DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 20 is objected to because of the following informalities: claim 20 requires “after providing the user prompt on to terminate the coronary sinus occlusion treatment”. There appear to be some words missing here, e.g., “prompt on a/the user interface”. 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 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schiemanck et al (U.S. 9,855,049). Schiemanck discloses (Figure 2) a coronary sinus occlusion device (122) operable to occlude at least a portion of a coronary sinus of a heart of a patient (col. 1, line 60-col. 2, line 23); and a control system (140) connectable to the coronary sinus occlusion device and configured to execute computer-readable instructions that perform operations (col. 6, lines 24-39) including: activating the coronary sinus occlusion device to intermittently occlude the coronary sinus during a plurality of occlusion phases of a coronary sinus occlusion treatment (col. 1, line 60-col. 2, line 23, especially “a control system and a catheter device that are operated to intermittently occlude a heart vessel for controlled periods of time for purposes of redistributing blood flow”), operating the coronary sinus occlusion device to release each intermittent occlusion of the coronary sinus during the coronary sinus occlusion treatment (col. 10, line 42-col. 11, line 15, especially “the control system 140 includes a computer processor that executes computer-readable instructions stored on a computer memory device so as to activate or deactivate the occlusion in the coronary sinus 20 in accordance with a particular process.”), receiving sensor data signals indicative of a hemodynamics parameter (“pressure sensor device 136”; col. 9, line 56-col. 10, line 20) of the heart during the plurality of occlusion phases, comparing a threshold value to an indicator value that is based on the sensor data signals of the plurality of occlusion phases (col. 11, lines 16-34, especially “the control system 140 can activate or deactivate the occlusion component 122 at the distal tip portion 121 of the coronary sinus occlusion catheter 120 while also receiving one or more sensor signals that provide data indicative of heart performance parameters (e.g., coronary sinus pressure, fluid temperature in the coronary sinus, volume or mass flow rate, rate of change of the volume or mass flow rate, acceleration of the coronary sinus vessel, displacement of the coronary sinus vessel, intra coronary sinus or other intra vessel electrocardiogram (ECG), surface electrocardiogram (ECG) information, contractility, or another measured parameter indicative of hemodynamic performance of the heart).”), and terminating the coronary sinus occlusion treatment based on said comparing the threshold value to the value (col. 14, line 64-col. 15, line 11, especially “if the coronary sinus pressure signal input to the control system 140 indicates a coronary sinus pressure that is above a selected threshold, the control circuit subsystem 155 can cause the graphical user interface 142 to display an alert in the form of a textual message or an error code. Further, in some embodiments, the control circuit subsystem 155 may automatically cause the pneumatic subsystem to deflate the balloon device 122 so as to immediately reduce the high pressure in the coronary sinus 20.”).
Regarding claim 2, Schiemanck discloses (col. 8, lines 14-28) the coronary sinus occlusion device comprises: an expandable member (122) insertable into the coronary sinus and expandable to occlude at least the portion of the coronary sinus (balloon is inflated), and a sensor that generates the sensor data signals (col. 6, line 32-col. 7, line 4, especially “the control system 140 may be employed to operate one or more components at the distal tip portion 121 of the coronary sinus occlusion catheter 120 while also receiving one or more sensor signals that provide data indicative of a heart performance parameter (e.g., coronary sinus pressure, electrocardiogram (ECG) information, or another measured parameter indicative of hemodynamic performance of the heart.)”).
Regarding claim 3, Schiemanck discloses the sensor (136) is positioned near the expandable member (col. 12, lines 6-53, especially “the proximal hub 132 joins the third line 135 with a coronary sinus pressure lumen 125 (FIGS. 4-5) extending through the coronary sinus occlusion catheter 120 and to the distal ports 129 that are forward of the balloon device 122. In this embodiment, the coronary sinus pressure lumen 125 and at least a portion of the third line 135 may operate as fluid-filled path (e.g., saline or another biocompatible liquid) that transfers the blood pressure in the coronary sinus 20 to pressure sensor device 136 along a proximal portion of the third line 135. The pressure sensor device 136 samples the pressure measurements (which are indicative of the coronary sinus pressure) and outputs an sensor signal indicative of the coronary sinus pressure to the corresponding port 145 of the controller system 140 for input to the internal control circuit 155”), under a broad interpretation of the word “near”.
Regarding claim 4, Schiemanck discloses (see the previous citation) the coronary sinus occlusion device comprises a catheter, and the expandable member and the sensor are positioned on a distal portion of the catheter.
Regarding claim 5, Schiemanck discloses (see the previous citation) the sensor is a pressure sensor configured to measure at least a pressure.
Regarding claim 6, Schiemanck discloses (col. 8, line 46-col. 9, line 13) the sensor is configured to measure at least a flow rate in a coronary venous system distal to a distal end of the coronary sinus occlusion device and a rate of change of the flow rate in the coronary venous system (“the catheter 120 can be configured to communicate at least one input signal indicative of a measured parameter in the coronary sinus, such as a fluid pressure (e.g., the coronary sinus pressure), a fluid temperature (e.g., using a temperature sensor positioned near the distal ports 129 and connected to the control system 140 via the sensor line 135), a volume or mass flow rate or rate of change thereof (e.g., using a flow sensor positioned near the distal ports 129 and connected to the control system 140 via the sensor line 135)”).
Regarding claim 7, Schiemanck discloses (col. 11, line 16-col. 12, line 5) the sensor is a first sensor, the sensor data signals are first sensor data signals, and the coronary sinus occlusion device further comprises a second sensor configured to generate second sensor data signals indicative of a pressure or a rate of change of the pressure in the coronary sinus, and the indicator value is based on the first sensor data signals and the second sensor data signals (a hub includes up to three sensor lines 133, 134, 135, which all communicate pressure data to
Regarding claim 8, Schiemanck discloses (Figure 3) an expandable member (122) insertable into the coronary sinus and expandable to occlude at least the portion of the coronary sinus (Figure 2), a first sensor that generates at least some of the sensor data signals (134), and a second sensor that generates at least some of the sensor data signals (135), wherein the first and second sensors are positioned on first and second sides of the expandable member.
Regarding claim 9, Schiemanck discloses (col. 11, lines 16-34) receiving, from a sensor configured to measure the hemodynamics parameter in an arterial system of the heart, the sensor data signals (“the control system 140 can activate or deactivate the occlusion component 122 at the distal tip portion 121 of the coronary sinus occlusion catheter 120 while also receiving one or more sensor signals that provide data indicative of heart performance parameters (e.g., coronary sinus pressure, fluid temperature in the coronary sinus, volume or mass flow rate, rate of change of the volume or mass flow rate, acceleration of the coronary sinus vessel, displacement of the coronary sinus vessel, intra coronary sinus or other intra vessel electrocardiogram (ECG), surface electrocardiogram (ECG) information, contractility, or another measured parameter indicative of hemodynamic performance of the heart).”).
Regarding claim 10, Schiemanck discloses (see above citation) sensor data signals are indicative of at least a pressure.
Regarding claim 11, Schiemanck discloses (col. 3, line 64-col. 4, line 15) determining the indicator value based on, for each of the plurality of occlusion phases, a maximum value of the pressure or the rate of change of the pressure in the coronary sinus in a period of time during a corresponding occlusion phase (“storing data indicative of at least pressure maxima and pressure minima measured during the sequence of multiple occlusion phases. The method may further include, after the occlusion phase of the occlusion device positioning test, calculating a pulsatile pressure parameter. The pulsatile pressure parameter may be calculated based at least in part upon the data the pressure maxima and pressure minima measured during the occlusion phase of the occlusion device positioning test.”).
Regarding claim 12, Schiemanck discloses (col. 24, lines 51-68) for each of the plurality of occlusion phases, the period of time corresponds to an end period of the corresponding occlusion phase (“The process 500 may also include operation 550, in which the control system 140 receives user input indicating an end to the treatment using the system 100.”).
Regarding claim 13, Schiemanck discloses (col. 16, lines 33-45) determining the indicator value based on, for each of the plurality of occlusion phases, an average value of the pressure.
Regarding claim 14, Schiemanck discloses (col. 20, line 56-col. 21, line 30) said terminating the coronary sinus occlusion treatment is performed in response to a determination that a plurality of indicator values that are based on the sensor data signals of the plurality of occlusion phases are substantially in steady state, the plurality of indicator values comprising the indicator value (“the global relative pressure 226 (FIG. 8B) drop can be monitored and compared to a predetermined threshold value and used to make a determination as to whether a satisfactory level of occlusion is attained.”).
Regarding claim 15, Schiemanck discloses (col. 19, line 64-col. 20, line 48) predicting a value of the hemodynamics parameter (“predetermined target threshold parameter”), wherein the indicator value corresponds to a difference between at least one of the plurality of indicator values and the predicted value (“in some embodiments the global relative pressure 226 (FIG. 8B) drop can be monitored and compared to a predetermined threshold value and used to make a determination as to whether a satisfactory level of occlusion is attained.”).
Regarding claim 16, Schiemanck discloses (see previous citation) the at least one of the plurality of indicator values corresponds to a last indicator value of the plurality of indicator values.
Allowable Subject Matter
Claims 17-20 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792