Notice of 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(maintained)
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.
2. Claim(s) 1-2, 8-9, and 15-16 stand rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Huang et al US 2012/0012638 (hereinafter Huang).
Regarding claim 1, Huang discloses a surgical instrument (510), comprising: an end effector (512); a knife (548) slidably receivable within the end effector (figs.14-16; par 0157-159); a control circuit (controller 770; par 0189) configured to: operate in an open-loop configuration to indirectly determine an amount of tissue positioned within the end effector based on a time required by the knife to traverse a first distance (non-automatic control response to move the knife a predetermined distance/time; par 0207); determine that the knife has traversed the first distance (initial cutting movement); determine the time required to traverse the first distance (initial movement of the knife 548 is sensed and tissue thickness is sensed); and operate in an closed-loop configuration to automatically advance the knife based on the time required to traverse the first distance (based on the sensed and measured position and resistance of the knife 548, knife speed can be controlled automatically in a closed loop logic to adjust the sealing/stapling and control of the knife 548, this includes both direct sensing of the tissue thickness by electrode sensor or hall sensors 780,781, in addition to indirectly determining tissue thickness based on the position and resistance of the knife member as is moves through the tissue during operation, this allows for a better tissue seal; par 0204-0207).
Regarding claim 2, Huang discloses the surgical instrument of claim 1, comprising a firing member (514) coupled to the knife (548; par 0152; figs 13-16).
Regarding claim 8, Huang discloses a surgical instrument (510), comprising: an end effector (512); a knife (548) slidably receivable within the end effector (512; figs.14-16; par 0157-159) a control circuit (controller 770; par 0189) configured to: operate in an open-loop configuration to indirectly determine an amount of tissue positioned within the end effector based on a time required by the knife to traverse a first distance determine that an initial time period has passed (non-automatic control response to move the knife a predetermined distance/time; par 0207); receive translation data describing a distal translation of the knife (548) during the initial time period (initial cutting movement); and operate in an closed-loop configuration to automatically advance the knife based on a distance of the distal translation of the knife during the initial time period (based on the sensed and measured position and resistance of the knife 548, knife speed can be controlled automatically in a closed loop logic to adjust the sealing/stapling and control of the knife 548, this includes both direct sensing of the tissue thickness by electrode sensor or hall sensors 780,781, in addition to indirectly determining tissue thickness based on the position and resistance of the knife member as is moves through the tissue during operation, this allows for a better tissue seal; par 0204-0207).
Regarding claim 9, Huang discloses the surgical instrument of claim 8, comprising a firing member (514) coupled to the knife (548; par 0152; figs 13-16).
Regarding claim 15, Huang discloses a surgical instrument (510), comprising: an end effector (512); a knife (548) slidably receivable within the end effector (512; figs.14-16; par 0157-159); a control circuit (controller 770; par 0189) configured to: operate in an open-loop configuration to indirectly determine an amount of tissue positioned within the end effector based on a time required by the knife to traverse a first distance maintain an initial motor setting for the first distance passed (non-automatic control response to move the knife a predetermined distance/time; par 0207); determine that the knife has traversed the first distance (initial cutting movement); determine the time required to traverse the first distance; and operate in a closed-loop configuration to automatically advance the knife based on the time required to traverse the first distance (based on the sensed and measured position and resistance of the knife 548, knife speed can be controlled automatically in a closed loop logic to adjust the sealing/stapling and control of the knife 548, this includes both direct sensing of the tissue thickness by electrode sensor or hall sensors 780,781, in addition to indirectly determining tissue thickness based on the position and resistance of the knife member as is moves through the tissue during operation, this allows for a better tissue seal; par 0204-0207).
Regarding claim 16, Huang discloses the surgical instrument of claim 15, comprising a firing member (514) coupled to the knife (548; par 0152; figs 13-16).
Claim Rejections - 35 USC § 103(maintained)
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.
3. Claim(s) 3-7,10-14,and 17-20 stand rejected under 35 U.S.C. 103 as being unpatentable over Huang et al US 2012/0012638 in view of Zemlok US 2015/0209035.
Regarding claim 3, Huang discloses the surgical instrument of claim 2, comprising an electrically conductive driver coupled to the firing member to translate the firing member between a stroke begin position and a stroke end position, but fails to explicitly disclose a motor to drive the firing member.
However Zemlok teaches a surgical instrument with calibration to adjust speed of the rotational motor 200 for controlling the speed of the firing rod 220; par 0185.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the surgical instrument with pulse modulation control as disclosed by Huang with the motor control and sensors as taught by Zemlok in order to control the speed and have indication of the position of the firing member and knife member to prevent false actuation or lockout due to feedback to the operator from the surgical stapling instrument (Zemlok par 0071-0074).
Regarding claim 4, Huang discloses the surgical instrument of claim 1, further comprising a plurality of sensors to determine various conditions of the surgical instrument such as proximity sensor for determining tissue thickness (par 0150) but fails to explicitly teach a position sensor positioned to sense a position of the knife.
However Zemlok teaches a surgical instrument configured to calibrate a firing motor including a pulse modulation algorithm which includes initiating translation of the firing rod, detecting at least one indicator on the firing rod using a position sensor (par 0007; par 0126-0127) and determining a time between when translation is initiated and when the indicator is detected by comparing time with a predetermined time value and adjusting; par 0010.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the surgical instrument with pulse modulation control as disclosed by Huang with the motor control and sensors as taught by Zemlok in order to control the speed and have indication of the position of the firing member and knife member to prevent false actuation or lockout due to feedback to the operator from the surgical stapling instrument (Zemlok par 0071-0074).
Regarding claim 5, Huang discloses the surgical instrument of claim 1, further teaching control of the speed of the firing member (par 0207) but fails to explicitly teach wherein advancing the knife comprises driving the knife at a constant speed.
However Zemlok teaches a surgical stapling instrument with motor control from microcontroller 500 which controls the drive motor 200 via pulse width modulation and can be configured to run in a plurality of modes, one being a constant speed mode using speed calculator 422 in conjunction with microcontroller 500; par 0185.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the surgical instrument with pulse modulation control as disclosed by Huang with the motor control and sensors as taught by Zemlok in order to control the speed and have indication of the position of the firing member and knife member to prevent false actuation or lockout due to feedback to the operator from the surgical stapling instrument and be able to adjust the instrument between a plurality of modes based on the needs of the operator (Zemlok par 0071-0074).
Regarding claim 6, Huang discloses the surgical instrument of claim 1, but fails to explicitly teach wherein advancing the knife comprises driving the knife with a constant power.
However Zemlok teaches a surgical stapling instrument with motor control from microcontroller 500 which controls the drive motor 200 via pulse width modulation and can be configured to run in a plurality of modes, and monitoring the speed can also be accomplished by measuring voltage across the terminals under constant current conditions (par 0145; par 0185).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the surgical instrument with pulse modulation control as disclosed by Huang with the motor control and sensors as taught by Zemlok in order to control the speed and power and have indication of the position of the firing member and knife member to prevent false actuation or lockout due to feedback to the operator from the surgical stapling instrument and be able to adjust the instrument between a plurality of modes based on the needs of the operator (Zemlok par 0071-0074).
Regarding claim 7, Huang as modified by Zemlok substantially teaches the surgical instrument of claim 3, wherein Huang further teaches the amount of tissue positioned within the end effector determines the advancement of the knife from the end of the open-loop to the stroke end position (based on the sensed and measured position and resistance of the knife 548, sensing of the tissue thickness by electrode sensor or hall sensors 780,781 determine tissue thickness based on the position and resistance of the knife member as is moves through the tissue during operation and advances the knife based on predetermined tissue thickness threshold, this allows for a better tissue seal; par 0204-0207).
Regarding claim 10, Huang discloses the surgical instrument of claim 9, comprising an electrically conductive driver coupled to the firing member to translate the firing member between a stroke begin position and a stroke end position, but fails to explicitly disclose a motor to drive the firing member.
However Zemlok teaches a surgical instrument with calibration to adjust speed of the rotational motor 200 for controlling the speed of the firing rod 220; par 0185.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the surgical instrument with pulse modulation control as disclosed by Huang with the motor control and sensors as taught by Zemlok in order to control the speed and have indication of the position of the firing member and knife member to prevent false actuation or lockout due to feedback to the operator from the surgical stapling instrument (Zemlok par 0071-0074).
Regarding claim 11, Huang discloses the surgical instrument of claim 8, further comprising a plurality of sensors to determine various conditions of the surgical instrument such as proximity sensor for determining tissue thickness (par 0150) but fails to explicitly teach a position sensor positioned to sense a position of the knife.
However Zemlok teaches a surgical instrument configured to calibrate a firing motor including a pulse modulation algorithm which includes initiating translation of the firing rod, detecting at least one indicator on the firing rod using a position sensor (par 0007; par 0126-0127) and determining a time between when translation is initiated and when the indicator is detected by comparing time with a predetermined time value and adjusting; par 0010.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the surgical instrument with pulse modulation control as disclosed by Huang with the motor control and sensors as taught by Zemlok in order to control the speed and have indication of the position of the firing member and knife member to prevent false actuation or lockout due to feedback to the operator from the surgical stapling instrument (Zemlok par 0071-0074).
Regarding claim 12, Huang discloses the surgical instrument of claim 8, further teaching control of the speed of the firing member (par 0207) but fails to explicitly teach wherein advancing the knife comprises driving the knife at a constant speed.
However Zemlok teaches a surgical stapling instrument with motor control from microcontroller 500 which controls the drive motor 200 via pulse width modulation and can be configured to run in a plurality of modes, one being a constant speed mode using speed calculator 422 in conjunction with microcontroller 500; par 0185.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the surgical instrument with pulse modulation control as disclosed by Huang with the motor control and sensors as taught by Zemlok in order to control the speed and have indication of the position of the firing member and knife member to prevent false actuation or lockout due to feedback to the operator from the surgical stapling instrument and be able to adjust the instrument between a plurality of modes based on the needs of the operator (Zemlok par 0071-0074).
Regarding claim 13, Huang discloses the surgical instrument of claim 8, but fails to explicitly teach wherein advancing the knife comprises driving the knife with a constant power.
However Zemlok teaches a surgical stapling instrument with motor control from microcontroller 500 which controls the drive motor 200 via pulse width modulation and can be configured to run in a plurality of modes, and monitoring the speed can also be accomplished by measuring voltage across the terminals under constant current conditions (par 0145; par 0185).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the surgical instrument with pulse modulation control as disclosed by Huang with the motor control and sensors as taught by Zemlok in order to control the speed and power and have indication of the position of the firing member and knife member to prevent false actuation or lockout due to feedback to the operator from the surgical stapling instrument and be able to adjust the instrument between a plurality of modes based on the needs of the operator (Zemlok par 0071-0074).
Regarding claim 14, Huang as modified by Zemlok substantially teaches the surgical instrument of claim 10, wherein Huang further teaches the amount of tissue positioned within the end effector determines the advancement of the knife from the end of the open-loop to the stroke end position (based on the sensed and measured position and resistance of the knife 548, sensing of the tissue thickness by electrode sensor or hall sensors 780,781 determine tissue thickness based on the position and resistance of the knife member as is moves through the tissue during operation and advances the knife based on predetermined tissue thickness threshold, this allows for a better tissue seal; par 0204-0207).
Regarding claim 17, Huang discloses the surgical instrument of claim 16, comprising an electrically conductive driver coupled to the firing member to translate the firing member between a stroke begin position and a stroke end position, but fails to explicitly disclose a motor to drive the firing member.
However Zemlok teaches a surgical instrument with calibration to adjust speed of the rotational motor 200 for controlling the speed of the firing rod 220; par 0185.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the surgical instrument with pulse modulation control as disclosed by Huang with the motor control and sensors as taught by Zemlok in order to control the speed and have indication of the position of the firing member and knife member to prevent false actuation or lockout due to feedback to the operator from the surgical stapling instrument (Zemlok par 0071-0074).
Regarding claim 18, Huang discloses the surgical instrument of claim 15, further comprising a plurality of sensors to determine various conditions of the surgical instrument such as proximity sensor for determining tissue thickness (par 0150) but fails to explicitly teach a position sensor positioned to sense a position of the knife.
However Zemlok teaches a surgical instrument configured to calibrate a firing motor including a pulse modulation algorithm which includes initiating translation of the firing rod, detecting at least one indicator on the firing rod using a position sensor (par 0007; par 0126-0127) and determining a time between when translation is initiated and when the indicator is detected by comparing time with a predetermined time value and adjusting; par 0010.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the surgical instrument with pulse modulation control as disclosed by Huang with the motor control and sensors as taught by Zemlok in order to control the speed and have indication of the position of the firing member and knife member to prevent false actuation or lockout due to feedback to the operator from the surgical stapling instrument (Zemlok par 0071-0074).
Regarding claim 19, Huang discloses the surgical instrument of claim 15, further teaching control of the speed of the firing member (par 0207) but fails to explicitly teach wherein advancing the knife comprises driving the knife at a constant speed.
However Zemlok teaches a surgical stapling instrument with motor control from microcontroller 500 which controls the drive motor 200 via pulse width modulation and can be configured to run in a plurality of modes, one being a constant speed mode using speed calculator 422 in conjunction with microcontroller 500; par 0185.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the surgical instrument with pulse modulation control as disclosed by Huang with the motor control and sensors as taught by Zemlok in order to control the speed and have indication of the position of the firing member and knife member to prevent false actuation or lockout due to feedback to the operator from the surgical stapling instrument and be able to adjust the instrument between a plurality of modes based on the needs of the operator (Zemlok par 0071-0074).
Regarding claim 20, Huang as modified by Zemlok substantially teaches the surgical instrument of claim 17, Huang further teaches the amount of tissue positioned within the end effector determines the advancement of the knife from the end of the open-loop to the stroke end position (based on the sensed and measured position and resistance of the knife 548, sensing of the tissue thickness by electrode sensor or hall sensors 780,781 determine tissue thickness based on the position and resistance of the knife member as is moves through the tissue during operation and advances the knife based on predetermined tissue thickness threshold, this allows for a better tissue seal; par 0204-0207).
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive.
First applicant argues on pages 5-7 that Huang fails to disclose determining an amount of tissue positioned in the end effector based on a time required by the knife to traverse a first distance, determine the time required to traverse the first distance and operate in a closed loop configuration to advance the knife based on the time required to traverse the first distance.
In furtherance of this argument states Huang fails to disclose a distance traversed by the knife, and more specifically determine the amount of tissue based on a time required by the knife to traverse a first distance.
And the Huang discloses “a predetermined tissue sealing time can be associated with each tissue thickness or each range of tissue thickness” which utilized sensors to determine tissue thickness but not operating in an open loop configuration to indirectly determine an amount of tissue positioned within the end effector based on a time required by the knife to traverse a first distance because Huang determines tissue thickness before the knife traverses the first distance.
However this argument is unpersuasive because the control system operates first in an open loop system operates by receiving an input, processing it and producing an output without monitoring or adjusting, such as Huang disclosing a non-automatic (open loop) control response to move the knife a predetermined distance/time; par 0207) and then based on the sensed and measured position and resistance of the knife 548, knife speed can be controlled automatically in a closed loop logic to adjust the sealing/stapling and control of the knife 548, this includes both direct sensing of the tissue thickness by electrode sensor or hall sensors 780,781, in addition to indirectly determining tissue thickness based on the position and resistance of the knife member as is moves through the tissue during operation, this allows for a better tissue seal, therefore the control circuit is configured to operate in an open loop to indirectly determine an amount of tissue, determine knife position, determine the time that it took for the knife to traverse and then automatically or in a closed loop configuration advance the knife based on the time.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/MARY C HIBBERT-COPELAND/Examiner, Art Unit 3731
/VERONICA MARTIN/Primary Examiner, Art Unit 3731
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