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
Regarding claims 4 and 13, Applicant’s arguments with respect to the previous rejection(s) of the claims have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Regarding Claim 1, applicant’s arguments are not found persuasive. Applicant contends that the action has failed to address the technical distinction; however, the Examiner recognizes that references cannot be arbitrarily combined and that there must be some reason why one skilled in the art would be motivated to make the proposed combination of primary and secondary references. In re Nomiya, 184 USPQ 607 (CCPA 1975). However, there is no requirement that a motivation to make the modification be expressly articulated. The test for combining references is what the combination of disclosures taken as a whole would suggest to one of ordinary skill in the art. In re McLaughlin, 170 USPQ 209 (CCPA 1971). references are evaluated by what they suggest to one versed in the art, rather than by their specific disclosures. In re Bozek, 163 USPQ 545 (CCPA) 1969. In this case, the purpose in the rejection is clear to improve the device by setting the optimal pacing parameters for the patient based on their individual contractility.
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 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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.
Claims 1, 3, 5-11, 15-18, 20, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 2012/0296228; hereinafter “Zhang”) in view of Wariar et al. (US 2007/0043299; hereinafter “Wariar”).
Regarding claim 1, Zhang discloses an apparatus comprising: a stimulus circuit configured to deliver electrical pacing therapy to a subject when operatively coupled to a plurality of electrodes (e.g. Fig. 2, ¶¶ 53); a heart sound sensing circuit configured to produce a sensed heart sound signal representative of mechanical cardiac activity (e.g. ¶¶ 53-55, 64-66, etc.); and a signal processing circuit configured to: obtain measures of an S1 heart sound amplitude as a function of heart rate using the sensed heart signal (e.g. ¶¶ 88 – “….amplitudes and/or durations of heart sounds S1-S4.”); identify a critical AV delay for the subject using the obtained measures of the S1 heart sound parameter (e.g. ¶¶ 115 – where the CRT optimization protocol specifies the optimization of the “AV delay pacing parameter” in this embodiment, and the maximum measured acoustic cardiographic metrics includes the maximum amplitude of S1 #206 in Fig. 11); wherein the stimulus circuit is configured to provide the electrical pacing therapy according to a therapy regiment (e.g. ¶¶ 116).
The examiner notes that the embodiment referenced above (Fig. 11) is directed towards the embodiment where S1 heart sounds are analyzed as a function of AV delay settings; however, the prior art as a whole is not limited to AV delay settings alone. Zhang discloses that the invention may optimize parameters for LV or RV pacing settings (e.g. ¶¶ 34 - “acoustic cardiographic metrics derived from heart sounds and EGM may be used to decide which modality to implement between left ventricle (LV) pacing (or "fusion pacing"), right ventricular (RV) pacing or biventricular (BiV) pacing”.) Zhang also discloses optimizing these pacing parameters as a function of heart rate (e.g. ¶¶ 36 – “The information may also be used to determine parameters for heart rate-adaptive AV delay and for adaptive CRT. Further, the physiologically relevant information may be used to optimize pacing parameter settings at different heart rates”).
Zhang fails to expressly disclose identifying a critical heart rate for the subject that is a heart rate above which cardiac contractility of the subject decreases and is a heart rate corresponding to a maximum measured S1 heart sound amplitude and set the maximum pacing rate to the identified critical heart rate as claimed. In the same field of endeavor, Wariar discloses identifying a critical heart rate for the subject that is a heart rate above which cardiac contractility of the subject decreases and is a heart rate corresponding to a maximum measured S1 heart sound amplitude and set the maximum pacing rate to the identified critical heart rate (e.g. ¶¶ 48-54) in order to determine the rate where the cardiac contractility is best (e.g. ¶¶ 30). It would have been obvious, to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known technique of setting the maximum pacing rate to the identified critical heart rate, as taught by Wariar, to the known device of Zhang, ready for improvement, to improve the device by setting the optimal pacing parameters for the patient based on their individual contractility.
Regarding claim 11, Zhang teaches an automated method of operation of a medical device system, the method comprising: sensing a heart sound signal representative of mechanical cardiac activity of a subject (e.g. ¶¶ 53-55, 64-66, etc.); delivering electrical cardiac pacing therapy to the subject, including varying a paced heart rate of the subject according to a specified paced heart rate protocol (e.g. ¶¶ 53); obtaining measures of an S1 heart sound parameter as a function of AV delay settings (e.g. ¶¶ 115; Fig.11, #206); identifying a critical AV delay for the subject using the obtained measures of the S1 heart sound parameter e.g. ¶¶ 115 – where the CRT optimization protocol specifies the optimization of the “AV delay pacing parameter” in this embodiment, and the maximum measured acoustic cardiographic metrics includes the maximum amplitude of S1 #206 in Fig. 11); wherein the stimulus circuit is configured to provide the electrical pacing therapy according to a therapy regimen (e.g. ¶¶ 116).
The examiner notes that the embodiment referenced above (Fig. 11) is directed towards the embodiment where S1 heart sounds are analyzed as a function of AV delay settings; however, the prior art as a whole is not limited to AV delay settings alone. Zhang discloses that the invention may optimize parameters for LV or RV pacing settings (e.g. ¶¶ 34 - “acoustic cardiographic metrics derived from heart sounds and EGM may be used to decide which modality to implement between left ventricle (LV) pacing (or "fusion pacing"), right ventricular (RV) pacing or biventricular (BiV) pacing”.) Zhang also discloses optimizing these pacing parameters as a function of heart rate (e.g. ¶¶ 36 – “The information may also be used to determine parameters for heart rate-adaptive AV delay and for adaptive CRT. Further, the physiologically relevant information may be used to optimize pacing parameter settings at different heart rates”).
Zhang fails to expressly disclose identifying a critical heart rate for the subject that is a heart rate above which cardiac contractility of the subject decreases and is a heart rate corresponding to a maximum measured S1 heart sound amplitude and set the maximum pacing rate to the identified critical heart rate as claimed. In the same field of endeavor, Wariar discloses identifying a critical heart rate for the subject that is a heart rate above which cardiac contractility of the subject decreases and is a heart rate corresponding to a maximum measured S1 heart sound amplitude and set the maximum pacing rate to the identified critical heart rate (e.g. ¶¶ 48-54) in order to determine the rate where the cardiac contractility is best (e.g. ¶¶ 30). It would have been obvious, to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known technique of setting the maximum pacing rate to the identified critical heart rate, as taught by Wariar, to the known device of Zhang, ready for improvement, to improve the device by setting the optimal pacing parameters for the patient based on their individual contractility.
Regarding claim 16, Zhang discloses a medical device system comprising: first medical device including: a stimulus circuit configured to deliver electrical pacing therapy to a subject when operatively coupled to a plurality of electrodes (e.g. Fig. 2, ¶¶ 53); a heart sound sensing circuit configured to produce a sensed heart sound signal representative of mechanical cardiac activity (e.g. ¶¶ 53-55, 64-66, etc.); a control circuit operatively coupled to the stimulus circuit and configured to vary a paced heart rate of the subject according to a specified paced heart rate protocol (e.g. ¶¶ 9 – “evaluation is based on at least one acoustic cardiographic metric and the evaluation includes varying the value of the cardiac pacing parameter over a predetermined range at a predetermined interval”); and a first communication circuit configured to transfer information wirelessly and a second medical device including: a second communication circuit configured to receive heart sound information from the first medical device (e.g. ¶¶ 42); a user interface including a display (e.g. ¶¶ 116 – “In some cases, the acoustic cardiographic metrics, including S2 timing are displayed on a remote device, and a physician reviews the values for S2 timing versus AV delay”; Fig. 11, etc.); and a signal processing circuit configured to: obtain measures of an S1 heart sound parameter as a function of heart rate using the sensed heart sound signal (e.g. ¶¶ 115; Fig.11, #206); determine a critical heart rate for the subject using the obtained measures of the S1 heart sound parameter as a function of AV delay settings (e.g. ¶¶ 115; Fig.11, #206); determine a critical AV delay for the subject using the obtained measures of the S1 heart sound parameter (e.g. ¶¶ 115 – where the CRT optimization protocol specifies the optimization of the “AV delay pacing parameter” in this embodiment, and the maximum measured acoustic cardiographic metrics includes the maximum amplitude of S1 #206 in Fig. 11); and present information related to heart rate criticality using the display (e.g. ¶¶ 116 – “In some cases, the acoustic cardiographic metrics, including S2 timing are displayed on a remote device, and a physician reviews the values for S2 timing versus AV delay”; Fig. 11, etc.).
The examiner notes that the embodiment referenced above (Fig. 11) is directed towards the embodiment where S1 heart sounds are analyzed as a function of AV delay settings; however, the prior art as a whole is not limited to AV delay settings alone. Zhang discloses that the invention may optimize parameters for LV or RV pacing settings (e.g. ¶¶ 34 - “acoustic cardiographic metrics derived from heart sounds and EGM may be used to decide which modality to implement between left ventricle (LV) pacing (or "fusion pacing"), right ventricular (RV) pacing or biventricular (BiV) pacing”.) Zhang also discloses optimizing these pacing parameters as a function of heart rate (e.g. ¶¶ 36 – “The information may also be used to determine parameters for heart rate-adaptive AV delay and for adaptive CRT. Further, the physiologically relevant information may be used to optimize pacing parameter settings at different heart rates”).
Zhang fails to expressly disclose identifying a critical heart rate for the subject that is a heart rate above which cardiac contractility of the subject decreases and is a heart rate corresponding to a maximum measured S1 heart sound amplitude and set the maximum pacing rate to the identified critical heart rate as claimed. In the same field of endeavor, Wariar discloses identifying a critical heart rate for the subject that is a heart rate above which cardiac contractility of the subject decreases and is a heart rate corresponding to a maximum measured S1 heart sound amplitude and set the maximum pacing rate to the identified critical heart rate (e.g. ¶¶ 48-54) in order to determine the rate where the cardiac contractility is best (e.g. ¶¶ 30). It would have been obvious, to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known technique of setting the maximum pacing rate to the identified critical heart rate, as taught by Wariar, to the known device of Zhang, ready for improvement, to improve the device by setting the optimal pacing parameters for the patient based on their individual contractility.
Regarding claims 2, 12, and 19, Zhang discloses the signal processing circuit is configured to: obtain measures of S1 heart sound amplitude as the S1 heart sound parameter; and identify the critical heart rate as a heart rate corresponding to a maximum measured S1 heart sound amplitude (e.g. ¶¶ 81; 115 – where the critical heart rate is the maximum measured acoustic cardiographic metrics which includes the maximum amplitude of S1 #206 in Fig. 11).
Regarding claim 3, 20 and 24, Zhang discloses a cardiac signal sensing circuit configured to produce a sensed cardiac signal representative of cardiac depolarization of the subject when coupled electrically to the plurality of electrodes; wherein signal processing circuit is configured to: obtain measures of a systolic time interval (STI) ratio as the heart sound parameter using the sensed cardiac signal and the sensed heart sound signal (e.g. ¶¶ 114 – “The S1-S2 interval is a surrogate for stroke volume, i.e., Left Ventricular Systolic Time (LVST)”); and identify the critical heart rate as a heart rate corresponding to a minimum measured STI ratio (e.g. ¶¶ 115 – “Acoustic cardiographic metric 204 is a systolic time interval (STI). In some examples the STI is LVST and is the interval between S1 and S2”).
Regarding claim 5 and 15, Zhang discloses the signal processing circuit is configured to: determine slope of the measures of the S1 heart sound parameter as a function of heart rate; and identify the critical heart rate as a heart rate corresponding to a minimum determined slope (e.g. ¶¶ 122 – where the pacing parameters are directed towards minimizing the acceleration time or slope of the S1 heart sound parameter).
Regarding claim 6, Zhang discloses a control circuit operatively coupled to the stimulus circuit and configured to vary a paced heart rate of the subject according to a specified paced heart rate protocol (e.g. ¶¶ 9 – “evaluation is based on at least one acoustic cardiographic metric and the evaluation includes varying the value of the cardiac pacing parameter over a predetermined range at a predetermined interval”); wherein the signal processing is configured to collect the measures of the S1 heart sound parameter according to the specified paced heart rate protocol and determine the critical heart rate using the collected measures of the heart sound parameter (e.g. ¶¶ 115 – where the critical heart rate is the maximum measured acoustic cardiographic metrics which includes the maximum amplitude of S1 #206 in Fig. 11).
Regarding claim 7, Zhang discloses the control circuit is configured to vary the paced heart rate according to one of a ramp-up pacing rate protocol (e.g. ¶¶ 94 – “pacing may be delivered for AV delays from 120 ms to 260 ms increasing at 10 ms increments”).
Regarding claim 8, Zhang discloses a physiologic sensing circuit configured to produce a sensed physiological signal representative of physiological information of the subject (e.g. ¶¶ 9, 64, etc.); wherein the control circuit is configured to change the paced heart rate up to a maximum heart rate limit according to the sensed physiological signal, and set the maximum heart rate limit to the determined critical heart rate (e.g. ¶¶ 115 – where the critical heart rate is the maximum measured acoustic cardiographic metrics which includes the maximum amplitude of S1 #206 in Fig. 11).
Regarding claim 9, Zhang discloses the signal processing circuit is configured to gather paired measures of the S1 heart sound parameter and heart rate during naturally occurring changes in heart rate over a specified time interval and use the paired measures of the heart sound parameter and heart rate to determine the critical heart rate (e.g. ¶¶ 114, 115, 118, etc. – where the examiner notes the R-R interval or heart rate is correlated or gathered at the same time as the heart sounds in order to normalize the different pacing parameters).
Regarding claim 10, Zhang discloses the signal processing circuit is configured to filter measures of the S1 heart sound parameter after a change in heart rate (e.g. ¶¶ 104 – “Cardiac signal analyzer 80 or another component of IMD 16 filters (e.g., band pass filter), the heart sound signal”) and use filtered measures of the heart sound parameter as a function of heart rate to determine the critical rate (e.g. ¶¶ 115 – where the critical heart rate is the maximum measured acoustic cardiographic metrics which includes the maximum amplitude of S1 #206 in Fig. 11).
Regarding claims 17-18, Zhang discloses the signal processing circuit is configured to present, using the display, a graphical plot of values of the S1 heart sound parameter measured as a function of heart rate in ambulatory settings (e.g. ¶¶ 116 – “In some cases, the acoustic cardiographic metrics, including S2 timing are displayed on a remote device, and a physician reviews the values for S2 timing versus AV delay”).
Allowable Subject Matter
Claims 4, 13, and 21-23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David 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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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796