DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 36-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 36 recites “a compliant region that has greater compliant than a region within which the mobile moves”. For the purpose of examination, having a “greater compliant” is interpreted to mean that one region is more compliant than another. “The mobile” is interpreted to be “the mobile element” of Claim 35.
Claims 37 and 38 are rejected based on their dependency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-10, 13, 15, 20-22, 25, 28-31, 34, 35-42, 45-47, 49, 51, 52, 56-58, 60, 66, and 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20220061872 A1 (Mintz) in view of US 20090082723 A1 (Krogh et al.).
Regarding Claim 1, Mintz teaches an instrument suitable for use in a medical procedure [Abstract], the instrument being electrically connected to a controller that provides electrical control signals and mechanical suction, comprising:
a body (12) (Fig. 2B) having a distal end (at 13) and a proximal end (the opposing end where the catheter body connects to the valve, seen in Fig. 1B), the body having a conduit (22) between the distal end and the proximal end through which a fluid moves under the suction [0031]; and
one or more actuators (36, or 34 in the alternate) (Fig. 3C) attached or embedded in the body that provides a mechanical motion at the distal end in response to stimulation by the electrical control signals (Mintz teaching a plurality of actuation means, including electrical [0101, 0227]), wherein the electrical control signals are provided according to at least one predetermined pattern [0113, 0228].
Mintz fails to teach each actuator comprising one or more electroactive polymer (EAP) layers.
Krogh teaches an instrument (10) suitable for use in a medical procedure [Abstract] wherein actuation of the device (corresponding to the electrically driven motion of Mintz) comprises one or more EAP layers (multilayer EAP based actuators [0017]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the actuation means of Mintz with the EAP of Krogh to allow for precise control of movements [Krogh 0124].
Regarding Claims 2-4, Mintz further teaches that each actuator may be controlled individually, or in a group [0119], with the user selecting the actuation for improved control [0119]. As the user may determine the pattern and the individual/group actuation, Mintz is considered to teach the predetermined pattern enables two or more groups of the actuators to be activated sequentially, and the predetermined pattern enables two or more groups of the actuators to be activated concurrently, as well as the predetermined pattern enables two or more groups of the actuators to be activated sequentially, one group after another, and wherein, within each group, two or more actuators are actuated concurrently.
Regarding Claim 5, Mintz further teaches the actuators (36) each extend along a longitudinal direction along a length of the body (12) (seen in Fig. 2B).
Regarding Claim 6, Mintz further teaches the two or more groups of actuators (36) are each located at a radial distance from a longitudinal axis (26) of the conduit (seen in Fig. 2B).
Regarding Claim 7, Mintz further teaches the mechanical suction (4) varies in a coordinated fashion with the predetermined pattern [0113].
Regarding Claim 8, Mintz further teaches actuation frequency and suction may be altered based on the cardiac cycle of the patient [0230]. The disclosure allows for movement and suction to occur at a variety of points during the cardiac cycle, which is considered to teach a scenario wherein a pressure of the mechanical suction is decreased when one of the mechanical motions comprise a longitudinal motion at the distal end of the body.
Regarding Claim 9, Mintz further teaches the distal end (at 13) of the body (12) has an opening (13) that exposes the conduit [0031], and wherein a portion of the body at the opening has a funnel-like shape (33) (Fig. 2B).
Regarding Claim 10, Mintz further teaches the actuators (36) are provided behind the opening (13), the actuators extending to the proximal end.
Regarding Claim 13, Mintz in view of Krogh fails to teach a first one of the actuators wraps substantially circumferential around the body relative to a longitudinal axis of the body.
Mintz teaches an alternate embodiment wherein a first one of the actuators (81A) (Figs. 11A and 11B) wraps substantially circumferential around the body [0179] relative to a longitudinal axis (26) of the body.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to arrange the actuators of Mintz in view of Krogh in circumferentially as taught by Mintz as this is a known and suitable arrangement in the art. Further, it is a matter of engineering design to arrange the ----actuator in different ways, where the change in form or shape, without any new or unexpected result, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04). Finally, one would have a reasonable expectation of success by changing the arrangement of the actuator to the claimed limitation as Mintz teaches this arrangement is a known and suitable arrangement in the art.
Regarding Claim 15, Mintz in view of Krogh fails to teach the first actuator has a first end and a second end, wherein the first end and the second end are separated from each other by a gap, and wherein the actuator attaches to a stiffening material that spans the gap.
Krogh further teaches the first actuator (22) has a first end (distal) and a second end (proximal), wherein the first end and the second end are separated from each other by a gap (the distance between ends), and wherein the actuator attaches to a stiffening material (22) that spans the gap [0118-0120].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the actuator arrange taught by Mintz in view of Krogh with the arrangement as taught by Krogh to allow the gap to be reduced by movement induced by the EAP, allowing controlled motion [Krogh 0118-0120].
Regarding Claim 20, Mintz in view of Krogh fails to teach each actuator comprises a first end and a second end, wherein one or both ends of the actuator are stiffened to constrain the mechanical motion of that actuator in the embodiment of Claim 1.
Mintz teaches an alternate embodiment (Fig. 6A) wherein each actuator (34) comprises a first end (proximal) and a second end (distal), wherein one or both ends of the actuator are stiffened to constrain the mechanical motion of that actuator (hinge 41 causing one end to be stiffer than the other).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the actuator of Mintz in view of Krogh with the actuator of Mintz to control the direction and range of motion [0124-0125].
Regarding Claim 21, Mintz further teaches each actuator (36) is embedded or attached to a portion of the body (12) that comprises a high-modulus material (stainless steel [0093] having a modulus of ~200GPa), the high-modulus material having a modulus that is higher than that the actuator’s electroactive polymer layers (Claim 1 teaching the EAP of Krogh which has a modulus of 200-500 MPa depending on state [0056], the portion of the body serving as a substrate (the body being the surface to which the actuators are attached).
Regarding Claim 22, Mintz in view of Krogh is considered to teach the portion of the high-modulus material is positioned to guide the mechanical motion as the material provides a base from which the actuators extend, thereby limiting motion.
Regarding Claim 25, Mintz further teaches the body (12) comprises a patterned or textured layer of material exposed to the conduit [0097-0098].
Regarding Claims 28 and 31, Mintz further teaches the use of etching [0098] which would create channels (depressions) between etched surfaces and is therefore considered to teach the patterned or textured layer has one or more fluted or raised portions, wherein adjacent fluted or raised portions are separated from each other by a channel.
Regarding Claims 29 and 30, as Mintz teaches optionally roughening [0098], the non-etched portions are considered to fulfill the claim requirement wherein each raised portion further includes a smooth surface and wherein each raised portion further includes a textured surface.
Regarding Claims 34-38, Mintz further teaches the patterned or textured layer (covering 18 as previously described) incorporates a mobile element (lower end of 34 which is covered by 35, as seen in Fig. 2B) capable of axial motion (moving outward from the longitudinal axis) including flexure beams (the junction at 48) that constrain the mobile element in primarily axial motion [0122];
wherein the patterned or textured layer further comprises a compliant region (region 35) (Fig. 2B) which is considered to have a “greater compliant than a region within which the mobile moves” as it lacks (33) which would restrict movement [0103];
wherein the compliant region comprises flexure beams (the upper portion of 34 left exposed) that are interconnected by elongation elements (35 elongated when 18 is expanded);
wherein the elongation elements urge against the flexure beams of the compliant region resulting in a radial expansion of the conduit ([0060-0061] describing the radial expansion).
Regarding Claim 39, Mintz further teaches a mechanical structure (18) that opens to the conduit (Fig. 3A), the mechanical structure enabling a flared opening (seen in Fig. 3C) to the conduit in one of two positions (open and closed). As the structure has limits on range of motion, it is considered to fulfill the requirement wherein the mechanical structure preserves a closure limit to a size of the conduit in the other one of the two positions.
Regarding Claim 40, Mintz further teaches the mechanical structure (18) is covered externally by a polymer covering [0128].
Regarding Claim 41, Mintz teaches the mechanical structure (18) comprises a first portion and a second portion (each individual prong being a portion) (Figs. 3A-3C) attached to each other by one or more elastic elements (the elements returning to their previous shape once the external force is removed).
Regarding Claim 42, Mintz in view of Krogh fails to teach the mechanical structure comprises a plurality of movable plates connected to each other by sheets of a foldable membrane material.
Mintz teaches an alternate embodiment (Fig. 5) wherein the mechanical structure (18) comprises a plurality of movable plates (34) connected to each other by sheets of a foldable membrane material (the membrane as described in [0128]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of Mintz in view of Krogh to incorporate the plates of Mintz as a simple change in shape. The change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04).
Regarding Claims 45 and 46, Mintz further teaches one or more supportive bands (30) on the body (12) (Fig. 2B) to provide mechanical support (preventing buckling [0075], wherein the supportive bands each comprise stainless steel [0077].
Regarding Claim 47, Mintz teaches the supportive bands maintain the conduit open [0077], but fails to specify the pressure ranges.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the support bands to maintain the conduit open when a pressure of the suction is at or below 30inHg as Mintz desire to prevent kinking and buckling during suction operations [0077].
Regarding Claim 48, Mintz further teaches one or more supportive bands (33 wrapping around and considered a band, as seen in Fig. 2B) on the body (12) to constrain longitudinal or axial motion of one or more of the actuators (36).
Regarding Claim 49, Mintz teaches a device suitable for use in a medical procedure [Abstract], the device being configured to operate in accordance with electrical signals received from a controller (8), the device comprising a catheter body (12) having a proximal end (12A) and a distal end (12B), the distal end comprising a tapered tip (18, seen in Fig. 3B), wherein (i) the catheter body includes a lumen (22) which forms a fluid conduit running continuously throughout the catheter body’s length to allow fluid to be received from an opening at the tapered tip and to flow to the proximate end of the catheter body under suction pressure [0031], (ii) the catheter body further comprises two or more electrical conductors [0099] in the catheter body to carry the electrical signals between the controller and tip (corresponding to the integrated EAP actuator), (iii) the actuator is stimulated by the electrical signals into motion [0101, 0227], and (iv) the electrical signals and the suction pressure are varied in a coordinated fashion according to one or more predetermined patterns [0113, 0228].
Mintz fails to teach an integrated electroactive polymer (EAP) actuator provided between the tapered tip and the proximal end of the body,
Krogh teaches an instrument (10) suitable for use in a medical procedure [Abstract] wherein actuation of the device (corresponding to the electrically driven motion of Mintz) comprises an integrated EAP actuator (multilayer EAP based actuators [0017]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the actuation means of Mintz with the EAP of Krogh to allow for precise control of movements [Krogh 0124].
Regarding Claim 51, Mintz further teaches the conduit (formed by 22) has a greater radius at the distal end of the catheter body than at the proximal end of the catheter body ([0091] teaching the expanded configuration being 300% wider).
Regarding Claim 52, Mintz further teaches a port (connected at 176, Fig. 1B) in the proximal end (12A) of the catheter body (12), the port being opened to the conduit and being adapted for connection to an aspiration device (4) [0034].
Regarding Claims 56 and 57, Mintz teaches mechanical support in the form of supportive bands (33) which maintain the conduit open [0077], but fails to specify the pressure ranges.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the support bands to maintain the conduit open when a pressure of the suction is at or below 30inHg as Mintz desire to prevent kinking and buckling during suction operations [0077].
Regarding Claim 58, Mintz is considered to teach the supportive rings or bands (33) constrain inward or longitudinal movements of EAP actuator by limiting the range of motion possible by (34) and (36).
Regarding Claim 60, Mintz in view of Krogh is considered to teach the integrated EAP actuator comprises one or more EAP actuators (having a plurality of actuators, 36) and an inner polymeric layer (38) [0090, 0128].
Regarding Claim 66, Mintz further teaches the conductors in the catheter body (12) are each embedded in the catheter body in the form of a conductive coil [0099].
Regarding Claim 67, Mintz further teaches an outer jacket (32) provided along an outer surface of the catheter body (12) except at the integrated EAP actuator (as seen in Fig. 2B where the outer jacket is not present at the distal end).
Claim(s) 11, 12, and 53-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Mintz in view of Krogh and further in view of US 20180243530 A1 (Lederman et al.), evidenced by US 20140031844 A1 (Kusleika).
Regarding Claims 11 and 12, Mintz in view of Krogh fails to teach the first actuator being wrapped around the body helically, or a second actuator being wrapped helically, but in a different chirality than the first actuator.
Lederman teaches a device (10) suitable for use in a medical procedure wherein the wires are wrapped with a different chirality in order to control the strength and ability to bend in the catheter [0004].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Mintz in view of Krogh to have a first one of the actuators wraps around the body helically and a second one of the actuators also wraps around the body helically but in a different chirality than the first actuator to provide the desired mechanical properties of the device [Lederman 0004], as evidenced by Kusleika which teaches that the use of helical wires within the catheter body may increase strength and other characteristics [0048].
Regarding Claims 53-55, Mintz in view of Krogh fails to teach the electrical conductors being wrapped around the body helically.
Lederman teaches a device (10) suitable for use in a medical procedure wherein the electrical conductors are each helically embedded in the catheter body, the one or more wires helically embedded in the catheter body to provide mechanical support [0004], wherein the wires are formed out of stainless steel [0018].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Mintz in view of Krogh to have the actuators wraps around the body helically and form said actuators of steel in order to provide the desired mechanical properties of the device [Lederman 0004], as evidenced by Kusleika which teaches that the use of helical wires within the catheter body may increase strength and other characteristics [0048].
Claim(s) 14, 16, 23, 24, 63, 65, and 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Mintz in view of Krogh and further in view of US 20040068161 A1 (Couvillon).
Regarding Claim 14, Mintz in view of Krogh fails to teach the first actuator has a first end and a second end, and wherein the first end and the second end abut each other during that actuator’s mechanical motion.
Couvillon teaches an actuator (605) having first and second ends (opposing ends as seen in Fig. 6A) which abut each other during mechanical motion (being connected as seen in Fig. 6B).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of Mintz in view of Krogh with that taught by Couvillon to provide for movement [0062] as well as the ability to incorporate additional gauges (or other elements) [Couvillon 0069].
Regarding Claim 16, Mintz in view of Krogh fails to teach a flexible circuit on which the actuators are mounted.
Couvillon teaches a flexible circuit (605) on which the actuators (610) are mounted.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Mintz in view of Krogh with the flexible circuit of Couvillon to allow for movement of the device when choosing from known cable configurations [Couvillon 0083].
Regarding Claim 23, Mintz in view of Krogh fails to teach a flexible circuit on which the actuators are mounted.
Couvillon teaches a flexible circuit formed on a substrate (605) and electrodes (610) provided on the flexible circuit to provide the electrical signals to the actuators.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Mintz in view of Krogh with the flexible circuit of Couvillon to allow for movement of the device when choosing from known cable configurations [Couvillon 0083].
Regarding Claim 24, Mintz in view of Krogh fails to teach each actuator is embedded or attached to a portion of the body that has a low-modulus material with a modulus lower than those of the electroactive polymer layers, the portion of the body serving as a substrate.
Couvillon teaches a flexible circuit formed on a substrate (605) and electrodes (610) provided on the flexible circuit to provide the electrical signals to the actuators.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Mintz in view of Krogh with the flexible circuit of Couvillon to allow for movement of the device when choosing from known cable configurations [Couvillon 0083].
The combined device is considered to teach each actuator is embedded or attached to a portion of the body that has a low-modulus material with a modulus lower than those of the electroactive polymer layers, the portion of the body serving as a substrate as Couvillon teaches the use of flexible polymers in the substrate layer (605) and the EAP of Krogh which has a modulus of 200-500 MPa depending on state [0056], as previously cited.
Regarding Claim 63, Mintz in view of Krogh fails to teach the integrated EAP actuator further comprises a flexible circuit having electrodes for attaching and electrically connecting the EAP actuators.
Couvillon teaches the integrated EAP actuator (610) further comprises a flexible circuit (605) having electrodes for attaching and electrically connecting the EAP actuators [0061].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Claim 60 to incorporate the flexible circuits of Couvillon as an alternate arrangement of the numerous known cable configurations [Couvillon 0083].
Regarding Claim 65, Mintz in view of Krogh fails to teach the EAP actuators are each formed from a rectangular sheet rolled circumferentially around the inner polymeric layer, such that opposite sides of a dimension of the rectangle are abutting.
Couvillon teaches a thrombolysis catheter wherein the electrical circuits are each formed from a rectangular sheet such that opposite sides of a dimension of the rectangle are abutting (Fig. 6) [0083], being between the inner liner and outer jacket [0065].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Claim 60 to incorporate the flexible circuits of Couvillon as an alternate arrangement of the numerous known cable configurations [Couvillon 0083].
The combined device is therefore considered to teach the EAP actuators are each formed from a rectangular sheet rolled circumferentially around the inner polymeric layer, such that opposite sides of a dimension of the rectangle are abutting.
Regarding Claim 68, Mintz in view of Krogh fails to teach the integrated EAP actuator is encapsulated in a thermoplastic polyurethane (TPU) material.
Couvillon teaches use of TPU to encapsulate the circuitry [0066].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the actuator of Mintz in view of Krogh with the TPU encapsulation taught by Couvillon as a simple substitution of one known biocompatible coating material for another with a reasonable expectation of protecting the circuitry from the environment MPEP 2143 I.
Claim(s) 17-19, 43, 59, and 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Mintz in view of Krogh and further in view of US 20200205845 A1 (Yang et al.), hereinafter Yang ‘845.
Regarding Claims 17-19, Mintz in view of Krogh fails to teach a mass placed on one of the actuators to modify a resonant frequency of the mechanical motion of that actuator.
Yang ‘845 teaches the inclusion of radiopaque marker consisting of tungsten [0320] on the distal end of the catheter [0244], said marker being a mass.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Mintz in view of Krogh with the radiopaque material of Yang ‘845 to provide for visibility under fluoroscopy [Yang ‘845 0206].
As Yang ‘845 teaches placement at the distal end of the catheter, this would result in the claimed placement in the combined device.
“[T]o modify a resonant frequency of the mechanical motion of that actuator” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding Claim 43, Mintz in view of Krogh fails to teach one or more radiopaque elements provided at the distal end of the body.
Yang ‘845 teaches the inclusion of radiopaque marker [0320] on the distal end of the catheter body [0244].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Mintz in view of Krogh with the radiopaque material of Yang ‘845 to provide for visibility under fluoroscopy [Yang ‘845 0206].
Regarding Claim 59, Mintz in view of Krogh fails to teach one or more of the supportive rings or bands serve as a radiopaque marker.
Yang ‘845 teaches the inclusion of radiopaque marker [0320] on the distal end of the catheter [0244] for guiding navigation of the distal end of the catheter body through vasculature [Yang ‘845 0206].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Mintz in view of Krogh with the radiopaque material of Yang ‘845 to provide for visibility under fluoroscopy [Yang ‘845 0206].
“[F]or guiding navigation of the distal end of the catheter body through vasculature” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding Claim 61, Mintz in view of Krogh fails to teach the inner polymeric layer comprises Pebax.
Yang ‘845 teaches the use of PEBAX as a catheter jacket material.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of Claim 60 with the PEBAX taught by Yang ‘845 when choosing from jacketing materials known in the art [Yang ‘845 0290].
Claim(s) 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Mintz in view of Krogh and further in view of US 20180102717 A1 (Hendriks et al.).
Regarding Claims 26 and 27, Mintz in view of Krogh fails to teach the patterned or textured layer of material comprises one or more of: polyvinylidene fluoride (PVDF), trifluoroethylene (TrFE), 1,1-chlorofluoroethylene (CFE), chlorotrifluoroethylene (CTFE).
Hendriks teaches an actuator device comprising EAP material which comprises one or more of: polyvinylidene fluoride (PVDF), trifluoroethylene (TrFE), 1,1-chlorofluoroethylene (CFE), chlorotrifluoroethylene (CTFE) [0158-0159], further teaching blends thereof and is therefore considered to teach the patterned or textured layer of material comprises a copolymer of polyvinylidene fluoride (PVDF) and one or more monomers selected from the group consisting of trifluoroethylene (TrFE), 1,1-chlorofluoroethylene (CFE), chlorotrifluoroethylene (CTFE).
It would have been obvious to one having ordinary skill in the art at the time the invention was made one or more of polyvinylidene fluoride (PVDF), trifluoroethylene (TrFE), 1,1-chlorofluoroethylene (CFE), chlorotrifluoroethylene (CTFE), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Further, it would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mintz in view of Krogh with the teachings of Hendriks by incorporating the electroactive polymer actuator comprises a material which includes one or more of: P(VDF-TrFE-CTFE) and P(VDF-TrFE-CFE) in order to improve electrorestriction in the electroactive polymer layer [Hendriks 0159].
Claim(s) 32 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Mintz in view of Krogh and further in view of US 20170303948 A1 (Wallace et al.)
Regarding Claims 32 and 33, Mintz in view of Krogh fails to teach wherein one of etched depressions is provided in as a rifled helical pattern extending longitudinally along the body.
Wallace teaches a thrombectomy catheter [Abstract] wherein an interior layer formed along the body (the tractor 144 being inverted to the interior), wherein said layer is provided in as a rifled helical pattern, or helical screw pattern, extending longitudinally along the body [0020], said patterns being formed by etching [0152]. The helical pattern (or slots as described in [0161]) is considered equivalent to a rifled pattern as a rifled pattern consists of grooves in a helical pattern).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the etching of Mintz in view of Krogh with the patterns taught by Wallace in order to improve traction on the clot, thereby improving retention [Wallace 0161].
Claim(s) 44, 69, and 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Mintz in view of Krogh and further in view of US 20240008891 A1 (Otake et al.).
Regarding Claim 44, Mintz in view of Krogh fails to teach a portion of the distal end of the catheter body is provided a hydrophilic coating.
Otake teaches a catheter wherein a portion of the distal end of the catheter body is provided a hydrophilic coating [0022, 0025] in order to provide a lubricated coating.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Mintz in view of Krogh with the coating of Otake to provide a hydrophilic lubricating coating on the distal end of the catheter [Otake 0025].
Regarding Claim 69, Mintz in view of Krogh fails to teach a portion of the distal end of the catheter body is provided a hydrophilic coating.
Otake teaches a catheter wherein a portion of the distal end of the catheter body is provided a hydrophilic coating [0022, 0025] in order to provide a lubricated coating.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Mintz in view of Krogh with the coating of Otake to provide a hydrophilic lubricating coating on the distal end of the catheter [Otake 0025].
Regarding Claim 70, the combined device of Claim 69 is considered to teach
the TPU material attaches to the inner polymeric layer and the outer jacket, as (Mintz 18) corresponds to the TPU material, which attaches to the catheter body (Mintz 12, Fig. 2B) and therefore the inner polymeric layer (Mintz 38) [0090, 0128], as well as outer jacket (Mintz 32), as seen in Fig. 2B.
Claim(s) 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Mintz in view of Krogh and further in view of US 20250025191 A1 (Penner et al.).
Regarding Claim 50, Mintz in view of Krogh fails to teach the tapered tip comprises a dilator.
Penner teaches a catheter comprising a dilator [0128] to dilate the vessel prior to entry.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tapered tip of Mintz in view of Krogh to incorporate the dilator of Penner to dilate the vessel prior to entry [Penner 0128].
Claim(s) 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Mintz in view of Krogh and further in view of US 20130144328 A1 (Weber et al.).
Regarding Claim 62, Mintz in view of Krogh fails to teach the inner polymeric layer comprises multiple layers of different durometers.
Wallace teaches a thrombectomy catheter (10) comprising multiple layers (teaching a plurality of different coatings, wherein one or more may be used [0031]), said layers being considered to necessarily have different durometers based on physical properties.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner polymeric layer of Mintz in view of Krogh with the multiple layers taught by Wallace to ensure coatings suitable for the procedure are present [Wallace 0031].
Claim(s) 64 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Mintz in view of Krogh and further in view of and further in view of Yang (US 20170231520 A1).
Regarding Claim 64, Mintz in view of Krogh fails to teach the flexible circuit further comprises conductive ink.
Yang is directed to an electrically conductive medical device and teaches each of the first and second electrodes (14) comprises a material using a conductive electric ink provided for electrically connecting the conductors in the catheter body to the electrodes [0029].
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Mintz in view of Krogh such that each of the first and second electrodes comprises a material using a conductive electric ink, as taught by Yang, in order to simplify the manufacturing process by removing the need for soldering traditional components and thereby lowering manufacturing costs [Yang 0013,].
Conclusion
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/HANS KALIHER/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781