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 .
The amendment filed on October 17, 2024 has been received and considered. By this amendment, claim 1 is amended, claims 10 and 11 are cancelled, and claims 1-8 and 12-22 are now pending in the application, with claims 6 and 7 withdrawn from further consideration as being drawn to a non-elected invention.
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.
Claims 1-4, 12, 14, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Osypka (Publication No. US 2014/0194965 A1, previously cited) in view of Ransbury (US 2012/0090627, previously cited).
Regarding claims 1-3 and 12, Osypka discloses an electromedical electrode comprising: at least one anchoring means (Fig. 1) on a distal end of the electrode (Fig. 2 (2) and pars. [0020]: …distal end sections of common temporary electrodes…); and
at least one sensor arranged on the at least one anchoring means and/or adjacent to the at least one anchoring means (Fig. 7 (23) and par. [0018]: The electrode poles of said assembly fixed on the heart surface have a large surface area, are multipolar and may be used at the same time as sensing and stimulation electrodes),
wherein the at least one anchoring means is made of printed circuit board material (pars. [0046], [0047]: ] The design of the novel electrode assembly varies as follows: Choice of materials: …electrically conductive plastic, also mixed with nanoparticles. Isolation: polyurethane, polyethylene, silicone, PTFE… polyimide, PEEK, all biocompatible plastics incl. coatings);
wherein the electromedical electrode comprises a base support which is made of printed circuit board material; and
wherein the printed circuit board material of the at least one anchoring means or the base support includes an outer layer made of biocompatible material, in particular polyurethane and /or silicone (par. [0047]: The design of the novel electrode assembly varies as follows: …Isolation: polyurethane, …silicone, …all biocompatible plastics incl. coatings).
However, Osypka fails to disclose:
wherein the electrode comprises at least one dislocation sensor which is configured for detecting a dislocation of the at least one anchoring means;
wherein the at least one dislocation sensor is configured for detecting a dislocation of the at least one anchoring means based on a deformation, straining, and /or damaging of the at least one anchoring means; and
wherein the at least one dislocation sensor comprises at least one electrical conductor which, in case of dislocation of at least one anchoring means, is severed and wherein the at least one electrical conductor includes a predetermined breaking point and /or is arranged on the anchoring means
However, Ransbury, in the same field of endeavor: dislodgement detector for intravascular medical device discloses the electrode comprises at least one dislocation sensor (Figs. 5A-C (508)) which is configured for detecting a dislocation of the at least one anchoring means (Fig. 5A (505) and pars. [0011], [0046]: …separation detection circuit 508 is arranged such that an open circuit is created if main body 502 separates from anchor 505);
the at least one dislocation sensor is configured for detecting a dislocation of the at least one anchoring means based on a deformation, straining, and /or damaging of the at least one anchoring means (par. [0012]: …an IID dislodgement detector… the detector is adapted to detect a magnitude of g-vector forces; detecting force includes detecting straining); and
the at least one dislocation sensor (Figs. 5A-C (508)) comprises at least one electrical conductor (par. [0046]: … separation detection circuit 508 is an electrical conductor adapted to break, and thus create a detectable open-circuit, if main body 502 separates from anchor 505) which, in case of dislocation of at least one anchoring means, is severed and wherein the at least one electrical conductor includes a predetermined breaking point and /or is arranged on the anchoring means (Fig. 6 and pars. [0046]: separation detection circuit 508 is an electrical conductor adapted to break, and thus create a detectable open-circuit, if main body 502 separates from anchor 505, [0048]: At 603, an electrical conductor is arranged to form a current loop between at least one portion of the anchor and at least one portion of the medical device… separation of the device from the anchor causes a detectable break in the electrical conductor) for the purpose of providing an indication of a device dislodgement event (par. [0011]).
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 electrode system of Osypka, to include a separation detection sensor with the anchor, as taught by Ransbury, in order to provide an indication of a device dislodgement event.
Regarding claim 4, Osypka discloses the electrode of claim 1, wherein at least one anchoring means (Figs. 2 and 6 (48)) is designed as pull-out protection (par. [0016]: …methods for fixing the leads temporarily at the cardiac muscle are shown in FIG. 1) and includes a free end having an application needle (Figs. 2 and 6 (49) and par. [0060], [0062]: ...heart needle (49)...).
Regarding claim 14, Osypka discloses the electrode of claim 1, wherein the at least one anchoring means is connected to a base support and / or wherein the at least one anchoring means and the base support are produced from a printed circuit board material preform such as a printed circuit board film blank (pars. [0046], [0047]: The electrode poles …may be formed of different materials. Silicone films with a plurality of conductive poles made of metal or conductive plastic may be used; conductive plastic construed as PCB).
Regarding claim 22 Osypka discloses the electrode of claim 1, wherein the electrode is designed as transcutaneous and / or implantable electromedical stimulation and / or sensing electrode (par. [0002] The invention relates to an implantable …electrode assembly).
Claims 5, 13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Osypka in view of Ransbury, as applied to claims 1-4, 12, 14, and 22 above, and further in view of Osypka ‘720 (Publication No. DE10-2017/008720 A1, previously cited).
Regarding claim 5, Osypka in view of Ransbury discloses the electrode of claim 1, wherein at least one anchoring means is hook-shaped (Fig. 1; see 5th option from top) or zigzag-shaped (Fig. 6 (48) and par. [0062]), and / or is a barbed hook (Fig. 1).
Osypka does not expressly disclose zigzag-shaped and includes at least two webs which are arranged so that they form a pull-out protection.
However, Osypka ‘720, in the same field of endeavor: a temporarily implantable myocardial bipolar electrode device, which is suitable both for monitoring and/or stimulating the heart muscle, discloses zigzag-shaped (Fig. 1 (4)) and includes at least two webs which are arranged so that they form a pull-out protection Fig. 1 (3), par. [0012]) for the purpose of fixing the electrode device to the heart (par. [0012]).
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 zig-zag shaped anchor of Osypka in view of Ransbury, to also include at least 2 webs, as taught by Osypka ‘720, in order to fix the electrode device to the heart.
Regarding claim 13, Osypka in view of Ransbury discloses the electrode of claim 1, except wherein a base support of the electrode connects a proximal end of the electrode to the distal end of the electrode.
Osypka ‘720 discloses a base support of the electrode (Fig. 1 (2)) connects a proximal end of the electrode to the distal end of the electrode (par. [0008]: …from a cardioversion pole ( 4 ), with an insulated strand ( 2 ), the cardioversion pole consisting of bare, wavy strand, having a distal and a proximal end…thus the electrical represents supply line) to provide the benefit of exerting no tension on the cardioversion pole (par. [0007]).
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 electrode system of Osypka in view of Ransbury, to include a base connecting distal and proximal ends, as taught by Osypka ‘720, in order to provide the benefit of exerting no tension on the cardioversion pole.
Regarding claim 15, Osypka in view of Ransbury discloses the electrode of claim 1, except wherein the electrode comprises at least two anchoring means, of which in each case at least one anchoring means is arranged on both sides of a longitudinal center axis of a distal end section of the electrode.
Osypka ‘720 discloses the electrode (Fig. 1 (3)) comprises at least two anchoring means (Fig. 1 (6)), of which in each case at least one anchoring means is arranged on both sides of a longitudinal center axis of a distal end section of the electrode (par. [0008]: …distal to the stimulation pole ( 3 ) is the fixation element ( 6 )) to provide the benefit of increasing the surface area of the cardioversion pole (par. [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 electrode system of Osypka in view of Ransbury, to include a base connecting distal and proximal ends, as taught by Osypka ‘720, in order to provide the benefit of increasing the surface area of the cardioversion pole.
Regarding claim 16, Osypka in view of Ransbury discloses the electrode of claim 14, wherein the base support comprises a distal end section on which at least one electromedical contact pole is formed and /or wherein at least one electromedical contact pole is arranged and/or formed on the at least one anchoring means.
Osypka ‘720 discloses the base support comprises a distal end section (Fig. 1 (2)) on which at least one electromedical contact pole is formed and /or wherein at least one electromedical contact pole (Fig. 1 (4)) is arranged and/or formed on the at least one anchoring means (par. [0008]: …from a cardioversion pole ( 4 ), with an insulated strand ( 2 ), the cardioversion pole consisting of bare, wavy strand, having a distal and a proximal end…) to provide the benefit keeping the cardioversion pole dimensionally stable during implantation (par. [0006]).
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 electrode system of Osypka in view of Ransbury, to include a contact pole on anchoring means, as taught by Osypka ‘720, in order to provide the benefit keeping the cardioversion pole dimensionally stable during implantation.
Regarding claim 17, Osypka in view of Ransbury discloses the electrode of claim 1 except further comprising a base support having at least one conducting track which is connected to at least one electromedical contact pole of the electrode.
Osypka ‘720 discloses a base support having at least one conducting track which is connected to at least one electromedical contact pole of the electrode (par. [0008]: …a stimulation pole ( 3 ) with an insulated strand ( 1 ), which is guided proximally to the external pacemaker and thus represents the electrical supply line; distal to the stimulation pole (3)) to provide the benefit of keeping the cardioversion pole dimensionally stable during implantation (par. [0006]).
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 electrode system of Osypka in view of Ransbury, to include a conducting track on the medical electromedical pole, as taught by Osypka ‘720, in order to provide the benefit keeping the cardioversion pole dimensionally stable during implantation.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Osypka in view of Ransbury, as applied to claims 1-4, 12, 14, and 22 above, and further in view of Pikov (Publication No. US 2020/0360696 A1, previously cited).
Regarding claim 8, Osypka in view of Ransbury discloses the electrode of claim 1, wherein the electrode comprises a processing module and /or a communication module.
However, Pikov in the same field of endeavor: devices systems and methods for delivering therapy, discloses the electrode comprises a processing module and /or a communication module (par. [0068]: The implantable signal delivery device 102 and/or temporary signal delivery device 117 may be used to apply a stimulation signal to a nerve (e.g., sacral nerve) using the stimulation electrodes 103, 119; devices 102 and 117 constitute a processing module and a communication module respectively) for the purpose of applying a screening stimulation signal (par. [0068]).
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 electrode system of Osypka in view of Ransbury, to include a signal delivery processing and communication module, as taught by Pikov, in order to apply a screening stimulation signal.
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Osypka in view of Ransbury, as applied to claims 1-4, 12, 14, and 22 above, and further in view of Regnier (Publication No. US 2021/0316148 A1, previously cited).
Regarding claim 18, Osypka in view of Ransbury discloses the electrode of claim 1, except wherein the electrode comprises a covering hose, in which a base support of the electrode is arranged.
However, Regnier in the same field of endeavor: autonomous cardiac implant, discloses the electrode comprises a covering hose (Fig. 1 (12)), in which a base support of the electrode is arranged (par. [0111]: This assembly is finally placed into the tubular body 12 of the leadless capsule (step 114) by positioning, centring and fastening per se known techniques) for the purpose of enclosing the various electronic circuits of the covering (par. [0070]).
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 electrode system of Osypka in view of Ransbury, to arrange the base support in a tubular body, as taught by Regnier, in order to enclose the various electronic circuits of the covering.
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Osypka in view of Ransbury, as applied to claims 1-4, 12, 14, and 22 above, and further in view of Martins (Publication No. US 2016/0310730 A1, previously cited).
Regarding claim 20, Osypka in view of Ransbury discloses the electrode of claim 1, except wherein on a proximal end thereof, further includes a connection plug which is made of printed circuit board material, the connection plug being a proximal end section of the base support and having a connection contact.
However, Martins in the same field of endeavor: a medical stimulation system discloses on a proximal end thereof, further includes a connection plug which is made of printed circuit board material (par. [0115]: The substrate 206 may be formed from any suitable material such as a flexible plastic or silicone and may have upper a…The substrate 206 may be formed from a suitable material…), the connection plug (Figs. 5, 8, 12 (533)(833)(1233) "electrode array connector") being a proximal end section of the base support (Figs. 5, 8 (506) (806)) and having a connection contact (Figs. 5, 8 (504) (804) and par. [0135]: A coupler may be coupled to one or more of the leads 818 and/or the electrode cable 804…) for the purpose of forming strain relief (par. [0135]).
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 electrode system of Osypka in view of Ransbury, to include connection plugs on the proximal end, as taught by Martins, in order to form a strain relief connection.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Osypka in view of Ransbury, as applied to claims 1-4, 12, 14, and 22 above, and further in view of Mathur (Publication No. US 2017/0239483 A1, previously cited).
Regarding claim 21, Osypka in view of Ransbury discloses the electrode of claim 1, except wherein the electrode comprises an electromedical pulse generator which is arranged and/or formed on a proximal end section of a base support of the electrode.
However, Mathur in the same field of endeavor: external pulse generator device, discloses the electrode comprises an electromedical pulse generator which is arranged and/or formed on a proximal end section of a base support of the electrode (Fig. 6 (40) (46) and par. [0005], [0074]: …the stimulation pulse generator 46, which produces stimulation pulses that are delivered to a connected neurostimulation lead via the connector receptacle 42) for the purpose of releasably mounting the EPG that is secured to the patient during trial stimulation treatment (par. [0004]).
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 electrode system base support of Osypka in view of Ransbury, to include a stimulation generator arranged on the proximal end of the base support, as taught by Marthur, in order to releasably mount the EPG that is secured to the patient during treatment.
Allowable Subject Matter
Claim 19 is 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.
Response to Arguments
Applicant's arguments filed October 17, 2024 have been fully considered but they are not persuasive. Applicant argues that Osypka fails to disclose a sensor arranged on the at least one anchoring means and/or adjacent to the at least one anchoring means, arguing that the assembly of Osypka includes electrode poles fixed on the heart having a large surface area that can be used for sensing and stimulating electrodes, but “nowhere does Osypka describe or suggest the assembly including at least one sensor arranged on the at least one anchoring means” and paragraph [0018] “does not describe a sensor arranged on the anchoring means”. It is respectfully submitted that the claim language includes “a sensor arranged on the at least one anchoring means and/or adjacent to the at least one anchoring means”. It is respectfully submitted that the configuration described in paragraph [0018] and shown in Figure 7 shows the sensor is arranged adjacent to the at least one anchoring means. As such, Osypka discloses this aspect of the claimed invention. Applicant further argues that Ransbury describes at paragraph [0049] a dislodgement detector that is an accelerometer or microphone. However, the embodiment of the dislodgement detector in paragraph [0049] is not relied upon to teach the claimed invention, rather the dislodgement sensor in paragraph [0046] is used for such a purpose. Applicant fails to present any arguments specifically against the embodiment of Ransbury that is relied upon or the combination of the references as previously presented. As such, the rejection is considered to stand.
Regarding the additional rejections of the claims as being unpatentable over Osypka ‘720, Pikov, Regnier, Martins, and Mathur, Applicant fails to present arguments specific to any of these additional rejections and, thus, the previous rejections are considered to stand for at least the reasons set forth above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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