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 § 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) 1-3, 5, 12-14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable by Malacowski(US 8035487 B2) (cited previously) in view of Martinu(US 20090246243 A1).
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; and monitoring the changing electrical properties of the variable indicator as the two or more layers wear during use of the surgical tool over time(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). Also, as mentioned above with respect to the data stored in chip controller/memory 84, this component may contain data that indicates the extent to which the cutting accessory is worn. One means of determining cutting accessory wear is now described by reference to FIG. 23. Specifically, controller 70, in addition to monitoring the amount of time a cutting accessory is actuated monitors the voltage applied to the handpiece that actuates the cutting accessory as well as the current drawn by the handpiece, step 370(Detailed Description, paragraph 94)). Malacowski fails to disclose “the variable indicator including two or more layers of coatings each layer having a different electrical property, the two or more layers configured to wear during use of the surgical tool effectively changing the electrical property of the surgical tool over time”.
However, Martinu teaches “In one aspect, the invention is a new coating architecture as shown in FIG. 1, obtained by controlling the interfaces between a metal substrate 110 (such as stainless steel--SS, Ti-alloys, and others) and DLC coatings 120 in order to make it suitable for biomedical applications. In one embodiment, the invention includes a DLC layer 120, with an intermediate (such as a bonding, adhesion or sealing) layer 130 formed by Si or Ti based materials such as Si.sub.xN.sub.y or TiN coated onto the metal surface 110.[0044]. The unique physical, chemical, electrical, mechanical, tribological, optical, biocompatibility and other properties of amorphous diamond like carbon (DLC), and doped or nano-structured DLC, together with the potential to adjust the properties by choosing appropriate deposition parameters, make DLCs suitable for a variety of applications. Exemplary applications include coatings on cutting tools, such as shaving blades and surgical knives, wear resistant components, body implants, computer memory discs, infrared windows, optical devices, sunglasses and ophthalmic lenses, micro-electro-mechanical systems (MEMS), sensors, flat panel displays, cold cathodes, sports equipment and specific functional or protective coatings with tailored surface characteristics[0003]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the surgical tool assembly of Malackowski with the metal coatings of Martinu. Doing so would specify the cutting tool would have a multi-layer coating to help with wear resistance over time.
Regarding claim 2, Malacowski in view of Martinu teaches the method for identifying a surgical tool for use with a surgical device according to claim 1, wherein the variable indicator includes two or more resistive layers(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 in view of Martinu teaches the method for identifying a surgical tool for use with a surgical device according to claim 2, further comprising integrating the variable indicator within a removeable shaft of a surgical cutting device(In Malacowski, 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 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 initially read the variable indicator and identify the surgical tool based on an initial quantifying reading of the variable indicator, wherein one or more operating parameters of the power console are calibrated based on the identification of the surgical tool and the operating parameters stored within the power console. and monitoring the changing electrical properties of the variable indicator as the two or more layers wear during use of the surgical tool over time (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). Also, as mentioned above with respect to the data stored in chip controller/memory 84, this component may contain data that indicates the extent to which the cutting accessory is worn. One means of determining cutting accessory wear is now described by reference to FIG. 23. Specifically, controller 70, in addition to monitoring the amount of time a cutting accessory is actuated monitors the voltage applied to the handpiece that actuates the cutting accessory as well as the current drawn by the handpiece, step 370(Detailed Description, paragraph 94)). Malacowski fails to disclose “the variable indicator including two or more layers of coatings each layer having a different electrical property, the two or more layers configured to wear during use of the surgical tool effectively changing the electrical property of the surgical tool over time”.
However, Martinu teaches “In one aspect, the invention is a new coating architecture as shown in FIG. 1, obtained by controlling the interfaces between a metal substrate 110 (such as stainless steel--SS, Ti-alloys, and others) and DLC coatings 120 in order to make it suitable for biomedical applications. In one embodiment, the invention includes a DLC layer 120, with an intermediate (such as a bonding, adhesion or sealing) layer 130 formed by Si or Ti based materials such as Si.sub.xN.sub.y or TiN coated onto the metal surface 110.[0044]. The unique physical, chemical, electrical, mechanical, tribological, optical, biocompatibility and other properties of amorphous diamond like carbon (DLC), and doped or nano-structured DLC, together with the potential to adjust the properties by choosing appropriate deposition parameters, make DLCs suitable for a variety of applications. Exemplary applications include coatings on cutting tools, such as shaving blades and surgical knives, wear resistant components, body implants, computer memory discs, infrared windows, optical devices, sunglasses and ophthalmic lenses, micro-electro-mechanical systems (MEMS), sensors, flat panel displays, cold cathodes, sports equipment and specific functional or protective coatings with tailored surface characteristics[0003]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the surgical tool assembly of Malackowski with the metal coatings of Martinu. Doing so would specify the cutting tool would have a multi-layer coating to help with wear resistance over time.
Regarding claim 13, Malacowski in view of Martinu teaches the system for identifying a surgical tool for use with a surgical device according to claim 12, wherein the variable indicator two or more resistive layers(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 in view of Martinu teaches the system for identifying a surgical tool for use with a surgical device according to claim 13, wherein the two or more resistive layers are 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 an initial quantifying reading of 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 based on the identification of the surgical tool; monitoring the changing electrical properties of the variable indicator as the two or more layers wear during use of the surgical tool over time((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). Also, as mentioned above with respect to the data stored in chip controller/memory 84, this component may contain data that indicates the extent to which the cutting accessory is worn. One means of determining cutting accessory wear is now described by reference to FIG. 23. Specifically, controller 70, in addition to monitoring the amount of time a cutting accessory is actuated monitors the voltage applied to the handpiece that actuates the cutting accessory as well as the current drawn by the handpiece, step 370(Detailed Description, paragraph 94)). Malacowski fails to disclose “the variable indicator including two or more layers of coatings each layer having a different electrical property, the two or more layers configured to wear during use of the surgical tool effectively changing the electrical property of the surgical tool over time”.
However, Martinu teaches “In one aspect, the invention is a new coating architecture as shown in FIG. 1, obtained by controlling the interfaces between a metal substrate 110 (such as stainless steel--SS, Ti-alloys, and others) and DLC coatings 120 in order to make it suitable for biomedical applications. In one embodiment, the invention includes a DLC layer 120, with an intermediate (such as a bonding, adhesion or sealing) layer 130 formed by Si or Ti based materials such as Si.sub.xN.sub.y or TiN coated onto the metal surface 110.[0044]. The unique physical, chemical, electrical, mechanical, tribological, optical, biocompatibility and other properties of amorphous diamond like carbon (DLC), and doped or nano-structured DLC, together with the potential to adjust the properties by choosing appropriate deposition parameters, make DLCs suitable for a variety of applications. Exemplary applications include coatings on cutting tools, such as shaving blades and surgical knives, wear resistant components, body implants, computer memory discs, infrared windows, optical devices, sunglasses and ophthalmic lenses, micro-electro-mechanical systems (MEMS), sensors, flat panel displays, cold cathodes, sports equipment and specific functional or protective coatings with tailored surface characteristics[0003]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the surgical tool assembly of Malackowski with the metal coatings of Martinu. Doing so would specify the cutting tool would have a multi-layer coating to help with wear resistance over time.
Claim(s) 4, 8-11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Malacowski in view of Martinu and further in view of Jensen(US 5807378 A) (cited previously).
Regarding claim 4, Malacowski in view of Martinu teaches the method for identifying a surgical tool for use with a surgical device according to claim 3, but Malacowski fails to disclose wherein the variable 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 8, Malacowski in view of Martinu and Jensen teach the method for identifying a surgical tool for use with a surgical device according to claim 4, wherein the two or more resistive layers are 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 Martinu and Jensen teach the method for identifying a surgical tool for use with a surgical device according to claim 8, further comprising monitoring a condition of the surgical tool as a function of the amount of wear of the two or more resistive layers 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, the method further comprises monitoring the resistance of the two or more resistive layers as each layer wears to prevent reuse of the surgical tool (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)). Malacowski fails to disclose “wherein each resistive layer of the two or more resistive layers includes a different resistance”.
However, Martinu teaches “In one aspect, the invention is a new coating architecture as shown in FIG. 1, obtained by controlling the interfaces between a metal substrate 110 (such as stainless steel--SS, Ti-alloys, and others) and DLC coatings 120 in order to make it suitable for biomedical applications. In one embodiment, the invention includes a DLC layer 120, with an intermediate (such as a bonding, adhesion or sealing) layer 130 formed by Si or Ti based materials such as Si.sub.xN.sub.y or TiN coated onto the metal surface 110[0044]”.
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It would be obvious to one of ordinary skill in the art before the effective filing date to configure the surgical tool assembly of Malackowski with the metal coatings of Martinu. Doing so would specify the cutting tool would have a multi-layer coating to help with wear resistance over time.
Regarding claim 11, Malacowski in view of Martinu 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 resistance of the resistive layer to a the 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 15, Malacowski in view of Martinu teaches the system for identifying a surgical tool for use with a surgical device according to claim 14, but fails to disclose wherein the two or more resistive layers are 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 8-15, and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant argues that previous art fails to disclose the two or more coating layers on the surgical tool with different electrical properties. However, Martinu teaches DLC coatings on metal substrates that are used to help with wear and protection for devise such as surgical cutting tools. As shown in figure 1, the coatings comprise of two layers atop the substrate, each made of a different material with different properties. Various wear tests are done in the Martinu reference to demonstrate how the coatings wear over time with usage. Malacowski discloses a wear profile to keep track of cutting tool wear over time so Malacowski already contains the ability to track the coating wear on the surgical tool. Malacowski can be naturally combined with Martinu and Jensen to disclose all claimed material.
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 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
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