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 § 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, 4-8, 12, 13, 17, 19-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being unpatentable by D'Alfonso(US 6166538 A).
Regarding claim 1, D’Alfonso discloses a monitoring system for a surgical instrument, the surgical instrument comprising a magnetic element and being configured to be subjected to a temperature-based sterilization process(An electronic autoclave cycle passively records the number of thermal cycles to which an instrument has been subjected in a steam autoclave. When a sterilization cycle has been completed, and the instrument is next energized in use, a microprocessor is employed to read the sensor and record the occurrence of a sterilization cycle. Information as to the cumulative number of cycles through which the instrument has been subjected is stored in a non-volatile memory(Abstract)), the monitoring system comprising:
a sensor configured to detect a magnetism parameter of the magnetic element(The sensor employed uses either the Curie temperature or a temperature near but below the Curie temperature of a ferromagnetic material by first magnetizing the material and then, later, checking its flux density to determine whether a thermal cycle has occurred(Abstract)); and
a controller in communication with the sensor and configured to(With reference to FIG. 3, the sensor sub-circuits 10, 20 are seen to be connected to a microcontroller 30 by conductors 31 and 33. Conductor 31 provides activation and de-activation signals for power source P. Conductor 33 conveys field strength signals from the sensor winding 25 (FIG. 2) or from the Hall effect sensor (FIG. 1) to the microcontroller 30 (FIGS. 3 and 4)(Specific Description of the Preferred Embodiments, paragraph 3)) :
evaluate the magnetism parameter(In a first embodiment, a Hall effect sensor is used to directly measure the magnetic field strength of the magnetizable material. In a second embodiment, a sensor winding is used to sense the magnetic field strength of the magnetizable material. The sensor winding is interconnected with an amplifier so that changes in flux can be sensed(Abstract)), and
based on the evaluation, generate an output indicative of usage of the surgical instrument(This data is suitably displayed on a display panel(Abstract)).
Regarding claim 4, D’Alfonso discloses the monitoring system of claim 1, further comprising the controller configured to evaluate the magnetism parameter by comparing the magnetism parameter relative to a threshold(FIG. 5 shows a flowchart of the operation of the present invention where the sensor sub-circuit of FIG. 1 is employed.(Specific Description of the Preferred Embodiments, paragraph 7)[FIG. 5]).
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Regarding claim 5, D’Alfonso discloses the monitoring system of claim 4, wherein the threshold is selected based upon a predictable degradation of the magnetism parameter per cycle of the sterilization process([Fig. 5]). Fig. 5 shows the iterative process of measuring the magnetic field and comparing to a threshold value established from the previous sterilization cycle.
Regarding claim 6, D’Alfonso discloses the monitoring system of claim 5, wherein the predictable degradation is based on an effect upon the magnetic element due to an autoclave sterilization process(When an unmagnetized ferromagnetic material is placed in a magnetic field, such as is the case when a current passes through a coil around the material, the flux density of the material rises. When the magnetic field is removed by stopping flow of the current, the flux density remains. This phenomenon is known as "permanent magnetism". If the temperature of the material is raised above a critical value called the "Curie temperature", the exchange coupling suddenly disappears and the material becomes simply "paramagnetic". Paramagnetic materials do not exhibit the properties of permanent magnetism and their flux density is zero in the absence of an external field. At temperatures near but below the Curie temperature, the effect is only partial causing a permanent magnet to lose some of its retained flux density.(Summary of the Invention paragraph 4). The passage above describes the process of autoclave sterilization and how it can cause slight degradation in magnetic properties of the instrument undergoing sterilization.
Regarding claim 7, D’Alfonso discloses the monitoring system of claim 4, wherein the controller compares the magnetism parameter to the threshold by comparing the magnetism parameter to: an absolute threshold value; or previously recorded magnetism parameter values and determining whether a relative threshold drop has occurred based upon the comparing(Each of the sensor sub-circuits disclosed herein and particularly illustrated in FIGS. 1 and 2 uses the concept of the Curie temperature or near Curie temperature of a ferromagnetic magnetizable material to determine whether an autoclave cycle has been experienced. During each case, the ferromagnetic material is first magnetized and then, sometime later, the flux density thereof is checked to determine if a formal cycle has occurred. If the ferromagnetic material has been exposed to a temperature at or near the Curie temperature, the magnetic flux density will fall and this can be sensed by either of the sensor sub-circuits described in FIGS. 1 and 2. If the flux density of the material has fallen, the material is re-magnetized by passing a current through the coil 13 or 23. This action re-sets the sensor 10 or 20 so that it is in a proper condition to observe another cycle of autoclaving. As explained above, it is not necessary to reach the Curie temperature to facilitate noting of a change in flux density. Merely approaching the Curie temperature results in some lowering of the flux density which is detected(Specific Description of the Preferred Embodiments, paragraph 8)[FIG. 5]).
Regarding claim 8, D’Alfonso discloses the monitoring system of claim 1, wherein the magnetism parameter is one or both of a magnetic field density or a magnetic flux(The sensor employed uses either the Curie temperature or a temperature near but below the Curie temperature of a ferromagnetic material by first magnetizing the material and then, later, checking its flux density to determine whether a thermal cycle has occurred. In a first embodiment, a Hall effect sensor is used to directly measure the magnetic field strength of the magnetizable material. In a second embodiment, a sensor winding is used to sense the magnetic field strength of the magnetizable material(Abstract)).
Regarding claim 12, D’Alfonso discloses monitoring system of claim 1, wherein the sensor is a magnetometer(The device of claim 1, wherein the sensor means comprises a Hall effect sensor(Claim 4)). A hall effect sensor is a type of magnetometer sensor.
Regarding claim 13, D’Alfonso discloses a surgical system comprising:
a surgical accessory comprising a magnetic element, wherein the surgical accessory is configured to be subjected to a temperature-based sterilization process(An electronic autoclave cycle passively records the number of thermal cycles to which an instrument has been subjected in a steam autoclave. When a sterilization cycle has been completed, and the instrument is next energized in use, a microprocessor is employed to read the sensor and record the occurrence of a sterilization cycle. Information as to the cumulative number of cycles through which the instrument has been subjected is stored in a non-volatile memory(Abstract));
a surgical device configured to receive the surgical accessory(The reference numeral 37 refers to an outer housing wall designed to enclose all of the components illustrated in FIG. 3 into a single assembly designed to be attached to an instrument for which the number of autoclaving cycles is to be measured(Specific Description of the Preffered Embodiments, paragraph 3), wherein the surgical device comprises a controller and a sensor, the controller being configured to(With reference to FIG. 3, the sensor sub-circuits 10, 20 are seen to be connected to a microcontroller 30 by conductors 31 and 33. Conductor 31 provides activation and de-activation signals for power source P. Conductor 33 conveys field strength signals from the sensor winding 25 (FIG. 2) or from the Hall effect sensor (FIG. 1) to the microcontroller 30 (FIGS. 3 and 4)(Specific Description of the Preferred Embodiments, paragraph 3) :
detect, with the sensor, a magnetism parameter of the magnetic element(The sensor employed uses either the Curie temperature or a temperature near but below the Curie temperature of a ferromagnetic material by first magnetizing the material and then, later, checking its flux density to determine whether a thermal cycle has occurred(Abstract));
evaluate the magnetism parameter(In a first embodiment, a Hall effect sensor is used to directly measure the magnetic field strength of the magnetizable material. In a second embodiment, a sensor winding is used to sense the magnetic field strength of the magnetizable material. The sensor winding is interconnected with an amplifier so that changes in flux can be sensed(Abstract)); and
based on the evaluation, generate an output to indicate usage of the surgical accessory(This data is suitably displayed on a display panel(Abstract)).
Regarding claim 19, D’Alfonso discloses a method to generate an output to indicate usage of a surgical instrument, the surgical instrument including a magnetic element and being configured to be repeatedly subjected to a temperature-based sterilization process((An electronic autoclave cycle passively records the number of thermal cycles to which an instrument has been subjected in a steam autoclave. When a sterilization cycle has been completed, and the instrument is next energized in use, a microprocessor is employed to read the sensor and record the occurrence of a sterilization cycle. Information as to the cumulative number of cycles through which the instrument has been subjected is stored in a non-volatile memory(Abstract)), the method comprising:
utilizing a sensor to detect a magnetism parameter of the magnetic element(The sensor employed uses either the Curie temperature or a temperature near but below the Curie temperature of a ferromagnetic material by first magnetizing the material and then, later, checking its flux density to determine whether a thermal cycle has occurred. In a first embodiment, a Hall effect sensor is used to directly measure the magnetic field strength of the magnetizable material. In a second embodiment, a sensor winding is used to sense the magnetic field strength of the magnetizable material. The sensor winding is interconnected with an amplifier so that changes in flux can be sensed(Abstract)); and
utilizing a controller for:
comparing the magnetism parameter to a threshold([FIG. 5]); and
based upon the comparison, generating the output to indicate usage of the surgical instrument(This data is suitably displayed on a display panel(Abstract)).
Regarding claim 20, D’Alfonso discloses the method of claim 19, further comprising: iteratively subjecting the surgical instrument to the temperature-based sterilization process; iteratively utilizing the sensor to detect the magnetism parameter; iteratively comparing the magnetism parameter to the threshold; and generating the output in response to identifying that the magnetism parameter has degraded past the threshold([FIG. 5]). Fig. 5 shows the iterative process of measuring the magnetic field and comparing to a threshold value established from the previous sterilization cycle.
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) 2, 3, 11, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over D’Alfonso in view of Fitzsimons(CN 110772342 A).
Regarding claim 2, D’Alfonso discloses the monitoring system of claim 1, but fails to explicitly state wherein the output indicative of usage of the surgical instrument is configured for indicating an end-of-life of the surgical instrument.
However, Fitzsimons teaches “In some aspects, the characteristic signal is configured to provide an indication of the remaining life of the component. the handle can include a display which is configured to provide an indication of the remaining life of the component(see attached translation, page 3, paragraph 4)
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the autoclave cycle monitor to include the end-of-life indication of the end-of -life delivery system of Fitzsimons. Doing so would specify the indication displayed after sterilization to include how many life cycles the instrument has before the integrity of the device is compromised.
Regarding claim 3, D’Alfonso discloses the monitoring system of claim 1, but fails to disclose wherein the output indicative of usage of the surgical instrument is configured for indicating: how many uses to which the surgical instrument has been subjected; and/or how much useful life the surgical instrument has left.
However, Fitzsimons teaches “In some aspects, the method comprises: when the member is proximate its ultimate use, disabling the surgical instrument. The method may include prior to use of the surgical instrument, display the remaining life of the component(see attached translation, page 4, paragraph 2)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the autoclave cycle monitor to include the end-of-life indication of the end-of -life delivery system of Fitzsimons. Doing so would specify the indication displayed after sterilization to include how many life cycles the instrument has before the integrity of the device is compromised.
Regarding claim 11, D’Alfonso discloses the monitoring system of claim 1, but fails to disclose wherein the sensor is disposed within an end effector of a surgical device that is configured to receive the surgical instrument.
However, Fitzsimons discloses “The handle 30 may include a sensor 20 disposed therein and in communication with the processor 22. Additionally or alternatively, the sensor 20 may be disposed within the adapter 18 or the end effector 19(see attached translation, page 5, paragraph 5)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the autoclave cycle monitor to include the sensor placement on the device of the end-of -life delivery system of Fitzsimons. Doing so would specify the placement of the sensor to capture the magnetic properties of the device post sterilization for an accurate reading on whether or not magnetic degradation occurred.
Regarding claim 14, D’Alfonso discloses the surgical system of claim 13, but fails to disclose wherein the surgical accessory is a cutting instrument or a burr guard for the cutting instrument.
However, Fitzsimons teaches “Referring now to FIG. 1, the surgical system 1 comprises a powered surgical device 10 and processor 60. network 50 or cloud 55 of surgical instrument 10 can be detailed hereinafter by communication with the processor 60. surgical instrument 10 a power handle 30 coupled to handle 30 and extends from the handle 30 the adapter 18 and connected to adapter 18 and end effector 18 extending from adapter 19. End effector 19 is configured to act on the tissue (e.g., driving the nail into the tissue, applying energy to the tissue, cutting tissue, applying a clamp to the tissue and manipulating tissues)(see attached translation, page 4, paragraph 13))”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the autoclave cycle monitor with the usage of the device of the end-of -life delivery system of Fitzsimons. Doing so would specify the use of the surgical instrument in surgical practice.
Regarding claim 15, D’Alfonso discloses the surgical system of claim 13, but fails to explicitly state wherein the output indicative of usage of the surgical accessory is configured for indicating how many uses to which the surgical accessory has been subjected.
However, Fitzsimons teaches “In some aspects, the characteristic signal is configured to provide an indication of the remaining life of the component. the handle can include a display which is configured to provide an indication of the remaining life of the component(see attached translation, page 3, paragraph 4)
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the autoclave cycle monitor to include the end-of-life indication of the end-of -life delivery system of Fitzsimons. Doing so would specify the indication displayed after sterilization to include how many life cycles the instrument has before the integrity of the device is compromised.
Regarding claim 16, D’Alfonso discloses the surgical system of claim 13, but fails to disclose wherein the output indicative of usage of the surgical accessory is configured for indicating how many uses to which the surgical accessory has been subjected.
However, Fitzsimons teaches “In some aspects, the method comprises: when the member is proximate its ultimate use, disabling the surgical instrument. The method may include prior to use of the surgical instrument, display the remaining life of the component(see attached translation, page 4, paragraph 2)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the autoclave cycle monitor to include the end-of-life indication of the end-of -life delivery system of Fitzsimons. Doing so would specify the indication displayed after sterilization to include how many life cycles the instrument has before the integrity of the device is compromised.
Regarding claim 17, D’Alfonso discloses the surgical system of claim 13, but fails to disclose wherein the output indicative of usage of the surgical accessory is configured for indicating how much useful life the surgical accessory has left.
However, Fitzsimons teaches “In some aspects, the method comprises: when the member is proximate its ultimate use, disabling the surgical instrument. The method may include prior to use of the surgical instrument, display the remaining life of the component(see attached translation, page 4, paragraph 2)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the autoclave cycle monitor to include the end-of-life indication of the end-of -life delivery system of Fitzsimons. Doing so would specify the indication displayed after sterilization to include how many life cycles the instrument has before the integrity of the device is compromised.
Regarding claim 18, D’Alfonso discloses the surgical system of claim 13, but fails to explicitly state wherein the sensor is disposed within an end effector of the surgical device that is configured to receive the surgical accessory.
However, Fitzsimons discloses “The handle 30 may include a sensor 20 disposed therein and in communication with the processor 22. Additionally or alternatively, the sensor 20 may be disposed within the adapter 18 or the end effector 19(see attached translation, page 5, paragraph 5)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the autoclave cycle monitor to include the sensor placement on the device of the end-of -life delivery system of Fitzsimons. Doing so would specify the placement of the sensor to capture the magnetic properties of the device post sterilization for an accurate reading on whether or not magnetic degradation occurred.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over D’Alfonso.
Regarding claim 9, D’Alfonso discloses the monitoring system of claim 1, but fails to explicitly disclose wherein the magnetic element includes samarium cobalt. However, D’Alfonso teaches “ With reference to FIG. 1, a first embodiment of the present invention includes a sensor sub-circuit generally designated by the reference numeral 10 and including a ferromagnetic magnetizable material 11 surrounded by a coil 13, with the material 11 connected to a Hall effect sensor 15 that includes three wires; namely, a power wire 17, a ground wire 19, and a signal output wire 21. A source of power P controlled by a microcontroller 30 (FIGS. 3-4) is used to re-magnetize material 11(Specific Description of the Preferred Embodiments, paragraph 1)”. Cobalt is a common type of ferromagnetic material so it would be obvious to one of ordinary skill in the art to configure the ferromagnetic element of D’Alfonso to include cobalt.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over D’Alfonso in view of Kumar(US 20150201918 A1).
Regarding claim 10, D’Alfonso discloses the monitoring system of claim 1, but fails to explicitly disclose wherein the magnetic element includes a neodymium (NdFeB) magnet.
However, Kuman teaches “These may comprise one or more rare-earth magnets such as, for example, nickel-plated neodymium magnets (aka NdFeB, NIB or Neo magnets). Neodymium magnets are permanent magnets made from an alloy of neodymium, iron and boron to form a Nd2Fe14B tetragonal crystalline structure and are one of the strongest types of permanent magnets commercially available[0144]”.
It would be obvious to of ordinary skill in the art before the effective filing date to configure the autoclave cycle monitor of D’Alfonso with the neodymium magnets of the surgical handpiece of Kuman. Doing so would clarify neodymium magnets as an element of the ferromagnetic material in the system.
Conclusion
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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