DETAILED ACTION
Response to Arguments
Applicant’s arguments, see page 14, filed on 3/04/2026, with respect to the drawing objections have been fully considered and are persuasive. The previous drawing objections have been withdrawn.
Applicant’s arguments, see page 14, filed on 3/04/2026, with respect to the specification objections have been fully considered and are persuasive. The previous specification objections pertaining to the abstract and informalities have been withdrawn.
Applicant’s arguments, see page 14, filed on 3/04/2026, with respect to the 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The previous 112(b) rejections have been withdrawn.
Applicant’s arguments, see pages 14-18, filed on 3/04/2026, with respect to the 35 U.S.C. 103 rejections of claims 1-2, 14, 19, and 33 under Kulkarni in view of Borenstein have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejections are made in view of Van Wijk (U.S. Patent No. 6,330,481) and King (U.S. PGPub No. 2014/0296941) due to a new search that was necessitated by the amendments. Furthermore, Applicant’s arguments regarding the other dependent claims have been fully considered, but are not persuasive due to the new grounds of rejections for the independent claims 1 and 19.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 8-9, 13, 19, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Van Wijk et al. (U.S. Patent No. 6,330,481) in view of Borenstein et al. (U.S. PGPub No. 2012/0223293) (cited previously) and Progress of Biodegradable Metals, 2014 (herein referred to as Li).
Regarding claim 1, Van Wijk teaches an implantable system (Fig. 1, Col. 5, lines
8-12), comprising: at least one implantable lead (Fig. 1, Col. 5, line 1) comprising a conductive core (Fig. 2, Col. 5, line 48), a polymeric insulator (Fig. 2, Col. 5, lines 47 and 51-56) encompassing at least a portion of a length of the conductive core (Fig. 2, Col. 6, lines 9-10), and at least one electrode (Fig. 1, Col. 5, line 12) on a distal end thereof (Fig. 2, Col. 6, lines 14-16) which comprises a portion of conductive core (Col. 6, lines 14-21) which is exposed to interface with tissue (Col. 7, lines 32-33), and electronic circuitry (Col. 5, lines 36-44) operatively connectible to the at least one implantable lead (Col. 5, lines 16-17) which is configured to provide a controlled electrical signal (Col. 9, lines 22-24) via the at least one electrode of the at least one implantable lead to tissue to effect treatment (Col. 5, lines 9-15).
Van Wijk does not teach that the conductive core and polymeric insulators are
biodegradable. Borenstein, however, teaches a biodegradable electronic device that can be implanted into a human that uses biodegradable materials as conductors (Paragraph 0027, lines 1-5), and biodegradable polymers as insulators (Paragraph 0029, lines 8-11).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate the teachings of Borenstein to utilize materials that can act as both conductors and insulators of electricity, and that are also biodegradable. Doing so would allow for more temporary solutions to implantable devices and lessen health and safety concerns for patients (Paragraph 0024), as recognized by Borenstein.
Van Wijk also does not teach that the biodegradable conductive core comprises at
least one of a biodegradable metal and a biodegradable metal alloy. Li teaches that biodegradable metals and metal alloys have been designed to safely and gradually corrode in vivo (Abstract). Li also describes that biodegradable metal matrix composites can be created with metals, metal alloys, and polymers to incorporate their advantages, including conductivity (Section 2.2).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate the
teachings of Li to use biodegradable metals and biodegradable metal alloys as a conductive material. Doing so would allow for improved biocompatibility and patient safety outcomes (Abstract), as recognized by Li.
Regarding claim 2, Van Wijk in view of Borenstein and Li discloses the claimed
invention of claim 1. Van Wijk further discloses the system (Fig. 1, Col. 5, lines
8-12) of claim 1 wherein the controlled electrical signal (Col. 9, lines 22-24) comprises pulses of electrical energy (Col. 14, lines 50-52).
Regarding claim 3, Van Wijk teaches the system (Fig. 1, Col. 5, lines 8-12) of
claim 1 that includes the conductive core (Fig. 2, Col. 5, line 48). Van Wijk does not teach that the conductive core is biodegradable, and consists essentially of at least one of the biodegradable metal and the biodegradable metal alloy.
Borenstein, however, teaches a biodegradable electronic device that can be implanted into a human that uses biodegradable materials as conductors (Paragraph 0027, lines 1-5). Li, however, teaches that biodegradable metals and metal alloys have been designed to safely and gradually corrode in vivo (Abstract). Li also describes that biodegradable metal matrix composites can be created with metals, metal alloys, and polymers to incorporate their advantages, including conductivity (Section 2.2).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate both the
teachings of Borenstein and Li to use biodegradable metals and biodegradable metal
alloys as a conductive material. Doing so would allow for improved biocompatibility and patient safety outcomes when using implantable electronic devices, as recognized by Borenstein (Paragraph 0024) and Li (Abstract).
Regarding claim 4, Van Wijk teaches the system (Fig. 1, Col. 5, lines 8-12) of
claim 1 that includes the conductive core (Fig. 2, Col. 5, line 48). Van Wijk does not teach that the conductive core is biodegradable and comprises the biodegradable metal alloy. Borenstein, however, teaches a biodegradable electronic device that can be implanted into a human that uses biodegradable materials as conductors (Paragraph 0027, lines 1-5). Li, however, teaches that biodegradable metal alloys have been designed to safely and gradually corrode in vivo (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate both the
teachings of Borenstein and Li to use a biodegradable metal alloy as a conductive material. Doing so would allow for improved biocompatibility and patient safety outcomes when using implantable electronic devices, as recognized by Borenstein (Paragraph 0024) and Li (Abstract).
Regarding claim 5, Van Wijk teaches the system (Fig. 1, Col. 5, lines 8-12) of
claim 1 that includes the conductive core (Fig. 2, Col. 5, line 48). Van Wijk does not teach that the at least one of the biodegradable metal and the biodegradable metal alloy is selected from the group consisting of magnesium, a magnesium alloy, iron, an iron alloy, zinc, a zinc alloy, molybdenum, a molybdenum alloy, zirconium, a zirconium alloy, calcium, and a calcium alloy.
Li, however, teaches that biodegradable metals and metal alloys have been designed to safely and gradually corrode in vivo (Abstract). Furthermore, Li teaches that biodegradable metals and metal alloys can comprise magnesium, iron, zinc, molybdenum, zirconium, or calcium (Section 4.3.4 and Section 5.1).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate the teachings of Li to use the at least one of the biodegradable metals and the biodegradable metal alloys including the elements listed above as a conductive material. Doing so would allow for improved biocompatibility and patient safety outcomes when using implantable electronic devices (Abstract), as recognized by Li.
Regarding claim 8, Van Wijk in view of Borenstein and Li discloses the claimed invention of claim 1. Van Wijk further discloses the system (Fig. 1, Col. 5, lines 8-12) of claim 1 wherein the electronic circuitry (Col. 5, lines 36-44) is configured to be positioned ex vivo (Col. 5, line 9) when placed in operative connection with the at least one implantable lead (Col. 5, lines 16-17) and the implantable lead is configured to be implanted percutaneously (Col. 15, line 33).
Regarding claim 9, Van Wijk teaches the system (Fig. 1, Col. 5, lines 8-12) of
claim 1 that includes the conductive core (Fig. 2, Col. 5, line 48). Van Wijk does not
teach that the conductive core is biodegradable and is formulated to provide a predetermined degradation profile over time.
Borenstein, however, teaches a biodegradable electronic device that can be implanted into a human that uses biodegradable materials as conductors (Paragraph 0027, lines 1-5). Li, however, teaches that various elements commonly used in biodegradable metals and metal alloys such as magnesium, iron, and zinc all have different degradation processes over a period of time (Section 1). Adding specific alloying elements, surface coatings, or other degradable biomaterials can create a controlled and predetermined degradation profile over time (Section 2.2).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate both the
teachings of Borenstein and Li to use biodegradable metals or biodegradable metal alloys
as a conductive material, as they can have predetermined degradation profiles. Doing so
would allow the ability to use biodegradable materials with desired and designed
degradation profiles in implantable electronic devices, which would improve device
monitoring, stability, and patient safety, as recognized by Borenstein (Paragraph 0024) and Li (Section 2.2).
Regarding claim 13, Van Wijk teaches the system (Fig. 1, Col. 5, lines 8-12) of
claim 5 that includes the conductive core (Fig. 2, Col. 5, line 48). Van Wijk does not teach that the conductive core is biodegradable and comprises zinc. Borenstein, however, teaches a biodegradable electronic device that can be implanted into a human that uses biodegradable materials as conductors (Paragraph 0027, lines 1-5). Li, however, teaches that biodegradable metals and metal alloys have been designed to safely and gradually corrode in vivo (Abstract). Li also teaches that biodegradable metals and metal alloys commonly comprise zinc (Section 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Van Wijk to incorporate the teachings of Borenstein and Li to use biodegradable metals or biodegradable metal alloys comprising zinc as a conductive material. Doing so would allow for improved biocompatibility and patient safety outcomes when using implantable electronic devices, as recognized by Borenstein (Paragraph 0024) and Li (Abstract).
Regarding claim 19, Van Wijk teaches a method (Col. 14, lines 38-39) of
transmitting electrical signals to in vivo tissue for treatment (Col. 5, lines 12-15), comprising: implanting at least one implantable lead (Fig. 1, Col. 5, line 1) comprising a conductive core (Fig. 2, Col. 5, line 48), a polymeric insulator (Fig. 2, Col. 5, lines 47 and 51-56) encompassing at least a portion of a length of the conductive core (Fig. 2, Col. 6, lines 9-10), and at least one electrode (Fig. 1, Col. 5, line 12) on a distal end thereof (Fig. 2, Col. 6, lines 14-16) which comprises a portion of conductive core (Col. 6, lines 14-21) which is exposed to interface with tissue (Col. 7, lines 32-33), and applying a controlled electrical signal (Col. 9, lines 22-24) to the tissue via the at least one electrode of the at least one implantable lead (Col. 5, lines 9-15) via electronic circuitry (Col. 5, lines 36-44) operatively connected to the at least one implantable lead (Col. 5, lines 16-17).
Van Wijk does not teach that the conductive core and polymeric insulators are
biodegradable. Borenstein, however, teaches a biodegradable electronic device that can
be implanted into a human that uses biodegradable materials as conductors (Paragraph 0027, lines 1-5), and biodegradable polymers as insulators (Paragraph 0029, lines 8-11).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate the teachings of Borenstein to utilize materials that can act as both conductors and insulators of electricity, and that are also biodegradable. Doing so would allow for more temporary solutions to implantable devices and lessen health and safety concerns for patients (Paragraph 0024), as recognized by Borenstein
Van Wijk also does not teach that the biodegradable conductive core comprises at
least one of a biodegradable metal and a biodegradable metal alloy. Li teaches that biodegradable metals and metal alloys have been designed to safely and gradually corrode in vivo (Abstract). Li also describes that biodegradable metal matrix composites can be created with metals, metal alloys, and polymers to incorporate their advantages, including conductivity (Section 2.2).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate the
teachings of Li to use biodegradable metals and biodegradable metal alloys as a conductive material. Doing so would allow for improved biocompatibility and patient safety outcomes (Abstract), as recognized by Li.
Regarding claim 39, Van Wijk teaches the system (Fig. 1, Col. 5, lines 8-12) of
claim 1 wherein the at least one implantable lead (Fig. 1, Col. 5, line 1), consists essentially of: the conductive core (Fig. 2, Col. 5, line 48), and the polymeric insulator (Fig. 2, Col. 5, lines 47 and 51-56) which is positioned directly adjacent to (Col. 5, lines 47-48) and encompasses at least a portion of the length of the conductive core (Fig. 2, Col. 6, lines 9-10).
Van Wijk does not teach that the conductive core and polymeric insulator are biodegradable. Borenstein, however, teaches a biodegradable electronic device that can be implanted into a human that uses biodegradable materials as conductors (Paragraph 0027, lines 1-5), and biodegradable polymers as insulators (Paragraph 0029, lines 8-11).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate the teachings of Borenstein to utilize materials that can act as both conductors and insulators of electricity, and that also are biodegradable. Doing so would allow for more temporary solutions to implantable devices and lessen health and safety concerns for patients (Paragraph 0024), as recognized by Borenstein.
Van Wijk also does not teach that the biodegradable conductive core is formed of a metal or metal alloy. Li teaches that biodegradable metals and metal alloys have been designed to safely and gradually corrode in vivo (Abstract). Li also describes that biodegradable metal matrix composites can be created with metals, metal alloys, and polymers to incorporate their advantages, including conductivity (Section 2.2).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate the
teachings of Li to use biodegradable metals and biodegradable metal alloys as a
conductive material. Doing so would allow for improved biocompatibility and patient safety outcomes (Abstract), as recognized by Li.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Van Wijk et al. (U.S. Patent No. 6,330,481) in view of Borenstein et al. (U.S. PGPub No. 2012/0223293) and Progress of Biodegradable Metals, 2014 (herein referred to as Li) as applied to claim 5 above, and further in view of Bruhnke et al. (DE Pub. No.
202019002860).
Regarding claim 6, Van Wijk teaches the system of (Fig. 1, Col. 5, lines 8-12) of claim 5. Van Wijk does not teach that the magnesium alloy comprises at least one species selected from the group consisting of zinc, aluminum, copper, cerium, calcium, silver, thorium, gadolinium, dysprosium, strontium, silicon, manganese, zirconium, neodymium and yttrium.
Li, however, teaches that biodegradable metals and metal alloys have been designed to safely and gradually corrode in vivo (Abstract). Li also teaches that biodegradable metals and metal alloys can comprise magnesium alloys, which may further comprise gadolinium, dysprosium, and strontium (Section 2). Furthermore, Bruhnke discloses that magnesium alloys may comprise zinc, aluminum, copper, cerium, calcium, silver, thorium, silicon, manganese, zirconium, neodymium, and yttrium (Paragraphs 0009, 0013, and 0015).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate the
teachings of Li and Bruhnke to use biodegradable metal alloys, such as magnesium alloy comprising any one of the elements listed above, as a conductive material. Doing so would improve implant biocompatibility, as magnesium alloys have excellent degradation properties for use inside the human body, as recognized by Li (Abstract) and Bruhnke (Paragraph 0009).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Van Wijk et al. (U.S. Patent No. 6,330,481) in view of Borenstein et al. (U.S. PGPub No. 2012/0223293) and Progress of Biodegradable Metals, 2014 (herein referred to as Li) as applied to claim 1 above, and further in view of Adhikari et al. (U.S. Patent No. 8,628,761).
Regarding claim 7, Van Wijk teaches the system (Fig. 1, Col. 5, lines 8-12) of
claim 1 that includes a polymeric insulator (Fig. 2, Col. 5, lines 47 and 51-56). Van Wijk does not teach that the polymeric insulator is biodegradable, and that it comprises a biodegradable polyurethane or polyurethane urea polymer or copolymer. Borenstein, however, teaches a biodegradable electronic device that uses biodegradable polymers as insulators (Paragraph 0029, lines 8-11). Adhikari, however, teaches a composition of biodegradable and biocompatible polyurethane and polyurethane urea polymers and copolymers that are used in tissue engineering scaffold applications (Col. 5).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate the
teachings of Borenstein and Adhikari to use biodegradable polymers comprising
polyurethane or polyurethane urea polymer or copolymer, as they are naturally insulative
materials. Doing so would improve temporary implant solutions and biocompatibility for
the insulator portion of the present invention, as recognized by Borenstein (Paragraph 0024) and Adhikari (Col. 5).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Van Wijk et al. (U.S. Patent No. 6,330,481) in view of Borenstein et al. (U.S. PGPub No. 2012/0223293) and Progress of Biodegradable Metals, 2014 (herein referred to as Li) as applied to claim 1 above, and further in view of Monomers, Polymers and Plastics, 2020 (herein referred to as Speight).
Regarding claim 10, Van Wijk teaches the system (Fig. 1, Col. 5, lines 8-12) of
claim 1 that includes the polymeric insulator (Fig. 2, Col. 5, lines 47 and 51-56). Van
Wijk does not teach that the polymeric insulator is biodegradable and is formulated to provide a predetermined degradation profile over time.
Borenstein, however, teaches a biodegradable electronic device that uses biodegradable polymeric materials as insulators (Paragraph 0029, lines 8-11). Speight, however, teaches that polymer properties such as tensile strength, shape, molecular weight, other chemicals, and physical structure can all provide predetermined degradation profiles over time for specific types of polymers or copolymers (Section 3.6).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate the
teachings of Borenstein and Speight to use biodegradable polymers as insulative
material, as they can have predetermined degradation profiles. Doing so would allow the
ability to use biodegradable materials with desired and designed degradation profiles in
implantable electronic devices, which would improve device monitoring, stability, and
patient safety, as recognized by Borenstein (Paragraph 0024) and Speight (Section 3.6).
Claims 11-12 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Van Wijk et al. (U.S. Patent No. 6,330,481) in view of Borenstein et al. (U.S. PGPub No. 2012/0223293) and Progress of Biodegradable Metals, 2014 (herein referred to as Li) as applied to claims 1 and 19 above, and further in view of Kulkarni et al. (WIPO Pub. No. 2021/133947) (cited previously).
Regarding claim 11, Van Wijk teaches the system (Fig. 1, Col. 5, lines 8-12) of claim 1. Van Wijk does not teach that the system comprises a plurality of implantable biodegradable leads. Kulkarni, however, teaches a system (Fig. 1A, paragraph 0079, lines 3-6) that comprises a plurality of implantable leads (Fig. 1A, paragraph 0070, line 3 and 6-7). Borenstein, however, teaches a biodegradable electronic device that uses biodegradable materials as conductors (Paragraph 0027, lines 1-5), and biodegradable polymers as insulators (Paragraph 0029, lines 8-11).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate the teachings of Kulkarni and Borenstein to use materials that are biodegradable in a plurality of implantable leads. Doing so would allow for more temporary solutions with implantable devices and improve biocompatibility, as recognized by Kulkarni (Paragraph 0070) and Borenstein (Paragraph 0024).
Regarding claim 12, Van Wijk teaches the system (Fig. 1, Col. 5, lines 8-12) of claim 11. Van Wijk does not teach that the system comprises a plurality of implantable biodegradable leads, where at least one functions as a recording electrode, and the electronic circuitry is configured to adjust the controlled electrical signal on the basis of feedback information from the recording electrode.
Kulkarni, however, teaches a system (Fig. 1A, paragraph 0079, lines 3-6) that comprises a plurality of implantable leads (Fig. 1A, paragraph 0070, line 3 and 6-7). Furthermore, Kulkarni teaches that at least one of plurality of implantable leads functions as a recording electrode (Paragraph 0080, lines 5-9) and electronic circuitry (Fig. 1A, paragraph 0079, line 1) is configured to adjust a controlled electrical signal (Paragraph 0079, lines 1-2) on the basis of feedback information from the recording electrode (Paragraph 0068, lines 8-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Van Wijk to incorporate the teachings of Kulkarni to include that the system has a plurality of implantable leads, where at least one of them functions as a recording electrode, and that the electronic circuitry can adjust the controlled signal based on feedback from the recording electrode. Doing so would allow patient information to be recorded and provided to a patient, a patient’s family member, or a healthcare provider (Paragraph 0068), as recognized by Kulkarni.
Regarding claim 33, Van Wijk teaches the method (Col. 14, lines 38-39) of claim 19 wherein the controlled electrical signal (Col. 9, lines 22-24) comprises a plurality of pulses of electrical energy (Col. 14, lines 50-52) which are applied to the tissue via the at least one electrode of the at least one implantable lead (Col. 5, lines 9-15). Van Wijk does not teach that the electrical signal is pulsed for pain therapy electrical stimulation.
Kulkarni, however, teaches a method (Paragraph 0063, lines 1-2) of transmitting
electrical signals (Paragraph 0079, lines 1-2) to in vivo tissue (Paragraph 0063, lines 10-12) for treatment. The method involves providing the controlled electrical signal that comprises a plurality of pulses of electrical energy (Paragraph 0073, lines 8-9) which are applied to tissue via at least one electrode (Paragraph 0071, lines 1-3) of at least one implantable lead (Fig. 1A, paragraph 0070, lines 3 and 6-7), and the electrical signal is pulsed for pain therapy electrical stimulation (Paragraph 0027, line 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Van Wijk to incorporate the teachings of Kulkarni to specify that the method is used for pain therapy electrical stimulation. Doing so would provide effective stimulation treatment to reduce patient pain and minimize un-intentional stimulation of non-target tissue (Paragraph 0136), as recognized by Kulkarni.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Van Wijk et al. (U.S. Patent No. 6,330,481) in view of Borenstein et al. (U.S. PGPub No. 2012/0223293) and Progress of Biodegradable Metals, 2014 (herein referred to as Li) as applied to claim 1 above, and further in view of King et al. (U.S. PGPub No. 2014/0296941).
Regarding claim 14, Van Wijk teaches the system (Fig. 1, Col. 5, lines 8-12) of claim 1 that includes the electronic circuitry (Col. 5, lines 36-44) and the at least one implantable lead (Fig. 1, Col. 5, line 1) via which the controlled electrical signal (Col. 9, lines 22-24) is provided. Van Wijk does not teach that the electronic circuitry is further configured to measure impedance at the interface of the tissue and the at least one implantable lead via which the controlled electrical signal is provided and to adjust the controlled electrical signal on the basis of the measured impedance.
King, however, discloses a neural stimulation system that includes electronic circuitry (Fig. 1, Paragraph 0030, line 3) and at least one implantable lead (Fig. 1, Paragraph 0030, lines 3-4). Furthermore, King teaches that the electronic circuitry is configured to measure impedance (Paragraph 0035, lines 9-10) at the interface of the tissue and the at least one implantable lead (Paragraph 0035, lines 2-3) via which the controlled electrical signal is provided (Paragraph 0035, lines 1-2), and that the electrical signal can be adjusted based on the measured impedance (Paragraph 0035, lines 6-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Van Wijk to incorporate the teachings of King to include that the electronic circuitry is configured to measure the impedance between the tissue and the at least one implantable lead to in turn adjust the controlled electrical signal based on the measured impedance. Doing so would ensure that the stimulation energy delivered to the tissue remains more or less the same (Paragraph 0035), as recognized by King.
Claims 15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Van Wijk et al. (U.S. Patent No. 6,330,481) in view of Borenstein et al. (U.S. PGPub No. 2012/0223293) and Progress of Biodegradable Metals, 2014 (herein referred to as Li) as applied to claim 1 above, and further in view of Doerr et al. (U.S. Patent No. 9,072,618).
Regarding claim 15, Van Wijk teaches the system (Fig. 1, Col. 5, lines 8-12) of
claim 1 wherein the electronic circuitry (Col. 5, lines 36-44) is further configured to transmit the controlled electrical signal (Col. 9, lines 22-24) to the least one implantable lead via the conductive core (Col. 5, lines 9-15). Van Wijk does not teach that the electronic circuitry is configured to transmit a degradation acceleration signal to increase a rate of degradation of the biodegradable core and the at least one electrode thereof.
Doerr, however, teaches a biocorrodable implant in which corrosion or degradation of the implant can be accelerated with an external stimulus (Col. 3, lines 45-47). Doerr further teaches that the external stimulus could be administered by supplying external energy (Col. 4, lines 1-3) from an external or ex vivo source (Col. 4, line 3).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate the
teachings of Doerr to use electrical energy as degradation acceleration electrical signals to speed up the degradation process of the biodegradable core and the at least one electrode thereof. Doing so would allow precise control of the degradation process and desired time frame for each system (Col. 3), as recognized by Doerr.
Regarding claim 17, Van Wijk teaches the system (Fig. 1, Col. 5, lines 8-12) of claim 15 that includes the conductive core (Fig. 2, Col. 5, line 48). Van Wijk does not teach that the degradation acceleration electrical signal converts the biodegradable conductive core and the at least one electrode to a form more readily resorbed in vivo.
Doerr, however, teaches a biocorrodable implant in which corrosion or degradation of the implant can be accelerated with an external stimulus (Col. 3, lines 45-47). Doerr teaches that the external stimulus could be administered by supplying external energy (Col. 4, lines 1-3) from an external or ex vivo source (Col. 4, line 3). Doerr teaches that the degradation acceleration electrical signal coverts the biodegradable materials into a form more readily resorbed in vivo (Col. 4, lines 29-34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Van Wijk to incorporate the teachings of Doerr to use electrical energy as degradation acceleration electrical signals to speed up the degradation process of the biodegradable conductive core and the at least one electrode. Doing so would allow precise control of the degradation process and desired time frame for each system (Col. 3), as recognized by Doerr.
Regarding claim 18, Van Wijk teaches the system (Fig. 1, Col. 5, lines 8-12) of claim 15 that comprises the conductive core (Fig. 2, Col. 5, line 48). Van Wijk does not teach that the conductive core is biodegradable and comprises a metal or a metal alloy. Furthermore, Van Wijk does not teach that degradation acceleration signal oxidizes the metal or the metal alloy.
Borenstein, however, teaches a biodegradable electronic device that uses biodegradable materials as conductors (Paragraph 0027, lines 1-5). Li, however, teaches that biodegradable metals and metal alloys have been designed to safely and gradually corrode in vivo (Abstract). Li also describes that biodegradable metal matrix composites can be created with metals and metal alloys to incorporate their advantages, including conductivity (Section 2.2).
Doerr, however, teaches a biocorrodable implant in which corrosion or degradation of the implant can be accelerated with an external stimulus (Col. 3, lines 45-47). Doerr teaches that the external stimulus could be administered by supplying external energy (Col. 4, lines 1-3) from an external or ex vivo source (Col. 4, line 3).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Van Wijk to incorporate the teachings of Borenstein, Li, and Doerr to use degradation acceleration electrical signals to assist in the further corrosion or oxidation of the metal and metal alloy used in the biodegradable conductive core. Doing so would allow precise control of the degradation process and desired time frame for each system, as recognized by Borenstein (Paragraph 0024), Li (Abstract), and Doerr (Col. 3).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Van Wijk et al. (U.S. Patent No. 6,330,481) in view of Borenstein et al. (U.S. PGPub No. 2012/0223293), Progress of Biodegradable Metals, 2014 (herein referred to as Li), and Doerr et al. (U.S. Patent No. 9,072,618) as applied to claim 15 above, and further in view of King et al. (U.S. PGPub No. 2014/0296941).
Regarding claim 16, Van Wijk teaches the system (Fig. 1, Col. 5, lines 8-12) of claim 15 that includes the electronic circuitry (Col. 5, lines 36-44) and the at least one implantable lead (Fig. 1, Col. 5, line 1) via which the controlled electrical signal (Col. 9, lines 22-24) is provided. Van Wijk does not teach that the electronic circuitry is further configured to measure impedance at the interface of the tissue and the at least one implantable lead via which the controlled electrical signal is provided and to adjust the controlled electrical signal on the basis of the measured impedance.
King, however, discloses a neural stimulation system that includes electronic circuitry (Fig. 1, Paragraph 0030, line 3) and at least one implantable lead (Fig. 1, Paragraph 0030, lines 3-4). Furthermore, King teaches that the electronic circuitry is configured to measure impedance (Paragraph 0035, lines 9-10) at the interface of the tissue and the at least one implantable lead (Paragraph 0035, lines 2-3) via which the controlled electrical signal is provided (Paragraph 0035, lines 1-2), and that the electrical signal can be adjusted based on the measured impedance (Paragraph 0035, lines 6-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Van Wijk to incorporate the teachings of King to include that the electronic circuitry is configured to measure the impedance between the tissue and the at least one implantable lead to in turn adjust the controlled electrical signal based on the measured impedance. Doing so would ensure that the stimulation energy delivered to the tissue remains more or less the same (Paragraph 0035), as recognized by King.
Conclusion
Applicant's amendment necessitated the new grounds 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.
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/H.A.H./Patent Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796