DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
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 12 recites the limitation "further comprising layering the resistive coating to prevent reuse, wherein each layer includes a different quantifier" in lines 2 and 3. It is unclear how layering resistive coating prevents reuse of the surgical device. The specification describes how the thickness of the coating is an indicator of the wear of the device, however there is no mention how this relates to potentially reusing a device in the future. It is further unclear what quantifiable level of thickness or layering qualifies wear or lack of reuse ability. Due to these issues, the claim is rendered indefinite.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 1-3, 5, 12-14, and 20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being unpatentable by Malacowski(US 8035487 B2).
Regarding claim 1, Malacowski discloses a method for identifying a surgical tool for use with a surgical device, comprising: integrating a variable indicator within a removably engageable component of a surgical tool of a surgical device; reading the variable indicator with a power console upon engagement of the surgical tool with the surgical device via one or more leads connected to the power console and identifying the surgical tool based on quantifying the variable indicator; and calibrating the power console according to the operating parameters of the surgical tool stored within the power console(A surgical tool system comprising a control console, a powered surgical device, an intermediate attachment removably connected to the surgical device and a cutting accessory removably connected to the intermediate attachment. Internal to the cutting accessory is an identification device that contains data specific to the operation of the accessory. The control console, through the transfer of signals through the powered surgical device and the intermediate attachment reads the data in the cutting accessory. Based on these data, the control console selectively actuates the powered surgical device(Abstract). Thus, in the current systems, the indicators mounted to a cutting accessory are only employed to provide data that describes a basic operating characteristic of the accessory or that describes its type(Background of the Invention, paragraph 10)).
Regarding claim 2, Malacowski discloses the method for identifying a surgical tool for use with a surgical device according to claim 1, wherein the variable indicator is a resistive indicator(Controller 570 generates energization control signals to a driver 572. The energization control signals are based on the cutting accessory 524 identified and the value selected by a manual actuator device 549. The manual actuator device 549 can be a trigger type push button controlling the output from a variable resistor or any other type of device providing a variable signal output(Detailed Description, paragraph 130)).
Regarding claim 3, Malacowski discloses the method for identifying a surgical tool for use with a surgical device according to claim 2, further comprising integrating the resistive indicator within a removeable shaft of a surgical cutting device(The NOVRAM 32 contains data that describes the operating characteristics of the handpiece 22. These data include: information that identifies the type of handpiece; information that describes the operating characteristics of the handpiece motor; the identification of the type of output signals provided by any sensors internal to the handpiece; and information useful for correcting the signals produced by the handpiece sensors to correct for their individual calibration characteristics. More information on the types of data contained in the handpiece NOVRAM 32 and how this information is used to regulate the operation of the handpiece 22 by the system 20(Detailed Description, paragraph 1). A controller 570 controls the overall operation of the system. Memory 569 in the surgical tool 522 contains the permanent operating instructions that are executed by controller 570 to control the system and regulate the actuation of the surgical tool 522 and the cutting accessory 524. Controller 570 generates energization control signals to a driver 572. The energization control signals are based on the cutting accessory 524 identified and the value selected by a manual actuator device 549. The manual actuator device 549 can be a trigger type push button controlling the output from a variable resistor or any other type of device providing a variable signal output(Detailed Description, paragraph 130)).
Regarding claim 5, Malacowski discloses the method for identifying a surgical tool for use with a surgical device according to claim 1, wherein the variable indicator is a resistive coating(A WEAR PROFILE field 112 contains data indicating the extent to which the cutting accessory has been worn during its use(Detailed Description, paragraph 26)).
Regarding claim 12, Malacowski discloses a system for identifying a surgical tool for use with a surgical device, comprising: a selectively removable tool of a surgical device, the selectively removeable tool including an integrated variable indicator disposed therein; and one or more leads configured to align with the removable tool upon engagement of the tool with the surgical device, the one or more leads connected to a power console configured to read the variable indicator and identify the surgical tool based on quantifying the variable indicator, wherein one or more operating parameters of the power console are calibrated based on information about the surgical tool stored within the power console(A surgical tool system comprising a control console, a powered surgical device, an intermediate attachment removably connected to the surgical device and a cutting accessory removably connected to the intermediate attachment. Internal to the cutting accessory is an identification device that contains data specific to the operation of the accessory. The control console, through the transfer of signals through the powered surgical device and the intermediate attachment reads the data in the cutting accessory. Based on these data, the control console selectively actuates the powered surgical device(Abstract). Thus, in the current systems, the indicators mounted to a cutting accessory are only employed to provide data that describes a basic operating characteristic of the accessory or that describes its type(Background of the Invention, paragraph 10). The handpiece 22 is removably attached to a control console 28 by a flexible cable 30. The control console 28 contains circuitry that is used to supply energization signals to the handpiece motor 26. The regulation of these energization signals is controlled by a microprocessor, controller 70 (FIG. 3), internal to the control console 28. Internal to the handpiece 22 or the cable 30 is a NOVRAM 32. (When the NOVRAM 32 is in the cable 30, the cable is integrally attached to the handpiece 22.)(Detailed Description, paragraph 1)).
Regarding claim 13, Malacowski discloses the system for identifying a surgical tool for use with a surgical device according to claim 12, wherein the variable indicator is a resistive indicator(Controller 570 generates energization control signals to a driver 572. The energization control signals are based on the cutting accessory 524 identified and the value selected by a manual actuator device 549. The manual actuator device 549 can be a trigger type push button controlling the output from a variable resistor or any other type of device providing a variable signal output(Detailed Description, paragraph 130)).
Regarding claim 14, Malacowski discloses the system for identifying a surgical tool for use with a surgical device according to claim 13, wherein the resistive indicator is integrated within a removeable shaft of a surgical cutting device(The NOVRAM 32 contains data that describes the operating characteristics of the handpiece 22. These data include: information that identifies the type of handpiece; information that describes the operating characteristics of the handpiece motor; the identification of the type of output signals provided by any sensors internal to the handpiece; and information useful for correcting the signals produced by the handpiece sensors to correct for their individual calibration characteristics. More information on the types of data contained in the handpiece NOVRAM 32 and how this information is used to regulate the operation of the handpiece 22 by the system 20(Detailed Description, paragraph 1). A controller 570 controls the overall operation of the system. Memory 569 in the surgical tool 522 contains the permanent operating instructions that are executed by controller 570 to control the system and regulate the actuation of the surgical tool 522 and the cutting accessory 524. Controller 570 generates energization control signals to a driver 572. The energization control signals are based on the cutting accessory 524 identified and the value selected by a manual actuator device 549. The manual actuator device 549 can be a trigger type push button controlling the output from a variable resistor or any other type of device providing a variable signal output(Detailed Description, paragraph 130)).
Regarding claim 20, Malacowski discloses a method for identifying a surgical tool for use with a surgical device, comprising: reading, with a power console, a variable indicator located within a removably engageable component of a surgical tool while a surgical device is attached to the power console via one or more leads, the power console: identifying the surgical tool based on quantifying the variable indicator; identifying a set of operating parameters for the surgical tool from a collection of operating parameters stored within the power console; and calibrating the power console according to the identified set of operating parameters((A surgical tool system comprising a control console, a powered surgical device, an intermediate attachment removably connected to the surgical device and a cutting accessory removably connected to the intermediate attachment. Internal to the cutting accessory is an identification device that contains data specific to the operation of the accessory. The control console, through the transfer of signals through the powered surgical device and the intermediate attachment reads the data in the cutting accessory. Based on these data, the control console selectively actuates the powered surgical device(Abstract). Thus, in the current systems, the indicators mounted to a cutting accessory are only employed to provide data that describes a basic operating characteristic of the accessory or that describes its type(Background of the Invention, paragraph 10). The handpiece 22 is removably attached to a control console 28 by a flexible cable 30. The control console 28 contains circuitry that is used to supply energization signals to the handpiece motor 26. The regulation of these energization signals is controlled by a microprocessor, controller 70 (FIG. 3), internal to the control console 28. Internal to the handpiece 22 or the cable 30 is a NOVRAM 32. (When the NOVRAM 32 is in the cable 30, the cable is integrally attached to the handpiece 22.)(Detailed Description, paragraph 1)).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Malacowski and further in view of Jensen(US 5807378 A).
Regarding claim 4, Malacowski discloses the method for identifying a surgical tool for use with a surgical device according to claim 3, but Malacowski fails to disclose wherein the resistive indicator is aligned between two bearings that support the removeable shaft, each bearing residing in registration with a corresponding lead connected to the power console.
However, Jensen teaches “Bearing 54 transmits lateral forces exerted by the instrument 14 to force sensing element 52, which is operably connected to the controller mechanism for transmitting these forces to the input control devices (not shown) held by the surgeon in the telerobotic system(Detailed Description of the Embodiments, paragraph 6). In addition, shafts 18, 20 are removably coupled to bearings 22 so that the shafts can be axially withdrawn from support members 17, 19 of frame 16, as shown in FIG. 1A. To this end, the distal bearings 22 preferably include a coupling mechanism for allowing the removal of shafts 18, 20(Detailed Description of the Preferred Embodiments, paragraph 8)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the surgical tool system of Malacowski to include the bearings structure of the surgical manipulator assembly of Jensen. Doing so would specify bearings to support the shaft in the surgical tool to the system so the tool can securely attach to the robotic system.
Regarding claim 15, Malacowski discloses the system for identifying a surgical tool for use with a surgical device according to claim 14, but fails to disclose wherein the resistive indicator is aligned between two bearings that support the removeable shaft, each bearing residing in registration with a corresponding lead connected to the power console.
However, Jensen teaches “Bearing 54 transmits lateral forces exerted by the instrument 14 to force sensing element 52, which is operably connected to the controller mechanism for transmitting these forces to the input control devices (not shown) held by the surgeon in the telerobotic system(Detailed Description of the Embodiments, paragraph 6). In addition, shafts 18, 20 are removably coupled to bearings 22 so that the shafts can be axially withdrawn from support members 17, 19 of frame 16, as shown in FIG. 1A. To this end, the distal bearings 22 preferably include a coupling mechanism for allowing the removal of shafts 18, 20(Detailed Description of the Preferred Embodiments, paragraph 8)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the surgical tool system of Malacowski to include the bearings structure of the surgical manipulator assembly of Jensen. Doing so would specify bearings to support the shaft in the surgical tool to the system so the tool can securely attach to the robotic system.
Claim(s) 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Malacowski and further in view of Clark(US 20140257272 A1).
Regarding claim 6, Malacowski discloses the method for identifying a surgical tool for use with a surgical device according to claim 5, but fails to disclose further comprising applying the resistive coating atop a removeable shaft of a surgical cutting device.
However, Clark teaches “RF cutter 1601 may be positioned in an insulating sleeve 1602 that electrically insulates RF cutter 1601 from the body of RF cutting module 1603. In some embodiments, the shaft or non-cutting portion of RF cutter 1601 may also be coated with an electrically insulating coating[0153]”.
It would be obvious to one or ordinary skill in the art before the effective filing date to configure the surgical tool system of Malacowski to include the shaft coating of the device for subcutaneous surgery of Clark. Doing so would specify a coating placed on the shaft of the device to maintain electrical properties throughout use.
Regarding claim 16, Malacowski discloses the system for identifying a surgical tool for use with a surgical device according to claim 12, but fails to disclose wherein the variable indicator is a resistive coating disposed atop a removeable shaft of a surgical cutting device.
However, Clark teaches “RF cutter 1601 may be positioned in an insulating sleeve 1602 that electrically insulates RF cutter 1601 from the body of RF cutting module 1603. In some embodiments, the shaft or non-cutting portion of RF cutter 1601 may also be coated with an electrically insulating coating[0153]”.
It would be obvious to one or ordinary skill in the art before the effective filing date to configure the surgical tool system of Malacowski to include the shaft coating of the device for subcutaneous surgery of Clark. Doing so would specify a coating placed on the shaft of the device to maintain electrical properties throughout use.
Claim(s) 7-11, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Malacowki in view of Clark and further in view of Jensen.
Regarding claim 7, Malacowski in view of Clark teaches the method for identifying a surgical tool for use with a surgical device according to claim 6, but fails to disclose further comprising aligning the resistive coating between two bearings that support the removeable shaft, each bearing residing in registration with a corresponding lead connected to the power console.
However, Jensen teaches “Bearing 54 transmits lateral forces exerted by the instrument 14 to force sensing element 52, which is operably connected to the controller mechanism for transmitting these forces to the input control devices (not shown) held by the surgeon in the telerobotic system(Detailed Description of the Embodiments, paragraph 6). In addition, shafts 18, 20 are removably coupled to bearings 22 so that the shafts can be axially withdrawn from support members 17, 19 of frame 16, as shown in FIG. 1A. To this end, the distal bearings 22 preferably include a coupling mechanism for allowing the removal of shafts 18, 20(Detailed Description of the Preferred Embodiments, paragraph 8)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the surgical tool system of Malacowski to include the bearings structure of the surgical manipulator assembly of Jensen. Doing so would specify bearings to support the shaft in the surgical tool to the system so the tool can securely attach to the robotic system.
Regarding claim 8, Malacowski in view of Clark and Jensen teach the method for identifying a surgical tool for use with a surgical device according to claim 7, wherein the resistive coating is configured to wear during use of the surgical tool effectively changing the electrical resistance of the surgical tool over time(Malacowski - A WEAR PROFILE field 112 contains data indicating the extent to which the cutting accessory has been worn during its use(Detailed Description, paragraph 26). The manual actuator device 549 can be a trigger type push button controlling the output from a variable resistor or any other type of device providing a variable signal output(Detailed Description, paragraph 130)).
Regarding claim 9, Malacowski in view of Clark and Jensen teach the method for identifying a surgical tool for use with a surgical device according to claim 8, further comprising monitoring the condition of the surgical tool as a function of the wear of the resistive coating over time(Malacowski - It should be understood that the data in the WEAR PROFILE data field 112 are used in the same generally manner as the data in the TIME USED field 110 are used. Specifically, these data are read by controller 70. During the use of the cutting accessory, in a location within the memory integral with control console 28 data representative of the cumulative watt minutes of power consumed in actuating the cutting accessory are stored. These data are based on the data read from the WEAR PROFILE field 112 as well as the data generated as a result of the periodic execution of steps 370 and 372 when the handpiece motor is actuated. These data representative of total cutting accessory wear are compared to a reference value. This reference value may be from data read from chip 62, (data storage field not shown) from the handpiece or a set value in the control console memory 69. If this comparison indicates that the total amount of power employed to drive the cutting accessory exceeds the reference value, a warning message is generated on the console display 71. This provides the surgeon with an indication that the cutting accessory may be worn to a level that the efficiency of the accessory has appreciably diminished(Detailed Description, paragraph 96)).
Regarding claim 10, Malacowski in view of Clark and Jense teach the method for identifying a surgical tool for use with a surgical device according to claim 8, further comprising layering the resistive coating to prevent reuse, wherein each layer includes a different quantifier(Malacowski - The system of this invention provides the surgeon with an indication of whether or not the cutting accessory attached to it was previously used. This provides the surgeon with an indication that the cutting accessory may be worn and, therefore, will not be able to satisfactorily perform the intended surgical procedure(Detailed Description, paragraph 34). System 20 of this invention also, during the surgical procedure, provides the surgeon an indication that a cutting accessory has been used for a period equal to its intended lifetime. This information is supplied to the surgeon to inform him/her that the cutting accessory, even if new when installed, may be worn to the level of reduced efficiency. Thus, the surgeon, upon receiving this information, can decide whether or not to continue using the current accessory or replace it with a new one(Detailed Description, paragraph 35)). Claim 10 is currently further rejected under 112(b) for lack of clarity so Malacowski can be interpreted to teach the claim as currently understood.
Regarding claim 11, Malacowski in view of Clark and Jensen teach the method for identifying a surgical tool for use with a surgical device according to claim 9, further comprising: removing the surgical tool from the surgical device when the power console associates a thickness of the resistive coating to a condition of the surgical tool recommending replacement; and replacing the surgical tool(Malacowski - System 20 of this invention also, during the surgical procedure, provides the surgeon an indication that a cutting accessory has been used for a period equal to its intended lifetime. This information is supplied to the surgeon to inform him/her that the cutting accessory, even if new when installed, may be worn to the level of reduced efficiency. Thus, the surgeon, upon receiving this information, can decide whether or not to continue using the current accessory or replace it with a new one(Detailed Description, paragraph 35)).
Regarding claim 17, Malacowski in view of Clark teaches the system for identifying a surgical tool for use with a surgical device according to claim 16, but fails to disclose wherein the resistive coating is aligned between two bearings that support the removeable shaft, each bearing residing in registration with a corresponding lead connected to the power console.
However, Jensen teaches “Bearing 54 transmits lateral forces exerted by the instrument 14 to force sensing element 52, which is operably connected to the controller mechanism for transmitting these forces to the input control devices (not shown) held by the surgeon in the telerobotic system(Detailed Description of the Embodiments, paragraph 6). In addition, shafts 18, 20 are removably coupled to bearings 22 so that the shafts can be axially withdrawn from support members 17, 19 of frame 16, as shown in FIG. 1A. To this end, the distal bearings 22 preferably include a coupling mechanism for allowing the removal of shafts 18, 20(Detailed Description of the Preferred Embodiments, paragraph 8)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the surgical tool system of Malacowski to include the bearings structure of the surgical manipulator assembly of Jensen. Doing so would specify bearings to support the shaft in the surgical tool to the system so the tool can securely attach to the robotic system.
Regarding claim 18, Malacowski in view of Clark and Jensen teaches the system for identifying a surgical tool for use with a surgical device according to claim 17, wherein the resistive coating is configured to wear during use of the surgical tool effectively changing the electrical resistance of the surgical tool over time(Malacowski - A WEAR PROFILE field 112 contains data indicating the extent to which the cutting accessory has been worn during its use(Detailed Description, paragraph 26). The manual actuator device 549 can be a trigger type push button controlling the output from a variable resistor or any other type of device providing a variable signal output(Detailed Description, paragraph 130)).
Regarding claim 19, Malacowski in view of Clark and Jensen teaches the system for identifying a surgical tool for use with a surgical device according to claim 18, wherein the power console monitors the condition of the surgical tool as a function of the wear of the resistive coating over time(Malacowski - It should be understood that the data in the WEAR PROFILE data field 112 are used in the same generally manner as the data in the TIME USED field 110 are used. Specifically, these data are read by controller 70. During the use of the cutting accessory, in a location within the memory integral with control console 28 data representative of the cumulative watt minutes of power consumed in actuating the cutting accessory are stored. These data are based on the data read from the WEAR PROFILE field 112 as well as the data generated as a result of the periodic execution of steps 370 and 372 when the handpiece motor is actuated. These data representative of total cutting accessory wear are compared to a reference value. This reference value may be from data read from chip 62, (data storage field not shown) from the handpiece or a set value in the control console memory 69. If this comparison indicates that the total amount of power employed to drive the cutting accessory exceeds the reference value, a warning message is generated on the console display 71. This provides the surgeon with an indication that the cutting accessory may be worn to a level that the efficiency of the accessory has appreciably diminished(Detailed Description, paragraph 96)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA CATHERINE ANTHONY/ Examiner, Art Unit 3796
/CARL H LAYNO/ Supervisory Patent Examiner, Art Unit 3796