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 § 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.
Claims 16, 17, 19-32 and 34-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Palmer (5,439,478).
Regarding claim 16, Palmer provides a distal end assembly of a medical device (Figure 2, for example) comprising a clevis (240 – Figure 4d) having a bushing (252) at a proximal end of the clevis. The clevis includes a slot (264) and the clevis is configured to receive the bushing in the slot. An end effector (18) is pivotally connected at a distal end of the clevis (Figure 2). A distal actuator (16) is connected to the end effector (at 76) wherein translation of the distal actuator actuates the end effector (arrow P). There is a shaft connector (59) which receives the bushing wherein the bushing is rotatable relative to the shaft connector (arrow S).
Regarding claim 17, the bushing is fixed to the clevis by a press-fit arrangement. Regarding claim 19, the end effector comprises two jaws (70,72). Regarding claim 20, pulling the actuator (16) closes the jaws, and pushing the actuator opens the jaws. Regarding claim 21, the end effector is pivotably connected to the distal actuator by a link (i.e. that extends through opening 76). Regarding claim 22, the clevis is rotatable relative to the shaft connector (arrow S and associated description). Regarding claim 23, rotation or actuator (16 at arrow R in Figure 2) causes rotation of the clevis and end effector (arrow S in Figure 2). Regarding claim 24, a shoulder of the shaft connector (i.e. proximal end) and a flange of the bushing (i.e. the flange where the bushing 252 joins 260) inhibit axial movement of the distal end assembly. See Figure 4d. Regarding claim 25, the distal actuator translates within the bushing (as shown in Figure 2). Regarding claim 26, the end effector is pivotably coupled to the distal actuator by a wire (i.e. the distal end of the actuator 16 that is inserted into opening 76). Regarding claim 27, there is inherently an annular gap between the bushing (252) and the shaft connector (59) to allow the bushing to rotate freely. Regarding claim 28, the shaft connector (59) defines a lumen with an opening at the distal end and the bushing (252) extending within the lumen and out the opening (Figure 4d). Regarding claim 29, there is an annular gap between the actuator and the bushing (see Figure 2). Regarding claim 30, the actuator (16) extends through a lumen (254) in the bushing (Figures 2 and 4d).
Regarding claim 31, Palmer provides a medical device comprising a handle (Figure 6 – 84,90) having at least one actuator (85,100), a shaft (14) having a proximal end attached to the handle and a distal assembly (20) connected to the distal end of the shaft. The distal assembly includes an end effector (18) and a distal actuator (16) as addressed with respect to claim 16 above. The distal actuator includes a bushing (252) and a shaft connector (59) wherein the bushing is within the shaft connector and rotatable relative thereto (arrow S in Figure 2). A wire (16) is coupled to the at least one actuator (i.e. handle) and to the shaft connector (i.e. extends therethrough) and actuation of one actuator (92) translates the wire and actuation of a second actuator (100) rotates the wire to rotate the end effector relative to the shaft.
Regarding claim 32, the first actuator is a knob (100) rotatable relative to a stationary part of the handle to rotate the end effector (Figure 6), and the second actuator (92) is an assembly slidably connected to the stationary portion of the handle such that translation of the second in either direction actuates the end effector to translate in two different directions (i.e. open and close).
Regarding claim 34, see discussion of claim 24 above. Regarding claim 35, Palmer discloses the method of positioning the device inside a body lumen and using the handle having two actuators to rotate the end effector relative to the shaft and to actuate the end effector (i.e. open and close) with the second actuator as addressed above. Regarding claim 36, the clevis includes a slot (i.e. bore 264) and the bushing (252) is received in the slot as addressed previously.
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 33 is rejected under 35 U.S.C. 103 as being unpatentable over Palmer (‘478) in view of the teaching of McBrayer e al (5,352,223).
Palmer fails to disclose an electrical connector to provide electrical energy to the end effector. The examiner maintains that it is generally well-known to provide surgical forceps/scissors with an electrosurgical connector to provide electrical energy at the end effectors to treat tissue.
To that end, McBrayer et al disclose another device having a clevis and a bushing for attaching an end effector to a shaft, the shaft being connected to a handle having actuators to open/close the end effector and to rotate the end effector assembly. In particular, McBrayer et al teach that it is known to provide an electrical connector (cable 58 and contacts 52 and 54) for providing electrosurgical energy to the end effector jaws.
To have provided the Palmer device with an electrical connector in the handle assembly to provide electrosurgical energy to the end effector to treat tissue would have been an obvious design modification for one of ordinary skill in the art at the time of the invention since McBrayer et al fairly show it is known to provide such an electrical connection in a similar medical device.
Response to Arguments
The examiner has now applied a different embodiment of Palmer, specifically the embodiment of Figure 4d which shows a bushing (252) received in a slot (264) of the clevis (240). The examiner maintains this embodiment of Palmer reads on the claims as proffered in the above rejections.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL PEFFLEY/
Primary Examiner
Art Unit 3794
/M.F.P/May 25, 2026
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