DETAILED ACTION
Response to Amendment
This Office Action is responsive to the Amendment filed 8 June 2026. Claims 1-20 are now pending. The Examiner acknowledges the amendments to claims 1, 2, 4, 5, 7, 8, 10, 12, 13, 15, 16, 19, 20.
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 .
Claim Objections
Claims 7, 13, 20 are objected to because of the following informalities:
-Claim 7 recites “sensor re.” in lines 2-3. Examiner recommends amending to –sensor.—
-Claim 13 recites “and wherein” in line 2. Examiner recommends amending to –and—
Applicant is advised that should claim 1 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Appropriate correction is required.
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 1-20 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 1 recites “the subject’s blood pressure” in lines 7-8. There is insufficient antecedent basis for this limitation in the claim. -Claim 12 recites “a value of the one or more control parameters” in lines 3-4. It is unclear whether this is the same or different from “values of one or more control parameters” in claim 1, line 7.
-Claim 19 recites “the subject’s blood pressure” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
-Claim 20 recites “the subject’s blood pressure” in lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1, 20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
-Claim 1 recites “sensors attached to a subject” in lines 5-6. This claim is directed to or encompassing a human organism and is ineligible. Examiner notes that this should read “sensors configured to attach to a subject.”
-Claim 20 recites “sensors to attach to a subject” in line 2. This claim is directed to or encompassing a human organism and is ineligible. Examiner notes that this should read “sensors configured to attach to a subject.”
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recites(s) a series of mental processes used to determine a control measure. This judicial exception is not integrated into a practical application because the processor is recited as performing the generic computer function of measuring, determining, comparing values and controlling a therapy system. The processor executing machine readable instructions and a process of measuring, determining and comparing these values is a generic function of computer-readable media. Further, mere instructions to apply a judicial exception using a generic processor does not impose meaningful limits on practicing the abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements recited in claims 1-20 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition to change a subject’s blood pressure.
An analysis of the claims is shown below:
Step 1: Claims 1-18, 20 are directed towards a system, which is a statutory category of invention. Claim 19 is directed towards a method which is a statutory category of invention.
Step 2A, prong 1: Claim 1 recites limitations that are directed to an abstract idea. Claims 1, 19 and 20 recite perform a control measure to change the subject’s blood pressure. These limitations, under their broadest reasonable interpretation, fall within the mental processes grouping of abstract ideas. It would be practically performable in a human’s mind, or with pen and paper, to determine a control measure of a device or make a decision based on a control measure to change a subject’s blood pressure. Analyzing information and making a determination based on information is akin to an observation, evaluation or judgement that defines the mental process grouping. Independent claims 1, 19 and 20 do not require use of a therapy system or any modification made to the system. While these claim limitations of do specify perform a control measure to change the subject’s blood pressure, this could equate to making a decision based on data collected. Thus claims 1, 19 and 20 are directed to a judicial exception, an abstract idea.
Step 2A, prong 2: Claims 1-20 do not recite additional elements that integrate the judicial exception into a practical application. Claims 1-20 recite the following additional elements:
-processor (claims 1, 3, 12, 16, 20)
-memory (claims 1, 20)
-one or more subcutaneous sensors (claims 1, 4, 5, 6, 7, 19, 20)
-optical sensor (claims 4, 5)
-ultrasound sensor (claim 4)
-impedance sensor (claim 6)
-subcutaneous blood pressure sensor (claim 7)
-device-pacemaker, neurostimulator, drug pump, or mechanical device (claim 11)
The processor, memory, one or more sensors, optical sensor, ultrasound sensor, impedance sensor, subcutaneous blood pressure sensor and device are generically recited at a high level of generality. Further, mere instructions or programs to apply judicial exception using generic processors independently does not impose meaningful limits on practicing the abstract idea.
Most notably, none of the additional elements recited in these claims apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. While the bodies of these claims discuss aspects related to blood pressure, parameters related to anatomical diameters and flow, thyroid and kidney function there is no claim limitation that recites a particular treatment method to change a subject’s blood pressure.
Thus claims 1-20 do not integrate the abstract idea into a practical application.
Step 2B: When considered individually and in combination, the claims do not recite additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of the measure, determine, compare, perform additional control measures (claim 3), deriving waveforms (claim 9), delivering therapy treatment (claim 10), outputting notifications (claim 10), selecting modes of a device (claim 11), setting a mode of a device (claim 11), deriving composite trigger values (Claim 16), providing values to a machine learning model (claim 17), and processing sets of values (claim 17) are also generically recited at a high level of generality. Mere determination or execution or control of a processor to apply a judicial exception using a generic setting of therapy treatment device does not impose meaningful limits on practicing the abstract idea. Furthermore, the processes and steps can be considered nonfunctional descriptive material because there are no elements that show how the modification of settings interacts with the processor of the therapy treatment device. The processes and steps recited in claims 9, 10, 16, 17 also amount to those of making calculations based on collected data.
In reconsidering the additional elements of the therapy system and methods, the additional elements were determined to be well-understood, routine and conventional based on the following evidence:
-Gottesman et al. U.S. 20060122864 discloses a processor [Fig. 1, element 130], memory [0014], one or more sensors [Fig. 1, elements “Sensor 1, 2 and 3”], optical sensor [Pg. 4, “Optical Sensor”], ultrasound sensor [Pg. 4, “Ultrasound Sensor”], impedance sensor [Pg. 4, “Impedance Sensor”], subcutaneous blood pressure sensor [0014] and [Pg. 4, “Subcutaneous device”] and a device [Pg. 3, “Pacemaker, “Implantable Drug Pump” “Neuro-Cardiac Stimulator” and “Defibrillator”] in reference to a therapeutic device and method that utilizes blood pressure monitoring. Therefore, these elements are demonstrated to be generic, well understood components that are commonly recited in the art.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 5-7, 9-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandgaard (U.S. 20220202350) in view of Garza (U.S. 20220022844).
Regarding Claim 1, Sandgaard teaches a system comprising:
a processor [Fig. 1, element 108 (processing circuitry)] and [0110]; and
a memory storing instructions thereon that [Fig. 1, element 124 (memory)] and [0092]—reference to microprocessors executing instructions stored on memory, when executed by the processor, when executed by the processor, cause the processor to:
determine values of one or more control parameters indicative of the subject's blood pressure based on the measured at least one biometric parameter [Fig. 2, element 208]; and
perform a control measure to change the subject's blood pressure based on a comparison of the values of the one or more control parameters to a threshold [Fig. 2, element 220].
Sandgaard is silent on measure, based on output of one or more subcutaneous sensors attached to a subject, at least one biometric parameter associated with the subject. Garza teaches measure, based on output of one or more subcutaneous sensors attached to a subject [Abstract], [0009], at least one biometric parameter associated with the subject [0009; “blood pressure monitoring”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate subcutaneous sensors as taught by Garza to monitor biometric parameters as suggested by Sandgaard, as Sandgaard discusses the use of sensors for monitoring being invasive and noninvasive [0099] with Garza because Garza teaches the clinical need for effective and minimally invasive methods to monitor and track blood pressure [0007].
Regarding Claim 2, Sandgaard further teaches wherein: determining the values of the one or more control parameters comprises deriving the values of the one or more control parameters based on measuring the at least one biometric parameter [0087]—reference to deriving physiological parameters to generate indicators and controls.
Regarding Claim 3, Sandgaard further teaches wherein the instructions are further executable by the processor to:
perform a second control measure based on a set of data points associated with the at least one biometric parameter [Fig. 2, element 224]—reference to control and prompts for treatment devices and procedures.
Regarding Claim 5, Sandgaard teaches comprises an optical sensor; and the at least one biometric parameter comprises a characteristic of a pulse associated with an anatomical element of the subject [0093]—further discusses the use of pulse oximetry and [0090]—mentions the physiological metrics such as heart rate used.
Sandgaard is silent on the one or more subcutaneous sensors. Garza teaches the one or more subcutaneous sensors [Abstract], [0009].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate subcutaneous sensors as taught by Garza to monitor biometric parameters via optical measurement as suggested by Sandgaard, as Sandgaard discusses the use of optical sensing for generating signals for measuring pulsatile-blood related parameters [0109] with Garza because Garza teaches using oxygen saturation sensors which are typically optical sensors [0052].
Regarding Claim 6, Sandgaard teaches wherein: comprise an impedance sensor [0068] and [0073]; and
the at least one biometric parameter comprises a characteristic of a pulse of an impedance measurement associated with an anatomical element of the subject [0073]—refers to heart rate, photoplethysmography (PPG) and bioelectrical impedance measured across a chest of a patient.
Sandgaard is silent on the one or more subcutaneous sensors. Garza teaches the one or more subcutaneous sensors [Abstract], [0009].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate subcutaneous sensors as taught by Garza to monitor biometric parameters via impedance measurement as suggested by Sandgaard, as Sandgaard discusses the use of bioelectrical impedance oxygen content [0068] with Garza because Garza teaches using impedance sensors [0052].
Regarding Claim 7, Sandgaard is silent on wherein: the one or more subcutaneous sensors comprise a subcutaneous blood pressure sensor. Garza teaches wherein: the one or more subcutaneous sensors comprise a subcutaneous blood pressure sensor [0009].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to calculate blood pressure characteristics based on control and previous data as taught by Garza to measure and monitor biometric parameters as suggested by Sandgaard as Sandgaard discusses the use of historical data while monitoring for sepsis [0134] with Garza because Garza teaches the use of this data to increase accuracy [0067].
Regarding Claim 9, Sandgaard further teaches wherein:
the at least one biometric parameter comprises an optical signal associated with an anatomical element [0090] and [0093], an electrical impedance associated with the anatomical element, or a pressure associated with the anatomical element [0068] and [0073];
determining the values of the one or more control parameters comprises deriving a waveform representation of the optical signal, the electrical impedance, or the pressure [0087]-discusses derivation of physiological signals and [0113]—where reference sepsis index over time includes control parameters; and
performing the control measure is based on comparing one or more characteristics of the waveform representation to a set of threshold criteria [0114]—reference to threshold-based sepsis analysis.
Regarding Claim 10, Sandgaard further teaches wherein performing the control measure comprises:
outputting a control signal to a device [0102]—reference to sensors outputting signals indicative of physiological parameters; and
at least one of: delivering therapy treatment to the subject based on the control signal [Fig. 2, element 224], [Fig. 16, element 1620], [0140] and [0105];
and outputting a notification based on the control signal, and wherein the notification comprises an indication of one or more actions associated with treating a medical condition [Fig. 2, element 220], [Fig. 16, element 1624], [0140].
Regarding Claim 11, Sandgaard further teaches wherein performing the control measure comprises:
selecting a mode of a device configured for delivering therapy treatment to the subject, the device comprising a pacemaker, a neurostimulator, a drug pump, or a mechanical device [0156]—reference to drug infusion pump; and
delivering the therapy treatment to the subject based on the mode [0157; “The sepsis monitor 106 may act as the master in the cooperative configuration where the sepsis monitor 106 receives additional monitoring data from the external device, and the sepsis monitor 106 generate signals to control the administration of the treatment.”].
Regarding Claim 12, Sandgaard further teaches wherein the instructions are further executable by the processor to: set a mode associated with performing the control measure [0084]—reference to administered therapy applied based on sepsis indication and baseline non-septic values and therapy responding proportionally to increasing the therapy as septic condition declines,
And wherein setting the mode is based on a value of the at least one biometric parameter, a value of the one or more control parameters, or both [0084]—references sepsis index, baseline, non-septic parameter values.
Regarding Claim 13, Sandgaard further teaches wherein measuring the at least one biometric parameter,
determining the values of the one or more control parameters, and wherein performing the control measure is in response to one or more trigger criteria [0071], [Fig. 2]—where is determining step is element 208, performing the control measure is element 224 and trigger criteria is elements 212 and 216.
Regarding Claim 14, Sandgaard further teaches wherein the one or more trigger criteria comprise at least one of:
temporal criteria (not required by the claim);
a change in posture of the subject (not required by the claim);
a change in value of the at least one biometric parameter [Fig. 2, element 208, 212] and [0103]—reference to patient parameter changes which is interpreted to be changes in physiological parameters as collected from the sensors; and
a change in activity level or activity status associated with the subject [0153]—references brain activity.
Regarding Claim 15, Sandgaard further teaches wherein the one or more trigger criteria comprise at least one of:
a control signal associated with delivering therapy treatment to the subject; and
delivery of the therapy treatment [0084; “The therapy may respond to the sepsis index value in a proportional manner where a controlled feedback loop between the device produces the effect of increasing the therapy as a patient's septic condition declines. As the sepsis index returns towards 100, signifying patient's septic condition improving, the therapy can be reduced. Multiple therapies can be interlinked with the sepsis monitor with this method, such as a fluid volume monitor along the sepsis monitor and administration devices for antibiotics, vasopressors, and fluids.”]
Regarding Claim 16, Sandgaard further teaches wherein:
the one or more trigger criteria comprise two or more trigger criteria [0132]—references sepsis scoring index steps repeating which would mean additional trigger criteria; and
the instructions are further executable by the processor to: derive a composite trigger value based on the two or more trigger criteria and respective weights of the two or more trigger criteria [0133; “Each monitored physiological parameter has an associated index coefficient (or multiplier) which is used to provide an appropriate weight of significance for the overall sepsis index value. As each monitored parameter changes away from its baseline, a percentage change is calculated (operation 1124) and the percentage change is multiplied by the parameter's associated coefficient to determine the parameter's impact on the sepsis index (operation 1128).”] ,
and wherein performing the control measure is in response to the composite trigger value satisfying one or more threshold values [0103; “Operation 208 includes comparing the patient parameters from operation 204 to one or more thresholds… Operation 212 may be optionally performed to calculate patient parameter changes for the purpose of determining a sepsis index, where such sepsis index is used to determine the sepsis state of the patient 104.”]
Regarding Claim 17, Sandgaard further teaches further comprising:
providing a set of values of the at least one biometric parameter to a machine learning model, wherein determining the values of the one or more control parameters comprises deriving, by the machine learning model, the values of the one or more control parameters in response to the machine learning model processing the set of values of the at least one biometric parameter [0082], [0098], and [0134].
Regarding Claim 18, Sandgaard further teaches wherein measuring the at least one biometric parameter [0102],
determining the values of the one or more control parameters, and performing the control measure are associated with a closed loop operating mode of the system [0084]—reference to closed loop feedback detection and administration solution including sepsis index, septic conditions with therapy administration.
Regarding Claim 19, Sandgaard teaches a method comprising:
measuring, [Fig. 2, element 204];
determining values of one or more control parameters indicative of the subject's blood pressure based on the measured at least one biometric parameter [Fig. 2, element 208]; and
performing a control measure to change the subject's blood pressure based on a comparison of the values of the one or more control parameters to a threshold [Fig. 2, element 220].
Sandgaard is silent on based on output of one or more subcutaneous sensors attached to a subject, at least one biometric parameter associated with the subject. Garza teaches based on output of one or more subcutaneous sensors attached to a subject [Abstract], [0009], at least one biometric parameter associated with the subject [0009; “blood pressure monitoring”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate subcutaneous sensors as taught by Garza to monitor biometric parameters as suggested by Sandgaard, as Sandgaard discusses the use of sensors for monitoring being invasive and noninvasive [0099] with Garza because Garza teaches the clinical need for effective and minimally invasive methods to monitor and track blood pressure [0007].
Regarding Claim 20, Sandgaard teaches a system comprising:
a processor [Fig. 1, element 108 (processing circuitry)] and [0110]; and
a memory storing instructions thereon that, when executed by the processor [Fig. 1, element 124 (memory)] and [0092]—reference to microprocessors executing instructions stored on memory, when executed by the processor, when executed by the processor, cause the processor to:
determine values of one or more control parameters indicative of the subject's blood pressure based on the measured at least one biometric parameter [Fig. 2, element 208]; and
perform a control measure to change the subject's blood pressure based on a comparison of the values of the one or more control parameters to a threshold [Fig. 2, element 220].
Sandgaard is silent on one or more subcutaneous sensors to attach to a subject [Abstract] and [0009]; measure, based on output of the one or more subcutaneous sensors, at least one biometric parameter associated with the subject [0009];
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate subcutaneous sensors as taught by Garza to monitor biometric parameters as suggested by Sandgaard, as Sandgaard discusses the use of sensors for monitoring being invasive and noninvasive [0099] with Garza because Garza teaches the clinical need for effective and minimally invasive methods to monitor and track blood pressure [0007].
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandgaard (U.S. 20220202350) in view of Garza (U.S. 20220022844) and in further view of Sverdlik (U.S. 20140012133).
Regarding Claim 4, Sandgaard teaches wherein:
comprise an optical sensor [0024]—reference to optical sensor, an ultrasound sensor, or both; Sandgaard is silent on the one or more subcutaneous sensors. Garza teaches the one or more subcutaneous sensors [Abstract] and [0009].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate subcutaneous sensors as taught by Garza to monitor biometric parameters as suggested by Sandgaard, as Sandgaard discusses the use of sensors for monitoring being invasive and noninvasive [0099] with Garza because Garza teaches the clinical need for effective and minimally invasive methods to monitor and track blood pressure [0007].
Sandgaard and Garza are silent on and the at least one biometric parameter comprises: a diameter associated with an anatomical element of the subject, a flow through the anatomical element, or both; or a pulse wave velocity value associated with the anatomical element. Sverdlik teaches and the at least one biometric parameter comprises: a diameter associated with an anatomical element of the subject [0005]—measure a diameter of the renal artery, a flow through the anatomical element [0004]—tracking arterial blood flow rate, or both; or a pulse wave velocity value associated with the anatomical element [0005]—pulse wave velocity of the renal artery.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use diameter, flow and pulse wave velocity measurements as taught by Sverdlik to measure and monitor biometric parameters as suggested by Sandgaard and Garza, as Sandgaard discusses measuring plurality of physiological parameters indicative of sepsis and Garza which discloses the sensor collecting vital signs such as blood flow [0070] with Sverdlik because Sverdlik teaches monitoring arterial stiffness to prevent hypertension, assess kidney function and determine correlations between blood pressure and kidney regulation [0078].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandgaard (U.S. 20220202350) in view of Kommala (U.S. 20180353670).
Regarding Claim 8, Sandgaard teaches wherein the at least one biometric parameter comprises at least one of:
a pulse shape, a heart rate, blood volume, a flow rate, a pressure, or a combination thereof in association with an anatomical element of the subject [0073] and [0090]; Sandgaard and Garza are silent on and a first marker of a kidney function associated with the blood pressure of the subject, a second marker of a thyroid function associated with the blood pressure, or a combination thereof.
Kommala teaches and a first marker of a kidney function associated with the blood pressure of the subject, a second marker of a thyroid function associated with the blood pressure, or a combination thereof [0021]—reference to the use of glomerular filtration rate associated with blood pressure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to correlate blood pressure and physiological data with that of kidney function data based on control and previous data as taught by Kommala to measure and monitor biometric parameters as suggested by Sandgaard and Garza, as Sandgaard discusses monitoring patients for life-threatening organ dysfunction [0057] and Garza which discloses the use of long-term monitoring systems [0043] with Kommala because Kommala teaches implementing a control variable when signs of kidney dysfunction are detected [0021].
Response to Arguments
Applicant's arguments filed 8 June 2026 with respect to the claim objections have been fully considered and are persuasive in light of the amendments.
Applicant's arguments filed 8 June 2026 with respect to 35 U.S.C. 112(b)
rejections have been fully considered and are persuasive however, new rejections are
presented in light of the amendments for claim 12.
Applicant's arguments filed 8 June 2026 with respect to 35 U.S.C. 101
rejections have been fully considered but are not persuasive. Applicant contends that the amendment to recite steps "determine values of one or more control parameters indicative of the subject's blood pressure based on the measured at least one biometric parameter," and "perform a control measure to change the subject's blood pressure based on a comparison of the values of the one or more control parameters to a threshold." The examiner maintains the previous rejection in light of the amendments for the following reasons:
The steps reciting determining and changing a blood pressure are vaguely recited and do not address a particular treatment or prophylaxis for a medical condition. While changing blood pressure does provide direction as to the control measure, it does not address treatment.
The additional elements are still held to be conventional, well-known and routine according to Gottesman et al. U.S. 20060122864. While subcutaneous sensors are specifying a particular type of application of a sensor, these sensors are still held to be conventional, well-known and routine to one of ordinary skill in the art.
Further, the examiner acknowledges that claims 10 and 11 recite outputting control signals to deliver therapy by outputting a notification indicating one or more actions associated with treating a medical condition, and selecting a mode of a device with a list of devices recited. The limitations in claim 10 are broadly recited and do not indicate a particular treatment method or treatment of a medical condition. Selecting a mode of a device is akin to making a decision based on treatment parameters for devices that are well-known, conventional and routine according to Gottesman et al. U.S. 20060122864.
In view of the foregoing, the rejection of claims 1-20 under 35 U.S.C. 101 is maintained.
Applicant’s arguments filed 8 June 2026 with respect to the rejection of
Claims 1-3, 5, 6, and 9-20 under 35 U.S.C.102(a)(1) have been fully considered but are not persuasive. Regarding Claims 1, 19 and 20, applicant contends that Sandgaard does not teach “subcutaneous sensors” and “indicative of the subject’s blood pressure.” The examiner agrees with the assertion that subcutaneous sensors are not taught by Sandgaard however, the reference does teach monitoring via sensors for the purpose of indicating a subject’s blood pressure. Garza teaches limitations regarding subcutaneous blood pressure monitoring.
New rejections are presented above in light of the amendments for claims 1, 2, 3, 5, 6, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 under 35 U.S.C. 103 citing Sandgaard in view of Garza, for claim 4 citing Sandgaard in view of Garza and in further view of Sverdlik and for claim 8 citing Sandgaard in view of Garza and in further view of Kommala.
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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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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