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 Status
Claims 1-27 are currently pending and under consideration.
Claim Objections
Claim 8 is objected to because of the following informalities: “during or after of the” in line 10 should read –during or after the—. 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.
Claims 2, 10, and 12 are 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.
The term “relatively” in claims 2 and 10 is a relative term which renders the claim indefinite. The term “relatively” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the applicant’s specification attempts to define the terminology in relation to the low suction force in ¶0037 with the statement, “which may be a minimum suction force or no suction force) there does not appear to be a specified defining of the limit to a range which the terminology “relatively” covers in regards to either the low suction force or the high suction force and as such the claims are considered indefinite.
The term “about” in claim 12 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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) 1-7, 9-11, 13, 15-22, and 26-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Teigen et al. (U.S. Publication 2020/0367917).
Regarding claim 1, Teigen discloses a method (Fig. 13) comprising:
determining (¶0072 determine flowrate), by control circuitry (¶0071 controller implements algorithm; ¶0064 controller, typically including a microprocessor on a printed circuit board), a flow rate of a fluid within a catheter lumen (¶0025 vacuum applied through an aspiration lumen…vacuum source coupled to a proximal end of the aspiration lumen by a connecting tube) fluidically coupled to a valve (¶0072 control the on-off valves to effect flow and therefor fluidically coupled);
comparing (¶0072 take instantaneous pressure differential and compare it to these max and minimum pressure differential windows), by the control circuitry, the flow rate to a first flow rate threshold (¶0072 max pressure differential window) and a second flow rate threshold (¶0072 minimum pressure differential window) less than the first flow rate threshold (minimum inherently less than maximum);
in response to determining that the flow rate is greater than the first flow rate threshold, controlling, by the control circuitry, the valve to be in a first operational state (¶0072 if the instantaneous pressure differential is above the minimum pressure differential the algorithm determines whether the instantaneous pressure differential is above the product of the max pressure differential multiplied by a confidence interval…if it is the algorithm restricts aspiration, ¶0070 controller implements algorithm that receives and analyzes pressure sensor data to open and close the on-off valve)
in response to determining that the flow rate is less than the second flow rate threshold, controlling, by the control circuitry, the valve to be in a second operational state (¶0072 if the instantaneous pressure differential is lower than the minimum pressure differential…the algorithm determines that the system is in clot and instructs the system to continue full aspiration, i.e. open operational state of valve).
While Teigen does not expressly disclose the response to determining the flow rate being greater than the first flow rate threshold or the response to determining the flow rate being less than the second flow rate threshold including “or equal to”, the prior art disclosed range of less than and greater than discloses the claimed range with sufficient specificity to have anticipated the equal to claim language as it has been held that “the disclosure of a range is no more a disclosure of the end points of the range than it is each of the intermediate points”. See MPEP 2131.03. The algorithm of Teigen would function in the same manner as the claimed range and therefore is seen to anticipate the current claim language.
Regarding claim 2, Teigen discloses the method of claim 1. Teigen further discloses the first operational state comprises a substantially closed valve state (¶0021 controller closes the valve; ¶0065 controller configured to open and close the valve to allow and prevent respectively the flow of clot and blood through tubing segment from the aspiration catheter) in which the valve enables application of a relatively low suction force (¶0072 restricts aspiration; ¶0064 prevent…flow; prevention of flow would result in no suction force) to the catheter lumen, and wherein the second operational state comprises a substantially open valve state in which the valve enables application of a relatively high suction force to the catheter lumen (¶0072 allows full aspiration; ¶0065 controller configured to open…the valve…to allow…the flow).
Regarding claim 3, Teigen discloses the method of claim 1. Teigen further discloses further comprising: determining, by the control circuitry, that a first predetermined amount of time has passed with the valve in the first operational state (¶0078 algorithm will cycle off aspiration and then open and close at a predetermined frequency, requirement of predetermined frequency inherently requires determination of timing); and in response to determining, by the control circuitry, that the first predetermined amount of time has passed with the valve in the first operational state, controlling the valve to be in the second operational state for a second predetermined amount of time (¶0078 algorithm may initiate a sampling mode when unrestricted flow is detected…the algorithm will cycle off aspiration and then open and close the on-off valve at a predetermined frequency, the requirement of frequency inherently requires the opening to occur at the specified frequency and thus after the first predetermined amount of time has past).
Regarding claim 4, Teigen discloses the method of claim 1. Teigen further discloses further comprising: in response to determining that the flow rate is less than the first flow rate threshold: determining, by the control circuitry and at a flow measurement sampling rate, a subsequent flow rate of the fluid within the catheter lumen (¶0078 algorithm will cycle off aspiration and then open and close the on-off valve at a predetermined frequency. The sampling state conducts and aspiration surge when the valve is briefly opened and makes an assessment of the pressure sensor readings); determining, by the control circuitry and at the flow measurement sampling rate, whether the subsequent flow rate of the fluid within the catheter lumen is greater than the second flow rate threshold (Fig. 13 shows algorithm returning to determination of flow rate of fluid greater vs less than flow rate thresholds); and in response to determining that the subsequent flow rate is greater than the second flow rate threshold, controlling, by the control circuitry, the valve to be in a first operational state (¶0079 if sensors indicate unrestricted flow, then an appropriate delay of time is calculated for which the on-off valve remains shut).
Regarding claim 5, Teigen discloses the method of claim 1. Teigen further discloses wherein controlling the valve to be in the first operational state comprises controlling the valve to be in the first operational state for a first predetermined amount of time (time from closing of valve to next state of valve initiated in accordance to algorithm sampling as indicated in Fig. 13), and wherein controlling the valve to be in the second operational state comprises controlling the valve to be in the second operational state for a second predetermined amount of time (period of time open before change in state due to sampling as indicated in Fig. 13), the method further comprising: in response to determining that the flow rate is less than the first flow rate threshold and greater than the second flow rate threshold: determining, by the control circuitry and at a flow measurement sampling rate, a subsequent flow rate of the fluid within the catheter lumen (¶0072 whenever aspiration is allowed, the algorithm continually takes instantaneous pressure differential readings and compares them to the max and minimum pressure differentials collected throughout the procedure); and controlling, by the control circuitry, the valve to alternatingly be in the first operational state for a third amount of time and to be in the second operational state for a fourth amount of time while the subsequent flow rate of the fluid within the catheter lumen is less than the first flow rate threshold and greater than the second flow rate threshold during the third or fourth amounts of time (¶0072 when a clot is detected the algorithm initiates an extraction cycle with pulsed aspiration; ¶0081 when extraction cycle is initiated, the vacuum on-off valve…is closed and the pressure in the aspiration catheter is increased, which may cause a positive pressure pulse and establish a pressure differential between the vacuum source and the catheter. When the on-off valve is then opened…frequency with which the on-off valve opens and closes may be predetermined or responsive to pressure sensor data, third amount of time equivalent to portion of frequency in off state with fourth amount of time equivalent to portion of frequency in on state; ¶0072 whenever aspiration is allowed, the algorithm continually takes instantaneous pressure differential readings and compares them to minimum pressure differentials).
Regarding claim 6, Teigen discloses the method of claim 1. Teigen further discloses wherein controlling the valve to be in the first operational state comprises controlling the valve to be in the first operational state for a first predetermined amount of time (period of time open before change in state due to sampling as indicated in Fig. 13), the method further comprising: controlling, by the control circuitry, the valve to be in the second operational state for a second predetermined amount of time (period of time open before change in state due to sampling as indicated in Fig. 13); determining, by the control circuitry and at a flow measurement sampling rate, that the flow rate during the first or second predetermined amount of time is greater than or equal to the first flow rate threshold (Fig. 13 shows sampling and determination pathway of flow rate); and controlling, by the control circuitry, the valve to be in the first operational state in response to determining the flow rate during the first or second predetermined amount of time is greater than the first flow rate threshold (Fig. 13 shows the algorithm pathway to the first operation state in response to determining the flow rate is greater than the first flow rate threshold).
Regarding claim 7, Teigen discloses the method of claim 1. Teigen further discloses wherein controlling the valve to be in the first operational state comprises controlling the valve to be in the first operational state for a first predetermined amount of time (period of time open before change in state due to sampling as indicated in Fig. 13), the method further comprising: controlling, by the control circuitry, the valve to be in the second operational state for a second predetermined amount of time (period of time open before change in state due to sampling as indicated in Fig. 13); determining, by the control circuitry and at a flow measurement sampling rate, that the flow rate during the first or second predetermined amount of time is less than the first flow rate threshold; (¶0072 whenever aspiration is allowed, the algorithm continually takes instantaneous pressure differential readings and compares them to the max and minimum pressure differentials collected throughout the procedure); and controlling, by the control circuitry, the valve to alternatingly be in the first operational state for a third amount of time and to be in the second operational state for a fourth amount of time while the subsequent flow rate of the fluid within the catheter lumen is less than the first flow rate threshold and greater than the second flow rate threshold during the third or fourth amounts of time (¶0072 when a clot is detected the algorithm initiates an extraction cycle with pulsed aspiration; ¶0081 when extraction cycle is initiated, the vacuum on-off valve…is closed and the pressure in the aspiration catheter is increased, which may cause a positive pressure pulse and establish a pressure differential between the vacuum source and the catheter. When the on-off valve is then opened…frequency with which the on-off valve opens and closes may be predetermined or responsive to pressure sensor data, third amount of time equivalent to portion of frequency in off state with fourth amount of time equivalent to portion of frequency in on state; ¶0072 whenever aspiration is allowed, the algorithm continually takes instantaneous pressure differential readings and compares them to minimum pressure differentials).
Regarding claim 9, Teigen discloses a valve (¶0070 on/off valve) configured to open or close to control a suction force applied to a catheter lumen (¶0068 valves of the present invention open to permit aspiration and close to block aspiration); and control circuitry (¶0071 controller implements algorithm; ¶0064 controller, typically including a microprocessor on a printed circuit board) configured to:
determine a flow rate (¶0072 determine flowrate) of a fluid within the catheter lumen (¶0025 vacuum applied through an aspiration lumen…vacuum source coupled to a proximal end of the aspiration lumen by a connecting tube);
compare (¶0072 take instantaneous pressure differential and compare it to these max and minimum pressure differential windows) the flow rate to a first flow rate threshold (¶0072 max pressure differential window) and a second flow rate threshold (¶0072 minimum pressure differential window) less than the first flow rate threshold(minimum inherently less than maximum);
in response to determining that the flow rate is greater than or equal to the first flow rate threshold, control the valve to be in a first operational state (¶0072 if the instantaneous pressure differential is above the minimum pressure differential the algorithm determines whether the instantaneous pressure differential is above the product of the max pressure differential multiplied by a confidence interval…if it is the algorithm restricts aspiration, ¶0070 controller implements algorithm that receives and analyzes pressure sensor data to open and close the on-off valve); and
in response to determining that the flow rate is less than or equal to the second flow rate threshold, control the valve to be in a second operational state (¶0072 if the instantaneous pressure differential is lower than the minimum pressure differential…the algorithm determines that the system is in clot and instructs the system to continue full aspiration, i.e. open operational state of valve).
While Teigen does not expressly disclose the response to determining the flow rate being greater than the first flow rate threshold or the response to determining the flow rate being less than the second flow rate threshold including “or equal to”, the prior art disclosed range of less than and greater than discloses the claimed range with sufficient specificity to have anticipated the equal to claim language as it has been held that “the disclosure of a range is no more a disclosure of the end points of the range than it is each of the intermediate points”. See MPEP 2131.03. The algorithm of Teigen would function in the same manner as the claimed range and therefore is seen to anticipate the current claim language.
Regarding claim 10, Teigen discloses the method of claim 9. Teigen further discloses the first operational state comprises a substantially closed valve state (¶0021 controller closes the valve; ¶0065 controller configured to open and close the valve to allow and prevent respectively the flow of clot and blood through tubing segment from the aspiration catheter) in which the valve enables application of a relatively low suction force (¶0072 restricts aspiration; ¶0064 prevent…flow; prevention of flow would result in no suction force) to the catheter lumen, and wherein the second operational state comprises a substantially open valve state in which the valve enables application of a relatively high suction force to the catheter lumen (¶0072 allows full aspiration; ¶0065 controller configured to open…the valve…to allow…the flow).
Regarding claim 11, Teigen discloses the method of claim 9. Teigen further discloses the control circuitry is further configured to: determine that a first predetermined amount of time has passed with the valve in the first operational state (¶0078 algorithm will cycle off aspiration and then open and close at a predetermined frequency, requirement of predetermined frequency inherently requires determination of timing); and in response to determining that the first predetermined amount of time has passed with the valve in the first operational state, control the valve to be in the second operational state for a second predetermined amount of time (¶0078 algorithm may initiate a sampling mode when unrestricted flow is detected…the algorithm will cycle off aspiration and then open and close the on-off valve at a predetermined frequency, the requirement of frequency inherently requires the opening to occur at the specified frequency and thus after the first predetermined amount of time has passed).
Regarding claim 13, Teigen discloses the method of claim 9. Teigen further discloses the control circuitry is further configured to: in response to determining that the flow rate is less than the first flow rate threshold: determine, at a flow measurement sampling rate, a subsequent flow rate of the fluid within the catheter lumen (¶0078 algorithm will cycle off aspiration and then open and close the on-off valve at a predetermined frequency. The sampling state conducts and aspiration surge when the valve is briefly opened and makes an assessment of the pressure sensor readings); determine, at the flow measurement sampling rate, whether the subsequent flow rate of the fluid within the catheter lumen is greater than the second flow rate threshold (Fig. 13 shows algorithm returning to determination of flow rate of fluid greater vs less than flow rate thresholds); and in response to determining that the subsequent flow rate is greater than the second flow rate threshold, control the valve to be in a first operational state (¶0079 if sensors indicate unrestricted flow, then an appropriate delay of time is calculated for which the on-off valve remains shut).
Regarding claim 15, Teigen discloses the method of claim 9. Teigen further discloses determining the flow rate comprises indirectly measuring the flow rate of the fluid within the catheter lumen by at least measuring the flow rate of the fluid within a volume fluidically coupled to the catheter lumen (¶0064 pressure sensor secured between a tube segment and a proximal end of the connecting tube).
Regarding claim 16, Teigen discloses the method of claim 9. Teigen further discloses controlling the valve to be in the first operational state comprises controlling the valve to be in the first operational state for a first predetermined amount of time (time from closing of valve to next state of valve initiated in accordance to algorithm sampling as indicated in Fig. 13), wherein controlling the valve to be in the second operational state comprises controlling the valve to be in the second operational state for a second predetermined amount of time (period of time open before change in state due to sampling as indicated in Fig. 13), wherein the control circuitry is further configured to: in response to determining that the flow rate is less than the first flow rate threshold and greater than the second flow rate threshold: determine, at a flow measurement sampling rate, a subsequent flow rate of the fluid within the catheter lumen (¶0072 whenever aspiration is allowed, the algorithm continually takes instantaneous pressure differential readings and compares them to the max and minimum pressure differentials collected throughout the procedure); and control the valve to alternatingly be in the first operational state for a third amount of time and to be in the second operational state for a fourth amount of time while the subsequent flow rate of the fluid within the catheter lumen is less than or equal to the first flow rate threshold and greater than or equal to the second flow rate threshold during the third or fourth amounts of time (¶0072 when a clot is detected the algorithm initiates an extraction cycle with pulsed aspiration; ¶0081 when extraction cycle is initiated, the vacuum on-off valve…is closed and the pressure in the aspiration catheter is increased, which may cause a positive pressure pulse and establish a pressure differential between the vacuum source and the catheter. When the on-off valve is then opened…frequency with which the on-off valve opens and closes may be predetermined or responsive to pressure sensor data, third amount of time equivalent to portion of frequency in off state with fourth amount of time equivalent to portion of frequency in on state; ¶0072 whenever aspiration is allowed, the algorithm continually takes instantaneous pressure differential readings and compares them to minimum pressure differentials).
Regarding claim 17, Teigen discloses the method of claim 16. Teigen further discloses the third amount of time and the fourth amount of time are substantially equal (¶0095 stable and consistent frequency).
Regarding claim 18, Teigen discloses the method of claim 16. Teigen further discloses the flow measurement sampling rate comprises time intervals that are less than the first predetermined amount of time, the second predetermined amount of time, the third amount of time, and the fourth amount of time. Pulsing have the sampling rate be less than pulses (¶0072 whenever aspiration is allowed, the algorithm continually takes instantaneous pressure differential readings and compares them to minimum pressure differentials).
Regarding claim 19, Teigen discloses the method of claim 9. Teigen further discloses controlling the valve to be in the first operational state comprises controlling the valve to be in the first operational state for a first predetermined amount of time (period of time open before change in state due to sampling as indicated in Fig. 13), and wherein the control circuitry is further configured to: control the valve to be in the second operational state for a second predetermined amount of time (period of time open before change in state due to sampling as indicated in Fig. 13); determine, at a flow measurement sampling rate, that the flow rate during the first or second predetermined amount of time is greater than or equal to the first flow rate threshold (Fig. 13 shows sampling and determination pathway of flow rate); and control the valve to be in the first operational state in response to determining the flow rate during the first or second predetermined amount of time is greater than or equal to the first flow rate threshold (Fig. 13 shows the algorithm pathway to the first operation state in response to determining the flow rate is greater than the first flow rate threshold).
Regarding claim 20,Teigen discloses the method of claim 9. Teigen further discloses controlling the valve to be in the first operational state comprises controlling the valve to be in the first operational state for a first predetermined amount of time (period of time open before change in state due to sampling as indicated in Fig. 13), and wherein the control circuitry is further configured to: control the valve to be in the second operational state for a second predetermined amount of time (period of time open before change in state due to sampling as indicated in Fig. 13); determine, at a flow measurement sampling rate, that the flow rate during the first or second predetermined amount of time is less than the first flow rate threshold (¶0072 whenever aspiration is allowed, the algorithm continually takes instantaneous pressure differential readings and compares them to the max and minimum pressure differentials collected throughout the procedure); and determine, at the flow measurement sampling rate, a subsequent flow rate of the fluid within the catheter lumen; and control the valve to alternatingly be in the first operational state for a third amount of time and to be in the second operational state for a fourth amount of time while the subsequent flow rate of the fluid within the catheter lumen is less than or equal to the first flow rate threshold and greater than or equal to the second flow rate threshold during the third or fourth amounts of time (¶0072 when a clot is detected the algorithm initiates an extraction cycle with pulsed aspiration; ¶0081 when extraction cycle is initiated, the vacuum on-off valve…is closed and the pressure in the aspiration catheter is increased, which may cause a positive pressure pulse and establish a pressure differential between the vacuum source and the catheter. When the on-off valve is then opened…frequency with which the on-off valve opens and closes may be predetermined or responsive to pressure sensor data, third amount of time equivalent to portion of frequency in off state with fourth amount of time equivalent to portion of frequency in on state; ¶0072 whenever aspiration is allowed, the algorithm continually takes instantaneous pressure differential readings and compares them to minimum pressure differentials).
Regarding claim 21, Teigen discloses the method of claim 20. Teigen further discloses the flow measurement sampling rate comprises time intervals that are less than the first predetermined amount of time, the second predetermined amount of time, the third amount of time, and the fourth amount of time (¶0072 whenever aspiration is allowed, the algorithm continually takes instantaneous pressure differential readings and compares them to minimum pressure differentials).
Regarding claim 22, Teigen discloses the method of claim 20. Teigen further discloses the third amount of time and the fourth amount of time are substantially equal (¶0095 stable and consistent frequency).
Regarding claim 26, Teigen discloses the method of claim 23. Teigen further discloses the control circuitry is further configured to determine a size of the catheter lumen based on a maximum flow rate of the plurality of cycles (¶0076 ANN utilizes novel pressure sensor data inputs and accurately predicts catheter size).
Regarding claim 27, Teigen discloses a medical device 200 for aspirating material from a patient (¶0060 for controlled clot aspiration), the device comprising: a suction source 40; an aspiration catheter (¶0068 aspiration catheter) defining a lumen fluidically coupled to the suction source (¶0068 connected to connecting tubing 206 which is connected to vacuum canister); a valve 260 configured to open or close to control a suction force applied to the catheter lumen (¶0068 solenoid is typoically present to open and close valve stem; ¶0068 valves of the present invention may open to allow fluid to enter the aspiration tubing and/or aspiration catheter and close to block the fluid); and control circuitry 220 configured to control the valve to open or close based on a flow rate (¶0070 controller may implement an algorithm that receives and analysises pressure sensor data to open and close the on-of fvalve), a first flow rate threshold (¶0072 max pressure differential window), and a second flow rate threshold (¶0072 minimum pressure differential window).
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) 8 and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teigen et al. (U.S. Publication 2020/0367917).
Regarding claim 8, Teigen discloses the method of claim 1. Teigen further discloses wherein the flow rate includes a first flow rate (calculation of flow rate necessitates at minimum a first flow rate), the method further comprising: controlling, by the control circuitry, the valve to alternatingly be in the first and second operational states for a plurality of valve cycles (¶0072 when a clot is detected the algorithm initiates an extraction cycle with pulsed aspiration; ¶0081 when extraction cycle is initiated, the vacuum on-off valve…is closed and the pressure in the aspiration catheter is increased, which may cause a positive pressure pulse and establish a pressure differential between the vacuum source and the catheter. When the on-off valve is then opened…frequency with which the on-off valve opens and closes may be predetermined or responsive to pressure sensor data), wherein each valve cycle of the plurality of valve cycles comprises: the first operational state in which the valve is closed to reduce a suction force applied to the catheter lumen for a first predetermined amount of time (time from closing of valve to next state of valve initiated in accordance with predetermined frequency); and the second operational state in which the valve is open to increase the suction force applied to the catheter lumen for a second predetermined amount of time (time from opening of valve to next state of valve initiated in accordance with predetermined frequency); determining, by the control circuitry, a subsequent flow rate during or after of the second predetermined amount of time (¶0072 whenever aspiration is allowed, the algorithm continually takes instantaneous pressure differential readings and compares them to minimum pressure differentials).
Teigen does not expressly disclose determining at least one of the first flow rate threshold or the second flow rate threshold based on the subsequent flow rate during the plurality of valve cycles. However, Teigen does disclose the control circuitry measuring max and minimum pressure differential windows over an assessment period ¶0072 and determining these minimum and maximums through the implementation of a learning algorithm that utilizes training date formed by collecting pressure readings along the length of the catheter in unrestricted flow, restricted flow, or clogged states with numerous pressure readings being recorded for each catheter state ¶0075. Teigen also further discloses the unrestricted and restricted states being due to open and closed states of the valve (¶0014 closing valve stops flow; ¶0021 open valve unrestricted flow).
While Teigen does not expressly disclose the collection of the data to train the minimum and maximum threshold being determined through the controller alternating for a plurality of valve cycles comprising the first operation state (closed state) and the second operational state (open state), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed the collection of training data disclosed by Teigen in this manner as Taigen discloses the need to collect numerous pressure data points for unrestricted and restricted catheter states to establish the thresholds and further discloses a method of collecting numerous pressure sensor readings that involves cycling the valve between open and closed states at a predetermined frequency (¶0078 sampling mode, algorithm will cycle off aspiration and then open and close the on-off valve at a predetermined frequency), and thus at predetermined first and second amounts of time correlating to a first amount of time in the first closed state and a second amount of time in the second open state, and assessing the pressure sensor reading during the open state (¶0078 valve is briefly opened and makes an assessment of the pressure sensor readings). Since it has been held that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying the known technique of repeatedly cycling the valve between on/off positions and recording pressure readings related to the state of the device to collect pressure data to apply to the training data for determining minimum and maximum differential pressures of a catheter lumen in relation to the state of the device in order to yield the predictable result of collecting multiple data points in relation to the unrestricted and restricted states of the device and then utilizing these data points as the training data for the algorithm. This would result in an efficient collection of multiple data points for each of the unrestricted and restricted catheter states. See MPEP 2143.
Regarding claims 23-25, Teigen discloses the method of claim 9. Teigen further discloses wherein the flow rate includes a first flow rate (calculation of flow rate necessitates at minimum a first flow rate), the method further comprising: controlling, by the control circuitry, the valve to alternatingly be in the first and second operational states for a plurality of valve cycles (¶0072 when a clot is detected the algorithm initiates an extraction cycle with pulsed aspiration; ¶0081 when extraction cycle is initiated, the vacuum on-off valve…is closed and the pressure in the aspiration catheter is increased, which may cause a positive pressure pulse and establish a pressure differential between the vacuum source and the catheter. When the on-off valve is then opened…frequency with which the on-off valve opens and closes may be predetermined or responsive to pressure sensor data), wherein each valve cycle of the plurality of valve cycles comprises: the first operational state in which the valve is closed to reduce a suction force applied to the catheter lumen for a first predetermined amount of time (time from closing of valve to next state of valve initiated in accordance with predetermined frequency); and the second operational state in which the valve is open to increase the suction force applied to the catheter lumen for a second predetermined amount of time (time from opening of valve to next state of valve initiated in accordance with predetermined frequency); determining, by the control circuitry, a subsequent flow rate during or after of the second predetermined amount of time (¶0072 whenever aspiration is allowed, the algorithm continually takes instantaneous pressure differential readings and compares them to minimum pressure differentials).
Teigen does not expressly disclose determining at least one of the first flow rate threshold or the second flow rate threshold based on the subsequent flow rate during the plurality of valve cycles. However, Teigen does disclose the control circuitry measuring max and minimum pressure differential windows over an assessment period ¶0072 and determining these minimum and maximums through the implementation of a learning algorithm that utilizes training date formed by collecting pressure readings along the length of the catheter in unrestricted flow, restricted flow, or clogged states with numerous pressure readings being recorded for each catheter state ¶0075. Teigen also further discloses the unrestricted and restricted states being due to open and closed states of the valve (¶0014 closing valve stops flow; ¶0021 open valve unrestricted flow) (Claim 23), determining, during a valve cycle of the plurality of valve cycles, that the subsequent flow rate is less than the frist flow rate threshold; and decreasing the first flow rate threshold to be less than or equal to the subsequent flow rate in response to determining that the subsequent flow rate is less than the first flow rate threshold (Claim 24) or determining, during a valve cycle of the plurality of valve cycles, that the subsequent flow rate is greater than a maximum flow rate; and increasing the first flow rate threshold based on the subsequent flow rate.
While Teigen does not expressly disclose the collection of the data to train the minimum and maximum threshold being determined through the controller alternating for a plurality of valve cycles comprising the first operation state (closed state) and the second operational state (open state), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed the collection of training data disclosed by Teigen in this manner as Taigen discloses the need to collect numerous pressure data points for unrestricted and restricted catheter states to establish the thresholds and further discloses a method of collecting numerous pressure sensor readings that involves cycling the valve between open and closed states at a predetermined frequency (¶0078 sampling mode, algorithm will cycle off aspiration and then open and close the on-off valve at a predetermined frequency), and thus at predetermined first and second amounts of time correlating to a first amount of time in the first closed state and a second amount of time in the second open state, and assessing the pressure sensor reading during the open state (¶0078 valve is briefly opened and makes an assessment of the pressure sensor readings). Since it has been held that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying the known technique of repeatedly cycling the valve between on/off positions and recording pressure readings related to the state of the device to collect pressure data to apply to the training data for determining minimum and maximum differential pressures of a catheter lumen in relation to the state of the device in order to yield the predictable result of collecting multiple data points in relation to the unrestricted and restricted states of the device and then utilizing these data points as the training data for the algorithm. This would result in an efficient collection of multiple data points for each of the unrestricted and restricted catheter states. See MPEP 2143.
Teagen further discloses utilizing a artificial neural network (ANN) ¶0076 to determine the thresholds (¶0075 learning algorithm is used to determine the contents flowing through an aspiration catheter; numerous pressure readings are recorded for each catheter state, and the algorithm then references those data sets to interpret never seen pressure readings to predict what state the catheter is in, i.e. catheter state thresholds, thus defining whether catheters contents should be classified as unrestricted, restricted, or clogged) based on actual outputs measured in the catheter (¶0076 training data includes both observed data as inputs and the actual outputs) wherein the learning algorithm modifies the thresholds by analyzing the difference between a calculated output and the actual pressure readings (¶0076 analyzing the difference between the ANN’s calculated output and the actual output. This difference is translated into an error function. The error function is backpropagated across the Ann, whereby the weight of each node is modified according to its contribution to the error function. Numerous sets of training data are propagated until the error function reaches convergence, i.e. some acceptable level of tolerance). This learning sequence would have resulted in a determination (determines the actual output through training data measurements), during a valve cycle of the plurality of valve cycles (see above rejection of claim 23), that the subsequent flow rate is less than a first flow rate threshold (calculated output threshold before the modification) the system decreasing the first flow rate threshold to be less than or equal to the subsequent flow rate in response as the system actively modifies the threshold based on the actual outputs such that the calculated outputs converge with the actual outputs which would require reduction of thresholds in response to a determination of measured outputs, i.e. flow rates, are less than the calculated outputs. As the first flow rate threshold as disclosed by Teigen is intended to be less than a maximum flow rate which would be equivalent to the subsequent flow rate as being the flow through the catheter when the valve is fully open, the first flow rate would be necessarily decreased to be less than the subsequent flow rate) and in a case that the subsequent flow rate, i.e. the actual output maximum of the catheter in use measured) is greater than the calculated maximum in the training data of ANN would be adjusted to increase the first flow rate threshold due to the modification of the weighting to converge the data as disclosed ¶0076.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teigen et al. (U.S. Publication 2020/0367917) in view of Calderon et al. (U.S. Publication 2024/0245414) with reliance on filin date of provision application 63/481,528.
Regarding claim 12, Teigen discloses the aspiration system of claim 11, Teigen further discloses the first predetermined amount of time being between 250 milliseconds and 2 seconds
Teigen does not expressly disclose the first predetermined amount of time being about 950 milliseconds, or the second predetermined amount of time being about 50 ms.
Regarding the first predetermined amount of time being about 950 milliseconds, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first predetermined amount of time to be about 950 milliseconds as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Teigen would not operate differently with the claimed range and discloses the range of 250 – 2000 milliseconds which encompasses the claimed “about 950 milliseconds”. Further, applicant places no criticality on the ranged claimed, indicating simply that the time period may be about 950 ms in some examples (¶0046 of applicant’s specification).
Regarding the second predetermined amount of time being about 50 ms, Calderon, in the same field of endeavor of aspiration catheters, teaches controlling a valve 25 to be in a second operation state, i.e. open state, during a procedure for determining a state of a catheter for the purpose of decreasing the flow to the catheter by at least 50 % when compared to a duty cycle of 100 ms for the purpose of mitigating blood loss (¶0150 if the vacuum valve pulse frequency is 10 Hz the total cycle time is 100 ms. However, if the vacuum valve is open for 50 ms during a cycle, the duty cycle becomes 50 % and the flow is decreased by at least 50% while the control determines a state of the catheter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second predetermined amount of time of Teigen to have been 50 ms, as taught by Calderon, rather than Teigen’s disclosed 150 ms for the purpose of reducing the time period in which the valve is in an open configuration and thus allowing full flow of blood through the catheter. This modification would result in a reduction of blood loss due to the decreased time in which flow is allowed through the catheter.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teigen et al. (U.S. Publication 2020/0367917) in view of Wainwright et al. (U.S. Publication 2024/0164801) as reliant upon provisional application 63/426,902 filed on Nov. 21, 2022.
Regarding claim 14, Teigen discloses the aspiration system of claim 9. Teigen does not expressly disclose determining the flow rate comprising directly measuring the flow rate of the fluid within the catheter lumen.
However, Wainwright, in the same field of endeavor of aspiration catheters, teaches directly measuring the flow rate of the fluid within the lumen (¶0088).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the flow sensor of Teigen that performs the function of sensing flow of fluid in an aspiration catheter fluid pathway for the flow sensor of Wainwright since these elements perform the same function of sensing fluid flow rate in a fluid pathway. Simply substituting one fluid flow rate sensing means for another would yield the predictable result of allowing a(n) fluid pathway to determine flow rate. See MPEP 2143.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Deville et al. (U.S. Patent No. 10,531,883) discloses an aspiration catheter with flow control.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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