The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Response to Arguments
On pages 3-4 of the Remarks dated April 6, 2026, the applicant argues that the previously cited prior art fails to “teach or suggest a robot system, wherein the end effector is arranged to receive the prosthetic device, the surgical guide, or the orthognathic element (of the system), with the particular element received by the end effector being provided in and selected from the system, which includes the prosthetic device, the surgical guide, and the orthognathic element (i.e., the dental robotic system includes a prosthetic device, a surgical guide and an orthognathic element, and the end effector can selectively /interchangeably receive any of the prosthetic device, the surgical guide, or the orthognathic element).” Previously, claim 35 recited “further comprising a prosthetic device or a surgical guide”, and claim 36 recited “wherein selectively receiving an orthognathic element further comprises selectively receiving a prosthetic device, a surgical guide, or the orthognathic element…”. However, claims 1 and 18 have now been amended to positively require all three, whereas at most claim 35 required only two. As such, the scope of all claims has changed and the following new rejections are applicable.
Claim Rejections - 35 USC § 112
Second Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rejected because “surgical element” in line 6 should state “surgical guide”.
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.
Claims 1 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang (KR 20200089488 A, foreign document and machine translation previously provided) in view of Kamer (US Patent Pub. No. 2010/0137881).
Hwang teaches “an orthognathic and facial bone surgery apparatus using a robot” (see Abstract), and Hwang states that its robot system can “accurately reposition the maxilla, mandible, and graft bone in a planned three-dimensional position using a robot” (see Technical-Field). Specifically, Hwang teaches a dental robotic system, comprising:
a fiducial marker adapted to be engaged with maxillofacial anatomy (see numeral 142 in Figures 4-7;
a prosthetic device, and a surgical guide, and an orthognathic element (note that Hwang explicitly teaches and illustrates an orthognathic element in Figures 4-7, see next reference regarding “a prosthetic device, and a surgical guide”);
an articulating arm member (see robot body 110) having an end effector engaged with a distal end thereof (see robot distal end 130), the end effector being arranged to selectively receive the prosthetic device, the surgical element, or the orthognathic element (note that Hwang explicitly teaches that “the effector portion 131 of the robot distal end 130 may be combined with any one of the maxilla, the mandible, and the graft bone through the connector 160”, see last paragraph on page 4), in a predetermined spatial relationship with the end effector (it is noted that if the end effector has received the orthognathic element, then it is inherently in a predetermined spatial relationship with the end effector); and
a controller device having a processor and a memory storing a computer program product executable by the processor to perform the steps of:
with the end effector being in receipt of the orthognathic element, the controller device communicating with the fiducial marker, the articulating arm member, and the end effector (Hwang teaches that “control unit 111 is to control the movement of the robot body 110” and “the control unit 111 may receive information from another device and move the robot body 110 accordingly. For example, the control unit 111 may receive information about the position of the robot distal end 130, the maxilla 10, the mandible bone, and the graft bone from the tracking tool 140”, see middle few paragraphs on page 4), to determine a disposition of the end effector in relation to the fiducial marker during movement of the end effector (Hwang teaches that “When the first tracking tool 141 mounted on the robot distal end 130 and the second tracking tool 142 mounted on the patient's head are used, the relative position of the maxilla 10 relative to the skull 20 is determined”, see third paragraph on page 6) in accordance with a virtual procedure plan for placing the orthognathic element in an aligned relation to the maxillofacial anatomy (Hwang teaches that “referring to FIG. 4, positions of the robot distal end 130 and the maxillary bone 10 recognized and tracked through the tracking tool 140 may be stored in the control unit 143, and the control unit The control unit 111 is moved based on the information stored in (143), so that the robot arm can be accurately positioned at a planned position”, see page 6, paragraph beginning “More specifically,…”); and
directing the articulating arm member to physically control allowable movement of the end effector, directly relative to the disposition of the end effector with respect to the fiducial marker engaged with the maxillofacial anatomy, according to the virtual procedure plan, in order to place the orthognathic element in the aligned relation for securement to the maxillofacial anatomy (again, Hwang teaches that “referring to FIG. 4, positions of the robot distal end 130 and the maxillary bone 10 recognized and tracked through the tracking tool 140 may be stored in the control unit 143, and the control unit The control unit 111 is moved based on the information stored in (143), so that the robot arm can be accurately positioned at a planned position”, see page 6, paragraph beginning “More specifically,…”);).
As indicated above, Hwang teaches that not only can a maxilla or mandible bone be connected to the end effector of the robot arm, but also a graft bone which is arguably a prosthetic. Also, Hwang teaches that “The jaw correction and facial bone surgical apparatus using a robot according to an embodiment of the present invention may further include the bone removing device 150, and the bone removing device 150 may include the slide unit 120 as shown in FIG. 7” (see page 7, paragraph beginning “If the operator accurately recognizes…”), which illustrates that the robot arm’s end effector is capable of be connected to more than just the maxilla, mandible and/or graft bone. However, Hwang does not explicitly and unequivocally teach a prosthetic device, and does not teach or imply the connection of a surgical guide.
Kamer teaches an arrangement for planning and carrying out a surgical procedure (see Title). The device includes a work means 2, which is a robotic arm. “The arm has a connecting means via which the tool, instrument or implant can be secured in a predetermined position on the arm” (see paragraph 13; also see the Abstract which similarly teaches that “an instrument, a tool, or an implant” may be connected to the working means). Kamer also teaches that a “drill sleeve 22 is used to guide a drill with which a hole for receiving an implant is drilled at a predetermined site in a jaw bone” (see paragraph 32 and Figures 1 and 2a). Additionally, “Arranged at the end 14a of the front part 14 there is a securing means 18 via which a part 19 can be connected to the arm 12. The part 19 is in particular an instrument, a tool or an implant. For example, the instrument can be a pointing instrument, a probe or the like. The tool is, for example, a drill or a reamer. The implant can be any medical implant, for example a dental implant. However, the part 19 can also be an aid, for example a drill sleeve. The important thing is that the part 19 can be secured in a predetermined position and orientation at the end 14a” (see paragraph 30, emphasis added). The underlined parts explicitly teach that a dental implant (i.e., a prosthetic device) and a drill sleeve (i.e., a drill/surgical guide) can be secured to the end 14a of the robotic arm of Kamer. Additionally, the final underlined portion explicitly teaches that by securing any of these parts 19 to the end 14a, it places them at a predetermined position and orientation at the end 14a (i.e. “in a predetermined spatial relationship with the end effector” as in lines 6-7 of claim 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to connect a multitude of different devices at the end of a robotic arm during a dental procedure, including a drill/surgical guide, a dental implant/prosthesis, a tool, etc., as taught by Kamer, and to make these connectable within the system and methods of Hwang who also teaches the connection to an orthognathic element (i.e., a maxilla or mandible, as well as a graft bone and to bone removal device(s) 150 which can be “a variety of devices”), thereby increasing the versatility of the system of Hwang to be capable of performing a plethora of additional procedures, or to utilize additional tools within the procedures explicitly taught by Hwang.
Claims 2-6, 8-17, 19-23 and 25-36 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang in view of Kamer as applied to claims 1 and 18 above, and further in view of Mozes et al. (US Patent Pub. No. 2016/0367343) – herein referred to as Mozes.
It is noted that most claims depend from claims 35 and 36, so these claims will be discussed first.
Regarding claims 11, 35 and 36, Hwang in combination Kamer with is described above with respect to claims 1 and 18. While Hwang teaches that “Through the tracking tool 140, the target position where the maxilla, the mandible, and the implanted bone fragment are repositioned can be accurately known, and through the information of the tracking tool 140, the maxilla, the mandible, and the implanted bone target Can be moved to the correct location” (see 3rd paragraph on the fifth page of the Machine Translation, emphasis added), and arguably the stated maxilla could be interpreted to read on “an orthognathic element” in claim 1, and Kamer explicitly teaches the use of surgical guides and/or dental implants/prosthetics, there is no teaching of controlling the allowable movement of the end effector in order to place the prosthetic device or guide in the aligned relation to anatomy.
Mozes teaches a surgical robot system for integrated surgical planning and implant preparation, and associated methods (see Title). The surgical robot of Mozes’2 is shown in Figures 2 and 3, and it is immediately apparent that this is, generally speaking, the same surgical robot device that is disclosed in Mozes. Mozes’2 teaches that “The guidance device may also be configured to interchangeably receive an implantation device, in addition to the site preparation device and the implant preparation device, and to guide the implantation device, relative to the fiducial marker, and in conjunction with manipulation of the implantation device by the user, to implant the dental implant within the patient's mouth” (see paragraph 52). Also, “For example, an implantation device 150 having the prosthetic member 600 attached thereto may be moved or manipulated in relation to the site in the patient's mouth, and the user may concurrently view a representation of the implantation device 150 having the virtual dental implant engaged therewith on the display device 800, in relation to a virtual projection of the interaction of the dental implant with the site within the patient's mouth, while the manipulation is occurring” (see paragraph 53). Also, paragraph 41 teaches that “the controller device 450/planning device may include a peripheral device (i.e., a trackball or joystick in conjunction with, for example, 3D goggles, all not shown) to assist with or otherwise permit virtual manipulation of the placement of the virtual implant(s) with respect to the image(s) of the patient's jaw structure in order to, for example, align the implant(s) relative to each other or relative to adjacent teeth, to align the implant(s) relative to the affected nerve, and/or to align the implant(s) relative to the jawbone structure. The controller device 450/planning device may be further configured to perform such manipulation manually, automatically, or semi-automatically, as necessary or desired” and paragraph 46 teaches that the actual motion allowed is dictated by the virtual implantation plan (i.e., “the system 100 may be configured to restrict the practitioner to performing the implantation procedure with respect to the patient, as determined via the virtual implantation plan and implemented via the controller device 450/planning device and the arm member 350, whereby the controller device 450/planning device controls the allowable movement of the arm member 350”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to configure the robotic system of Hwang as combined with Kamer providing limiting movement based on a procedure plan as taught by Mozes, thereby increasing the safety of the robotic system.
Regarding claims 2 and 19, the following portions of the references teach the limitations of claim 2: paragraph 46 of Mozes.
Regarding claims 3 and 20, see paragraph 22 of Mozes.
Regarding claims 4 and 21, see paragraph 46 of Mozes.
Regarding claim 5-6 and 22-23, it can be seen in Figures 4-7 of Hwang that maxilla 10 is attached to the end effector of the robotic arm in a predetermined manner, thereby being in a predetermined spatial relationship with the end effector via attachment 160. Additionally, it would have been obvious to one of ordinary skill in the art that the end effector that couples with other devices/structures would have a particular attachment mechanism associated therewith such that attaching anything thereto would be in some predetermined spatial relationship to the end effector. In other words, one would not super glue any of these structures to the end effector in an arbitrary manner or couple things with a rubber band arbitrarily. The end effector, if being used in a surgical procedure, would have a predetermined manner by which surgical instruments or surgical implants would be held to or by the end effector to allow for precision and safety.
Regarding claims 8 and 25, it is noted that paragraphs 50-52 of Mozes teaches the use of anchors to accept the crown and paragraph 46 teaches haptic feedback used to direct the user to a particular location for performing the procedure.
Regarding claims 9, 26 and 28, it is re-iterated that Kamer teaches a drill sleeve, which is a surgical guide as claimed. Additionally, the incorporation of Mozes teaches limiting the allowable movement of the robotic arm according to a plane.
Regarding claims 10 and 27, the prosthetic member(s) of Mozes having guide holes within which dental implant 300 (see Figure 1B) is inserted. As such, this helps to guide the prosthetic into place during the procedure based on its shape.
Regarding claims 12-13, 15, 29-30 and 32, Mozes teaches the following in paragraph 39:
For example, the fiducial marker may be communicated via a communication element 400 comprising a wireless transceiver, a hardwire connection, an optical communication system (i.e., a camera or other video device), an acoustic tracking system, or any other suitable mechanism, whether electrical, mechanical, electromechanical, acoustic, or optical in nature. That is, in various instances, the kinematic mount, itself, may comprise an attachment point for a tracking portion (or tracking arm or other tracking provision) associated with the guidance system for the surgical robot (i.e., wherein, for instance, reflective markers may be mounted to the attachment point for optical tracking of the fiducial marker or the splint device itself, or the attachment point may include a securing site for forming a mechanical connection therewith for mechanical tracking of the fiducial marker, or the attachment point may otherwise be configured to receive an appropriate element associated with any other suitable tracking arrangement for the fiducial marker). In other aspects, the kinematic mount may be configured or otherwise arranged to function as a fixed mounting site for particular tracking devices such as, for example, one or more markers that may be permanently affixed to the kinematic mount 500 and configured to be trackable by an optical-type tracking device (i.e., an optical tracking marker).
Regarding claims 14 and 31, see numeral 400 of Figure 2, and see paragraph 39 or Mozes.
Regarding claims 16 and 33, Mozes illustrates in Figure 4 that the fiducial markers 140 are in communication with the control unit via tracking unit 143 in a wireless capacity.
Regarding claims 17 and 34, Mozes teaches that, while the use operates the surgical robot, a display may show graphical manipulation of an image of the maxillofacial anatomy to either form the surgical plan, or it may show movement with regard to the patient’s anatomy in real-time during the procedure (see paragraphs 53 and 55-56).
Claims 7 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang in view of Kamer and Mozes as applied to claim 35 above, and further in view of Kofford et al. (US Patent Pub. No. 2021/0275279, having priority to provisional application 63/026,646 filed on May 18, 2020).
Hwang in combination with Kamer and Mozes is described above with regard to claim 35, however, none of these explicitly teach the use of a bite form to which a prosthesis is attached.
Kofford teaches a robotic assisted screw-attached pick-up dental coping system and method (see Title). Most importantly, Kofford teaches a “prosthesis delivery jig illustrated in FIG. 60 comprises a bite fork 155 with an adapter block 305 for attachment to the handpiece end 205” (see paragraph 175). It is noted that this figure is also illustrated in Figures 9-10 of provisional 63/026,646, and similarly discussed in the specification therein as follows:
In an embodiment, FIG. 4 - FIG. 8, show a delivery jig 7 comprised of a bite fork 8, and robot attachment bracket assembly 11. In this example, bracket 11 mechanically attaches to the handpiece 4 that is mounted to the robot arm. FIG. 9 and FIG. 10 show the bracket assembly and bite fork attached to the handpiece 4 (the handpiece in this example is attached to the robotic arm in a known position and orientation). In this example, bracket 11 is located and retained onto handpiece 4 using a contoured surface 12 that fits the body of the handpiece 4, and a shaft feature 14 that installs and locks into the normal tool holder/collet of the handpiece. A U-bolt 13 further locks the bracket 11 to handpiece 4. The bite fork 8 is attached in a known position to bracket 11 with alignment features 9 on the bite fork, to mating features on the bracket 11. Locating holes 10 are present on the bite-fork for registration of the prosthesis onto the bite-fork.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a bite fork attachment to the surgical robot of Hwang as combined with Kamer and Mozes, as such an attachment is taught by Kofford, because “Robot-assisted surgery for implants has potential benefits over the complex mechanical surgical guide approaches that have been developed” (see Background of provisional 63/026,646).
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 JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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