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
Drawings
Applicant’s arguments, filed October 15, 2025, with respect to the drawing objections have been fully considered and are persuasive in view of the specification amendments. The drawing objections of July 15, 2025 has been withdrawn.
Specification
Applicant’s arguments, filed October 15, 2025, with respect to the objections to the specification have been fully considered and are persuasive. The objections to the specification of July 15, 2025 have been withdrawn.
35 USC § 112
Applicant’s arguments, filed October 15, 2025, with respect to 35 USC § 112 rejection of claim 1 have been fully considered and are persuasive in view of claim 1’s amendments. The 35 USC § 112 rejection(s) of July 15, 2025 has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments with respect to claim(s) 1-6 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In the instant case, the newly applied references as taught by Choi, Y.S., Yin, R.T., Pfenniger, A. et al. Fully implantable and bioresorbable cardiac pacemakers without leads or batteries. Nat Biotechnol 39, 1228–1238 (2021). https://doi.org/10.1038/s41587-021-00948-x, hereinafter Choi, teaches a similar cardio-stimulation system comprising biodegradable electrodes which dissolve over a period of weeks, and Schulman (US 20100152825 A1 – hereinafter Schulman) which teaches a similar cardiac stimulation system comprising biodegradable insulated sections which dissolve over a period of weeks, as stated in the claim 1 rejection below.
Information Disclosure Statement
The information disclosure statement(s) filed June 16, 2023 has/have been considered by the Examiner.
Claim Interpretation
The term(s) “configured to” in the claim(s) may be interpreted as intended use. Intended use/functional language does not require that references teach or disclose the intended use of an element. A recitation of the intended use of the claimed invention 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 intended use, then it meets the claim. See MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART.
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 and 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bendel (US 5350419 A – hereinafter Bendel) in view of Shchervinsky (US 6217369 B1 – hereinafter Shchervinsky) [BOTH PREVIOUSLY CITED], and in further view of Choi, Y.S., Yin, R.T., Pfenniger, A. et al. Fully implantable and bioresorbable cardiac pacemakers without leads or batteries. Nat Biotechnol 39, 1228–1238 (2021). https://doi.org/10.1038/s41587-021-00948-x, hereinafter Choi [NEW], and Schulman (US 20100152825 A1 – hereinafter Schulman) [NEW].
Re. claim 1, Bendel teaches an epicardial pacing wire assembly (abstract – “…cardiac pacing lead. The pacing lead has a conductive wire…”) for use with a pacemaker for temporary pacing after cardiac surgery (figure 4C; column 3, lines 66-68: “An electrode needle is conductively attached to the proximal end of the wire for connection to an external pacing or monitoring device”), said pacing wire assembly comprising;
an epicardium needle (figure 1, surgical needle 40),
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an electrode segment (figure 1, distal section 30 used to deliver electrical signals, column 4, lines 60-64: “At least part of section 30 of the conductive wire 20 will be in electrical contact with the myocardium for transmitting and receiving electrical signals.”),
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an insulated segment (figure 1, insulative coating 26) and a chest wall piercing needle (figure 1, needle electrode proximal point 62; column 9, lines 49-53: “The surgeon then pushes the electrode needle 60, having score line 68, through the patient's chest wall in between an intercostal space so that the point 62 of the needle protrudes through the chest wall of the patient.”),
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the epicardium needle comprises a tip configured to be secured to a patient’s epicardium (figure 1, distal point 42 of needle 40) and a base attached to the electrode segment (figure 1, proximal end 43 of needle 40 connects to distal segment 30, which is used to deliver electrical signals, column 4, lines 60-64: “At least part of section 30 of the conductive wire 20 will be in electrical contact with the myocardium for transmitting and receiving electrical signals.”),
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the electrode segment comprising one or more linear wire electrodes configured to contact the epicardium and deliver electric energy that stimulates myocardium action potential (figure 1, linear distal section 30 of wire 20 used to deliver electrical signals, column 4, lines 60-64: “At least part of section 30 of the conductive wire 20 will be in electrical contact with the myocardium for transmitting and receiving electrical signals.”),
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one end of the electrode segment configured to attach to the epicardium needle (figure 1, proximal end 43 [of needle 40] connects to distal segment 30 used to deliver electrical signals) and the other end configured to attach to the insulated segment (figure 1, distal segment 30, used to deliver electrical signals, connects to insulative coating 26 of conductive wire 20),
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the insulated segment comprising, one end of the insulating segment connected to the electrode segment (figure 1, wire 20 with electrical insulating coating 26 has a distal end 24 connected to the distal section 30 used to deliver electrical signals) and the other end connected to the chest wall piercing needle (figure 1, wire proximal end 22 with insulative coating 26 connects to needle 60),
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Bendel further teaches insulating composition surrounding the wire and insulating them from the surrounding environment (column 6, lines 29-31: “As seen in FIG. 1, the wire 20 has an electrically insulative, polymer coating 26 sufficient to effectively prevent conduction through the coating.”),
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the chest wall piercing needle comprising one end connected to the insulated segment (figure 1, electrode needle 60 is connected to the wire 20 with insulative coating 26; column 5, lines 27-28: “The electrode needle 60 is attached to the proximal tip 23 of the conductive wire 20”) and a free end configured to pierce the patient’s chest wall so that a surgeon can pierce the chest well from inside though to the outside and drawn the connected elements of the pacing wire assembly outside the patient’s chest (figure 1, needle electrode proximal point 62; column 9, lines 49-53: “The surgeon then pushes the electrode needle 60, having score line 68, through the patient's chest wall in between an intercostal space so that the point 62 of the needle protrudes through the chest wall of the patient.”),
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Bendel further teaches a wire running from each of the one or more electrodes at one end of the insulating segment through the central longitudinal axis and out the other end of the insulating segment (figure 1, a wire 20 includes proximal section 22, and distal section 30 used to deliver electrical signals, and runs through the insulative coating 26 through the central longitudinal axis).
Bendel does not teach wires running from each of the one or more electrodes at one end of the segment through the central longitudinal axis and out the other end of the segment.
Shchervinsky teaches a temporary pacing lead (Shchervinsky abstract – “A temporary cardiac pacing wire, or a similar device, includes an electrically conductive lead…”) with a distal needle 14 (Shchervinsky figure 1) and teaches wires running from each of the one or more electrodes at one end of the segment through the central longitudinal axis and out the other end of the segment (Shchervinsky figure 1 shows electrode wires 18 and 20 connected to electrode 22, where each wire has a “surrounding layer of insulation made from polyethylene”, Shchervinsky column 4, lines 21-27).
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Since Bendel teaches pacing lead with the wire and the insulative coating, and Shchervinsky teaches the pacing lead with wires and the insulative coating, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wire of Bendel to incorporate the wires connecting the electrode through the insulation as taught by Shchervinsky since such modification would predictably result in, for example, to “transmit electrical signals from one to the other for the purpose of stimulating, pacing, sensing, monitoring, or defibrillating the heart” (column 4, lines 39-42).
The combined invention of Bendel in view of Shchervinsky (hereinafter the combined invention) teaches the claimed invention as stated above, but does not explicitly teach wherein the electrode segment is made of biodegradable material that will dissolve over a period of weeks and need not be removed following the temporary pacing.
Choi teaches a similar cardiac stimulation system (Choi page 1228, column 2, lines 12-13: “Here we present a fully bioresorbable, implantable, leadless cardiac pacemaker that operates in a battery-free fashion and is externally controlled and programmable”) comprising a dissolvable electrode segment (Choi figure 1a, W/Mg electrode; page 1229, column 1, Results: “The schematic illustration in Fig. 1a (left) shows a thin, flexible, bioresorbable, leadless cardiac pacemaker on the surface of a heart. As part of the surgical implantation process, an integrated contact pad containing two dissolvable metallic electrodes (that is, bipolar channels) attaches to the myocardium”),
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which dissolves in over a period of weeks and need not be removed following the temporary pacing (Choi page 1229, column 2, lines 12-14: “The constituent materials largely dissolve within 5 weeks, and the remaining residues completely disappear after 7weeks”; page 1236, column 1, lines 11-13: “The device largely dissolves within 3 weeks, and the remaining residues completely disappear after 12 weeks”).
The combined invention and Choi all teach within the field of cardiac stimulation systems; the combined invention teaches the cardiac electrodes as stated above, while Choi teaches the biodegradable cardiac electrodes as stated above. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined invention, specifically the cardiac electrodes, to incorporate the dissolvable biodegradable electrodes which dissolve in weeks, as taught by Choi, since such modification would predictably result in eliminating the need for invasive electrode extraction.
The newly combined invention including Choi (hereinafter the combined invention) teaches the claimed invention as stated above, including the biodegradable electrodes as stated above, but does not explicitly teach wherein the insulated segment is made of biodegradable material that will dissolve over a period of weeks and need not be removed following the temporary pacing.
Schulman teaches a similar cardiac stimulation system (Schulman abstract – “An absorbable pacing lead assembly may comprise a core, a conductive coating surrounding the core, and an insulator surrounding the conductive coating along a middle portion of the assembly”; figure 1, lead assembly 100).
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Schulman further teaches the assembly 100 comprises a barb 108, and an insulated segment (Schulman figure 1, insulator 110) made of biodegradable material that will dissolve over a period of weeks and need not be removed following the temporary pacing (Schulman paragraph 0019 – “It should be appreciated that the insulators 110, 224 may be comprised of other absorbable materials, including absorbable suture materials. The material for constructing the insulators 110, 224 may be selected so as to facilitate absorption of the insulators 110, 224 in about three months…the insulators 110, 224 may be constructed of material such as, for example, polyglycolic acid, which may be absorbed in about two weeks”).
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The combined invention and Schulman all teach within the field of cardiac stimulation systems; the combined invention teaches the insulated segments as stated above, while Schulman teaches the biodegradable insulated segment as stated above. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined invention, specifically the insulated segments, to incorporate the dissolvable biodegradable insulated segments which dissolve in weeks, as taught by Schulman, since such modification would predictably result in eliminating the need for invasive extraction of the system, including the insulated segment.
Re. claim 4, the combined invention further teaches wherein each of said electrode and said wire are a seamless one piece length of the same material (Bendel figure 1, distal section 30, used to deliver electrical signals, is a seamless one piece length of the wire 20, column 4, lines 60-64: “At least part of section 30 of the conductive wire 20 will be in electrical contact with the myocardium for transmitting and receiving electrical signals”, and is made of a single filament conductor, column 5, lines 51-54: “The conductive wire 20 will be made from a single filament, low modulus metal having the requisite electrical properties, biocompatibility properties and mechanical properties”).
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Re. claim 5, the combined invention further teaches wherein said electrode segment further comprises a single electrode for unipolar epicardial pacing (Bendel figure 1, singular distal section 30, used to deliver electrical signals, column 4, lines 60-64: “At least part of section 30 of the conductive wire 20 will be in electrical contact with the myocardium for transmitting and receiving electrical signals.”).
Re. claim 6, the combined invention as is teaches an electrode (Bendel figure 1, singular distal section 30, used to deliver electrical signals) and wires through the electrode (Shchervinsky figure 1 shows electrode wires 18 and 20 connected to electrode 22, where each wire has a “surrounding layer of insulation made from polyethylene”, column 4, lines 21-27) as stated above in claim 1, but does not include the wherein said electrode segment further comprises two electrodes for bipolar epicardial pacing.
Shchervinsky of the combined invention however teaches the bipolar temporary cardiac pacing wire in figure 1 (Shchervinsky column 4, lines 3-4: “Referring to FIG. 1, a bipolar temporary cardiac pacing wire 10…”) that includes two electrodes 22 and 24 which connect to the wires 18 and 20.
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode of the combined invention to incorporate the bipolar two electrode configuration as taught by Shchervinsky since such modification would predictably result in, for example, to transmit bipolar electrical signals from one to the other for the purpose of stimulating, pacing, sensing, monitoring, or defibrillating the heart (column 4, lines 39-42).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bendel (US 5350419 A – hereinafter Bendel) in view of Shchervinsky (US 6217369 B1 – hereinafter Shchervinsky) [BOTH PREVIOUSLY CITED], and in further view of Choi, Y.S., Yin, R.T., Pfenniger, A. et al. Fully implantable and bioresorbable cardiac pacemakers without leads or batteries. Nat Biotechnol 39, 1228–1238 (2021). https://doi.org/10.1038/s41587-021-00948-x, hereinafter Choi [NEW], and Schulman (US 20100152825 A1 – hereinafter Schulman) [NEW], and in further view of Hendricks (US 20110257504 A1 – hereinafter Hendricks) [PREVVIOUSLY CITED].
Re. claim 2, the combined invention of Bendel, Shchervinsky, Choi and Schulman (hereinafter the combined invention) further teaches the electrodes and wires in claim 1 as stated above, but does not explicitly teach wherein said electrodes and wires further comprise melanin.
Hendricks teaches a stimulation electrode (Hendricks abstract; paragraph 0009 – “Methods and compositions are provided for the construction of an electrochemical sensing and stimulation device wherein the electrode is intimately in contact with a biological component during the recordation and stimulating process.”), where the electrode includes wires and leads (paragraph 0036 – “…the electrode can be connected in part or in whole to other device components, including wires, leads, conductive polymers that are in electrical communication with other device components…”) and further teaches that electrodes and electrical connections can be made of natural or synthetic melanins (paragraph 0070 – “The present technology further provides methods for creating integrated biomedical electrodes, electrical connections, and conductive and connective pathways that are grown, deposited, and/or created in place (e.g., in situ) and in contact with tissue or an injected scaffold, in vitro cell scaffold, tissue engineering product or construct, and/or artificial tissue. The electrode or electrical connection is made of conducting polymers (e.g., polythiophenes, polypyrroles, natural or synthetic melanins…”).
Since the combined invention and Hendricks all pertain within the field of stimulation electrodes, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulation electrodes and wires of the combined invention to incorporate the melanin stimulation electrode and electrical connections as taught by Hendricks since such modification would predictably result in natural electrode/connection degradation within the body (Hendricks paragraph 0070 – “The tissue-integrated conducting polymer electrode/connection may be permanent or degradable.”).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bendel (US 5350419 A – hereinafter Bendel) in view of Shchervinsky (US 6217369 B1 – hereinafter Shchervinsky) [BOTH PREVIOUSLY CITED], and in further view of Choi, Y.S., Yin, R.T., Pfenniger, A. et al. Fully implantable and bioresorbable cardiac pacemakers without leads or batteries. Nat Biotechnol 39, 1228–1238 (2021). https://doi.org/10.1038/s41587-021-00948-x, hereinafter Choi [NEW], and Schulman (US 20100152825 A1 – hereinafter Schulman) [NEW], and in further view of Wang (US 20190381324 A1 – hereinafter Wang) [PREVIOUSLY CITED].
Re. claim 3, the combined invention of Bendel, Shchervinsky, Choi and Schulman (hereinafter the combined invention) teach the claimed invention of claim 1 as stated above, but does not explicitly teach wherein said insulating composition is selected from the group of silk or cellulose.
Wang teaches an electrical stimulation lead (figure 1, leads 34) with electrode wires and insulating composition surrounding the wires an insulated section (Wang figure 1, insulated electrode wires 30a-30b; paragraph 0040 – “The electrode wires 30 may be insulated conducting wires, for example, copper wires insulated with polydimethylsiloxane (PDMS)…”), and further teaches wherein said insulating composition is selected from the group of silk or cellulose (Wang paragraph 0078 – “All or part of the generator 24, including the electrode wires 30 may be biodegradable so that the wires disintegrate harmlessly within the body over a certain amount of time, for example in less than three years. In this regard, the conductors may use metallic glasses based on magnesium zinc and calcium or thin aluminum conductors covered with biodegradable insulator such as silk”).
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The combined invention and Wang all teach within the field of cardiac electrical stimulation systems; the combined invention teaches the electrical stimulation lead with electrodes and insulation as stated above in claim 1, while Wang teaches the electrical stimulation leads with biodegradable electrodes and insulation as stated above. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the insulation composition of the combined invention, to incorporate the biodegradable insulation made of silk as taught by Wang since such modification would predictably result in the electrode and insulation to disintegrate harmlessly within the body over a certain amount of time, for example in less than three years (Wang paragraph 0078) without need for invasive extraction.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Grandjean (US 5086787 A) teaches a stimulation lead with a suture needle 118, insulative sheath 108 and electrode 114.
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 Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796