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, see page 7-8, filed 2/5/2026, with respect to the rejection(s) of claim(s) 1, 7, 16, and 19 under 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Altman (previously used in claims 11-12 and 21-22. Applicant argues Altman discloses a compliant fixation device and does not disclose “and rotatable relative to and independently from the housing”. The examiner notes that in Column 5 lines 66 to Column 6 line 1, Altman et al discloses ball 580 is allowed to rotate with respect to piston 550 (housing). Column 6 lines 5-15 discloses allowing ball 580 to rotate with respect to the socket in any direction allows housing movement to be absorbed by the ball and socket configuration and not directly transferred to fixation helix.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 contains amendments that are not properly marked. For example claim 1 added “a longitudinal” in the second to last line. The examiner would appreciate identification of any additional missed markings.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 4, 5, 7, 11-12, 16, 18-19, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drasler et al. (US Publication 2007/0135882) in view of Altman et al. (US Patent 5658327).
Regarding claim 1, Drasler et al discloses a biostimulator (Abstract; Fig. 5), comprising: a pacing electrode (fixation assembly 130; para. 51: “Still referring to FIG. 5, in some embodiments of the wireless electrode assembly 120, the fixation device 130 may also serve as at least a portion of the distal electrode 129”); a housing having an electronics compartment containing pacing circuitry electrically connected to the pacing electrode (wireless electrode assembly 120; para. 23: “each of the wireless electrode assemblies 120 may include a circuit comprising an internal coil and an electrical charge storage device (not shown in FIG. 1)… each of the wireless electrode assemblies 120 has a triggering mechanism in the circuit to deliver stored electrical charge to adjacent heart tissue”); and a header assembly mounted to the housing (e.g. Figure 5, Element 129) and having a joint between the pacing electrode and the housing such that the pacing electrode is pivotable relative to the housing (para. 50: “the fixation device 130 may include a biasing portion 136 that is coiled around a pin 135 and presses against a portion of the electrode body 128 (e.g., presses against the end face 129a of distal electrode 129). As such, the biasing portion 136 applies a torque load so that the body 128 of the wireless electrode assembly 120 is pivotable about a pin axis 134 relative to the fixation device 130”; Fig. 6A depicts pivoting of electrode about joint 135). However, Drasler et al does not explicitly disclose the pacing electrode is pivotable relative to a longitudinal axis of the housing and rotatable relative to and independently from the housing.
Altman et al teaches that it is known to use a joint having a ball and socket configuration where the ball is connected to the fixation component and the socket to the housing and is pivotable relative to a longitudinal axis of the housing and rotatable relative to and independently from the housing as set forth in Figure 5 and Column 5 lines 66 to Column 6 line 15 to provide allows the ball to rotate with respect to the socket in any direction which allows housing movement to be absorbed by the ball and socket configuration and not directly transferred to fixation helix; which reduces the risk of damage and irritation to the tissue where the fixation element is attached. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Drasler et al, with the pacing electrode is pivotable relative to a longitudinal axis of the housing and rotatable relative to and independently from the housing as taught by Altman et al, since such a modification would provide the predictable results of reducing the risk of damage and irritation to the tissue where the fixation element is attached.
Regarding claims 4 and 18, Drasler et al in view of Altman et al discloses the joint includes a spherical bearing (e.g. Altman et al Figure 5 and Column 5 lines 66 to Column 6 line 15).
Regarding claim 5, Drasler et al in view of Altman et al discloses the header assembly mounted on the housing and having a socket, wherein a ball is connected to the pacing electrode, and wherein the spherical bearing includes the ball in the socket (e.g. Altman et al Figure 5 and Column 5 lines 66 to Column 6 line 15).
Regarding claim 7, Drasler et al in view of Altman et al discloses a torque element having a distal element end connected to the pacing electrode and a proximal element end electrically connected to the pacing circuitry (Fig. 6A, biasing device 136 which has distal end connected to fixation element/electrode 130 and proximal end electrically connected to electrode 129, which must be electrically connected to pacing circuitry in order for the device to function as disclosed).
Regarding claims 11 and 21, Drasler et al in view of Altman et al does not disclose the joint includes a universal joint.
Altman, however, teaches an intracardiac lead having a compliant fixation device (Abstract) wherein a joint between a lead body and fixation element comprises a universal joint (Fig. 9; Col. 7, ll. 50-53: “first and second annular members 960, 970 combine to form a universal joint”, wherein the cited passage includes a typo that says 980 instead of 970). Additionally, Altman teaches annular members 960 and 970 can freely swivel about one another to provide a flexible connection between fixation helix 930 and distal end 920. Thus, movements of the patient will not be directly transferred to fixation helix 930 (Col. 7-8, ll. 65-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Drasler such that the joint includes a universal joint. Making this modification would be useful for provide a flexible connection between fixation helix and distal end. Thus, movements of the patient will not be directly transferred to fixation helix, as taught by Altman.
Regarding claims 12 and 22, modified Drasler does not teach a conductor extends through the universal joint between the pacing circuitry and the pacing electrode. Instead, the conductor 965 extends outside and around the universal joint (see Fig. 9). Altman does teach, however, that one or more conductors, such as a small, flexible conductor 965, can be attached to both annular members 960 and 970 to provide electrical continuity across the universal joint (Col. 8, ll. 9-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Drasler such that conductor extends through the universal joint between the pacing circuitry and the pacing electrode as an obvious matter of rearrangement of parts and design choice (MPEP 2144.04(VI)(C)) in absence of a criticality for the placement of the electrical conductor, and in order to provide electrical continuity across the universal joint, as taught by Altman. Examiner submits that placing the conductor through the universal joint rather than around it would not modify the operation of modified Drasler and instead would provide the same functionality of providing electrical continuity across the universal joint.
Regarding claim 16, Drasler et al discloses a biostimulator system (Figs. 7A-E), comprising: a biostimulator transport system (delivery catheter 115, tube portion 140, plunger mechanism 144; para. 68-72); and a biostimulator mounted on the biostimulator transport system (Figs. 7A-E depict biostimulator of Fig. 5 mounted on at least the plunger mechanism 144), wherein the biostimulator includes a pacing electrode, a housing having an electronics compartment containing pacing circuitry electrically connected to the pacing electrode, and a header assembly mounted to the housing (e.g. Figure 5, Element 129) and having a joint between the pacing electrode and the housing such that the pacing electrode is pivotable relative to the housing (see rejection of claim 1 above). However, Drasler et al does not explicitly disclose the pacing electrode is pivotable relative to a longitudinal axis of the housing and rotatable relative to and independently from the housing.
Altman et al teaches that it is known to use a joint having a ball and socket configuration where the ball is connected to the fixation component and the socket to the housing and is pivotable relative to a longitudinal axis of the housing and rotatable relative to and independently from the housing as set forth in Figure 5 and Column 5 lines 66 to Column 6 line 15 to provide allows the ball to rotate with respect to the socket in any direction which allows housing movement to be absorbed by the ball and socket configuration and not directly transferred to fixation helix; which reduces the risk of damage and irritation to the tissue where the fixation element is attached. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Drasler et al, with the pacing electrode is pivotable relative to a longitudinal axis of the housing and rotatable relative to and independently from the housing as taught by Altman et al, since such a modification would provide the predictable results of reducing the risk of damage and irritation to the tissue where the fixation element is attached.
Regarding claim 19, Drasler et al in view of Altman et al discloses a torque element having a distal element end connected to the pacing electrode and a proximal element end electrically connected to the pacing circuitry (see rejection of claim 7 above).
Claims 2, 17, 26-29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Drasler et al in view of Altman et al (US Patent 5658327) as applied above, and further in view of Lokhoff et al. (US 2004/0215301).
Regarding claims 2 and 17, Drasler et al in view of Altman et al does not disclose the pacing electrode includes an electrode shaft having a distal shaft end, and a helical electrode mounted on the distal shaft end.
Lokhoff, however, teaches a medical lead with a pivotable tip (Abstract) wherein a pacing electrode includes an electrode shaft having a distal shaft end, and a helical electrode mounted on the distal shaft end (Fig. 5, electrode 52 comprises proximal electrode shaft in the form of straight portion of electrode 52 with helical portion mounted on the distal end thereof; para. 38-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Drasler et al such that the pacing electrode includes an electrode shaft having a distal shaft end, and a helical electrode mounted on the distal shaft end by adopting the electrode structure of Lokhoff et al. Making this modification would amount to a simple substitution of one known element (pacing electrode of Drasler et al) for another (Lokhoff’s pacing electrode) to obtain predictable results (fixation of device to cardiac tissue and providing stimulation, see para. 38-39 of Lokhoff et al) (MPEP 2141(III)(B)).
Regarding claim 26, Drasler et al discloses a method, comprising: affixing a pacing electrode of a biostimulator to an interventricular wall; and articulating the biostimulator at a joint of a header assembly of the biostimulator such that an electrode axis of the pacing electrode extends in a different direction than a housing axis of a housing of the biostimulator, wherein the header assembly is mounted to the housing and has a joint between the pacing electrode and the housing (Fig. 4 depicts wireless stimulators 120 implanted within interventricular walls of heart and with housing extending in different direction than electrode 130 and Figure 5, Element 139 illustrates a header assembly mounted to the biostimulator between the housing 128 and the electrode 130).
Drasler et al does not disclose affixing the pacing electrode of the biostimulator to an interventricular septal wall; and the pacing electrode is pivotable relative to a longitudinal axis of the housing and rotatable relative to and independently from the housing.
Altman et al teaches that it is known to use a joint having a ball and socket configuration where the ball is connected to the fixation component and the socket to the housing and is pivotable relative to a longitudinal axis of the housing and rotatable relative to and independently from the housing as set forth in Figure 5 and Column 5 lines 66 to Column 6 line 15 to provide allows the ball to rotate with respect to the socket in any direction which allows housing movement to be absorbed by the ball and socket configuration and not directly transferred to fixation helix; which reduces the risk of damage and irritation to the tissue where the fixation element is attached. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Drasler et al, with the pacing electrode is pivotable relative to a longitudinal axis of the housing and rotatable relative to and independently from the housing as taught by Altman et al, since such a modification would provide the predictable results of reducing the risk of damage and irritation to the tissue where the fixation element is attached.
Lokhoff et al, however, teaches medical lead with pivotal tip (Abstract) wherein the pacing electrode is affixed to an interventricular septal wall (Fig. 6; para. 40-41). Lokhoff et al further teaches some recent advancements in pacing have made use of non-conventional locations for delivery of pacing pulses, such as left ventricular locations, atrial roof locations, inter-ventricular septum locations, and epicardium locations to name a few (para. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Drasler et al to include affixing the pacing electrode of the biostimulator to an interventricular septal wall. Making this modification would be useful for providing pacing in a non-conventional location, as taught by Lokhoff et al.
Regarding claim 27, Drasler et al in view of Altman et al and Lokhoff et al does not disclose the pacing electrode includes an electrode shaft having a distal shaft end, and a helical electrode mounted on the distal shaft end.
Lokhoff et al, however, teaches a medical lead with a pivotable tip (Abstract) wherein a pacing electrode includes an electrode shaft having a distal shaft end, and a helical electrode mounted on the distal shaft end (Fig. 5, electrode 52 comprises proximal electrode shaft in the form of straight portion of electrode 52 with helical portion mounted on the distal end thereof; para. 38-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Drasler et al such that the pacing electrode includes an electrode shaft having a distal shaft end, and a helical electrode mounted on the distal shaft end by adopting the electrode structure of Lokhoff et al. Making this modification would amount to a simple substitution of one known element (pacing electrode of Drasler et al) for another (Lokhoff’s pacing electrode) to obtain predictable results (fixation of device to cardiac tissue and providing stimulation, see para. 38-39 of Lokhoff et al) (MPEP 2141(III)(B)).
Regarding claim 28, Drasler et al in view of Altman et al and Lokhoff et al discloses the joint includes a spherical bearing (e.g. Altman et al Figure 5 and Column 5 lines 66 to Column 6 line 15).
Regarding claim 29, Drasler et al in view of Altman et al and Lokhoff et al discloses a torque element having a distal element end connected to the pacing electrode and a proximal element end electrically connected to the pacing circuitry (Fig. 6A, biasing device 136 which has distal end connected to fixation element/electrode 130 and proximal end electrically connected to electrode 129, which must be electrically connected to pacing circuitry in order for the device to function as disclosed).
Regarding claim 31, modified Drasler does not teach the joint includes a universal joint.
Altman, however, teaches an intracardiac lead having a compliant fixation device (Abstract) wherein a joint between a lead body and fixation element comprises a universal joint (Fig. 9; Col. 7, ll. 50-53: “first and second annular members 960, 970 combine to form a universal joint”, wherein the cited passage includes a typo that says 980 instead of 970). Additionally, Altman teaches annular members 960 and 970 can freely swivel about one another to provide a flexible connection between fixation helix 930 and distal end 920. Thus, movements of the patient will not be directly transferred to fixation helix 930 (Col. 7-8, ll. 65-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Drasler such that the joint includes a universal joint. Making this modification would be useful for provide a flexible connection between fixation helix and distal end. Thus, movements of the patient will not be directly transferred to fixation helix, as taught by Altman.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Drasler in view of Altman et al and Lokhoff, further in view of Shchervinsky (US 6021355).
Regarding claim 3, modified Drasler does not teach a masking element covering an outer surface of the electrode shaft.
Shchervinsky, however, teaches a surgical electrode of the type used as a temporary cardiac pacing wire provides electrical contact between a patient's heart and a source of electrical pulses (i.e., a pacemaker). One end of the wire attaches to the heart. The other end is attached to a surgical needle that has a weakened zone in its shaft, to permit the sharp end of the needle to be broken off and discarded. The remaining shaft connects to the pacemaker. By providing an insulating coating over part of the shaft, the electrode of the invention protects against harm to the patient that would otherwise be caused by mis-connecting the electrode or by shorting the two electrodes that comprise a setup (Abstract and Column 3 lines 30-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Drasler to include a masking element covering an outer surface of the electrode shaft. Making this modification would be useful for providing an insulating coating over part of the shaft and thus the electrode of the invention protects against harm to the patient that would otherwise be caused by mis-connecting the electrode, as taught by Shchervinsky.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Drasler et al in view of Altman et al, as applied above, and further in view of Strandberg et al. (WO 2010/112245) (hereinafter Strandberg).
Regarding claim 8, Drasler et al in view of Altman et al does not disclose the torque element includes a tubular braid.
Strandberg, however, teaches a medical implantable lead (Abstract) wherein a torque transferring member can be used as a reinforcement to a conductor coil, in the form of a braid or a tube of electrically insulating material, which is bonded to the outside of the conductor coil (pg. 4, ll. 10-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Drasler such that the torque element includes a tubular braid in order to provide reinforcement to the torque element, as suggested by Strandberg.
Claims 9-10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Drasler et al in view of Altman et al, as applied above, and further in view of Mar et al. (US 2019/0134413) (hereinafter Mar).
Regarding claim 9, Drasler et al in view of Altman et al does not disclose the pacing electrode includes one or more backstop elements.
Mar, however, teaches a biostimulator, such as a leadless cardiac pacemaker, including a fixation element to engage tissue and one or more backstop elements to resist back-out from the tissue. The backstop elements can include non-metallic filaments, such as sutures, or can include a pinch point of the biostimulator. The backstop features can grip the tissue to prevent unscrewing of the fixation element (Abstract; Fig. 2, backstop elements 203).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Drasler such that the pacing electrode includes one or more backstop elements. Making this modification would be useful for preventing unscrewing of the fixation element, as taught by Mar.
Regarding claims 10 and 20, Drasler et al in view of Altman et al does not disclose a helix mount mounted on the housing and including a fixation helix mounted on the helix mount, wherein the fixation helix is movable relative to the helix mount.
Mar, however, teaches a biostimulator having fixation element (Abstract) which includes a helix mount mounted on the housing (Fig. 27A, helix mount 206) and including a fixation helix mounted on the helix mount (Fig. 27A, fixation helix 205), wherein the fixation helix is movable relative to the helix mount (para. 87 discloses that the fixation element can be flexible, and thus movable relative to the helix mount). Mar also teaches that the helix mount has a helix mount flange, which can include one or more marks defining an alignment range such that the leading point can be aligned with the alignment range (para. 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Drasler to include a helix mount mounted on the housing and including a fixation helix mounted on the helix mount, wherein the fixation helix is movable relative to the helix mount. Making this modification would be useful for including an alignment range such that the leading point can be aligned with the alignment range, as taught by Mar.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Drasler in view of Altman et al and Lokhoff, further in view of Mar.
Regarding claim 30, modified Drasler does not teach the biostimulator includes a helix mount mounted on the housing, and a fixation helix mounted on the helix mount, and further comprising moving the fixation helix relative to the helix mount to advance the fixation helix into the interventricular septal wall.
Mar, however, teaches a biostimulator having fixation element (Abstract) which includes a helix mount mounted on the housing (Fig. 27A, helix mount 206) and including a fixation helix mounted on the helix mount (Fig. 27A, fixation helix 205), wherein the fixation helix is movable relative to the helix mount (para. 87 discloses that the fixation element can be flexible, and thus movable relative to the helix mount). Mar also teaches that the helix mount has a helix mount flange, which can include one or more marks defining an alignment range such that the leading point can be aligned with the alignment range (para. 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Drasler to include a helix mount mounted on the housing and including a fixation helix mounted on the helix mount, wherein the fixation helix is movable relative to the helix mount. Making this modification would be useful for including an alignment range such that the leading point can be aligned with the alignment range, as taught by Mar.
Allowable Subject Matter
Claims 6, 13-15, 23-25, and 32 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest cited prior art does not disclose a header assembly mounted on the housing and having a socket, wherein a ball is connected to the pacing electrode, and wherein the spherical bearing includes the ball in the socket (claim 5), in combination with other limitations; wherein the universal joint includes a driving yoke and a driven yoke connected to a spider, and wherein the conductor passes through a channel of the spider (claims 13 and 23), in combination with other limitations; torquing the housing to screw the pacing electrode into the interventricular septal wall, wherein the universal joint pivots such that the electrode axis and the housing axis remain at a driving angle when the pacing electrode screws into the interventricular septal wall (claim 32), in combination with other limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kveen et al. (US 2009/0082827) discloses hinged anchors for wireless pacing electrodes (Abstract).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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/William J Levicky/Primary Examiner, Art Unit 3796
Prosecution Insights