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 .
Response to Arguments
Applicant’s arguments/remarks filed on 12/23/2025 have been fully considered.
With respect to the claim rejection(s) under 35 U.S.C. § 103, Applicant’s arguments have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is presented in this Office action.
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.
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) 2-5 and 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bergersen (US 20130244194) in view of Wen (WO 2006096558A2 – of record), and further in view of Nakamura (US 5198159).
Regarding claim 2, Bergersen discloses a method (P0053, Fig. 2) comprising:
defining a plurality of object cross-sections of a dental appliance (providing a digital three-dimensional image of a model of a dental appliance, wherein the appliance can be fabricated by stereolithography directly from the digital three-dimensional image of the model: P0009, 0062-0064, steps 18 and 24 of Fig. 2; wherein the term stereolithography inherently requires a step of slicing the 3D model into plurality of object cross-sections to enable layer-by-layer stereolithography fabrication of the plurality of object cross-sections: See ordinary definition of stereolithography, secondary references and other prior art of record in which), wherein the dental appliance (400) comprises:
an outer shell (outer layer 501) comprising a plurality of teeth-receiving cavities (503), wherein the outer shell comprises a first stiffness (P0068-0069, Fig. 5A), and
an inner structure (inner layer 502) coupled to an inner surface of the outer shell (P0010, 0068-0069, Fig. 5A), wherein the inner structure comprises a second stiffness … (P0010, 0068-0069, Fig. 5A); and
sequentially polymerizing the plurality of object cross-sections to create the dental appliance (Bergersen implicitly discloses the claimed step because the taught the appliance 400 is fabricated by stereolithography directly from the digital three-dimensional image of the model: P0009, 0062-0063, steps 107 and 111 of Fig. 1 and steps 18 and 24 of Fig. 2; wherein the term stereolithography inherently requires a step of sequentially polymerizing the plurality of object cross-sections to create the dental appliance: See ordinary definition of stereolithography, secondary references and other prior art of record),
wherein the sequentially polymerizing comprises integrally forming the outer shell … with the inner structure (Bergersen implicitly discloses the claimed limitation because the taught the dental appliance is fabricated by stereolithography directly from the digital three-dimensional image of the model: P0009, 0062-0063, steps 107 and 111 of Fig. 1 and steps 18 and 24 of Fig. 2; each horizontal cross-section of the disclosed dental appliance 400 comprises the outer shell 501 and the inner structure 502: Fig. 5A; during stereolithography, each object cross-section is integrally formed/photo-polymerized such that and the plurality of object cross-sections yield one-piece 3D objects with integral layers: See ordinary definition of stereolithography, secondary references applied below such as Nakamura, and other prior art of record; Bergersen is silent about forming the 501 and 502 via separate steps).
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While Bergersen discloses/suggests to customize stiffness/softness in the dental appliance (P0007-0008, 0044, 0068), Bergersen fails to disclose that the second stiffness is less than the first stiffness in his embodiment of Fig. 5A (P0069).
In the same field of endeavor, manufacturing of dental appliances/aligners, Wen discloses to manufacture a dental appliance comprising:
an outer shell (outer layer of a multi-layer aligner: P00189, 00199), wherein the outer shell comprises a first stiffness (higher stiffness), and
an inner structure (inner layer of the multi-layer aligner: P00189, 00199) coupled to an inner surface of the outer shell, wherein the inner structure comprises a second stiffness less than the first stiffness (lower stiffness: P00199-00203) for the benefit(s) of making the dental appliance more comfortable for the patient to wear and/or improving contact/fitting to the patient’s teeth (P00199-00203).
Since Bergersen discloses/suggests to customize stiffness/softness in the dental appliance (as applied above) and to provide a stiffer material as an outer supporting structure (P0068), it would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Bergersen in view of Wen by making the second stiffness less than the first stiffness for yielding the predictable benefit(s) of using the outer shell as the stiffer outer supporting structure by making the outer shell with higher stiffness, making the dental appliance more comfortable for the patient to wear by making the inner structure with lower stiffness and/or improving contact/fitting to the patient’s teeth by making the inner structure with lower stiffness as suggested by Bergersen and Wen. See MPEP §§ 2143 I C, 2143 I G, and/or 2144 II.
Bergersen/combination does not explicitly/necessarily disclose the condition concurrently in the limitation “wherein the sequentially polymerizing comprises integrally forming the outer shell concurrently with the inner structure”.
However, upon reading Bergersen and prior art of record, a person of ordinary skill in the art would have recognized that concurrently forming is one of a finite number of options (i.e., concurrently and sequential) available in stereolithography to achieve the predictable formation of the disclosed dental appliance. A person of ordinary skill in the art, upon reading Bergersen and prior art of record, would have recognized that integrally and concurrently forming yields the predictable result(s) of enhancing efficiency and adhesion.
In the same field of endeavor, stereolithography methods, Nakamura discloses the technique of sequentially polymerizing a plurality of object cross-sections (photocuring successive cross-sectional layers 100 of a light curable resin to form a 3D object: Abstract, C3, L22-C4, L11; C11, L56-C12, L12, Fig. 13A) such that sequentially polymerizing comprises integrally forming an outer shell (100A) concurrently with an inner structure (100B: C12, L28-60, Fig. 15) for the benefit(s) of enabling integral and simultaneous forming of composite outer and inner layers and increasing efficiency and accuracy (C1, L8-12; C12, L28-60, Fig. 15). Nakamura further discloses that stereolithography yields one-piece 3D object with integral cross-sectional layers (Abstract, C7, L13-18). Nakamura further discloses that stereolithography can be form an outer shell/layer and an inner structure/layer either sequentially (Figs. 4A-B) or concurrently (C12, L28-60: Fig. 15).
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to further have modified the method of Bergersen in view of Nakamura by sequentially polymerizing the plurality of object cross-sections such that sequentially polymerizing comprises integrally forming the outer shell concurrently with the inner structure for yielding the predictable benefit(s) of enabling integral and simultaneous forming of outer shell and inner structure and increasing efficiency and/or accuracy as suggested by Nakamura. See MPEP §§ 2143 I C, 2143 I E, 2143 I G, and/or 2144 II.
Regarding claim 3, Bergersen, as modified above, further discloses wherein the outer shell comprises a first material comprising the first stiffness, and the inner structure comprises a second material comprising the second stiffness (P0064, 0064, 0069, Fig. 5A). Wen further discloses and obviates wherein the outer shell comprises a first material comprising the first stiffness, and the inner structure comprises a second material comprising the second stiffness (Abstract, P00199-00203). Nakamura further discloses and obviates wherein the outer shell (100A) comprises a first material (fully cured liquid resin) comprising the first stiffness, and the inner structure (100B) comprises a second material (half-cured liquid resin) comprising the second stiffness (the different degree of crosslinking/curing of the curable liquid resin yields different properties for 100A and 100B including different stiffness: C12, L28-60, Fig. 15, and prior art of record).
Regarding claim 4, Bergersen, as modified above, fails to disclose that the first material and the second material are the same material.
However, Nakamura further discloses wherein the outer shell (100A) comprises a first material (fully cured liquid resin) comprising the first stiffness, and the inner structure (100B) comprises a second material (half-cured liquid resin) comprising the second stiffness, the first material and the second material are the same material (same liquid resin), and the first and second stiffnesses are produced by varying a degree of crosslinking of the same material (the different degree of curing/crosslinking of the curable liquid resin are expected to yield different properties for 100A and 100B including different stiffness: Abstract, C12, L28-60, Fig. 15, and prior art of record disclosing that degree of crosslinking and stiffness of resins/polymers are inherently interrelated) for the benefit(s) of facilitating integral and simultaneous forming of composite outer and inner layers and increasing efficiency (C1, L8-12; C12, L28-60, Fig. 15). Wen further discloses/suggests to use same polymer material produced under different process conditions to yield the different properties for the layers (P0043-0044, 00201, Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to further have modified the method of Bergersen in view of Nakamura and Wen by using the same resin/polymer material as the first material and the second material such that the first and second stiffnesses are produced by varying a degree of crosslinking of the same material for yielding the predictable benefit(s) of facilitating integral and simultaneous forming of outer shell and inner structure and increasing efficiency as suggested by Nakamura and Wen. See MPEP §§ 2143 I C, 2143 I E, 2143 I G, and/or 2144 II.
Regarding claim 5, Nakamura further discloses determining one or more curing parameters to vary the degree of crosslinking of the same material, and applying the one or more curing parameters (e.g. focusing spot size) while sequentially polymerizing the plurality of object cross-sections to produce the first stiffness of the outer shell and the second stiffness of the inner structure (C12, L28-60, Fig. 15). Thus, the combination, as applied above, further discloses/obviates the claimed subject matter.
Regarding claim 8, Bergersen further implicitly discloses wherein the sequentially polymerizing comprises depositing and curing a resin in a layer-by-layer manner (appliance is fabricated by stereolithography directly from the digital three-dimensional image of the model using a resin/thermoplastic: P0062-0064; wherein the term stereolithography inherently requires the steps of depositing and curing a curable resin in a layer-by-layer manner: See ordinary definition of stereolithography, secondary references and other prior art of record).
Regarding claim 9, Bergersen further implicitly discloses wherein curing the resin comprises photopolymerizing the resin (the term stereolithography inherently requires the steps of photopolymerizing/photo-curing the curable resin: See ordinary definition of stereolithography, secondary references and other prior art of record).
Regarding claim 10, Bergersen further implicitly discloses wherein the dental appliance is an aligner (Bergersen does not explicitly mention the term aligner in his disclosure; however, the description of his dental appliance such as “U-shaped orthodontic appliance worn on teeth in a mouth of a patient wherein at least one of the teeth require correcting” reads on the ordinary definition and applicant’s disclosure of the term aligner: P0010, 0017, 0030, Fig. 4). Wen also discloses the subject matter (Abstract, P0029).
Regarding claim 11, Bergersen further discloses wherein the dental appliance is configured to implement a treatment plan to reposition a patient's teeth from a first arrangement (incorrect position) toward a second arrangement (correct/straight position: Abstract, P0010, 0014-0017, 0030). Wen also discloses the subject matter (Abstract, P0029, P00111).
Claim Rejections - 35 USC § 103
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bergersen (US 20130244194) in view of Wen (WO 2006096558A2 – of record) and Nakamura (US 5198159) as applied to claim 5 above, and further in view of Neckers (US 6200646 – of record).
Regarding claim 6, the combination, as applied to claim 5 above, fails to mention grayscale values as the one or more curing parameters.
In the same field of endeavor, stereolithography methods, Neckers discloses that stereolithography allows the simultaneous modulation of polymeric properties (degree of crosslinking, hardness, other properties that vary with light exposure,) in the x, y, z coordinates of an object by controlling irradiation/curing parameters such as grayscale intensity for each radiation pixel in one radiation step (this implies integrally and concurrently forming portions of a layer of the object with different polymeric properties by photocuring/polymerizing with different irradiation irradiation/curing parameters) for the benefit(s) improving efficiency of the method and control of properties (Abstract, C2, L46-C3, L4; C3, L13-42; C5, L54-C6, L6; C7, L30-60).
Since Nakamura further discloses to control curing parameters/conditions to vary the degree of curing/crosslinking (as applied above) while Neckers discloses to control irradiation/curing parameters such as grayscale intensity for each radiation pixel in one radiation step to obtain different degrees of crosslinking and different polymeric properties (as applied above), it would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to further have modified the method of Bergersen in view of Nakamura and Neckers by using grayscale values as the one or more curing parameters to vary the degree of crosslinking of the same material when sequentially polymerizing the plurality of object cross-sections to produce the first stiffness of the outer shell and the second stiffness of the inner structure for yielding the predictable benefit(s) of controlling the different degrees of crosslinking and producing the first stiffness and the second stiffness efficiently as suggested Nakamura and Neckers. See MPEP §§ 2143 I C, 2143 I E, 2143 I G, and/or 2144 II.
Conclusion
Additional prior art made of record and not relied upon that is considered to be pertinent to
Applicant’s disclosure:
Shivapuja (US 20160256240 – of record) discloses a relevant method for manufacturing aligners with different properties at different locations such as hard-soft aligners in a single processing step using a stereolithography process (all pages, in particular: Abstract, P0013, 0054).
Kitching (US 20130122448 – of record) discloses that stereolithography allows the manufacture of different parts of an aligner integrally layer-by-layer (this implies integrally forming portions of a layer/cross-section of the object with different polymeric properties by photocuring/polymerizing) and cross-linking different parts of the aligner to different levels to control/tune viscoelastic behavior using a single material (P0015-0019, 0054-0055, 0085-0086, 0106-0110, Figs. 2-3).
Abolfathi (US 20050136371) discloses that stiffness and crosslinking of a polymer are interrelated (P0062 – of record).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JERZI H MORENO HERNANDEZ whose telephone number is (571)272-0625. The examiner can normally be reached 1:00-10:00 PM PT.
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/JERZI H MORENO HERNANDEZ/Primary Examiner, Art Unit 1743
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