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
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection. It is noted that the claims have been altered from their previous form, requiring substantial reconsideration and re-evaluation. For example, independent claim 1 now requires “pressures required for pneumatic operations of the surgical tool”, which was one of a plurality of options in previous Markush claim 7. Additionally, new independent claim 15 is the same are previous claim 1, but additionally requires “light wavelengths required by the surgical tool”, which was a different one of the plurality of options in previous Markush claim 7, while new independent claim 20 is the same are previous claim 1, but additionally requires “light strengths required by the surgical tool”, which was a different one of the plurality of options in previous Markush claim 7. Since previous claim 7 was a Markush claim and the rejection only required a single one of the plurality of options to be met, and the previous rejection did not mention any of these three options of the plurality of options, these amendments force a new rejection to be made.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Brik et al. (US Patent Pub. No. 2023/0013550) in view of Todd et al. (US Patent Pub. No. 2006/0129140).
Regarding claim 1, Brik discloses a method of performing robotic surgery (see Abstract), comprising:
Receiving data from a surgical tool connected to a working end of a robotic manipulator (see paragraph 15, “methods disclosed herein allow for automatic identification of a particular end effector by a robotic surgical system based on data received from … the end effector” And “the end effector can be prompted by the robotic surgical system to send the data, such as after coupling”); and
Controlling the robotic manipulator based, at least in part, on the data received from the surgical tool (see paragraph 16, “The end effector can store parameter data thereon that is configured to be identified by the system. The system can be configured to adjust its operation based on the parameters.”).
However, Brik does not teach that the data comprises pressures required for pneumatic operations of the surgical tool.
Regarding claim 1, Todd teaches a “system and method for identifying a component, such as an optical probe or pneumatic scissors, of an ophthalmic surgical device. A component of a surgical device includes an identifier, such as an RFID tag. Data from the RFID tag is transmitted to a RFID reader in the device… The RFID data can also be used to calibrate the surgical device for use with the particular component” (see Abstract). “[C]alibration data 900 may include instructions or parameter settings relating to … pneumatic vitrecomy probe actuation pressure points” (see paragraph 61).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application for the data of Brik to include or relate probe actuation pressure points, as taught by Todd, if and when the tool being connected to the robot of Brik is a pneumatic vitrecomy probe. It is noted that Brik does not specify any single type of end effector that is to be used, nor any limitation on what type of end effector is to be used with its system, and one of ordinary skill in the art would find it obvious and beneficial to utilize any surgical tool that has communication capabilities, such as those taught by Todd, within a system and method as taught by Brik, thereby increasing the utility and options for robotic surgery.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Brik in view Todd, as applied to claim 1 above, and further in view of Asadian et al. (US Patent Pub. No. 2021/0045827).
Regarding claim 3, Brik in combination with Todd was described above with respect to claim 1. Additionally, Brik teaches that in step 104 of Figure 1, “the end effector communicates data to the system, and the system identifies the end effector (e.g., using data received from or regarding the end effector). Examples of data include a unique identifier, a version identifier, a class identifier, manufacturing information, shape, a dimension, weight, center of mass, duration of use, lifetime information, service history, or sterilization history” (see paragraph 18), which includes “center of mass”, which is mass-related data. Additionally, Brik teaches “Several different adjustments can be made by the system in view of accessed parameters. For example, the system can compensate for various masses and centers of mass of a given end effector 908 to ensure that the system is balanced and maintains precision” (see paragraph 54; also see paragraph 19, “Examples of adjustments include an adjustment to the robot arm based on an estimated load and/or force exerted by the end effector weight or center of mass”). This relates to lines 2-6 of claim 3.
Also, Brik teaches in paragraph 18 that one of the many data that may be obtained by the robotic system include weight. While weight is not the same as mass, it is known that mass is simply the weight divided by gravity, and it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to obtain mass or weight within the system of Brik, as these are easily converted from one to another and can contribute to the same effective utilization by such a system. Brik explicitly teaches the obtaining of the center of mass (see, at least, paragraph 18). Additionally, Brik teaches that “data can include general characteristics of the end effector, such as dimensions, shape” (see paragraph 15), and paragraph 56 explicitly teaches that “the end effector 908 can store dimensional constrains thereon. … For example, the end effector 908 can store working volume parameters thereon such that the system can determine the length, width, and depth of the overall system when the end effector is attached thereto”.
However, Brik does not teach that the data would include a moment of inertia.
Asadian teaches a robotic system with a surgical tool connected thereto (see Figure 2). Particularly, Asadian teaches that “preset torque threshold may be selected based on the moment of inertia for the surgical tool 240 and/or the drive system. For example, when the surgical tool 240 is coupled to the tool driver 230, the processor 312 may determine (e.g., through electrical contact, RFID tag, bar code, or other techniques) an identifier for the surgical tool 240 or end effector 246. In addition, data for the identifiers for the tool disks being used, the type of transmission for the tool disks, and/or one or more tool calibration values may be received at the processor 312. The processing 312 or memory 314 may include a lookup table that associates the possible identifiers for the surgical tool and/or drive system with inertial values or with preset torque thresholds” (see paragraph 107).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application include additional data points such as a moment of inertia for the surgical tool, as taught by Asadian, within the system and methods of Brik in order to more optimally control the engagement between the robot arm and the driving mechanisms of the tool (see paragraph 105-106 of Asadian), thereby improving performance of the overall robotic system.
Regarding claim 5, Brik teaches that “the end effector 908 can store dimensional constrains thereon. … For example, the end effector 908 can store working volume parameters thereon such that the system can determine the length, width, and depth of the overall system when the end effector is attached thereto. Knowledge of the working volume can allow the system to be aware of the extents of the end effector so the system and its components can be prevented from colliding with other known volumes or other objects within the operating room” (see paragraph 56). This reads on lines 2-5 of claim 5. Also, Brik teaches that “the end effector 908 can store dimensional constrains thereon. … For example, the end effector 908 can store working volume parameters thereon such that the system can determine the length, width, and depth of the overall system when the end effector is attached thereto. Knowledge of the working volume can allow the system to be aware of the extents of the end effector so the system and its components can be prevented from colliding with other known volumes or other objects within the operating room” (see paragraph 56). Although this does not explicitly state a first/second/third maximum offset from a centerline, it does state “the system can determine the length, width, and depth of the overall system”. In other words, the system (i.e., the robotic arm) will obviously know its own dimensions, and then determining “the length … of the overall system” would therefore require the system to know the length of the surgical tool that extends beyond the attachment point of the robotic arm. Similarly, determining “the width … of the overall system” would therefore require the system to know the width of the surgical tool that extends beyond the attachment point of the robotic arm, and determining “the depth … of the overall system” would therefore require the system to know the depth of the surgical tool that extends beyond the attachment point of the robotic arm. Each of these refers to a maximum offset in a distinct direction from the point of connection to the surgical robot, which would be a “centerline of the surgical tool” (also see paragraph 50, which states that “the dimensions can be used to calibrate a position of a center line of a tool”).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Brik in view of Todd and Asadian as applied to claim 5, and further in view of Culp et al. (US Patent No. 6,017,354).
Brik in combination with Todd and Asadian is described above with regard to claim 5.
Regarding claim 9, Brik teaches that the data related to the surgical tool comprises identification data (see paragraph 18, “In some embodiments, the end effector sends a unique identifier, and the system uses the unique identifier to query a database and obtain data regarding the end effector”). Brik teaches that “the controller is further configured to determine a parameter regarding the end effector. In some embodiments, the parameter is retrieved from a database. In some embodiments, the parameter is detected by the controller. In some embodiments, the parameter is at least one of a version, a class, manufacturing information, shape, a dimension, weight, center of mass, duration of use, lifetime information, service history, or sterilization history” (see paragraph 60). It is noted that “dimension” as underlined above reads on “dimensional data” as claimed, and “center of mass” (and weight) reads on “mass-related data” as claimed. Additionally, paragraph 50 of Brik teaches the querying of a database to determine “specific model information and specifications stored for various types (e.g., models) of end effectors. The end effector 908 can send data identifying its type or model. The controller 1012 can retrieve information indicating certain dimensions associated with the type or model. For example, such that the robot arm 1020 can detect and attach to the end effector 908 in a proper configuration). Alternatively, the dimensions can be used to calibrate a position of a center line of a tool (not depicted). A distance (D) between a trajectory A3 of the tool from an axial axis A4 of the distal end of the robot arm 1020 can be retrieved by the controller 1012. An angle (C) of the end effector trajectory A3 relative to a longitudinal axis L3 of the distal end of the robot arm 1020 can be retrieved by the controller 1012”, which reads on “calibration data” as claimed and controlling operation of the surgical tool based on this data. This relates to lines 2-9 of claim 9.
However, Brik does not teach that the data includes a serial number, a description and a name.
Culp teaches “an integrated surgical tool system for energizing different powered surgical handpieces. Internal to each handpiece is a non-volatile memory (72) which stores data regarding the operating parameters of the handpiece” (see Abstract). Culp teaches that “FIG. 13 is a block diagram of the data fields contained within the NOVRAM 72 within a handpiece. … Handpiece identification fields 343-345 contain such information as the name of the handpiece, for example, sagittal saw, the part number for the handpiece, the handpiece serial number” (see column 15, lines 40-58). Additionally, “Handpiece definition field 350 contains information that Describes the characteristics of the handpiece. This information can include a description of: whether the handpiece is a micro duty or heavy duty handpiece; if the forward/reverse direction controls are convention or in reverse orientation, whether the motor is run with or without feedback; whether the light and water accessories can be used with the handpiece; and the number of significant digits that should be presented on the image formed on display screen 37” (see column 16, lines 1-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to include additional data points, such as various different identification fields, as taught by Culp, within the system and methods of Brik because the more information a handpiece can provide to the system of Brik, the more efficiently the overall system can function and the quicker and more safely the procedure can be accomplished (see column 55, lines 55-64 of Culp).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Brik in view Todd, as applied to claim 1 above, and further in view of Heiliger (US Patent Pub. No. 2021/0378773).
Brik in combination with Todd was described above with respect to claim 1. However, Brik does not explicitly teach the manner by which the surgical tool is connected to the robotic system.
Heiliger teaches a sterile interface assembly for surgical instruments such as for use in robotic surgical systems (see Title). Specifically, Heiliger teaches the following in paragraph 36:
Turning to FIGS. 4A-7, in order to maintain sterility of a surgical environment and/or prevent contamination of robotic surgical system 500 (FIG. 3), a sterile interface assembly 1000 is provided for operably coupling surgical instrument 10 (or any other suitable surgical instrument) with a robotic surgical system, e.g., robotic surgical system 500 (FIG. 3). Sterile interface assembly 1000 includes a proximal adapter 1100 and a seal module 1200 including a distal adapter 1220, a sterile drape 1240, and a clip 1260. Seal module 1200 is configured to sealingly operably engage housing 20 and proximal segment 34 of shaft 30 of instrument 10, while proximal adapter 1100 is configured to connect distal adapter 1220 of seal module 1200 with robotic surgical system 500 (FIG. 3). In some configurations, proximal adapter 1100 is omitted and distal adapter 1220 of seal module 1200 is configured to connect directly with robotic surgical system 500 (FIG. 3).
As such, this teaches an tool portion (see numeral 10 in Figure 5) and a connector portion (see either the combined units of 1100 and 1220, or just element 1220 as it states above “In some configurations, proximal adapter 1100 is omitted and distal adapter 1220 of seal module 1200 is configured to connect directly with robotic surgical system 500”).
Additionally, paragraph 43 teaches that “Latching components 1236, 1238 enable releasable engagement of distal adapter 1100 with housing 20 of instrument 10, e.g., via mechanical latching (such as with latch levers (as illustrated)), snap-fit engagement, press-fit engagement, or other suitable engagement, and with proximal adapter 1100 (via engagement of latching components 1160 with latching components 1238) or directly to the robotic surgical system 500 (FIG. 3)” (emphasis added).
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 connector portion and to use a press fit engagement portion, as taught by Heiliger, within the system and methods of Brik as combined with Todd, since Brik teaches that “The robot arm 320 can include one or more features for mating with counterpart mating features of the end effector 308” (see paragraph 31) and provides an example in Figure 7 of a possible mating configuration, but Brik also states in paragraph 31 that “Alternative arrangements of the mating features are within the scope of the present disclosure” because Brik is less concerned with how the instrument is physically connected to the robotic system and is more concerned with the transfer of the data therebetween these components and the calibration based on the data that is transferred. As such a modification of the coupling mechanisms taught by Heiliger with those of Brik amounts to substitution of known equivalents for connecting an instrument to the end of a robotic arm to yield predictable results (KSR v. Teleflex).
Claims 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Brik et al. (US Patent Pub. No. 2023/0013550) in view of Neuberger et al. (US Patent Pub. No. 2004/0122419).
Regarding claims 15 and 20, Brik discloses a method of performing robotic surgery (see Abstract), comprising:
Receiving data from a surgical tool connected to a working end of a robotic manipulator (see paragraph 15, “methods disclosed herein allow for automatic identification of a particular end effector by a robotic surgical system based on data received from … the end effector” And “the end effector can be prompted by the robotic surgical system to send the data, such as after coupling”); and
Controlling the robotic manipulator based, at least in part, on the data received from the surgical tool (see paragraph 16, “The end effector can store parameter data thereon that is configured to be identified by the system. The system can be configured to adjust its operation based on the parameters.”).
However, Brik does not teach that the data comprises light wavelengths required by the surgical tool.
Neuberger teaches a treatment system that includes a probe 2 which is coupled to a console that includes a laser source 4 and an “Identification/recordation unit 6 is attached to delivery device 2 near its proximal end” (see paragraph 42). “Attached to inner cylinder 14 and protected by outer cylinder 16 is transponder 18, into which a memory chip is incorporated, and transponder coil 20” (see paragraph 43 and Figures 2a-b). As stated in paragraph 35:
Another benefit of the read-write feature is that it can retain information for use in automatically calibrating the radiation source so that the proper radiation parameters are used in conjunction with the delivery device. Radiation characteristics that can be stored for calibration include wavelength, power range, treatment duration, treatment modes such as continuous or pulsed, pulse duration, and pulse shape or laser spot size. Delivery device characteristics that can be stored for calibration include fiber type, diameter, maximum power levels, and application handpiece treatment modalities. Software settings can be limited depending on the desired application. The delivery device defines the software of the laser and the range of allowed treatment settings. In a preferred embodiment, the radiation delivery device is an optical fiber.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide operational parameter as the calibration data to be transferred, as taught by Neuberger, within the system and methods of Brik if and when the tool being connected to the robot of Brik is an optical treatment probe. It is noted that Brik does not specify any single type of end effector that is to be used, nor any limitation on what type of end effector can to be used with its system, and one of ordinary skill in the art would find it obvious and beneficial to utilize any surgical tool that has communication capabilities, such as those taught by Neuberger, within a system and method as taught by Brik, thereby increasing the utility and options for robotic surgery.
Claims 16-17 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Brik in view Neuberger, as applied to claims 15 and 20 above, and further in view of Asadian.
Regarding claims 16 and 21, Brik in combination with Neuberger was described above with respect to claims 15 and 20. Additionally, Brik teaches that in step 104 of Figure 1, “the end effector communicates data to the system, and the system identifies the end effector (e.g., using data received from or regarding the end effector). Examples of data include a unique identifier, a version identifier, a class identifier, manufacturing information, shape, a dimension, weight, center of mass, duration of use, lifetime information, service history, or sterilization history” (see paragraph 18), which includes “center of mass”, which is mass-related data. Additionally, Brik teaches “Several different adjustments can be made by the system in view of accessed parameters. For example, the system can compensate for various masses and centers of mass of a given end effector 908 to ensure that the system is balanced and maintains precision” (see paragraph 54; also see paragraph 19, “Examples of adjustments include an adjustment to the robot arm based on an estimated load and/or force exerted by the end effector weight or center of mass”). This relates to lines 2-6 of claim 3.
Also, Brik teaches in paragraph 18 that one of the many data that may be obtained by the robotic system include weight. While weight is not the same as mass, it is known that mass is simply the weight divided by gravity, and it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to obtain mass or weight within the system of Brik, as these are easily converted from one to another and can contribute to the same effective utilization by such a system. Brik explicitly teaches the obtaining of the center of mass (see, at least, paragraph 18). Additionally, Brik teaches that “data can include general characteristics of the end effector, such as dimensions, shape” (see paragraph 15), and paragraph 56 explicitly teaches that “the end effector 908 can store dimensional constrains thereon. … For example, the end effector 908 can store working volume parameters thereon such that the system can determine the length, width, and depth of the overall system when the end effector is attached thereto”.
However, Brik does not teach that the data would include a moment of inertia.
Asadian teaches a robotic system with a surgical tool connected thereto (see Figure 2). Particularly, Asadian teaches that “preset torque threshold may be selected based on the moment of inertia for the surgical tool 240 and/or the drive system. For example, when the surgical tool 240 is coupled to the tool driver 230, the processor 312 may determine (e.g., through electrical contact, RFID tag, bar code, or other techniques) an identifier for the surgical tool 240 or end effector 246. In addition, data for the identifiers for the tool disks being used, the type of transmission for the tool disks, and/or one or more tool calibration values may be received at the processor 312. The processing 312 or memory 314 may include a lookup table that associates the possible identifiers for the surgical tool and/or drive system with inertial values or with preset torque thresholds” (see paragraph 107).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application include additional data points such as a moment of inertia for the surgical tool, as taught by Asadian, within the system and methods of Brik in order to more optimally control the engagement between the robot arm and the driving mechanisms of the tool (see paragraph 105-106 of Asadian), thereby improving performance of the overall robotic system.
Regarding claims 17 and 22, Brik teaches that “the end effector 908 can store dimensional constrains thereon. … For example, the end effector 908 can store working volume parameters thereon such that the system can determine the length, width, and depth of the overall system when the end effector is attached thereto. Knowledge of the working volume can allow the system to be aware of the extents of the end effector so the system and its components can be prevented from colliding with other known volumes or other objects within the operating room” (see paragraph 56). This reads on lines 2-5 of claim 5. Also, Brik teaches that “the end effector 908 can store dimensional constrains thereon. … For example, the end effector 908 can store working volume parameters thereon such that the system can determine the length, width, and depth of the overall system when the end effector is attached thereto. Knowledge of the working volume can allow the system to be aware of the extents of the end effector so the system and its components can be prevented from colliding with other known volumes or other objects within the operating room” (see paragraph 56). Although this does not explicitly state a first/second/third maximum offset from a centerline, it does state “the system can determine the length, width, and depth of the overall system”. In other words, the system (i.e., the robotic arm) will obviously know its own dimensions, and then determining “the length … of the overall system” would therefore require the system to know the length of the surgical tool that extends beyond the attachment point of the robotic arm. Similarly, determining “the width … of the overall system” would therefore require the system to know the width of the surgical tool that extends beyond the attachment point of the robotic arm, and determining “the depth … of the overall system” would therefore require the system to know the depth of the surgical tool that extends beyond the attachment point of the robotic arm. Each of these refers to a maximum offset in a distinct direction from the point of connection to the surgical robot, which would be a “centerline of the surgical tool” (also see paragraph 50, which states that “the dimensions can be used to calibrate a position of a center line of a tool”).
Claims 18 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Brik in view of Neuberger and Asadian as applied to claims 17 and 22, and further in view of Culp.
Brik in combination with Neuberger and Asadian is described above with regard to claims 17 and 22.
Regarding claims 18 and 23, Brik teaches that the data related to the surgical tool comprises identification data (see paragraph 18, “In some embodiments, the end effector sends a unique identifier, and the system uses the unique identifier to query a database and obtain data regarding the end effector”). Brik teaches that “the controller is further configured to determine a parameter regarding the end effector. In some embodiments, the parameter is retrieved from a database. In some embodiments, the parameter is detected by the controller. In some embodiments, the parameter is at least one of a version, a class, manufacturing information, shape, a dimension, weight, center of mass, duration of use, lifetime information, service history, or sterilization history” (see paragraph 60). It is noted that “dimension” as underlined above reads on “dimensional data” as claimed, and “center of mass” (and weight) reads on “mass-related data” as claimed. Additionally, paragraph 50 of Brik teaches the querying of a database to determine “specific model information and specifications stored for various types (e.g., models) of end effectors. The end effector 908 can send data identifying its type or model. The controller 1012 can retrieve information indicating certain dimensions associated with the type or model. For example, such that the robot arm 1020 can detect and attach to the end effector 908 in a proper configuration). Alternatively, the dimensions can be used to calibrate a position of a center line of a tool (not depicted). A distance (D) between a trajectory A3 of the tool from an axial axis A4 of the distal end of the robot arm 1020 can be retrieved by the controller 1012. An angle (C) of the end effector trajectory A3 relative to a longitudinal axis L3 of the distal end of the robot arm 1020 can be retrieved by the controller 1012”, which reads on “calibration data” as claimed and controlling operation of the surgical tool based on this data. This relates to lines 2-9 of claim 9.
However, Brik does not teach that the data includes a serial number, a description and a name.
Culp teaches “an integrated surgical tool system for energizing different powered surgical handpieces. Internal to each handpiece is a non-volatile memory (72) which stores data regarding the operating parameters of the handpiece” (see Abstract). Culp teaches that “FIG. 13 is a block diagram of the data fields contained within the NOVRAM 72 within a handpiece. … Handpiece identification fields 343-345 contain such information as the name of the handpiece, for example, sagittal saw, the part number for the handpiece, the handpiece serial number” (see column 15, lines 40-58). Additionally, “Handpiece definition field 350 contains information that Describes the characteristics of the handpiece. This information can include a description of: whether the handpiece is a micro duty or heavy duty handpiece; if the forward/reverse direction controls are convention or in reverse orientation, whether the motor is run with or without feedback; whether the light and water accessories can be used with the handpiece; and the number of significant digits that should be presented on the image formed on display screen 37” (see column 16, lines 1-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to include additional data points, such as various different identification fields, as taught by Culp, within the system and methods of Brik because the more information a handpiece can provide to the system of Brik, the more efficiently the overall system can function and the quicker and more safely the procedure can be accomplished (see column 55, lines 55-64 of Culp).
Claims 19 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Brik in view Neuberger, as applied to claims 15 and 20 above, and further in view of Heiliger.
Brik in combination with Neuberger was described above with respect to claim claims 15 and 20. However, Brik does not explicitly teach the manner by which the surgical tool is connected to the robotic system.
Heiliger teaches a sterile interface assembly for surgical instruments such as for use in robotic surgical systems (see Title). Specifically, Heiliger teaches the following in paragraph 36:
Turning to FIGS. 4A-7, in order to maintain sterility of a surgical environment and/or prevent contamination of robotic surgical system 500 (FIG. 3), a sterile interface assembly 1000 is provided for operably coupling surgical instrument 10 (or any other suitable surgical instrument) with a robotic surgical system, e.g., robotic surgical system 500 (FIG. 3). Sterile interface assembly 1000 includes a proximal adapter 1100 and a seal module 1200 including a distal adapter 1220, a sterile drape 1240, and a clip 1260. Seal module 1200 is configured to sealingly operably engage housing 20 and proximal segment 34 of shaft 30 of instrument 10, while proximal adapter 1100 is configured to connect distal adapter 1220 of seal module 1200 with robotic surgical system 500 (FIG. 3). In some configurations, proximal adapter 1100 is omitted and distal adapter 1220 of seal module 1200 is configured to connect directly with robotic surgical system 500 (FIG. 3).
As such, this teaches an tool portion (see numeral 10 in Figure 5) and a connector portion (see either the combined units of 1100 and 1220, or just element 1220 as it states above “In some configurations, proximal adapter 1100 is omitted and distal adapter 1220 of seal module 1200 is configured to connect directly with robotic surgical system 500”).
Additionally, paragraph 43 teaches that “Latching components 1236, 1238 enable releasable engagement of distal adapter 1100 with housing 20 of instrument 10, e.g., via mechanical latching (such as with latch levers (as illustrated)), snap-fit engagement, press-fit engagement, or other suitable engagement, and with proximal adapter 1100 (via engagement of latching components 1160 with latching components 1238) or directly to the robotic surgical system 500 (FIG. 3)” (emphasis added).
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 connector portion and to use a press fit engagement portion, as taught by Heiliger, within the system and methods of Brik as combined with Neuberger, since Brik teaches that “The robot arm 320 can include one or more features for mating with counterpart mating features of the end effector 308” (see paragraph 31) and provides an example in Figure 7 of a possible mating configuration, but Brik also states in paragraph 31 that “Alternative arrangements of the mating features are within the scope of the present disclosure” because Brik is less concerned with how the instrument is physically connected to the robotic system and is more concerned with the transfer of the data therebetween these components and the calibration based on the data that is transferred. As such a modification of the coupling mechanisms taught by Heiliger with those of Brik amounts to substitution of known equivalents for connecting an instrument to the end of a robotic arm to yield predictable results (KSR v. Teleflex).
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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