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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of monitoring an insertion condition associated with an electrode lead) without significantly more.
Step 1
The claimed invention in claims 1-20 are directed to statutory subject matter as the claims recite a method/system for monitoring an insertion condition associated with an electrode lead.
Step 2A, Prong One
Regarding claims 1-20, the recited steps are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper (See MPEP 2106.05(a)(2) subsection (III)).
Regarding claims 1, 10 and 17, the limitation of “determining, based on the pre-operative audiogram and the one or more attributes, one or more stimulation frequencies…” is a process, as drafted, that can be performed by a human mind (including an observation, evaluation, and judgment) under the broadest reasonable interpretation but for the recitation of generic computer components (memory, processor).
Step 2A, Prong Two
For claims 1-20, the judicial exception is not integrated into a practical application. For claims 1, 10, and 17, the additional limitations of “a memory” and “a processor” are recited at a high level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into a practical application.
Further, the limitations of “obtaining a pre-operative audiogram of a recipient” and “obtaining one or more attributes associated with the lead insertion procedure” amount to nothing more than the pre-solution activity of data gathering (MPEP 2106.05(g)).
Step 2B
The claims do not include additional elements that are sufficient enough to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional limitations of obtaining a pre-operative audiogram and one or more attributes associated with the lead insertion procedure are directed to nothing more than the pre-solution activity of data gathering, which does not amount to an inventive concept. In addition, “an electrode lead having a plurality of electrodes” is recited at a high level of generality and considered to be well known, routine, and conventional in the art. See Heasman et al (US 2018/0056058) [0032] and Koka et al (US 2019/0030323) [0022].
Dependent claims 2-5, 7, 11-13, 16, and 18-20 are further directed to the abstract idea. The above mentioned claims do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses.
Dependent claims 6, 8-9, and 14-15 are further directed to extra-solution activities (MPEP 2106.05(g)). The above mentioned claims do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5 and 8-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heasman et al (US 2018/0056058) hereinafter Heasman.
Regarding claims 1, 10, and 17, Heasman discloses a method (Fig. 3), a computer program product embodied on a non-transitory computer readable medium and comprising computer instructions [0095], and a system (Fig. 1B) comprising:
a memory (memory 194) storing instructions [0095]; and
a processor (processors 188) communicatively coupled to the memory and configured to execute the instructions to perform a process [0095] comprising:
obtaining a pre-operative audiogram of a recipient ([0057] one or more pre-operative tests can include an audiogram; Fig. 3: step 176),
the pre-operative audiogram generated prior to a lead insertion procedure during which an electrode lead having a plurality of electrodes is inserted into a cochlea of the recipient ([0032] stimulating assembly 126 is configured to be at least partially implanted in the recipient's cochlea 120 (FIG. 1A) and includes a plurality of longitudinally spaced intra-cochlear electrical stimulating contacts (electrodes) 138; Examiner notes that Fig. 3 shows the pre-operative tests 176 occurring before insertion 180);
obtaining one or more attributes associated with the lead insertion procedure ([0062] results of the pre-operative measurements can also be used to set a minimum insertion depth); and
determining, based on the pre-operative audiogram and the one or more attributes, one or more stimulation frequencies for stimulation that is to be used during the lead insertion procedure to elicit evoked responses within the recipient ([0060] At 178, the results of the pre-operative measurements (e.g., audiogram, CT scan, initial inner potential measurement, etc.) are used to set a target stop point for the stimulating assembly 126; [0065] the acoustic signals can have a frequency that is the same as, or close to, the frequency of the target stop point),
the evoked responses usable to monitor an insertion condition associated with the electrode lead ([0068] an expected change indicative of a target stop condition comprises the detection of a peak or near peak in acoustically-evoked inner ear potentials (e.g., CM components of ECoG responses)).
Regarding claims 2, 11, and 18, Heasman discloses determining, based on the one or more attributes, a stimulation level to use during the lead insertion procedure for each of the one or more stimulation frequencies ([0035] generate electrical stimulation signals e.g., current signals) for delivery to the recipient's cochlea via one or more stimulating contacts 138; Examiner notes there would necessarily have to be a determined stimulation level in order to deliver the stimulation).
Regarding claims 3 and 12, Heasman discloses wherein the one or more stimulation frequencies include a plurality of stimulation frequencies that are concurrently used during the insertion procedure to elicit the evoked responses within the recipient ([0069] inner ear potential measurements can be used to monitor or track the progression of the stimulating assembly 126 within the cochlea 120 using one or more complex acoustic inputs (sound signals) comprising multiple frequencies).
Regarding claims 4 and 13, Heasman discloses the one or more stimulation frequencies include a first stimulation frequency and a second stimulation frequency that is different than the first stimulation frequency ([0064] one or more acoustic tones (e.g., pure tone(s)) at a selected frequency or frequencies are delivered to the recipient's outer ear); and
the first stimulation frequency is not harmonic with respect to the second stimulation frequency (Examiner notes that pure tones would not be harmonic with each other).
Regarding claims 5, 16, and 19, Heasman discloses monitoring, during the lead insertion procedure, the evoked responses elicited within the recipient based on the one or more stimulation frequencies ([0064] the intra-operative system 105 monitors the inner ear response at one or more of the stimulating contacts 138); and
providing, based on the monitoring of the evoked responses, feedback regarding the insertion condition during the lead insertion procedure ([0066] At 182, an insertion stop condition is detected and, in response to the detection, a feedback mechanism is initiated/triggered).
Regarding claims 8 and 14, Heasman discloses wherein the one or more attributes associated with the lead insertion procedure include one or more of an intended insertion depth based on anatomy or pre-operative imaging ([0060] he results of the pre-operative measurements (e.g., audiogram, CT scan, initial inner potential measurement, etc.) are used to set a target stop point ; [0062] results of the pre-operative measurements can also be used to set a minimum insertion depth).
Regarding claims 9 and 15, Heasman discloses wherein the one or more attributes associated with the lead insertion procedure include one or more of a predicted insertion depth, statistical information associated with additional cochlear implant recipients, or system capabilities ([0062] results of the pre-operative measurements can also be used to set a minimum insertion depth).
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) 6-7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Heasman (US 2018/0056058) in view of Koka et al (US 2019/0030323) hereinafter Koka.
Regarding claim 6, Heasman discloses wherein the feedback includes a notification [0079], but fails to expressly disclose wherein the feedback includes one or more of an audible sound notification or a graphical notification presented for display by way of a display device. However, Koka discloses wherein the feedback includes one or more of an audible sound notification or a graphical notification presented for display by way of a display device ([0057] monitoring system 600 may notify (e.g., by an audible sound, a visible warning light, a message displayed on a graphical user interface). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Heasman with wherein the feedback includes one or more of an audible sound notification or a graphical notification presented for display by way of a display device as taught by Koka. Such a modification would provide the predictable results of notifying the surgeon that trauma may have occurred at the cochlea (Koka, [0057]).
Regarding claims 7 and 20, Heasman discloses monitoring, during the lead insertion procedure, the evoked responses elicited within the recipient based on the one or more stimulation frequencies ([0069] inner ear potential measurements can be used to monitor or track the progression of the stimulating assembly 126 within the cochlea 120 using one or more complex acoustic inputs (sound signals) comprising multiple frequencies), but fails to disclose determining, based on the monitoring of the evoked responses, that trauma has occurred within the cochlea during the lead insertion procedure.
However, Koka discloses determining, based on the monitoring of the evoked responses, that trauma has occurred within the cochlea during the lead insertion procedure ([0019] during the insertion procedure and based on the determination that the change is greater than the predetermined threshold, the monitoring system may determine that cochlear trauma has likely occurred at the second insertion depth of the intracochlear electrode within the cochlea). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Heasman with determining, based on the monitoring of the evoked responses, that trauma has occurred within the cochlea during the lead insertion procedure as taught by Koka. Such a modification would provide the predictable results of detecting trauma to the cochlea in real-time as the insertion procedure takes place (Koka, [0001]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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