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
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(s) 1-6, 16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hata et al. (US 2010/0286684 A1) in view of Rittman et al. (US 2008/0200972 A1).
With regard to claim 1, Hata et al. teach a tubular catheter for neuromodulation, comprising: an electrically non-conductive catheter wall circumscribing a lumen that extends from a proximal end of the tubular catheter to a distal end thereof (Fig. 1 non-conductive portions 18 circumscribe a lumen 13 which extends from a proximal to a distal end), the distal end having a tapered portion forming a tip with an opening for delivery of a medication (Fig. 1 tapered end 14 with opening 15); a first electrically conductive portion formed substantially about the entire tapered portion (Fig. 1 member 14); a first electrical conductor extending from the proximal end of the tubular catheter to electrically interconnect to the first electrically conductive portion (exemplary Figs. 8, 9, 14, 15, wires 70, [0043], [0048]); and one or more holes extending through the catheter wall for delivery of the medication through the one or more holes (Fig. 1 members 22). Hata et al. teach non-conductive and conductive portions may be press-fit together ([0034]) but do not explicitly disclose the conductive portion is “on” the tapered portion. However, Rittman et al. teach conductive and non-conductive catheter portions may be press fit ([0118]) or the conductive portions is “on” the non-conductive portion (Fig. 2 conductive portions 22). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to place the conductive portions on the catheter in Hata et al. as Rittman et al. teach this is an art effective equivalent means for providing conducive portions along with non-conductive portions and would yield the same predictable result.
With regard to claims 2 and 3, see Fig. 14, the connector comprises 207 as well as the unnumbered fluid lumen connected to 215, the portion of 207 connected to the wires is taken as a contact post ([0048]).
With regard to claim 4, Hata et al. show the wires routed through lumens but does not explicitly disclose the wires are embedded within the wall. However, Rittman et al. teach wires connected to conductive portions are embedded in the catheter wall (Fig. 2 wire 23) or may be routed through a lumen ([0119]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to embed the wires of Hata et al. as Rittman et al. teach this is an art effective equivalent means for providing conductor wires and would yield the same predictable result.
With regard to claim 5, see Fig. 1 members 16, which as combined would be placed on the exterior surface.
With regard to claim 6, Hata et al. show wires 70 but do not explicitly show the connections to the electrically conductive portions. However, Rittman et al. teach branch conductors may be used between electrodes ([0081]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the conductive portions electrically interconnected in Hata et al. as Rittman et al. teach this is effective to provide electrical pulses to the various electrodes and would yield the same predictable result.
With regard to claim 16, Hata et al. teach a pain mitigation system, comprising: a tubular catheter having: an electrically non-conductive catheter wall circumscribing a lumen that extends from a proximal end of the tubular catheter to a distal end thereof (Fig. 1 non-conductive portions 18 circumscribe a lumen 13 which extends from a proximal to a distal end), the distal end having a tapered portion forming a tip with an opening for delivery of a medication (Fig. 1 tapered end 14 with opening 15); a first electrically conductive portion formed substantially about the entire tapered portion (Fig. 1 member 14); a first electrical conductor extending from the proximal end of the tubular catheter to electrically interconnect to the first electrically conductive portion (exemplary Figs. 8, 9, 14, 15, wires 70, [0043], [0048]); and one or more holes extending through the catheter wall for delivery of the medication through the one or more holes (Fig. 1 members 22), a nerve stimulator configured to apply electrical pulses to the first electrically conductive portion (Fig. 14 generator 203, [0048]), and a port providing access to the lumen at the proximal end of the tubular catheter (Fig. 14 see port connected to 215). Hata et al. teach non-conductive and conductive portions may be press-fit together ([0034]) but do not explicitly disclose the conductive portion is “on” the tapered portion. However, Rittman et al. teach conductive and non-conductive catheter portions may be press fit ([0118]) or the conductive portions is “on” the non-conductive portion (Fig. 2 conductive portions 22). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to place the conductive portions on the catheter in Hata et al. as Rittman et al. teach this is an art effective equivalent means for providing conducive portions along with non-conductive portions and would yield the same predictable result.
With regard to claim 17, the device may be used for denervation ([0012]) and would be capable of receiving such medication ([0002]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hata et al. (US 2010/0286684 A1) and Rittman et al. (US 2008/0200972 A1) as applied to claim 5 above, and further in view of Massengale et al. (US 2008/0600530 A1).
With regard to claim 7, Hata et al. show wires 70 but do not explicitly show the connections to the electrically conductive portions. However, Rittman et al. teach it is beneficial to have the electrically conductive portions be independently activated via isolated conductors ([0133], [0134]). Further, Massengale teaches equivalently having independent or connected conductors depending on the desired activation of the exterior conductive portions ([0127], [0128]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a second electrical conductor isolated from the first electrically conductive potion in Hata et al. as Rittman et al. teach independently controlling the conductive portions and Massengale teaches equivalently having conductive portions which are independent or connected depending on desired activation.
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hata et al. (US 2010/0286684 A1) and Rittman et al. (US 2008/0200972 A1) as applied to claim 17 above, and further in view of Spinner et al. (US 2007/0213771 A1).
With regard to claims 18 and 19, Hata et al. teach the device may be used for denervation ([0012]) but does not disclose a particular amperage. However, Spinner et al. teach treating post-operative pain ([0028]) using pulses between .2-8 mA and a duration of 100 microseconds and is selected as suitable as needed to alter a nerve’s impulse propagation function ([0051]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use values in Hata et al. as in Spinner et al. for post-operative pain management as Spinner et al. teach such values are effective for blocking neural impulses and would yield the desired result.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783