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 current application has the effective filing date of 08/29/203 according to the priority chain on the record.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 6 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “the housing is connected to the energy absorber and serves as a component of the energy absorber.” This limitation is indefinite because the housing is both connected to the energy absorber, and serves as a component of energy absorber; it would appear that ‘connected to’ and ‘serves as’ are mutually exclusive. The utilization of the term ‘serves’ does not set forth a positive recitation, it is unclear whether “the housing” merely acts/serves as an energy absorber, or “the housing” actually contains material to absorb energy. Clarification is required.
Claim 6 recites a similar feature with regard to “the housing” and is thus rejected under the same rationale as discussed to claim 2 above.
Regarding claim 12, the term “the coil of conductor wires” lacks proper antecedent basis, because claim 5- from which claim 12 depends from, does not disclose a conductor wire coil.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 1-3, 5-7, 9 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. US 10,398,893 B2 (hereinafter “Li”).
Regarding claim 1, Li discloses a system (exemplary Figs.1-2: systems 20 or 30) for providing neurostimulation to a patient, the system (20, 30) comprising:
a pulse generator (neurostimulator 12, 32a or 32b, see col.4, ll.8-col.5, ll.17) including a housing (inherent, see Figs. 1-2), and
an implantable neurostimulation lead (leads 16, 38a and 38b), wherein the implantable neurostimulation lead is configured to connect with the pulse generator (implicit, as shown in Figs. 1-2, also see col.4, ll.12-16 “…a lead extension 14 having a proximal end coupled to the neurostimulator 12, and a lead 16 having a proximal end coupled to a distal end of the extension 14 and having a distal end coupled to one or more electrodes 18…”);
wherein the pulse generator (neurostimulator 12, 32a or 32b) is configured to generate a plurality of electrical impulses for delivering a neurostimulation treatment to the patient through the neurostimulation lead when the lead is implanted at a target location (see col.4, ll.8-col.5, ll.3 pulse generator produces stimulating pulses via electrodes 18, 42a, 42b to the desired treatment site, e.g. spinal cord 22, brain 40);
wherein the implantable neurostimulation lead (leads 16, 38a or 38b) includes one or more conductors (“insulated electrical conductors”) extending from a proximal end of the implantable neurostimulation lead to one or more neurostimulation electrodes disposed at or near a distal end of the implantable neurostimulation lead (see col.4, ll.35-37 “lead 16 includes one or more insulated electrical conductors each coupled at their proximal end to a connector 24 and to the electrodes 18 (or contacts) at its distal end”);
wherein the implantable neurostimulation lead (leads 16, 38a or 38b) includes an energy absorber (shield covering 74) comprising carbon nanotube material (col.8, ll.11-36 electromagnetic radiation shielding using carbon structures, e.g. nanofibers, filaments, nanotubes, and nanoflakes) and extending substantially along the length of the one or more conductors (col.8, ll.14-26, and coverings 74a and 74b covering the leads 70a and 70b; also see col.11, ll.41-col.12, ll.12 and Fig. 12, lead/extension having covering 74 for electromagnetic shielding effect of lead/extension); and
wherein the energy absorber (covering 74) is configured to absorb electromagnetic energy and conduct electromagnetic energy along the length of the implantable neurostimulation lead (col.8, ll.14-26 conducting and semiconducting layer coverings 74a-72b).
Regarding claim 2, Li discloses the system of claim 1, wherein the housing is connected to the energy absorber (covering 74) and serves as a component of the energy absorber. (col.8, ll.21-26 “The coverings 74a and 74b can be in contact with the housing of the medical device (e.g., IMD) from which they stem, where the device can act as an additional surface for dissipation of energy received by the coverings 74a and 74b from electromagnetic waves.”)
Regarding claim 3, Li discloses the system of claim 2, wherein the housing is configured to dissipate the electromagnetic energy absorbed and conducted by the energy absorber. (See rejection to claim 2 above.)
Regarding claim 5, Li discloses a system (exemplary Figs.1-2: systems 20 or 30) for providing neurostimulation to a patient, the system (20, 30) comprising:
a pulse generator (neurostimulator 12, 32a or 32b, see col.4, ll.8-col.5, ll.17) including a housing (inherent, see Figs. 1-2), and
an implantable neurostimulation lead (leads 16, 38a and 38b), wherein the implantable neurostimulation lead is configured to connect with the pulse generator (implicit, as shown in Figs. 1-2, also see col.4, ll.12-16 “…a lead extension 14 having a proximal end coupled to the neurostimulator 12, and a lead 16 having a proximal end coupled to a distal end of the extension 14 and having a distal end coupled to one or more electrodes 18…”);
wherein the pulse generator (neurostimulator 12, 32a or 32b) is configured to generate a plurality of electrical impulses for delivering a neurostimulation treatment to the patient through the neurostimulation lead when the lead is implanted at a target location (see col.4, ll.8-col.5, ll.3 pulse generator produces stimulating pulses via electrodes 18, 42a, 42b to the desired treatment site, e.g. spinal cord 22, brain 40);
wherein the implantable neurostimulation lead (leads 16, 38a or 38b) includes a plurality of conductor wires (“insulated electrical conductors”) extending from a proximal end of the implantable neurostimulation lead to one or more neurostimulation electrodes disposed at or near a distal end of the implantable neurostimulation lead (see col.4, ll.35-37 “lead 16 includes one or more insulated electrical conductors each coupled at their proximal end to a connector 24 and to the electrodes 18 (or contacts) at its distal end”);
wherein the implantable neurostimulation lead (leads 16, 38a or 38b) includes an energy absorber (shield covering 74) including a carbon nanotube material (col.8, ll.11-36 electromagnetic radiation shielding using carbon structures, e.g. nanofibers, filaments, nanotubes, and nanoflakes) that is configured to shield the conductor wires from electromagnetic energy (col.8, ll.11-36, col.11, ll.41-col.12, ll.2 electromagnetic shielding); and
wherein the energy absorber (covering 74) is configured to absorb electromagnetic energy and conduct electromagnetic energy along the length of the implantable neurostimulation lead (col.8, ll.14-26 conducting and semiconducting layer coverings 74a-72b).
Regarding claim 6, Li discloses the system of claim 5, wherein the housing is connected to the energy absorber (covering 74) and serves as a component of the energy absorber. (col.8, ll.21-26 “The coverings 74a and 74b can be in contact with the housing of the medical device (e.g., IMD) from which they stem, where the device can act as an additional surface for dissipation of energy received by the coverings 74a and 74b from electromagnetic waves.”)
Regarding claim 7, Li discloses the system of claim 6, wherein the housing is configured to dissipate the electromagnetic energy absorbed and conducted by the energy absorber. (See rejection to claim 6 above.)
Regarding claim 9, Li discloses the system of claim 5, wherein the carbon nanotube material is a composite carbon nanotube material. (col.5, ll.34-52, polymer-matrix composite comprising carbon nanotube)
Regarding claim 12, Li discloses the system of claim 5, wherein the energy absorber (covering 74) overlies the coil of conductor wires. (col.11, ll.41-44 “layer 122 is formed of a conductive non-metallic material that is in a wrapped or woven form… the layer 122 is adapted to enhance the shielding effect of the lead/extension 120.”)
Regarding claim 13, Li discloses the system of claim 12, wherein the energy absorber (covering 74) includes a wire embedded in the plurality of electrode wires. (col.11, ll.41-44 “layer 122 is formed of a conductive non-metallic material that is in a wrapped or woven form… the layer 122 is adapted to enhance the shielding effect of the lead/extension 120.”)
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claim 1 above, and further in view of Qian et al. US 2013/0109905 A1 (hereinafter “Qian”).
Regarding claim 4, Li discloses the system of claim 1, Li discloses that the energy absorber overlies the housing of the pulse generator (col.8, ll.21-26), but does not teach wherein the energy absorber overlies the one or more electrodes.
Qian, another prior art reference in the analogous art, discloses a system (Fig. 1: system 10) for providing neurostimulation to a patient ([0020] stimulation to brain is taken to encompass “neurostimulation” in the claim), comprising a pulse generator (10), wherein the implantable neurostimulation lead (24) is configured to connect with the pulse generator (see Fig. 1, [0022]); wherein the pulse generator is configured to generate a plurality of electrical impulses for delivering a neurostimulation treatment to the patient through the neurostimulation lead when the lead is implanted at a target location ([0020-0021] electrical stimulation to brain or heart tissue); wherein the implantable neurostimulation lead includes an energy absorber comprising carbon nanotube material and extending substantially along the length of the one or more conductors; and wherein the energy absorber is configured to absorb electromagnetic energy and conduct electromagnetic energy along the length of the implantable neurostimulation lead and wherein the energy absorber overlies the one or more electrodes ([0056] “first conductor 441 is a twisted carbon nanotube wire… the electrode 28 can be electrically connected to control circuit through the first conductor 441 and the first conductive contact.” In here, the electrical connection is interpreted as energy absorber overlies the one or more electrodes). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Li to further include the carbon nanotube shield layer over the electrode, in view of Qian, the motivation for doing so for additional surface for dissipation of energy received electrodes from electromagnetic waves. (Li: col.8, ll.19-26)
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claim 1 above.
Regarding claim 8, Li discloses the system of claim 5, Li discloses the system of claim 5, wherein the carbon nanotube material is a composite carbon nanotube material (col.5, ll.34-52, polymer-matrix composite comprising carbon nanotube); but does not disclose wherein the carbon nanotube material is a homogenous carbon nanotube material. However, this would have been an obvious design choice to a person of ordinary skill in the art at the time of invention.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claim 5, and further in view of Qian.
Regarding claim 10, Li discloses the system of claim 5, Li discloses an energy absorber (shield covering 74; see col.8, ll.11-36 carbon nanotubes); but Li does not disclose the wherein the plurality of conductor wires are arranged in a coil extending along the length of the neurostimulation lead. However Qian, another prior art reference in the analogous art, discloses a system (Fig. 1: system 10) for providing neurostimulation to a patient ([0020] stimulation to brain is taken to encompass “neurostimulation” in the claim), comprising a pulse generator (10) including a housing (inherent, see Fig. 1), an implantable neurostimulation lead (24), wherein the implantable neurostimulation lead (24) is configured to connect with the pulse generator (see Fig. 1, [0022]); wherein the pulse generator is configured to generate a plurality of electrical impulses for delivering a neurostimulation treatment to the patient through the neurostimulation lead when the lead is implanted at a target location ([0020-0021] electrical stimulation to brain or heart tissue). Qian further discloses wherein the plurality of conductor wires are arranged in a coil extending along the length of the neurostimulation lead wherein the energy absorber is configured as an elongated wire embedded in the plurality of conductor wires ([0062] and Fig. 10). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Li’s conductor wire and energy absorber carbon nanotube shielding layer to take the shape of a conductor wire having carbon nanotube woven into the conductor coil, in view of Qian; the motivation for doing so is to provide a known alternative embodiment to the layer shield embodiment based on design preferences (Qian: [0041-0044])
Regarding claim 11, Li in view of Qian discloses the system of claim 10, wherein the energy absorber (shield covering 74) is configured as an elongated wire embedded in the plurality of conductor wires. (See rejection to claim 10 above.)
Claims 14-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Li and Qian.
Regarding claim 14, Li discloses a system (exemplary Figs.1-2) for providing neurostimulation to a patient, the system comprising:
a pulse generator (neurostimulator 12, 32a or 32b, see col.4, ll.8-col.5, ll.17) including a housing (as shown in Figs. 1-2), and
an implantable neurostimulation lead (leads 14, 36a or 36b), wherein the implantable neurostimulation lead is configured to connect with the pulse generator (as shown in Figs. 1-2);
wherein the pulse generator (neurostimulator 12, 32a or 32b) is configured to generate a plurality of electrical impulses for delivering a neurostimulation treatment to the patient through the neurostimulation lead when the lead is implanted at a target location (see col.4, ll.8-col.5, ll.17 for stimulating desired treatment site, e.g. spinal cord 22, brain 40);
wherein the implantable neurostimulation lead includes a plurality of conductors forming a conductor wire extending from a proximal end of the implantable neurostimulation lead to one or more neurostimulation electrodes disposed at or near a distal end of the implantable neurostimulation lead (col.4, ll.35-37 “The lead 16 includes one or more insulated electrical conductors each coupled at their proximal end to a connector 24 and to the electrodes 18 (or contacts) at its distal end”; same structure in analogous leads 32a and 32b);
wherein the implantable neurostimulation lead (leads 16, 38a or 38b) includes an energy absorber (shield covering 74) comprised of a carbon nanotube material (col.8, ll.11-36 electromagnetic radiation shielding using carbon structures, e.g. nanofibers, filaments, nanotubes, and nanoflakes);
wherein the energy absorber (covering 74) is configured as at least one wire that is woven into the conductor wire (col.11, ll.41-44 “layer 122 is formed of a conductive non-metallic material that is in a wrapped or woven form… the layer 122 is adapted to enhance the shielding effect of the lead/extension 120.”); and
wherein the energy absorber (covering 74) is configured to absorb electromagnetic energy and conduct electromagnetic energy along the length of the implantable neurostimulation lead (col.8, ll.14-26 conducting and semiconducting layer coverings 74a-72b).
Li does not disclose wherein the plurality of conductors forming a conductor coil extending from the extending from a proximal end of the implantable neurostimulation lead to one or more neurostimulation electrodes disposed at or near a distal end of the implantable neurostimulation lead and wherein the energy absorber is configured as at least one wire that is woven into the conductor coil. However Qian, another prior art reference in the analogous art, discloses a system (Fig. 1: system 10) for providing neurostimulation to a patient ([0020] stimulation to brain is taken to encompass “neurostimulation” in the claim), comprising a pulse generator (10) including a housing (inherent, see Fig. 1), an implantable neurostimulation lead (24), wherein the implantable neurostimulation lead (24) is configured to connect with the pulse generator (see Fig. 1, [0022]); wherein the pulse generator is configured to generate a plurality of electrical impulses for delivering a neurostimulation treatment to the patient through the neurostimulation lead when the lead is implanted at a target location ([0020-0021] electrical stimulation to brain or heart tissue); wherein the implantable neurostimulation leads include a plurality of conductors forming a conductor coil ([0062] conductive coil) extending from a proximal end of the implantable neurostimulation lead to one or more neurostimulation electrodes disposed at or near a distal end of the implantable neurostimulation lead ([0062] and Fig. 10), wherein the implantable neurostimulation lead includes an energy absorber comprises a carbon nanotube material ([0037] “…shielding layer 246 can be located on an outer surface of the insulation layer 244 and can be used to shield electromagnetic signals or external signals…) and wherein the energy absorber is configured as at least one wire that is woven into the conductor coil ([0037] “shielding layer 246 can be formed by weaving conductive wires or by winding conductive films around the insulating layer 244. The wires for forming the shielding layer 246 can be metal wires, carbon nanotube wires or composite wires having carbon nanotubes…”). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Li’s conductor wire and energy absorber carbon nanotube shielding layer to take the shape of a conductor wire having carbon nanotube woven into the conductor coil, in view of Qian; the motivation for doing so is to provide a known alternative embodiment to the layer shield embodiment based on design preferences (Qian: [0041-0044])
Regarding claim 15, Li and Qian teach the system of claim 14, wherein the energy absorber and conductor coil are woven together in a plain weave pattern. (see rejection to claim 14, Qian [0037, 0045])
Regarding claim 17, Li and Qian teach the system of claim 14, wherein the energy absorber comprises a plurality of wires. (see rejection to claim 15, Qian teaches a plurality of woven wires, and conductor wires; see Qian [0045])
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Li and Qian as applied to claim 14 above, and further in view of Gis.
Regarding claim 16, Li and Qian teach the system of claim 14, wherein the energy absorber and conductor coil are woven together in a plain weave pattern (see Qian []); neither Li nor Qian discloses the energy absorber and conductor coil are woven together in a twill weave pattern. However, this is a mere design choice that would have been obvious to a person of ordinary skill in the art at the time of invention.
Alternatively Gi, another prior art reference in the analogous art discloses an electrode lead comprising carbon nanotube/nanofilaments ([0016-0017]) in which the conductor wire and the carbon wires are twisted or woven in different styles as shown through Figs. 1a-4b, see [0030-0034]; at least Figs. 1a, 2a, 2c, 3a and 4a can be taken to encompass “twill weave” in the claims. It would have been a design choice at the time of invention to further modify Li and Qian in view to include a twill weave based on the various different embodiments shown in Gi: Figs. 1a-4b.
Conclusion
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/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792 June 7, 2026
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