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 § 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.
Claims 1, 2, 4 and 6-10 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.
Regarding claim 1, the recitation of “is supported by the support via the peripheral portion, and the occlusion portion, the buccal portion, or the lingual portion, the peripheral portion, and the support are continuously formed along the manufacturing direction” in lines 19-22 is indefinite. The construction of the recitation makes it confusing to understand if the intention is to only describe where the support is connected, or that the recitation includes separated distinct descriptions of the connection and direction of manufacturing, e.g. “is supported by the support via the peripheral portion or[[, and]] the occlusion portion, the buccal portion, or the lingual portion, the peripheral portion;[[,]] and the support are continuously formed along the manufacturing direction”. For examination purposes, the term will be interpreted as “is supported by the support via the peripheral portion or[[, and]] the occlusion portion, the buccal portion, or the lingual portion, the peripheral portion;[[,]] and the support are continuously formed along the manufacturing direction”.
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 1, 2, 4, 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Webber et al. (US 20160128803 A1) in view of Benarouch et al. (FR 3057156 A1), in further view of Hasan et al. (US 20190336254 A1), and in further view of Weber et al. (CN 107106263 A).
[AltContent: ][AltContent: textbox (Lingual portion)][AltContent: ][AltContent: textbox (Buccal portion)][AltContent: ][AltContent: textbox (Tooth crown)][AltContent: textbox (Mouthpiece)][AltContent: arrow]
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Regarding claims 1 and 7, Webber et al. discloses a method for manufacturing a mouthpiece (300), wherein the mouthpiece (300) is to be placed within an oral cavity to cover teeth, the method including:
additive manufacturing a manufactured product using an additive manufacturing device (see [0048-0049] – where Webber describes that even when thermoforming machine is used for the manufacture of the mouthpiece, other alternate methods can be used, such as rapid prototyping, stereolithography; where such alternate methods are considered additive manufacturing), the manufactured product including the mouthpiece (300), a peripheral portion connected to the mouthpiece (300), and
removing the peripheral portion from the manufactured product (see Fig. 3 above and [0050] – where the “aligner may also … be trimmed along a gingival cut line“; therefore, the peripheral portion in Fig. 3 has been already trimmed along the gingival line),
wherein the peripheral portion is formed to cover a gingiva within the oral cavity of a patient and formed in a shape that follows the gingiva (see annotated Fig. 3 above and [0049-0050] – where the additive manufacturing includes rapid prototyping, stereolithography; and a peripheral portion is formed by the manufacturing process (not shown in the figures), in which is identified as extending over the gingival tissue, and it is trimmed along the gingival cut line; in this way, it is understood that the shape of the mouthpiece follows the gingiva shape along the gingival line),
wherein the manufactured product includes a plurality of hardened layers laminated at a predetermined lamination pitch in a vertical direction perpendicular to an occlusal plane along which portions of the mouthpiece that cover the teeth are arranged, and wherein each of the plurality of hardened layers is arranged in a continuous shape (see [0049] – due to the alternate manufacturing devices includes the rapid prototyping, stereolithography, the layers of material as claimed is an intrinsic step of the process used by the alternate manufacturing devices; furthermore, based that the manufacturing is done first the bottom to the top of the mouthpiece, it is understood that lamination pitch is done in the vertical direction perpendicular to an occlusal plane),
where a buccal portion, and a lingual portion of the mouthpiece is directly connected to the peripheral portion (as described above, the peripheral portion is formed by the manufacturing process (not shown in the figures), in which is identified as extending over the gingival tissue and trimmed along the gingival cut line; therefore, the claimed peripheral portion is directly connected to the buccal portion and the lingual portion at the gingival line).
However, Webber et al. does not disclose that the plurality of hardened layers are laminated at the predetermined lamination pitch is in a vertical direction perpendicular to the occlusal plane; also, that the continuous shape is from a root to a tip of a tooth crown so that a structure of the mouthpiece becomes convex in a manufacturing direction perpendicular to the occlusal plane; also, that a support is configured to support the peripheral portion, and wherein the support is connected to a bottom end of the peripheral portion to support the peripheral portion, wherein the support, the peripheral portion, and the mouthpiece are manufactured in this order; and wherein an occlusion portion, a buccal portion, or a lingual portion of the mouthpiece is not directly connected to the support, but is supported by the support via the peripheral portion or the occlusion portion, the buccal portion, or the lingual portion, the peripheral portion; and the support are continuously formed along the manufacturing direction (for claim 1); and that the support is formed in a columnar shape (for claim 7).
[AltContent: textbox (Mouthpiece)][AltContent: arrow]
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[AltContent: textbox (Columnar support shape)][AltContent: arrow][AltContent: textbox (Peripheral portion)][AltContent: arrow][AltContent: textbox (Support)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Manufactured product)]
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Benarouch et al. teaches a method including additive manufacturing for forming a mouthpiece (40) (see Fig. 1 and 5c-5d above - where the label 40 represents the preform of the final mouthpiece 10), and a support (42) configured to support the mouthpiece attached to the base (36) of the additive manufacturing machine (see Fig. 5d above), and wherein the support (42) is connected to a bottom surface of the manufactured mouthpiece (40), where said bottom surface includes the peripheral portion of the mouthpiece (see page 9, lines 4-5 of the translation) (for claim 1); and where the support (42) is formed in a columnar shape (see annotated Fig. 5d – where the support extends from the base 36 towards the mouthpiece in a columnar shape) (for claim 7).
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 method of manufacturing the mouthpiece and peripheral portion of Webber, with the support structure connected to the bottom surface including the peripheral portion of the manufactured mouthpiece of Benarouch, in order to provide a stable connection with the base of the additive manufacturing machine across all the portions of the mouthpiece in this way capable of maintaining its shape during its manufacture.
However, Webber/Benarouch does not disclose that the support, the peripheral portion, and the mouthpiece are manufactured in this order, and wherein an occlusion portion, a buccal portion, or a lingual portion of the mouthpiece are continuously formed with the peripheral portion and the support, and that the continuous shape is from a root to a tip of a tooth crown so that a structure of the mouthpiece becomes convex in a manufacturing direction perpendicular to the occlusal plane (for claim 1).
On the other hand, Webber discloses that the mouthpiece includes a periphery portion, in which is identified as a material extending over the gingival tissue, and that it is trimmed along the gingival cut line after manufacturing. Due to the peripheral portion is formed to cover the gingiva along the perimeter of the mouthpiece, it is understood that said gingiva extends through the lingual and buccal areas of the mouthpiece. For that reason, the lingual and buccal areas are only in direct contact with the peripheral portion during the additive manufacturing in the combination of Webber and Benarouch.
[AltContent: arrow][AltContent: textbox (Translucent bottom )][AltContent: arrow][AltContent: arrow][AltContent: textbox (Liquid polymer)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Liquid polymer)][AltContent: textbox (Manufactured product)][AltContent: arrow][AltContent: textbox (Support)][AltContent: arrow][AltContent: textbox (Base)][AltContent: arrow]
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At the same time, Benarouch teaches that the printing process of his invention begins by submerging the preform support 36 into the batch to define a lower layer (38). Said lower layer (38) is irradiated through the transparent bottom (39) of the tank (32). Said preform support (36) is taken out the bath and to then immerse it again to a predetermined depth for the formation of the new layer of liquid polymer (38) for hardening with the light (34) through the translucent bottom tank (32). This process is repeated to form each layer from the bottom towards the manufactured produce (40), where the manufactured produce (40) is attached to the to the support (42) by the surface portion engaging the teeth. Finally, the support (42) is removed from the manufactured product (40) to make the final mouth piece (10) (see Fig. 5a-5E above and page 8, line 21 through page 9, line 5).
If the 3D printing process of Benarouch forms each layer from the preform support 36 towards the manufactured product (40)/ then mouthpiece (10). Where the portions between the preform support (36) and the mouthpiece is the support portion (42). When using said process in Webber’s, it would has first formed the support 42 as in Benarouch, followed by the periphery portion of Webber, because it is the first material that extends over the gingival tissue that is adjacent to the tooth and to the gum line that will be trim away, and ending with the mouthpiece of Webber.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the use of the method of Benarouch with the mouthpiece of Webber would have first manufactured the support followed by the peripheral portion, and ending with the manufactured product of the mouthpiece.
However, Webber/Benarouch does not disclose that an occlusion portion, a buccal portion, or a lingual portion of the mouthpiece are continuously formed with the peripheral portion and the support, and that the continuous shape is from a root to a tip of a tooth crown so that a structure of the mouthpiece becomes convex in a manufacturing direction perpendicular to the occlusal plane (for claim 1).
[AltContent: arrow][AltContent: textbox (Liquid polymer solution bath)][AltContent: ][AltContent: textbox (Base)][AltContent: arrow][AltContent: textbox (Mouthpiece)]
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[AltContent: arrow][AltContent: textbox (Base)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Mouthpiece)][AltContent: textbox (Support)][AltContent: arrow][AltContent: arrow]
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Hasan et al. teaches a 3D printing process for fabricating a mouthpiece (see 300 and 600), where the mouthpiece can be manipulated to a specific spatial orientation and angular inclination with respect to a base (500) of the 3D printer (see the device at 0O angle with respect to the base in Fig. 5A, in element 520a-c for angular inclination in annotated Fig. 5B above, and abstract).
Furthermore, the orientation and angulation of the mouthpiece with respect to the base (500) during printing impact the quality of the final product in terms of dimensional deviations with respect to the digital model of the intended original design, in terms of minor surface distortions to extensive, major changes in overall size or the general shape of the final product due to warping. Some of the reasons affecting a printed object is the result of gravitational forces on areas of the object during the printing and curing process.
For that reason, it is added in key points support structures (610) between the base (500) and the mouthpiece (600) during the process of printing, in this way it helps to maintain the overall size and shape of each of the structural components of the mouthpiece during the printing process and curing, in which are configured to be removed afterward (see annotated Fig. 6A-6C above, [0003, 0006, 0048-0049]). For that reason, all the components lying in the same printing layer will be continuously formed at the same time, layer by layer, during the fabrication of the mouthpiece.
Therefore, if Hasan teaches that the orientation of the manufacture mouthpiece can be manipulated. It is understood that he is capable of providing a continuous hardening layer arranged to form a root to tip of the tooth crown, so that the structure of the mouthpiece becomes convex in the manufacturing direction perpendicular to the occlusal plane.
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 method of manufacturing the mouthpiece of Webber/Benarouch, with the continuous formation of any of the buccal portion, or a lingual portion of the mouthpiece with the peripheral portion and the support, and the continuous hardening layers arranged to form a root to tip of the tooth crown so that the structure of the mouthpiece becomes convex of Hasan, in order for the peripheral portion and the support to maintain the overall size and shape of each of the structural components of the mouthpiece throughout the printing process and curing.
Regarding claim 2, Webber/Benarouch/Hasan discloses the claimed invention substantially as claimed, as set forth above for claim 1, and where Webber discloses that the peripheral portion is connected to a root portion of the mouthpiece, the root portion corresponding to a root of a tooth crown (see [0050] – where the peripheral portion is formed through the manufacturing process (not shown in the figures), in which is identified as extending over the gingival tissue, and that it is trimmed along the gingival cut line; therefore, the peripheral portion is connected distally with the mouthpiece, considered to be the root portion of the mouthpiece).
Regarding claim 4, Webber/Benarouch/Hasan discloses the claimed invention substantially as claimed, as set forth above for claim 1, and where Webber discloses that the, mouthpiece (300) includes a lamination trace (see (see Fig. 3 above) and [0049] — where if it is formed though 3D printing or additive manufacturing, the mouthpiece 300 is made of thin layers or laminas; in this way having lamination trace), and wherein the mouthpiece (300) does not include a support trace (see Fig. 3 above — where the final mouthpiece 300, does not have marks or support trace on the mouthpiece, because it was removed as part of the process).
Regarding claim 6, Webber/Benarouch/Hasan discloses the claimed invention substantially as claimed, as set forth above for claim 1, and where Webber discloses that the peripheral portion is connected to a bottom end of the buccal portion and a bottom end of the lingual portion (see annotated Fig. 3 above, and [0049-0050] - peripheral portion is formed by the manufacturing process (not shown in the figures), in which is identified as extending over the gingival tissue, and it is trimmed along the gingival cut line).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Webber et al. (US 20160128803 A1) in view of Benarouch et al. (FR 3057156 A1), in further view of Hasan et al. (US 20190336254 A1) as applied to claim 1 above, and further in view of Sun et al. (CA 2889331 A1).
Regarding claim 8, Webber/Benarouch/Hasan discloses the claimed invention substantially as claimed, as set forth above for claim 1.
However, Webber/Benarouch/Hasan does not disclose further including the step of removing unreacted substances from the manufactured product.
Sun et al teaches three-dimensional fabricating material system for producing dental products, where the product is fabricated using 3D printing or stereolithography, and after the product is cured, it is washed in solvent (e.g., ethyl acetate, alcohols, acetone, THF, heptane, etc. or their combinations) to remove uncured resin from the 3D dental object (see page 15, lines 5-6).
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 method of Webber/Benarouch/Hasan, with the step of removing unreacted substances from the product of Sun, in order to remove uncured resin from the 3D dental object.
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Webber et al. (US 20160128803 A1) in view of Benarouch et al. (FR 3057156 A1), in further view of Hasan et al. (US 20190336254 A1) as applied to claim 1 above.
Regarding claim 9, Webber/Benarouch/Hasan discloses the claimed invention substantially as claimed, as set forth above for claim 1.
However, Webber/Benarouch/Hasan does not disclose that wherein the step of removing the peripheral portion from the manufactured product includes removing the peripheral portion and the support integrally from the manufactured product.
On the other hand, Webber discloses that the peripheral portion that it is identified as extending over the gingival tissue, and that it is trimmed along the gingival cut line in order to form the final mouthpiece (see [0049-0050]), and that when Webber’s uses the process of Benarouch to make the support portion in order to provide a stable connection. If that support is initially manufactured followed by the peripheral portion and finished with the mouthpiece. When Webber discloses trimming the peripheral portion that extends over the gingival tissue, it would also remove the support connected to the peripheral portion.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that when trimming along the gingival cut line of the mouthpiece, it would have removed the peripheral portion and the support.
However, Webber/Benarouch/Hasan does not disclose that both, the support and peripheral portion are removed integrally.
On the other hand, removing the support and the peripheral portion integrally does not change the final product manufactured, that in this case is the mouthpiece. Therefore, removing the support and peripheral portion integrally or in pieces, is considered that since it has been held that where the general conditions of a claim are disclosed in the prior arts, discovering the optimum sequence of steps involves only routine skill in the art.
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Webber et al. (US 20160128803 A1) in view of Benarouch et al. (FR 3057156 A1), in further view of Hasan et al. (US 20190336254 A1) as applied to claim 1 above, and in further view of Formlabs (Supports, Orientation, and Lasers! – Understanding SLA 3D Printing Webinar (see https://www.youtube.com/watch?v=5VlprrdGYKM).
Regarding claim 10, Webber/Benarouch/Hasan discloses the claimed invention substantially as claimed, as set forth above for claim 1, and where Webber discloses that the 3D printer includes that the additive manufacturing device includes a container containing a liquid photo-curable resin (ultraviolet laser), and the movable stage that is vertically movable within the container (see [0047]).
However, even when Benarouch/Hasan does not disclose that the additive manufacturing device includes a movable stage that is vertically movable within a container, and an ultraviolet laser device disposed above the container and configured to emit an ultraviolet laser light, and wherein the additive manufacturing includes repeatedly scanning a layer of the photo- curable resin on the movable stage with the ultraviolet laser light using a predetermined pattern and moving the movable stage downward by a predetermined distance.
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Formlabs teaches in the video above (see Fig. 1 above - minute 1:46-2:16 of the video) that it is well known in the art the use of SLA printer using a container filled with photocurable resin liquid and above a laser configured to form a pattern of the object in the liquid. Where the laser forms the object by curing the liquid resin layer by layer. Where each time a layer is formed, the container base/build platform moves vertically, in this way submerging the object into the container. Furthermore, it is described that SLA printer can have a laser below of the container, and the base is not submerged in the liquid. But, the base with the object moves vertically above the surface of the liquid. The main difference between using the laser above the reservoir or below the reservoir resides on the size of the printed object. If the object to be printed is larger than the height of the container, it is recommended to use a printer having the laser below the container so that the photocurable resin liquid bath does not have to cover the extend of the final object. However, if the object to be printed is small, any of the above printers can be use (see Fig. 2 above - beginning at minute 3:32-4:10 of the video).
Due to the use of a 3D printer having the laser above or below the photocurable liquid resin and consequently having the base with the printed object submerged or not in the container during the formation of each layer does not provide a significant benefit in the printed object, other than subject to the size the object, if it is larger than the container. Due to the claimed printed object is a mouthpiece, in which it is considered a small object that can be manufactured in any of the above printer configurations. It is considered that manufacturing the mouthpiece in any of the above 3D printer configurations is an obvious matter of design choice, because it is not found a significant benefit between the two kind of 3D printer when manufacturing a small object like the claimed mouthpiece.
Response to Arguments
Applicant's arguments filed 20 February 2026 have been fully considered but they are not persuasive.
Regarding claim 1 rejection, applicant argues that the prior art of Webber does not disclose that the occlusal, buccal or lingual portion is supported via a peripheral portion without being directly connected to a support.
The Office disagrees, Webber discloses that during manufacturing of the mouthpiece a portion of material is generated that cover the gingival, in which it is later cut away through the gingival line. Said material is understood to be the claimed peripheral portion. It is understood that said material that cover the gingival is on the lingual and buccal portions. For that reason, if that material over the gingival area is in direct contact with the lingual and buccal portions, the support generated through the teachings of Benarouch and Hasan, would be place on the peripheral portion, not in direct contact with the lingual and buccal portions. In this way it is understood that at least that added language is found in the combination of Webber, Benarouch and Hasan.
With respect to Webber failing to disclose that the hardened layer is arranged so as to be convex from the base to the tip of the crown. The position of the Office is that Webber does not disclose it.
Benarouch teaches that the first part created is the support, then followed by the rest of the mouthpiece.
Hasan teaches that the mouthpiece can be manipulated to a specific spatial orientation and angular inclination with respect to a base, in order to possibly avoid the effects of gravitational forces on areas of the object. Therefore, if the mouthpiece can be manufactured in different orientation.
The manufacturing process of Webber can be modified with any of the teachings of Benarouch and Hasan. In this way, Webber in combination with Benarouch and Hasan is capable of manufacturing the mouthpiece that is oriented in a way that it is from root to tip, in which complies with the claim language.
Regarding that the prior arts above fail to recognize the problem of the formation of support marks on the occlusal, buccal or lingual areas. Webber discloses that the material covering the gingiva is cut away. In this way it is understood that any support trace is removed in combination with that material covering the gingiva.
Therefore, it is understood that the prior arts used in the rejections above includes the claimed subject matter, making the preset set of claims 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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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.
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/MIRAYDA A APONTE/Examiner, Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772
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