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 Objections
Claim 6 is objected to because of the following informalities: line 3 of the claim recites “the shaft or forms this the distal end”. The term “this” appears to be extraneous. Appropriate correction is required.
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.
Claims 1-4, 6, 7, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sartor et al (2016/0089199) in view of the teaching of Komiya (4,311,143).
Regarding claim 1, Sartor et al provide a surgical instrument comprising a shaft (50) constructed as a hollow tube that has a longitudinal axis and proximal and distal ends (Figure 1). A metal wire (generally 10) has a first end section (11 – Figure 1) a first shaft section (extending through lumen 40 – Figure 3), a second shaft section (extending through lumen 30 – Figure 3) wherein the first end section is arranged in the area of the proximal end of the shaft (Figure 1), and the first shaft section is electrically insulated from the second shaft section via insulated tubes (30,40). The wire is arranged to move along the longitudinal axis of the shaft into a first position where the working section (10) projects out of the shaft. The device is bipolar and provides a second electrode (20) on a portion of the shaft. In Sartor et al, the second electrode (20) is at the end of the shaft which would preclude the working section from be retracted completely within the shaft.
Komiya provides an analogous device having a wire loop device (5) extending from a hollow shaft (1) with the wires making up the loop extending through the hollow shaft. In particular, Komiya provides a ground electrode (8) on a periphery of the shaft which allows the wire loop portion to be withdrawn within the shaft (Figure 2, for example).
To have provided the Sartor et al device with a ground electrode on the circumference of the shaft to allow the loop section to be completely withdrawn into the shaft for deployment and retrieval would have been an obvious design modification for one of ordinary skill in the art at the time of the invention since Komiya fairly discloses such a relationship for the return electrode in an analogous device.
Regarding claim 2, the metal wire of both Komiya and Sartor et al is a shape-memory wire that assumes the looped shape when deployed. Regarding claim 3, there are two shaft sections in Sartor (extending through lumens 30 and 40) and the working section (i.e. loop 10) is arranged between the two shaft sections. Regarding claim 4, the working section is a loop (Figure 2 of Sartor et al, and Figure 1 of Komiya). Regarding claim 6, Komiya et al teach providing the second electrode on a distal end section of the shaft, and Sartor et al provide the shaft sections extending through the shaft as claimed. Regarding claim 7, a tubular insulation element (33,43) is arranged on the shaft of Sartor et al (Figure 3, for example). Regarding claims 12 and 13, Sartor et al provide an adjustment element (70 - Figures 1 and 2) mounted to move the wires in a longitudinal direction to deploy the loop member, including a grip element (76) on the adjustment element.
Claims 5, 8-11 and 14-21 are rejected under 35 U.S.C. 103 as being unpatentable over Sartor et al (‘199) and Komiya (‘143) and further in view of the teaching of Hassidov (2018/0028217).
These claims all deal with the particular sizing for the loop and for the length of the device. The examiner maintains that one of ordinary skill in the art would obviously recognize the necessary dimensions for a snare loop device, including the size of the loop and the length of the device, dependent upon the specific needs of the procedure. It is noted that applicant’s specification merely offers a variety of size ranges for the device, and fails to provide any criticality or unexpected results associated with the specific dimensions of the device. Many of the cited references disclose that the device may be of any particular size/length as needed for a procedure and fail to provide specific dimensions for the elements as that would be an obvious design consideration. Hassidov disclose various dimensions, including a loop diameter of 3.5mm (para. [0138]). Hassidov also disclose various other dimensions depending on whether the device is inserted through a colonoscope or a trocar (para. [0153-0156]) and also discloses a diameter of the wire that may be between 0.3-1.0mm (para. [0160]). Hassidov expressly disclose that the lengths and diameters may be adapted to different uses of the device (para. [0354]). Specific to claim 14, Hassidov also teach the wire loop may be constructed from NITINOL (para. [0095]).
To have provided the Komiya device with any reasonable dimensions for the diameter of the loop, the diameter of the wire and the length of the wire would have been an obvious design consideration for one of ordinary skill in the art at the time of the invention since it is generally known to provide such a device with a wide range of dimensions for specific uses as fairly taught by Hassidov.
Response to Arguments
The examiner has now applied the Sartor et al reference as the base reference for the rejection to address the rejected claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/Primary Examiner, Art Unit 3794