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 After Final Amendment
This Office Action is responsive to the after final amendment filed 03 June 2026. As per the after final response: no claims have been added, cancelled, or amended and claims 3, 5, and 21-29 remain withdrawn. Thus, claims 1-2, 4, and 6-11 are currently pending and under examination.
Response to Arguments
Applicant’s arguments, see pg. 5-7, filed 03 June 2026, with respect to the rejection(s) of claim(s) 1, 6, and 9-11 under Clark in view of Coblentz have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Andersen et al. (US 2015/0202456 A1), hereinafter Andersen further in view of Schultheis et al. (US 2022/0397262 A1), hereinafter Schultheis.
Andersen teaches an implantable optical applicator may comprise a cuff configured to at least partially circumferentially surround a portion of the targeted tissue with a plurality of reflective elements disposed on, within, or beneath the interior surface of the cuff body, wherein each of the reflective elements separated from each other and from the at least one light emitter by at least one portion of the cuff body ([0081] “The nontransparent electrode may be made to serve as a reflective layer along the outer surface on an optical applicator, as will be explained later.”, [0120] “Sleeve S may be made to be a reflector, as well, and serve to confine light to the intended target. Reflective material(s), such as Mylar, metal foils, or sheets of multilayer dielectric thin films may be located within the bulk of Sleeve S, or along its inner or outer surfaces.” , [0146] “Here Waveguide (WG) contains Textured Area (TA), and the addition of Reflector (M) that at least partially surrounds target anatomy (N). This configuration provides for exposure of the far side of the target by redirecting purposefully exposed and scattered light toward the side of the target opposite the applicator. FIG. 19B illustrates the same embodiment, along cross-section A-A, showing schematically the use of a mirror (as Reflector M) surrounding Target (N.) Although not shown, WG and M may be affixed to a common casing (not shown) that forms part of the applicator. Reflector (M) is shown as being comprised of a plurality of linear faces, but need not be. In one embodiment it may be made to be a smooth curve, or in another embodiment, a combination of the two.”).
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 Clark to incorporate the teachings of Andersen to have a plurality of reflective elements disposed on, within, or beneath the interior surface of the cuff body, wherein each of the reflective elements separated from each other and from the at least one light emitter by at least one portion of the cuff body, as these prior art references are directed to cuff surrounding nerves. One would be motivated to do this to prevent light scattered to escape, as recognized by Andersen ([0115]).
Andersen fails to explicitly teach wherein each of the reflective elements is configured to reflect at least 50% of light of a predetermined wavelength or range of wavelengths that is emitted from the at least one light emitter and illuminated the reflective element.
However, Schultheis teaches an illumination system that comprises at least one light source, an optical waveguide, and optical element wherein “the optical element may have a lateral surface that is covered by a light-reflecting reflector layer, at least in a section thereof, which reflector layer preferably includes a mirror layer, so the optical element comprises a light-reflecting area that is covered by the reflector layer, and comprises a light-transmissive area which preferably remains free of the reflector layer, so that the light to be emitted by the optical element can at least partially be reflected and light can be emitted from the light-transmissive area… the reflectance of the reflector layer is greater than 90% for at least one wavelength range. The reflector layer may also be in the form of a mirror layer.” ([0022]-[0023], [0039]).
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 Clark and Andersen to incorporate the teachings of Schultheis to have each of the reflective elements is configured to reflect at least 50% of light of a predetermined wavelength or range of wavelengths that is emitted from the at least one light emitter and illuminated the reflective element, as these prior art references are directed to illumination systems. One would be motivated to do this reflect the light back to the target area and prevent light loss.
Therefore, claims 1-2, 4, 6, and 9-11 remain rejected under 35 USC 103.
No additional specific arguments were presented for previously set forth 35 U.S.C. 103 rejections of dependent claims 7-8, nor specifically with respect to previously cited reference: Bolea.
Therefore, claims 7-8 remain rejected under 35 U.S.C. 103, as described in detail below.
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) 1-2, 4, 6, and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark et al. (US 2020/0376262 A1, previously cited), hereinafter Clark in view of Andersen et al. (US 2015/0202456 A1, previously cited), hereinafter Andersen further in view of Schultheis et al. (US 2022/0397262 A1), hereinafter Schultheis.
Regarding claim 1, Clark discloses an optical lead ([0002] “The present invention is also directed to implantable electrical and optical stimulation leads”), comprising:
a cuff body (cuff 540) having an exterior surface and an interior surface (/view Examiner modified Figure 5(b)), wherein the cuff body defines a nerve channel for receiving a portion of a nerve (Claim 12: “the cuff is configured to apply pressure on a portion of a nerve disposed within the cuff to flatten the portion of the nerve”);
a lead body (lead body 106) coupled, or coupleable, to the cuff body (Claim 8: “a paddle or cuff attached to the lead body”));
at least one light emitter disposed on or within the cuff body or the lead body (Claim 8: “a plurality of light emitters disposed on the paddle or cuff and configured to emit light”)
Although, Clark discloses electrodes located within the interior surface of the cuff body, Clark fails to explicitly disclose a plurality of reflective elements disposed on, within, or beneath the interior surface of the cuff body, wherein each of the reflective elements separated from each other and from the at least one light emitter by at least one portion of the cuff body, wherein each of the reflective elements is configured to reflect at least 50% of light of a predetermine wavelength or range of wavelengths that is emitted from the at least one light emitter and illuminates the reflective element.
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Examiner Modified Figure 5(B)
However, Andersen teaches an implantable optical applicator may comprise a cuff configured to at least partially circumferentially surround a portion of the targeted tissue with a plurality of reflective elements disposed on, within, or beneath the interior surface of the cuff body, wherein each of the reflective elements separated from each other and from the at least one light emitter by at least one portion of the cuff body ([0081] “The nontransparent electrode may be made to serve as a reflective layer along the outer surface on an optical applicator, as will be explained later.”, [0120] “Sleeve S may be made to be a reflector, as well, and serve to confine light to the intended target. Reflective material(s), such as Mylar, metal foils, or sheets of multilayer dielectric thin films may be located within the bulk of Sleeve S, or along its inner or outer surfaces.” , [0146] “Here Waveguide (WG) contains Textured Area (TA), and the addition of Reflector (M) that at least partially surrounds target anatomy (N). This configuration provides for exposure of the far side of the target by redirecting purposefully exposed and scattered light toward the side of the target opposite the applicator. FIG. 19B illustrates the same embodiment, along cross-section A-A, showing schematically the use of a mirror (as Reflector M) surrounding Target (N.) Although not shown, WG and M may be affixed to a common casing (not shown) that forms part of the applicator. Reflector (M) is shown as being comprised of a plurality of linear faces, but need not be. In one embodiment it may be made to be a smooth curve, or in another embodiment, a combination of the two.”).
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 Clark to incorporate the teachings of Andersen to have a plurality of reflective elements disposed on, within, or beneath the interior surface of the cuff body, wherein each of the reflective elements separated from each other and from the at least one light emitter by at least one portion of the cuff body, as these prior art references are directed to cuff surrounding nerves. One would be motivated to do this to prevent light scattered to escape, as recognized by Andersen ([0115]).
Clark and Andersen, alone or in combination, fails to explicitly teach wherein each of the reflective elements is configured to reflect at least 50% of light of a predetermined wavelength or range of wavelengths that is emitted from the at least one light emitter and illuminated the reflective element.
However, Schultheis teaches an illumination system that comprises at least one light source, an optical waveguide, and optical element wherein “the optical element may have a lateral surface that is covered by a light-reflecting reflector layer, at least in a section thereof, which reflector layer preferably includes a mirror layer, so the optical element comprises a light-reflecting area that is covered by the reflector layer, and comprises a light-transmissive area which preferably remains free of the reflector layer, so that the light to be emitted by the optical element can at least partially be reflected and light can be emitted from the light-transmissive area… the reflectance of the reflector layer is greater than 90% for at least one wavelength range. The reflector layer may also be in the form of a mirror layer.” ([0022]-[0023], [0039]).
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 Clark and Andersen to incorporate the teachings of Schultheis to have each of the reflective elements is configured to reflect at least 50% of light of a predetermined wavelength or range of wavelengths that is emitted from the at least one light emitter and illuminated the reflective element, as these prior art references are directed to illumination systems. One would be motivated to do this reflect the light back to the target area and prevent light loss.
Regarding claim 2, Clark in view of Andersen further in view of Schultheis teaches the optical lead of claim 1 (as shown above). Clark and Schultheis, alone or in combination, fails to teach wherein each of the reflective element comprises a reflective foil, reflective coating, or reflective particles.
However, Andersen teaches an implantable optical applicator may comprise a cuff configured to at least partially circumferentially surround a portion of the targeted tissue wherein each of the reflective elements comprises reflective coating ([0115] “Outer Surface (OS) may be made to be reflective, as described earlier, to prevent light scattered from a TA to escape the waveguide via OS and enhance the overall efficiency of the device. A coating may be used for the reflective element. Such coating might be, for example, metallic coatings, such as, Gold, Silver, Rhodium, Platinum, Aluminum.”, view Figure 11A-11D, [0081] “The nontransparent electrode may be made to serve as a reflective layer along the outer surface on an optical applicator, as will be explained later.”, ).
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 Clark and Schultheis to incorporate the teachings of Andersen to have each of the reflective elements comprise reflective coating, as these prior art references are directed to cuff surrounding nerves. One would be motivated to do this to prevent light scattered to escape, as recognized by Andersen ([0115]).
Regarding claim 4, Clark in view of Andersen further in view of Schultheis teaches the optical lead of claim 1 (as shown above).
Clark and Schultheis, alone or in combination, fail to explicitly teach wherein the plurality of reflective elements comprises a plurality of reflective strips disposed on the interior surface of the cuff body.
However, Andersen teaches wherein “Sleeve S shown in FIG. 10B. Sleeve S may be made to be a reflector, as well, and serve to confine light to the intended target. Reflective material(s), such as Mylar, metal foils, or sheets of multilayer dielectric thin films may be located within the bulk of Sleeve S, or along its inner or outer surfaces”([0120]).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clark and Schultheis to incorporate the teachings of Andersen to have the plurality of reflective elements comprises a plurality of reflective strips disposes on the interior surface of the cuff body, as these prior art references are directed to neural cuffs. One would be motivated to do this to circumvent a potential light loss towards surrounding tissues or neighboring nerves.
Regarding claim 6, Clark in view of Andersen further in view of Schultheis teaches the optical lead of claim 1 (as shown above). Clark further discloses a plurality of electrodes disposed on or with the cuff body ([0073] “In FIG. 5B, the electrodes 534 and light emitters 535 are arranged on an interior surface 573 of the cuff 540 that fits around a nerve.”), wherein the lead body comprises a plurality of conductors coupled to the electrodes to provide electrical stimulation ([0047] “The electrically-conductive wires (“conductors”) may be embedded in the non-conductive material of the lead body 106 or can be disposed in one or more lumens (not shown) extending along the lead body 106.”, [0038] “The lead also includes electrodes 134 disposed along the lead body 106, and one or more terminals (e.g., 310 in FIG. 2A-2B) disposed along each of the one or more lead bodies 106 and coupled to the electrodes 134 by conductors (not shown). In at least some embodiments, one or more terminals (e.g., 310 in FIG. 2A-2B) may also be used to convey electrical signals to a light source that acts as the light emitter 135 by conductors (not shown) extending along the lead.”)
Clark fails to teach wherein the plurality of reflective elements comprises a plurality of electrodes disposed on or with the cuff body.
However, Andersen teaches “The nontransparent electrode may be made to serve as a reflective layer along the outer surface on an optical applicator, as will be explained later.” ([0081]).
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 Clark’s electrodes to incorporate the teachings of Andersen to have the plurality of reflective elements comprises a plurality of electrodes disposed on or with the cuff body, as these prior art references are directed to cuff surrounding nerves. One would be motivated to do this to prevent light scattered to escape, as recognized by Andersen ([0115]).
Regarding claim 9, Clark in view of Andersen further in view of Schultheis teaches the optical lead of claim 1 (as shown above). Clark further discloses wherein the light emitter is a light source ([0037] “The light emitter 135 can be a light source, such as a light-emitting diode (“LED”), laser diode, organic light-emitting diode (“OLED”), or the like, or can be a terminus of a light transmission element, such as an optical fiber, in which case the light source is distant from the distal portion of the lead (for example, in the control module or in a proximal portion of the lead)”).
Regarding claim 10, Clark in view of Andersen further in view of Schultheis teaches the optical lead of claim 1 (as shown above). Clark further discloses wherein the light emitter is an emission region of an optical fiber ([0037] “The light emitter 135 can be a light source, such as a light-emitting diode (“LED”), laser diode, organic light-emitting diode (“OLED”), or the like, or can be a terminus of a light transmission element, such as an optical fiber, in which case the light source is distant from the distal portion of the lead (for example, in the control module or in a proximal portion of the lead”).
Regarding claim 11, Clark discloses a system ([0002] “The present disclosure is directed to the area of electrical and optical stimulation systems”, an electrical/optical stimulation system 100), comprising:
the optical lead of claim 1 (view the rejection of claim 1 above); and
a control module (control module 102) coupled, or coupleable, to the optical lead ([0036] “The electrical/optical stimulation system includes a control module (e.g., a stimulator) 102 and a lead 103 coupleable to the control module 102 (such as an implantable or external pulse generator (IPG) or external trial stimulation (ETS))”) and configured to direct intermittent delivery of light via the at least one light emitter (Claim 7: “the control module configured to direct the emission of the light from the light emitters of the lead”).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Andersen further in view of Schultheis as applied to claim 1 above, and further in view of Bolea et al. (US 2008/0103545 A1, previously cited), hereinafter Bolea.
Regarding claim 7, Clark in view of Andersen further in view of Schultheis teaches the optical lead of claim 1 (as shown above).
Clark, Andersen, and Schultheis, alone or in combination, fail to explicitly teach wherein the cuff body has a spiral arrangement for self- sizing of the cuff body around a nerve.
However, Bolea teaches wherein the cuff body has a spiral arrangement for self-sizing of the cuff body around a nerve (view Figure 16A, “With specific reference to FIGS. 16A and 16B, another self-sizing and expandable design…the implantable nerve cuff electrode 160 comprises a compliant sheet wrap 162 configured to be wrapped about a nerve”).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clark, Andersen, and Schultheis to incorporate the teachings of Bolea to have the cuff body has a spiral arrangement for self- sizing of the cuff body around a nerve, as these prior art references are directed to nerve cuffs. One would be motivated to do this to accommodate for nerve swelling and/or over-tightening, as recognized by Bolea ([0102]).
Regarding claim 8, Clark in view of Andersen further in view of Schultheis teaches the optical lead of claim 1 (as shown above).
Clark, Andersen, and Schultheis, alone or in combination, fail to explicitly teach the optical lead further comprising at least one suture tab, suture sleeve, or lead anchor configured for attaching the cuff body or lead body to tissue.
However, Bolea teaches at least one suture tab configured for attaching the cuff body or lead body to tissue ([0102] “the implantable nerve cuff electrode 160 comprises a compliant sheet wrap 162 configured to be wrapped about a nerve and secured thereto by connecting opposite portions of the sheet 162 by sutures 168.”, view Figure 16A, [0105]).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clark, Andersen, and Schultheis to incorporate the teachings of Bolea to have the optical lead further comprising at least one suture tab, suture sleeve, or lead anchor configured for attaching the cuff body or lead body to tissue, as these prior art references are directed to nerve cuffs. One would be motivated to do this to be able to secure the nerve cuff to the nerve, as recognized by Bolea ([0105]).
Conclusion
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/ATTIYA SAYYADA HUSSAINI/ Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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