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 Arguments
Applicant's arguments filed August 14, 2026 have been fully considered but they are considered moot in light of the new ground of rejection, necessitated by amendment, presented below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 7-15, 17 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Muessig et al. (US 2007/0265667 A1) in view Koh et al. (US 7,310,551).
Muessig et al. discloses a device (external portable device, depicted in Figure 2) comprising: a memory (Figure 2); and processing circuitry (microprocessor, Figure 2) coupled to the memory (Figure 2) and configured to: receive, from an implantable medical device (IMD) implanted in a patient (implant communication unit, Figure 2), an indication that the IMD has detected an arrhythmia in the patient ([0086]; Figure 3); generate an output indicating that the IMD has detected the arrhythmia ([0086]; Figure 3); receive, via an external device, an input from a user of the external device (input control unit in Figure 2; [0085]; Figure 3); and in response to the input from the user, transmit to the IMD a command to cause the IMD to modify a therapy plan determined by the IMD ([0085, 0088, 0090]; “Upon reception of the warning trigger signal, the external device will put out a warning message and activate an AF delay button which enables a patient to delay or delete a scheduled atrial fibrillation therapy” [0090]; Figure 3).
As to claim 1, Muessig et al. discloses the invention substantially as claimed with detecting an arrhythmia in the patient, but does not explicitly disclose “generate an output in response to receiving the indication that the IMD has detected the arrhythmia in the patient and in response to determining that the activity level of the patient is at or above a specified level”. Koh et al. discloses “microcontroller 220 is also equipped with multiple detectors 234 used to detect or compute parameters indicative, suggestive, or predictive of heart failure (HF). Examples of HF parameter detectors 234 include an arrhythmia detector to detect arrhythmia parameters, a morphology detector to detect morphological parameters, impedance circuitry to detect DC impedance (e.g., transthoracic impedance), activity sensor to detect activity and activity duration, posture sensors to sense posture or patient position, exercise compliance monitor to evaluate exercise compliance, heart rate detectors to detect heart rate and heart rate variability, pressure sensors to detect pressure, cardiac output sensors, and so forth. It is noted that these detectors are examples and others types of detectors may be employed. Essentially, the microcontroller 220 may implement any detector that produces a parameter that may be used alone or in combination with another to predict or diagnose heart failure” (col. 5, lines 23-39) and “the activity signal alone can be used to indicate whether a patient is active or resting. The activity measurement can further be used to determine an activity variance parameter. A large activity variance signal is indicative of a prolonged exercise state. Low activity and activity variance signals are indicative of a prolonged resting state. The activity variance can be monitored diurnally to detect the low variance in the measurement corresponding to the sleep state” (col. 8, lines 28- col. 9, line 3). Therefore, Koh et al. discloses determining an activity level of the patient (col. 8, lines 28- col. 9, line 3) and detecting arrhythmia and activity level (col. 5, lines 23-39) and when the activity is at or above a specified level (col. 8, lines 28- col. 9, line 3). when determining arrythmia determinations. As such, verifying a patient is exercising or resting would ensure that therapy is not inappropriately applied. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify sensed data and analyzed data of Muessig et al. to incorporate a means of collecting and analyzing patient activity or exercise as disclosed by Koh et al. so as to not provide therapy during an exercise induced arrhythmia in order to provide the predictable results modifying the treatment to meet specific patient therapeutic needs and requirements and not subject the patient to unnecessary therapy.
As to claim 2, the modified Muessig et al. discloses the input comprises a request by the user to delay receiving defibrillation therapy from the IMD ([0090]; Figure 3).
As to claim 3, the modified Muessig et al. discloses the input comprises a request by the user to expedite receiving defibrillation therapy from the IMD ([0100]).
As to claim 7, the modified Muessig et al. discloses in Figure 3, a therapy plan that includes delivering ATP (anti tachycardia pacing) prior to administering defibrillation. In the event the patient presses the delay button, the patient command modifies the therapy plan for the IMD to only provide pacing without providing defibrillation therapy until the delay expires. “Alternatively, patient may opt to cancel the schedule atrial therapy by setting an extremely long therapy delay”([0094]). Therefore, the modified Muessig et al. discloses the therapy plan includes delivering defibrillation therapy (Figure 3), and the command causes the IMD to modify the therapy plan to include pacing therapy instead of the defibrillation therapy ([0094]).
As to claim 8, the modified Muessig et al. discloses the therapy plan includes delivering defibrillation therapy at a first time, and the command causes the IMD to modify the therapy plan to deliver the defibrillation therapy at a second time that is later than the first time (Figure 3; “Upon reception of the warning trigger signal, the external device will put out a warning message and activate an AF delay button which enables a patient to delay or delete a scheduled atrial fibrillation therapy” [0090]; the delivery of therapy can be delayed from a first planned time when the “AF therapy delay button” is activated. Therefore the defibrillation therapy is delivered at a second time that is later than a first time).
As to claim 9, the modified Muessig et al. discloses the processing circuitry is configured to: in response to receiving the indication that the IMD has detected the arrhythmia in the patient, establish a secure telemetry session with the IMD (Figure 3; [0083-0085]).
As to claim 10, the modified Muessig et al. discloses a system (Figures 1-2) comprising: an implantable medical device (IMD) configured to detect an arrhythmia in a patient ([0086]; Figure 3); and an external device (external portable device, depicted in Figure 2) comprising processing circuitry (microprocessor, Figure 2) and configured to: receive from the IMD an indication that the IMD has detected the arrhythmia in the patient ([0086]; Figure 3); generate an output indicating that the IMD has detected the arrhythmia ([0086]; Figure 3); receive an input from a user (input control unit in Figure 2; [0086]; Figure 3); and in response to the input from the user, transmitting to the IMD a command to cause the IMD to modify a therapy plan determined by the IMD ([0085, 0088, 0090]; “Upon reception of the warning trigger signal, the external device will put out a warning message and activate an AF delay button which enables a patient to delay or delete a scheduled atrial fibrillation therapy” [0090]; Figure 3).
As to claim 11, the modified Muessig et al. discloses the input comprises one of a request by the user to delay receiving defibrillation therapy from the IMD ([0090]; Figure 3) or a request by the user to expedite receiving defibrillation therapy from the IMD ([0100]).
As to claim 12, the modified Muessig et al. discloses the processing circuitry is further configured to apply the modified therapy plan to a subsequent arrhythmia following the detected arrhythmia ([0093]).
As to claim 13, the modified Muessig et al. discloses receiving, at an external device from an implantable medical device (IMD) implanted in a patient, an indication that the IMD has detected an arrhythmia in the patient ([0086]; Figure 3); generating, by the external device, an output indicating that the IMD has detected the arrhythmia ([0086]; Figure 3); receiving, at the external device, an input from a user of the external device(input control unit in Figure 2; [0086]; Figure 3); and in response to the input from the user, transmitting, from the external device to the IMD, a command to cause the IMD to modify a therapy plan determined by the IMD ([0085, 0088, 0090]; “Upon reception of the warning trigger signal, the external device will put out a warning message and activate an AF delay button which enables a patient to delay or delete a scheduled atrial fibrillation therapy” [0090]; Figure 3).
As to claim 14, the modified Muessig et al. discloses the input comprises one of a request by the user to delay receiving defibrillation therapy from the IMD ([0090]; Figure 3) or a request by the user to expedite receiving defibrillation therapy from the IMD ([0100]).
As to claim 15, the modified Muessig et al. discloses the processing circuitry is further configured to apply the modified therapy plan to a subsequent arrhythmia following the detected arrhythmia ([0093]).
As to claim 17, the modified Muessig et al. discloses in Figure 3, a therapy plan that includes delivering ATP (anti tachycardia pacing) prior to administering defibrillation. In the event the patient presses the delay button, the patient command modifies the therapy plan for the IMD to only provide pacing without providing defibrillation therapy until the delay expires. “Alternatively, patient may opt to cancel the schedule atrial therapy by setting an extremely long therapy delay”([0094]). Therefore, Muessig et al. discloses the therapy plan includes delivering defibrillation therapy (Figure 3), and the command causes the IMD to modify the therapy plan to include pacing therapy instead of the defibrillation therapy ([0094]).
As to claim 19, the modified Muessig et al. discloses in Figure 3, a therapy plan that includes delivering ATP (anti tachycardia pacing) prior to administering defibrillation. In the event the patient presses the delay button, the patient command modifies the therapy plan for the IMD to only provide pacing without providing defibrillation therapy until the delay expires. “Alternatively, patient may opt to cancel the schedule atrial therapy by setting an extremely long therapy delay”([0094]). Therefore, Muessig et al. discloses the therapy plan includes delivering defibrillation therapy (Figure 3), and the command causes the IMD to modify the therapy plan to include pacing therapy instead of the defibrillation therapy ([0094]).
As to claim 20, the modified Muessig et al. discloses the therapy plan includes delivering defibrillation therapy at a first time, and the command causes the IMD to modify the therapy plan to deliver the defibrillation therapy at a second time that is later than the first time (Figure 3; “Upon reception of the warning trigger signal, the external device will put out a warning message and activate an AF delay button which enables a patient to delay or delete a scheduled atrial fibrillation therapy” [0090]; the delivery of therapy can be delayed from a first planned time when the “AF therapy delay button” is activated. Therefore, the defibrillation therapy is delivered at a second time that is later than a first time).
As to claim 21, the modified Muessig et al. discloses one or more accelerometers, and the IMD is configured to determine the activity level of the patient based on outputs of the one or more accelerometers (Koh et al., col. 8, lines 28- col. 9, line 3).
Claims 5-6, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over the modified Muessig et al., as applied to claims 1-3, 7-15, 17 and 19-21 above, in further view of Ideker et al. (US 2006/0155334 A1).
As to claim 5, the modified Muessig et al. discloses the invention substantially as claimed with receiving an in put for a user, but does not explicitly disclose the input comprises a confirmation from the user that the patient has taken a medication. Ideker et al. discloses “various treatment techniques for reducing discomfort and/or the defibrillation threshold can be combined with administering a therapeutic drug. For example, a shock pulse sequence and/or shock timing for reducing the blood in the atria at the time of defibrillation can be combined with the administration of one or more therapeutic drugs. A therapeutic drug can be administered at a time and in an amount effective to decrease the strength of the defibrillation shock required to treat fibrillation” ([0047]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the user input system of the modified Muessig et al. to include receiving confirmation from the user that the patient has taken a medication as disclosed by Ideker et al. in order to provide the predictable results of modifying treatment to meet specific patient therapeutic needs and requirements and verifying the defibrillation energy needed by the patient to provide appropriate treatment.
As to claims 6, 16 and 18, the modified Muessig et al. discloses the therapy plan delivers defibrillation therapy at a first voltage (in absence of verification of therapeutic drugs), and the command (input from the patient verifying the administration of therapeutic drugs; Ideker et al. [0047]) causes the IMD to modify the therapy plan to include delivering the defibrillation therapy at a second voltage different than the first voltage (Ideker et al., [0047]; “A therapeutic drug can be administered at a time and in an amount effective to decrease the strength of the defibrillation shock required to treat fibrillation” ([0047]). Therefore, the defibrillation strength or voltage applied to the patient is reduced to a second lower voltage after the input confirming the administration of therapeutic drugs.
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 ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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