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 .
DETAILED ACTION
Acknowledgement is made of applicant’s amendment which was received by the office on March 16, 2026. Claims 1 and 3-21 are current pending and under examination.
Claim Objections
In view of the amendments filed on 3/16/2026 to claims 1,4-5 and 14-16 to clarify the language of the claims the objections made against the claims in the office action of 12/17/2025 have been withdrawn.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 3-9, 11-13, 15-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0240496 to von Arx et al. (Arx) in view of US 2019/0083801 to Yang et al. (Yang ‘801) and US 2017/0209689 to Chen et al. (Chen) (all previously cited).
In reference to at least claim 1
Arx discloses a medical device (e.g. pacemaker “medical device” 1, Figs. 1,11) comprising: a device body configured to position within a heart (e.g. housing 10, Figs. 1,11), the device body defining a device proximal end (e.g. distal end of housing 10 near tine array 50, Figs. 1,11) a device distal end (e.g. proximal end of housing 10 near return electrode 12, Figs. 1,11), and the device defining a longitudinal axis extending between the device proximal end and the device distal end (e.g. longitudinal axis between proximal and distal end of housing 10, Figs. 1,11); a fixation mechanism attached to a device distal end (e.g. tine array 50 “fixation mechanism” attached to the distal end, Figs. 1,11), wherein the fixation mechanism is configured to attach to tissue of a chamber of the heart (e.g. tine array 50 “fixation mechanism” attached to the distal end, Figs. 1,11, tine array for anchoring, para. [0040]); and a leadlet mechanically supporting an electrode at a leadlet distal end (e.g. lead extension “leadlet” 40, includes electrodes 41 and 42, Figs. 1,11), wherein the leadlet defines a leadlet proximal end, the leadlet distal end, and a leadlet body between the leadlet proximal end and the leadlet distal end (e.g. lead extension 40 has a body a proximal end near electrode 12 and distal end near electrode 41, Figs. 1,11), wherein the leadlet proximal end is attached to the device body (e.g. lead extension 40 is attached to housing 10, Figs. 1,11), wherein the leadlet proximal end comprises a shape memory material configured to urge the leadlet body toward a preset orientation relative to the device body and configured to cause the electrode to contact a surface of the tissue when the fixation mechanism attached to the tissue (e.g. shape memory wire 45 contained within body, para. [0047], [0085]; “the shape memory alloy wire extends throughout an entire length of the elongate lead extension (i.e., at least throughout 90% of said length),”, para. [0049]), and wherein the leadlet is configured to define a radial displacement between the leadlet distal end and the longitudinal axis, or an axis parallel to the longitudinal axis, when the shape memory material urges the leadlet body toward the preset orientation (e.g. shape memory alloy set to a curved configuration, Figs. 1,11 para. [0047]-[0049], “and in another embodiment it is shape set to have a gentle curve.”, para. [0090]).
Arx discloses that the leadlet is configured to urge the leadlet body toward a preset orientation relative to the device body and configured to cause the electrode to contact a surface of the tissue when the fixation mechanism attached to the tissue (e.g. shape memory wire 45 contained within body, para. [0047], [0085]; “the shape memory alloy wire extends throughout an entire length of the elongate lead extension (i.e., at least throughout 90% of said length),”, para. [0049]) and that electrode 41 and 42 can provide pacing is near excitable tissue (e.g. “As long as the ring electrodes 41, 42 in the atrium A are near excitable tissue, pacing as well as sensing could be achieved with this configuration.”, para. [0082]-[0083]). Arx further discloses a pacing electrode (e.g. 11) being located on an end of the housing along with the fixation mechanism (e.g. Fig. 3).
However, Arx but does not explicitly teach the leadlet contacting a surface of the chamber when the fixation mechanism attaches to the tissue of the chamber, i.e. leadlet contacting a surface of the chamber that the fixation mechanism is configured to attached to.
It was well known in the art to provide an extension “leadlet” supporting an electrode at a distal end as evidence by Yang ‘801 (e.g. distal extension “leadlet” 15 supporting electrode 42, “. Tip electrode 42 may be a hemispherical, flat, ring, helical, conical or other electrode type that is held in intimate contact, against or in close proximity to, a pacing or sensing site when fixation member portion 52 is deployed to anchor pacemaker 10 at the pacing or sensing site”, para. [0035]) and/or Chen (e.g. electrode 206 spaced apart from the distal end, “According to the illustrated embodiment, electrode 206 may function in conjunction with electrode 207 for bipolar pacing and sensing, when elastically deformable tines 303 of fixation mechanism 30 hold electrode 206 in intimate tissue contact at a target implant site”, para. [0026]-[0027]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Arx to include providing a lead extension with shape memory material similar to element 40 containing an electrode on the device end containing the tines 50 as such arrangement for providing an electrode on a distal extension located on a same end as a fixation mechanism was known in the art and would have yielded the predictable result of providing intimate tissue contact at a target implant site for providing sensing and/or pacing to the heart chamber (‘801, para. [0035], ‘689, para. [0027]).
In reference to at least claim 3
Arx discloses wherein the shape memory material is configured to generate an internal stress tending to oppose an external force exerted on the leadlet body when the shape memory material urges the leadlet body toward the preset orientation (e.g. shape memory alloy set to a curved configuration, Figs. 1,11, para. [0047]-[0049]; “and in another embodiment it is shape set to have a gentle curve.”, para. [0090]).
In reference to at least claim 4
Arx discloses wherein the leadlet body defines a curvature between the leadlet proximal end and the leadlet distal end (e.g. shape memory alloy set to a curved configuration, Figs. 1,11, para. [0047]-[0049; “and in another embodiment it is shape set to have a gentle curve.”, para. [0090]). The modified device of Arx in view of Yang ‘801 and/or Chen would be configured to cause the electrode to contact the surface of the chamber when the fixation mechanism is attached to the tissue of the chamber and the shape memory material urges the leadlet body toward the preset orientation (e.g. contact tissue within the atrium, para. [0080]-[0082]).
In reference to at least claim 5
The modified device of Arx in view of Yang ‘801 and/or Chen would include wherein the leadlet body defines a facing surface configured to substantially face the surface of the chamber when the fixation mechanism is attached to the tissue of the chamber (e.g. lead extension 40 has a surface that contacts a surface of the tissue within the atrium, para. [0080]-[0082]) and the shape memory material urges the leadlet body toward the preset orientation (e.g. shape memory alloy set to a curved configuration, Figs. 1,11, para. [0047]-[0049]; “and in another embodiment it is shape set to have a gentle curve.”, para. [0090]).
In reference to at least claim 6
Arx discloses wherein the device body defines a maximum radial displacement from the longitudinal axis, and wherein the radial displacement between the leadlet distal end and the longitudinal axis is greater than the maximum device radial displacement (e.g. shape memory alloy set to a curved configuration that has a radial displacement greater than maximum device radial displacement, Figs. 1,11, para. [0047]-[0049]; “and in another embodiment it is shape set to have a gentle curve.”, para. [0090]).
In reference to at least claim 7
Arx discloses wherein the leadlet is configured to radially displace the electrode from the longitudinal axis or the axis parallel to the longitudinal axis when the leadlet defines the radial displacement between the leadlet distal end and the longitudinal axis (e.g. shape memory alloy set to a curved configuration that has a radially displaces the electrode from the longitudinal axis of the device body, Figs. 1,11, para. [0047]-[0049]; “and in another embodiment it is shape set to have a gentle curve.”, para. [0090]).
In reference to at least claim 8
Arx discloses a conductor mechanically supported by the leadlet body (e.g. electrodes 41,42 connected to electronic module 20 via wires 44, para. [0070]), wherein the conductor is electrically connected to the electrode (e.g. electrodes 41,42 connected to electronic module 20 via wires 44, para. [0070]), and wherein the leadlet is configured to radially displace the conductor from the longitudinal axis or the axis parallel to the longitudinal axis when the leadlet defines the radial displacement between the leadlet distal end and the longitudinal axis (e.g. shape memory alloy set to a curved configuration that has a radially displaces the electrode from the longitudinal axis of the device body, Figs. 1,11, para. [0047]-[0049]; “and in another embodiment it is shape set to have a gentle curve.”, para. [0090]).
In reference to at least claim 9
Arx discloses circuitry configured to deliver therapy signals to the heart using the electrode (e.g. electronic module 20 provides pacing, para. [0078]; pacing provided using electrode 41, 42, para. [0082]), wherein the conductor is electrically connected to the circuitry (e.g. electrodes 41,42 connected to electronic module 20 via wires 44, para. [0070]).
In reference to at least claim 11
Arx discloses wherein the fixation mechanism includes one or more tines (e.g. tine array 50, Figs. 1,11,11), wherein a tine includes a fixed end and a free end, wherein the fixed end is mechanically coupled to the device body (e.g. tine array 50 has an fixed end attached to the device body and a free end, Figs. 1,11), and wherein the tine is biased to drive the free end radially outward from the longitudinal axis (e.g. free end of tine array 50 is biased radially outward from the longitudinal axis, Figs. 1,11).
In reference to at least claim 12
Arx discloses wherein: the one or more tines includes a first tine and a second tine (e.g. tine array 50 includes a first tine and a second tine, Figs. 1,11). The modified device of Arx in view of Yang ‘801 and/or Chen would provide the leadlet is secured to the device distal end, and the leadlet body is configured to pass between the first tine and the second tine when the leadlet body substantially establishes the preset orientation since the lead extension containing the electrode would be located on the device end along with the tines.
In reference to at least claim 13
Arx discloses the electrode is a first contact electrode (e.g. electrodes 41,42 supported by lead extension 40, para. [0070]), and further comprising: a first conductor mechanically supported by the leadlet body, wherein the first conductor is electrically connected to the first contact electrode and electrically connected to circuitry of the medical device (e.g. electrodes 41,42 connected to electronic module 20 via wires 44, para. [0070]); a second contact electrode mechanically supported by the leadlet body (e.g. electrodes 41,42, supported by lead extension 40); and a second conductor mechanically supported by the leadlet body, wherein the second conductor is electrically connected to the second contact electrode and electrically connected to the circuitry of the medical device (e.g. electrodes 41,42 connected to electronic module 20 via wires 44, para. [0070]), wherein the circuitry of the medical device is configured to deliver therapy signals to the heart using at least one of the first contact electrode or the second contact electrode (e.g. electronic module 20 provides pacing, para. [0078]; pacing provided using electrode 41, 42, para. [0082]).
In reference to at least claim 15
Arx discloses a distal electrode extending from a distal portion of the device body, wherein the distal portion includes the device distal end (e.g. pacing electrode 11 extending from distal end, Figs. 1,11). The modified device of Arx in view of Yang ‘801 and/or Chen would include wherein the distal electrode is configured to flexibly maintain contact with wall tissue of the chamber when the fixation mechanism is attached to the tissue of the chamber (e.g. tine array 50 “fixation mechanism” attached to the distal end, Figs. 1,11, tine array for anchoring, para. [0040]).
In reference to at least claim 16
Arx discloses a medical device (e.g. pacemaker “medical device” 1, Figs. 1,11) comprising: a device body configured to position within a heart (e.g. housing 10, Figs. 1,11), the device body defining a device proximal end (e.g. distal end of housing 10 near tine array 50, Figs. 1,11) a device distal end (e.g. proximal end of housing 10 near return electrode 12, Figs. 1,11), and the device defining a longitudinal axis extending between the device proximal end and the device distal end (e.g. longitudinal axis between proximal and distal end of housing 10, Figs. 1,11); a fixation mechanism attached to a device distal end (e.g. tine array 50 “fixation mechanism” attached to the distal end, Figs. 1,11), wherein the fixation mechanism is configured to attach to tissue of a chamber of the heart (e.g. tine array 50 “fixation mechanism” attached to the distal end, Figs. 1,11, tine array for anchoring, para. [0040]); a leadlet mechanically supporting an electrode at a leadlet distal end (e.g. lead extension “leadlet” 40, includes electrodes 41 and 42, Figs. 1,11), wherein the leadlet defines a leadlet proximal end, a leadlet distal end, and a leadlet body between the leadlet proximal end and the leadlet distal end (e.g. lead extension 40 has a body a proximal end near electrode 12 and distal end near electrode 41, Figs. 1,11), wherein the leadlet proximal end is attached to the device body (e.g. lead extension 40 is attached to housing 10, Figs. 1,11), wherein the leadlet proximal end comprises a shape memory material configured to urge the leadlet body toward a preset orientation relative to the device body (e.g. shape memory wire 45 contained within body, para. [0047], [0085]; “the shape memory alloy wire extends throughout an entire length of the elongate lead extension (i.e., at least throughout 90% of said length),”, para. [0049]), wherein the leadlet is configured to define a radial displacement between the leadlet distal end and the longitudinal axis, or an axis parallel to the longitudinal axis, when the shape memory material urges the leadlet body toward the preset orientation (e.g. shape memory alloy set to a curved configuration, Figs. 1,11 para. [0047]-[0049], “and in another embodiment it is shape set to have a gentle curve.”, para. [0090]); wherein the shape memory material is configured to generate an internal stress tending to oppose an external force exerted on the leadlet body when the shape memory material urges the leadlet body toward the preset orientation (e.g. shape memory alloy set to a curved configuration, Figs. 1,11 para. [0047]-[0049], “and in another embodiment it is shape set to have a gentle curve.”, para. [0090]).
Arx discloses that the leadlet is configured to urge the leadlet body toward a preset orientation relative to the device body and configured to cause the electrode to contact a surface of the tissue when the fixation mechanism attached to the tissue (e.g. shape memory wire 45 contained within body, para. [0047], [0085]; “the shape memory alloy wire extends throughout an entire length of the elongate lead extension (i.e., at least throughout 90% of said length),”, para. [0049]) and that electrode 41 and 42 can provide pacing is near excitable tissue (e.g. “As long as the ring electrodes 41, 42 in the atrium A are near excitable tissue, pacing as well as sensing could be achieved with this configuration.”, para. [0082]-[0083]). Arx further discloses a pacing electrode (e.g. 11) being located on an end of the housing along with the fixation mechanism (e.g. Fig. 3).
However, Arx but does not explicitly teach the leadlet contacting a surface of the chamber when the fixation mechanism attaches to the tissue of the chamber, i.e. leadlet contacting a surface of the chamber that the fixation mechanism is configured to attached to.
It was well known in the art to provide an extension “leadlet” supporting an electrode at a distal end as evidence by Yang ‘801 (e.g. distal extension “leadlet” 15 supporting electrode 42, “. Tip electrode 42 may be a hemispherical, flat, ring, helical, conical or other electrode type that is held in intimate contact, against or in close proximity to, a pacing or sensing site when fixation member portion 52 is deployed to anchor pacemaker 10 at the pacing or sensing site”, para. [0035]) and/or Chen (e.g. electrode 206 spaced apart from the distal end, “According to the illustrated embodiment, electrode 206 may function in conjunction with electrode 207 for bipolar pacing and sensing, when elastically deformable tines 303 of fixation mechanism 30 hold electrode 206 in intimate tissue contact at a target implant site”, para. [0026]-[0027]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Arx to include providing a lead extension with shape memory material similar to element 40 containing an electrode on the device end containing the tines 50 as such arrangement for providing an electrode on a distal extension located on a same end as a fixation mechanism was known in the art and would have yielded the predictable result of providing intimate tissue contact at a target implant site for providing sensing and/or pacing to the heart chamber (‘801, para. [0035], ‘689, para. [0027]).
In reference to at least claim 17
Arx discloses wherein the leadlet is configured to radially displace the electrode from the longitudinal axis or the axis parallel to the longitudinal axis when the leadlet defines the radial displacement between the leadlet distal end and the longitudinal axis (e.g. shape memory alloy set to a curved configuration that has a radially displaces the electrode from the longitudinal axis of the device body, Figs. 1, para. [0047]-[0049]; “and in another embodiment it is shape set to have a gentle curve.”, para. [0090]).
In reference to at least claim 18
Arx discloses a conductor mechanically supported by the leadlet body (e.g. electrodes 41,42 connected to electronic module 20 via wires 44, para. [0070]), wherein the conductor is electrically connected to the electrode (e.g. electrodes 41,42 connected to electronic module 20 via wires 44, para. [0070]), and wherein the leadlet is configured to radially displace the conductor from the longitudinal axis or the axis parallel to the longitudinal axis when the leadlet defines the radial displacement between the leadlet distal end and the longitudinal axis (e.g. shape memory alloy set to a curved configuration that has a radially displaces the electrode from the longitudinal axis of the device body, Figs. 1,11, para. [0047]-[0049]; “and in another embodiment it is shape set to have a gentle curve.”, para. [0090]), wherein the conductor is electrically connected to the circuitry (e.g. electrodes 41,42 connected to electronic module 20 via wires 44, para. [0070]).
In reference to at least claim 19
Arx discloses establishing a radial displacement between a leadlet distal end of a leadlet and a longitudinal axis of a device body or an axis parallel to the longitudinal axis using a shape memory material configured to urge a leadlet body toward a preset orientation relative to the device body (e.g. lead extension 40 is attached to housing 10, Figs. 1,11; shape memory alloy set to a curved configuration, Figs. 1,11, para. [0047]-[0049], “and in another embodiment it is shape set to have a gentle curve.”, para. [0090]), wherein the leadlet body is between a leadlet proximal end and the leadlet distal end, wherein the leadlet proximal end is attached to the device body (e.g. lead extension 40 has a body a proximal end near electrode 12 which is attached to housing 10 and distal end near electrode 41, Figs. 1,11), wherein the shape memory material extends from the leadlet proximal end towards the leadlet distal end (e.g. shape memory wire 45 contained within body, para. [0047], [0085]; “the shape memory alloy wire extends throughout an entire length of the elongate lead extension (i.e., at least throughout 90% of said length),”, para. [0049]), and wherein the longitudinal axis extends between a device proximal end of the device body and a device distal end of the device body (e.g. longitudinal axis between proximal and distal end of housing 10, Figs. 1,11); and attaching a fixation mechanism to tissue of a chamber of a heart (e.g. tine array 50 “fixation mechanism” attached to the distal end, Figs. 1,11, tine array for anchoring, para. [0040]), wherein the fixation mechanism is attached to the device distal end (e.g. tine array 50 “fixation mechanism” attached to the distal end, Figs. 1,11, tine array for anchoring, para. [0040]), wherein the device body is configured to position within the heart, and wherein the leadlet mechanically supports an electrode at the leadlet distal end configured to contact a surface of the heart when the shape memory material urges the leadlet body toward the preset orientation (e.g. lead extension “leadlet” 40, includes electrodes 41 and 42, Figs. 1,11; (e.g. contact tissue within the atrium, para. [0080]-[0082]).
Arx discloses that the leadlet is configured to urge the leadlet body toward a preset orientation relative to the device body and configured to cause the electrode to contact a surface of the tissue when the fixation mechanism attached to the tissue (e.g. shape memory wire 45 contained within body, para. [0047], [0085]; “the shape memory alloy wire extends throughout an entire length of the elongate lead extension (i.e., at least throughout 90% of said length),”, para. [0049]) and that electrode 41 and 42 can provide pacing is near excitable tissue (e.g. “As long as the ring electrodes 41, 42 in the atrium A are near excitable tissue, pacing as well as sensing could be achieved with this configuration.”, para. [0082]-[0083]). Arx further discloses a pacing electrode (e.g. 11) being located on an end of the housing along with the fixation mechanism (e.g. Fig. 3).
However, Arx but does not explicitly teach the leadlet contacting a surface of the chamber when the fixation mechanism attaches to the tissue of the chamber, i.e. leadlet contacting a surface of the chamber that the fixation mechanism is configured to attached to.
It was well known in the art to provide an extension “leadlet” supporting an electrode at a distal end as evidence by Yang ‘801 (e.g. distal extension “leadlet” 15 supporting electrode 42, “. Tip electrode 42 may be a hemispherical, flat, ring, helical, conical or other electrode type that is held in intimate contact, against or in close proximity to, a pacing or sensing site when fixation member portion 52 is deployed to anchor pacemaker 10 at the pacing or sensing site”, para. [0035]) and/or Chen (e.g. electrode 206 spaced apart from the distal end, “According to the illustrated embodiment, electrode 206 may function in conjunction with electrode 207 for bipolar pacing and sensing, when elastically deformable tines 303 of fixation mechanism 30 hold electrode 206 in intimate tissue contact at a target implant site”, para. [0026]-[0027]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Arx to include providing a lead extension with shape memory material similar to element 40 containing an electrode on the device end containing the tines 50 as such arrangement for providing an electrode on a distal extension located on a same end as a fixation mechanism was known in the art and would have yielded the predictable result of providing intimate tissue contact at a target implant site for providing sensing and/or pacing to the heart chamber (‘801, para. [0035], ‘689, para. [0027]).
In reference to at least claim 20
Arx discloses penetrating the surface of the chamber using the fixation mechanism to attach the fixation mechanism to the tissue of the heart (e.g. tine array for anchoring the housing of the pacemaker device to cardiac tissue, para. [0040]). The modified device of Arx in view of Yang ‘801 and/or Chen would include contacting the surface of the chamber with the electrode when the fixation mechanism attaches to the tissue of the chamber and the shape memory material urges the leadlet body toward the preset orientation (e.g. contact tissue within the atrium, para. [0080]-[0082]; (e.g. shape memory alloy set to a curved configuration, Figs. 1,11, para. [0047]-[0049]; “and in another embodiment it is shape set to have a gentle curve.”, para. [0090]).
In reference to at least claim 21
The modified device of Arx in view of Yang ‘801 and/or Chen would provide the leadlet proximal end is attached to the device distal end since the lead extension containing the electrode would be located on the device end along with the tines.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0240496 to von Arx et al. (Arx) in view of US 2019/0083801 to Yang et al. (Yang ‘801) and US 2017/0209689 to Chen et al. (Chen) as applied to claim 1 further in view of US 2007/0288077 to Bulkes et al. (Bulkes) (previously cited).
In reference to at least claim 10
Arx as evidence by Yang ‘801 and/or Chen discloses a medical device according to claim 1. Arx further discloses the lead extension including a shape memory material (e.g. shape memory wire, para. [0047]-[0049]; “and in another embodiment it is shape set to have a gentle curve.”, para. [0090]). However, Arx does not explicitly teach the shape memory material being a polymer. It was well-known in the art before the effective filing date of the claimed invention to use as a shape memory material a metal alloy such as Nitinol or stainless steel or to use a non-conductive shape memory material such as well-known polymers as evidence by Bulkes et al. (e.g. para. [0044]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Arx to include as the shape memory material a polymer instead of a metal alloy since such modification would have been a simple substitution of one known material for another, i.e. shape memory polymer substituted for the shape memory metal ally, to obtain the predictable result of providing shape memory properties. In the alternative, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the shape memory material comprise a polymer, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0240496 to von Arx et al. (Arx) in view of US 2019/0083801 to Yang et al. (Yang ‘801) and US 2017/0209689 to Chen et al. (Chen) as applied to claim 1 further in view of US 2012/0323253 to Garai et al. (Garai) (previously cited).
In reference to at least claim 14
Arx as evidence by Yang ‘801 and/or Chen discloses a medical device according to claim 1. Arx further discloses positioning a first surface facing toward the surface of the heart when the fixation mechanism attaches to the tissue of the heart and the leadlet body substantially establishes the preset orientation (e.g. lead extension 40 has a surface that contacts a surface of the tissue within the atrium, para. [0080]-[0082]). However, Arx does not explicitly teach wherein the leadlet body defines a sheet defining a first side and a second side opposite the first side, wherein the first side defines a substantially planar first surface and the second side defines a substantially planar second surface, wherein the leadlet body is configured position the first surface facing toward the surface of the heart.
Garai discloses a lead (e.g. 110) for positioning an electrode in tissue such as heart tissue (e.g. Fig. 2) which discloses that the lead can include a variety of shapes including cylindrical but may alternatively be substantially flat or planar (e.g. para. [0022]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Arx to include as the lead extension body “leadlet body” a substantially planar lead including a substantially planar first surface and second side that defines a substantially planar second surface, wherein the leadlet body is configured to position the first surface facing toward the surface of the heart, as disclosed by Garai, to provide close contact between the lead extension and the tissue for improving fixation and anchoring of the lead extension within the tissue (e.g. ‘253, para. [0056]).
Response to Arguments
Claim Rejection Under 35 USC 101
Applicant’s arguments, see pgs. 8-9, filed 3/16/2026, with respect to the 35 USC 101 rejection against claims 1,3-18 and 21 have been fully considered and are persuasive, in particular the arguments which state that the fixation mechanism is already recited as being “configured to attach to tissue of a chamber of the heart” and that “The recitation of "when the fixation mechanism attaches to the tissue of the chamber" is not directed to the "tissue" or a human organism but provides a configuration for the shape memory material (that the shape memory material is configured to cause the electrode to contact a surface of the chamber when the fixation mechanism attaches to the tissue of the chamber). The recitation provides a relationship between the fixation mechanism and the electrode that the shape memory material is configured to cause and does not include a human organism.” The 35 USC 101 rejection against claims 1,3-18 and 21 has been withdrawn.
Claim Rejection Under 35 USC 103
Independent claims 1,16 and 19
Applicant argues “A person of ordinary skill in the art, based on the teachings of Arx, would not have been motivated to modify Arx's device in a manner that is suggested by the Office (e.g., having the electrode contact a surface of the same chamber that the device body is fixed to) to arrive at the subject matter of claims 1, 16, and 19, as doing so would remove the benefits (e.g., long vector of lead extension 40, ability to sense in atrium and ventricle, etc.) that is taught as being superior by Arx.”, see pg. 11 of response filed 3/16/2026. This is not persuasive. The modification of Arx to include providing a lead extension with shape memory material similar to element 40 containing an electrode on the device end containing the tines 50 would not remove other lead extensions already present on the pacemaker device including the elongated lead extension extending into the atrium, therefore the medical device disclosed within Arx would still have the capability to provide VDD and/or VDDR pacing therapy. Additionally, “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.”, see MPEP 2123. Neither Arx nor Yang nor Chen criticizes, discredits or otherwise discourages the modification.
Dependent Claims
Separate arguments are not provided for dependent claims 2-9,10-1,17 and 20-21. The patentability of the dependent claims is argued based on their dependency from independent claims 1,16 and 19 which have been fully addressed above.
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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/JG/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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