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
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.
Claims 4 are 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 4 is rejected because it is unclear what is considered a “bounding box” as claimed. The specification mentions bounding boxes in the following three paragraphs (of the PGPUB 2024/0366327): paragraphs 128, 142 and 160. However, none of these paragraphs clearly define what structural aspect of the invention is considered to be the bounding box(es).
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)(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 1-4 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Johnson et al. (US Patent Pub. No. 2024/0020840, with effective filing date of March 15, 2023).
Johnson discloses a surgical robot system 100 in accordance with an exemplary embodiment as shown in Figures 10 and 11. “Surgical robot system 100 may include, for example, a surgical robot 102, one or more robot arms 104, a base 106, a display 110, an end-effector 112, for example, including a guide tube 114, and one or more tracking markers 118… The surgical robot system 100 may also utilize a camera 200… The camera 200 may include any suitable camera or cameras, such as one or more infrared cameras (e.g., bifocal or stereophotogrammetric cameras), able to identify, for example, active and passive tracking markers 118” (see paragraph 103). “End-effector 112 may be coupled to the robot arm 104 and controlled by at least one motor. In exemplary embodiments, end-effector 112 can comprise a guide tube 114, which is able to receive and orient a surgical instrument 608 (described further herein) used to perform surgery on the patient 210” (see paragraph 105). “FIG. 15 illustrates a surgical robot system 600 consistent with an exemplary embodiment. Surgical robot system 600 may comprise end-effector 602” (see paragraph 125). Paragraphs 127-129 then teach the following:
FIGS. 16A, 16B, and 16C illustrate a top view, front view, and side view, respectively, of end-effector 602 consistent with an exemplary embodiment. End-effector 602 may comprise one or more tracking markers 702. Tracking markers 702 may be light emitting diodes or other types of active and passive markers, such as tracking markers 118 that have been previously described. In an exemplary embodiment, the tracking markers 702 are active infrared-emitting markers that are activated by an electrical signal (e.g., infrared light emitting diodes (LEDs)). Thus, tracking markers 702 may be activated such that the infrared markers 702 are visible to the camera 200, 326 or may be deactivated such that the infrared markers 702 are not visible to the camera 200, 326. Thus, when the markers 702 are active, the end-effector 602 may be controlled by the system 100, 300, 600, and when the markers 702 are deactivated, the end-effector 602 may be locked in position and unable to be moved by the system 100, 300, 600.
Markers 702 may be disposed on or within end-effector 602 in a manner such that the markers 702 are visible by one or more cameras 200, 326 or other tracking devices associated with the surgical robot system 100, 300, 600. The camera 200, 326 or other tracking devices may track end-effector 602 as it moves to different positions and viewing angles by following the movement of tracking markers 702. The location of markers 702 and/or end-effector 602 may be shown on a display 110, 304 associated with the surgical robot system 100, 300, 600, for example, display 110 as shown in FIG. 11 and/or display 304 shown in FIG. 12. This display 110, 304 may allow a user to ensure that end-effector 602 is in a desirable position in relation to robot arm 604, robot base 610, the patient 210, and/or the user.
For example, as shown in FIG. 16A, markers 702 may be placed around the surface of end-effector 602 so that a tracking device placed away from the surgical field 208 and facing toward the robot 102, 301 and the camera 200, 326 is able to view at least 3 of the markers 702 through a range of common orientations of the end-effector 602 relative to the tracking device 100, 300, 600. For example, distribution of markers 702 in this way allows end-effector 602 to be monitored by the tracking devices when end-effector 602 is translated and rotated in the surgical field 208.
In addition, in exemplary embodiments, end-effector 602 may be equipped with infrared (IR) receivers that can detect when an external camera 200, 326 is getting ready to read markers 702. Upon this detection, end-effector 602 may then illuminate markers 702. The detection by the IR receivers that the external camera 200, 326 is ready to read markers 702 may signal the need to synchronize a duty cycle of markers 702, which may be light emitting diodes, to an external camera 200, 326. This may also allow for lower power consumption by the robotic system as a whole, whereby markers 702 would only be illuminated at the appropriate time instead of being illuminated continuously. Further, in exemplary embodiments, markers 702 may be powered off to prevent interference with other navigation tools, such as different types of surgical instruments 608.
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Based on the above, it is evident that Johnson teaches a system comprising:
A robot arm (see numeral 604 of Figure 15) having a tracking section (see numeral 602 in Figures 15 and 16);
A first fiducial array at the tracking section having first fiducials (see tracking markers 702 as shown in any one of Figures 16A, 16B, or 16C);
A second fiducial array at the tracking section having second fiducials (see tracking markers 702 as shown in any other one of Figures 16A, 16B or 16C not considered as the first fiducial array). In other words, it is clearly illustrated in Figures 16A-C that there are multiple fiducials and Figure 16A shows a first set/array, Figure 16B shows a second set/array, and Figure 16C shows a third set/array.
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Regarding claim 2, it can be seen in the reproduction of Figure 16C to the right that the tracking section 602 has a frustoconical shape with a smaller diameter end of the frustoconical shape being distal to a larger diameter end of the frustoconical shape, as claimed.
Regarding claim 3, paragraph 127 of Johnson states that “End-effector 602 may comprise one or more tracking markers 702. Tracking markers 702 may be light emitting diodes or other types of active and passive markers, such as tracking markers 118 that have been previously described. In an exemplary embodiment, the tracking markers 702 are active infrared-emitting markers that are activated by an electrical signal (e.g., infrared light emitting diodes (LEDs)).”
Regarding claim 4, in light of the rejection above under 35 USC 112(b) and as best understood, it is noted that the fiducial markers (i.e., tracking markers 702) of Johnson, as illustrated above in Figures 16A, 16B and 16C include the overlap (or re-use) of some markers. That is, the interpretation of Johnson results in some markers 702 residing in the first fiducial array (e.g., those in Figure 16A) are shared by a second fiducial array (e.g., those in Figures 16B or 16C, or some combination of these figures).
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 5-15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Ghanam et al. (US Patent Pub. No. 2021/0236212).
Johnson is described above with respect to claim 1. However, Johnson teaches that “Markers 702 may be disposed on or within end-effector 602” (see paragraph 128) without providing details of receptacles or pods.
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Ghanam teaches an optical tracker usable with a surgical object (see Abstract). Figures 3 and 4 show “the tracker having a tracker frame coupled to a surgical instrument and with three radial segments arranged about a longitudinal axis of the tracker” (see paragraph 8). Figure 6 illustrates a top view and Figure 7 illustrates a proximal view of the tracker (see paragraphs 11 and 12). Figure 11 illustrates an interior of the tracker frame and the marker arrays. The tracker is made of a tracker frame 102, which reads on the claimed “first receptacle”. As illustrated, there are three body shells 120 and interior space(s) 122, which read on at least “a first pod having a first housing sized to fit within the first receptacle”, in that these body shells connect to the tracker frame 102 and together create a fully enclosed unit. Additionally, it can be seen in Figure 11 that there are three large holes in each body shell through which the tracking markers reside, which reads on “wherein the first pod has the first fiducial array”. See paragraph 57.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to create a modular tracker, as taught by Ghanam, within the system and methods of Johnson because making the tracking arrays 612 removably coupled to the tracker frame 602 will permit replacement or service, such as sterilization (see paragraph 135 of Ghanam).
Regarding claim 6, Ghanam teaches that “The tracker 100 comprises an electrical circuit… disposed in the tracker frame 102” (see paragraph 77). Figure 11 shows that “each electrical circuit comprises an IR-LED (i.e. marker 128), which is attached (e.g. via soldering) to a printed circuit board (PCB) 176, 178, 180, which in turn is coupled to the tracker frame 102” (see paragraph 90). As illustrated in Figure 11, the PCB(s) are within the first housing and interior 122, surrounded by tracker frame 102 and body shell(s) 120. Additionally, the infrared LEDs, which are the markers of Ghanam, are electrically coupled to the PCB(s).
Regarding claim 7, Figure 11 and paragraph 90 teach that the infrared LEDs, which are the markers of Ghanam, are electrically coupled to the PCB(s).
Regarding claim 8, it is noted that Johnson teaches that infrared LEDs (i.e., tracking markers) may be selectively activated and otherwise remain deactivated (see at least paragraph 130), and that “This may also allow for lower power consumption by the robotic system as a whole, whereby markers 702 would only be illuminated at the appropriate time instead of being illuminated continuously” (see paragraph 130). It is noted that if this selective activation of the markers “allow[s] for lower power consumption by the robotic system as a whole” as stated by Johnson, then it would have been obvious to one of ordinary skill in the art that the markers are electrically connected with the remainder of the surgical robot. Since the combination of Johnson with Ghanam teaches PCB(s) 176, 178 and 180 on which the infrared LEDs reside and are powered, then it would be obvious that these PCB(s) would connected to the surgical robot, such that deactivation of the LEDs would thereby “lower power consumption of the robotic system as a whole”.
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Regarding claim 9, it can be seen from the reproduction of Figure 11 to the right, that there is at least one guide pin (see labeled guide pin #1) that fits into a corresponding section of the tracker frame, configured to facilitate placement of the firat pod (i.e., body shell 120) within the first receptable (i.e., tracker frame 102). It is additionally noted that there is another guide pin wihtin the tracker frame (see labeled guide pin #2) that facilitates proper placement and securment with guiding apertures within the PCB and body shell (see labeled “guiding apertures”). It is noted that it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to swap the “guide pin #2” from residing within the tracking frame and to place it on the body shell, as a it has been held that rearrangeing parts of an invention involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) – see MPEP 2144(VI)(C).
Regarding claim 10, the reproductions of Figure 16C of Johnson (left) and the top portion Figure 11 of Ghanam found below illustrate that both references teach hollows in the locations of the infrared markers:
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Regarding claims 11-12, it is clear from Figure 11 of Ghanam that the hollow comprises an upper boundary that is larger in diameter than a lower boundary, which supports the interpretation that this hollow is a truncated cone. It is further noted that the infrared LED resides at the lower boundary. It can also be seen in Figure 16C of Johnson immediately above that the hollow comprises a wide top portion (i.e., an upper boundary) and a smaller offset center portion (i.e., a lower boundary), where the infrared emitter 702 of Johnson resides at this “lower boundary” location.
Regarding claim 13, it can be seen from the reproduction of Figure 7 of Ghanam that the top infrared LEDs of the device are aimed one general focal point/area, while those of the other two sides are aimed at different general focal points)/areas.
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Regarding claim 14, it is noted that it would be obvious, if not inherent, that the infrared LEDs have “a respective fiducial normal extending therefrom”, although it is noted that the figure immediately above does not show the arrows as such normals. However, it is noted that the fiducial normals of the infrared LEDs on the top surface as illustrated in Figure 7 immediately above would converge toward a first focal point, although that focal point would be at infinity. Additionally, the infrared LEDs on either the left and right side would converge toward a second focal point, which would also be at infinity.
Regarding claim 15, it has been addressed above in the rejection of claims 13 and 14 how the various LEDs are aimed at particular focal points. Additionally, it has been addressed how the LEDs are within hollows in the rejection of claims 11-12.
Regarding claim 20, Johnson teaches that “In an exemplary embodiment, the tracking markers 702 are active infrared-emitting markers that are activated by an electrical signal (e.g., infrared light emitting diodes (LEDs)). Thus, tracking markers 702 may be activated such that the infrared markers 702 are visible to the camera 200, 326 or may be deactivated such that the infrared markers 702 are not visible to the camera 200, 326” 9see paragraph 127). Additionally, Johnson teaches that “end-effector 602 may be equipped with infrared (IR) receivers that can detect when an external camera 200, 326 is getting ready to read markers 702. Upon this detection, end-effector 602 may then illuminate markers 702. The detection by the IR receivers that the external camera 200, 326 is ready to read markers 702 may signal the need to synchronize a duty cycle of markers 702, which may be light emitting diodes, to an external camera 200, 326. This may also allow for lower power consumption by the robotic system as a whole, whereby markers 702 would only be illuminated at the appropriate time instead of being illuminated continuously. Further, in exemplary embodiments, markers 702 may be powered off to prevent interference with other navigation tools, such as different types of surgical instruments 608” (see paragraph 130). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that these teachings would require a controller in order to selectively activate the infrared LEDs based on the particularly scenarios taught by Johnson. It is additionally emphasized that Johnson teaches that “markers 702 would only be illuminated at the appropriate time instead of being illuminated continuously” and “Further, in exemplary embodiments, markers 702 may be powered off to prevent interference with other navigation tools, such as different types of surgical instruments 608” (see paragraph 130 for both quotes), which implies that there would be a schedule of activation between the tracking markers and other surgical instruments 608 such that interference can be prevented (i.e., turn off markers in synchrony with activation of such tools).
Claims 16 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Devengenzo et al. (US Patent Pub. No. 2017/0086934).
Johnson is described above with respect to claim 1. However, Johnson teaches does not teach the use of a drape.
Devengenzo teaches “a surgical drape for a patient side cart of a teleoperated surgical system may include a body and an attachment device feature” (see Abstract; see Figure 2). Figures 10A, 10B and 11 illustrates an attachment feature of a sterile drape 710. The attachment feature includes first part 712 on sterile drape 710, and corresponding second part 702 the device to which the drape is being attached (i.e., robotic arm, see numeral 332 of Figure 2; see paragraph 76). Therefore, Devengenzo teaches a capture area (see entire area shown in Figures 10-11) configured to resist distal movement of an anchor of a drape (i.e., numeral 712) covering the robot arm (see Figure 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to include a sterile drape and attachment features, as taught by Devengenzo, within the system and methods of Johnson because “the attachment devices described herein permit easy installation and removal of a surgical drape” (see paragraph 97 of Devengenzo).
Regarding claims 18-19, Devengenzo teaches that “A surgical system may be configured to provide feedback that a surgical drape has not been installed because the surgical system may sense whether the drape has been installed” (see paragraph 97). As shown in Figures 10B and 11, there is “a sensor 706 may detect the present of first part 712. Sensor 706 may subsequently transmit a signal indicating that surgical drape 710 has been attached” (see paragraph 78). While Devengenzo teaches that the sensor may be an inductive sensor in paragraph 79, it also teaches that “A sensor to detect the attachment of a surgical drape may be, for example, an optical sensor” and teaches at least two ways by which an optical sensor would function in this manner (see paragraph 80).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson and Devengenzo as applied to claim 16 above, in view of Penny et al. (US Patent Pub. No. 2020/0205909).
Johnson in combination with Devengenzo is described above with respect to claim 16. While Devengenzo teaches multiple types of capture areas and attachment configurations throughout, there is no clear “lead-in groove” along with “a pocket”.
Penny teaches a robotic system, which includes a sterile drape (see Figure 20A). The drape connector of Penny is illustrated in Figure 21 and shows protrusions 152, which include a large protrusion in the center and two shallower protrusions at the ends. These fit into corresponding holes within the robotic arm, which are shown as 150 in Figures 20A and 22. The shallow protrusions at the ends would fit into shallower holes (i.e., lead-in grooves) and the large protrusion at the center would fit into a larger hole (i.e., a pocket) (see paragraph 60).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize this configuration of larger and smaller protrusions and corresponding holes in the robotic arm, as illustrated by Penny, within the system and methods of Johnson as combined with Devengenzo, as such a modification amounts to substitution of known equivalents for [insert intended purpose of substituted parts] to yield predictable results (KSR v. Teleflex). Additionally, the use of three protrusions and corresponding holes would ensure that the drape is connected in the right configuration, ensuring that it can only be attached in two possible ways where one way would clearly be upside-down.
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.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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