DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a continuation of US Application no. 17/103,283, now US Patent no. 11,944,799, filed 24 November 2020, which is a continuation of US Application no. 16/055,471, now US Patent no. 10,881,772, filed 6 August 2017, which is a continuation of US Application no. 15/785,097, now US Patent no. 10,086,122, filed 16 October 2017, which is a continuation of US Application no. 15/221,456, now US Patent no. 9,801,988, filed 27 July 2016, which is a continuation of US Application no. 14/592,630, now US Patent no. 9,433,717, filed 8 January 2015, which is a continuation of US Application no. 14/261,817, now US Patent no. 8,961,388, filed 25 April 2014, which is a continuation of US Application no. 13/926,044, now US Patent no. 9,011,312, filed 25 June 2013, which is a division of US Application no. 13/241,831, now US Patent no. 8,506,471, filed 23 September 2011, which receives the benefit of priority from US Provisional Application no. 61/386,018, filed 24 September 2010.
Response to Amendment
The preliminary amendment filed 14 May 2024 has been acknowledged. Claims 2-21 are pending, wherein claims 2-21 are new.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 2-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,944,799. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘799 patent recite limitations render obvious the limitations of the present claims. The limitations in conflict are described below:
Claim 2 of the present invention:
A mechanical circulatory assist system comprising:
a blood pump comprising a centrifugal rotor configured to be rotated at a rotational speed to generate a centrifugal flow, wherein the blood pump is adapted to pump blood from the left ventricle of a patient to the aorta of the patient; and
a controller comprising a sensor and a processor, wherein the sensor generates a signal indicative of a power consumption of the blood pump, wherein the controller is operatively connected to the blood pump and configured to operate the blood pump in an artificial pulse mode comprising:
(a) rotating the centrifugal rotor at a first speed in a first segment for a first segment duration;
(b) reducing the rotational speed of the centrifugal rotor from the first speed to a second speed;
(c) rotating the centrifugal rotor at the second speed in a second segment for a second segment duration; and
(d) repeating (a) through (c),
wherein each of the first segments is synchronized with a respective relaxation of the left ventricle, and
wherein the processor is configured to detect, based on the rotational speed of the centrifugal rotor and the power consumption of the blood pump, relaxations of the left ventricle.
Claim 1 in view of claims 4 and 9 of the ‘799 patent:
A mechanical circulatory assist system comprising: a continuous-flow pump comprising a centrifugal rotor configured to generate a centrifugal flow, wherein the continuous-flow pump is adapted to pump blood from a left ventricle of a heart of a patient to an aorta of the patient to assist blood flow from the left ventricle to the aorta; and
a controller comprising a sensor that generates a signal indicative of a power consumption of the continuous-flow pump, wherein the controller is operatively connected to the continuous-flow pump and configured to operate the continuous-flow pump in an artificial pulse mode comprising recurring changes in a rotational speed of the continuous-flow pump, wherein at least one of the recurring changes in the rotational speed of the continuous-flow pump are synchronized-in synchronization with contractions of the left ventricle, wherein the controller comprising a processor configured to detect, based on a speed of the continuous-flow pump and the power consumption of the continuous-flow pump, the contractions of the left ventricle.
4. (Previously Presented) The mechanical circulatory assist system of claim 3, wherein the artificial pulse mode comprises:
(a) operating the continuous-flow pump at a first speed for a first speed duration;
(b) reducing the speed of the continuous-flow pump from the first speed to a second speed;
(c) operating the continuous-flow pump at the second speed for a second speed duration;
(d) reducing the speed of the continuous-flow pump from the second speed to a third speed;
(e) operating the continuous-flow pump at the third speed for a third speed duration; and repeating steps (a) through (e).
9. (Original) The mechanical circulatory assist system of claim 4, wherein the controller operates the continuous-flow pump at the first speed during relaxation of the left ventricle.
In these claims, the presently recited “blood pump” is considered read on by the narrower limitation of a “continuous flow pump” recited in claim 1 of the ‘799 patent. The present claims also operate in the same manner to provide the artificial pulse comprising steps (a)-(c) which are performed by the ‘799 patent. Where the claims differ is with respect to the synchronization and configuration of the processor to regulate the speed of the pump with respect to the left ventricle. The present claim synchronizes and configures the pump speed with respect to the relaxation of the left ventricle, whereas the ‘799 does so with respect to the contractions of the left ventricle. However, claim 9 of the ‘799 recites this aspect. Claim 9 of the ‘799 patent recites that the controller controls the pump speed based on the relaxation of the ventricle which then is construed to suggest that the controller and processor of the pump must necessarily also synchronize the pump to the relaxation phase of the left ventricle and to control the speed to the relaxation phase. In this manner, the present invention is considered to comprise an obvious combination of limitations claimed in the ‘799 patent.
Claim 12 of the present invention:
A method of controlling a blood pump, the method comprising:
generating, by a sensor, a signal indicative of indicative of a power consumption of the blood pump comprising a centrifugal rotor configured to generate a centrifugal flow, wherein the blood pump receives a blood flow from the left ventricle of a patient and pumps the blood flow to the aorta of the patient;
detecting, by a controller based on a speed of the blood pump and the power consumption of the blood pump, relaxations of the left ventricle; and
controlling, by the controller, the speed of the blood pump to operate in an artificial pulse mode that produces a pulsatile blood flow, wherein the artificial pulse mode comprises:
(a) rotating the centrifugal rotor at a first speed in a first segment for a first segment duration;
(b) reducing a rotational speed of the centrifugal rotor from the first speed to a second speed;
(c) rotating the centrifugal rotor at the second speed in a second segment for a second segment duration; and
(d) repeating (a) through (c),
wherein at least one of the first segments and the second segments are synchronized with respective relaxations of the left ventricle.
Claim 11 in view of claims 14 and 19 of the ‘799 patent:
A method of controlling a continuous-flow ventricular assist device, the method comprising: generating, by a sensor, a signal indicative of indicative of a power consumption of a continuous-flow ventricular assist device comprising a centrifugal rotor configured to generate a centrifugal flow, wherein the continuous-flow ventricular assist device receives blood from a ventricle of a heart of a patient and pumps the blood to an aorta of the patient to assist blood flow from the ventricle to the aorta; detecting, by a controller based on a speed of the continuous-flow ventricular assist device and the power consumption of the continuous-flow ventricular assist device, contractions of the ventricle; and
controlling, by the controller, the speed of the continuous-flow ventricular assist device to operate in an artificial pulse mode that produces a pulsatile blood flow, wherein the artificial pulse mode comprises recurring changes in a rotational speed of the continuous-flow ventricular assist device, and wherein at least one of the recurring changes in the rotational speed of the continuous-flow ventricular assist device are synchronized-in synchronization with the contractions of the ventricle.
4. (Previously Presented) The method of claim 11, wherein the artificial pulse mode comprises:
(a) operating the continuous-flow pump at a first speed for a first speed duration;
(b) reducing the speed of the continuous-flow pump from the first speed to a second speed;
(c) operating the continuous-flow pump at the second speed for a second speed duration;
(d) reducing the speed of the continuous-flow pump from the second speed to a third speed;
(e) operating the continuous-flow pump at the third speed for a third speed duration; and repeating steps (a) through (e).
9. (Original) The method of claim 14, wherein the controller operates the continuous-flow pump at the first speed during relaxation of the left ventricle.
In these claims, the presently recited “blood pump” is considered read on by the narrower limitation of a “continuous flow ventricular assist device” recited in claim 11 of the ‘799 patent. The present claims also operate in the same manner to provide the artificial pulse comprising steps (a)-(c) which are performed by the ‘799 patent. Where the claims differ is with respect to the synchronization and configuration of the processor to regulate the speed of the pump with respect to the left ventricle. The present claim synchronizes and configures the pump speed with respect to the relaxation of the left ventricle, whereas the ‘799 does so with respect to the contractions of the left ventricle. However, claim 19 of the ‘799 recites this aspect. Claim 19 of the ‘799 patent recites that the controller controls the pump speed based on the relaxation of the ventricle which then is construed to suggest that the controller and processor of the pump must necessarily also synchronize the pump to the relaxation phase of the left ventricle and to control the speed to the relaxation phase. In this manner, the present invention is considered to comprise an obvious combination of limitations claimed in the ‘799 patent.
Allowable Subject Matter
Claims 1-19 would be allowable should Applicant’s reply comply with or specifically traverse the requirements of the double patenting rejection set forth above.
Claims 20 and 21 are allowed.
The following is an examiner’s statement of reasons for allowance: the prior art fails to teach operation of the pump in the manner of steps (a)-(c) synchronized with the relaxation with the left ventricle.
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 BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 12 May 2026
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