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
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 46-47, 49, 52-53, 56, 64-66, 68-70, and 72-75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen (US 2020/0023112 A1) in view of Salo (US 6044298), further in view of Pianca (US 6466821 B1).
Regarding claim 46, Hansen discloses a blood circulation assist system, comprising: a ventricular assist device (VAD) comprising an inlet, an outlet, an impeller, and a motor stator operable to rotate the impeller to pump a blood flow (eg. Abstract, Fig. 3-4, Para. 40-45), wherein the inlet is configured for coupling with a ventricle of a patient to receive the blood flow from the ventricle (eg. Para. 38), wherein the outlet is configured for coupling with a blood vessel of the patient to transfer the blood flow to the blood vessel (eg. Para. 41, 43, 52); and a controller configured to process a accelerometer output indicative of accelerations of the patient at a accelerometer location and control a rotation speed of the impeller based on the accelerometer output (eg. Para. 6-14, 54-58, 62, 76); and a accelerometer configured to generate the accelerometer output (eg. Para. 6-14, 54-58, 62, 76, accelerometer inherently outputs a reading), Hansen does not specifically disclose the remote accelerometer is configured to be implanted in the patient at the remote accelerometer location, and wherein the remote accelerometer location is separated from the VAD to isolate the remote accelerometer from noise generated by the VAD.
Salo teaches an accelerometer incorporated into an implantable cardiac device that can be worn at a user’s pectoral region (eg. Col. 5, Ln. 5-34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Hansen with a separated accelerometer location as taught by Salo to provide the predictable result of providing a cleaner signal by filtering out non-cardiac noise (eg. Salo, Col. 1, Ln. 40 – Col. 2, Ln. 40).
Pianca teaches a multi-axis accelerometer for determining patient activity and body position (eg. Col. 2, Ln. 40-67, Col. 2, Ln. 49-62, Col. 4, Ln. 63 – Col. 5, Ln. 55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Hansen and Salo with the multi-axis accelerometer that can determine activity and posture for better compensation and using multi-axis accelerometers for determining activity and posture are well-known in the art.
Regarding claim 47, the combined invention of Hansen, Salo, and Pianca discloses the remote accelerometer is configured for implantation in a pectoral region of the patient or abdominal wall region of the patient (eg, Salo, Col. 5, Ln. 5-35).
Regarding claim 49, the combined invention of Hansen, Salo, and Pianca discloses the controller is configured to: process the remote accelerometer output to determine a heart rate of the patient; and control the rotation speed of the impeller based on the heart rate (eg. Hansen, Para. 74 and 82).
Regarding claim 52, the combined invention of Hansen, Salo, and Pianca discloses the controller is configured to process the remote accelerometer output to determine a respiration rate of the patient (Eg. Hansen, Para. 14, 18, 56).
Regarding claim 53, the combined invention of Hansen, Salo, and Pianca discloses the controller is configured to process the remote accelerometer output to monitor for an occurrence of pump thrombosis in the VAD, an occurrence of an occlusion in the VAD,and/or an occurrence of an instability of the impeller (eg. Hansen, Para. 21, 73, vibrations of the impeller).
Regarding claim 56, the combined invention of Hansen, Salo, and Pianca discloses the controller is configured to process the remote accelerometer output to monitor an orientation of the patient (Eg. Hansen, Para. 14, 18, 53, 58, 65).
Regarding claim 64, the combined invention of Hansen, Salo, and Pianca discloses the controller is configured to process the remote accelerometer output to determine whether the patient is active or at rest (eg. Hansen, Para. 5, 13-14, 56-58, 76-77).
Regarding claim 65, the combined invention of Hansen, Salo, and Pianca discloses the controller is configured to process the remote accelerometer output to determine a wellness indicator for the patient (Eg. Hansen, Para. 5, 69, activity, health issues, etc.).
Regarding claim 66, the combined invention of Hansen, Salo, and Pianca discloses the controller is configured to process the remote accelerometer output to detect a cardiac cycle timing of the patient; the cardiac cycle timing comprises a heart rate and a time of occurrence for each of one or more cardiac cycle events; and the controller is configured to vary the rotation speed of the impeller in sync with the cardiac cycle timing (eg. Hansen, Para. 7, 79-83).
Regarding claim 68, the combined invention of Hansen, Salo, and Pianca discloses the controller is configured to: process the remote accelerometer output to detect a time of occurrence of at least one heart sound; and detect the cardiac cycle timing based on the time of occurrence of the at least one heart sound (eg. Hansen, Para. 9, 56, 70-71, 80).
Regarding claim 69, the combined invention of Hansen, Salo, and Pianca discloses the at least one heart sound comprises: a sound of closure of at least one atrioventricular valve of the patient; and/or a sound of closure of at least one semilunar valve of the patient (eg. Hansen, Para. 9, 56, 70-71, 80).
Regarding claim 70, the combined invention of Hansen, Salo, and Pianca discloses the controller is configured to vary the rotation speed of the impeller over a target cardiac cycle based on detected timing of one or more cardiac cycles that occur prior to the target cardiac cycle and/or the detected timing of the target cardiac cycle (eg. Hansen, Para. 10-12, claims 2-3).
Regarding claim 72 and 74, the combined invention of Hansen, Salo, and Pianca discloses the controller is configured to: process the remote accelerometer output to measure an activity level of the patient; and control the rotation speed of the impeller based on the activity level (eg. Hansen, Para. 13, 56-58, 76claim 13).
Regarding claims 73 and 75, the combined invention of Hansen, Salo, and Pianca discloses the controller is configured to process the remote accelerometer output to measure a respiration rate for the patient and/or a diaphragm contraction for the patient, and base the activity level on the respiration rate and/or the diaphragm contraction (eg. Hansen, Para. 14, 18, 56-58, 77, 90, 94).
Claim(s) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen (US 2020/0023112 A1) in view of Salo (US 6044298), further in view of Pianca (US 6466821 B1), further in view of Strimling (US 4512726)
Regarding claim 48, the combined invention of Hansen, Salo, and Pianca discloses the invention of claim 1, but does not disclose the VAD further comprises power transistors that are used to control supply of electrical currents to windings of the motor stator; and the remote accelerometer location is separated from the VAD to isolate the remote accelerometer from electrical switching noise generated by the power transistors.
Strimling teaches an artificial heart device with a stator that uses power switching circuitry using transistors (eg. Fig. 11, Col. 6, Ln. 32 – Col. 7, LN. 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Hansen, Salo, and Pianca with the power transistors as taught by Strimling since transisitors are well-known in the art for power switching. Furthermore, the accelerometer is already separate based on the above cited prior art such as Salo (eg. Col. 5, Ln. 5-34). The limitation of isolation of noise is written as intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim(s) 50-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen (US 2020/0023112 A1) in view of Salo (US 6044298), further in view of Pianca (US 6466821 B1), further in view of Harjes (US 2021/0121617 A1).
Regarding claim 50, the combined invention of Hansen, Salo, and Pianca discloses the invention of claim 46 but does not disclose the controller is configured to process the remote accelerometer output to determine a valve opening timing of the patient.
Harjes teaches an accelerometer based heart sound detection system that detects a degree of valve opening and diagnose valvular disorders such as regurgitation or stenosis (eg. Para. 52, 55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Hansen, Salo, and Pianca with the Harjes since Hansen already teaches detecting valves closing and identifying the degree of valve opening would provide the predictable result of detecting valvular disorders (eg. Para. 52).
Regarding claim 51, the combined invention of Hansen, Salo, Pianca, and Harjes discloses the controller is configured to process the remote accelerometer output to monitor for a valve disorder of the patient (eg. Harjes, Para. 52).
Claim(s) 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen (US 2020/0023112 A1) in view of Salo (US 6044298), further in view of Pianca (US 6466821 B1), further in view of Scholten (US 8814811 B2).
Regarding claim 62, the combined invention of Hansen, Salo, and Pianca discloses the invention of claim 46, but does not disclose the controller is configured to process the remote accelerometer output to monitor for a fall of the patient.
Scholten teaches a medical device with a three-axis accelerometer to detect that a patient has fallen (eg. Abstract, Col. 1, Ln. 55 – Col. 3, Ln. 50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Hansen, Salo, and Pianca with the fall detection as taught by Scholten since fall detection using accelerometers is well-known in the art.
Conclusion
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/MICHAEL J LAU/Examiner, Art Unit 3796
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