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 .
Information Disclosure Statement
The information disclosure statement(s) filed 09/06/2024, 07/31/2025, 04/14/2026, and 08/07/2026 has/have been considered by the Examiner.
Response to Arguments
Claim Objections
Applicant’s arguments, filed 08/07/2026, with respect to the claim objections to claims 11-13 and 15 have been fully considered and are persuasive. The claim objections of 05/07/2026 has been withdrawn.
Double Patenting
Applicant’s arguments, filed 08/07/2026, recites:
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However, no Terminal Disclaimer was found to be submitted in conjunction with the arguments. Therefore, the double patenting rejection is considered by the Examiner to be held in abeyance. To provide clarity, the double patenting rejection is presented again in this office action.
Claim Rejections - 35 USC § 102
Applicant’s arguments with respect to claim(s) 8-27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, the newly cited reference as taught by Walters (US 20120172656 A1 – hereinafter Walters), teaches a similar catheter pump apparatus comprising a curved atraumatic tip positioned distal of the at least one impeller blade/cannula, as required by claims 8, 17 and 24, in combination with the primary reference of Liebing (US 20170014562 A1 – hereinafter Liebing) as stated in the rejection below.
Information Disclosure Statement
The information disclosure statement(s) filed 09/06/2024 has/have been considered by the Examiner.
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 8-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 11,331,467 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims of U.S. application 18/827,046 are broader than the issued U.S. 11,331,467 B2 patent, and therefore the issued U.S. Patent 11,331,467 B2 anticipates the U.S. application 18/827,046 claims of the catheter pump comprising a cannula with an inlet, outlet, blood flow channel, axially movable impeller blade and the actuator, as shown in the table below, and are therefore indistinct.
U.S. Application 18/827,046
U.S. Patent 11,331,467 B2
A catheter pump comprising:
a cannula comprising
an inlet,
an outlet,
and a blood flow channel extending between the inlet and the outlet along a longitudinal axis of the cannula;
and at least one impeller blade being operable to convey blood through the blood flow channel between the inlet and the outlet;
wherein the at least one impeller blade is axially movable relative to the blood flow channel in a first direction toward the inlet and in a second direction away from the inlet.
A catheter pump, comprising:
an expandable cannula…
a single inlet zone including a flared portion that widens radially between a proximal end and a distal end to receive and securely engage a bearing assembly,
and an outlet zone
…defining a blood flow channel
and comprising an impeller blade zone, and an impeller system comprising an impeller body rotatably coupled to the bearing assembly, the impeller system movable relative to the expandable cannula along a longitudinal axis of the catheter pump,
wherein the catheter pump is selectively transitionable between a separated configuration in which the impeller body and the bearing assembly are axially spaced from the expandable cannula along the longitudinal axis, and an operational configuration in which the impeller body is positioned within the impeller blade zone of the expandable cannula and the bearing assembly is engaged with the flared portion, thereby securing the impeller system relative to the expandable cannula, and wherein when the catheter pump is in the separated configuration, the inlet zone includes the flared portion, such that the flared portion is not held open by the bearing assembly and such that the flared portion is sizeable and shapeable according to a size and a shape of the impeller body and the bearing assembly before the impeller body and the bearing assembly are received.
A catheter pump comprising:
a cannula comprising
an inlet,
an outlet,
and a blood flow channel extending between the inlet and the outlet;
and at least one impeller blade operable to convey blood through the blood flow channel from the inlet to the outlet;
wherein the at least one impeller blade is axially translatable relative to the blood flow channel between respectively different first and second positions.
A catheter pump, comprising:
an expandable cannula…
a single inlet zone including a flared portion that widens radially between a proximal end and a distal end to receive and securely engage a bearing assembly,
and an outlet zone
…defining a blood flow channel
and comprising an impeller blade zone, and an impeller system comprising an impeller body rotatably coupled to the bearing assembly, the impeller system movable relative to the expandable cannula along a longitudinal axis of the catheter pump,
wherein the catheter pump is selectively transitionable between a separated configuration in which the impeller body and the bearing assembly are axially spaced from the expandable cannula along the longitudinal axis, and an operational configuration in which the impeller body is positioned within the impeller blade zone of the expandable cannula and the bearing assembly is engaged with the flared portion, thereby securing the impeller system relative to the expandable cannula, and wherein when the catheter pump is in the separated configuration, the inlet zone includes the flared portion, such that the flared portion is not held open by the bearing assembly and such that the flared portion is sizeable and shapeable according to a size and a shape of the impeller body and the bearing assembly before the impeller body and the bearing assembly are received.
A catheter pump comprising:
an expandable cannula comprising
an inlet,
an outlet,
and a blood flow channel extending between the inlet and the outlet;
at least one impeller blade operable to convey blood from the inlet to the outlet,
wherein the at least one impeller blade is axially movable relative to the expandable cannula along a longitudinal axis;
and an actuator operable to adjust a relative axial spacing of the at least one impeller blade with respect to the inlet.
A catheter pump, comprising:
an expandable cannula…
a single inlet zone including a flared portion that widens radially between a proximal end and a distal end to receive and securely engage a bearing assembly,
and an outlet zone
…defining a blood flow channel
and comprising an impeller blade zone, and an impeller system comprising an impeller body rotatably coupled to the bearing assembly, the impeller system movable relative to the expandable cannula along a longitudinal axis of the catheter pump,
wherein the catheter pump is selectively transitionable between a separated configuration in which the impeller body and the bearing assembly are axially spaced from the expandable cannula along the longitudinal axis, and an operational configuration in which the impeller body is positioned within the impeller blade zone of the expandable cannula and the bearing assembly is engaged with the flared portion, thereby securing the impeller system relative to the expandable cannula, and wherein when the catheter pump is in the separated configuration, the inlet zone includes the flared portion, such that the flared portion is not held open by the bearing assembly and such that the flared portion is sizeable and shapeable according to a size and a shape of the impeller body and the bearing assembly before the impeller body and the bearing assembly are received.
The catheter pump of claim 1, further comprising:
an actuator configured to transition the catheter pump between the separated configuration and the operational configuration…
Claims 8-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 11,679,234 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims of U.S. application 18/827,046 are broader than the issued U.S. 11,679,234 B2 patent claims, and therefore the issued U.S. Patent 11,679,234 B2 anticipates the U.S. application 18/827,046 claims of the catheter pump comprising a cannula with an inlet, outlet, blood flow channel, axially movable impeller blade and the actuator, as shown in the table below, and are therefore indistinct.
U.S. Application 18/827,046
U.S. Patent 11,679,234 B2
A catheter pump comprising:
a cannula comprising
an inlet,
an outlet,
and a blood flow channel extending between the inlet and the outlet along a longitudinal axis of the cannula;
and at least one impeller blade being operable to convey blood through the blood flow channel between the inlet and the outlet;
wherein the at least one impeller blade is axially movable relative to the blood flow channel in a first direction toward the inlet and in a second direction away from the inlet.
A catheter pump comprising: an elongate body having a distal end and a proximal end opposite the distal end;
an expandable cannula
an inlet zone provided at a distal end of the impeller blade zone and adapted to securely engage a bearing assembly at the distal end
an outlet zone at a proximal end of the impeller blade zone;
defining a blood flow channel and comprising an impeller blade zone,
an impeller system comprising an impeller body rotatably coupled to the bearing assembly, the impeller system coupled to a distal portion of a drive shaft that extends through the elongate body, wherein the bearing assembly includes a basket bearing located distal of the impeller body;
and an actuator at a proximal end of the drive shaft, the actuator having an input device for selectively transitioning between a separated configuration and an operational configuration,
wherein, selecting the operational configuration causes the impeller body to translate proximally along a longitudinal axis such that the impeller body is positioned within the impeller blade zone of the expandable cannula and located axially near the expandable cannula along the longitudinal axis,
and the bearing assembly to securely engage the inlet zone of the expandable cannula to secure the impeller system relative to the expandable cannula without being completely disposed within a distal end of the expandable cannula, and wherein, selecting the separated configuration causes the impeller body to translate distally along a longitudinal axis such that the impeller body is positioned out of the impeller blade zone of the expandable cannula.
A catheter pump comprising:
a cannula comprising
an inlet,
an outlet, and
a blood flow channel extending between the inlet and the outlet;
and at least one impeller blade operable to convey blood through the blood flow channel from the inlet to the outlet;
wherein the at least one impeller blade is axially translatable relative to the blood flow channel between respectively different first and second positions.
A catheter pump comprising: an elongate body having a distal end and a proximal end opposite the distal end;
an expandable cannula
an inlet zone provided at a distal end of the impeller blade zone and adapted to securely engage a bearing assembly at the distal end
an outlet zone at a proximal end of the impeller blade zone;
defining a blood flow channel and comprising an impeller blade zone,
an impeller system comprising an impeller body rotatably coupled to the bearing assembly, the impeller system coupled to a distal portion of a drive shaft that extends through the elongate body, wherein the bearing assembly includes a basket bearing located distal of the impeller body;
and an actuator at a proximal end of the drive shaft, the actuator having an input device for selectively transitioning between a separated configuration and an operational configuration,
wherein, selecting the operational configuration causes the impeller body to translate proximally along a longitudinal axis such that the impeller body is positioned within the impeller blade zone of the expandable cannula and located axially near the expandable cannula along the longitudinal axis,
and the bearing assembly to securely engage the inlet zone of the expandable cannula to secure the impeller system relative to the expandable cannula without being completely disposed within a distal end of the expandable cannula, and wherein, selecting the separated configuration causes the impeller body to translate distally along a longitudinal axis such that the impeller body is positioned out of the impeller blade zone of the expandable cannula.
A catheter pump comprising:
an expandable cannula comprising
an inlet,
an outlet, and
a blood flow channel extending between the inlet and the outlet;
at least one impeller blade operable to convey blood from the inlet to the outlet,
wherein the at least one impeller blade is axially movable relative to the expandable cannula along a longitudinal axis;
and an actuator operable to adjust a relative axial spacing of the at least one impeller blade with respect to the inlet.
A catheter pump comprising: an elongate body having a distal end and a proximal end opposite the distal end;
an expandable cannula
an inlet zone provided at a distal end of the impeller blade zone and adapted to securely engage a bearing assembly at the distal end
an outlet zone at a proximal end of the impeller blade zone;
defining a blood flow channel and comprising an impeller blade zone,
an impeller system comprising an impeller body rotatably coupled to the bearing assembly, the impeller system coupled to a distal portion of a drive shaft that extends through the elongate body, wherein the bearing assembly includes a basket bearing located distal of the impeller body;
wherein, selecting the operational configuration causes the impeller body to translate proximally along a longitudinal axis such that the impeller body is positioned within the impeller blade zone of the expandable cannula and located axially near the expandable cannula along the longitudinal axis,
and an actuator at a proximal end of the drive shaft, the actuator having an input device for selectively transitioning between a separated configuration and an operational configuration,
and the bearing assembly to securely engage the inlet zone of the expandable cannula to secure the impeller system relative to the expandable cannula without being completely disposed within a distal end of the expandable cannula, and wherein, selecting the separated configuration causes the impeller body to translate distally along a longitudinal axis such that the impeller body is positioned out of the impeller blade zone of the expandable cannula.
Claims 8-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-8 of U.S. Patent No. 12,097,333 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims of U.S. application 18/827,046 are broader than the issued U.S. 12,097,333 B2 patent claims, and therefore the issued U.S. Patent 12,097,333 B2 anticipates the U.S. application 18/827,046 claims of the catheter pump comprising a cannula with an inlet, outlet, blood flow channel, axially movable impeller blade and the actuator, as shown in the table below, and are therefore indistinct.
Claims 24-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7-8 of U.S. Patent No. 12,097,333 B2 in view of Liebing (US 20170014562 A1 – hereinafter Liebing). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims 24-27 of U.S. application 18/827,046 are taught by the issued U.S. 12,097,333 B2 patent claims, including to the catheter pump comprising a cannula with an inlet, outlet, blood flow channel, axially movable impeller blade and the actuator, as shown in the table below; however, the U.S. Patent 12,097,333 B2 does not explicitly teach the actuator operable to adjust a relative axial spacing of the at least one impeller blade with respect to the inlet.
Liebing teaches a catheter pump (figure 1, catheter 4 with fluid pump 3) comprising an impeller (figure 3, rotor 7), and an actuator (rotation drive, figure 11; paragraph 0060 – “FIG. 11. the proximal end of a drive shaft with a coupling to a rotation drive…”) operable to adjust a relative axial spacing of the at least one impeller blade with respect to the inlet (paragraph 0084 – “FIG. 11 shows the proximal end of the shaft 8 and its coupling to a drive, which is to permit an axial displacement ability of the drive shaft by 10 to 14 mm…to be able to pull back the bearing arrangement and the rotor into the pump housing by way of pulling back the drive shaft”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify catheter pump of the U.S. Patent 12,097,333 B2, to incorporate the actuator as taught by Liebing, since such modification would predictably result in controlling and allowing the rotor to move in and out of the pump housing.
U.S. Application 18/827,046
U.S. Patent 12,097,333 B2
A catheter pump comprising:
a cannula comprising
an inlet,
an outlet,
and a blood flow channel extending between the inlet and the outlet along a longitudinal axis of the cannula;
and at least one impeller blade being operable to convey blood through the blood flow channel between the inlet and the outlet;
wherein the at least one impeller blade is axially movable relative to the blood flow channel in a first direction toward the inlet
and in a second direction away from the inlet.
A catheter pump comprising:
a cannula comprising
a blood flow inlet zone having an increasing outer diameter culminating at a first maximum outer diameter,
a blood flow outlet zone having a decreasing outer diameter starting from a second maximum outer diameter,
and a blood flow channel extending between the inlet zone and the outlet zone, wherein the first maximum outer diameter is greater than the second maximum outer diameter;
and an impeller system comprising a rotatable impeller body operable to convey blood from the inlet zone to the outlet zone.
8. The catheter pump of claim 7,
wherein the impeller body is received within the cannula in an operational position.
7. The catheter pump of claim 1,
wherein the impeller body is axially spaced from the cannula in a separated position.
The catheter pump of claim 12, wherein the cannula is expandable.
The catheter pump of claim 1, wherein the cannula is expandable.
The catheter pump of claim 13, wherein the cannula includes a shape memory material.
The catheter pump of claim 5, wherein the cannula includes a shape memory material.
A catheter pump comprising:
a cannula comprising
an inlet,
an outlet,
and a blood flow channel extending between the inlet and the outlet;
and at least one impeller blade operable to convey blood through the blood flow channel from the inlet to the outlet;
wherein the at least one impeller blade is axially translatable relative to the blood flow channel between respectively different first
and second positions.
A catheter pump comprising:
a cannula comprising
a blood flow inlet zone having an increasing outer diameter culminating at a first maximum outer diameter,
a blood flow outlet zone having a decreasing outer diameter starting from a second maximum outer diameter,
and a blood flow channel extending between the inlet zone and the outlet zone, wherein the first maximum outer diameter is greater than the second maximum outer diameter;
and an impeller system comprising a rotatable impeller body operable to convey blood from the inlet zone to the outlet zone.
8. The catheter pump of claim 7,
wherein the impeller body is received within the cannula in an operational position.
7. The catheter pump of claim 1,
wherein the impeller body is axially spaced from the cannula in a separated position.
The catheter pump of claim 17, wherein the cannula is expandable.
The catheter pump of claim 1, wherein the cannula is expandable.
The catheter pump of claim 22, wherein the cannula includes a shape memory material.
The catheter pump of claim 5, wherein the cannula includes a shape memory material.
A catheter pump comprising:
an expandable cannula comprising
an inlet,
an outlet,
and a blood flow channel extending between the inlet and the outlet;
at least one impeller blade operable to convey blood from the inlet to the outlet,
wherein the at least one impeller blade is axially movable relative to the expandable cannula along a longitudinal axis;
and an actuator operable to adjust a relative axial spacing of the at least one impeller blade with respect to the inlet.
A catheter pump comprising:
a cannula comprising
a blood flow inlet zone having an increasing outer diameter culminating at a first maximum outer diameter,
a blood flow outlet zone having a decreasing outer diameter starting from a second maximum outer diameter,
and a blood flow channel extending between the inlet zone and the outlet zone, wherein the first maximum outer diameter is greater than the second maximum outer diameter;
and an impeller system comprising a rotatable impeller body operable to convey blood from the inlet zone to the outlet zone.
8. The catheter pump of claim 7,
wherein the impeller body is received within the cannula in an operational position.
7. The catheter pump of claim 1,
wherein the impeller body is axially spaced from the cannula in a separated position.
Claims 8-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-17, 19-22 of U.S. Patent No. 12,109,367 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims of U.S. application 18/827,046 AND the issued U.S. 11,679,234 B2 patent claims, are substantially directed to the catheter pumps comprising a cannula with an inlet, outlet, blood flow channel, axially movable impeller blade and the actuator, as shown in the table below, and are therefore indistinct.
U.S. Application 18/827,046
U.S. Patent 12,109,367 B2
A catheter pump comprising:
a cannula comprising
an inlet,
an outlet,
and a blood flow channel extending between the inlet and the outlet along a longitudinal axis of the cannula;
and at least one impeller blade being operable to convey blood through the blood flow channel between the inlet and the outlet;
wherein the at least one impeller blade is axially movable relative to the blood flow channel in a first direction toward the inlet and in a second direction away from the inlet.
A catheter pump comprising:
a cannula comprising
an inlet,
an outlet,
and a blood flow channel extending between the inlet and the outlet along a longitudinal axis, wherein the blood flow channel has a constant diameter along the longitudinal axis and wherein at least the inlet has a variable diameter along the longitudinal axis;
and at least one impeller blade being operable to convey blood through the blood flow channel between the inlet and the outlet;
wherein the at least one impeller blade is axially movable relative to the cannula in a first direction toward the inlet and in a second direction away from the inlet.
The catheter pump of claim 8,
wherein the at least one impeller blade is selectively positionable relative to the blood flow channel between a first position and a second position,
wherein the at least one impeller blade is inside the blood flow channel in at least the first position.
The catheter pump of claim 1,
wherein the at least one impeller blade is selectively positionable relative to the inlet between a first predetermined position and a second predetermined position, and
wherein the at least one impeller blade is operable to convey blood through the blood flow channel in at least one of the first predetermined position and the second predetermined position.
The catheter pump of claim 9, wherein the at least one impeller blade is separated from the blood flow channel in the second position.
The catheter pump of claim 2, wherein the at least one impeller blade is at least partly separated from the cannula in at least one of the first and second predetermined positions.
The catheter pump of claim 11, wherein the at least one impeller blade is collapsible.
The catheter pump of claim 3, wherein the at least one impeller blade is collapsible.
The catheter pump of claim 12, wherein the cannula is expandable.
The catheter pump of claim 4, wherein the cannula is expandable.
The catheter pump of claim 13, wherein the cannula includes a shape memory material.
The catheter pump of claim 5, wherein the cannula includes a shape memory material.
The catheter pump of claim 9, further comprising an actuator operable to cause a relative repositioning of the at least one impeller blade between the first and second positions.
The catheter pump of claim 2, further comprising an actuator operable to cause a relative repositioning of the at least one impeller blade between the first and second predetermined positions.
The catheter pump of claim 15, wherein the actuator includes a knob, a button, a spring, or a motor.
The catheter pump of claim 7, wherein the actuator includes a knob, a button, a spring, or a motor.
The catheter pump of claim 8, wherein the at least one impeller blade is slidably movable within the blood flow channel.
The catheter pump of claim 1, wherein the at least one impeller blade is slidably movable within the blood flow channel.
A catheter pump comprising:
a cannula comprising
an inlet,
an outlet,
and a blood flow channel extending between the inlet and the outlet;
and at least one impeller blade operable to convey blood through the blood flow channel from the inlet to the outlet;
wherein the at least one impeller blade is axially translatable relative to the blood flow channel between respectively different first and second positions.
11. A catheter pump comprising:
a cannula comprising
an inlet having a varying internal diameter,
an outlet having a varying internal diameter,
and a blood flow channel having a uniform internal diameter extending between the inlet and the outlet;
and at least one impeller blade operable to convey blood through the blood flow channel from the inlet to the outlet;
wherein the at least one impeller blade is axially translatable relative to the cannula between respectively different first and second positions.
The catheter pump of claim 17,
wherein in the first position the at least one impeller blade is entirely within the blood flow channel.
The catheter pump of claim 11,
wherein in the first position the at least one impeller blade is entirely within the blood flow channel.
The catheter pump of claim 18, wherein in the second position the at least one impeller blade is at least partially withdrawn from the blood flow channel.
The catheter pump of claim 12, wherein in the second position the at least one impeller blade is at least partially withdrawn from the blood flow channel.
The catheter pump of claim 19,
further comprising an actuator configured to cause a transition of the at least one impeller blade between the first and second positions.
The catheter pump of claim 13,
further comprising an actuator configured to cause a transition of the at least one impeller blade between the first and second positions.
The catheter pump of claim 20,
wherein the actuator includes a knob, a button, a spring, or a motor.
The catheter pump of claim 14,
wherein the actuator includes a knob, a button, a spring, or a motor.
The catheter pump of claim 17, wherein the cannula is expandable.
The catheter pump of claim 11, wherein the cannula is expandable.
The catheter pump of claim 22, wherein the cannula includes a shape memory material.
The catheter pump of claim 15, wherein the cannula includes a shape memory material.
A catheter pump comprising:
an expandable cannula comprising
an inlet,
an outlet,
and a blood flow channel extending between the inlet and the outlet;
at least one impeller blade operable to convey blood from the inlet to the outlet,
wherein the at least one impeller blade is axially movable relative to the expandable cannula along a longitudinal axis;
and an actuator operable to adjust a relative axial spacing of the at least one impeller blade with respect to the inlet.
A catheter pump comprising:
an expandable cannula comprising
a tapered inlet zone,
a tapered outlet zone,
and a blood flow channel extending between the tapered inlet zone and the tapered outlet zone;
at least one impeller blade operable to convey blood from the inlet to the outlet,
wherein the at least one impeller blade is axially movable relative to the expandable cannula along a longitudinal axis;
and an actuator operable to adjust a relative axial spacing of the at least one impeller blade with respect to the inlet.
The catheter pump of claim 24, further comprising an impeller body, wherein the impeller body is slidably moveable within the blood flow channel between a first adjusted position and a second adjusted position.
The catheter pump of claim 19, further comprising an impeller body, wherein the impeller body is slidably moveable within the blood flow channel between a first adjusted position and a second adjusted position.
The catheter pump of claim 24, wherein the at least one impeller blade is at least partially separated from the inlet in one of the first and second adjusted positions.
The catheter pump of claim 19, wherein the at least one impeller blade is at least partially separated from the tapered inlet in one of the first and second adjusted positions.
The catheter pump of claim 24, wherein the actuator includes a knob, a button, a spring, or a motor.
The catheter pump of claim 19, wherein the actuator includes a knob, a button, a spring, or a motor.
Claim Interpretation
The term(s) “operable to” and “configured to” in the claim(s) may be interpreted as intended use. Intended use/functional language does not require that references teach or disclose the intended use of an element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART.
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.
Claim(s) 8-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liebing (US 20170014562 A1 – hereinafter Liebing) [previously cited] in view of Walters (US 20120172656 A1 – hereinafter Walters) [NEW].
Re. claim 8, Liebing teaches catheter pump (figure 1, catheter 4 with fluid pump 3) comprising:
a cannula (figure 3, pump housing 6) comprising
an inlet (figure 3 shows the fixation ring 19 placed at the inlet),
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an outlet (figure 3, outlet where the driveshaft 8 extends from),
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and a blood flow channel extending between the inlet and the outlet along a longitudinal axis of the cannula (paragraph 0065 – “…a fluid pump 3 is introduced into the heart chamber 1, which there sucks blood and pumps this into the blood vessel 2”);
and at least one impeller blade being operable to convey blood through the blood flow channel between the inlet and the outlet (figure 3, rotor 7; paragraph 0066 – “The rotor 7 is rotatably mounted on a drive shaft 8 and comprises delivery elements, which on rotation suck the blood in the direction of the arrows 9 or eject it in the direction of the arrows 10 into the blood vessel 2”);
wherein the at least one impeller blade is axially movable relative to the blood flow channel in a first direction toward the inlet and in a second direction away from the inlet (figures 3-4; paragraph 0084 – “…to be able to pull back the bearing arrangement and the rotor into the pump housing by way of pulling back the drive shaft”).
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Liebing teaches the claimed invention as stated above, but does not expressly teach an atraumatic tip positioned distal of the at least one impeller blade, the atraumatic tip having an arcuate configuration.
Walters similarly teaches a catheter pump (abstract – “A heart pump and a catheter assembly therefor are provided that include a flexible catheter body having a proximal end and a distal end, the catheter body having a plurality of lumens therethrough”), comprising an impeller assembly (figure 1A, impeller assembly 116),
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and an atraumatic tip positioned distal of the at least one impeller blade, the atraumatic tip having an arcuate configuration (figure 1A, arcuate atraumatic tip 182 positioned distal to the impeller assembly 116, which contains impeller 200 with blades 212; paragraph 0053 – “FIGS. 1A and 2 also show that the distal end 108 of the catheter assembly 100 includes an atraumatic tip 182 disposed distal of the impeller assembly 116 in one embodiment. FIG. 1A shows that the atraumatic tip 182 can have an arcuate configuration such that interactions with the vasculature are minimally traumatic”; paragraph 0054 – “The impeller assembly 116 can take any suitable form, but in various embodiments, includes an impeller 200 adapted to move a fluid such as blood from an inlet to an outlet of the catheter assembly 100”; paragraph 0055 – “FIG. 3 shows that the impeller 200 includes a shaft 204, a central body or hub 208, and one or more blades 212”).
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Therefore, 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 catheter pump of Liebing, to incorporate the arcuate atraumatic tip as taught by Walters, since such modification would predictably result in ensuring interactions with the catheter pump and vasculature are minimally traumatic (Walters paragraph 0053).
Re. claim 9, Liebing of the combined invention further teaches wherein the at least one impeller blade is selectively positionable relative to the blood flow channel between a first position and a second position (figures 3-4 show the rotor outside and inside the pump housing 6, respectively),
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wherein the at least one impeller blade is inside the blood flow channel in at least the first position (figure 4).
Re. claim 10, Liebing of the combined invention further teaches wherein the at least one impeller blade is separated from the blood flow channel in the second position (figure 3).
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Re. claim 11, Liebing of the combined invention further teaches wherein the at least one impeller blade is collapsible (paragraph 0071 – “The constructional shape of the rotor may also differ from that which has been described above, by way of using collapsible or pivotable elements, in order to form a delivery blade surface”).
Re. claim 12, Liebing of the combined invention further teaches wherein the cannula is expandable (paragraph 0021 – “Additionally to the outlined embodiments of the pump housing and the rotor, also other compressible and expandable construction shapes are conceivable for the application of the invention”; paragraph 0045 – “The invention apart from a fluid pump device of the initially mentioned type, also relates to a method for operation of such a device, wherein one envisages the fluid pump device in the compressed condition being brought to a location of application, thereafter at least partly expanding the pump housing and thereafter displacing the pump housing…”).
Re. claim 13, Liebing of the combined invention further teaches wherein the cannula includes a shape memory material (paragraph 0020 – “The pump housing may for example consist of an elastic framework, e.g. of a memory alloy or of a plastic, which is coated with a membrane, for example of polyurethane”).
Re. claim 14, Liebing of the combined invention further teaches an actuator (rotation drive, figure 11; paragraph 0060 – “FIG. 11. the proximal end of a drive shaft with a coupling to a rotation drive…”) operable to cause a relative repositioning of the at least one impeller blade between the first and second positions (paragraph 0084 – “FIG. 11 shows the proximal end of the shaft 8 and its coupling to a drive, which is to permit an axial displacement ability of the drive shaft by 10 to 14 mm, in order after the introduction of the individual elements of the fluid pump to the application location, to be able to pull back the bearing arrangement and the rotor into the pump housing by way of pulling back the drive shaft”).
Re. claim 15, Liebing of the combined invention further teaches wherein the actuator includes a knob, a button, a spring, or a motor (drive shaft 8 connected to a motor, disclosed by paragraph 0017 – “Furthermore, in the first mentioned case, there is also the possibility of applying a more suitable pull means additionally to a drive shaft”; paragraph 0018 – “Such a pull means may for example be a cable of plastic or a wire cable or also a wire or any other suitable pull means. In the case of the use of an implantable miniature electric motor, one could for example also use the cable necessary for operation of the motor, as a pull means…”).
Re. claim 16, Liebing of the combined invention further teaches wherein the at least one impeller blade is slidably movable within the blood flow channel (figures 3-4; paragraph 0084 – “…to be able to pull back the bearing arrangement and the rotor into the pump housing by way of pulling back the drive shaft”).
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Re. claim 17, Liebing teaches a catheter pump (figure 1, catheter 4) comprising:
a cannula (figure 3, pump housing 6) comprising
an inlet (figure 3 shows the fixation ring 19 placed at the inlet),
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an outlet (figure 3, outlet where the driveshaft 8 extends from),
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and a blood flow channel extending between the inlet and the outlet (paragraph 0065 – “…a fluid pump 3 is introduced into the heart chamber 1, which there sucks blood and pumps this into the blood vessel 2”);
and at least one impeller blade operable to convey blood through the blood flow channel from the inlet to the outlet (figure 3, rotor 7; paragraph 0066 – “The rotor 7 is rotatably mounted on a drive shaft 8 and comprises delivery elements, which on rotation suck the blood in the direction of the arrows 9 or eject it in the direction of the arrows 10 into the blood vessel 2”);
wherein the at least one impeller blade is axially translatable relative to the blood flow channel between respectively different first and second positions (figures 3-4; paragraph 0084 – “…to be able to pull back the bearing arrangement and the rotor into the pump housing by way of pulling back the drive shaft”).
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Liebing teaches the claimed invention as stated above, but does not expressly teach a curved tip portion extending distally of the cannula.
Walters similarly teaches a catheter pump (abstract – “A heart pump and a catheter assembly therefor are provided that include a flexible catheter body having a proximal end and a distal end, the catheter body having a plurality of lumens therethrough”), comprising an impeller assembly (figure 1A, impeller assembly 116),
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and a curved atraumatic tip positioned distal of the cannula (figure 1A, arcuate atraumatic tip 182 positioned distal to the impeller housing 202; paragraph 0053 – “FIGS. 1A and 2 also show that the distal end 108 of the catheter assembly 100 includes an atraumatic tip 182 disposed distal of the impeller assembly 116 in one embodiment. FIG. 1A shows that the atraumatic tip 182 can have an arcuate configuration such that interactions with the vasculature are minimally traumatic”).
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Therefore, 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 catheter pump of Liebing, to incorporate the curved atraumatic tip as taught by Walters, since such modification would predictably result in ensuring interactions with the catheter pump and vasculature are minimally traumatic (Walters paragraph 0053).
Re. claim 18, Liebing of the combined invention further teaches wherein in the first position the at least one impeller blade is entirely within the blood flow channel (figure 4).
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Re. claim 19, Liebing of the combined invention further teaches wherein in the second position the at least one impeller blade is at least partially withdrawn from the blood flow channel (Liebing teaches that the rotor 7 can be axially moved in paragraph 0084 – “…to be able to pull back the bearing arrangement and the rotor into the pump housing by way of pulling back the drive shaft”. Furthermore, it is reminded that if the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART. Therefore, it is considered by the Examiner that the pump as taught Liebing is capable of partially withdrawing the rotor 7 from the pump housing 6, and therefore meets the claim).
Re. claim 20, Liebing of the combined invention further teaches an actuator (rotation drive, figure 11; paragraph 0060 – “FIG. 11. the proximal end of a drive shaft with a coupling to a rotation drive…”),
configured to cause a transition of the at least one impeller blade between the first and second positions (paragraph 0084 – “FIG. 11 shows the proximal end of the shaft 8 and its coupling to a drive, which is to permit an axial displacement ability of the drive shaft by 10 to 14 mm, in order after the introduction of the individual elements of the fluid pump to the application location, to be able to pull back the bearing arrangement and the rotor into the pump housing by way of pulling back the drive shaft”).
Re. claim 21, Liebing of the combined invention further teaches wherein the actuator includes a knob, a button, a spring, or a motor (drive shaft 8 connected to a motor, disclosed by paragraph 0017 – “Furthermore, in the first mentioned case, there is also the possibility of applying a more suitable pull means additionally to a drive shaft”; paragraph 0018 – “Such a pull means may for example be a cable of plastic or a wire cable or also a wire or any other suitable pull means. In the case of the use of an implantable miniature electric motor, one could for example also use the cable necessary for operation of the motor, as a pull means…”).
Re. claim 22, Liebing of the combined invention further teaches wherein the cannula is expandable (paragraph 0021 – “Additionally to the outlined embodiments of the pump housing and the rotor, also other compressible and expandable construction shapes are conceivable for the application of the invention”; paragraph 0045 – “The invention apart from a fluid pump device of the initially mentioned type, also relates to a method for operation of such a device, wherein one envisages the fluid pump device in the compressed condition being brought to a location of application, thereafter at least partly expanding the pump housing and thereafter displacing the pump housing…”).
Re. claim 23, Liebing of the combined invention further teaches wherein the cannula includes a shape memory material (paragraph 0020 – “The pump housing may for example consist of an elastic framework, e.g. of a memory alloy or of a plastic, which is coated with a membrane, for example of polyurethane”).
Re. claim 24, Liebing teaches catheter pump comprising:
an expandable cannula (paragraph 0045 - “The invention apart from a fluid pump device of the initially mentioned type, also relates to a method for operation of such a device, wherein one envisages the fluid pump device in the compressed condition being brought to a location of application, thereafter at least partly expanding the pump housing…”) comprising
an inlet (figure 3 shows the fixation ring 19 placed at the inlet),
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an outlet (figure 3, outlet where the driveshaft 8 extends from),
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and a blood flow channel extending between the inlet and the outlet (paragraph 0065 – “…a fluid pump 3 is introduced into the heart chamber 1, which there sucks blood and pumps this into the blood vessel 2”);
at least one impeller blade operable to convey blood from the inlet to the outlet (figure 3, rotor 7; paragraph 0066 – “The rotor 7 is rotatably mounted on a drive shaft 8 and comprises delivery elements, which on rotation suck the blood in the direction of the arrows 9 or eject it in the direction of the arrows 10 into the blood vessel 2”);
wherein the at least one impeller blade is axially movable relative to the expandable cannula along a longitudinal axis (figures 3-4; paragraph 0084 – “…to be able to pull back the bearing arrangement and the rotor into the pump housing by way of pulling back the drive shaft”);
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and an actuator (rotation drive, figure 11; paragraph 0060 – “FIG. 11. the proximal end of a drive shaft with a coupling to a rotation drive…”) operable to adjust a relative axial spacing of the at least one impeller blade with respect to the inlet (paragraph 0084 – “FIG. 11 shows the proximal end of the shaft 8 and its coupling to a drive, which is to permit an axial displacement ability of the drive shaft by 10 to 14 mm…to be able to pull back the bearing arrangement and the rotor into the pump housing by way of pulling back the drive shaft”).
Liebing teaches the claimed invention as stated above, but does not expressly teach a tip portion having an arcuate configuration, the tip portion disposed distally of the at least one impeller blade.
Walters similarly teaches a catheter pump (abstract – “A heart pump and a catheter assembly therefor are provided that include a flexible catheter body having a proximal end and a distal end, the catheter body having a plurality of lumens therethrough”), comprising an impeller assembly (figure 1A, impeller assembly 116),
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and a tip portion having an arcuate configuration, the tip portion disposed distally of the at least one impeller blade (figure 1A, arcuate atraumatic tip 182 positioned distal to the impeller assembly 116, which contains impeller 200 with blades 212; paragraph 0053 – “FIGS. 1A and 2 also show that the distal end 108 of the catheter assembly 100 includes an atraumatic tip 182 disposed distal of the impeller assembly 116 in one embodiment. FIG. 1A shows that the atraumatic tip 182 can have an arcuate configuration such that interactions with the vasculature are minimally traumatic”; paragraph 0054 – “The impeller assembly 116 can take any suitable form, but in various embodiments, includes an impeller 200 adapted to move a fluid such as blood from an inlet to an outlet of the catheter assembly 100”; paragraph 0055 – “FIG. 3 shows that the impeller 200 includes a shaft 204, a central body or hub 208, and one or more blades 212”).
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Therefore, 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 catheter pump of Liebing, to incorporate the curved atraumatic tip distal to the impeller as taught by Walters, since such modification would predictably result in ensuring interactions with the catheter pump and vasculature are minimally traumatic (Walters paragraph 0053).
Re. claim 25, Liebing of the combined invention further teaches an impeller body (figure 3, rotor 7), wherein the impeller body is slidably moveable within the blood flow channel between a first adjusted position and a second adjusted position (figures 3-4; paragraph 0084 – “…to be able to pull back the bearing arrangement and the rotor into the pump housing by way of pulling back the drive shaft”);
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Re. claim 26, Liebing of the combined invention further teaches wherein the at least one impeller blade is at least partially separated from the inlet in one of the first and second adjusted positions (Liebing teaches that the rotor 7 can be axially moved in paragraph 0084 – “…to be able to pull back the bearing arrangement and the rotor into the pump housing by way of pulling back the drive shaft”. Furthermore, it is reminded that if the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART. Therefore, it is considered by the Examiner that the pump as taught Liebing is capable of partially withdrawing the rotor 7 from the pump housing 6, and therefore meets the claim).
Re. claim 27, Liebing of the combined invention further teaches wherein the actuator includes a knob, a button, a spring, or a motor (drive shaft 8 in figure 3 is connected to a motor, disclosed by paragraph 0017 – “Furthermore, in the first mentioned case, there is also the possibility of applying a more suitable pull means additionally to a drive shaft”; paragraph 0018 – “Such a pull means may for example be a cable of plastic or a wire cable or also a wire or any other suitable pull means. In the case of the use of an implantable miniature electric motor, one could for example also use the cable necessary for operation of the motor, as a pull means…”).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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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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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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