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 .
Amendment
This action is in response to the Amendment filed on 1/23/2026.
Claims 1-13, 15,17 and 23-27 are pending.
Response to Arguments
Applicant's arguments with respect to claims 1-13, 15,17 and 23-17 have been fully considered but are moot in view of the new grounds of rejection as necessitated by the amendment.
Rejections under 35 U.S.C. 112
In view of the amendments, the rejection has been withdrawn.
Rejections under 35 U.S.C.102(a) - U.S. Patent 5,964,788 ("Greenhut").
Applicant’s arguments in view of the amendments and Greenhut’s teachings have been considered and are persuasive. Therefore, the rejection is withdrawn.
However, upon further search and consideration the claims are rejected as discussed in the current office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 26 and 27 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 26 and 27 recite limitations that are same as amended claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-13, 15,17 and 23-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cho et al (U.S. Patent application Publication Number: US 2012/0290032 A, hereinafter “Cho”).
Regarding claims 1 and 24-27, Cho teaches a controller for a pacing device (e.g. Fig.1, Figs. 6, 7,9, [0042]), a method for providing a pacing signal for pacing a heart of a patient and a computer program product storing executable instructions for performing the method configured to:
receive sensor data comprising respiratory data (e.g. [0030], [0037]);
determine a respiratory sinus arrhythmia, RSA, factor of a pacing signal for inducing RSA in a patient based on the sensor data, wherein the RSA factor comprises one or more parameters of the pacing signal which provide a heart rate which is higher during an inspiration portion of a respiratory cycle than during an expiration portion of the respiratory cycle (e.g. 300 Figs. 6,7, 9 [0037]);
determine a cardio-respiratory phase synchronisation, CRPS, factor of the pacing signal for inducing CRPS in the patient based on the sensor data, wherein the CRPS factor comprises one or more parameters (i.e. pacing rate) of the pacing signal which provide heartbeat pulses with respiratory phase values that repeat over an integer number of respiratory cycles (e.g. N and M cardiac cycles 304,306 Figs. 6, 7, 9); and
provide the pacing signal for pacing a heart of a patient in accordance with the RSA factor and the CRPS factor (e.g. [0039]: IMD may provide cardiac pacing based on the phase of respiration (e.g., inhalation or exhalation) as detected by the IMD, [0049]: IMD 106 may modulate the cardiac pacing rate based on at least one of the detected breathing rate of patient 104 and the breathing phase of patient 104.).
Regarding claim 2, Cho teaches determining a patient activity level based on the sensor data; and determining the RSA factor based on the patient activity level (e.g. [0068]).
Regarding claim 3, Cho teaches the sensor data further comprises one or more of: cardiological data (e.g. [0053], [0054]), pulse oximeter data (e.g. [0030]: optical (oxygenation) parameters), accelerometer data (e.g. [0070]), body temperature data, perspiration data, camera data, an adenosine triphosphate, ATP, level and an adrenaline level.
Regarding claim 4, Cho teaches the controller is configured to determine the CRPS factor based on the RSA factor (e.g. Fig.6,7, 9: modified pacing parameters are determined based on the breathing rate).
Regarding claim 5, Cho teaches the controller is configured to provide the pacing signal in accordance with the RSA factor by controlling a timing of pulses (i.e. pacing rate e.g. Figs. 6, 7, 9) in the pacing signal according to:
a first rate when the respiratory data indicates inspiration (e.g.304 Fig. 6,7, 406,404 Fig. 9); and
a second rate when the respiratory data indicates expiration, wherein the first rate is greater than the second rate (e.g.304 Fig. 6,7, 410,408 Fig.9).
Regarding claim 6, Cho teaches the sensor data comprises cardiological data and the controller is configured to: determine a baseline heart rate from the cardiological data; and set the first rate and second rate based on the baseline heart rate (e.g. [0069], [0080]).
Regarding claim 7, Cho teaches the controller is configured to set a ratio of the first rate to the second rate based on the baseline heart rate (e.g. [0080]).
Regarding claim 8, Cho teaches the controller is configured to: determine a patient activity level based on the sensor data; and set a ratio of the first rate to the second rate based on the patient activity level (e.g. [0070], [0080]).
Regarding claims 9 and 15, Cho teaches the controller is configured to provide the pacing signal in accordance with the CRPS factor by controlling a timing of pulses in the pacing signal to correspond to a same set of respiratory phase angles (e.g. Figs. 5 and 8) in a repeat sequence over an integer number of respiratory cycles and to reduce the number of respiratory cycles over which the pacing signal repeats (e.g. Figs. 6,7,9 pacing rate controlled for M and N cycles during exhalation and inhalation).
Regarding claim 10, Cho teaches the controller is configured to set the first rate and the second rate to control the timing of the pulses in the pacing signal to correspond to the same set of respiratory phase angles (e.g. Figs. 5 and 8) in a repeat sequence over an integer number of respiratory cycles (e.g. Figs. 6,7,9 pacing rate controlled for M and N cycles during exhalation and inhalation).
Regarding claim 11, Cho teaches the sensor data comprises cardiological data (e.g. [0069]) and wherein the controller is configured to:
determine a patient activity level based on the sensor data (e.g. [0069]);
determine the RSA factor based on the patient activity level (e.g. [0076]);
set a ratio of the first rate to the second rate based on the RSA factor (e.g. [0080]); determine the CRPS factor as values of the first rate and second rate that provide the repeat sequence based on the ratio, a baseline heartrate of the sensor data and a respiratory rate of the respiratory data (e.g. Figs 8A,B, 9 and 10); and
provide the pacing signal based on the first rate and the second rate.
Regarding claims 12 and 13, Cho teaches the controller is configured to determine a first rate and a second rate and to adjust the ratio of the first rate to the second rate to determine the CRPS factor as values of the first rate and second rate that provide the repeat sequence that provide a modified baseline heart rate in the pacing signal to provide the repeat sequence (e.g. [0080]).
Regarding claim 17, Cho teaches the sensor data comprises cardiological data (e.g. [0069]) and the controller is configured to: determine a baseline number of heartbeats per respiratory cycle( e.g. [0069: initial condition) and / or baseline phase angles based on the cardiological data and the respiratory data; and determine the set of respiratory phase angles (e.g. Figs 5,8) based on the baseline number of heartbeats and / or the baseline phase angles(e.g. Figs. 6,7,9 pacing rate controlled for M and N cycles during exhalation and inhalation).
Regarding claim 23, Cho teaches a pacemaker system comprising: the controller of claim 1 (as discussed above); one or more sensors for providing the sensor data (e.g. [0030], [0053], [0054], [0070]); and one or more pacing electrodes for applying the pacing signal to the heart of the patient (e.g. 124, 126 Fig.1, [0040], [0046]-[0048]).
Conclusion
Applicant's amendment necessitated the new grounds 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 MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792