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
Election/Restrictions
Applicant's election with traverse of the unity of invention in the reply filed on July 8, 2025 is acknowledged. The system as disclosed is a surgical robotic system capable of utilizing plural end effectors to perform a single surgery. As such, the orthognathic element, the prosthetic device and the surgical guide are for use by the same system and within the same method. Therefore, the restriction requirement is withdrawn and claims 1-36 are pending.
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, 11, 18 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Mozes et al. (US Patent Pub. No. 2014/0272789) in view of Hwang et al. (KR 2020-0089488 A).
Regarding claims 1 and 18, Mozes teaches a dental robotic system (see Figures 5-7), comprising:
A fiducial marker adapted to be engaged with maxillofacial anatomy (see paragraph 7 – “a procedure comprises forming a secure and physical interaction between a fiducial device and a site within a mouth of a patient to form a fiducial marker, and forming a virtual incising plan for incising a portion of a maxilla of the patient, in registration with and with respect to the fiducial marker”);
An orthognathic element (see addition of Hwang below);
An articulating arm member (see numeral 150 in Figure 5) having an end effector engaged with a distal end thereof (see numeral 500 in Figure 5), the end effector being arranged to selectively receive the orthognathic element (see addition of Hwang below), 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 (see controller 450 in Figures 6-7, which is computer) storing a computer program product executable by the processor to perform the steps of:
Communicating with the fiducial marker, the articulating arm member, and the end effector (see paragraphs 28-33, for instance, which teaches the controller capable of knowing the position of the fiducial marker via imaging or other means, as well as providing limitations the movability of the end effector and/or articulating arm 150), to determine a disposition of the end effector in relation to the fiducial marker during movement of the end effector in accordance with a virtual procedure plan for placing the orthognathic element in an aligned relation to the maxillofacial anatomy (see paragraph 28-33 again, noting that this teaches the use of a cutting device rather stating “an orthognathic element”; also note that paragraph 29 explicitly teaches that “the communication element 400 is configured to engage the arm member 350 in a manner known to the system 100, such that the position/movement characteristics of the end effector of the arm 350 are also known”); and
Directing the articulating arm member to physical control allowable movement of the end effector (at least see paragraph 30, “the arm member 350 may be configured to include any number of mechanisms, arrangements, or provisions, that may restrict or regulate the freedom of motion of the arm 350 in particular direction, while freely or unrestrictedly allowing freedom of motion in other particular directions (i.e., restricted freedom of motion when the motion of the end effector/cutting device 150 deviates from the virtual incising plan, but unrestricted freedom of motion when the motion of the end effector/cutting device 150 is moved in accordance with the virtual incising plan)”), 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 (see paragraph 30 as quoted above, noting that this teaches the use of a cutting device rather stating “an orthognathic element”).
As indicated above, the disclosure of Mozes teaches a cutting device, although this cutting device is taught as being used to “cut a small window or portal 40 in the bone structure 30 of the maxilla 15” (see paragraph 20). It is noted, however that Mozes teaches in paragraph 33 that “One skilled in the art will further appreciate that aspects of the system 100 disclosed herein may also be implemented to perform a dental implant procedure (i.e., as disclosed in US 2009/0253095 incorporated herein by reference) subsequent to the sinus augmentation procedure disclosed herein, and that the involvement of the system may provide additional advantages and benefits to those disclosed herein.”
Hwang teaches “an orthognathic and facial bone surgery apparatus using a robot” (see Abstract). Hwang teaches that “the maxilla 10, the mandible, and the graft bone fragment may be directly coupled to the effector portion 131 of the robot distal end 130” (see last paragraph on the 4th page of the Machine Translation provided). Hwang also teaches that “tracking tool 140 may also recognize and track the position of the maxilla, the mandible, and the graft bone piece coupled to the effector portion 131 of the robot distal end 130. 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).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a maxilla (i.e., an orthognathic element) on a distal end of a surgical robot during an orthognathic surgery, as taught by Hwang, and to utilize such an element as part of a dental implant procedure via the robotic system of Mozes, since Mozes explicitly teaches that “One skilled in the art will further appreciate that aspects of the system 100 disclosed herein may also be implemented to perform a dental implant procedure”, which is true for both the implant procedure described in the patent document stated by Mozes, as well as for the one described in Hwang, which also utilizes a robot and tracking elements for precise, correct placement of the distal end elements.
Regarding claim 11, it is noted that this claim is a system claim. Section 2114(II) of the MPEP states (with emphasis in the original), “’Apparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).” Section 2114(II) of the MPEP states, “A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987.” Claim 11 recites the phrase “so as to allow securement holes to be drilled in the portion or the remainder o the maxillofacial anatomy or to allow fasteners to be engaged with the securement holes so as to secure a bracket between the portion and the remainder of the maxillofacial anatomy”. It is noted that everything that comes after “so as to” is intended use of the functions prescribed to the controller recited earlier in the claim (i.e., “…directing the articulating arm member to physically control the allowable movement of the end effector…”). Mozes teaches the controller that providing limits to movement of the end effector based on a procedure plan and is capable of providing limits, based on said plan, to place the maxilla (as incorporated by Hwang) at any desired/necessary position with respect to the remaining anatomy, so as to allow drilling or fixation to securement holes.
Regarding claim 28, similarly with regard to the discussion above of claim 11, the limitations of claim 28 fail to positively teach any method steps of drilling securement holes or fastening via securement holes. Instead, this claim requires that the articulating arm be moved in a particular manner to allow the orthognathic element to be moved into a specific position so that a surgeon may be allowed to drill holes or secure the orthognathic element, without positively requiring it. The teachings of Mozes in the independent claim read on this subject matter.
Claims 2-6, 8, 10, 12-17, 19-23, 25, 27 and 29-35 are rejected under 35 U.S.C. 103 as being unpatentable over Mozes in view of Hwang as applied to claim 1 above, and further in view of Mozes et al. (US Patent Pub. No. 2016/0367343) – herein referred to as Mozes’2.
It is noted that most claims depend from claims 35 and 36, so these claims will be discussed first.
Regarding claims 35 and 36, Mozes in combination with Hwang is described above with respect to claim 1. 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, while the implanted bone could be interpreted to read on “a prosthetic device”; it could be argued that this does not read on “a prosthetic device”.
Mozes’2 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).
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 Mozes to couple with a tool, an anatomical portion (i.e., the maxilla as taught by Hwang) or a prosthetic member as taught by Mozes’2, thereby increasing the versatility of the robotic system, seeing as each of Mozes, Hwang and Mozes’2 all relate to dental robotic systems for implantation surgery, and because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ 2d at 1395).
Regarding claims 2 and 19, the following portions of the references teach the limitations of claim 2: paragraph 31 of Mozes; paragraph 46 of Mozes’2.
Regarding claims 3 and 20, Mozes teaches that “Such fiducial device may comprise or otherwise be associated with, for example, a splint 250 configured to engage the patient's mouth in a "firm" or secure interaction (i.e., the splint 250 is engaged with the patient's teeth and does not move with respect to the patient's mouth), as shown in FIGS. 5 and 6” (see paragraph 24). Also see paragraph 22 of Mozes’2.
Regarding claims 4 and 21, Mozes teaches “one skilled in the art will appreciate that the system 100 may be further configured to provide other manners of feedback (tactile, haptic, or otherwise) to the practitioner such as, for example, via a deviation warning indicia or other indicator, or any other suitable audio and/or visual mechanism” (see paragraph 33). Also see paragraph 46 of Mozes’2.
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’2 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 10 and 27, the prosthetic member(s) in Mozes’2 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’2 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).
Additionally, Mozes teaches “the fiducial marker may be communicated via a communication element 400 comprising a wireless transceiver, a hardwire connection, an optical communication system, or any other suitable mechanism, whether electrical, mechanical, electromechanical, or optical in nature” (see paragraph 27).
Regarding claims 14 and 31, see numeral 400 of Figure 7, and see paragraphs 27-29.
Regarding claims 16 and 33, Mozes teaches that “the fiducial marker may be communicated via a communication element 400 comprising a wireless transceiver” (see paragraph 27).
Regarding claims 17 and 34, Mozes’2 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 Mozes in view of Hwang and Mozes’2 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).
Mozes in combination with Hwang and Mozes’2 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 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).
Claims 9 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Mozes in view of Hwang and Mozes’2 as applied to claim 35 above, and further in view of Gantes (US Patent Pub. No. 2012/0046668).
Mozes in combination with Hwang and Mozes’2 is described above with regard to claim 35, however, none of these explicitly teach the use of a surgical guide via the surgical robot.
Gantes teaches a robotic surgery system (see Title). Gantes teaches “An active and/or passive robotic apparatus may be provided to assist in the surgical technique. The robotic apparatus may be an active robotic which includes surgical tools whereby the medical professional may perform the surgical technique with the assistance of the active robotic apparatus” (see Abstract). “The surgical guide includes drill guides that direct the dental professional's hand in terms of location and trajectory of holes to be drilled into the jaw and into which implants will eventually be mounted. An example of a surgical procedure using a physical guide is shown in FIG. 11” (see paragraph 130-131). “The surgical guide is designed to ensure that the hole drilled follows the desired path and extends to the desired depth, as determined in the treatment plan” (see paragraph 133). As recited in claim 8 of Gantes, the system includes “a surgical guide based on the digitally fabricated computerized image which is utilized by the robotic surgical tool.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide for robotic assistance to a dental surgery, by allowing the robotic surgical tool to be or hold a surgical guide, as taught by Gantes, and to utilize this within the system and methods of Mozes as combined with Hwang and Mozes’2, thereby increasing the versatility of the robotic system, seeing as each of Mozes, Hwang, Mozes’2 and Gantes all relate to dental robotic systems for implantation surgery, and because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ 2d at 1395).
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAMES KISH/ Primary Examiner, Art Unit 3792