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
1. Claims 7-9, 11-12, 16-18, and 20 are objected to because of the following informalities:
In regards to claims 7-9, 11-12, 16-18, and 20, “a position” should be amended to “the position” since this has already been claimed
In regards to claims 7-9, 11-12, and 16, “a patient” should be amended to “the patient” since this has already been claimed.
Appropriate correction is required.
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.
2. Claim(s) 1-3, 5, 7-13, and 15-20, is/are rejected under 35 U.S.C. 103 as being unpatentable over Almedhychy (US 20220184377 A1) in view of Obermiller (US 20190167122 A1).
In regards to claims 1 and 12, Almedhychy discloses a circulatory support device (Abstract and Par. 0002), comprising:
an intracardiac blood pump comprising an inlet, an outlet, and a cannula arranged between the inlet and the outlet (Par. 0025 teaches an intracardiac blood pump [100] with a cannula [110]. Fig 1 shows there being an inlet and outlet of the blood pump on either side of the cannula);
at least one sensor associated with the cannula (Par. 0054 teaches there being a sensor); and
at least one controller (Par. 0038 teaches the system comprising a controller [302]) configured to:
determine a position of the intracardiac blood pump in a patient based, at least in part, on at least one signal sensed by the at least one sensor (Par. 0055 teaches that the sensor data is used to determine if the blood pump is in the correct position); and
provide an indication of the position of the intracardiac blood pump on a user interface of the circulatory support device (Par. 0040 discloses that there is a display for showing information to the user).
While Almedhychy teaches using sensors for determining the position of the blood pump, they do not disclose wherein these sensors are capacitive. However, in the same field of endeavor, Obermiller teaches an implantable medical device with an expandable portion for monitoring blood flow (Abstract) wherein there are capacitor sensors placed on the device (Par. 0046-47) in order to help determine if the expandable portion is inflated/deflated, which would be a position of the medical device. (Par. 0046-47).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Almedhychy and modified them by having the system use capacitor sensors, as taught and suggested by Obermiller, in order to help determine if the expandable portion is inflated/deflated, thus determining a position of the device (Par. 0046-47 of Obermiller).
In regards to claim 2, the combined teachings of Almedhychy and Obermiller disclose the circulatory support device of claim 1, further comprising: a capacitive material surrounding the cannula (Par. 0055 teaches there being capacitor elements); and a signal generator configured to impart an electromagnetic field surrounding the capacitive material (Par. 0035 of Obermiller teaches there being electrodes, i.e. signal generators, that can create an electromagnetic field)
In regards to claims 3 and 13, the combined teachings of Almedhychy and Obermiller disclose the circulatory support device of claim 2/12, wherein the at least one capacitive signal corresponds to at least one interference signal sensed when an object enters the electromagnetic field (Par. 0035 of Obermiller teaches that the signal can be if the expandable member is inflating, i.e. if it is in the field).
In regards to claims 5 and 15, the combined teachings of Almedhychy and Obermiller disclose the circulatory support device of claim 1/12, wherein the at least one controller is further configured to determine the position of the intracardiac blood pump based, at least in part, on a comparison of the at least one capacitive signal with plurality of stored signal representations (Par. 0073 of Almedhychy discloses comparing signals from the sensors to reference signals, i.e. stored signals, to determine the position).
In regards to claims 7 and 16, the combined teachings of Almedhychy and Obermiller disclose the circulatory support device of claim 1/12, wherein the at least one capacitive sensor comprises a plurality of capacitive sensors, each of which is configured to sense a respective capacitive signal, and the at least one controller is further configured to determine a position of the intracardiac blood pump in a patient based, at least in part, on the plurality of capacitive signals (Par. 0067-68 of Almedhychy discloses taking in multiple signals from multiple sensors to determine the positioning. The art of Obermiller teaches the use of capacitive sensors).
In regards to claims 8 and 17, the combined teachings of Almedhychy and Obermiller disclose the circulatory support device of claim 7/16, wherein the at least one controller is further configured to determine a position of the intracardiac blood pump in a patient based, at least in part, on the plurality of capacitive signals by: comparing each of the plurality of capacitive signals to a stored signal representation; and determining the position of the intracardiac blood pump based, at least in part, on the comparisons (Par. 0067-68 of Almedhychy discloses taking in multiple signals from multiple sensors to determine the positioning. Par. 0073 of Almedhychy discloses comparing signals from the sensors to reference signals, i.e. stored signals, to determine the position. The art of Obermiller teaches the use of capacitive sensors).
In regards to claims 9 and 18, the combined teachings of Almedhychy and Obermiller disclose the circulatory support device of claim 7/16, wherein the at least one controller is further configured to determine a position of the intracardiac blood pump in a patient based, at least in part, on the plurality of capacitive signals by: combining each of the plurality of capacitive signals to generate a combined signal; and determining the position of the intracardiac blood pump based, at least in part, on a comparison of the combined signal with plurality of stored signal representations (Par. 0068 of Almedhychy teaches taking in sensor data from the first sensor and then taking in sensor data from the second sensor and then comparing these combined signals to a reference signal, i.e. stored signa. The art of Obermiller teaches the sensors being capacitive sensors)
In regards to claims 10-11 and 19-20 the combined teachings of Almedhychy and Obermiller disclose the circulatory support device of claim 1, wherein the at least one controller is further configured to: determine based, at least in part, on the at least one capacitive signal, an anatomy type of a tissue proximal to the cannula, determine a position of the intracardiac blood pump in a patient based, at least in part, on the determined anatomy type. (Par. 0068 of Almedhychy teaches that the position of the blood pump is determined relative to the heart, i.e. the tissue anatomy).
3. Claim(s) 4 and 14, is/are rejected under 35 U.S.C. 103 as being unpatentable over Almedhychy and Obermiller, and in view of Timms (US 20200171224 A1)
In regards to claim 4 and 14, the combined teachings of Almedhychy and Obermiller disclose the circulatory support device of claim 3/13, except for it further comprising an analog-to- digital converter configured to transform the at least one interference signal to a digital signal,
wherein the at least one controller is further configured to determine the position of the intracardiac blood pump based, at least in part, on the digital signal.
However, in the same field of endeavor, Timms discloses a heart pump system (Abstract) wherein the system takes in interference signals and uses an analog to digital converter to condition the signals (Par. 0349) in order to determine interference with a hostile body environment (Par. 0349).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Almedhychy and Obermiller and modified them by having the system use an analog to digtical converter on the interference signal, as taught and suggested by Timms, in order to determine interference with a hostile body environment (Par. 0349 of Timms).
4. Claim(s) 6, is/are rejected under 35 U.S.C. 103 as being unpatentable over Almedhychy and Obermiller, and in view of Srinivasa (US 20150051468 A1)
In regards to claim 6, the combined teachings of Almedhychy and Obermiller disclose the circulatory support device of claim 1, except for it further comprising: a shielding material arranged adjacent to the at least one capacitive sensor.
However, in the same field of endeavor, Srinivasa teaches a capacitive sensing system (Abstract) wherein the sensing system comprises a shielding material around the capacitive sensor (Par. 0011) in order to make sure that the sensor field is concentrated in the correct direction (Par. 0011).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Almedhychy and Obermiller and modified them by having the system comprise a shielding material, as taught and suggested by Srinivasa, in order to make sure that the sensor field is concentrated in the correct direction (Par. 0011 of Srinivasa).
5. Claim(s) 1 and 12 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Almedhychy (US 20220184377 A1) in view of Dirksen (US 20220071506 A1).
In regards to claims 1 and 12, Almedhychy discloses a circulatory support device (Abstract and Par. 0002), comprising:
an intracardiac blood pump comprising an inlet, an outlet, and a cannula arranged between the inlet and the outlet (Par. 0025 teaches an intracardiac blood pump [100] with a cannula [110]. Fig 1 shows there being an inlet and outlet of the blood pump on either side of the cannula);
at least one sensor associated with the cannula (Par. 0054 teaches there being a sensor); and
at least one controller (Par. 0038 teaches the system comprising a controller [302]) configured to:
determine a position of the intracardiac blood pump in a patient based, at least in part, on at least one signal sensed by the at least one sensor (Par. 0055 teaches that the sensor data is used to determine if the blood pump is in the correct position); and
provide an indication of the position of the intracardiac blood pump on a user interface of the circulatory support device (Par. 0040 discloses that there is a display for showing information to the user).
While Almedhychy teaches using sensors for determining the position of the blood pump, they do not disclose wherein these sensors are capacitive. However, in the same field of endeavor, Dirksen discloses a mechanism for tracking the position of an interventional device (Abstract) wherein capacitive pressure sensing arrangements are placed on the device (Par. 0070) in order to determine if there is the presence of a narrowing anomaly such as a lesion or stenosis (Par. 0070).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Almedhychy and modified them by having capacitive pressure sensing arrangements placed on the device, as taught and suggested by Dirksen, in order to determine if there is the presence of a narrowing anomaly such as a lesion or stenosis (Par. 0070 of Dirksen).
Conclusion
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/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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