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 Objections
Claims 6 and 15 [and all claims that depend from claims 6 and 15] are objected to because of the following informalities:
Claims 6 and 15 [both] use "exits" instead of "exists" in the phrase "the blockage condition exits".
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 [and dependent claims 2-10] is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 contains an antecedent basis error; the claim introduces "a stepper motor" but later refers to "the step motor" (missing "per"). This creates indefiniteness because "the step motor" lacks a proper antecedent. It is recommended to amend the phrase "the step motor" to "the stepper motor" in order to overcome this lack of antecedent basis rejection.
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.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 4,256,437) in view of Germain et al. (WO2014/168985A1; hereinafter “Bek”).
Claim 1 of this application discloses:
“[a] surgical fluid management system, comprising:
a fluid pump configured to pump fluid along a fluid flow path into or out of a surgical site; and
a pump drive and control assembly operably coupled to the fluid pump, the pump drive and control assembly including:
a stepper motor configured, in response to driving of the stepper motor, to provide a rotational output to drive the fluid pump;
a driver configured to provide electrical drive pulses to the stepper motor to drive the stepper motor; and
a controller configured to command the driver to provide the electrical drive pulses to the stepper motor and to receive feedback from at least one of the stepper motor or the driver, the controller further configured to:
evaluate an indicator of a load associated with the stepper motor; and
determine whether a blockage condition associated with the fluid flow path exists based upon the evaluation of the indicator.”
In relation to independent claim 1, Brown discloses a peristaltic infusion pump for administering intravenous fluids (see Title and Figure 1), which constitutes a surgical fluid management system. The pump includes a continuous tubular arrangement (a fluid flow path) adapted to pass intravenous fluids to a patient (a surgical site), and a peristaltic pump head (a fluid pump) that engages the tubing to pump the fluid (see Abstract and Specification; column 2, lines 8-16).
Brown teaches sensing an occlusion (a blockage condition) in the tubular arrangement by continuously sensing the load of the motor means during operation of the pump (see Specification; column 9, lines 6-9). This is accomplished by sensing the back EMF across the coils during rotation of the drive head, which serves as an indicator of a load associated with the stepper motor (see Specification, column 6, lines 63-68 and column 7, lines 1-9). The back EMF is a form of feedback from the stepper motor, and the controller evaluates this indicator to determine whether a blockage condition exists.
Brown explicitly teaches that the pump head is rotated by an electromagnetic stepping motor (a stepper motor) having a fixed stator, a cooperating rotor, and an output shaft connecting the rotor with the pump head, thereby providing rotational output to drive the fluid pump (see Specification; column 4, lines 44-50). The motor includes electromagnetic coil means that are subjected to successive predetermined current signals at spaced intervals in time, which constitutes a driver providing electrical drive pulses to drive the stepper motor (see Specification; column 5, lines 23-32). The system includes control circuitry that commands these current signals (see Specification; column 4, lines 25-29 and column 5, lines 33-40).
Brown partially discloses a controller, but not as a single integrated modern controller. Bek discloses in the Abstract, an integrated controller for a surgical fluid management system:
"A fluid management system...includes a controller. An inflow pump is operated by the controller...An outflow pump is operated by the controller...The controller is configured to actuate an inflow pump and an outflow pump in response to various signals..."
Based on the above teachings, it would have been obvious to one of ordinary skill to update Brown's 1978-era discrete circuitry with the modern, integrated microcontroller-based controller taught by Bek for the known benefits of miniaturization, cost reduction, and improved reliability.
In relation to claim 2, claim 2 depends from claim 1 and further recites: the indicator is back electromotive force (EMF). As discussed above, Brown explicitly teaches that the means for sensing occlusion is accomplished by sensing the back EMF across the coils of the stepping motor (see Specification, column 6, lines 63-68 and column 7, lines 1-9). Since this enhancement was well-known in the art at the time of filing, its use or implementation in the invention would have been considered an obvious alternative in the design of the fluid management system.
In relation to claim 3, claim 3 depends from claim 1 and further recites: the indicator is load angle. Neither Brown nor Bek explicitly teach using load angle as the indicator. However, Brown teaches using back EMF as an indicator of motor load for detecting occlusion. Load angle is a well-known parameter in the art of stepper motor control that represents the angular displacement between the rotor's magnetic field and the stator's magnetic field.1 Load angle is directly related to motor torque and load, and can be derived from back EMF measurements. Both back EMF and load angle are indicators of the motor's load state and are proportional to the load applied to the motor.
Based on the above comments, it would have been obvious to a person of ordinary skill in the art at the time of the invention to use load angle as an alternative or equivalent indicator of motor load for the purpose of detecting a blockage in Brown's system. The motivation would be to achieve the same result of blockage detection using a different but equivalent parameter. The substitution of one known load indicator (back EMF) for another known load indicator (load angle) to achieve the same result would have been a matter of routine engineering design choice, requiring no more than ordinary skill in the art.
In relation to claim 4, claim 4 depends from claim 1 and further recites: the indicator is inversely proportional to the load associated with the stepper motor. Brown teaches using back EMF as the load indicator. It is a fundamental and well-understood principle in the field of electric motors that back EMF is inversely proportional to the motor's load. As the load on a motor increases, the rotational speed tends to decrease, which in turn reduces the back EMF generated. This inverse relationship between back EMF and motor load is an inherent characteristic of motor operation and is implicit in Brown's disclosure of using back EMF to sense motor load for occlusion detection.
In relation to claim 5, claim 5 depends from claim 1 and further recites: the controller is configured to evaluate the indicator by comparing the indicator to a threshold. Brown teaches evaluating the back EMF to sense occlusion but does not explicitly describe comparing it to a predetermined threshold value. However, Bek compares a measured sensor value to a predetermined threshold to trigger an event (see paragraphs 0016 and 0018). Accordingly, it would have been obvious to an artisan of ordinary skill in the art to implement Brown's occlusion detection by comparing the measured back EMF value against a set threshold value to determine when a blockage condition exists. This is the most straightforward and standard method for implementing a binary decision based on a continuous measurement. The motivation would be to provide a clear and reliable trigger point for detecting occlusion.
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In relation to claim 6, claim 6 depends from claim 1 and further recites: in a case where the controller determines that the blockage condition exists, the controller is further configured to provide instructions to output at least one of an audible, tactile, or visual signal to indicate to a user that the blockage condition exits. Brown shows a front panel on the pump that includes an "OCCLUSION indicator" among other indicators such as AIR-IN-LINE, BATTERY LOW, and INFUSION COMPLETE. This OCCLUSION indicator is a visual signal that indicates to the user when an occlusion (blockage condition) is detected. Accordingly, since this enhancement was well-known in the art at the time of filing, its use or implementation in the invention would have been considered an obvious alternative in the design of the fluid management system.
In relation to claim 7, claim 7 depends from claim 1 and further recites: in a case where the controller determines that the blockage condition exists, the controller is further configured to stop commanding the driver, thereby stopping operation of the stepper motor and the fluid pump.
As discussed above, Brown teaches detecting an occlusion condition in the tubular arrangement by sensing motor load through back EMF, but does not explicitly state that the motor is stopped in response to detecting the occlusion. Bek teaches a medical fluid management system for use in tissue resection procedures that includes inflow and outflow pumps controlled by a controller. The system monitors motor parameters including power, voltage, and current to detect blocked flow conditions. When a blockage is detected, the controller deactivates the pumps and may also deactivate the resecting device. Bek explicitly teaches that the system will deactivate pumps when motor power exceeds a threshold, when motor voltage falls below a threshold, or when motor current exceeds a threshold for a pre-selected time interval (see paragraphs 0011, 0013, 0015 and claims 13 and 17). Based on the above teachings, it would have been obvious to an artisan skilled in the art to modify the system of Brown to include the safety feature from Bek of stopping the pump motor upon detection of a blockage. The motivation to combine these teachings would be to enhance patient safety and equipment protection by preventing continued build-up of pressure in an occluded line, which could cause the tubing to burst, force fluid into unintended areas, or damage the pump mechanism. This combination of known elements (occlusion detection from Brown and pump deactivation upon blockage detection from Bek) would yield a predictable result with no unexpected synergies.
In relation to claim 8, claim 8 depends from claim 1 and further recites: a surgical device operably coupled to the fluid flow path, wherein the fluid pump is configured to pump fluid along the fluid flow path, through the surgical device, and into the surgical site. Brown's peristaltic infusion pump is designed for administering intravenous fluids to a patient. Such a system necessarily includes a delivery mechanism such as an IV needle or catheter (a surgical device) that is connected to the tubular arrangement (fluid flow path) and inserted into the patient's vein (a surgical site). The fluid is pumped through the tubular arrangement, through this delivery device, and into the patient's circulatory system. This is the inherent and intended use of an intravenous infusion pump. Accordingly, since this enhancement was well-known in the art at the time of filing, its use or implementation in the invention would have been considered an obvious alternative in the design of the fluid management system.
In relation to claim 9, claim 9 depends from claim 8 and further recites: a fluid source, wherein the fluid pump is configured to pump fluid from the fluid source, along the fluid flow path, through the surgical device, and into the surgical site. Brown's system for delivering intravenous fluids inherently includes a fluid source, such as an IV bag or bottle containing the intravenous solution, from which the fluid is drawn by the pump. The specification refers to the tubular arrangement having a "supply end" from which fluid enters the system (see column 3, lines 34-42). The pump draws fluid from this source, pumps it through the tubular arrangement, and delivers it to the patient. Accordingly, since this enhancement was well-known in the art at the time of filing, its use or implementation in the invention would have been considered an obvious alternative in the design of the fluid management system.
In relation to claim 10, claim 10 depends from claim 1 and further recites: the fluid pump is a peristaltic pump. Brown's patent is titled "Peristaltic infusion pump and method," and the abstract and entire specification consistently describe the pump as a peristaltic pump with a pump head including tube engaging members that successively engage the tubular arrangement during rotation for peristaltically pumping fluid. Accordingly, since this enhancement was well-known in the art at the time of filing, its use or implementation in the invention would have been considered an obvious alternative in the design of the fluid management system.
In relation to independent claim 11, as discussed above for claim 1, Brown discloses a peristaltic infusion pump for administering intravenous fluids (see Title and Figure 1), which constitutes a surgical fluid management system. The pump includes a continuous tubular arrangement (a fluid flow path) adapted to pass intravenous fluids to a patient (a surgical site), and a peristaltic pump head (a fluid pump) that engages the tubing to pump the fluid (see Abstract and Specification; column 2, lines 8-16).
Brown teaches sensing an occlusion (a blockage condition) in the tubular arrangement by continuously sensing the load of the motor means during operation of the pump (see Specification; column 9, lines 6-9). This is accomplished by sensing the back EMF across the coils during rotation of the drive head, which serves as an indicator of a load associated with the stepper motor (see Specification, column 6, lines 63-68 and column 7, lines 1-9). The back EMF is a form of feedback from the stepper motor, and the controller evaluates this indicator to determine whether a blockage condition exists.
Brown explicitly teaches that the pump head is rotated by an electromagnetic stepping motor (a stepper motor) having a fixed stator, a cooperating rotor, and an output shaft connecting the rotor with the pump head, thereby providing rotational output to drive the fluid pump (see Specification; column 4, lines 44-50). The motor includes electromagnetic coil means that are subjected to successive predetermined current signals at spaced intervals in time, which constitutes a driver providing electrical drive pulses to drive the stepper motor (see Specification; column 5, lines 23-32). The system includes control circuitry that commands these current signals (see Specification; column 4, lines 25-29 and column 5, lines 33-40).
Brown partially discloses a controller, but not as a single integrated modern controller. Bek discloses in the Abstract, an integrated controller for a surgical fluid management system:
"A fluid management system...includes a controller. An inflow pump is operated by the controller...An outflow pump is operated by the controller...The controller is configured to actuate an inflow pump and an outflow pump in response to various signals..."
Based on the above teachings, it would have been obvious to one of ordinary skill to update Brown's 1978-era discrete circuitry with the modern, integrated microcontroller-based controller taught by Bek for the known benefits of miniaturization, cost reduction, and improved reliability.
Additionally, based on the above teachings, the combination of Brown and Bek, discloses the steps of:
driving a stepper motor to thereby drive a fluid pump to pump fluid along a fluid flow path into or out of a surgical site;
evaluating an indicator of a load associated with the stepper motor; and
determining whether a blockage condition associated with the fluid flow path exists based upon the evaluation of the indicator.
Accordingly, since these process enhancements were well-known in the art at the time of filing, their use or implementation in the invention would have been considered obvious alternatives in the design of the fluid management system.
In relation to claim 12, claim 12 depends from claim 11 and further recites: evaluating the indicator includes evaluating back electromotive force (EMF). As discussed above, Brown explicitly teaches that the method of sensing occlusion is accomplished by sensing the back EMF across the coils of the stepping motor. Accordingly, since this enhancement was well-known in the art at the time of filing, its use or implementation in the invention would have been considered an obvious alternative in the design of the fluid management system.
In relation to claim 13, claim 13 depends from claim 11 and further recites: evaluating the indicator includes evaluating load angle. For the same reasons provided in the rejection of claim 3, it would have been obvious to a person of ordinary skill in the art to evaluate the load angle as an alternative indicator of motor load to detect a blockage in the method of Brown. Load angle and back EMF are both well-known indicators of stepper motor load that can be used interchangeably for the same purpose. The motivation and reasoning are identical to those provided for Claim 3.
In relation to claim 14, claim 14 depends from claim 11 and further recites: evaluating the indicator includes comparing the indicator to a threshold. For the same reasons provided in the rejection of claim 5, it would have been obvious to a person of ordinary skill in the art to implement the evaluation step in Brown's method by comparing the load indicator (back EMF) to a predetermined threshold. This is the most straightforward and standard implementation for making a binary determination based on a continuous measurement. The motivation and reasoning are identical to those provided for claim 5.
In relation to claim 15, claim 15 depends from claim 11 and further recites: in a case where the blockage condition is determined to exist, the method further includes: providing instructions to output at least one of an audible, tactile, or visual signal to indicate to a user that the blockage condition exits.
As established in the rejection of Claim 6, Brown discloses an "OCCLUSION indicator" on the device's front panel that provides a visual signal to the user when an occlusion is detected. This is a step in Brown's method of operation. Accordingly, since this enhancement was well-known in the art at the time of filing, its use or implementation in the invention would have been considered an obvious alternative in the design of the fluid management system.
In relation to claim 16, claim 16 depends from claim 11 and further recites: in a case where the blockage condition is determined to exist, the method further includes: stopping operation of the stepper motor, thereby stopping operation of the fluid pump. For the same reasons provided in the rejection of claim 7, it would have been obvious to add the step of stopping the motor upon blockage detection to the method of Brown, as taught by Bek, for enhanced patient safety and equipment protection. The motivation to combine is to prevent dangerous pressure build-up and potential equipment damage.
In relation to claim 17, claim 17 depends from claim 11 and further recites: driving the stepper motor includes: commanding a driver to provide electrical drive pulses to the stepper motor. Brown teaches that the stepping motor is driven by subjecting its electromagnetic coils to "successive predetermined current signals at spaced intervals in time" (see column 2, lines 23-24) for driving the rotor through successive magnetic detents. This constitutes commanding a driver to provide electrical drive pulses to the stepper motor. Accordingly, since this enhancement was well-known in the art at the time of filing, its use or implementation in the invention would have been considered an obvious alternative in the design of the fluid management system.
In relation to claim 18, claim 18 depends from claim 11 and further recites: receiving feedback associated with the driving of the stepper motor; and determining the indicator based at least in part upon the received feedback. Brown's method involves sensing the back EMF across the motor coils during rotation of the drive head. This back EMF is a form of feedback from the stepper motor that is directly associated with the driving of the motor. Brown uses this feedback to determine the load indicator, which is then used to detect occlusion. Therefore, Brown's method includes receiving feedback associated with the driving of the stepper motor and determining the indicator (back EMF) based upon that received feedback. Accordingly, since this enhancement was well-known in the art at the time of filing, its use or implementation in the invention would have been considered an obvious alternative in the design of the fluid management system.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
1 Derammelaere et al., Load Angle estimation for two-phase hybrid stepping motors, page 258, first column, second paragraph, published in IET Electric Power Applications, received on 9th July 2013, revised on 28th February 2014, accepted on 6th March 2014; doi: 10.1049/iet-epa.2013.0333.