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 Amendment
The preliminary amendment filed May 17, 2024 and August 26, 2025 have been entered. Claims 1-27 are canceled. Currently, claims 28-47 are pending for examination.
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 28-37, 42-47 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 28-37, 42-47 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p. 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019).
Claim 28 is directed to an apparatus reciting the following limitations:
A medical device comprising:
a sensor configured to be implanted in a recipient of the medical device and to obtain measurements from an inner ear of the recipient; and
a processor configured to:
detect changes in a permeability of a blood labyrinth barrier of the inner ear based on the measurements obtained by the sensor; and
estimate health of the inner ear of the recipient based on the changes in the permeability of the blood labyrinth barrier.
Step 2A – Prong 1: The above bolded emphasized limitations are drawn to an abstract idea because they are, under their broadest reasonable interpretation, mere steps that are capable of being mentally performed or with a pen and paper. For example, looking at measurement values obtained from a sensor to determine changes in a permeability of a blood labyrinth barrier and then using these determined changes to then make an estimate of the health of the inner ear involves only a matter of observation, evaluation, judgement and opinion recognized by the courts as a mental process. See MPEP 2106.04(a)(2).
Step 2A – Prong 2: The above italicized emphasized limitations do not integrate the exception into a practical application of the exception because the elements are directed to insignificant extra-solution activity. A medical device, sensor, and processor are recited at a high level of generality to perform the abstract idea and are merely regarded as including instructions to implement the abstract idea on a computer, or merely using a computer as a tool to perform the abstract idea. See MPEP 2106.04(d) and 2106.05(f). Obtaining measurements from an inner ear does not integrate the exception into a practical application of the exception because it does not amount to more than generally linking the use of the exception to a particular technological environment or field of use. See MPEP 2106.05(h). The judicial exception does not integrate the claim as a whole into a practical application because the claimed invention does not improve another technology or technical field.
Step 2B: Claim 28 does not recite additional elements that amount to significantly more than the judicial exception itself. The medical device, sensor, and processor are recited at a high level of generality to perform the abstract idea. See MPEP 2106.04(d) and 2106.05(f). The medical device, sensor and processor are well-understood, routine, and conventional elements as evidenced by Wells et al. (US 2011/0295331) disclosing, “electronics and sensors of a conventional cochlear implant system” ([0150]) and Zilberman et al. (US 2001/0053872) disclosing, “a conventional cochlear sound processor 22” ([0013]) in a “conventional cochlear implant electronics device 12” ([0015]). Obtaining measurements from an inner ear is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). The italicized emphasized elements do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)).
In view of the above, the italicized additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, 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 the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Claim 29 is a dependent claim that further limits the sensor is configured to detect at least one type of inflammatory cytokine within the inner ear of the recipient. However this is still interpreted as “collecting information and analyzing it”. Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016).
Claims 30-31 are dependent claims that only further limit the judicial exception.
Claim 32 is a dependent claim that recites the limitation, “the processor is configured to initiate one or more restorative actions that reduce permeability of the blood labyrinth barrier responsive to an estimate that the inner ear health of the recipient is deteriorating”. Without further detailing what these “restorative actions” are, it is within reason for one in the art to interpret a display of the estimated health of the inner ear for a person to perform an action that reduces the permeability of the blood labyrinth layer, as a type of restorative action. Outputting data on a display is simply an attempt to limit the use of the abstract idea to a particular technological environment. Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). Instructions to a human is regarded as a an abstract idea directed to method of organizing human activity.
Claims 33-35 are dependent claims that only further limit the implantation location of the sensor, the type of the medical device (still regarded as conventional, see Wells et al., above) or further limit the abstract idea.
Claim 36 is directed to an apparatus reciting the following limitations:
A method comprising:
obtaining one or more measurements from an inner ear of a recipient of a medical device;
determining, based on the one or more measurements, an increased permeability of a blood labyrinth barrier of the inner ear; and
based on the determining, performing a restorative action that reduces permeability of the blood labyrinth barrier.
Step 2A – Prong 1: The above bolded emphasized limitation is drawn to an abstract idea because they are, under their broadest reasonable interpretation, mere steps that are capable of being mentally performed or with a pen and paper. For example, looking at measurement values to determine an increased permeability of a blood labyrinth barrier involves only a matter of observation, evaluation, judgement and opinion recognized by the courts as a mental process. See MPEP 2106.04(a)(2).
Step 2A – Prong 2: The above italicized emphasized limitations do not integrate the exception into a practical application of the exception because the elements are directed to insignificant extra-solution activity. The medical device is recited at a high level of generality to perform the abstract idea and are merely regarded as including instructions to implement the abstract idea on a computer, or merely using a computer as a tool to perform the abstract idea. See MPEP 2106.04(d) and 2106.05(f). Obtaining measurements from an inner ear does not integrate the exception into a practical application of the exception because it does not amount to more than generally linking the use of the exception to a particular technological environment or field of use. See MPEP 2106.05(h). Without further detailing what the “restorative action” is, it is within reason for one in the art to interpret a display of the estimated health of the inner ear for a person to perform an action that reduces the permeability of the blood labyrinth layer, as a type of restorative action. Outputting data on a display is simply an attempt to limit the use of the abstract idea to a particular technological environment. Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). The judicial exception does not integrate the claim as a whole into a practical application because the claimed invention does not improve another technology or technical field.
Step 2B: Claim 36 does not recite additional elements that amount to significantly more than the judicial exception itself. The medical device is recited at a high level of generality to perform the abstract idea. See MPEP 2106.04(d) and 2106.05(f). The medical device is well-understood, routine, and conventional elements as evidenced by Wells et al. (US 2011/0295331) disclosing, “electronics and sensors of a conventional cochlear implant system” ([0150]). Obtaining measurements from an inner ear and displaying results of a judicial exception as a “restorative action” is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). The italicized emphasized elements do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)).
In view of the above, the italicized additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, 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 the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Claim 37 is a dependent claim that further limits the one or more measurements to indicate a concentration of cytokine in the inner ear of the recipient. However claims 36 and 37 are broadly written for it to be within reason for one in the art to interpret these obtained measurements are simply tabulated data presented to a person to perform the judicial exception in the same manner as “collecting information and analyzing it”. Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016).
Claim 38 is a dependent claim that further limits the restorative action to comprising administration of a pharmaceutical formulation to inhibit cytokine expression or activity. This limitation is regarded as an additional element that amounts to significantly more than the judicial exception itself. Therefore claim 38 is patent eligible under 35 U.S.C. 101. Claim 39 is also patent eligible under 35 U.S.C. 101 for being dependent on claim 38.
Claim 40 is a dependent claim that further limits the restorative action to comprising administration of a small interfering ribonucleic acid to interfere with production of connexin 43. This limitation is regarded as an additional element that amounts to significantly more than the judicial exception itself. Therefore claim 39 is patent eligible under 35 U.S.C. 101.
Claim 41 is a dependent claim that further limits the restorative action to comprising editing genes associated with adjusting permeability of the blood labyrinth barrier to excise or replace a section of the genes associated with encoding regulators or cytokine availability at the blood labyrinth barrier. This limitation is regarded as an additional element that amounts to significantly more than the judicial exception itself. Therefore claim 41 is patent eligible under 35 U.S.C. 101.
Claim 42 is directed to a method reciting the following limitations:
A method comprising:
an implantable medical device obtaining measurements from the inner ear of a recipient of the implantable medical device over a period of time following implantation of the implantable medical device;
detecting, based on the measurements obtained by the implantable medical device, changes to the permeability of the blood labyrinth barrier of the recipient; and
estimating, based on the detected changes in permeability of the recipient’s blood labyrinth barrier, a measure of inner ear health of the recipient.
Step 2A – Prong 1: The above bolded emphasized limitations are drawn to an abstract idea because they are, under their broadest reasonable interpretation, mere steps that are capable of being mentally performed or with a pen and paper. For example, looking at measurement values obtained from a sensor to determine changes in a permeability of a blood labyrinth barrier and then using these determined changes to then make an estimate of the health of the inner ear involves only a matter of observation, evaluation, judgement and opinion recognized by the courts as a mental process. See MPEP 2106.04(a)(2).
Step 2A – Prong 2: The above italicized emphasized limitations do not integrate the exception into a practical application of the exception because the elements are directed to insignificant extra-solution activity. The implantable medical device is recited at a high level of generality to perform the abstract idea and are merely regarded as including instructions to implement the abstract idea on a computer, or merely using a computer as a tool to perform the abstract idea. See MPEP 2106.04(d) and 2106.05(f). Obtaining measurements from an inner ear does not integrate the exception into a practical application of the exception because it does not amount to more than generally linking the use of the exception to a particular technological environment or field of use. See MPEP 2106.05(h). The judicial exception does not integrate the claim as a whole into a practical application because the claimed invention does not improve another technology or technical field.
Step 2B: Claim 42 does not recite additional elements that amount to significantly more than the judicial exception itself. The implantable medical device is recited at a high level of generality to perform the abstract idea. See MPEP 2106.04(d) and 2106.05(f). The implantable medical device is well-understood, routine, and conventional elements as evidenced by Wells et al. (US 2011/0295331) disclosing, “electronics and sensors of a conventional cochlear implant system” ([0150]) and Zilberman et al. (US 2001/0053872) disclosing a “conventional cochlear implant electronics device 12” ([0015]). Obtaining measurements from an inner ear is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). The italicized emphasized elements do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)).
Claim 43 is a dependent claim that further limits the one or more measurements to indicate a concentration of cytokine in the inner ear of the recipient. However, this is still interpreted as, “collecting information and analyzing it”. Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016).
Claim 44 is a dependent claim that only further limits the judicial exception.
Claim 45 is a dependent claim that recites the limitation, “wherein the method comprises initiating one or more restorative actions that reduce permeability of the blood labyrinth barrier responsive to an estimate that the inner ear health of the recipient is deteriorating”. Without further detailing what these “restorative actions” are, it is within reason for one in the art to interpret a display of the estimated health of the inner ear for a person to perform an action that reduces the permeability of the blood labyrinth layer, as a type of restorative action. Outputting data on a display is simply an attempt to limit the use of the abstract idea to a particular technological environment. Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). Instructions to a human is regarded as a an abstract idea directed to method of organizing human activity.
Claim 46 is a dependent claim that recites the limitation, “wherein the method comprises programming the implantable medical device based on the estimated inner ear health of the recipient”. Without further detailing what is programmed, it is within reason for one in the art to view this limitation, recited at a high level of generality, such that it amounts to no more than using a computer to implement the abstract idea.
Claim 47 is a dependent claim that recites the limitation, “wherein the implantable medical device comprises a neurostimulator, and the method comprises programming the neurostimulator with electrical stimulation parameters derived from the estimate of inner ear health”. This step is not particular enough, and is instead merely instructions to “apply” the exception in a generic way and does not integrate the mental analysis step into a practical application. See MPEP 2106.04(d)(2).
Allowable Subject Matter
Claims 38-41 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Smyth (US 2021/0001113).
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/ERICA S LEE/Primary Examiner, Art Unit 3796