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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/11/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 28 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 28:
lines 9-13 recite “wherein the implantable TETS receiver comprises a TETS receiver housing and a first electrocardiogram electrode that forms a portion of an exterior surface of the implantable TETS receiver”.
lines16-17 recite “an implantable controller having an implantable controller exterior surface and comprising a second electrocardiogram electrode”.
lines 18-19 recite “wherein the first electrocardiogram electrode forms a portion of the implantable controller exterior surface.”
This language is unclear. In lines 9-13 there is a TETS receiver housing and an exterior surface of the TETS receiver, it is unclear if this is the same or a different component. Lines 18-19 further recite that the first ECG electrode is on the implantable controller exterior surface. This language is unclear because it is ambiguous as to where the electrodes are actually located, particularly the first electrode. The first electrode cannot be on both the exterior surface of the TETS receiver housing and the exterior surface of the implantable controller exterior surface unless the TETS receiver and the controller are housed in the same housing. For the purposes of expedited examination, and based on the indefiniteness of the claim, it will be assumed that the TETS and the controller are housed together.
Response to Arguments
Applicant’s arguments, see Applicants Response, filed 2/11/2026, with respect to the rejections under Yomtov US 2017/0087289 in view of Cabelka et al. US 2014/00088656 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 Yomtov et al. US 2017/0072121 and Hess et al. US 2021/0187309.
Specifically regarding the arguments presented:
Applicant argues, on page 11, that Yomtov does not disclose ECG electrodes forming a portion of an exterior surface, this was covered by the secondary reference of Cabelka (see Cabelka figure 1). Cabelka teaches of electrodes 28, figure 1, which are positioned on the housing.
Applicant further argues that the signal processing circuitry of Yomtov is not configured to convert wirelessly transmitted electrical power to an output electrical power. In response, Yomtov discloses that an internal battery within the implant (“implantable power source”) is charged from an external power source (paragraph 0004) which occurs via inductive coupling (paragraph 0019). The pump drive circuit applies the power to the pump (paragraph 0019). It is common in the art for the power from an external charger to require some internal processing by the internal device in order to condition and rectify the power. However, Yomtov ‘289 does not discuss how the inductive charging works. In response to these claim amendments Yomtov ‘121 teaches of a similar system, to the same inventor and clearly in the same field of endeavor. Yomtov ‘121 teaches of a TET system (abstract) which includes external module 110 (figure 1), and internal module 120 (figure 1). The external module includes circuitry 116 and primary coil 114 and the internal module includes internal circuitry 126 and secondary coil 124 (figure 1). Yomtov ‘121 further teaches that the TET receiver 226 (figure 2) includes rectifier circuitry for converting electrical energy at the secondary coil into direct current (paragraph 0021). Yomtov ‘121 further teaches of wire connections (“power cables”, paragraph 0019) between the TET module 120 and the blood pump 102 and a separate wire connection to the implanted battery 128 (figure 1).
The arguments presented on page 12, second paragraph state “Likewise, Yomtov in view of Cabelka fails to discloser or suggest the implantable cardiac monitor with integrated electrocardiogram electrodes (as recited in claim 24) or the combination of a TETS receiver with a first electrocardiogram electrode and an implantable controller with a second electrocardiogram electrode (as recited in claim 28)”. As discussed above, Cabelka teaches of electrodes 28, figure 1, which are positioned on the housing. Hess further teaches of a TETS system (title and abstract) with the implanted system including three separate devices 50 (figure 3) is the coil which is connected to the internal circuitry 52 (figure 3) and the internal circuitry 52 is also connected to a VAD 20 (paragraph 0023). Hess teaches that the internal coil, power source, transceiver and controller can all be in the same housing (paragraph 0019) or they can each be in separate housing (paragraph 0046). The distinction of electrodes on a housing is not considered novel in light of the fact that this appears to be an arrangement of parts as to where to locate the ECG electrodes, applying them to a housing is taught in Cabelka, and having separate or combined housings is found in Hess. Having the ECG electrodes on any of the housings would not yield unexpected results.
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.
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.
Claims 1-2, 7, 9-18, 24 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Yomtov US 2017/0087289 previously recited herein Yomtov ‘289 in view of Yomtov et al. US 2017/0072121 herein Yomtov ‘121 in view of Hess et al. US 2021/00187309 and further in view of Cabelka et al. US 2014/00088656 previously recited.
Regarding claims 1, 24 and 28: Yomtov ‘289 discloses a circulatory support system (figure 1, the system includes a pump 2, pump drive 6 and signal processing circuitry 23 in figure 1); the system comprises:
a ventricular assist device 2 (“pump”, figure 1) which pumps blood from a ventricle of a heart to an artery to supplement pumping of blood by the ventricle to the artery (paragraphs 0007 and 0016);
an implanted telemetry system 16 (figure 1), Yomtov discloses that an internal battery within the implant (“implantable power source”, 0006) is charged from an external power source (paragraph 0004) which occurs via inductive coupling (paragraph 0019 this is considered to be transcutaneous energy transfer TET); the implanted electronics 22 (figure 5) includes ECG electrodes 30/32/34/36 (figure 5) configured to generate an ECG signal (the pump driver also includes a drive circuit, paragraph 0021, and the battery paragraph 0018);
an implantable controller comprising a processor 15 (figure 1) which includes tangible memory (figure 1), the memory stores instructions (“algorithms”, paragraph 0020) which cause the processor to: a controller comprising a processor 15 (figure 1) which includes tangible memory (figure 1), the memory stores instructions (“algorithms”, paragraph 0020) which cause the processor to:
process ECG signals to determine physiological parameters which are indicative of cardiac cycle timing; determine operating parameters for the VAD based on the physiological parameters and control operation of the VAD in accordance with the operating parameters (figure 6 is a flow diagram, the beat detection at 102 is based on the ECG signal, once the beat is determined the ST segment, considered to be timing, is determined and the device enters either ischemia mode, normal sinus rhythm mode or myocardial infarction mode. Each mode specifies a pump speed, see paragraphs 0008-0009, 0018-0019, 0025, 0027-0028).
However, Yomtov ‘289 is silent as to the TETS system including a receiver with a housing and the receiver configured to convert wirelessly transmitted electrical power to output electrical power, a first cable connecting the TETS receiver to the implanted controller to output power from the TETS to the implant controller and a second electrical cable connecting the implantable controller to the VAD.
Yomtov ‘121 however teaches of a similar device which includes a TET system 100 (figure 1), the TET system 100 (figure 1) includes external circuitry 116 (figure 1) and primary power coil 114 (figure 1) and the internal system includes internal module 120 (figure 1) housing the secondary power coil 124 (figure 1) and internal circuitry 126 (figure 1), an implant 102 (figure 1) disclosed as a VAD (paragraph 0018) and an implanted battery 128 (figure 1). The power cables (paragraph 0019) connect the internal module to the implant 102 (figure 1) and a separate power cable connects the internal module 120 to the implanted battery 128 (figure 1). Yomtov ‘121 further teaches that TET receiver 226 (figure 4) includes rectifiers and filters for converting energy received at the secondary coil from AC to DC (paragraph 0041). Yomtov ‘121 further teaches that the TET receiver 226 not only converts the electrical energy received from AC to DC it also outputs power from the TET to the microcontroller and the implantable battery (paragraph 0021). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Yomtov ‘289 to include the TET system operative to convert wirelessly received power transmitted transcutaneous into output power to power the controller as well as the pump as well as cables operably connecting the TETs to the implant controller and the VAD, as taught by Yomtov ‘121, in order to wirelessly power the implanted devices.
Yomtov ‘289/ Yomtov ‘121 therefore discloses the claimed invention however Yomtov ‘289/ Yomtov ‘121 does not disclose that the TETS receiver and implant controller can be within the same housing. It is noted that the claim language is broadly interpreted to include the TETS and implant controller within the same housing. Hess however, teaches of a similar device with a TETs (abstract, title). Hess teaches of three implanted components 50/52/53 (figure 3). The first component 50 (figure 3) includes the secondary/internal coil 16 (figure 1), a cable 54 (figure 3) connects the secondary coil 50 to the internal circuitry 52 (figure 3) and cable 56 (figure 3) connects the internal circuitry 52 (figure 3) to the pump 20 (figure 3). Hess further teaches that the components can all be housed within the same housing or separate housings (paragraphs 0019 and 0046).
Yomtov ‘289/ Yomtov ‘121/Hess therefore discloses the claimed invention including the implanted components housed separately or together. However Yomtov ‘289/ Yomtov ‘121/Hess does not specifically disclose electrodes on the housing of the TETs for sensing ECG signals. It is noted that Yomtov ‘289 discloses the use of ECG electrodes 30/32/34/36 (figure 5) which are contained on leads to obtain ECG signals to supply a feedback signal to operate the pump (paragraph 0026). Cabelka however teaches of an implanted device 14 (figure 1) which includes recharging circuitry (similar to TETs circuitry, paragraph 00447) and electrodes 28 (figures 1-3) which are formed on the exterior surface of the implanted device housing (paragraphs 0028-0029) to form orthogonal signal vectors (paragraph 0027). Cabelka further teaches that the internal circuitry includes software, firmware and hardware to monitor ECG (paragraph 0030, 0033). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Yomtov ‘289/ Yomtov ‘121/Hess which includes a singular housing for the circuitry and TETs to include ECG electrodes on the surface of an implanted module which houses the circuitry, as taught by Cabelka, in order to subcutaneously monitor ECG signals.
Regarding claim 2: Yomtov’ 298 discloses that the operating parameter comprises a reference rotational speed 218 (figure 6, the normal sinus rhythm mode is considered to be the reference rotational speed, see paragraph 0034).
Regarding claim 7: Yomtov’ 298 discloses a constant non-pulsatile speed which is a reference for ischemia (paragraphs 0009, 0027, 0049).
Regarding claim 9: Yomtov’ 298 discloses that the processor operates the VAD in a pulsatile mode (paragraphs 0009, 0027, 0042) in which rotational speed is varied based on physiological parameters (paragraphs 0008-0009, 0018-0019, 0027-0028).
Regarding claim 10: Yomtov’ 298 discloses that the rotational speed is synchronized with the cardiac cycle (abstract “a varying speed synchronized with the cardiac cycle” and paragraph 0028).
Regarding claims 11-12: Yomtov’ 298 discloses that the processor processes the ECG to identify a time occurrence of a reference point in a cardia cycle (“R-wave”) determine a delay time based on a heart rate and begin a next cycle of the repeating rotational speed profile at a point in time that the delay time from the time of occurrence of the reference point in the cardiac cycle of the heart (paragraphs 0037-0040), these parameters are inherently set by a medical professional.
Regarding claim 13: Yomtov’ 298 discloses that the processor determines a rotational speed variation amplitude for the repeating rotational speed profile (paragraph 0008); wherein the controller uses the rotational speed variation amplitude to control the operation of the VAD to maximum rotational speed greater than a minimum rotational speed (paragraphs 0009, 0027-28, figures 3 and 6).
Regarding claim 14: Yomtov’ 298 discloses the rotational speed variation amplitude is set to be equal to a first rotational speed variation amplitude at a first reference heart rate; the rotational speed variation amplitude is set to be equal to a second rotational speed variation amplitude at a second reference heart rate; the second rotational speed variation amplitude is greater than the first rotational speed variation amplitude; and the second reference heart rate is greater than the first reference heart rate (paragraph 0038-40).
Regarding claims 15-16: Yomtov’ 298 inherently discloses a pressure pulse in that the VAD is acting as a cardiac replacement and when blood is pumped a pressure pulse will inherently occur. The speed is varied and synchronized with the cardiac cycle (paragraphs 0008, 0027-28) it is synchronized I the same manner each time and is therefore synchronized with systole and diastole.
Regarding claim 17: Yomtov’ 298 discloses determining a rotational speed-variation pulse amplitude for the repeating rotational speed profile, wherein the controller uses the rotational speed-variation pulse amplitude to control operation of the ventricular assist device so that a maximum rotational speed of the repeating rotational speed profile is greater than a minimum rotational speed of the repeating rotational speed profile by the rotational pulse amplitude (paragraphs 0008-0009, 0025, 0027-28 and figures 3 and 6).
Regarding claim 18: Yomtov’ 298 discloses the rotational speed pulse amplitude is set to be equal to a first rotational speed pulse amplitude at a first reference heart rate; the rotational speed pulse amplitude is set to be equal to a second rotational speed pulse amplitude at a second reference heart rate; the second rotational speed pulse amplitude is greater than the first rotational speed pulse amplitude; and the second reference heart rate is greater than the first reference heart rate (paragraphs 0008-0009, 0025, 0027-28, 0038, 0040 and figures 3 and 6.
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Yomtov US 2017/0087289 previously recited herein Yomtov ‘289 in view of Yomtov et al. US 2017/0072121 herein Yomtov ‘121 in view of Hess et al. US 2021/00187309 and further in view of Cabelka et al. US 2014/00088656 previously recited and further in view of Xu et al. US 2016/0263299 previously recited .
Regarding claim 3: Yomtov ‘289/ Yomtov ‘121/Hess/Cabelka discloses the claimed invention however Yomtov ‘289/ Yomtov ‘121/Hess/Cabelka does not specifically disclose a lookup table that stores rotational speeds associated with heart rates. Xu however teaches of a blood pump control system (title and abstract) which collects heart rate and adjusts the rotational speed based on heart rate with the use of a fixed correspondence relation table (paragraph 0047). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Yomtov ‘289/ Yomtov ‘121/Hess/Cabelka to include a lookup table that stores rotational speeds associated with heart rates, as taught by Xu, in order to adjust the blood pump rotational speed to assist in flow.
Regarding claim 5: Yomtov ‘289 discloses adjusting the rotational speed based on heart rate (paragraph 0025) this is inherently performed via software.
Regarding claims 4 and 6: Yomtov ‘289 discloses memory and algorithms stored in the memory, the physician programs the threshold which is considered to be the thresholds stored in memory and programmed by the physician (paragraph 0027, 0029 and 0032-33). It is considered inherent that when a physician is programming something they are programming into memory, in this case the physician is programming the ischemic and myocardial infarction modes of operation which include the thresholds at which ischemia and infarction occur as well as their associated rotational speeds upon detection.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Yomtov US 2017/0087289 previously recited herein Yomtov ‘289 in view of Yomtov et al. US 2017/0072121 herein Yomtov ‘121 in view of Hess et al. US 2021/00187309 and further in view of Cabelka et al. US 2014/00088656 previously recited and further in view of Tan et al. US 2020/0405929 previously cited.
Regarding claim 19: Yomtov ‘289/ Yomtov ‘121/Hess/Cabelka discloses the claimed invention including determine cardiac rhythm issues 218 (figure 6). However, Yomtov ‘289/ Yomtov ‘121/Hess/Cabelka does not specifically disclose an arrhythmia alarm. Tan however teaches of a similar device with an alarm when pacing is required (paragraph 0048), pacing is initiated based on arrhythmia (paragraph 0009). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Yomtov ‘289/ Yomtov ‘121/Hess/Cabelka to include an arrythmia alarm, as taught by Tan, in order to alert the user of a medical issue.
Claims 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yomtov US 2017/0087289 previously recited herein Yomtov ‘289 in view of Yomtov et al. US 2017/0072121 herein Yomtov ‘121 in view of Hess et al. US 2021/00187309 and further in view of Cabelka et al. US 2014/00088656 previously recited and further in view of Mohl et al. US 2016/0000983 previously cited
Regarding claims 8 and 20: Yomtov ‘289/ Yomtov ‘121/Hess/Cabelka discloses the claimed invention, however, Yomtov ‘289/ Yomtov ‘121/Hess/Cabelka is silent as to a second rotational speed which is higher than the first rotational speed. Mohl however teaches of increasing the rotational speed with increased heart rate and decreasing rotational speed with decreased heart rate (paragraphs 0032-0033), this demonstrates various speeds for various heart rates. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Yomtov ‘289/ Yomtov ‘121/Hess/Cabelka to include increasing or decreasing the speed of the pump based on patient activity, as taught by Mohl in order to compensate for differences in ejection period.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Yomtov US 2017/0087289 previously recited herein Yomtov ‘289 in view of Yomtov et al. US 2017/0072121 herein Yomtov ‘121 in view of Hess et al. US 2021/00187309 and further in view of Cabelka et al. US 2014/00088656 previously recited and further in view of Wariar et al. US 2015/0073203 previously cited and further in view of Burton US 2007/0032733 previously cited.
Regarding claim 21: Yomtov ‘289/ Yomtov ‘121/Hess/Cabelka discloses the claimed invention however Yomtov ‘289/ Yomtov ‘121/Hess/Cabelka does not specifically disclose using both respiration and heart rate to alter the speed of the pump. Wariar however teaches of using heart rate and respiration to set the final pump speed (paragraph 0064). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Yomtov ‘289/ Yomtov ‘121/Hess/Cabelka to include using both respiration and heart rate to alter the speed of the pump, as taught by Wariar, in order to control the speed to a garget speed to treat congestion. Yomtov ‘289/ Yomtov ‘121/Hess/Cabelka /Wariar disclose the claimed invention however Yomtov ‘289/ Yomtov ‘121/Hess/Cabelka /Wariar does not specifically disclose that the ECG signal is used to determine respiration. Burton however teaches of an ECG derived respiration (paragraph 0044). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Yomtov ‘289/ Yomtov ‘121/Hess/Cabelka /Wariar to include ECG derived respiration, as taught by Burton, in order to reduce the amount of sensors needed.
Conclusion
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
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