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 § 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 1-5 and 7-10 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Mirza et al. (US 2008/0086120).
Regarding claim 1, Mirza discloses a medical device, the medical device comprising: an elongate member (fig.6E; tubular member 210) having an elongate member proximal end (proximal end of tubular member 210 ) and an elongate member distal end (distal end of tubular member 210 ), the elongate member being electrically conductive and defining a lumen from the elongate member proximal end to the elongate member distal end [0039]; an energy delivery device (fig.6E, electrode 106) configured for puncturing tissue spaced from the elongate member distal end (fig.6E), the energy delivery device including a conductive spacer (see annotated figured); and a layer of insulation(fig.6E; first electrically insulating layer 218) covering the elongate member and extending distal of the elongate member distal end to the energy delivery device [0052].
Regarding claim 2, Mirza discloses the medical device of claim 1, further comprising a support spine attached to and extending proximally from the energy delivery device (see annotated figure above).
Regarding claim 3, Mirza discloses the medical device of claim 1, wherein the support spine is configured to contact the elongate member to provide a pathway for electrical energy to the energy delivery device (fig.6E; see annotated figure below).
Regarding claim 4, Mirza discloses the medical device of claim 3, wherein a proximal end of the support spine includes a spinal curve to facilitate contact between the support spine and the elongate member (see annotated figure below).
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Regarding claim 5, Mirza discloses the medical device of claim 3, wherein a proximal portion of the support spine is bent to facilitate contact between the support spine and the elongate member (see annotated figure below).
Regarding claim 7, Mirza discloses the medical device of claim 1, wherein the layer of insulation includes a taper distal of the elongate member (fig.6E).
Regarding claim 8, Mirza discloses the medical device of claim 1, wherein the layer of insulation includes a first material covering the elongate member, and a second material distal of the elongate member [0052].
Regarding claim 9, Mirza discloses the medical device of claim 1, wherein the energy delivery device includes a conductive dome distal of the conductive spacer, and the conductive dome is free from the layer of insulation (see annotated figure above).
Regarding claim 10, Mirza discloses the medical device of claim 1, wherein the elongate member includes a varying wall thickness with a constant outer diameter along its length, or a varying outer diameter with a constant wall thickness along its length [0040].
Claims 11-15 and 17-20 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Abou-Marie (US 2011/0118735).
Regarding claim 11, Abou-Marie discloses a medical device, the medical device comprising: an elongate member (fig.1A; elongate member 102) having an elongate member proximal end (proximal end of elongate member 102) and an elongate member distal end (distal end of elongate member 102), the elongate member being electrically conductive [0042] and defining a lumen [0043] from the elongate member proximal end to the elongate member distal end [0039]; an energy delivery device (fig.1A, electrode tip 112) configured for puncturing tissue spaced from the elongate member distal end (fig.1A); a thermal shield (fig.1A; heat shield 118) proximal of the energy delivery device and distal of the elongate member [0050], the thermal shied including a non-conductive material [0050]; and a layer of insulation (fig.1; insulation layer 114) extending distal of the elongate member distal end and partially (junction 112) covering the thermal shield (fig.1A).
Regarding claim 12, Abou-Marie discloses the medical device of claim 11, further comprising a support spine attached to and extending proximally from the energy delivery device (see annotated figure below).
Regarding claim 13, Abou-Marie discloses the medical device of claim 11, wherein the support spine is configured to contact the elongate member to provide a pathway for electrical energy to the energy delivery device (see annotated figure above).
Regarding claim 14, Abou-Marie discloses the medical device of claim 13, wherein a proximal end of the support spine includes a spinal curve to facilitate contact between the support spine and the elongate member (see annotated figure above).
Regarding claim 15, Abou-Marie discloses the medical device of claim 13, wherein a proximal portion of the support spine is bent to facilitate contact between the support spine and the elongate member (see annotated figure above).
Regarding claim 17, Abou-Marie discloses the medical device of claim 13, wherein the support spine includes a flare to facilitate contact between the support spine and the elongate member (see annotated figure above).
Regarding claim 18, Abou-Marie discloses the medical device of claim 11, wherein the non-conductive material is a ceramic or a polymer [0079].
Regarding claim 19, Abou-Marie discloses the medical device of claim 11, wherein the energy delivery device includes a conductive dome distal (fig.1A) and a support structure (support structure 120).
Regarding claim 20, Abou-Marie discloses the medical device of claim 11, wherein the elongate member includes a varying wall thickness with a constant outer diameter along its length, or a varying outer diameter with a constant wall thickness along its length [0040].
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.
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.
Claim(s) 11-15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mirza et al. (US 2008/0086120) in view of Abou-Marie (US 2011/0118735).
Regarding claim 11, Mirza discloses a medical device, the medical device comprising: an elongate member (fig.6E; tubular member 210) having an elongate member proximal end (proximal end of tubular member 210 ) and an elongate member distal end (distal end of tubular member 210 ), the elongate member being electrically conductive and defining a lumen from the elongate member proximal end to the elongate member distal end [0039]; an energy delivery device (fig.6E, electrode 106) configured for puncturing tissue spaced from the elongate member distal end (fig.6E); a layer of insulation (fig.6E; insulating layer 220) extending distal of the elongate member distal end (fig.6E). In a different embodiment, Mirza teaches a thermally insulative material, for example Zirconium Oxide or polytetrafluoroethylene (PTFE), may be applied over approximately the distal-most 2 cm of the electrical insulator [0053].
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However, Mirza does not disclose the layer of insulation extending distal of the elongate member distal end and partially covering the thermal shield. Abou-Marie teaches a device comprises an elongate member for receiving the energy from an electrical energy source (abstract). Abou-Marie further teaches the layer of insulation extending distal of the elongate member distal end (fig.1A; insulation layer 114) and partially covering the thermal shield (see annotated figure below). The junction 122 that is formed between the insulation layer 114 and heat sink 118 helps to limit the arcing to the electrode tip [0057].Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by Mirza with the layer of insulation extending distal of the elongate member distal end and partially covering the thermal shield as taught by Abou-Marie for the purpose of preventing arcing.
Regarding claim 12, Mirza/ Abou-Marie teaches the medical device of claim 11, further comprising a support spine attached to and extending proximally from the energy delivery device (see annotated figure of Mirza).
Regarding claim 13, Mirza discloses the medical device of claim 11, wherein the support spine is configured to contact the elongate member to provide a pathway for electrical energy to the energy delivery device (see annotated figure above of Mirza).
Regarding claim 14, Mirza discloses the medical device of claim 13, wherein a proximal end of the support spine includes a spinal curve to facilitate contact between the support spine and the elongate member (see annotated figure above of Mirza).
Regarding claim 15, Mirza discloses the medical device of claim 13, wherein a proximal portion of the support spine is bent to facilitate contact between the support spine and the elongate member (see annotated figure above of Mirza).
Regarding claim 17, Mirza discloses the medical device of claim 13, wherein the support spine includes a flare to facilitate contact between the support spine and the elongate member (see annotated figure above of Mirza).
Regarding claim 18, Mirza discloses the medical device of claim 11, wherein the non-conductive material is a ceramic or a polymer ([0079] of Mirza).
Regarding claim 19, Mirza discloses the medical device of claim 11, wherein the energy delivery device includes a conductive dome distal (fig.1A) and a support structure (support structure 120).
Regarding claim 20, Mirza discloses the medical device of claim 11, wherein the elongate member includes a varying wall thickness with a constant outer diameter along its length, or a varying outer diameter with a constant wall thickness along its length ([0040] of Mirza).
Allowable Subject Matter
Claim 6 and 16 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:
None of the references teach wherein the support spine is floppy to facilitate contact between the support spine and the elongate member.
Conclusion
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
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