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 01/08/2025 has/have been considered by the Examiner.
Claim Interpretation
In accordance to MPEP 2111.04, such term(s) as “configured to” in the claim(s) do not limit claim scope to the particular function performed, and merely suggest optional functionality since the claim does not introduce any structure that positively recites and limits the features of the invention for exclusive use as intended. Absent limiting structural features, limitations following said clauses will be interpreted as recitations of intended use, wherein prior art will be evaluated based on its capability of performing and its suitability for the intended use. 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. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim, Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5, 8-9 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Reitan (US 20120059460 A1 – hereinafter Reitan).
Re. claim 1, Reitan teaches apparatus, comprising:
a left-ventricular assist device configured to assist left-ventricular functioning of a subject (paragraph 0004 – “The insertion of the pump is accomplished via a puncture in the arterial system, preferably in the femoral artery in the groin through an introducer sheath…The blood pressure decrease created in the upper part of the aorta facilitates the ejection of the left ventricle”; figure 1),
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the left-ventricular assist device comprising:
a frame (figure 1, cage 2);
a rigid axial shaft extending from a proximal end of the frame to a distal end of the frame (figure 1, drive shaft 4);
an impeller disposed on the rigid axial shaft;
a motor configured to be disposed outside a body of the subject (figure 1, rotor/propeller 3);
a flexible drive cable configured to extend from outside the subject's body to the axial shaft, the drive cable being configured to impart rotational motion from the motor to the rigid axial shaft, to thereby rotate the impeller (figure 1, drive cable 5 which connects to an external drive unit; paragraph 0009 – “The drive unit contains the DC motor and is positioned at the bed side of the patient and has a magnetic coupling for connection to the catheter pump at one end (the drive coupling). The other end of the drive unit is connected to the console via an electric cable”; paragraph 0034 – “FIG. 1 shows the distal end of a first embodiment of the catheter according the invention. 1 is the pumphead consisting of a cage 2 enclosing the propeller 3 on a drive shaft 4 connected to a drive cable 5 running through a sleeve 6”).
Re. claim 3, Reitan further teaches wherein the drive cable is coupled to the rigid axial shaft via a welding overtube (figure 1, elongated sleeve 6 connecting the drive cable 5 to the drive shaft 4).
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Re. claim 5, Reitan further teaches wherein the rigid axial shaft comprises a rigid tube that defines a lumen therethrough (paragraph 0007 – “One-third of the fluid is returned via the internal drive shaft lumen…”; figure 1 shows the drive shaft 4 as a tube).
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Re. claim 8, Reitan further teaches wherein the impeller comprises proximal and distal bushings (figure 1, arrows labeled 22 are interpreted as proximal and distal bushings), and defines an axial lumen that extends from the proximal bushing to the distal bushing, and wherein the rigid axial shaft is disposed within the lumen (figure 1, arrows labeled 22 interpreted as proximal and distal bushings shows the drive shaft 4 which extends through the proximal and distal bushings 22).
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Re. claim 9, Reitan further teaches wherein a first one of the proximal and distal bushings of the impeller is axially-fixed to the axial shaft, such that the first bushing is held in an axially- fixed position with respect to the axial shaft, and a second one of the proximal and distal bushings of the impeller is not axially-fixed to the axial shaft, and wherein the impeller is configured to become axially elongated by the second bushing sliding distally along the axial shaft (figures 1-2 shows that the impeller can be axially elongated from the bushings 22; paragraph 0035 – “FIG. 2 shows the pumphead 1 in insertion position together with an introducer 8. The extension 7 is from its natural form shown in FIG. 1 stretched out and inserted partly into the introducer 8”; abstract – “…the propeller (3) and the cage (2) are foldable from an insertion position close to the drive shaft (4) to an expanded working position, characterized by means (7, 7a, 2a, 19)…”).
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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) 2, 4, 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reitan (US 20120059460 A1 – hereinafter Reitan) in view of Shifflette (US 20080306327 A1 – hereinafter Shifflette).
Re. claim 2, Reitan teaches the claimed invention of claim 1 in its entirety, but does not expressly teach wherein the drive cable comprises a plurality of coiled wires.
Shifflette teaches a similar ventricular drive cable system (paragraph 0051 – “The drive cables described herein are not limited for use in catheter blood pumps. Rather, they are suitable for use in any medical device that requires a torque-transmission cable within a curved portion of the anatomy, such as, for example, within other parts of the vasculature, the gastrointestinal tract, or the spinal canal/ventricular system of the brain”), comprising drive cables (figure 2B, drive cable 126A) further comprising five segments (230A-230C and 234A-234B; paragraph 0085 – “Turning now to FIG. 2A, drive cable 126A comprises a plurality of discrete segments, and is therefore referred to as a "composite" drive cable. By way of illustration, but not limitation, drive cable 126A depicted in FIG. 2A includes five discrete segments 230A, 230B, 230C, 234A, and 234B”) made of a plurality of coiled wires (paragraph 0091 – “Each of the segments 234 in the second group has a structural configuration that renders it flexible enough to rotate while conforming to a curved path. In the illustrative embodiment, segments 234 are configured as coils, which are preferably, but not necessarily, hollow (i.e., have lumens)”).
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 drive cable of Reitan, to try incorporating the plurality of coiled wires as taught by Shifflette, since such modification would predictably result in providing configuration flexibility (bending and retraction).
Re. claim 4, Reitan further teaches the axial shaft comprises a lumen (paragraph 0007 – “One-third of the fluid is returned via the internal drive shaft lumen…”).
Reitan does not expressly disclose the drive cable lumen.
Shifflette teaches a similar ventricular drive cable system (paragraph 0051 – “The drive cables described herein are not limited for use in catheter blood pumps. Rather, they are suitable for use in any medical device that requires a torque-transmission cable within a curved portion of the anatomy, such as, for example, within other parts of the vasculature, the gastrointestinal tract, or the spinal canal/ventricular system of the brain”), comprising drive cables (figure 2B, drive cable 126A) further comprising five segments (230A-230C and 234A-234B; paragraph 0085 – “Turning now to FIG. 2A, drive cable 126A comprises a plurality of discrete segments, and is therefore referred to as a "composite" drive cable. By way of illustration, but not limitation, drive cable 126A depicted in FIG. 2A includes five discrete segments 230A, 230B, 230C, 234A, and 234B”) made of a plurality of coiled wires with a lumen (paragraph 0091 – “Each of the segments 234 in the second group has a structural configuration that renders it flexible enough to rotate while conforming to a curved path. In the illustrative embodiment, segments 234 are configured as coils, which are preferably, but not necessarily, hollow (i.e., have lumens)”).
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 apparatus of Reitan, specifically the drive cable of Reitan, to try incorporating the plurality of coiled wires with the lumen as taught by Shifflette to create the continuous lumen, since such modification would predictably result in allowing fluid flow through the lumen.
Re. claims 6-7, Reitan teaches the drive cable as stated above (figure 1, drive cable 5).
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But does not expressly teach wherein the drive cable comprises a plurality of different portions, and Reitan teaches the claimed invention of claim 1 as stated above, but does not expressly teach wherein the drive cable comprises a plurality of coiled wires.
Shifflette teaches a similar ventricular drive cable system (paragraph 0051 – “The drive cables described herein are not limited for use in catheter blood pumps. Rather, they are suitable for use in any medical device that requires a torque-transmission cable within a curved portion of the anatomy, such as, for example, within other parts of the vasculature, the gastrointestinal tract, or the spinal canal/ventricular system of the brain”), comprising drive cables (figure 2B, drive cable 126A) further comprising five segments (230A-230C and 234A-234B; paragraph 0085 – “Turning now to FIG. 2A, drive cable 126A comprises a plurality of discrete segments, and is therefore referred to as a "composite" drive cable. By way of illustration, but not limitation, drive cable 126A depicted in FIG. 2A includes five discrete segments 230A, 230B, 230C, 234A, and 234B”) made of a plurality of coiled wires (paragraph 0091 – “Each of the segments 234 in the second group has a structural configuration that renders it flexible enough to rotate while conforming to a curved path. In the illustrative embodiment, segments 234 are configured as coils, which are preferably, but not necessarily, hollow (i.e., have lumens)”).
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 drive cable of Reitan, to try incorporating the plurality of coiled wires as taught by Shifflette, since such modification would predictably result in providing configuration flexibility (bending and retraction).
The combined invention does not expressly teach wherein the drive cable comprises a plurality of different portions having respective characteristics that are different from each other, and respective different numbers of coiled wires are disposed in respective portions of the drive cable.
However, it is reminded that limitations regarding the number of coiled wires in each respective section holds no patentable significance unless a new and unexpected result is produced, as per in re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), see MPEP 2144.04. The drive cable of the combined invention as stated above, regardless of its portions/sections and their number of coiled wires, would not change its operation in connecting the impeller to a motor for actuation.
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 drive cable of the combined invention, specifically of Shifflette as stated above, to try numbers of coiled wires for each section of the drive cable, since such modification would still predictably result in connecting the drive shaft to the drive source for impeller actuation.
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reitan (US 20120059460 A1 – hereinafter Reitan) in view of Schwammenthal (US 20160022890 A1 – hereinafter Schwammenthal).
Re. claim 21, Reitan teaches the claimed invention of claim 1 as stated above, but does not expressly teach wherein the frame has a length of more than 25 mm, when disposed in a non-radially constrained configuration.
Schwammenthal teaches a catheter apparatus (abstract) which includes an impeller 152 within an impeller cage 154 (figure 12B).
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Schwammenthal further teaches that the cage can have a length of more than 25 mm (paragraph 0645 – “For some applications, when cage 154 is in its radially-expanded configuration, a length L8 of the cage, measured along the longitudinal axis of the cage, and including rings 202 of the cage, is greater than 17 mm, less than 26 mm, and/or between 17 and 26 mm… Typically, for such applications, when the cage is axially elongated by being crimped (configuration not shown), the length of the cage, measured along the longitudinal axis of the cage, and excluding rings 202 of the cage is greater than 18 mm, less than 30 mm, and/or between 18 and 30 mm”).
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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 length of the frame of Reitan, to incorporate the frame length as taught by Schwammenthal, since such modification would predictably result in providing support to the impeller for laminar flow of blood.
Re. claim 22, the combined invention of Reitan and Schwammenthal further teaches wherein the frame has a length of more than 30 mm, when disposed in a non-radially constrained configuration (Schwammenthal paragraph 0645 – “For some applications, when the cage is axially elongated, and radially compressed, by being crimped (configuration not shown), the length of the cage, measured along the longitudinal axis of the cage, and including rings 202 of the cage, is greater than 22 mm, less than 35 mm, and/or between 22 and 35 mm”).
Allowable Subject Matter
Claims 10-20 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.
Conclusion
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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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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