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.
Claim(s) 1, 4-6, and 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. (US 2006/0047240) in view of Olde et al. (US 2014/0231319), and further in view of Kumar et al. (US 2006/0122557).
Regarding claims 1 and 6, Kumar et al. (henceforth Kumar ‘240) discloses a medical device for introducing fluids into a body cavity during a medical procedure, comprising: a controllable fluid pump (3), a supply line (4) operatively connected to the fluid pump for supplying a fluid into the body cavity (11), a pressure sensor in the supply line (sensor 5 branches off of supply line 4 in Figure 1; ¶ [0087]), a second line (12) for enabling the fluid to flow out of the body cavity, a controller (17; ¶¶ [0079] and [0099]) for controlling the fluid pump, a software module executed on a microcontroller (for controlling the pump via the controller), wherein a pressure measured by the pressure sensor is a measurable state variable for calculating an observer error for the state observer (the system utilizes pressure feedback to maintain the pressure within the cavity via controlling of the inflow pump based upon pressure readings in the fluid line, ¶ [0027]; also see ¶¶ [0097] and [0100] which set forth the use of a feedback control system to maintain cavity pressure by altering the input speed of the input pump). Kumar fails to disclose wherein the feedback mechanism is a state observer (or time-discrete as per claim 6) such as a Luenberger observer or a Kalman filter, and the reaching of a set point pressure in a range of +/- 10 mmHg during use.
Olde et al. (henceforth Olde) teaches a medical fluid pump system which utilizes a Kalman filter algorithm as feedback control for a medical fluid control system using pressure sensor (4a-4d) data (see also ¶¶ [0065] and [0138]).
It would therefore be obvious to one of ordinary skill in the art at the time of filing apply this control algorithm to the pump of Kumar ‘240 for the purpose of , since it is known for use in medical systems for smoothing sensor data to use to control the system during a procedure. The Kalman filter and algorithm track the desired pressure signal more closely while reducing noise which provides better feedback signals for pump control. Therefore, it provides for a smoother, more reliable estimate of the actual cavity pressure than raw sensor output can provide. This features prevents the pump controller from over-compensating for transient spikes or dips. Finally, for these reasons, the Kalman algorithm provides for the best linear unbiased estimate of the state given past data which is what one of ordinary skill would desire when providing a signal to control a fluid pump.
As above, Kumar ‘240/Olde fail to teach reaching the selected setpoint pressure in a range of +/- 10 mmHg.
Kumar et al. (henceforth Kumar ‘557) teaches a medical fluid flow system which aims to utilize a pressure control system to achieve a desired set-point to maintain a pressure over time (¶ [0090]) and which teaches reaching a target cavity pressure within 10 seconds (see e.g., ¶ [0110] which teaches reaching and maintaining a pressure value within 10 seconds) and maintaining a cavity pressure in a range between 10 mmHg during a procedure (¶ [0101] discloses maintaining the pressure difference in a range of between 0 and 2 mmHg)
It would have been obvious to one of ordinary skill in the art at the time of filing to utilize a state-space Kalman filter model for the pump controller as it represents a well-understood feedback control mechanism which may be utilized in fluid flow systems to achieve a specific pump control function such as that disclosed by Kumar ‘240/Olde. In such a combination the continuous time monitoring of the pressure in the cavity may be controlled by changing pump rotation speed which is determined by the state-space model output, as set forth above for claim 1. The cavity pressure control of Kumar which is achieved via the real-time alteration of the input pump rotation speed, based on the smoothed data from the pressure sensor data from supply line, would be maintained with the use of a state-space Kalman filter model which would correct for sensed error of a cavity pressure versus a target pressure and manipulate the input pump speed to achieve and/or maintain the desired cavity pressure as set forth above. Finally, it would have been obvious to one of ordinary skill in the art at the time of filing to maintain the target pressure within a very narrow pressure range as taught by Kumar ‘557 so as to ensure the procedure proceeds as desired with the target pressure value so as to avoid unwanted complications during the procedure.
Regarding claims 4 and 9, Kumar ‘240 further discloses wherein the fluid is a liquid (e.g., ¶ [0087]).
Regarding claims 5 and 10, Kumar ‘240 further discloses wherein the device is adapted for use in arthroscopy (the structure and method of control are known from the cited prior art as applied above to claims 1 and 6; the device is fully capable of being used in an arthroscopy procedure).
Regarding claims 11 and 12, Kumar ‘240 as modified by Olde teaches the use of a Kalman filter for controlling pump flow to maintain the body cavity at a desired pressure, as disclosed above for claim 6, and which includes outflow from the body cavity as per claim 12.
Claim(s) 2-3 and 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kumar ‘240 in view of Olde, in view of Kumar ‘557, and further in view of Mantell (US 2005/0137529).
Regarding claims 2-3 and 7-8, Kumar’240/Olde/Kumar ‘557 teach the claimed invention substantially as set forth above for claims 1 and 6. However, they fail to teach wherein the fluid is a gas supplied by an insufflator.
Mantell teaches a medical fluid pump apparatus (Figure 1) which comprises a pump (insufflator 14 as per claims 3 and 8) for filling a body cavity with a gas during a procedure (¶ [0023]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Kumar ‘240/Olde/Kumar ‘557 to replace the irrigation fluid with the insufflation gas of Mantell to provide a means of delivering a gas to a body cavity during a procedure for the purposes of specific treatment such as chemotherapy or pain management as taught by Mantell (e.g., ¶¶ [0008] [0009]). Mantell also teaches the use of the insufflation portion of the system in concert with an infusion portion (or the concept of switching out the insufflation catheter for an infusion catheter) to deliver either gas or treatment fluid to the cavity via the pump (¶ [0024]). For this reason, it would be obvious to modify the prior art to either provide for gas flow into the cavity (gas and liquid are fluids which would be similarly managed via the feedback to control cavity pressure), or to add gas flow through the same pump system to be used in addition to the infusion flow during a separate part of the procedure as taught by Mantell.
Conclusion
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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