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 1-18 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 1 recites the limitation "the catheter assembly" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-18 are rejected by virtue of their dependency on claim 1.
Regarding claim 4, the claim recites “the spines” in line 1 and it is unclear if these are the same spines or are different spines from the “plurality of spines” recited in claim 1, from which claim 4 depends. For examination purposes, these are the same spines and the limitation will be interpreted as “the plurality of spines”.
Claim 14 recites the limitation "the catheter shaft assembly" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 is also rejected by virtue of its dependency on claim 14.
Regarding claim 16, the claim recites “the spines” in line 1 and it is unclear if these are the same spines or are different spines from the “plurality of spines” recited in claim 1, from which claim 16 depends. For examination purposes, these are the same spines and the limitation will be interpreted as “the plurality of spines”.
Regarding claim 17, the claim recites “the spines” in line 1 and it is unclear if these are the same spines or are different spines from the “plurality of spines” recited in claim 1, from which claim 17 depends. For examination purposes, these are the same spines and the limitation will be interpreted as “the plurality of spines”.
Claim 18 is also rejected by virtue of its dependency on claim 17.
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.
Claims 1-4, 11-12 & 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salahieh et al. (U.S. Pub. No. 20140058197), herein referred to as “Salahieh”.
Regarding claim 1, Salahieh teaches an apparatus ([0273]: a catheter; Fig. 64; [0276]: Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or a variation of a sub-combination) comprising:
(a) a catheter shaft (shaft 57) having a proximal end (proximal end of shaft 57) and a distal end (distal end of shaft 57), the catheter assembly defining a longitudinal axis (the axis defined by guidewire 1007 in Fig. 64), the catheter assembly including an outer sheath (sheath 31; Figs. 60A & 60B) with a distal end (distal end of sheath 31 in Figs. 60A & 60B); and
(b) an end effector (electrode assembly 105) associated with the distal end of the catheter assembly (see Fig. 64), the end effector comprising a panel assembly (flexible membrane 54), the panel assembly being configured to transition between a first state and a second state (see transition in Figs. 60A & 60B), the panel assembly being configured to fit within the outer sheath in the first state (see Fig. 60A; [0152]: A sheath 31 can cover the electrodes and support structure for a low profile delivery), the panel assembly being configured to expand outwardly away from the longitudinal axis in the second state when exposed distally relative to the distal end of the outer sheath (see transition in Fig. 60B; [0152]: Once inside the desired location, the sheath can be pulled back, exposing the structure 98 and the electrodes 6; [0153]: The structure 98 is directly attached to the catheter shaft 57 which creates a funnel shape at the junction of the shaft and the structure. This facilitates sheathing and unsheathing of the structure), the panel assembly comprising:
(i) a flexible circuit substrate (substrate 52; [0105]: As mentioned above, the electrode assembly 105 of the devices described herein can include one or more branching flex circuits 89),
(ii) a plurality of spines (expandable structure 98) extending along the flexible circuit substrate ([0152]: flexible membrane 54 can be disposed around an expandable structure 98), and
(iii) a plurality of microelectrodes (electrodes 6) positioned along the plurality of spines ([0152]: flexible membrane 54 can be disposed around an expandable structure 98 … Electrodes 6 may be arranged over the tubular thin walled membrane 54).
Regarding claim 2, Salahieh teaches the outer sheath (sheath 31) being operable to translate relative to the end effector between a first longitudinal position and a second longitudinal position ([0152]: sheath 31 can cover the electrodes and support structure for a low profile delivery. Once inside the desired location, the sheath can be pulled back, exposing the structure 98 and the electrodes 6; where this motion describes longitudinal movement), the outer sheath being configured to contain the end effector in the first longitudinal position ([0152]: sheath 31 can cover the electrodes and support structure for a low profile delivery; see Fig. 60A), the outer sheath being configured to expose the end effector in the second longitudinal position ([0152]: Once inside the desired location, the sheath can be pulled back, exposing the structure 98 and the electrodes 6; see Fig. 60B).
Regarding claim 3, Salahieh teaches the end effector being operable to translate relative to the outer sheath between a first longitudinal position and a second longitudinal position ([0152]: sheath 31 can cover the electrodes and support structure for a low profile delivery. Once inside the desired location, the sheath can be pulled back, exposing the structure 98 and the electrodes 6; where in this motional relationship, an equivalent motion would be moving the end effector relative to the outer sheath as holding one object static and the other in motion has an equivalent motion if the other object is held static and the first object in motion), the end effector being configured to be contained in the outer sheath in the first longitudinal position ([0152]: sheath 31 can cover the electrodes and support structure for a low profile delivery; see Fig. 60A), the end effector being configured to be exposed from the outer sheath in the second longitudinal position ([0152]: Once inside the desired location, the sheath can be pulled back, exposing the structure 98 and the electrodes 6; see Fig. 60B).
Regarding claim 4, Salahieh teaches the spines being expandable outwardly away from the longitudinal axis in the second state when exposed distally relative to the distal end of the outer sheath (see Fig. 60B; [0152]: an expandable structure 98 that is self-expanding such as a braid, coil or the like, as shown in FIGS. 60A-60D; where the expansion is shown as away from the longitudinal axis).
Regarding claim 11, Salahieh teaches the panel assembly defining a profile ([0153]: a funnel shape), the profile having a first surface area in the first state (see Fig. 60A where in the first state, electrode assembly 105 has a small surface area in this first state) and a second surface area in the second state (see Fig. 60B where in the second state, electrode assembly 105 has a large surface area in this second state), the surface area in the second state being larger than the surface area in the first state (see the larger surface area in Fig. 60B in comparison to the surface area shown in Fig. 60A).
Regarding claim 12, Salahieh teaches the plurality of microelectrodes being arranged in a matrix configuration (see Figs. 5E & 5F; [0130]: One or more rows of electrodes 6 can be used. Each row of electrodes 6 can have the same shape or can vary in shape and size … The rows of electrodes can have electrodes that line up … they may incorporate two rows as in FIGS. 5D-5F, or they may incorporate more than two rows).
Regarding claim 16, Salahieh teaches the spines being resiliently biased to expand outwardly away from the longitudinal axis in the second state when exposed distally relative to the distal end of the outer sheath ([0152]: an expandable structure 98 that is self-expanding; see Figs. 60A & 60B where the expansion is shown as away from the longitudinal axis).
Claims 19-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Siekmeyer et al. (U.S. Pub. No. 5846196), herein referred to as “Siekmeyer”.
Regarding claim 19, Siekmeyer teaches an apparatus for performing electrophysiological mapping (Abstract: An intraventricular multielectrode cardiac mapping probe) comprising:
(a) a catheter assembly (catheter 40) having a proximal end (portion of catheter proximal to 47, Fig. 6) and a distal end (portion of catheter including 47 and anything distal), the catheter assembly defining a longitudinal axis (longitudinal axis along 45, Fig. 6), the catheter assembly including an outer sheath (basic body 46) with a distal end (distal end of basic body 46); and
(b) an end effector (electrode array 44) associated with the distal end of the catheter assembly (see Fig. 6), the end effector comprising a panel assembly (foil 43) comprising:
(i) a flexible circuit substrate (foil 43; Col. 6, lines 11-15: The foil 43 is connected with opposite sides to wire-like elements 41, 42, which are elastic and push the opposite sides of the sheath apart in a resilient manner, so that, in the unfolded state shown in FIG. 6, the carrier 43 is maintained in a stretched position),
(ii) a plurality of spines (wire-like elements 41,42) extending along the flexible circuit substrate (Col. 6, lines 11-12: The foil 43 is connected with opposite sides to wire-like elements 41, 42), and
(iii) a plurality of microelectrodes positioned along the plurality of spines (individual electrodes not given numerical call outs but see electrodes 6 in Fig. 1 and that 44 is an electrode array 44) and configured to sense potentials in tissue (Col. 6, lines 23-25: As soon as the distal end of the catheter 40 has been placed at a position where the treatment is to be carried out; lines 36-41: If during the mapping procedure an abnormal focus is found (one, for example, where the rate is more rapid than those foci found or proximal to the atrial focus and one which would govern the overall heart rate) it can be interrupted or destroyed by using a conductive path between any two of the electrodes to provide a more normal heart rate; wherein mapping is seen as sensing potentials),
the end effector being operable to transition between a first state (Col. 6, lines 28-19: Following the treatment, the operative end is then drawn once again inside the basic body 46; stored state), a second state (Col. 6, lines 15-18: The sheath 43 is also connected to a central pin 45, which serves to support the sheath 43 and to fold the carrier in order to be able to retract it into the basic body 46; wherein this folded state is seen as a second state), and a third state (see Fig. 6),
the panel assembly being configured to fit within the outer sheath in the first state (Col. 6, lines 28-29: Following the treatment, the operative end is then drawn once again inside the basic body 46),
the panel assembly being configured to extend distally from the distal end of the outer sheath in the second state with the panel assembly collapsed inwardly toward the longitudinal axis (folded state; Col. 6, lines 15-18: The sheath 43 is also connected to a central pin 45, which serves to support the sheath 43 and to fold the carrier in order to be able to retract it into the basic body 46), and
the panel assembly being configured to adopt a flat, planar configuration in the third state (Col. 6, lines 14-15: in the unfolded state shown in FIG. 6, the carrier 43 is maintained in a stretched position).
Regarding claim 20, Siekmeyer teaches a method (Col. 4, lines 36-37: the electrodes 6 of the electrode array 5 are maneuvered against the wall of the heart) comprising:
(a) actuating a user input feature of a catheter assembly to transition an end effector of the catheter assembly from a first state to a second state (Col. 4, lines 59-63: When electrical current is turned on, the carrier 18 is heated to above the transition temperature, as a result of which the relatively relaxed unfolded state, as illustrated in FIG. 1, is created; where the configuration shown in Fig. 3 is the first state and the configuration shown in Fig. 1 is the second state), the catheter assembly including an outer sheath (cylindrical body 3), the end effector comprising a panel assembly (carrier 18) including an array of microelectrodes (electrode array 6) arranged in a matrix (see Fig. 1 for the matrix/grid configuration of electrode array 6) and configured for electrophysiological mapping (Col. 4, lines 31-34: catheter 1 may be used to map electrical activity in the inner wall of the heart of the patient), the panel assembly being contained in the outer sheath in the first state (see Fig. 3; Col. 3, lines 30-32: FIG. 3 is a sectional view, with portions broken away, which illustrates the electrode array assembly positioned within the lumen of the catheter), the panel assembly being exposed relative to the outer sheath in the second state (see Fig. 1) with the panel assembly expanded outwardly away from a longitudinal axis defined by the catheter assembly in the second state (Col. 4, lines 52-53: unfolded state of the carrier 18, that is to say the state in which it forms a more planar or flat sheet; where the longitudinal axis is the axis defined by fluid channel 20); and
(b) actuating the end effector to transition from the second state to the first state, the panel assembly returning to within the outer sheath in the first state (Col. 4, lines 65-66: In order to fold the electrode array 5, the heating means is turned off; Col. 5, lines 3-5: As a result the back section of the carrier will cool down to body temperature and cause the carrier 18 to roll up along its longitudinal axis).
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.
Claims 5-8 & 13 are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh as applied to claim 1 above, and further in view of Tegg (U.S. Pub. No. 20200060569), herein referred to as “Tegg”.
Regarding claim 5, Salahieh discloses the panel assembly further comprising at least one control wire ([0167]: include one or more pull wires), but fails to disclose the at least one control wire operable to transition the panel assembly from the first state to the second state.
However, Tegg discloses the panel assembly further comprising at least one control wire (tether 128), the at least one control wire operable to transition the panel assembly from the first state to the second state ([0053]: proximal end of the tether 128 can be connected to an actuator, which can be used to apply a particular amount of tension to the tether 128; where the first state is arc shape shown in Fig. 3A and the second state is as described in [0063]: the flexible framework 104 can have zero degrees of arc Θ and can be disposed along a flat planar surface). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the control wire of Salahieh to the control wire of Tegg for the purpose of enabling the catheter to have a variable arc diameter, depending on the amount of tension applied to the tether (Tegg: [0062]).
Regarding claim 6, Salahieh in view of Tegg discloses the plurality of spines extending distally from the at least one control wire (Tegg: [0053]: the tether 128 can extend through a lumen defined by the catheter shaft 114 from the proximal end 116 through the distal end 118 and can be connected to the connector 126 or a distal end of the arms 106, 108, 110, 112).
Regarding claim 7, Salahieh in view of Tegg discloses the at least one control wire operable to expand the panel assembly such that the panel assembly adopts a flat, planar configuration in the second state (Tegg: [0055]: the tether 128 can be configured to break at a certain force; [0063]: the flexible framework 104 can have zero degrees of arc Θ and can be disposed along a flat planar surface; when in an untensioned state from the breaking of the tether 128, the framework 104 adopts a flat and planar configuration, the second state).
Regarding claim 8, Salahieh in view of Tegg discloses the at least one control wire being configured to cause the plurality of spines to deflect outward from the longitudinal axis such that the panel assembly adopts the flat, planar configuration of the second state in response to adding tension to the at least one control wire (Tegg: [0055]: the tether 128 can be configured to break at a certain force … the force at which the tether 128 can be configured to break can be in a range from 1 to 5; [0063]: the flexible framework 104 can have zero degrees of arc Θ and can be disposed along a flat planar surface; after the breaking of the tether 128 following an added tension, the framework 104 adopts a flat and planar configuration, the second state).
Regarding claim 13, Salahieh discloses sensing microelectrodes ([0098]: the electrodes and electrode assemblies described herein can be used for a variety of functions as is known in the art, including but not limited to, ablation, mapping, sensing, and/or stimulating a variety of cells types and tissue types) and a bipolar configuration ([0139]: The electrode assembly 105 can be used exclusively in the bipolar configuration) but fails to disclose the microelectrodes comprising at least one pair of bipolar sensing microelectrodes configured to sense potentials in tissue.
However, Tegg discloses the microelectrodes comprising at least one pair of bipolar sensing microelectrodes configured to sense potentials in tissue ([0078]: Each of the arms 342 includes a number of electrodes 344 which may be used to sense the electrophysiological characteristics of tissue (often operating in a bipolar configuration with another adjacent electrode); [0079]: Such a system may conduct electrophysiology mapping using a bipolar configuration of electrodes across a surface of the flexible framework 340). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the sensing electrodes of Salahieh to the bipolar sensing microelectrodes of Tegg for the purpose of enabling the electrodes to be used for electrophysiological studies, pacing, cardiac mapping, and ablation (Tegg: [0049]).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh as applied to claim 1 above, and further in view of Marecki et al. (U.S. Pub. No. 20150351652), herein referred to as “Marecki”.
Regarding claim 9, Salahieh fails to disclose the at least one control wire operable to contract the panel assembly to thereby cause the panel assembly to collapse inwardly toward the longitudinal axis.
However, Marecki discloses the at least one control wire ([0076]: the actuation mechanism 48 may include a pull wire) operable to contract the panel assembly to thereby cause the panel assembly to collapse inwardly toward the longitudinal axis ([0076]: actuation mechanism 48 may include a pull wire that may be coupled to the expandable electrode assembly 30 that, when actuated in a proximal direction as indicated by the arrow shown in FIG. 2B, causes the expandable electrode assembly 30 to transition from the collapsed configuration to the expanded configuration; see in the transition from Figs. 2A to 2B that pulling the pull wire expands the electrode assembly away from the longitudinal axis so therefore the opposite movement, releasing the pull wire, will move the electrode assembly towards the longitudinal axis). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the control wire of Salahieh to the control wire and control wire operation of Marecki for the purpose of utilizing the actuation mechanism to transition the expandable electrode assembly from a collapsed configuration suitable for delivery of the catheter to a target location and an expanded configuration suitable for use in a diagnostic procedure and/or delivery of a therapy (Marecki: [0076]).
Regarding claim 10, Salahieh in view of Marecki discloses the at least one control wire being configured to cause the plurality of spines to move inward toward the longitudinal axis such that the panel assembly adopts a cylindraceous configuration of the first state in response to removing tension from the at least one control wire (Marecki: [0102]: FIG. 9C shows the two edges 132, 134 juxtaposed with both edges 132, 134 fixed to define a generally cylindrical structure; [0076]: actuation mechanism 48 may include a pull wire that may be coupled to the expandable electrode assembly 30 that, when actuated in a proximal direction as indicated by the arrow shown in FIG. 2B, causes the expandable electrode assembly 30 to transition from the collapsed configuration to the expanded configuration; see in the transition from Figs. 2A to 2B (and Figs. 9C to 9D) that pulling the pull wire expands the electrode assembly away from the longitudinal axis so therefore the opposite movement, releasing the pull wire, will move the electrode assembly towards the longitudinal axis).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh as applied to claim 1 above, and further in view of Basu et al. (U.S. Pub. No. 20170100187), herein referred to as “Basu”.
Regarding claim 14, Salahieh fails to disclose a position sensor (electromagnetic position sensor 127), the position sensor being operable to generate a signal indicative of a position of one or both of at least a portion of the catheter shaft assembly or at least a portion of the end effector in three-dimensional space ([0102]: In some embodiments, distal and proximal ring electrodes 23 may be provided on the connector tubing 146 (best seen in FIG. 4A) to serve as reference electrodes for visualization of the catheter on a 3-D mapping system, such as CARTO 3 available from Biosense Webster, Inc., which automatically locates the EM position sensor 127, processes reference location values from electrodes 38D and 38P, which are at a constant location from the EM position sensor and determines the location of the spine 17 and visualizes the assembly 15). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the position senor of Salahieh to the position sensor of Basu for the purpose of enabling the visualization of the catheter on a 3-D mapping system and for determining the location ad orientation of the distal assembly (Basu: [0150]).
Regarding claim 15, Salahieh in view of Basu disclose the position sensor being located on a portion of the panel assembly (Basu: [0150]: EM position sensor 127, processes reference location values from electrodes 38D and 38P, which are at a constant location from the EM position sensor and determines the location of the spine 17 and visualizes the assembly 15. Likewise, one or more additional ring electrodes may also be provided on any selected spine 17 to serve as a reference electrode for indicating orientation of the distal assembly 15; where the electrodes on the spines are part of the position sensor and are located on the spines).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh as applied to claim 1 above, and further in view of Siekmeyer.
Regarding claim 17, Salahieh discusses the use of a shape memory material ([0150]: The expandable structure 93 can be a shape memory material such as Nitinol; where both reference number 93 and 98 are described as “expandable structure”, however, 98 is not explicitly described is being made of nitinol), but Salahieh fails to explicitly disclose the spines comprising a shape memory material.
However, Siekmeyer discloses the spines comprising a shape memory material (Col. 4, lines 50-51: carrier 18 of the electrode array 6 may be formed of a memory material such as nitinol). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the material of the splines of Salahieh to the shape memory material of Siekmeyer for the purpose of bringing the carrier from the folded state into the unfolded state in response to a temperature change (Siekmeyer: Col. 4, lines 46-64).
Regarding claim 18, Salahieh in view of Siekmeyer discloses the shape memory material comprising a temperature sensitive material (Siekmeyer: Col. 4, lines 50-51: carrier 18 of the electrode array 6 may be formed of a memory material such as nitinol; where nitinol is a temperature sensitive material), such that the shape memory material is configured to transition from a first shape to a second shape in response to a change in temperature (Col. 4, lines 59-64: When electrical current is turned on, the carrier 18 is heated to above the transition temperature, as a result of which the relatively relaxed unfolded state, as illustrated in FIG. 1, is created. The transition temperature may for instance be designed to occur at approximately 45 degrees centigrade).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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