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
Claim 16 objected to because of the following informalities:
Claim 16, line 7-8 change “a surface shaped to contact one or more teeth of a second arch of the patient shaped to guide the one or more teeth of a second arch of the patient to a target” to “a surface shaped to contact one or more teeth of a second arch of the patient and shaped to guide the one or more teeth of a second arch of the patient to a target”.
Claim 21, lines 8-9 change “an occlusal surface along the second arch of the patient” to “an occlusal surface of a second arch of the patient’s dentition”.
Claim 21, line 9-10 change “thereby presenting an adjusted occlusal surface to the second arch of the patient’s dentition” to “thereby presenting the second surface as an adjusted occlusal surface to the second arch of the patient’s dentition”.
Claim 21, line 10 change “dentition shaped to guide the teeth of the second arch to a target position” to “dentition, wherein the adjusted occlusal surface shaped to guide teeth of the second arch to a target position”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Enoch (US 2008/0053463).
Regarding claim 16, Enoch discloses an appliance (mouthpiece 10) for the treatment or prevention of temporomandibular joint dysfunction (TMD) (par 5 discloses the repositioning of the lower jaw forward to prevent snoring and can also reposition the lower jaw forward in a manner that can relieve pain), comprising:
a shell (U shaped upper arch 12) comprising a plurality of tooth-receiving cavities shaped to fit teeth of a first arch of a patient's dentition (upper surface 14 which discloses a shape to fit the upper teeth in par 21); and
a lingual repositioning splint (mandibular anterior extension28, see figures 1-3) attached to the shell (see figures 1-3), and extending away from the shell (see figures 1-3), the lingual repositioning splint (28) comprising a surface (exterior surface 32) shaped to contact one or more teeth of a second arch of the patient when the appliance is worn (par 26 discloses the extension 28 being aligned to contact the back of the patient’s teeth and pushing the lower teeth forward) and shaped to guide the one or more teeth of a second arch of the patient to a target position (par 27-28 discloses shifting the opposite jaw forward a desired amount from a natural resting position which is interpreted as a target position), and to thereby adjust the patient's bite from a natural bite configuration toward a target bite configuration based on the contact between the one or more teeth of the second arch and the surface of the lingual repositioning splint (par 28-29 disclose repositioning the jaw of the patient to a desired forward position from a natural one, which results in a change in the bite to a target bite related to the repositioned jaw).
Regarding claim 18, Enoch discloses the surface is shaped to correct an overbite (the surface is shaped to correct an overbite (the limitation is interpreted as intended use of the claimed invention, as Enoch discloses the claimed structure as set forth in claim 16, it is considered capable of performing the intended use, this is further supported by the extension being used to push the jaw forward as disclosed in par 26).
Regarding claim 19, Enoch discloses the surface is shaped to correct an underbite (the limitation is interpreted as intended use of the claimed invention, as Enoch discloses the claimed structure as set forth in claim 16, it is considered capable of performing the intended use).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4-8, 10-12, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Ball (US 2005/0022824) in view of Magness (US 2016/0200102).
Regarding claim 4, Ball discloses an appliance (see figures 1 and 2) comprising:
an occlusal repositioning splint (occlusal splint 2) comprising:
a first surface (upper part 4/moulded pockets 6) shaped to extend over a plurality of teeth (see figures 1 and 2), and
a second surface (contact portion 8) opposite the first surface and having a varying surface height (see figure 8-9), thereby forming an adjusted occlusal surface to a second arch of the patient's dentition when the appliance is worn (via three sections 10,20 and 30), wherein the adjusted occlusal surface is shaped to contact an occlusal surface along the second arch of the patient and guide the teeth of the second arch to a target position in relation to the second surface of the occlusal repositioning splint (see figures 10-13),
wherein the adjusted occlusal surface is shaped to alter the natural occlusion of the first and second arches, thereby urging the patient's bite from a natural bite configuration towards a target bite configuration, and wherein the occlusal repositioning splint is shaped to modify a gap between occlusal surfaces of the teeth of the first arch and the second arch resulting from the target bite configuration (see figures 10-13 which shows a difference in bite configuration and spacing between the arches, this is further supported in par 55 which discloses the splint being worn in “the normal habitual teeth together position which is comfortable as the spacing” and par 56 discloses the splint being pushing forward “resulting in the spacing of the rear teeth being least maintained substantially at a spacing”).
Ball fails to disclose a shell comprising a plurality of tooth-receiving cavities shaped to fit teeth of a first arch of a patient's dentition and the first surface of the occlusal repositioning splint being shaped to attach to the shell and extend over a plurality of tooth- receiving cavities of the shell.
Magness teaches an appliance (appliance 10, see figures 1-3) comprising a shell (base 20) comprising a plurality of tooth-receiving cavities shaped to fit teeth of a first arch of a patient's dentition (par 51 discloses the bass 20 being shaped to selectively engage one or more teeth of a patient as seen in figure 1) and an occlusal repositioning splint (feature 22) comprising a first surface (floor 38 of channel 30) shaped to attach to the shell and extend over a plurality of tooth- receiving cavities of the shell (par 59 discloses the attachment of the feature 22 to the base 20 via channel 30 and extends over a plurality of teeth as seen in figures 2-3) for the purpose of preserving an orthodontic tooth position and reduce muscle strain, tension and pain in the muscles of the jaw (par 62).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Ball teaches combining the occlusal repositioning splint with a shell comprising a plurality of tooth-receiving cavities shaped to fit teeth of a first arch of a patient's dentition, having the first surface of the occlusal repositioning splint being shaped to attach to the shell and extend over a plurality of tooth- receiving cavities of the shell as taught by Magness for the purpose of preserving an orthodontic tooth position and reduce muscle strain, tension and pain in the muscles of the jaw.
Regarding claim 5, Ball further discloses the appliance is for the treatment of temporomandibular joint dysfunction (TMD) (par 6).
Regarding claim 6, Ball further discloses the appliance is for the prevention of temporomandibular joint dysfunction (TMD) (par 5-6).
Regarding claim 7, Ball further discloses the appliance (figures 1-2) further comprises a tooth engagement structure (three sections or portions 10,20,30) to apply a tooth moving force to the teeth of the second arch when the appliance is worn, thereby urging one or more teeth of the patient to fill the gap between occlusal surfaces (see figures 10-13).
Regarding claim 8, Ball/Magness discloses the claimed invention as set forth above. Magness teaches the adjusted occlusal surface (28) is shaped to occlude with an appliance shell (20/22) worn on the teeth of the second arch of the patient's dentition (see figure 1), for the reasons set forth above.
Regarding claim 10, Ball/Magness discloses the claimed invention as set forth above. Magness teaches the occlusal repositioning splint is integrally attached to the shell (par 59 discloses 20 and 22 being integral), for the reasons set forth above.
Regarding claim 11, Ball further discloses the second surface is shaped to fit a disocclusion between a subset of posterior teeth of the first arch and second arch, in a resting jaw position (see par 55-56).
Regarding claim 12, Ball/Magness disclose the claimed invention as set forth above in claim 4. Magness further teaches the second surface (28) comprises one or more sliding ramped contacts on anterior teeth of the patient (see figures 20-22, where the concave surface provides one or more ramped surfaces to the center portion), the sliding ramped contacts shaped to provide anterior guidance during lateral excursions and anterior protrusions of the jaw (see figure 21-22 which shows lateral movement of the anterior portion of the jaw), for the reasons set forth above.
Regarding claim 21, Ball discloses an appliance (see figures 1 and 2) comprising:
an occlusal repositioning splint (2) comprising:
a first surface (4/6) extends over a plurality of teeth (see figures 1 and 2),
a second surface (8) opposite the first surface and having a varying surface height (see figures 8-9) wherein the second surface is shaped to contact an occlusal surface along the second arch of the patient (see figures 10-13) when the appliance is worn thereby presenting an adjusted occlusal surface to a second arch of the patient’s dentition and shaped to guide the teeth of the second arch to a target position when the appliance is worn (see figures 10-13, which shows a difference in bite configuration and spacing between the arches, this is further supported in par 55 which discloses the splint being worn in “the normal habitual teeth together position which is comfortable as the spacing” and par 56 discloses the splint being pushing forward “resulting in the spacing of the rear teeth being least maintained substantially at a spacing”),
wherein the adjusted occlusal surface is shaped to alter the natural occlusion of the first and second arches, thereby urging the patient’s bite from a natural bite configuration towards a target bite configuration (par 55 as set forth above the splint pushes the jaw forward resulting in a new positioning of the bite), and
wherein the occlusal repositioning splint is shaped to modify a gap between occlusal surfaces of the teeth of the first and second arch resulting from the target bite configuration (see par 10-13, where the gap between the arches changes from “s” to “t”, further stated in par 56).
Ball fails to disclose the appliance including a shell comprising a plurality of tooth receiving cavities shaped to fit teeth of a first arch of a patient’s dentition and the first surface shaped to attach to the shell and extend over a plurality of tooth receiving cavities of the shell.
Magness teaches an appliance (appliance 10, see figures 1-3) comprising a shell (base 20) comprising a plurality of tooth-receiving cavities shaped to fit teeth of a first arch of a patient's dentition (par 51 discloses the bass 20 being shaped to selectively engage one or more teeth of a patient as seen in figure 1) and an occlusal repositioning splint (feature 22) comprising a first surface (floor 38 of channel 30) shaped to attach to the shell and extend over a plurality of tooth- receiving cavities of the shell (par 59 discloses the attachment of the feature 22 to the base 20 via channel 30 and extends over a plurality of teeth as seen in figures 2-3) for the purpose of preserving an orthodontic tooth position and reduce muscle strain, tension and pain in the muscles of the jaw (par 62).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Ball teaches combining the occlusal repositioning splint with a shell comprising a plurality of tooth-receiving cavities shaped to fit teeth of a first arch of a patient's dentition, having the first surface of the occlusal repositioning splint being shaped to attach to the shell and extend over a plurality of tooth- receiving cavities of the shell as taught by Magness for the purpose of preserving an orthodontic tooth position and reduce muscle strain, tension and pain in the muscles of the jaw.
Regarding claim 22, Ball/Magness disclose the claimed invention as set forth above in claim 21. The limitation “the appliance is for treatment of an overbite”, is interpreted as intended use of the claimed invention, where depending on the positioning of the appliance of Ball/Magness (on the upper or lower dentition) the disclosed path of the second surface of Ball can correct an overbite.
Regarding claim 23, Ball/Magness disclose the claimed invention as set forth above in claim 21. The limitation “the appliance is for prevention of an underbite”, is interpreted as intended use of the claimed invention, specifically the maximum position of the opposite arch in Ball provides a second surface that stops prior to achieving an underbite, see figures 12-13.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ball in view of Magness as applied to claim 4 above, and further in view of Rayek et al (US 2016/0228286).
Regarding claim 9, Ball/Magness discloses the claimed invention as set forth above in claim 4, but fails to explicitly disclose the occlusal repositioning splint is removably attached to the shell.
Rayek teaches an occlusal repositioning splint (fins and ridges 206/208) which is removably attached to a shell (aligners 202/204, see figure 7) for the purpose enabling separate day and night therapy (par 39)
Therefore, it would be obvious to one of ordinary skill in the art, to modify Ball/Magness to have the occlusal repositioning splint is removably attached to the shell as taught by Rayek for the purpose of enabling separate day and night therapies.
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ball et al in view of Magness as applied to claim 4 above, and further in view of Falkel (US 2018/0078344).
In regard to claim 13, Ball/Magness discloses the claimed invention as set forth above by claim 4, but fails to disclose further including a first mandibular repositioning structure extending from the shell and shaped to engage and apply a condylar repositioning force to a second mandibular repositioning structure extending from a second shell when the second shell is worn on a mandibular arch of a patient.
However, Falkel teaches a first mandibular repositioning structure (maxillary block 12) extending from the shell (aligner 38a) and shaped to engage and apply an condylar repositioning force to a second mandibular repositioning structure (mandibular block 14) extending from a second shell (mandibular aligner 38b) when the second shell is worn on a mandibular arch of a patient (par 108 discloses the integration of posterior guides to guide the positioning of the lower and upper arches into a closed position thus applying forces on the condyle) for the purpose of providing TMD in concurrence with the orthodontic movement of teeth (par 109).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Ball/Magness to have a first mandibular repositioning structure extending from the shell and shaped to engage and apply an condylar repositioning force to a second mandibular repositioning structure extending from a second shell when the second shell is worn on a mandibular arch of a patient as taught by Falkel for the purpose of concurrently treating TMD with orthodontic movement of teeth.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ball in view of Magness as applied to claim 4 above, and further in view of Gardner (US 2018/0078342).
Regarding claims 14-15, Ball/Magness discloses at least one appliance according to claim 4 above, but fails to disclose plurality of appliances for the treatment or prevention of temporomandibular joint dysfunction (TMD), wherein the plurality of appliances is configured to move the patient's dentition from the natural bite configuration to a final bite configuration through a sequence on incremental steps when the plurality of appliances is worn in succession and at least one appliance of the plurality of appliances comprises a tooth engagement structure to apply a tooth moving force when the appliance is worn, thereby urging one or more teeth of the patient to fill the gap between occlusal surfaces.
However, Gardner teaches plurality of appliances for the treatment or prevention of temporomandibular joint dysfunction (TMD (par 10 discloses a set of dental appliances being used for teeth alignment and treatment of temporomandibular dysfunction) wherein the plurality of appliances is configured to move the patient's dentition from the natural bite configuration to a final bite configuration through a sequence on incremental steps when the plurality of appliances is worn in succession (par 32 discloses the design of the polymeric shells in an order to shift teeth to a desired position) and at least one appliance of the plurality of appliances comprises a tooth engagement structure to apply a tooth moving force when the appliance is worn (which is interpreted as the shape of the shell, according to par 32-33 which is designed to apply repositioning force to the teeth which are targeted for movement by design), thereby urging one or more teeth of the patient to fill the gap between occlusal surfaces (see par 32-33 which discloses the design of the shells being to apply incremental repositioning force for targeted teeth, which can include occlusal surface) for the purpose of treating TMD and aligning teeth concurrently (par 31).
Therefore it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Ball/Magness to plurality of appliances for the treatment or prevention of temporomandibular joint dysfunction (TMD), wherein the plurality of appliances is configured to move the patient's dentition from the natural bite configuration to a final bite configuration through a sequence on incremental steps when the plurality of appliances is worn in succession and at least one appliance of the plurality of appliances comprises a tooth engagement structure to apply a tooth moving force when the appliance is worn, thereby urging one or more teeth of the patient to fill the gap between occlusal surfaces as taught by Gardner for the purpose of treating TMD and aligning teeth concurrently.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Enoch as applied to claim 16 above, and further in view of Kussick (US 4,773,853).
In regard to claim 17, Enoch discloses the claimed invention as set forth above in claim 16, but fails to disclose the surface is shaped with an indentation to receive the one or more teeth of the second arch, the indentation positioned to provide an incremental adjustment of the bite of the patient away from the natural bite configuration and toward the target bite configuration.
Kussick teaches a surface is shaped with an indentation (longitudinal ridges 130,132,134, 150 and 152 are positioned on a surface facing away from the tongue, see figure 1) to receive the one or more teeth of a second arch (see figure 7), the indentation positioned to provide an incremental adjustment of the bite of the patient away from the natural bite configuration and toward the target bite configuration (col 7, lines 40-52 disclose repositioning the teeth on the indention lines to treat different malocclusions) for the purpose of comfortably modifying the teeth position (col 7, lines 30-35) .
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Enoch to have the surface shaped with an indentation to receive the one or more teeth of the second arch, the indentation positioned to provide an incremental adjustment of the bite of the patient away from the natural bite configuration and toward the target bite configuration for the as taught by Kussick for the purpose of comfortably modifying the teeth position.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Enoch as applied to claim 16 above, and further in view of Gardner.
Regarding claim 20, Enoch discloses the claimed invention as set forth above for claim 16, but fails to disclose the appliance further comprises a tooth engagement structure to apply a tooth moving force when the appliance is worn.
However, Gardner teaches an appliance (polymeric shell 10) that comprises tooth engagement structure (which is interpreted as the shape of the shell, according to par 32-33 which is designed to apply repositioning force to the teeth which are targeted for movement by design) to apply a tooth moving force when the appliance is worn (see par 32-33 which discloses the design of the shells being to apply incremental repositioning force for targeted teeth, which can include occlusal surface) for the purpose of treating TMD and aligning teeth concurrently (par 31).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Enoch to have to a tooth engagement structure to apply a tooth moving force when the appliance is worn as taught by Gardner for the purpose of concurrently treating TMD and aligning teeth concurrently.
Response to Arguments
Applicant’s arguments with respect to claims 4-15 and 21-23 have been considered but are moot because the new ground of rejection does not rely on the combination of reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments regarding claims 16-20 have been fully considered but they are not persuasive.
Applicant states on page 8-9, that Enoch fails to recite or teach every element of claim 16, specifically "a surface shaped to contact one or more teeth of a second arch of the patient shaped to guide the one or more teeth of a second arch of the patient to a target position when the appliance is worn, and to thereby adjust the patient's bite... based on the contact between the one or more teeth of the second arch and the surface of the lingual repositioning splint" and further elaborates by stating that Enoch does not disclose contact between one or more teeth of the second arch and the lingual repositioning splint and does not disclose repositioning of the occlusal surface to a target position. The examiner disagrees, as set forth above, Enoch does disclose contact between one or more teeth of the opposite arch and the lingual repositioning splint (par 26 discloses the extension 28, which extends from the lower surface of the mouthpiece body 12, being against the back of the front teeth, pushing the tongue back and the jaw of the user forward). Enoch also discloses repositioning the jaw during wear to a targeted or final position (par 28-29 disclose repositioning the jaw of the patient to a desired forward position from a natural one), which results in a change in the bite to a target bite related to the repositioned jaw.
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.
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/S.N.B./ Examiner, Art Unit 3772
/THOMAS C BARRETT/ SPE, Art Unit 3799