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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following feature(s) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Claim 13, “an electrically conductive stimulation electrode at the wire proximal end”. Examiner notes: Applicant’s specification and drawings only show an electrically conductive stimulation electrode at the wire distal end, not the wire proximal end.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
Claim 1, line 10, “the proximal end of the tubing”. It should be amended as “the proximal end of the electrically insulating tubing”.
Claim 1, line 11, “within the tubing”. It should be amended as “within the electrically insulating tubing”.
Claim 1, line 12, “the inner diameter of the tubing”. It should be amended as “the inner diameter of the electrically insulating tubing”.
Claim 1, line 12, “the stimulation wire”. It should be amended as “the electrically conductive stimulation wire”.
Claim 1, line 13, “in the tubing”. It should be amended as “in the electrically insulating tubing”.
Claim 1, line 14, “the stimulation electrode”. It should be amended as “the electrically conductive stimulation electrode”.
Claim 1, line 14, “the distal end of the tubing”. It should be amended as “the distal end of the electrically insulating tubing”.
Claim 1, line 15, “the stimulation wire”. It should be amended as “the electrically conductive stimulation wire”.
Claim 1, line 15, “the proximal end of the tubing”. It should be amended as “the proximal end of the electrically insulating tubing”.
Claim 1, line 16, “the proximal end of the tubing”. It should be amended as “the proximal end of the electrically insulating tubing”.
Claim 1, line 16, “the stimulation wire”. It should be amended as “the electrically conductive stimulation wire”.
Claim 1, line 17, “an outer side of the tubing”. It should be amended as “an outer side of the electrically insulating tubing”.
Claim 2, line 1, “the stimulation electrode”. It should be amended as “the electrically conductive stimulation electrode”.
Claim 3, line 1, “the stimulation electrode”. It should be amended as “the electrically conductive stimulation electrode”.
Claim 3, line 2, “the outer diameter of the tubing”. It should be amended as “the outer diameter of the electrically insulating tubing”.
Claim 4, line 1, “the stimulation electrode”. It should be amended as “the electrically conductive stimulation electrode”.
Claim 4, line 2, “the stimulation electrode”. It should be amended as “the electrically conductive stimulation electrode”.
Claim 4, line 3, “the tubing”. It should be amended as “the electrically insulating tubing”.
Claim 4, line 4, “the tubing”. It should be amended as “the electrically insulating tubing”.
Claim 4, line 4, “between stimulation wire and tubing and/or the stimulation electrode”. It should be amended as “between the electrically conductive stimulation wire and the electrically insulating tubing and/or the electrically conductive stimulation electrode”.
Claim 5, line 1, “the proximal end of the tubing”. It should be amended as “the proximal end of the electrically insulating tubing”.
Claim 5, line 2, “the stimulation cable”. It should be amended as “the electrically conductive stimulation cable”.
Claim 5, line 3, “the stimulation cable”. It should be amended as “the electrically conductive stimulation cable”.
Claim 5, line 4, “the tubing”. It should be amended as “the electrically insulating tubing”.
Claim 6, line 1, “the stimulation wire”. It should be amended as “the electrically conductive stimulation wire”.
Claim 7, line 1, “the stimulation wire”. It should be amended as “the electrically conductive stimulation wire”.
Claim 8, line 1, “the tubing”. It should be amended as “the electrically insulating tubing”.
Claim 9, line 1, “the tubing”. It should be amended as “the electrically insulating tubing”.
Claim 10, line 1, “the tubing”. It should be amended as “the electrically insulating tubing”.
Claim 11, line 1, “the tubing”. It should be amended as “the electrically insulating tubing”.
Claim 12, line 1, “the tubing”. It should be amended as “the electrically insulating tubing”.
Claim 13, line 3, “the tubing”. It should be amended as “the electrically insulating tubing”.
Claim 13, line 7, “the tubing”. It should be amended as “the electrically insulating tubing”.
Claim 13, line 8, “the stimulation wire”. It should be amended as “the electrically conductive stimulation wire”.
Claim 14, line 3, “the tubing”. It should be amended as “the electrically insulating tubing”.
Claim 15, line 2, “the stimulation electrode”. It should be amended as “the electrically conductive stimulation electrode”.
Claim 15, line 3, “the tubing”. It should be amended as “the electrically insulating tubing”.
Claim 15, line 4, “the tubing”. It should be amended as “the electrically insulating tubing”.
Claim 15, line 4, “between stimulation wire and tubing and/or the stimulation electrode”. It should be amended as “between the electrically conductive stimulation wire and the electrically insulating tubing and/or the electrically conductive stimulation electrode”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 13-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 13 recites “an electrically conductive stimulation wire located within the tubing” such that “an electrically conductive stimulation electrode at the wire proximal end, wherein the electrically conductive stimulation electrode projects beyond the tubing distal end.”
Claims 14-15 are rejected by virtue of depending on claim 13.
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 13-15 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.
Regarding claim 13, the phrase " the electrically conductive stimulation electrode projects beyond the tubing distal end " renders the claim indefinite because it is unclear how the electrode at the proximal end of the wire can project beyond the tubing distal end while the wire is located within the tubing. For the purpose of compact prosecution, Examiner interpreted the location of the electrode based on Applicant’s specification and drawings such that the electrode is at the wire distal end.
Claims 14-15 are rejected by virtue of depending on claim 13.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boezaart (US 2011/0054383).
Regarding claim 13, Boezaart discloses
A device (100, figs. 1-2A and pars. 0018-0023) for neurostimulation (pars. 0007-0010) comprising:
an electrically insulating tubing (114, fig. 1) with a tubing distal end (distal end of 114 – away from the insertion site) and a tubing proximal end (proximal end of 114 – towards the insertion site);
an electrically conductive stimulation wire (116, fig. 1) located within the tubing (see figs. 1 and 2A) and having a wire distal end (distal end of 116 – away from the insertion site) and a wire proximal end (proximal end of 116 – towards the insertion site);
an electrically conductive stimulation electrode (118) at the wire proximal end (see figs. 1 and 2A), wherein the electrically conductive stimulation electrode projects beyond the tubing distal end (see figs. 1 and 2A); and
an interspace (interspace within central bore 112) for supplying fluid between an inner wall of the tubing and an outer surface of the stimulation wire (see figs. 1 and 2A and par. 0020 for the interspace for a liquid to pass through freely).
Regarding claim 14, Boezaart discloses
The device of claim 13, wherein the wire proximal end projects beyond the tubing proximal end and bends around the tubing proximal end such that the wire proximal end is guided to an outer side of the tubing (Examiner notes: the limitation “projects beyond … and bend around … such that the wire proximal end is guided to an outer side of the tubing” is interpreted as functional limitation. See figs. 1 and 2A, and par. 0007 for the proximal end of wire 116 extending proximally beyond the proximal end of the catheter; therefore, the proximal end of wire 116 is capable of bending around the catheter/tubing for the wire proximal end to guide to an outer side of the catheter/tubing).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boezaart (US 2011/0054383) in view of Pajunk et al. (US 2008/0058757).
Regarding claim 15, Boezaart discloses the device of claim 13, wherein the stimulation electrode further comprises a securement section formed by a distal end of the stimulation electrode (see figs. 1 and 2A and par. 0021 for 118 being attached to 116), wherein the securement section is disposed with the tubing (Examiner notes: the attachment between 116 and 118).
Boezaart is silent about wherein the tubing further comprises an injection opening in a wall of the tubing terminating into the interspace between stimulation wire and tubing and/or the stimulation electrode comprises an axial through-opening.
However, Pajunk teaches a catheter (20) comprising an injection opening in a wall of the catheter (26, fig. 3 and par. 0021).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Boezaart tubing by adding an injection opening in the wall of the tubing, as taught by Pajunk, for the purpose of allowing the liquid to be injected as needed.
Allowable Subject Matter
Claims 1-12 are allowed over the prior art of records.
The following is an examiner’s statement of reasons for allowance: the prior art of record fails to disclose or teach either singly or in combination the claimed device.
The closest prior art of records is Boezaart (US 2011/0054383).
Regarding independent claim 1, the cited prior art fails to disclose/teach among all the limitation or render obvious a device for neurostimulation in combination with the total structure and function as claimed. No combination of prior art was found to teach or suggest each and every element of independent claim 1.
Boezaart is silent about an electrically conductive stimulation cable connected at the proximal end of the stimulation wire and an injection tube slipped in sections over the proximal end of the tubing forming a seal.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DUNG T ULSH/Primary Examiner, Art Unit 3783
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