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
This Office Action is responsive to the amendment filed on 02/16/2026. As directed by the amendment: Claims 1 and 17 have been amended, claims 11-14 have been cancelled, and no claims have been added. Thus, claims 1-10, and 15-26 are presently under consideration in this application.
Response to Arguments
Applicant's arguments, see pages 8-10, filed 02/16/2026, regarding 35 U.S.C. 112(a) have been fully considered but they are not persuasive. Applicant asserts on page 9 that “The Examiner has failed to meet the initial burden of providing sufficient evidence or reasoning to overcome the presumption that Applicant's specification provides adequate written description to show Applicant's possession of the "determine a change in the plurality of subcutaneous tissue impedance values over the period of time is indicative of a decrease in stroke volume of the heart of the patient" subject matter in claims 1 and 17. Nor can the Examiner meet this burden, as Applicant's specification fully describes this aspect.” Applicant then argues on pages 9-10 that “Applicant's specification discusses that stable baseline tissue impedance measurements can enable stroke detection based on deviations from the baseline and that a significant change in the impedance values from the baseline over a period of time, associated with decreased stroke volume, may be used as evidence of a suprathreshold likelihood of stroke.”
Examiner disagrees because it remains unknown how stroke volume is even determined from impedance in the neck region. Applicant may have a reason to measure impedance in the head region to view a significant change, but fails to detail its relation to stroke volume and risk of stroke. Furthermore, the instant specification provides insufficient detail as to what this algorithm may be and how this algorithm can use impedance values for detecting change and determine this functional result of stroke volume. Furthermore, the subcutaneous measurement of impedance in the neck region may require additional calculations that Applicant fails to disclose how the invention takes this into account. This leaves a person of ordinary skill in the art a large gap in understanding the steps and calculations made from the subcutaneous impedance to achieve this stroke volume from the neck. Therefore, the rejection is maintained.
Applicant's arguments, see pages 10-24, filed 02/16/2026, with respect to 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues on page 12 that “Similar to how the claims in Thales were determined to be patent eligible because the “claims [were] directed to a new and useful technique for using sensors to more efficiently track an object on a moving platform” claim 1 is directed to a new and useful technique of using “a plurality of electrodes” carried on a housing, “the housing being configured for subcutaneous implantation and configured to be disposed at or adjacent to a rear portion of a neck or a skull of a patient,” for “determin[ing] a plurality of subcutaneous tissue impedance values.” Claim 1 recites using particular data (e.g., similar to the raw data from the sensors in Thales) to “determine... a stroke metric indicative of a risk of stroke of the patient.” Just as the first inertial sensor and the second inertial sensor in Thales were not dismissed as “nothing more than pre-solution activity of data gathering,” the system of claim 1 is configured to determine one or more subcutaneous tissue impedance signals via the plurality of electrodes carried by the housing (e.g., similar to receipt of signals from said first and second inertial sensors specifically positioned in the system) are also not “routine means for collecting data”! as claim 1 uses the system comprising a housing carrying the plurality of electrodes on the housing and configured to be disposed at or adjacent to a rear portion of a neck or a skull of a patient to determine subcutaneous tissue impedance signals of to determine a stroke metric of the patient. The plurality of electrodes being on a housing configured to be disposed at or adjacent to a rear portion of a neck or a skull of a patient “advantageously enables recording of clinically useful brain activity and cardiac activity signals via electrodes positioned at the target region 104 at the rear of the patient’s neck or head.”!! Thus, the claims are not directed to an abstract idea for at least similar reasons that were given in in Thales.”
Examiner disagrees. On page 10 of the Thales decision, the courts held that ‘...the claims are directed to systems and methods that use inertial sensors in a non-conventional manner to reduce errors in measuring the relative position and orientation of a moving object on a moving reference frame’. There is nothing on the record attesting to the unconventional nature of any of the additional elements and the field of inertial sensors used in the manner in the Thales case is markedly different than the housing and electrodes of the presently claimed system. The plurality of electrodes is generic gathering structure placed in a generic housing. Further, the subcutaneous tissue impedance obtained from the neck remains insignificant data gathering. The additional element of “receiving” does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of receiving steps amounts to no more than mere data gathering. This element amounts to receiving data over a network and are well-understood, routine, conventional activity (WURC). See MPEP 2106.05(d), subsection II (i). This cannot provide an inventive concept.
Further, MPEP 2106.05(d)(I)(2) cites “As such, an examiner should determine that an element (or combination of elements) is well-understood, routine, conventional activity only when the examiner can readily conclude, based on their expertise in the art, that the element is widely prevalent or in common use in the relevant industry. The analysis as to whether an element (or combination of elements) is widely prevalent or in common use is the same as the analysis under 35 U.S.C. 112(a) as to whether an element is so well-known that it need not be described in detail in the patent specification.” See Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1546 ( Fed. Cir. 2016). As shown in Hareland et al. (US 20130165987), the implantation of the housing subcutaneously for subcutaneous impedance is WURC and does not add significantly more to the claim. The prior art shows that the implantation subcutaneously of a housing with electrodes for obtaining impedance is known.
Applicant asserts on page 13 regarding Hareland that “the asserted reference does not disclose or suggest an implantable housing "configured to be disposed at or adjacent to a rear portion of a neck or a skull of a patient," as recited in independent claim 1.”
Due to amendments to the claims, Donoghue (US20210267523) teaches the implantation of the housing subcutaneously for subcutaneous impedance from housed electrodes configured to obtain impedance ([0196]) and is WURC and does not add significantly more to the claim. Other references include Koh (8099146) , “Respiration rate may be detected based on an analysis of trans-thoracic impedance sensed between an electrode implanted within the heart and an electrode connected to the housing of the pacer/ICD, using otherwise conventional techniques” (Col. 5 lines 58-64).
Applicant asserts on pages 13-14 that “the claims at issue in Medtronic’s application are analogous to the claims described as being patent eligible in the exemplary Federal Circuit cases described in the “mental processes” MPEP section,” and argues “Likewise for Medtronic’s claims, the human mind is not equipped to detect and predict strokes using electrodes carried on a subcutaneously implantable housing and to sense subcutaneous tissue impedance data and analyze the subcutaneous tissue impedance data using the particular method of determining a stroke metric indicative of a stroke risk recited in claim 1.”
Examiner disagrees because in SR/ International, Inc. v. Cisco Systems, Inc., 930 F.3d 1295, 1301 (Fed. Cir. 2019), the claims are directed to a different art as the facts to the case are different than the instant claims. The Applicant has failed to provide evidence to the assertion that the “human mind is not equipped to detect and predict strokes... and determin[e] a stroke metric”. Nevertheless, the determining of changes in impedance can be done by a human by observing and analyzing these changes in the impedance.
Applicant then argues on page 14-15 in regards to the Aug. 5th 2025 Memo that “Claim 1 clearly recites a system including a medical device comprising a housing with
electrodes disposed on the housing, the housing being configured for subcutaneous implantation
and configured to be disposed at or adjacent to a rear portion of a neck or a skull of a patient.
Claim 1 further recites that the system comprises sensing circuitry configured to determine subcutaneous tissue impedance values via the electrodes over time, and processing circuitry configured to determine a change in the subcutaneous tissue impedance values over the time in indicative of a decrease in stroke volume, and based on that determination, determine a stroke metric indicative of a stroke risk of the patient. Applicant respectfully submits that a human mind
or a person with pen and paper cannot practically perform the subject matter disclosed in claim
1. Claim 1 requires specific hardware (e.g., the medical device with the housing configured to
subcutaneous implantation at or adjacent to a rear portion of a neck or a skull) and processing
circuitry to perform steps that cannot be performed in the human mind or with pen and paper.”
Examiner disagrees because the Memo is directed to a different field of endeavor, as Desjardins is directed to the improvement of storage using machine learning. No such assertion is made in the present application and thus the facts of that case are not pertinent or related to the fact pattern presented in the present application.
Applicant then argues on pages 16-17 that “much like the claims of the '207 patent recite a specific method for identifying atrial fibrillation and atrial flutter by determining a set of intervals between R- waves of a cardiac signal and calculating a variability of these intervals, claim 1, as amended, recites a specific method for determining a plurality of subcutaneous tissue impedance values, in which the impedance values vary as a function of contractions of a heart of a patient, determining whether the change in the plurality of subcutaneous tissue impedance values is indicative of a decrease in stroke volume of the heart of the patient, and determining a stroke metric indicative of a risk of stroke of the patient based on the plurality of subcutaneous tissue impedance values being indicative of the decrease in stroke volume. In other words, the claims of the '207 patent and claim 1 both recite specific steps detailing how an acute health event is detected/predicted... [and] The Federal Circuit held that claim 1 of the '207 patent does not merely recite a computerized version of a diagnostic process long performed mentally by doctors and therefore does not recite a mental process. Applicant submits that the Office has not demonstrated mental performance of the features of Applicants’ claims, and that independent claim 1 likewise does not recite a mental process.” However, CardioNet, LLC v. InfoBionic, Inc. was directed to an improper assertion that the claimed device contained conventional structure. In the instant case, the use of electrodes on a housing is well-understood, routine, and conventional as shown in Annoni et al. (US 20180153476) which teaches canned electrodes on a housing and therefore is conventional structure. As shown in Hareland et al. (US 20130165987), the implantation of the housing subcutaneously for subcutaneous impedance is WURC and does not add significantly more to the claim. Therefore, any argument relating Cardionet to not being an abstract idea is deemed moot.
Applicant then argues on page 17 that “Claim 31 of the '850 patent merely recites one limitation for identifying arrythmia events without including any detail describing how the events are identified. Since amended claim 1 recites specific steps for determining the risk of stroke, claim 1 recites significantly more than steps for collecting, analyzing, and displaying data.” Examiner notes that the instant claims are directed to determining a risk of stroke through the use of impedance values, which is a means of which a human analyzes data and evaluates a risk of stroke, which therefore is a mental process.
Applicant then argues on pages 17-18 that “any argument relating Cardionet to not being an abstract idea is deemed moot.”’” However, this is not a valid basis to distinguish CardioNet, since the principle of the holding is not dependent on the improper assertion that the claimed device contained conventional structure and is instead dependent on ' Office Action dated May 1, 2025, page 4. the erroneous assertion that the CardioNet claims were directed to a mental process abstract idea.”° Applicant has demonstrated how the instant facts are analogous to CardioNet in this respect, and thus how Applicant’s claims are not directed to an abstract idea.” Examiner disagrees but nevertheless, every case turns on its own facts, and the instant limitations do contain an abstract idea.
Applicant then discusses on pages 18-19 the prosecution history of 16/436,012 specifying the Director vacating, remanding the Board’s decision and argues on page 19 that “claim 1 should be held patent eligible under CardioNet because they are directed to an improvement in monitoring technology, i.e., stroke monitoring via sensed subcutaneous tissue impedance signals, and the claims should be determined patent eligible.” Applicant is asserting the abstract idea itself as the improvement. However, the abstract idea cannot be an “additional element” that shows integration into a practical application. The order of calculations and the particular calculations claimed do not make the abstract idea any less abstract. The claims are currently structured as simply using a generic computer to implement the abstract idea (mental process), which is not enough to show a practical application. Further, Examiner notes that Application 16/436,012 are directed to PVC and that the improvement is directed to the position of the sensors on the structure. The instant claims are not directed to PVC and the arguments showing improvement in the technological field are not the same. Each case turns on its own facts.
Applicant further asserts on page 19 that stroke monitoring via sensed subcutaneous tissue impedance signals are patent eligible and that Applicant has demonstrated the instant claims are analogous to 16/436,012 and that improvements not being identical should not preclude the Office from considering the remarks. Examiner disagrees because ‘012 are not directed to the same field of endeavor. Furthermore, the structure of the instant claims is different than the structure recited in ‘012. Examiner has considered ‘012 and notes that the case turns on its own facts, and the instant limitations do contain an abstract idea that do not recite improvements.
Applicant argues on page 20 that “current claims focus on a specific manner for improving health condition status detection technology that provide practical technological improvements, such as determining a risk of stroke using subcutaneous tissue impedance values via a plurality of electrodes carried by a housing “configured to be disposed at or adjacent to a rear portion of a neck or a skull of a patient.” Claim 1 achieves the practical application of determining a stroke metric “to detect and predict the risk of stroke using brain, cardiac, and motion signals sensed via a single sensor device”*” by “advantageously enabl[ing] recording of clinically useful brain activity and cardiac activity signals via electrodes positioned at the target region 104 at the rear of the patient’s neck or head.” Applicant is asserting the abstract idea itself as the improvement. However, the abstract idea cannot be an “additional element” that shows integration into a practical application. The order of calculations and the particular calculations claimed do not make the abstract idea any less abstract. The claims are currently structured as simply using a generic computer to implement the abstract idea (mental process), which is not enough to show a practical application.
Applicant then argues on pages 20-22 that “Detecting and predicting the risk of stroke by advantageously enabling recording of clinically useful signals using electrodes positioned at the rear of the patient’s head or neck is most certainly a practical application of the alleged abstract idea. By recording clinically useful signals via the electrodes positioned at the rear of the patient’s neck or head, claim 1 achieves a practical application of the alleged abstract idea, at least due to the particularity of the housing carrying the electrodes… since the features of the claims, including the specific requirements at each of the individual features, cover a particular way to provide an improvement to health detection technology, and the claims reflect an improvement to health detection technology described in the Specification, the claims apply, rely on, or use the alleged judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception… The claims themselves reflect the new and useful technique for using subcutaneous tissue impedance values using a plurality of electrodes carried by a housing “configured to be disposed at or adjacent to a rear portion of a neck or a skull of a patient” to determine a risk of stroke of the patient. The particular features of claim 1 help provide for an improved determination of a risk of stroke and provide the new and useful technique for determining the risk of stroke… the features of the claims, including the specific requirements at each of the individual features, cover a particular way to provide an improvement to health condition status detection technology, and the claims reflect an improvement to health condition status detection technology described in the Specification, the claims apply, rely on, or use the alleged judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception …claims, as a whole, integrate the recited judicial exception into a practical application of the alleged abstract idea. Therefore, because the abstract idea is so integrated, the claims are not directed to a judicial exception and are eligible.” As shown in Hareland et al. (US 20130165987), the implantation of the housing subcutaneously for subcutaneous impedance is WURC and does not add significantly more to the claim. Examiner disagrees since the processing of data on a microcontroller unit is merely performing this process on a generic computer structure. The transmitting of signals is simply a generic computer function performed by a generic computer structure, wherein implementing the abstract idea with a generic computer is not enough to show integration into a practical application or significantly more than the abstract idea itself. The transmission of data to and from the sensor systems is merely data gathering, which is insignificant extra-solution activity.
Applicant then argues on pages 23-24 that “claim 1 recites an improvement to a medical device technology for determining a risk of stroke of a patient based on tissue impedance values collected by a medical device. For example, independent claim 1 recites techniques for sensing tissue impedance subcutaneously and relates tissue impedance to contractions of a heart of a patient, determining the tissue impedance is indicative of a decrease in stroke volume, and determining a risk of stroke of the patient based on the tissue impedance being indicative of the decrease in stroke volume. Analyzing tissue impedance and changes stroke volume is beneficial because decreased stroke volume can be indicative of an increased risk of stroke… Applicant’s specification clearly describes that analyzing tissue impedance is beneficial for determining increased stroke risk. Using impedance values to determine stroke metric based on the relationship between decreased stroke volume and tissue impedance is an improvement to a medical device technology because this method allows the medical device to determine whether a patient is at risk of experiencing and/or is experiencing a stroke… the additional elements of the claim amount to more than what is well- understood, routine, and conventional. For example, the step of "determin[ing] a change in the
plurality of subcutaneous tissue impedance values over the period of time is indicative of a
decrease in stroke volume of the heart of the patient" imposes meaningful limits on the claim, as
required by MPEP § 2106.05(g). In addition, the housing of claim 1 being configured for
implantation at a rear portion of the skull or neck of the patient, particularly in combination with
the other subject matter of claim 1, is more than what is well-understood, routine, and
conventional.” Applicant is asserting the abstract idea itself as the improvement. However, the abstract idea cannot be an “additional element” that shows integration into a practical application. The order of calculations, determinations and the particular calculations, including the determining of the change in impedance and the stroke risk, claimed do not make the abstract idea any less abstract. The claims are currently structured as simply using a generic computer to implement the abstract idea (mental process), which is not enough to show a practical application. Therefore, the rejection is maintained.
Applicant’s arguments, see pages 24-29, filed 02/16/2026, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 103 have been fully considered. Applicant argues on page 26 that “Claim 1 requires that the housing carrying the electrodes be physically structured for subcutaneous implantation at or adjacent to the rear portion of the neck or skull of the patient. Therefore, contrary to the assertion of the Examiner, "the housing being configured for subcutaneous implantation and configured to be disposed at or adjacent to a rear portion of a neck or a skull of a patient," as recited in claim 1, contains patentable weight.” Examiner notes that the limitation is intended use so the device has to be capable of being disposed at or adjacent to a rear portion of a neck or a skull with electrodes on the housing which contains patentable weight. Due to the amendments to the claim, the scope of the claims has been altered, thereby obviating the rejection of record.
Applicant argues on page 27 that “the Office's assertion that the device of Annoni "would be [a] small enough size for implantation into the body"⁵⁵ is not enough does not disclose or suggest Applicant's system as claimed.” Examiner agrees.
Applicant then argues on page 28 that “Annoni in view of Poupko and Bornzin does not disclose or suggest processing circuitry configured to "determine a plurality of subcutaneous tissue impedance values via the electrodes over a period of time...;" "determine a change in the plurality of subcutaneous tissue impedance values over the period of time is indicative of a decrease in stroke volume of the heart of the patient;" or "determine, at least based on the change in the plurality of subcutaneous tissue impedance values being indicative of the decrease in stroke volume, a stroke metric indicative of a risk of stroke of the patient." Instead, Annoni discloses, "Examples of the physiological signal may include an intracardiac impedance signal. ,,56 Annoni discloses measuring an intracardiac impedance signal, which is completely different from a subcutaneous tissue impedance value and provides different information. Annoni does not disclose or suggest a subcutaneous impedance value.” Examiner agrees because the amendments require the collection of impedance comes from housed electrodes capable of being disposed at or adjacent to a rear portion of a neck or skull. Therefore, the rejection has been withdrawn.
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 1-10 and 15-26 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.
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 §§ 2163.02 and 2181, subsection IV.
Merely recite a description of the problem to be solved while claiming all solutions to it, leaving the industry to “complete an unfinished invention.” See Ariad, 598 F.3d at 1353
Disclosure of function alone is little more than a wish possession. See MPEP 2163(II)(A)(3)(a).
The written description requirement is not satisfied by merely outlining the goals or results one hopes to achieve with the invention. See MPEP 2163(II)(A)(3)(a).
Claims 1 and 17 fail to sufficiently describe the determining of stoke volume from subcutaneous tissue impedance in enough detail for one skilled in the art to understand how the inventor intended the function to be performed. The mere statement and recitation of the determination of a change in subcutaneous being indicative of a decrease in stroke volume in claims 1 and 17 is unknown how stroke volume is even determined from impedance in the neck region. In [0125] of the instant specification discloses “A significant change in the impedance values over a period of time associated with decreased stroke volume may be used by an algorithm as evidence of a suprathreshold likelihood of stroke.” However, the instant specification provides insufficient detail as to what this algorithm may be and how this algorithm can use impedance values for detecting change and determine this functional result of stroke volume. Furthermore, the subcutaneous measurement of impedance in the neck region may require additional calculations that Applicant fails to disclose how the invention takes this into account. This leaves a person of ordinary skill in the art a large gap in understanding the steps and calculations made from the subcutaneous impedance to achieve this stroke volume from the neck. Therefore, claims 1-10 and 15-26 do not provide sufficient detail to have written description.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 and 15-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each of independent claims 1 and 17 recites a step determine a change in the plurality of subcutaneous tissue impedance values over the period of time is indicative of a decrease in stroke volume of the heart of the patient…determine, …, a stroke metric indicative of a risk of stroke of the patient, which is a mental process. This judicial exception is not integrated into a practical application because the generically recited computer elements (ie. Memory, sensing circuitry, and processing circuitry), determining impedance values, and determining stroke a metric do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are to receiving data, processing data, and determining a stroke metric, which are all well-understood, routine, and conventional computer functions. See MPEP § 2106.05(d).
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 1 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Claim 17 is directed to a method and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claims 1 and 17, the following step is an abstract idea:
“determine a change in the plurality of subcutaneous tissue impedance values over the period of time is indicative of a decrease in stroke volume of the heart of the patient…determine, …, a stroke metric indicative of a risk of stroke of the patient”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could analyze use a tissue impedance value to determine a stroke metric.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claims 1 and 17, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “memory”, “electrode”, “sensing circuity”, and “processing circuitry” are recited at a high level of generality and are generic computer components amounting to insignificant extra-solution activity in that they are merely objects on which the functional limitations operate [MPEP 2106.05(b)].
- “tissue impedance values”, “stroke volume”, and “contractions” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “memory”, “electrode”, “sensing circuity”, and “processing circuitry” are recited at a high level of generality and are generic computer components amounting to insignificant extra-solution activity in that they are merely objects on which the functional limitations operate [MPEP 2106.05(b)].
- “tissue impedance values”, “stroke volume”, and “ejection fraction” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
The additional elements of claims 1 and 17, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the memory, sensory circuitry, and processing circuitry, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The use of electrodes on a housing is well-understood, routine, and conventional as shown in Annoni et al. (US 20180153476) which teaches canned electrodes on a housing and therefore is conventional structure, Donogue (WO2019211314) that teaches electrodes near the skull for obtaining impedance (Abstract), and Koh (8099146) , “Respiration rate may be detected based on an analysis of trans-thoracic impedance sensed between an electrode implanted within the heart and an electrode connected to the housing of the pacer/ICD, using otherwise conventional techniques” (Col. 5 lines 58-64). The additional elements of tissue impedance values, ejection fraction, and stroke metric are insignificant extra-solution activity and do not amount to more than what is well- understood, routine, and conventional.
Dependent claims 2-10, 15-16 and 18-26 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 1 and 17. The dependent claim limitations are directed to the stroke metric (insignificant extra-solution activity) (claims 2-8 and 18-26) and to the device (generic computer component) (claims 9-10 and 15-16), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 1-10 and 15-26 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
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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/MOUSSA HADDAD/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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