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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-6) in the reply filed on 11/22/2024 is acknowledged.
Response to Arguments
Applicant's arguments filed 05/19/2025 have been fully considered but they are not persuasive. The current application states in [0149] “The force required to cause this actuation (e.g., firing the surgical instrument) is sometimes referred to herein as a resistive load force, a firing force, or a force-to-fire (FTF)”. Zemlok (US 20090090763 A1) teaches a back electromotive force ("EMF") induced in the drive motor which is proportional to the rotational force of the motor ([0120] The back EMF voltage of the drive motor 200 is directly proportional to the rotational speed of the drive motor 200). Further, [0121] states “Thus, measuring the voltage across the drive motor 200 provides for determining the load being placed thereon”. Therefore, Zemlok teaches calculating a force that is requires to actuate the device based on the activated battery voltage ([0120] The speed calculator 422 is also coupled to a voltage sensor 428 which measures the back electromotive force ("EMF") induced in the drive motor 200), the PWM value ([0119] The encoder 426 transmits the pulses correlating to the rotation of the drive motor 200 which the speed calculator 422 then uses to calculate the linear speed of the firing rod 220), and the actuator velocity ([0119] the speed calculator 422 is coupled to a rotational sensor 239 which detects the rotation of the drive tube 210, thus, measuring the rate of rotation of the drive tube 210 which allows for determination of the linear velocity of the firing rod 220).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zemlok (US 20090090763 A1).
Regarding claim 1, Zemlok teaches a surgical instrument, comprising: a battery (Fig 4; the instrument 10 includes a power source 400 which may be a rechargeable battery); a motor powered by the battery (Fig 4; drive motor 200); an end effector configured to grasp tissue ([0081] rod 220 which actuates jaw members 162,164 of the end effector 160 to grasp or clamp tissue held therebetween); an actuator coupled to the end effector (Fig 4; switch 114), wherein the motor is configured to cause the actuator to move to yield a surgical treatment of the tissue by the end effector ([0057] This allows the switches 114a and 114b to operate the drive motor 200 in multiple speed modes, such as gradually increasing the speed of the drive motor 200 either incrementally or gradually depending on the type of the control circuit 115 being used, based on the depression of the switches 114a and 114b); and a control circuit ([Fig 4; control circuit 115), configured to: measure an activated battery voltage during an activation of the motor to move the actuator ([0169] the microcontroller 600 can regulate the voltage supply of the drive motor 200) identify a pulse width modulation (PWM) value associated with the motor activation ([0169] or supply a pulse modulated signal thereto to adjust the power and/or torque output to prevent system damage or optimize energy usage); calculate an actuator velocity based on a sensed position change of the actuator ([0119] the speed calculator 422 is coupled to a rotational sensor 239 which detects the rotation of the drive tube 210, thus, measuring the rate of rotation of the drive tube 210 which allows for determination of the linear velocity of the firing rod 220); and calculate a resistive load force based on the activated battery voltage ([0120] The speed calculator 422 is also coupled to a voltage sensor 428 which measures the back electromotive force ("EMF") induced in the drive motor 200), the PWM value ([0119] The encoder 426 transmits the pulses correlating to the rotation of the drive motor 200 which the speed calculator 422 then uses to calculate the linear speed of the firing rod 220), and the actuator velocity ([0119] the speed calculator 422 is coupled to a rotational sensor 239 which detects the rotation of the drive tube 210, thus, measuring the rate of rotation of the drive tube 210 which allows for determination of the linear velocity of the firing rod 220).
Regarding claim 2, Zemlok teaches the surgical instrument of claim 1, wherein the control circuit is further configured to: identify a velocity constant based on the actuator and a volt characterization of the motor ([0158] The motor driver is also configured to switch between a plurality of operational modes which include an electronic motor braking mode, a constant speed mode, an electronic clutching mode, and a controlled current activation mode); and determine an open loop actuator velocity based on the activated battery voltage ([0121] Monitoring of the speed of the drive motor 200 can also be accomplished by measuring the voltage across the terminals thereof under constant current conditions), the PWM ([0119] The encoder 426 transmits the pulses correlating to the rotation of the drive motor 200 which the speed calculator 422 then uses to calculate the linear speed of the firing rod 220), and the velocity constant ([0124] the velocity of the firing rod 220 as measured by the speed calculator 422 may be then compared to the current draw of the drive motor 200 to determine whether the drive motor 200 is operating properly).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zemlok (US 20090090763 A1) in view of Shelton (US 20180360452 A1).
Regarding claim 3, Zemlok teaches the surgical instrument of claim 2, wherein the control circuit is further configured to determine a maximum output force of the motor ([0103] the microcontroller 500 also adjusts the motor speed or torque of the instrument 10 based on the measured feedback) ([0168] embodiment, the microcontroller 600 is connected to the drive motor 200 and is configured and arranged to monitor the battery impedance, voltage, temperature and/or current draw and to control the operation of the instrument 10. The load or loads on battery 400, transmission, drive motor 200 and drive components of the instrument 10 are determined to control a motor speed if the load or loads indicate a damaging limitation is reached or approached. For example, the energy remaining in battery 400, the number of firings remaining, whether battery 400 must be replaced or charged, and/or approaching the potential loading limits of the instrument 10 may be determined. The microcontroller 600 may also be connected to one or more of the sensors of the instrument 10 discussed above) (The indication if a damaging limitation is reached or approached implies that there is threshold of maximum output force of the motor). Zemlok fails to fully teach wherein the control circuit is further configured to determine a maximum output force of the motor. However, Shelton teaches wherein the control circuit is further configured to determine a maximum output force of the motor ([0122] The electric motor 82 may be a DC brushed motor having a maximum rotational speed of approximately 25,000 RPM). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zemlok to include wherein the control circuit is further configured to determine a maximum output force of the motor. Doing so allows for an actual output force to be compared to the maximum output force.
Regarding claim 4, Zemlok teaches the surgical instrument of claim 3, but fails to fully teach wherein the control circuit is configured to calculate the resistive load force based on the open loop actuator velocity and the maximum output force. However, Shelton teaches wherein the control circuit is configured to calculate the resistive load force based on the open loop actuator velocity ([0178] The I-beam 2514 force may be determined by monitoring the actual position of the I-beam 2514 moving at an expected velocity based on the current set velocity of the motor 2504 after a predetermined elapsed period T.sub.1 and comparing the actual position of the I-beam 2514 relative to the expected position of the I-beam 2514 based on the current set velocity of the motor 2504 at the end of the period T.sub.1) and the maximum output force (an expected velocity based on the current set velocity of the motor 2504). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zemlok to include wherein the control circuit is configured to calculate the resistive load force based on the open loop actuator velocity and the maximum output force. Doing so calculates a resistive force reference to be compared to open loop velocity and at max output force.
Regarding claim 5, Zemlok teaches the surgical instrument of claim 4, but fails to fully teach wherein the control circuit is further configured to store the calculated resistive load force. However, Shelton teaches wherein the control circuit is further configured to store the calculated resistive load force ([0282] a variable motor control voltage can be applied to the motor 82 to control the velocity of the motor 82. The velocity of the motor 82 may be controlled by comparing the I-beam 178 firing force to different maximum thresholds based on articulation angle of the end effector 2300) ([0284] The control circuit 2510 may include a memory storing the value or values of the predetermined thresholds). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zemlok to include wherein the control circuit is further configured to store the calculated resistive load force. Doing so allows for the data to be stored for later use.
Regarding claim 6, Zemlok teaches the surgical instrument of claim 4, but fails to fully teach wherein the control circuit is configured to optimize a target firing position of the surgical instrument based on the calculated resistive load force. However, Shelton teaches wherein the control circuit is configured to optimize a target firing position of the surgical instrument based on the calculated resistive load force ([0287] the control circuit 2510 receives 3701 a firing signal, drives 3702 the motor 2504 to translate the displacement member such as, for example, the I-beam 2514, receives 3704 I-beam movement and force to fire (FTF) data, determines 3705 whether the force to fire (FTF) at a present position of the I-beam 2514 is greater than or equal to a predetermined threshold 3510, and determines 3706 whether the present position of the I-beam 2514 is within a predetermined zone or zones). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Zemlok to include wherein the control circuit is configured to optimize a target firing position of the surgical instrument based on the calculated resistive load force. Doing so ensures an accurate position based on a measured force of the instrument to perform a safe operation.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached on 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794