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 .
Election/Restrictions
Applicant’s election without traverse of claims 13-26 in the reply filed on 06/10/2025 is acknowledged.
Claims 1-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/10/2025.
Remarks
This action is in response to the Remarks filed 06/10/2025.
Claims 13-26 are examined in the office action below.
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 13-26 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.
The term “substantial” in claim 13 is a relative term which renders the claim indefinite. The term “substantial” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 24, it is unclear how the electrodes are configured, as the method of claim 13 only requires finding a set of active electrodes.
Claims 14-23, 25, and 26 are rejected based on their dependency on claim 13.
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 13-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a method for active electrode selection in a cochlear implant. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 13 is directed towards a method, and thus meets the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claim 13 recites a method for active electrode selection in a cochlear implant comprising estimating an activation region of each electrode, and automatically finding a set of active electrodes that do not have substantial activation region overlap. The limitation of a method for active electrode selection as drafted in claim 13, under its broadest reasonable interpretation, covers performance of the limitation in the mind, but for the recitation of a cochlear implant (claim 25) and computing device (claims 25 and 26). The method of claim 13 falls under both a mental process and a mathematical concept.
For example, estimating an activation region of each electrode, and automatically finding a set of active electrodes that do not have substantial activation region overlap in the context of this claim encompasses a human estimating an activation region of electrodes, and determining active electrodes that do not have overlap. Nothing in the elements of the claim precludes the step from practically being performed in the mind.
Further, the method of claim 13 can be described as a mathematical concept. The claim simply requires estimating an activation region based on a calculation of distance between the electrode and a nerve, and then determining a set of active electrodes based on the calculation. Therefore, this falls under the abstract idea of a mathematical concept. Please see MPEP 2106.04(a)(2).
Therefore, claim 13 recites the abstract idea of both a mental process and a mathematical concept.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
The additional elements of a cochlear implant (claim 25) and computing device (claims 25 and 26) are recited at a high level of generality (i.e. as generic computer components to acquire, process, and analyze data; See MPEP 2106.05(h)) such that they amount to no more than mere instructions to apply the exception using generic computer components.
Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of a cochlear implant and computing device amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Furthermore, the additional elements do not amount to more than generically linking the use of a judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). Therefore, the claims are not patent eligible.
Claims 14-26 depend on claim 13 and recite the same abstract idea as claim 13 from which they depend. Further, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the additional limitations recited in claims 14-20 (i.e. providing details about the graph-based algorithm used) is simply further describing the data analysis performed. The limitations of claims 21 and 22 (i.e. providing specific equations used to determine the activation region and cost function) are directed to the abstract idea of a mathematical formula (see MPEP 2106.04(a)(2). The additional elements individually do not amount to significantly more than the judicial exception explained above (the abstract idea). Looking at the limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves any technology or includes a particular solution to a computer-based problem or a particular way to achieve a computer-based outcome. Rather, the collective functions of the claimed invention merely provides a conventional computer implementation, i.e. the computer (processor) is simply a tool to perform the claimed invention.
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 13 and 24-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao et al. (Zhao Y, Dawant BM, Noble JH. Automatic selection of the active electrode set for image-guided cochlear implant programming. J Med Imaging (Bellingham). 2016 Jul;3(3):035001. doi: 10.1117/1.JMI.3.3.035001. Epub 2016 Sep 22. PMID: 27704031; PMCID: PMC5031788. – APPLICANT CITED ON IDS), hereinafter Zhao.
Regarding claim 13, Zhao discloses a method for active electrode selection (e.g. Abstract) in a cochlear implant having an electrode array with a plurality of electrodes implanted in a cochlea of a living subject (e.g. page 035001-2, section 2. Methods: dataset consists of subjects with implanted electrode arrays), comprising:
estimating an activation region (AR) of each electrode based on its distance to nerve sites (e.g. paragraph spanning pages 035001-1 – 035001-2: the DVF determines the spatial relationship between the electrode and nerve; page 035001-2: determining activated regions, “Our active electrode set selection approach is to keep active the largest subset of electrodes that are not likely to cause stimulation overlap.”); and
automatically finding a set of active electrodes that do not have substantial AR overlap (e.g. page 035001-2: determining activated regions, “Our active electrode set selection approach is to keep active the largest subset of electrodes that are not likely to cause stimulation overlap.”; page 035001-9: left column: “These results suggest that our method is a viable approach for automatically selecting electrode configurations”).
Regarding claim 24, Zhao further discloses a method for automatically selecting electrodes to deactivate for image guided cochlear implant programming (IGCIP), comprising: configuring the plurality of electrodes of the electrode array implanted in the cochlea of the living subject using the method of claim 13 (e.g. page 035001-2: determining activated regions, “Our active electrode set selection approach is to keep active the largest subset of electrodes that are not likely to cause stimulation overlap.”; see rejection of claim 13 above).
Regarding claim 25, Zhao further discloses a system for active electrode selection, comprising: a CI device being implanted in a cochlea of a living subject, the CI device comprising an electrode array having a plurality of electrodes (e.g. page 035001-2, section 2. Methods: dataset consists of subjects with implanted electrode arrays); and at least one computing device having one or more processors and a storage device storing computer executable code, wherein the computer executable code, when executed at the one or more processors, is configured to perform the method of claim 13 for active electrode selection in the CI device (e.g. page 035001-6, section 3. Results: MATLAB and Windows Server PC used; see rejection of claim 13 above).
Regarding claim 26, Zhao further discloses a non-transitory computer-readable medium storing computer executable code, wherein the computer executable code, when executed at one or more processors, causes a system to perform the method of claim 13 for active electrode selection in a cochlear implant having an electrode array with a plurality of electrodes implanted in a cochlea of a living subject (e.g. page 035001-6, section 3. Results: MATLAB and Windows Server PC used; see rejection of claim 13 above).
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (Zhao Y, Dawant BM, Noble JH. Automatic selection of the active electrode set for image-guided cochlear implant programming. J Med Imaging (Bellingham). 2016 Jul;3(3):035001. doi: 10.1117/1.JMI.3.3.035001. Epub 2016 Sep 22. PMID: 27704031; PMCID: PMC5031788. – APPLICANT CITED ON IDS), hereinafter Zhao, as applied to claim 13 above, and further in view of Noble et al. (Noble JH, Dawant BM. Automatic graph-based localization of cochlear implant electrodes in CT. Med Image Comput Comput Assist Interv. 2015 Oct;9350:152-159. doi: 10.1007/978-3-319-24571-3_19. Epub 2015 Nov 20. PMID: 27158686; PMCID: PMC4854292. – APPLICANT CITED ON IDS), hereinafter Noble.
Regarding claim 14, Zhao fails to specifically disclose wherein said automatically finding the set of active electrodes is performed by a graph-based optimization algorithm. Noble, in a similar field of endeavor, is directed towards an automatic graph-based localization of cochlear implant electrodes. Noble discloses automatically finding active electrodes by using a graph-based optimization algorithm (e.g. Abstract; page 2: “Our solution is to simultaneously identify the centers of the electrodes and their connectivity using a novel, graph-based path finding technique.”; page 2, section 2. Methods: electrode localization step (3) in which a graph search technique is used) and explains that doing so could lead to advances in implant design or surgical techniques, and can further be used to determine patient specific cochlear implant settings (e.g. page 2: “Such an approach could permit localizing electrodes on large numbers of datasets to better analyze the relationship between electrode position and outcome, which may lead to advances in implant design or surgical techniques. It could also automate the electrode localization process in systems designed to determine patient-customized CI settings, such as the one proposed in [7], reducing the technical expertise required to use such technologies and facilitating transition to large scale clinical use.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Zhao’s step of automatically finding the electrode set to include using a graph-based optimization method as taught by Noble, because doing so could result in advances in implant design or surgical techniques, and to determine patient specific cochlear implant settings (e.g. Noble, page 2).
While there are no prior art rejections for claims 15-23, they are not indicated as allowable due to the rejections under 35 U.S.C. 101 and 35 U.S.C. 112(b).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796