structure of the restorations is restricted by the limitations. It is unclear what is the mechanism that allows the multilayer dental restoration to compensate differences between the volume of the interior region and a patient tooth. A review of the Specification failed to clarify these limitations.
Claim 1 recites “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”; however, the claim previously recites “the inner layer has an elasticity that is higher than an elasticity of the outer layer”. It is unclear if these requirements are both required since the ranges claimed allow for both to be 2500 MPa.
Claims 116-117 recite respectively: “wherein the multilayer dental restoration can compensate up to about 30% difference between the volume of the interior region and the patient tooth” and “wherein the multilayer dental restoration can compensate up to about 40% difference between the volume of the interior region and the patient tooth”. However, claim 1, from which these two claims depend, recites a narrower range/scope of “about 25%”. Therefore, the scope of these two claims is indefinite.
Claims 2-5, 8-13 and 18-20 are rejected by virtue of their dependency on claim 1.
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, 5, 11, 13 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over as obvious over Worthington (US 7726970 B2) in view of Curbell Plastics (see NPL attached to the Office Action filed on 06/27/2025), further in view of Parkar (US 20210153978 A1).
Regarding claim 1, Worthington discloses a multilayer dental restoration (1080, Figure 63, col 20, lines 56-67), comprising an outer layer (polycarbonate outer layer) formed of a first polymeric material, an inner layer (acrylic resin inner layer) formed of a second polymeric material that is different from the first polymeric material, 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 (col 20, lines 56-67); and wherein the multilayer dental restoration can compensate up to about 25% difference between the volume of the interior region and a patient tooth (since Worthington’s dental restoration has all the necessary structures to be capable of compensating up to about 25% difference between the volume of the interior region and a patient tooth). Additionally, Worthington’s dental restoration offers good margins, good contacts, and good occlusions to prevent tooth shift (col 5, lines 24-29).
Worthington discloses the outer layer being made of polycarbonate and the inner layer made of acrylic resin (col 20, lines 56-67) but does not explicitly disclose the values of the hardness of these materials, therefore does not specifically disclose wherein the inner layer has a hardness that is lower than a hardness for the outer layer and the inner layer has an elasticity that is higher than an elasticity of the outer layer.
However, Curbell Plastics teaches examples of available types of polycarbonate and acrylic resin and their hardness and elasticity values. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Worthington’s polymeric materials to make them with the properties disclosed by Curbell Plastics, since such modification would merely be a case of applying/using known materials to a known device (dental restoration) ready for improvement to yield predictable results (e.g. the hardness of acrylic resin is lower than that of polycarbonate and the elasticity of acrylic resin is higher than polycarbonate).
Worthington and Curbell Plastics, as combined above, fails to specifically disclose “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.
Parkar discloses a multilayer dental restoration comprising polymeric compositions (Abstract, Figure 7G); wherein the material has a modulus of elasticity of about 1,500 MPa to 2,500 MPa (300 MPa and about 5 GPa ,[0018]). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Worthington/Curbell Plastics’ inner polymeric layers and outer layer to make them comprising a modulus of elasticity of about 300 MPa and about 5 GPa, since such modification would provide the device with sufficient stiffness even where inner layer is relatively thin ([0018]). The Examiner notes that 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).
Regarding claim 5, Worthington, Curbell Plastics and Parkar, as combined above in the rejection of claim 1, discloses wherein the outer layer has a flexural strength of about 65 MPa to about 150 MPa (since the outer layer is Curbell Plastics’ polycarbonate, which has a flexural strength of about 13,500 psi, approximately 93 MPa).
Regarding claim 11, Worthington, Curbell Plastics and Parkar, as combined above in the rejection of claim 1, discloses wherein the first polymeric material is a composite (Worthington: col 9, lines 28-35).
Regarding claim 13, Worthington, Curbell Plastics and Parkar, as combined above in the rejection of claim 1, discloses the invention substantially as claimed. Worthington discloses wherein the first polymeric material comprises a filler (since it is 20% fine fiber-glass filled polycarbonate, see col 9, lines 28-29).
Regarding claim 18, Worthington, Curbell Plastics and Parkar, as combined above in the rejection of claim 1, discloses the invention substantially as claimed. Worthington discloses wherein the second polymeric material is a composite (since it is glass-filled acrylic resin; col 18, lines 7-10).
Regarding claim 19, Worthington, Curbell Plastics and Parkar, as combined above in the rejection of claim 1, discloses the invention substantially as claimed. Worthington discloses wherein the second polymeric material comprises poly methylmethacrylate (acrylic resin, also known as PMMA).
Regarding claim 20, Worthington, Curbell Plastics and Parkar, as combined above in the rejection of claim 1, discloses the invention substantially as claimed. Worthington discloses wherein the second polymeric material comprises a filler (since the resin used in the invention is preferably Super-T glass-filled acrylic resin; see col 9, lines 31-33).
Regarding claim 116, Worthington, Curbell Plastics and Parkar, as combined above in the rejection of claim 1, discloses the invention substantially as claimed. Wherein the multilayer dental restoration can compensate up to about 30% difference between the volume of the interior region and the patient tooth (since Worthington’s dental restoration has all the necessary structures to be capable of compensating up to about 30% difference between the volume of the interior region and a patient tooth). Additionally, Worthington’s dental restoration offers good margins, good contacts, and good occlusions to prevent tooth shift (col 5, lines 24-29).
Regarding claim 117, Worthington, Curbell Plastics and Parkar, as combined above in the rejection of claim 1. Wherein the multilayer dental restoration can compensate up to about 40% difference between the volume of the interior region and the patient tooth ((since Worthington’s dental restoration has all the necessary structures to be capable of compensating up to about 40% difference between the volume of the interior region and a patient tooth). Additionally, Worthington’s dental restoration offers good margins, good contacts, and good occlusions to prevent tooth shift (col 5, lines 24-29).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Worthington in view of Curbell Plastics in view of Parkar, further in view of Omnexus (see NPL attached to the Office Action filed on 06/27/2025).
Regarding claim 2, Worthington, Curbell Plastics and Parkar, as combined above in the rejection of claim 1, discloses the inner layer is acrylic resin, also known as Polymethyl Methacrylate (PMMA), but fails to specifically disclose “wherein the inner layer has a flexural modulus of about 1500 to about 2500 MPa”.
Omnexus discloses an available type of PMMA comprising a flexural modulus of 2.5-3.5 GPa. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Worthington/Curbell Plastics/Parkar’ polymeric material to make the inner layer with the properties disclosed by Omnexus, since such modification would merely be a case of applying/using known materials to a known device (dental restoration) ready for improvement to yield predictable results (e.g. the inner layer having an appropriate flexural modulus for dental applications).
Regarding claim 3, Worthington, Curbell Plastics and Parkar, as combined above in the rejection of claim 1, discloses the outer layer is polycarbonate, but fails to specifically disclose
“wherein the outer layer has a flexural modulus of about 2500 MPa to about 6000 MPa”.
Omnexus discloses an available type of polycarbonate having a flexural modulus of 6 GPa. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Worthington/Curbell Plastics/Parkar’ polymeric material to make the outer layer with the properties disclosed by Omnexus, since such modification would merely be a case of applying/using known materials to a known device (dental restoration) ready for improvement to yield predictable results (e.g. the outer layer having an appropriate flexural modulus for dental applications).
Should applicant traverse the Examiner’s position above, the Examiner further notes that Omnexus teaches ranges overlapping the claimed limitations with respect to flexural modulus. In this case since the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. (Please see MPEP 2144.05(I)).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Worthington in view of Curbell Plastics in view of Parkar, as applied to claim 1 above, further in view of Sun (US 20110049738 A1).
Regarding claim 4, Worthington, Curbell Plastics and Parkar, as combined above in the rejection of claim 1, discloses the multilayer dental restoration substantially as claimed, but fails to disclose “wherein the inner layer has a flexural strength of about 35 to about 50 MPa”.
Sun discloses a multilayer dental restoration comprising polymeric compositions (Abstract); wherein the material has a flexural strength of about 35 to 50 MPa (7000 psi, approximately 48 MPa [0018]). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Worthington/Curbell Plastics/Parkar’ inner polymeric layers to make it comprising a flexural strength of about 48MPa, since such modification provide the inner layer with a high flexural strength that provides the ability of resisting bending under load constant load.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Worthington in view of Curbell Plastics, in view of Parkar, as applied to claim 1 above, and further in view of Jones (US 20110207087 A1).
Regarding claim 8, Worthington, Curbell Plastics and Parkar, as combined above in the rejection of claim 1, discloses the multilayer dental restoration substantially as claimed, but fails to disclose “wherein the inner layer has an elongation at break of more than about 20%”.
Jones discloses a multilayer dental restoration comprising polymeric compositions (Abstract, Figure 1) wherein the material has an elongation at break of more than 20% (since it could be 350%, [0145]). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Worthington/Curbell Plastics/Parkar’ inner polymeric layers to make it comprising an elongation at break of 350%, since such modification would create a device that is capable of supporting large tensile loads.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Worthington in view of Curbell Plastics, in view of Parkar, as applied to claim 1 above, further in view MarkeltFrom (see NPL attached to the Office Action filed on 06/27/2025).
Regarding claim 9, Worthington, Curbell Plastics and Parkar, as combined above in the rejection of claim 1, discloses the outer layer is polycarbonate, but fails to specifically disclose “wherein the outer layer has an elongation of break of about 5% to about 20%”.
MarkeltFrom discloses an available type of polycarbonate having an elongation of break of about 3.5-110%. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Worthington/Curbell Plastics/Parkar’ polymeric material to make the outer layer with the properties disclosed by MarkeltFrom, since such modification would merely be a case of applying/using known materials to a known device (dental restoration) ready for improvement to yield predictable results (e.g. the outer layer having an appropriate elongation of break for dental applications).
Should applicant traverse the Examiner’s position above, the Examiner further notes that MarkelFrom teaches ranges overlapping the claimed limitations with respect to elongation of break. In this case since the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. (Please see MPEP 2144.05(I)).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Worthington in view of Curbell Plastics, in view of Parkar, as applied to claim 1 above, and further in view of Shoher (ES 2316498 T3).
Regarding claim 10, Worthington, Curbell Plastics and Parkar, as combined above in the rejection of claim 1, discloses the multilayer dental restoration substantially as claimed, but fails to disclose “wherein the inner layer is about 10% to about 75% by volume of the multilayer dental restoration”.
Shoher discloses a multilayer dental restoration comprising polymeric compositions (Figure 1, claim 1), wherein the inner layer is about 10% to about 75% by volume of the multilayer dental restoration at least one layer of a base material composition containing a binder in a concentration of between 20% and 80% by volume of the composition of the base material (claim 1). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Worthington/Curbell Plastics/Parkar’ inner polymeric layers to make it comprising in a concentration of between 20% and 80% by volume of the composition, since such modification would provide the device with a proper proportions of materials as recognized in the art.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Worthington in view of Curbell Plastics, in view of Parkar, as applied to claim 1 above, and further in view of Herrmann (US 10610330 B2).
Regarding claim 12, Worthington and Curbell Plastics, as combined above in the rejection of claim 1, discloses the multilayer dental restoration substantially as claimed, but fails to disclose “wherein the first polymeric material comprises triethylene glycol dimethacrylate (TEGDMA), Bis-GMA, Urethane dimethacrylate, or poly methylmethacrylate”.
Herrmann discloses a multilayer dental restoration comprising polymeric compositions (Figure 1, claim 1), wherein one of the polymeric material comprises TEGDMA (col 23, lines 8-15). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Worthington/Curbell Plastics/Parkar’ first polymeric material to make it comprising TEGDMA, since such modification would merely be a case of adding a known material to a known device (dental restoration) ready for improvement to yield predictable results (e.g. the first polymeric material having TEGDMA, which is a monomer, typically used as a component in resin-based composites to improve the flow characteristics of the composite).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUIS RUIZ whose telephone number is (571)270-0839. The examiner can normally be reached on M-F 8 Am - 5 PM (EST). 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/
Patent Examiner
Art Unit 3772
/ERIC J ROSEN/ Supervisory Patent Examiner, Art Unit 3772