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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 lacks sufficient structure to support the function of ejecting a liquid. That is, there is no claimed liquid source to provide for the function. Claim 7 lacks clear antecedent basis for “the electrode”. It is noted that claim 1 recites “a plurality of electrodes”, so it is not clear if the singular electrode recited in claim 7 is different from the plurality, or one of the plurality.
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 1-3 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Danek et al (7,198,635).
Danek et al provide a catheter device comprising a catheter shaft (102) including a near-distal end structure (104) comprising a plurality of electrodes (106). A handle is mounted on a proximal end of the catheter and the handle includes a handle body (124) and a slide mechanism (128) configured to be slidable along the axial direction of the handle body (Figures 5D and 5E, for example) during a deformation operation in which a shape of the near-distal end structure is deployed between first and second shapes (Figures 5F and 5G, for example) along an axial direction.
Regarding claim 2, the near-distal end structure is settable to any intermediate shape according to a slide position. That is, the slider (128) may be deployed any desired amount to affect the desired amount of deployment. Regarding claim 3, a distal end of a fixation wire (122) is fixed to the near-distal end structure to effect deployment, and a proximal end side of the fixation wire is fixed by the slide mechanism by insertion into a rigid tube (102) in the handle body. Regarding claim 7, the near-distal end structure includes a branch point of the catheter shaft (Figures 5F and 5G, for example), and a joining point (118) near the most distal end of the catheter shaft. A plurality of branch structures (106) including electrodes are connected to the branch point and the joining point in a curved shape forming a petal shape in the non-deployed shape (Figure 5f) and a deployed shape in which the petal shaped is deployed along the axial direction (Figure 5G).
Claims 1-3 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deford et al (2009/0240248).
Deford et al provide a catheter comprising a catheter shaft (12) having a near-distal end structure (28) comprising a plurality of electrodes (50). The device includes a handle including a handle body (14) and a slide mechanism (252) configured to be slid along an axial direction in the handle body (Figure 25, for example) to change the near-distal end structure between first (non-deployed) and second (deployed) shapes. See Figures 4 and 5, for example.
Regarding claim 2, the near-distal end structure is settable to any intermediate shape according to a slide position. That is, the slider (252) may be deployed any desired amount to affect the desired amount of deployment. Regarding claim 3, the distal end side of a deformation wire (162a and 162b) is fixed to the near-distal end structure, and a proximal end side of the deformation wire is fixed by the slide mechanism in a state of being inserted into a rigid tube (shown but not labeled in Figure 25 – the tubes through which the wires extend through the handle to the catheter). Regarding claim 5, Deford et al also provide a rotation operation portion to deflect a portion of the catheter near the distal end, the rotation operation portion including a rotating plate (122 – Figure 25) configured to be rotatable about a rotation axis perpendicular to the axial direction with respect to the handle body and a path defining member (206) formed from a member different from a member of the rotating plate and defining a non-rotational (i.e. linear) path through which the deformation wire (162c and 162d) passes.
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Danek et al (‘635) in view of the teaching of Fung et al (6,120,476).
Danek et al fail to disclose a slide mechanism that includes an interface on both a front surface side and a back surface side of the handle body.
Fung et al disclose another catheter device having a slider mechanism to actuate a near-distal end structure similar to Danek et al. In particular, Fung et al specifically teach that the sliding mechanism (126) may be circumferentially disposed about the housing to enable movement of the slider from any rotational position. Such a circumferential slide mechanism/knob inherently covers all sides of the handle, including a front and back surface.
To have provided the Danek et al device with a slide mechanism including a knob that extends around the circumference of the handle to enable actuation of the slide mechanism from any angular orientation would have been an obvious design consideration for one of ordinary skill in the art at the time of the invention since Fung et al fairly teach that such a slide mechanism is generally known in the art.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Deford et al (‘248) in view of the teaching of Shockey et al (5,275,151).
Deford et al disclose the catheter device having a near-distal end structure and a slide mechanism to deform the near-distal end structure as addressed with respect to claim 1 above. Deford et al also disclose a means to provide an irrigation fluid to be ejected outside the near-distal end structure. However, Deford et al fail to show the specific tube structure and liquid stop member as required by claim 4.
Shockey et al disclose another catheter device including a slide mechanism to cause a deformation of a near-distal end structure of the catheter. The slide mechanism of Shockey et al includes a deformation wire (20) secured to the slide mechanism (174) to control deformation of the near-distal end structure. In particular, a distal end-side region of the rigid tube (12) is configured to be insertable into a protective tube (66) such that fluid from the fluid source (via Y-tube (92)) flows into a gap between the protective tube and the rigid tube toward the near-distal end structure, and a liquid stop member (106) is configured to suppress leakage of the fluid into the handle member. See, for example, Figure 5.
To have provided the Deford et al device with the fluid distribution arrangement taught by Shockey et al to provide a fluid to the near-distal end structure and prevent leakage of the fluid into the handle would have been an obvious design alternative for one of ordinary skill in the art at the time of the invention since Shockey et al disclose the use of such a fluid providing structure in a similar catheter device having a deployable near-distal end structure and a slide mechanism.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bowden et al (5,611,777), Kohler et al (2003/0114832), Fuimaono et al (6,741,878), Highsmith (9,522,035) and Olson et al (12,465,721) disclose other devices having a deformable distal structure and a slide mechanism to deform the distal structure.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/ December 11, 2025