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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9, 11-17, 19-21 have been considered but are moot because the new ground of rejection over Risi et al. US 2012/0130465 in view of Buytaert US 2022/0273952 in view of Adunka et al. US 2022/0313998.
Applicant argues that Adunka et al. fails to disclose obtaining real-time feedback during insertion of the vestibular electrode array into the vestibule; and using the real-time feedback to monitor insertion of the vestibular electrode array into the vestibule.
However, Examiner is not relying on Adunka et al. for teaching insertion of a vestibular electrode array or electric stimulation. Rather Adunka et al. is only relied upon for teaching the use of real-time feedback during insertion of an electrode array for monitoring the electrode array during positioning resulting from a stimulation. Adunka et al. teaches a method of inserting an electrode array (paragraph 0004), further obtaining electrophysiological feedback during insertion of the electrode (paragraph 0067, electrophysiological assessment for monitoring real time feedback); and using the electrophysiological feedback can monitor insertion of the vestibular electrode array with respect to vestibular anatomy (paragraph 0067, signals recorded through the electrode array) wherein obtaining electrophysiological feedback during insertion of the electrode array comprises: delivering stimulation via the vestibular electrode array (paragraph 0067, for example, acoustic stimulation); and measuring one or more responses via the vestibular electrode array (paragraph 0067, electrophysiological assessment for monitoring real-time feedback), wherein measuring one or more responses via the electrode array comprises: obtaining at least one of a neural response or a myogenic response to the stimulus (paragraph 0054, response includes neural responses), to provide feedback during surgery to allow for modifying surgical technique to avoid trauma by electrode insertion (paragraph 0067). Adunka et al. teaches providing “real-time” feedback as amended to allow for modifying surgical technique to avoid trauma by electrode insertion (paragraph 0067). Risi et al. discloses an electrode array being positioned within a vestibule as claimed. Therefore, in combination the amendment including obtaining and monitoring real-time feedback fails to overcome the prior art.
Applicant further argues that the prior art, particularly Adunka et al. fails to disclose that stimulation is delivered via any electrode array for obtaining electrophysiological feedback, there being no electrical stimulation via the vestibular electrode array. Applicant argues Adunka et al. discloses using acoustic stimulation to assess a peripheral auditory system. Applicant argues any combination fails to disclose delivering stimulation by an electrode array and obtaining electrophysiological feedback in response to stimulation.
However, Risi et al. discloses the electrode array being adapted to deliver electrical stimuli (paragraph 0011), and adapted to measure neural responses to electrical stimuli (paragraph 0012) the stimulation device is operated so as to produce stimuli from the array, the neural response to said stimuli measured, and may be repeated at different positions, so the array is positioned in the most desirable location (paragraph 0012, the electrical stimulation comprises electrophysiological feedback in response to the electrical stimulation at different positions), each of the electrodes being adapted to selectively deliver electrical stimulation of the vestibular periphery (paragraph 0013, 0053). Risi et al. fails to disclose providing real-time feedback in response to delivering electrical stimulation via the vestibular electrode array.
Adunka et al. discloses providing a stimulation signal applied using the electrode array (paragraph 0006), an electrode array configured to delivery electrical stimulation (paragraph 0020), or providing acoustic stimulation (paragraph 0067) and providing real-time feedback to avoid trauma caused by the electrode insertion (paragraph 0067).
Claims 22 and 23 have been newly added.
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.
Claim 11, 12 and 22 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.
Claim 11 discloses “wherein obtaining the real-time feedback in response to the electrical stimulation comprises obtaining electrophysiological feedback” in lines 2-3. Claim 1 does not disclose the “obtaining” being in response to the electrical stimulation, but just “obtaining” during insertion of the vestibular electrode array. Examiner suggests language, for example, such as “obtaining the real-time feedback is in response to the electrical stimulation and comprises obtaining electrophysiological feedback”.
Claim 22 discloses “inserting part of the vestibular electrode array through the opening” on line 1. This language is indefinite as it is unclear as to whether “the opening” is referring the opening the cochlea (claim 22) or the opening in the oval window (claim 13).
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) 1-3, 11-13, 16 and 17, is/are rejected under 35 U.S.C. 103 as being unpatentable over Risi et al. US 2012/0130465 in view of Buytaert US 2022/0273952 in view of Adunka et al. US 2022/0313998.
Regarding claims 1-3, 11-13, 16 and 17, Risi et al. disclose a method comprising: surgically exposing an oval window of an inner ear of a recipient (paragraph 0044, implantation via oval window), wherein the stapes includes a footplate adjacent the oval window of the inner ear (normal anatomy comprises a stapes including a footplate); surgically forming an opening in the oval window (paragraph 0044, implantation via a round or oval window); and inserting a vestibular electrode array or positioning at least a portion of the vestibular electrode array into a vestibule of an inner ear of the recipient proximate to the otolithic organs of the inner ear via the opening in the oval window (paragraph 0044, electrode array placed in one semicircular canal, implantation of the vestibule, via a round or oval window), comprising delivering electrical stimulation via the vestibular electrode array (paragraph 0013, 0053), the electrode array being adapted to deliver electrical stimuli (paragraph 0011), and adapted to measure neural responses to electrical stimuli (paragraph 0012) the stimulation device is operated so as to produce stimuli from the array, the neural response to said stimuli measured, and may be repeated at different positions, so the array is positioned in the most desirable location (paragraph 0012, the electrical stimulation comprises electrophysiological feedback in response to the electrical stimulation at different positions), each of the electrodes being adapted to selectively deliver electrical stimulation of the vestibular periphery (paragraph 0013, 0053).
Risi et al. fails to explicitly disclose exposing a stapes, and prior to insertion of the vestibular electrode array into the vestibule, removing at least a portion of the stapes, to surgically form the opening in the oval window for inserting the vestibular electrode array into the vestibule of the inner ear, and obtaining real-time feedback during insertion of the vestibular electrode array into the vestibule; and using the real-time feedback to monitor insertion of the vestibular electrode into the vestibule, wherein obtaining the real-time feedback in response to the electrical stimulation comprises obtaining electrophysiological feed back in response to the electrical stimulation.
Buytaert teaches inserting a vestibular electrode array (paragraph 0035), being inserted into the inner ear and forming an opening in a stapes of the recipient and guiding the electrode array through the opening in the stapes (paragraph 0035, inserted through an anterior opening such as a stapedotomy), and records over a period of time following delivery of electrical stimulation signals to the vestibular system (paragraph 0021), muscle responses potentially representative of one or more vestibular evoked myogenic potentials (paragraph 0021), the responses are then used to control operation of the vestibular nerve stimulation (paragraph 0021), but fails to disclose obtaining real-time feedback.
Adunka et al. teaches a method of inserting an electrode array (paragraph 0004), further obtaining electrophysiological feedback during insertion of the electrode (paragraph 0067, electrophysiological assessment for monitoring real time feedback); and using the electrophysiological feedback can monitor insertion of the electrode array with respect to vestibular anatomy (paragraph 0067, signals recorded through the electrode array) wherein obtaining electrophysiological feedback during insertion of the electrode array comprises: delivering stimulating via the electrode array (paragraph 0067, electrophysiological assessment for monitoring real time feedback, signals recorded through the electrode array); and measuring one or more responses via the electrode array (paragraph 0067, electrophysiological assessment for monitoring real-time feedback, signals recorded through the electrode array), wherein measuring one or more responses via the electrode array comprises: obtaining at least one of a neural response or a myogenic response to the stimulus (paragraph 0054, response includes neural responses), to provide feedback during surgery to allow for modifying surgical technique to avoid trauma by electrode insertion (paragraph 0067).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Risi et al. by guiding the vestibular electrode array through the oval window and opening in the stapes footplate and by obtaining in electrophysiological feedback, the feedback being myogenic feedback during insertion of the vestibular electrode array into the vestibule, as taught by Buytaert and known in the art to provide an opening such as a stapedotomy for insertion of the plurality of electrodes into the target location and to control operation or set parameters, and to modify Risi et al, by obtaining in real-time electrophysiological feedback during insertion of the vestibular electrode array into the vestibule, using the electrophysiological feedback to monitor insertion of the electrode array with respect to the anatomy, delivering stimulation via the electrode array, obtaining real-time feedback or electrophysiological feedback in response to the stimulus, the electrophysiological feedback comprises obtaining at least one of a neural response or a myogenic response to the stimulus, as taught by Adunka et al. to provide feedback during surgery to allow for modifying surgical technique to avoid trauma by electrode insertion.
Claim(s) 4-8 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Risi et al. US 2012/0130465 in view of Buytaert US 2022/0273952 in view of Adunka et al. US 2022/0313998 as discussed above, and further in view of Lesinski et al. US 5772575.
Regarding claims 4-8 and 19-21, Risi et al. in combination discloses the method essentially as claimed as discussed above, but fails to disclose wherein removing at least a portion of the stapes comprising removing at least one portion of the footplate of the stapes, removing at least one portion of the footplate of the stapes comprising: removing the at least one portion with a drill, forming an opening in the footplate of the stapes, wherein inserting or positioning the vestibular electrode array into the vestibule via the opening in the oval window comprises: inserting or positioning the vestibular electrode array into the vestibule via the opening in the footplate, wherein removing at least one portion of the footplate comprises removing less than half of the footplate of the stapes, wherein the opening in the oval window comprises an opening through an anulus of the oval window beside the footplate of the stapes associated with the inner ear, and inserting the vestibular electrode array into the vestibule via the opening formed through the anulus of the oval window beside the footplate of the stapes.
Lesinki et al. teaches removing at least a portion of the stapes (column 3 line 66-column 4, line 13, surgical fenestration of the oval window by removal of the stapes bone, stapedectomy, or by creating a hole in the fixed stapes footplate, stapedotomy), comprising removing at least one portion of
the footplate of the stapes (column 3 line 66-column 4, line 13, surgical fenestration of the oval window by removal of the stapes bone, stapedectomy, or by creating a hole in the fixed stapes footplate, stapedotomy), comprising removing at least one portion of the footplate of the stapes comprising: removing the at least one portion with a drill (column 3 line 66-column 4, line 13, surgical fenestration utilizing mechanical drills or surgical lasers), forming an opening in the footplate of the stapes (column 3
line 66-column 4, line 13, surgical fenestration of the oval window by removal of the stapes bone,
stapedectomy, or by creating a hole in the fixed stapes footplate, stapedotomy), inserting or positioning the vestibular electrode array into the vestibule via the opening in the oval window comprises: inserting the vestibular electrode array into the vestibule via the opening in the footplate (column 3 line 66-column 4, line 13, surgical fenestration of the oval window by removal of the stapes bone, stapedectomy, or by creating a hole in the fixed stapes footplate, stapedotomy), wherein removing at least one portion of the footplate comprises removing less than half of the footplate of the stapes (column 3 line 66-column 4, line 13, surgical fenestration of the oval window by creating a hole in the fixed stapes footplate), forming an opening through an anulus of the oval window beside the footplate of the stapes associated with the inner ear and inserting the vestibular electrode array into the vestibule via the opening formed through the anulus of the oval window beside the footplate of the stapes (column 3 line 66-column 4, line 13, surgical fenestration of the oval window by removal of the stapes bone, stapedectomy, or by creating a hole in the fixed stapes footplate, stapedotomy). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to remove at least one portion of the footplate comprises removing less than half of the footplate of the stapes since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Risi et al. by removing at least a portion of the stapes, comprising removing at least one portion of the footplate of the stapes, comprising removing at least one portion of the footplate of the stapes comprising: removing the at least one portion with a drill, forming an opening in the footplate of the stapes, inserting the vestibular electrode array into the vestibule via the opening in the oval window comprises: inserting the vestibular electrode array into the vestibule via the opening in the footplate, wherein removing at least one portion of the footplate comprises removing less than half of the footplate of the stapes, and inserting the vestibular electrode array into the vestibule via the opening formed through the anulus of the oval window beside the footplate of the stapes, as taught by Lesinki et al., as known in art for providing a fenestration through a stapedectomy or a stapedotomy for removing all of or part of the stapes footplate with a drill through or adjacent the oval window for advancing an electrode array.
Claim(s) 9, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Risi et al. US 2012/0130465 in view of Buytaert US 2022/0273952 in view of Adunka et al. US 2022/0313998 as discussed above, and further in view of Gibson US 2018/0104474.
Regarding claims 9, 14 and 15, Risi et al. in combination discloses the method essentially as claimed as discussed above, but fails to disclose wherein the vestibular electrode array includes a stopper, and wherein inserting the vestibular electrode array into the vestibule comprises: inserting the vestibular electrode array until the stopper physically contacts a predetermined location being at least one of the oval window or the footplate of the stapes.
Gibson teaches wherein the vestibular electrode array includes a stopper 240, and wherein inserting the vestibular electrode array into the vestibule comprises: inserting the vestibular electrode array until the stopper physically contacts at least one of the oval window or the footplate of the stapes (figure 1, paragraph 0035, carrier member 202 passed through the round window and advanced until the stop is adjacent the exterior surface, however, it is noted that the member may be alternatively passed through the oval window, and would therefore be advanced until it is adjacent the oval window), wherein the vestibular electrode array comprises a stopper 240, and wherein positioning at least a portion of the vestibular electrode array in the inner ear comprises: inserting at least a portion of the vestibular electrode array into the inner ear until the stopper reaches a predetermined location (figure 1, paragraph 0035), wherein the predetermined location is at least one of the oval window or a stapes footplate (figure 1, paragraph 0035, carrier member 202 passed through the round window and advanced until the stop is adjacent the exterior surface, however, it is noted that the member may be alternatively passed through the oval window, and would therefore be advanced until it is adjacent the oval window) to prevent fluid from escaping from cochlea (paragraph 0035).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Risi et al. with a stop member and inserting the vestibular electrode array until the stopper physically contacts a predetermined location, as taught by Gibson, to be stopped and positioned adjacent the predetermined location or the oval window and further sealing the opening.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Risi et al. US 2012/0130465 in view of Buytaert US 2022/0273952 in view of Adunka et al. US 2022/0313998 as discussed above, and further in view of Heasman et al. US 2020/0238002.
Regarding claim 22, Risi et al. in combination discloses the method essentially as claimed comprising inserting part of a vestibular electrode array through the opening to position at least a portion of the vestibular electrode array in the vestibule of the inner ear of the recipient (paragraph 0044, electrode array placed in one semicircular canal, implantation of the vestibule, via a round or oval window), but fails to additionally disclose forming an opening in a cochlea of the inner ear of the recipient.
Heasman et al. teaches inserting an electrode stimulating assembly at a treatment site delivered via the vestibular system, oval window, cochleostomy or cochlea (paragraph 0065). Examiner notes delivering treatment via a cochleostomy would result in forming an opening in the cochlea, as currently presented it is unclear as to whether the electrode array is positioned through the opening in the cochlea or in the opening of the oval window.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Risi et al. US 2012/0130465 in view of Buytaert US 2022/0273952 in view of Adunka et al. US 2022/0313998 as discussed above, and further in view of Haller et al. US 2010/0114288.
Regarding claim 23, Risi et al. in combination discloses the method essentially as claimed as discussed above, but fails to disclose the real-time feedback during positioning of the at least a portion of the vestibular electrode array in the vestibule comprises obtaining a fluoroscopic feedback of the vestibular electrode array in the recipient.
Haller et al. teaches inserting an electrode 190 and using real-time feedback during positioning of the at least a portion of an electrode in the desired location, the real time feedback may be generated in a variety of ways including fluoroscopy (paragraph 0065) to immediately detect unforeseeable events (paragraph 0065).
Therefore, it would have been obvious to one having ordinary skill in the art to provide real-time feedback comprising a fluoroscopic feedback, as taught by Haller et al. as a known method of generating real time images for placement of an electrode while avoiding unforeseeable events during implantation.
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 CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTINA C LAUER/Examiner, Art Unit 3771
Prosecution Insights