DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is responsive to the amendment filed 06 December 2026. As per the amendment: claims 1-43 remain cancelled, claims 49-54 and 62 have been amended, and no claims have been added or cancelled. Thus, claims 44-67 are presently pending and under examination.
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.
Claim 57 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 57 recites the limitation "the lead body" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 57 should be read as if dependent on claim 45 that recites “a lead body”.
Regarding claim 57, the phrase “optionally” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP 2173.05(h)(II). Thus, under BRI of the claim Examiner notes that any apparatus that has an anchoring tab comprises a coated mesh reads on the claims regardless if the mesh is coated with a material that fills the mesh.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 44-46, 61 and 63 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Mrva et al. (Publication No. US 2008/0172116 A1, hereinafter “Mrva”, cited by Applicant).
Regarding claim 44, Mrva discloses a neural interface comprising:
at least one C-ring portion for applying a radial pressure in a range of 1 mmHg to 30 mmHg to a target tissue arranged within the C-ring portion (Fig. 2 (14) (16) and par. [0072]: …to allow the cuff electrode to fit gently about the periphery of a nerve, and not too tightly to cause damage (i.e., exerts a maximum pressure about the nerve N that does not exceed about 20 mmHg)) and comprising at least one electrode arranged on the at least one C-ring portion (Figs. 2, 9 and 19 (18) (72) (76)).
Regarding claim 45, Mrva discloses the neural interface of claim 44, further comprising a lead body (Figs. 6A-7, 22 (12)) comprising a conductor (Figs. 18-19 (25)) connectable to an implantable pulse generator (Fig. 22 (28) (50)), wherein the at least one electrode is electrically coupled to the conductor (Fig. 22 and par. [0075]: …connector 28 at the proximal end of the lead 12 provides electrical continuity and mechanical attachment to the mating connector 48 of an implantable pulse generator 50, [0089]: …lead wire 25 to extend from the electrode 76 through a channel 38 and into the lumen 13. The lead wire 25 then extends to the connector 28 on the proximal end of the lead 12).
Regarding claim 46, Mrva discloses the neural interface of claim 44, wherein the C-ring portion applies a radial pressure based upon one or more of the group comprising:
rigidity of an insulating material that makes up a body of the C-ring portion (par. [0072]: The elasticity of the cuff is selected to gently wrap about the nerve N without causing damage or trauma. To this end, it is believed desirable that the elastic memory of the cuff exhibits a predictable and repeatable pressure vs. diameter relationship).
Regarding claim 61, Mrva discloses the neural interface of claim 44, wherein a plurality of electrodes (Figs. 6A and 9 (18)) are electrically connected in parallel (Figs. 11-13 and par. [0073]: …the lead 12 may be composed of several individually insulated wires 25 connecting multiple electrodes 18 to multiple contacts of the connector 28…each separate insulated wire may be composed of multiple strands of wire …with each strand electrically connected in parallel at the electrode end and at the connector end).
Regarding claim 63, Mrva discloses a system comprising: the neural interface of claim 44; and a deployment tool (Figs. 31A-C (144)) being removably coupleable to the neural interface for deployment of the neural interface. (Figs. 31A-C (144) (146) (150) and par. [0102]: …slider 150…pushes against the cuff 14 and ultimately ejects the cuff 14 from the applicator body 146 onto the nerve N… The applicator tool 144…removed from the nerve N, leaving the system 10 implanted about the nerve).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrva as applied to claim 44 above, and further in view of Gaunt et al. (US 2006/0184211 A1), hereinafter Gaunt.
Regarding claim 47, Mrva discloses the neural interface of claim 44 (as shown above). Mrva fails to explicitly teach wherein the at least one C-ring portion having an inner diameter and a cross-sectional thickness, with a ratio of the inner diameter to the cross-sectional thickness being in a range of 5: 1 to 6: 1.
However, Gaunt teaches an implant, system, and method for electrically stimulating a target tissue to either activate or block neural impulses (Abstract) wherein the at least one C-ring portion having an inner diameter and a cross-sectional thickness, with a ratio of the inner diameter to the cross-sectional thickness being in a range of 5: 1 to 6: 1 ([0051] “silastic elastomer cuffs ranging from 5 mm to 15 mm in length, 4 mm to 6 mm inside diameter, and 1 mm thick are suitable”, Examiner notes that ratio would be calculated from the inside diameter: thickness, and thus Gaunt’s cuffs would have a ratio in a range of 4:1 to 6:1.)
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mrva to incorporate the teachings of Gaunt to have the at least one C-ring portion having an inner diameter and a cross-sectional thickness, with a ration of the inner diameter to the cross-section thickness being in a range of 5:1 to 6:1, as these prior art references are directed to nerve cuffs. One would be motivated to do this to ensure sufficient surface area for providing high conductivity contact with body tissues, as recognized by Gaunt ([0049]).
Claim(s) 48-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrva in view of Brunnett et al. (Publication No. US 2010/0145221, hereinafter "Brunnett").
Regarding claim 48, Mrva discloses the neural interface of claim 44, except wherein the at least one electrode comprises an electrode contact on an electrode flange, the electrode flange mechanically coupling the electrode to the C-ring portion and comprising a plurality of perforations.
However, Brunnett in the same field of endeavor: nerve electrode system, discloses the at least one electrode (Fig. 2A (160) (161) (180)) comprises an electrode contact (Fig. 2A (180)) on an electrode flange ((Fig. 2A (152)), the electrode flange mechanically coupling the electrode to the C-ring portion (Fig. 2A, 3 (152) (160) and par. [0103]: …a nerve electrode 150… comprises an elongate body 152 and a cuff portion 160… the elongate body 152 includes a distal portion 158 adjacent the cuff portion 204…) and comprising a plurality of perforations (Fig. 12 (442) (444)) for the purpose of facilitating fixing the elongate body flange relative to structures surrounding or adjacent to the target nerve (par. [0142]).
Therefore, it would have been obvious to one having ordinary skill int the art before the effective filing date of the claimed invention to include in the neural interface device of Mrva, to include an elongate body electrode flange coupled to a cuff electrode and containing perforations, as taught by Brunnett, in order to facilitate fixing the elongate body flange relative to structures surrounding or adjacent to the target nerve.
Regarding claim 49-51, Mrva discloses the neural interface of claim 48, except wherein the electrode flange comprises a curved under edge;
wherein the plurality of perforations comprise at least one perforation on a first side of the electrode flange and at least one perforation on a second opposing side of the electrode flange; and
wherein the first side of the electrode flange and the second opposing side of the electrode flange are longer than a third side and a fourth side of the electrode flange.
Brunnett discloses the electrode flange comprises a curved under edge (Fig. 6 (192));
wherein the plurality of perforations comprise at least one perforation on a first side of the electrode flange (Fig. 12 (400) (442)) and at least one perforation on a second opposing side of the electrode flange (Fig. 12 (400) (444)); and
wherein the first side of the electrode flange and the second opposing side of the electrode flange (Fig. 5 "L1") are longer than a third side and a fourth side of the electrode flange (Fig. 4 "W1") to provide the benefit of a strong support or anchor for forceps to move tab toward and against the flange with the width providing an ample target that the distal tips of the forceps can grasp and length providing better reach to facilitate advancing the cuff portion about the nerve (par. [0104]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the neural interface device of Mrva, to include an elongate body electrode flange with a curve, aperture perforations on each of the sides and a rectangular shape with first and second sides longer than third and fourth sides, as taught by Brunnett, in order to provide the benefit of a strong support or anchor for forceps to move tab toward and against the flange with the width providing an ample target that the distal tips of the forceps can grasp and length providing better reach to facilitate advancing the cuff portion about the nerve.
Regarding claim 52, Mrva discloses the neural interface of claim 48, except wherein each of the plurality of perforations is rectangular with rounded corners.
While Brunnett teaches a plurality of perforations, it does not specifically teach rectangular perforations with rounded corners. However Burnett does teach a pair round of apertures 442 adjacent proximal end 402 and a second pair of apertures 444 located distal to the first pair of apertures 442. The respective apertures are sized and positioned on the elongate body 415 and spaced apart from the nerve-engaging portion 417 to facilitate fixing elongate body 415 relative to structures surrounding or adjacent to the target nerve (par. [0141]). Further the Applicant's specification discloses perforation " size, shape, spacing, placement, orientation, or other characteristics of perforations 936A can vary" (pg. 52, lines 19-20) and that "perforations 938B are round or circular" (pg. 52, line 22). However, there was no evidence of the criticality of the claimed shape of perforation holes.
Therefore, it would have been an obvious matter of design choice to make the perforations rectangular with rounded corners such a modification would have involved a mere change in the shape the hole. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Additionally, it would have been obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to use rectangular perforations with rounded corners within the invention of the prior art in order facilitate fixing elongate body flange relative to structures surrounding or adjacent to the target nerve (par. [0142]). Applicant has not disclosed that the perforation shape solves any stated problem of the prior art or is for any particular purpose. It appears that the invention would perform equally well with the perforations of Brunnett since both designs conduct power from a power source equally well.
Claim(s) 53-56 and 60, 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrva in view of Mrva et al. (Publication No. US 2006/0030919 A1, hereinafter "Mrva '919”, sited by Applicant).
Regarding claims 53-54, Mrva discloses the neural interface of claim 45, except further comprising: a spinal portion having a first end and a second end, a circumference of the first end of the spinal portion tapering from a maximum circumference to a minimum circumference; the lead body being coupled to the first end of the spinal portion and extending at least partially into the spinal portion; and
wherein the spinal portion has a substantially circular cross-section, and the second end of the spinal portion has an angled surface such that a plane parallel to the substantially circular cross-section is at an angle of greater than 0 degrees and less than 90 degrees with respect to a plane defined by the angled surface.
However Mrva ‘919 in the same field of endeavor: devices systems and methods employing a molded nerve cuff, discloses
a spinal portion having a first end and a second end (Fig. 2B (40)), a circumference of the first end of the spinal portion tapering from a maximum circumference to a minimum circumference (Fig. 2B (12)(40)); the lead body being coupled to the first end of the spinal portion and extending at least partially into the spinal portion (Figs. 1 and 2 (30) and par. [0037]); and
the spinal portion has a substantially circular cross-section, and the second end of the spinal portion has an angled surface such that a plane parallel to the substantially circular cross-section is at an angle of greater than 0 degrees and less than 90 degrees with respect to a plane defined by the angled surface (par. [0037]: The strain relief boot 40 may take on any desired shape (i.e., coiled, bent, cone, or zigzag) to aid in its strain relief properties and to improve manufacturability. It is to be appreciated that the lead to cuff interface may be at any desired angle and is not limited to a parallel or perpendicular configuration) to provide the benefit of aiding in strain relief properties and to improve manufacturability (par. [0037]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in the neural interface with a conductor of Mrva, to include spinal portion as taught by Mrva ‘919 in order to provide the benefit of aiding in strain relief properties and to improve manufacturability.
Regarding claims 55-56, Mrva discloses the neural interface of claim 45, except wherein the maximum circumference of the first end of the spinal portion is proximate the at least three C-ring portions, and the minimum circumference of the first end of the spinal portion occurs where the spinal portion terminates on the lead body; and
Mrva ‘919 discloses wherein the maximum circumference of the first end of the spinal portion is proximate the at least three C-ring portions (Fig. 2B, (18) (40)), and the minimum circumference of the first end of the spinal portion (Fig. 2B (40)) occurs where the spinal portion terminates on the lead body (Fig. 2B (12) and par. [0040]: ); and
wherein a distance between the maximum circumference and the minimum circumference is in a range of 2 mm to 5 mm (Fig. 2B (18) and par. [0040]: …electrically conductive surface 18 measures at least one mm of length along the axis of the nerve N; according to Fig. 2B, the maximum circumference of the spine portion spans the length of cuff body 20, after which the minimum circumference begins, there are 3 one mm conductive surfaces within the cuff body each measuring 1 mm for a total length of 3 mm, the distance between the maximum circumference and the minimum circumference is therefore 3mm) for the purpose of strengthening the junction, to resist the effect of torque forces that might be applied during implantation and use along the lead (par. [0040]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in the neural interface with a conductor of Mrva, maximum and minimum circumferences of the spinal portion as taught by Mrva ‘919 in order to provide the benefit of aiding in strain relief properties and to improve manufacturability.
Regarding claim 60, Mrva discloses the neural interface of claim 45, except wherein the lead body comprises increased flexibility in a portion closer to the C-ring portion compared to a portion of the lead body further away from the C-ring portion.
Mrva ‘919 discloses the lead body comprises increased flexibility in a portion closer to the C-ring portion compared to a portion of the lead body further away from the C-ring portion (Fig. 2B (40) and par. [0037]: …the electrode 16… desirably includes…section forming a strain relief boot 40 at the junction between the lead 12 and the cuff body 20; ) to provide the benefit of preventing tension and/or motion from damaging the lead to cuff interface for a longer flex life (par. [0037]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in the neural interface with a conductor of Mrva, a flexible strain relief portion of the lead body closest to the cuff body as taught by Mrva ‘919 in order to provide the benefit of preventing tension and/or motion from damaging the lead to cuff interface for a longer flex life.
Regarding claim 62, Mrva discloses the neural interface of claim 45, except wherein the conductor comprises a single continuous coil electrically coupled to a plurality of electrodes on one of the C-ring portions .
Mrva ‘919 discloses the conductor (Fig. 4B (18)) and par. [0041]: comprises a single continuous coil electrically coupled to a plurality of electrodes on one of the C-ring portions (Figs. 2A, 2B, 4B (18) and par. [0041]: …the strip contact surfaces 18 are then wrapped in a desired spiral configuration around the core 32… surfaces 18 held in this spiral configuration within the core 32… resulting electrode 16 comprises the coiled configuration shown in FIG. 2A) to provide the benefit of a cuff manufacturing process that is reliable and repeatable (par. [0042]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in the neural interface with a conductor of Mrva, a spiral coil configured electrode cuff portion as taught by Mrva ‘919 in order to provide the benefit of a cuff manufacturing process that is reliable and repeatable.
Claim(s) 57-58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrva as applied to claim 44 above, and further in view of Warman et al. (US 2003/0105501 A1), hereinafter Warman.
Regarding claim 57, Mrva discloses the neural interface of claim 44 (as shown above), further comprising at least one anchoring tab coupled to the lead body (spiraling element 62, [0076]). Mrva fails to disclose wherein the at least one anchoring tab comprises a coated mesh, optionally wherein the mesh is coated with a material that fills the mesh.
However, Warman teaches an apparatus with a lead body and electrodes wherein the at least one anchoring tab comprises a coated mesh ([0052] “sleeve 68 may formed of a Dacron mesh sleeve, or may include a layer or coating formed of ePTFE. Sleeve 68 may be affixed to lead 54 using an adhesive or another means of fixation. The dimensions of sleeve 68, and the shape and size of openings 70 of the mesh, are illustrative. Any dimensions, size or shape may be employed to promote tissue in-growth adjacent to electrode 64. When tissue grows into mesh sleeve 68, lead 54 acquires enhanced anchoring, and electrode 64 is less likely to be disturbed from contact with the tissue”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substitute the spiral of Mrva with the coated mesh of Warman, as these prior art references are directed to lead body and electrodes. One would be motivated to do this to enhance anchoring of the lead body to the tissue, as recognized by Warman ([0013]).
Regarding claim 58, Mrva in view of Warman teaches the neural interface of claim 57 (as shown above). Mrva further discloses wherein the C-ring portion is provided at a first end of the lead body (view Figure 22: split cuff 14) and a connector to an implantable pulse generator (IPG) is provided at a second of the lead body (view Figure 22, [0093] “the connector 28 at the proximal end of the lead 12 is coupled to a mating connector 48 of a stimulation pulse generator 50”), further wherein the anchoring tab is provided between the first end and the second end of the lead body (Figure 15: spiral fastener 60, [0076] “FIG. 15 shows a spiral fastener 60. The spiral fastener 60 is shown positioned over the lead 12, although it may also be an integral component of the lead. The fastener 60 includes a spiraling element 62 to wrap loosely around the nerve N, as shown.”).
Claim(s) 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrva in view of Warman as applied to claim 58 above, and further in view of Bonde et al. (US 2011/0160827 A1), hereinafter Bonde.
Regarding claim 59, Mrva in view of Warman teaches the neural interface of claim 58 (as shown above). Mrva and Warman, alone or in combination, fail to teach wherein the anchoring tab is provided between the first end of the lead body and a middle section of the lead body situated half-way between the first end and the second end of the lead body, further wherein a ratio of a distance between the first end of the lead body and the anchoring tab and a distance between the second end of the lead body and the anchoring tab is between 1:1 and 1:50, optionally 1:2, 1:3, 1:4, or 1:5.
However, Bonde teaches an electrode lead assembly including a cuff electrode and an anchor wherein the anchoring tab is provided between the first end of the lead body and a middle section of the lead body situated half-way between the first end and the second end of the lead body, further wherein a ratio of a distance between the first end of the lead body and the anchoring tab and a distance between the second end of the lead body and the anchoring tab is between 1:1 and 1:50, optionally 1:2, 1:3, 1:4, or 1:5 ([0032] “in FIG. 6, in one embodiment, the lead system 200 comprises a cuff electrode 202, a first lead portion 204, a second lead portion 208, an anchor 206, and a connector 210”, [0033] “the first lead portion 204 extends proximally from the cuff electrode 202 and is formed of a resilient material to have a pre-formed… the second lead portion 208 has a length substantially greater than a length of the first lead portion 204. For example, in one non-limiting example, the second lead portion 208 has a length about seven times the length of the first lead portion 204.”,[0035] “the anchor 206 is interposed between the first lead portion and the second lead portion 208 and is configured to be secured relative to a body structure adjacent to the target nerve on which the cuff electrode 202 is mounted. The connector 210 extends proximally from the second lead portion 208 and is configured to electrically connect to an implantable pulse generator (such as IPG 55 in FIG. 1).”, [0041]-[0042] Examiner notes that the ratio would be L2:L4 = 1:7 or L1:L3 = 3:10-3:12) .
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mrva and Warman to incorporate the teachings of Bonde to have the anchoring tab is provided between the first end of the lead body and a middle section of the lead body situated half-way between the first end and the second end of the lead body, further wherein a ratio of a distance between the first end of the lead body and the anchoring tab and a distance between the second end of the lead body and the anchoring tab is between 1:1 and 1:50, optionally 1:2, 1:3, 1:4, or 1:5, as these prior art references are directed electrode lead devices. One would be motivated to do this for the lengths and anchoring position to be suitable for placement at the target nerve, as recognized by Bonde ([0033]).
Claim(s) 64-65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrva as applied to claim 63 above, and further in view of Melius et al. (US 2020/0108247 A1), hereinafter Melius.
Regarding claim 64, Mrva discloses the system of claim 63 (as shown above). Mrva fails to explicitly disclose the system further comprising a lead cap device having a first end and second end comprising a body defining an internal cavity that extends from the first end toward the second end, and a suture loop coupled to the second end, the lead cap device configured to removably receive a portion of the lead body in the internal cavity.
However, Melius teaches a lead anchor for a neuromodulation lead wherein the system further comprising a lead cap device (lead anchor 1) having a first end and second end (view Figure 1A) comprising a body (an elongate anchor body 10) defining an internal cavity (lumen 102) that extends from the first end toward the second end (view Figure 1A), and a suture loop coupled to the second end ([0045] “the anchor body 10 has fastener portions 101 in the form of eyelets for fastening the anchor body 10 to a patient's tissue (e.g., fascia) by means of a suture.”), the lead cap device configured to removably receive a portion of the lead body in the internal cavity ([0045]-[0046] “The anchor body 10 defines a lumen 102 that is configured for receiving a portion of the lead 2”).
Additionally, Examiner would like to note that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the suture loop coupled to the second end, to allow for better positioning of the device, and since it has been held that the rearrangement of parts was a matter of choice one of ordinary skill in the art would have found obvious and does not change the functionality of the device. See MPEP 2144.04 V1. C. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Additionally, the present disclosure has no criticality for having the suture loop coupled to the second end.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mrva to incorporate the teachings of Melius to have a lead cap device having a first end and second end comprising a body defining an internal cavity that extends from the first end toward the second end, and a suture loop coupled to the second end, the lead cap device configured to removably receive a portion of the lead body in the internal cavity, as these prior art references are directed to lead bodies. One would be motivated to do this to secure the lead and allow for easy adjustment, as recognized by Melius ([0006]-[0018]).
Regarding claim 65, Mrva in view of Melius teaches the system of claim 64 (as shown above). Mrva fails to disclose wherein an IPG connector portion of the lead body is removably received in the internal cavity of the lead cap device, further wherein the lead cap device comprises a set screw block arranged in the body such a setscrew intersects with the internal cavity, and is configured to secure the portion of the lead body in the internal cavity by the setscrew.
However, Melius teaches wherein an IPG connector portion of the lead body is removably received in the internal cavity of the lead cap device ([0043] “a lead anchor 1 for a neuromodulation lead 2 in accordance with one or more embodiments. More precisely, an arrangement of a lead 2 and a lead anchor 1 is shown in a state wherein the lead 2 is secured to the lead anchor 1.”), further wherein the lead cap device comprises a set screw block (set screw collar 121) arranged in the body such a setscrew (set screw 124) intersects with the internal cavity (view Figure 1A-1B and 2A-2B) , and is configured to secure the portion of the lead body in the internal cavity by the setscrew ([0048] “The set screw 124 may be (reversibly) activated, e.g., by means of a torque wrench, to clamp the portion of the lead 2 extending inside the lumen 1210 of the set screw collar 121. In other words, the set screw 124 serves as an actuator that is configured to reversibly activate the clamping function of the clamping element 12.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mrva to incorporate the teachings of Melius to have an IPG connector portion of the lead body is removably received in the internal cavity of the lead cap device, further wherein the lead cap device comprises a set screw block arranged in the body such a setscrew intersects with the internal cavity, and is configured to secure the portion of the lead body in the internal cavity by the setscrew, as these prior art references are directed to lead bodies. One would be motivated to do this to have a fully reversible, set screw which can provide adequate retention forces while reducing complexity, as recognized by Melius ([0034]).
Claim(s) 66-67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mrva.
Regarding claim 66, Mrva discloses a system comprising a set comprising a plurality of neural interface devices according to claim 44 (as shown above and view Figures 2 and 14-15), wherein inner diameters of the neural interface device differ whilst total electrode area of each neural interface device is substantially equal ([0077] “In a representative embodiment, the cuff(s) 14, 16, possess a minimum diameter (when in its normal molded condition) of as small as one mm, which makes it well suited for implantation about small nerves. The minimum diameter of the cuff can, of course, be molded to possess larger minimum diameters, to provide a family of implant systems 10 of different diameters that accommodate the range of diameters of human and animal nerves, from small to large.”, view Figure 2: electrodes 18, both comprise same area of electrodes).
Additionally, Examiner would like to note that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the inner diameters of the neural interface differ whilst total electrode area of each neural interface device is substantially equal, to allow better conformation to the nerves while maintaining electrode contact, and since it has been held that the change in size was a matter of choice one of ordinary skill in the art would have found obvious and does not change the functionality of the device. See MPEP 2144.04 IV. A. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Additionally, the present disclosure has no criticality for having the inner diameters of the neural interface differ whilst total electrode area of each neural interface device is substantially equal.
Regarding claim 67, Mrva discloses wherein an electrode of large inner diameter neural interface device comprises a smaller width and a larger length than an electrode of a smaller inner diameter neural interface ([0068] “The electrodes 18 may measure about 4 mm of length along the axis of the nerve N and about 2 mm of width along the circumference of the nerve N. In one representative embodiment, the electrodes 18 each measure about 1.5 mm.times.0.75 mm in length and width, respectively. In the illustrated embodiment, the electrically conductive surfaces 18 are carried in an exposed array positioned longitudinally along the axis of the nerve N. This geometry is well suited for applying nerve conduction blocks, but has application for use in other indications as well. Other geometries, sizes, and configurations can, of course, be used for other indications.”).
Additionally, Examiner would like to note that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the inner diameters of the neural interface differ whilst total electrode area of each neural interface device is substantially equal, to allow better conformation to the nerves while maintaining electrode contact, and since it has been held that the change in size was a matter of choice one of ordinary skill in the art would have found obvious and does not change the functionality of the device. See MPEP 2144.04 IV. A. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Additionally, the present disclosure has no criticality for having the inner diameters of the neural interface differ whilst total electrode area of each neural interface device is substantially equal.
Conclusion
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/ATTIYA SAYYADA HUSSAINI/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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