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
Information Disclosure Statement
Examiner has confirmed that lined through references were provided in one or more parent applications and has updated the IDS (09/04/2025) accordingly.
Claim Rejections 35 U.S.C. 103 Rejections
Applicant’s arguments filed on 02/17/2026 have been fully considered but are moot in view of a new grounds of rejection.
Claim Objections
Claim 9 is objected to because of the following informalities. Appropriate correction is required.
In re claim 9, the limitation “…the control electronics is configured for transmitting the operational data for the ventricular assist device” , should read “…the control electronics are configured for transmitting the operational data for the ventricular assist device”.
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.
Claims 2 and 3 are 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.
In re claim 2, the limitation “wherein the percutaneous driveline comprises three of the power transmission wires”, raises a clarity concern when viewed in combination with the limitation “a percutaneous driveline comprising power transmission wires” from claim 1. Specifically, it is unclear how the driveline could comprise “three of the power transmission wires”, when claim 1 already require that the driveline comprise power transmission wires. As best understood, Examiner believes applicant is trying to require that the percutaneous driveline comprise a specific number of wires, as illustrated in Applicant’s figure 8. Therefore, for examination purposes, the limitation “wherein the percutaneous driveline comprises three of the power transmission wires”, will be interpreted as requiring the drive line to have three wires.
In re claim 3, Examiner notes that the same analysis (see above (In re claim 2)) applies to the limitation “wherein the percutaneous driveline has four of the power transmission wires”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5 and 6-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Angwin et al. (US 2015/0290375).
In re claim 1, Angwin discloses a mechanical circulatory support system (Fig. 1. Fig. 6) comprising:
a ventricular assist device (Fig. 3: 100, shown in greater detail in FIG. 4) comprising
a housing (110),
an annular magnetic rotor (140 which includes first portion 140a and second portion 140b),
centrifugal impeller blades (143),
a stator assembly (120), and
control electronics (130),
wherein the housing defines an inlet opening (101) and an outlet opening (105),
wherein the housing comprises a dividing wall (115) that delineates an inner volume that fluidly connects the inlet opening and the outlet opening (Fig. 4),
wherein the annular magnetic rotor comprises one or more permanent magnets (141),
wherein the annular magnetic rotor is disposed within a portion of the inner volume (portion that houses 140a, 140b; [0035]) shaped to accommodate the annular magnetic rotor in a levitated position and orientation (FIG. 4; [0043]) in which the annular magnetic rotor is separated from the dividing wall by a secondary blood flow path ([0044]: defined as blood moving from 103 through gaps 108 and 109),
wherein the centrifugal impeller blades are carried by the annular magnetic rotor ([0035]: “the rotor has a second portion 140b that includes the impeller blades 143”),
wherein the stator assembly comprises drive coils (125) and levitation coils (127),
wherein the drive coils are arranged radially relative to the annular magnetic rotor (Fig. 3, Fig. 4),
wherein the drive coils are operable to electromagnetically drive rotation of the annular magnetic rotor within the inner volume (Fig. 4; [0046],
wherein the levitation coils are arranged radially relative to the annular magnetic rotor (Fig. 3, Fig. 4),
wherein the levitation coils are operable to electromagnetically levitate the annular magnetic rotor [0042] to control a radial position of the annular magnetic rotor within the inner volume ([0042]: “…levitation coil for generating an electromagnetic filed to control the radial position of the rotor”),
wherein the control electronics are
disposed within the housing (Fig. 3) and
configured to control electrical supply to the drive coils and the levitation coils [0038, 0047], and
wherein the control electronics comprise a receiver ([0042]: component of “control electronics 130” that functions to “receive electrical power from a remote power supply via cable 119”);
a percutaneous driveline (Fig. 1: 26) comprising power transmission wires ([0005, 0013] connected to the control electronics (apparent as 26 feeds into housing of pump, see Fig.1); and
an external controller (20)
connected to the percutaneous driveline (Fig. 1) and
configured to transmit electrical power over the power transmission wires to the control electronics ([0033]: controller receives power from “remote power supply” 22; [0042]: “control electronics 130 and stator receive electrical power from a remote power supply via cable 119”) ,
wherein the external controller comprises a transmitter (component responsible for [0051]: “transmit[ing] a data request to the onboard electronics 130” configured to transmit a data signal ([0051]: “data request”) over the power transmission wires to the receiver (apparent as a single driveline connects external controller to the control electronics (FIG. 1; [0042, 0051]), and
wherein the external controller is configured to overlay the data signal onto the electrical power via modulation of the electrical power to produce a data signal modulated electrical power (apparent, see * below).
*Examiner notes that the limitation “data signal” is broad and can be interpreted as any electronic signal capable of transmitting information. Therefore, under the broadest reasonable interpretation, a power signal is an example of a “data signal”, as it transmits information about power. It is apparent that the external controller of Angwin would be configured to “overlay the data signal onto the electrical power via modulation of the electrical power to produce a data signal modulated electrical power”, given that the electrical power is a type of “data signal”.
In re claim 5, Angwin discloses, wherein the control electronics are configured to covert a direct current (DC) electrical power ([0042]: “electrical power”, received from [0047]: “battery supply”); As known by one of ordinary skill in the art, batteries supply “direct current electrical power”) into currents supplied to the stator assembly to control operation of the ventricular assist device [0042] based on one or more stored parameters ([0050]: “patient parameters can be stored in the on board electronics 130 and used…to control operational aspects of the pump assembly”; Examiner notes FIG. 8 shows a set of patient specific parameters that can be stored).
In re claim 6, Angwin discloses, wherein at least one of the one or more stored parameters can be changed via the data signal [0052].
In re claim 7, Angwin discloses, wherein the one or more stored parameters (Fig. 8; [0050]) defined a pump speed (“set speed for blood pump”), a desired pumped flow rate, and/or a pulse generation (“operating mode for blood pump”; [0050]: “continuous or pulse mode”).
In re claim 8, Angwin discloses, further comprising a system monitor (Fig. 6: 32) that is operable by an operator to configure the external controller and/or the control electronics to control operation of the ventricular assist device [0047, 0050].
In re claim 9, Angwin discloses, wherein
the one or more stored parameters specify generation and or collection of operational data for the ventricular assist device (Fig. 8: “log rate for event and periodic data”; [0050, 0051]); and
the control electronics is configured for transmitting the operational data for the ventricular assist device to the external controller over the power transmission wires [0050].
In re claim 10, Angwin discloses, wherein the control electronics are configured to
generate and/or collect operational data for the ventricular assist device ([0050]: “how often to record data with respect to patient parameters”) and
transmit the operational data for the ventricular assist device to the external controller over the power transmission wires [0051].
In re claim 15, Angwin discloses, wherein the receiver is configured to:
process the data signal modulated electrical power to determine the data signal ([0019]: see act “(a)”); and
supply the data signal to the control electronics ([0019]: see act “c)”).
In re claim 16, Angwin discloses, wherein the external controller comprises an internal battery (FIG. 6: 20 includes “Emergency Backup Battery”) and an input port (lines connected to 22 that feed into 20) connectable to a power supply (22).
In re claim 17, Angwin discloses, wherein a removably attached portion (118) of the housing partially defines a volute portion (107) of the inner volume.
In re claim 18, Angwin discloses, wherein blood flowing through the secondary blood flow path does not act as a bearing so that the annular magnetic rotor is only magnetically-levitated ([0044] : “That is to say, the blood does not act as a bearing within the gaps 108, 109 and the rotor is only magnetically-levitated”)
In re claim 19, Angwin discloses, wherein the secondary blood flow path has a secondary blood flow gap (108) of approximately 0.5 mm ([0043]: “gap 108 may be formed from about 0.2 millimeters to 2.0 millimeters”).
In re claim 20, Angwin discloses, wherein the secondary blood flow path has a secondary blood flow gap (109) in a range from 0.2 mm to 1.0 mm ([0043]: “gap 109 is from about 0.2 millimeters to 2.0 millimeters”).
In re claim 21, Angwin discloses, wherein the one or more permanent magnets provide a permanent magnetic attractive force between the annular magnetic rotor and the stator assembly that acts as a passive axial centering force that resists movement of the annular magnetic rotor along an axis of rotation of the annular magnetic rotor [0043].
In re claim 22, Angwin discloses, wherein:
the housing has a puck-shaped portion (portion of housing 110 that spans T) and an inlet-cannula portion (112) that extends from the puck-shaped portion (Fig. 4); and
the puck-shaped portion has a diameter (W) in a range from 1 inch to 4 inches ([0036]: “…the width W is from about 1 inch to about 4 inches”) thickness T is from about 0.5 inches to 1.5 inches “).
In re claim 23, Angwin discloses, wherein the puck- shaped portion has a diameter of approximately 2 inches ([0036]: “…the width W is from about 1 inch to about 4 inches”).
In re claim 24, the proposed combination yields (all mapping directed to Angwin), wherein:
the housing has a puck-shaped portion (portion of 110 that spans T) and an inlet-cannula portion (112) that extends from the puck-shaped portion (Fig. 4); and the puck-shaped portion has a thickness (T) in a range from 0.5 inch to 1.5 inches ([0036]: “The thickness T is from about 0.5 inches to about 1.5 inches”).
In re claim 25, Angwin discloses, wherein the puck- shaped portion has a thickness (T) of approximately 1 inch ([0036]: “The thickness T is from about 0.5 inches to about 1.5 inches”).
In re claim 26, Angwin discloses, wherein:
the housing has a puck-shaped portion (portion of 110 that spans T) and an inlet-cannula portion (112) that extends from the puck-shaped portion (Fig. 4); and
the puck-shaped portion has a width to thickness ratio in a range from 1.0 to 5 ( [0036]: “for example the width can be approximately 2 inches, and the thickness T can be approximately 1 inch”; Examiner asserts that this would result in a width to thickness ratio of 2).
In re claim 27, Angwin discloses, wherein the inner volume comprises a volute portion (107) through which blood flow impelled by the centrifugal impeller blades flows to the outlet opening [0035].
In re claim 28, Angwin discloses, wherein an annular portion (portion of secondary blood flow path that runs along top sides and bottom of “N” and “S”) of the secondary blood flow path separates the annular magnetic rotor form a cylindrical inner surface (surface of dividing wall 115 that surrounds “N”, “S”) of the dividing wall.
In re claim 29, Angwin discloses, wherein a radial portion (portion of secondary blood flow path that runs along the top of “N” and “S”) of the secondary blood flow path extends perpendicular to an axis of rotation (imaginary vertical line running between “N” and “S”) of the annular magnetic rotor.
In re claim 30, Angwin discloses, wherein:
the stator assembly comprises a back iron (121) and pole pieces (123 which includes 123a-123f, shown in Fig. 5) arranged annularly at intervals [0039]; and
each of the drive coils is extends around one of the pole pieces [0039].
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5 and 6-30 are rejected under 35 U.S.C. 103 as being unpatentable over Angwin et al. (US 2015/0290375), in view of Yodfat et al. (US 2011/0009824), in view of Rossing et al. (US 7,835,797), and in view of Arber et al. (US 2012/01250291).
In re claim 1, see above (In re claim 1).
Examiner acknowledges that Angwin may be interpreted as lacking the limitation “wherein the external controller is configured to overlay the data signal onto the electrical power via modulation of the electrical power to produce a data signal modulated electrical power”, therefore, in the interest of advancing prosecution Examiner alternatively rejects claim 1 under 35 U.S.C. 103 as follows:
Examiner notes that the technique of “overlay the data signal onto the electrical power via modulation of the electrical power to produce a data signal modulated electrical power” is known as evidenced by Yodfat, Rossing and Arber. Specifically, Yodfat discloses a medical device system (Fig. 4) that consists of an external charging component (30) and a medical device (10; [0113]). As discussed in Yodfat, the external charging component is configured to send a modulated power signal (17), that is, a power signal that has been modulated with data related to the operation of the medical device to a receiving unit (171) of the medical device. Once the modulated power signal has been received, the medical device uses its internal processing components to demodulate the modulated power signal and extract the data related to the operation of the medical device [0048]. It should be noted that Rossing similarly discusses combining functions of data/signal communication and power delivery in the context of mechanical circulatory support systems (Rossing, Fig. 1; col. 11, lines 13-20). Additionally, Arber discloses a ventricular assist device capable of receiving both power and control signals (Arber, [0131]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the external controller of Angwin to be configured to overlay the data signal onto the electrical power via modulation of the electrical power to produce a data signal modulated electrical power, because it is a known technique as evidenced above. Moreover, one would have been motivated to make this modification because doing so would reduce the total number of wires required to be implanted in a patient. Examiner asserts that such a modification would, in turn, reduced likelihood of degradation and increase device longevity (Rossing, col. 11, lines 15-20).
In re claim 5, see above (In re claim 5).
In re claim 6, see above (In re claim 6).
In re claim 7, see above (In re claim 7).
In re claim 8, see above (In re claim 8).
In re claim 9, see above (In re claim 9).
In re claim 10, see above (In re claim 10).
In re claim 15, see above (In re claim 15).
In re claim 16, see above (In re claim 16).
In re claim 17, see above (In re claim 17).
In re claim 18, see above (In re claim 18).
In re claim 19, see above (In re claim 19).
In re claim 20, see above (In re claim 20).
In re claim 21, see above (In re claim 21).
In re claim 22, see above (In re claim 22).
In re claim 23, see above (In re claim 23).
In re claim 24, see above (In re claim 24).
In re claim 25, see above (In re claim 25).
In re claim 26, see above (In re claim 26).
In re claim 27, see above (In re claim 27).
In re claim 28, see above (In re claim 28).
In re claim 29, see above (In re claim 29).
In re claim 30, see above (In re claim 30).
Claims 2, 3, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Angwin et al. (US 2015/0290375), in view of Burke (US 2012/0022645).
In re claim 2, Angwin does not disclose, wherein the percutaneous drive line comprises three of the power transmission wires.
Burke discloses an analogous mechanical circulatory support system (abstract, FIG. 1). As shown in FIG. 1 the mechanical circulatory support system includes two ventricular assist devices (108, 106), two drive lines (116, 118) and an external controller (combination of 102 and 104-shown in greater detail in FIGS. 2A-2B). As shown in FIG. 2B each driveline consists of three power transmission wires (FIG. 2B: indicated by 6 total wires coming out of driveline connector 252).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the percutaneous driveline of Angwin, to comprise three power transmission wires, as taught by Burke. One would have been motivated to make this modification both percutaneous drivelines with three power transmission wires are known in the art (as evidenced by Burke) and because one of ordinary skill in the art would be able to choose a number of power transmission wires that would best meet their needs.
In re claim 3, the proposed combination does not yield, wherein the percutaneous driveline has four of the power transmission wires.
As discussed above, Burke discloses an analogous mechanical circulatory support system (FIG. 1) with a percutaneous driveline (116 or 118) that comprises three of the power transmission wires (Fig. 2B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination to include an additional power transmission wire. One would have been motivated to make this modification to have a “back-up wire” that can be used in the event that one of the main wires becomes damaged or non-operational (Burke, [0045]). Accordingly, such a modification would yield “wherein the percutaneous driveline has four of the power transmission wires”.
In re claim 4, see above (In re claim 3).
Claims 11, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Angwin et al. (US 2015/0290375), in view of Tuseth et al. (US 2017/0043077).
In re claim 11, Angwin does not disclose, wherein the external controller is configured to
generate an alternative current (AC) electrical power from a DC electrical power,
transmit an AC electrical power over the power transmission wires to the control electronics; and
overlay the data signal onto the AC electrical power vial modulation of the AC electrical power to produce a data signal modulated AC electrical power.
Tuseth, like Angwin, discloses a ventricular assist device (Fig. 1: 104;[0066]) that is powered by a power module (112, shown in greater detail in FIG. 4). In one embodiment the power module includes a DC/AC converter, arranged to convert the DC power into AC power [0084].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the external controller of Angwin to be configured to generate an alternative current (AC) electrical power from a DC electrical power, as taught by Tuseth. One would have been motivated to make this modification because doing so would ensure that the external controller could also be compatible with multiple types of ventricular assist devices, including those that require AC electrical power. Accordingly, such a modification would yield the external controller being configured to “transmit an AC electrical power over the power transmission wires to the control electronics and overlay the data signal onto the AC electrical power via modulation of the AC electrical power to produce a data signal modulated AC electrical power”, since the external controller of the proposed combination is already configured to transmit electrical power and overlay the data signal onto the electrical power (see above rejection (In re claim 1)).
In re claim 12, the proposed combination does not yield wherein the ventricular assist device comprises a rectifier configured to:
generate DC electrical power from the AC electrical power; and
supply the DC electrical power to the control electronics.
Tuseth further discloses the power module optionally including a rectifier arrangement that is configured to convert received AC power into DC power [0085].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ventricular assist device of the proposed combination, to include a rectifier configured to generate DC electrical power from the AC electrical power, as taught by Tuseth. One would have been motivated to make this modification to ensure that the ventricular assist device could still be used, even in the event that an external controller is powered by an AC electrical power source. Accordingly, such a modification would yield “supply the DC electrical power to the control electronics”, given that the ventricular assist device of the proposed combination is already configured to do so (see above rejection (In re claim 1); Angwin ([0042, 0047]).
In re claim 13, the proposed combination yields (all mapping directed to Tuseth unless indicated otherwise), wherein the receiver is configured to:
process the data signal modulated AC electrical power (see proposed modification above (In re claim 11) to determine the data signal (apparent given that the control electronics receive both “operating power and control signals” from the external controller [0041, 0052]; additionally [0052] provides examples of “control electronics 130” identifying “data signals” from the totality of signals received from the external controller); and
supply the data signal to the control electronics [0052].
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wiess (US 6,579,315) discloses an apparatus adapted to supply power to a mechanical circulatory assist system (abstract: “artificial heart assembly”). Wiess further discloses modulating a power signal to transmit data regarding the operation of the mechanical circulatory assist system (col. 13, lines 46-49).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
Prosecution Insights