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 .
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.
Drawings
The drawings are objected to because Fig. 14, uses the label “Cell well” and is not disclosed in the specification. 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
The use of the term AHMED ® valve, BAERVELDT ® shunt, and BLUETOOTH ® which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The term “Cell well” in Fig. 14 is not mentioned in the specification. Instead “microwell” is used.
Claim Objections
Claim 4 is objected to because of the following informalities:
Lines 1, and 2 “wherein the display is coupled to a retina of an eye the user” should read “wherein the display is coupled to the retina of the user’s eye”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 1-20 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.
Claim 1 recites the limitation "content" in line 1, and “the content” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying- online/eterminal-disclaimer.
Claim(s) 1, 2, 4, 7, 11, 12, 14, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 5, 12, 13, 18, and 20 of copending Application No. (18600364).
This is a provisional nonstatutory double patenting rejection.
Hodak et al. (18,740854)
Hodak et al. (18,600364)
1. A system, comprising:
a controller comprising:
a receiver configured to receive content; and
a processor configured to determine display instructions based on the content;
a sensor configured to measure a state of genetically modified cells in a user wherein the display instructions are adjusted based on the state; and
a display configured to be implanted in the user, the display comprising an array of μLEDs configured to emit light signals according to the adjusted display instructions, wherein the light signals are receivable by the genetically modified cells.
18. further comprising a connector comprising a plurality of electronic connections configured to transmit the display instructions from the controller to the display.
4. The system of claim 1, wherein the display is coupled to a retina of an eye the user, wherein the genetically modified cells comprise genetically modified cells in the retina.
1. A system, comprising:
a controller, wherein the controller is configured to couple to an outer surface of an eye of a user, the controller comprising:
a receiver configured to receive content from an external device; and
a processor configured to determine display instructions based on the content;
a connector comprising a plurality of electronic connections configured to transmit the display instructions from the controller to a display; and
the display, wherein the display is configured to couple to a retina of the user, the display comprising:
an array of μLEDs configured to emit light signals according to the display instructions, wherein the light signals are receivable by genetically modified cells in the retina.
18. wherein the system further comprises a sensor configured to be implanted in a user, wherein the display instructions are adjusted based on measurements from the sensor.
1. A system, comprising:
a controller comprising:
a receiver configured to receive content; and
a processor configured to determine display instructions based on the content;
a sensor configured to measure a state of genetically modified cells in a user wherein the display instructions are adjusted based on the state; and
a display configured to be implanted in the user, the display comprising an array of μLEDs configured to emit light signals according to the adjusted display instructions, wherein the light signals are receivable by the genetically modified cells.
2. wherein the state comprises one of: a current or a voltage.
20. wherein the sensor is configured to measure a cell state of native cells of the user, wherein the cell state comprises at least one of current or voltage, wherein the display instructions are adjusted based on the cell state.
11. wherein adjusting the display instructions comprises one of increasing or decreasing an intensity of a light signal emitted by a μLED of interest in the array of μLEDs based on the state.
5. wherein the display further comprises logic components, wherein the display instructions comprise μLED state change instructions.
1. A system, comprising:
a controller comprising:
a receiver configured to receive content; and
a processor configured to determine display instructions based on the content;
a sensor configured to measure a state of genetically modified cells in a user wherein the display instructions are adjusted based on the state; and
a display configured to be implanted in the user, the display comprising an array of μLEDs configured to emit light signals according to the adjusted display instructions, wherein the light signals are receivable by the genetically modified cells.
11. wherein adjusting the display instructions comprises one of increasing or decreasing an intensity of a light signal emitted by a μLED of interest in the array of μLEDs based on the state.
12. wherein the display instructions are adjusted based on the measurements of a cell of interest in the genetically modified cells, wherein adjusting the display instructions comprises one of increasing or decreasing an intensity of a light signal emitted by a μLED in the array of μLEDs, the μLED corresponding to the cell of interest.
14. wherein the genetically modified cells are transfected with a gene for a light-sensitive protein, wherein the genetically modified cells produce biochemical signals in response to receiving the light signals.
7. wherein the display further comprises a cell support configured to retain the genetically modified cells, wherein the array of μLEDs is coupled to the cell support.
12. wherein the state comprises a state of a set of cells in the genetically modified cells, wherein the μLED of interest is configured to emit light signals receivable by the set of cells.
1. A system, comprising:
a controller comprising:
a receiver configured to receive content; and
a processor configured to determine display instructions based on the content;
a sensor configured to measure a state of genetically modified cells in a user wherein the display instructions are adjusted based on the state; and
a display configured to be implanted in the user, the display comprising an array of μLEDs configured to emit light signals according to the adjusted display instructions, wherein the light signals are receivable by the genetically modified cells.
13. A system, comprising:
a cell support comprising a set of microwells configured to retain a set of cells transfected with a gene for a light-sensitive protein;
a μLED array coupled to the cell support, wherein the μLED array is configured to emit light signals based on display instructions, wherein the light signals are receivable by the set of cells;
a receiver configured to receive content from an external device; and
a processor configured to determine the display instructions based on the content.
Claims 1, 2, 4, 7, 11, 12, 14, and 18
Claims 1, 5, 12, 13, 18, and 20 of the reference application recites the same limitations as claims 1, 2, 4, 7, 11, 12, 14, and 18 of the instant application.
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.
Claims 1, 4-6, 14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg et al. (US 2011/0118807) in view of Degenaar et al. (US 2010/0152849), and further in view of Punkka et al. (US 2019/0192698).
Regarding, claim 1, Greenberg et al. discloses a system (see [0028] disclosing a multi-component retinal prosthesis system and its components), comprising:
a controller (see [0029] disclosing an electronics package (14) is integrated into a molded silicone body (18)), comprising:
a receiver configured to receive content (see [0029] disclosing the electronics package (14) is coupled to a secondary inductive coil (16) (made of wound wire traces), thereby serving as a telemetric receiver configured to wirelessly capture incoming power and external visual data frames sent across the orbital threshold); and
a processor (see [0041] disclosing the electronics package (14) having internal integrated circuits (e.g., flip-chip)) configured to determine display instructions based on the content (see [0029] disclosing the electronics package (14) with integrated circuits, thereby forming an embedded processing layer that extracts the content to calculate and encode the display instructions); and
a display (see [0028] disclosing the flexible circuit electrode array (10), which is the functional equivalent of a display that couples to the retina to deliver visual patterns) configured to be implanted in the user (see [0028] disclosing the flexible circuit electrode array (10) is affixed to a retinal tack directly onto the epiretinal surface (coupling to the retina)).
Greenberg et al. fails to disclose a sensor configured to measure a state of genetically modified cells in a user wherein the display instructions are adjusted based on the state; and the display comprising an array of μLEDs configured to emit light signals according to the adjusted display instructions, wherein the light signals are receivable by the genetically modified cells.
Degenaar et al. also discloses genetic modification of retinal ganglion cells (see [0012]), and gene encoding (see [0033]), and an array (26) of light sources (see [0025]). Degenaar et al. teaches the display comprising an array of μLEDs configured to emit light signals according to the adjusted display instructions (see [0025] disclosing an array (26) in the form of LED devices (28), to which the array of light sources can function as μLEDs, are turned on and off independently by instruction from the addressing chip (24)), wherein the light signals are receivable by the genetically modified cells (see [0033] disclosing the genetically modified neural cells induced to express light sensitive proteins (e.g., melanopsin) upon absorbing light).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s implantable retinal prosthesis, with the display comprising an array of μLEDs configured to emit light signals according to the adjusted display instructions, wherein the light signals are receivable by the genetically modified cells, as further taught by Degenaar et al. Doing so would provide a means to implant an array of μLEDs on the user, in order to emit light signals receivable by genetically modified cells according to adjusted display instructions (see [0025]).
Greenberg et al. as modified by Degenaar et al. fails to disclose a sensor configured to measure a state of genetically modified cells in a user wherein the display instructions are adjusted based on the state.
Punkka et al. also discloses genetically modified regenerative cells (see [0058]), and a display system (see Fig. 6). Pukka et al. teaches a sensor configured to measure a state of genetically modified cells in a user wherein the display instructions are adjusted based on the state (see [0058] disclosing the genetically modified regenerative cells act as a sensitive and vital biosensor becomes part of the host cells, thereby providing feedback in a user; Fig. 6 illustrating the display system consisting of a light sensor, processor and display).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s modified implantable retinal prosthesis, a sensor configured to measure a state of genetically modified cells in a user wherein the display instructions are adjusted based on the state, as further taught by Punkka et al. Doing so would provide a means to measure a state of genetically modified cells in a user, in order to adjust display instructions based on the measured state (see [0058]).
Regarding claims 4, and 5, Greenberg et al. further teaches wherein the display is coupled to a retina of an eye the user (see [0028] disclosing the retinal prosthesis, comprising a flexible circuit (1) and a flexible circuit electrode array (10) is coupled to the epiretinal surface of the eye).
Greenberg et al. as modified by Punkka et al. fails to disclose wherein the genetically modified cells comprise genetically modified cells in the retina, and wherein the genetically modified cells comprise retinal ganglion cells.
Degenaar et al. further teaches wherein the genetically modified cells comprise genetically modified cells in the retina (see [0033] disclosing the genetically modified light sensitive cells), and wherein the genetically modified cells comprise retinal ganglion cells (see [0034] disclosing genetically modified light sensitive retinal ganglion cells).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s modified implantable retinal prosthesis, wherein the genetically modified cells comprise genetically modified cells in the retina, and wherein the genetically modified cells comprise retinal ganglion cells, as further taught by Degenaar et al. Doing so would provide a means to measure a current or a voltage representing a state of genetically modified cells in the retina comprising retinal ganglion cells, in order to adjust display instructions based on the measured state (see [0034]).
Regarding claim 6, Greenberg et al. further teaches wherein: the controller is configured to couple to an outer surface of the eye of the user (see [0032] disclosing the implant coupled to and supported by the sclera (outer surface of the eye).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s modified implantable retinal prosthesis, wherein: the controller is configured to couple to an outer surface of the eye of the user, as further taught by Greenberg et al. Doing so would provide a means couple a hermetic electronics package controller to a strap surrounding the sclera on the outer surface of the eye, in order to provide closed-loop control and adjust display instructions for retinal stimulation (see [0032]).
Regarding claim 14, Degenaar et al. teaches wherein the genetically modified cells are transfected with a gene for a light-sensitive protein (see [0033] disclosing the specific protein melanopsin), wherein the genetically modified cells produce biochemical signals in response to receiving the light signals (see [0033] disclosing the biochemical signal G-protein type cascade produced by the genetically modified cells).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s modified implantable retinal prosthesis, wherein the genetically modified cells are transfected with a gene for a light-sensitive protein, wherein the genetically modified cells produce biochemical signals in response to receiving the light signals, as further taught by Degenaar et al. Doing so would provide a means to measure a current of a voltage representing a state of genetically modified cells that are transfected with a gene for a light-sensitive protein, in order to enable the genetically modified cells to produce biochemical signals in response to receiving the light signals (see [0033]).
Regarding claim 16, Degenaar et al. further teaches wherein each μLED in the array of μLEDs is configured to emit a light signal receivable by less than 20 of the genetically modified cells (see [0026] disclosing the light beams (32) can be focused so that each of them covers a localized area on the retina with a diameter of 50 to 200 micrometers, thereby confining each light signal to a small spatial footprint, requiring the light from each μLED to be restricted to a small receptive area containing a limited number
of retinal cells (e.g., 20)).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective
filing date of the claimed invention to have provided Greenberg et al.’s modified display, wherein each μLED in the array of μLEDs is configured to emit a light signal receivable by less than 20 of the genetically modified cells, as further taught by Degenaar et al. Doing so would provide a means to measure a current or a voltage representing a state of genetically modified cells, in order to configure each μLED in the array of μLED to emit a light signal receivable by less than 20 of the genetically modified cells (see [0026]).
Regarding claim 17, Degenaar et al. further teaches wherein: the display instructions comprise a timeseries of light array patterns (see [0031] disclosing an algorithm operating on the basis of the scanning speed of the Led array, in order to control the time intervals when LEDs are turned on and off), wherein: each light array pattern comprises light intensity parameters (see [0015] disclosing the control means determine light beam time-dependent intensities), wherein: each light array pattern encodes a frame of the content (see [0015] disclosing the control means arranged to determine light intensities are based on the captured image).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective
filing date of the claimed invention to have provided Greenberg et al.’s modified display, wherein the
display instructions comprise a timeseries of light array patterns, wherein each light array pattern
comprises light intensity parameters, wherein each light array pattern encodes a frame of the content,
as further taught by Degenaar et al. Doing so would provide a means to transmit display instructions
from a controller to a retinal display, in order to emit a time series of light array patterns where each light array pattern comprises light intensity parameters that encode a frame of the content (see [0015]).
Regarding claim 18, Greenberg et al. further teaches further comprising a connector comprising a plurality of electronic connections configured to transmit the display instructions from the controller to the display (see [0028] disclosing a flexible circuit cable (12), which functions as the connector that pierces the eye wall to transmit stimulation signals from the outer scleral controller package into the inner eye).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective
filing date of the claimed invention to have provided Greenberg et al.’s modified display, further comprising a connector comprising a plurality of electronic connections configured to transmit the display instructions from the controller to the display, as further taught by Greenberg et al. Doing so would provide a means to measure a current or a voltage representing a state of genetically modified cells, in order to comprise a connector comprising a plurality of electronic connections configured to transmit the display instructions from the controller to the display (see [0028]).
Claims 2, and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg et al. (US 2011/0118807) in view of Degenaar et al. (US 2010/0152849), in view of Punkka et al. (US 2019/0192698) as applied to claim 1 above, and further in view of Bartlett et al. (US 2023/0191130).
Regarding claim 2, Greenberg et al. in view of Degenaar et al., and Punkka et al., fails to disclose wherein: the state comprises one of: a current or a voltage.
Bartlett et al. also discloses a system (100) with a recording amplifier (104), and a processor (106) (see [0037]). Bartlett et al. teaches wherein the state comprises one of: a current or a voltage (see [0067] disclosing voltage waveform recordings).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s modified implantable retinal prosthesis, wherein: the state comprises one of: a current or a voltage, as further taught by Bartlett et al. Doing so would provide a means to measure a current or a voltage representing a state of genetically modified cells, in order to adjust display instructions based on the measured state (see [0067]).
Regarding claim 3, Bartlett et al. further teaches wherein the sensor comprises a set of electrodes (see [0048] disclosing the use of electrodes).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s modified implantable retinal prosthesis, wherein the sensor comprises a set of electrodes, as further taught by Bartlett et al. Doing so would provide a means to utilize a set of electrodes to record individual or network neuron activity and local field potentials, in order to monitor the nervous system and measure neural dynamics for closed-loop neuromodulation (see [0048]).
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg et al. (US 2011/0118807) in view of Degenaar et al. (US 2010/0152849), in view of Punkka et al. (US 2019/0192698) as applied to claim 1 above, in view of Sofman et al. (US 2020/0292944), and further in view of Cullen et al. (US 2019/0126043).
Regarding claim 7, Greenberg et al. in view of Degenaar et al., and Punkka et al., fails to disclose wherein: the display further comprises a cell support configured to retain the genetically modified cells, wherein the array of μLEDs is coupled to the cell support.
Sofman et al. also discloses a customizable hydrogel with microwells and microchannels (see [0014)). Sofman et al. teaches wherein the display further comprises a cell support configured to retain the genetically modified cells (see [0016] disclosing the array of microwells used to retain cells for
cell culturing (e.g., genetically modified cells).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s modified implantable retinal prosthesis, wherein: the display further comprises a cell support configured to retain the genetically modified cells, as further taught by Sofman et al. Doing so would provide a means to measure a current or a voltage representing a state of genetically modified cells, in order to comprise a cell support configured to retain the genetically modified cells (see [0016]).
Greenberg et al., as modified by Degenaar et al., Punkka et al., and Sofman et al., fails to disclose wherein the array of μLEDs is coupled to the cell support.
Cullen et al. also discloses an extracellular matrix core used for promote axonal growth (see
[0052]). Cullen et al. teaches wherein the array of μLEDs is coupled to the cell support (see Fig. 28 illustrating an LED array (1), effectively functioning as a μLED array when scaled down to match the same performance and density, is used to optically stimulate axonal growth within the cell support structure of the extracellular matrix core).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s modified implantable retinal prosthesis, wherein the array of μLEDs is coupled to the cell support, as further taught by Cullen et al. Doing so would provide a means to apply optical stimulation via an array of μLEDs, in order to couple the array of μLEDs to the cell support (see [0052]).
Regarding claim 8, Cullen et al. further teaches wherein the genetically modified cells comprise neurons (see [0012] disclosing genetically modified neurons), wherein the cell support is configured to couple to a brain of the user (see [0082] disclosing the micro-TENN neurons survive, integrate with local host neurons, and maintain their local architecture, serving as a functional relay to and from deep regions of the brain; Fig. 28b illustrating this configuration).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s modified implantable retinal prosthesis, wherein the genetically modified cells comprise neurons, wherein the cell support is configured to couple to a brain of the user, as further taught by Cullen et al. Doing so would provide a means to include a microwell-based cell support configured to retain genetically modified cells comprising neurons and apply optical stimulation via an array of μLEDs, in order to couple the cell support to a brain of the user for neural prosthetic stimulation (see [0082]).
Regarding claim 9, Cullen et al. further teaches wherein the cell support comprises a gel (see [0055] disclosing the extracellular matrix core (102) which effectively functions as a cell support, is surrounded by a hydrogel sheath (104) implanted with neurons), wherein the gel is configured to support growth of axons of the genetically modified cells out of the gel (see [0061] disclosing axonal growth within the hydrogel tube).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s modified implantable retinal prosthesis, wherein the cell support comprises a gel, wherein the gel is configured to support growth of axons of the genetically modified cells out of the gel, as further taught by Cullen et al. Doing so would provide a means to provide a substantially cylindrical extracellular matrix core and hydrogel sheath, in order to support growth of axons of dash-like or longitudinally aligned neurites out of the gel and into host tissue (see 0061]).
Regarding claim 10, Sofman et al. further teaches wherein the cell support further comprises an array of retention units scaffolding the gel (see [0036], [0037] disclosing an array of hydrogel microwells, effectively functioning as retention units, and its support structure).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s modified implantable retinal prosthesis, wherein the cell support further comprises an array of retention units scaffolding the gel, as further taught by Sofman et al. Doing so would provide a means to measure a current or a voltage representing a state of genetically modified cells, in order to comprise a cell support further comprising an array of retention units scaffolding the gel (see [0036]).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg et al. (US 2011/0118807) in view of Degenaar et al. (US 2010/0152849) in view of Punkka et al. (US 2019/0192698) as applied to claim 1 above, and further in view of Newman et al. (doi: 10.7554/eLife.07192; see attached document).
Regarding claims 11, 12, and 13, Greenberg et al., in view of Degenaar et al., and Punkka et al., fails to disclose wherein: adjusting the display instructions comprises one of increasing or decreasing an intensity of a light signal emitted by a μLED of interest in the array of μLEDs based on the state; wherein: the state comprises a state of a set of cells in the genetically modified cells, wherein: the μLED of interest is configured to emit light signals receivable by the set of cells; and wherein: the state comprises a measure of cell activity.
Newman et al. also discloses genetically modified neurons (see p. 2 line 4), and an optogenetic feedback control (see p. 2, line 37). Newman et al. teaches wherein: adjusting the display instructions comprises one of increasing or decreasing an intensity of a light signal emitted by a μLED of interest in the array of μLEDs based on the state (see p. 20 disclosing the mathematical transformations of control variables (𝑈𝐶 for excitation and 𝑈𝐻 for inhibition to increase or decrease light intensity) into specific optical power values (e.g., scaling light intensity for 465 nm and 590 nm LEDs); wherein: the state comprises a state of a set of cells in the genetically modified cells (see Fig. 7 illustrating optogenetic feedback of the genetically modified neural cells to control background firing states in single units of the thalamic ventral posteromedial nucleus (Vpm)), wherein: the μLED of interest is configured to emit light signals receivable by the set of cells (see p. 19 disclosing different colored LED’s used to elicit a response from neural cells); and wherein: the state comprises a measure of cell activity (see Fig. 1A illustrating an amplifier detecting spike activity from neural cells).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s modified implantable retinal prosthesis, wherein: adjusting the display instructions comprises one of increasing or decreasing an intensity of a light signal emitted by a μLED of interest in the array of μLEDs based on the state; wherein: the state comprises a state of a set of cells in the genetically modified cells, wherein: the μLED of interest is configured to emit light signals receivable by the set of cells; and wherein: the state comprises a measure of cell activity, as further taught by Newman et al. Doing so would provide a means comprise a connector that includes a plurality of electronic connections configured to transmit display instructions from a controller to a display, in order to increase or decrease an intensity of a light signal emitted by a μLED of interest in the array of μLEDs based on a measure of cell activity (see p. 19).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Greenberg et al. (US 2011/0118807) in view of Degenaar et al. (US 2010/0152849) in view of Punkka et al. (US 2019/0192698) as applied to claim 14 above, and further in view of Schrepfer (WO 2023/019226).
Greenberg et al., in view of Degenaar et al., and Punkka et al., fails to disclose wherein: the genetically modified cells comprise hypoimmune cells, wherein the genetically modified cells are further transfected with a killswitch gene.
Schrepfer also discloses the use of genetically modified hypoimmunogenic cells (see [0324]). Schrepfer teaches wherein: the genetically modified cells comprise hypoimmune cells (see [0324] disclosing engineered hypoimmunogenic cells), wherein the genetically modified cells are further transfected with a killswitch gene (see [0268] disclosing the suicide switch and gene).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s modified implantable retinal prosthesis, wherein the genetically modified cells comprise hypoimmune cells, wherein the genetically modified cells are further transfected with a killswitch gene, as further taught by Schrepfer. Doing so would provide a means to induce controlled cell death or apoptosis of the engineered cell, in order to safely eliminate the cells in the event of cytotoxicity, undesirable proliferation, or other negative consequences in the individual (see [0268]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Greenberg et al. (US 2011/0118807) in view of Degenaar et al. (US 2010/0152849), in view of Punkka et al. (US 2019/0192698) as applied to claim 1 above, and further in view of Bugaj et al. (US 2018/0016538).
Greenberg et al. in view of Degenaar et al., and Punkka et al., fails to disclose wherein: the array of μLEDs comprises at least 1000 μLEDs.
Bugaj et al. also discloses a plurality of LED light fixtures (20) (see Fig. 2A). Bugaj et al. teaches
wherein the μLED array comprises at least 1000 μLEDs (see [0049] disclosing the printed circuit board
design which can be modified with LED illuminated wells ranging from 1 96-well to 4 384-wells, to which
a custom script is used to modify the number of LED lights used in the wells to at least 1000 μLEDs).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s modified implantable retinal prosthesis, wherein: the array of μLEDs comprises at least 1000 μLEDs, as further taught by Bugaj et al. Doing so would provide a means to integrate high-density electronic connections, driver channels, and opto-plate architectures to support an expanded micro-light source configuration, in order to enable high-resolution, high-throughput independent optical stimulation across an array comprising at least 1000 μLEDs without optical bleed-through (see [0049]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Greenberg et al. (US 2011/0118807) in view of Degenaar et al. (US 2010/0152849), in view of Punkka et al. (US 2019/0192698) as applied to claim 1 above, and further in view of Seiflein (US 2016/0037137).
Greenberg et al., in view of Degenaar et al., and Punkka et al., fails to disclose wherein: the content comprises an image, wherein: the content is received from an external device comprising a camera configured to sample the image.
Seiflein also discloses a system as a head mounted, wearable device (see [0007]), at least one video camera with a feedback system (see [0008]), and a CPU ([0044]). Seiflein teaches wherein: the content comprises an image (see [0007] disclosing the device receives real-time images), wherein: the content is received from an external device comprising a camera configured to sample the image (see [0035] disclosing an eyeglass-style wearable device with a camera configured to process images).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Greenberg et al.’s modified implantable retinal prosthesis, wherein: the content comprises an image, wherein: the content is received from an external device comprising a camera configured to sample the image, as further taught by Seiflein et al. Doing so would provide a means to integrate wireless communication interfaces, wearable imaging sensors, and prosthetic display/stimulation architecture, in order to receive and process content comprising an image from an external device comprising a camera configured to sample the image (see 0035]).
Conclusion
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/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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