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 .
In the amendment filed 11/5/25, claims 13,20-37 and 39-48 have been canceled. Claims 1-12,14-19 and 38 remain in the application with claims 16-19 and 38 having been withdrawn from consideration as being directed toward a non-elected invention. Claims 1-12,14 and 15 remain in the application for prosecution thereof.
Considering the amendment filed 11/5/25, the 35 USC 103 rejection has been withdrawn. However, the following rejection has been necessitated by the amendment.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-6,10,11,14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Zegarelli (2016/0278900) in combination with either Zegarelli (2017/0347956) or Cinader et al. (2006/0084026) further in combination with Fernandez (2017/0043896) and Takahashi (10,300,597).
Zegarelli (2016/0278900) teaches an oral appliance for delivery of medicaments and/or other substances to at least a portion of teeth and/or soft tissue areas inside a mouth. The oral appliance contains an interior having a medicant material disposed in or on at least a portion of and/or the entire surface of the oral appliance. The interior surface of the oral cavity is formed to fit contours of at least the portion of the teeth and/or soft tissue areas inside the oral cavity (abstract). Zegarelli (2016/0278900) teaches the medicament is disposed in or on at least a portion (claimed discrete regions) of the interior surface of the oral appliance [0013],[0014],[0019],[0042].
Zegarelli (2016/0278900) fails to teach providing a robotic dispensing device and dispensing medicament to the discrete regions.
Zegarelli (2017/0347956) teaches oral data collecting device for diagnosis or prognosis (abstract). Zegarelli (2017/0347956) teaches in Fig 6B, a hydrogel disposed by hand or robotically on the interior surface of the oral appliance in discrete positions [0036],[0091].
Cinader et al. (2006/0084026) teaches an orthodontic methods and apparatus for applying a composition to patient’s teeth such as a bonding composition to selected areas (claimed discrete regions) simultaneously (abstract). Cinader et al. (2006/0084026) teaches in Fig. 5, a composition (34) being dispensed onto transfer section (32) in automated fashion using a robotic arm that is connected to a source of the composition (34) [0080].
Therefore, it would have been obvious for one skilled in the art before the effective filing date of the claimed invention to have modified Zegarelli (2016/0278900) by applying the medicament to discrete regions using a robotic arm as evidenced by Zegarelli (2017/0347956) or Cinader et al. (2006/0084026) with the expectation of producing a medicament oral appliance for treating the oral cavity at desired and discrete locations.
Zegarelli (2016/0278900) in combination with either Zegarelli (2017/0347956) or Cinader et al. (2006/0084026) fails to teach using a robotic arm with gripper to hold oral appliance for further dispensing of medicament into the oral appliance and a wrist connected and configured to laterally move gripper.
Fernandez (2017/0043896) teaches an automated machine for assembling oral medicaments dispensers whereby grippers are utilized to hold a syringe for subsequent dispensing of the medicament therein (abstract, [0023] and Fig. 8).
Takahashi (10,300,597) teaches a robot and method of operating a robot which includes a wrist section (236 connected to a twist mechanism (470) allowing for movement thereof (abstract, Fig. 1 and col. 5, lines 9-27).
Therefore, it would have been obvious for one skilled in the art before the effective filing date of the claimed invention to have modified Zegarelli (2016/0278900) in combination with either Zegarelli (2017/0347956) or Cinader et al. (2006/0084026) process to include the gripper having a wrist connected thereto for laterally moving the gripper for handling the oral appliance as evidenced by Fernandez (2017/0043896) with the expectation of precise application of the medicament to discrete regions of the oral appliance.
While the Examiner acknowledges Fernandez (2017/0043896) teaches a syringe for receiving the medicament, the Examiner takes the position that one skilled in the art would have had a reasonable expectation of success using the oral appliance of Zegarelli (2016/0278900) in combination with Zegarelli (2017/0347956) would produce more precise coating thereof using a robotic arm/gripper device. Takahashi (10,300,597) teaches using a robot for handling a workpiece and in combination with the above reference which teach using robots to apply medicament to oral appliance, one skilled in the art would have had a reasonable expectation of similar success using the claimed robot/gripper/wrist combination for coating medicament in an oral appliance.
Regarding claim 1, the claims recite oral appliance having a projection or recess comprising a handle or gripping surface” whereby the reference teach using a robotic arm to grip the oral appliance which would inherently have a “gripping surface” (surface area which is gripped by the gripper meets the claimed “gripping surface”).
Regarding claim 2, Cinader et al. (2006/0084026) teaches in Fig. 5 a composition (34) being dispensed onto transfer section (32) in automated fashion using a robotic arm that is connected to a source of the composition (34) [0080].
Regarding claim 3, Zegarelli (2016/0278900) teaches the discrete regions are adjacent to a treatment area and the medicament is configured to contact the treatment area [0042].
Regarding claims 4 and 5, Zegarelli (2016/0278900) teaches the oral appliance is configured for supporting and holding the medicament which would meet the claimed “virtual channel configured” [0014] and is continuous and extends along gumline (Fig. 1).
Regarding claim 6 and 11, Zegarelli (2017/0347956) teaches in Fig 6A, a pressure sensor robotically mounted to assist in bite equilibrium (claimed registering position) [0035]. Zero-point markers are known registering positioners.
Regarding claim 10, Zegarelli (2016/0278900) teaches the medicament is applied in the oral cavity and then would seal between the channel and the teeth and/or soft tissue area of the oral cavity and form the claimed “barrier”.
Regarding claim 15, Zegarelli (2016/0278900) teaches forming the oral appliance by 3D printing [0049] which is a “additive manufacturing process” or by impression molding [0039].
Regarding claim 12, the claims recite using cartesian coordinates for controlling the robotic dispenser and this is well known in the art to allow for precise application and control over the dispensing of the material to the desired areas.
Regarding claim 14, the claims recite dispensing at about 90 degrees from vertical to utilize gravitational flow and reduce needed pressure would have been within the skill of one practicing in the art as these are known advantages associated with dispensing material at 90 degrees absent a showing of other criticality thereof.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Zegarelli (2016/0278900) in combination with either Zegarelli (2017/0347956) or Cinader et al. (2006/0084026) further in combination with Fernandez (2017/0043896) and Takahashi (10,300,597) further in combination with Kittelsen (5,460,527).
Features detailed above concerning the teachings of Zegarelli (2016/0278900) in combination with either Zegarelli (2017/0347956) or Cinader et al. (2006/0084026) further in combination with Fernandez (2017/0043896) and Takahashi (10,300,597) are incorporated here.
Zegarelli (2016/0278900) in combination with either Zegarelli (2017/0347956) or Cinader et al. (2006/0084026) further in combination with Fernandez (2017/0043896) and Takahashi (10,300,597) fails to teach a projection or recess to manipulate oral appliance and the projection being removeable.
Kittelsen (5,460,527) teaches a composite dental beaching tray whereby the mouthpiece is used to provide bleachable material (claimed medicament) to the teeth with the aid of a handle to “manipulate” the oral appliance and the handle is removeable (abstract).
Therefore, it would have been obvious for one skilled in the art before the effective filing date of the claimed invention to have modified Zegarelli (2016/0278900) in combination with either Zegarelli (2017/0347956) or Cinader et al. (2006/0084026) further in combination with Fernandez (2017/0043896) and Takahashi (10,300,597) oral appliance medicament delivery process to include a handle for positioning the oral appliance and this handle being removeable as evidenced by Kittelsen (5,460,527) with the expectation of controlling the oral appliance within the oral cavity.
Regarding claim 9, the oral appliance has a handle, and this would necessarily be configured to mate with the robotic arm for application of the medicament during handling and removal of the oral appliance.
Response to Amendment
Applicant’s arguments with respect to claims 1-12,14 and 15 have been considered but are not found persuasive.
Applicant argued one skilled in the art would not combine the references as the Examiner has done as he has picked and chosen from the references and lack reason to combine which is clear hindsight reasoning
The Examiner disagrees. As detailed in the rejection, The rejection is based upon a combination rejection whereby the Examiner has provided sound reasoning to combine the references as such with the basis that the use of robot arm/gripper device would lead to more precise coating of the medicament on the oral appliance. In addition, the claims recite oral appliance having a projection or recess comprising a handle or gripping surface” whereby the reference teach using a robotic arm to grip the oral appliance which would inherently have a “gripping surface” (surface area which is gripped by the gripper meets the claimed “gripping surface”).
Furthermore, it is well settled that it is not inventive to broadly provide a mechanical or automatic means to replace a manual activity which has accomplished the same results. In re Venner and Bowser 120 USPQ192.
Applicant argued the Examiner used hindsight in the reconstruction of the rejection.
Applicant has attacked the individual reference and not the combination as the references must be taken collectively in establishing the combination rejection. Pointing out the differences between the reference and each individual reference is not sufficient to over come a rejection based on a combination of the references. One cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 231 USPQ 375 (Fed. Cir. 1986). The test of obviousness is not express suggestion of the claimed invention in any or all references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them. In re Rosselet, 347 F.2d 847, 146 USPQ 183 (CCPA 1965); In re Hedges, 783 F.2d 1038.
In particular, Applicant has argued that Takahashi (10,300,597) does not disclose an oral appliance, dispense the medicament, mating of the oral appliance or moving the dispensing device to apply medicament. The Examiner agrees in part, however, as detailed above Takahashi (10,300,597) is relied upon for teaching a robot and method of operating a robot which includes a wrist section (236 connected to a twist mechanism (470) allowing for movement thereof (abstract, Fig. 1 and col. 5, lines 9-27) and not for the argued limitations as those are taught by the primary references.
THIS ACTION IS MADE FINAL. 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 BRIAN K TALBOT whose telephone number is (571)272-1428. The examiner can normally be reached Mon-Thurs 6:30-5PM - Fri OFF.
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/BRIAN K TALBOT/Primary Examiner, Art Unit 1715