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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 1 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In regards to claim 1, the limitations located in lines 2 and 3 of “a ground electrode located on a first side of optic nerve damage” and “a stimulation electrode located on a second side of the optic nerve damage” require the human body, specifically an optic nerve.
Examiner suggests amending the claim such that it clearly recites a functional limitation by stating the electrode is adapted or configured to be located on a first side of optic nerve damage or a second side of the optic nerve damage.
Claim Rejections - 35 USC § 103
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 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 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barriga-Rivera et al. (hereinafter ‘Barriga-Rivera’, U.S. PGPub No. 2019/0232052) in view of Gefen et al. (hereinafter ‘Gefen’, U.S. PGPub No. 2014/0143559).
In regards to claim 1, note that examiner is interpreting the claim limitations “located on a first side of optic nerve damage” and “located on a second side of optic nerve damage” as functional limitations (see MPEP 2114Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)).
Barriga-Rivera discloses a retinal ganglion cell (RGC) stimulation system for an optic nerve ([0010]: "In an embodiment, the primary stimulating signal is applied at a proximal portion of a retinal ganglion cell. It may be applied at the soma or initial segment of the axon. In an embodiment, the step of affecting comprises providing a secondary stimulating signal to the retinal ganglion cells distal of the primary stimulating location."), the system comprising electrodes located at different sites for stimulation ([0041]: "The RGC axons tend to run approximately radially, converging to the optic disc to form the optic nerve. Placing the secondary stimulating electrodes at or near the optic disc or at or near the optic nerve is advantageous, as this is where all the axons converge. The neural responses elicited by the primary stimulus may therefore be precisely affected by secondary stimulating electrodes positioned at these sites.", [0044]: "FIG. 4 shows a further example of an embodiment of an electrode configuration. A primary group of electrodes (403 active, 405 inactive) are arranged in a hexagonal mosaic configuration. The secondary group of electrodes 409 are arranged as a cuff about the optic nerve 407.", Fig. 4), a voltage or current source connected to both the ground electrode and the stimulation electrode and configured to stimulate the stimulation electrode with an electrical waveform having a first voltage and a first current ([0037]: "After processing, a series of stimulating waveforms are delivered through the plurality of stimulating sources 112 (current sources in this embodiment) to two groups of stimulating electrodes 114, 116."), and a controller connected to the voltage or current source and controlling the first voltage and the first current of the electrical waveform ([0037]: "The processor 106 acquires, digitises and processes a series of frames and stores these in the memory unit 108. After processing, a series of stimulating waveforms are delivered through the plurality of stimulating sources 112 (current sources in this embodiment) to two groups of stimulating electrodes 114, 116.").
Furthermore, while Barriga-Rivera discloses an electrode array in a monopolar, bipolar, or multipolar configuration ([0051]: “In a monopolar configuration, the return electrode, generally of larger size than the stimulating electrodes, is placed far from the active electrodes.”) which typically use a ground electrode that is placed away from active electrodes, Barriga-Rivera does not disclose a ground electrode configured to be on a first side of optic nerve damage.
However, Gefen teaches placing a ground electrode on the side of an optic nerve ([0247]: "In its closed state, switch 36M4 connects electrode 434 to a local, human body, ground electrode 436. By way of example, ground electrode 436 is assumed to be connected to the outside of the optic nerve, which acts as a local ground."). Thus, placing it anywhere on the body to act as a local ground is a matter of design choice (the position of the electrodes is a simple rearrangement of parts that is taught by Gefen, and that is not significant enough to alter the operation of the device beyond what is presented in Barriga-Rivera/Gefen combination, see 2144.04 (VI)C, In re Japiske) since a ground electrode may be connected to any convenient location on the body that may act as a local ground ([0247]: "However, electrode 436 may be connected to any other convenient location which is able to act as a local human body ground.").
In regards to claim 24, Barriga-Rivera discloses a method of retinal ganglion cell (RGC) stimulation for an optic nerve ([0010]: "In an embodiment, the primary stimulating signal is applied at a proximal portion of a retinal ganglion cell. It may be applied at the soma or initial segment of the axon. In an embodiment, the step of affecting comprises providing a secondary stimulating signal to the retinal ganglion cells distal of the primary stimulating location."), providing a voltage or current source connected to the electrodes and configured to stimulate the electrodes with an electrical waveform having a first voltage and a first current ([0037]: "After processing, a series of stimulating waveforms are delivered through the plurality of stimulating sources 112 (current sources in this embodiment) to two groups of stimulating electrodes 114, 116."), and controlling by a controller connected to the voltage or current source, the first voltage and the first current of the electrical waveform to generate a waveform, wherein the first voltage changes over time ([0019]: "In an embodiment, the time periods of the primary and the secondary stimulating signals may be varied to vary stimulation. Further, a time period between application of the primary stimulation signal and secondary stimulation signal may be varied.").
Furthermore, while Barriga-Rivera discloses an electrode array in a monopolar, bipolar, or multipolar configuration ([0051]: “In a monopolar configuration, the return electrode, generally of larger size than the stimulating electrodes, is placed far from the active electrodes.”) which typically use a ground electrode that is placed away from active electrodes, Barriga-Rivera does not disclose a ground electrode configured to be on a first side of optic nerve damage.
However, Gefen teaches placing a ground electrode on the side of an optic nerve ([0247]: "In its closed state, switch 36M4 connects electrode 434 to a local, human body, ground electrode 436. By way of example, ground electrode 436 is assumed to be connected to the outside of the optic nerve, which acts as a local ground."). Thus, placing it anywhere on the body to act as a local ground is a matter of design choice (the position of the electrodes is a simple rearrangement of parts that is taught by Gefen, and that is not significant enough to alter the operation of the device beyond what is presented in Barriga-Rivera/Gefen combination, see 2144.04 (VI)C, In re Japiske) since a ground electrode may be connected to any convenient location on the body that may act as a local ground ([0247]: "However, electrode 436 may be connected to any other convenient location which is able to act as a local human body ground.").
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barriga-Rivera in view of Gefen and in further view of Peyman (U.S. PGPub No. 2007/0237797).
In regards to claim 2, Barriga-Rivera/Gefen combination discloses the invention substantially as described above in claim 1.
However, Barriga-Rivera/Gefen combination does not disclose that the first side of the optic nerve damage comprises an area behind an eye and the second side of the optic nerve damage comprises an area proximate to a frontal lobe of a brain or a temporal lobe of the brain.
Peyman teaches that an electrode could be configured to be located on a first side of the optic nerve damage which comprises an area behind an eye and a second side of the optic nerve damage which comprises an area proximate to a frontal lobe of a brain or a temporal lobe of the brain ([0061]: "An electrode of opposite polarity (cathode and/or anode) is inserted at a site opposite the device. For example, one electrode may be located on a contact lens inserted in the eye, and the other electrode may be positioned at the area of the occipital lobe, the visual processing center of the brain located at the back of the skull."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the stimulation system to use an electrode system with one grounding electrode on one side of optic nerve damage and a stimulating electrode on another side of optic nerve damage, as taught by Peyman, as doing so would provide full stimulation coverage of the optic nerve and associated nerve structures for therapy, such as the occipital lobe ([0061]: “"For example, one electrode may be located on a contact lens inserted in the eye, and the other electrode may be positioned at the area of the occipital lobe, the visual processing center of the brain located at the back of the skull.").
In regards to claim 3, Barriga-Rivera/Gefen combination discloses the invention substantially as described above in claim 1.
However, Barriga-Rivera/Gefen combination does not disclose that the first side of the optic nerve damage comprises an area behind an eye and the second side of the optic nerve damage comprises an area proximate to a frontal lobe of a brain or a temporal lobe of the brain.
Peyman teaches that an electrode could be configured to be located on a first side of the optic nerve damage which comprises an area in front of an eye and a second side of the optic nerve damage which comprises an area proximate to an occipital lobe of a brain of the brain ([0061]: "An electrode of opposite polarity (cathode and/or anode) is inserted at a site opposite the device. For example, one electrode may be located on a contact lens inserted in the eye, and the other electrode may be positioned at the area of the occipital lobe, the visual processing center of the brain located at the back of the skull."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the stimulation system to use an electrode system with one grounding electrode on one side of optic nerve damage and a stimulating electrode on another side of optic nerve damage, as taught by Peyman, as doing so would provide full stimulation coverage of the optic nerve and associated nerve structures for therapy, such as the occipital lobe ([0061]: “"For example, one electrode may be located on a contact lens inserted in the eye, and the other electrode may be positioned at the area of the occipital lobe, the visual processing center of the brain located at the back of the skull.").
In regards to claim 4, Barriga-Rivera/Gefen combination discloses the invention substantially as described above in claim 1.
However, Barriga-Rivera/Gefen combination does not disclose that the first side of the optic nerve damage comprises an area behind an eye and the second side of the optic nerve damage comprises an area proximate to a frontal lobe of a brain or a temporal lobe of the brain.
Peyman teaches that an electrode could be configured to be located on a first side of the optic nerve damage which comprises an area in front of an eye and a second side of the optic nerve damage which comprises an area proximate to or within a nasal cavity ([0061]: "An electrode of opposite polarity (cathode and/or anode) is inserted at a site opposite the device. For example, one electrode may be located on a contact lens inserted in the eye, and the other electrode may be positioned at the area of the occipital lobe, the visual processing center of the brain located at the back of the skull."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the stimulation system to use an electrode system with one grounding electrode on one side of optic nerve damage and a stimulating electrode on another side of optic nerve damage, as taught by Peyman, as doing so would provide full stimulation coverage of the optic nerve and associated nerve structures for therapy, such as the occipital lobe ([0061]: “"For example, one electrode may be located on a contact lens inserted in the eye, and the other electrode may be positioned at the area of the occipital lobe, the visual processing center of the brain located at the back of the skull.").
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barriga-Rivera in view of Gefen and in further view of Duong et al. (hereinafter ‘Duong’, U.S. PGPub No. 2020/0299628).
In regards to claim 6, Barriga-Rivera/Gefen combination discloses the invention substantially as described in claim 1.
However, Barriga-Rivera/Gefen combination does not disclose a molecular scaffold located at the optic nerve damage.
Duong teaches use of molecular scaffold at sites of nerve damage to promote damage prevention and nerve regrowth ([0067]: "The present disclosure is contemplated for use in nerve replacements designed to stop or reverse nerve damage. For example, by employing the self-healing microgel particle scaffold 14 in the bioreactor 10 of FIG. 3, neural structures can be printed with unprecedented versatility and fidelity."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the stimulation system to use molecular scaffolds, as taught by Duong, as doing so would promote nerve regrowth and lessen or prevent damage which would aid the stimulation’s purpose ([0067]: "The scaffold enables pre-defined nerve shapes to be seeded in arbitrary geometries (length, diameter, bifurcations, and axonal microstructuring) that are tailored in real-time to particular maladies or neural regeneration needs. The scaffold further enables the pre-defined nerve shapes to be seeded with cell mimicking polymer microgels (CMPMs) that present growth factors, which encourage specific neural growth rates and spatial orientation.").
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barriga-Rivera in view of Gefen and in further view of Kauper et al. (hereinafter ‘Kauper’, U.S. PGPub No. 20150073381).
In regards to claim 8, Barriga-Rivera/Gefen combination discloses the invention substantially as described in claim 1.
However, Barriga-Rivera/Gefen combination does not disclose a Ciliary neurotrophic factor (CTNF) containing implant placed proximate to the optic nerve damage.
Kauper teaches using a Ciliary neurotrophic factor implant to promote nerve regrowth ([0154]: "As used herein, a "biologically active molecule" ("BAM") is any substance that is capable of exerting a biologically useful effect upon the body of an individual in whom a device is implanted.", "In various embodiments, such molecules can include, but are not limited to, C3a inhibitors, C3b inhibitors, other agents targeting and inhibiting or modulating immunologic pathway molecules, brain derived neurotrophic factor (BDNF), NT-4, ciliary neurotrophic factor (CNTF)..."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the stimulation system to use a CTNF implant, as taught by Kauper, as doing so would promote nerve regrowth and lessen or prevent damage which would aid the stimulation’s purpose ([0154]: "BAMs may include immunologic factors or targets, growth factor inhibitors, soluble receptors, anti-angiogenic antibodies and molecules, anti-angiogenic antibody scaffolds, cytokine, growth factors, neurotrophic factors, angiogenic factors, neurotransmitters, hormones, enzymes, anti-inflammatory factors, therapeutic proteins, gene transfer vectors, antibodies and antibody fragments, antigens, peptides, and any combination thereof.").
Claim(s) 11, 18-19, 21, 23, 25-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barriga-Rivera in view of Gefen and in further view of Oldham (U.S. PGPub No. 20020016617).
In regards to claim 11, Barriga-Rivera/Gefen combination discloses the invention substantially as described in claim 1.
However, Barriga-Rivera/Gefen combination does not disclose that the electrical waveform is an asymmetric charge balanced biphasic waveform configured to promote neuronal regeneration of a retinal ganglion cell axon, wherein the first voltage changes over time.
Oldham teaches that asymmetric biphasic waveforms with a changing voltage are known in the art (See [0007], claim limitation is known in the art [0007]: "The shape of individual pulses may be for example symmetric biphasic pulses (for example a positive going square wave immediately followed by a negative going square wave of equal amplitude and width) or asymmetric biphasic (for example a positive going square wave immediately followed by a negative going exponentially decaying waveform...Thus using the term "pulse" to signify a single electrical stimulation event in which an applied electrical voltage or current changes from a steady state baseline, each pulse generally consisting of both a single positive going phase and a single negative going phase, using the term "waveform" to represent the shape of an individual pulse, and using the term "wavetrain" to describe a series of pulses, the clinician can determine the amplitude and width of individual pulses, the waveform of individual pulses, the frequency of pulses within a single wavetrain and the duration of and spacing between successive wavetrains."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the stimulation system to use an electrical waveform is an asymmetric charge balanced biphasic waveform, as taught by Oldham, as doing so is commonly known in the art ([0007]: "Clinicians want this freedom because the effectiveness of one wavetrain pattern as compared to another is unknown and therefore clinicians tend to proceed on the basis of trial and error.").
In regards to claims 18-19 and 21, Barriga-Rivera/Gefen combination discloses the invention substantially as described in claim 1.
However, Barriga-Rivera/Gefen combination does not disclose the electrical waveform comprises both positive pulses and negative pulses relative to a ground potential of the ground electrode wherein the positive pulses have greater amplitude and shorter duration and the negative pulses have lower amplitude and longer duration (or vice versa), or the same length and amplitude.
Oldham teaches delivering an electrical waveform stimulus with a positive and negative portion which can have varied pulse lengths and amplitudes, including longer or shorter positive or negative pulse lengths and amplitudes ([0042]: "As described in greater detail below, the amplitude of the positive going portion 9 of the waveform can be varied by the patient, for example between zero and 90 mA, the width of the pulse portion 9 can be varied by the clinician, for example between 50 ms and 350 ms, and the system is set up such that the area of the negative pulse portion 10 is substantially equal to the area of the positive pulse portion 9 with each of the areas being limited to a maximum of for example 50."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the stimulation system to use waveforms with varying parameters of the positive and negative pulses, as taught by Oldham, as doing so is well known in the art and provides enhanced flexibility for treatment options ([0007]: "Clinicians want this freedom because the effectiveness of one wavetrain pattern as compared to another is unknown and therefore clinicians tend to proceed on the basis of trial and error.").
In regards to claim 23, Barriga-Rivera/Gefen combination discloses the invention substantially as described in claim 1.
However, Barriga-Rivera/Gefen combination does not disclose that the electrical waveform is an asymmetric charge balanced biphasic waveform configured to promote neuronal regeneration of a retinal ganglion cell axon, wherein the first voltage changes over time.
Oldham teaches that asymmetric biphasic waveforms with a changing voltage are known in the art (See [0007], claim limitation is known in the art [0007]: "The shape of individual pulses may be for example symmetric biphasic pulses (for example a positive going square wave immediately followed by a negative going square wave of equal amplitude and width) or asymmetric biphasic (for example a positive going square wave immediately followed by a negative going exponentially decaying waveform...Thus using the term "pulse" to signify a single electrical stimulation event in which an applied electrical voltage or current changes from a steady state baseline, each pulse generally consisting of both a single positive going phase and a single negative going phase, using the term "waveform" to represent the shape of an individual pulse, and using the term "wavetrain" to describe a series of pulses, the clinician can determine the amplitude and width of individual pulses, the waveform of individual pulses, the frequency of pulses within a single wavetrain and the duration of and spacing between successive wavetrains."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the stimulation system to use an electrical waveform is an asymmetric charge balanced biphasic waveform, as taught by Oldham, as doing so is commonly known in the art ([0007]: "Clinicians want this freedom because the effectiveness of one wavetrain pattern as compared to another is unknown and therefore clinicians tend to proceed on the basis of trial and error.").
In regards to claim 25, Barriga-Rivera/Gefen combination discloses the invention substantially as described in claim 24.
However, Barriga-Rivera/Gefen combination does not disclose that the electrical waveform is an asymmetric charge balanced biphasic waveform configured to promote neuronal regeneration of a retinal ganglion cell axon, wherein the first voltage changes over time.
Oldham teaches that the waveform generating both positive pulses and negative pulses relative to a ground potential of the ground electrode are known in the art (See [0007], claim limitation is known in the art [0007]: "The shape of individual pulses may be for example symmetric biphasic pulses (for example a positive going square wave immediately followed by a negative going square wave of equal amplitude and width) or asymmetric biphasic (for example a positive going square wave immediately followed by a negative going exponentially decaying waveform...Thus using the term "pulse" to signify a single electrical stimulation event in which an applied electrical voltage or current changes from a steady state baseline, each pulse generally consisting of both a single positive going phase and a single negative going phase, using the term "waveform" to represent the shape of an individual pulse, and using the term "wavetrain" to describe a series of pulses, the clinician can determine the amplitude and width of individual pulses, the waveform of individual pulses, the frequency of pulses within a single wavetrain and the duration of and spacing between successive wavetrains."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the stimulation system to use an electrical waveform is an asymmetric charge balanced biphasic waveform, as taught by Oldham, as doing so is commonly known in the art ([0007]: "Clinicians want this freedom because the effectiveness of one wavetrain pattern as compared to another is unknown and therefore clinicians tend to proceed on the basis of trial and error."). Furthermore, neuronal regeneration and charge balancing of the positive and negative pulses would be an obvious result and intended use of the stimulation.
In regards to claims 26-28, Barriga-Rivera/Gefen combination discloses the invention substantially as described in claim 24.
However, Barriga-Rivera/Gefen combination does not disclose the electrical waveform comprises both positive pulses and negative pulses relative to a ground potential of the ground electrode wherein the positive pulses have greater amplitude and shorter duration and the negative pulses have lower amplitude and longer duration (or vice versa), or the same length and amplitude.
Oldham teaches delivering an electrical waveform stimulus with a positive and negative portion which can have varied pulse lengths and amplitudes, including longer or shorter positive or negative pulse lengths and amplitudes ([0042]: "As described in greater detail below, the amplitude of the positive going portion 9 of the waveform can be varied by the patient, for example between zero and 90 mA, the width of the pulse portion 9 can be varied by the clinician, for example between 50 ms and 350 ms, and the system is set up such that the area of the negative pulse portion 10 is substantially equal to the area of the positive pulse portion 9 with each of the areas being limited to a maximum of for example 50."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the stimulation system to use waveforms with varying parameters of the positive and negative pulses, as taught by Oldham, as doing so is well known in the art and provides enhanced flexibility for treatment options ([0007]: "Clinicians want this freedom because the effectiveness of one wavetrain pattern as compared to another is unknown and therefore clinicians tend to proceed on the basis of trial and error."). Furthermore, neuronal regeneration and charge balancing of the positive and negative or asymmetrical or symmetrical pulses would be an obvious result and intended use of the stimulation.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable Barriga-Rivera in view of Gefen and in further view of Durand et al. (hereinafter ‘Durand’, U.S. PGPub No. 2018/0110989).
In regards to claim 17, Barriga-Rivera/Gefen combination discloses that the ground electrode and the stimulation electrode are selected from a group consisting of: (i) the ground electrode and the stimulation electrode are both platinum, (ii) the ground electrode and the stimulation electrode are both tungsten, and (iii) the ground electrode is tungsten and the stimulation electrode is platinum.
However, Barriga-Rivera/Gefen combination does not disclose that the electrodes are made up of tungsten, platinum, or a combination of either.
Durand teaches electrodes for use in nerve damage systems which are mad up of tungsten, platinum, and other conductive materials that are well-known in the art ([0038]: " Additionally, the conductive wire can be made of one or more materials capable of conducting a current therethrough. The one or more materials can be metallic or non-metallic. Examples of such materials can include platinum, iridium, gold, silver, tungsten, carbon, combinations, oxides, or the like."). Therefore, it would be obvious to one of ordinary skill in the art to use an electrode material that is conductive and not harmful to the site of stimulation.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barriga-Rivera in view of Gefen and in further view of Gefen et al. (hereinafter ‘Gefen 2017’, U.S. PGPub No. 2017/0224998).
In regards to claim 22, Barriga-Rivera/Gefen combination discloses the invention substantially as described in claim 1.
Barriga-Rivera further discloses that the stimulation electrode has a positive voltage relative to the ground electrode (see Fig. 8, [0050]).
However, Barriga-Rivera/Gefen combination does not disclose that the electrical waveform stimulates RGC axon growth toward an electrode of the ground electrode.
Gefen 2017 teaches an ocular medical device with electrodes that promotes growth of retinal ganglion cell axons towards the electrodes ([0016]: "Rough electrode surfaces and perforations passing through the electrodes allow neuronal processes to grow therethrough, further improving cell-electrode coupling and increasing stimulation.", [0175]: "As mentioned hereinabove, for some applications electrodes 64 are disposed in the layer of ganglion cells 12. In such applications, the axons of the ganglion cells grow through the perforations in electrode tips 70, increasing coupling between the neuronal processes and electrodes 64, and improving stimulation of the ganglion cell layer.", [0195]: "For some applications, metal ring 2020 functions as DC grounding for electrodes 1064."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the stimulation system stimulate RGC axon growth toward the electrodes, as taught by Gefen 2017, as doing so would increase contact of retinal tissue which enhances treatment of retinal tissue ([0016]: "Increased and direct contact of the retinal tissue by penetrating perforated electrodes enhances stimulation of the retina resulting in enhanced image resolution.").
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barriga-Rivera in view of Gefen and in further view of Gefen et al. (hereinafter ‘Gefen’, U.S. PGPub No. 2017/0224998).
In regards to claim 29, Barriga-Rivera/Gefen combination discloses the invention substantially as described in claim 24.
However, Barriga-Rivera/Gefen combination does not disclose that the voltage or current source further comprises providing an active circuit and the method of RGC stimulation further comprises increasing, by the active circuit, the first voltage between the ground electrode and the stimulation electrode and limiting, by the active circuit, the first current between the ground electrode and the stimulation electrode.
Siesbye teaches electrostimulation for wound care wherein the circuit may increase the voltage ([0020]: "The control module may be any circuit that can read analogue or digital inputs that encode voltage and/or current level values.", [0058]: "In an embodiment, the control module is further configured to increase the voltage outputted from the controlled voltage source from a first level to a second level.", [0059]) or limit the current ([0056]: "In an embodiment, the average current outputted from the controlled voltage source is limited to the range of 1 to 10 mA.") of the stimulation. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the stimulation system to increase the voltage or limit the current of stimulation, as taught by Siesbye, as doing so would allow for adjustment of voltage to induce required stimulation after voltage drops that may occur ([0011] - [0012]: "receive one or more measured voltage drops from the voltage measurement circuit, the voltage drop(s) being measured with the sense electrodes; and adjust the voltage outputted from the controlled voltage source, based on the measured voltage drop(s).") and to not further cause damage to the tissue undergoing therapy ([0057]: "Such a current is generally not tissue damaging and results in a current suitable for electrotherapy. The device may be limited to these output levels in order to mitigate applying harmful currents to wounds. The peak current levels may be greater than e.g. 10 mA.").
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barriga-Rivera in view of Oldham.
In regards to claim 30, Barriga-Rivera discloses a system for electric-field directed nerve stimulation comprising a first electrode, a second electrode ([0037]: "The primary group of electrodes 114 is placed in close proximity to the retinal neural cells and these will be used to deliver a series of primary stimulation waveforms which will recruit target retinal cells. These primary stimulation waveforms will electrically stimulate the RGCs to generate neural responses. The secondary group of electrodes 116 is distributed in the vicinity of the optic disc, where the axons of the RGC converge to form the optic nerve."), a voltage or current source connected to both the first electrode and the second electrode and configured to stimulate the first electrode with an electrical waveform having a first voltage and a first current, and a controller connected to the voltage or current source and controlling the first voltage and the first current of the electrical waveform ([0037]: "The processor 106 acquires, digitises and processes a series of frames and stores these in the memory unit 108. After processing, a series of stimulating waveforms are delivered through the plurality of stimulating sources 112 (current sources in this embodiment) to two groups of stimulating electrodes 114, 116.").
However, Barriga-Rivera does not disclose that the electrical waveform is an asymmetric cathodic-first charge balanced biphasic waveform.
Oldham teaches that asymmetric biphasic waveforms with a changing voltage are known in the art (See [0007], claim limitation is known in the art [0007]: "The shape of individual pulses may be for example symmetric biphasic pulses (for example a positive going square wave immediately followed by a negative going square wave of equal amplitude and width) or asymmetric biphasic (for example a positive going square wave immediately followed by a negative going exponentially decaying waveform...Thus using the term "pulse" to signify a single electrical stimulation event in which an applied electrical voltage or current changes from a steady state baseline, each pulse generally consisting of both a single positive going phase and a single negative going phase, using the term "waveform" to represent the shape of an individual pulse, and using the term "wavetrain" to describe a series of pulses, the clinician can determine the amplitude and width of individual pulses, the waveform of individual pulses, the frequency of pulses within a single wavetrain and the duration of and spacing between successive wavetrains."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the stimulation system to use an electrical waveform is an asymmetric charge balanced biphasic waveform, as taught by Oldham, as doing so is commonly known in the art ([0007]: "Clinicians want this freedom because the effectiveness of one wavetrain pattern as compared to another is unknown and therefore clinicians tend to proceed on the basis of trial and error.").
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN M LEE whose telephone number is (703)756-1789. The examiner can normally be reached 9:00 am - 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571)272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/B.M.L./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
Prosecution Insights