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 .
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 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.
Status of the Claims
The current office action is made responsive to claims filed 12/31/2024.
Claims 1-20 are pending. A complete action on the merits appears below.
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 1-20 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.
Claims 1 & 19 are rejected as it is unclear how the recited electrodes are “proximal” to one another, in an attempt to forward compact prosecution the Examiner is reading the claim limitation in view of two possible interpretations: 1) one electrode is positioned proximal to the other or 2) the electrodes are proximate to another. The currently cited reference of Basu ‘982 as modified teaches both of these interpretations of this limitation as 1) the electrodes are positioned along the length of the spines and therefore at least one electrode is positioned proximal to another electrode and 2) all claimed elements are taught as being “proximate” to all other elements of a single embodiment as broadly as is currently claimed.
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.
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 1-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Basu ‘982 (US 20180184982 A1) in view of Wong (US 20240156518 A1) and Pederson (US 20230190198 A1).
Regarding claim 1, Basu ‘982 teaches an end effector (Fig. 1; hybrid electrode assembly 16; [0074]) of a medical probe (Fig. 1; catheter 10), the end effector comprising:
a plurality of spines (Fig. 1; spines 18 having a structural substrate 40) extending radially outward from a longitudinal axis of the end effector in an expanded configuration ([0046]);
a membrane (Fig. 1; inflatable balloon 22; [0047] & [0074]) connected to the plurality of spines, the membrane comprising a distal end that surrounds the longitudinal axis and defining a volume ([0046]), the membrane including a first surface and a second surface opposite the first surface (Fig. 1 shows the hybrid electrode assembly having spines and a balloon as having an inner and outer surface);
a first flexible circuit (Fig. 4-5; polymeric layer 42 is discussed as being any suitable polymer provided with a conductive trace, such as in known flexible circuit techniques; [0059]) disposed on the first surface of the membrane ([0049], [0060]) proximate each of the plurality of spines and extending around the longitudinal axis ([0046], [0059]);
a plurality of first pairs of electrodes (Fig. 1, 4, 5; electrodes 20) disposed on the first flexible circuit proximal to one another and a spine of the plurality of spines ([0046]).
However, Basu ‘982 fails to teach the volume as having an open end.
Basu ‘982 does teach a catheter for ablation having an expandable basket-shaped distal electrode assembly (Abstract- [0001])).
Wong teaches a medical instrument system having a medical instrument such as a catheter for ablation having an expandable distal element, referred to as a stylet ([0030]- [0031]).
Wong further teaches the electrically conductive stylet as being provided in a variety of known configurations such as an expandable basket (Fig. 5A-B) and an umbrella-shaped configuration (Fig. 6A-B).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the expandable basket-shaped distal electrode assembly as is taught by Basu ‘982 with the umbrella-shaped configuration as is taught by Wong as both expandable electrode assemblies perform the same function of providing electrodes to patient tissue and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Basu ‘982 further fails to teach the end effector comprising: a second flexible circuit disposed on the second surface of the membrane proximate each of the plurality of spines and extending around the longitudinal axis; and a plurality of second pairs of electrodes disposed on the second flexible circuit proximal to one another and a spine of the plurality of spines such that the first and second pairs of electrodes, with the membrane between the first and second pairs of electrodes, define a mirror image configuration.
Pederson teaches an expandable basket electrode assembly being coupled to the distal end of a shaft for delivery within a patient’s body having a plurality of electrodes for ablation ([0037]).
Pederson further teaches an exemplary spline having a flexible circuit assembly suitable for use in the electrode assembly ([0050]). Where the splines comprise first and second mirrored subassemblies on inner and outer surfaces of the spline each comprising electrodes disposed on outer and inner surfaces ([0050]- [0053]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the electrodes on the spline comprising first and second mirrored subassemblies, as is taught by Pederson, into the splines as is taught by Basu ‘982, to produce the predictable result of providing a spline having electrodes, as is taught by Pederson, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 2, Basu ‘982 teaches the end effector of claim 1, the plurality of spines being radially disposed about the longitudinal axis ([0046]).
Regarding claim 3, Basu ‘982 teaches the end effector of claim 1, each spine comprising a proximal end fixed to a probe shaft (Fig. 21; shows a proximal portion of the spines positioned within proximal region 84 as having a proximal end fixed to the proximal shaft [0074]) and a free distal end (Fig. 21; spines 18 are shown as having an end which is distal to the proximal region at the hemispherical portion between the proximal region 84 and the distal region 82), the distal end of the membrane extending beyond the free distal end of each spine ([0074] teaches the balloon as being positioned between the spines of the balloon throughout the length of the balloon including at the hemispherical portion of the balloon).
Regarding claim 4, Basu ‘982 teaches the end effector of claim 1, each spine comprising a proximal end fixed to a first probe shaft and a distal end fixed to a second probe shaft (Fig. 21; the distal portions of the spines are shown as being fixed to the distal tubular element and the proximal portion of the spines are shown as being fixed to the proximal tubular element as broadly as is currently claimed).
Regarding claim 5, Basu ‘982 teaches the end effector of claim 1, the membrane being biased to the expanded configuration by the plurality of spines ([0047] teaches the balloon as being formed of a compliant balloon material allowing the splines to formed the balloon configuration).
Regarding claim 6, Basu ‘982 teaches the end effector of claim 1, the membrane comprising a generally semi-spherical (Fig. 21; distal region 82), semi-conical shape (Fig. 21; proximal region 84), or polygonal pyramidal shape in the expanded configuration that defines the volume and further comprising a polymer material ([0047]).
Regarding claim 7, Basu ‘982 teaches the end effector of claim 1, the end effector being moveable between a collapsed configuration, in which the plurality of spines and the membrane are disposed generally along the longitudinal axis, and the expanded configuration ([0037]).
Regarding claim 8, Basu ‘982 teaches the end effector of claim 1, the first surface facing away from the longitudinal axis and the second surface facing towards the longitudinal axis (Fig. 1 shows the hybrid electrode assembly having spines and a balloon as having an inner and outer surface).
Regarding claim 9, Pederson teaches the end effector of claim 1, the first flexible circuit and the second flexible circuit being spaced apart from the plurality of spines along a vertical axis ([0052]- [0053]).
In accordance with the above modification, Basu ‘982 teaches each first pair of electrodes being respectively electrically connected together to define a single first electrode of a plurality of first electrodes on the first surface and each second pair of electrodes being respectively electrically connected together to define a single second electrode of a plurality of second electrodes on the second surface ([0051]).
Regarding claim 10 Basu ‘982 as modified teaches the end effector of claim 9, a portion of the membrane being disposed between the plurality of spines and the first flexible circuit and between the plurality of spines and the second flexible circuit ([0046]).
Regarding claim 11, Wong as modified teaches the end effector of claim 1, comprising a plurality of voids defined through the membrane, the first flexible circuit, and the second flexible circuit between adjacent spines of the plurality of spines ([0039] teaches the expandable portions of the stylet as having a separation between the plurality of tines).
Regarding claim 12, The end effector of claim 1, the membrane comprising a layer, the layer surrounding the longitudinal axis, with the layer comprising an insulative material ([0047]).
However, Basu ‘982 fails to teach the layer as being a plurality of layers.
While Basu ‘982 does not explicitly teach the layer as being a plurality of layers, there is no evidence that more than one layer being a plurality of layers makes a meaningful difference to the function of the device compared to the currently taught layer and it has been held that a duplication of parts is an obvious modification, as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
In accordance with the modification, Basu ‘982 as modified teaches each layer is further taught as surrounding the longitudinal axis and at least one of the layers comprises an insulative material.
Regarding claim 13, in accordance with the above rejection, Pederson further teaches the end effector of claim 12, the plurality of layers of each leaf comprising at least one layer comprising a dielectric material ([0052] as broadly as is currently claimed).
Regarding claim 14, Pederson teaches the end effector of claim 1, the first flexible circuit comprising a first flexible substrate that is circumferentially spaced around the longitudinal axis, each first electrode being disposed on a respective first flexible substrate ([0050]- [0053]).
While Pederson does not explicitly teach the first flexible substrate as being a plurality of first flexible substrates, there is no evidence that more than one flexible substrates makes a meaningful difference to the function of the device compared to the currently taught first flexible substrate and it has been held that a duplication of parts is an obvious modification, as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
Regarding claim 15, Basu ‘982 as modified teaches the end effector of claim 1.
While, Basu ‘982 as modified fails to specifically teach the end effector comprising a number of spines of the plurality of spines being greater than a number of the first pairs of electrodes, Basu ‘982 does teach that one skilled in the art will recognize that the number of spines may vary as desired depending on the particular application and that as will be appreciated, the flex circuit technique allows for significant design freedom with regard to the number of electrodes ([0050], [0060]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have provided any relative number of spines and electrodes, such as the number of the spines being greater than the number of electrodes, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (MPEP 2144.05(I-II), In re Aller, 105 USPQ 233.)
Further, there does not appear to be any disclosed criticality for this range. Pending a statement of criticality, the recited range does not patentably distinguish over that of the prior art.
Regarding claim 16, Basu ‘982 teaches the end effector of claim 1, each first pair of electrodes being flush with an outer surface of the membrane ([0060] teaches that the electrodes may be flush or protrude).
Regarding claim 17, Basu ‘982 teaches the end effector of claim 1, each first pair of electrodes protruding from an outer surface of the membrane ([0060] teaches that the electrodes may be flush or protrude).
Regarding claim 19, Basu ‘982 teaches a medical system ([0046], [0074]) comprising:
a medical probe (Fig. 1; catheter 10) comprising an elongated probe body (Fig. 1; elongated catheter body 12) and an end effector (Fig. 1; hybrid electrode assembly 16; [0074]) connected to a distal end of the elongated probe body ([0046]), the elongated probe body and the end effector extending along a longitudinal axis, the end effector comprising:
a plurality of spines (Fig. 1; spines 18 having a structural substrate 40) connected to the elongated probe body and extending radially outward from the longitudinal axis of the end effector in an expanded configuration ([0046]);
a membrane (Fig. 1; inflatable balloon 22; [0047] & [0074]) connected to the plurality of spines, the membrane comprising a distal end that surrounds the longitudinal axis and defining a volume ([0046]), the membrane including a first surface and a second surface opposite the first surface;
a first flexible circuit (Fig. 4-5; polymeric layer 42 is discussed as being any suitable polymer provided with a conductive trace, such as in known flexible circuit techniques; [0059]) disposed on the first surface of the membrane ([0049], [0060]) proximate each of the plurality of spines and extending around the longitudinal axis ([0046], [0059]);
a plurality of first pairs of ablation electrodes (Fig. 1, 4, 5; electrodes 20) disposed on the first flexible circuit and proximal to one another and a spine of the plurality of spine; and
an ablation generator configured to provide ablation pulses to the plurality of first pairs of electrodes ([0071]).
However, Basu ‘982 fails to teach the volume as having an open end.
Basu ‘982 does teach a catheter for ablation having an expandable basket-shaped distal electrode assembly (Abstract- [0001])).
Wong teaches a medical instrument system having a medical instrument such as a catheter for ablation having an expandable distal element, referred to as a stylet ([0030]- [0031]).
Wong further teaches the electrically conductive stylet as being provided in a variety of known configurations such as an expandable basket (Fig. 5A-B) and an umbrella-shaped configuration (Fig. 6A-B).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the expandable basket-shaped distal electrode assembly as is taught by Basu ‘982 with the umbrella-shaped configuration as is taught by Wong as both expandable electrode assemblies perform the same function of providing electrodes to patient tissue and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Basu ‘982 further fails to teach the end effector comprising: a second flexible circuit disposed on the second surface of the membrane proximate each of the plurality of spines and extending around the longitudinal axis; and a plurality of second pairs of electrodes disposed on the second flexible circuit proximal to one another and a spine of the plurality of spines such that the first and second pairs of electrodes, with the membrane between the first and second pairs of electrodes, define a mirror image configuration.
Pederson teaches an expandable basket electrode assembly being coupled to the distal end of a shaft for delivery within a patient’s body having a plurality of electrodes for ablation ([0037]).
Pederson further teaches an exemplary spline having a flexible circuit assembly suitable for use in the electrode assembly ([0050]). Where the splines comprise first and second mirrored subassemblies on inner and outer surfaces of the spline each comprising electrodes disposed on outer and inner surfaces ([0050]- [0053]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the electrodes on the spline comprising first and second mirrored subassemblies, as is taught by Pederson, into the splines as is taught by Basu ‘982, to produce the predictable result of providing a spline having electrodes, as is taught by Pederson, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 20, the recited methods are considered inherent in the ordinary production of the device as described by Basu ‘982/Wong/Pederson.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Basu ‘982 (US 20180184982 A1) in view of Wong (US 20240156518 A1) and Pederson (US 20230190198 A1) further in view of Basu ‘093 (US 20180161093 A1).
Regarding claim 18, Basu ‘982 teaches the end effector of claim 1.
However, Basu ‘982 fails to teach the end effector comprising each electrode of the first and second pairs of electrodes comprising an elongated segment comprising a plurality of conductive stripes running parallel to each other to form an overall shape of the elongated segment.
Basu ‘093 teaches a balloon device having a plurality of electrodes in a flex circuit electrode assembly (Abstract).
Basu ‘093 further teaches the electrodes being formed as leaves where the leaves have a plurality of radiating stripe (Fig. 3; leaf 30).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the shape of the electrodes as being leaves, as is taught by Basu ‘093, into the electrode as is taught by Basu ‘982, to produce the predictable result of an electrode for providing energy to patient tissue, as is taught by Basu ‘982, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Conclusion
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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