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
Applicant’s arguments filed 06/29/2026 have been fully considered but are not persuasive.
Applicant argues, “Koop '236 in view of Eggen and/or Liu does not disclose or suggest "wherein the housing extends along a longitudinal axis from a proximal end and to a distal end and comprises a proximal end face at the proximal end, a distal end face at the distal end, and a housing wall connecting the proximal end face to the distal end face, the housing wall comprising a distal portion, a proximal portion, and a middle portion connecting the proximal portion and the distal portion, the distal portion of the housing wall connected to the distal end face and the proximal portion of the housing wall connected to the proximal end face; [and] a first leadlet comprising a first proximal end and a first distal end, wherein the first proximal end protrudes from the middle portion of the housing wall" as recited in amended independent claim 1 and similarly recited in amended independent claims 16 and 19”.
Examiner respectfully disagrees. Koop discloses:
wherein a housing (fig. 5: 502)
extends along a longitudinal axis (see Examiner fig. 1 below: right to left of 500) from a proximal end (see Examiner fig. 1 below: right side of 500) and to a distal end (see Examiner fig. 1 below) and
comprises
a proximal end face (see Examiner fig. 1 below: bottom side of body 502) at the proximal end (fig. 5: bottom right side of 502),
a distal end face (see Examiner fig. 1 below: top side of body 502) at the distal end (see Examiner fig. 1 below), and
a housing wall (fig. 5: outer exterior portions of 502) connecting the proximal end face to the distal end face (see Examiner fig. 1 below where exterior parts of 502 are connected to one another);
the housing wall comprising
a distal portion (fig. 5: top surface of right side of 502 which connects to leadlet 501),
a proximal portion (fig. 5: bottom curved edge of right side of 502), and
a middle portion (fig. 5: middle portion is space between top right side of 502 and bottom right side of 502) connecting the proximal portion and the distal portion (fig. 5: middle portion would connect the proximal portion and the distal portion),
the distal portion of the housing wall connected to the distal end face (fig. 5: the distal portion of the housing wall would be connected to the distal end face) and the proximal portion of the housing wall connected to the proximal end face (fig. 5: the proximal portion of the housing wall would be connected to the proximal end face);
a first leadlet (501; [0083]) comprising
a first proximal end (fig. 5: top part of extension 501) and
a first distal end (526),
wherein the first proximal end protrudes from the middle portion of the housing wall (fig. 5).
Applicant argues, “Under the interpretation supported by the descriptions and FIG. 5 of Koop '236, Koop '236 merely describes that "body 502 may include extension 503 extending from proximal end 520 of the body 502"9 and that "in some instances, pacing device 500 may optionally include extension 501 extending from distal end 522 of body 502."10 Koop '236 does not describe "wherein the first proximal end [of the first leadlet] protrudes from the middle portion of the housing wall" as recited in the amended independent claims…Koop'236 further describes that "extension 502 extending from proximal end 520 of the body 502" and illustrates extension 502 extending from proximal end 520 at the "top side" of body 502.8 This contradicts the Office's interpretation that the "top side" of body 502 is the "distal body face at the distal end" of body 502. Thus, Applicant submits that one of ordinary skill in the art would not have interpreted the device of Koop '236 in the manner alleged by the Office.”
Examiner respectfully disagrees. Although paragraph 236 of Koop may refer to a different component as being a ‘proximal end’, under broadest reasonable interpretation, the recited proximal end may be interpreted as an end nearer to a center of a body or point of attachment. Therefore, although the specification of Koop may recite its own ‘proximal end’, under broadest reasonable interpretation, the claimed proximal end may be interpreted as a different component. For instance, see Examiner fig. 1 below, where the housing of Koop comprises a proximal and distal end.
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.
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.
Claims 1-14, 19-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Koop (US 2019/0351236) in view of Eggen et al. (US 9,526,891) and/or in view of Liu et al. (US 2020/0306547).
In re claim 1, Koop discloses a medical system (fig. 1: 20; [0004, 0081]) comprising:
an implantable medical device (500; [0082-0083]) configured to be
positioned within an atrium of a heart [0082-0083] and
comprising a housing (fig. 5: body 502; [0083]) carrying a return electrode (any one of electrodes 507a-507d; [0084]),
wherein the housing
extends along a longitudinal axis (see Examiner fig. 1 below: right to left of 500) from a proximal end (see Examiner fig. 1 below: right side of 500) and to a distal end (see Examiner fig. 1 below) and
comprises
a proximal end face (see Examiner fig. 1 below: bottom side of body 502) at the proximal end (fig. 5: bottom right side of 502),
a distal end face (see Examiner fig. 1 below: top side of body 502) at the distal end (see Examiner fig. 1 below), and
a housing wall (fig. 5: outer exterior portions of 502) connecting the proximal end face to the distal end face (see Examiner fig. 1 below where exterior parts of 502 are connected to one another);
the housing wall comprising
a distal portion (fig. 5: top surface of right side of 502 which connects to leadlet 501),
a proximal portion (fig. 5: bottom curved edge of right side of 502), and
a middle portion (fig. 5: middle portion is space between top right side of 502 and bottom right side of 502) connecting the proximal portion and the distal portion (fig. 5: middle portion would connect the proximal portion and the distal portion),
the distal portion of the housing wall connected to the distal end face (fig. 5: the distal portion of the housing wall would be connected to the distal end face) and the proximal portion of the housing wall connected to the proximal end face (fig. 5: the proximal portion of the housing wall would be connected to the proximal end face);
a first leadlet (501; [0083]) comprising
a first proximal end (fig. 5: top part of extension 501) and
a first distal end (526),
wherein the first proximal end protrudes from the middle portion of the housing wall (fig. 5), and
wherein the first leadlet carries a first electrode (fig. 5: any one of electrodes 510a-510e; [0091]);
a second leadlet (503) comprising
a second proximal end (fig. 5: bottom part of extension 503) and
a second distal end (524),
wherein the second proximal end is attached to the distal end face of the housing (see Examiner fig. 1 below), and
wherein the second leadlet carries a second electrode (fig. 5: any one of electrodes 505a-505e; [0088]); and
a fixation device (535; [0134]) protruding from the distal end face of the housing (fig. 5: 535 protrudes from the top portion of 502),
*wherein the first leadlet is configured to extend within a coronary sinus (11) of the heart (fig. 1: extension 501 extends through coronary sinus ostium 12 of coronary sinus 11; [0090]) when the fixation device secures the housing to heart tissue in the coronary sinus ([0134]; fig. 5 and fig. 11), and
*wherein the second distal end is configured to engage the heart tissue (fig. 1; [0136]) when the fixation device secures the housing to the heart tissue in the coronary sinus ([0134]; fig. 5 and fig. 11).
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Examiner Fig. 1 – Annotated Fig. 5 (Koop)
*Regarding the limitations “wherein the first leadlet is configured to extend within a coronary sinus of the heart when the fixation device secures the distal end to heart tissue in the atrium” and “wherein the second distal end is configured to engage the heart tissue when the fixation device secures the distal end of the housing to the heart tissue in the atrium”, the recited limitations are directed to functional language/intended use, and since these limitations are directed to an apparatus, it is only required that the structure is capable of being configured to do the recited limitations. For instance, the fixation device has all of the necessary structure needed to secure the distal end of the housing to the heart tissue in the atrium so that the first leadlet is configured to extend within a coronary sinus of the heart and so the second distal end is configured to engage the heart tissue.
Therefore, since the fixation device has all of the necessary structure to secure the distal end to heart tissue in the atrium, it is therefore capable of and/or able to be configured to do the above limitations, see MPEP 2114 "[A]pparatus claims cover what a device is, not what a device does." See MPEP 2114.
Additionally, it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the position of the fixation device of Koop in view of Eggen and/or in view of Lui to be secured to the heart tissue in the atrium, as discussed below.
Koop fails to explicitly disclose
wherein the first leadlet is configured to extend within a coronary sinus of the heart when the fixation device secures the distal end to heart tissue in the atrium, and
wherein the second distal end is configured to engage the heart tissue when the fixation device secures the distal end of the housing to the heart tissue in the atrium.
Eggen teaches a pacing device (fig 1: 12) comprising of
a main portion (50) and
a leadlet (30) connected to an electrode (fig. 1: electrode 32 connected to leadlet),
the main portion being affixed to an internal side of an atrial wall (fig 1; Col. 3, lines 7-17; Col. 3, lines 21-25: fixation member 40 secures the pacing device within a right or left atrium) and
the electrode being affixed remotely from the main portion (Col. 3, lines 25-30).
Eggen further teaches that the pacing device can be stably fixed in a desired location via the fixation member 40 (Col. 3, lines 21-25), and that the desired locations include within a right or left atrium (Col. 3, lines 21-25), which may be required for certain conditions in order to maintain a regular heart rhythm (Col. 1, lines 32-35).
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the position of the fixation device of Koop, to provide wherein the fixation device is secured to an internal side of an atrial wall, as taught by Eggen, because securing the fixation device to an internal side of an atrium wall may be required for certain conditions in order to maintain a regular heart rhythm, and because the pacing device of Eggen is capable of being securely positioned to an internal side of either the right atrium wall or the left atrium wall depending on which location is desired.
The proposed combination would yield wherein the first leadlet of Koop is configured to extend within a coronary sinus of the heart and wherein the second distal end of Koop is configured to engage the heart tissue when the fixation device of Koop secures the distal end of the housing to an internal side of an atrial wall.
Additionally or alternatively, Liu teaches an analogous leadless pacing device [0005], wherein a first leadlet (fig. 1: 24; [0057]) is configured to extend within a coronary sinus (15) of a heart (fig. 1; [0057]) when a fixation device (fig. 14: 50; [0128]) secures a distal end (fig. 14: right side of housing 22 near electrode 28) of a housing (22) to heart tissue in an atrium ([0128]: fixation 50 may engage tissue of wall 84 which is part of left atrium 12 while leadless pacing device 20 is inserted into coronary sinus 15).
Liu further teaches that having the fixation member engage the left atrium wall allows for good electrical contact with a wall defining at least one chamber of the heart [0128], and also allows for electrodes (26, 28) to be in good electrical contact with the left atrium wall [0128]. Liu further teaches that although housing 22 is depicted as being in both the right atrium 11 and the left atrium 12 [0163], the housing 22 may instead be entirely positioned in either sides of the atrium [0163], which would allow the leadless pacing device 20 to be programmed to sense and/or pace the right and/or the left atrium based on the respective electrodes [0163].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the medical system of Koop and/or the proposed combination, to provide wherein the first leadlet is configured to extend within a coronary sinus of the heart when the fixation device secures the distal end to heart tissue in the atrium, as taught by Liu, because having the fixation member engage the left atrium wall allows for good electrical contact with a wall defining at least one chamber of the heart and also allows for electrodes on the housing to be in good electrical contact with the left atrium wall, which is useful if the leadless pacing device needs to be programmed to sense and/or pace the left atrium using the respective electrodes.
Regarding the limitation, “wherein a second distal end is configured to engage the heart tissue when the fixation device secures the distal end of the housing to the heart tissue in the atrium,” the proposed combination would yield wherein a second distal end is configured to engage the heart tissue when the fixation device secures the distal end of the housing to the heart tissue in the atrium (if the proposed combination yields the fixation device securing the distal end of the housing to heart tissue in the atrium, then the second distal end of Koop would still engage the heart tissue, as shown in Koop: fig. 1 and Koop: [0136]).
In re claim 2, the proposed combination yields (all mapping directed to Koop unless otherwise stated) wherein the first leadlet is configured to position the first electrode within the coronary sinus when the first leadlet extends within the coronary sinus (fig. 1: 501 extends within coronary sinus 11 and the first electrodes 510a-510e are positioned within the coronary sinus 11; [0138]).
In re claim 3, the proposed combination yields (all mapping directed to Koop unless otherwise stated) wherein the implantable medical device further comprises
therapy delivery circuitry (fig. 6: combination of 532, 534, 536, 538, 542, and 544; [0139]) mechanically supported within the housing (fig. 6; [0139]),
wherein
the first electrode ([0139]: extension 548 extends through extension 501),
the second electrode ([0139]: extension 546 extends through extension 503; fig. 6: 546; [0136]), and
the return electrode [0084, 0139]
are electrically coupled to the therapy delivery circuitry ([0139]; fig. 6; [0084]), and
wherein the therapy delivery circuitry is configured to:
deliver therapy to the heart using
the first electrode [0091] and
the return electrode [0084]
when the first leadlet extends within the coronary sinus [0090-0091]; and
deliver therapy to the heart using
the second electrode [0088] and
the return electrode [0084]
when the second distal end engages the heart tissue (fig. 1; [0088, 0136]).
In re claim 4, the proposed combination yields (all mapping directed to Koop unless otherwise stated) wherein the second distal end is configured to penetrate the heart tissue ([0087]: fixation elements 506 of the extension 503 secures 503 to the right atrium 21 and may comprise of a helical coil or talons) when a distal force is applied to the second leadlet ([0137]: when pacing device is implanted i.e. a distal force is applied, fixation elements 506 secures the distal end 524 to the right atrium 21).
In re claim 5, the proposed combination yields (all mapping directed to Koop unless otherwise stated) wherein the first distal end is configured to penetrate coronary sinus tissue when a distal force is applied to the first leadlet ([0156-0157]: guidewire may be positioned within coronary sinus 11 and is inserted into guide wire port which results in a distal force being applied to the first leadlet and allows the first distal end to penetrate coronary sinus tissue; [0090]).
In re claim 6, the proposed combination yields (all mapping directed to Koop unless otherwise stated) wherein the first leadlet is configured to position the first electrode in the coronary sinus tissue when the first distal end penetrates the coronary sinus tissue (fig. 1: the first electrode is in the coronary sinus tissue 11 when the first distal end penetrates the coronary sinus tissue; [0138]).
In re claim 7, the proposed combination yields (all mapping directed to Koop unless otherwise stated)
wherein the first leadlet is configured to receive an elongate member ([0135]: extension 501 may receive a guide wire through guide wire port 433 [0157]; fig. 14A: guide wire port 433 is equivalent to guide wire port 543 in figs. 5 & 8; [0171]: features can be combined between embodiments), and
wherein
the elongate member is configured to apply the distal force to the first leadlet when
the first leadlet receives the elongate member ([0157]: guidewire may be placed through the guide wire port 543, which will exert the distal force to the first leadlet when the first leadlet receives the elongate member since the guidewire will push on the first leadlet to enter the guide wire port; fig. 14A: first leadlet receives guidewire 1002; [0135]) and
a distal force is exerted on the elongate member ([0157]: elongate member applying the distal force will also result in a distal force being exerted on the elongate member i.e. a reactive force; fig. 14: 1002; [0135]).
In re claim 8, the proposed combination yields (all mapping directed to Koop unless otherwise stated)
wherein the implantable medical device defines an inner lumen (fig. 14A: inner lumen is part of 500 where guidewire 1002 goes inside 500) extending from a lumen opening (431) defined by the implantable medical device (fig. 14A) toward the first distal end (fig. 14A: lumen opening goes from 431 to the first distal end near opening 433), and
wherein the inner lumen is configured to receive the elongate member (fig. 14A).
In re claim 9, the proposed combination yields (all mapping directed to Koop unless otherwise stated) wherein the first leadlet defines a first bearing structure (fig. 5: first bearing structure is distal combination of fixation elements 512 and wire port 543) configured to transmit the distal force to the first distal end when the elongate member exerts the distal force on the first bearing structure ([0157]: when elongate member exerts the distal force on the first bearing structure while being inserted into the guide wire port 433, the distal force will be transmitted from the first bearing structure to the rest of the first distal end; fig. 14A).
In re claim 10, the proposed combination yields (all mapping directed to Koop unless otherwise stated)
wherein the first distal end is configured to move in a distal direction to penetrate the coronary sinus tissue [0157], and
wherein the first distal end comprises a fixation structure (fig. 5: 512) configured to resist motion in a proximal direction when the first distal end penetrates the coronary sinus tissue ([0090]: fixation elements 512 secures the distal end within coronary sinus 12 and comprises of a helical coil and/or talons; fig. 1).
In re claim 11, the proposed combination yields (all mapping directed to Koop unless otherwise stated) further comprising
an elongate member (fig. 14A: guidewire 1002),
*wherein the elongate member comprises a tip (fig. 14A) configured to penetrate the heart tissue to form a puncture sized to allow the second leadlet to be inserted therethrough (the guidewire 1002 can be used to penetrate the heart tissue so that a puncture is made to allow the second leadlet to be inserted), and
wherein the second leadlet is configured to allow the elongate member to extend beyond the second distal end of the second leadlet (fig. 14A: the guidewire 1002 extends to the left beyond the second distal end 524 of the second leadlet 503).
*Regarding the limitations, “wherein the elongate member comprises a tip configured to penetrate the heart tissue to form a puncture sized to allow the second leadlet to be inserted therethrough,” a recitation of the functional language of the claimed invention, such as the recitation of “configured to”, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim. In this case, the elongate member i.e. a guidewire can be used to penetrate the heart tissue to form a puncture that will then allow the second leadlet to be inserted through the puncture; see MPEP § 2114 (I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432
In re claim 12, the proposed combination yields (all mapping directed to Koop unless otherwise stated)
wherein the implantable medical device defines an inner lumen (fig. 14A: inner portion of 500 where guidewire 1002 enters opening 433 and exits opening 431) extending from a lumen opening (fig. 14A: 433) defined by the implantable medical device (fig. 14A) toward the second distal end of the second leadlet (fig. 14A: opening starts at 433 and ends at 431 which goes toward the second distal end of the second leadlet i.e. goes from right to left of 500),
wherein the inner lumen is configured to receive the elongate member (fig. 14A).
In re claim 13, the proposed combination yields (all mapping directed to Koop unless otherwise stated) further comprising a third electrode (fig. 5: any one of electrode 507a-507d not selected earlier; [0084]), configured to contact a surface of the heart tissue when the fixation device secures the implantable medical device to the heart tissue (fig. 1; [0084]).
In re claim 14, the proposed combination yields (all mapping directed to Koop unless otherwise stated)
wherein the third electrode is electrically coupled to the therapy delivery circuitry [0084, 0139], and
wherein the therapy delivery circuitry is configured to provide stimulation to the heart using the third electrode [0084].
In re claim 19, regarding the limitations, “a method of implanting a medical system, the method comprising:
positioning an implantable medical device within an atrium of a heart,
wherein the implantable medical device comprises:
a housing carrying a return electrode,
wherein the housing
extends along a longitudinal axis from a proximal end to a distal end and
comprises
a proximal end face at the proximal end,
a distal end face at the distal end, and
a housing wall connecting the distal end face and the proximal end face;
the housing wall comprising
a distal portion,
a proximal portion, and
a middle portion connecting the proximal portion and the distal portion,
the distal portion of the housing wall connected to the distal end face and the proximal portion of the housing wall connected to the proximal end face;
a first leadlet comprising
a first proximal end and
a first distal end,
wherein the first proximal end protrudes from the middle portion of the housing wall, and
wherein the first leadlet carries a first electrode;
a second leadlet comprising
a second proximal end and
a second distal end,
wherein the second proximal end is attached to the distal end face of the housing, and
wherein the second leadlet carries a second electrode; and
a fixation device protruding from the distal end face of the housing;
securing the fixation device to the heart tissue in the atrium;
extending the first leadlet of the implantable medical device into a coronary sinus of the heart; and
positioning the second distal end within the heart tissue,”
see in re claim 1 above.
In re claim 20, regarding the limitations, “further comprising delivering, using therapy delivery circuitry, at least one of:
therapy to the heart using the first electrode when the first leadlet extends within the coronary sinus; or
therapy to the heart using the second electrode when the second distal end positions within the heart tissue,”
see in re claim 3 above.
In re claim 22, the proposed combination yields (all mapping directed to Koop unless otherwise stated) wherein the first proximal end of the first leadlet protrudes from the middle portion of the housing wall (see in re claim 1 above) perpendicular to the longitudinal axis (see Examiner fig. 1 above: first leadlet extends from the middle portion of the housing wall and goes in a direction from top to bottom of 501, which would be perpendicular from the longitudinal axis which goes from left to right of the housing 502).
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Koop (US 2019/0351236) (hereinafter referred to Koop (‘236)) in view of Eggen et al. (US 9,526,891) and/or in view of Liu et al. (US 2020/0306547) in view of Koop et al. (US 2020/0306530) (hereinafter referred to Koop (‘530)).
In re claim 16, regarding the limitations, “a medical system comprising:
an implantable medical device
configured to be positioned within an atrium of a heart and
comprising a housing carrying a return electrode,
wherein the housing
extends along a longitudinal axis from a proximal end to a distal end and
comprises
a proximal end face at the proximal end,
a distal end face at the distal end, and
a housing wall connecting the proximal end face to the distal end face;
the housing wall comprising a distal portion, a proximal portion, and a middle portion connecting the proximal portion and the distal portion,
the distal portion of the housing wall connected to the distal end face and the proximal portion of the housing wall connected to the proximal end face;
a first leadlet comprising
a first proximal end and
a first distal end,
wherein the first proximal protrudes from the middle portion of the housing wall, and
wherein the first leadlet carries a first electrode;
a second leadlet comprising
a second proximal end and
a second distal end,
wherein the second proximal end is attached to the distal end face of the housing,
wherein the second leadlet carries a second electrode….
a fixation device protruding from the distal end face of the housing,
wherein the first leadlet is configured to extend within a coronary sinus of the heart when the fixation device secures the housing to heart tissue in the atrium,”
see in re claim 1 above.
Regarding the limitations, “wherein the second distal end is configured to penetrate the heart tissue when a distal force is applied to the second leadlet,” see in re claim 4 above.
Regarding the limitation, “… a third electrode disposed on the distal end face of the housing”, the proposed combination yields (all mapping directed to Koop (‘236) unless otherwise stated) a third electrode (fig. 5: any one of electrodes 510a-510e: ) attached to the distal end face of the housing (fig. 5)
The proposed combination fails to yield a third electrode disposed on the distal end face of the housing (fig. 5).
Koop (‘530) teaches an analogous leadless pacing device (fig. 1: 20) and teaches a third electrode (28) disposed on a distal end face (fig. 1: distal end face is on a right side of a housing 22) of a housing (fig. 1).
Koop (‘530) further teaches that the housing may comprise of an electrode on the housing that is formed on, along, and/or from a fixation member 50 ([0059]; fig. 2). Koop (‘530) further teaches that an electrodes (fig. 2: 30-36) may span either an entire length or a partial length of distal extension 24 (fig. 2), for instance, on a top portion of distal extension 24 that touches the distal end face of the housing 22 (fig. 2; [0068]).
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the medical system yielded by the proposed combination, to provide a third electrode disposed on the distal end face of the housing, as taught by Koop (‘530), because the third electrode may be disposed on a plurality of places, for instance on the distal end face of the housing.
Regarding the limitation, “wherein the first leadlet is configured to position the first electrode within the coronary sinus when the first leadlet extends within the coronary sinus,” see in re claim 2 above.
Regarding the limitation, “wherein the third electrode is configured to contact a surface of the heart tissue when the fixation device secures the implantable medical device to the heart tissue,” the proposed combination would yield wherein the third electrode is configured to contact a surface of the heart tissue when the fixation device secures the implantable medical device to the heart tissue (Koop (‘236): fig. 1: proposed combination above would yield the electrode being disposed on the distal end face of the housing, which would be contacting heart tissue when the fixation device secures the implantable medical device to the heart tissue; [0082-0084]).
In re claim 17, regarding the limitations, “further comprising therapy delivery circuitry configured to at least one of:
deliver therapy to the heart using the first electrode when the first leadlet extends within the coronary sinus,
deliver therapy to the heart using the second electrode when the second distal end penetrates the heart tissue, or
deliver therapy to the heart using the third electrode when the third electrode contacts the surface of the heart tissue,”
see in re claim 3 above.
In re claim 18, the proposed combination yields (all mapping directed to Koop unless otherwise stated) wherein the therapy delivery circuitry is configured to deliver one or more of
ventricle-from-atrium cardiac therapy ("VfA therapy") ([0095]: pacing pulses delivered to right atrium/left atrium which causes synchronous contractions of right ventricle and left ventricle; [0093-0094]) or
left bundle branch pacing therapy ("LBB therapy") using the first electrode ([0091]: first electrode may deliver stimulation to the atrium or the ventricle), or
cardiac resynchronization therapy ("CRT") [0094] using the second electrode [0088].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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