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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 24th, 2024 is being considered by the examiner.
Priority
Acknowledgment is made of applicant’s claim for priority. The certified copy has been filed in parent Application No. CN202220209369.3, filed on January 25th, 2022.
Claim Interpretation
In claims 1-20, the term “electrode sheet” is being interpreted as one electrode in a multi-electrode array.
Claims 3, 4, 5, 12, 13, and 14 recite the limitation “guide shape”. The guide shape is interpreted under specification [0014] as a design that distinguishes between electrode sheets.
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 1-20 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.
Claims 1, 3, 7, 10, 12, 16, and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The “sliced” feature of the claims appears to be essential, such that it is a structural or functional feature of the claimed electrodes that does not appear to have any accompanying disclosure for how the structural or functional “sliced” feature is formed or used. The term “sliced” in claim 1, 3, 7, 10, 12, 16, and 19 in “sliced stimulation electrode” is a term which renders the claim indefinite. The term “sliced” is not defined by the claim, the specification does not describe a standard for ascertaining a “sliced” stimulation lead, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination, “sliced” is interpreted as an electrode with segmented electrode surfaces.
The term “smooth” in claims 6 and 15 is a relative term which render the claims indefinite. The terms “smooth” is not defined by the claim. The specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination, “smooth” is interpreted as elliptical edge or other equivalent edges.
The terms “smoothly” in claims 5 and 14 is a relative term which render the claims indefinite. The term “smoothly” is not defined by the claim. The specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination, “smoothly” is interpreted as electrically coupled.
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.
Claims 1-2, 8, 10-11, 17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moffitt et al. (US 20100268298).
Regarding claim 1, Moffitt teaches a sliced stimulation electrode, comprising a stimulating end and a connecting end which are opposite to each other, ([0005] “a lead having… plurality of electrodes disposed along the longitudinal surface of the lead near the distal end”) wherein: a plurality of electrode sheets for applying electrical stimulation are disposed on a periphery surface of the stimulating end of the sliced stimulation electrode ([0005] “segmented electrodes disposed around a circumference of the lead at a first longitudinal position along the lead”); electrode sheets of the plurality of electrode sheets and passing through a same radial plane of the sliced stimulation electrode are a group of electrode sheets ([0066] “electrodes 130 are grouped in sets of segmented electrodes, each set disposed around the circumference of the lead at or near a particular longitudinal position”); and in at least one group of electrode sheets, at least one electrode sheet has a different shape from the other electrode sheets so that electrode sheets in the at least one group of electrode sheets are capable of being distinguished from each other ([0066] “segmented electrodes 130 may vary in size and shape”; see also [Fig. 27] electrode (2702) is distinguished from electrodes (2704)).
Regarding claim 10, Moffitt teaches a stimulation system, comprising a stimulator, a wire and a stimulation electrode ([0008] “The implantable stimulation device also includes a control unit coupleable to the lead”), wherein the stimulator is connected to the stimulation electrode through the wire ([0068] “conductors… from the ring electrodes … also pass through the lead body”), and the stimulation electrode is a sliced stimulation electrode comprising a stimulating end and a connecting end which are opposite to each other ([0005] “ a lead having… plurality of electrodes disposed along the longitudinal surface of the lead near the distal end”); wherein a plurality of electrode sheets for applying electrical stimulation are disposed on a periphery surface of the stimulating end of the sliced stimulation electrode ([0005] “segmented electrodes disposed around a circumference of the lead at a first longitudinal position along the lead”); electrode sheets of the plurality of electrode sheets and passing through a same radial plane of the sliced stimulation electrode are a group of electrode sheets ([0066] “electrodes 130 are grouped in sets of segmented electrodes, each set disposed around the circumference of the lead at or near a particular longitudinal position”); and in at least one group of electrode sheets, at least one electrode sheet has a different shape from the other electrode sheets so that electrode sheets in the at least one group of electrode sheets are capable of being distinguished from each other ([0066] “segmented electrodes 130 may vary in size and shape”; see also [Fig. 27] electrode (2702) is distinguished from electrodes (2704)).
Regarding claim 2 and 11, Moffitt teaches all of the limitations of claim 1 and 10. Moffitt also teaches wherein a shape of each electrode sheet of the plurality of electrode sheets is different ([0066] “segmented electrodes 130 may vary in size and shape”), or a shape of each electrode sheet in the group of electrode sheets is different. ([0070] “sets of segmented electrodes 130 may be disposed in different configurations”)
Regarding claims 8 and 17, Moffitt all of the limitations of claim 1 and 10. Moffitt also teaches wherein the group of electrode sheets comprises two to ten electrode sheets. ([0066] “lead may have any number of sets of segmented electrodes. In at least some embodiments, the lead has one, two, three, four, five, six, seven, or eight sets of segmented electrodes”)
Regarding claim 19, Moffitt teaches all of the limitations of claim 1. Moffitt also teaches wherein strength [i.e., current], frequencies [i.e., stimulus pulses] and action positions [i.e., centroid of stimulus] of signals output by different sliced stimulation electrodes [i.e., multi-channeled device] are specified [i.e., independent]. ([0008] “device is a constant-current, multi-channel device, with independent programmability of each stimulation channel to provide current steering”; see also [0088] “Independent current control of each stimulation channel permits radial current steering, (i.e., where at least two electrodes, placed closely together, deliver simultaneous stimulus pulses, having same or different current amplitudes, and effectively place the centroid of stimulus at an angular position between the two electrodes”)
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 3-7, 9, 12-16, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Moffitt et al. (US 20100268298) as applied to claims 1 and 10 above, in view of Mercanzini et al (US20160059004).
Regarding claim 3 and 12, Moffitt teaches all of the limitations of claim 1 and 10. Moffitt also teaches wherein the plurality of electrode sheets are arranged in an array and at intervals ([Fig 19] electrodes 1910 are arranged in an array and at intervals). Regarding claims 3 and 12, Moffitt does not explicitly teach, as taught by Mercanzini, in a flattened state of the stimulating end of the sliced stimulation electrode ([Fig. 6A] electrodes (120) are flattened and folded) … a guide shape [i.e., periphery trace] is formed on at least one electrode sheet in the group of electrode sheets, wherein the guide shape of the at least one electrode sheet is used for distinguishing between the electrode sheets in the group of electrode sheets. ([Fig. 16a] electrodes with periphery traces (314) electrically coupled). Moffitt and Mercanzini are both in the same field of endeavor of deep brain stimulation and disclose features for the purpose of delivering electrical stimulation for neuron engagement. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modify Moffitt’s device to explicitly include a distinguishing mark for individual electrodes to in a folded and unfolded state to “enable a neurosurgeon to determine the placement and rotation of the stimulation lead” [0101], as taught and suggested by Mercanzini.
Regarding claim 4 and 13, Moffitt teaches all of the limitations of claim 3 and 10. Regarding claims 4 and 13, Moffitt does not explicitly teach, as taught by Mercanzini wherein the guide shape [i.e., periphery trace] of the at least one electrode sheet is located on a side edge of the at least one electrode sheet or two opposite side edges of the at least one electrode sheet. ([Fig. 16a] electrodes with periphery traces (314), where the periphery traces are attached to two opposite sides of one electrode sheet (316)). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modify Moffitt’s device to explicitly include a distinguishing mark on the edge of an electrode as a routine design choice for individual electrodes to “enable a neurosurgeon to determine the placement and rotation of the stimulation lead” [0101], as taught and suggested by Mercanzini.
Regarding claim 5 and 14, Moffitt teaches all of the limitations of claim 4 and 13. Regarding claims 5 and 14, Moffitt does not explicitly teach, as taught by Mercanzini wherein the guide shape of the at least one electrode sheet is formed by a wave, a sine curve, a semicircle, a rounded rectangle or a rounded triangle ([Fig. 16a] electrodes with periphery traces (314) shaped in a semicircle); the guide shape of the at least one electrode sheet is smoothly connected to the at least one electrode sheet; ([Fig. 16a] periphery traces are attached to two opposite sides of one electrode sheet (316)) and a shape of a peripheral edge of each electrode sheet of the plurality of electrode sheets is a closed curve. ([Fig. 16a] electrodes (120) are elliptical). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modify Moffitt’s device to explicitly include a distinguishing mark on the edge of an electrode shaped in a semicircle as a routine design choice for individual electrodes to “enable a neurosurgeon to determine the placement and rotation of the stimulation lead” [0101], as taught and suggested by Mercanzini.
Regarding claim 6 and 15, Moffitt teaches all of the limitations of claim 1 and 10. Regarding claims 6 and 15, Moffitt does not explicitly teach, as taught by Mercanzini wherein a shape of a peripheral edge of each electrode sheet of the plurality of electrode sheets is a smooth contour curve. ([Fig. 16a] electrodes (120) are elliptical; see also [0104] “stimulating electrodes may be shaped or configured differently”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modify Moffitt’s device to explicitly include a smooth contour curve for an electrode as a routine design choice for individual electrodes to “enable a neurosurgeon to determine the placement and rotation of the stimulation lead” [0101], as taught and suggested by Mercanzini.
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For the purposes of applying art, Fig. 19 of Moffitt will be referenced.
Regarding claim 7 and 16, Moffitt teaches all of the limitations of claim 1 and 10. Moffitt also teaches wherein the plurality of electrode sheets are arranged in an array and at intervals ([Fig 19] electrodes 1910 are arranged in an array and at intervals); and a row of electrode sheets of the plurality of electrode sheets in a length direction of the sliced stimulation electrode have a same shape. ([Fig. 19] electrodes 1904 in a length direction have the same shape). Moffitt does not explicitly teach, as taught by Mercanzini in a flattened state of the stimulating end of the sliced stimulation electrode ([Fig. 6A] electrodes (120). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modify Moffitt’s device to explicitly start unfolded and fold into a cylindrical shape, as taught and suggested by Mercanzini “to increase the surface area of the lead” [0094] and thus providing a more effective stimulation.
Regarding claim 9 and 18, Moffitt teaches all of the limitations of claim 1 and 10. Regarding claims 9 and 18, Moffitt does not explicitly teach, as taught by Mercanzini wherein in the group of electrode sheets, local thickness of at least one electrode sheet is different from thickness of the other part of the at least one electrode sheet. ([0118] “A mesh electrode configuration can be used to concentrate current density in certain areas of the electrode surface” where density comprises different thickness; see also [0118] “the bands may be narrower toward the center of the electrode”) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modify Moffitt’s device to adjust thickness of an electrode, as taught and suggested by Mercanzini. “Narrowing each of the bands towards the center of the mesh electrode can increase current density towards the center of the electrode” [0118], providing a more effective stimulation.
Regarding claim 20, Moffitt teaches all of the limitations of claim 1. Moffitt also teaches wherein the plurality of electrode sheets are evenly distributed at equal intervals ([0067] “the spaces, gaps, or cutouts between segmented electrodes may be uniform for a particular set of segmented electrodes or for all sets of segmented electrodes” around the circumference of the electrode on an unfolded surface).Regarding claim 20, Moffitt does not explicitly teach, as taught by Mercanzini on an unfolded surface of the sliced stimulation electrode. ([Fig. 6A] electrodes (120) evenly distributed). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modify Moffitt’s device to explicitly start unfolded and fold into a cylindrical shape, as taught and suggested by Mercanzini “to increase the surface area of the lead” [0094] and thus providing a more effective stimulation.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Howard (US20130261684) discloses an implantable lead for an electrical stimulation system for electrode identification.
Chen (US20110130817) discloses a stimulation lead with electrodes that can be selected and adjusted radially. These electrodes contain a variety of orientations, including rounded, sinusoidal, and rectangular shapes.
Whitehurst et al. (US20070129780) discloses a stimulator arrangement with malleable arrangement.
Rondoni et al. (US20200230412) discloses a cuff-shaped implantable electrode that wraps around a nerve and delivers electrical stimulation with strategically placed electrode arrays.
Carcieri et al. (WO2014055328) discloses a method for implanting a lead within brain tissue of a patient, wherein the lead comprises a set of radially segmented electrodes. This supplies the segmented ring group structure
McFall et all. (CN112292176) discloses and orientation determination structure to aim the lead longitudinally and radially.
Zhang et al. (US20180064930) discloses systems for determining a set of stimulation parameters for an implantable stimulation device.
Bokil et al. (US20170056678) discloses a method for determining a rotational orientation of a lead for use in electrostimulation of a body tissue.
Conclusion
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/R.A.S/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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