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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/30/25 has been entered.
Response to Amendment
The amendments made to claims 1, 6, 13, and 14 in the response filed 10/30/25 are acknowledged.
Claims 1-3, 6, 7, and 10-20 are now pending in the application and are examined below.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 6, 7, and 10-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s arguments on p. 6-8 regarding the amendments to claim 1 are moot in view of new reference Boronkay; please see detailed rejection below.
Claim Objections
Claim 1 is objected to because of the following informalities: “the unit cells” in line 13 should be amended to recite --the plurality of unit cells--. Appropriate correction is required.
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.
Claim(s) 1-3, 6, 7, 10-12, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark WO 2018/161112 A1 in view of Wen US 2017/0100214 A1 further in view of Kuo US 2010/0129763 A1 and Boronkay US 2017/0007363 A1.
Regarding claim 1, Clark discloses a polymer mouthguard 10 for protecting teeth of a wearer (fig. 1 and p. 3, lines 21-22), comprising:
a lingual portion 20, a facial portion 18, and an occlusal portion 22 connected with one another in a shape of an arch and together defining a trough 24 for receiving upper (maxillary) or lower (mandibular) teeth of the wearer (fig. 1 and p. 8, lines 12-15, front section 18 is the facial portion, back section 20 is the lingual portion, and bridging section 22 is the occlusal portion that connects the front and back sections 18/20 to form teeth engaging channel 24; p. 9, lines 8-10 state that the mouthguard 10 is used to protect the maxillary arch but could be made for the mandibular arch);
wherein at least one, or both, of said facial portion 18 and said occlusal portion 22 have a shock absorbing lattice formed therein (fig. 1 and p. 8, lines 19-21, the mouthguard is perforated by slots 26 throughout all surfaces of the mouthguard, thus forming a lattice structure of material; Merriam-Webster defines lattice as “a framework or structure of cross wood or metal strips” and “a network or design resembling a lattice”; in this case, due to the regular array of slots 26, the material around the openings forms a network resembling a lattice; further, Clark refers to its device as a “mouthguard”, and p. 1, lines 10-14 describes mouthguards as aiming to absorb energy associated with impact).
Clark is silent on the shock absorbing lattice comprising a plurality of repeating unit cells, each unit cell comprising interconnected lattice struts and nodes, and wherein said shock absorbing lattice in different regions differ from one another in unit cell type, lattice strut diameter, lattice strut length, or a combination thereof, to thereby impart different shock-absorbing properties to said different regions.
However, Wen teaches a dental tray ([0002], dental appliances such as retainers and aligners) comprising an analogous lattice comprising a plurality of repeating unit cells ([0218], the dental appliance may comprise or consist of a lattice structure with one or more types of unit cells; [0235], the lattice structure is a framework which contains a regular, repeating pattern defined by unit cells), each unit cell comprising interconnected lattice struts and nodes ([0236]-[0237] and fig. 12B, the lattice structure framework 432 is made up of strips/bars/beams forming openings of the unit cell 434; as can be seen in the figure, the nodes are the intersections of each horizontal and vertical strip, and the struts are the horizontal and vertical strips), and wherein said lattice of different regions differ from one another in unit cell type, lattice strut diameter, lattice strut length, or a combination thereof, to thereby impart different shock-absorbing properties to said different regions ([0244], the dental appliance may have certain regions of different stiffnesses, which is achieved by varying unit cell dimensions or geometries (i.e., unit cell type); varying stiffnesses would impart different shock-absorbing properties).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the shock absorbing lattice of Clark to comprise a plurality of repeating unit cells, each unit cell comprising interconnected lattice struts and nodes, and wherein said shock absorbing lattice in different regions differ from one another in unit cell type, lattice strut diameter, lattice strut length, or a combination thereof, to thereby impart different shock-absorbing properties to said different regions, as taught by Wen, because using lattice structures provides increased control over the topology and properties of the appliance, as discussed in [0244], since different lattice variables can result in differing properties.
Clark in view of Wen is silent on said different regions being specifically the facial portion and occlusal portion.
However, Kuo teaches a combined orthodontic and mouthguard appliance 54 (fig. 4A and [0001]), wherein the shock-absorbing properties of the facial portion and occlusal portion differ (fig. 4B and [0035], the occlusal portion 52 exhibits an impact absorbing compliance to reduce forces transmitted between the jaws during an impact that forces the lower teeth into the upper teeth).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the different regions of different shock-absorbing properties of Clark in view of Wen to be the facial portion and occlusal portion, as taught by Kuo, to protect the occlusal surfaces of the teeth during impact.
Clark in view of Wen further in view of Kuo is silent on the unit cells included in the facial portion forming a stiffness gradient therein.
However, Boronkay teaches a dental tray 100 (fig. 1A and [0084], tooth aligner), wherein the facial portion forms a stiffness gradient therein ([0156], the interior portions of the appliance near the teeth may be formed from more elastic material than exterior portions away from the teeth, or vice-versa; in other words, the thickness of the walls of the appliance (which would include the facial portion/wall) form a stiffness gradient therein).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the unit cells in the facial portion of Clark in view of Wen further in view of Kuo to form a stiffness gradient therein, as taught by Boronkay, such that the surfaces directly interfacing with the teeth and gumline are softer and more comfortable to wear, while still being robust on the outer surface; please note that while Boronkay does not specifically teach unit cells forming a stiffness gradient, this rejection is based on a combination of references, including Clark, whose facial portion already comprises unit cells; [0124] describes the mechanical properties including stiffness being varied along different directions via structure and/or material; thus, changing the material of the unit cells in the facial portion would result in the claimed stiffness gradient as taught by Boronkay.
Regarding claim 2, Clark in view of Wen further in view of Kuo and Boronkay discloses the claimed invention as discussed above.
Clark further discloses said lingual portion 20 having a smooth comfort surface formed thereon (please see annotated fig. A below, which shows the smooth curve forming the top surface of the lingual portion 20, which may provide a comfortable feel in the mouth).
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Regarding claim 3, Clark in view of Wen further in view of Kuo and Boronkay discloses the claimed invention as discussed above.
Clark further discloses said mouthguard being produced as a single object by additive manufacturing (fig. 1 shows the single, unitary object/mouthguard 10; p. 11, lines 24-29, the mouthguard 10 may be formed by 3D printing, which is additive).
Regarding claim 6, Clark in view of Wen further in view of Kuo and Boronkay discloses the claimed invention as discussed above.
Clark further discloses said shock absorbing lattice of said facial portion 18, and/or said shock absorbing lattice of said occlusal portion 22, comprising a conformal lattice (p. 8, lines 5-7, for simplicity of illustration, the molded impressions of teeth were not shown in figs. 1-3, indicating that the mouthguard 10 is molded with impressions of the teeth; thus, the lattice material forming the mouthguard 10 conforms to the shapes of the teeth).
Regarding claim 7, Clark in view of Wen further in view of Kuo and Boronkay discloses the claimed invention as discussed above.
Clark further discloses said mouthguard 10 including edge and corner portions, wherein at least some, or all, of said edge and corner portions are radiused (please see annotated fig. B below, which shows corner and edge portions that are rounded).
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Regarding claim 10, Clark in view of Wen further in view of Kuo and Boronkay discloses the claimed invention as discussed above.
Boronkay further teaches said analogous shock absorbing material of said facial portion, and/or said shock absorbing material of said occlusal portion, comprising at least two different energy attenuation regions ([0156], the interior portions of the appliance near the teeth may be formed from more elastic material than exterior portions away from the teeth, or vice-versa; in other words, the thickness of the walls of the appliance (which would include the facial portion/wall and occlusal portion/wall) form a stiffness gradient therein, forming at least two different energy attenuation regions due to the varying stiffness), such that the surfaces directly interfacing with the teeth and gumline are softer and more comfortable to wear, while still being robust on the outer surface.
Regarding claim 11, Clark in view of Wen further in view of Kuo and Boronkay discloses the claimed invention as discussed above.
Clark further discloses said shock absorbing lattice of said facial portion 18, and/or said shock absorbing lattice of said occlusal portion 22, are configured to promote a flow of air therethrough during breathing by the wearer (p. 8, lines 15-17).
Regarding claim 12, Clark in view of Wen further in view of Kuo and Boronkay discloses the claimed invention as discussed above.
Clark further discloses said shock absorbing lattice of said facial portion 18, and/or said shock absorbing lattice of said occlusal portion 22, are configured to promote drainage of saliva therethrough by the wearer (p. 8, lines 15-17).
Regarding claim 15, Clark in view of Wen further in view of Kuo and Boronkay discloses the claimed invention as discussed above.
Boronkay further teaches the analogous dental tray 100 consisting essentially of a flexible or elastic polymer ([0322], fabrication materials include, for example, silicone rubber and various elastomers, or combinations thereof, indicating that the materials may be singly utilized), to ensure comfort and wearability of the apparatus.
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark WO 2018/161112 A1 in view of Wen US 2017/0100214 A1 further in view of Kuo US 2010/0129763 A1, Boronkay US 2017/0007363 A1, and Washburn et al. US 2004/0154626 A1.
Regarding claim 13, Clark in view of Wen further in view of Kuo and Boronkay discloses the claimed invention as discussed above.
Clark in view of Wen further in view of Kuo and Boronkay is silent on said lingual portion, facial portion, and occlusal portion each further defining an opposite trough for receiving the opposite (maxillary or mandibular) teeth of the wearer.
However, Washburn teaches a mouthguard 60 (fig. 2 and [0042]) comprising an analogous lingual portion 69, facial portion 67, and occlusal portion 61 further defining an opposite trough 65 for receiving the opposite (maxillary or mandibular) teeth of the wearer (fig. 6 and [0054], outer/facial wall 67, inner/lingual wall 69, and occlusal portion 61 form an upper 64 and lower trough 65 for receiving the maxilla and mandible).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified each of said lingual portion, facial portion, and occlusal portion of Clark in view of Wen further in view of Kuo and Boronkay to further define an opposite trough for receiving the opposite (maxillary or mandibular) teeth of the wearer, as taught by Washburn, to further protect the mandibular teeth as well.
Regarding claim 14, Clark in view of Wen further in view of Kuo and Boronkay discloses the claimed invention as discussed above.
Clark further discloses at least one of said facial portion 18 and said lingual portion 20 including a conforming lattice facing said upper and/or lower trough 24, the conforming lattice configured to aid in fitting said mouthguard 10 to the wearer, and/or to aid in retaining the mouthguard 10 on the teeth of the wearer during a sport or athletic activity (p. 8, lines 5-7, for simplicity of illustration, the molded impressions of teeth were not shown in figs. 1-3, indicating that the mouthguard 10 is molded with impressions of the teeth; thus, the lattice material forming the walls of the mouthguard 10 facing the channel/teeth conforms to the shapes of the teeth).
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark WO 2018/161112 A1 in view of Wen US 2017/0100214 A1 further in view of Kuo US 2010/0129763 A1, Boronkay US 2017/0007363 A1, and Layzell et al. US 2017/0282451 A1.
Regarding claim 16, Clark in view of Wen further in view of Kuo and Boronkay discloses the claimed invention as discussed above.
Clark further discloses a method of making a mouthguard 10 of claim 1, comprising the steps of: creating a dental arch data file, the data file produced by scanning at least one, or both, dental arches of the wearer; and then additively manufacturing the mouthguard 10 from said mouthguard data file (p. 11, lines 24-27, a 3D model (i.e., data) is generated using an optical scanner, and a mouthguard is then 3D printed).
Clark in view of Wen further in view of Kuo and Boronkay is silent on a computer-implemented method comprising inputting into a computer the dental arch data file; generating in the computer a mouthguard data file from said dental arch data file.
However, Layzell teaches a method of making a mouthpiece ([0006]) comprising a computer-implemented method comprising inputting into a computer the dental arch data file ([0008], a computer stores image data from the 3D scanner that scans a mold of the teeth); generating in the computer a mouthguard data file from said dental arch data file ([0008], the image data stored in the computer is modified according to several preferences, which would thus generate a mouthpiece data file different from the dental arch data file; this modified image data is sent to a 3D printer that prints the mouthpiece).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Clark in view of Wen further in view of Kuo and Boronkay to be a computer-implemented method comprising inputting into a computer the dental arch data file; generating in the computer a mouthguard data file from said dental arch data file, as taught by Layzell, to allow the user to manipulate or edit the data according to their preferences ([0032]), making the device more customized.
Regarding claim 17, Clark in view of Wen further in view of Kuo, Boronkay, and Layzell discloses the claimed invention as discussed above.
Layzell further teaches inputting user preference data for the wearer into the computer, and then modifying said generating step and/or said additively manufacturing step based on said user preference data ([0032], the stored image data may be manipulated or edited according to preferences set by a user to include features of a mouthpiece that are different from features originally scanned, which is then 3D printed in [0033]), to allow the user to manipulate or edit the data according to their preferences ([0032]), making the device more customized.
Regarding claim 18, Clark in view of Wen further in view of Kuo, Boronkay, and Layzell discloses the claimed invention as discussed above.
Layzell further teaches said user preference data comprising at least one, two, or three different mouthguard characteristics ([0032], data may be edited according to preferences (plural) set by a user, indicating at least two characteristics), to allow the user to manipulate or edit the data according to their preferences ([0032]), making the device more customized.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark WO 2018/161112 A1 in view of Wen US 2017/0100214 A1 further in view of Kuo US 2010/0129763 A1, Boronkay US 2017/0007363 A1, and Layzell et al. US 2017/0282451 A1 and Khouri US 2017/0100215 A1.
Regarding claim 19, Clark in view of Wen further in view of Kuo, Boronkay, and Layzell discloses the claimed invention as discussed above.
Clark in view of Wen further in view of Kuo, Boronkay, and Layzell is silent on said different mouthguard characteristics being selected from: stiffness, weight, impact absorption, ease of air flow (breathability), degree of saliva drainage, surface texture, size, and/or mouthguard color.
However, Khouri teaches an analogous oral device 434 formed by 3D printing (fig. 12A and [0155], clip member 434 may be manufactured using 3D printing) having different customizable characteristics selected from: size and color ([0155], clip member 434 may be manufactured in customizable sizes and colors).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified said different mouthguard characteristics of Clark in view of Wen further in view of Kuo, Boronkay, and Layzell to be selected from: stiffness, weight, impact absorption, ease of air flow (breathability), degree of saliva drainage, surface texture, size, and/or mouthguard color, as taught by Khouri, to allow for a customizable fit as well as aesthetic preference of the mouthguard.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark WO 2018/161112 A1 in view of Wen US 2017/0100214 A1 further in view of Kuo US 2010/0129763 A1, Boronkay US 2017/0007363 A1, Layzell et al. US 2017/0282451 A1, and Bologna et al. US 2020/0215415 A1.
Regarding claim 20, Clark in view of Wen further in view of Kuo, Boronkay, and Layzell discloses the claimed invention as discussed above.
Layzell further teaches said user preference data comprising at least two different characteristics ([0032], data may be edited according to preferences (plural) set by a user, indicating at least two characteristics), to allow the user to manipulate or edit the data according to their preferences ([0032]), making the device more customized.
Clark in view of Wen further in view of Kuo, Boronkay, and Layzell is silent on said characteristics being prioritized, and wherein said modifying and/or generating steps are carried out based on said prioritized characteristics, with a characteristic having a lesser priority being de-emphasized or deleted during said modifying and/or generating steps when they are incompatible with a characteristic having a greater priority.
However, Bologna teaches a device worn on the body ([0011], helmets for protecting the player; [0012], analogously uses lattice cells for the framework to build a customized/tailored device) that is manufactured by including characteristics being prioritized, and wherein said modifying and/or generating steps are carried out based on said prioritized characteristics, with a characteristic having a lesser priority being de-emphasized or deleted during said modifying and/or generating steps when they are incompatible with a characteristic having a greater priority ([0208], the method includes taking measurements of the head, and also generating an impact matrix/score, where the impact/matrix score is prioritized over the head measurements; thus, for example, a helmet may be made that is slightly larger than would have been recommended based on the head measurement, in order to better match the impact matrix/score; in other words, the head measurement characteristic is de-emphasized while the impact/matrix score takes priority).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the at least two different characteristics of Clark in view of Wen further in view of Kuo, Boronkay, and Layzell to have said characteristics being prioritized, and wherein said modifying and/or generating steps are carried out based on said prioritized characteristics, with a characteristic having a lesser priority being de-emphasized or deleted during said modifying and/or generating steps when they are incompatible with a characteristic having a greater priority, as taught by Bologna, to increase control over the final customized product according to what the user deems most important.
Conclusion
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786