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 § 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 3-10, 12-13, 15-17, and 19-23 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.
In claim 3, in line 2, “…within a body chamber” is vague and sounds as if there is a connection to the body. Apparatus claims cannot claim a connection to the body and it is suggested to use functional language, such as “when the distal section is within a body chamber…”.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14 and 44 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The subject matter which was not described in the original disclosure is for claim 14, the lead forms an arc having a first radius with the decoupling structure, and the elongate stimulation assembly forms a corner having a second radius, less than the first radius, with the decoupling structure, in combination with the other elements in the claim(s).
Similarly, the subject matter which was not described in the original disclosure for claim 44 is wherein the extension region forms an arc with the lead to enable movement of the lead relative to the extension region, and the pre-formed bend forms a corner with the elongate stimulation assembly to discourage movement of the extension region relative to the elongate stimulation assembly, in combination with the other elements in the claim(s).
The examiner could not find these limitations in the original disclosure or the description of arcs, radiuses or corners.
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.
Claims 1-10, 12-16, 18-20, 22-23, and 38-46 are rejected under 35 U.S.C. 102a1 as being anticipated by Dhanasingh et al (9522268). Dhanasingh meets the claimed limitations as follows:
--a stimulator unit (e.g. abstract, elements 108/701, etc.)
--an elongate stimulation cochlear assembly with electrodes (e.g. figure 5C, elements 510 and 501, figure 6C, right hand side after 601, etc.) and a straight portion (e.g. figure 5C, element 501; figure 6C, right hand side, etc.)
--a flexible lead with a wire connecting the electrode to the stimulator (e.g. abstract, figures 5C, straight bottom section next to element 509; figure 6C, left hand side etc.)
--decoupling structure connecting distal end of lead to proximal end of stimulation assembly (e.g. figure 5C, element 509-506; figure 6C, element 601, etc.) that mechanically decouples torsional, linear, and angular forces (e.g. abstract, col. 3, lines 5-12, etc.) from the lead.
--the decoupling structure is arranged such that the proximal end of the elongate stimulation assembly and the distal end of the lead are not co-linear (e.g. figure 5C, straight area near serpentine section 509 is not co-linear with 510; figure 6C, left hand side is not co-linear with right hand side, figure below, etc.).
--For claim 38, lead having a second axis and straight portion having a first axis offset from second axis, the decoupling structure has a pre-formed bend (e.g. where the decoupling structure meets the elongate stimulation assembly—e.g. figure below, right hand side straight section after section 601, etc.) and a proximal extension that is oriented at an angle to a straight portion to axially offset the first axis of the straight portion from the second axis of the lead.
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For claims 3-8, 40-43, Dhanasingh shows the decoupling structure with a pre-formed bend and proximal extension, extending from the bend back to the lead, at an angle relative to the axis of the straight portion at approximately 90 degrees to the straight section (e.g. figure 5c, last serpentine section nearest element 510; figure 6C above, last 90 corner with stimulation assembly, with extension region, etc.). For claim 9, the bend is malleable and moldable during insertion (e.g. col. 3, lines 5-6, etc.). For claim 10, the material may be pre-molded into the angle (e.g. nitinol, col. 3, lines 10-12, figure 6, col. 6, lines 40-59, etc.). For claims 12 and 13, the pre-formed bend is a pre-biased shape element that can be straightened or configured to adopt the predetermined angle after implantation, as the system can be straightened and or molded after insertion (e.g. figure 6, col. 6, lines 48-49; col. 3, lines 5-6, etc.). For claim 14, as seen above in figure 6C, the corner at the approximately 90 degree angle will take a smaller radius circle than at the arc where the lead meets the decoupling structure resulting in a larger radius circle. For claims 15, 16, 45 and 46, as seen in figures 5C and/or 6C, the length of the extension, extending from the bend back to the lead, is over 10 times the diameter of the stimulation assembly. For claim 18, figure 5C and 6C show the lead and stimulation substantially parallel to each other. For claim 19, the proximal section does has a linear shape (e.g. figure 5c, straight/linear section from area 503 toward numeral 507, etc.). For claims 20 and 22-23, the shape can be non-linear, a coil, undulating or serpentine (e.g. figure 5c for non-linear, undulating or serpentine; figure 6b for coil or non-linear, etc.). For claim 44, as seen above in figure 6C, the lead forms an arc with the extension region allowing for movement between the two, and the bend forms a corner with the stimulation assembly discouraging movement between the two due to the corner, this also as a result of the lower radius circle that fits at the 90 degree corner bend compared to the larger radius circle at the arc where the lead meets the decoupling structure.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Dhanasingh et al in view of Dadd et al (2010/0305676). Dhanasingh discloses the claimed invention except for the predetermined length being at least 2.5 mm. Dadd teaches that it is known that the decoupling structure be at least 2.5 mm, such as 24 mm or 5 mm (e.g. paras. 15, 34, etc.) so that the lead is decoupled from the stimulation assembly to allow movement of the lead with minimal movement of the stimulation assembly. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Dhanasingh, with the predetermined length being at least 2.5 mm, such as 24 mm or 5 mm as taught by Dadd, since it would provide the predictable results of providing enough slack/length for the structure to effectively decouple any forces from the lead onto the assembly.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Dhanasingh et al. Dhanasingh discloses the claimed invention having different shapes for the pre-formed non-linear shape, such as serpentine or undulating for the off axis lead to stimulation assembly axis, but does not disclose the shape being a coil. Dhanasingh discloses other shapes, such as a coil shape in figure 6B to provide another shape to allow the lead and stimulation assembly to decouple from each other. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system with the off axis lead and stimulation assembly axis as taught by Dhanasingh, with the coiled pre-formed non-linear shape, as also taught by Dhanasingh, since it would provide the predictable results of another substitute/alternate shape to easily decouple the lead from the stimulation assembly to prevent movement of the assembly.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection necessitated by amendment. The new claim limitations are addressed above in the 102 rejection. In regards to claim 17, of the decoupling structure being at least 2.5 mm, the evidence requested to be used in the rejection has been added to the 103.
Conclusion
The prior art made of record is considered pertinent to applicant's disclosure and shows some of the well-known in the art elements.
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 George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 8/12/26
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