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 .
Response to Amendment
This office action is in response to the amendment filed on 12/16/2025. Currently claims 1-8 and 11-31 are pending with claim 31 withdrawn based on restriction by original presentation.
Response to Arguments
Applicant’s arguments, see pg. 8, filed 12/16/2025, with respect to the previous 112 rejections of claims 21-22, 24 and 30 have been fully considered and are persuasive. The previous 112 rejections of claims 21-22, 24 and 30 has been withdrawn.
Applicant’s arguments, see pgs. 8-10, filed 12/16/2025, with respect to the rejection(s) of:
claim(s) 1-2, 5-6, 8-10, 18, 26, 28-29 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuan
claims(s) 3-4, 14, 16-17, 19, 22 and 30 rejected under 35 U.S.C. 103 as being unpatentable over Tuan
claim(s) 11-13, 21 and 23-25 rejected under 35 USC 103 as being unpatentable over Tuan in view of Kubota
claim(s) 7 rejected under 35 USC 103 as being unpatentable over Tuan in view of Bahmani
claim(s) 27 rejected under 35 USC 103 as being unpatentable over Tuan in view of Samec
claims 15 and 20 rejected under 35 USC 103 as being unpatentable over Tuan in view of Zhou in view of Luttrull
have been fully considered and are persuasive based on the amendments to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the additional reference of Lemoff et al (US 20190355287) hereafter known as Lemoff as outlined below.
While a new ground of rejection has been raised as outlined below, since much of the same prior art is being used, some of applicant’s key arguments will be addressed to help provide clarity on the record.
Applicant argues that Tuan (the primary reference) fails to disclose protecting the entire fovea and part or all of the macula by blocking or reducing treatment light using a dark color / black / dark grey spot/ area. Furthermore, applicant argues that putting a protective area would change the principle of operation of Tuan. Therefore, Tuan teaches away from the claimed invention.
As applicant argues:
“In short, Tuan does not teach anything about protecting a retina's entire fovea and part of all of the macula during ocular light therapy treatment, such as by configuring the system to block or reduce treatment light using one or more of, a black spot or area, a dark grey spot or area, or a dark color toned spot or area. Indeed, Tuan, including FIG. 1 below, teaches away from the present invention by unequivocally teaching using a light emitter (femtoprojector 120A) to directly shine ocular photo-bio-stimulation light on the central portion of the retina 152, which includes the fovea and the macula.
Additionally, not only does Tuan fail to teach protecting the entire fovea and part or all of the macula according to the currently amended claims-it teaches whole flooding of the retina using several femtoprojectors all shining light on different areas of the retina, including the center (see, e.g., Tuan, at FIG. 2 and FIG. 4). Importantly, if a protective area for the macula/fovea, as presently claimed herein, was added to the disclosure of Tuan, it would make Tuan inoperable, as it would block the central femtoprojector 120A and undermine the purpose and principle of operation of Tuan. As the Office is aware, "[i]fthe proposed modification or combination of prior art would change the principle of operation of the prior art invention being modified, then the teachings of the references are not sufficient to render the claims prima facie obvious." (See, MPEP § 2143.01 (emphasis added).) Therefore, Applicant respectfully submits that the Office's rejection cannot stand either as a matter of the scientific principles related to ocular therapy, or the applicable rules and regulations governing this application's examination.” [see pgs. 8-9 of applicant’s arguments received on 12/16/2025]
In response these arguments are not fully persuasive. The arguments equate protection with blocking or reducing the bio-stimulation light. However, this is never recited in the claims. The closest the claims come to this support this interpretation is only in dependent claim 5. Dependent claim 5 recites the fixation target as attenuating some or all of the ocular photo-bio-stimulation light, but this is only one of multiple options recited in claim 5. Additionally, this attenuation only requires some not all bio-stimulation be attenuated. So, under broadest reasonable interpretation it can be argued that the light from an image at specific wavelengths reduces, filters or attenuates at the very least some of the recited biostimulation light ranges claimed. Thus, even for dependent claim 5 the claims are broader than what applicant argues. Furthermore, there doesn’t appear to be a special definition that imports protection to mean this. Thus, this particular argument is not persuasive. Thus, applicant’s arguments are not commensurate with the broadest reasonable interpretation of the claims. Therefore, even though there is a new grounds of rejection, Tuan is still being applied in the new grounds of rejection.
Election/Restrictions
Newly submitted claims 31 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 31 is directed to an ocular light therapy system. Thus, the previous claimed invention (specially claims 1-28 of the set of claims received on 7/1/2025) and the newly added claims 31 are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the claim 31 can be used as a flash light.
Additionally, claim 31 and the previous claimed invention (specially claims 29-30 of the set of claims received on 7/1/2025) are related systems for applying ocular light. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different design, mode of operation, function, or effect. Claim 31 requires the limitation of “a physical object, a filter, a second light source integrated with the first light source, or a separate second light source” while claim 28-30 of the previous set of claims require “a fixation target”. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Also, the identified materially different design, mode of operation, function, or effect will require additional text searching be performed for claim 31 that differs from the searches for the originally presented invention (original claims 1-30), thereby causing a search burden.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim(s) 31 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 22 and 30 are objected to because of the following informalities:
The limitation in claim 22 of:
“wherein the ocular photo-bio-stimulation light comprises wavelengths within a range of one or more of, 480nm +/-30nm, 650nm +/- 30nm, 700nm +/- 30nm, 600nm - 700nm, 830nm +/- 30nm, or a combination of two or more of, 480nm +/-30nm, 650nm +/- 30nm 700nm +/- 30nm 600nm - 700nm or 830nm +/- 30nm.”
This should be changed to:
“wherein the ocular photo-bio-stimulation light comprises wavelengths within a range of one or more of, 480nm +/-30nm, 650nm +/- 30nm, 700nm +/- 30nm, 600nm - 700nm, 830nm +/- 30nm
The limitation in claim 30 of:
“wherein the ocular photo-bio-stimulation treatment light comprises light wavelengths within a range of one or more of, 480nm +/- 30nm, 530nm +/- 20nm, 600nm - 700nm, 700nm +/- 30nm, 830nm +/- 30nm, or a combination of two or more of, 480nm +/-30nm, 530nm +/- 20nm, 600nm - 700nm, 700nm +/-30nm, or 830nm +/- 30nm.”
Should be changed to:
“wherein the ocular photo-bio-stimulation treatment light comprises light wavelengths within a range of one or more of, 480nm +/- 30nm, 530nm +/- 20nm, 600nm - 700nm, 700nm +/- 30nm, 830nm +/- 30nm.”
The struck-out sections are redundant as one or more wavelengths includes a combination of two or more wavelengths. Thus, to improve clarity it is suggested that this section be removed.
Appropriate correction is required.
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.
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.
Claim(s) 1-6, 8, 14, 16-19, 22, 26, 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuan et al (US 20180017814) hereafter known as Tuan in view of Lemoff et al (US 20190355287) hereafter known as Lemoff.
Independent claim:
Regarding claim 1:
Tuan discloses:
A method of preventing myopia [see claim 12…. “A method of controlling eye focusing disorders in a patient” and claim 14… “The method of claim 12 where the diagnosed eye focusing disorder is myopia” and para 16… “Myopia control with defocused femtoprojectors is an example of the use of an eye-mounted display to affect eyeball growth and thereby contain the development of eye focusing disorders in children.”], the method comprising:
identifying a child prone to myopia, likely to become myopic, or having a predisposition for myopia, before the child becomes myopic [see claims 12-14…. “diagnosing an eye focusing disorder for the patient” and “where the patient is less than 18 years of age” and “where the diagnosed eye focusing disorder is myopia” and Fig. 5 and para 30… “FIG. 5 is a table of eye conditions and treatments, especially for children and those under 18 years of age or whose eyes are still growing. For example, children with myopia may be helped by seeing images with peripheral myopic defocus while their central vision is corrected conventionally.”];
treating a retina of the child using ocular photo-biostimulation light [see Fig 1 and claim 12…. “a first group of one or more femtoprojectors mounted in the contact lens, the first group projecting light into the patient's eye”]; and
However, Tuan fails to disclose “casting or imparting one or more of, a black spot or area, a dark grey spot or area, or a dark color toned spot or area, over an entire fovea and part or all of a macula of the retina of the child, wherein the one or more of, the black spot or area, the dark grey spot or area, or the dark color toned spot or area, is operative to protect the entire fovea and the part or all of the macula of the retina of the child from the ocular photo-bio-stimulation light” as recited by claim 1.
Tuan also discloses light sources that have the capability to produce light between 400-700 nm [see para 20… “In addition, femtoprojectors may project images that over- or underemphasize certain parts of the visual spectrum. Humans can see light ranging from about 400 nm to about 700 nm in wavelength. Roughly speaking, wavelengths in the band from 620 to 700 nm are perceived as red, those in the band from 495 nm to 570 nm are perceived as green, and those in the band from 450 nm to 495 nm are perceived as blue. A femtoprojector may show an image in which blue wavelengths are displayed more brightly than normal, as an example.”].
Lemoff discloses in the analogous art of eye devices with femtoprojectors [abstract… “In some designs, an eye-mounted display includes multiple femtoprojectors contained inside a contact lens. Femtoprojectors that project to peripheral regions of the retina can have lower resolution.” And para 1… “This disclosure relates generally to projectors for eye-mounted displays.”] overlapping peripheral femtoprojectors with central femtoprojectors for the purpose of allowing images to be stitched together thereby allowing for the projection of larger images [see para 18… “Different femtoprojectors project to different areas of the retina. In one approach, some femtoprojector(s) project images onto the fovea and other femtoprojectors project images onto more peripheral regions of the retina. These will be referred to as central femtoprojector(s) and peripheral femtoprojectors, respectively. If the images are overlapping, they can be stitched together to create a larger image in the aggregate. Because the retina has higher resolution in the fovea and lower resolution in the periphery, the requirements on the image sources and the optical systems can be different between the central and peripheral femtoprojectors, or even between peripheral femtoprojectors projecting to different regions of the retina.” And para 4… “The femtoprojectors in an eye-mounted display include an image source and an optical system. A femtoprojector's optical system is designed to project images from the image source onto the retina so that the images appear in a person's field of vision.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Tuan by using a dark color from the range of one or more using a range of one or more of, 480nm +/-30nm, 650nm +/- 30nm, 700nm +/- 30nm, 600nm - 700nm for the central projector and peripheral femtoprojectors because these are subranges of ranges of light of 400-700nm disclosed by Tuan.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Tuan by sizing the central femtoprojector and the peripheral femtoprojectors so that the image projected by the central femtoprojector encompasses the entire fovea and the borders of the macula with overlapping from the peripheral femtoprojectors on the edges similarly to that disclosed by Lemoff (i.e. thereby reciting “casting or imparting one or more of, a black spot or area, a dark grey spot or area, or a dark color toned spot or area, over an entire fovea and part or all of a macula of the retina of the child, wherein the one or more of, the black spot or area, the dark grey spot or area, or the dark color toned spot or area, is operative to protect the entire fovea and the part or all of the macula of the retina of the child from the ocular photo-bio-stimulation light”) because this will allow for images to be stitched together thereby allowing for larger image size in the view of vision thereby allowing for different sizing of different images which one of ordinary skill in the art would expect to allow for increased versatility.
Independent claim:
Regarding claim 29:
A device for providing ocular photo-bio-stimulation treatment light to a user of the device [see Figs 3-4 elements 110, elements 420A, 420B and para 28… “FIG. 4 is a cross-sectional diagram of a femtoprojector array mounted in a contact lens 110 as worn on a person's eyeball 150.”], the device comprising:
one or more ocular photo-bio-stimulation treatment light sources providing the ocular photo-bio-stimulation treatment light to the user and a fixation target; [see Fig. 4 elements 420A and 420B and para 15… “A femtoprojector includes an image source and an optical system. The image source may be a display chip that includes an array of light-emitting pixels. A light emitting diode (LED) array is an example of a display chip.” and para 20… “In addition, femtoprojectors may project images that over- or underemphasize certain parts of the visual spectrum.” And see para 20… “In addition, femtoprojectors may project images that over- or underemphasize certain parts of the visual spectrum. Humans can see light ranging from about 400 nm to about 700 nm in wavelength. Roughly speaking, wavelengths in the band from 620 to 700 nm are perceived as red, those in the band from 495 nm to 570 nm are perceived as green, and those in the band from 450 nm to 495 nm are perceived as blue. A femtoprojector may show an image in which blue wavelengths are displayed more brightly than normal, as an example.” The diode(s) in the femtoprojector(s) are at least a light sources and the femtoprojectors produce images which are fixation targets];
However, Tuan fails to disclose: “wherein a selected size and location of the fixation target is operative to protect an entire fovea of an eye of the user from some or all harmful effects of the provided ocular photo bio-stimulation treatment light” as recited by claim 29.
Tuan also discloses light sources that have the capability to produce light between 400-700 nm [see para 20… “In addition, femtoprojectors may project images that over- or underemphasize certain parts of the visual spectrum. Humans can see light ranging from about 400 nm to about 700 nm in wavelength. Roughly speaking, wavelengths in the band from 620 to 700 nm are perceived as red, those in the band from 495 nm to 570 nm are perceived as green, and those in the band from 450 nm to 495 nm are perceived as blue. A femtoprojector may show an image in which blue wavelengths are displayed more brightly than normal, as an example.”]. Also Tuan discloses another embodiment where the central projectors (i.e. elements 420A and 420B) are surrounded by peripheral projectors [see Fig. 2] and that the scope of the invention includes different combinations of embodiments [see para 36… “It should be appreciated that the scope of the disclosure includes other embodiments not discussed in detail above. Various other modifications, changes and variations which will be apparent to those skilled in the art may be made in the arrangement, operation and details of the method and apparatus disclosed herein without departing from the spirit and scope as defined in the appended claims.”]
Lemoff discloses in the analogous art of eye devices with femtoprojectors [abstract… “In some designs, an eye-mounted display includes multiple femtoprojectors contained inside a contact lens. Femtoprojectors that project to peripheral regions of the retina can have lower resolution.” And para 1… “This disclosure relates generally to projectors for eye-mounted displays.”] overlapping peripheral femtoprojectors with central femtoprojectors for the purpose of allowing images to be stitched together thereby allowing for the projection of larger images [see para 18… “Different femtoprojectors project to different areas of the retina. In one approach, some femtoprojector(s) project images onto the fovea and other femtoprojectors project images onto more peripheral regions of the retina. These will be referred to as central femtoprojector(s) and peripheral femtoprojectors, respectively. If the images are overlapping, they can be stitched together to create a larger image in the aggregate. Because the retina has higher resolution in the fovea and lower resolution in the periphery, the requirements on the image sources and the optical systems can be different between the central and peripheral femtoprojectors, or even between peripheral femtoprojectors projecting to different regions of the retina.” And para 4… “The femtoprojectors in an eye-mounted display include an image source and an optical system. A femtoprojector's optical system is designed to project images from the image source onto the retina so that the images appear in a person's field of vision.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Tuan by including peripheral projectors around the central projector(s) similarly to that disclosed by the embodiment of Tuan disclosed by Fig 2 because this is just a subcombination of combinations of different embodiments disclosed by Tuan.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Tuan by using a dark color from the range of one or more using a range of one or more of, 480nm +/-30nm, 650nm +/- 30nm, 700nm +/- 30nm, 600nm - 700nm for the central projector and peripheral femtoprojectors because these are subranges of ranges of light of 400-700nm disclosed by Tuan.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Tuan by sizing the central femtoprojector and the peripheral femtoprojectors so that the image projected by the central femtoprojector encompasses the entire fovea and the borders of the macula with overlapping from the peripheral femtoprojectors on the edges similarly to that disclosed by Lemoff (i.e. thereby reciting “wherein a selected size and location of the fixation target is operative to protect an entire fovea of an eye of the user from some or all harmful effects of the provided ocular photo bio-stimulation treatment light”) because this will allow for images to be stitched together thereby allowing for larger image size in the view of vision thereby allowing for different sizing of different images which one of ordinary skill in the art would expect to allow for increased versatility.
Dependent claims:
Claim 2, see rejection to claim 1 above which discloses treating children. Additionally, see para 30 of Tuan [see “FIG. 5 is a table of eye conditions and treatments, especially for children and those under 18 years of age or whose eyes are still growing.”] which describes children as being under 18 years of age (i.e. under 25 years of age) this recites at least one of the possible listed choices.
Regarding claim 3:
Tuan in view of Lemoff discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above. Additionally, Tuan discloses the device as being used on individuals that need sphere correction [see para 30… “The contact lens may be designed to provide sphere and cylinder correction as needed for conventional vision correction.”]
However, Tuan in view of Lemoff fails to explicitly disclose the sphere correction is specifically -.5D or less. Thus, Tuan fails to disclose “wherein a refractive status of the child comprises one of, +0.75D or less hyperopia, plano (no refractive error), or a spherical equivalent that is less than -0.50D.” as recited by claim 3.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Tuan in view of Lemoff by using the device on an individual with a spherical equivalent that is less than -0.50D (i.e. claim 3) because this is a subset of sphere correction disclosed by Tuan.
Regarding claim 4, see Fig. 1 and para 15-16 of Tuan [see…. “A femtoprojector includes an image source and an optical system.” And “Femtoprojectors in a contact lens may project images that are focused before, on, or after the retina. Furthermore, femtoprojectors may project images with certain parts of the visual spectrum enhanced as compared to a normal image.”] The projected image is at least a fixation target and as the projected image being formed by the femtoprojectors of Tuan in view of Lemoff is a dark color, the fixation target cast or impart as claimed.
Regarding claim 5, see Fig. 6 “blue enhancement” and para 34 of Tuan [see “FIG. 6 is a graph of a visual spectrum pointing out blue enhancement. In FIG. 6, an image spectrum is plotted on a graph of image intensity (in arbitrary units) versus wavelength (in nanometers). The image spectrum shows how bright different colors are in a certain image (not shown). A dashed line marked “blue enhancement” shows how the violet and blue part of an image—the wavelengths between about 400 nm and about 500 nm—may be increased in intensity. The best wavelength range for myopia control may be determined experimentally.”] discloses increasing the blue intensity relative to other wavelengths of the images (i.e. a contrasting color to that that of the bio-stimulation light)
Regarding claims 6 and 8 see Fig. 1 and para 15 of Tuan [see “A femtoprojector includes an image source and an optical system. The image source may be a display chip that includes an array of light-emitting pixels. A light emitting diode (LED) array is an example of a display chip. The optical system includes lenses and/or mirrors that focus light from the image source onto the retina. A femtoprojector may be aimed at a specific part of the retina.”] discloses the femtoprojector which produces the image (i.e. fixation target) includes lenses and/or mirrors (i.e. lens) that keeps the target in focus as recited by claim 8. Also Fig. 1 the targets (i.e. location image(s)) are provides as being at the center of 164 which is closer to the line of sight than the femtoprojectors (which include the light sources) as recited in claim 6.
Regarding claim 14:
Tuan in view of Lemoff discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above and wherein the ocular photo-bio-stimulation light is provided by an ocular photo-bio-stimulation light source [see Fig. 1 of Tuan and para 15 of Tuan… “A femtoprojector includes an image source and an optical system. The image source may be a display chip that includes an array of light-emitting pixels. A light emitting diode (LED) array is an example of a display chip. The optical system includes lenses and/or mirrors that focus light from the image source onto the retina. A femtoprojector may be aimed at a specific part of the retina.”]
However, Tuan in view of Lemoff fails to disclose if the light source or the fixation target is located in front of one or the other; therefore, Tuan fails to disclose “wherein the fixation target is located along a Z axis in front of the ocular photo-bio-stimulation light source closer to the one or both eyes of the child.”
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Tuan in view of Lemoff by placing the fixation target located along a Z axis in front of the ocular photo-bio-stimulation light source closer to the one or both eyes of the child because there are only three possible positions to position the two elements (fixation target in front of light source, fixation target at same location as the light source or fixation target behind the light source along a Z axis) and this is one of those three possible positions.
Regarding claim 16:
Tuan in view of Lemoff discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above. Additionally, Tuan in view of Lemoff discloses the device as being used on individuals that need sphere correction [see para 30 of Tuan… “The contact lens may be designed to provide sphere and cylinder correction as needed for conventional vision correction.”] and light sources that have the producing light between 400-700 nm [see para 20… “In addition, femtoprojectors may project images that over- or underemphasize certain parts of the visual spectrum. Humans can see light ranging from about 400 nm to about 700 nm in wavelength. Roughly speaking, wavelengths in the band from 620 to 700 nm are perceived as red, those in the band from 495 nm to 570 nm are perceived as green, and those in the band from 450 nm to 495 nm are perceived as blue. A femtoprojector may show an image in which blue wavelengths are displayed more brightly than normal, as an example.”]
However, Tuan in view of Lemoff fails to explicitly disclose the sphere correction or exact wavelength used. Thus, Tuan fails to disclose “wherein the ocular photo-bio- stimulation light is configured to increase retinal dopamine of the child if the refractive status of the child is one or more of, +0.75D or less hyperopia, plano (no optical power), a spherical equivalent being less than -0.50D, or an ocular dopamine test of the child shows an indication of low dopamine” as recited by claim 16
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Tuan in view of Lemoff by using the device on an individual with a spherical equivalent that is less than -0.50D and using a light within the range of 495-500 nm because these are the subranges of the ranges of treating individuals needing spherical corrections light of 400-700 disclosed by Tuan in view of Lemoff. Please note that based on para 89 of applicant’s specification received on 6/4/2025 [see… “Cyan light (blue green) wavelengths (~495nm — 520nm) have been found to contribute more towards increasing choroidal thickness which is an important parameter in treating / stopping myopia.”] and para 90 of applicant’s specification received on 6/4/2025 [see “Blue light wavelengths (~450nm - 495 nm or ~450nm- 500nm) are helpful for the eye, by way of reducing the eye’s axial length, another important factor when treating myopia and stopping its progression. Also, blue light increases one’s alertness, improves cognitive function and other beneficial neurological functions. This occurs due to the stimulation of or one or more of dopamine, serotonin or norepinephrine in the brain.”] this wavelength causes an increase in dopamine, thereby reciting claim 16
Regarding claims 17 and 19:
Tuan in view of Lemoff discloses the invention substantially as claimed including all the limitations of claim 1.
Tuan in view of Lemoff also discloses light sources that have the capability to produce light between 400-700 nm [see para 20 of Tuan… “In addition, femtoprojectors may project images that over- or underemphasize certain parts of the visual spectrum. Humans can see light ranging from about 400 nm to about 700 nm in wavelength. Roughly speaking, wavelengths in the band from 620 to 700 nm are perceived as red, those in the band from 495 nm to 570 nm are perceived as green, and those in the band from 450 nm to 495 nm are perceived as blue. A femtoprojector may show an image in which blue wavelengths are displayed more brightly than normal, as an example.”]
However, Tuan in view of Lemoff fails to explicitly disclose “further comprising
two or more of the following: treating the child to increase a choroidal or scleral thickness of the retina of the child, treating the child to increase dopamine in the retina of the child, or treating the child to increase the B wave amplitude of an electroretinogram of the retina of the child” as recited in claim 17 or “wherein the method offsets or prevents axial elongation or myopia of the retina of the child” as recited by claim 19.
It would have been obvious to one having ordinary skill in the art a the time the invention was filed to modify Tuan in view of Lemoff by using a light within the range of 495-500 nm because this is the subrange of the ranges of light of 400-700 disclosed by Tuan. Please note that based on para 89 of applicant’s specification received on 6/4/2025 [see… “Cyan light (blue green) wavelengths (~495nm — 520nm) have been found to contribute more towards increasing choroidal thickness which is an important parameter in treating / stopping myopia.”] and para 90 of applicant’s specification received on 6/4/2025 [see “Blue light wavelengths (~450nm - 495 nm or ~450nm- 500nm) are helpful for the eye, by way of reducing the eye’s axial length, another important factor when treating myopia and stopping its progression. Also, blue light increases one’s alertness, improves cognitive function and other beneficial neurological functions. This occurs due to the stimulation of or one or more of dopamine, serotonin or norepinephrine in the brain.”] this recites an increase in dopamine and increase in choroidal thickness, thereby reciting claims 17 as claimed and prevent axial elongation as recited in claim 19.
Regarding claim 18: see Figs. 1 elements 110 and 120 of Tuan, para 22 of Tuan [see “Turning now to the drawings, FIG. 1 is a cross-sectional diagram of a femtoprojector array 120 mounted in a contact lens 110 as worn on a person's eyeball 150.”] and para 15 of Tuan [see “A femtoprojector includes an image source and an optical system. The image source may be a display chip that includes an array of light-emitting pixels. A light emitting diode (LED) array is an example of a display chip. The optical system includes lenses and/or mirrors that focus light from the image source onto the retina. A femtoprojector may be aimed at a specific part of the retina.”] which describe multiple femtoprojectors each with a light diodes / emitting pixels (i.e. an additional ocular photo-bio-stimulation light) and a contact lens that provides defocused light to the retina (i.e. one or more myopia control lenses)
Regarding claim 22: see rejection to claim 1 which discloses light with the claimed range.
Regarding claims 26 and 28, see Figs. 1 element 110 of Tuan, para 22 of Tuan [see… “Turning now to the drawings, FIG. 1 is a cross-sectional diagram of a femtoprojector array 120 mounted in a contact lens 110 as worn on a person's eyeball 150. The femtoprojector array 120 has peripheral myopic defocus.”] and which describe a contact lens as eyewear that provide defocused light through a myopia control light as recited by claim and provides light as claimed 28.
Regarding claim 30: see rejection to claim 30 which recites a stimulation treatment light with a wavelength as claimed.
Claim(s) 11-13, 21 and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuan in view of Lemoff as applied to claims 1 and 4 above, and further in view of Kubota et al (US 20210031051) hereafter known as Kubota.
Regarding claims 11-13, 21 and 23:
Tuan in view of Lemoff discloses the invention substantially as claimed including all the limitations of claim 1.
However, Tuan in view of Lemoff fails to disclose “wherein the fixation target moves within, or is in a stationary position within, the ocular photo-biostimulation light while treating the retina of the child using the ocular photo-bio-stimulation light” as recited by claim 11, “wherein when the fixation target moves, the ocular photo-bio-stimulation light paints the retina of the child” as recited by claim 12, “wherein the
fixation target is stationary and fixed while treating the retina of the child using the ocular photo-bio-stimulation light” as recited by claim 13, “wherein ocular
photo-bio-stimulation light that strikes the retina of the child is at least 300 lux or greater” as recited by claim 21 or “wherein the ocular photo-bio-stimulation light flickers, or wherein the ocular photo-bio-stimulation light modulates within a range of 5Hz to 15Hz, l0Hz to 20Hz, or 40Hz +/- 20Hz” as recited by claim 23.
Kubota discloses in the analogous art of phototherapy for myopia treatment [see para 13… “In some embodiments, a device to stimulate to the retina is configured to project one or more images on the retina that falls outside the fovea.” And para 84… “The device as described herein can be used to treat advancement of refractive error such as myopia”] known parameters used include a dynamic image (i.e. fixation target moves and paints the eye) with modulation frequency of 1- 500 Hz and/or a still image (i.e. fixation target stationary) [see para 13… “The projected image may comprise a still image or a dynamic image, for example with a refresh rate in the range from 1 Hz to 500 Hz.”] and luminance of 100-5000 lux [see para 57… “The micro-display may have a luminance within a range from 1 nit to 10,000 nits or 10 nits to 1000 nits, or from 100 lux to 5,000 lux, for example.”]
Since Tuan in view of Lemoff is silent as to many of the details of the fixation target images, and Kubota discloses a known parameters for addressing myopia in the eye, it would have been obvious to one having ordinary skill in the art at the time the invention to modify Tuan in view of Lemoff to have the images move and be still (i.e. claims 11-13) and to use a modulation frequency between 1-500 Hz and an intensity of 100-5000 lux similarly to that disclosed by Kubota as these are known parameters for addressing myopia in the eye.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Tuan in view of Lemoff in view of Kubota by using a frequency of 20-60Hz and intensity of 5000 lux (i.e. claims 21 and 23) as these are subsets of frequencies and intensities disclosed by Tuan in view of Lemoff in view of Kubota for addressing myopia in the eye.
Regarding claims 24-25
Tuan in view of Lemoff discloses the invention substantially as claimed including all the limitations of claim 1.
However, Tuan in view of Lemoff fails to disclose “wherein a duration of a single ocular-photo-bio-stimulation light treatment session is one hour or less, and wherein the ocular photo-bio-stimulation light treatment is repeated after a first ocular photo-bio-stimulation light treatment” as recited by claim 24 or “wherein the ocular-photo-bio-stimulation light is timed and automatically stopped” as recited by claim 25.
Kubota discloses in the analogous art of phototherapy for myopia treatment [see para 13… “In some embodiments, a device to stimulate to the retina is configured to project one or more images on the retina that falls outside the fovea.” And para 84… “The device as described herein can be used to treat advancement of refractive error such as myopia”] using a timed treatment of 15 minutes (i.e. one hour or less) [see para 64… “The projected image may have a duration as short as 15 minutes.”] that is controlled by a controller (i.e. light is timed and automatically stopped) [see para 72… “An embodiment comprises a reprogrammable MCU or ASIC controlling the operation of the micro-displays, and a real time clock that will enable adjustment of the treatment duration and periodicity by the caregiver, throughout the treatment.”]
Since Tuan in view of Lemoff is silent as to many of the details of the fixation target images, and Kubota discloses a known parameter and way to apply light to address myopia in the eye, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Tuan in view of Lemoff to include a controller that provides an automatically controlled timed treatment of 15 minutes similarly to that disclosed by Kubota (i.e. claims 24-25) as these are known way and parameters for addressing myopia in the eye.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuan in view of Lemoff as applied to claims 1 and 4 above, and further in view of Bahmani et al (US 20200108272) hereafter known as Bahmani
Tuan in view of Lemoff discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, Tuan in view of Lemoff fails to disclose “using a sensor that turns the ocular photo-bio-stimulation light off if the child is not looking at or fixated on the fixation target”
Bahmani discloses in the analogous art of ophthalmological light therapy to address myopia [see abstract… “A method for application of light to one or more eyes (300) of a user is disclosed.” and para 28… “The method has many applications, such as the treatment of myopia”] including an electrooculogram or electroretinograph electrodes (i.e. a sensor) to determine a gaze direction and to turn of the light if the light is not positioned correctly to a user’s gaze (i.e. using a sensor that turns the ocular photo-bio-stimulation light off if the child is not looking at or fixated on the fixation target) for the purpose of preventing light from falling on the wrong sensitive parts of the retinal [see para 69… “In another aspect, the electrooculogram (EOG) or the electroretinograph electrodes are housed in the spectacle frame 24 and temples, as discussed above. The EOG signals the gaze direction and enables automatic on/off switching of the light emitting source 34 according to the position of the eye 300. When the eye is looking straight relative to the light emitting source 34, the stimulation pattern falls on the optic disk 330. When the eye 300 is looking off-center, the pattern switches off, in order to not fall on the other light sensitive parts of retina 320 (see also US 20040070729 A1).”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Tuan in view of Lemoff by including and using electrooculogram or electroretinography electrode to determine a user’s gaze and to turn off the light if the individual is not looking at the target based on the electrode similar to that disclosed by Bahmani (i.e. reciting claim 7) as this prevent the wrong parts of the retina from receiving the light thereby leading one of ordinary skill to expect improved safety with the device.
Claim(s) 15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuan in view of Lemoff as applied to claims 1 above, and further in view of Zhou et al (US 20220016023) hereafter known as Zhou in view of Luttrull et al (US 20190328577) hereafter known as Luttrull.
Regarding claim 15:
Tuan discloses the invention substantially as claimed including all the limitations of claim 1 above.
However, Tuan is silent as to exactly how the child is determined to have or be prone to have myopia. Thus, Tuan fails to disclose “two or more of the following: measuring a refractive status of the child, measuring a choroidal thickness or scleral thickness of the retina of the child, measuring for an indication of low dopamine in the retina of the child, measuring for a B wave amplitude of an electroretinogram of the retina of the child, measuring contrast sensitivity of the child's vision, or measuring a best visual acuity of the child” as recited by claim 15.
Zhou discloses in the analogous art of myopia treatment [see para 2… “The present invention relates to the technical field of myopia treatment, and in particular to a method for treating myopia”] a known way to determine if a user has or is at risk of myopia is based on measured the thickness of choroid (i.e. measuring a choroidal thickness or scleral thickness) [see Claim 9… “A method for diagnosing myopia or predicting a risk of myopia, comprising: detecting a choroidal blood flow condition or measuring the thickness of choroid; and if it is found that a choroidal blood flow is less than a normal blood flow, or the thickness of the choroid is thinned, there is a risk of myopia.”]
Luttrull discloses in the analogous art of myopia treatment [see Para 2… “The present invention generally relates to systems and processes for treating eye disorders. More particularly, the present invention resides in systems and processes for preventing or treating myopia “] spherical equivalent refractive error at baseline (i.e. refractive status of the child) is a known way to determine if a user has or is at risk of myopia [see para 42… “Other tests can be used as a myopia predictor, including spherical equivalent refractive error at baseline, ratio of accommodative convergence to accommodation, relative peripheral refractive error, accommodative lag, and astigmatism magnitude by orientation.”]
Since Tuan in view of Lemoff is silent as to the details of how a child is determined to be prone or have a predisposition for myopia and Zhou discloses one known way to determine this (i.e. measuring a choroidal thickness or scleral thickness) and Luttrull discloses another way to determine this (i.e. refractive status of the child), it would have been obvious to one having ordinary skill in the art at the time the invention was filed to determine a child as being prone or have a predisposition for myopia by measuring choroidal thickness or scleral thickness as disclosed by Zhou and using the refractive status of the child as disclosed by Luttrull because these are known ways to determine if a user has or is at risk of myopia.
Regarding claim 20
Tuan in view of Lemoff discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, Tuan in view of Lemoff is silent as to the details of how a child is determined to be prone or have a predisposition for myopia. Thus, Tuan fails to disclose “wherein two or more of the following are utilized to determine if the child is prone to myopia, likely to become myopic, or having a predisposition for myopia: an autorefractor, a genetic test, an electroretinogram, a contrast sensitivity test, or a device to measure choroidal thickness or scleral thickness.” as recited by claim 20.
Zhou discloses in the analogous art of myopia treatment [see para 2… “The present invention relates to the technical field of myopia treatment, and in particular to a method for treating myopia”] a known way to determine if a user has or is at risk of myopia is based on the measured thickness of choroid (i.e. measuring a choroidal thickness or scleral thickness) [see Claim 9… “A method for diagnosing myopia or predicting a risk of myopia, comprising: detecting a choroidal blood flow condition or measuring the thickness of choroid; and if it is found that a choroidal blood flow is less than a normal blood flow, or the thickness of the choroid is thinned, there is a risk of myopia.”]
Luttrull discloses in the analogous art of myopia treatment [Para 2… “The present invention generally relates to systems and processes for treating eye disorders. More particularly, the present invention resides in systems and processes for preventing or treating myopia “] genetic testing is a known way to determine a known way to determine if a user has or is at risk of myopia [see para 38… “Patient history, such as in the form of a questionnaire or by verbal questioning, could also indicate whether genetic factors are in play as a predictor of myopia. Genetically, linkage studies have identified eighteen possible loci on fifteen different chromosomes that are associated with myopia. It has been found that children of parents who have myopia are at a greater risk of developing myopia as well. Thus, a genetic test could be performed and/or a determination made whether one or both parents of the patient has or has had myopia.”]
Since Tuan in view of Lemoff is silent as to the details of how a child is determined to be prone or have a predisposition for myopia and Zhou discloses one known way to determine this (i.e. measuring a choroidal thickness or scleral thickness) and Luttrull discloses another way to determine this (i.e. a genetic test), it would have been obvious to one having ordinary skill in the art at the time the invention was filed to determine a child as being prone or have a predisposition for myopia by measuring choroidal thickness or scleral thickness as disclosed by Zhou and using genetic testing as disclosed by Luttrull because these are known ways to determine if a user has or is at risk of myopia.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuan in view of Lemoff as applied to claims 1 above, and further in view of Samec et al (US 20160270656) hereafter known as Samec.
Tuan in view of Lemoff discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above. Additionally, Tuan in view of Lemoff discloses that when addressing myopia certain parameters such as the wavelength ranges used should be determined experimentally [see para 34 of Tuan… “The best wavelength range for myopia control may be determined experimentally.”]
However, Tuan fails to disclose how these parameters are determined beyond that by experiment and therefore fail to disclose “wherein information and/or data related to the ocular photo-bio-stimulation treatment is sent to a computing device, reported to one or more persons monitoring the prevention or progress of the child's myopia, or both” as recited by claim 27.
Samec discloses in the analogous art of ophthalmological phototherapy to address refractive errors of the eye [see abstract… “Configurations are disclosed for a health system to be used in various healthcare applications, e.g., for patient diagnostics, monitoring, and/or therapy. The health system may comprise a light generation module to transmit light or an image to a user, one or more sensors to detect a physiological parameter of the user's body, including their eyes”] a known way to determine a user’s known visual issues is to apply tests and report the clinician the results [see para 1799-1802… see “The responses of the user may be recorded, and analyzed to determine if the user has any vision defects. The results can be reported back to the clinician or patient.”] and that sending information via the internet (i.e. via a computing device) allows for communication to obtain optical prescriptions to help treat vision defects [see Fig. 3C and para 1785…. “the process flow 1700 may be one input used to define an optical prescription. Other methods of determining vision defects are possible, for example, as described throughout this disclosure. In some embodiments, the ophthalmic system may be configured to receive an optical prescription from a third party. For example, a doctor may be able to send a user optical prescription wirelessly (e.g., over the internet, Bluetooth connection, etc.), which is received by a receiver or transceiver and stored in the digital memory of the local processing module (72).”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Tuan by including a step of testing a user’s vision and to report the results to a clinician and to send the device over the internet similar to that disclosed by Samec (i.e. thereby reciting claim 27) as this is a known way to assess a user’s eyesight and further obtain prescriptions to help further treat the vision defect.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792