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 § 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.
Claims 1, 5-9 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ho et al. (U.S. Publication No. 20030214412).
Regarding claim 1, Ho teaches a method, comprising: maintain a fluid connection between at least one measurement instrument (Figs.7-8, 44+46) and a fluid within a fluid tubing (Figs.7-8, 22) upstream or downstream of a pump element of an infusion device (Paragraphs 2 and 23-24, “infusion pumps” and “pump 10”), the pump element (Paragraphs 23-24, “pumping elements 32”) configured to periodically cause a compression of the fluid tubing, the compression fluidically isolating a downstream portion of the fluid tubing from an upstream portion of the fluid tubing when the pump element is operating under a normal operating condition (Paragraphs 23-31); receiving the fluid tubing (Figs.7-8, 22) into the infusion device; causing the pump element to cause the compression of the fluid tubing (Paragraphs 23-31); measuring, with the at least one measurement instrument (Figs.7-8, 44+46), a response of the fluid when the pump element is caused to compress the fluid tubing; and determining, based on the measured response, whether the compression has isolated the fluid in the downstream portion from the fluid in the upstream portion when the pump element is caused to compress the fluid tubing (Abstract, “A computer program is provided for closing the valve, for activating the pumping mechanism for a partial pumping stroke, for receiving a first pressure signal from said pressure sensor indicating the sensed pressure after the partial pumping stroke, for holding the pumping mechanism stationary during a predetermined period of time, for receiving a second pressure signal indicating the pressure in the tubing after the predetermined period of time, for comparing the first and second pressure signals to determine whether there is leakage in the tubing indicating improper tubing installation and if so for providing an alarm signal to indicate improper tubing installation”).
Regarding claim 5, Ho teaches wherein the at least one measurement instrument comprises a pressure sensor, the method further comprising: measuring, with the pressure sensor, a pressure of the fluid when the pump element is caused to compress the fluid tubing; and determining whether the compression has isolated the fluid in the downstream portion from the fluid in the upstream portion based on the measured pressure (Abstract).
Regarding claim 6, Ho teaches wherein the compression is determined to fluidically isolate the downstream portion from the upstream portion when the measured pressure satisfies a threshold pressure, the method further comprising: determining that the measured pressure satisfies the threshold pressure; and determining that the compression isolated the fluid in the downstream portion from the fluid in the upstream portion based on determining that the measured pressure satisfies the threshold pressure (Abstract and paragraphs 32-35).
Regarding claim 7, Ho teaches wherein the infusion device comprises a first pump element and a second pump element, the method further comprising: causing the infusion device to position the first pump element to be in an open position wherein the fluid flows freely past the first pump element; causing the infusion device to position the second pump element to be in a closed position to cause the compression of the fluid tubing; and measuring the pressure when the second pump element is in the closed position (Abstract and paragraphs 32-35).
Regarding claim 8, Ho teaches wherein the infusion device comprises the pressure sensor and is operably connected to the at least one measurement instrument, the method further comprising: communicating, by the infusion device, the measured pressure to the at least one measurement instrument (Abstract and paragraphs 32-35).
Regarding claim 9, Ho teaches wherein the pressure sensor is integrated into an infusion set and is operably connected to the at least one measurement instrument, the method further comprising: communicating, by the infusion set, the measured pressure to the at least one measurement instrument (Abstract and paragraphs 32-35).
Regarding claim 12, Ho teaches wherein causing the compression of the fluid tubing comprises causing a compression of a tube segment prefilled with the fluid and sealed at both ends (Abstract and paragraphs 32-35).
Regarding claim 13, Ho teaches wherein measuring the response of the fluid with the at least one measurement instrument comprises measuring the response using an inline pressure sensor within the fluid tubing at each end of the fluid tubing (Abstract and paragraphs 32-35).
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 2-4 and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ho et al. (U.S. Publication No. 20030214412) in view of Heide et al. (U.S. Publication No. 20190143015).
Regarding claim 2, Ho teaches all the feature of claim 1 as outlined above, Ho is silent about wherein the at least one measurement instrument comprises a first electrode and a second electrode, the method further comprising: fluidically connecting the first electrode to a fluid within upstream portion of the fluid tubing; fluidically connecting the second electrode to a fluid within the downstream portion of the fluid tubing; applying a voltage across the first and second electrodes; and determining whether the compression has isolated the fluid in the downstream portion from the fluid in the upstream portion based on whether a current is generated by the applied voltage.
Heide teaches wherein the at least one measurement instrument comprises a first electrode and a second electrode (Abstract, “The electrodes 16A, 16B), the method further comprising: fluidically connecting the first electrode to a fluid within upstream portion of the fluid tubing; fluidically connecting the second electrode to a fluid within the downstream portion of the fluid tubing; applying a voltage across the first and second electrodes; and determining whether the compression has isolated the fluid in the downstream portion from the fluid in the upstream portion based on whether a current is generated by the applied voltage (Paragraphs 19 and 42-46).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to replace Ho’s pressure sensors 44 and 46 with Heide’s electrodes 16A and 16B because electrodes could be integrated into Ho’s tubes to reduce the size of Ho’s monitoring system.
Regarding claim 3, the combination of Ho and Heide teaches all the feature of claim 2 as outlined above, Heide further teaches detecting the current when the pump element is caused to compress the fluid tubing; and determining that the compression isolated the fluid in the downstream portion from the fluid in the upstream portion based on detecting the current (Paragraphs 19 and 42-46).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to replace Ho’s pressure sensors 44 and 46 with Heide’s electrodes 16A and 16B because electrodes could be integrated into Ho’s tubes to reduce the size of Ho’s monitoring system.
Regarding claim 4, the combination of Ho and Heide teaches all the feature of claim 2 as outlined above, Heide further teaches wherein the infusion device comprises a first pump element and a second pump element, the method further comprising: causing the infusion device to position the first pump element to be in an open position, wherein the fluid flows freely past the first pump element; causing the infusion device to position the second pump element to be in a closed position to cause the compression of the fluid tubing; and measuring, after applying the voltage, the response of the fluid when the second pump element is in the closed position (Paragraphs 19 and 42-46).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to replace Ho’s pressure sensors 44 and 46 with Heide’s electrodes 16A and 16B because electrodes could be integrated into Ho’s tubes to reduce the size of Ho’s monitoring system.
Regarding claim 14, Ho teaches all the feature of claim 12 as outlined above, Ho is silent about wherein measuring the response of the fluid with the at least one measurement instrument comprises measuring the response using an electrode at each end of the fluid tubing.
Heide teaches wherein measuring the response of the fluid with the at least one measurement instrument comprises measuring the response using an electrode at each end of the fluid tubing (Paragraphs 19 and 42-46).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to replace Ho’s pressure sensors 44 and 46 with Heide’s electrodes 16A and 16B because electrodes could be integrated into Ho’s tubes to reduce the size of Ho’s monitoring system.
Regarding claim 15, Ho teaches all the feature of claim 1 as outlined above, Ho is silent about communicating the measured response to an external measurement device remote from the infusion device and the fluid tubing; and causing a display of a waveform representative of the measured response on a display device.
Heide teaches communicating the measured response to an external measurement device (Abstract and Fig.1, “a monitoring apparatus 15”) remote from the infusion device and the fluid tubing (As shown in Fig.1, monitoring apparatus 15 is remote from the pump 6); and causing a display of a waveform representative of the measured response on a display device (Paragraphs 41 and 50-51).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to make Ho’s measurement device remote from Ho’s test set because it would provide easier access to an operator.
Regarding claim 16, Ho teaches a test infusion set, comprising: a fluid carrying compressible tubing (Figs.7-8, 22) prefilled with a fluid and fluidically sealed at each end (Paragraph 33); a pair of measurement devices (Figs.7-8, 44+46), each measurement device (Figs.7-8, 44+46) being at a respective end of the fluid carrying compressible tubing (As shown in Figs. 7-8); and at least one measurement instrument in fluid communication with the fluid, wherein the at least one measurement instrument is configured to measure a response of the fluid when the fluid carrying compressible tubing is compressed by a pump element of an infusion device and to communicate the measured response to a measurement device (Abstract, “A computer program is provided for closing the valve, for activating the pumping mechanism for a partial pumping stroke, for receiving a first pressure signal from said pressure sensor indicating the sensed pressure after the partial pumping stroke, for holding the pumping mechanism stationary during a predetermined period of time, for receiving a second pressure signal indicating the pressure in the tubing after the predetermined period of time, for comparing the first and second pressure signals to determine whether there is leakage in the tubing indicating improper tubing installation and if so for providing an alarm signal to indicate improper tubing installation”).
Ho is silent about each measurement device being integrated at a respective end of the fluid carrying compressible tubing; and at least one measurement instrument integrated with the fluid carrying compressible tubing, and the measurement device is remote from the test infusion set.
Heide teaches each measurement device (Abstract, “electrodes 16A, 16B”) being integrated at a respective end of the fluid carrying compressible tubing; and at least one measurement instrument integrated with the fluid carrying compressible tubing (Abstract, “The electrodes 16A, 16B are preferably integral component parts of a connecting piece 10”, and paragraphs 44-46), and the measurement device (Abstract and Fig.1, “a monitoring apparatus 15”) is remote from the test infusion set (As shown in Fig.1, monitoring apparatus 15 is remote from the pump 6).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to replace Ho’s pressure sensors 44 and 46 with Heide’s electrodes 16A and 16B because electrodes could be integrated into Ho’s tubes to reduce the size of Ho’s monitoring system, also it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to make Ho’s measurement device remote from Ho’s test set because it would provide easier access to an operator.
Regarding claim 17, the combination of Ho and Heide teaches all the feature of claim 16 as outlined above, Heide further teaches wherein the at least one measurement instrument comprises a first electrode and a second electrode (Abstract, “The electrodes 16A, 16B), and the response comprises a voltage across the first and second electrodes (Paragraph 19).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to replace Ho’s pressure sensors 44 and 46 with Heide’s electrodes 16A and 16B because electrodes could be integrated into Ho’s tubes to reduce the size of Ho’s monitoring system.
Regarding claim 18, the combination of Ho and Heide teaches all the feature of claim 16 as outlined above, Heide further teaches wherein the at least one measurement instrument comprises a pressure sensor, and the response comprises a pressure of the fluid within the fluid carrying compressible tubing (Abstract and paragraphs 32-35).
Regarding claim 19, the combination of Ho and Heide teaches all the feature of claim 16 as outlined above, Ho further teaches wherein the fluid carrying compressible tubing comprises a respective pressure sensor embedded within the fluid carrying compressible tubing at each end of the fluid carrying tubing, each of the pressure sensors configured to communicate a pressure reading to the measurement device (Abstract and paragraphs 32-35).
Ho is silent about the measurement device is remote from the test infusion set.
Heide teaches the measurement device (Abstract and Fig.1, “a monitoring apparatus 15”) is remote from the test infusion set (As shown in Fig.1, monitoring apparatus 15 is remote from the pump 6).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to make Ho’s measurement device remote from Ho’s test set because it would provide easier access to an operator.
Allowable Subject Matter
Claims 10-11 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: The primary reasons for allowance of dependent claim 10 is the inclusion of the specific limitations of “wherein the infusion device comprises a occluder valve, the occluder valve comprising the pump element and being configured to compress the pump element against a platen of the infusion device to compress the fluid tubing, the method further comprising: iteratively receiving one or more shims between the platen and a portion of the occluder valve to move the platen away from the pump element; and causing the pump element to cause the compression of the fluid tubing while each respective shim of the one or more shims is inserted between the platen and the portion of the occluder valve, wherein a response of the fluid is measured for each respective shim”, in combination of with all other recited method steps in a method.
The primary reasons for allowance of dependent claim 20 is the inclusion of the specific limitations of “one or more shims coupled to the fluid carrying compressible tubing and each configured to be inserted between a platen and a portion of an occluder valve of the infusion device to move the platen away from a pump element responsible for compressing the fluid carrying compressible tubing when the response is measured by the at least one measurement instrument”, in combination of with all other recited associated elements in a test infusion set.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIN Y ZHONG whose telephone number is (571)272-3798. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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/XIN Y ZHONG/ Primary Examiner, Art Unit 2855