Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
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.
Claims 1-25 are rejected under 35 U.S.C. 103 as being unpatentable over Lipshitz et al., US PGPUB 20040236421 hereinafter referenced as Lipshitz in view of Saini, US PGPUB 20200345554.
As to claim 1, Lipshitz discloses a device configured to be implanted in an eye, comprising: an imaging system that receives visible light incoming to the eye (as shown in fig. 2, one of the main reasons for using filter 48 is to regulate the amount of light that passes through implant 6 in order to adjust the relative light intensity between the central visual field image and the peripheral visual field image); and
a projection system comprising a display and a lens that are configured to generate and project an image onto a retina of the eye in which the device is implanted, the image being based on the light received by the imaging system ([0081] Peripheral light 28 passes through lens 10 and is projected onto the retina as light rays 32).
Lipshitz discloses light projected onto retina but does not explicitly disclose the light image is projected from a projection system.
However, in the same endeavor, Saini discloses the light image is projected from a projection system ([0032] By placing a rearward-facing projector 46 on an intraocular implant device 40, an artificial image may be projected onto the retina to simulate natural light, thereby allowing a user to see the artificial image generated by the projector much like the patient would see normally using natural light).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the disclosure of Lipshitz to further include Saini’s projector, in order to improving, restoring, augmenting or restoring vision in humans.
As to claim 2, the combination of Lipshitz and Saini discloses the device of claim 1. The combination further discloses a control circuitry that causes the display and the lens to project the image onto a determined area of the retina (Lipshitz, [0051] FIG. 13 is a view of the intraocular implant of FIG. 1a having a single partially internally mounted central optical element, the implant being configured to form a continuous image on the retina).
As to claim 3, the combination of Lipshitz and Saini discloses the device of claim 2. The combination further discloses the lens is between the display and the retina when the device is implanted in the eye; and the display comprises a plurality of individually controllable light emitting elements (Lipshitz, [0082] it will be appreciated by those ordinarily skilled in the art that lenses 12, 14 can be formed of a graded index material or lenses 12, 14 can have coatings that modify the transmission of light through the lenses).
As to claim 4, the combination of Lipshitz and Saini discloses the device of claim 2. The combination further discloses the determined area of the retina is a healthy area of the retina (Lipshitz, [0033] According to a further feature of the present invention, the step of implanting is performed by implanting the implant in a location in the eye, the location being selected from the group consisting of the capsular bag of the eye, the anterior chamber of the eye, the posterior chamber of the eye and the sulcus).
As to claim 5, the combination of Lipshitz and Saini discloses the device of claim 4. The combination further discloses the control circuitry determines the determined area of the retina using a stored mapping (Saini, [0044] Transmitter 64a may include locally stored image data to be used for input signal 66. Alternatively, transmitter 64a may connect dynamically to a remote image storage database 76 via a network, or cloud 74 to access content for input signal 66).
As to claim 6, the combination of Lipshitz and Saini discloses the device of claim 5. The combination further discloses the imaging system, the control circuitry, the display, and the lens are arranged in a chip stack (Saini, [0037] Wireless receiver 66 may be positioned at any suitable location on intraocular implant device 40, including on a common circuit board structure with one or more other circuit components).
As to claim 7, the combination of Lipshitz and Saini discloses the device of claim 6. The combination further discloses the imaging system is at a first side of the chip stack; and the display and the lens are at a second side of the chip stack opposite the first side of the chip stack (Lipshitz, [0081] For example, the optical components of central optical component 8 can be disposed at least partially in lens 10 or on the surface of lens 10 or other arrangements as described in the various embodiments described hereinbelow).
As to claim 8, the combination of Lipshitz and Saini discloses the device of claim 7. The combination further discloses the device comprises a body comprising a central portion and tabs extending outward from the central portion; and the chip stack is in the central portion (Lipshitz, [0086] Reference is now made to FIG. 6, which is a view of intraocular implant 6 of FIG. 1a having a split central optical element 8. In this embodiment, lens 10 has an outer portion 48 and an inner portion 46).
As to claim 9, the combination of Lipshitz and Saini discloses the device of claim 5. The combination further discloses a wireless communication antenna that is configured to receive wireless communication signals from outside the device (Saini, e.g., wireless receiver 52, fig. 3).
As to claim 10, the combination of Lipshitz and Saini discloses the device of claim 9. The combination further discloses the control circuitry is configured to program the mapping based on the wireless communication signals (Saini, [0034] The generated pattern of photons or generated image 58 projected onto the retina 14 is generated by projector 46 using an input signal 66 received by a wireless receiver 52 in some embodiments, as seen in FIG. 3 and in an alternative embodiment in FIG. 4).
As to claim 11, the combination of Lipshitz and Saini discloses the device of claim 2. The combination further discloses a rechargeable battery that is configured to power the imaging system, the control circuitry, and the light generation panel (Saini, [0029] Power supply 54 in some embodiments includes a battery configured for storing electrical power generated by photoelectric array 44 for later use by one or more other circuit components).
As to claim 12, the combination of Lipshitz and Saini discloses the device of claim 11. The combination further discloses the rechargeable battery is configured to be recharged wirelessly from a charging system located outside the eye (Saini, [0029] Power supply 54 may be continuously recharging as additional incoming light is incident on photoelectric array 44 and also simultaneously distributing electrical current to another circuit component).
As to claim 13, the combination of Lipshitz and Saini discloses the device of claim 1. The combination further discloses the device is configured to be implanted in a capsular bag of the eye (Lipshitz, [0081] It will be appreciated by those ordinarily skilled in the art that implant 6 can either be implanted in order to replace the natural lens of the eye (best shown in FIG. 24), can be implanted along with the natural lens of the eye still in place (best shown in FIG. 30) or be implanted in an eye already with an IOL as a secondary implant (best shown in FIGS. 25, 26 and 27)).
As to claim 14, the combination of Lipshitz and Saini discloses the device of claim 1. The combination further discloses the device is configured to be implanted in a ciliary sulcus of the eye (Lipshitz, [0106] In FIG. 26, loops 13 are located in the posterior chamber of eye 95, the sulcus 117 as a "piggy-back implant", after implantation of a regular IOL in bag 29 so that loops 13 are located at an angle 117 between iris 97 and ciliary body and not in capsular bag 29).
As to claim152, the combination of Lipshitz and Saini discloses the device of claim 1. The combination further discloses the device is configured to be implanted in a chamber of the eye anterior to the iris (Lipshitz, implant 6, fig. 1).
As to claim 16, the combination of Lipshitz and Saini discloses a method comprising implanting the device of claim 1 into the eye (Lipshitz, implant 6, fig. 1).
As to claim 17, the combination of Lipshitz and Saini discloses the method of using device of claim 1. The combination further discloses causing the device to project a diagnostic image on different locations of the retina of the eye; receiving patient feedback for each of the different locations; creating a mapping of the retina of the eye based on the feedback; and programming the mapping into the device (Lipshitz, [0082] the patient sees the world in the way it is presented in image 4--a central enlarged image flush with, a normal size or slightly enlarged, peripheral visual field).
As to claim 18, the combination of Lipshitz and Saini discloses the method of claim 17. The combination further discloses optimizing the mapping using artificial intelligence (Saini, [0046] The above-referenced devices may also be utilized for non-medical applications such as consumer entertainment, professional vision augmentation, virtual reality content generation and display, military applications, or other non-medical applications).
As to claim 19, the combination of Lipshitz and Saini discloses the method of claim 17. The combination further discloses the mapping maps the retina into functional areas and non-functional areas (Saini, [0032] The emitted light from the projector 46 is incident on the retina much in the way natural light may be incident on the retina after passing through the cornea and the lens).
As to claim 20, the combination of Lipshitz and Saini discloses the method of claim 17. The combination further discloses the device is configured to control one or more elements of the display based on the mapping to project an image onto a functional area of the retina to reduce or eliminate a scotoma caused by a non-functional area of the retina (Saini, [0032] by the time the light entering the eye makes it to the retina the light pattern is greatly distorted or blocked entirely, causing vision to be distorted or blurred, or causing blindness. By placing a rearward-facing projector 46 on an intraocular implant device 40, an artificial image may be projected onto the retina to simulate natural light, thereby allowing a user to see the artificial image generated by the projector much like the patient would see normally using natural light).
As to claim 21, the combination of Lipshitz and Saini discloses the device of claim 1. The combination further discloses the imaging system and the projection system comprise electronics (Saini, [0032] One application of the 10-PEPS feature on an intraocular implant device 40 is to power a projector device 46, shown for example in FIG. 3, housed on the same implant device 40 or otherwise disposed within the eye 10).
As to claim 22, the combination of Lipshitz and Saini discloses the device of claim 1. The combination further discloses the projection system comprises an enclosure that supports the lens relative to the display so that the lens is between the display and the retina when the device is implanted in the eye (Lipshitz, [0082] Implant 6 of FIG. 1b also includes optical elements 24 and 26).
As to claim 23, the combination of Lipshitz and Saini discloses the device of claim 22. The combination further discloses the display is spaced apart from the lens in the projection system (Saini, [0042] Referring to FIG. 6 and FIG. 7, in additional embodiments, external light source 68 may include a wearable technology including one or more light emitters spaced from the eye 10 and configured to emit light back toward the eye 10).
As to claim 24, the combination of Lipshitz and Saini discloses the device of claim 1. The combination further discloses the display includes individually controllable light emitting elements in which a first subset of the light emitting elements are configured to be turned on concurrently with a second subset of the light emitting elements being turned off (Saini, [0042] Referring to FIG. 6 and FIG. 7, in additional embodiments, external light source 68 may include a wearable technology including one or more light emitters spaced from the eye 10 and configured to emit light back toward the eye 10).
As to claim 25, the combination of Lipshitz and Saini discloses the device of claim 24. The combination further discloses a direction of light transmitted through the lens is configured to be varied based on which ones of the light emitting elements are included in the first subset and which ones of the light emitting elements are included in the second subset at any given time (Saini, [0042] Referring to FIG. 6 and FIG. 7, in additional embodiments, external light source 68 may include a wearable technology including one or more light emitters spaced from the eye 10 and configured to emit light back toward the eye 10).
Response to Arguments
Applicant's arguments filed 05/06/2026 have been fully considered but they are not persuasive.
Applicant argues on page 8 of REMARKS that “First, the applied art does not teach all the limitations of claim 1 including "a projection system comprising a display and a lens that are configured to generate and project an image onto a retina of the eye in which the device is implanted." In particular, the rejection does not identify a projection system that includes both a display and a lens, and the prior art (Lipshitz and Saini) does not show a projection system that includes both a display and a lens. Lipshitz does not disclose a projection system. Saini discloses a projector 46 but does not teach that the projector includes both a display and a lens. For example, Saini teaches at paragraph 0032 that the projector 46 may include any suitable light emitter. However, Saini says nothing about the projector 46 including a lens. Therefore, Saini does not teach "a projection system comprising a display and a lens that are configured to generate and project an image onto a retina of the eye in which the device is implanted" as recited in claim 1. As such, the applied art does not teach all the limitations of claim 1 and the rejection should be withdrawn for this reason alone.”
In accordance with MPEP, “USPTO personnel to give claims their broadest reasonable interpretation in light of the supporting disclosure. Limitations appearing in the specification but not recited in the claim should not be read into the claim.
For instant case, in various embodiment, Lipshitz discloses how light/image projected on to retina. For example, Lipshitz discloses in paragraph 82 that how the central light rays 22 are projected on to retina 30. Also, Lipshitz in paragraph 95 discloses how the light emerges from element 66 and is projected onto retina 30 as image 4. However, even though there should be something to project those light/image, Lipshitz does not explicitly disclose they are projected from a projector. However, in the same endeavor, Saini discloses for example, placing a rearward-facing projector 46 on an intraocular implant device 40, an artificial image may be projected onto the retina to simulate natural light, thereby allowing a user to see the artificial image generated by the projector much like the patient would see normally using natural light as shown in fig. 3.
Therefore, the current 103 rejection is sustained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kubota et al., US PGPUB 20210031051 discloses a device to stimulate the retina comprises one or more light sources coupled to one or more optical elements. The one or more optical elements is configured to illuminate the retina with one or more images at a location away from a fovea of a wearer. In some embodiments, each of the one or more images comprises a depth of focus and a spatial resolution. The one or more images can be formed at a distance anterior to the retina, at a distance posterior to the retina or on the retina. In some embodiments, the depth of focus is less than the distance, and the spatial resolution greater than a spatial resolution of the retina at the location.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SAHLU OKEBATO/ Primary Examiner, Art Unit 2625
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