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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/09/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5, 7-11, and 21-23 have been considered but are moot because the new ground of rejection has been made in view of the newly cited prior art of Thakur et al. (U.S. Patent Application Publication 2017/0100081) – used as a primary prior art reference, in view of Wariar et al. (U.S. Patent Application Publication 2011/0301473) – as a secondary teaching prior art reference which was previously used as a anticipatory prior art reference. The reason for using the Thakur et al. prior art is it shows the obviousness of previously objected claims 5 and 7.
Applicant is invited to request an interview to discuss suggestions to find an acceptable conclusion of the prosecution for all parties.
Due to the RCE, this action is made non-final.
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.
Claims 1-3, and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. (U.S. Patent Application Publication 2017/0100081) in view of Wariar et al. (U.S. Patent Application Publication 2011/0301473).
Regarding claim 1, Thakur et al. disclose a system comprising:
a first detector circuit (comprising A) “heart sound (HS)-based HF event detection circuit” 113, or 200, see [0050], [0055] and figures 1-2, or B) “signal sensor circuit 210 can sense HS information,” see [0056], and alternate/equivalent counterparts in other embodiments) configured to detect heart event(s) using a heart sound signal sensed from a patient; and
a physiologic event detector circuit (comprising A) “trending circuit 223,” see [0066] and figure 2, and B) “processor 220,” see [0055] and figure 2, and alternate/equivalent counterparts in other embodiments) configured to, in response to detection of the heart event(s) by the first detector circuit, generate a diastolic function indicator (see [0064], and [0092]) using physiologic information sensed from the patient during the heart event(s), and to detect a worsening heart failure (WHF) (see abstract, [0009]-[0010], [0044], [0050], [0068] for example) event based at least in part on the generated diastolic function indicator (see [0008], [0064], and [0092]).
Thakur et al. fail to explicitly disclose the first detector circuit is Valsalva maneuver (VM) detector circuit configured to detect a VM session/event.
Like Thakur et al., Wariar et al. disclose a system for detecting heart sounds and indicating heart failure and /or worsening heart failure using an accelerometer, impedance measurements and teach a Valsalva maneuver can be identified by using both correlated heart sounds and impedance measurements (see [0014], [0024], [0046]-[0047] for example) in order to better enhance heart failure measurement and diagnosis.
It should be understood the prior art combination makes the first detector circuit (of Thakur et al.) used to detect (and/or identify) a Valsalva maneuver.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Thakur et al., as taught by Wariar et al., to use the first detector circuit comprising the heart sounds detection/measurement as a Valsalva detection circuit in in order to better enhance heart failure measurement and diagnosis.
Regarding claim 2, Thakur et al. disclose the physiologic event detector circuit is configured to generate the diastolic function indicator using the physiologic information that includes a heart sound component of the heart sound signal (see for example [0066]-[0067]).
Regarding claim 3, Thakur et al. disclose the heart sound component used for generating the diastolic function indicator includes a third heart sound (S3) intensity, wherein the physiologic event detector circuit is configured to generate the diastolic
function indicator indicating an impaired diastolic function in response to the S3 intensity
exceeding a reference S3 intensity by a specific margin during the detected VM session (see [0062], [0068], [0072] for example).
Regarding claim 8, Thakur et al. disclose the heart sound component used for generating the diastolic function indicator includes a cardiac timing parameter including at least one of: a pre-ejection period; a systolic timing interval; a left-ventricular ejection time; or a diastolic timing interval (see [0064]).
Regarding claim 9, Thakur et al. in view of Wariar et al. disclose (or make obvious) wherein to detect the VM session includes to determine one or more VM phases using the sensed heart sound signal, wherein the physiologic event detector circuit is configured to generate the diastolic function indicator during at least one of the determined one or more VM phases (see Wariar et al. [0006], [0014], and [0055] for example).
Regarding claim 10, Thakur et al. in view of Wariar et al. disclose (or make obvious)
detect the VM session includes to determine the one or more VM phases using an increase trend or a decrease trend of one or more of a first heart sound (S1) intensity, a second heart sound (S2) intensity, a third heart sound (S3) intensity, or a fourth heart sound (S4) intensity (see Thakur et al. [0065]).
Regarding claim 11, Thakur et al. a therapy circuit configured to initiate or adjust a therapy (see [0051]) to the patient in response to the detection of the WHF event.
Claims 5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. (U.S. Patent Application Publication 2017/0100081) in view of Wariar et al. (U.S. Patent Application Publication 2011/0301473) as applied to claim 2 above, and further in view of case law – Limited Options (Limited Universe).
Regarding claims 5 and 7, Thakur et al. in view of Wariar et al. show the invention above, including:
Thakur et al. disclosing using the ratio of heart sound intensities of S1, S2, S3, and S4 (see [0066]-[0067] specifically, and [0062]-[0067] in general).
Yet, Thakur et al. fail to explicitly recite:
1) the heart sound component used for generating the diastolic function indicator includes a ratio of a third heart sound (S3) intensity to a fourth heart sound (S4) intensity; wherein the physiologic event detector circuit is configured to generate the diastolic function indicator indicating an impaired diastolic function in response to the ratio of the S3 intensity to the S4 intensity falling below a first threshold value lower than a baseline value range {claim 5}; or
2) the heart sound component used for generating the diastolic function indicator includes a ratio of a third heart sound (S3) intensity to a fourth heart sound (S4) intensity, wherein the physiologic event detector circuit is configured to generate the diastolic function indicator indicating a restrictive ventricular filling in response to the ratio of the S3 intensity to the S4 intensity exceeding a second threshold value greater than a baseline value range {claim 7}.
However, where there is a limited universe of potential options, the selection of any particular option would have been obvious to one of ordinary skill in the art. In re Jones, 412 F.2d 241, 162 USPQ 224 (CCPA 1962). Therefore, since there are only six heart sound intensity ratios, it would have been obvious to one of ordinary skill in the art to modify Thakur et al. in view of Wariar et al. show to use the heart sound intensity ratio of S3/S4 (or S4/S3) to use as an indicator relating to heart failure.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Thakur et al. in view of Wariar et al., as taught by Limited Options, to explicitly use the ratio of the heart sound intensity ratio of S3/S4 (or S4/S3) to use as an indicator relating to heart failure.
Additionally and finally, regarding the recitation of the ratio being less than or greater than a threshold, see Thakur et al. [0062].
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. (U.S. Patent Application Publication 2017/0100081) in view of Wariar et al. (U.S. Patent Application Publication 2011/0301473) and further in view of case law – Limited Options (Limited Universe).
Regarding claims 21-23, Thakur et al. disclose a system comprising:
a first detector circuit (comprising A) “heart sound (HS)-based HF event detection circuit” 113, or 200, see [0050], [0055] and figures 1-2, or B) “signal sensor circuit 210 can sense HS information,” see [0056], and alternate/equivalent counterparts in other embodiments) configured to detect heart event(s) using a heart sound signal sensed from a patient; and
a physiologic event detector circuit (comprising A) “trending circuit 223,” see [0066] and figure 2, and B) “processor 220,” see [0055] and figure 2, and alternate/equivalent counterparts in other embodiments) configured to, in response to detection of the heart event(s) by the first detector circuit, generate a diastolic function indicator (see [0064], and [0092]) using physiologic information sensed from the patient during the heart event(s), and to detect a worsening heart failure (WHF) (see abstract, [0009]-[0010], [0044], [0050], [0068] for example) event based at least in part on the generated diastolic function indicator (see [0008], [0064], and [0092]).
Additionally, regarding the recitation of the ratio being less than or greater than a threshold, see Thakur et al. [0062].
Thakur et al. fail to explicitly disclose:
1) the first detector circuit is Valsalva maneuver (VM) detector circuit configured to detect a VM session/event;
2) detecting a third heart sound (S3) intensity and a fourth heart sound (S4) intensity from the heart sound signal sensed during the detected VM session;
3) generating a diastolic function indicator using a combination (in the form of a ratio) of the S3 intensity and the S4 intensity; and
Like Thakur et al., Wariar et al. disclose a system for detecting heart sounds and indicating heart failure and /or worsening heart failure using an accelerometer, impedance measurements and teach a Valsalva maneuver can be identified by using both correlated heart sounds and impedance measurements (see [0014], [0024], [0046]-[0047] for example) in order to better enhance heart failure measurement and diagnosis.
It should be understood the prior art combination makes the first detector circuit (of Thakur et al.) used to detect (and/or identify) a Valsalva maneuver.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Thakur et al., as taught by Wariar et al., to use the first detector circuit comprising the heart sounds detection/measurement as a Valsalva detection circuit in in order to better enhance heart failure measurement and diagnosis.
Thakur et al. disclose using the ratio of heart sound intensities of S1, S2, S3, and S4 (see [0066]-[0067] specifically, and [0062]-[0067] in general).
Where there is a limited universe of potential options, the selection of any particular option would have been obvious to one of ordinary skill in the art. In re Jones, 412 F.2d 241, 162 USPQ 224 (CCPA 1962). Therefore, since there are only six heart sound intensity ratios, it would have been obvious to one of ordinary skill in the art to modify Thakur et al. in view of Wariar et al. show to use the heart sound intensity ratio of S3/S4 (or S4/S3) to use as an indicator relating to heart failure.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Thakur et al. in view of Wariar et al., as taught by Limited Options, to explicitly use the ratio of the heart sound intensity ratio of S3/S4 (or S4/S3) to use as an indicator relating to heart failure.
Additionally and finally, regarding the recitation of the ratio being less than or greater than a threshold, see Thakur et al. [0062].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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/AARON F ROANE/Primary Examiner, Art Unit 3792