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 filed 12/29/2025 have been fully considered but they are not persuasive.
As a general note, the examiner is not commenting on any hypotheticals, analogies, rhetorical questions or references presented by Applicant that are not directed to the current application or the current claim language, as these arguments are immaterial to the current rejection and are therefore moot. It is emphasized that the examiner is maintaining every rejection from the non-final office action, and any argument that is not specifically addressed by the examiner in this action is not an admission that the Applicant’s argument is persuasive.
Regarding the 35 USC 101 rejection, Applicant argues on pages 14-20 under the Remarks that the step of “energizing an electrode implanted in a recipient, the electrode being part of an assembly” is not abstract. Applicant further states “That is not a mental process”.
The Examiner maintains that the step in question was not asserted to be a mental process. The mental process was identified in step 2A, Prong 1 as “the recited step of ‘determining data based on the received data’”. Further, as noted in the Final Rejection dated 09/11/2024, particularly under the Step 2A, Prong 2 analysis, “the step of ‘energizing…’ amounts to insignificant, extra-solution activity in that the application of energy is solely done to create the environment in which data is gathered for the mental analysis step. This is not a particular prophylaxis. See Example C in MPEP M§2106.04(d)(2).” As such, it was concluded that the additional element of “energizing…” did not integrate the judicial exception into a practical application.
Regarding the Patents/publications cited by Applicant on pp. 20-33, the Examiner reiterates that “each case turns on its own set of facts and that citing patents does not address any of the analysis performed with respect to the current claim set”, see the Response to Arguments in the Final Rejection dated 09/11/2024 and the Non-Final Rejection dated 09/29/2025.
Regarding Claims 123-129, 139, 142-144, 146 and 148, Applicant argues the identifying various conditions such as a relative absence of perilymph; absence of fibrous tissue growth; presence of significant fibrous tissue growth; a puncture, etc. has the exact text in the specification and therefore has written description support. Applicant further argues on pp. 37-40 under the Remarks that the Examiner has not pointed to any functional language in the claims regarding this rejection. The Examiner respectfully disagrees.
However, as noted on page 3 of the Final Rejection dated 09/11/2024 and p. 5 of the Non-Final Rejection dated 09/29/2025, “The Examiner is not asserting that the words from the claim cannot be found in the specification. That is not the basis for the rejection. Instead, when dealing with functional recitations particular in the realm of computer-implemented functional recitations,
‘Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does
not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the
computer function are not explained at all or are not explained in sufficient detail (simply
restating the function recited in the claim is not necessarily sufficient). In other words,
the algorithm or steps/procedure taken to perform the function must be described with
sufficient detail so that one of ordinary skill in the art would understand how the inventor
intended the function to be performed. See MPEP §2161.01.
Applicants claims and specification recite the functional results of ‘determining a
physiological feature of an interior of a duct of a cochlea based on the obtained electrical data’ and ‘the determined physiological feature is the relative absence of fibrous tissue growth...’ but the claims and specification do not disclose how the electrical data is converted to a physiological feature of an interior of a duct of the cochlea, such as presence or absence of fibrous tissue growth; presence or absence of perilymph, etc. The steps/algorithm required to obtained these functional results are not disclosed by Applicant. The rejection is therefore maintained.” MPEP §2161.01 further states “ It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015)”.
Applicant cites par. [0133] of the specification on p. 41 under the Remarks as providing written description support. However, the paragraph simply, repeats the functional language of “the determined physiological feature is the relative absence of fibrous tissue growth due to implantation of the electrode array into the duct of the cochlea.” This paragraph specifies “a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved.” MPEP §2161.01.
Regarding the rejection of Claim 141 under 35 USC 112(a), Applicant argues on pp.41-42 under the Remarks that various Provisionals are incorporated by reference which include the statement “ Thus, the teachings detailed herein are applicable, in at least some embodiments, to partially implantable and/or totally implantable medical devices that provide a wide range of therapeutic benefits to recipients, patients, or other users including hearing implants having an implanted microphone, auditory brain stimulators, pacemakers, visual prostheses (e.g. bionic eyes), sensors, drug delivery systems, defibrillators, functional electrical stimulation devices, etc.”.
First, the Examiner notes the title of two of the cited Provisionals are “Electrical Techniques for Biomarker Detection in a Cochlea” and “Electrical Field Usage in Cochleas” clearly indicating that the invention is indeed concerned with the cochlea and not “…an assembly other than an electrode array of a cochlear implant located in a cochlea”. Additionally, Claim 114 (the independent claim from which claim, 141 depends) states “energizing an electrode implanted in a human recipient, the electrode being part of an assembly located in and/or on the recipient”. Claim 130 (the claim from which claim 141 immediately depends) states that “the determined data is spatial position data of the assembly based on the received data”. Furthermore, Claim 141 states that the assembly is “an assembly other than an electrode array of a cochlear implant located in a cochlea”. Therefore, Claim 141 defines an invention that energizes an electrode implanted in a recipient, the electrode being part of an assembly other than an electrode array of a cochlear implant located in a cochlea, wherein data received from one or more recording electrodes is used to determine spatial position data of the assembly. Other than the broad statement in the referenced Provisionals that any possible partially implantable or totally implantable can be used, the disclosure in the present application only references the cochlea and clearly states in the background and summary of the invention that the presently claimed and disclosed invention is solely described with respect to a cochlear implant (see par. [0001-0007] of the present specification). Likewise, the drawings clearly show a cochlear implant as the intended assembly and detecting features such a presence or absence of perilymph as claimed in various claims and described in the specification would not make sense with a defibrillator, brain stimulator, visual prosthesis, etc. since perilymph is only found in the inner ear, particularly the scala tympani and scala vestibuli. Also, how would an electrode assembly work with non-electrostimulation devices such as a drug delivery system or sensor as cited in the Provisionals?
Regarding the 35 USC 112(a) enablement rejection of claim 151, Applicant does not provide any specific arguments on pp. 44-47 under the Remarks addressing any of the Wands factors set forth in the rejection. The Examiner maintains the rejection is proper according to the fact pattern set out in the rejection and according to the guidance set forth in MPEP §2164.01(a). The rejection is maintained.
Regarding the 35 USC 112(b) rejection of Claim 150, Applicant argues on p. 49 under the Remarks that “the assertions of indefiniteness are conclusory and without support or rationale.” The Examiner respectfully disagrees. As noted in the Non-Final Rejection dated 9/29/2025, “This is not an active, positively recited method step and instead simply states the intent of the method. It is unclear if Applicant is claiming an actual step of diagnosing or is simply defining the context in which the method is performed. The required steps of the method are unclear and therefore the metes and bounds of the claim are unclear.” The rejection is maintained.
Regarding the 35 USC 112(b) rejection of Claim 120, the Examiner asserted the limitation of “the actions of energizing, receiving and determining are actions that are part of a vertical electrical sounding method applied to a mammal” read “like Applicant is claiming the steps of energizing, receiving and determining are ‘used’ in a vertical electrical sounding method. Essentially, Applicant is attempting to claim a process ‘a vertical electrical sounding method’ without setting forth any steps involved in the process (see MPEP §2173.05(q)). It is ultimately unclear what this process encompasses and how the steps of energizing, receiving and determining fit within this unclearly defined process. The metes and bounds of the claim are unclear.” The amendment to the claim stating “the method is a vertical electrical sounding method applied to the recipient” does not overcome this rejection as Applicant is still attempting to claim a process ‘a vertical electrical sounding method’ without setting forth any steps involved in the process (see MPEP §2173.05(q))
Applicant argues on pp. 50-53 under the Remarks that the rejection is based on breadth and not indefiniteness.. The Examiner respectfully disagrees as the previous statement cited from the Final Rejection and the Non-Final Rejection dated 9/29/2025 sets forth the MPEP support and the rationale used to make the rejection. Again the metes and bounds of the claim are unclear as it is “unclear what this process encompasses and how the steps of energizing, receiving and determining fit within this unclearly defined process”. The rejection is maintained.
Regarding the 35 USC 102 rejection of Claim 114 with respect to Kals, Applicant argues the same argument on p. 55 under the Remarks that was presented in the Final Rejection dated 9/11/2024 and the Non-Final Rejection dated 9/29/2025, namely “Where is method action of energizing an electrode implanted within a cochlea in the above?”. The Examiner responded in the Non-Final Rejection dated 9/29/2025, “The Examiner notes Kals is concerned with a cochlear implant (see Abstract). Kals also discloses the desire to detect fold-over in cochlear implants (see par. [0025]) which is the same problem Applicant claims in Claim 118. Kals discloses a cochlear electrode array has 1-N electrodes (par. [0026]) and par. [0027] states a measurement is taken on measurement electrode j in response to stimulation electrode i, wherein stimulation occurs by energizing the electrode. The rejection is maintained.” In response, Applicant asserts “This does not answer our questions”. The Examiner respectfully disagrees and maintains the explanation previously provided addresses this question.
Regarding Claim 148, Applicant argues on p. 57 under the Remarks there is nothing in Carter about tracking lead migration. The Examiner relied upon Carter to disclose determining a location of an electrode with respect to a structure such as the modiolus (par. [0041, 0080]). Carter further discloses the information can be presented to a user so the relative distance of the lead to the structure can be visualized (par. [0081]). Upon reading par. [0081], Carter states “As noted, in embodiments the data is presented in real time (so the tone or visual data changes more or less instantaneously as the stimulating lead assembly is moved) or it may be presented after the fact. The advantage of real time is that it allows the surgeon to respond instantly to any detected changes or problems associated with the proximity to neural structures.” In other words, Carter discloses that movement (i.e. migration) of the lead can be monitored in real-time during implantation, which is what the claim requires.
Regarding Claims 140 and 144, Applicant argues on p. 55 under the Remarks that the language of the claims is not addressed. Applicant provides no particular arguments with respect to the applied art and just states they are not addressed. The Examiner maintains the rejections for the reasons set forth in the Non-Final Rejection dated 9/29/2025.
In regards to Claim 138, Applicant argues the rejection does not address any of the limitations, particularly step (iv). The Examiner respectfully disagrees. This argument has bene addressed by the response with respect to claim 148 above as they both dela with tracking lead migration and are rejected for the same reasons.
Regarding Claim 139, Applicant argues “All that the Office Action addresses is that the cochlea ‘is normally filled with endolymph, perilymph”. The Examiner respectfully disagrees. Claim 139 was rejected in par. 48 of the Non-Final Rejection dated 09/29/2025 indicating impedance is measured wherein the value fluctuates based on a relative position to perilymph. Therefore the impedance will be reflective of relative presence or absence of perilymph (see par. [0043]).
In regards to the rejection of Claim 147, Applicant argues the “at least four respective distances of the assembly at least four respective locations along the array” is not addressed. The Examiner respectfully disagrees. As noted in the Non-Final Rejection dated 09/29/2025, “Carter discloses repeating the impedance measurement for a plurality of electrodes thus providing for a plurality of points of spatial data that each show a relative distance of a particular electrode to a structure such as the modiolus and/or lateral wall (par. [0052]) such that an accurate picture of the distance of the stimulation assembly to particular structures of the cochlear can be visualized (par. [0070, 0079-0080)).” The cited portion of par. [0052] teaches at least 22 separate points of data, which meets the “at least four” limitation.
Regarding Claim 143, Applicant argues “significant fibrous tissue growth” is not addressed. The Examiner respectfully disagrees. As noted in the Non-Final Rejection dated 09/29/2025, Carter discloses using impedance measurements to detect the presence or absence of scar tissue (par. [0042]). Thus the Examiner, in the rejection, is equating the presence of scar tissue to the presence of “significant fibrous tissue growth”. Applicant has not defined in the claim or specification to what extent scar tissue has to be present to be considered “significant” and thus detectable scar tissue would fall within the BRI of significant fibrous tissue growth.”
Applicant does not provide any specific arguments regarding any of the 35 USC 103 claim rejections.
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 114-153 and 156-158 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract, specially a mental process abstract idea, idea without significantly more.
Step 1
The claimed invention in claim 114 is directed to statutory subject matter as the claimed recite a process.
Step 2A, Prong 1
Regarding Claim 114, the recited step of “determining data based on the received data, wherein the method is a medical investigative method” is directed to a mental process of performing concepts in the human mind or by a human using the aid of pen and paper. For example, this limitation simply amounts to a clinician reading a data printout and making a mental determination as to the meaning of the data.
Step 2A, Prong 2
Regarding Claim 114, the judicial exception is not integrated into a practical application. The claim includes the additional elements of “energizing an electrode implanted in a human recipient, the electrode being part of an assembly located in and/or on the recipient” and “receiving data from one or more recording electrodes located in and/or on the recipient”. The step of “energizing…” amounts to insignificant, extra-solution activity in that the application of energy is solely done to create the environment in which data is gathered for the mental analysis step. This is not a particular prophylaxis. See Example C. in MPEP §2106.04(d)(2). Additionally, the step of “receiving data…” is also insignificant extra-solution activity in the form of mere data gathering.
Step 2B
Regarding Claim 114, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As with step 2A, Prong 2 above, The claim includes the additional elements of “energizing an electrode implanted in a human recipient, the electrode being part of an assembly located in and/or on the recipient” and “receiving data from one or more recording electrodes located in and/or on the recipient”. The step of “energizing…” amounts to insignificant, extra-solution activity in that the application of energy is solely done to create the environment in which data is gathered for the mental analysis step. This is not a particular prophylaxis. See Example C. in MPEP §2106.04(d)(2). Additionally, the step of “receiving data…” is also insignificant extra-solution activity in the form of mere data gathering. The claim limitations when viewed individually and in combination therefore do not amount to significantly more than the abstract idea itself. The claims are therefore ineligible.
Claims 115-153 and 156-158 only further define the data gathered (insignificant, extra-solution activity” and/or the decisions made with the gathered data (i.e. only further define the mental process). Therefore, the claims do not include any additional elements that show integration into a practical application and do not include any additional elements that amount to significantly more than the abstract idea. The claims are ineligible.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 123-129, 139, 142-144, 146, 148, 149 and 151-153 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As noted in MPEP §2161.01,
“Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed.”
Regarding Claims 123-129, 139, 142-144, 146, 148, 149 and 151-153, Applicant has claimed identifying various conditions such as a relative absence of perilymph; absence of fibrous tissue growth; presence if significant fibrous tissue growth; a puncture, presence of blood in a duct, etc. However, the Examiner was unable to find any particular steps or algorithms that use the received data to make these determinations and/or distinguish among these possible options. Applicant claims and describes the functional results (see Fig. 43; par. [0148, 0149, 0185] of the PPGUB of the present application, PGPUB 2022/0016416) without any clear steps on how these results/determinations are actually made. While Applicant states the use of an NRT method in par. [0149] and claim 126 as well as electrical resistive tomography and ECoG measurements (claims 149, 151), Applicant has not set forth any details on what the steps of this method would encompass or how tomography and ECoG measurements are manipulated, transformed, analyzed to produce the claimed results. It is essentially described as a black-box algorithm.
Additionally, Claim 151 states that ECoG measurements are used to identify a section of the assembly in contact with the wall and a section of the assembly not in contact with the wall. However, Appendix F, which Applicant’s specification indicates provides support for the ECoG measurements (see par. [0212]) at best discloses that ECoG is used to determine when the stimulation assembly passes a tonotopic region (par. [0041-0054]). The Examiner was unable to find support for identifying a section of the assembly in contact with the wall and a section of the assembly not in contact with the wall using ECoG measurements as claimed.
Claim 141 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The Examiner was unable to find support in the originally filed disclosure for electrode arrays other than cochlear electrode arrays. The Examiner notes the title of two of the cited Provisionals are “Electrical Techniques for Biomarker Detection in a Cochlea” and “Electrical Field Usage in Cochleas” clearly indicating that the invention is indeed concerned with the cochlea and not “…an assembly other than an electrode array of a cochlear implant located in a cochlea”. Additionally, the disclosure in the present application only references the cochlea and clearly states in the background and summary of the invention that the presently claimed and disclosed invention is solely described with respect to a cochlear implant (see par. [0001-0007] of the present specification). Likewise, the drawings clearly show a cochlear implant as the intended assembly.
Claim 151 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding the undue experimentation factors (see MPEP §2164.01(a)), the breadth (A) of Claim 151 encompasses executing ECoG measurements and then, from the data obtained from those measurements, identifying a section of the assembly in contact with the wall and a section of the assembly not in contact with the wall. The state of the prior art (C) notes “Electrocochleography (ECoG) testing is a clinical technique that can be used to assess a recipient's residual hearing. ECoG testing involves the delivery of acoustic stimuli to a recipient's cochlea, and recording one or more responses of the cochlea to the acoustic stimulus. In conventional/standard techniques, the EcoG testing is performed within a clinical environment, typically using complex equipment and techniques implemented by trained audiologists/clinicians. In particular, during conventional ECoG testing procedures, a clinician plays preselected/predetermined clicks or tones to a recipient while ECoG recordings are performed, for example, using an electrode in or near the patient's middle ear or inner ear.” (see Carter et al. (2017/0304632) for this excerpt regarding ECoG and it typical application in cochlear implant systems). In other words, ECoG is typically used in the art to provide hearing checks. Analysis of the ability of a person to hear certain clicks or tones and not electrode positions within a body. The amount of direction provided by the inventor (F) can be found in appendix F of the application (as noted in par. [0212] of the present disclosure). The appendix discloses that ECoG is used to determine when the stimulation assembly passes a tonotopic region (par. [0041-0054]) but does not provide any guidance or direction indicating how hearing responses in a ECoG test can be used to determine when an electrode hits a wall (and if so what section) and what sections do not contact a wall as claimed. There are no working examples (G) regarding using ECoG to determine wall contact of a section of an assembly and lack of all contact with another section of the assembly as claimed. Therefore, the quantity of experimentation (H) in adapting a hearing test with respect to tones to a mode of determining wall contact of a portion of an assembly and lack of wall contact with another portion of the assembly would be undue. This appears to be an adaptation of a hearing test for a purpose different from what is actually designed for.
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 120, 126, 127, 143 and 150 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 120 states “the method is a vertical electrical sounding method applied to the recipient”. Applicant is attempting to claim a process “a vertical electrical sounding method” without setting forth any steps involved in the process (see MPEP §2173.05(q)). It is ultimately unclear what this process encompasses and how the steps of energizing, receiving and determining fit within this unclearly defined process. The metes and bounds of the claim are unclear.
Claims 126, 127 and 143 contain the same issue with the use of an NRT method.
Claim 150 states “wherein the method is a method of diagnosing a medical related condition and/or a condition related to a medical device implanted in the recipient based on the determined data.” This is not an active, positively recited method step and instead simply states the intent of the method. It is unclear if Applicant is claiming an actual step of diagnosing or is simply defining the context in which the method is performed. The required steps of the method are unclear and therefore the metes and bounds of the claim are unclear.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 114, 118 and 120 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kals (2015/0112408).
Regarding Claims 114, 118 and 120, Kals discloses energizing an electrode i that is part of an assembly implanted within a cochlea of a recipient (par. [0028], “…with row index i for stimulated electrode contact “); receiving data from one or more recording electrodes j located in and/or on a recipient (see par. [0028]); and determining data based on the received data, such as the presence of an electrode fold-over (par. [0027-0028]).
Claim(s) 114-127, 129-141, 143-148, 150, 152 and 156-158 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Carter (2012/0316454).
Regarding Claims 114, 118, 120, 129, 134, 141, 150, 156 and 157, Carter discloses energizing an electrode 348 that is part of stimulating lead assembly 318 implanted within a cochlea of a recipient (Fig. 3A, B; par. [0037, 0046]); receiving data from one or more recording electrodes located in and/or on a recipient, e.g. such as from an extra-cochlear electrode 450 (see par. [0051]); and determining data based on the received data, such as the proximity of an electrode to a particular structure (par. [0079-0080]) and/or tip fold over (par. [0042]), which is a medical related condition determination since the diagnosis of electrode proximity to particular structures is in the context of cochlear array implantation (a medical procedure). This spatial relation is also related to an interior duct of the cochlea, i.e. the position of the lead within the duct of the cochlea.
In regards to Claims 115-117, 130-133, 135, 136, 138-140, 144, 146 and 148, Carter discloses the determined data deals with the location of an electrode to a structure such as the modiolus, lateral wall, etc. (par. [0041, 0080]) of the cochlea which is normally filled with endolymph, perilymph and intrastrial fluid and that this information can be presented to a user so the relative distance of the lead to the structure can be visualized (par. [0081]). This helps track/prevent over insertion and track lead migration or movement from a desired area
With regards to Claims 119, 122, 145, 147, 152 and 158, Carter discloses repeating the impedance measurement for a plurality of electrodes thus providing for a plurality of points of spatial data that each show a relative distance of a particular electrode to a structure such as the modiolus and/or lateral wall (par. [0052]) such that an accurate picture of the distance of the stimulation assembly to particular structures of the cochlear can be visualized (par. [0070, 0079-0080]).
In regards to Claims 121 and 137, Carter discloses this process is part of a procedure to help with the implantation of a cochlear stimulation lead and the spatial data is used to help guide the positioning of the lead into the cochlea and to stop positioning once final implantation is complete (par. [0080-0081]).
Regarding Claims 123 and 139, Carter discloses the impedance value will fluctuate based on an electrodes relative position to perilymph (par. [0043]). Therefore the physiological data will be representative of a presence or absence of perilymph.
With regards to Claims 124-127 and 143, Carter discloses using impedance measurements to detect the presence or absence of scar tissue (par. [0042]).
Claim(s) 114, 122, 128, 142 and 153 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ramos de Miguel, Sr,. et al. (2018/0140829), herein Ramos.
Regarding Claims 114, 122, 128 and 142, Ramos discloses a cochlear implant system that energizes a first implanted electrode; reads a response at a second implanted electrode (Abstract) and determines, from that response, the presence of scala dislocation where the electrode array rides up and punctures the basilar membrane (par. [0058]).
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 149 is rejected under 35 U.S.C. 103 as being unpatentable over Carter (2012/0316454) in view of Choi et al. (2013/0085362)
Regarding Claim 149, Carter discloses using impedance values do determine electrode positioning but fails to disclose electrical impedance tomography (EIT). However, Choi discloses that EIT can be used to determine spatial relationships of electrodes to tissue structures (Abstract; par. [0007, 0050]) for the purpose of quickly identifying the boundary of a stimulation target and precise positions of implanted probes , thus increasing the accuracy of probe insertion during surgeries (par. [0008]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Carter reference to include EIT, as taught and suggested by Choi, for the purpose of quickly identifying the boundary of a stimulation target and precise positions of implanted probes , thus increasing the accuracy of probe insertion during surgeries.
Claims 154 and 155 are rejected under 35 U.S.C. 103 as being unpatentable over Haller et al. (2010/0114288) in view of Patrick et al. (2014/0350640). Haller discloses a robotic system for implanting a cochlear lead comprising an insertion guide 630 for inserting the cochlear implant into the cochlea (par. [0050]). Haller further discloses obtaining sensed information such as force and electrode placement from various sensors; monitoring insertion progress from the sensors and automatically halting movement/interrupting movement of the robot when a substantial deviation from expected parameters is detrained (par. [0069, 0079-0083]). Haller is silent regarding the use of electrical data from recording electrodes pertaining to physiological features of an interior of a duct of a cochlea. However, in the same field of endeavor of cochlear implant insertion devices, Patrick discloses utilizing recording electrodes to detect electrical potential differences (as a result of energizing some electrodes of an array) between electrodes and surrounding tissue of the duct of the cochlea to detect spatial abnormalities such as dislocation (par. [0091]). Patrick further discloses that such a system can be used in a robotic surgical system, that assists in implanting the cochlear array, wherein such as system could use the signals to automatically halt the procedure(par. [0115]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Haller reference to include recording electrodes for detecting physiological information in the duct of the cochlea and halting a robotic procedure based on the detected signals, as taught and suggested by Parker, for the purpose of detecting abnormalities such as dislocation as well as preventing injury to the patient.
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.
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