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 Objections
Claims 1, 3-5, 7-13, 17, and 20 are objected to because of the following informalities:
Regarding claim 1, “custom fitted to a patient’s maxillary teeth” in line 1 should be recited as “configured to be custom fitted to a patient’s maxillary teeth”.
Regarding claim 1, “a shell which fits securely over the maxillary teeth” in line 2 should be recited as “a shell which is configured to fit securely over the patient’s maxillary teeth”.
Regarding claim 1, “an aperture located at an end of central incisor papilla” in line 6 should be recited as “an aperture configured to be located at an end of a central incisor papilla”.
Regarding claim 1, “the tongue” in line 7 should be recited as “a tongue”.
Regarding claim 1, “a handle perpendicular to the anterior labial side of the shell at a left and right central incisor” in lines 8-9 should be recited as “a handle configured to be perpendicular to the anterior labial side of the shell at a left and right central incisor.”
Regarding claim 3, “the shell fits over the front eight maxillary teeth” in lines 1-2 should be recited as “the shell is configured to fit over a front eight maxillary teeth”.
Regarding claim 3, “eight protrusions on each of a central incisor” in line 3 should be recited as “eight protrusions configured to be on each of a central incisor”.
Regarding claim 3, “three protrusions on each of a lateral incisor” in line 4 should be recited as “three protrusions configured to be on each of a lateral incisor”.
Regarding claim 3, “two protrusions on each of a bilateral cuspid” in line 5 should be recited as “two protrusions configured to be on each of a bilateral cuspid”.
Regarding claim 3, “three protrusions on each of a bilateral pre-molar” in line 6 should be recited as “three protrusions configured to be on each of a bilateral pre-molar.”
Regarding claim 4, “wherein the shell fits over anterior teeth” in line 1 should be recited as “wherein the shell is configured to fit over anterior teeth.”
Regarding claim 5, “occlusal surfaces of molars are exposed and the anterior labial side of anterior teeth is exposed” in lines 1-2 should be recited as “occlusal surfaces of molars are configured to be exposed and an anterior labial side of anterior teeth is exposed.”
Regarding claim 7, “the protrusions” in line 1 should be recited as “the plurality of protrusions”.
Regarding claim 7, “extending perpendicular to central and lateral incisors” in lines 1-2 should be recited as “configured to extend perpendicular to central and lateral incisors.”
Regarding claim 8, “the protrusions protrude from 1 mm to 5 mm into a patient’s mouth” in lines 1-2 should be recited as “where the plurality of protrusions are configured to protrude from 1 mm to 5 mm into the patient’s mouth.”
Regarding claim 9, “the protrusions protrude 1 mm into a patient’s mouth” in lines 1-2 should be recited as “the plurality of protrusions are configured to protrude 1 mm into the patient’s mouth.”
Regarding claim 10, “custom fitted to the patient’s maxillary teeth” in line 1 should be recited as “configured to be custom fitted to a patient’s maxillary teeth”.
Regarding claim 10, “a shell which fits securely over the maxillary teeth” in line 2 should be recited as “a shell which is configured to fit securely over the patient’s maxillary teeth”.
Regarding claim 10, “an aperture located at the end of central incisor papilla” in line 5 should be recited as “an aperture configured to be located at an end of a central incisor papilla”.
Regarding claim 10, “the tongue” in line 6 should be recited as “a tongue”.
Regarding claim 10, “a handle which is perpendicular to the anterior labial side of the shell at a left and right central incisor” in lines 7-8 should be recited as “a handle which is configured to be perpendicular to the anterior labial side of the shell at a left and right central incisor.”
Regarding claim 11, “wherein the shell fits over all the maxillary teeth, occlusal surfaces of molars are exposed and an anterior labial side of anterior teeth is exposed” in lines 1-3 should be recited as “wherein the shell is configured to fit over all the patient’s maxillary teeth, occlusal surfaces of molars are configured to be exposed and an anterior labial side of anterior teeth is configured to be exposed”.
Regarding claim 12, “the plurality of protrusions are placed bilaterally” in lines 1-2 should be recited as “the plurality of protrusions are configured to be placed bilaterally”.
Regarding claim 13, “the shell fits over all the maxillary teeth” in line 1 should be recited as “the shell is configured to fit over all the patient’s maxillary teeth.”
Regarding claim 17, “the appliance” in lines 2-3 should be recited as “the tongue training appliance”.
Regarding claim 17, “the appliance” in line 4 should be recited as “the tongue training appliance”.
Regarding claim 17, “the tongue protrusions” in line 7 should be recited as “the plurality of protrusions”.
Regarding claim 20, “the appliance” in lines 1-2 should be recited as “the tongue training appliance”.
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, 3-4, 10, 12, 14, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stiene (US 2023/0157860 A1) in view of Morgan et al. (referred to as “Morgan”) (US 2013/0008453 A1).
Regarding claim 1, Stiene discloses a tongue training appliance (100) which is custom fitted to a patient’s maxillary teeth (D) (see Figs. 1-4 and [0027] which discusses how oral appliance 100 may be used to train proper lingual resting posture and thus is a tongue training appliance, and oral appliance 100 is a custom-made appliance for securement to maxillary dentition D) having:
a shell (102) which fits securely over the maxillary teeth (D) having an anterior labial side and a posterior lingual side (110) (see Figs. 1-4 and [0028]; shell 102 fits securely over maxillary dentition D, and shell 102 has an anterior labial side, which is the front surface of shell 102 that is shown in Figs. 2-3, and labeled in Annotated Fig. 2 of Stiene, and shell 102 has a posterior lingual side or posterior surface 110, which is a rear surface of shell 102 shown in Fig. 1);
a plurality of protrusions (104) on the posterior lingual side (110) of the shell (102) (see Figs. 1-4 and [0030]; tongue spikes 104 are a plurality of protrusions as they project posteriorly from the posterior surface 110 of the shell 102);
a platform (106) extending from the posterior lingual side (110) of the shell (102) (see Figs. 1-4 and [0028]; lingual resting platform 106 extends from the posterior surface of the shell 102, as seen in Fig. 1); and
an aperture (114) located at an end of central incisor papilla at an anterior part of an upper palate where the tongue should rest (see Figs. 1-4 and [0032]; aperture 114 is capable of being located at an end of central incisor papilla at an anterior part of an upper palate depending on a user’s anatomy, as aperture 114 is on the platform 106 which extends posteriorly and upwardly towards the palate from a central location of posterior rim 112, and aperture 114 is configured to guide and encourage the anterior end of the tongue to rest).
Stiene is silent on a handle perpendicular to the anterior labial side of the shell at a left and right central incisor.
However, Morgan teaches an analogous shell (10), and a handle (100) perpendicular to the anterior labial side of the shell (10) at a left and right central incisor (see Fig. 1 and [0037]; mouth guard 10 is an analogous shell as mouth guard 10 fits securely over maxillary teeth, and mouth guard 10 has an anterior labial side, which is labeled in Annotated Fig. 1 of Morgan, and handle 100 is perpendicular to the height of the anterior labial side of the mouth guard 10 and is capable of being perpendicular at the left and right central incisor, as handle 100 projects outwardly from the center where left and right central incisors may be positioned depending on a user’s anatomy), providing an easier way for a user to grasp the appliance for easy removal.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a center portion of the anterior labial side of the shell (102) in the device of Stiene with a handle that is perpendicular to the anterior labial side of the shell at a left and right central incisor as taught by Morgan to have provided an improved tongue training appliance that provides an easier way for a user to grasp the appliance for easy removal.
PNG
media_image1.png
305
468
media_image1.png
Greyscale
Annotated Fig. 2 of Stiene.
PNG
media_image2.png
384
410
media_image2.png
Greyscale
Annotated Fig. 1 of Morgan.
Regarding claim 3, Stiene in view of Morgan discloses the invention as discussed in claim 1. Stiene in view of Morgan further discloses wherein the shell (102 of Stiene) fits over the front eight maxillary teeth (see [0029] which discusses how the shell 102 of Stiene is configured to fit over the anterior eight of the maxillary dentition D of Stiene, although not explicitly shown) and the plurality of protrusions further comprises: two protrusions on each of a bilateral cuspid (see Figs. 1-4 and [0031] which discusses how each crown 108 may have two tongue spikes 104, which are protrusions, and thus each of a bilateral cuspid may have two tongue spikes 104).
Although Stiene in view of Morgan does not explicitly disclose wherein the plurality of protrusions further comprises: eight protrusions on each of a central incisor; three protrusions on each of a lateral incisor; and three protrusions on each of a bilateral pre-molar, it is noted that the applicant does not indicate that the claimed dimension is used for a particular purpose, solves a stated problem, or is otherwise critical (see page 10 paragraph 2 of applicant’s specification). Therefore, in Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device, and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of protrusions (104 of Stiene) in the device of Stiene in view of Morgan to further comprise: eight protrusions on each of a central incisor; three protrusions on each of a lateral incisor; and three protrusions on each of a bilateral pre-molar to have a sufficient amount of protrusions to act as a tactile cue and deterrent without injuring the wearer’s tongue (see [0030] of Stiene), as Stiene also contemplates each crown 108 of the shell 102 having more than two tongue spikes 104, see [0031] of Stiene).
Regarding claim 4, Stiene in view of Morgan discloses the invention as discussed in claim 1. Stiene in view of Morgan further discloses wherein the shell (102 of Stiene) fits over anterior teeth (see Figs. 1-4 and [0029] which discusses how the shell 102 of Stiene is configured to fit over the anterior teeth).
Regarding claim 10, Stiene discloses a tongue training appliance (100) which is custom fitted to the patient’s maxillary teeth (D) (see Figs. 1-4 and [0027] which discusses how oral appliance 100 may be used to train proper lingual resting posture and thus is a tongue training appliance, and oral appliance 100 is a custom-made appliance for securement to maxillary dentition D) having:
a shell (102) which fits securely over the maxillary teeth (D) having an anterior labial side and a posterior lingual side (110) (see Figs. 1-4 and [0028]; shell 102 fits securely over maxillary dentition D, and shell 102 has an anterior labial side, which is the front surface of shell 102 that is shown in Figs. 2-3, and labeled in Annotated Fig. 2 of Stiene, and shell 102 has a posterior lingual side or posterior surface 110, which is a rear surface of shell 102 shown in Fig. 1);
a platform (106) extending from the posterior lingual side (110) of the shell (102) (see Figs. 1-4 and [0028]; lingual resting platform 106 extends from the posterior surface of the shell 102, as seen in Fig. 1); and
an aperture (114) located at an end of central incisor papilla at an anterior part of an upper palate where the tongue should rest (see Figs. 1-4 and [0032]; aperture 114 is capable of being located at an end of central incisor papilla at an anterior part of an upper palate depending on a user’s anatomy, as aperture 114 is on the platform 106 which extends posteriorly and upwardly towards the palate from a central location of posterior rim 112, and aperture 114 is configured to guide and encourage the anterior end of the tongue to rest).
Stiene is silent on a handle which is perpendicular to the anterior labial side of the shell at a left and right central incisor.
However, Morgan teaches an analogous shell (10), and a handle (100) perpendicular to the anterior labial side of the shell (10) at a left and right central incisor (see Fig. 1 and [0037]; mouth guard 10 is an analogous shell as mouth guard 10 fits securely over maxillary teeth, and mouth guard 10 has an anterior labial side, which is labeled in Annotated Fig. 1 of Morgan, and handle 100 is perpendicular to the height of the anterior labial side of the mouth guard 10 and is capable of being perpendicular at the left and right central incisor, as handle 100 projects outwardly from the center where left and right central incisors may be positioned depending on a user’s anatomy), providing an easier way for a user to grasp the appliance for easy removal.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a center portion of the anterior labial side of the shell (102) in the device of Stiene with a handle that is perpendicular to the anterior labial side of the shell at a left and right central incisor as taught by Morgan to have provided an improved tongue training appliance that provides an easier way for a user to grasp the appliance for easy removal.
Regarding claim 12, Stiene in view of Morgan discloses the invention as discussed in claim 1. Stiene in view of Morgan further discloses wherein for patients with a lateral tongue thrust, the plurality of protrusions (104 of Stiene) are placed bilaterally or unilaterally on teeth (see Figs. 1-4 of Stiene; the tongue spikes 104 of Stiene are placed bilaterally on teeth via shell 102 of Stiene as seen in Figs. 1 and 4 of Stiene for patients with a lateral tongue thrust).
Regarding claim 14, Stiene in view of Morgan discloses the invention as discussed in claim 1. Stiene in view of Morgan further discloses wherein the aperture is round (see Fig. 2 of Stiene and [0032] of Stiene which discusses how the aperture of Stiene has a circular shaped exit opening 114b of Stiene, and thus is round).
Although Stiene in view of Morgan does not explicitly disclose wherein the aperture is between 3 to 5 mm in diameter, it is noted that the applicant does not indicate that the claimed dimension is used for a particular purpose, solves a stated problem, or is otherwise critical (see Pg. 11, second paragraph of applicant’s specification), therefore, in Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device, and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameter of the aperture (106 of Stiene) in the device of Stiene in view of Morgan to be between 3 to 5 mm in order to have an aperture that is of sufficient size to properly receive the tongue of a user.
Regarding claim 17, Stiene in view of Morgan discloses the invention as discussed in claim 1. Stiene in view of Morgan further discloses a method for training a tongue (see Figs. 1-4 of Stiene and [0001] of Stiene which discusses how the oral appliance trains the tongue for proper lingual resting posture) comprising:
providing the tongue training appliance (100 of Stiene) of claim 1 causing a patient to wear the appliance (100 of Stiene) (see Figs. 3-4 of Stiene which shows the oral appliance 100 of Stiene worn by a patient)
where the aperture (114 of Stiene) on the appliance (100 of Stiene) is configured to provide a spot which habituates proper lingual resting posture (see Figs. 1-4 of Stiene and [0032]-[0033], and [0026] of Stiene; aperture 114 of Stiene is configured to provide a spot which habituates proper lingual resting posture) and wherein the aperture (114 of Stiene) is configured to receive a tip of the patient’s tongue and acts as a tactile cue for where the tongue tip should rest (see Figs. 1-6 of Stiene and [0032]-[0033], and Abstract of Stiene; the aperture 114 of Stiene is configured to receive a tip of the patient’s tongue, and acts as a tactile cue for where the tongue tip should rest), and wherein the tongue protrusions (104 of Stiene) deter the tongue from resting on the maxillary teeth (see Figs. 1-4 of Stiene and [0030]-[0031] of Stiene; the tongue spikes 104 of Stiene deter the tongue from resting on the maxillary teteh as the tongue spikes 104 of Stiene act as a deterrent and re-direct the tongue away from the maxillary teeth).
Regarding claim 18, Stiene in view of Morgan discloses the method as discussed in claim 17. Stiene in view of Morgan further discloses wherein the appliance (100 of Stiene) improves overall speech resonance quality and intelligibility, decreases a “slushy sound” while articulating, improves articulatory precision of most lingual alveolar and lingual palatal sounds, wherein the sounds are s, z, t, d, l, n, sc, ch, and j (see [0026] of Stiene which discusses how the oral appliance 100 of Stiene improves overall speech resonance quality and intelligibility, decreasing a “slushy sound” while articulating, and improves articulatory precision of most lingual alveolar and lingual palatal sounds, where the sounds are s, z, t, d, l, n, sc, ch, and j).
Regarding claim 19, Stiene in view of Morgan discloses the method as discussed in claim 17. Stiene in view of Morgan further discloses wherein the appliance (100 of Stiene) is useful to treat orthodontic conditions, temporomandibular joint disease problems, sleep apnea, snoring, noxious oral habits, and mouth breathing (see [0026]-[0027], [0002] of Stiene which discusses how the oral appliance 100 of Stiene is useful to treat orthodontic conditions, temporomandibular joint disease problems, sleep apnea, snoring, noxious oral habits, and mouth breathing).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stiene in view of Morgan further in view of Fisher et al. (referred to as “Fisher”) (US 2013/0130193 A1).
Regarding claim 2, Stiene in view of Morgan discloses the invention as discussed in claim 1.
Stiene in view of Morgan is silent on wherein the handle is textured.
However, Fisher teaches an analogous handle (100), wherein the handle (100) is textured (see Fig. 8 and [0037] which discusses how handle 60 has a gripping projections 63 making handle 60 textured), providing to facilitate gripping of the handle during use.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the handle (100 of Morgan) in the device of Stiene in view of Morgan to be textured as taught by Fisher to have provided an improved tongue training appliance that provides to facilitate gripping of the handle during use.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stiene in view of Morgan in view of Fisher further in view of O’Leary et al. (referred to as “O’Leary”) (US 11,534,974 B2).
Regarding claim 5, Stiene in view of Morgan further in view of Fisher discloses the invention as discussed in claim 2.
Stiene in view of Morgan further in view of Fisher is silent on wherein occlusal surfaces of molars are exposed and the anterior labial side of anterior teeth is exposed.
However, O’Leary teaches an analogous shell (300), wherein occlusal surfaces of molars are exposed and the anterior labial side of anterior teeth is exposed (see Figs. 3A-3D, Col. 11 lines 19-24, and Col. 19 lines 17-33; the retainer 300 is an analogous shell as retainer 300 may fit securely over maxillary teeth, and occlusal surfaces of molars are exposed, as best seen in Fig. 3A, and the anterior labial side of anterior teeth is exposed, as the retainer 300 only provides full coverage on the lingual side of the anterior teeth, as best seen in Fig. 3B), providing increase occlusal settling, and improving the aesthetics of the appliance while still providing enough support to retain the appliance in place (see Col. 19 lines 26-33).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shell (102 of Stiene) in the device of Stiene in view of Morgan further in view of Fisher such that occlusal surfaces of molars are exposed and the anterior labial side of anterior teeth is exposed as taught by O’Leary to have provided an improved tongue training appliance that provides increased occlusal settling, and improving the aesthetics of the appliance while still providing enough support to retain the appliance in place (see Col. 19 lines 26-33).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stiene in view of Morgan in view of Fisher in view of O’Leary further in view of Kalivoshko (US 2021/0330487 A1).
Regarding claim 6, Stiene in view of Morgan in view of Fisher further in view of O’Leary discloses the invention as discussed in claim 5.
Stiene in view of Morgan in view of Fisher further in view of O’Leary is silent on wherein the plurality of protrusions are optional.
However, Kalivoshko teaches analogous plurality of projections (32), wherein the plurality of protrusions (32) are optional (see Fig. 1 and [0023] which discusses how surface variation 32 can comprise any suitably shaped projections, such as conical projections, and thus are a plurality of protrusions, and the surface variation 32 can be removably coupled to the device and thus can be optional), providing removably couplable protrusions to allow a user with the option for attachment based off of need.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of protrusions (104 of Stiene) in the device of Stiene in view of Morgan in view of Fisher further in view of O’Leary to be optional as taught by Kalivoshko to have provided an improved tongue training appliance that has removably couplable protrusions to allow a user with the option for attachment based off of need.
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stiene in view of Morgan further in view of Kalivoshko.
Regarding claim 7, Stiene in view of Morgan discloses the invention as discussed in claim 1. Stiene in view of Morgan further discloses wherein the protrusions (104 of Stiene) are spikes extending perpendicular to central and lateral incisors (see [0030] of Stiene which discusses how the tongue spikes 104 of Stiene extend/project perpendicularly relative to the posterior surface 110 of Stiene and to central and lateral incisors).
Stiene in view of Morgan is silent on wherein the protrusions are conical.
However, Kalivoshko teaches analogous plurality of protrusions (32), wherein the protrusions are conical (see [0023] which discusses how surface variation 32 may be conical projections or protrusions), providing a non-smooth variation configured to contact and irritate a user’s tongue (see [0023]) without harming the user to cause the user to reflexively move the tongue out of the user’s airway (see [0019]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of protrusions (tongue spikes 104 of Stiene) in the device of Stiene in view of Morgan to be conical spikes as taught by Kalivoshko to have provided an improved tongue training appliance that has a non-smooth variation configured to contact and irritate a user’s tongue (see [0023]) without harming the user to cause the user to reflexively move the tongue out of the user’s airway (see [0019]).
Regarding claim 8, Stiene in view of Morgan further in view of Kalivoshko discloses the invention as discussed in claim 7.
Kalivoshko further teaches where the protrusions (32) protrude from 1 mm to 5 mm into a patient’s mouth (see Fig. 1 and [0023] which discusses how surface variation 32 may be conical projections, and may have a length of 0.50 mm to 10.0 mm, and thus can protrude from 1 mm to 5 mm into a patient’s mouth), providing protrusions with a sufficient length to contact a user’s tongue without obstructing the inside of the mouth.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of protrusions (104 of Stiene) in the device of Stiene in view of Morgan further in view of Kalivoshko to protrude from 1 mm to 5 mm into a patient’s mouth as taught by Kalivoshko to have provided an improved tongue training appliance that has protrusions with a sufficient length to contact a user’s tongue without obstructing the inside of the mouth.
Regarding claim 9, Stiene in view of Morgan further in view of Kalivoshko discloses the invention as discussed in claim 8. Stiene in view of Morgan further in view of Kalivoshko further discloses where the protrusions (104 of Stiene) protrude 1 mm into a patient’s mouth (as previously modified above, see claim 8, the tongue spikes 104 of Stiene protrude 1 mm into a patient’s mouth).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stiene in view of Morgan in view of Knutzen et al. (referred to as “Knutzen”) (US 2022/0087854 A1) further in view of O’Leary.
Regarding claim 15, Steine in view of Morgan discloses the invention as discussed in claim 1.
Stiene in view of Morgan is silent on a soft resin material and prepared using a 3-D printing machine.
However, Knutzen teaches an analogous oral appliance (30) further comprising a soft resin material (see Figs. 1-2 and [0048] which discusses how dental guard 30 can be made from ethylene-vinyl acetate copolymer resin, which is known in the art as being a soft resin material), providing a material that provides enough cushion to a user’s teeth without being too hard on the teeth.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the tongue training appliance (100 of Stiene) in the device of Stiene in view of Morgan to be a soft resin material as taught by Knutzen to have provided an improved tongue training appliance that has a material that provides enough cushion to a user’s teeth without being too hard on the teeth.
Stiene in view of Morgan further in view of Knutzen discloses the invention as discussed above.
Stiene in view of Morgan further in view of Knutzen is silent on the tongue training appliance prepared using a 3-D printing machine.
However, O’Leary teaches an analogous appliance (100) prepared using a 3-D printing machine (see Figs. 1A-1D and which discusses how the retainer 100 is prepared using a 3-D printing machine), providing for many customization options and configurations that cannot be made using in-office dental molding techniques for improved flexibility for treating each patient’s unique dental anatomy (see Col. 14 lines 32-37).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tongue training appliance of Stiene in view of Morgan further in view of Knutzen to be prepared using a 3-D printing machine as taught by O’Leary to have provided an improved tongue training appliance that allows for many customization options and configurations that cannot be made using in-office dental molding techniques for improved flexibility for treating each patient’s unique dental anatomy (see Col. 14 lines 32-37).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stiene in view of Morgan further in view of Knutzen.
Regarding claim 16, Stiene in view of Morgan discloses the invention as discussed in claim 1.
Stiene in view of Morgan is silent on wherein the shell has a thickness between 0.5 to 1 mm.
However, Knutzen teaches an analogous shell (30) (see Figs. 1-2, [0014], and [0041] which discusses how the dental guard 30 is configured to fit teeth in an upper dental arch of a user and thus is an analogous shell), wherein the shell (30) has a thickness between 0.5 to 1 mm (see Figs. 1-2 and [0010] and [0050] which discusses how the body of the dental guard 30 may have a thickness from 0.6 mm to 0.9 mm, and thus is within the claimed range), providing an oral appliance that is strong, rigid, resilient, and flexible and properly retaining its general shape to protect teeth (see [0050]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shell (102 of Stiene) in the device of Stiene in view of Morgan to have a thickness between 0.5 to 1 mm as taught by Knutzen to have provided an improved tongue training appliance that is strong, rigid, resilient, and flexible and properly retaining its general shape to protect teeth (see [0050]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stiene in view of Morgan in view of O’Leary in view of Ingram (US 2019/0125496 A1) further in view of Raio et al. (referred to as “Raio”) (US 2024/0428920 A1).
Regarding claim 20, Stiene in view of Morgan discloses the invention as discussed in claim 1. Stiene in view of Morgan further discloses the appliance (100 of Stiene) (see Figs. 1-4 of Stiene; oral appliance 100 of Stiene).
Stiene in view of Morgan is silent on a kit, wherein the kit comprises the appliance, a patient instruction booklet, and myofunctional therapy training program material.
However, Ingram teaches an analogous oral appliance (12), and a kit (70), wherein the kit (70) comprises the appliance (12) and a patient instruction booklet (see Fig. 7 and [0031] which discusses a package kit 70 comes with a guard 12 and an instruction booklet for a patient), providing a comprehensive packaging that includes the oral appliance and instructions on how to use the oral appliance.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tongue training appliance (100 of Stiene) in the device of Stiene in view of Morgan to comprise a kit that comprises the tongue training appliance and patient instruction booklet as taught by Ingram to have provided an improved tongue training appliance that provides a comprehensive package that includes the oral appliance and instructions on how to use the oral appliance.
Stiene in view of Morgan further in view of Ingram discloses the invention as discussed above.
Stiene in view of Morgan further in view of Ingram is silent on the kit comprising myofunctional therapy training program material.
However, Raio teaches an analogous kit and oral appliance (see [0008], [0189], [0235]-[0238] which discusses how the system, which is interpreted as a kit, as the system is described as including a set of elements, such as an oral appliance), wherein the kit comprises myofunctional therapy training program material (see [0189]-[0190] which discusses how the system, or kit, can include written instructions for performing at least one orofacial myofunctional therapy exercise, see Fig. 1C-1F, and thus is myofunctional therapy training program material), providing to combine orofacial myofunctional therapy exercises with an oral appliance to better treat orofacial muscle disorders non-surgically (see Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the kit in the device of Stiene in view of Morgan further in view of Ingram to comprise myofunctional therapy training program material as taught by Raio to have provided an improved tongue training appliance that combines orofacial myofunctional therapy exercises with an oral appliance to better treat orofacial muscle disorders non-surgically (see Abstract).
Claim(s) 10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tortorici (US 8,118,592 B2) in view of Morgan.
Regarding claim 10, Tortorici discloses a tongue training appliance (200) which is custom fitted to the patient’s maxillary teeth (see Fig. 2 and Col. 3 lines 43-45 and Col. 3 lines 47-51; the appliance 200 is custom fitted to the patient’s maxillary teeth and can train the tongue as it is also a thrusting appliance providing a resting area for the tongue), having:
a shell (202) which fits securely over the maxillary teeth having an anterior labial side and a posterior lingual side (see Annotated Fig. 2 of Tortorici and Col. 3 lines 43-45, and Abstract; dental encasing component 202 is a shell as it fits securely over the maxillary teeth and has an anterior labial side and a posterior lingual side, which are labeled in Annotated Fig. 2, as the anterior labial side is the front surface of the dental encasing component 202 and the posterior lingual side is the opposite rear surface of the dental encasing component 202);
a platform (204) extending from the posterior lingual side of the shell (202) (see Annotated Fig. 2 of Tortorici and Col. 3 lines 47-51; the rigid component 204 is a platform as it is an area overlaying the palate of the patient, and thus is a raised surface relative to the dental encasing component 202, and the rigid component 204 extends from the posterior lingual side of the dental encasing component 202);
an aperture (206) located at the end of central incisor papilla at the anterior part of an upper palate where the tongue should rest (see Fig. 2 and Col. 3 lines 47-51; aperture 206 is located on the rigid component 204 such that it is capable of being located at an end of central incisor papilla at an anterior part of an upper palate where the tongue should rest depending on a user’s anatomy, and as aperture 206 is located centrally on the rigid component 204 to receive the tongue for rest).
Tortorici is silent on a handle perpendicular to the anterior labial side of the shell at a left and right central incisor.
However, Morgan teaches an analogous shell (10), and a handle (100) perpendicular to the anterior labial side of the shell (10) at a left and right central incisor (see Fig. 1 and [0037]; mouth guard 10 is an analogous shell as mouth guard 10 fits securely over maxillary teeth, and mouth guard 10 has an anterior labial side, which is labeled in Annotated Fig. 1 of Morgan, and handle 100 is perpendicular to the height of the anterior labial side of the mouth guard 10 and is capable of being perpendicular at the left and right central incisor, as handle 100 projects outwardly from the center where left and right central incisors may be positioned depending on a user’s anatomy), providing an easier way for a user to grasp the appliance for easy removal.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a center portion of the anterior labial side of the shell (202) in the device of Tortorici with a handle that is perpendicular to the anterior labial side of the shell at a left and right central incisor as taught by Morgan to have provided an improved tongue training appliance that provides an easier way for a user to grasp the appliance for easy removal.
PNG
media_image3.png
376
427
media_image3.png
Greyscale
Annotated Fig. 2 of Tortorici.
Regarding claim 13, Tortorici in view of Morgan discloses the invention as discussed in claim 10. Tortorici in view of Morgan further discloses wherein the shell (200 of Tortorici) fits over all the maxillary teeth (see Fig. 2 of Tortorici and Col. 3 lines 43-45 of Tortorici; the dental encasing component 200 of Tortorici is configured to fit over all the maxillary teeth).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tortorici in view of Morgan in view of Stiene further in view of O’Leary.
Regarding claim 11, Tortorici in view of Morgan discloses the invention as discussed in claim 10. Tortorici in view of Morgan further discloses wherein the shell fits over all maxillary teeth (see Fig. 2 and Col. 3 lines 47-51 of Tortorici; the dental encasing component 202 of Tortorici fits over all maxillary or upper teeth).
Tortorici in view of Morgan is silent on further comprising protrusions, occlusal surfaces of molars are exposed and an anterior labial side of anterior teeth is exposed.
However, Stiene teaches an analogous tongue training appliance (100) (see Figs. 1-4 and [0027] which discusses how oral appliance 100 may be used to train proper lingual resting posture and thus is a tongue training appliance), further comprising protrusions (104) (see Figs. 1 and 4, and [0030]; tongue spikes 104 are protrusions as they project posteriorly from posterior surface 110), providing to act as a tactile cue and deterrent (see [0030]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the tongue training appliance (200 of Tortorici) in the device of Tortorici in view of Morgan with protrusions (104) as taught by Stiene to have provided an improved tongue training appliance that acts as a tactile cue and deterrent (see [0030]).
Tortorici in view of Morgan further in view of Stiene discloses the invention as discussed above.
Tortorici in view of Morgan further in view of Stiene is silent on occlusal surfaces of molars are exposed and an anterior labial side of anterior teeth is exposed.
However, O’Leary teaches an analogous shell (300), and occlusal surfaces of molars are exposed and an anterior labial side of anterior teeth is exposed (see Figs. 3A-3D, Col. 11 lines 19-24, and Col. 19 lines 17-33; the retainer 300 is an analogous shell as retainer 300 may fit securely over maxillary teeth, and occlusal surfaces of molars are exposed, as best seen in Fig. 3A, and an anterior labial side of anterior teeth is exposed, as the retainer 300 only provides full coverage on the lingual side of the anterior teeth, as best seen in Fig. 3B), providing increase occlusal settling, and improving the aesthetics of the appliance while still providing enough support to retain the appliance in place (see Col. 19 lines 26-33).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shell (200 of Tortorici) in the device of Tortorici in view of Morgan further in view of Stiene such that occlusal surfaces of molars are exposed and an anterior labial side of anterior teeth is exposed as taught by O’Leary to have provided an improved tongue training appliance that provides increased occlusal settling, and improving the aesthetics of the appliance while still providing enough support to retain the appliance in place (see Col. 19 lines 26-33).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBIN HAN whose telephone number is (408)918-7579. The examiner can normally be reached Monday - Thursday, 9-5 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571)270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBIN HAN/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786