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 .
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.
Claim(s) 1-5 and 8-20 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Zaidi et al. (Publication No. WO 2019/020985 A1, hereinafter, “Zaidi”). NOTE: for the purposes of prior art rejections below, the US Publication Zaidi et al. (US 2020/0230399 A1) has been cited.
Regarding claim 1, Zaidi discloses a neural interface system (Fig. 1, element 100), comprising: a lead body (Fig. 1, element 118) including a first electrode (Fig. 1. element 112); a cuff body (Fig. 1, element 102) having a first section (Fig. 1, element 104) and a second section (Fig. 1, element 106) separated by a gap for providing a path of least electrical resistance (Para 32; “The substrate 102 may include… a spinal portion forming a helix of one turn (when combined with a center portion 109 and one of the portions 104 or 106)”), a second electrode positioned within the first section (Fig. 1, element 114); and a junction between the lead body and the cuff body (Figs. 2A-2B; elements 120 and 220 respectively), wherein the gap extends around an axis of the cuff body and comprises a first area proximal to the junction (Para 32; “The substrate 102 may include two C-ring portions 104 and 106, each connected by a spinal portion forming a helix of one turn (when combined with a center portion 109 and one of the portions 104 or 106)”).
Regarding claim 2, Zaidi discloses the gap extends at least 180-degress around an axis of the cuff body (Para 32 “The substrate 102 may include…forming a helix of one turn”; a helix of 1 turn gap extends at least 270 degrees and hence 180 degrees around).
Regarding claim 3, Zaidi discloses the second electrode comprises a central electrode portion (Fig. 1, element 112) substantially opposite the first area of the gap proximal to the junction (Refer to annotated Figure 1 below, the gap first area is opposite to the first electrode 112; by opposite examiner interprets it to be substantially on the opposing surface).
Regarding claim 4, Zaidi discloses the cuff body is cylindrical (Fig. 1, element 108; cuff 108 has a circular/cylindrical shape).
Regarding claim 5, Zaidi discloses the first and second sections are formed of an electrically insulative material (Para 31 “The neural interface 100 may comprise a hybrid cuff, including a partially-helically formed supporting substrate 102, manufactured of silicone or a similar flexible substance, such as …polyurethane…” which are electrically insulative materials).
Regarding claim 8, Zaidi discloses the second section is an anchoring device for at least partially maintaining contact between the second section and a target nerve or neurovascular bundle or neurovascular vessel to be stimulated (Para 34 “The substrate 102 may include a number of attributions 110 placed at different points on or in the substrate 102. The attribution may be configured to enable a deployment tool (not shown) to grip, manipulate and deploy the neural interface 100”, Para 35 “the attributions 110 may be placed sufficiently near the open ends of the C-rings of portions 104 and 106 …so that the neural interface may be positioned around the target vessel”).
Regarding claim 9, Zaidi discloses the first electrode does not extend beyond a point where the lead body joins the junction (Fig. 2A, elements, 114 and 120; electrode 114 does not extend beyond lead body spinal junction 120, see also annotated Figure 2B below that shows junction 220 and the lead 218 extending to the electrodes through the junction, therefore the electrode does not surpass the junction).
Regarding claim 10, Zaidi discloses the first electrode is a flexible coil electrode (Para 38 “to minimize the rigidity of the electrode, i.e., making it sufficiently flexible, the electrode may have to be very thin (typically between 25 um and 50 um), which may make the interconnection of the conductors to the electrodes more challenging”).
Regarding claim 11, Zaidi discloses the first electrode is a ring electrode (Para 32; Arranged within each C-ring end portion 104 and 106 may be multiple platinum or platinum alloy electrodes (or electrode arrays), such as electrode arrays 112 and 114…).
Regarding claim 12, Zaidi discloses the second electrode is a single electrode (Fig.1 element 114) and occupies at least 180 degrees around the axis of the cuff body thereby extending at least half of a circumference of the circular cuff body (Fig. 1, element 114; in Fig. 1, electrode 114 is a part of a C-ring that occupies over 270 degrees and hence over 180 degrees of the circumference).
Regarding claim 13, Zaidi discloses the second electrode is a segmented electrode (Fig. 2B, element 214) and occupies approximately 180 degrees of a circumference of the circular cuff body thereby extending at least half of a circumference of the circular cuff body (Fig. 2B, element 214; in Fig. 1, segmented electrode array 214 is a part of a C-ring that occupies over 180 degrees).
Regarding claim 14, Zaidi discloses the second electrode is substantially normal to the gap (Fig. 1, element 114; electrode 114 is contained within C-ring portion 104 and is located across from the C-ring opening).
Regarding claim 15, Zaidi discloses the second electrode forms a partial cylinder (Fig. 1, element 114; electrode 114 is a part of C-ring portion 104 which is in a C-shape making it a partial cylinder).
Regarding claim 16, Zaidi discloses the cuff body (Fig. 5, elements 510, 512, and 514) has a length and the lead body (Fig. 5 element 502) is substantially perpendicular to the length (Fig. 5 and Para 44; “The portions 510, 512 and 514 may be substantially orthogonal to the spinal portion 502”).
Regarding claim 17, Zaidi discloses the cuff body has a length and the lead body is substantially parallel to the length (Fig. 3, elements 302, 304, 306, and 308 and Para 37: …flexible substrate 302 of similar material and may have two end portions 304 and 306 forming C-ring configurations that may be affixed to a spinal portion 308; this is also very clearly shown in Figure 2B that shows lead 218 parallel to the body 202).
Regarding claim 18, Zaidi discloses the gap starts at a proximal end of the cuff body and extends along a length of the cuff body until past a distal end of the cathode, whereupon the gap turns and is configured to form the second section (Para 36: …the substrate 202 may include three C-ring portions 204, 206 and 208, with each C-ring end portion 204 and 206 connected by a one turn helix in the opposite direction from a common center section of an C-ring central portion 208…) .
Regarding claim 19, Zaidi discloses the gap starts at a proximal end of the cuff body proximal the junction and extends along a length of the cuff body until turning at least 270-degrees to from the second section (Para 32: The substrate 102 may include… a spinal portion forming a helix of one turn; a helix of 1 turn gap extends at least 270 degrees and hence 180 degrees around).
Regarding claim 20, Zaidi discloses the lead body is substantially parallel to a length of the cuff body (Fig. 3, elements 302, 304, 306, and 308 and Para 37: …flexible substrate 302 of similar material and may have two end portions 304 and 306 forming C-ring configurations that may be affixed to a spinal portion 308, and wherein the gap starts at a distal end of the cuff body proximal the lead body and extends along the length of the cuff body until turning at least 270-degrees to form the second section (Para 36: …the substrate 202 may include three C-ring portions 204, 206 and 208, with each C-ring end portion 204 and 206 connected by a one turn helix in the opposite direction from a common center section of an C-ring central portion 208…).
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/020985 A1, hereinafter, “Zaidi”, in view of US 2019/0175912 Gelfand et al., hereinafter “Gelfand”.
Regarding claim 6, Zaida discloses all the limitations of claim 1.
Zaidi does not disclose the first electrode is configured to be a return electrode and the second electrode is configured to be a stimulating electrode when the system is configured to stimulate, and wherein the first electrode is configured to be a stimulating electrode and the second electrode is configured to be a return electrode when the system is configured to block.
However, Gelfand discloses in the same field of endeavor: devices and methods for treatment via electrical stimulation (Abstract) and teaches the first electrode is configured to be a return electrode and the second electrode is configured to be a stimulating electrode when the system is configured to stimulate, and wherein the first electrode is configured to be a stimulating electrode and the second electrode is configured to be a return electrode when the system is configured to block (Figs. 12A-B and Para 97: The implantable device further includes a high frequency blocking module 220, neurostimulation pulse generator 221…the neurostimulation pulse generator 221 is capable of delivering trains of pulses that selectively excite an approximate nerve …The high frequency blocking 220 is capable of delivering trains of pulses that selectively block the nerve creating temporary blocking of nerve conduction… clm 5: A nerve cuff adapted to deliver blocking therapy and further adapted to confirm the blocking therapy, comprising: a cuff sized and configured to be positioned around a …nerve; at least first, second, and third blocking therapy electrodes secured to the cuff …at least one …stimulation electrode secured to the cuff and axially spaced from the first, second and third blocking therapy electrodes) for the purpose of confirmation of blocking therapy effectiveness Para 85).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the first and second electrodes of the neural interface system, of Zaida, to have an electrode deliver stimulation and the other return when blocking therapy, of Gelfand, in order to confirm blocking therapy effectiveness (Gelfand; Para 97).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/020985 A1, hereinafter, “Zaidi”, in view of US 2020/0316372Bashirullah et al., hereinafter “Bashirullah”.
Regarding claim 7, Zaidi discloses all the limitations of claim 1.
Zaidi does not disclose a surface area of the first electrode is larger than a surface area of the second electrode, and wherein the ratio between the first electrode area to the second electrode area ranges between 3:1 to 10:1.
Bashirullah discloses a nerve interface system (Abstract) and teaches a surface area of the first electrode is larger than a surface area of the second electrode, and wherein the ratio between the first electrode area to the second electrode area ranges between 3:1 to 10:1 (Para 75; In bipolar electrode arrangements, the length of the first electrode (in the longitudinal direction) may also be less than or equal to five times the length of the first electrode (in the longitudinal direction) to provide the benefit of increased blocking efficiency of the second electrode).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the first and second electrodes of the neural interface system, of Zaida, to have a first electrode that is 5 times the length of the second electrode, of Bashirullah, in order to provide the benefit of increased blocking efficiency of the second electrode (Bashirullah; Para 75).
Response to Arguments
Applicant's arguments filed 06/28/2024 have been fully considered but they are not persuasive.
Examiner has withdrawn the 112 (b) rejections based on the amendments made on record.
Regarding applicants arguments on the U.S.C. 102 (a)(1) rejection, examiner respectfully disagrees. Without looking at the applicants drawings, examiner believes that reference Zaidi discloses all the limitations shown in claim 1. The claim is interpreted under broadest reasonable interpretation and the rejection of claim 1 will be explained down below in more detail:
a neural interface system (Figure 1, element 100 and Abstract)
a lead body (Annotated Figure 1, element 118; it is described to be a lead in Para 32); including a first electrode (Figure 1, element 112).
Attorney argues this limitation, stating “there are no electrodes on the lead body”, first in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “on the lead body”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Nowhere in the claim does it recites “a first electrode disposed on the lead body” instead, the claim states “a lead body, including a first electrode” this can be interpreted in many different ways, a lead body that is physically connected to a first electrode reads on this limitation. Para 32 of Zaidi discloses “The electrodes arrays 112 and 114 may be of a conventional type and wired to a controller through conventional conductors 118”. The electrodes are wired and connected to the lead body (can be interpreted as part of the lead body or as applicant argues “on” the lead body). See Annotated Figure 2B below that shows how the lead connects to the electrodes, which is similar to the applicant’s specification description.
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Annotated Figure 2B
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Annotated Figure 1
a cuff body (Fig. 1, element 102) having a first section (Annotated Fig. 1, element 104) and a second section (Annotated Fig. 1, element 106) separated by a gap for providing a path of least electrical resistance (Annotated Figure 1 shows this, Para 32; “The substrate 102 may include… a spinal portion forming a helix of one turn (when combined with a center portion 109 and one of the portions 104 or 106)”; also note that “for providing a path of least electrical resistance is a statement of intended use
a second electrode positioned within the first section (Annotated Fig. 1, element 114); and a junction between the lead body and the cuff body (Figs. 2A-2B; elements 120 and 220 respectively; see also Annotated Figure 1 that shows a junction between leady body 118 and the cuff),
wherein the gap extends around an axis of the cuff body and comprises a first area proximal to the junction (Para 32 and Annotated Figure 1 show the gap extending helically around an axis of the cuff body and the “gap first area” is proximate to the junction; the term “proximate” can be interpreted very broadly, in fact it is used broadly if compared to Applicant’s Figure 1, that shows the junction 106 as proximate to gap 120).
For the above reasons, examiner respectfully disagrees with applicants arguments and recommends an amendment.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/Benjamin J Klein/ Supervisory Patent Examiner, Art Unit 3792
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