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
In response to the amendment filed 12/11/2025; claims 1-8, 10-18 and 20 are pending; claims 9 and 19 have been cancelled.
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 1-8, 10-18 and 20 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.
Claims 1, 11 and 20 recites “identifying an oscillation pattern in the heart rate signal and a frequency in the oscillation pattern … determining a start time of an action exercise … with an incline in the oscillation pattern of the heart rate signal”. The following paragraphs are the only citation related oscillation of a heart rate: i.e.,
[0012] In some aspects, the techniques described herein relate to a computer-implemented method, further including: for at least one state: identifying a frequency in oscillation of the heart rate signal; and determining a start time of an exercise based on the frequency in the oscillation of the heart rate signal to align the exercise with an incline in the heart rate signal.
[0022] In some aspects, the techniques described herein relate to a non-transitory computer-readable storage medium, the operations further including: for at least one state: identifying a frequency in oscillation of the heart rate signal; and determining a start time of an exercise based on the frequency in the oscillation of the heart rate signal to align the exercise with an incline in the heart rate signal.
However, there is no mention of identifying an oscillation pattern of heart rate signal and determining a start time with an incline in the oscillation pattern of the heart rate signal. The office requests that Applicant to cite relevant paragraphs to support the newly added limitations.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 – 6, 10 – 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sohne et al. (US 2020/0035337 A1) in view of Osorio (US 2022/0176124 A1).
Re claims 1, 11, 20:
Sohne teaches 1. A computer-implemented method (Sohne, [0052]) comprising:
initializing, via a client device, an autonomic nervous system (ANS) regulation program (Sohne, Abstract; [0007]; [0015]) comprising a state model comprising a plurality of states (Sohne, [0118], “sub emotion states upset, stressed and tense”; figs. 15 - 18), wherein each state includes one or more criteria for transitioning to another state of the plurality of states (Sohne, figs. 15 – 18; [0141] – [0168]; pg. 19, claim 14, “determining an emotional state value by determining a change of the state value over a time with a state threshold value”);
obtaining a heart rate signal, via one or more health sensors wirelessly coupled to the client device during the ANS regulation program (Sohne, [0003]; [0112], “For example logged are the HR, HRV, flow state value, activity, gps, video, photo, sound, etc. to capture the moment. Current (such as wearable) devices have or could have a lot of sensors on board”); and
for each state of the state model (Sohne, figs. 15 - 18):
prompting, via the client device, a user of the client device to perform one or more actions to regulate an ANS of the user (Sohne, [0138], “Proposed is to use the (for example flow) state value and a pre-determined or adaptable sequence of activities within a specific training, professional, medical, leisure or any field for example biking, swimming, fitness, work process, leisure, dating, treatment in which the user acts”; i.e., [0160], “If HR long<96 AND flow<2500 then Advice=“Deep breath, hold, tighten muscles 10 seconds, then relax””; i.e., [0158], “If HR long>60 AND flow>3000 then Advice="Sport/work/hobby ready"”),
determining whether the heart rate signal obtained during the one or more actions for the state satisfy the one or more criteria for the state (Sohne, [0131], “determine specific advice based upon the real time heart rate frequency value and real time hear rate variability value to optimize peak flow”; [0132], “Care must be taken before advising taking a cold shower whether the health of the user is high enough to be able to advice this; so advices are given based upon for example a specific thresholds with respect to HR/HRV ratio over a longer period of time and/or depending on the flow level”), and responsive to determining that the one or more criteria are satisfied, transitioning to another state of the plurality of states (Sohne, fig. 25; figs. 15 – 18 shows different criteria from different mental states; [0076], “FIG. 25 illustrates a trigger level for which above the trigger will initialize users behavior change”; [0131], “the ratio average flow value over time is an important factor which should be above a certain threshold to keep the body & mind in a healthy state”).
11. A non-transitory computer-readable storage medium storing instructions that, when executed by a computer processor, cause the computer processor to perform operations (Sohne, [0052]) comprising:
initializing, via a client device, an autonomic nervous system (ANS) regulation program (Sohne, Abstract; [0007]; [0015]) comprising a state model comprising a plurality of states (Sohne, [0118], “sub emotion states upset, stressed and tense”; figs. 15 - 18), wherein each state includes one or more criteria for transitioning to another state of the plurality of states (Sohne, figs. 15 – 18; [0141] – [0168]; pg. 19, claim 14, “determining an emotional state value by determining a change of the state value over a time with a state threshold value”);
obtaining a heart rate signal, via one or more health sensors wirelessly coupled to the client device during the ANS regulation program (Sohne, [0003]; [0112], “For example logged are the HR, HRV, flow state value, activity, gps, video, photo, sound, etc. to capture the moment. Current (such as wearable) devices have or could have a lot of sensors on board”); and
for each state of the state model (Sohne, figs. 15 - 18):
prompting, via the client device, a user of the client device to perform one or more actions to regulate an ANS of the user (Sohne, [0138], “Proposed is to use the (for example flow) state value and a pre-determined or adaptable sequence of activities within a specific training, professional, medical, leisure or any field for example biking, swimming, fitness, work process, leisure, dating, treatment in which the user acts”; i.e., [0160], “If HR long<96 AND flow<2500 then Advice=“Deep breath, hold, tighten muscles 10 seconds, then relax””; i.e., [0158], “If HR long>60 AND flow>3000 then Advice="Sport/work/hobby ready"”),
determining whether the heart rate signal obtained during the one or more actions for the state satisfy the one or more criteria for the state (Sohne, [0131], “determine specific advice based upon the real time heart rate frequency value and real time hear rate variability value to optimize peak flow”; [0132], “Care must be taken before advising taking a cold shower whether the health of the user is high enough to be able to advice this; so advices are given based upon for example a specific thresholds with respect to HR/HRV ratio over a longer period of time and/or depending on the flow level”), and
responsive to determining that the one or more criteria are satisfied, transitioning to another state of the plurality of states (Sohne, fig. 25; figs. 15 – 18 shows different criteria from different mental states; [0076], “FIG. 25 illustrates a trigger level for which above the trigger will initialize users behavior change”; [0131], “the ratio average flow value over time is an important factor which should be above a certain threshold to keep the body & mind in a healthy state”).
20. A system (Sohne, [0052]) comprising:
a computer processor; and a non-transitory computer-readable storage medium storing instructions that, when executed by the computer processor, cause the computer processor to perform operations (Sohne, [0052]) comprising:
initializing, via a client device, an autonomic nervous system (ANS) regulation program (Sohne, Abstract; [0007]; [0015]) comprising a state model comprising a plurality of states (Sohne, [0118], “sub emotion states upset, stressed and tense”; figs. 15 - 18),
wherein each state includes one or more criteria for transitioning to another state of the plurality of states (Sohne, figs. 15 – 18; [0141] – [0168]; pg. 19, claim 14, “determining an emotional state value by determining a change of the state value over a time with a state threshold value”);
obtaining a heart rate signal, via one or more health sensors wirelessly coupled to the client device during the ANS regulation program (Sohne, [0003]; [0112], “For example logged are the HR, HRV, flow state value, activity, gps, video, photo, sound, etc. to capture the moment. Current (such as wearable) devices have or could have a lot of sensors on board”);
identifying an oscillation pattern in the heart rate signal and a frequency in the oscillation pattern; and
for each state of the state model (Sohne, figs. 15 - 18):
prompting, via the client device, a user of the client device to perform one or more actions to regulate an ANS of the user (Sohne, [0138], “Proposed is to use the (for example flow) state value and a pre-determined or adaptable sequence of activities within a specific training, professional, medical, leisure or any field for example biking, swimming, fitness, work process, leisure, dating, treatment in which the user acts”; i.e., [0160], “If HR long<96 AND flow<2500 then Advice=“Deep breath, hold, tighten muscles 10 seconds, then relax””; i.e., [0158], “If HR long>60 AND flow>3000 then Advice="Sport/work/hobby ready"”),
determining whether the heart rate signal obtained during the one or more actions for the state satisfy the one or more criteria for the state (Sohne, [0131], “determine specific advice based upon the real time heart rate frequency value and real time hear rate variability value to optimize peak flow”; [0132], “Care must be taken before advising taking a cold shower whether the health of the user is high enough to be able to advice this; so advices are given based upon for example a specific thresholds with respect to HR/HRV ratio over a longer period of time and/or depending on the flow level”), and
responsive to determining that the one or more criteria are satisfied, transitioning to another state of the plurality of states (Sohne, fig. 25; figs. 15 – 18 shows different criteria from different mental states; [0076], “FIG. 25 illustrates a trigger level for which above the trigger will initialize users behavior change”; [0131], “the ratio average flow value over time is an important factor which should be above a certain threshold to keep the body & mind in a healthy state”).
Sohne teaches criteria for transition between mental states wherein the criteria are HR and HRV (figs. 15 – 18). Sohne does not explicitly disclose
identifying an oscillation pattern in the heart rate signal and a frequency in the oscillation pattern; and
for at least one state:
determining a start time of an action based on the frequency in the oscillation of the heart rate signal to align the action with an incline in the oscillation pattern of the heart rate signal; and
prompting, via one or more graphical elements in a user interface presented on an electronic display of the client device, the user to perform the action at the start time to align the action with the incline in the oscillation pattern of the heart rate signal.
Osorio (US 2022/0176124 A1) teaches methods, apparatus, and systems for performing vagus nerve stimulation (VNS) (Osorio, Abstract). Osorio teaches identifying an oscillation pattern in the heart rate signal and a frequency in the oscillation pattern (Osorio, fig. 11 - 15); and
for at least one state:
determining a start time of an action based on the frequency in the oscillation of the heart rate signal to align the action with an incline in the oscillation pattern of the heart rate signal (Osorio, [0342], “a dysfunction of the patient's autonomic nervous system”; [0350], “oscillations at two frequencies (e.g., slow and fast) or more than two frequencies (e.g., very fast, slow, and very slow) may overlap to form a pattern that is commonly associated with a circumictal period”; figs. 11 – 15; fig. 12 shows a stimulation / therapy trigger while the heart rate is in an upward trend; fig. 14, A1 – 1404, “A1, A2 … System alerted and ready to trigger Stimulation / Therapy”, “B1, B2 … Stop Stimulation / Therapy”); and
prompting, via one or more graphical elements in a user interface presented on an electronic display of the client device, the user to perform the action at the start time to align the action with the incline in the oscillation pattern of the heart rate signal (Osorio, [0342], “a dysfunction of the patient's autonomic nervous system”; [0350], “oscillations at two frequencies (e.g., slow and fast) or more than two frequencies (e.g., very fast, slow, and very slow) may overlap to form a pattern that is commonly associated with a circumictal period”; figs. 11 – 15; fig. 12 shows a stimulation / therapy trigger while the heart rate is in an upward trend; fig. 14, A1 – 1404, “A1, A2 … System alerted and ready to trigger Stimulation / Therapy”, “B1, B2 … Stop Stimulation / Therapy”; [0396], “A state change warning may be given as, for example, a warning tone or light, vibration, pressure, or scent implemented by a medical device or a device adapted to receive indications of the state change; as an automated email, text message, telephone call, or video message sent from a medical device or a unit in communication with a medical device to the patient's cellular telephone, PDA, computer, television, 911 or another emergency contact number for paramedic/EMT services”; [0442]).
Therefore, in view of Osorio, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method/system described in Sohne, by providing heart rate oscillations and providing threshold as taught by Osorio, since different nerve
fiber types (e.g., A, B, and C-fibers that may be targeted) respond differently to stimulation from electrical signals because they have different stimulation thresholds (or different trigger heart rate) (Osorio, [0094]).
Re claims 2, 12:
2. The computer-implemented method of claim 1,
wherein initializing the ANS regulation program comprises presenting, via the client device, the user interface on the electronic display of the client device (Sohne, [0111], “Or giving advice (step S8) to the user in the case of trespassing the low threshold about what to do to solve the worse state quickly for example by indicating that the user should "relax" or "change activity", or take a "deep breath out" by for example words, sounds or pictures, or a video”; [0204]; fig. 21; [0193]).
12. The non-transitory computer-readable storage medium of claim 11,
wherein initializing the ANS regulation program comprises presenting, via the client device, the user interface on the electronic display of the client device (Sohne, [0111], “Or giving advice (step S8) to the user in the case of trespassing the low threshold about what to do to solve the worse state quickly for example by indicating that the user should "relax" or "change activity", or take a "deep breath out" by for example words, sounds or pictures, or a video”; [0204]; fig. 21; [0193]).
Re claims 3, 13:
3. The computer-implemented method of claim 1,
wherein determining whether the heart rate signal obtained during the one or more actions for the state satisfy the one or more criteria for the state (Sohne, [0131], “determine specific advice based upon the real time heart rate frequency value and real time hear rate variability value to optimize peak flow”; [0132], “Care must be taken before advising taking a cold shower whether the health of the user is high enough to be able to advice this; so advices are given based upon for example a specific thresholds with respect to HR/HRV ratio over a longer period of time and/or depending on the flow level”) comprises:
determining whether the heart rate signal reaches a target heart rate for the one or more actions (Sohne, [0160], “If HR long<96 AND flow<2500 then Advice=“Deep breath, hold, tighten muscles 10 seconds, then relax””; i.e., [0158], “If HR long>60 AND flow>3000 then Advice="Sport/work/hobby ready"”); and prompting, via the client device, the user to end the one or more actions (Sohne, [0111]; [0204]; fig. 21; [0193], “local or the (cloud) remote user interface”).
13. The non-transitory computer-readable storage medium of claim 11,
wherein determining whether the heart rate signal obtained during the one or more actions for the state satisfy the one or more criteria for the state (Sohne, [0131], “determine specific advice based upon the real time heart rate frequency value and real time hear rate variability value to optimize peak flow”; [0132], “Care must be taken before advising taking a cold shower whether the health of the user is high enough to be able to advice this; so advices are given based upon for example a specific thresholds with respect to HR/HRV ratio over a longer period of time and/or depending on the flow level”) comprises:
determining whether the heart rate signal reaches a target heart rate for the one or more actions (Sohne, [0160], “If HR long<96 AND flow<2500 then Advice=“Deep breath, hold, tighten muscles 10 seconds, then relax””; i.e., [0158], “If HR long>60 AND flow>3000 then Advice="Sport/work/hobby ready"”); and prompting, via the client device, the user to end the one or more actions (Sohne, [0111]; [0204]; fig. 21; [0193], “local or the (cloud) remote user interface”).
Re claims 4, 14:
4. The computer-implemented method of claim 3,
wherein determining whether the heart rate signal obtained during the one or more actions for the state satisfy the one or more criteria for the state (Sohne, [0131], “determine specific advice based upon the real time heart rate frequency value and real time hear rate variability value to optimize peak flow”; [0132], “Care must be taken before advising taking a cold shower whether the health of the user is high enough to be able to advice this; so advices are given based upon for example a specific thresholds with respect to HR/HRV ratio over a longer period of time and/or depending on the flow level”) comprises:
determining whether the heart rate signal reaches a recovery level, following prompting of the user to end the one or more actions (Sohne, [0138], “Based upon these states advice is given to the user to go for example for a walk to reach for a higher level of flow (indicated by colors; higher level of flow is more green for example)”; [0186], “generating real time advice and indicates when and only then to make decisions when a threshold flow level is surpassed or certain HR and HRV combinations are reached”; [0211], “The user is asked to undertake sport until the flow drops below a certain threshold”; pg. 19, claim 21).
14. The non-transitory computer-readable storage medium of claim 13,
wherein determining whether the heart rate signal obtained during the one or more actions for the state satisfy the one or more criteria for the state (Sohne, [0131], “determine specific advice based upon the real time heart rate frequency value and real time hear rate variability value to optimize peak flow”; [0132], “Care must be taken before advising taking a cold shower whether the health of the user is high enough to be able to advice this; so advices are given based upon for example a specific thresholds with respect to HR/HRV ratio over a longer period of time and/or depending on the flow level”) comprises:
determining whether the heart rate signal reaches a recovery level, following prompting of the user to end the one or more actions (Sohne, [0138], “Based upon these states advice is given to the user to go for example for a walk to reach for a higher level of flow (indicated by colors; higher level of flow is more green for example)”; [0186], “generating real time advice and indicates when and only then to make decisions when a threshold flow level is surpassed or certain HR and HRV combinations are reached”; [0211], “The user is asked to undertake sport until the flow drops below a certain threshold”; pg. 19, claim 21; [0138]).
Re claims 5, 15:
5. The computer-implemented method of claim 1, wherein obtaining the heart rate signal comprises one or both of:
obtaining the heart rate signal from a heart rate monitor coupled to the user (Sohne, [0112]; [0052]); and
calculating the heart rate signal from R-R intervals of an electrocardiogram signal obtained from a electrocardiogram monitor (Sohne, [0019]; [0063]; [0008]).
15. The non-transitory computer-readable storage medium of claim 11, wherein obtaining the heart rate signal comprises one or both of:
obtaining the heart rate signal from a heart rate monitor coupled to the user (Sohne, [0112]; [0052]); and
calculating the heart rate signal from R-R intervals of an electrocardiogram signal obtained from a electrocardiogram monitor (Sohne, [0019]; [0063]; [0008]).
Re claims 6, 16:
6. The computer-implemented method of claim 1, further comprising:
for an initial state of the state model, determining whether a physiological state of the user is stable based on the heart rate signal (Sohne, [0097]; [0098], “The (for example flow) state threshold value is initialized”; [0212], “flow baseline”).
16. The non-transitory computer-readable storage medium of claim 11, the operations further comprising:
for an initial state of the state model, determining whether a physiological state of the user is stable based on the heart rate signal (Sohne, [0097]; [0098], “The (for example flow) state threshold value is initialized”; [0212], “flow baseline”).
Re claim 10:
10. The computer-implemented method of claim 1, further comprising:
for each state of the state model: responsive to determining that the one or more criteria are not satisfied, continuing the state (Sohne, [0138], “Based upon these states advice is given to the user to go for example for a walk to reach for a higher level of flow (indicated by colors; higher level of flow is more green for example)”; [0186], “generating real time advice and indicates when and only then to make decisions when a threshold flow level is surpassed or certain HR and HRV combinations are reached”; [0211], “The user is asked to undertake sport until the flow drops below a certain threshold”; pg. 19, claim 21; [0138]).
Claim 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sohne et al. (US 2020/0035337 A1) in view of Osorio (US 2022/0176124 A1) as applied to claims 6 and 16 above, and further in view of Markowitz et al. (US 2003/0139780 A1).
Re claims 7, 17:
Sohne does not explicitly disclose calculating a slope of the heart rate signal over a past window of time. Markowitz teaches methods and apparatus for detection and treatment of syncope in an implantable medical device, and particularly to detection of syncope as a function of a predetermined increase in one or more respiration parameter and drop in heart rate and optionally delivering a pacing therapy in response thereto. Markowitz teaches the missing features: 7. The computer-implemented method of claim 6, wherein determining whether the physiological state of the user is stable comprises: calculating a slope of the heart rate signal over a past window of time; and determining whether the slope of the heart rate signal is within a tolerance of a zero slope. 17. The non-transitory computer-readable storage medium of claim 16, wherein determining whether the physiological state of the user is stable comprises: calculating a slope of the heart rate signal over a past window of time; and determining whether the slope of the heart rate signal is within a tolerance of a zero slope (Markowitz, [0058] – [0062]; [0058], “a predetermined window length to develop a current HR slope or rate of change”). Therefore, in view of Markowitz, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method/system described in Sohne, by providing the HR threshold slope as taught by Markowitz, since the heart rate slope can be used to prescribe an intervention therapy (Markowitz, [0061], “pacing following a first prescribed syncope therapy rate format is initiated for a prescribed syncope pacing time when the above-described respiration parameter(s) satisfies threshold respiration criteria heart rate HR drops below the HR threshold slope or rate of change”)
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Sohne et al. (US 2020/0035337 A1) in view of Osorio (US 2022/0176124 A1) as applied to claims 6 and 16 above, and further in view of Salo (US 5312452 A).
Re claims 8, 18:
Sohne does not explicitly disclose a heart rate magnitude between max and min value. Salo teaches a dual chamber cardiac pacemaker incorporating a microprocessor-based controller which is programmed to automatically establish an A-V interval at a value which provides optimum cardiac function (Salo, Abstract). Salo teaches 8. The computer-implemented method of claim 6, wherein determining whether the physiological state of the user is stable comprises: calculating a spread of the heart rate signal over a past window of time as a difference between a maximum value and a minimum value in the past window of time; and determining whether the spread of the heart rate signal is within a threshold spread. 18. The non-transitory computer-readable storage medium of claim 16, wherein determining whether the physiological state of the user is stable comprises: calculating a spread of the heart rate signal over a past window of time as a difference between a maximum value and a minimum value in the past window of time; and determining whether the spread of the heart rate signal is within a threshold spread (Salo, col. 5, lines 3 – 16, “For example, by monitoring the maximum and minimum heart rates during a day or by generating a histogram of heart rates, the heart rate threshold can be set at a value that is a predetermined number of beats-per-minute above the minimum heart rate and the variability threshold can be set at a percentage of the difference between maximum and minimum heart rates and/or the variability of the heart rate”; col. 2, lines 46 – 61, “the heart rate is determined to be stable and when variations in the heart rate are determined to be below a predetermined threshold”). Therefore, in view of Salo, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method and system described in Sohne,, by determining the heart rate stability based on heart rate variability as taught by Salo, so that the system can halt the intervention (stimulation) when the heart rate becomes steady.
Response to Arguments
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive.
Applicant argues:
In turn, the Office Action relies on Osorio as teaching this element. At the cited portion, Osorio discloses: "In another example, the oscillation does not matter whether the heart rate change is in an increasing direction or a decreasing direction. In various examples, the systems, devices, and/or method may reduce an amplitude of change (e.g., damping the change in heart rate) to enhance system performance and/or to reduce side effects. In addition, the determination of one or more side effects may initiate a reduction in therapy, a stoppage of therapy, a modification of therapy (e.g., changing a therapy that reduces heart rate to another therapy that increases heart rate), one or more warnings, and/or one or more logging of data." Osorio, ¶ [0248]. Here, Osorio is overviewing how a therapy is adapted to heart rate change. This portion describes modifying a therapy in response to heart rate changes, though fails to describe details on how the therapy is being modified … Here, Osorio describes determining heart rate oscillation, and determining a triggering event when the heart rate oscillation hits a threshold value. It's unclear the metrics of the threshold value, but contextually seems to refer to the frequency of the oscillation. Alas, if the frequency hits the threshold value, the triggering condition is met.
Referring to applicant’s own specification for “oscillating heart rate” on para. [0012] and [0022] in published application,
[0012] In some aspects, the techniques described herein relate to a computer-implemented method, further including: for at least one state: identifying a frequency in oscillation of the heart rate signal; and determining a start time of an exercise based on the frequency in the oscillation of the heart rate signal to align the exercise with an incline in the heart rate signal.
[0022] In some aspects, the techniques described herein relate to a non-transitory computer-readable storage medium, the operations further including: for at least one state: identifying a frequency in oscillation of the heart rate signal; and determining a start time of an exercise based on the frequency in the oscillation of the heart rate signal to align the exercise with an incline in the heart rate signal.
The Applicant’s specification does not clearly outline how to identify oscillation patterns or specify what types of oscillation patterns the system is intended to detect. The examiner requests the applicant to cite relevant paragraphs from the original specification to support these limitations.
According to MPEP 2111 [R-5], during patent examination, the pending claims must be “given their broadest reasonable interpretation consistent with the specification.” The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005) expressly recognized that the USPTO employs the “broadest reasonable interpretation” standard. Osorio explicitly recite having “heart rate oscillation occur every 2-3 seconds is much more serious than every 1-2 hours. In one example, one benefit may be that the window to act is lengthen which can save lives. In one embodiment, a system for treating a medical condition in a patient includes: a sensor for sensing at least one body data stream; a heart rate unit which determines a heart rate and a heart rate oscillation of the patient based on the at least one body data stream; and a logic unit which compares via one or more processors a monitored value which is determined based on one or more data points relating to the heart rate and to the heart rate oscillation to a threshold value …” Based on the BRI, Osorio’s heart rate oscillation in an increasing direction or the trigger condition (i.e., 120bpm) is part of the oscillation pattern. The triggering threshold heart rate oscillation meets the BRI interpretation of “determining a start time of an action based on the frequency in the oscillation of the heart rate signal to align the action with an incline in the oscillation pattern of the heart rate signal”.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACK YIP whose telephone number is (571)270-5048. The examiner can normally be reached Monday thru Friday; 9:00 AM - 5:00 PM EST.
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, XUAN THAI can be reached at (571) 272-7147. 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.
/JACK YIP/Primary Examiner, Art Unit 3715