DETAILED ACTION
A complete action on the merits of pending claims 1-20 appears below.
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.
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, 4-8, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oral US 20060111702.
Regarding claims 1 and 8, Oral teaches a tubular shaft including a proximal end and a distal end (Fig. 2 tube 34), the tubular shaft extending along a longitudinal axis; and an expandable basket assembly coupled to the distal end of the tubular shaft (Fig. 3 electrode array 23), the expandable basket assembly comprising: a plurality of spines configured to bow radially outward from the longitudinal axis when the expandable basket assembly is in an expanded configuration (Fig. 6 arms 39); and a plurality of electrodes attached to the plurality of spines (Fig. 6 electrodes 40), each electrode of the plurality of electrodes comprising: a body including a first end (Fig. 4 outer surface of 40) and a second end (Fig. 4 point of 40 by 44), the body being attached to a respective spine of the plurality of spines such that the first end is oriented for contacting tissue when the expandable basket assembly is in the expanded configuration (Fig. 4), the first end comprising a conductive surface forming a generally triangular shape and an area that is greater than the second end, and the body converging from the first end to the second end (Fig. 4 second surface is the point at the center which is smaller than the other surfaces).
Regarding claim 11, Oral teaches wherein the plurality of electrodes are attached to each of the spines such that each adjacent spine comprises an electrode, and wherein the plurality of electrodes are aligned in a direction perpendicular to the longitudinal axis (Fig. 6).
Regarding claims 4 and 12, Oral teaches the body being configured for attachment to the spine such that a first edge of the generally triangular shape is oriented perpendicular to the spine (Figs. 4 and 6).
Regarding claim 5, Oral teaches the electrode being configured for ablation of the tissue (par. [0022]).
Regarding claim 6, Oral teaches the conductive surface forming the generally triangular shape comprising a compound curved surface that presents a rounded profile with respect to the longitudinal axis (Fig. 4 curved corners of the triangle).
Regarding claim 7, Oral teaches the electrode being configured for mapping electrophysiological characteristics of the tissue (par. [0021] the device can be used for mapping).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 9, 15, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Oral in view of Kunis US 20070083194.
Regarding claims 2 and 9, Oral does not explicitly teach the body comprising a tetrahedron. However, Oral does teach where the shape of the electrodes is a triangular prism (Figs. 3 and 4).
Kunis, in an analogous device, teaches the electrodes can have any shape such as oral, triangular, rectangular, trapezoidal, etc. and that there can be different shapes within the ablation basket (par. [0058]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the shape of Oral to be a tetrahedron. The applicant has not presented any evidence that the shape is critical and even states in par. [0053] of the instant specification that the faces can change as long as the basket can be collapsed down. This is also taught by Oral par. [0024]. Further, any shape is seen to preform equally as well for ablation as demonstrated by Kunis where any shaped electrode can be used.
Regarding claim 15, Oral teaches a tubular shaft including a proximal end and a distal end, the tubular shaft extending along a longitudinal axis (Fig. 2 tube 34); and an expandable basket assembly coupled to the distal end of the tubular shaft (Fig. 3 electrode array 23), the expandable basket assembly comprising: a plurality of spines configured to bow radially outward from the longitudinal axis when the expandable basket assembly is in an expanded configuration (Fig. 6 arms 39); and a plurality of electrodes attached to the plurality of spines (Fig. 6 arms 39), each electrode of the plurality of electrodes including a body comprising an outwardly-facing end (Fig. 4 outer surface of 40) and an inwardly-facing end (Fig. 4 point of 40 by 44), the outwardly-facing end including a conductive surface comprising an area that is greater than an area of the inwardly-facing end and configured to contact tissue when the expandable basket assembly is in the expanded configuration, the body converging from the outwardly-facing end to the inwardly-facing end (Fig. 4 the inward surface is the point at the center which is smaller than the outward surfaces).
Oral does not explicitly teach the body comprising a tetrahedron. However, Oral does teach where the shape of the electrodes is a triangular prism (Figs. 3 and 4).
Kunis, in an analogous device, teaches the electrodes can have any shape such as oral, triangular, rectangular, trapezoidal, etc. and that there can be different shapes within the ablation basket (par. [0058]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the shape of the electrodes in Oral to be a tetrahedron. The applicant has not presented any evidence that the shape is critical and even states in par. [0053] of the instant specification that the faces can change as long as the basket can be collapsed down. This is also taught by Oral par. [0024]. Further, any shape is seen to preform equally as well for ablation as demonstrated by Kunis where any shaped electrode can be used.
Regarding claim 17, Oral teaches wherein the plurality of electrodes are attached to each of the spines such that each adjacent spine comprises an electrode, and wherein the plurality of electrodes are aligned in a direction perpendicular to the longitudinal axis (Fig. 6).
Regarding claim 18, Oral teaches the body of each electrode of the plurality of electrodes being attached to the respective spine such that a first edge of the conductive surface is oriented perpendicular to the spine (Fig. 4).
Claims 3, 10, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Oral in view of Demarais US 20070129720.
Regarding claims 3, 10, 13, and 14, Oral does not explicitly teach wherein the second end is misaligned with the first end such that a first line extending perpendicularly to the conductive surface from a first point at a center of the first end is spaced a distance apart from a second line parallel to the first line and extending through a second point at a center of the second end and wherein a first electrode of the plurality of electrodes is attached to the respective spine in a first orientation such that the first edge is at a distal end of the body, and wherein a second electrode of the plurality of electrodes is attached to an adjacent spine of the plurality of spines in a second orientation such that the first edge is at a proximal end of the body and wherein the plurality of electrodes are attached to the plurality of spines such that the plurality of electrodes are attached to adjacent spines in alternating first and second orientations. However, Oral teaches where there are multiple splines with multiple electrodes on each (Fig. 6).
Demarais, in an analogous device, teaches where the positioning of the electrodes along the length of the splines has different angular orientations (par. [0050]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Oral to have the triangular electrodes in different orientations along the splines as in Demarais. The different orientations allow for preferential effects on different anatomical structures for energy propagation (par. [0050]).
Claims 16, 19, and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Oral and Kunis as applied to claim 15 above, and further in view of Demarais.
Regarding claims 16, 19, and 20, Oral and Kunis do not explicitly teach wherein the inwardly-facing end is misaligned with the outwardly-facing end such that a first line extending perpendicularly to the conductive surface from a first point at a center of the first end is spaced a distance apart from a second line parallel to the first line and extending through a second point at a center of the second end and wherein a first electrode of the plurality of electrodes is attached to the respective spine in a first orientation such that a first edge of the conductive surface is at a distal end of the body, and wherein a second electrode of the plurality of electrodes is attached to an adjacent spine of the plurality of spines in a second orientation such that a first edge of the conductive surface is at a proximal end of the body and wherein the plurality of electrodes are attached to the plurality of spines such that the plurality of electrodes are attached to adjacent spines in alternating first and second orientations.
Demarais, in an analogous device, teaches where the positioning of the electrodes along the length of the splines has different angular orientations (par. [0050]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Oral to have the triangular electrodes in different orientations along the splines as in Demarais. The different orientations allow for preferential effects on different anatomical structures for energy propagation (par. [0050]).
Conclusion
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/R.T.C./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
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