DETAILED ACTION
The Examiner acknowledges the amendments received 08 June 2026. New claims 21-22 are entered; claims 1-22 are pending.
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 .
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 08 June 2026, with respect to the rejection(s) of claim(s) 1-20 under Halvorsen, Yomtov, Ross, Pham, and Wariar have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yu and Gohean.
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.
Claims 1-11, 15, 17, 19 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al (U.S. 2016/0235899) in view of Gohean et al (U.S. 2010/0268333). Yu discloses a ventricular assist device (VAD) (par. 0057) comprising a housing (Fig. 1-2) defining a blood flow conduit (par. 0053), an impeller (par. 0055) disposed within the blood flow conduit, a motor stator (par. 0059) operable to rotate the impeller, and an accelerometer (par. 0077) disposed within the housing, wherein the housing comprises an inlet cannula and is configured to be coupled to a heart of a patient to receive blood into the inlet cannula from a ventricle of the heart and pump the blood to a blood vessel of the patient, and wherein the accelerometer is configured to generate an accelerometer output indicative of accelerations of the VAD; and a controller (15) operatively coupled with the VAD, wherein the controller is configured to process the accelerometer output.
Yu discloses the claimed invention except for a controller configured to detect and/or measure one or more of heart wall motions of the patient, heart sounds of the patient, or diaphragm contractions of the patient; generate patient monitoring data for the patient based on the one or more of heart wall motions of the patient, heart sounds of the patient, or diaphragm contractions of the patient; and output the patient monitoring data. Gohean, however, discloses (par. 0015 and 0045) an accelerometer for sensing at least “heart contraction and diaphragm motion”. Gohean and Yu both disclose VADs (par. 0024 of Gohean) controlled by sensed patient data. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yu’s impeller pump system with Gohean’s sensed heart wall motions and diaphragm contractions in order to provide a more tailored treatment for acute patient needs.
Regarding claim 2, Yu discloses (par. 0058) the controller is configured to be implanted within the patient.
Regarding claim 3, Yu discloses (par. 0058) the controller is configured to transmit the patient monitoring data to an external device.
Regarding claim 4, Yu discloses (par. 0058) the controller is configured as an external system controller.
Regarding claim 5, Yu discloses (par. 0053) a percutaneous driveline via which the controller is operatively coupled with the VAD.
Regarding claim 6, Yu discloses (Fig. 1-2) the VAD comprises control electronics disposed within the housing; the control electronics are configured to control drive currents supplied to the motor stator to control magnetic levitation and/or rotation of the impeller (par. 0020-0021); and the control electronics comprise the accelerometer.
Regarding claim 7, Yu discloses (par. 0061) the controller is configured to generate the patient monitoring data further based on operational parameters of the VAD; and the operational parameters of the VAD comprise at least a rotational speed of the impeller.
Regarding claim 8, Yu discloses (par. 0050) the patient monitoring data comprises orientations of the patient.
Regarding claim 9, it would have been obvious to take a running average since it would provide the predictable result of smoothing out the orientations so that the device would not adjust abruptly and harm the patient
Regarding claim 10, Gohean discloses (par. 0194) the patient monitoring data comprises acceleration-based activity levels of the patient.
Regarding claim 11, Gohean discloses (par. 0015) the patient monitoring data comprises heart wall motions of the patient.
Regarding claim 15, Gohean discloses (par. 0015) the patient monitoring data comprises diaphragm contractions of the patient.
Regarding claim 17, Yu discloses (par. 0079-0080) the controller is further configured to process the accelerometer output to generate VAD monitoring data for the VAD and output the VAD monitoring data.
Regarding claim 19, Yu discloses (par. 0070) the VAD monitoring data is indicative of whether a suction event has occurred during an acquisition time period for the VAD monitoring data.
Regarding claim 21, Yu discloses (par. 0057) a ventricular assist device (VAD) comprising a housing (Fig. 1-2) defining a blood flow conduit (par. 0053), an impeller (par. 0055) disposed within the blood flow conduit, a motor stator (par. 0059) operable to rotate the impeller, and an accelerometer (par. 0077), wherein the housing comprises an inlet cannula and is configured to be coupled to a heart of a patient to receive blood into the inlet cannula from a ventricle of the heart and pump the blood to a blood vessel of the patient, and wherein the accelerometer is configured to generate an accelerometer output indicative of accelerations of the VAD; and a controller (15) operatively coupled with the VAD, wherein the controller is configured to: process the accelerometer output to measure accelerations of the VAD.
Yu discloses the claimed invention except for a controller configured to detect and/or measure one or more of heart wall motions of the patient, heart sounds of the patient, or diaphragm contractions of the patient; generate patient monitoring data for the patient based on the one or more of heart wall motions of the patient, heart sounds of the patient, or diaphragm contractions of the patient; and output the patient monitoring data. Gohean, however, discloses (par. 0015 and 0045) an accelerometer for sensing at least “heart contraction and diaphragm motion”. Gohean and Yu both disclose VADs (par. 0024 of Gohean) controlled by sensed patient data. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yu’s impeller pump system with Gohean’s sensed heart wall motions and diaphragm contractions in order to provide a more tailored treatment for acute patient needs.
Regarding claim 22, Yu discloses (par. 0057) a ventricular assist device (VAD) comprising a housing (Fig. 1-2) defining a blood flow conduit (par. 0053), an impeller (par. 0055) disposed within the blood flow conduit, a motor stator (par. 0059) operable to rotate the impeller (par. 0077) , and an accelerometer, wherein the housing comprises an inlet cannula and is configured to be coupled to a heart of a patient to receive blood into the inlet cannula from a ventricle of the heart and pump the blood to a blood vessel of the patient, and wherein the accelerometer is configured to generate an accelerometer output indicative of accelerations of the VAD; a system monitor (par. 0079); and a controller (15) operatively coupled with the VAD, wherein the controller comprises a processor and a memory device (par. 0047) that stores non-transient instructions executable by the processor to: process the accelerometer output to measure accelerations of the VAD.
Yu discloses the claimed invention except for a controller configured to detect and/or measure one or more of heart wall motions of the patient, heart sounds of the patient, or diaphragm contractions of the patient; generate patient monitoring data for the patient based on the one or more of heart wall motions of the patient, heart sounds of the patient, or diaphragm contractions of the patient; and output the patient monitoring data. Gohean, however, discloses (par. 0015 and 0045) an accelerometer for sensing at least “heart contraction and diaphragm motion”. Gohean and Yu both disclose VADs (par. 0024 of Gohean) controlled by sensed patient data. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yu’s impeller pump system with Gohean’s sensed heart wall motions and diaphragm contractions in order to provide a more tailored treatment for acute patient needs.
Claims 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al (U.S. 2016/0235899) in view of Gohean et al (U.S. 2010/0268333), in further view of Halvorsen et al (U.S. 2017/0049945). Yu and Gohean disclose the claimed invention except for monitoring heart sounds of the patient. Halvorsen, however, discloses (Fig. 1, pump 6) a VAD that measures (par. 0073) heart sounds. Yu, Gohean, and Halvorsen all disclose VADs including rotational control and motor stators for providing control of blood flow based on patient needs. Therefore, it would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to modify Yu and Gohean’s blood pump control using cardiac wall or diaphragm movement with Halvorsen’s heart sounds monitoring in order “to detect regional myocardial ischemia during coronary artery occlusion, but also to detect changes in global heart function (as illustrated in FIGS. 4a and 4 b, which show a signal analysis for an accelerometer signal obtained during adrenaline infusion)” (par. 0073 of Halvorsen).
Regarding claim 18, Halvorsen discloses (par. 0015) the VAD monitoring data is indicative of vibrations of the impeller.
Claims 13, 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al (U.S. 2016/0235899) in view of Gohean et al (U.S. 2010/0268333) and Halvorsen et al (U.S. 2017/0049945), and further in view of Pham et al (2019/0167897). Yu, Gohean, and Halvorsen disclose the claimed invention except for the controller is configured to process the accelerometer output using a band-pass filter to isolate accelerations due to the heart sounds of the patient, to isolate accelerations due to the diaphragm contractions of the patient, or as part of generating the VAD monitoring data. Pham, however, teaches using a band pass filter to extract different pump parameters, see at least par. 0049. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the band pass filter of Pham since it would help reveal important information about the pump in a predictable manner).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Yu et al (U.S. 2016/0235899) in view of Gohean et al (U.S. 2010/0268333) and Halvorsen et al (U.S. 2017/0049945), and further in view of Wariar et al (2015/0073203). Yu, Gohean and Halvorsen disclose the claimed invention except for the controller is configured to process the heart sounds to monitor for occurrence of aortic insufficiency. Wariar, however, teaches (par. 0040) monitoring murmur for aortic insufficiency. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to monitor for aortic insufficiency so that alterations can be made to the pump to correct any adverse condition.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12,14,15,17-19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,241,570 in view of Ross et al (2006/0036126). Re claim 1, patent claim 1 includes all of the subject matter except for a controller outputting monitoring data. Ross teaches an external system 150, including a controller 256. It would have been obvious to provide the bidirectional communication capability of Ross with the controller of claim 1 of the ‘570 patent since it would allow for monitoring of the patient, as taught in at least ¶50 of Ross. Re claim 2, see patent claim 13. Re claim 3, see comments above re Ross. Re claim 4, see patent claim 14. Re claim 5, see patent claim 5 where it states that the controller and housing are operatively coupled together. Re claim 6, see patent claim 17. Re claim 7, see patent claim 12. Re claim 8, see patent claim 15. Re claim 9, see as mentioned supra, to take a running average would smooth out the differing orientations and make the pump work more smoothly. Re claim 10, see patent claim 1. Re claim 11, see patent claim 4. Re claim 12, see patent claim 4. Re claim 14, see patent claim 5. Re claim 15, see patent claim 10. Re claim 17, see patent claims 1,16. Re claim 18, see patent claim 17. Re claim 19, see patent claim 18.
Claims 13,16,20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,241,570 in view of Ross et al (2006/0036126) and Pham et al (2019/0167897).
Re claims 13,16,20, see patent claim, 1,16. Further, the patent claims are silent as to a band pass filter. Pham teaches using a band pass filter to extract different pump parameters, see at least ¶49. It would have been obvious to use the band pass filter of Pham since it would help reveal important information re the pump in a predictable manner.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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