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) 1-3,5-7,11, 14,16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2023/0289173 to St. George et al in view of U.S. Patent 11,437,141 to Mensinger et al. in view of U.S. Patent 9,492,136 to Karmazyn et al.
As to claim 1, St. George discloses a method for monitoring, analyzing, and adjusting performance of an individual medical device (St. George see apheresis system 200 with one or more sensors to detect and/or monitor different parameters, and automatically adjust, one or more settings for optimization of operations [0308], [0424], [0519], [0526], [0527], [0586], [0596]), the method comprising:
analyzing, by the individual medical device, at least one variable (St. George see monitoring factors such as temperature, pressure, flow rate, color of fluid, weight of plasma received, data received from a scanner, motor control, centrifuge speed, software failure modes, and/or other factors relating to the donation process [0424], [0587]); and
when analyzing, if the at least one variable is not as expected, at least one of alerting, by the individual medical device, an operator of the individual medical device (St. George see alarm event may be detected when one of the factors crosses a threshold or reaches a particular value, e.g., in response to detecting a change in flow of a fluid, the apheresis system 200 may generate and/or issue one or more alarms to alert a user [0427], [0591], [0593]) and adjusting, by the individual medical device, one or more operating parameters for the individual medical device (St. George see instructions to move the apheresis system 200 from an alarm state to an operating state; for e.g. in response to detecting a change in flow of a fluid the apheresis system 200 may lower a flow rate through one or more tubes on the apheresis system 200 such as by adjusting an amount of power applied to one or more pumps in the apheresis system 200 and/or by adjusting a speed of the centrifuge [0433], [0596]).
However, St. George does not explicitly teach the at least one variable is not as expected when an out of ordinary shift is experienced in the collected performance data, the out of ordinary shift includes an instance where the collected performance data deviates by an amount greater than a determined standard deviation, the standard deviation being determined, by the individual medical device, using the collected performance data from an on-going cycle of the individual medical device.
Mensinger discloses the at least one variable is not as expected when an out of ordinary shift is experienced in the collected performance data, the out of ordinary shift includes an instance where the collected performance data deviates by an amount greater than a determined standard deviation, the standard deviation being determined, by the individual medical device, using the collected performance data from an on-going cycle of the individual medical device (Mensinger column 14 lines 61-67 and column 15 lines 1-22).
It would have been obvious to one of ordinary skill in the art before the effective filing date to determine performance based on standard deviation of the collected data as in Mensinger in the system of St. George to improve the identification of anomalous data.
However, St. George and Mensinger do not explicitly teach determining, by the individual medical device, using collected performance data, when at least one variable exceeds the predetermined threshold, analyzing, by the individual medical device, the at least one variable using the collected performance data.
Karmazyn does not explicitly teach determining, by the individual medical device, using collected performance data, when at least one variable exceeds the predetermined threshold, analyzing, by the individual medical device, the at least one variable using the collected performance data (Karmazyn column 5 lines 24-67 and column 6 lines 1-44).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to perform multiple levels of analysis of a medical device as in Karmazyn in the system of St. George and Mesinger to improve the operation of the device, such as by reducing radiation exposure to the patient.
As to claim 2, see the discussion of claim 1, additionally, St. George discloses wherein the method further includes:
identifying the at least one variable, the at least one variable (St. George see determine particular settings which may be required for the donation procedure, such as target volume, flow rate, etc. [0321]) being identified by an operator of the individual medical device (St. George see data entry process used to initialize an apheresis system 200 by operator to ensure a target amount or volume of plasma based on donor weight or other donor information is obtained [0301], [0317])
As to claim 3, see the discussion of claim 1, additionally, St. George discloses wherein the method further includes:
collecting, by the individual medical device, performance data of the individual medical device (St. George see receiving data from one or more sensors such as temperature sensors, pressure sensors, flow rate sensors, color sensors, valve sensors, weight sensors, a scanner, or other device [0425]).
As to claim 5, see the discussion of claim 3, additionally, St. George discloses wherein the method further includes:
storing, by the individual medical device, at least a portion of the collected performance data (St. George see apheresis system 200 includes storage 1008 to receive information from various sensors: figure 10: para [0292]).
As to claim 6, see the discussion of claim 3, additionally, St. George discloses wherein the method further includes:
identifying, by the individual medical device, the at least one variable using the collected performance data (St. George see detecting a change in flow and/or a change in composition of a fluid, by analyzing, such as through the use of a sensor, flow rate, flow pressure, temperature, color of fluid, shape of tubing, and/or other factors relating to the flow of fluid throughout the apheresis system 200; para [0587]).
As to claim 7, see the discussion of claim 6, additionally, St. George discloses the method wherein the at least one variable is identified, by the individual medical device, when the collected performance data exceeds a predetermined threshold (St. George see one or more pressure sensors may be used to detect a pressure of fluid and/or air through one or more tubes, compared to upper and lower thresholds, a pressure increase may indicate that the centrifuge is full or almost full, or a change in composition of fluid; paras [0587], [0588]).
As to claim 10, see the discussion of claim 8, additionally, Mensinger discloses the method further includes: determining the standard deviation , by the individual medical device, using the collected performance data from the on-going cycle of the individual medical device and also the collected performance data from one or more previous cycles of the individual medical device (Mensinger column 14 lines 61-67 and column 15 lines 1-22).
As to claim 11, see the discussion of claim 1, additionally, St. George discloses the method wherein at least one variable is analyzed after a selected time period (St. George see rates of flow may be monitored continuously or at intervals; para [0531)]).
As to claim 14, see the discussion of claim 1, additionally, St. George discloses the method wherein the analyzing includes:
comparing the at least one variable to a predetermined threshold value and if the at least one variable is greater than the predetermined threshold value St. George see (comparing and determining flow of fluid has a pressure [variable] that is above a predetermined threshold pressure; para [0527]) at least one of: the operator of the individual medical device is alerted (St. George see alerting an operator through an alarm condition; para [0527]); and one or more operating parameters are adjusted (St. George see adjusting the rate of the one or more pumps of the apheresis system 200 including turning off the one or more pumps of the apheresis system 200; para [0527]).
As to claim 16, see the discussion of claim 1, additionally, St. George discloses the method wherein the analyzing includes:
comparing the at least one variable to a predetermined threshold value and if the at least one variable is lower than the predetermined threshold value (St. George see detecting that the rate of flow of fluid is below a predetermined threshold; paras [0525], [0526]) at least one of: the operator of the individual medical device is alerted (St. George see alerting an operator through an alarm condition; para [0527]); and one or more operating parameters are adjusted (St. George see in response to detecting a flow of fluid is below a predetermined threshold rate, a computer system of the apheresis system 200 may adjust a rate of one or more of the pumps of the apheresis system 200; para [0527]).
As to claim 18, St. George discloses a method for monitoring, analyzing, and adjusting performance of an individual medical device (St. George see apheresis system 200 with one of more sensors to detect and/or monitor different parameters, and automatically adjust, one or more settings for optimization of operations; paras [0308], [0424], [0519], [0526], [0527], [0586], [0596]), the method comprising:
collecting, by the individual medical device, performance data of the individual medical device (St. George see receiving data from one or more sensors such as temperature sensors, pressure sensors, flow rate sensors, color sensors, valve sensors, weight sensors, a scanner, or other device; para [0425]);
identifying, by the individual medical device, the at least one variable using the collected performance data (St. George see detecting a change in flow and/ or a change in composition of a fluid, by analyzing, such as through the use of a sensor, flow rate, flow pressure, temperature, color of fluid, shape of tubing, and/or other factors relating to the flow of fluid throughout the apheresis system 200; para [0587]);
analyzing, by the individual medical device, the at least one variable by comparing the at least one variable to a predetermined threshold (St. George see detecting that the rate of flow of fluid is below a predetermined threshold; paras [0525], [0526]); and
if the at least one variable is not as expected, at least one of alerting, by the individual medical device, an operator of the individual medical device (St. George see in response to detecting a change in flow of a fluid, alerting an operator through an alarm condition; paras [0527], [0591]) and adjusting, by the individual medical device, one or more operating parameters for the individual medical device (St. George see in response to detecting a flow of fluid is below a predetermined threshold rate, a computer system of the apheresis system 200 may adjust a rate of one or more of the pumps of the apheresis system 200; paras [0527], [0596]).
However, St. George does not explicitly teach the at least one variable is not as expected when an out of ordinary shift is experienced in the collected performance data, the out of ordinary shift includes an instance where the collected performance data deviates by an amount greater than a determined standard deviation, the standard deviation being determined, by the individual medical device, using the collected performance data from an on-going cycle of the individual medical device.
Mensinger discloses the at least one variable is not as expected when an out of ordinary shift is experienced in the collected performance data, the out of ordinary shift includes an instance where the collected performance data deviates by an amount greater than a determined standard deviation, the standard deviation being determined, by the individual medical device, using the collected performance data from an on-going cycle of the individual medical device (Mensinger column 14 lines 61-67 and column 15 lines 1-22).
It would have been obvious to one of ordinary skill in the art before the effective filing date to determine performance based on standard deviation of the collected data as in Mensinger in the system of St. George to improve the identification of anomalous data.
However, St. George and Mensinger do not explicitly teach determining, by the individual medical device, using collected performance data, when at least one variable exceeds the predetermined threshold, analyzing, by the individual medical device, the at least one variable using the collected performance data.
Karmazyn does not explicitly teach determining, by the individual medical device, using collected performance data, when at least one variable exceeds the predetermined threshold, analyzing, by the individual medical device, the at least one variable using the collected performance data (Karmazyn column 5 lines 24-67 and column 6 lines 1-44).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to perform multiple levels of analysis of a medical device as in Karmazyn in the system of St. George and Mesinger to improve the operation of the device, such as by reducing radiation exposure to the patient.
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) 4, 13, 15, 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2023/0289173 to St. George et al. in view of U.S. Patent 11,437,141 to Mensinger et al. in view of U.S. Patent 9,492,136 to Karmazyn et al. in view of U.S. Patent Application Publication 2007/0238923 to Kubach et al.
As to claim 4, see the discussion of claim 3, additionally, St. George discloses wherein the performance data of the individual medical device is collected during the on-going cycle of the individual medical device (St. George see during a plasma donation process, a processor of a computer system or microcontroller within the apheresis system 200 may be configured to detect a factor such as temperature, pressure, flow rate, color, weight, input data from a scanner, or other factors; para [0423]).
However, St. George does not explicitly teach one or more previous cycles of the individual medical device. Kubach discloses performance data of the individual medical device is collected during one or more previous cycles of the individual medical device (Kubach see profile of testing parameters may be specifically based on prior performance of the same endoscope 901 in the same tests; para [0058]). It would have been obvious to one of ordinary skill in the art at the time of the effective filing of the application by Applicant, to modify St. George to include performance data of the individual medical device is collected during one or more previous cycles of the individual medical device, as described by Kubach to better characterize expected performance based on changes in past runs.
As to claim 13, see the discussion of claim 1, additionally, St. George discloses the method wherein the at least one variable is analyzed when an out of ordinary shift is experienced in the at least one variable detecting the flow of fluid is below a predetermined threshold may comprise measuring a rate of flow through the tubing, identifying a color of fluid within the tubing; para [0526]). However, St. George does not explicitly teach the out of ordinary shift including instances where the at least one variable deviates by an amount greater than a determined standard deviation. Kubach discloses the out of ordinary shift including instances where the at least one variable deviates by an amount greater than a determined standard deviation (Kubach see calculation may be the humidity of the endoscope 901 test results compared to the environmental humidity, the difference in humidity, or a comparative value such as standard deviation, determining if the comparative value is within an area of tolerance; para [0098]). It would have been obvious to one of ordinary skill in the art at the time of the effective filing of the application by Applicant to modify St. George to include the out of ordinary shift including instances where the at least one variable deviates by an amount greater than a determined standard deviation, as described by Kubach to provide a more robust characterization system by using comparative analysis of representative parameters.
As to claim 15, see the discussion of claim 14, however, St. George discloses wherein the method further includes collecting, by the individual medical device, performance data of the individual medical device (St. George see receiving measured pressure, density, compressibility, resistance, and/or combinations thereof at one or more points along the section of the tubing; para [0524]). However, St. George does not explicitly teach the predetermined threshold value is determined, by the individual medical device, using the performance data of the individual medical device. Kubach discloses the predetermined threshold value is determined, by the individual medical device, using the performance data of the individual medical device (Kubach see floating baseline over time of the score the endoscope 901 based on prior tests; para [0060]). It would have been obvious to one of ordinary skill in the art at the time of the effective filing of the application by Applicant to modify St. George to include the predetermined threshold value is determined, by the individual medical device, using the performance data of the individual medical device, as described by Kubach to provide a more accurate evaluation of the medical device by using relative characterization under similar conditions.
As to claim 17, see the discussion of claim 16, additionally, St. George discloses wherein the method further includes collecting, by the individual medical device, performance data of the individual medical device (St. George see receiving measured pressure, density, compressibility, resistance, and/or combinations thereof at one or more points along the section of the tubing; para [0524]). St. George does not explicitly teach the predetermined threshold value is determined, by the individual medical device, using the performance data of the individual medical device. Kubach discloses the predetermined threshold value is determined, by the individual medical device, using the performance data of the individual medical device (Kubach see floating baseline over time of the score the endoscope 901 based on prior tests; para [0060]). It would have been obvious to one of ordinary skill in the art at time of the effective filing of the application by Applicant to modify St. George to include the predetermined threshold value is determined, by the individual medical device, using the performance data of the individual medical device, as described by Kubach to provide a more accurate evaluation of the medical device by using relative characterization under similar conditions.
As to claim 19, see the discussion of claim 18, additionally, St. George discloses wherein the performance data of the individual medical device is collected during the on-going cycle of the individual medical device (St. George see during a plasma donation process, a processor of a computer system or microcontroller within the apheresis system 200 may be configured to detect a factor such as temperature, pressure, flow rate, color, weight, input data from a scanner, or other factors; para [0423]). However, St. George does not explicitly teach performance data of the individual medical device is collected during one or more previous cycles of the individual medical device. Kubach discloses performance data of the individual medical device is collected during one or more previous cycles of the individual medical device (Kubach see profile of testing parameters may be specifically based on prior performance of the same endoscope 901 in the same tests; para [0058]). It would have been obvious to one of ordinary skill in the art at the time of the effective filing of the application by Application to modify St. George to include performance data of the individual medical device is collected during one or more previous cycles of the individual medical device, as described by Kubach to better characterize expected performance based on changes in past runs.
Response to Arguments
Applicant’s arguments with respect to claim(s) 5/26/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eliza Lam whose telephone number is (571)270-7052. The examiner can normally be reached Monday-Friday 8-4:30PST.
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/ELIZA A LAM/ Primary Examiner, Art Unit 3681
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