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 .
Priority
Claims 1-20 are deemed to have an effective filing date of August 15, 2023.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the processing arrangement, memory, transmitter, and battery unit of claim 12 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13 recites: a method of using an implantable bioelectronic device into a body of a subject of claim 1, but claim 1 is directed to an implantable bioelectronic device. Thus, “of claim 1” should follow “device”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. It is unclear from the originally-filed specification how the processing arrangement carries out the method of claim 13. In particular, the processing arrangement is for processing and analyzing recorded stimulation data and is part of the bioelectronic electronic device, and claim 13 recites steps of obtaining the implantable bioelectronic device, implanting a biological sample on top of the device, and implanting the device within a subject. The originally-filed specification on page 8, lines 24-25 states the claim language except that the specification refers to “the aforementioned method”.
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.
Claims 3, 6-7, 9-11, and 14 are 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.
In claim 3, “a first element” and “a second element” are inferentially included and it is unclear if the applicant is positively reciting or functionally reciting the element. It appears that Applicant’s intent may not be to positively recite the “first and second elements”; but, to functionally recited that the bioelectronic device is capable of connected a first element to a second element as dependent claim 11 recites “an electrically active cell” and “muscle tissue” as the elements, respectively. Please confirm.
Claim 6 recites the limitations "the first element" and "the second element" in line 3. There is insufficient antecedent basis for this limitation in the claim as claim 1 does not recited those elements.
In claim 9, “a flexible wafer” is inferentially included and it is unclear if the applicant is positively reciting or functionally reciting the element. If the element is being functionally recited, it is suggested to use functional terms such as “adapted to be” or “for”. If the element is being positively recited, it is suggested to first state the system includes the element before it is used in a connection in the claim. The scope of claim 9 is rendered indefinite as it is unclear of the base material comprises a polymer layer which is capable of being deposited on a silicon wafer, or, if the base comprises a polymer layer and a silicon wafer.
With respect to claim 10, the recitation of “such as human induced pluripotent stem cells” (lines 3) renders the claim indefinite because it is unclear whether those specific cells are required to meet the claim, or, if only an undifferentiated/immature biological cell type is sufficient (how the Examiner interprets the claim).
Claims 7 and 11 are rejected because they depend from an indefinite claim.
Claim 14, line 2, includes the connector “such that” that renders the phrase following the connector indefinite as “such” connotes “of the kind, character, degree” which does not mean that the phrase following the connector is required for the claim. The Examiner suggests the connector “so that”.
Claim 14 also recites “a bottom layer “ (line 2) and a “top layer” (lines 3-4). It is presumed that these layers are different form the top and bottom layers of claim 1.
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)(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.
Claims 1, 3, 5, 8, and 10-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Patent Application Publication No. 2023/0390461 to Crook et al. (EFD 10/19/2021; hereinafter referred to as “Crook”).
Regarding claim 1, Crook discloses an implantable bioelectronic device (e.g., title, Abstract, and paragraph [0116]), the implantable bioelectronic device comprising a base material (e.g., paragraph [0128]: e-nerve guide is wrapped around severed/damaged nerves) with a top layer and a bottom layer opposite the top layer (e.g., flexible substrate necessarily has a top layer and a bottom layer as shown in Fig. 11), the base material comprising at least one electrical component (e.g., Abstract: electrostimulatable 3D electrogel scaffold comprises piezoelectric nanoparticles; paragraphs [0105]: 3D electrogel precursor solution is formed into a predetermined pattern or layer; [0128]: electric nerve-guide comprises an outer base collagen membrane and an inner electro-gel coating; and [0130]-[0131]: the electro-gel of the invention acts as a protective conduit and an electroceutical device); and a biological sample seeded on the top layer of the base material (e.g., paragraphs [0108]-[0109]: following extrusion or bioprinting forming the predetermined pattern/layers, cells are seeded to result in a cell laden 3D electro-gel scaffold).
With respect to claim 3, Crook discloses the implantable bioelectronic device of claim 1, when in use in vivo, enables connecting a first element and a second element for restoration of an interrupted biological function between the first and second elements (e.g., paragraph [0128]: The e-nerve-guide is designed to be wrapped around and rejoin severed or severely damaged peripheral nerves, while concomitantly wirelessly-electrically-stimulating axonal growth for active nerve regeneration and repair as e-stimulation has of a damaged nerve, encourages axonal regeneration and function for nerve repair).
As to claim 4, Crook discloses the implantable bioelectronic device of claim 1, wherein the biological sample can be seeded on a hydrogel (e.g., paragraph [0008]: 3D electrogel scaffold comprises piezoelectric nanoparticles uniformly dispersed throughout a porous homongenous hydrogel polymer matrix) that includes at least one of: a fibrin hydrogel, a poly(ethylene glycol) (PEG) hydrogel, a poly(acrylic acid) (PAA) hydrogel, an alginate hydrogel, a chitosan hydrogel, a gelatin-based hydrogel (e.g., paragraph [0008]: the hydrogel polymer matrix is gelled and includes alginate and chitosan polymers).
With respect to claim 5, Crook discloses the implantable bioelectronic device of claim 1, wherein the base material includes at least one: Polyimide, elastomers, polydimethylsiloxane (PDMS), polyurethane, conductive silicone, polymers, poly(3,4-ethylenedioxythiophene) (PEDOT), polypyrrole, Carbon-based materials, graphene, Carbon nanotubes, organic semiconductors, pentacene, rubrene, biodegradable materials, polylactic acid (PLA), polycaprolactone (PCL), polyhydroxyalkanoates (PHA) (e.g., paragraph [0127], page 13, column 1: Fluorodishes containing the cell laden scaffolds are placed on the sonoporator probe with a polyurethane mount).
As to claim 8, Crook discloses the implantable bioelectronic device of claim 1, wherein the electrical component (e.g., nanoparticle) includes at least two electrical components (nanoparticles), and wherein the at least two electrical components are arranged in a symmetrical array occupying an area in a range of 1.0×1.0 millimetre to 10×10 millimetres within the base material (e.g., paragraph [0127]: Bioprinting - … electrogel is loaded into a printing cartridge and samples are extrusion printed into a square construct (6 mm x 6 mm)).
As to claim 10, Crook discloses the implantable bioelectronic device of claim 1, wherein the biological sample is selected from an undifferentiated biological cell type such as human induced pluripotent stem cells (iPSC) (e.g., paragraphs [0002], [0054]: human stem cells such as neural stem cells and induced pluripotent stem cells (iPSCs) have the ability to self-renew and make compelling candidates for cell replacement and tissue and organ engineering; and [0098]: 3D electrogel precursor solution include pluripotent stem cells).
With respect to claim 11, Crook discloses the implantable bioelectronic device of claim 3, wherein the first element is an electrically active cell and the second element is selected from an electrically active cell, muscle tissue and an electrical component (e.g., paragraph [0128] where both elements are electrically active cells of the severed nerve).
Claims 1, 4-5, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 9,283,386 to Park et al. (hereinafter referred to as Park).
Regarding claims 1 and 4-5, Park discloses an implantable bioelectronic device (e.g., title, Abstract), the implantable bioelectronic device comprising a base material (e.g., column 3, lines 62-67: flexible substrate including polyimide) with a top layer and a bottom layer opposite the top layer (e.g., substrate has a top layer 3 and a bottom layer 1 as shown in Fig. 1; column 6, line 60-63 and column 7, lines 12-13 the support layer of the substrate includes a hydrogel), the base material comprising at least one electrical component (e.g., Fig. 7, nanowires 21 in nanowire module 20; column 8, lines 1-8, Fig. 4, nanowires 524; column 10, lines 42-67); and a biological sample seeded on the top layer of the base material (e.g., column 7, lines 41-44: support layer 3 may include a brain-derived neurotrophic factor (BDNF) that promotes nerve regeneration) .
With respect to claim 9, Park discloses the implantable bioelectronic device of claim 1, wherein the base material (substrate 1,3) comprises a polymer layer, selected from a parylene derivative (e.g., column 6, line 63 to column 7, line 6: support layer may include a biocompatible thin or thick film such as parylene with the hydrophilic functional group), capable of being deposited on a flexible wafer (e.g., column 6, line 64 to column 7, line 1: biocompatible thin film or thick film may be stacked on a resin substrate) selected from a silicon, a glass, or polymers (e.g., column 9, lines 56-60: electrode including the nanowires where the base 531 is formed on a silicon wafer).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Crook as applied to claim 1 above, and further in view of US Patent Application Publication No. 2024/0342343 to Van Apeldoorn et al. (EFD 05/18/2022 and hereinafter referred to as “Apeldoorn”).
Crook discloses the implantable bioelectronic device of claim 1, wherein the base material is flexible to wrap around injured nerves (nervous system tissue) (e.g., paragraph [0128]), but does not expressly disclose that the base material has a Young's modulus measurement of stiffness no greater than 1 GPa. However, Apeldoorn, in a related art: microfabrication of polymer films for islet encapsulation teaches that the Young’s modulus of polymer thin films that are implanted into a rat has a Young’s modulus of less than 1GPa (1 Gigapascal = 1000 Megapascal) (e.g., paragraphs [0085]-[0086] and Fig. 2, E). Accordingly, one of ordinary skill in the art would have recognized the benefits of an implantable polymer film having a Young’s modulus of no greater than 1GPa in view of the teachings of Apeldoorn. Consequently, one of ordinary skill in the art would have modified the implantable bioelectronic device of Crook so that the base material of its bioelectronic device has a Young’s modulus of stiffness no greater than 1 GPa in view of the teachings of Apeldoorn that such was a known Young’s modulus of stiffness employed in implantable polymer films, and because the combination would have yielded a predictable result.
Claims 6-7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Crook as applied to claim 1, and further in view of US Patent No. 9,549,704 to Buerger et al. (hereinafter referred to as “Buerger”).
With respect to claim 6, Crook discloses the implantable bioelectronic device of claim 1, wherein the implantable bioelectronic device is configured to restore the interrupted biological function between the first element and the second element (e.g., paragraphs [0022] and [0120]-[0123]: method of repair and/or regeneration of tissue malfunction or injury using a stimulated 3D electrogel scaffold; [0112]-[0113]: to generate a piezoelectric response from the scaffold (stimulate cells), sufficient acoustic intensity is required and the response occurs when the intensity is greater than 0.8W/cm2; and [0128]); but does not expressly disclose that the implantable bioelectronic device is configured to record the restoration as stimulation data. However, Buerger, in a related art: implanted neural interfaces, teaches an artificial sensory that records neural responses from the subject in the form of electrical neural stimuli applied to the nervous system of the subject (stimulation data) (e.g., Buerger: column 2, lines 19-29; column 3, line 54 to column 4, line 14: sensors for sensing environmental attributes which have the capability for bidirectional communication of neural stimuli and neural responses between the nervous system of the subject and (optional) external communication system where the stimulating and recording nerve implant portion is powered by a battery). Accordingly, one of ordinary skill in the neural interfaces/implant art would have recognized the benefits of recording the neural responses to the electrical stimuli as stimulation data using sensors in view of the teachings of Buerger. Consequently, one of ordinary skill in the art would have modified the bioelectronic device of Crook to have a sensor that records the neural response to the electrical stimuli in view of the teachings of Buerger that such was a well-known engineering expedient in the implanted neural interface art, and because the combination would yielded a predictable result.
As to claim 7, Crook in view of Buerger teaches the implantable bioelectronic device of claim 6, wherein implantable bioelectronic device is configured to provide the electrical stimulation as a pulse of an activation threshold (e.g., Crook paragraph [0112]: preferred electrical stimulation step involves a set of ultrasound parameters optimized for the chosen cell and tissue type including ultrasound pulse design, pulse repetition frequency, and pulse duration) ranging from 10 to 200 microampere using a pre-defined duration pulse (e.g., column 6, lines 49-58 of Buerger: pulse shape parameters when a laboratory rat is the subject include 35 microamps and a pre-defined pulse as shown in Fig. 3). Accordingly, one of ordinary skill in the art would have recognized the benefits of the electrical stimulation pulse ranging from 10 to 200 microampere using a pre-defined duration pulse in view of the teachings of Buerger. Consequently, one of ordinary skill in the art would have modified the implantable bioelectronic device of Crook in view of Buerger to induce a stimulation pulse of 35 µA as such is a well-known stimulation pulse in the implanted neural interface arts as taught by Buerger, and because the combination would have yielded a predictable result.
With respect to claim 12, Crook discloses the implantable bioelectronic device of claim 1, but does not expressly disclose a processing arrangement for processing and analysing recorded stimulation data; a memory unit; a transmitter that is configured to translate the stimulation data, and a battery unit. However, Buerger, in a related art, teaches an electrode/sensor 240 for delivering neural stimulus and recording the neural response; a processing arrangement for processing and analyzing recorded stimulation data and including a memory unit 234, a transmitter 232 and communication link 228 that is configured to transmit the stimulation data and a battery unit 236 (e.g., Figure 2 and column 8, line 61 to column 7, line 5 and column 9, lines 21-25 of Buerger). Accordingly, one of ordinary skill in the art would have recognized the benefits of a processing arrangement for processing and analyzing recorded stimulation data, a memory unit, a transmitter that is configured to transmit the stimulation data, and a battery unit in view of the teachings of Buerger. Consequently, in order to transmit the recorded stimulation data to an external device as taught by Buerger, one of ordinary skill in the art would have modified the implantable bioelectronic device of Crook with a processing arrangement for processing and analyzing recorded stimulation data, a memory unit, a transmitter that is configured to transmit the stimulation data, and a battery unit as such were well-known engineering expedients for transmitting recorded stimulation data to an external device as taught by Buerger, and because the combination would have yielded a predictable result.
Claims 13-14, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Crook or Park as applied to claim 1 above, and further in view of US Patent Application Publication No. 2010/0098742 to Vacanti et al. (hereinafter referred to as “Vacanti”).
Referring to claim 13, Crook or Park discloses a method of using an implantable bioelectronic device [of claim 1] into a body of a subject, the method comprising performing an in vitro activity for cell culture on the implantable bioelectronic device, the in vitro activity comprising: obtaining the implantable bioelectronic device (see the rejections of claim 1 in paragraphs 11-12 above), and performing an in vivo activity comprising: implanting the implantable bioelectronic device with the biological sample thereon into the subject at a desired location, wherein the implantation of the implantable bioelectronic device enables connecting a first element and a second element for restoration of an interrupted biological function between the first and second elements (e.g., paragraph [0128] of Crook: The e-nerve-guide is designed to be wrapped around and rejoin severed or severely damaged peripheral nerves, while concomitantly wirelessly-electrically-stimulating axonal growth for active nerve regeneration and repair as e-stimulation has of a damaged nerve, encourages axonal regeneration and function for nerve repair; Park- Abstract: neural device including a nanowire and a support layer is inserted into nerves to obtain electrical signals or apply electrical signals; column 6, lines 63-66: support layer 3 is formed of biocompatible material in order to be inserted into a human body; column 7, lines 41-44: support layer includes a material promoting nerve regeneration; column 9, lines 21-23: base material includes a through hole through which a cross-section of a cut nerve fiber may be regenerated and recovered). The method of Crook or Park differs from the claimed invention in that they do not expressly disclose seeding a biological sample on top of the implantable bioelectronic device and allowing the biological sample to grow for a pre-defined time. However, Vacanti, in a related art: methods and materials for making complex living, vascularized tissues for organ and tissue replacement, teaches that a mold or polymer scaffold can be seeded with desired sets of cells and each cell layer is maintained in culture for a week or so in order to obtain population doubling (e.g., paragraphs [0134]-[0137] and [0139] of Vacanti). Accordingly, one of ordinary skill in the art would have recognized the benefits of adding cells to an implantable bioelectronic device and maintaining the seeded device in vitro for a pre-defined time in view of the teachings of Vacanti. Consequently, one of ordinary skill in the art would have modified the method of Crook or Park to provide an additional set of cells to the bioelectronic device before implanting the same in view of the teachings of Vacanti that such would allow the seeded cells to double in number, and because the combination would have yielded a predictable result.
With respect to claim 14, Crook or Park in view of Vacanti teaches the method of claim 13, wherein the method includes implanting the implantable bioelectronic device in the subject such that a bottom layer of the implantable bioelectronic device is laid against a first part of the subject's body and a top layer having the biological sample thereon faces an electrically active cell proximal to the first part of the subject's body (e.g., when a nerve of a subject is wrapped as taught by Crook – an inner layer would be facing an electrically active cell proximal to a first part of the body, which could be the a severed nerve and the device is laid against the nerve).
With respect to claim 17, Crook or Park in view of Vacanti teaches the method of claim 13, wherein the number of electrical components used is at least two, and wherein the at least two electrical components are arranged in a symmetrical array occupying an area in a range of 1.0×1.0 millimetre to 10×10 millimetre within the base material (e.g., Crook paragraph [0127]: Bioprinting - … electrogel is loaded into a printing cartridge and samples are extrusion printed into a square construct (6 mm x 6 mm); and Park – column 10, lines 42-47: Fig. 7 shows a patch type neural device including a nanowire module having a lattice form (symmetrical array) where the size of the patch would be obvious since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233]).
As to claim 19, Crook or Park in view of Vacanti teaches the method of claim 13, further comprising preparing the implantable bioelectronic device using at least one of: a photolithography technique, printing technique (e.g., Crook paragraph [0067]: 3D electrogel construct or scaffold is made from a bioprinting process; Park column 9, lines 56-60: electrode including the nanowires is made using a photolithography technique “base including the through-hole is formed in a silicon wafer through a photo mask and etching process), and a metal lift-off technique (not required as only 1 is necessary).
Claims 15-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Crook or Park in view of Vacanti as applied to claim 13 above, and further in view of Buerger.
With respect to claim 15, Crook or Park in view of Vacanti teaches the method of claim 13, does not expressly disclose recording a stimulation data, in vivo, by the implantable bioelectronic device. However, Buerger, in a related art: implanted neural interfaces, teaches an artificial sensory that records neural responses from the subject in the form of electrical neural stimuli applied to the nervous system of the subject (stimulation data) (e.g., Buerger: column 2, lines 19-29; column 3, line 54 to column 4, line 14: sensors for sensing environmental attributes which have the capability for bidirectional communication of neural stimuli and neural responses between the nervous system of the subject and (optional) external communication system where the stimulating and recording nerve implant portion is powered by a battery). Accordingly, one of ordinary skill in the neural interfaces/implant art would have recognized the benefits of recording the neural responses to the electrical stimuli as stimulation data using sensors in view of the teachings of Buerger. Consequently, one of ordinary skill in the art would have modified the method of Crook or Park in view of Vacanti to have a sensor/electrode that records the neural response to the electrical stimuli in view of the teachings of Buerger that such was a well-known engineering expedient in the implanted neural interface art, and because the combination would yielded a predictable result.
As to claim 16, Crook or Park in view of Vacanti teaches the method of claim 13, wherein the method further includes providing the electrical stimulation as a pulse of an activation threshold (e.g., Crook paragraph [0112]: preferred electrical stimulation step involves a set of ultrasound parameters optimized for the chosen cell and tissue type including ultrasound pulse design, pulse repetition frequency, and pulse duration; Park – column 3, lines 15-21: neural device applies electrical signals to nerve fibers), but does not expressly teach that the electrical stimulation is a pulse ranging from 10 to 200 microampere using a pre-defined duration pulse. However, Buerger, in a related art, teaches stimulation pulses having a pulse shape parameter when a laboratory rat is the subject that include 35 microamps and a pre-defined pulse duration as shown in Fig. 3 (e.g., column 6, lines 49-58 of Buerger). Accordingly, one of ordinary skill in the art would have recognized the benefits of the electrical stimulation pulse ranging from 10 to 200 microampere using a pre-defined duration pulse in view of the teachings of Buerger. Consequently, one of ordinary skill in the art would have modified the implantable bioelectronic device of Crook or Park in view of Vacanti to induce a stimulation pulse of 35 µA as such is a well-known stimulation pulse in the implanted neural interface arts as taught by Buerger, and because the combination would have yielded a predictable result.
With respect to claim 18, Crook or Park in view of Vacanti teaches the method of claim 13, but does not expressly teach processing and analysing, using a processing arrangement, recorded stimulation data; storing, in a memory unit, the recorded stimulation data; translating, using a transmitter, the recorded stimulation data, and powering, using a battery unit, the implantable bioelectronic device. However, Buerger, in a related art, teaches an electrode/sensor 240 for delivering neural stimulus and recording the neural response; processing and analyzing recorded stimulation data using a processing arrangement that a memory unit 234, a transmitter 232 and communication link 228 that is configured to transmit the stimulation data and a battery unit 236 to power the bioelectronic device (e.g., Figure 2 and column 8, line 61 to column 7, line 5 and column 9, lines 21-25 of Buerger). Accordingly, one of ordinary skill in the art would have recognized the benefits of a processing arrangement for processing and analyzing recorded stimulation data, a memory unit, a transmitter that is configured to transmit the stimulation data, and a battery unit in view of the teachings of Buerger. Consequently, in order to transmit the recorded stimulation data to an external device as taught by Buerger, one of ordinary skill in the art would have modified the implantable bioelectronic device of Crook or Park in view of Vacanti with a processing arrangement for processing and analyzing recorded stimulation data, a memory unit, a transmitter that is configured to transmit the stimulation data, and a battery unit as such were well-known engineering expedients for transmitting recorded stimulation data to an external device as taught by Buerger, and because the combination would have yielded a predictable result.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2018/0133457 to Yao et al. is directed to implantable electrodes comprising biocompatible hydrogels where the electrodes can take the form of mesh-like metal structures and the starting seed metal may be patterned with photolithography (e.g., paragraph [0036]).
US Patent Application Publication No. 2020/0261726 Oh et al. is directed to conductive polymer implant combining electrical and chemical stimulation to improve neural recovery where the neural implant 106 has a base material (polymer scaffold 108) comprises at least one electrical component (electrode) and a biological sample (stem cells 130) (e.g., abstract, paragraphs [0016], [0023]-[0024] and Fig. 1B).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792