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
The amendment filed 02/02/2026 has been entered. Claims 1-25 remain pending in the application.
Applicant’s arguments, see page 12 lines 6-27 and page 11 lines 1-7, filed 02/02/2026, with respect to claims 5 and 13 have been fully considered and are persuasive. The 35 U.S.C. § 112(b) rejection of claims 5 and 13 has been withdrawn.
Applicant's arguments, see page 12 lines 7 – 27, filed 02/02/2026, have been fully considered but they are not persuasive. Applicant argues Bjoerling does not disclose an electrode positioned in the left atrium or positioned in the left ventricle. However, examiner respectfully disagrees. Bjoerling discloses electrodes placed in both the left atrium and left ventricle ([Bjoerling, Summary of Invention pp 16])
Applicant's arguments, see page 13 lines 8-21, filed 02/02/2026 have been fully considered but they are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, applicant argues that a person of ordinary skill in the art would not modify the teachings of Bjoerling and Menon. Examiner respectfully disagrees. Menon discloses a method of advancing a canula through the mitral valve for the purpose of entering the left ventricle ([Menon, (6)]). Bjoerling specifically discloses placing electrodes in the left ventricle ([Bjoerling, Summary of Invention pp16)]. Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the transseptal lead as disclosed by Bjoerling with the method of crossing the mitral valve as disclosed by Menon.
Applicant’s arguments, see page 13 lines 1 – 6, filed 02/02/2026, in view of amendments, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C § 103 have been fully considered. However, applicant does not claim a lead that is positioned through the interatrial septum rather that the lead is “postionable” through the septum this merely indicates that the lead can be positioned. It is not claimed that it is. Therefore, Bjoerling lead is seen as being positionable through the interatrial septum.
Applicant’s arguments, see page 15 lines 10 – 28, filed 02/02/2026, in view of amendments, with respect to the rejection(s) of claim(s) 9 under 35 U.S.C § 103 have been fully considered. Examiner acknowledges claim 24 was not specifically mentioned in the office action. However, Claim 24 is rejected in view of Bjoerling further in view of Menon further in view of Blomqvist. Bjoerling discloses electrodes placed in both the left atrium and left ventricle ([Bjoerling, Summary of Invention pp 16]). Menon discloses advancing through the interatrial septum to record physiological parameters of the heart. ([Abstract]). Bjoerling discloses identifying one or more cardiac conditions based on determined right atrium to left atrium electrical activation. ([0065])
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bjoerling (US 20100121398 A1)in view of Menon et al. (US 12097315 B2) further in view of Blomqvist et al. (US 9277886 B2)
Regarding claim 1, Bjoerling discloses: An implantable medical device (IMD) ([0002];” The present invention relates to an implantable medical device “) comprising: a controller ([0062]; “control unit 140” comprising one or more processors ([0064];” impedance signal processor 150” operably coupled to a transseptal lead ([Figure 11] Bjoerling discloses processor 150 operably connected to leads 30 and 20) extending from a proximal end to a distal end ([Figure 1]; Bjoerling discloses leads extending from proximal end closer to stimulation device 10 to a distal end) and comprising at least one left atrial electrode ([Figure 1]; Bjoerling discloses electrode 36 which is seen as a left atrial electrode) and at least one left ventricular electrode ([Figure 1]; Bjoerling discloses left vertical tip electrode 32), the transseptal lead positionable through the interatrial septum from the right atrium to the left atrium of a patient's heart to position the at least one left atrial electrode in the left atrium and position the at least one left ventricular electrode in the left ventricle. ([Figure 1] Bjoerling discloses lead 30 positionable through the interatrial septum from right atrium to left atrium, Bjoerling further discloses electrodes in the left atrium and left ventricle ([0029]).) a left atrial impedance using the at least one left atrial electrode, and a left ventricular impedance using the at least one left ventricular electrode ([0016];” measuring impedance variations between at least one electrode placed adjacent to or substantially at the level of the valve plane and at least one electrode attached in an atrium and at least one electrode attached in a ventricle”); and determine one or more indicators of mitral valve disease based on one or more of the cross mitral valve impedance, the left atrial impedance, and the left ventricular impedance. ([0065];” A number of different parameters may be extracted from the measured impedances and monitored including pre-ejection period, a contraction patter, mitral regurgitation, a synchronicity between the left and right hand sides of the heart, etc”. Bjoerling does not explicitly disclose: The lead further through the mitral valve , the controller configured to: monitor one or more of a cross mitral valve impedance between the at least one left atrial electrode and the at least one left ventricular electrode
However, Menon discloses: The lead further through the mitral valve ([Column 3 line 67 and Column 4 lines 1-6] “comprises advancing the cannula from the left atrium through the mitral valve “)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the IMD as disclosed by Bjoerling with the lead crossing through the mitral valve as disclosed by Menon the motivation being to place the lead in the left ventricle ([Column 3 lines 1-7])
However, Blomqvist discloses: controller configured to ([Abstract]” an implantable medical device (100) comprises an impedance processor (130) for determining impedance data reflective of the transvalvular impedance of a heart valve (11, 13, 15, 17) of a heart (10) during a heart cycle”): monitor one or more of a cross mitral valve impedance between the at least one left atrial electrode and the at least one left ventricular electrode ([Column 2 lines 41-46] “An electric signal is applied, using the electrodes, over at least a portion of the heart and a resulting electric signal is collected from the heart using the electrodes. The electric signals are processed by an impedance processor for determining impedance data reflective of the transvalvular impedance of a heart valve that is being monitored”)
It would have been obvious to one of ordinary skill in the art to modify the IMD as disclosed by Bjoerling with the cross mitral valve impedance measurement the motivation being to determine heart valve malfunction ([Abstract])
Regarding claim 2, Bjoerling in view of Menon further in view of Blomqvist disclose: The IMD of claim 1. Bjoerling does not explicitly disclose: wherein the one or more indicators of mitral valve disease comprises one or more stenosis and regurgitation.
However, Blomqvist discloses: wherein the one or more indicators of mitral valve disease comprises one or more stenosis and regurgitation. ([Abstract]; ”comprises an impedance processor (130) for determining impedance data reflective of the transvalvular impedance of a heart valve (11, 13, 15, 17) of a heart (10) during a heart cycle.”, “A condition processor (150) determines the presence of any heart valve malfunction, such as valve regurgitation and/or stenosis, of the heart valve (11, 13, 15, 17) based on the estimated diastolic and systolic transvalvular impedance representations.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the IMD as disclosed by Bjoerling with the regurgitation and stenosis indicators the motivation being to determine heart valve malfunction ([Abstract])
Regarding claim 3, Bjoerling in view of Menon further in view of Blomqvist disclose: The IMD of claim 1. Bjoerling further discloses: wherein the controller is further configured to determine filling abnormalities in one or both of the left atrium and the left ventricle based on one or more of the cross mitral valve impedance, the left atrial impedance, and the left ventricular impedance. ([0066]; “Through the impedance measurements, blood volume changes are detected. Blood has a higher conductivity (lower impedance) than myocardial tissue and lungs. The impedance-volume relationship is inverse; the more blood—the smaller impedance. Accordingly, the impedance will vary over the cardiac cycle in connection with the contraction and filling of the atria and ventricles,”)
Regarding claim 4, Bjoerling in view of Menon further in view of Blomqvist disclose: The IMD of claim 1. Bjoerling further discloses: wherein the controller is further configured to determine ejection abnormalities in one or both of the left atrium and the left ventricle based on impedance ([0065];” A number of different parameters may be extracted from the measured impedances and monitored including pre-ejection period, a contraction patter, mitral regurgitation, a synchronicity between the left and right hand sides of the heart, etc.”) Bjoerling does not explicitly discloses: based on one or more of the cross mitral valve impedance, the left atrial impedance, and the left ventricular impedance.
However, Blomqvist discloses: based on one or more of the cross mitral valve impedance, the left atrial impedance, and the left ventricular impedance. ([Abstract];” comprises an impedance processor (130) for determining impedance data reflective of the transvalvular impedance of a heart valve (11, 13, 15, 17) of a heart (10) during a heart cycle.”)
It would have been obvious to one of ordinary skill in the art to modify the IMD as disclosed by Bjoerling with the cross mitral valve impedance measurement the motivation being to determine heart valve malfunction ([Abstract])
Regarding claim 5, Bjeorling in view of Menon further in view of Blomqvist discloses: The IMD of claim 1. Bjoerling further discloses: wherein the at least one left atrial electrode comprises a first left atrial electrode positioned in the left atrium ([Figure 1]; electrode 35 which is seen as a left atrium electrode, Bjoerling further discloses electrodes in the left atrium ([0029]).) and a second left atrial electrode postioned in the left atrium ([Figure 1]; electrode 36, Bjoerling further discloses electrodes in the left atrium ([0029]).) , wherein the controller is configured to monitor the left atrial impedance using the first left atrial electrode positioned in the left atrium ([0048]; “In order to sense left atrium and ventricular cardiac signals and impedances and to provide pacing therapy for the left ventricle LV, the stimulation device 10 is coupled to a “coronary sinus” lead 30” , “ and measurement electrode 35, which may a annular or ring electrode, is located adjacent to the right atrium RA.”, Bjoerling further discloses electrodes in the left atrium and left ventricle ([0029]).) and wherein the at least one left ventricular electrode comprises a first left ventricular electrode positioned in the left ventricle ([Figure 1]; 34, Bjoerling further discloses electrodes in the left atrium and left ventricle ([0029]).) and a second left ventricle electrode positioned in the left ventricle ([Figure 1]; 32, Bjoerling further discloses electrodes in the left atrium and left ventricle ([0029]).), wherein the controller is configured to monitor the left ventricular impedance using the first left ventricular electrode positioned in the left ventricle.(([Figure 1]Bjoerling discloses lead 30 with electrodes placed in the left chambers of the heart. [0065] Further Bjoerling discloses using of impedance to diagnose mitral regurgitation. Bjoerling further discloses electrodes in the left atrium and left ventricle ([0029]).) Bjoerling does not explicitly disclose: electrodes used to monitor the cross mitral valve impedance using the second left ventricle electrode.
However, Blomqvist discloses: electrodes used to monitor the cross mitral valve impedance using the second left ventricle electrode. ([Abstract];” comprises an impedance processor (130) for determining impedance data reflective of the transvalvular impedance of a heart valve (11, 13, 15, 17) of a heart (10) during a heart cycle.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the IMD as disclosed by Bjoerling with the regurgitation and stenosis indicators the motivation being to determine heart valve malfunction ([Abstract])
Regarding claim 6, Bjoerling in view of Menon further in view of Blomqvist disclose: The IMD of claim 1. Bjoerling further teaches: wherein the controller is further configured to: monitor a left atrial electrogram using the at least one left atrial electrode positioned in the left atrium; monitor a left ventricular electrogram using the at least one left ventricular electrode positioned in the left ventricle; and determine one or more pacing intervals based on the left atrial and left ventricular electrograms. ([0048]; “In the illustrated example, the LV lead 30 has an annular ring electrode 34 for sensing electrical activity related to the left ventricle LV of the heart” “electrical activity” is seen as including electrograms of which pacing intervals can be determined, [0029]; Bjoerling further discloses electrodes in the left atrium and left ventricle)
Regarding claim 7, Bjoerling in view of Menon further in view of Blomqvist disclose: The IMD of claim 6. Bjoerling further teaches: wherein the one or more pacing intervals comprises an atrioventricular timing interval extending between a left atrial activation and a left ventricular activation. ([0048]; Bjoerling teaches the measuring of electrical activity and further [0065]; Bjoerling teaches extracting contraction patterns this is seen as having timing interval information)
Regarding claim 8, Bjoerling in view of Menon further in view of Blomqvist disclose: The IMD of claim 1. Bjoerling further teaches: wherein the transseptal lead further comprises at least one right atrial electrode positionable in the right atrium ([Figure 1]; electrode 26), wherein the controller is further configured to: monitor a right atrial electrogram using the at least one right atrial electrode positioned in the right atrium ([0047]; “In order to sense right ventricular and atrium cardiac signals and impedances and to provide stimulation therapy to the right ventricle RV, the stimulation device 10” [0029]; Bjoerling further discloses electrodes in the left atrium and left ventricle); monitor a left atrial electrogram using the at least one left atrial electrode positioned in the left atrium ([0048];” In order to sense left atrium and ventricular cardiac signals and impedances and to provide pacing therapy for the left ventricle LV, the stimulation device 10 “[0029]; Bjoerling further discloses electrodes in the left atrium and left ventricle) determine right atrium to left atrium electrical activation based on the right and left atrial electrograms; and identify one or more cardiac conditions based on the determined right atrium to left atrium electrical activation. ([0065];” A number of different parameters may be extracted from the measured impedances and monitored including pre- ejection period, a contraction patter, mitral regurgitation, a synchronicity between the left and right hand sides of the heart, etc.”)
Claim(s) 9-16 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bjoerling in view of Bloomqvist.
Regarding claim 9, Bjoerling discloses: An implantable medical device (IMD). Bjoerling further discloses: comprising ([0002];” The present invention relates to an implantable medical device “): a transseptal lead extending from a proximal end to a distal end ([Figure 1]; Bjoerling discloses leads 30 and 20 extending from proximal end closer to stimulation device 10 to a distal end) and comprising at least one left atrial electrode ([Figure 1]; Bjoerling discloses electrode 36 which is seen as a left atrial electrode) and at least one left ventricular electrode ([Figure 1]; Bjoerling discloses left vertical tip electrode 32), the transseptal lead positionable through the interatrial septum from the right atrium to the left atrium of a patient's heart to position the at least one left atrial electrode in the left atrium and further through the mitral valve to position the at least one left ventricular electrode in the left ventricle ([Figure 1] Bjoerling discloses lead 30 positioned through the interatrial septum from right atrium to left atrium with electrode 36 which would be positionable in the left atrium and electrode 32 in the left ventricle); a right lead extending from a proximal end to a distal end ([Figure 1]; Bjoerling discloses leads 30 and 20 extending from proximal end closer to stimulation device 10 to a distal end) and comprising at least one right ventricular electrode ([Figure 1]; Bjoerling discloses electrode 24), the right lead positionable through the right atrium into the right ventricle of the patient's heart to position the at least one right ventricular electrode in the right ventricle ([Figure 1]; Bjoerling discloses lead 20 positionable through the right atrium and right ventricle of a heart), wherein at least one of the transseptal lead and the right lead further comprises at least one right atrial electrode positionable in the right atrium ([Figure 1]; Bjoerling discloses electrode 26 positionable in the right atrium); and a controller ([0062]; “control unit 140”) comprising one or more processors ([0064];” impedance signal processor 150”) operably coupled to the transseptal and right leads ([Figure 11] Bjoerling discloses processor 150 operably connected to leads 30 and 20) and a cross tricuspid valve impedance between the at least one right atrial electrode positioned in the right atrium and the at least one right ventricular electrode positioned in the right ventricle and determine one or more indicators of valve disease based on one or more of the cross mitral valve impedance and the cross tricuspid valve impedance. (“In another embodiment of the present invention, a synchronicity between a closure of the mitral valve and the tricuspid valve, respectively, is determined based on the impedances.”, [0029]; Bjoerling further discloses electrodes in the left atrium and left ventricle) Bjoerling does not explicitly disclose: and configured to: monitor a cross mitral valve impedance between the at least one left atrial electrode and the at least one left ventricular electrode
However, Blomqvist discloses: and configured to: a cross mitral valve impedance between the at least one left atrial electrode and the at least one left ventricular electrode ([Column 2 lines 41-46] “An electric signal is applied, using the electrodes, over at least a portion of the heart and a resulting electric signal is collected from the heart using the electrodes. The electric signals are processed by an impedance processor for determining impedance data reflective of the transvalvular impedance of a heart valve that is being monitored”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the IMD as disclosed by Bjoerling with the cross valve impedance measurement the motivation being to determine heart valve malfunction ([Abstract])
Regarding claim 10, Bjoerling in view of Bloomqvist disclose: The IMD of claim 9. Bjoerling does not explicitly disclose: wherein the one or more indicators of valve disease comprises one or more stenosis and regurgitation.
However, Blomqvist discloses: wherein the one or more indicators of mitral valve disease comprises one or more stenosis and regurgitation. ([Abstract]; ”comprises an impedance processor (130) for determining impedance data reflective of the transvalvular impedance of a heart valve (11, 13, 15, 17) of a heart (10) during a heart cycle.”, “A condition processor (150) determines the presence of any heart valve malfunction, such as valve regurgitation and/or stenosis, of the heart valve (11, 13, 15, 17) based on the estimated diastolic and systolic transvalvular impedance representations.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the IMD as disclosed by Bjoerling with the regurgitation and stenosis indicators the motivation being to determine heart valve malfunction ([Abstract])
Regarding claim 11, Bjoerling in view of Bloomqvist disclose: The IMD of claim 9. Bjoerling further discloses: wherein the controller is further configured to: monitor one or more of a right atrial impedance using the at least one right atrial electrode positioned in the right atrium ([0047]; “In order to sense right ventricular and atrium cardiac signals and impedances and to provide stimulation therapy” “having a ventricular tip electrode 22, a ventricular annular or ring electrode 24, and a first valve plane electrode 26. The ring electrode 24 is arranged for sensing electrical activity, intrinsic or evoked, in the right ventricle RV”), a right ventricular impedance using the at least one right ventricular electrode positioned in the right ventricle ([0047]), a left atrial impedance using the at least one left atrial electrode positioned in the left atrium ([0048]), and a left ventricular impedance using the at least one left ventricular electrode positioned in the left ventricle ([0048]); and determine filling abnormalities in one or more of the right atrium, the right ventricle, the left atrium, and the left ventricle based on one or more of the right atrial impedance, the right ventricular impedance, the left atrial impedance, and the left ventricular impedance. ([0029]; Bjoerling discloses electrodes in the left atrium and left ventricle and the right atrium and right ventricle [0066]; “Through the impedance measurements, blood volume changes are detected. Blood has a higher conductivity (lower impedance) than myocardial tissue and lungs. The impedance-volume relationship is inverse; the more blood—the smaller impedance. Accordingly, the impedance will vary over the cardiac cycle in connection with the contraction and filling of the atria and ventricles,”)
Regarding claim 12, Bjoerling in view of Bloomqvist disclose: The IMD of claim 9. Bjoerling further discloses: wherein the controller is further configured to: monitor one or more of a right atrial impedance using the at least one right atrial electrode positioned in the right atrium ([0047]), a right ventricular impedance using the at least one right ventricular electrode positioned in the right ventricle ([0047]), a left atrial impedance using the at least one left atrial electrode ([0048]), and a left ventricular impedance using the at least one left ventricular electrode positioned in the left ventricle ([0048], [0029]; Bjoerling further discloses electrodes in the left atrium and left ventricle and in the right atrium and ventricle); and determine ejection abnormalities in one or more of the right atrium, the right ventricle, the left atrium, and the left ventricle based on one or more of the right atrial impedance, the right ventricular impedance, the left atrial impedance, and the left ventricular impedance. ([0065];” A number of different parameters may be extracted from the measured impedances and monitored including pre-ejection period, a contraction patter, mitral regurgitation, a synchronicity between the left and right hand sides of the heart, etc.”)
Regarding claim 13, Bjoerling in view of Bloomqvist disclose: The IMD of claim 9. Bjoerling further discloses: wherein the at least one right atrial electrode comprises a first right atrial electrode ([Figure 1]; electrode 25) and a second right atrial electrode ([Figure 1]; electrode 26), wherein the controller is configured to monitor the right atrial impedance using the first right atrial electrode positioned in the right atrium ([0029]; Bjoerling discloses electrodes in the right atrium) and monitor the cross tricuspid valve impedance using the second right atrial electrode ([0029]; Bjoerling discloses electrodes in the right atrium, [0020]” In another embodiment of the present invention, a synchronicity between a closure of the mitral valve and the tricuspid valve, respectively, is determined based on the impedances.”), wherein the at least one right ventricular electrode comprises a first right ventricular electrode and a second right ventricle electrode positioned in the right ventricle ([Figure 1]; electrodes 24 and 22, [0029]; Bjoerling discloses electrodes in the right ventricle)), wherein the controller is configured to monitor the right ventricular impedance using the first right ventricular electrode and monitor the cross tricuspid valve impedance with the second right ventricle positioned in the right ventricle ([0020]” In another embodiment of the present invention, a synchronicity between a closure of the mitral valve and the tricuspid valve, respectively, is determined based on the impedances.”, [0029]; Bjoerling discloses electrodes in the right ventricle) , wherein the at least one left atrial electrode comprises a first left atrial electrode and a second left atrial electrode positioned in the left atrium ([Figure 1], [0029]; Bjoerling discloses electrodes in the left atrium), wherein the controller is configured to monitor the left atrial impedance using the first left atrial electrode positioned in the left atrium ([0048];” In order to sense left atrium and ventricular cardiac signals and impedances “, [0029]; Bjoerling discloses electrodes in the left atrium) and wherein the at least one left ventricular electrode comprises a first left ventricular electrode and a second left ventricle electrode, wherein the controller is configured to monitor the left ventricular impedance using the second left ventricle electrode positioned in the right ventricle ([0048];” In order to sense left atrium and ventricular cardiac signals and impedances and to provide pacing therapy for the left ventricle LV, the stimulation device 10 is coupled to a “coronary sinus” lead 30 “… “ LV lead 30 has an annular ring electrode 34 for sensing electrical activity related to the left ventricle LV of the heart. Moreover, a second valve plane electrode 36,”… “Furthermore, at the left hand side of the heart 1, the impedance Z36-32 between the left ventricular tip electrode 32 and the valve plane electrode 36 and the impedance Z36-35 between the valve plane electrode 36 and the electrode 35 located adjacent to the right atrium RA can be detected,” , [0029]; Bjoerling discloses electrodes in the left atrium)
Bjoerling does not explicitly disclose: and monitor the cross mitral valve impedance using the second left atrial electrode
However, Bloomqvist discloses: and monitor the cross mitral valve impedance using the second left atrial electrode ([Column 2 lines 41-46] “An electric signal is applied, using the electrodes, over at least a portion of the heart and a resulting electric signal is collected from the heart using the electrodes. The electric signals are processed by an impedance processor for determining impedance data reflective of the transvalvular impedance of a heart valve that is being monitored”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the IMD as disclosed by Bjoerling with the cross valve impedance measurement the motivation being to determine heart valve malfunction ([Abstract])
Regarding claim 14. Bjoerling in view of Bloomqvist disclose: The IMD of claim 9. Bjoerling further discloses: wherein the controller is further configured to: monitor a right atrial electrogram using the at least one right atrial electrode positioned in the right atrium ([0029]; Bjoerling discloses electrodes in the right atrium) monitor a right ventricular electrogram using the at least one right ventricular electrode positioned in the right ventricle ([0029]; Bjoerling discloses electrodes in the right ventricle); monitor a left atrial electrogram using the at least one left atrial electrode positioned in the left atrium ([0029]; Bjoerling discloses electrodes in the left atrium); monitor a left ventricular electrogram using the at least one left ventricular electrode positioned in the left ventricle ([0029]; Bjoerling discloses electrodes in the right atrium) ; and determine one or more pacing intervals based on the right atrial, right ventricular, left atrial, and left ventricular electrograms. . ([0047]; “right ventricular lead 20 having a ventricular tip electrode 22, a ventricular annular or ring electrode 24, and a first valve plane electrode 26. The ring electrode 24 is arranged for sensing electrical activity,” “electrical activity” is seen as including electrograms, [0065]; Bjoerling teaches extracting contraction patterns this is seen as pacing interval)
Regarding claim 15, Bjoerling in view of Bloomqvist disclose: The IMD of claim 14. Bjoerling further discloses: wherein the one or more pacing intervals comprises at least one of an atrioventricular timing interval between left atrial activation and left ventricular activation and an intraventricular timing interval between left ventricular activation and right ventricular activation. ([0047]; Bjoerling teaches the measuring of electrical activity and further [0065]; Bjoerling teaches extracting contraction patterns this is seen as timing interval information)
Regarding claim 16, Bjoerling in view of Bloomqvist disclose: The IMD of claim 9. Bjoerling further discloses: wherein the controller is further configured to: monitor a right atrial electrogram using the at least one right atrial electrode positioned in the right atrium ([Figure 1], [0029]; Bjoerling discloses electrodes in the right atrium); monitor a right ventricular electrogram using the at least one right ventricular electrode positioned in the right ventricle ([Figure 1], [0029]; Bjoerling discloses electrodes in the right ventricle); monitor a left atrial electrogram using the at least one left atrial electrode positioned in the left atrium ([Figure 1], [0029]; Bjoerling discloses electrodes in the left atrium); monitor a left ventricular electrogram using the at least one left ventricular electrode positioned in the left ventricle ([Figure 1], [0029]; Bjoerling discloses electrodes in the left ventricle); determine cardiac electrical activation timing of the patient's heart based on the right atrial, right ventricular, left atrial, and left ventricular electrograms; and identify one or more cardiac conditions based on the determined cardiac electrical activation timing of the patient's heart. ([0063]; “A physician using an extracorporeal programmer 144 can communicate, via a telemetry unit 142, with the heart stimulator 10 and thereby obtain information on identified conditions and also reprogram the different functions of the heart stimulator 10.”)
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bjoerling in view of Bloomqvist further in view of Kacricherla (US 7389134 B1)
Regarding claim 17, Bjoerling in view of Bloomqvist disclose: The IMD of claim 9. Bjoerling further dislcoses: A controller is further configured to monitor right ventricular pressure ([0065]; “the heart stimulator 10 has a hemodynamic parameter determining circuit 152 adapted to determine at least one hemodynamic parameter based on impedances received from the impedance measuring circuit 146 “ [0066] “ Accordingly, the impedance will vary over the cardiac cycle in connection with the contraction and filling of the atria and ventricles, respectively, in, hence, in connection with the pressure variations during the cycle. For example, the ventricle volume is at a maximum level at the onset of the systolic phase of the ventricles, which corresponds to a minimum impedance measured over the ventricles, and the ventricle volume is at a minimum level at onset of diastolic phase of the ventricles, which corresponds to a maximum”) Bjoerling does not explicitly disclose: wherein the transseptal lead further comprises a left ventricular pressure sensor positionable in the left ventricle and the right lead further comprises a right ventricular pressure sensor positionable in the right ventricle, wherein the controller is further configured to monitor right ventricular pressure using the right ventricular pressure sensor positioned in the right ventricle and monitor left ventricular pressure using the left ventricular pressure sensor positioned in the left ventricle.
However, Karicherla dislcoses: wherein the transseptal lead further comprises a left ventricular pressure sensor positionable in the left ventricle ([0047];” Through the use of leads that provide a secure and safe attachment to the septal wall and, in some case, other leads and sensors (e.g., lead 125 and sensor 127) implanted in the patient, the implantable cardiac device may be used to provide a variety of pressure measurements in real time”) and the right lead further comprises a right ventricular pressure sensor positionable in the right ventricle ([Figure 1] pressure sensor 107), wherein the controller is further configured to monitor right ventricular pressure using the right ventricular pressure sensor positioned in the right ventricle ([(124)]; Karicherla discloses pressure sensor being positioned in the right ventricle) and monitor left ventricular pressure using the left ventricular pressure sensor positioned in the left ventricle. ([0081];” (81) In some embodiments device 100 also may include circuitry for processing signals from one or more pressure sensors”, [(42)]; Karicherla discloses pressure sensing in the left ventricle)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the IMD as disclosed by Bjeorling with the pressure sensors as disclosed by Karicherla. The motivation being to obtain pressure measurements in real time to diagnose cardiac problems ([0047]).
Regarding claim 18, Bjoerling in view of Bloomqvist disclose: The IMD of claim 9. Bjoerling further discloses: wherein the controller is further configured to: monitor right ventricular pressure using the right ventricular pressure sensor positioned in the right ventricle ([0029]; Bjoerling discloses electrodes in the right ventricle) and monitor left ventricular pressure using the left ventricular pressure sensor positioned in the left ventricle ([0029]; Bjoerling discloses electrodes in the left ventricle); monitoring of one or more of a right atrial impedance using the at least one right atrial electrode positioned in the right atrium ([Figure 1]; electrode 26, [0047]; “In order to sense right ventricular and atrium cardiac signals and impedances and to provide stimulation therapy to the right ventricle RV, the stimulation device 10”, [0029]; Bjoerling discloses electrodes in the right atrium);, a right ventricular impedance using the at least one right ventricular electrode positioned right ventricle ([0047], [0029]; Bjoerling discloses electrodes in the right ventricle) , a left atrial impedance using the at least one left atrial electrode positioned in the left atrium ([0029]; Bjoerling discloses electrodes in the left atrium), and a left ventricular impedance using the at least one left ventricular electrode positioned in the left ventricle ([0048]; “In order to sense left atrium and ventricular cardiac signals and impedances and to provide pacing therapy for the left ventricle LV, the stimulation device 10 is coupled to a “coronary sinus” lead 30” , “ and measurement electrode 35, which may a annular or ring electrode, is located adjacent to the right atrium RA.”, ([0029]; Bjoerling discloses electrodes in the left ventricle). Bjorling does not explicitly disclose: wherein the transseptal lead further comprises a left ventricular pressure sensor positionable in the left ventricle and the right lead further comprises a right ventricular pressure sensor positionable in the right ventricle, wherein the controller is further configured to: monitor right ventricular pressure using the right ventricular pressure sensor positioned in the right ventricle and monitor left ventricular pressure using the left ventricular pressure sensor positioned in the left ventricle; and determine pressure-volume loop data based on the right and left ventricular pressures, right atrial impedance, right ventricular impedance, left atrial impedance, and left ventricular impedance.
However, Karicherla dislcoses: wherein the transseptal lead further comprises a left ventricular pressure sensor positionable in the left ventricle ventricle ([0047];” Through the use of leads that provide a secure and safe attachment to the septal wall and, in some case, other leads and sensors (e.g., lead 125 and sensor 127) implanted in the patient, the implantable cardiac device may be used to provide a variety of pressure measurements in real time”) and the right lead further comprises a right ventricular pressure sensor positionable in the right ventricle ([Figure 1] pressure sensor 107), wherein the controller is further configured to: monitor right ventricular pressure using the right ventricular pressure sensor positioned in the right ventricle and monitor left ventricular pressure using the left ventricular pressure sensor positioned in the left ventricle ([0081];” (81) In some embodiments device 100 also may include circuitry for processing signals from one or more pressure sensors”; and determine pressure-volume loop data based on the right and left ventricular pressures, right atrial impedance, right ventricular impedance, left atrial impedance, and left ventricular impedance. ( [0077]; “The stimulation device 100” , “measuring stroke volume; and detecting the opening of heart valves, etc” , [0082]; “A typical pressure sensor generates electrical signals indicative of changes in a sensed pressure. Thus, one or more wires may be used to connect a sensor to the device 100” the device would be able to, and it would be obvious to, generate a pressure volume loop)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the IMD as disclosed by Bjoerling with the pressure sensors and data acquisition as disclosed by Karicherla the motivation being to obtain pressure measurements in real time to diagnose cardiac problems ([0047]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bjoerling in view of further in view of Karicherla further in view of Rodgers (US 20160206244 A1)
Regarding claim 19, Bjoerling in view of Bloomqvist further in view Karicherla disclose The IMD of claim 18. Bjoerling does not explicitly disclose: wherein the pressure-volume loop data comprises information indicative of hypertrophy and cardiomyopathy.
However, Rodgers discloses: wherein the pressure-volume loop data comprises information indicative of hypertrophy ([0019]; ”FIG. 12 illustrates pressure-volume loops showing left ventricular hypertrophy”) and cardiomyopathy. ([0018];” [0018] FIG. 11 illustrates pressure-volume loops showing dilated cardiomyopathy.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the IMD as disclosed by Bjoerling with the hypertrophy data and cardiomyopathy data as disclosed by Rodgers the motivation being to determine a persons health and health trend ([0027])
Claim(s) 20 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bjoerling in view of Bloomqvst further in view of Karicherla further in view of Gilkerson et al. (US 20070129765 A1)
Regarding claim 20. Bjoerling in view of Bloomqvst further in view of Karicherla discloses: The IMD of claim 18. Bjoerling does not explicitly disclose: wherein the pressure-volume loop data comprises contractility data.
However, Gilkerson discloses: wherein the pressure-volume loop data comprises contractility data. ([0025];” The contractility index, or the capacity of the muscle for becoming shorter in response to a suitable stimulus, of the heart 8 can be estimated by calculating the slope of the end systolic pressure-volume line”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the IMD as disclosed by Bjoerling in view of Karicherla with the ability to obtain contractile data as disclosed by Gilkerson the motivation being to determine the heart muscles capacity to shorten in response to stimulus ([0025])
Regarding claim 22, Bjoerling in view of Bloomqvst further in view of Karicherla discloses: The IMD of claim 18. Bjoerling does not explicitly disclose: wherein the pressure-volume loop data comprises information indicative of pulmonary congestion or edema.
However, Gilkerson discloses: wherein the pressure-volume loop data comprises information indicative of pulmonary congestion or edema. ( [0026]; “FIG. 3B illustrates how a variety of abnormalities in the heart 8 result in changes in the PV loop. PV loop 74 is representative of congestive heart failure.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the IMD as disclosed by Bjoerling in view of Karicherla with the ability to obtain pulmonary congestion data the motivation being to identify abnormal cardiac conditions ([0026])
Regarding claim 23, Bjoerling in view of Bloomqvst further in view of Karicherla disclose: The IMD of claim 18, wherein the pressure-volume loop data comprises information indicative of cardiac muscular function.
However, Gilkerson discloses: wherein the pressure-volume loop data comprises information indicative of cardiac muscular function. ([0025];” The contractility index, or the capacity of the muscle for becoming shorter in response to a suitable stimulus, of the heart 8 can be estimated by calculating the slope of the end systolic pressure-volume line”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the IMD as disclosed by Bjoerling in view of Karicherla with the ability to obtain cardiac muscle function data as disclosed by Gilkerson the motivation being to determine the heart muscles capacity to shorten in response to stimulus ([0025])
Claim(s) 21 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bjoerling in view of further in view of Karicherla further in view of Dori et al. (US 20120172944 A1)
Regarding claim 21, Bjoerling in view of Bloomqvst further in view of Karicherla disclose: The IMD of claim 18. Bjoerling does not explicitly disclose: wherein the pressure-volume loop data comprises information indicative of diastolic heart failure.
However, Dori discloses: wherein the pressure-volume loop data comprises information indicative of diastolic heart failure. ([0077] “According to an aspect of some embodiments of the present invention there is provided a method of diagnosing diastolic heart failure including using the above-mentioned apparatus.” , [0340];” Reference is now made to FIG. 3D, which is a simplified graph 250 illustrating effects of LV diastolic failure caused by decreased ventricular compliance on LV pressure-volume loop.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the IMD as disclosed by Bjoerling in view of Karicherla with the ability to obtain diastolic heart failure data the motivation being to identify and treat diastolic heart failure ([0109])
Regarding claim 25, Bjoerling in view of Bloomqvst further in view of Karicherla further in view of Dori discloses: The IMD of claim 24. Bjoerling does not explicitly disclose: wherein the one or more cardiac conditions comprises atrial fibrillation.
However, Karicherla discloses: wherein the one or more cardiac conditions comprises atrial fibrillation. ([0031]; “. Each sensing circuit 244 and 246 preferably employs one or more low power, precision amplifiers with programmable gain and/or automatic gain control, bandpass filtering, and a threshold detection circuit, as known in the art, to selectively sense the cardiac signal of interest. The automatic gain control enables the device 100 to deal effectively with the difficult problem of sensing the low amplitude signal characteristics of atrial or ventricular fibrillation. “)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the IMD as disclosed by Bjoerling with the atrial fibrillation detection as disclosed by Aranda the motivation being know when to delivery defibrillation therapy to the heart ([0031]).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bjoerling in view of Menon
Regarding claim 24, Bjeorling teaches: An implantable medical device (IMD) ([0002];” The present invention relates to an implantable medical device “): comprising: a transseptal lead extending from a proximal end to a distal end ([Figure 1]; Bjoerling teaches leads 30 and 20 extending from proximal end closer to stimulation device 10 to a distal end) and comprising at least one right atrial electrode and at least one left atrial electrode ([Figure 1]; Bjoerling teaches electrode 36 which is seen as a left atrial electrode), the transseptal lead positionable through the interatrial septum from the right atrium to the left atrium of a patient's heart ([Figure 1]; Bjoerling teaches the lead extending over the interatrial septum (5) which is seen as positionable through the interatrial septum) to position the at least one right atrial electrode in the right atrium ([Figure 1]; (35)) and further through the mitral valve to position the at least one left atrial electrode in the left atrium ([Figure 1]; (36)); and a controller comprising one or more processors operably coupled to the transseptal lead and configured to: monitor a right atrial electrogram using the at least one right atrial electrode positioned in the right atrium ([0029]; Bjoerling teaches electrodes in the right atrium); monitor a left atrial electrogram using the at least one left atrial electrode positioned in the left atrium ([0029]; Bjoerling teaches electrodes in the left atrium); determine right atrium to left atrium electrical activation based on the right and left atrial electrograms ([0048]; Bjeorling teaches the use of electrodes to record electrical activity which is seen as an electrogram); and identify one or more cardiac conditions based on the determined right atrium to left atrium electrical activation. ([0049]; “36-35 between the valve plane electrode 36 and the electrode 35 located adjacent to the right atrium RA can be detected, [0009] Bjoerling teaches the use of impedance to diagnosis cardiac conditions) Bjeorling does not explicitly disclose: The lead further through the mitral valve.
However, Menon discloses: The lead further through the mitral valve ([Column 3 line 67 and Column 4 lines 1-6] “comprises advancing the cannula from the left atrium through the mitral valve “)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the IMD as disclosed by Bjoerling with the lead crossing through the mitral valve as disclosed by Menon the motivation being to place the lead in the left ventricle ([Column 3 lines 1-7])
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/CASEY GEORGE CHA/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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