DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Information Disclosure Statement
2. The Information Disclosure Statement submitted on 11 December 2025 has been considered by the Examiner.
Claim Rejections - 35 USC § 103
3. 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.
4. Claims 1-3, 9, 12-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hildebrand et al. (US 2020/0246527 A1) in view of Aboul-Hosn et al. (US 2019/0054224 A1).
Regarding claim 1, Hildebrand teaches a blood pump system (blood pump system 1100 [abstract, 0170, FIG. 2, FIG. 4]), comprising:
a catheter having a distal end coupled to a blood pump (the blood pump system 1100 comprises a blood pump portion 1104 that is coupled to the elongate catheter portion 1106 [170, 0182, FIG. 2, FIG. 4]), the blood pump having a driveshaft (the drive mechanism 1117 [0181-0182, FIG. 2, FIG. 4]) rotationally coupled to one or more impellers of the blood pump (the impellers 1116 are each rotationally coupled to the drive mechanism 1117 [0181-0182, FIG. 2]); and
a motor assembly having a distal portion coupled to the catheter (the motor may include a portion that is coupled to elongate catheter portion 1106 [0170, 0182]), the motor assembly including a motor rotationally coupled to the driveshaft (the motor is rotationally coupled to the drive mechanism 1117 [0170, 0181]), wherein the distal portion of the motor assembly includes a coupling member (the motor includes a motor coupling region [0060, 0170]) comprising:
one or more fluid channels configured to direct fluid from the motor assembly toward the blood pump via the catheter (the motor includes a motor coupling region having a guidewire port that interfaces with a fluid line coupler [0060, 0063, 0073, 0282, 0327]. Alternatively, an inlet fluid may be advanced into the guidewire port from a fluid line [0060, 0073]. The Examiner respectfully submits that inlet fluid is provided through the guidewire port of the motor coupling region and is delivered to the impellers of the blood pump via the catheter [0060, 0073, 0230, 0269, 0323]); and
one or more access channels (guidewire port positioned relative to the motor assembly coupling region [0060, 0270]).
Hildebrand does not explicitly teach wherein the one or more access channels are configured to direct one or more elongate components from the blood pump toward the motor assembly via the catheter.
The prior art by Aboul-Hosn is analogous to Hildebrand, as they both teach the use of a blood pump ([abstract]).
Aboul-Hosn teaches wherein the one or more access channels are configured to direct one or more elongate components from the blood pump toward the motor assembly via the catheter (the guide mechanism 16 includes a guide wire 22, imaging wires, and a central lumen 74 (e.g., access channel) [0093, 0097, 0101, FIGS. 1-2]. Specifically, the central lumen 74 (e.g., access channel) extends through the motor coupler 24, the drive cable assembly 18, the catheter 132, the blood pump 12, and the cannula 14 [0007, 0093, 0097, 0101, FIG. 2, FIGS. 13-15]. Furthermore, the central lumen 74 provides passageway for elongated components (e.g., guidewire 22 and/or the imaging wires) to be inserted or retracted through the motor coupler 24, drive cable assembly 18, blood pump 12, catheter 132, and the cannula 14 [0007, 0093, 0097, 0101, FIG. 2, FIGS. 13-14]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Hildebrand’s access channels to direct one or more elongate components from the blood pump toward the motor assembly via the catheter, as taught by Aboul-Hosn. This modification is beneficial, as it will allow a guidewire to slide the blood pump to a desired location of the device (see paragraphs [0007, 0093, 0097] by Aboul-Hosn).
Regarding claim 2, Aboul-Hosn teaches wherein the one or more elongate components includes one or more electrical wires (the central lumen 74 provides passageway for elongated components (e.g., guidewire 22 and/or the imaging wires) to be inserted or retracted through the motor coupler 24, drive cable assembly 18, blood pump 12, catheter 132, and the cannula 14 [0007, 0093, 0097, 0101, FIG. 2, FIGS. 13-14]).
Regarding claim 3, Aboul-Hosn teaches wherein the one or more fluid channels and the one or more access channels are longitudinal cutouts along an outer surface of the coupling member (the central lumen 74 (e.g., access channel) is a longitudinal or cutout or passageway extends through the motor coupler 24, the drive cable assembly 18, the catheter 132, the blood pump 12, and the cannula 14 [0007, 0093, 0097, 0101, FIG. 2, FIGS. 13-15]. Specifically, the central lumen 74 provides passageway for elongated components (e.g., guidewire 22 and/or the imaging wires) to be inserted or retracted through the motor coupler 24, drive cable assembly 18, blood pump 12, catheter 132, and the cannula 14 [0007, 0093, 0097, 0101, FIG. 2, FIGS. 13-14]. Meanwhile, the motor coupler 24 is mated with a housing 96 that comprises a plurality of side lumens 76 (e.g., fluid channels) which defines a longitudinal cutout or passageway for an inflow of fluid [0101, 0105, FIG. 13, FIG. 15]).
Regarding claim 9, Hildebrand in view of Aboul-Hosn suggests the blood pump system of claim 1. Hildebrand and Aboul-Hosn do not explicitly teach a second coupling member proximal to the blood pump, the second coupling member including:
one or more one or more second fluid channels configured to direct fluid from the catheter toward the blood pump; and
one or more second access channels each configured to direct one or more elongate components from the blood pump toward the catheter.
The Examiner respectfully submits that Hildebrand teaches the use of a coupling member comprising fluid channels configured to direct fluid from the catheter toward the blood pump (the fluid line is configured to direct an inlet fluid through the guidewire port of the motor coupling region to the catheter and into the impellers of the blood pump [0060, 0073, 0230, 0269, 0323]). Meanwhile, Aboul-Hosn teaches the coupling member comprising access channels for navigating elongated components from the blood pump toward the catheter (the central lumen 74 provides a passageway for elongated components (e.g., guidewire 22 and/or the imaging wires) to be inserted through the motor coupler 24, drive cable assembly 18, blood pump 12, catheter 132, and the cannula 14 [0007, 0093, 0097, 0101, FIG. 2, FIGS. 13-14]). Thus, configuring a second coupling member that is associated with second fluid channels and second access channels would be a matter of duplicating the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 12, Hildebrand teaches a blood pump system (blood pump system 1100 [abstract, 0170, FIG. 2, FIG. 4]), comprising:
a motor assembly including a motor rotationally coupled to a driveshaft (the motor is rotationally coupled to the drive mechanism 1117 [0170, 0181]);
a catheter including proximal portion coupled to the motor assembly (the motor may include a portion that is coupled to elongate catheter portion 1106 [0170, 0182]), the catheter including a distal portion coupled to a blood pump (the blood pump system 1100 comprises a blood pump portion 1104 that is coupled to the elongate catheter portion 1106 [170, 0182, FIG. 2, FIG. 4]), the blood pump having one or more impellers rotationally coupled to the driveshaft (the impellers 1116 are each rotationally coupled to the drive mechanism 1117 [0181-0182, FIG. 2]), wherein the distal portion of the catheter includes a coupling member comprising one or more fluid channels configured to direct fluid from the motor assembly toward the blood pump via the catheter (the Examiner respectfully submits that the elongate catheter portion 1106 comprises a catheter shaft 1119 having a portion that is coupled with the pump portion 1104 [0170, 0181-0182]. Specifically, the fluid communication is established between the motor, the elongate catheter portion 1106 and the pump portion 1104 [0170, 0181-0182]).
Hildebrand does not explicitly teach one or more access channels each configured to direct one or more elongate components from the blood pump toward the motor assembly via the catheter.
The prior art by Aboul-Hosn is analogous to Hildebrand, as they both teach the use of a blood pump ([abstract]).
Aboul-Hosn teaches wherein the one or more access channels are configured to direct one or more elongate components from the blood pump toward the motor assembly via the catheter (Specifically, the central lumen 74 (e.g., access channel) extends through the motor coupler 24, the drive cable assembly 18, the catheter 132, the blood pump 12, and the cannula 14 [0007, 0093, 0097, 0101, FIG. 2, FIGS. 13-15]. Furthermore, the central lumen 74 provides passageway for elongated components (e.g., guidewire 22 and/or the imaging wires) to be inserted or retracted through the motor coupler 24, drive cable assembly 18, blood pump 12, catheter 132, and the cannula 14 [0007, 0093, 0097, 0101, FIG. 2, FIGS. 13-14]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Hildebrand’s coupler to include access channels for directing one or more elongate components from the blood pump toward the motor assembly via the catheter, as taught by Aboul-Hosn. This modification is beneficial, as it will allow a guidewire to slide the blood pump to a desired location of the device (see paragraphs [0007, 0093, 0097] by Aboul-Hosn).
Regarding claim 13, Aboul-Hosn teaches wherein the one or more elongate components includes one or more electrical wires (the central lumen 74 provides passageway for elongated components (e.g., guidewire 22 and/or the imaging wires) to be inserted or retracted through the motor coupler 24, drive cable assembly 18, blood pump 12, catheter 132, and the cannula 14 [0007, 0093, 0097, 0101, FIG. 2, FIGS. 13-14]).
Regarding claim 16, Aboul-Hosn teaches wherein the one or more fluid channels and the one or more access channels are longitudinal cutouts along an outer surface of the coupling member (the central lumen 74 (e.g., access channel) is a longitudinal or cutout or passageway extends through the motor coupler 24, the drive cable assembly 18, the catheter 132, the blood pump 12, and the cannula 14 [0007, 0093, 0097, 0101, FIG. 2, FIGS. 13-15]. Specifically, the central lumen 74 provides passageway for elongated components (e.g., guidewire 22 and/or the imaging wires) to be inserted or retracted through the motor coupler 24, drive cable assembly 18, blood pump 12, catheter 132, and the cannula 14 [0007, 0093, 0097, 0101, FIG. 2, FIGS. 13-14]. Meanwhile, the side lumens 76 (e.g., fluid channels) which defines a longitudinal cutout or passageway for an inflow of fluid [0101, 0105, FIG. 13, FIG. 15]).
5. Claims 4, 8, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hildebrand et al. in view of Aboul-Hosn et al., further in view of Muller et al. (US 2018/0021495 A1).
Regarding claims 4 and 17, Hildebrand in view of Aboul-Hosn suggests the blood pump of claims 1 and 12. Hildebrand and Aboul-Hosn do not explicitly teach one or more tube covers fixedly coupled to an outer surface of the coupling member, wherein the one or more fluid channels and the one or more access channels provide spaces between the one or more tube covers and the coupling member.
The prior art by Muller is analogous to Hildebrand, as they both teach a blood pump comprising a motor assembly [0020]).
Muller teaches teach one or more tube covers fixedly coupled to an outer surface of the coupling member (figure 1B and figures 2-3 illustrates the motor housing assembly 1 comprising a flow diverter 3 (e.g., fluid channel) having a distal portion 5 that is sealed or coupled to the sleeve 21 (e.g., tube cover) of the catheter 120a [0059, 0077, FIG. 1B, FIGS. 2-3, FIG. 6A]), wherein the one or more fluid channels and the one or more access channels provide spaces between the one or more tube covers and the coupling member (the guidewire tube 20 (e.g., access channel) extends from the motor assembly 1 throughout the catheter pump 100A [0055, 0059, FIG. 1B, FIGS. 2-3]. Specifically, figures 3 and 6B illustrates the guidewire tube 20 (e.g., access) channel providing separation or space between the motor assembly 1 and the sleeve 21 (e.g., tube cover) of the catheter 120a [FIG. 3]. Meanwhile, figures 2-3 and 6B illustrates the fluid diverter 3 (e.g., fluid channel) providing separation or space between the motor assembly 1 and the sleeve 21 of the catheter 120a [0059, 0077, FIGS. 2-3, FIG. 6B]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the blood pump suggested by Hildebrand in view of Aboul-Hosn to include a tube cover that is spaced from the coupling member via the fluid channels and the access channels, as taught by Muller. This modification is beneficial as the tube cover may help seal various components (see paragraphs [0059, 0077] by Muller).
Regarding claim 8, Muller teaches wherein the distal portion of the motor assembly further includes a coupler assembly, the coupler assembly including a fluid inlet port configured to direct fluid from an external console of the blood pump system toward the coupling member (figure 1B and figure 2 illustrates the motor assembly 1 comprising an inlet port or supply line 6 that is configured to receive fluid from an external console 122 [0052, 0065, FIG. 1B, FIG. 2]. Furthermore, the inlet port or supply line 6 is configured to direct the fluid towards the catheter pump 100a [0052, 0065, FIG. 1B, FIG. 2]).
6. Claims 5-6 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Hildebrand et al. in view of Aboul-Hosn et al., further in view of Nitzan et al. (US 2018/0126130 A1, referred to herein as “Nitzan-130”).
Regarding claims 5 and 18, Hildebrand in view of Aboul-Hosn suggests the blood pump system of claims 1 and 12. Hildebrand teaches a catheter shaft tube that is positioned radially within an outer sheath (figure 2 illustrates the catheter 1106 comprising a catheter shaft tube 1119 that is positioned within an outer elongated conduit 1120 (e.g., sheath) [0174, 0182, 0324, FIG. 2]).
Hildebrand and Aboul-Hosn do not explicitly teach wherein the catheter includes a drive shaft tube, and wherein the drive shaft tube is positioned radially within the catheter shaft tube.
The prior art by Nitzan-130 is analogous to Hildebrand, as they both teach a blood pump system comprising a catheter ([abstract, 0018]).
Nitzan-130 teaches wherein the catheter includes a drive shaft tube (the catheter system 700 comprises a drive shaft 703 [0155]), a catheter shaft tube (the catheter system 700 comprises a catheter shaft tube 702 [0155]), and an outer sheath (the catheter system 700 comprises a sheath 706 [0155]), wherein the drive shaft tube is positioned radially within the catheter shaft tube (the drive shaft 703 extends through the catheter shaft tube 702 [0155, FIGS. 7-8]), and the catheter shaft tube is positioned radially within the outer sheath (the catheter shaft tube 702 extends through the lumen of the sheath 706 [0155, FIGS. 7-8]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the catheter suggested by Hildebrand in view of Aboul-Hosn to include a drive shaft tube that is positioned radially within the catheter shaft tube, as taught by Nitzan-130. The advantage of such modification will provide the catheter with a drive shaft that can be releasably coupled to the motor. Specifically, the releasable connection will allow the drive shaft to be replaced if necessary (see paragraphs [0155, 0162] by Nitzan).
Regarding claims 6 and 19, Hildebrand teaches wherein the one or more fluid channels is configured to direct fluid between the catheter shaft tube and the outer sheath (fluid may be delivered between the catheter shaft tube 1119 and the outer elongated conduit 1120 (e.g., sheath) [0168, 0173-0174, 0181-0182, FIG. 2]); and
Nitzan-130 teaches the one or more access channels is configured to direct the one or more elongate components between the drive shaft tube and the catheter shaft tube (the catheter system 700 can be fully cannulated (e.g., access channel) such that a guidewire can be inserted through the entire system, including the distal tip 708 [0155, 0168, FIG. 7]. The Examiner respectfully submits that the cannulation of the system 700 would allow the guidewire to be inserted between the drive shaft 703 and the catheter shaft tube 702 [0155, 0168, FIGS. 7-8]).
7. Claims 7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hildebrand et al. in view of Aboul-Hosn et al., further in view of Nitzan et al. (US 2020/0397963 A1, referred to herein as “Nitzan-963”).
Regarding claim 7, Hildebrand in view of Aboul-Hosn suggests the blood pump system of claim 1. Hildebrand and Aboul-Hosn does not explicitly teach wherein the coupling member is fixedly coupled to a hypotube that surrounds a driveshaft tube, the driveshaft tube accommodating the driveshaft therein.
The prior art by Nitzan-963 is analogous to Hildebrand, as they both teach the use of a blood pump comprising impellers ([0036]).
Nitzan-963 teaches wherein the coupling member is fixedly coupled to a hypotube that surrounds a driveshaft tube, the driveshaft tube accommodating the driveshaft therein (the motor 143 is coupled to driveshaft 111 which is surrounded by a drive shaft tube sleeve 122 [0054]. Furthermore, the hypotube 119 is configured to surround the drive shaft tube sleeve 122 and the drive shaft 111 [0041, 0054, FIG. 2, FIG. 5]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the coupling member suggested by Hildebrand in view of Aboul-Hosn to include a hypotube that surrounds a driveshaft tube, as taught by Nitzan-963. The advantage of such modification may will provide a tube or hypotube that is configured to seal the driveshaft tube (e.g. driveshaft tube sleeve) and the drive shaft (see paragraphs [0041, 0054] by Nitzan-963).
Regarding claim 20, Hildebrand in view of Aboul-Hosn suggests the blood pump system of claim 12. Hildebrand and Aboul-Hosn do not explicitly teach wherein the coupling member is fixedly coupled to a driveshaft tube that surrounds the driveshaft.
The prior art by Nitzan-963 is analogous to Hildebrand, as they both teach the use of a blood pump comprising impellers ([0036]).
Nitzan-963 teaches wherein the coupling member is fixedly coupled to a driveshaft tube that surrounds the driveshaft (the motor 143 is coupled to driveshaft 111 which is surrounded by a drive shaft tube sleeve 122 [0054]. Furthermore, the hypotube 119 is configured to surround the drive shaft tube sleeve 122 and the drive shaft 111 [0041, 0054, FIG. 2, FIG. 5]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the coupling member suggested by Hildebrand in view of Aboul-Hosn to be coupled to a driveshaft tube that surrounds the driveshaft, as taught by Nitzan-963. This modification is beneficial, as the tube will seal the driveshaft (see paragraphs [0041, 0054] by Nitzan-963).
8. Claims 10-11 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hildebrand et al. in view of Aboul-Hosn et al., further in view of Itamochi et al. (US 2018/0272055 A1).
Regarding claims 10 and 14, Hildebrand in view of Aboul-Hosn suggests the blood pump system of claims 9 and 12. Hildebrand and Aboul-Hosn does not explicitly teach wherein the second one or more access channels include a sensor holder configured to support one or more sensors therein.
The prior art by Itamochi is analogous to Hildebrand, as they both teach the use of a blood pump comprising a motor ([0026-0027]).
Itamochi teaches wherein the second one or more access channels include a sensor holder configured to support one or more sensors therein (the removable pressure sensor assembly 30 comprises a main body portion 31 (e.g., holder) that may be removably mounted at any location along the channels 11, 12, and/or 19 ([abstract, 0031-0032, 0036]. Specifically, the main body portion 31 (e.g., holder) is configured to be attached to the pressure measurement element 40 [abstract, 0036]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the access channels suggested by Hildebrand in view of Aboul-Hosn to coupled with a holder that supports one or more sensors, as taught by Itamochi. This modification is beneficial, as the holder will allow for removable attaching a sensor at any location along the tubes or channels (see the [abstract] and paragraphs [0031-0032, 0036] by Itamochi).
Regarding claims 11 and 15, Itamochi teaches wherein the one or more sensors includes a pressure sensor ([0031-0032, 0036]).
Statement on Communication via Internet
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For those applications where applicant wishes to communicate with the examiner via Internet communications, e.g., email or video conferencing tools, the following is a sample authorization form which may be used by applicant:
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Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.B.S./Examiner, Art Unit 3792
/ANKIT D TEJANI/Primary Examiner, Art Unit 3796