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 remarks concerning the previous § 102 rejections have been fully considered but are not persuasive. Applicant acknowledges that Carter teaches a frequency map, but argues that Carter’s map does not associate “frequencies of the acoustic stimulation to respective electrodes of the electrode array.” To support this, Applicant argues primarily that the discussion of tonotopic mapping in Para. 56 is merely a discussion of how the conventional art functions, which fails to address the limitation of associating frequencies to electrodes. The Examiner respectfully disagrees with the conclusions drawn from this line of argument. The Examiner agrees that the statement about “the cochlea 120 is tonotopically mapped, that is, partitioned into regions each responsive to stimulus signals in a particular frequency range …” is generally describing the conventional art. However, in the same paragraph, after describing this conventional function, Carter immediately goes on to state “This same concept may be applied to ECoG response recording where the electrode(s) 138 positioned in, or closest to, the tonotopic region most closely associated with the frequency of the acoustic stimuli are used for the resulting ECoG response recording. That is, in certain examples, ECoG measurement structures have a frequency profile that falls within a pre-programmed frequency range that will correspond to one or more intra-cochlear electrodes 138.” As such, the “frequency map” referred to in Para. 57 of Carter is necessarily constructed based on different frequencies (also note the rejections of e.g. claims 9 and 16 more specifically pointed to portions covering stimulation at multiple frequencies) that have been associated with respective electrodes of the array. Put another way, Carter’s frequency map represents different ECoG responses to different frequencies that Carter teaches are associated with respective electrodes of the array.
Concerning claims 10 and 17, Applicant argues that the rejections of these claims do not clear up the alleged unclear issues in the rejections of the independent claims. The Examiner respectfully disagrees. The additional portions cited for these claims are provided to address the additional limitations in claims 10 and 17, specifically to show that Carter teaches subsequent stimulation and measurement of cochlea responses. The rejections of these dependent claims were not intended to clarify the rejections of the independent claims, nor would they need to since (as discussed above) the rejections of the independent claims require no further clarification. Carter’s frequency map clearly associates different frequencies with respective electrodes of the array as discussed in the paragraph above.
Concerning new claims 31-32, grounds of rejection under §103 are introduced based on a newly discovered prior art reference to address the newly added, more specific limitations found in those claims.
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 1-4, 9-11 and 13-17 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 2017/0304632 A1 to Carter et al. (hereinafter “Carter ‘632”).
Regarding Claims 1 and 13, Carter ‘632 teaches a method comprising:
delivering acoustic stimulation to a recipient of a cochlear implant (see e.g. Para. 35: “an automated ECoG measurement initiated by ECoG monitoring system 118 involves the delivery of acoustic stimuli to the recipient's cochlea 120”), wherein the cochlear implant includes an electrode array (140) configured to be inserted into a cochlea (120) of the recipient (see e.g. FIG. 1B and Para. 27);
recording, using one or more electrodes disposed at the cochlea of the recipient, one or more acoustically-evoked responses, specifically electrocochleography (ECochG), to the acoustic stimulation (see e.g. Para. 56: “As noted above, the ECoG responses are recorded by one or more of the intra-cochlear electrodes 138”);
analyzing the one or more acoustically-evoked responses (ECochG signals) to determine a frequency map (see generally Paras. 56-57, especially “A frequency map of a recipient's residual hearing may be constructed by measuring a series of ECoG recordings in response to a series of acoustic stimuli presented at a series of different frequencies” in Para. 57), wherein the frequency map associates respective frequencies of the acoustic stimulation to respective electrodes of the electrode array (see generally Paras. 56-57, especially “More specifically, because the cochlea 120 is tonotopically mapped, that is, partitioned into regions each responsive to stimulus signals in a particular frequency range, different acoustic frequencies are generally allocated to different intra-cochlear electrodes 138 based on their positioning in the cochlea 120. Accordingly, electrical stimulation signals are generally delivered via intra-cochlear electrodes 138 positioned in, or closest to, the tonotopic region most closely associated with the frequency of the sound signal portion represented by the electrical stimulation signals” in Para. 56 and “This data may be useful, for example, to assist with remapping a recipient's acoustic frequency specific amplification level” in Para. 57); and
delivering, using the electrode array, electrical stimulation to the recipient, wherein the electrical stimulation is delivered via the respective electrodes of the electrode array based on the frequency map (see generally Paras. 56-57 including the specific portions cited above; see the phrase “electrical stimulation” throughout Carter ‘632; this is ultimately the purpose of the implant).
Regarding Claim 2, see e.g. discussion of microphones 208 in Paras. 37-38.
Regarding Claims 3-4 and 14, see e.g. Paras. 56-57 including the specific portions cited above.
Regarding Claim 15, see e.g. Paras. 58-59.
Regarding Claims 9 and 16, see e.g. the discussion of bursts in Paras. 43-46, 56, 58 and 60. See the discussion of multiple bursts covering different frequencies in Para. 60.
Regarding Claims 10 and 17, see e.g. Para. 22 (“Over time, a plurality of ECoG measurements can be used to determine/detect a change in a recipient's residual hearing and possibly initiate one or more corrective actions to address the residual hearing change.”), 32, 59-61.
Regarding Claim 11, see discussion of cochlear microphonic in Paras. 51-52.
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 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Carter ‘632 in view of US 2018/0280687 A1 to Carter et al. (hereinafter “Carter ‘687).
Regarding Claims 12 and 18, Carter ‘632 teaches the methods discussed above but fails to specifically teach performing a plurality of impedance measurements using one or more of the electrodes of the electrode array into the cochlea; and using the plurality of impedance measurements to determine a position of the electrodes of the electrode array in the cochlea. However, Carter ‘687 teaches these limitations in another cochlear implant (see e.g. Paras. 240, 294, 327, 328). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Carter ‘632 to further include “performing a plurality of impedance measurements using one or more of the electrodes of the electrode array into the cochlea; and using the plurality of impedance measurements to determine a position of the electrodes of the electrode array in the cochlea” as taught in Carter ‘687 because this would predictably and advantageously help track the location of the electrodes.
Claims 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Carter ‘632 in view of US 2022/0072308 A1 to Koka (hereinafter “Koka”).
Regarding Claims 31-32, Carter ‘632 further teaches wherein delivering the acoustic stimulation to the recipient of the cochlear implant comprises delivering a tone burst at a plurality of frequencies (see e.g. the discussion of bursts in Paras. 43-46, 56, 58 and 60. See the discussion of multiple bursts covering different frequencies in Para. 60.), wherein recording the one or more acoustically-evoked responses to the acoustic stimulation comprises recording, using an electrode of the one or more electrodes, a plurality of acoustically-evoked responses to the tone burst (see generally Paras. 56-60; as noted above, using a range of different frequencies is taught in e.g. Paras. 57 and 60), each respective acoustically-evoked response of the plurality of acoustically-evoked responses being in response to a respective frequency of the plurality of frequencies … (see generally Paras. 56-60; as noted above, using a range of different frequencies is taught in e.g. Paras. 57 and 60)
Carter ‘632 fails to specifically teach:
[from claim 31] … wherein analyzing the one or more acoustically-evoked responses to determine the frequency map comprises selecting a frequency of the plurality of frequencies for association with the electrode based on the plurality of acoustically-evoked responses.
[from claim 32] wherein selecting the frequency of the plurality of frequencies is based on the respective acoustically-evoked response in response to the frequency being the highest among the plurality of acoustically-evoked responses.
Another reference, Koka, teaches an analogous cochlear implant with mapping of different frequencies of evoked responses to acoustic stimulation to respective electrodes of the implant (see e.g. Para. 15 and 91-94), wherein analyzing the one or more acoustically-evoked responses to determine the frequency map comprises selecting a frequency of the plurality of frequencies for association with the electrode based on the plurality of acoustically-evoked responses (see e.g. Paras. 91-95; for example, Para. 92 explains how a frequency might be selected from among multiple frequencies, and Para. 93 explains that different frequencies are ultimately mapped to individual electrodes) wherein selecting the frequency of the plurality of frequencies is based on the respective acoustically-evoked response in response to the frequency being the highest (“peak amplitude value” in e.g. Para. 92) among the plurality of acoustically-evoked responses (see e.g. Para. 92). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Carter ‘632 to perform the tuning/mapping procedure of Koka because it would advantageously and predictably lead to a more accurate and personalized frequency map/allocation for each electrode based on that patient’s specific physiology.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2022/0305264 A1 to Koka: see e.g. Para. 31.
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 JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NIKETA PATEL can be reached at (571)-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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