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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 8 and 9 are objected to because of the following informalities:
Claim 8 states “an ultrasonic sensor sensitive to gas in an infusion tube, the ultrasonic sensor sensitive to gas in an infusion tube” which should be “an ultrasonic sensor sensitive to gas in an infusion tube”
Claim 9 is objected to for being dependent from an objected to claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 11, 12, 14, 15, and 19-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5482446 (Williamson hereinafter).
Regarding claim 11, Williamson teaches a pump system that discloses a tube platen (Platen 98 in Figure 4); a plunger (Plunger 120 in Figures 31A-D); an inlet valve upstream of the plunger configured for actuation between an occluding position and a non-occluding position (Valve 122 in Figures 31A-D) of Williamson; and an outlet valve downstream of the plunger configured for actuation between an occluding position and a non-occluding position (Valve 124 in Figures 31A-D of Williamson); and a processor operatively coupled to the position sensor to receive an estimated plunger position of the plunger and to estimate fluid flow in accordance with the estimated plunger position when at least one of the inlet and outlet valve are occluded (Processor 542 as used in Section N Subsections 1-9 of Williamson [Column 35 Line 7 through Column 43 Line 42]).
Regarding claim 12, Williamson’s teachings are described above in claim 11 where Williamson discloses a bias member configured to urge the plunger toward the tube platen (Bias member per Column 16 Lines 24-54).
Regarding claim 14, Williamson’s teachings are described above in claim 11 where Williamson discloses a pressure sensor configured to estimate a position of the plunger (Williamson discloses a leak test in Figure 36 G which shows the use of a pressure sensor and the position of the plunger).
Regarding claim 15, Williamson’s teachings are described above in claim 11 where Williamson discloses an ultrasonic sensor sensitive to gas in an infusion tube (Ultrasonic sensor 130 per Column 21 Lines 29-58 of Williamson).
Regarding claim 19, Williamson’s teachings are described above in claim 11 where Williamson discloses a processor configured to determine that an occlusion has occurred based on a predetermined condition (Column 40 Line 26 through Column 41 Line 14 paired with Figures 36B-F, particularly Figure 36B, disclose a method of testing for valve leaks where the position of plunger is used is part to detect an anomaly when the inlet valve or the outlet valve is occluded).
Regarding claim 20, Williamson’s teachings are described above in claim 11 where Williamson discloses a processor configured to determine that a leak has occurred based on a predetermined condition (Williamson Column 40 Line 26 through Column 41 Line 14 discloses the delivery rate being the base of the leak test where a leak would constitute an anomaly).
Regarding claim 21, Williamson’s teachings are described above in claim 11 where Williamson discloses a processor configured to determine an anomaly has occurred based at least in part on a deviation from an expected rate of plunger position (Williamson Column 40 Line 26 through Column 41 Line 14 discloses the delivery rate being the base of the leak test and the delivery rate would involve the change of height of the plunger and therefore the expected rate of the plunger).
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.
Claims 2-8, 10, 13, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US 5482446 (Williamson) in view of US 4105028 (Sadlier hereinafter).
Regarding claim 2, Williamson teaches a pump system that discloses a tube platen (Platen 98 in Figure 4); a plunger (Plunger 120 in Figures 31A-D); a bias member configured to urge the plunger toward the tube platen (Bias member per Column 16 Lines 24-54); and an actuator mechanism configured to control an actuation of the plunger (Actuator per Column 15 Line 59 through Column 16 Line 23), the actuator mechanism being disengagable from the plunger (Inherent of the operation of the plunger during a release phase of the pumping motion).
Williamson is silent with respect that when the actuator mechanism is disengaged, the bias member is a sole source of actuation force of the plunger toward the tube platen.
However, Sadlier teaches a medical pumping system that discloses a plunger cam follower coupled to the cam shaft, the plunger cam being configured to lift the plunger away from the tube platen (Column 7 Line 62 through Column 8 Lines 23 with Figures 6-8 with spring 323). The resultant combination would be such that the biasing member (spring of Sadlier) would drive the plunger towards the platen and actuator would return the plunger away from the platen therefore teaching that when the actuator mechanism is disengaged, the bias member is a sole source of actuation force of the plunger toward the tube platen.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the plunger design of Williamson with the plunger design of Sadlier to allow for the tubing to be closed in the event the plunger/motor/drive source malfunction therefore preventing a leakage of fluid.
Regarding claim 3, Williamson’s modified teachings are described above in claim 2 where the combination of Williamson and Sadlier would further disclose a position sensor configured to estimate a position of the plunger (Position sensor per Column 19 Lines 1-27 of Williamson).
Regarding claim 4, Williamson’s modified teachings are described above in claim 3 where the combination of Williamson and Sadlier would further disclose a processor configured to detect an anomaly based at least in part on the estimated plunger position (Processor 542 as used in Section N Subsections 1-9 of Williamson [Column 35 Line 7 through Column 43 Line 42]).
Regarding claim 5, Williamson’s modified teachings are described above in claim 4 where the combination of Williamson and Sadlier would further disclose that the processor is further configured to estimate fluid flow in accordance with the estimated plunger position when the actuator mechanism is disengaged from the plunger (Column 23 Line 3 through Column 24 Line 47 of Williamson details the various flow rate profiles used and the control of the pump must be done to obtain these set flow rate values which will utilize the plunger position being sensed at all times).
Regarding claim 6, Williamson’s modified teachings are described above in claim 2 where the combination of Williamson and Sadlier would further disclose an inlet valve upstream of the plunger configured for actuation between an occluding position and a non-occluding position (Valve 122 in Figures 31A-D) of Williamson; and an outlet valve downstream of the plunger configured for actuation between an occluding position and a non-occluding position (Valve 124 in Figures 31A-D of Williamson).
Regarding claim 7, Williamson’s modified teachings are described above in claim 2 where the combination of Williamson and Sadlier would further disclose a pressure sensor configured to estimate a position of the plunger (Williamson discloses a leak test in Figure 36 G which shows the use of a pressure sensor and the position of the plunger).
Regarding claim 8, Williamson’s modified teachings are described above in claim 2 where the combination of Williamson and Sadlier would further disclose an ultrasonic sensor sensitive to gas in an infusion tube (Ultrasonic sensor 130 per Column 21 Lines 29-58 of Williamson).
Regarding claim 10, Williamson’s modified teachings are described above in claim 6 where the combination of Williamson and Sadlier would further disclose a processor configured to estimate a plunger position when the actuator mechanism is disengaged from the plunger to determine fluid flow and to determine a volume of air pumped downstream based on the estimated plunger position (Figure 36B of Williamson with steps from 708-803 determine air being pumped with the plunger position being sensed).
Regarding claim 13, Williamson’s teachings are described above in claim 12 where Williamson further discloses an actuator mechanism configured to control an actuation of the plunger (Actuator per Column 15 Line 59 through Column 16 Line 23), the actuator mechanism being disengagable from the plunger (Inherent of the operation of the plunger during a release phase of the pumping motion).
Williamson is silent with respect that when the actuator mechanism is disengaged, the bias member is a sole source of actuation force of the plunger toward the tube platen.
However, Sadlier teaches a medical pumping system that discloses a plunger cam follower coupled to the cam shaft, the plunger cam being configured to lift the plunger away from the tube platen (Column 7 Line 62 through Column 8 Lines 23 with Figures 6-8 with spring 323). The resultant combination would be such that the biasing member (spring of Sadlier) would drive the plunger towards the platen and actuator would return the plunger away from the platen therefore teaching that when the actuator mechanism is disengaged, the bias member is a sole source of actuation force of the plunger toward the tube platen.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the plunger design of Williamson with the plunger design of Sadlier to allow for the tubing to be closed in the event the plunger/motor/drive source malfunction therefore preventing a leakage of fluid.
Regarding claim 17, Williamson’s modified teachings are described above in claim 13 where the combination of Williamson and Sadlier would further disclose a processor configured to estimate a plunger position when the actuator mechanism is disengaged from the plunger to determine fluid flow and to determine a volume of air pumped downstream based on the estimated plunger position (Figure 36B of Williamson with steps from 708-803 determine air being pumped with the plunger position being sensed).
Regarding claim 18, Williamson’s modified teachings are described above in claim 13 where the combination of Williamson and Sadlier would further disclose that the processor is further configured to estimate fluid flow in accordance with the estimated plunger position when the actuator mechanism is disengaged from the plunger (Column 23 Line 3 through Column 24 Line 47 of Williamson details the various flow rate profiles used and the control of the pump must be done to obtain these set flow rate values which will utilize the plunger position being sensed at all times).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over US 5482446 (Williamson) in view of US 4105028 (Sadlier) and further in view of US 2011/0028937 (Powers hereinafter).
Regarding claim 9, Williamson’s modified teachings are described above in claim 8 where the combination of Williamson and Sadlier is silent with respect that the ultrasonic sensor is located downstream of the plunger.
However, Powers teaches an infusion pump that discloses an ultrasonic sensor is located downstream of the plunger (¶ 48)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the location of the ultrasonic sensor of Williamson with the outlet location of Powers to additionally check if the pump operation is causing air/bubbles to occur in the fluid being delivered.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over US 5482446 (Williamson) in view of US 2011/0028937 (Powers).
Regarding claim 16, Williamson’s teachings are described above in claim 15 but are silent with respect that the ultrasonic sensor is located downstream of the plunger.
However, Powers teaches an infusion pump that discloses an ultrasonic sensor is located downstream of the plunger (¶ 48)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the location of the ultrasonic sensor of Williamson with the outlet location of Powers to additionally check if the pump operation is causing air/bubbles to occur in the fluid being delivered.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 5924852 (Moubayed) discloses a peristaltic pump that uses a spring to bias part of a plunger towards the platen at all times.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR J. TREMARCHE whose telephone number is (571)272-2175. The examiner can normally be reached Monday - Thursday 0700-1700 Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL HOANG can be reached at (571) 272-6460. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CONNOR J TREMARCHE/Primary Examiner, Art Unit 3762
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