DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Continued Examination Under 37 CFR 1.114
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 27 January 2026 has been entered.
Status of Claims
3. Claims 1-30 are pending, of which claims 1, 12, and 24 have been amended; claim 30 has been added; and claims 1-30 are under consideration for patentability.
Response to Arguments
4. Applicant’s arguments dated 18 December 2025, referred to herein as “the Arguments”, have been fully considered, but they are not persuasive.
Applicant argues that Liu does not explicitly teach the amended limitation that recites wherein the IMD extends along the longitudinal axis from a proximal end of the IMD to a distal end of the IMD (pages 8-10 of the Arguments). The Examiner respectfully disagrees, as Liu teaches the IMD to have a flexible component which can bent to align with a central longitudinal axis of the IMD ([0080, 0096-0097]). For example, Liu teaches the IMD or pacing device 20 comprising a housing 22 consisting of a first portion 22a (e.g., proximal portion) and a header 22b that extends along a central longitudinal axis parallel to line A ([0056, 0080, FIG. 2]). Furthermore, the distal extension 24 is flexible component that is configured to extend from the housing 22 at any suitable angle relative to the central longitudinal axis ([0080, 0096-0097, FIG. 2]). In this case, the Examiner respectfully submits that the distal extension 24 may be configured to extend at an angle that aligns with the central longitudinal axis of the housing 22 ([0080, 0096-0097]). Thus, the Examiner respectfully maintains that Liu suggests wherein the IMD extends along the longitudinal axis from a proximal end of the IMD to a distal end of the IMD.
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1-7, 9-10, 24-25, 28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2020/0306547 A1).
Regarding claim 1, Liu teaches an implantable medical device (IMD) (the pacing device 20 is implanted within the patient’s heart 10 [0056, FIG. 1]) comprising:
a housing defining a longitudinal axis (the pacing device 20 includes a housing 22 which defines a central longitudinal axis [0020, 0057, 0080, FIG. 2]);
a header at a distal end of the housing (the header 22b is disposed at the distal end of the housing 22 [0080, FIG. 2]), the header defining a header plane (the header 22b of the housing 22 defines a longitudinal plane or axis [0080, FIG. 2]), the header plane disposed at an angle (the header 22b of the housing 22 may be bent at an angle [0080]. Specifically, this would affect the angle of the plane that is defined by the header 22b [0080]);
wherein the IMD extends along the longitudinal axis from a proximal end of the IMD to a distal end of the IMD (the IMD or pacing device 20 comprising a housing 22 consisting of a first portion 22a (e.g., proximal portion) and a header 22b that extends along a central longitudinal axis parallel to line A [0056, 0080, FIG. 2]. Furthermore, the distal extension 24 is flexible component that is configured to extend from the housing 22 at any suitable angle relative to the central longitudinal axis [0080, 0096-0097, FIG. 2]. In this case, the Examiner respectfully submits that the distal extension 24 may be configured to extend at an angle that aligns with the central longitudinal axis of the housing 22 [0080, 0096]);
a fixation mechanism extending from the header (the header 22b comprises a distal extension 24 which includes anchors (e.g., tines) that are configured to engage the tissue [0068, 0082, FIG. 2]), the fixation mechanism configured to be advanced into tissue of a heart of a patient to fix at least a portion of the IMD to the heart ([0068]);
one or more electrodes that extend directly from the header (the one or more electrodes (e.g., electrodes 30-36) may be configured to span a length (e.g., an entire length or a partial length) of the distal extension 24 which extends from the header 22b of the housing 22 [0067, 0070]. This configuration would allow the one or more electrodes to extend directly from the header, as the one or more electrodes will span or cover the entire length of the distal extension 24 which is directly attached to the header 22b [0060, 0067, 0070]. Alternatively, the one or more electrodes may cover or span a portion (e.g., partial length) of the distal extension 24 that is attached is attached directly to the header 22b [0060, 0067, 0070]) and are configured to engage with heart tissue ([0064, 0070-0071]); and
circuitry within the housing (the housing 22 of the pacing device 20 comprises an electronics module or circuit which includes a pulse generating module 62 [0053, 0099, 0105]), wherein the circuitry is configured to deliver cardiac pacing to the heart via the one or more electrodes (the electronics module or circuit includes a pulse generating module 62 that provides the stimulation pulses to the electrodes 30, 32, 34, and 36 [0099, 0105]. Specifically, the electrodes 30, 32, 34, and 36 are configured to provide cardiac pacing [0060, 0064, 0074]).
Liu does not explicitly teach wherein the angle of the header plane is positioned relative to a reference plane, where the reference plane is perpendicular to the longitudinal axis.
The Examiner respectfully submits, as Liu teaches the use of a header plane (the header 22b of the housing 22 may be bent at an angle [0080]. Specifically, this would affect the angle of the plane that is defined by the header 22b [0080]), configuring the angle of the header plane to be positioned relative to a reference plane that is perpendicular to the longitudinal axis would be a matter of rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 2, Liu suggests the IMD of claim 1, wherein the header plane may be disposed at various angles (the header 22b of the housing 22 may be bent at a desired angle [0080]. Specifically, this would affect the angle of the plane or axis that is defined by the header 22b [0080]).
Liu does not explicitly teach wherein the angle is 5 – 45 degrees from the reference plane.
The Examiner respectfully submits that a person having ordinary skill in the art would have found it obvious to use an angle that is 5 – 45 degrees from the reference plane. This modification may allow the header to positioned at such an angle that improves the engagement between the electrodes and the tissue (see paragraph [0080] by Liu). The Examiner further submits that the skilled artisan could arrive at the claimed range of angles via routine experimentation (MPEP 2144.05).
Regarding claim 3, Liu suggests the IMD of claim 2, wherein the header plane may be disposed at various angles (the header 22b of the housing 22 may be bent at a desired angle [0080]. Specifically, this would affect the angle of the plane or axis that is defined by the header 22b [0080]).
Liu does not explicitly teach wherein the angle is 15 degrees.
The Examiner respectfully submits that a person having ordinary skill in the art would have found it obvious to use an angle that is 15 degrees from the reference plane. This modification may allow the header to positioned at such an angle that improves the engagement between the electrodes and the tissue (see paragraph [0080] by Liu). The Examiner further submits that the skilled artisan could arrive at such an angle via routine experimentation (MPEP 2144.05).
Regarding claim 4, Liu suggests the IMD of claim 1, wherein the one or more electrodes comprise:
a first electrode extending distally and directly from the header at a first length (the header 22b may comprise a plurality of distal extensions 24 that are covered by one or more respective electrodes (e.g., electrodes 30, 32, 34, and 36) [0057, 0070, 0082, FIG. 2]. Specifically, the one or more electrodes (e.g., electrodes 30, 32, 34, and 36) may span a length (e.g., entire length or partial length) of each distal extension 24 which extends from the header 22b [0057, 0067, 0070, 0082, FIG. 2]. For example, the first electrode (e.g., electrode 30) may be configured to cover or span a portion (e.g., partial length) of the first distal extension 24 that is attached to the header 22b [0057, 0060, 0067, 0070]. As stated previously in claim 1, this configuration allows the one or more electrodes to extend directly from the header [see claim 1 above]) and are configured to engage with heart tissue ([0064, 0070-0071]);
a second electrode extending distally and directly from the header at a second length (the header 22b may comprise a plurality of distal extensions 24 that are covered by one or more respective electrodes (e.g., electrodes 30, 32, 34, and 36) [0057, 0070, 0082, FIG. 2]. Specifically, the one or more electrodes (e.g., electrodes 30, 32, 34, and 36) may span a length (e.g., entire length or partial length) of each distal extension 24 which extends from the header 22b [0057, 0067, 0070, 0082, FIG. 2]. For example, the second electrode (e.g., electrode 32) may be configured to cover or span an entire length of the second distal extension 24 that is attached to the header 22b [0057, 0060, 0067, 0070]. As stated previously in claim 1, this configuration allows the one or more electrodes to extend directly from the header [see claim 1 above]); and
wherein the second length is greater than the first length (as stated previously above, the first electrode (e.g., electrode 30) may be configured to cover or span a portion (e.g., partial length) of the first distal extension 24 that is attached to the header 22b [0057, 0060, 0067, 0070]. Meanwhile, the second electrode (e.g., electrode 32) may be configured to cover or span an entire length of the second distal extension 24 that is attached to the header 22b [0057, 0060, 0067, 0070]. The Examiner respectfully submits that this configuration would result in the second electrode (e.g., electrode 32) having a greater length than the first electrode (e.g., electrode 30) [0057, 0060, 0067, 0070]).
Regarding claim 5, Liu teaches wherein the circuitry is configured to deliver atrial pacing therapy via the first electrode, and ventricular pacing therapy via the second electrode (the pulse generating module 62 of the pacing device 20 is configured to provide pacing pulses to the right atrium, left atrium, right ventricle, and/or left ventricle via the electrodes 30, 32, 34, and 36 [0054, 0056, 0071, 0098-0099]. As stated previously in claim 4, the header 22b may comprise a plurality of distal extensions 24 that have a respective set of electrodes (e.g., electrodes 30, 32, 34, and 36) [0057, 0070, 0082, FIG. 2]. Specifically, the first distal extension 24 may position the first set of electrodes 30, 32, 34, and 36 within the left atrium 12 to provide pacing to the left atrium 12 of the patient’s heart 10 [0056-0057, 0098]. Furthermore, the second distal extension 24 may position the second set of electrodes 30, 32, 34, and 36 within the left ventricle 14 to provide pacing to the left ventricle 14 of the patient’s heart 10 [0056-0057, 0071]).
Regarding claim 6, Liu teaches wherein the first electrode is configured to extend into tissue of a first chamber of the heart, and the second electrode configured to extend into tissue of a second chamber of the heart (the pulse generating module 62 of the pacing device 20 is configured to provide pacing pulses to the right atrium, left atrium, right ventricle, and/or left ventricle via the electrodes 30, 32, 34, and 36 [0054, 0056, 0071, 0098-0099]. As stated previously in claim 4, the header 22b may comprise a plurality of distal extensions 24 that have a respective set of electrodes (e.g., electrodes 30, 32, 34, and 36) [0057, 0070, 0082, FIG. 2]. Specifically, the first distal extension 24 may position the first set of electrodes 30, 32, 34, and 36 within the left atrium 12 to provide pacing to the left atrium 12 of the patient’s heart 10 [0056-0057, 0098]. Furthermore, the second distal extension 24 may position the second set of electrodes 30, 32, 34, and 36 within the left ventricle 14 to provide pacing to the left ventricle 14 of the patient’s heart 10 [0056-0057, 0071]).
Regarding claim 7, Liu suggests the IMD of claim 1. Liu does not explicitly teach wherein the one or more electrodes are configured to extend parallel to the longitudinal axis.
The Examiner respectfully submits, as Liu teaches the use of electrodes (the distal extension 24 includes the electrodes 30, 32, 34 and 36 [0070, FIG. 2]) and a longitudinal axis (the housing 22 defines a central longitudinal axis [0020, 0057, 0080, FIG. 2]), configuring the electrodes to extend parallel to the longitudinal axis would be a matter of rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 9, Liu teaches wherein the fixation mechanism comprises a plurality of tines ([0068]).
Regarding claim 10, Liu suggests the IMD of claim 9. Liu does not explicitly teach wherein the plurality of tines includes a first set of tines and a second set of tines, the first set of tines having a different length than the second set of tines.
The Examiner respectfully submits, as the Liu teaches a plurality of tines ([0068]), configuring the exact number and lengths of tines as claimed would be a matter of duplicating and changing the size of the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 24, Liu teaches a method ([0002]) comprising:
advancing a medical device system within a patient ([0066]), the medical device system comprising a catheter extending to a distal end (the pacing device 20 may be positioned within the delivery / retrieval catheter 88 [0066, 0160, FIG. 28]. Specifically, figure 28 illustrates the delivery / retrieval catheter 88 extending from a proximal to a distal end [0160, FIG. 28]), the catheter having a cup at the distal end of the catheter (figure 28 illustrates the delivery / retrieval catheter 88 having a cup or receptacle which contains the pacing device 20 [0160, FIG. 28]), the cup having a distal cup end (figure 28 illustrates the receptacle of the delivery / retrieval catheter 88 having a distal end [0160, FIG. 28]), the distal cup end defined by a cup end plane and a cup longitudinal axis (the Examiner respectfully submits that the receptacle of the delivery / retrieval catheter 88 includes a distal end which is inherently defined by a plane and longitudinal axis [FIG. 28]), and an implantable medical device (IMD) disposed within the cup (the pacing device 20 may be positioned within the receptacle of the delivery / retrieval catheter 88 [0160, FIG. 28]), the IMD comprising a housing having a header (the pacing device 20 comprises a housing 22 having a header 22b [0080, FIG. 2]), the header having one or more electrodes that extend directly from the header (the one or more electrodes (e.g., electrodes 30-36) may be configured to span a length (e.g., an entire length or a partial length) of the distal extension 24 which extends from the header 22b of the housing 22 [0067, 0070]. This configuration would allow the one or more electrodes to extend directly from the header, as the one or more electrodes will span or cover the entire length of the distal extension 24 which is directly attached to the header 22b [0060, 0067, 0070]. Alternatively, the one or more electrodes may cover or span a portion (e.g., partial length) of the distal extension 24 that is attached is attached directly to the header 22b [0060, 0067, 0070]), the housing defined in part by a longitudinal axis (the pacing device 20 includes a housing 22 which defines a central longitudinal axis [0020, 0057, 0080, FIG. 2]), the header is defined by a header plane (the header 22b of the housing 22 defines a longitudinal plane or axis [0080, FIG. 2]), the header plane disposed at an angle (the header 22b of the housing 22 may be bent at an angle [0080]. Specifically, this would affect the angle of the plane that is defined by the header 22b [0080]), wherein the IMD extends along the longitudinal axis from a proximal end of the IMD to a distal end of the IMD (the IMD or pacing device 20 comprising a housing 22 consisting of a first portion 22a (e.g., proximal portion) and a header 22b that extends along a central longitudinal axis parallel to line A [0056, 0080, FIG. 2]. Furthermore, the distal extension 24 is flexible component that is configured to extend from the housing 22 at any suitable angle relative to the central longitudinal axis [0080, 0096-0097, FIG. 2]. In this case, the Examiner respectfully submits that the distal extension 24 may be configured to extend at an angle that aligns with the central longitudinal axis of the housing 22 [0080, 0096]), the IMD comprising one or more electrodes configured to be advanced into heart tissue of a patient (the header 22b comprises a distal extension 24 having a plurality of electrodes 30, 32, 34, and 36 that are advanced into a heart tissue [0060, 0064, 0070-0071, 0082, FIG. 2]), wherein the one or more electrodes are configured to deliver cardiac pacing to the heart tissue (the electrodes 30, 32, 34, and 36 are configured to provide cardiac pacing [0060, 0064, 0074]);
delivering the IMD to an implant site with the catheter and placing the cup end plane on the tissue (the cup or receptacle of the delivery / retrieval catheter 88 includes a distal end that is placed into contact with the tissue wall [0163]. Specifically, this allows the pacing device 20 to be delivered through the receptacle of the delivery / retrieval catheter 88 and into the tissue wall [0066, 0163]);
advancing the IMD from the cup (the pacing device 20 is delivered through the receptacle of the delivery / retrieval catheter 88 and into the tissue wall [0066, 0163]); and
engaging the one or more electrodes with the tissue (the electrodes 30, 32, 34 and 36 are configured to engage the tissue [0060, 0064, 0071]).
Liu do not explicitly teach wherein the cup end plane is disposed at a cup angle relative to the cup longitudinal axis, and wherein the cup longitudinal axis is non-orthogonal relative to a tissue plane
The Examiner respectfully submits, as Liu teaches the use of a cup end plane and cup longitudinal axis (the receptacle of the delivery / retrieval catheter 88 includes a distal end which is inherently defined by a plane and longitudinal axis [FIG. 28]), configuring the cup plane to be disposed at a cup angle relative to the cup longitudinal axis and the cup longitudinal axis to be non-orthogonal relative to a tissue plane would be a matter of changing the shape and rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Liu does not explicitly teach wherein the angle of the header plane is positioned relative to a reference plane, wherein the reference plane is perpendicular to the longitudinal axis.
The Examiner respectfully submits, as Liu teaches the use of a header plane (the header 22b of the housing 22 may be bent at an angle [0080]. Specifically, this would affect the angle of the plane or axis that is defined by the header 22b [0080]), configuring the angle of the header plane to be positioned relative to a reference plane that is perpendicular to the longitudinal axis would be a matter of rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 25, Liu suggests the method of claim 24, wherein the longitudinal axis of the housing is positioned relative to the tissue plane when engaging the one or more electrodes with the tissue (the pacing device 20 comprising a housing 22 having a longitudinal axis that is positioned relative to the tissue when the electrodes 30, 32, 34, and 36 are engaged with the tissue [0064, 0074, 0080, 0130]).
However, Liu does not explicitly teach wherein the longitudinal axis of the housing is non-orthogonal relative to the tissue plane.
The Examiner respectfully submits, as Liu teaches the longitudinal axis of the housing being positioned relative to the tissue plane (the housing 22 includes a longitudinal axis that is positioned relative to the tissue [0064, 0074, 0080, 0130]), configuring the longitudinal axis of the housing to be non-orthogonal relative to the tissue plane would be a matter of rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 28, Liu teaches wherein delivering the IMD to the implant site with the catheter comprises delivering the IMD to a coronary sinus ostium ([0056, 0160-0161]).
Regarding claim 30, Liu teaches wherein the one or more electrodes extend in a direction parallel to the longitudinal axis (as stated previously in claim 1, the one or more electrodes (e.g., electrodes 30-36) may be configured to span a length (e.g., an entire length or a partial length) of the distal extension 24 which extends from the header 22b of the housing 22 [0067, 0070]. Specifically, the distal extension 24 is flexible component that is configured to extend from the housing 22 at any suitable angle relative to the central longitudinal axis [0080, 0096-0097]. In this case, the distal extension 24 may be positioned at an angle that allows the one or more electrodes to extend in a direction that is parallel to the central longitudinal axis of the housing 22 [0070, 0080, 0096]).
7. Claims 8, 11-16, and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. in view of Yang (US 2019/0083801 A1).
Regarding claim 8, Liu suggests the IMD of claim 1. Liu does not explicitly teach wherein the one or more electrodes are configured to pierce a septum of the heart.
The prior art by Yang is analogous to Liu, as they both teach an implantable device that is configured to provide cardiac pacing ([abstract, 0035]).
Yang teaches wherein the one or more electrodes are configured to pierce a septum of the heart (the distal assembly 36 may include a tissue-pierce electrode that is configured to pierce a ventricular septum or an atrial septum [0035]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the electrodes suggested by Liu to pierce a septum of the heart, as taught by Yang. The advantage of such modification will allow the electrodes to provide pacing at a desired depth within the atrial septum or ventricular septum (see paragraph [0035] by Yang).
Regarding claim 11, Yang teaches wherein the plurality of tines is configured to be advanced into the septum by piercing the septum (the fixation member portion 52 comprises fixation tines 52a-52d that are configured to penetrate through a pacing site (e.g., ventricular septum or atrial septum) [0034-0035]).
Regarding claim 12, Liu teaches a medical device system ([abstract]) comprising:
an implantable medical device (IMD) (the pacing device 20 is implanted within the patient’s heart 10 [0056, FIG. 1]) comprising:
a housing defining a longitudinal axis (the pacing device 20 includes a housing 22 which defines a central longitudinal axis [0020, 0057, 0080, FIG. 2]);
a header at a distal end of the housing (the header 22b is disposed at the distal end of the housing 22 [0080, FIG. 2]), the header defining a header plane (the header 22b of the housing 22 defines a longitudinal plane or axis [0080, FIG. 2]), the header plane disposed at an angle (the header 22b of the housing 22 may be bent at an angle [0080]. Specifically, this would affect the angle of the plane that is defined by the header 22b [0080]);
wherein the IMD extends along the longitudinal axis from a proximal end of the IMD to a distal end of the IMD (the IMD or pacing device 20 comprising a housing 22 consisting of a first portion 22a (e.g., proximal portion) and a header 22b that extends along a central longitudinal axis parallel to line A [0056, 0080, FIG. 2]. Furthermore, the distal extension 24 is flexible component that is configured to extend from the housing 22 at any suitable angle relative to the central longitudinal axis [0080, 0096-0097, FIG. 2]. In this case, the Examiner respectfully submits that the distal extension 24 may be configured to extend at an angle that aligns with the central longitudinal axis of the housing 22 [0080, 0096]);
a fixation mechanism extending from the header (the header 22b comprises a distal extension 24 which includes anchors (e.g., tines) that are configured to engage the tissue [0068, 0082, FIG. 2]), the fixation mechanism configured to be advanced into tissue of a heart of a patient to fix at least a portion of the IMD to the heart ([0068]);
one or more electrodes that extend directly from the header (the one or more electrodes (e.g., electrodes 30-36) may be configured to span a length (e.g., an entire length or a partial length) of the distal extension 24 which extends from the header 22b of the housing 22 [0067, 0070]. This configuration would allow the one or more electrodes to extend directly from the header, as the one or more electrodes will span or cover the entire length of the distal extension 24 which is directly attached to the header 22b [0060, 0067, 0070]. Alternatively, the one or more electrodes may cover or span a portion (e.g., partial length) of the distal extension 24 that is attached is attached directly to the header 22b [0060, 0067, 0070]) and are configured to engage with heart tissue ([0064, 0070-0071]);
circuitry within the housing (the housing 22 of the pacing device 20 comprises an electronics module or circuit which includes a pulse generating module 62 [0053, 0099, 0105]), wherein the circuitry is configured to deliver cardiac pacing to the heart via the one or more electrodes (the electronics module or circuit includes a pulse generating module 62 that provides the stimulation pulses to the electrodes 30, 32, 34, and 36 [0099, 0105]. Specifically, the electrodes 30, 32, 34, and 36 are configured to provide cardiac pacing [0060, 0064, 0074]); and
a catheter extending to a distal end (the pacing device 20 may be positioned within the delivery / retrieval catheter 88 [0160, FIG. 28]. Specifically, figure 28 illustrates the delivery / retrieval catheter 88 extending from a proximal to a distal end [0160, FIG. 28]), the catheter having a cup at the distal end of the catheter (figure 28 illustrates the delivery / retrieval catheter 88 having a cup or receptacle which contains the pacing device 20 [0160, FIG. 28]), the cup having a distal cup end (figure 28 illustrates the receptacle of the delivery / retrieval catheter 88 having a distal end [0160, FIG. 28]), the distal cup end defined by a cup end plane and a cup longitudinal axis (the Examiner respectfully submits that the receptacle of the delivery / retrieval catheter 88 includes a distal end which is inherently defined by a plane and longitudinal axis [FIG. 28]), and wherein the IMD is configured to be disposed within the cup (the pacing device 20 may be positioned within the receptacle of the delivery / retrieval catheter 88 [0160, FIG. 28]).
Liu does not explicitly teach wherein the angle of the header plane is positioned relative to a reference plane, where the reference plane is perpendicular to the longitudinal axis.
The Examiner respectfully submits, as Liu teaches the use of a header plane (the header 22b of the housing 22 may be bent at an angle [0080]. Specifically, this would affect the angle of the plane or axis that is defined by the header 22b [0080]), configuring the angle of the header plane to be positioned relative to a reference plane that is perpendicular to the longitudinal axis would be a matter of rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Although Liu teaches the IMD being disposed within the cup (the pacing device 20 may be positioned within the receptacle of the delivery / retrieval catheter 88 [0160, FIG. 28]), Liu does not explicitly teach the IMD to be disposed within the cup while the IMD is delivered to a septum within the patient.
The prior art by Yang is analogous to Liu, as they both teach an implantable device that is configured to provide cardiac pacing ([abstract, 0035]).
Yang teaches the IMD to be disposed within the cup while the IMD is delivered to a septum within the patient (the pacemaker 10 is disposed within the cup or receptacle 108 of an outer catheter 102 [0063, 0067, FIG. 6]. Specifically, pacemaker 10 is retained within the receptacle 108 while being delivered to the implant or pacing site (e.g., ventricular septum or atrial septum) [0035, 0063]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Liu’s IMD to be maintained within the cup while being delivered to a septum within the patient, as taught by Yang. The advantage of such modification will allow the IMD provide pacing at a desired depth within the atrial septum or ventricular septum (see paragraphs [0035, 0063] by Yang).
Regarding claim 13, Liu in view of Yang suggests the medical device system of claim 12. Liu and Yang do not explicitly teach wherein the cup end plane is disposed at a cup angle relative to the cup longitudinal axis.
The Examiner respectfully submits, as Liu teaches the use of a cup end plane and cup longitudinal axis (the receptacle of the delivery / retrieval catheter 88 includes a distal end which is inherently defined by a plane and longitudinal axis [FIG. 28]), configuring the cup plane to be disposed at a cup angle relative to the cup longitudinal axis would be a matter of changing the shape and rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 14, Liu in view of Yang suggests the medical device system of claim 14. Liu and Yang do not explicitly teach wherein the cup angle is 5 – 45 degrees relative to the cup longitudinal axis.
The Examiner respectfully submits that a person having ordinary skill in the art would have found it obvious to use a cup angle that is 5 – 45 degrees relative to the cup longitudinal axis. The advantage of such modification may provide the cup of the catheter with an improved angle for delivering the IMD to the implant site and/or retrieving the IMD from the implant site (see paragraphs [0160, 0166]). The Examiner respectfully submits that the skilled artisan could arrive at such an angle via routine experimentation (MPEP 2144.05).
Regarding claim 15, Liu in view of Yang suggests the medical device of claim 14. Liu and Yang do not explicitly teach wherein the cup angle is 15 degrees.
The Examiner respectfully submits that a person having ordinary skill in the art would have found it obvious to use a cup angle that is 15 degrees relative to the cup longitudinal axis. The advantage of such modification may provide the cup of the catheter with an improved angle for delivering the IMD to the implant site and/or retrieving the IMD from the implant site (see paragraphs [0160, 0166]). The Examiner respectfully submits that the skilled artisan could arrive at such an angle via routine experimentation (MPEP 2144.05).
Regarding claim 16, Liu in view of Yang suggests the medical device system of claim 13. Liu and Yang do not explicitly teach wherein the cup end plane is parallel with the header plane.
The Examiner respectfully submits, as Liu teaches the use of a cup end plane (the receptacle of the delivery / retrieval catheter 88 includes a distal end which is inherently defined by a plane and longitudinal axis [FIG. 28]) and a header plane ((the header 22b of the housing 22 defines a longitudinal plane and axis [0080, FIG. 2]), configuring the cup end plane to be parallel with the header plane would be a matter of rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 19, Liu in view of Yang suggests the medical device of claim 12. Liu teaches wherein the header plane may be disposed at various angles (the header 22b of the housing 22 may be bent at a desired angle [0080]. Specifically, this would affect the angle of the plane or axis that is defined by the header 22b [0080]).
Liu and Yang do not explicitly teach wherein the angle is 5 – 45 degrees from the reference plane.
The Examiner respectfully submits that a person having ordinary skill in the art would have found it obvious to use an angle that is 5 – 45 degrees from the reference plane. This modification may allow the header to positioned at such an angle that improves the engagement between the electrodes and the tissue (see paragraph [0080] by Liu). The Examiner further submits that the skilled artisan could arrive at the claimed range of angles via routine experimentation (MPEP 2144.05).
Regarding claim 20, Liu in view of Yang suggests the medical device of claim 19. Liu teaches wherein the header plane may be disposed at various angles (the header 22b of the housing 22 may be bent at a desired angle [0080]. Specifically, this would affect the angle of the plane or axis that is defined by the header 22b [0080]).
Liu and Yang do not explicitly teach wherein the angle is 15 degrees.
The Examiner respectfully submits that a person having ordinary skill in the art would have found it obvious to use an angle that is 15 degrees from the reference plane. This modification may allow the header to positioned at such an angle that improves the engagement between the electrodes and the tissue (see paragraph [0080] by Liu). The Examiner further submits that the skilled artisan could arrive at such an angle via routine experimentation (MPEP 2144.05).
Regarding claim 21, Liu in view of Yang suggests the medical device system of claim 12. Liu teaches wherein the one or more electrodes comprise:
a first electrode extending distally and directly from the header at a first length (the header 22b may comprise a plurality of distal extensions 24 that are covered by one or more respective electrodes (e.g., electrodes 30, 32, 34, and 36) [0057, 0070, 0082, FIG. 2]. Specifically, the one or more electrodes (e.g., electrodes 30, 32, 34, and 36) may span a length (e.g., entire length or partial length) of each distal extension 24 which extends from the header 22b [0057, 0067, 0070, 0082, FIG. 2]. For example, the first electrode (e.g., electrode 30) may be configured to cover or span a portion (e.g., partial length) of the first distal extension 24 that is attached to the header 22b [0057, 0060, 0067, 0070]. As stated previously in claim 12, this configuration allows the one or more electrodes to extend directly from the header [see claim 12 above]) and are configured to engage with heart tissue ([0064, 0070-0071]);
a second electrode extending distally and directly from the header at a second length (the header 22b may comprise a plurality of distal extensions 24 that are covered by one or more respective electrodes (e.g., electrodes 30, 32, 34, and 36) [0057, 0070, 0082, FIG. 2]. Specifically, the one or more electrodes (e.g., electrodes 30, 32, 34, and 36) may span a length (e.g., entire length or partial length) of each distal extension 24 which extends from the header 22b [0057, 0067, 0070, 0082, FIG. 2]. For example, the second electrode (e.g., electrode 32) may be configured to cover or span an entire length of the second distal extension 24 that is attached to the header 22b [0057, 0060, 0067, 0070]. As stated previously in claim 12, this configuration allows the one or more electrodes to extend directly from the header [see claim 12 above]); and
wherein the second length is greater than the first length (as stated previously above, the first electrode (e.g., electrode 30) may be configured to cover or span a portion (e.g., partial length) of the first distal extension 24 that is attached to the header 22b [0057, 0060, 0067, 0070]. Meanwhile, the second electrode (e.g., electrode 32) may be configured to cover or span an entire length of the second distal extension 24 that is attached to the header 22b [0057, 0060, 0067, 0070]. The Examiner respectfully submits that this configuration would result in the second electrode (e.g., electrode 32) having a greater length than the first electrode (e.g., electrode 30) [0057, 0060, 0067, 0070]).
Regarding claim 22, Liu teaches wherein the circuitry is configured to deliver atrial pacing therapy via the first electrode, and ventricular pacing therapy via the second electrode (the pulse generating module 62 of the pacing device 20 is configured to provide pacing pulses to the right atrium, left atrium, right ventricle, and/or left ventricle via the electrodes 30, 32, 34, and 36 [0054, 0056, 0071, 0098-0099]. The Examiner respectfully submits that the header 22b may comprise a plurality of distal extensions 24 which have a respective set of electrodes (e.g., electrodes 30, 32, 34, and 36) [0057, 0070, 0082, FIG. 2]. Specifically, the first distal extension 24 may position the first set of electrodes 30, 32, 34, and 36 within the left atrium 12 to provide pacing to the left atrium 12 of the patient’s heart 10 [0056-0057, 0098]. Furthermore, the second distal extension 24 may position the second set of electrodes 30, 32, 34, and 36 within the left ventricle 14 to provide pacing to the left ventricle 14 of the patient’s heart 10 [0056-0057, 0071]).
Regarding claim 23, Liu teaches wherein the first electrode is configured to extend into tissue of a first chamber of the heart, and the second electrode configured to extend into tissue of a second chamber of the heart (the pulse generating module 62 of the pacing device 20 is configured to provide pacing pulses to the right atrium, left atrium, right ventricle, and/or left ventricle via the electrodes 30, 32, 34, and 36 [0054, 0056, 0071, 0098-0099]. The Examiner respectfully submits that the header 22b may comprise a plurality of distal extensions 24 which have a respective set of electrodes (e.g., electrodes 30, 32, 34, and 36) [0057, 0070, 0082, FIG. 2]. Specifically, the first distal extension 24 may position the first set of electrodes 30, 32, 34, and 36 within the left atrium 12 to provide pacing to the left atrium 12 of the patient’s heart 10 [0056-0057, 0098]. Furthermore, the second distal extension 24 may position the second set of electrodes 30, 32, 34, and 36 within the left ventricle 14 to provide pacing to the left ventricle 14 of the patient’s heart 10 [0056-0057, 0071]).
8. Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. in view of Yang, further in view of Meade et al. (US 2018/0280058 A1).
Regarding claim 17, Liu in view of Yang suggests the medical device system of claim 12. Liu and Yang do not explicitly teach wherein the catheter is a deflectable catheter.
The prior art by Meade is analogous to Liu, as they both teach an implantable medical device that is configured to provide cardiac pacing to a patient’s heart ([0026-0027, 0029]).
Meade teaches wherein the catheter is a deflectable catheter ([0052, 0054]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the catheter suggested by Liu in view of Yang to be a deflectable catheter, as taught by Meade. The advantage of such modification will allow the catheter to be deflected into a desired position at the implant site (see paragraphs [0052, 0054] by Meade).
Regarding claim 18, Liu in view of Yang and Meade suggests the medical device system of claim 12. Liu, Yang, and Meade do not explicitly teach wherein the deflectable catheter is configured to deflect such that the cup end plane is parallel to the tissue of the patient when the IMD is delivered to the septum.
However, the Examiner respectfully submits that Meade and Yang suggests wherein the deflectable catheter is configured to deflect such that the cup end plane is moved into a desired position when the IMD is delivered to the septum (Meade teaches the catheter 700 comprises a distal opening or cup 72 that may be deflected when the IMD 300 is delivered to the implant site [0052, 0054, FIG. 9B]. As stated previously in claim 12, Yang teaches the implant site to be the ventricular septum or atrial septum [0035, 0063]). Thus, a person having ordinary skill in the art would have found it obvious to try to deflect the catheter such that the cup end plane is parallel to the tissue of the patient when the IMD is delivered to the septum (MPEP 2143). The advantage of such modification may improve the positioning or alignment of the IMD on the tissue during the implantation process (see paragraphs [0052, 0054] by Meade).
9. Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. in view of Drake (US 2020/0197705 A1).
Regarding claim 27, Liu suggests the method of claim 24. Liu does not explicitly teach wherein delivering the IMD to the implant site with the catheter comprises delivering the IMD to a triangle of Koch.
The prior art by Drake is analogous to Liu, as they both teach an implantable medical device that is configured to provide cardiac pacing ([0009]).
Drake teaches wherein delivering the IMD to the implant site with the catheter comprises delivering the IMD to a triangle of Koch ([0037, 0062, 0194, 0197]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the catheter suggested by Liu to deliver the IMD to a triangle of Koch, as taught by Drake. This modification is beneficial, as the IMD can be positioned at the Koch region in the right atrium to facilitate pacing of the endocardium and/or the His bundle conduction system (see paragraphs [0037, 0062, 0194, 0197] by Drake).
10. Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. in view of Meade et al.
Regarding claim 28, Liu suggests the method of claim 24. Liu does not explicitly teach wherein delivering the IMD to the implant site with the catheter and placing the cup end plane on the tissue includes deflecting the distal end of the catheter.
The prior art by Meade is analogous to Liu, as they both teach an implantable medical device that is configured to provide cardiac pacing to a patient’s heart ([0026-0027, 0029]).
Meade teaches wherein delivering the IMD to the implant site with the catheter and placing the cup end plane on the tissue includes deflecting the distal end of the catheter (the catheter 700 comprises a distal opening or cup 72 that may be deflected when the IMD 300 is delivered to the implant site [0052, 0054, FIG. 9B]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the distal end of the catheter suggested by Liu to be deflected when delivering the IMD to the implant site, as taught by Meade. The advantage of such modification will allow the catheter to be deflected into a desired position at the implant site (see paragraphs [0052, 0054] by Meade).
11. Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. in view of Doerr et al. (WO 2021/083792 A1, with citations to the corresponding US Publication No. 2022/0362546 A1).
Regarding claim 29, Liu suggests the method of claim 24. Liu does not explicitly teach wherein delivering the IMD to the implant site with the catheter comprises delivering the IMD to a right septal wall such that at least one of the one or more electrodes is proximate to a left bundle branch.
The prior art by Doerr is analogous to Liu, as they both teach an implantable medical device that is configured to provide cardiac pacing ([0054, 0089]).
Doerr teaches wherein delivering the IMD to the implant site with the catheter comprises delivering the IMD to a right septal wall such that at least one of the one or more electrodes is proximate to a left bundle branch (figures 3-4 illustrates the IMD 1 being delivered through the right ventricle (RV) and penetrating through a right septal wall such that the electrode 1 is proximate to a left bundle branch (LBB) [0017, 0077-0078, 0080, 0089, FIGS. 3-4]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the IMD suggested by Liu to be delivered to the right septal wall to position one or more of the electrodes in proximity to a left bundle branch, as taught by Doerr. The advantage of such modification will allow the electrodes to provide pacing to the left bundle branch (see paragraph [0017] by Doerr).
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Conclusion
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792