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 .
A complete action on the merits of pending claims 1-20 appears herein.
Claim Objections
Claim 20 is objected to because of the following informalities:
Regarding claim 20, the term “zwire” should read --wire--
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-5, 7-11, 13-17, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmidt (US 2002/0095202 A1).
Regarding claim 1, Schmidt teaches
an elongate body having a proximal portion, a distal portion, and a lumen extending from the proximal portion to the distal portion; (Fig. 1, Char. 4: tube)
an electrode located on the distal portion; (Fig. 1: The distal most coiled electrode (10)) and
a conductor (Fig. 1, Char. 6: wire leads) extending from the electrode to the proximal portion, wherein the electrode and the conductor are formed of a single piece of continuous material. (Fig. 1 and Par. [0036]: Wire leads (6) each have terminal ends (2) and coiled electrodes (10))
Regarding claim 2, Schmidt further teaches the medical device is a dilator, guidewire, catheter, or perforation device. (Par. [0036]: Fig. 1 depicts and electrode catheter)
Regarding claim 3, Schmidt further teaches a first surface electrode positioned proximal of the electrode. (Fig. 1: The second distal most coiled electrode (10))
Regarding claim 4, Schmidt further teaches a second surface electrode positioned proximal of the first surface electrode. (Fig. 1: The third distal most coiled electrode (10))
Regarding claim 5, Schmidt further teaches the electrode, the first surface electrode, and the second surface electrode have a same diameter. (Absent a statement otherwise, one of ordinary skill in the art would expect all coiled electrodes (10) of Schmidt to have the same diameter)
Regarding claim 7, Schmidt further teaches the electrode comprises a plurality of loops positioned along a longitudinal axis of the elongate body. (Fig. 1: each of the coiled electrodes (10) comprise three loops)
Regarding claim 8, Schmidt further teaches the electrode includes a plurality of undulations. (Merriam-webster.com defines undulation as “a wavy appearance, outline, or form;” Fig. 1-3: Coiled electrodes (10) have a wavy outline)
Regarding claim 9, Schmidt further teaches the plurality of undulations are arranged parallel or perpendicular to a longitudinal axis of the elongated body. (Fig. 1)
Regarding claim 10, Schmidt further teaches the plurality of loops are joined by a conductive material. (Fig. 10, and Par. [0049]: Cross-bar (56) is formed by welds or a fusing of the coils (54))
Regarding claim 11, Schmidt further teaches the conductor extends within the lumen to the proximal end. (Fig. 1)
Regarding claim 13, Schmidt further teaches the conductor extends along a surface of the elongate body. (Fig. 1: wire leads (6) extend along an inner surface of tube (4))
Regarding claim 14, Schmidt further teaches the distal portion includes a taper. (Fig. 1: tip member (12) comprises a tapered end)
Regarding claim 15, Schmidt teaches
an elongate body (Fig. 1, Char. 4: tube) having a proximal portion (Fig. 1, the proximal half of tube (4)) and a tapered distal end; (Fig. 1, the distal half of tube (4))
a coiled electrode located on the tapered distal end; (Fig. 1: The distal most coiled electrode (10)) and
a conductor (Fig. 1, Char. 6: wire leads) extending from the coiled electrode to the proximal portion, wherein the coiled electrode and the conductor are formed of a single piece of continuous material. (Fig. 1 and Par. [0036]: Wire leads (6) each have terminal ends (2) and coiled electrodes (10))
Regarding claim 16, Schmidt further teaches a first surface electrode positioned proximal of the coiled electrode. (Fig. 1: The second distal most coiled electrode (10))
Regarding claim 17, Schmidt further teaches a second surface electrode positioned proximal of the first surface electrode. (Fig. 1: The third distal most coiled electrode (10))
Regarding claim 19, Schmidt further teaches the coiled electrode comprises a plurality of loops positioned along a longitudinal axis of the elongate body. (Fig. 1: each of the coiled electrodes (10) comprise three loops)
Regarding claim 20, the method steps for making the device would be intuitive to the structure provided in Schmidt, as applied to claim 1 above, given that the method steps of claim 20, as best understood by examiner, appear to make the device of claim 1.
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) 6 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt (US 2002/0095202 A1), as applied to claims 4 and 17 respectively above, and further in view of Chen (US 2015/0196357 A1).
Regarding claims 6 and 18, Schmidt, as applied to claims 4 and 17 respectively above, is silent regarding the first surface electrode and the second surface electrode have different lengths.
Chen, in a similar field of endeavor, teaches an electrode group comprising electrodes of varying sizes/lengths. (Claim 1)
Absent a statement of criticality and unexpected results, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Schmidt, as applied to claims 4 and 17 respectively above, such that the coiled electrodes (10) of Schmidt have varying lengths. Such a modification would have involved a mere change in the size of a component, and would allow for an increased number of different ablation patterns and lesion sizes to be created. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Schmidt (US 2002/0095202 A1), in view of Anderson (US 2014/0214059 A1).
Regarding claim 12, Schmidt as applied to claim 1 above, is silent regarding the conductor is encapsulated in a wall of the elongate body.
Anderson, in a similar field of endeavor, teaches encapsulating an electrical conductor within a wall of an elongate body. (Par. [0039])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Schmidt, as applied to claim 1 above, to incorporate the teachings of Anderson, and configure the wire leads (6) of Schmidt to be encapsulated within the walls of tube (4) of Schmidt. Doing so would be a simple substitution of one wire containment configuration for another for the predictable result of containing/protecting wires (6), and would help to anchor wires (6) in place.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/N.S.B./ Examiner, Art Unit 3794