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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on [ 06/25/2026] and (02/11/2025) .The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) Claims 1, 5, 6, 10–14, and 17–21 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Burke (US 2012/0022645 A1).
Claims 1,14,19: Burke teaches a controller for a heart pump system that includes a first heart pump and a second heart pump, namely, a single, universal blood pump controller that provides simultaneous and independent control of two blood pumps arranged in a bi-ventricular (BiVAD) configuration .The controller includes a data interface (common signal interface 224 and communication interface) configured to receive first data and second data from the pumps, the microcontroller requesting power and flow measurements, actual blood pump speed, and operational/fault status for each blood pump control channel ([0027], lines 13-18). At least one processor is programed to display, by way of system display module and per-VAD status symbols indicating the operational state of each connected VAD, an indication of the first data in a first portion and an indication of the second data in a second portion of the user interface and to control an operation of the first and/or second heart pump by issuing control outputs that command the speed at which the VADs operate. Burke also teaches that the recited first heart pump placed in the left side and second heart pump placed in the right side of the heart ([0037]), and carries out the recited method steps of receiving the first and second data, displaying an indication of each in a respective portion of the user interface, and operating the controller to control an operation of the first and/or second pump during use (Par:004,005,0027,0028,0029,0037,0043,0061-64 Figs 1,2 ).
[AltContent: textbox (102: Blood pump controller
202: Blood pump controller
224:
Common signal interface
210: Status symbols/input keys
206: Microcontroller
208: Display module )]
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Claims 5,6,11,18,21: Burke teaches that the first and second data each include information describing the operation of the respective heart pump; power and flow measurements, actual blood pump speed, and operational fault status for each pump. Also, Burke teaches that controlling an operation comprises controlling a pump speed, the microcontroller commanding the speed(s) at which the VADs operate ;(Paragraph 0027, figure 2A).
Claim 10: Burke teaches that at least one control element status symbols and input keys configured to receive user input and, in response, to control an operation of the first and/or second heart pump, e.g., setting the speed at which the connected VADs operate; (Paragraphs 0029–0030).
Claims 11,12,17,20: Burke teaches multi-pump controller controls an operation of the first and second heart pump and that the pump speed is controlled based, at least in part, on the received data, the control logic calculating speeds for the two pumps from status and configuration information received from the pumps ;(Paragraph 0007).
Claim 13: Burke teaches the first heart pump configured to be placed in the left side of the heart (LVAD microcontroller 230, operating a VAD configured to assist the left ventricle) and the second heart pump configured to be placed in the right side of the heart (RVAD microcontroller 232, operating a VAD configured to assist the right ventricle); (Paragraph 0037, fig 2B).
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230: LVAD
232: RVAD
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 2–4, 7, 8, and 16 are rejected under 35 U.S.C. § 103 as being unpatentable over Burke (US2012/0022645 A1-hereinafter Burke) in view of El Katerji (US 11,581,083 B2-hereinafter ElKaterji).
Regarding claims 2,3 and 4: Burke teaches a user interface that displays alerts and status symbols reflecting the monitor stat of the pumps. However, Burke does not explicitly recite alerts displayed in designated third and fourth portions of the interface, nor does it disclose alerts that include operational recommendations for the clinician. El Khaterji discloses a dedicated notification area on the console that presents alerts and status indicators derived from each pump’s measured data, as well as actionable recommendations such as instructing the clinician to “reduce P-level” to adjust pump speed. Therefore, it would have been obvious to a person of ordinary skill in the art to incorporate EL Katerji alert display structure and recommendation functionality into Burke interface, in which the combination of known display element within the same field of cardiac support that would yield no more than predictable results. (El Katerji Figures 2a-2h)
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Regarding claims 7,8: Burke discloses a user interface that displays an indication of each pumps’ data, but it does not explicitly recite that such indications are presented as a waveform; Pressure waveforms. El Katerji teaches the display of heart pump data in waveform format, including a placement signal pressure waveform. Therefore, it would have been obvious to a person of ordinary skill in the art to display each pump’s data in Burke as respective waveform, as pressure waveform, as taught by El Katarji, giving that doing so, it would provide the clinician with a real time visual representation of each pump’s hemodynamics status through a combination of known elements yielding of, cardiac support, predictable results.
Regarding claim 16: Burke teaches a two-pump heart pump system with a multi-pump controller; however, Burke does not disclose a purge system. El Katerji teaches a purge subsystem that delivers purge fluid to the heart pump to prevent blood from entering the motor (fig 1C). Therefore, it would have been obvious to incorporate a purge system into Burke’s two pump system, as doing so, it represents a routine application of a known protective mechanism to each pump’s motor.
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150: purge subsystem
Claims 9 and 15 are rejected under 35 U.S.C. § 103 as being unpatentable over Burke (2012/002264 A1-hereinafter Burke) in view of Morello ’328 (US 2009/0226328 A1-hereinafter Morello).
Burke teaches communicating pump operating-state information to an external medical monitor by way of the controller’s wired and wireless communication modules ;(Paragraphs 0032,0033 Fig 2A), but does not expressly recite an auxiliary monitor that displays at least some of the first and/or second pump data. Morello discloses a remote monitor module (18) that communicates with the controller and provides a user interface similar or identical to the controller module, enabling a user to remotely monitor the pump’s performance ;(Paragraphs 0007, 0018 Fig 1A). Therefore, it would have been obvious to provide Burke controller with a communication interface that supplies at least some of the first and second pump data to such an auxiliary monitor for display, as taught by Morello, to permit remote monitoring of the connected pumps, a combination of known elements in the same field that yields predictable results.
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Morello:
18: RDM-remote data monitor
112: processing device
110-111: user interface
12:VAD pump
120:Wireless link
16: controller module
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMAD HASSAN KANAAN whose telephone number is (571)270-0363. The examiner can normally be reached I work from 8am:5pm.
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/MOHAMAD HASSAN KANAAN/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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