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 .
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.
(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.
Claim(s) 2, 6-7, 13-15, 19-20 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 20150367049 to Chen et al. (hereinafter Chen – Cited in IDS dated 2/24/25).
Regarding Claim 2, an interpretation of Chen discloses a mechanical circulatory support system (abstract, [0001], [0022]) comprising:
a ventricular assist device (abstract, [0001], [0022]) comprising control electronics via which the ventricular assist device is operated ([0027]-[0029] see also [0022]);
an external controller configured to transmit electrical power and a data signal to the ventricular assist device ([0029]-[0030]); and
a driveline that electrically connects the external controller to the ventricular assist device ([0029]-[0030]), wherein the driveline comprises power transmission wires over which the electrical power and the data signal are transmitted ([0031], [0034], Figs. 4, 7 see also [0021], [0031], Figs. 3, 5-6; Examiner notes that wires are structural elements, what is put through them power or data is an intended use of the lines).
Regarding Claim 6, an interpretation of Chen further discloses wherein the driveline is configured as a percutaneous cable (104 Figs. 1-9, abstract, [0024]).
Regarding Claim 7, an interpretation of Chen further discloses wherein the ventricular assist device comprises a magnetically levitated blood flow impeller (abstract, [0025], [0027]-[0028]).
Regarding Claim 13, an interpretation of Chen further discloses the external controller comprises a first transceiver configured to transmit the data signal ([0030], Figs. 4, 7 see also [0029], [0031], [0034], Figs. 3, 5-6; Examiner notes Applicants discussion explaining “transceiver” in their Pg Pub [0066]).
Regarding Claim 14, an interpretation of Chen further discloses wherein the control electronics comprises a second transceiver configured to receive the data signal ([0030], Figs. 4, 7 see also [0029], [0031], [0034], Figs. 3, 5-6; Examiner notes Applicants discussion explaining “transceiver” in their Pg Pub [0066]).
Regarding Claim 15, an interpretation of Chen further discloses the control electronics are configured to generate and/or collection operational data for the ventricular assist device and transmit the operational data to the external controller over the power transmission wires ([0030] including “The extracorporeal monitor 122 also includes communication circuitry 126, which exchanges information with the motor controller and/or the magnetic bearing controller in the electronic module 120 inside the pump. . . .” and the external controller receiving “operating conditions such as pump speed and electric current of motor and of magnetic bearings”, [0031], Figs. 4, 7 see also Figs. 3, 5-6; Examiner notes that while not currently applied for this element. Dague discloses control electronics configured to generate/collect operation data for the VAD and transmit it to the external controller via the cable [0055]-[0057]).
Regarding Claim 19, an interpretation of Chen further discloses 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 ([0031], [0034]).
Regarding Claim 20, an interpretation of Chen further discloses the ventricular assist device comprises a transceiver ([0030]-[0031], [0034], Figs. 4, 7 see also [0029]; Examiner notes Applicants discussion explaining “transceiver” in their Pg Pub [0066]) configured to: process the data signal modulated electrical power to determine the data signal ([0030]-[0031], [0034], Figs. 4, 7 see also [0029]); and supply the data signal to the control electronics ([0030]-[0031], [0034], Figs. 4, 7 see also [0029]).
Claim Rejections - 35 USC § 102/103
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.
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.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by Chen or, in the alternative, under 35 U.S.C. 103 as obvious over Chen in view of US 20140073838 to Dague et al. (hereinafter Dague - Cited in IDS dated 2/24/25).
Regarding Claim 8, an interpretation of Chen discloses wherein the control electronics are configured to convert a direct current (DC) electrical power into drive current supplied to a motor stator of the ventricular assist device to control operation of the ventricular assist device based on one or more stored parameters ([0027] including “Power electronics and control circuitry 140 for the motor is built on the electronics module 120. . . . the motor control circuitry 140 inside the pump may include a microcontroller or a Digital Signal Processor. The motor control circuitry 140 uses a sensorless control scheme to drive the motor”, [0030] see also [0025], [0028]; Controller(s) applies loaded/stored code and settings for the operation of the pump. Examiner notes that microcontrollers (or digital systems) run on DC power).
In the alternative, while Chen discloses the power source can be AC or DC power, Chen may not explicitly disclose wherein the control electronics are configured to convert a direct current (DC) electrical power into drive current.
However, in the same field of endeavor (implantable medical devices), Dague teaches wherein the control electronics are configured to convert a direct current (DC) electrical power into drive current ([0028], [0032]-[0033], [0055]; explicitly discloses power provided to controller from DC source such as a battery which is converted to drive current).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified an implanted blood pump with controller, an external controller and a plurality of leads or wires in a driveline including for power and data as recited by Chen to include control electronics configured to convert DC electrical power into drive current as recited by Dague because it is the use of known technique (the technique of Dague) to improve similar devices (the system of Chen) in the same way.
Regarding Claim 9, an interpretation of Chen further discloses wherein at least one the one or more stored parameters can be changed via the data signal ([0030] including “The communication circuitry 126 provides top-level commands . . . such as setting and altering the pump speed.”; Examiner notes that while not currently applied for this element. Dague discloses parameters being stored on the implanted control circuitry [0055]-[0056]).
Regarding Claim 10, an interpretation of Chen further discloses wherein the one or more stored parameters define a desired pump speed ([0030]; Examiner notes that while not currently applied for this element. Dague discloses parameters being stored on the implanted control circuitry [0055]-[0056]).
Claim Rejections - 35 USC § 103
Claim(s) 3-5, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Dague.
Regarding claim 3, an interpretation of Chen may not explicitly disclose wherein the plurality of power transmission wires comprise three power transmission wires.
However, in the same field of endeavor (medical devices), Dague teaches wherein the plurality of power transmission wires comprise three power transmission wires ([0047]-[0050]; Examiner notes MPEP 2144.04(II)(A). Examiner notes that wires are structural elements and “power” is an intended use of the device, the structural elements are functionally capable of performing the intended use).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified an implanted blood pump with controller, an external controller and a plurality of leads or wires in a driveline including for power and data as recited by Chen to include three power transmission wires as recited by Dague because it is the use of known technique (the technique of Dague) to improve similar devices (the system of Chen) in the same way.
Regarding Claim 4, an interpretation of Chen may not explicitly disclose wherein the driveline has four of the power transmission wires.
However, in the same field of endeavor (medical devices), Dague teaches wherein the driveline has four of the power transmission wires ([0047]-[0050]; Examiner notes that wires are structural elements and “power” is an intended use of the device, the structural elements are functionally capable of performing the intended use).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified an implanted blood pump with controller, an external controller and a plurality of leads or wires in a driveline including for power and data as recited by Chen to include four power transmission wires as recited by Dague because it is the use of known technique (the technique of Dague) to improve similar devices (the system of Chen) in the same way.
Regarding Claim 5, an interpretation of Chen may not explicitly disclose wherein the driveline has four of the power transmission wires.
However, in the same field of endeavor (medical devices), Dague teaches wherein the driveline has four of the power transmission wires ([0047]-[0050], Fig. 4; Discloses a total of four wires which can be used for power and/or data. Examiner notes that wires are structural elements and “power” is an intended use of the device, the structural elements are functionally capable of performing the intended use).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified an implanted blood pump with controller, an external controller and a plurality of leads or wires in a driveline including for power and data as recited by Chen to include four power transmission wires as recited by Dague because it is the use of known technique (the technique of Dague) to improve similar devices (the system of Chen) in the same way.
Regarding Claim 11, an interpretation of Chen further discloses further comprising
an interpretation of Chen may not explicitly disclose a system monitor that is operable by an operator to configure the external controller and/or the control electronics to control operation of the ventricular assist device
However, in the same field of endeavor (implanted medical devices), Dague teaches a system monitor that is operable by an operator to configure the external controller and/or the control electronics to control operation of the ventricular assist device ([0029], [0055], [0070], [0072]; discloses a system monitor which is user operable such as a programming wand, PDA, laptops etc. to configure the parameters for the VAD).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified an implanted blood pump with controller, an external controller and a plurality of leads or wires in a driveline including for power and data as recited by Chen to include a system monitor operable by a user to reconfigure the parameters of the device as recited by Dague so a user can improve the usage of the device or intervene if an alarm is received ([0055], [0058]).
Regarding Claim 12, an interpretation of Chen further discloses the gathering of operational parameters and the control electronics is configured for transmitting the operational data to the external controller over the power transmission wires ([0030] including “The extracorporeal monitor 122 also includes communication circuitry 126, which exchanges information with the motor controller and/or the magnetic bearing controller in the electronic module 120 inside the pump. . . .” and the external controller receiving “operating conditions such as pump speed and electric current of motor and of magnetic bearings”, [0031], Figs. 4, 7 see also Figs. 3, 5-6).
An interpretation of Chen may not explicitly disclose the one or more stored parameters specify generation and/or collection of operational data for the ventricular assist device.
However, in the same field of endeavor (implantable medical devices), Dague teaches the one or more stored parameters specify generation and/or collection of operational data for the ventricular assist device ([0055]-[0056] see also [0057]); and, the control electronics is configured for transmitting the operational data to the external controller over the power transmission wires ([0055]-[0056] see also [0057]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified an implanted blood pump with controller, an external controller and a plurality of leads or wires in a driveline including for power and data as recited by Chen to include transmitting gathered operational data and transmit the data to an external controller for review as recited by Dague so a user can improve/adjust the usage of the device as desired or intervene if an alarm is received ([0055], [0058]).
Claim Rejections - 35 USC § 103
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of US 20130314047 to Eagle et al. (hereinafter Eagle - Cited in IDS dated 2/24/25).
Regarding Claim 21, an interpretation of Chen may not explicitly disclose the external controller comprises an internal battery and an input port connectable to a power supply.
However, in the same field of endeavor (implantable medical device systems), Eagle teaches the external controller comprises an internal battery and an input port connectable to a power supply ([0026]-[0029], Figs. 1-2; Figs. 1 labeled prior art shows batteries 88 and 84 in external controller and an input for power 87).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified an implanted blood pump with controller, an external controller and a plurality of leads or wires in a driveline including for power and data as recited by Chen to include the external controller having an internal battery and port for power input as disclosed by Eagle because as Eagle has acknowledge it was “conventional” approach as of 2013 ([0011], [0015], [0017]) and using it with the external controller of Chen is merely the use of known technique (the technique of Eagle) to improve similar devices (the system of Chen) in the same way.
Allowable Subject Matter
Claim 16-18 are allowed over the prior art but claims 16-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 16 recites “wherein the external controller is configured to: generate an alternating current (AC) electrical power from a DC electrical power; transmit the AC electrical power over the power transmission wires to the control electronics”. The prior art discloses transmitting through a percutaneous cable AC or DC power. However, it does not disclose taking DC converting it to AC then transmitting the AC to control electronics (with support for “control electronics” to be found in [0054], [0060]). Examiner notes that modulating data onto power signals see US 20140303426 see [0013]-[0014], [0032].
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 2-10, 13-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10933182 in view of Chen. Claim 2 recites 2. a mechanical circulatory support system (claim 1 of ‘182) comprising: a ventricular assist device comprising control electronics via which the ventricular assist device is operated (‘182 claim 1); an external controller configured to transmit electrical power (‘182 claim 1); and a driveline that electrically connects the external controller to the ventricular assist device (‘182 claim 1), wherein the driveline comprises power transmission wires over which the electrical power (‘182 claim 1; Examiner notes that wires are structural elements and “power” is an intended use of the device, the structural elements are functionally capable of performing the intended use).
‘182 claim 1 may not explicitly disclose driveline transmitting a data signal to the ventricular assist device; and driveline with power transmission wires over which the data signal is transmitted.
However, this is disclosed by Chen see the rejection of claim 2 above. It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the disclosure of an external controller, internal pump with control electronics and a driveline with power wires connected from the external controller to the to include the power wires also provide data because the ability to provide data allows for the decrease in wires needed and reduce the size of the cable ([0007]).
Claim 3 see ‘182 claims 6 and 9.
Claim 4 see ‘182 claim 9.
Claim 5 see ‘182 claim 9.
Claim 6 see ‘182 claim 3.
Claim 7 see ‘182 claim 1.
Claim 8-10, 13-15, 19-20 see ‘182 claim 1 in view of the Chen in the rejections of claims 8-10, 13-15 and 19-20 above. It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the disclosure of an external controller, internal pump with control electronics and a driveline with power wires connected from the external controller to the to include the power wires also provide data because the ability to provide data allows for the decrease in wires needed and reduce the size of the cable ([0007]).
Claim 16 generate an alternating current (AC) electrical power from a DC electrical power (‘182 claim 1); transmit the AC electrical power over the power transmission wires to the control electronics (‘182 claim 1);
an interpretation of ‘182 claim 1 may not explicitly disclose 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. However, Chen teaches overlaying data signals on to the electrical power via modulating the power signal ([0030]-[0031], [0034], Figs. 4, 7 see also [0029]). It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the disclosure of an external controller, internal pump with control electronics and a driveline with power wires connected from the external controller to the to include the power wires also provide data because the ability to provide data allows for the decrease in wires needed and reduce the size of the cable ([0007]).
Claims 17 see ‘182 claim 1.
Claims 18 see ‘182 claim 1 in view of Chen discloses the transfer of a modulated AC signal with data. an interpretation of ‘182 claim 1 may not explicitly disclose process the data signal modulated AC electrical power to determine the data signal; and supply the data signal to the control electronics. However, Chen teaches process the data signal modulated electrical power to determine the data signal; and supply the data signal to the control electronics. ([0030]-[0031], [0034], Figs. 4, 7 see also [0029]). It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the disclosure of an external controller, internal pump with control electronics and a driveline with power wires connected from the external controller to the to include the power wires also provide data because the ability to provide data allows for the decrease in wires needed and reduce the size of the cable ([0007]).
Claims 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10933182 in view of Chen in further view of Dague.
Claims 11-12 see ‘182 claim 1 in view of Chen in further view of Dague in the rejection of claims 11-12 above. It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified an implanted blood pump with controller, an external controller and a plurality of leads or wires in a driveline including for power and data as recited by ‘182 claim 1 in view of Chen to include a system monitor operable by a user to review received data from the internal device and reconfigure the parameters of the device as recited by Dague so a user can improve the usage of the device or intervene if an alarm is received ([0055], [0058]).
Claims 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21 of U.S. Patent No. 10933182 in view of Chen in further view of Eagle.
Claim 21 see ‘182 claim 1 may not explicitly disclose wherein the external controller comprises an internal battery and an input port connectable to a power supply. However, in the same field of endeavor (implantable medical device systems), Eagle teaches the external controller comprises an internal battery and an input port connectable to a power supply ([0026]-[0029], Figs. 1-2; Figs. 1 labeled prior art shows batteries 88 and 84 in external controller and an input for power 87).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified an implanted blood pump with controller, an external controller and a plurality of leads or wires in a driveline including for power and data as recited by ‘182 claim 1 to include the external controller having an internal battery and port for power input as disclosed by Eagle because as Eagle has acknowledge it was “conventional” approach as of 2013 ([0011], [0015], [0017]) and using it with the external controller of ‘182 claim 1 is merely the use of known technique (the technique of Eagle) to improve similar devices (the system of ‘182 claim 1) in the same way.
Conclusion
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/James Moss/Examiner, Art Unit 3792
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