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 § 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, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers(US 11160489 B2) in view of Jia(WO 2021067905 A1).
Regarding claim 1, Rogers discloses a multifunctional fiber probe comprising: a polymer fiber segment having (i) a proximal end and (ii) a distal end configured to be inserted into tissue; a microfluidic channel running along a length of the polymer fiber segment and having a first opening at the proximal end of the polymer fiber segment and a second opening at the distal end of the polymer fiber segment and configured to convey fluid between the first opening and the second opening(In an aspect, the present invention is an implantable, injectable and/or surface-mountable biomedical device for interfacing with a target tissue, the device comprising: a flexible substrate having a Young's modulus selected from a range of 100 KPa to 50 MPa; one or more microfluidic channels embedded in or supported by the substrate; wherein at least a portion of the substrate and the one or more microfluidic channels form an implantable or injectable elongated probe; wherein each microfluidic channel comprises an outlet at a distal end and an inlet at a proximal end; wherein the inlet of the microfluidic channel is in fluid communication with a reservoir containing a fluid to be delivered to the target tissue; and a fluid actuator in operational communication with the one or more reservoirs and responsive to a wireless control signal(Summary of the Invention, paragraph 2); electrodes running along the length of the polymer fiber segment and configured to make electrophysiology measurements of the tissue(. In an embodiment, for example, the invention comprises an implantable or surface mounted biomedical device wherein the device component comprises one or more electrodes each independently having an active electrode area selected from the range of 1×10.sup.2 μm.sup.2 to 1×10.sup.6 μm.sup.2(Summary of the Invention, paragraph 42); electrical interconnects running along the length of the polymer fiber segment; solid-state devices disposed along the length of the polymer fiber segment or disposed along a distal portion of the polymer fiber segment in electrical communication with the electrical interconnects and configured to interact with the tissue; and a control module at a proximal end of the polymer fiber segment and connected to the electrical interconnects and the electrodes and configured to record the electrophysiology measurements and to control the solid-state devices(A “component” is used broadly to refer to an individual part of a device. An “interconnect” is one example of a component, and refers to an electrically conducting structure capable of establishing an electrical connection with another component or between components. In particular, an interconnect may establish electrical contact between components that are separate. Depending on the desired device specifications, operation, and application, an interconnect is made from a suitable material(Detailed Description of the Invention, paragraph 8). Combining μ-ILEDs with electronic sensors and actuators yields multifunctional integrated systems that can be configured in single or multilayer (e.g. stacked) formats. FIGS. 1B and C illustrate the latter option, in which the sensors/actuators include a Pt microelectrode for electrophysiological recording or electrical stimulation(Detailed Description of the Invention, paragraph 40). A wireless connector or wireless adapter may be used to interface with external controllers, thereby permitting the subject in which the device is implanted to be freely mobile and unconstrained by physical connection to external components. The active electronic components that interface with biological tissue may be positioned at a distal end of the device, such as at a tip end that is blunt (top panel), rounded (bottom panel), shaped to correspond to the geometry of a to-be-interfaced tissue, cells, or cell, or that is sharpened toward a point to facilitate deep-tissue insertion with minimal tissue damage(Detailed Description of the Invention, paragraph 143)). Rogers fails to explicitly disclose a multifunctional probe comprising a polymer fiber segment.
However, Jia teaches “A multifunctional fiber probe is provided for interfacing with tissue in the brain of a subject in need thereof, the multifunctional fiber probe having an elongated probe body having a probe end for insertion into the brain region of the subject and a proximal end opposite the probe end; a plurality of interfacing elements extending within the elongated fiber body from the proximal end to the probe end, and one or more sites on an exterior surface of the elongated fiber body operably coupled to an interfacing element in the plurality of interfacing elements to interface with the tissue, the one or more sites along the length of the fiber probe at a distance from the probe end to allow for the interfacing with the tissue to occur along the length of the fiber probe[0015]. The methods can include inserting a probe end of one or more multifunctional fiber probes described herein in or near the brain of the subject; and interfacing with the tissue at one or more of the sites along the length of the fiber probe. The interfacing can include one, two, three, or more of injecting a therapeutic, prophylactic, or diagnostic agent through a microfluidic channel and into the tissue at or near a site; applying an electrical stimulation through an electrode to the tissue at or near a site; detecting an electrical signal through an electrode in the tissue at or near a site; applying an optical stimulation through an optical waveguide to the tissue at or near a site; and detecting an optical signal through an optical waveguide in the tissue at or near a site[0089].FIG. 20 shows location of depth-dependent fiber probe implanted angularly to the brain surface for electrophysiological recording[0041]. In some aspects, one or more of the interfacing elements in the plurality of interfacing elements include a microfluidic channel having openings on the exterior surface of the fiber probe at sites along the length of the fiber probe; and the interfacing includes one or both of delivering a therapeutic, prophylactic, or diagnostic agent to the tissue at or near the sites and sampling the tissue at or near the sites[0064]”.
It would be obvious to one of ordinary skill of the art before the effective filing date to configure the optofluidic system of Rogers with the polymer fiber of the neural probes of Jia. Doing so would clarify the polymer fibers in the probe so the probe has the correct material composition to stretch and move and maintain integrity throughout usage.
Regarding claim 2, Rogers in view of Jia teaches the multifunctional fiber probe of claim 1, wherein the polymer fiber segment comprises at least one of polycarbonate (PC) or styrene-ethylene-butylene-styrene (SEBS)(Rogers - Polymers useable in the methods, devices and components include, but are not limited to, plastics, elastomers, thermoplastic elastomers, elastoplastics, thermoplastics and acrylates. Exemplary polymers include, but are not limited to, acetal polymers, biodegradable polymers, cellulosic polymers, fluoropolymers, nylons, polyacrylonitrile polymers, polyamide-imide polymers, polyimides, polyarylates, polybenzimidazole, polybutylene, polycarbonate, polyesters, polyetherimide, polyethylene, polyethylene copolymers and modified polyethylenes, polyketones, poly(methyl methacrylate), polymethylpentene, polyphenylene oxides and polyphenylene sulfides, polyphthalamide, polypropylene, polyurethanes, styrenic resins, sulfone-based resins, vinyl-based resins, rubber (including natural rubber, styrene-butadiene, polybutadiene, neoprene, ethylene-propylene, butyl, nitrile, silicones), acrylic, nylon, polycarbonate, polyester, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyolefin or any combinations of these(116)(Detailed Description of the Invention, paragraph 32)).
Regarding claim 3, Rogers in view if Jia teaches the multifunctional fiber probe of claim 1, wherein the polymer fiber segment has a Young's modulus of about 2.3 GPa to about 3.0 GPa(Rogers - In an embodiment, a high modulus layer has a Young's modulus greater than 100 MPa, optionally greater than 10 GPa, and optionally a Young's modulus selected from the range of 1 GPa to 100 Gpa(Detailed Description of the Invention, paragraph 39)).
Regarding claim 4, Rogers in view of Jia teaches the multifunctional fiber probe of claim 1, wherein the polymer fiber segment has a Young's modulus of about 5 MPa to about 30 MPa(Rogers - In an embodiment, a low modulus layer has a Young's modulus less than 100 MPa, optionally less than 10 MPa, and optionally a Young's modulus selected from the range of 0.1 MPa to 50 Mpa(Detailed Description of the Invention, paragraph 39)).
Regarding claim 5, Rogers in view of Jia teaches the multifunctional fiber probe of claim1, wherein the solid-state devices comprise light-emitting diodes configured to ontogenetically modulate tissue with pulses of green light and/or blue light(Rogers - In an embodiment, the invention provides an implantable or surface mounted biomedical device wherein the device component comprises one or more photodiodes, light emitting diodes, lasers, electrodes, piezoelectric elements, antennas, nanoelectromechanical (NEMS) devices, microelectromechanical (MEMS) devices, acoustic sources, micro- or nano-heaters, integrated electronic circuits, energy sources, chemical sources, biological sources or any combinations or arrays of these(Summary of the Invention, paragraph 37). A 200 μm, 0.48 NA diameter fiber optic coupled to a 465 nm blue LED (Plexon) or devices with four, 100×100×6.45 μm 450 nm blue μ-ILEDs are adjusted to have the same (˜280 μW) light output( Detailed Description of the Invention, paragraph 122)).
Regarding claim 6, Rogers in view of Jia teaches multifunctional fiber probe of claim 1, wherein the solid-state devices comprise temperature sensors configured to measure a temperature of the tissue around the distal portion of the polymer fiber segment(Rogers - This results in a multifunctional implantable or surface mounted biomedical device, where each layer can provide a different function. For example, a multifunctional device may electrically, optically and thermally interface with the target tissue. In this manner, one device may monitor both temperature and electrical potential and, as necessary, also control electrical potential and temperature(Summary of the Invention, paragraph 47)).
Regarding claim 7, Rogers in view of Jia teaches the multifunctional fiber probe of claim 1, wherein the control module comprises a wireless transceiver configured to receive commands from an external device and/or to transmit data to the external device(Rogers - A schematic illustration of a wireless control system for the device is depicted in FIG. 70. The wireless control system is based on serial communication using an infrared (IR) LED in the transmitter and an IR detector in the receiver. The transmitter consists of nine buttons to control four individual micro-heaters, to operate micro-LED in four different mode (5, 10, 20, 40 Hz frequency with 10 ms pulse width), and to activate the power save mode. When the user presses a button, the micro-controller in the transmitter send out a corresponding command signal (ASCII code) and the modulated information is transmitted with a 38 kHz carrier frequency signal using IR light(Detailed Description of the Invention, paragraph 440)).
Regarding claim 8, Rogers in view of Jia teaches the multifunctional fiber probe of claim 1, further comprising: a stretchable interconnect connecting the proximal end of the polymer fiber segment to the control module(Rogers - FIGS. 44-47 illustrate a potential separation of cable in a proximal location of the device toward the head/circuit board. The device cable appears to have separated at the final joint to the circuit board. FIG. 47 summarizes good electrical connection for the portion of the device that is at and near the distal end of the device that interfaces with the tissue and electrical disconnection at a proximal end far from the interfacing portion and toward the head(Detailed Description of the Invention, paragraph 148). FIG. 48 is a table summary summarizing modifications made to address the disconnection of the device illustrated in FIGS. 44-47. Any one or more of the following may be employed to improve device functionality and prevent unwanted disconnection: (1) substrate composition (thin PET layer (less than 10 μm or about 6 μm) and PDMS) and/or geometry/length; (2) Interconnection to a serpentine configuration to accommodate device stretching, folding, and/or bending; (3) decrease in total device length; (4) decrease in thickness(Detailed Description of the Invention, paragraph 149)).
Regarding claim 10, Rogers in view of Jia teaches the multifunctional fiber probe of claim 8,wherein the polymer fiber segment and at least a part of stretchable interconnect are configured to be implanted in the tissue(Rogers - To provide good flexibility or stretchability, at least one of the inorganic semiconductor components or one or more metallic conductor components is optionally a flexible or a stretchable structure. The flexible or stretchable structure may be an interconnect that connects island structures, such as island structures that tend to be relatively less stretchable or flexible. In this manner, the interconnects may accommodate stresses and strains associated with stretching or flexing(Summary of the Invention, paragraph 56). As an example of the utility of the present invention, stretchable devices were implanted into an animal model for optogenetic control of the sciatic nervous system in a freely moving animal(Detailed Description of the Invention, paragraph 451)).
Allowable Subject Matter
Claims 9 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796