Detailed office Action
Applicant’s amendments and arguments dated 4/7/2026 have been entered and fully considered. Claims 1-3, 7-8, 12, and 27 are amended. Claims 13-22 are cancelled. Claims 1-12 and 23-30 remain pending.
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 Amendments and Arguments
Applicant’s amendments have overcome claims objections and 35 USC 112(b) rejections previously set forth in the non-final office action of 1/9/2026. The objections and rejections are withdrawn.
The amendments to independent claims 1 and 12 are noted. As recited by these amendments, the primary art of CHEN discloses these limitations. The Examiner notes that the amendments recite that the mounting surface, and not the dental appliance, is spaced away from tooth or gingiva (emphasis added by the Examiner). CHEN discloses this limitation {[FIG. 2A] note that the mounting surface where 103b/200b is located is below the gum line of the dental appliance 101b (note the top line contacts the gum line) and also the thickness of the dental appliance 101b keeps the mounting surface away from the tooth}.
However, and in the interest of compact prosecution, if this limitation is amended so that it recites “wherein the dental appliance, at the mounting surface location, is spaced away from a patient’s tooth or gingiva”, a rejection over a new cited art is made in the office action and detailed below in the 35 USC 103 section.
Claim Objections
Claim 8 is objected to because of the following informalities: in line 2 replace “surfaces” with “surface” to be consistent with earlier limitations. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, 9, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over CHEN (CN-205359667-U, of record, the English translation provided by Examiner), hereinafter CHEN, in view of KNOPP (US-2008/0109198), hereinafter KNOPP, and WEBBER (US-2016/0361139), hereinafter WEBBER. Note that the italicized text below are the instant claims.
Regarding claims 1-2, CHEN discloses A method for attaching a monitoring electronics unit to a dental appliance {[abstract] tooth socket is the dental appliance (note highlighted text on page 1) and the sensor is the monitoring unit}, the method comprising:
fabricating the dental appliance, wherein the dental appliance includes a mounting surface {[P4] note the highlighted text on 3D printing that is the method of fabrication of the dental appliance, [FIG. 2A] note the mounting surface on the dental appliance 100b},
wherein the mounting surface of the dental appliance is spaced away from a patient's tooth or gingiva {[FIG. 2A] note that the mounting surface where 103b/200b is located is below the gum line of the dental appliance 101b (note the top line contacts the gum line) and also the thickness of the dental appliance 101b keeps the mounting surface away from the tooth};
positioning a housing at least partially enclosing the monitoring electronics unit on the mounting surface {[FIG. 2B] note 103b is the housing that houses the monitoring electronics unit 200b; and
welding the housing to the mounting surface {[P4] note the highlighted text regarding welding}.
CHEN, however, is silent on limitation of claim 1 reciting that the mounting location is determined by a mounting location optimization protocol and the details of this protocol as recited in claim 2.
In the same field of endeavor that is related to attachment device for dental appliances, KNOPP discloses mounting surface at a mounting location determined by a mounting location optimization protocol (claim 1), further comprising determining the mounting surface at the mounting location by the mounting location optimization protocol comprising: optimizing a location of the mounting surface in a digital model of the dental appliance by: iteratively adjusting one or more of a position, an angulation and an orientation of the mounting surface relative to a patient's dental arch corresponding to the digital model of the patient's dentition, until each of the position, the angulation and the orientation of the mounting surface in the digital model of the dental appliance are within a constrained range relative to a digital model of a patient's dentition and the mounting surface does not collide with the patient's teeth or with a treatment feature of the dental appliance (claim 2) {[abstract] note providing digital model of the attachment and the tooth or patient’s dentition, [0010] note teachings regarding specific positional relationship, [0016] note the attachment device or housing can be connected to a dental feature or dental appliance, [0017] note determining the appropriate location that meets the constraints and thus not colliding, note that the attachment device or housing can be designed to work with a removable dental appliance thus attached to it, [0082]-[0083] note the optimization protocol regarding the position and orientation of the attachment, note adjusting requires iteration}.
At the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to have incorporated the teachings of KNOPP in the method of CHEN and have used the optimization protocol of KNOPP using digital models of the appliance and patient’s dentition to determine an optimum location and orientation of the housing or attachment. As disclosed by KNOPP, the advantage of this method is greater accuracy and less operator training {[0014], [0075]}.
As discussed under the argument section above, and in the interest of compact prosecution, if the amended limitation of claim 1 is changed to “wherein the dental appliance, at the mounting surface location, is spaced away from a patient’s tooth or gingiva”, modified CHEN is silent on this limitation.
In the same field of endeavor that is related to dental appliance with binding structure, WEBBER discloses wherein the dental appliance, at the mounting surface location, is spaced away from a patient’s tooth or gingiva {[0057], [FIG. 2] note mounting surfaces 205-1 and 205-N of the dental appliance 202 are bulged out thus, at this location the dental appliance is spaced aways from gum and tooth}.
At the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to have incorporated the teachings of WEBBER in the method of modified CHEN and have incorporated the binding structure taught by WEBBER. As disclosed by WEBER, the advantage of this structure is that additional mounting surfaces can be created {[0057]}. This allows for attachment of more than one sensor.
Regarding claim 3, modified CHEN discloses further comprising placing the monitoring electronics unit into the housing {[FIG. 2B] note 200b is placed into 103b}.
Regarding claim 5, modified CHEN discloses wherein the dental appliance comprises an aligner {[FIG. 2A] note 100b is an aligner}.
Regarding claim 9, KNOPP discloses where positioning the housing includes applying clamping force to the housing {[0019] note the attachment body or housing is clamped by force of a flexible band to stay in location}.
At the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to have incorporated the teachings of KNOPP in the method of CHEN and have used the clamping force of the flexible band. As shown above, this method keeps the housing secure.
Regarding claim 23 limitation of “wherein iteratively adjusting the position comprises iteratively adjusting a distance from the mounting surface to a gingiva surface, further wherein the constraint range of the distance from the mounting surface to the gingiva surface is between 0.5 and 1.0 mm”, KNOPP discloses that a desired location for the attachment needs to be found based on the above disclosed optimization protocol and this desired location is dependent on a set goal {[0020]}. As such, KNOPP recognizes the desired location or the constraint distance as a result-effective variable that depends on the goal of this appliance and attachment.
It is well established that determination of optimum values of result-effective variables (in this case, the distance of the mounting surface in relation to gingiva surface) is within the skill of one practicing in the art {see MPEP 2144.05 (ll)(B)}. At the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to have optimized this location which is a result-effective variable through routine experimentation to have determined the desired location that in certain circumstances could reach the claimed distances.
Claims 4, 7-8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over CHEN, KNOPP, and WEBBER as applied to claim 1 above, and further in view of KUGELMAN (US-2014/0127668), hereinafter KUGELMANN.
Regarding claims 4, 7-8, and 10-11, combination of CHEN, KNOPP, and WEBBER discloses all the limitations of claim 1 as discussed above. This combination, however, is silent on the preparation of the mounting surfaces of the housing for the detailed welding of the housing to the dental appliance using an infrared laser.
In the same field of endeavor that is related to the laser welding of polymeric material, KUGELMAN discloses further comprising preparing mounting surfaces of the housing (claim 4), wherein preparing the mounting surfaces include applying an infrared-absorbent spray to the mounting surfaces of the housing (claim 7), further comprising applying the infrared- absorbent spray to the mounting surface of the dental appliance (claim 8), wherein welding includes heating the housing and the dental appliance via a laser (claim 10), wherein the laser is a Yttrium-Aluminum Garnet laser (claim 11) {[abstract], [0005] note laser in infrared range, [0007] note infrared dye or absorber, [0008] note preparation of surface by functional coating of an absorber; note that it is known that coating can be done by spraying, [0066] note Yttrium-Aluminum Garnet laser}.
At the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to have incorporated the teachings of KUGELMANN in the combination method of CHEN, KNOPP, and WEBBER and have performed the welding of the parts by the infrared laser welding and application of an infrared absorber of KUGELMANN. As disclosed by KUGELMANN, the advantage of this welding method is that complex geometries of the joint surfaces can be welded quickly and efficiently {[0004]}.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over CHEN, KNOPP, and WEBBER as applied to claim 1 above, and further in view of KOPELMAN (US-2019/0192259), hereinafter KOPELMAN.
Regarding claim 6, combination of CHEN, KNOPP, and WEBER discloses all the limitations of claim 1 as discussed above. This combination, however, is silent on the monitoring electronics unit comprising an ECI.
In the same field of endeavor that is related to dental appliances with attachment, KOPELMAN discloses wherein the monitoring electronics unit comprises an electronics compliance indicator (ECI) {[0034]}.
At the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to have substituted the sensor of CHEN with the ECI of KOPELMAN, since it has been held that simple substitution of one known element for another to obtain predictable results is within the skill of one of ordinary skill in the art {see MPEP 2143 (I)(B)}. Moreover, as disclosed by KOPELMAN, the advantage of this sensor is to monitor the compliance of the patient in wearing the dental appliance {[0005], [0034]}.
Claims 12, 24, and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over CHEN, in view of KNOPP, KUGELMANN, and WEBBER.
Regarding claims 12, 26-27, and 29, CHEN discloses A method for attaching a monitoring electronics unit to a dental appliance {[abstract] tooth socket is the dental appliance (note highlighted text on page 1) and the sensor is the monitoring unit}, the method comprising:
fabricating the dental appliance, wherein the dental appliance includes a mounting surface {[P4] note the highlighted text on 3D printing that is the method of fabrication of the dental appliance, [FIG. 2A] note the mounting surface on the dental appliance 100b},
wherein the mounting surface of the dental appliance is spaced away from a patient's tooth or gingiva {[FIG. 2A] note that the mounting surface where 103b/200b is located is below the gum line of the dental appliance 101b (note the top line contacts the gum line) and also the thickness of the dental appliance 101b keeps the mounting surface away from the tooth};
placing the monitoring electronics unit into a housing {[FIG. 2B] note 200b is placed into 103b}:
positioning the housing at least partially enclosing the monitoring electronics unit on the mounting surface {[FIG. 2B] note 103b is the housing that houses the monitoring electronics unit 200b}; and
welding the housing to the mounting surface {[P4] note the highlighted text regarding welding}.
CHEN, however, is silent on that the mounting location is determined by a mounting location optimization protocol and the details of this protocol.
In the same field of endeavor that is related to attachment device for dental appliances, KNOPP discloses mounting surface at a mounting location determined by a mounting location optimization protocol, wherein the mounting location optimization protocol comprising: optimizing a location of the mounting surface in a digital model of the dental appliance by iteratively adjusting one or more of a position, an angulation and an orientation of the mounting surface relative to a patient's dental arch corresponding to the digital model of the patient's dentition, until each of the position, the angulation and the orientation of the mounting surface in the digital model of the dental appliance are within a constrained range relative to the digital model of the patient's dentition and the mounting surface does not collide with the patient's teeth or with a treatment feature of the dental appliance {[abstract] note providing digital model of the attachment and the tooth or patient’s dentition, [0010] note teachings regarding specific positional relationship, [0016] note the attachment device or housing can be connected to a dental feature or dental appliance, [0017] note determining the appropriate location that meets the constraints and thus not colliding, note that the attachment device or housing can be designed to work with a removable dental appliance thus attached to it, [0082]-[0083] note the optimization protocol regarding the position and orientation of the attachment, note adjusting requires iteration}.
At the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to have incorporated the teachings of KNOPP in the method of CHEN and have used the optimization protocol of KNOPP using digital models of the appliance and patient’s dentition to determine an optimum location and orientation of the housing or attachment. As disclosed by KNOPP, the advantage of this method is the greater accuracy and less operator training {[0014], [0075]}.
Combination of CHEN and KNOPP, however, is silent on the preparation of the mounting surfaces of the housing (claim 12) for the detailed welding of the housing to the dental appliance using an infrared laser (claims 26-27 and 29).
In the same field of endeavor that is related to the laser welding of polymeric material, KUGELMAN discloses preparing mounting surfaces of the housing (claim 12), wherein preparing the mounting surfaces include applying an infrared-absorbent spray to the mounting surfaces of the housing (claim 26), further comprising applying an infrared- absorbent spray to mounting surfaces of the dental appliance (claim 27), wherein welding includes heating the housing and the dental appliance via a laser (claim 29) {[abstract], [0005] note laser in infrared range, [0007] note infrared dye or absorber, [0008] note preparation of surface by functional coating of an absorber; note that it is known that coating can be done by spraying, [0066] note laser}.
At the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to have incorporated the teachings of KUGELMANN in the combination method of CHEN and KNOPP and have performed the welding of the parts by the infrared laser welding and application of an infrared absorber of KUGELMANN. As disclosed by KUGELMANN, the advantage of this welding method is that complex geometries of the joint surfaces can be welded quickly and efficiently {[0004]}.
As discussed under the argument section above, and in the interest of compact prosecution, if the amended limitation of claim 12 is changed to “wherein the dental appliance, at the mounting surface location, is spaced away from a patient’s tooth or gingiva”, modified CHEN is silent on this limitation.
In the same field of endeavor that is related to dental appliance with binding structure, WEBBER discloses wherein the dental appliance, at the mounting surface location, is spaced away from a patient’s tooth or gingiva {[0057], [FIG. 2] note mounting surfaces 205-1 and 205-N of the dental appliance 202 are bulged out thus, at this location the dental appliance is spaced aways from gum and tooth}.
At the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to have incorporated the teachings of WEBBER in the method of modified CHEN and have incorporated the binding structure taught by WEBBER. As disclosed by WEBER, the advantage of this structure is that additional mounting surfaces can be created {[0057]}. This allows for attachment of more than one sensor.
Regarding claim 24, modified CHEN discloses wherein the dental appliance comprises an aligner {[FIG. 2A] note 100b is an aligner}.
Regarding claim 28, KNOPP discloses where positioning the housing includes applying clamping force to the housing {[0019] note the attachment body or housing is clamped by force of a flexible band to stay in location}.
At the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to have incorporated the teachings of KNOPP in the method of CHEN and have used the clamping force of the flexible band. As shown above, this method keeps the housing secure.
Regarding claim 30 limitation of “wherein iteratively adjusting the position comprises iteratively adjusting a distance from the mounting surface to a gingiva surface, further wherein the constraint range of the distance from the mounting surface to the gingiva surface is between 0.5 and 1.0 mm”, KNOPP discloses that a desired location for the attachment needs to be found based on the above disclosed optimization protocol and this desired location is dependent on a set goal {[0020]}. As such, KNOPP recognizes the desired location or the constraint distance as a result-effective variable that depends on the goal of this appliance and attachment.
It is well established that determination of optimum values of result-effective variables (in this case, the distance of the mounting surface in relation to gingiva surface) is within the skill of one practicing in the art {see MPEP 2144.05 (ll)(B)}. At the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to have optimized this location which is a result-effective variable through routine experimentation to have determined the desired location that in certain circumstances could reach the claimed distances.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over CHEN, KNOPP, KUGELMANN, and WEBBER as applied to claim 12 above, and further in view of KOPELMAN.
Regarding claim 25, combination of CHEN, KNOPP, KUGELMANN, and WEBBER discloses all the limitations of claim 12 as discussed above. This combination, however, is silent on the monitoring electronics unit comprising an ECI.
In the same field of endeavor that is related to dental appliances with attachment, KOPELMAN discloses wherein the monitoring electronics unit comprises an electronics compliance indicator (ECI) {[0034]}.
At the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to have substituted the sensor of CHEN with the ECI of KOPELMAN, since it has been held that simple substitution of one known element for another to obtain predictable results is within the skill of one of ordinary skill in the art {see MPEP 2143 (I)(B)}. Moreover, as disclosed by KOPELMAN, the advantage of this sensor is to monitor the compliance of the patient in wearing the dental appliance {[0005], [0034]}.
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 S. BEHROOZ GHORISHI whose telephone number is (571)272-1373. The examiner can normally be reached Mon-(alt Fri) 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Abbas Rashid can be reached at 571-270-7457. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S. BEHROOZ GHORISHI/Primary Examiner, Art Unit 1748
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