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” which is not mentioned in the description. 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.
Claim Objections
Claims 14, and 16 are objected to because of the following informalities:
In claim 14, line 1, “the set of cells comprise neurons” should read “the set of cells comprises neurons”
In claim 16, line 1, “the set of cells comprise hypoimmune cells” should read “the set of cells comprises hypoimmune cells”
Appropriate correction is required.
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, 5, 12, 13, 18, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 2, 4, 7, 11, 12, 14, and 18 of copending Application No. (18740854) in view of Greenberg et al. (US 2011/0118807).
This is a provisional nonstatutory double patenting rejection.
Hodak et al. (18,600364)
Hodak et al. (18,740854)
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.
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.
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.
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.
5. wherein the display further comprises logic components, wherein the display instructions comprise μLED state change instructions.
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.
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.
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.
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.
Claims 1 and 13
Claims 1, 4, 7, 12, 14, and 18 of the co-pending application recites all of the limitations of claims 1 and 13 of the instant application except “external device.” However, Greenberg et al. also discloses an electronics package (14) and an inductive coil (16) (see [0029]). Greenberg et al. teaches an external device (see [0029] disclosing a receiver configured to receive content from an external device, comprising an electronics package (14) coupled to a secondary inductive coil (16) (made of wound wire traces). 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 Hodak et al.’s external device, with an external device comprised of an electronics package (14) and an indicative coil (16), as further taught by Greenberg et al. Doing so would provide a means to connect or communicate with an external device, in order to exchange operational data, configuration commands, or control signals remotely (see [0029]).
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 1-5 and 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).
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), which functions as the controller) wherein the controller is configured to couple to an outer surface of an eye of a user (see [0030] disclosing the molded body (18) which is integrated into the electronics package (14), narrows to form a strap (22) that is configured to wrap around and couple directly to the outer surface of the sclera (outer surface of the eye), the controller comprising:
a receiver configured to receive content from an external device (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);
a connector comprising a plurality of electronic connections configured to transmit the display instructions from the controller to a 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); and
the 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), wherein the display is configured to couple to a retina of 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 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.
Degenaar et al. also discloses a retinal prosthetic device based on optical stimulation using light emitting diodes (see [0006]), and an array (26) of light sources in the form of LED devices (28) (see [0025]). Degenaar et al. teaches an array of μLEDs (see [0025] disclosing an array (26) of light sources, to which, when combined functions as μLEDs) configured to emit light signals according to the display instructions (see [0031] disclosing a viewed image is analyzed to determining a group of LEDs to be turned on, and data is sent to the LED driver (24)), wherein the light signals are receivable by genetically modified cells in the retina (see [0033] disclosing light sensitization of neural cells is achieved through genetic engineering).
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 display with 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, as taught by Degenaar et al. Doing so would provide a means to secure a low-profile electronics package and secondary inductive coil to the outer surface of an eye, in order to transmit display instructions to a retinal display that emits light signals receivable by genetically modified cells in the retina (see [0031]).
Regarding claims 2, and 3, Degenaar et al. further teaches wherein: the genetically modified cells are transfected with a gene for a light-sensitive protein (see [0033] disclosing the use of the light sensitive protein melanopsin in the genetically modified neural cells), 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); and wherein the genetically modified cells comprise retinal ganglion cells (see [0012] disclosing genetically modified 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 display, 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; and wherein the genetically modified cells comprise retinal ganglion cells, as further taught by Degenaar et al. Doing so would provide a means to transmit display instructions from a controller to an array of micro-LEDs coupled to the retina, in order to emit light signals receivable by the genetically modified retinal ganglion cells so that they produce biochemical signals in response (see [0033]).
Regarding claim 4, 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 5, Degenaar et al. further teaches wherein: the display further comprises logic components (see [0025] an LED stimulating addressing chip (24) that independently turns the LEDs on and off), wherein the display instructions comprise μLED state change instructions (see [0034] disclosing the LED array (26) which functions as μLEDs, include an LED driver (24) and control modules (72, 74) that process stored data to identify which LEDs needs to be turned on and off, thereby establishing change instructions).
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 further comprises logic components, wherein the display instructions comprise μLED state change instructions, 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 process and execute the state changes of the μLEDs using the displays logic components (see [0034]).
Regarding claim 7, Degenaar et al. further teaches wherein: the array of μLEDs is configured to emit light signals with a fixed wavelength (see [0032] disclosing direct light of a particular wavelength or range of wavelengths onto targeted 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 display, wherein the array of μLEDs is configured to emit light signals with a fixed wavelength, 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 light signals with a fixed wavelength via the array of μLEDs (see [0032]).
Regarding claim 8, Degenaar et al. further teaches wherein the fixed wavelength is between 510 nm and 550 nm (see [0034] disclosing the use of green light, which has an inherent 495-570 nm range, thereby falling within the 510-550 nm range).
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 fixed wavelength is between 510 nm and 550 nm, 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 light signals with a fixed wavelength (such as green light for deactivating light-sensitive molecules) via the array of μLEDs (see [0034]).
Regarding claim 9, Degenaar et al. further teaches wherein the display further comprises a microoptical component configured to collimate the light signals (see [0025] disclosing a lens (30) in front of each LED device (28) to focus light into a beam (32); [0026] disclosing an optical system (38) comprising lenses arranged to shape and parallelize the path of the light beams, to which both the lens and the optical system collectively form the microoptical components).
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 further comprises a microoptical component configured to collimate the light signals, 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 collimate the light signals using the microoptical component of the display (see [0025]; [0026]).
Regarding claim 10, Degenaar et al. further teaches wherein: each μLED is configured to emit a light signal receivable by less than 20 of the genetically modified cells in the retina (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 is configured to emit a light signal receivable by less than 20 of the genetically modified cells in the retina, 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 light signal from each μLED that is receivable by less than 20 of the genetically modified cells in the retina (see [0026]).
Claim 6 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) as applied to claim 1 above, and further in view of Fan (US 2012/0107999).
Greenberg et al. in view of Degenaar et al., fails to disclose wherein: the system is manufactured using monolithic integration on a thin film.
Fan also discloses a flexible artificial retina with a pixel unit comprising a micro electrode, photosensor, signal processor, and driver circuitry (see [0008]). Fan teaches wherein: the system is manufactured using monolithic integration on a thin film (see [0008] disclosing a single flexible CMOS chip, which is monolithic, integrates an array of pixel units, and is fabricated thin enough to conform to the shape of the retina).
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 system is manufactured using monolithic integration on a thin film, as taught by Fan. Doing so would provide a means transmit display instructions from a controller to a retinal display, in order to manufacture the system using monolithic integration on a thin film (see [0008]).
Claim 11 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) as applied to claim 1 above, and further in view of Seiflein (US 2016/0037137).
Greenberg et al. in view of Degenaar et al., fails to disclose wherein: the content comprises an image, wherein: the external device comprises glasses and a camera configured to sample the image.
Seiflein also discloses a head mounted, wearable device (see [0007]). Seiflein teaches wherein: the content comprises an image (see [0007] disclosing the device receives real-time images), wherein: the external device comprises glasses and a camera configured to sample the image (see [0035] disclosing an eyeglass-style embodiment 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 display, wherein the content comprises an image, wherein the external device comprises glasses and a camera configured to sample the image, as further taught by Seiflein. Doing so would provide a means to transmit display instructions from an external device to a retinal display, in order to process content comprising an image where the external device comprises glasses and a camera configured to sample the image (see [0035]).
Claim 12 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) as applied to claim 1 above, and further in view of Newman et al. (DOI: 10.7554/eLife.07192; see attached document).
Greenberg et al. in view of Degenaar et al., fails to disclose 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.
Newman et al. also discloses adjusting optical stimulation and control signals based on real-time measurements of single units (see p. 1). Newman et al. teaches wherein: the display instructions are adjusted based on the measurements of a cell of interest in the genetically modified cells (see Fig. 7 illustrating optogenetic feedback to control background firing states in single units of the thalamic ventral posteromedial nucleus (Vpm)), 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 (see p. 20 disclosing the mathematical transformations of control variables (
U
C
for excitation and
U
H
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), the μLED corresponding to the cell of interest (see Fig. 1 illustrating an LED interface corresponding to the cell of interest via an electrode).
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 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, as further taught by Newman et al. Doing so would provide a means transmit display instructions from a controller to a retinal display, in order to adjust the display instructions based on measurements of a cell of interest by increasing or decreasing an intensity of a light signal emitted by a μLEDs corresponding to the cell of interest in the array of μLEDs (see Fig. 1).
Claims 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Sofman et al. (US 2020/0292944) in view of Cullen et al. (US 2019/0126043), Degenaar et al. (US 2010/0152849), and Greenberg et al. (US 2011/0118807)
Regarding claim 13, Sofman et al. discloses a system, comprising:
a cell support comprising a set of microwells (see [0014] disclosing an array of microwells) configured to retain a set of cells (see [0015] disclosing the array of microwells used to retain cells for cell culturing).
Sofman et al. fails to disclose 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.
Cullen et al. also discloses an extracellular matrix core used for promote axonal growth (see [0052]). Cullen et al. teaches a μLED array 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 Sofman et al.’s cell support system comprising a set of microwells, with a μLED array coupled to the cell support, as further taught by Cullen et al. Doing so would provide a means to apply optical stimulation via an LED array, in order to establish a μLED array coupled to a microwell-based cell support (see [0052]).
Sofman et al. as modified by Cullen et al. fails to disclose cells transfected with a gene for a light-sensitive protein; 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.
Degenaar et al. also discloses light sensitization of neural cells (see [0033]), a light sensitive protein (see [0033]), an array of light sources (26) comprising LED devices (28) (see [0025]), an LED driver (24) with a main processor (22) (see [0034]). Degenaar et al. teaches cells transfected with a gene for a light-sensitive protein (see [0033] disclosing the light sensitive protein melanopsin); wherein: the μLED array (see [0025] disclosing an array (26) of light sources, to which, when combined functions as μLEDs) is configured to emit light signals based on display instructions (see [0031] disclosing a viewed image is analyzed to determining a group of LEDs to be turned on, and data is sent to the LED driver (24) is configured to emit light signals based on display instructions), wherein: the light signals are receivable by the set of cells (see [0014 disclosing the stimulating array of beams is incident on photosensitive cells of the retina, a visual sensation corresponding to the captured image is generated, thereby establishing light signals are receivable by the cells); and a processor configured to determine the display instructions based on the content (see [0025] disclosing a processor (22) that performs operations simulating retinal processing functions on signals received from a CMOS image sensor array, thereby determining display instructions based on the content).
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 Sofman et al.’s modified cell support system comprising a set of microwells, cells transfected with a gene for a light-sensitive protein; 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; and a processor configured to determine the display instructions based on the content, as further taught by Degenaar et al. Doing so would provide a means to generate optical stimulation signals and process light inputs via integrated circuitry, in order to stimulate transfected cells that receive light signals and an external content receiver (see [0025]).
Sofman et al. as modified by Cullen et al., and Degenaar et al. fails to disclose a receiver configured to receive content from an external device.
Greenberg et al. also discloses a receiver and an external device (see [0040]). Greenberg et al. teaches a receiver configured to receive content from an external device (see [0040] disclosing the implant’s secondary inductive coil (16) establishes a link between the external video processor and the implanted device, tuned to receive both power and data).
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 Sofman et al.’s modified cell support system comprising a set of microwells, with a receiver configured to receive content from an external device, as further taught by Greenberg et al. Doing so would provide a means to receive external content and determine display instructions using a receiver and processor, in order to emit controlled light signals from a micro-LED array onto a set of light-sensitive transfected cells retained within the hydrogel cell support of neural prosthetic stimulation (see [0040]).
Regarding claim 14, Cullen et al. further teaches wherein: the set of cells comprise neurons derived from pluripotent stem cells (see [0109] disclosing neurons derived from induced pluripotent stem cells), wherein: the cell support is configured to couple to a brain of a 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 Sofman et al.’s modified cell support system comprising a set of microwells, wherein the set of cells comprise neurons derived from pluripotent stem cells, wherein the cell support is configured to couple to a brain of a user, as further taught by Cullen et al. Doing so would provide a means to integrate optical stimulation and processing circuitry with implantable neutral interface constructs, in order to provide a system wherein the set of cells comprise neurons derived from pluripotent stem cells, and wherein the cell support is configured to couple to a brain of a user (see [0082]).
Claims 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sofman et al. (US 2020/0292944) in view of Cullen et al. (US 2019/0126043), Degenaar et al. (US 2010/0152849), and Greenberg et al. (US 2011/0118807) as applied to claim 13 above, and further in view of Bugaj et al. (US 2018/0016538).
Regarding claim 15, Sofman et al. in view of Cullen et al., Degenaar et al, and Greenberg et al., fails to disclose wherein the μLED array 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 Sofman et al.’s modified cell support system comprising a set of microwells, wherein the μLED array comprises at least 1000 μLEDs, as further taught by Bugaj et al. Doing so would provide a means to modify and scale the circuit board layout and increase the density of independently addressable optoelectronic elements, in order to yield a μLED array comprising at least 1000 μLEDs (see [0049]).
Regarding claim 17, Sofman et al. in view of Cullen et al., Degenaar et al, and Greenberg et al., fails to disclose wherein each μLED in the μLED array corresponds to a single microwell in the set of microwells, wherein the single microwell is configured to retain a single cell in the set of cells.
Bugaj et al. also discloses the structural relationship between the LED fixtures (20) and the wells of culture plates (10) (see Fig. 2A). Bugaj et al. teaches wherein each μLED in the μLED array corresponds to a single microwell in the set of microwells (see [0024] disclosing the LED fixtures (20) are disposed to be adjacent to and individually illuminate the wells of a culture plate (10); Fig. 2A 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 Sofman et al.’s modified cell support system comprising a set of microwells, wherein each μLED in the μLED array corresponds to a single microwell in the set of microwells, as further taught by Bugaj et al. Doing so would provide a means to couple programmable LED driver circuitry with multi-well illumination plate layouts, in order to position individual LED fixtures in alignment with specific well locations (see [0024]).
Sofman et al. further discloses wherein the single microwell is configured to retain a single cell in the set of cells (see [0015] disclosing the array of microwells used to retain cells for cell culturing).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Sofman et al. (US 2020/0292944) in view of Cullen et al. (US 2019/0126043), Degenaar et al. (US 2010/0152849), and Greenberg et al. (US 2011/0118807) as applied to claim 13 above, and further in view of Schrepfer (WO 2023/019226).
Sofman et al. in view of Cullen et al., Degenaar et al., and Greenberg et al., fails to disclose wherein: the set of cells comprise hypoimmune cells, wherein: the set of cells are further transfected with a killswitch gene.
Schrepfer also discloses the use of genetically modified hypoimmunogenic cells (see [0324]). Schrepfer teaches wherein: the set of cells comprise hypoimmune cells (see [0324]) disclosing engineered hypoimmunogenic cells), wherein: the set of cells are further transfected with a killswitch gene (see [0268] disclosing the engineered cells comprise a suicide gene or a suicide switch (kill switch)).
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 Sofman et al.’s modified cell support system comprising a set of microwells, wherein: the set of cells comprise hypoimmune cells, wherein: the set of cells are further transfected with a killswitch gene, as further taught by Schrepfer. Doing so would provide a means to engineer hypoimmune cells designed to evade recipient immune system reactions while being transfected with a killswitch gene, in order to achieve immune evasion in an allogeneic recipient while maintaining a safety control mechanism to selectively eliminate the cells (see [0268]).
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Sofman et al. (US 2020/0292944) in view of Cullen et al. (US 2019/0126043), Degenaar et al. (US 2010/0152849), and Greenberg et al. (US 2011/0118807) as applied to claim 13 above, and further in view of Cabrera, Jr. et al. (US 2018/0042559).
Sofman et al. in view of Cullen et al., Degenaar et al., and Greenberg et al., fails to discloses 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.
Cabrera Jr. et al. also discloses an implantable glucose sensor (see [0180]). Cabrera Jr. et al. teaches wherein: the system further comprises a sensor configured to be implanted in a user (see [0180] disclosing an implantable glucose sensor); wherein: the display instructions are adjusted based on measurements from the sensor (see [0072] disclosing display devices including software with display instructions configured to display sensor information and query the sensor electronics module to obtain sensor measurements).
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 Sofman et al.’s modified cell support system comprising a set of microwells, 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, as further taught by Cabrera Jr. et al. Doing so would provide a means to integrate an implantable sensing mechanism into the system, in order to dynamically adjust display instructions based on real-time measurements obtained from the implantable sensor (see [0180]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Sofman et al. (US 2020/0292944) in view of Cullen et al. (US 2019/0126043), Degenaar et al. (US 2010/0152849), and Greenberg et al. (US 2011/0118807) as applied to claim 18 above, and further in view of Liu et al (DOI: 10.1109/JSEN.2016.2577688; see attached document)).
Sofman et al. in view of Cullen et al., Degenaar et al., and Greenberg et al., fails to disclose wherein the sensor comprises at least one of a temperature sensor or a humidity sensor.
Liu et al. also discloses an implantable neural stimulator (see Fig. 1). Liu et al. teaches wherein the sensor comprises at least one of a temperature sensor or a humidity sensor (see Fig. 1 illustrating the implantable neural stimulator with a temperature and humidity sensor).
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 Sofman et al.’s modified cell support system comprising a set of microwells, wherein the sensor comprises at least one of a temperature sensor or a humidity sensor, as further taught by Liu et al. Doing so would provide a means to integrate a temperature sensor or a humidity sensor into the system, in order to monitor internal micropackage humidity or local operating temperature to ensure device safety and prevent thermal or electrolytic damage to the tissue (see Fig. 1).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Sofman et al. (US 2020/0292944) in view of Cullen et al. (US 2019/0126043), Degenaar et al. (US 2010/0152849), Greenberg et al. (US 2011/0118807), and Cabrera, Jr. et al. (US 2018/0042559) as applied to claim 18 above, and further in view of Bartlett et al. (US 2023/0191130).
Sofman et al. in view of Cullen et al., Degenaar et al., Greenberg et al., and Cabrera, Jr. et al., fails to disclose 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.
Bartlett et al. also discloses a system (100) with a recording amplifier (104), and a processor (106) and sensors (102) (see [0037]). Bartlett et al. teaches wherein: the sensor is configured to measure a cell state of native cells of the user (see [0037] disclosing the use of sensors (102) and an amplifier (104) to record neural activity of the user), wherein: the cell state comprises at least one of current or voltage (see Fig. 5 illustrating the current of voltage detected by the sensors from neural activity), wherein: the display instructions are adjusted based on the cell state (see [0060] disclosing an user interface (118) may include an interface for displaying graphical information, to which the sensors that detect neural activity, display instructions based on the activity of the neuron).
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 Sofman et al.’s modified cell support system comprising a set of microwells, 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, as further taught by Bartlett et al. Doing so would provide a means to incorporate a voltage or current sensor to measure the electrical state of native cells, in order to dynamically adjust display instructions based on the measured cell state (see [0060]).
Conclusion
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/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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