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 .
Status of Claims
Claims 1-21 are currently pending in this application.
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 features of “a second ground electrode configured to be positioned within the cochlea on an apical side of an obstruction within the cochlea” wherein “the electrode array is configured to be inserted into the cochlea such that the distal end of the electrode array advances from a base of the cochlea towards an apex of the cochlea to a point located basally of the obstruction” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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
The claims are objected to because they include reference characters which are not enclosed within parentheses.
Specifically, claim 10 recites “electrode array 202”.
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
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.
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.
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.
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Landsberger et al. (US 20180369571 A1), hereinafter Landsberger, in view of Kuzma et al. (US 6487453 B1), hereinafter Kuzma.
Regarding claim 1, Landsberger discloses a cochlear implant (Fig. 2, paragraph [0026], cochlear implant 200), comprising:
a first ground electrode configured to be positioned external to a cochlea of a patient (Fig. 2, paragraph [0028], first ground electrode 210);
a second ground electrode configured to be positioned within the cochlea (Fig. 2, paragraph [0028], second ground electrode 212);
a flexible electrode array having a distal end and a proximal end defining a length therebetween (Fig. 2, paragraph [0026], "electrode array 202 formed from a flexible material ... electrode array 202 may have a distal end 204 and a proximal end 206 defining a length therebetween"), the electrode array comprising a plurality of electrode contacts arranged along at least a portion of the length of the electrode array (Fig. 2, paragraph [0026], electrode contacts 208), wherein the electrode array is configured to be inserted into the cochlea such that the distal end of the electrode array advances from a base of the cochlea towards an apex of the cochlea (paragraph [0026], "When the electrode array is inserted into the cochlea, a distal end 204 of the electrode array is advanced from the base through the turn(s) towards the apex"); and
a processing arrangement configured to map a first one of the electrode contacts to the first ground electrode for providing a first electrical stimulation from the first electrode contact to the first ground electrode to stimulate hearing of the patient at a first location in the cochlea, and a second mapping for providing a second electrical stimulation from the first electrode contact to the second ground electrode to stimulate hearing of the patient at a second location in the cochlea (paragraph [0030], "Each of the electrode contacts 208 on the electrode array 202 may be mapped with the first ground electrode, the second ground electrode, or with both. For example, each electrode contact 208 on the electrode array 202 may be mapped with the first and/or second electrode 210, 212 such that each combination may deliver an electrical signal that stimulates hearing in the cochlea within a different predetermined frequency channel or frequency range"; paragraph [0047], "an electrode contact 208 within an electrode array 202 as described herein could be used with either an extracochlear ground electrode 210 or an apical ground electrode 210, in the alternative, to provide to stimulation at two different possible cochlear locations. Therefore, a single electrode contact within the electrode array 202 may be used to provide electrical stimulation to two different possible locations in the cochlea, depending on which ground electrode is used in combination with the electrode contact 208"),
wherein the first location in the cochlea is positioned adjacent to the first electrode contact when the implant is inserted into the cochlea in an operating position, and the second location in the cochlea is positioned further towards the apex of the cochlea as compared to the first electrode contact when the implant is in the operating position (paragraph [0031], "the first location may be adjacent to the electrode contact 208 and the second location may be more apical than the location of the electrode contact 208").
Landsberger does not explicitly disclose that the second ground electrode is configured to be positioned on an apical side of an obstruction within the cochlea, not that the electrode array is configured to be inserted to a point located basally of the obstruction.
However, Kuzma teaches an electrode array for use within an ossified cochlea in conjunction with a cochlear stimulation system (column 1, lines 12-14), wherein a first electrode is configured to be positioned within a cochlea on an apical side of an obstruction within the cochlea (Figs. 4-5, column 5, lines 45-48), and wherein a distal end of an electrode array advances from a base of the cochlea towards an apex of the cochlea to a point located basally of the obstruction (Figs. 4-5, column 4, lines 24-26; column 5, lines 25-27).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Landsberger with the teachings of Kuzma so that the second ground electrode is configured to be positioned on an apical side of an obstruction within the cochlea, not that the electrode array is configured to be inserted to a point located basally of the obstruction, because doing so affords a patient having an ossified cochlea the opportunity to hear with the aid of an implantable cochlear stimulator and electrode (Kuzma, column 6, lines 9-11).
Regarding claim 2, the cochlear implant system of claim 1 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that the first electrical stimulation is a monopolar electrical stimulation (paragraph [0005], "the first electrical stimulation is a monopolar electrical stimulation").
Regarding claim 3, the cochlear implant system of claim 1 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that the second electrical stimulation is a bipolar electrical stimulation (paragraph [0032], "This alternative embodiment may be stimulated in a bipolar mode with other more proximal electrode contacts or singularly in combination with a ground electrode (e.g., an external ground electrode)").
Regarding claim 4, the cochlear implant system of claim 1 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that the second ground electrode includes a ball tip at a distal end thereof configured for insertion into the cochlea (paragraph [0028], "the second ground electrode 212 may be a ball electrode. ... The second ground electrode 212 may be surgically placed at or near the apex of the cochlea, e.g., via an apical cochleostomy").
Regarding claim 5, the cochlear implant system of claim 1 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that the first ground electrode includes a plate electrode (paragraph [0028], "the first ground electrode 210 may be a plate electrode").
Regarding claim 6, the cochlear implant system of claim 5 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that the first ground electrode is on an implant package configured to be positioned in use external to the cochlea (paragraph [0024], "One ground electrode may be positioned external to the cochlea, such as, for example, on an implant package"; paragraph [0028], "The first ground electrode 210 may be placed on an implant package, which may be placed external of the cochlea").
Regarding claim 7, the cochlear implant system of claim 1 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that the electrode array is configured to be inserted into the cochlea along a curve of no more than 540 degrees from the base of the cochlea toward the apex of the cochlea (paragraph [0026], "the electrode array 202 may have a length configured for insertion into the cochlea by no more than about 540 degrees, 450 degrees, or 360 degrees into the cochlea towards the apex").
Regarding claim 8, the cochlear implant system of claim 7 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that the electrode array is configured to be inserted into the cochlea along a curve of no more than 450 degrees from the base of the cochlea toward the apex of the cochlea (paragraph [0026], "the electrode array 202 may have a length configured for insertion into the cochlea by no more than about 540 degrees, 450 degrees, or 360 degrees into the cochlea towards the apex").
Regarding claim 9, the cochlear implant system of claim 8 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that the electrode array is configured to be inserted into the cochlea along a curve of no more than 360 degrees from the base of the cochlea toward the apex of the cochlea (paragraph [0026], "the electrode array 202 may have a length configured for insertion into the cochlea by no more than about 540 degrees, 450 degrees, or 360 degrees into the cochlea towards the apex").
Regarding claim 10, the cochlear implant system of claim 1 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that an extended length of the electrode array 202 is less than 31 mm (paragraph [0026], "electrode array 202 may have an extended length (i.e., when the electrode array 202 is uncoiled and extended lengthwise) less than approximately 31 mm, less than approximately 28 mm, less than approximately 25 mm, less than approximately 20 mm, or less than approximately 16 mm").
Regarding claim 11, the cochlear implant system of claim 10 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that an extended length of the electrode array 202 is less than 28 mm (paragraph [0026], "electrode array 202 may have an extended length (i.e., when the electrode array 202 is uncoiled and extended lengthwise) less than approximately 31 mm, less than approximately 28 mm, less than approximately 25 mm, less than approximately 20 mm, or less than approximately 16 mm").
Regarding claim 12, the cochlear implant system of claim 11 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that an extended length of the electrode array 202 is less than 25 mm (paragraph [0026], "electrode array 202 may have an extended length (i.e., when the electrode array 202 is uncoiled and extended lengthwise) less than approximately 31 mm, less than approximately 28 mm, less than approximately 25 mm, less than approximately 20 mm, or less than approximately 16 mm").
Regarding claim 13, the cochlear implant system of claim 10 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that an extended length of the electrode array 202 is less than 20 mm (paragraph [0026], "electrode array 202 may have an extended length (i.e., when the electrode array 202 is uncoiled and extended lengthwise) less than approximately 31 mm, less than approximately 28 mm, less than approximately 25 mm, less than approximately 20 mm, or less than approximately 16 mm").
Regarding claim 14, the cochlear implant system of claim 10 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that an extended length of the electrode array 202 is less than 16 mm (paragraph [0026], "electrode array 202 may have an extended length (i.e., when the electrode array 202 is uncoiled and extended lengthwise) less than approximately 31 mm, less than approximately 28 mm, less than approximately 25 mm, less than approximately 20 mm, or less than approximately 16 mm").
Regarding claim 15, the cochlear implant system of claim 1 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that a number of electrode contacts in the electrode array is no less than 10 and no more than 30 (paragraph [0027], "electrode array 202 may comprise N contacts, where N can be any suitable integer from 10 to 30").
Regarding claim 15, the cochlear implant system of claim 1 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that the number of electrode contacts in the electrode array is 22 (paragraph [0027], "electrode array 202 may comprise 22 electrode contacts"; paragraph [0036], "the electrode array may comprise 22 electrode contacts").
Regarding claim 17, the cochlear implant system of claim 1 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses a transmitter and a receiver configured to transmit data to an external processing arrangement and to receive instructions from the external processing arrangement (paragraph [0029], "the cochlear implant may comprise a transmitter and a receiver, or a transceiver, configured to transmit data to an external processing arrangement and receive instructions from the external processing arrangement").
Regarding claim 18, the cochlear implant system of claim 17 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that the processing arrangement is configured to map each of the electrode contacts to one or more of the first and second ground electrodes (paragraph [0029], "The processing arrangement may comprise one or more computer processors configured to execute one or more sets of instructions configured to map each of the electrode contacts to one or more ground electrodes"; paragraph [0030], "Each of the electrode contacts 208 on the electrode array 202 may be mapped with the first ground electrode, the second ground electrode, or with both").
Regarding claim 19, the cochlear implant system of claim 17 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that the electrode contacts are electrically isolated from one another along the electrode array (paragraph [0027], "Each of the electrode contacts 208 may be electrically isolated from the other electrode contacts 208"; paragraph [0032], "Each of the electrode contacts 408 may be electrically isolated from each other").
Regarding claim 20, the cochlear implant system of claim 1 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses a distalmost one of the electrode contacts that is movable relative to a proximal portion of the electrode array so that, when the electrode array is positioned as desired within the cochlea, the distalmost electrode contact may be advanced further apically into the cochlea relative to the proximal portion of the electrode array (paragraph [0032], "The electrode array 402 may also include a distal most electrode contact 411 positioned at or near the distal end of the electrode array, in particular, at the distal tip of the electrode array 402. The distalmost contact 411 may comprise a component that projects distally from the distal end of the electrode array 402 (e.g., a wire stylet extendable from the distal end of the electrode array 402). The distalmost contact 411, in particular, the distally projectable component of the distalmost contact 411, may be connected to a wire 409d that is sufficiently long to allow for further apical advance of the distalmost contact 411 while operably connecting the distalmost contact to a power source and/or a controller or processing arrangement for controlling delivery of stimulation to the cochlea via the distalmost electrode 411. Therefore, this alternative embodiment of an electrode array 402 may be inserted into the cochlea and advanced more apically (and therefore into lower frequency regions of the cochlea) than the insertion depth of the electrode array, in particular, by pushing/advancing the distalmost contact 411 (e.g., wire stylet) towards the apex of the cochlea. For example, when in use, the electrode array 402 may be first inserted inserted into a cochlea of a patient and the distalmost contact 411 may be advanced further apically after full electrode insertion, as shown in FIG. 6b").
Regarding claim 21, the cochlear implant system of claim 1 is obvious over Landsberger and Kuzma, as explained above. Landsberger further discloses that the distalmost electrode contact is connected to a wire sufficiently to permit the distalmost electrode contact to be further apically while remaining coupled to the processing arrangement (paragraph [0032], "The distalmost contact 411 may comprise a component that projects distally from the distal end of the electrode array 402 (e.g., a wire stylet extendable from the distal end of the electrode array 402). The distalmost contact 411, in particular, the distally projectable component of the distalmost contact 411, may be connected to a wire 409d that is sufficiently long to allow for further apical advance of the distalmost contact 411 while operably connecting the distalmost contact to a power source and/or a controller or processing arrangement for controlling delivery of stimulation to the cochlea via the distalmost electrode 411").
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE SISON whose telephone number is (703)756-4661. The examiner can normally be reached 8 am - 5 pm PT, Mon - Fri.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
