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 § 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.
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 21-23, 25-26, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application 20140171961 awarded to Lacey et al, hereinafter Lacey, in view of U.S. Patent Application 20150224326 awarded to Toth et al, hereinafter Toth.
Regarding Claim 21, Lacey teaches a lead paddle (abstract), comprising: an elongated paddle body having an upper side and a contact side defined by a major axis and a minor axis perpendicular to the major axis, the upper side and the contact side terminating at first and second lateral edges (Fig. 7, paddle lead 702); the paddle body including a plurality of electrodes arranged on the contact side of the paddle body wherein some electrodes are offset to each other (Fig. 7, Para. 0074, unnumbered square electrodes spaced evenly along the paddle body, see annotated figure below); the paddle body further including at least two guiding channels for receiving a guiding wire being inserted into the at least two guiding channels (Fig. 7, Para. 0074, stylet lumens 710a and 710b (Examiner notes that there appears to be an error in Fig. 7 of the prior art, mislabeling 710b as an additional 710a, see annotated Fig. 7 below)), the at least two guiding channels arranged along the first and second lateral edges of the paddle body and extending over more than half of a length of the lead paddle (Fig. 7); a first and second lateral edges of the paddle body are joined by a distal edge forming a round tip (Fig. 7); and wherein the guiding wire is configured to allow pushing and steering in the at least two guiding channels and is dis-engageable from the at least two guiding channels (Para. 0070, “Once the stylet 330 is inserted into the paddle lead 502, a user may use the insertion tool 302 to guide, steer, and position, the paddle lead 502 at a target stimulation location within a patient. Once the paddle body 504 of the paddle lead 502 is positioned, the stylet 330 may be removed from the paddle body 504. In at least some embodiments, the stylet 330 is removed from the paddle body 504 without moving the paddle body 504”). Lacey does not teach wherein one of the at least two guiding channels is arranged along a first lateral edge of the paddle body, and a remaining of the two guiding channels is arranged along a second lateral edge of the paddle body.
However, in the art of implantable neuromodulation devices, Toth teaches a sensing surgical tool (Fig. 11, surgical tool 1110) that contain guide wires (Para. 0279, tendons 1150a and 1150b, Para. 0228 describes the tendons as “polymeric and/or fibrous wires”, Examiner notes that the surgical tool of Toth would necessarily have to include a channel to accommodate placement of the tendons in the tool) located on the outermost lateral sides of the sensing device (Fig. 11), for maneuverability of the tool (Para. 0279).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lead paddle of Lacey to position the guiding channels to be placed on the outermost lateral side of the paddle body as shown in Toth, for the predictable purpose of substituting one known configuration of guide wire placement for another to change maneuverability as necessitated by one of ordinary skill in the art.
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Regarding Claim 22, Lacey in view of Toth makes obvious the lead paddle of claim 21, wherein one of the at least two guiding channels follows a form of the outer edge region (1150a and 1150b of Fig. 11 in Toth).
Regarding Claim 23, Lacey in view of Toth makes obvious the lead paddle of Claim 21. Lacey further teaches wherein the paddle is shaped to fit in a spinal channel (Para. 0031, “The electrical stimulation system can be used for a variety of applications including, but not limited to neural stimulation, spinal cord stimulation, muscle stimulation, and the like”).
Regarding Claim 25, Lacey in view of Toth makes obvious the lead paddle of claim 21, wherein the at least two guiding channels extends over more than 80% of the length of the lead paddle (1150a and 1150b of Fig. 11 in Toth, Para. 0279 states the tendons control the movement of tool 1110, and the tendons would need to extend along a majority of the tool).
Regarding Claim 26, Lacey in view of Toth makes obvious the lead paddle of Claim 21. Lacey further teaches wherein the plurality of electrodes are identically shaped and embedded in the paddle body (Fig. 7, paddle lead 702’s electrodes (labeled 508 on paddle lead 502, paddle lead 702 only showing a different lumen configuration)).
Regarding Claim 28, Lacey in view of Toth makes obvious the lead paddle of Claim 21. Lacey further teaches wherein wherein a flexibility of the paddle in an axial direction measured along the major axis is different from the flexibility of the paddle in a radial direction measured along the minor axis (Para. 0075, stating flexibility is only in one plane, as the paddle of Lacey is an elongate shape, the axial flexibility along the major axis is less flexible than the axial flexibility along the minor axis (see annotated figure above)).
Regarding Claim 29, Lacey in view of Toth makes obvious the lead paddle of Claim 28. Lacey further teaches wherein the flexibility of the paddle is higher in the radial direction than in the axial direction (Para. 0075, stating flexibility is only in one plane, as the paddle of Lacey is an elongate shape, the axial flexibility along the major axis is less flexible than the axial flexibility along the minor axis (see annotated figure below)).
Allowable Subject Matter
Claims 24 and 27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Lacey et al cited above is the closest prior art of record to the Applicant’s claimed device, but does not contain the claimed element of a U-shaped connecting section connecting the two guiding channels, and the Applicant’s Specification states that this particular configuration of the connecting section is critical to the improvement of the Applicant’s device over the prior art (Applicant’s Specification Para. 0022).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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/JLM/
Examiner, Art Unit 3792
/JAMES M KISH/Supervisory Patent Examiner, Art Unit 3792