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 with traverse of Invention II, drawn to a system of Claims 23-25 and 27-30 in the reply filed on 03/30/2026 is acknowledged. The traversal is on the ground(s) that the examiner did not address 37 CFR 1.475(b) in the restriction requirement, filed 01/30/2026.
This is not found persuasive because the Examiner did not assert unity was lacking based on the claims being directed to different categories of invention. 37 CFR 1.475(b) applies when an international or a national stage application contains claims to different categories of invention and unity is found under those circumstances set forth in the rule. Here, the Examiner found lack of unity because the shared technical feature is not a special technical feature as it does not make a contribution over the prior art.
The Examiner indicated that the shared technical feature between the inventions of Groups 1 and 2 was not a special technical feature as it does not make a contribution over the prior art in view of Pawsey (US Pub. No. 20180050196), hereinafter Pawsey (Examiner's Note: As indicated in the restriction requirement, filed 01/30/2026). As such, it was indicated that Groups 1 and 2 lack unity of invention a posterori.
The Examiner further indicated that the shared technical feature between the inventions Groups 1 and 3, was not a special technical feature as it does not make a contribution over the prior art in view of Pawsey (Examiner's Note: As indicated in the restriction requirement, filed 01/30/2026). As such, it was indicated that Groups 1 and 3 lack unity of invention a posterori.
The Examiner further indicated that the shared technical feature between the inventions of Groups 2 and 3 was not a special technical feature as it does not make a contribution over the prior art in view of Pawsey (Examiner's Note: As indicated in the restriction requirement, filed 01/30/2026). As such, it was indicated that Groups 2 and 3 lack unity of invention a posterori.
Additionally, the Applicant has failed to address the Examiner's reason for finding lack of unity, and the requirement is maintained.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-3, 5-7, and 9 and claims 31-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/30/2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 23-25 and 27-30 are hereby under examination.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 29: The claim limitation “therapeutic substance delivery device” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “device” coupled with functional language “therapeutic substance delivery” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “device”.
Claim 29: The claim limitation “an indicator subsystem controlled by the medium for automatically indicating to the healthcare professional the data based on the data” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “subsystem” coupled with functional language “for automatically indicating to the healthcare professional the data based on the data” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “subsystem”.
Claim 29: The claim limitation “an automatic dispensing subsystem controlled by the medium for automatically executing the therapeutic substance delivery action” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “subsystem” coupled with functional language “for automatically executing the therapeutic substance delivery action” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “subsystem”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
A device with a catheter, needle, or equivalents thereof, as described in Par. 74 of the disclosure filed on 02/23/2024,
A light, microphone, or equivalents thereof, as described in Par. 185 of the disclosure
A processor connected with a device with a catheter, needle, or equivalents thereof, as described in Par. 74, 142, 185 of the disclosure filed on 02/23/2024
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 23-25 and 27-30 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 23 recites the limitation “automatically indicating to a healthcare professional data based on data indicative of a sensor component being located in a cochlea based on an analysis executed using the code for analyzing”, which fails to effectively define the metes and bounds of the claim as it is unclear as to where the indication is being made. Is it to a healthcare professional, where it is specifically to an individual? Is it to a “healthcare professional data”, where the indication is made to data? If the latter is true, then what is the location of healthcare professional data? Is the indication the data? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as an indication being made in the form of data to a healthcare professional.
Claim 23 recites the limitation “data indicative of a sensor component being located in a cochlea based on an analysis executed using the code for analyzing”, which fails to effectively define the metes and bounds of the claim as it is unclear as to whether the “sensor component” is referring to the same “sensor” as previously indicated within the claim as “code for analyzing input from a sensor indicative of electrical phenomena within a cochlea”, or whether is an entirely new sensor structure. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, as the “code for analyzing” is involved with both limitations, the “sensor component” will be interpreted as being the same as “a sensor”. Claims 24-25 and 27-30 are dependent on claim 23, and as such are also rejected.
Claim 23 recites the limitation “code for analyzing input from a sensor indicative of electrical phenomena within a cochlea”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what type of analysis is being performed. What type of analysis is occurring? In what way is the input analyzed? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as any type of analysis involving impedance (Par. 182-183 of applicant’s spec.). Claims 27-30 are dependent on claim 23, and as such are also rejected.
Claim 23 recites the limitation “code for analyzing input from a sensor indicative of electrical phenomena within a cochlea”, while also reciting “automatically indicating to a healthcare professional data based on data indicative of a sensor component being located in a cochlea based on an analysis executed using the code for analyzing”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what data is included with “data indicative of a sensor component being located in a cochlea based on an analysis executed using the code for analyzing”. For example, the first of the above limitations indicates that the code analyzes input from a sensor that is indicative of electrical phenomena within a cochlea, where the only indicated input to the “code for analyzing” is the input that is indicative of electrical phenomena within a cochlea. Now, with the second of the above limitations, the indication to a healthcare professional is made based on data indicative of a sensor component being located in a cochlea based on an analysis executed using the code for analyzing. However, this creates confusion as this appears to be a redundant step as the input to the code for analyzing is already indicated as “indicative of electrical phenomena within a cochlea”. Does “an analysis executed using the code for analyzing” involve a different type of data? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, the “data indicative of a sensor component being located in a cochlea based on an analysis executed using the code for analyzing” will be interpreted as being the output of “code for analyzing input from a sensor indicative of electrical phenomena within a cochlea” (Examiner's Note: where the analysis is interpreted as any type of analysis involving impedance (Par. 182-183 of applicant’s spec.)). Claims 24-25 are dependent on claim 23, and as such are also rejected.
Claim 23 recites the limitation “automatically executing a therapeutic substance delivery action based on an analysis executed using the code for analyzing.”, which fails to effectively define the metes and bounds of the claim as it is unclear as to the type of analysis referred to by the phrase “an analysis”. The code for analyzing is defined within the claim as “code for analyzing input from a sensor indicative of electrical phenomena within a cochlea”, however, what type of analysis is performed within the step “an analysis executed using the code for analyzing”? Is there a different input that is present? Is there a different type of sensor data? What type of analysis is performed? Are there any thresholds being used? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, “an analysis executed using the code for analyzing” will be interpreted as being the same type of analysis as present within the “code for analyzing”, which is analysis involving impedance (Par. 182-183 of applicant’s spec.). Claims 24-25 and 27-30 are dependent on claim 23, and as such are also rejected.
Claims 24-25 and 27-30 recite the phrase “medium”, which lacks consistency between the claims, as claim 23, which the above claims are dependent on, recites “A non-transitory computer-readable media”. As such, the applicant has failed to effectively define the metes and bounds of the claim as it is unclear whether the “media” and “medium” are referring to the same structure. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, “media” and “medium” will be interpreted as being the same structure.
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.
The claims are generally directed towards a computer program with code for analyzing input from a sensor, and at least one of; code for indicating to a healthcare professional based on the code for analyzing, or code for executing a therapeutic substance delivery action.
Claim(s) 23 and 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heasman (WO 2019186373 A1) hereinafter Heasman, and further in view of Alimohammadi (US Pub. No. 20210076990) hereinafter Alimohammadi.
Regarding claim 23, Heasman discloses A program for executing at least a portion of a method (Par. 77, “In view of the above, FIG. 14 presents an exemplary flowchart for an exemplary algorithm for a method, method 1400…”), the program including:
code for analyzing input from a sensor indicative of electrical phenomena within a cochlea (Par. 77, “method 1400, which includes method action 1410, which includes energizing one or more electrodes of a cochlear electrode array to induce a current flow in the cochlea at a plurality of temporal locations…”)(Par. 79, “Method 1400 also includes method action 1420, which includes measuring one or more electrical properties at one or more locations in the cochlea resulting from the induced current flow at the plurality of different temporal locations.”) (Fig. 14, step 1420); and
code for at least one of:
automatically indicating to a healthcare professional data based on data indicative of a sensor component being located in a cochlea based on an analysis executed using the code for analyzing; or
executing a therapeutic substance delivery action based on an analysis executed using the code for analyzing (Par. 92, “FIG. 17 presents another exemplary algorithm for an exemplary method, method 1700, which includes method action 1710 and method action 1720, which respectively include executing method 1400…”)(Par. 93, Fig. 17, step 1730, “…actions are taken to treat the cochlea locally with a drug agent that is configured to minimize or interrupt any inflammatory cascade that leads to the eventual fibrosis…”).
Heasman fails to explicitly disclose a non-transitory computer-readable media having recorded thereon, a computer program for executing at least a portion of a method.
However, Heasman does disclose an algorithm (Par. 77, “In view of the above, FIG. 14 presents an exemplary flowchart for an exemplary algorithm for a method, method 1400…”).
Alimohammadi teaches a non-transitory computer-readable media having recorded thereon, a computer program for executing at least a portion of a method (Fig. 3A,3B, Par. 46, “electrochemical system 30 may further include a processing unit 38 that may be utilized to record and analyze electrochemical measurements made by electrochemical stimulator/analyzer 34…”) (Par. 47, “processing unit 38 may be implemented as a programmable logic controller with at least one processor 380, and at least one memory 382 that may be coupled to at least one processor 380. In an exemplary embodiment, at least one memory 382 may store executable instructions to urge at least one processor 380 to perform operations”) (Par. 48-50 (processing unit))(Par. 56-57, (computer programs)).
Heasman and Alimohammadi are considered to be analogous art to the claimed invention as they are involved with ear-related devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Heasman with that of Alimohammadi to include a non-transitory computer-readable media having recorded thereon, a computer program for executing at least a portion of a method of Heasman through the combination of references as differing computational structures are known (Heasman (Par. 48-50, 56-57)) and it would have yielded the predictable result of providing the computational structures needed to execute the algorithm of Heasman.
Modified Heasman fails to explicitly disclose automatically executing a therapeutic substance delivery action based on an analysis executed using the code for analyzing.
However, Heasman does disclose executing a therapeutic substance delivery action based on an analysis executed using the code for analyzing (Par. 92, “FIG. 17 presents another exemplary algorithm for an exemplary method, method 1700, which includes method action 1710 and method action 1720, which respectively include executing method 1400…”)(Par. 93, Fig. 17, step 1730, “…actions are taken to treat the cochlea locally with a drug agent that is configured to minimize or interrupt any inflammatory cascade that leads to the eventual fibrosis…”).
Heasman teaches a method action performed automatically or manually (Par. 81, “Method action 1430 can be executed by the control unit of figure 5, or by the external component of the cochlear electrode array, providing that such is programmed to execute such. This can be done automatically or manually.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Heasman and Alimohammadi with that of Heasman to include automatically executing a therapeutic substance delivery action based on an analysis executed using the code for analyzing through automating a manual process as manual and automatic executions of a method step are known (Heasman (Par. 81)) and it would have yielded the predictable result of executing the step without the need for an external intervention.
Regarding claim 28, modified Heasman fails to explicitly disclose the limitations of the claim.
However, Heasman does disclose executing a therapeutic substance delivery action based on an analysis executed using the code for analyzing (Heasman (Par. 92, “FIG. 17 presents another exemplary algorithm for an exemplary method, method 1700, which includes method action 1710 and method action 1720, which respectively include executing method 1400…”)(Par. 93, Fig. 17, step 1730, “…actions are taken to treat the cochlea locally with a drug agent that is configured to minimize or interrupt any inflammatory cascade that leads to the eventual fibrosis…”)).
Heasman further teaches a method action performed automatically or manually (as indicated in claim 23 above).
Alimohammadi teaches the medium (as indicated in claim 23 above).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Heasman and Alimohammadi with that of Heasman to include the medium includes the code for automatically executing a therapeutic substance delivery action based on an analysis executed using the code for analyzing for the reasoning as indicated in claim 23 above.
Regarding claim 29, modified Heasman further discloses A system comprising (Fig. 17): a therapeutic substance delivery device (Heasman (Par. 93, (catheter device connect to a pump))); and
a computational device having the non-transitory medium of claim 23 (as taught by Heasman and Alimohammadi as indicated above).
Modified Heasman fails to explicitly disclose the system is configured with at least one of: an automatic dispensing subsystem controlled by the medium for automatically executing the therapeutic substance delivery action.
However, Heasman does disclose a therapeutic substance delivery device used with an algorithm (Heasman (Par. 93, (catheter device connect to a pump))).
Alimohammadi further teaches the system is configured with at least one of: an automatic dispensing subsystem controlled by the medium for automatically executing the therapeutic substance delivery action (Alimohammadi (Par. 34-37, (system 10 with drug delivery system 128)) (Par. 37, “such electrochemical system formed by coupling implanted electrochemical microsensor 1422 and electrochemical stimulator/analyzer 126 may further be coupled to drug delivery system 128 to send feedback to drug delivery system 128…” “…by delivering more drug to the inner ear by drug delivery system 128…”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Heasman and Alimohammadi with that of Alimohammadi to include the system is configured with at least one of: an automatic dispensing subsystem controlled by the medium for automatically executing the therapeutic substance delivery action through the combination of references as it would have yielded the predictable result of allowing for feedback and electronic communication between the therapeutic device and medium (Alimohammadi (Par. 37)).
Regarding claim 30, modified Heasman fails to explicitly disclose the medium includes the code for automatically executing a therapeutic substance delivery action based on an analysis executed using the code for analyzing.
However, Heasman does disclose executing a therapeutic substance delivery action based on an analysis executed using the code for analyzing (Heasman (Par. 92, “FIG. 17 presents another exemplary algorithm for an exemplary method, method 1700, which includes method action 1710 and method action 1720, which respectively include executing method 1400…”)(Par. 93, Fig. 17, step 1730, “…actions are taken to treat the cochlea locally with a drug agent that is configured to minimize or interrupt any inflammatory cascade that leads to the eventual fibrosis…”)).
Heasman further teaches a method action performed automatically or manually (as indicated in claim 23 above).
Alimohammadi teaches the medium (as indicated in claim 23 above).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Heasman and Alimohammadi with that of Alimohammadi to include the medium includes the code for automatically executing a therapeutic substance delivery action based on an analysis executed using the code for analyzing for the reasoning as indicated in claim 23 above.
Modified Heasman fails to explicitly disclose wherein the therapeutic substance delivery action is an adjustment of an amount of therapeutic substance delivery relative to a prior amount previously delivered.
However, Alimohammadi further teaches wherein the therapeutic substance delivery action is an adjustment of an amount of therapeutic substance delivery relative to a prior amount previously delivered (Alimohammadi (Par. 34-37, (system 10 with drug delivery system 128)) (Par. 37, “such electrochemical system formed by coupling implanted electrochemical microsensor 1422 and electrochemical stimulator/analyzer 126 may further be coupled to drug delivery system 128 to send feedback to drug delivery system 128…” “…by delivering more drug to the inner ear by drug delivery system 128…” (adjustment of drug amount))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Heasman and Alimohammadi with that of Alimohammadi to include wherein the therapeutic substance delivery action is an adjustment of an amount of therapeutic substance delivery relative to a prior amount previously delivered through the combination of references as it would have yielded the predictable result of ensuring the optical amount of treatment is provided to the patient (Alimohammadi (Par. 37)).
Claim(s) 24-25 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heasman in view of Alimohammadi as applied to claim 23 above, and further in view of Carter (US Pub. No. 20120316454) hereinafter Carter.
Heasman and Alimohammadi teach the system of claim 23 above.
Regarding claim 24, modified Heasman fails to explicitly disclose the limitations of the claim.
Heasman does disclose an algorithm (as indicated in claim 23 above).
Alimohammadi teaches the medium (as indicated in claim 23 above).
However, Carter teaches executing a spectroscopy analysis (Par. 44, “FIG. 4 provides a simplified diagram of exemplary circuitry for impedance spectroscopy…”) (Fig. 5 (impedance measurements)) (Par. 62, “Once measurements are obtained for each electrode pair to be measured, the process proceeds to block 518 and measurements are analyzed…”)(Abstract (impedance spectroscopy)) (Par. 40,41 (impedance spectroscopy to obtain information regarding surrounding tissue)) (Par. 43, “an embodiment of the present invention uses impedance spectroscopy to obtain an impedance spectroscopy plot and then compares the obtained plot with different characteristic plot shapes to obtain information regarding the stimulating lead assembly, such as, for example, the proximity of the electrode(s) to various cochlear structures, characteristics of the tissue surrounding the electrode(s), issues with the stimulating lead assembly (e.g., tip fold-over, faults, etc.)”) (Par. 77, “From the frequency domain current, I(s), and the frequency domain voltage, V(s), the frequency domain impedance, also known as the impedance spectrogram, can be calculated as: Z(s)=V(s)/I(s). As noted above, the measured impedance data may be analyzed in various manners depending on the particular implementation…”).
Heasman, Alimohammadi, and Carter are considered to be analogous art to the claimed invention as they are involved with ear-related devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Heasman and Alimohammadi with that of Carter to include wherein: the code for analyzing input is code for executing a spectroscopy analysis through the substitution of analysis techniques as it would have yielded the predictable result of providing a more detailed picture of the state of the electrode and surrounding tissue (Carter (Par. 40-41, 43)).
Regarding claim 25, modified Heasman fails to explicitly disclose the limitations of the claim.
However, Carter further teaches the spectroscopy is impedance spectroscopy (Carter (Par. 44, “FIG. 4 provides a simplified diagram of exemplary circuitry for impedance spectroscopy…”) (Fig. 5 (impedance measurements)) (Par. 62, “Once measurements are obtained for each electrode pair to be measured, the process proceeds to block 518 and measurements are analyzed…”)(Abstract (impedance spectroscopy)) (Par. 40,41 (impedance spectroscopy to obtain information regarding surrounding tissue)) (Par. 43, “an embodiment of the present invention uses impedance spectroscopy to obtain an impedance spectroscopy plot and then compares the obtained plot with different characteristic plot shapes to obtain information regarding the stimulating lead assembly, such as, for example, the proximity of the electrode(s) to various cochlear structures, characteristics of the tissue surrounding the electrode(s), issues with the stimulating lead assembly (e.g., tip fold-over, faults, etc.)”) (Par. 77, “From the frequency domain current, I(s), and the frequency domain voltage, V(s), the frequency domain impedance, also known as the impedance spectrogram, can be calculated as: Z(s)=V(s)/I(s). As noted above, the measured impedance data may be analyzed in various manners depending on the particular implementation…”))
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Heasman, Alimohammadi, and Carter with that of Carter to include the spectroscopy is impedance spectroscopy for the reasoning as indicated in claim 24 above.
Regarding claim 27, modified Heasman fails to explicitly disclose the limitations of the claim.
Heasman further teaches a method action performed automatically or manually (Heasman (Par. 81, “Method action 1430 can be executed by the control unit of figure 5, or by the external component of the cochlear electrode array, providing that such is programmed to execute such. This can be done automatically or manually.”)).
Alimohammadi further teaches the medium (Alimohammadi (Fig. 3A,3B, Par. 46, “electrochemical system 30 may further include a processing unit 38 that may be utilized to record and analyze electrochemical measurements made by electrochemical stimulator/analyzer 34…”) (Par. 47, “processing unit 38 may be implemented as a programmable logic controller with at least one processor 380, and at least one memory 382 that may be coupled to at least one processor 380. In an exemplary embodiment, at least one memory 382 may store executable instructions to urge at least one processor 380 to perform operations”) (Par. 48-50 (processing unit))(Par. 56-57, (computer programs))).
However, Carter teaches indicating to a healthcare professional data based on data indicative of a sensor component being located in a cochlea based on an analysis executed using the code for analyzing (Par. 77, “…the raw current measurements may be provided by control circuit 402 (FIG. 4) to an external device that analyzes the measurements to display information to a surgeon regarding the location of the stimulating lead assembly. This external device may be, for example, a computer or specialized piece of hardware and/or software. “) (Par. 80, “In an embodiment, this information is provided in real time so that a surgeon implanting a stimulating lead assembly can obtain real time data about the cochlear structures near the stimulating lead assembly. This information may be displayed to the surgeon in a visual form (for example a head up display of one or more of the impedance spectroscopy plots).”)
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Heasman and Alimohammadi with that of Carter to include the medium includes the code for automatically indicating to a healthcare professional data based on data indicative of a sensor component being located in a cochlea based on an analysis executed using the code for analyzing through combination of references as it would have yielded the predictable result of providing direct feedback to the surgeon (Carter (Par. 80)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 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, Jason Sims can be reached at (571) 272-7540. 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.
/ARI S PADDA/Examiner, Art Unit 3791
/RENE T TOWA/Primary Examiner, Art Unit 3791
