DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments made to claims 1-17 and 20 in the responses filed 10/17/25 and 11/14/25 are acknowledged.
Claims 1-20 are pending in the application and are examined below.
Response to Arguments
Applicant's arguments filed 11/14/25 have been fully considered but they are not persuasive. Applicant argues on p. 8-9 that Kussick fails to teach the newly added limitations regarding the textured surface claimed in claim 10. However, the lingual/inner surface of Kussick’s shell 10 at the molars has an inherent texture, as all materials have some type of texture (i.e., smooth, rough, etc.)). Applicant argues on p. 10-11 that the prior art of record fail to disclose or teach the newly added limitations regarding the plurality of protrusions being disposed in multiple rows. However, However, Bergersen teaches a plurality of protrusions 32/23 on an analogous posterior lingual side 16 of the shell 10 (fig. 1 and [0048], spurs 32 extend from wall 33 of inner shield 16; [0056], bumps 23 are provided on the lingual palatal tabs 22), wherein the plurality of protrusions 32/23 are disposed in multiple rows (fig. 1, spurs 32 form one row in the center, left bumps 23 form another row on the left, and right bumps 23 form another row on the right).
Claim Objections
Claims 17 and 18 are objected to because of the following informalities:
“6 causing” in claim 17, line 2 should be amended to recite --6 and causing--
“intelligibility, decreases a ‘slushy sound’ while articulating, improves articulatory precision of most lingual alveolar” in claim 18, lines 2-3 should be amended to recite --intelligibility, improves articulatory precision of lingual alveolar--, as it is unclear what constitutes a “slushy sound” or what quantity is considered “most”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 10, 13, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kussick US 4,997,182.
Regarding claim 10, Kussick discloses a tongue training appliance 10 (fig. 1 and col. 1, lines 5-7) configured to be custom fitted to a patient’s maxillary teeth (col. 3, lines 33-37) having:
a shell 10 configured to fit securely over the maxillary teeth having an anterior labial side and a posterior lingual side (col. 3, lines 31-36; please see annotated fig. A below, which shows the anterior labial side and posterior lingual/inner side of shell/body 10),
wherein the shell 10 represents an outline of the maxillary teeth (fig. 5, the shell 10 follows the general u-shaped outline of the maxillary teeth),
wherein the shell 10 is configured to fit over at least one pair of molars of the patient (fig. 5), and
wherein the posterior lingual side of the shell 10 includes a textured surface configured to be disposed at the at least one pair of molars of the patient (fig. 5, the shell 10 extends over the molars, and the lingual/inner surface at the molars has an inherent texture, as all materials have some type of texture (i.e., smooth, rough, etc.));
a platform 33 configured to extend from a gum line of the patient from the posterior lingual side of the shell 10 (fig. 1 and col. 3, lines 60-67; annotated fig. A further shows the extent of ramp 33 that is being interpreted as the “platform”, where the bottom end of the platform extends upwards from the gum line adjacent the top of the tooth 51); and
an aperture 37 configured to be located at an end of central incisor papilla at an anterior part of an upper palate where the tongue should rest (figs. 1-3 and col. 4, lines 2-11, where aperture 37 in upper ramp 33 is located adjacent to the curved aspect of the palate anterior bend of the palate to accommodate the apex of the tongue; the curved aspect of the palate’s anterior bend can be considered the upper end of the central incisor papilla at an anterior part of an upper palate).
Regarding claim 13, Kussick discloses the shell 10 being configured to fit over all the maxillary teeth (figs. 1 and 2 and col. 3, lines 33-36 and 52-55, shell 10 has a planar occlusal surface that conforms to the posterior dentition as well as the anterior teeth; this continuous surface forming the U-shaped shell as seen in the noted figures is capable of fitting over the occlusal surface of all the maxillary teeth depending on the specific size and shape of the wearer’s maxillary dentition).
Regarding claim 15, Kussick discloses a soft resin material (col. 5, lines 20-30, resin material is provided to be pressed against the dental arch to be shaped for retention, indicating its softness at this stage) and prepared using a 3-D printing machine (this is considered a product-by-process limitation, as there is no evidence that a resin material prepared by 3D printing or other method (for example, injection molding) would be structurally distinct from each other; please see MPEP 2113).
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, 2, 4, 6, 7, 12, 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kussick US 4,997,182 in view of Bergersen US 2022/0409424 A1.
Regarding claim 1, Kussick discloses a tongue training appliance 10 (fig. 1 and col. 1, lines 5-7) configured to be custom fitted to a patient’s maxillary teeth (col. 3, lines 33-37) having:
a shell 10 configured to fit securely over the maxillary teeth having an anterior labial side and a posterior lingual side (col. 3, lines 31-36; please see annotated fig. A below, which shows the anterior labial side and posterior lingual side of shell/body 10);
a platform 33 extending from the posterior lingual side of the shell 10 (fig. 1 and col. 3, lines 60-67; annotated fig. A further shows the extent of ramp 33 that is being interpreted as the “platform”); and
an aperture 37 configured to be located at an end of central incisor papilla at an anterior part of an upper palate where the tongue should rest (figs. 1-3 and col. 4, lines 2-11, where aperture 37 in upper ramp 33 is located adjacent to the curved aspect of the palate anterior bend of the palate to accommodate the apex of the tongue; the curved aspect of the palate’s anterior bend can be considered the upper end of the central incisor papilla at an anterior part of an upper palate).
Kussick is silent on a plurality of protrusions on the posterior lingual side of the shell, wherein the plurality of protrusions are disposed in multiple rows.
However, Bergersen teaches an analogous tongue training appliance 10 (fig. 1 and [0009]-[0011]) comprising a plurality of protrusions 32/23 on an analogous posterior lingual side 16 of the shell 10 (fig. 1 and [0048], spurs 32 extend from wall 33 of inner shield 16; [0056], bumps 23 are provided on the lingual palatal tabs 22), wherein the plurality of protrusions 32/23 are disposed in multiple rows (fig. 1, spurs 32 form one row in the center, left bumps 23 form another row on the left, and right bumps 23 form another row on the right).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the posterior lingual side of the shell of Kussick with a plurality of protrusions on the posterior lingual side of the shell, wherein the plurality of protrusions are disposed in multiple rows, as taught by Bergersen, to prevent the tongue from thrusting forward and positioning itself in an unideal location; both Kussick and Bergersen are concerned with preventing tongue thrust, and Kussick’s aperture provides the proper location of the tongue, while adding Bergersen’s spurs further guides the tongue away from the location of the spurs and bumps to properly locate itself elsewhere (e.g., in Kussick’s aperture).
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Regarding claim 2, Kussick in view of Bergersen discloses the claimed invention as discussed above.
Kussick further discloses the shell 10 being configured to fit over all the maxillary teeth (figs. 1 and 2 and col. 3, lines 33-36 and 52-55, shell 10 has a planar occlusal surface that conforms to the posterior dentition as well as the anterior teeth; this continuous surface forming the U-shaped shell as seen in the noted figures is capable of fitting over the occlusal surface of all the maxillary teeth depending on the specific size and shape of the wearer’s maxillary dentition).
Regarding claim 4, Kussick in view of Bergersen discloses the claimed invention as discussed above.
Kussick further discloses the shell 10 being configured to fit over anterior teeth (figs. 1 and 2 and col. 3, lines 33-36 and 52-55, shell 10 has a planar occlusal surface that conforms to the posterior dentition as well as the anterior teeth).
Regarding claim 6, Kussick discloses the claimed invention as discussed above.
Kussick is silent on a plurality of protrusions on the posterior lingual side of the shell.
However, Bergersen teaches an analogous tongue training appliance 10 (fig. 1 and [0009]-[0011]) comprising a plurality of protrusions 32/23 on an analogous posterior lingual side 16 of the shell 10 (fig. 1 and [0048], spurs 32 extend from wall 33 of inner shield 16; [0056], bumps 23 are provided on the lingual palatal tabs 22).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the posterior lingual side of the shell of Kussick with a plurality of protrusions on the posterior lingual side of the shell, as taught by Bergersen, to prevent the tongue from thrusting forward and positioning itself in an unideal location; both Kussick and Bergersen are concerned with preventing tongue thrust, and Kussick’s aperture provides the proper location of the tongue, while adding Bergersen’s spurs further guides the tongue away from the location of the spurs and bumps to properly locate itself elsewhere (e.g., in Kussick’s aperture).
Regarding claim 7, Kussick in view of Bergersen discloses the claimed invention as discussed above.
Bergersen further teaches the protrusions 32/23 being conical spikes configured to extend perpendicular to central and lateral incisors (fig. 1 shows spurs 32 being conical spikes; fig. 4 and [0034], fig. 4 being a rear view of the appliance, indicating that spurs 32 as shown in the figure project directly into the rear direction (indicated by their centrally located points), which is perpendicular to the planar rear surface of the central and lateral incisors; [0048] further states that spurs 32 extend toward the rear of the appliance), to prevent the tongue from thrusting forward and positioning itself in an unideal location.
Regarding claim 12, Kussick in view of Bergersen discloses the claimed invention as discussed above.
Bergersen further teaches wherein for patients with a lateral tongue thrust, the plurality of protrusions 32/23 are configured to be placed bilaterally or unilaterally on teeth (fig. 1 and [0056], bumps 23 are located on the lingual surfaces of lingual palatal tabs 22, which are located on each side of the maxilla (i.e., bilaterally)), to prevent the tongue from thrusting forward and positioning itself in an unideal location.
Regarding claim 17, Kussick in view of Bergersen discloses the claimed invention as discussed above.
Kussick further discloses a method for training a tongue (col. 4, lines 22-11, ramp 33 and aperture 37 initiate normal swallowing by positioning the tongue) comprising:
providing the tongue training appliance 10 of claim 6 causing a patient to wear the appliance (col. 3, lines33-39);
wherein the aperture 37 on the appliance 10 is configured to provide a spot which habituates proper lingual resting posture and wherein the aperture 37 is configured to receive a tip of the patient’s tongue and acts as a tactile cue for where the tongue tip should rest (fig. 6 and col. 4, lines 2-25).
Kussick is silent on the plurality of protrusions deterring the tongue from resting on the maxillary teeth.
However, Bergersen further teaches the plurality of protrusions 32/23 deterring the tongue from resting on the maxillary teeth (fig. 1 and [0048], spurs 32 prevent the tongue from thrusting forward, and fig. 1 shows the spurs 32 being located on the inner wall 33 where the maxillary teeth are; thus, spurs 32 deter the tongue from thrusting forward towards the maxillary 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 plurality of protrusions of Kussick in view of Bergersen to deter the tongue from resting on the maxillary teeth, as taught by Bergersen, to encourage a proper swallow ([0048]).
Regarding claim 19, Kussick in view of Bergersen discloses the claimed invention as discussed above.
Kussick further discloses the appliance 10 being useful to treat noxious oral habits (col. 1, lines 5-7, the device is adapted to correct tongue thrust, which can be considered a noxious oral habit; a “noxious oral habit” is interpreted to mean any oral habit that is considered abnormal or unhealthy).
Kussick is silent on the appliance being useful to treat orthodontic conditions, temporomandibular joint problems, sleep apnea, snoring, and mouth breathing.
However, Bergersen teaches the analogous appliance 10 for treating tongue thrust ([0048], prevents tongue from thrusting forward) being useful to treat orthodontic conditions ([0003], tongue thrust causing poor resting tongue position can cause a narrow posterior maxillary arch), temporomandibular joint problems ([0003], tongue thrust causes mouth breathing; [0005], mouth breathing causes the mandible to be posteriorly displaced, which can be considered a TMJ problem), sleep apnea, snoring ([0005], mouth breathing causes posterior displacement of mandible and tongue, narrowing the oropharynx, which is known in the art to cause sleep apnea and snoring), and mouth breathing ([0003], tongue thrust causes mouth breathing).
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 appliance of Kussick in view of Bergersen to be useful to treat orthodontic conditions, temporomandibular joint problems, sleep apnea, snoring, and mouth breathing, as taught by Bergersen, to prevent sleep issues caused by tongue thrust that can seriously affect the health of a patient ([0003]).
Claim(s) 3, 8, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kussick US 4,997,182 in view of Bergersen US 2022/0409424 A1 further in view of Alvarez et al. US 2016/0367342 A1.
Regarding claim 3, Kussick in view of Bergersen discloses the claimed invention as discussed above.
Kussick in view of Bergersen is silent on the plurality of protrusions further comprising: eight protrusions configured to be disposed on each of a central incisor; three protrusions configured to be disposed on each of a lateral incisor; two protrusions configured to be disposed on each of a bilateral cuspid; and three protrusions configured to be disposed on each of a bilateral pre-molar.
However, Alvarez teaches an analogous tongue positioning device (fig. 5A and [0001]) comprising a plurality of protrusions 131 (fig. 5A and [0035], implants 501; [0012], the implants are installed to extend horizontally into the oral cavity to reposition the tongue, similar to Bergersen’s spurs) comprising: eight protrusions configured to be disposed on each of a central incisor; three protrusions configured to be disposed on each of a lateral incisor; two protrusions configured to be disposed on each of a bilateral cuspid; and three protrusions configured to be disposed on each of a bilateral pre-molar (while Alvarez does not teach these specific quantities and corresponding locations, Alvarez teaches in [0034]-[0036] that the protrusions/implants 501 are provided in positions and numbers specific to the anatomy of the patient to accommodate differences in oral anatomy; thus, Alvarez contemplates a variety of configurations that is capable of including the claimed configuration, depending on the patient).
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 plurality of protrusions of Kussick in view of Bergersen to include a specific number of protrusions in specific locations of the patient depending on the anatomy and needs of the patient, as taught by Alvarez, since “the anatomy of each individual is unique” ([0034]); please further note that the instant specification does not provide evidence as to the criticality of the claimed number of protrusions and locations.
Regarding claim 8, Kussick in view of Bergersen discloses the claimed invention as discussed above.
Kussick in view of Bergersen is silent on the plurality of protrusions being configured to protrude from 1 mm to 5 mm into the patient’s mouth.
However, Alvarez teaches an analogous tongue positioning device 11 (fig. 1 and [0031]) comprising analogous plurality of protrusions 20/21 being configured to protrude from 1 mm to 5 mm into the patient’s mouth (fig. 1 and [0049], protuberances 20/21 may have a height of 1-5 mm).
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 plurality of protrusions of Kussick in view of Bergersen to be configured to protrude from 1 mm to 5 mm into the patient’s mouth, as taught by Alvarez, to elicit a specific response from the tongue based on the topography of the patient’s mouth ([0049]).
Regarding claim 9, Kussick in view of Bergersen further in view of Alvarez discloses the claimed invention as discussed above.
Alvarez further teaches the protrusions 20/21 being configured to protrude 1 mm into the patient’s mouth (fig. 1 and [0049], protuberances 20/21 may have a height of 1-5 mm), to elicit a specific response from the tongue based on the topography of the patient’s mouth ([0049]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kussick US 4,997,182 in view of Bergersen US 2022/0409424 A1 further in view of Kuo US 2018/0153733 A1.
Regarding claim 5, Kussick in view of Bergersen discloses the claimed invention as discussed above.
Kussick further discloses the tongue training appliance 10 being configured to expose anterior labial side of anterior teeth (figs. 1 and 5 show the shell 10 lacking an anteriormost wall to cover the anterior labial side of anterior teeth).
Kussick in view of Bergersen is silent on the tongue training appliance being configured to expose occlusal surfaces of molars.
However, Kuo teaches an analogous oral device 200 (figs. 2A/B and [0040]) being configured to expose occlusal surfaces of molars (fig. 2B and [0040], cut-out regions 212/214 expose the occlusal surfaces of the molars).
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 appliance of Kussick in view of Bergersen to be configured to expose occlusal surfaces of molars, as taught by Kuo, to make the appliance lighter and less intrusive in an area that doesn’t matter for proper tongue positioning.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kussick US 4,997,182 in view of Kuo US 2018/0153733 A1.
Regarding claim 11, Kussick discloses the claimed invention as discussed above.
Kussick further discloses the tongue training appliance 10 being configured to expose anterior labial side of anterior teeth (figs. 1 and 5 show the shell 10 lacking an anteriormost wall to cover the anterior labial side of anterior teeth).
Kussick is silent on the tongue training appliance being configured to expose occlusal surfaces of molars.
However, Kuo teaches an analogous oral device 200 (figs. 2A/B and [0040]) being configured to expose occlusal surfaces of molars (fig. 2B and [0040], cut-out regions 212/214 expose the occlusal surfaces of the molars).
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 appliance of Kussick to be configured to expose occlusal surfaces of molars, as taught by Kuo, to make the appliance lighter and less intrusive in an area that doesn’t matter for proper tongue positioning.
Claim(s) 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kussick US 4,997,182 in view of Kussick US 5,779,470 (“Kussick ‘470”).
Regarding claim 14, Kussick discloses the claimed invention as discussed above.
Kussick discloses the aperture 37 being round (fig. 1).
Kussick is silent on the aperture being between 3 to 5 mm in diameter.
However, Kussick ‘470 teaches an analogous oral device 20 for positioning the tongue (fig. 1 and col. 1, lines 4-6) comprising an 9/9’ aperture being between 3 to 5 mm in diameter (fig. 2 and col. 6, lines 43-46, holes 9/9’ have a diameter from 2 to 8 mm, which includes 3 to 5 mm).
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 aperture of Kussick to have a diameter between 3 to 5 mm, as taught by Kussick ‘470, to accommodate tongues of smaller size or patients who are using smaller appliances, such as children; please also note that while Kussick ‘470 doesn’t specifically teach a diameter between 3-5 mm, the instant specification does not indicate any criticality of the claimed range.
Regarding claim 16, Kussick discloses the claimed invention as discussed above.
Kussick is silent on the shell having a thickness of between 0.5 to 1 mm.
However, Kussick ‘470 teaches an analogous oral device 20 for positioning the tongue (fig. 1 and col. 1, lines 4-6) comprising a shell having a thickness of between 0.5 to 1 mm (fig. 1 and col. 8, lines 44-48, a portion 1 of the device 20 may have a thickness of 1-2 mm, which includes 1 mm).
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 shell of Kussick to have a thickness of between 0.5 to 1 mm, as taught by Kussick ‘470, to be light and comfortable to wear; please also note that while Kussick ‘470 doesn’t specifically teach a thickness between 0.5-1 mm, the instant specification does not indicate any criticality of the claimed range.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kussick US 4,997,182 in view of Bergersen US 2022/0409424 A1 further in view of North US 4,718,662.
Regarding claim 18, Kussick in view of Bergersen discloses the claimed invention as discussed above.
Kussick in view of Bergersen is silent on the appliance improving 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.
However, North teaches an analogous appliance 1 for correcting tongue thrust (fig. 1 and col. 1, lines 51-58), the appliance improving 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 (col. 1, lines 6-15, 20-40; col. 2, lines 7-23, the appliance producing better speaking abilities such as better production of speech sounds (which would include resonance and intelligibility, and improvement of articulatory precision of sounds) and correcting defective speech sounds (which would include decreasing a slushy sound, which is interpreted as any defective speech sound resulting from tongue thrust); while specific sounds are not taught by North, it is understood that since both North and the instant invention improve speech by preventing tongue thrust, the specific sounds that are treated would largely be the same absent evidence that the instant invention targets specific unexpected sounds).
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 appliance of Kussick in view of Bergersen to improve 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, as taught by North, to correct speech problems that are typically attributed to tongue thrusting (col. 1, lines 30-35).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kussick US 4,997,182 in view of Parker US 6,357,444 B1.
Regarding claim 20, Kussick discloses the claimed invention as discussed above.
Kussick is silent on a kit, wherein the kit comprises the appliance, a patient instruction booklet, and myofunctional therapy training program material.
However, Parker teaches a therapeutic appliance 110 (fig. 9 and col. 7, lines 64-65) being provided in a kit 900, wherein the kit 900 comprises the appliance 110, a patient instruction booklet 912, and relevant therapy training program material (col. 7, line 63-col. 8, line 2, kit 900 includes pad 110 with instruction manual 912, wherein the instructions in the instruction manual is the relevant therapy training program material).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the myofunctional therapy appliance (tongue thrust being an orofacial myofunctional problem) of Kussick in a kit, wherein the kit comprises the appliance, a patient instruction booklet, and relevant training program material, as taught by Parker, to teach patients how to easily use the appliance themselves.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 4, 6, 7, 12, 17, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,712,365 B2 in view of Kussick US 4,997,182 further in view of Bergersen US 2022/0409424 A1.
Regarding claim 1, claim 6 of the conflicting patent claims an oral appliance which is configured to be custom fitted to a patient's maxillary teeth (col. 6, lines 3-6) having: a shell configured to fit securely over the maxillary teeth (col. 6, lines 4-6); a plurality of protrusions on the posterior lingual side of the shell (col. 6, lines 7-8, the lingual side being inherently posterior on a crown); a platform extending from the posterior lingual side of the shell (col. 6, line 16, posterior of a crown being inherently the lingual side); and an aperture (col. 6, lines 16-18).
The conflicting patent is silent on the oral appliance being a tongue training appliance; the shell having an anterior labial side and a posterior lingual side; the aperture configured to be located at an end of central incisor papilla at an anterior part of an upper palate where the tongue should rest.
However, Kussick teaches a tongue training appliance 10 (fig. 1 and col. 1, lines 5-7) having: a shell 10 having an anterior labial side and a posterior lingual side (col. 3, lines 31-36; please see annotated fig. A, which shows the anterior labial side and posterior lingual side of shell/body 10); an aperture 37 configured to be located at an end of central incisor papilla at an anterior part of an upper palate where the tongue should rest (figs. 1-3 and col. 4, lines 2-11, where aperture 37 in upper ramp 33 is located adjacent to the curved aspect of the palate anterior bend of the palate to accommodate the apex of the tongue; the curved aspect of the palate’s anterior bend can be considered the upper end of the central incisor papilla at an anterior part of an upper palate).
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 appliance of the conflicting patent to be a tongue training appliance; the shell having an anterior labial side and a posterior lingual side; the aperture configured to be located at an end of central incisor papilla at an anterior part of an upper palate where the tongue should rest, as taught by Kussick, to properly position the tongue (col. 2, lines 46-66).
The conflicting patent in view of Kussick is silent on the plurality of protrusions are disposed in multiple rows.
However, Bergersen teaches an analogous tongue training appliance 10 (fig. 1 and [0009]-[0011]) comprising a plurality of protrusions 32/23 on an analogous posterior lingual side 16 of the shell 10 (fig. 1 and [0048], spurs 32 extend from wall 33 of inner shield 16; [0056], bumps 23 are provided on the lingual palatal tabs 22), wherein the plurality of protrusions 32/23 are disposed in multiple rows (fig. 1, spurs 32 form one row in the center, left bumps 23 form another row on the left, and right bumps 23 form another row on the right).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the posterior lingual side of the shell of the conflicting patent in view of Kussick with the plurality of protrusions are disposed in multiple rows, as taught by Bergersen, to prevent the tongue from thrusting forward and positioning itself in an unideal location; both Kussick and Bergersen are concerned with preventing tongue thrust, and Kussick’s aperture provides the proper location of the tongue, while adding Bergersen’s spurs further guides the tongue away from the location of the spurs and bumps to properly locate itself elsewhere (e.g., in Kussick’s aperture).
Regarding claim 2, the conflicting patent in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
Kussick further teaches the shell 10 being configured to fit over all the maxillary teeth (figs. 1 and 2 and col. 3, lines 33-36 and 52-55, shell 10 has a planar occlusal surface that conforms to the posterior dentition as well as the anterior teeth; this continuous surface forming the U-shaped shell as seen in the noted figures is capable of fitting over the occlusal surface of all the maxillary teeth depending on the specific size and shape of the wearer’s maxillary dentition), to be more securely retained in the posterior of the mouth.
Regarding claim 4, the conflicting patent in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
Kussick further teaches the shell 10 being configured to fit over anterior teeth (figs. 1 and 2 and col. 3, lines 33-36 and 52-55, shell 10 has a planar occlusal surface that conforms to the posterior dentition as well as the anterior teeth), to be more securely retained in the anterior of the mouth.
Regarding claim 6, the conflicting patent in view of Kussick discloses the claimed invention as discussed above.
The conflicting patent in view of Kussick is silent on a plurality of protrusions on the posterior lingual side of the shell.
However, Bergersen teaches an analogous tongue training appliance 10 (fig. 1 and [0009]-[0011]) comprising a plurality of protrusions 32/23 on an analogous posterior lingual side 16 of the shell 10 (fig. 1 and [0048], spurs 32 extend from wall 33 of inner shield 16; [0056], bumps 23 are provided on the lingual palatal tabs 22).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the posterior lingual side of the shell of the conflicting patent in view of Kussick with a plurality of protrusions on the posterior lingual side of the shell, as taught by Bergersen, to prevent the tongue from thrusting forward and positioning itself in an unideal location; both Kussick and Bergersen are concerned with preventing tongue thrust, and Kussick’s aperture provides the proper location of the tongue, while adding Bergersen’s spurs further guides the tongue away from the location of the spurs and bumps to properly locate itself elsewhere (e.g., in Kussick’s aperture).
Regarding claim 7, the conflicting patent in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
Bergersen further teaches the protrusions 32 being conical spikes configured to extend perpendicular to central and lateral incisors (fig. 1 shows spurs 32 being conical spikes; fig. 4 and [0034], fig. 4 being a rear view of the appliance, indicating that spurs 32 as shown in the figure project directly into the rear direction (indicated by their centrally located points), which is perpendicular to the planar rear surface of the central and lateral incisors; [0048] further states that spurs 32 extend toward the rear of the appliance), to prevent the tongue from thrusting forward and positioning itself in an unideal location.
Regarding claim 12, the conflicting patent in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
Bergersen further teaches wherein for patients with a lateral tongue thrust, the plurality of protrusions 23 are configured to be placed bilaterally or unilaterally on teeth (fig. 1 and [0056], bumps 23 are located on the lingual surfaces of lingual palatal tabs 22, which are located on each side of the maxilla (i.e., bilaterally)), to prevent the tongue from thrusting forward and positioning itself in an unideal location.
Regarding claim 17, the conflicting patent in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
Kussick further teaches a method for training a tongue (col. 4, lines 22-11, ramp 33 and aperture 37 initiate normal swallowing by positioning the tongue) comprising: providing the tongue training appliance 10 of claim 6 causing the patient to wear the appliance (col. 3, lines33-39); wherein the aperture 37 on the appliance 10 is configured to provide a spot which habituates proper lingual resting posture and wherein the aperture 37 is configured to receive a tip of the patient’s tongue and acts as a tactile cue for where the tongue tip should rest (fig. 6 and col. 4, lines 2-25), to allow a patient to use the appliance to improve tongue positioning and health.
The conflicting patent in view of Kussick further in view of Bergersen is silent on the tongue protrusions deterring the tongue from resting on the maxillary teeth.
However, Bergersen teaches the tongue protrusions 32 deterring the tongue from resting on the maxillary teeth (fig. 1 and [0048], spurs 32 prevent the tongue from thrusting forward, and fig. 1 shows the spurs 32 being located on the inner wall 33 where the maxillary teeth are; thus, spurs 32 deter the tongue from thrusting forward towards the maxillary 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 tongue protrusions of the conflicting patent in view of Kussick further in view of Bergersen to deter the tongue from resting on the maxillary teeth, as taught by Bergersen, to encourage a proper swallow ([0048]).
Regarding claim 19, the conflicting patent in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
Kussick further teaches the appliance 10 being useful to treat noxious oral habits (col. 1, lines 5-7, the device is adapted to correct tongue thrust, which can be considered a noxious oral habit), to improve the oral health of the patient.
The conflicting patent in view of Kussick is silent on the appliance being useful to treat orthodontic conditions, temporomandibular joint problems, sleep apnea, snoring, and mouth breathing.
However, Bergersen further teaches the analogous appliance 10 for treating tongue thrust ([0048], prevents tongue from thrusting forward) being useful to treat orthodontic conditions ([0003], tongue thrust causing poor resting tongue position can cause a narrow posterior maxillary arch), temporomandibular joint problems ([0003], tongue thrust causes mouth breathing; [0005], mouth breathing causes the mandible to be posteriorly displaced, which can be considered a TMJ problem), sleep apnea, snoring ([0005], mouth breathing causes posterior displacement of mandible and tongue, narrowing the oropharynx, which is known in the art to cause sleep apnea and snoring), and mouth breathing ([0003], tongue thrust causes mouth breathing).
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 appliance of the conflicting patent in view of Kussick further in view of Bergersen to be useful to treat orthodontic conditions, temporomandibular joint problems, sleep apnea, snoring, and mouth breathing, as taught by Bergersen, to prevent sleep issues caused by tongue thrust that can seriously affect the health of a patient ([0003]).
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,712,365 B2 in view of Kussick US 4,997,182 further in view of Bergersen US 2022/0409424 A1 and Alvarez et al. US 2016/0367342 A1.
Regarding claim 3, the conflicting patent in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
The conflicting patent in view of Kussick further in view of Bergersen is silent on the plurality of protrusions further comprising: eight protrusions configured to be disposed on each of a central incisor; three protrusions configured to be disposed on each of a lateral incisor; two protrusions configured to be disposed on each of a bilateral cuspid; and three protrusions configured to be disposed on each of a bilateral pre-molar.
However, Alvarez teaches an analogous tongue positioning device (fig. 5A and [0001]) comprising a plurality of protrusions 131 (fig. 5A and [0035], implants 501; [0012], the implants are installed to extend horizontally into the oral cavity to reposition the tongue, similar to Bergersen’s spurs) comprising: eight protrusions configured to be disposed on each of a central incisor; three protrusions configured to be disposed on each of a lateral incisor; two protrusions configured to be disposed on each of a bilateral cuspid; and three protrusions configured to be disposed on each of a bilateral pre-molar (while Alvarez does not teach these specific quantities and corresponding locations, Alvarez teaches in [0034]-[0036] that the protrusions/implants 501 are provided in positions and numbers specific to the anatomy of the patient to accommodate differences in oral anatomy; thus, Alvarez contemplates a variety of configurations that is capable of including the claimed configuration, depending on the patient).
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 plurality of protrusions of the conflicting patent in view of Kussick further in view of Bergersen to include a specific number of protrusions in specific locations of the patient depending on the anatomy and needs of the patient, as taught by Alvarez, since “the anatomy of each individual is unique” ([0034]); please further note that the instant specification does not provide evidence as to the criticality of the claimed number of protrusions and locations.
Claims 5 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,712,365 B2 in view of Kussick US 4,997,182 further in view of Kuo US 2018/0153733 A1.
Regarding claim 5, the conflicting patent in view of Kussick discloses the claimed invention as discussed above.
Kussick further teaches the tongue training appliance 10 being configured to expose anterior labial sides of anterior teeth (figs. 1 and 5 show the shell 10 lacking an anteriormost wall to cover the anterior labial side of anterior teeth), to be less noticeable when worn.
The conflicting patent in view of Kussick is silent on the tongue training appliance being configured to expose occlusal surfaces of molars.
However, Kuo teaches an analogous oral device 200 (figs. 2A/B and [0040]) allowing occlusal surfaces of molars to be exposed (fig. 2B and [0040], cut-out regions 212/214 expose the occlusal surfaces of the molars).
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 appliance of the conflicting patent in view of Kussick to be configured to expose occlusal surfaces of molars, as taught by Kuo, to make the appliance lighter and less intrusive in an area that doesn’t matter for proper tongue positioning.
Regarding claim 11, the conflicting patent in view of Kussick discloses the claimed invention as discussed above.
However, Kussick further teaches the tongue training appliance 10 being configured to expose anterior labial sides of anterior teeth (figs. 1 and 5 show the shell 10 lacking an anteriormost wall to cover the anterior labial side of anterior teeth), to be securely retained on the teeth and be less visible when worn.
The conflicting patent in view of Kussick is silent on the tongue training appliance being configured to expose occlusal surfaces of the molars.
However, Kuo teaches an analogous oral device 200 (figs. 2A/B and [0040]) allowing occlusal surfaces of molars to be exposed (fig. 2B and [0040], cut-out regions 212/214 expose the occlusal surfaces of the molars).
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 appliance of conflicting patent in view of Kussick to be configured to expose occlusal surfaces of the molars, as taught by Kuo, to make the appliance lighter and less intrusive in an area that doesn’t matter for proper tongue positioning.
Claims 8 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,712,365 B2 in view of Kussick US 4,997,182 further in view of Bergersen US 2022/0409424 A1 and Alvarez et al. US 2013/0298916 A1.
Regarding claim 8, the conflicting patent in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
The conflicting patent in view of Kussick further in view of Bergersen is silent on the plurality of protrusions being configured to protrude from 1 mm to 5 mm into a patient’s mouth.
However, Alvarez teaches an analogous tongue positioning device 11 (fig. 1 and [0031]) comprising analogous protrusions 20/21 being configured to protrude from 1 mm to 5 mm into a patient’s mouth (fig. 1 and [0049], protuberances 20/21 may have a height of 1-5 mm).
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 protrusions of the conflicting patent in view of Kussick further in view of Bergersen to be configured to protrude from 1 mm to 5 mm into a patient’s mouth, as taught by Alvarez, to elicit a specific response from the tongue based on the topography of the patient’s mouth ([0049]).
Regarding claim 9, the conflicting patent in view of Kussick further in view of Bergersen and Alvarez discloses the claimed invention as discussed above.
Alvarez further teaches the protrusions 20/21 being configured to protrude 1 mm into a patient’s mouth (fig. 1 and [0049], protuberances 20/21 may have a height of 1-5 mm), to elicit a specific response from the tongue based on the topography of the patient’s mouth ([0049]).
Claims 10, 13, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,712,365 B2 in view of Kussick US 4,997,182.
Regarding claim 10, claim 6 of the conflicting patent claims an oral appliance which is configured to be custom fitted to a patient's maxillary teeth (col. 6, lines 3-6) having: a shell configured to fit securely over the maxillary teeth (col. 6, lines 4-6); a platform configured to extend from the posterior lingual side of the shell (col. 6, line 16, posterior of a crown being inherently the lingual side); and an aperture (col. 6, lines 16-18).
The conflicting patent is silent on the oral appliance being a tongue training appliance; the shell having an anterior labial side and a posterior lingual side; wherein the shell represents an outline of the maxillary teeth, wherein the shell is configured to fit over at least one pair of molars of the patient, and wherein the posterior lingual side of the shell includes a textured surface configured to be disposed at the at least one pair of molars of the patient; the aperture configured to be located at an end of central incisor papilla at an anterior part of an upper palate where the tongue should rest.
However, Kussick teaches a tongue training appliance 10 (fig. 1 and col. 1, lines 5-7) having: a shell 10 having an anterior labial side and a posterior lingual side (col. 3, lines 31-36; please see annotated fig. A, which shows the anterior labial side and posterior lingual side of shell/body 10); wherein the shell 10 represents an outline of the maxillary teeth (fig. 5, the shell 10 follows the general u-shaped outline of the maxillary teeth),
wherein the shell 10 is configured to fit over at least one pair of molars of the patient (fig. 5), and
wherein the posterior lingual side of the shell 10 includes a textured surface configured to be disposed at the at least one pair of molars of the patient (fig. 5, the shell 10 extends over the molars, and the lingual/inner surface at the molars has an inherent texture, as all materials have some type of texture (i.e., smooth, rough, etc.));
a platform 33 configured to extend from a gum line of the patient from the posterior lingual side of the shell 10 (fig. 1 and col. 3, lines 60-67; annotated fig. A further shows the extent of ramp 33 that is being interpreted as the “platform”, where the bottom end of the platform extends upwards from the gum line adjacent the top of the tooth 51); and
an aperture 37 configured to be located at an end of central incisor papilla at an anterior part of an upper palate where the tongue should rest (figs. 1-3 and col. 4, lines 2-11, where aperture 37 in upper ramp 33 is located adjacent to the curved aspect of the palate anterior bend of the palate to accommodate the apex of the tongue; the curved aspect of the palate’s anterior bend can be considered the upper end of the central incisor papilla at an anterior part of an upper palate).
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 appliance of the conflicting patent to be a tongue training appliance; the shell having an anterior labial side and a posterior lingual side; wherein the shell represents an outline of the maxillary teeth, wherein the shell is configured to fit over at least one pair of molars of the patient, and wherein the posterior lingual side of the shell includes a textured surface configured to be disposed at the at least one pair of molars of the patient; the aperture configured to be located at an end of central incisor papilla at an anterior part of an upper palate where the tongue should rest, as taught by Kussick, to properly position the tongue (col. 2, lines 46-66).
Regarding claim 13, the conflicting patent in view of Kussick discloses the claimed invention as discussed above.
Kussick further teaches the shell 10 being configured to fit over all the maxillary teeth (figs. 1 and 2 and col. 3, lines 33-36 and 52-55, shell 10 has a planar occlusal surface that conforms to the posterior dentition as well as the anterior teeth; this continuous surface forming the U-shaped shell as seen in the noted figures is capable of fitting over the occlusal surface of all the maxillary teeth depending on the specific size and shape of the wearer’s maxillary dentition), to be more securely retained in the mouth.
Regarding claim 15, the conflicting patent in view of Kussick discloses the claimed invention as discussed above.
Kussick further teaches a soft resin material (col. 5, lines 20-30, resin material is provided to be pressed against the dental arch to be shaped for retention, indicating its softness at this stage) and prepared using a 3-D printing machine (this is considered a product-by-process limitation, as there is no evidence that a resin material prepared by 3D printing or other method (for example, injection molding) would be structurally distinct from each other; please see MPEP 2113), to be accurately retained in the mouth according to individual teeth anatomy.
Claim(s) 14 and 16 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,712,365 B2 in view of Kussick US 4,997,182 further in view of Kussick US 5,779,470 (“Kussick ‘470”).
Regarding claim 14, the conflicting patent in view of Kussick discloses the claimed invention as discussed above.
The conflicting patent claims the aperture being round (claim 6, the aperture is circular).
The conflicting patent in view of Kussick is silent on the aperture being between 3 to 5 mm in diameter.
However, Kussick ‘470 teaches an analogous oral device 20 for positioning the tongue (fig. 1 and col. 1, lines 4-6) comprising an 9/9’ aperture being between 3 to 5 mm in diameter (fig. 2 and col. 6, lines 43-46, holes 9/9’ have a diameter from 2 to 8 mm, which includes 3 to 5 mm).
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 aperture of the conflicting patent in view of Kussick to have a diameter between 3 to 5 mm, as taught by Kussick ‘470, to accommodate tongues of smaller size or patients who are using smaller appliances, such as children; please also note that while Kussick ‘470 doesn’t specifically teach a diameter between 3-5 mm, the instant specification does not indicate any criticality of the claimed range.
Regarding claim 16, the conflicting patent in view of Kussick discloses the claimed invention as discussed above.
The conflicting patent in view of Kussick is silent on the shell having a thickness of between 0.5 to 1 mm.
However, Kussick ‘470 teaches an analogous oral device 20 for positioning the tongue (fig. 1 and col. 1, lines 4-6) comprising a shell having a thickness of between 0.5 to 1 mm (fig. 1 and col. 8, lines 44-48, a portion 1 of the device 20 may have a thickness of 1-2 mm, which includes 1 mm).
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 shell of the conflicting patent in view of Kussick to have a thickness of between 0.5 to 1 mm, as taught by Kussick ‘470, to be light and comfortable to wear; please also note that while Kussick ‘470 doesn’t specifically teach a thickness between 0.5-1 mm, the instant specification does not indicate any criticality of the claimed range.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,712,365 B2 in view of Kussick US 4,997,182 further in view of Bergersen US 2022/0409424 A1 and North US 4,718,6621.
Regarding claim 18, the conflicting patent in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
The conflicting patent in view of Kussick further in view of Bergersen is silent on the appliance improving 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.
However, North teaches an analogous appliance 1 for correcting tongue thrust (fig. 1 and col. 1, lines 51-58), the appliance improving 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 (col. 1, lines 6-15, 20-40; col. 2, lines 7-23, the appliance producing better speaking abilities such as better production of speech sounds (which would include resonance and intelligibility, and improvement of articulatory precision of sounds) and correcting defective speech sounds (which would include decreasing a slushy sound, which is interpreted as any defective speech sound resulting from tongue thrust); while specific sounds are not taught by North, it is understood that since both North and the instant invention improve speech by preventing tongue thrust, the specific sounds that are treated would largely be the same absent evidence that the instant invention targets specific unexpected sounds).
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 appliance of the conflicting patent in view of Kussick further in view of Bergersen to improve 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, as taught by North, to correct speech problems that are typically attributed to tongue thrusting (col. 1, lines 30-35).
Claim(s) 20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,712,365 B2 in view of Kussick US 4,997,182 further in view of Parker US 6,357,444 B1.
Regarding claim 20, the conflicting patent in view of Kussick discloses the claimed invention as discussed above.
The conflicting patent in view of Kussick is silent on a kit, wherein the kit comprises the appliance, a patient instruction booklet, and myofunctional therapy training program material.
However, Parker teaches a therapeutic appliance 110 (fig. 9 and col. 7, lines 64-65) being provided in a kit 900, wherein the kit 900 comprises the appliance 110, a patient instruction booklet 912, and relevant therapy training program material (col. 7, line 63-col. 8, line 2, kit 900 includes pad 110 with instruction manual 912, wherein the instructions in the instruction manual is the relevant therapy training program material).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the myofunctional therapy appliance (tongue thrust being an orofacial myofunctional problem) of the conflicting patent in view of Kussick in a kit, wherein the kit comprises the appliance, a patient instruction booklet, and relevant training program material, as taught by Parker, to teach patients how to easily use the appliance themselves.
Claims 1, 2, and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of copending Application No. 18/445,197 in view of Bergersen US 2022/0409424 A1.
This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, claim 1 of the conflicting app claims the entirety of the claim except the plurality of protrusions being disposed in multiple rows.
However, Bergersen teaches an analogous tongue training appliance 10 (fig. 1 and [0009]-[0011]) comprising a plurality of protrusions 32/23 on an analogous posterior lingual side 16 of the shell 10 (fig. 1 and [0048], spurs 32 extend from wall 33 of inner shield 16; [0056], bumps 23 are provided on the lingual palatal tabs 22), wherein the plurality of protrusions 32/23 are disposed in multiple rows (fig. 1, spurs 32 form one row in the center, left bumps 23 form another row on the left, and right bumps 23 form another row on the right).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the posterior lingual side of the shell of the conflicting app with the plurality of protrusions disposed in multiple rows, as taught by Bergersen, as Bergersen’s spurs further guides the tongue away from the location of the spurs and bumps to properly locate itself elsewhere.
Regarding claim 2, the conflicting app in view of Bergersen discloses the claimed invention as discussed above.
Bergersen further teaches the shell 10 being configured to fit over all of the maxillary teeth (fig. 1 shows the u-shaped device 10 that is capable of receiving all of the maxillary teeth depending on the size of the user’s mouth), to be securely worn on the teeth.
Regarding claim 4, claim 4 of the conflicting app claims the entirety of the claim.
Claim 5 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/445,197 in view of Bergersen US 2022/0409424 A1 further in view of Kussick US 4,997,182 and Kuo US 2018/0153733 A1.
This is a provisional nonstatutory double patenting rejection.
Regarding claim 5, the conflicting app in view of Bergersen is silent on the tongue training appliance being configured to expose anterior labial sides of anterior teeth.
However, Kussick teaches the tongue training appliance 10 being configured to expose anterior labial side of anterior teeth (figs. 1 and 5 show the shell 10 lacking an anteriormost wall to cover the anterior labial side of anterior 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 tongue training appliance of the conflicting app in view of Bergersen to be configured to expose anterior labial sides of anterior teeth, as taught by Kussick, to be lightweight and comfortable.
The conflicting app in view of Bergersen further in view of Kussick is silent on the tongue training appliance being configured to expose occlusal surfaces of molars.
However, Kuo teaches an analogous oral device 200 (figs. 2A/B and [0040]) being configured to expose occlusal surfaces of molars (fig. 2B and [0040], cut-out regions 212/214 expose the occlusal surfaces of the molars).
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 appliance of the conflicting app in view of Bergersen further in view of Kussick to be configured to expose occlusal surfaces of molars, as taught by Kuo, to make the appliance lighter and less intrusive in an area that doesn’t matter for proper tongue positioning.
Claims 6, 7, 12, 17, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/445,197 in view of Kussick US 4,997,182 further in view of Bergersen US 2022/0409424 A1.
Regarding claim 6, the conflicting app in view of Kussick discloses the claimed invention as discussed above.
The conflicting app in view of Kussick is silent on a plurality of protrusions on the posterior lingual side of the shell.
However, Bergersen teaches an analogous tongue training appliance 10 (fig. 1 and [0009]-[0011]) comprising a plurality of protrusions 32/23 on an analogous posterior lingual side 16 of the shell 10 (fig. 1 and [0048], spurs 32 extend from wall 33 of inner shield 16; [0056], bumps 23 are provided on the lingual palatal tabs 22).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the posterior lingual side of the shell of the conflicting app in view of Kussick with a plurality of protrusions on the posterior lingual side of the shell, as taught by Bergersen, to prevent the tongue from thrusting forward and positioning itself in an unideal location; both Kussick and Bergersen are concerned with preventing tongue thrust, and Kussick’s aperture provides the proper location of the tongue, while adding Bergersen’s spurs further guides the tongue away from the location of the spurs and bumps to properly locate itself elsewhere (e.g., in Kussick’s aperture).
Regarding claim 7, the conflicting app in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
Bergersen further teaches the protrusions 32 being conical spikes configured to extend perpendicular to central and lateral incisors (fig. 1 shows spurs 32 being conical spikes; fig. 4 and [0034], fig. 4 being a rear view of the appliance, indicating that spurs 32 as shown in the figure project directly into the rear direction (indicated by their centrally located points), which is perpendicular to the planar rear surface of the central and lateral incisors; [0048] further states that spurs 32 extend toward the rear of the appliance), to prevent the tongue from thrusting forward and positioning itself in an unideal location.
Regarding claim 12, the conflicting app in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
Bergersen further teaches wherein for patients with a lateral tongue thrust, the plurality of protrusions 23 are configured to be placed bilaterally or unilaterally on teeth (fig. 1 and [0056], bumps 23 are located on the lingual surfaces of lingual palatal tabs 22, which are located on each side of the maxilla (i.e., bilaterally)), to prevent the tongue from thrusting forward and positioning itself in an unideal location.
Regarding claim 17, the conflicting app in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
Kussick further teaches a method for training a tongue (col. 4, lines 22-11, ramp 33 and aperture 37 initiate normal swallowing by positioning the tongue) comprising: providing the tongue training appliance 10 of claim 6 causing the patient to wear the appliance (col. 3, lines33-39); wherein the aperture 37 on the appliance 10 is configured to provide a spot which habituates proper lingual resting posture and wherein the aperture 37 is configured to receive a tip of the patient’s tongue and acts as a tactile cue for where the tongue tip should rest (fig. 6 and col. 4, lines 2-25), to allow a patient to use the appliance to improve tongue positioning and health.
The conflicting app in view of Kussick further in view of Bergersen is silent on the tongue protrusions deterring the tongue from resting on the maxillary teeth.
However, Bergersen teaches the tongue protrusions 32 deterring the tongue from resting on the maxillary teeth (fig. 1 and [0048], spurs 32 prevent the tongue from thrusting forward, and fig. 1 shows the spurs 32 being located on the inner wall 33 where the maxillary teeth are; thus, spurs 32 deter the tongue from thrusting forward towards the maxillary 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 tongue protrusions of the conflicting app in view of Kussick further in view of Bergersen to deter the tongue from resting on the maxillary teeth, as taught by Bergersen, to encourage a proper swallow ([0048]).
Regarding claim 19, the conflicting app in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
Kussick further teaches the appliance 10 being useful to treat noxious oral habits (col. 1, lines 5-7, the device is adapted to correct tongue thrust, which can be considered a noxious oral habit), to improve the oral health of the patient.
The conflicting app in view of Kussick is silent on the appliance being useful to treat orthodontic conditions, temporomandibular joint problems, sleep apnea, snoring, and mouth breathing.
However, Bergersen further teaches the analogous appliance 10 for treating tongue thrust ([0048], prevents tongue from thrusting forward) being useful to treat orthodontic conditions ([0003], tongue thrust causing poor resting tongue position can cause a narrow posterior maxillary arch), temporomandibular joint problems ([0003], tongue thrust causes mouth breathing; [0005], mouth breathing causes the mandible to be posteriorly displaced, which can be considered a TMJ problem), sleep apnea, snoring ([0005], mouth breathing causes posterior displacement of mandible and tongue, narrowing the oropharynx, which is known in the art to cause sleep apnea and snoring), and mouth breathing ([0003], tongue thrust causes mouth breathing).
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 appliance of the conflicting app in view of Kussick further in view of Bergersen to be useful to treat orthodontic conditions, temporomandibular joint problems, sleep apnea, snoring, and mouth breathing, as taught by Bergersen, to prevent sleep issues caused by tongue thrust that can seriously affect the health of a patient ([0003]).
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/445,197 in view of Kussick US 4,997,182 further in view of Bergersen US 2022/0409424 A1 and Alvarez et al. US 2016/0367342 A1.
Regarding claim 3, the conflicting app in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
The conflicting app in view of Kussick further in view of Bergersen is silent on the plurality of protrusions further comprising: eight protrusions configured to be disposed on each of a central incisor; three protrusions configured to be disposed on each of a lateral incisor; two protrusions configured to be disposed on each of a bilateral cuspid; and three protrusions configured to be disposed on each of a bilateral pre-molar.
However, Alvarez teaches an analogous tongue positioning device (fig. 5A and [0001]) comprising a plurality of protrusions 131 (fig. 5A and [0035], implants 501; [0012], the implants are installed to extend horizontally into the oral cavity to reposition the tongue, similar to Bergersen’s spurs) comprising: eight protrusions configured to be disposed on each of a central incisor; three protrusions configured to be disposed on each of a lateral incisor; two protrusions configured to be disposed on each of a bilateral cuspid; and three protrusions configured to be disposed on each of a bilateral pre-molar (while Alvarez does not teach these specific quantities and corresponding locations, Alvarez teaches in [0034]-[0036] that the protrusions/implants 501 are provided in positions and numbers specific to the anatomy of the patient to accommodate differences in oral anatomy; thus, Alvarez contemplates a variety of configurations that is capable of including the claimed configuration, depending on the patient).
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 plurality of protrusions of the conflicting app in view of Kussick further in view of Bergersen to include a specific number of protrusions in specific locations of the patient depending on the anatomy and needs of the patient, as taught by Alvarez, since “the anatomy of each individual is unique” ([0034]); please further note that the instant specification does not provide evidence as to the criticality of the claimed number of protrusions and locations.
Claims 8 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/445,197 in view of Kussick US 4,997,182 further in view of Bergersen US 2022/0409424 A1 and Alvarez et al. US 2013/0298916 A1.
Regarding claim 8, the conflicting app in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
The conflicting app in view of Kussick further in view of Bergersen is silent on the plurality of protrusions being configured to protrude from 1 mm to 5 mm into a patient’s mouth.
However, Alvarez teaches an analogous tongue positioning device 11 (fig. 1 and [0031]) comprising analogous protrusions 20/21 being configured to protrude from 1 mm to 5 mm into a patient’s mouth (fig. 1 and [0049], protuberances 20/21 may have a height of 1-5 mm).
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 protrusions of the conflicting app in view of Kussick further in view of Bergersen to be configured to protrude from 1 mm to 5 mm into a patient’s mouth, as taught by Alvarez, to elicit a specific response from the tongue based on the topography of the patient’s mouth ([0049]).
Regarding claim 9, the conflicting app in view of Kussick further in view of Bergersen and Alvarez discloses the claimed invention as discussed above.
Alvarez further teaches the protrusions 20/21 being configured to protrude 1 mm into a patient’s mouth (fig. 1 and [0049], protuberances 20/21 may have a height of 1-5 mm), to elicit a specific response from the tongue based on the topography of the patient’s mouth ([0049]).
Claims 10, 11, 13, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/445,197 in view of Kussick US 4,997,182.
Regarding claim 10, claim 6 of the conflicting patent claims a tongue training appliance which is configured to be custom fitted to a patient's maxillary teeth (col. 6, lines 3-6) having: a shell configured to fit securely over the maxillary teeth having an anterior labial side and a posterior lingual side; a platform configured to extend from the posterior lingual side of the shell (col. 6, line 16, posterior of a crown being inherently the lingual side); and an aperture (col. 6, lines 16-18).
The conflicting patent is silent on the shell represents an outline of the maxillary teeth, wherein the shell is configured to fit over at least one pair of molars of the patient, and wherein the posterior lingual side of the shell includes a textured surface configured to be disposed at the at least one pair of molars of the patient; the platform configured to extend from a gum line of the patient.
However, Kussick teaches a tongue training appliance 10 (fig. 1 and col. 1, lines 5-7) having: a shell 10 represents an outline of the maxillary teeth (fig. 5, the shell 10 follows the general u-shaped outline of the maxillary teeth), wherein the shell 10 is configured to fit over at least one pair of molars of the patient (fig. 5), and wherein the posterior lingual side of the shell 10 includes a textured surface configured to be disposed at the at least one pair of molars of the patient (fig. 5, the shell 10 extends over the molars, and the lingual/inner surface at the molars has an inherent texture, as all materials have some type of texture (i.e., smooth, rough, etc.)); a platform 33 configured to extend from a gum line of the patient from the posterior lingual side of the shell 10 (fig. 1 and col. 3, lines 60-67; annotated fig. A further shows the extent of ramp 33 that is being interpreted as the “platform”, where the bottom end of the platform extends upwards from the gum line adjacent the top of the tooth 51).
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 appliance of the conflicting app in view of Bergersen such that the shell represents an outline of the maxillary teeth, wherein the shell is configured to fit over at least one pair of molars of the patient, and wherein the posterior lingual side of the shell includes a textured surface configured to be disposed at the at least one pair of molars of the patient; the platform configured to extend from a gum line of the patient, as taught by Kussick, to properly position the tongue (col. 2, lines 46-66).
Regarding claim 11, the conflicting app in view of Kussick discloses the claimed invention as discussed above.
The conflicting app further claims the entirety of the claim.
Regarding claim 13, the conflicting app in view of Kussick discloses the claimed invention as discussed above.
The conflicting app further claims the entirety of the claim.
Regarding claim 15, the conflicting app in view of Kussick discloses the claimed invention as discussed above.
Kussick further teaches a soft resin material (col. 5, lines 20-30, resin material is provided to be pressed against the dental arch to be shaped for retention, indicating its softness at this stage) and prepared using a 3-D printing machine (this is considered a product-by-process limitation, as there is no evidence that a resin material prepared by 3D printing or other method (for example, injection molding) would be structurally distinct from each other; please see MPEP 2113), to be accurately retained in the mouth according to individual teeth anatomy.
Claim(s) 14 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/445,197 in view of Kussick US 4,997,182 further in view of Kussick US 5,779,470 (“Kussick ‘470”).
Regarding claim 14, the conflicting app in view of Kussick discloses the claimed invention as discussed above.
The conflicting app claims the aperture being round (claim 6, the aperture is circular).
The conflicting app in view of Kussick is silent on the aperture being between 3 to 5 mm in diameter.
However, Kussick ‘470 teaches an analogous oral device 20 for positioning the tongue (fig. 1 and col. 1, lines 4-6) comprising an 9/9’ aperture being between 3 to 5 mm in diameter (fig. 2 and col. 6, lines 43-46, holes 9/9’ have a diameter from 2 to 8 mm, which includes 3 to 5 mm).
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 aperture of the conflicting app in view of Kussick to have a diameter between 3 to 5 mm, as taught by Kussick ‘470, to accommodate tongues of smaller size or patients who are using smaller appliances, such as children; please also note that while Kussick ‘470 doesn’t specifically teach a diameter between 3-5 mm, the instant specification does not indicate any criticality of the claimed range.
Regarding claim 16, the conflicting app in view of Kussick discloses the claimed invention as discussed above.
The conflicting app in view of Kussick is silent on the shell having a thickness of between 0.5 to 1 mm.
However, Kussick ‘470 teaches an analogous oral device 20 for positioning the tongue (fig. 1 and col. 1, lines 4-6) comprising a shell having a thickness of between 0.5 to 1 mm (fig. 1 and col. 8, lines 44-48, a portion 1 of the device 20 may have a thickness of 1-2 mm, which includes 1 mm).
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 shell of the conflicting app in view of Kussick to have a thickness of between 0.5 to 1 mm, as taught by Kussick ‘470, to be light and comfortable to wear; please also note that while Kussick ‘470 doesn’t specifically teach a thickness between 0.5-1 mm, the instant specification does not indicate any criticality of the claimed range.
Claim 18 is are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/445,197 in view of Kussick US 4,997,182 further in view of Bergersen US 2022/0409424 A1 and North US 4,718,6621.
Regarding claim 18, the conflicting app in view of Kussick further in view of Bergersen discloses the claimed invention as discussed above.
The conflicting app in view of Kussick further in view of Bergersen is silent on the appliance improving 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.
However, North teaches an analogous appliance 1 for correcting tongue thrust (fig. 1 and col. 1, lines 51-58), the appliance improving 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 (col. 1, lines 6-15, 20-40; col. 2, lines 7-23, the appliance producing better speaking abilities such as better production of speech sounds (which would include resonance and intelligibility, and improvement of articulatory precision of sounds) and correcting defective speech sounds (which would include decreasing a slushy sound, which is interpreted as any defective speech sound resulting from tongue thrust); while specific sounds are not taught by North, it is understood that since both North and the instant invention improve speech by preventing tongue thrust, the specific sounds that are treated would largely be the same absent evidence that the instant invention targets specific unexpected sounds).
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 appliance of the conflicting app in view of Kussick further in view of Bergersen to improve 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, as taught by North, to correct speech problems that are typically attributed to tongue thrusting (col. 1, lines 30-35).
Claim(s) 20 is are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/445,197 in view of Kussick US 4,997,182 and Parker US 6,357,444 B1.
Regarding claim 20, the conflicting app in view of Kussick discloses the claimed invention as discussed above.
The conflicting app in view of Kussick is silent on a kit, wherein the kit comprises the appliance, a patient instruction booklet, and myofunctional therapy training program material.
However, Parker teaches a therapeutic appliance 110 (fig. 9 and col. 7, lines 64-65) being provided in a kit 900, wherein the kit 900 comprises the appliance 110, a patient instruction booklet 912, and relevant therapy training program material (col. 7, line 63-col. 8, line 2, kit 900 includes pad 110 with instruction manual 912, wherein the instructions in the instruction manual is the relevant therapy training program material).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the myofunctional therapy appliance (tongue thrust being an orofacial myofunctional problem) of the conflicting app in view of Kussick in a kit, wherein the kit comprises the appliance, a patient instruction booklet, and relevant training program material, as taught by Parker, to teach patients how to easily use the appliance themselves.
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 MICHELLE J LEE whose telephone number is (571)270-7303. The examiner can normally be reached 9 AM - 5 PM.
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786