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 Arguments
Applicant’s arguments, see applicant remarks, filed 10/22/2025, with respect to the objection to the drawings, the objection to claim 19, the 35 USC 112(f) interpretation, and 35 USC 112(b) rejection of claim 7 have been fully considered and are persuasive. The aforementioned objections, rejections, and interpretations have been withdrawn.
Applicant’s arguments, see applicant remarks, filed 10/22/2025, with respect to the rejection(s) of claim(s) 1-8,10,11,12, 15-17 and 20 under 35 USC 103 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 Therefore, the rejection has been withdrawn.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 Chabrol et al (US 20180154152 A1); hereinafter Chabrol.
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.
Claim(s) 1-8,10,11,13,15-17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park et al (WO2021141163A1); hereinafter Park in view of Zhang et al (US20180369607A1); hereinafter Zhang (both cited previously) and Chabrol et al (US 20180154152 A1); hereinafter Chabrol.
Regarding claim 1, Park teaches a photobiomodulation system (transparent electrode array 100), comprising:
A photobiomodulation lead comprising:
a lead body (figs 1-7) comprising a proximal end portion and a distal end portion;
at least one light emitter (optical fiber 200 may include a light emitting unit (not shown)) disposed along, or coupled to, the distal end portion of the lead body and configured to emit light out of the photobiomodulation lead (fig 5 part 200 is on the distal end);
and at least one stimulation electrode (120).
Park teaches that the intended use of the transparent electrodes is to improve imaging quality, and while it would also be obvious to try using the same structure of Park to emit rather than collect light, Zhang explicitly teaches that the electrode is disposed on or over the at least one light emitter and in a path of the light emitted by at least one of the at least one light emitter ([0030] in at least some embodiments, at least one of the electrodes 134 is formed from an optically-transparent material). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Park with Zhang because this would be applying a known technique to a known device for improvement to yield predictable results. The implantable lead of Park already has transparent electrodes that allow light to more easily pass through for imaging purposes. Using that same structure to change the directionality of the light to be irradiating the tissue instead of collecting light for imaging would be an obvious improvement. Since Park already teaches that the transparency makes it easier for light to pass in, the same would also be true for light passing out.
The combination of Park and Zhang fails to teach that the electrode is used for stimulation rather than sensing. Chabrol teaches a transparent stimulation electrode that allows an optical signal to pass through ([0030] a central channel which is not used for electric stimulation, the material of the probe body (e.g., silicone, or polyurethane) is usually transparent to wavelengths of interest for the optical stimulation, and the electrical stimulation electrodes do not cover the entire distal portion of the probe, particularly the end thereof, which thus leaves a surface area for optical emission). Chabrol further teaches “an implantable control module coupled or couplable to the photobiomodulation lead and configured to control emission of light by the at least one light emitter and configured to provide electrical stimulation through the at least one stimulation electrode ([0075] control signal).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Park and Zhang with Chabrol because there is some teaching, suggestion, or motivation to do so. Chabrol teaches “the invention is based on the observation by the inventors of the fact that DBS probes of the state of the art may be simply modified to also implement an optical stimulation” ([0030]).
Regarding claim 2, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 1. Park further teaches the at least one electrode is transparent or translucent (transparent electrode array 100 is a graphene sheet 121). Chabrol teaches that the electrode provides stimulation rather than sensing ([0030]).
Regarding claim 3, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 2. Park further teaches at least one of the at least one electrode comprises graphene (graphene sheet 121), carbon nanotubes (the carbon material is any one selected from the group consisting…carbon nanofiber), or indium tin oxide. Chabrol teaches that the electrode provides stimulation rather than sensing ([0030]).
Regarding claim 4, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 1. Park further teaches at least one of the at least one electrode is a mesh electrode that allow transmission of at least 50% of light through the mesh electrode (a metal mesh). Chabrol teaches that the electrode provides stimulation rather than sensing ([0030]).
Regarding claim 5, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 1. Park further teaches at least one of the at least one electrode defines a grid of holes that allow transmission of at least 50% of light through the electrode (a metal mesh). Chabrol teaches that the electrode provides stimulation rather than sensing ([0030]).
Regarding claim 6, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 5. Park further teaches the least one light emitter comprises a plurality of waveguides, wherein at least one of the waveguides extends into or through at least one of the holes of the grid of holes (deep brain stimulation transparent electrode array 100 may further include an optical fiber 200).
Regarding claim 7, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 1. Park further teaches at least one of the at least one light emitter is a light source (light emitting unit). Chabrol teaches that the electrode provides stimulation rather than sensing ([0030]).
Regarding claim 8, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 1, Park further teaches at least one of the at least one light emitter is configured to emit light from a distal tip of the photobiomodulation lead (the light emitting unit and the light receiving unit are formed on the optical fiber 200 may be formed together at one end).
Regarding claim 10, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 1. Park further teaches at least one of the at least one light emitter is a directional light emitter (directing incident light to the tissue).
Regarding claim 11, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 1. Park further teaches a paddle body attached to the distal end portion of the lead body, wherein at least one of the at least one light emitter is disposed on the paddle body (fig. 1 - paddle design).
Regarding claim 13, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 1. Zhang further teaches at least one electrode is a plurality of electrodes and the plurality of electrodes comprises at least one set of segmented electrodes disposed at a same longitudinal position along the photobiomodulation lead ([0087] emitting light around the entire circumference of the lead via, for example, rotation of the light emitter (or a mirror). In the embodiments illustrated in FIGS. 6A-6E, the five light emitters are arranged into a proximal-most (along the length of the lead) set of light emitters). Chabrol teaches that the electrode provides stimulation rather than sensing ([0030]).
Regarding claim 15, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 1. Park further teaches at least one of the at least one light emitter is an optical waveguide configured to receive light from a light source and to emit the light out of the photobiomodulation lead (deep brain stimulation transparent electrode array 100 may further include an optical fiber 200).
Regarding claim 16, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 15. Zhang further teaches at least one of the at least one electrode is disposed on the optical waveguide, the photobiomodulation lead further comprising a conductive trace extending along the optical waveguide from the at least one of the at least one electrode (fig. 1 – the conductive trace for the light (135) at the end of the lead must extend along the lead which serves as a waveguide and electrode 134 is on the way). Chabrol teaches that the electrode provides stimulation rather than sensing ([0030]).
Regarding claim 17, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 15. Park further teaches the light source disposed within the photobiomodulation lead (optical fiber 200 may further include a light emitting unit (not shown) for transmitting an input optical signal to the optical fiber).
Regarding claim 20, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 1. Park further teaches emitting light from the at least one light emitter of the photobiomodulation lead of claim 1 implanted in the tissue (abstract - deep brain stimulation).
Regarding claim 21, the combination of Park, Zhang, and Chabrol teaches the method of claim 20. Chabrol further teaches stimulating the tissue using at least one of the least one stimulation electrode ([0030] electrical stimulation electrodes).
Claim(s) 9, 12, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Park, Zhang, and Chabrol in view of Clark et al (US 20200376262 A1); hereinafter Clark.
Regarding claim 9, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 1. The combination fails to teach light is emitted from the side of the lead. Clark teaches at least one of the at least one light emitter is configured to emit light from a side of the photobiomodulation lead (fig. 1 part 435 (light emitter) is on the side of the lead). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Park and Zhang with Clark because it is an obvious matter of design choice where the light is located.
Regarding claim 12, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 1. The combination fails to teach that the light is disposed on the cuff body. Clark teaches a cuff body attached to the distal end portion of the lead body, wherein at least one of the at least one light emitter is disposed on the cuff body (abstract - light emitters disposed on the paddle or cuff; and stimulation electrodes disposed on the paddle or cuff). It would have been obvious to modify the combination of Park and Zhang with Clark because there is some teaching, suggestion, or motivation to do so. Clark teaches that “the cuff is configured to apply pressure on a portion of a nerve disposed within the cuff to flatten the portion of the nerve” ([0011]). Therefore, there is an obvious benefit to the form factor of the device being a cuff.
Regarding claim 18, the combination of Park, Zhang, and Chabrol teaches the photobiomodulation system of claim 1. The combination fails to teach light emitters disposed in a ring. Clark teaches the plurality of light emitters comprises a set of light emitters disposed in a ring within the photobiomodulation lead ([0072] light emitters 435 form a set of rings around the circumference of the lead). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Park and Zhang with Clark because it would constitute a matter of design choice to put the lights on a ring rather than at the distal end of a lead.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park, Zhang, and Chabrol further in view of Kim. The combination of Park, Zhang, and Chabrol teach the photobiomodulation system of claim 1. The combination fails to teach an insulative layer. Kim teaches an optical assembly comprising at least one of the at least one light emitter and an insulative layer between at least a portion of the at least one electrode and a portion of the optical assembly ([0151] The first insulating layer 161 may be in contact with a lower portion of the light emitting structure 110 in which the first and second electrodes 151 and 153 are disposed.). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Park, Zhang, and Chabrol with Kim because there is some teaching, suggestion, or motivation to do so. Kim teaches “the first electrode 151 may be electrically insulated from the second electrode 153” ([0105]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 Dhrasti SNEHAL Dalal whose telephone number is (571)272-0780. The examiner can normally be reached Monday - Thursday 8:30 am - 6:00 pm, Alternate Friday off, 8:30 am - 5:00 pm.
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/D.S.D./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796