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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 22, 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016134152 A1 (Ogata et al.) in view of CN 114366284 A (Yan et al.).
Regarding Claim 1, Ogata teaches a plasma guide wire [10] comprising:
a conductive core shaft [12] configured to be connected to a high-frequency generator (see para. 0013, "A radiofrequency guidewire includes a core wire configured to be coupled to a radiofrequency generator"; see also Fig. 1);
a conductive coil body [16] that surrounds a part of the core shaft on a distal end side of the core shaft;
and a distal tip [20] that includes a conductive material and fixes a distal end of the core shaft and a distal end of the coil body (see Fig. 2), the distal tip being configured to receive a high frequency wave from the high-frequency generator via the core shaft (see para. 0036, “The distal tip structure 20(1) serves as an electrode for delivering energy generated by a radiofrequency generator coupled to the core wire 12(1) for generating plasma at an occlusion site.”), wherein an outer surface of the distal tip includes:
a proximal end side region (the region of the tip defined by the area between the proximal end and the cross-section of largest diameter) (see e.g., [34] in Fig. 4B) located on a side of the coil body and
a distal end side region located distally relative to the proximal end side region (the region of the tip defined by the area between the distal end and the cross-section of largest diameter) (see e.g., [36] in Fig. 4B).
Ogata does not explicitly teach that the distal end side region has an electric resistance value that is lower than an electric resistance value of the proximal end side region. However, Ogata suggests modifying the tip structure such as to localize the electric field at any edge where plasma generation is most desired, and several exemplary embodiments of Ogata show the electric field strongest at a distal tip region (see para. 0037 and para. 0047; see also e.g., [22(7)] in Fig. 6A).
Yan teaches electrodes that include sub-electrodes with comparatively lower resistances forming the outer edges of the electrodes (see p. 3, para. 5, “the first electrode comprises at least three sub-electrodes, the resistance value of the sub-electrode in the middle of the first electrode is greater than the resistance of the sub-electrode edge”; see also Fig. 10). Yan further teaches that this type of configuration directs the highest electric field intensity towards the portions with lower resistance and away from the portions of higher resistance (see e.g. p. 21, para. 3).
It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Ogata and Yan to arrive at the claimed invention. This could be done by modifying Ogata to provide that the distal end side region of the tip be, for example, formed of a lower resistance metal than that of the proximal end side region, as suggested by Yan. Doing so would allow for the electric field to be further localized at the distal end side region of the tip and potentially avoid exposing the plasma to vulnerable insulation material near the base of the distal tip structure, a motivation recognized by Ogata (see para. 0024).
Regarding Claim 2, Ogata teaches a portion of the outer surface of the distal tip in the distal end side region has a corner portion that is sharper than a remaining portion of the outer surface of the distal tip in the distal end side region (see e.g., [22(7)] in Fig. 6A).
Regarding Claim 3, Ogata teaches the proximal end side region does not have any corner portion (see e.g., [34] in Fig. 4B).
Regarding Claim 4, Ogata teaches the distal tip includes a distal end marker (see e.g., collar [18(5)]) indicating a position of the distal tip (see e.g., Fig. 3C), the distal end marker being insulative (see also para. 0038, “the insulated collar”).
Regarding Claim 5, Ogata teaches the distal tip fixes the distal end of the core shaft and the distal end of the coil body in only the proximal end side region (see e.g., Fig. 2).
Regarding Claim 6, Ogata teaches the distal end of the core shaft and the distal end of the coil body are embedded in the distal tip in the proximal end side region (see Fig. 2).
Regarding Claim 7, Ogata teaches a surface area of the distal tip in the distal end side region is smaller than a surface area of the distal tip in the proximal end side region (see Fig. 4B; see also para. 0038, “the ratio of a length of the base 34 to a length of the tapered section 36 is greater than 50%).
Regarding Claim 8, Ogata suggests an interface between the distal end side region and the proximal end side region of the distal tip that extends in a direction perpendicular to a central longitudinal axis of the plasma guide wire (e.g., the interface in Fig. 4B between regions [34] and [36] is perpendicular).
Regarding Claim 9, Ogata does not explicitly teach an interface between the distal end side region and the proximal end side region of the distal tip that extends in a direction that is not perpendicular to a central longitudinal axis of the plasma guide wire. However, Ogata suggests plasma generation at edge surfaces away from the central longitudinal axis (e.g., Fig. 4D) as well as at other locations not shown in the figures (see e.g., para. 0038, “other edge surfaces may be located at other locations on the distal tip structure 20(3) to direct plasma generation). A person having ordinary skill in the art could have taken the teachings of Ogata and Yan as discussed in Claim 1 above and further provide for the location and shape of the interface between the two regions to not be perpendicular to the central longitudinal axis. For example, in situations where plasma generation is preferred away from the central longitudinal line (e.g., at either 22(6) of Fig. 4D), it would have been obvious for the lower resistance region to be focused around those points, which would foreseeably result in an interface that is not perpendicular to the central longitudinal axis. Having such an interface would serve to direct plasma generation towards those desired areas.
Conclusion
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/C.S./ Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/ Supervisory Patent Examiner, Art Unit 3794
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