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 12/18/2025. Currently claims 1-16, 18-23, and 26-32 are pending
Response to Arguments
Applicant's arguments, see pgs. 10-15 filed 12/18/2025, with respect to the rejection(s) of:
claim(s) 1, 5, 9, 12-16, 18-22, 27 rejected under 35 USC 103 as being unpatentable over Tuan in view of Kubota
Claim(s) 10-11 and 26 rejected under 35 USC 103 is unpatentable over Tuan in view of Kubota in view of Kubota II
Claim(s) 18 rejected under 35 USC 103 as being unpatentable over Tuan in view of Kubota in view of Bahmani
claim(s) 28 rejected under 35 USC 103 as being unpatentable over Tuan in view of Kubota in view of Bahmani
have been fully considered but they are not persuasive.
The crux of applicant’s arguments is that both Tuan and Kubota the (primary and second references, respectfully used in the previous prior art rejections of independent claim 1) do not protecting the macula and or fovea by using one or more of an optical stop, fixation target or a fine-tuned fixation target and that adding one would block the central view and render the either Tuan or Kubota inoperable. Please see pgs. 10-15 of applicant’s arguments received on 12/18/2025 for full of details of applicant’s arguments.
In response, these arguments are not persuasive because they are not commensurate with the scope of the claims. First an optical stop, fixation target and/or fine-tuned fixation target is not recited in claim 1 and these dependent claims so applicant is arguing features not current recited in the claims. Second, these claims are rather broad on the claimed feature of protecting all or a portion of the macula as the protective features of the protective image, shadow, umbra, penumbra and dark color is not recited in these claims but rather in other claims so protecting a portion or all the macula is much broader than applicant appears to interpret protecting a portion or all of the macula. Finally, as a note to the continual use of Tuan and Kubota, it is also noted that protecting a portion of the macula is rather broad and could incorporate blocking the edges of the macula which wouldn’t completely block the field of view. Additionally protecting can include stopping or removing or reducing some light or a specific band of light as well. So, under broadest reasonable interpretation it can be argued that the light from an image at specific wavelengths reduces at the very least some ranges of the broadly claimed biostimulation light. Thus, these arguments are not persuasive and while the rejection has been updated to account for changes in the claim language and/or correct minor typos, much of the grounds of rejection for these claims are substantially the same.
Applicant’s arguments, see pgs. 10-15, filed 12/18/2025, with respect to the rejection(s) of:
claim(s) 23 and 30 rejected under 35 USC 103 as being unpatentable over Tuan in view of Kubota
claims(s) 4, 8-9 rejected under 35 USC 103 as being unpatentable over Tuan in view of Kubota in view of Kubota II
have been fully considered and are persuasive based on applicant’s arguments 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 Zhou et al (US 20220107508) as outlined in the rejection below.
Applicant’s arguments, see pgs. 10-15, filed 12/18/2025, with respect to the previous rejection(s) of:
claims(s) 4 and 6-8 rejected under 35 USC 103 as being unpatentable over Tuan in view of Kubota in view of Kubota II
claim(s) 29 rejected under 35 USC 103 as being unpatentable over Tuan in view of Kubota in view of Kubota II in view of Bahmani
have been fully considered and are persuasive. The previous 103 rejections of claims 4, 6-8 and 29 have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-4, 6-8 and 30-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
All these claims are dependent on either claim 2 or claim 30.
Dependent claim 2 recites the limitation:
“including an optical stop, wherein the optical stop is configured to cast or impart one or more of a full protective image, a shadow, an umbra, a penumbra, a dark color toned spot, or a black spot, over the all or the portion of the macula of the subject's eye, and wherein the casted or imparted one or more of the full protective image, the shadow, the umbra, the penumbra, the dark color toned spot, or the black spot, are operative to protect the all or the portion of the macula of the subject's eye from the applied ocular photo-bio-stimulation light”
Dependent claim 30 recites the limitation:
“wherein the optical stop is configured to form, cast, or impart, a protective image or shadow over part or the all or the portion of the macula of the subject's eye”,
Both these limitations appear to include newly amended subject matter. While, applicant cites several paragraphs and/or figures in their arguments as to where all the limitations are support in the specification, it is not readily clear if applicant has support for all of these features from these cited sections or the rest of the disclosure. First the term “optical stop” is not recited in the disclosure once. However, based on the cited sections Fig. 100 seems most relevant to the optical stop. As a micro-lens as understood by examiner would be interpreted by one of ordinary skill to be a type of optical stop that is aligned with a fixation target and fine-tuned fixation target to apply on the retina. Thus, there appears to be support for an optical stop forming, casing or imparting a protective image. However, nowhere in the disclosure does the applicant recite the words “shadow”, “umbra” or “penumbra” and Figs do not readily appear to show any blocking or shielding by the optical stop as the micro lens (i.e. optical stop) of Fig. 100 is understood by the examiner to transmit a protective image to the retina. Thus, the position taken in this office action is that the additional embodiments of specifically “shadow”, “umbra” or “penumbra” being cast or imparted by the optical stop doesn’t appear to have support as it appears as if the image itself is being projected onto the retina. Thus, these features of claims 2 and 30 appear to be new matter. If applicant believes these features are supported by the disclosure (as examiner could have missed something or be mistaken in their assessment of how one of ordinary skill would interpret the disclosure), then applicant can clarify where and how these features/embodiments are supported in the specification in their next response. If applicant can successfully clarify their position and show how a shadow, umbra and/or penumbra being transmitted from the optical stop onto the retina are supported in the disclosure, this 112(a) and the related 112(b) rejection will be withdrawn. Otherwise, applicant needs to amend the claims to include only the features/embodiments supported by the specification. Thus claims 2 and 30 are rejected under 35 USC 112(a). Claims 3-4, 6-8 and 31-32 are rejected as well based on dependency to claim 2 and/or 30.
Claims 2-4, 6-8 and 30-32 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. As explained above, there doesn’t appear to be support for specially a “shadow”, “umbra” or “penumbra” being cast or imparted by the optical stop onto the macula in claims 2 and 30. Thus, as there is no description, it is not clear what the metes and bounds for these related limitations in the claims when the claims are interpreted in light of the specification. Thus claims 2 and 30 are rejected under 35 USC 112(b) as well for indefiniteness. Claims 3-4, 6-8 and 31-32 are rejected as well based on dependency to claim 2 and/or 30.
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, 5, 9, 12-16, 18-22, 27 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 Kubota et al (US 20210031051) hereafter known as Kubota.
Independent claim:
Regarding claim 1:
A method for slowing or stopping myopia progression of a subject’s eye [see Fig. 4 and
claim 12…. “A method of controlling eye focusing disorders in a patient” and claim 14…. “where the diagnosed eye focusing disorder is myopia and the first group projects light into the patient's eye with peripheral myopic defocus” and para 5… “Similarly in the presence of myopic defocus—images formed before the retina rather than on it—the eyeball grows proportionally shorter to meet the image.”], the method comprising:
applying ocular photo-bio-stimulation light to a retina of the subject’s eye during an ocular light therapy session while protecting all or a portion of a macula of the subject’s eye from the applied ocular photo-bio-stimulation light [see Fig. 4 and para 28… “The system of FIG. 4 includes two central projectors: one 420A is focused on the retina, and the other 420B is focused before the retina at the dashed line 464. The femtoprojector 420B projects images with central myopic defocus. All of the central projectors are aimed in the central field of view; i.e. at the fovea and its surroundings. In fact, the central projectors 420 may all be aimed at exactly the same area of the retina.” 420B provides an image of light and is understood to provide photo-bio-stimulation light to the retina while 420A focuses an image onto the center of the retia (i.e. protecting all or part of a macula)],
wherein the ocular photo-bio-stimulation light is applied by one or more ocular photo-bio-stimulation light sources [see Fig. 4 element 420B is a light source and para 28… “two central projectors: one 420A is focused on the retina, and the other 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.”],
providing a myopia control lens worn by the subject [see Figs. 1-4 element 110 and claim 12… “having the patient wear an eye mounted treatment device comprising: a contact lens; and a first group of one or more femtoprojectors mounted in the contact lens”]
causing, by the method as configured, the slowing or stopping of the myopia progression of the subject’s eye by way of one or more of, increasing choroidal thickness of the subject’s eye, slowing or stopping axial elongation of the subject’s eye, or slowing or stopping a subject’s need for an increase in an optical power configured to treat or correct myopia [see para 28… “one 420A is focused on the retina, and the other 420B is focused before the retina at the dashed line 464. The femtoprojector 420B projects images with central myopic defocus.” And para 5… “Similarly in the presence of myopic defocus—images formed before the retina rather than on it—the eyeball grows proportionally shorter to meet the image.” The myopic light shortens the eyeball (i.e. stopping axial elongation)]
However, Tuan is silent as to the amount of time the stimulation light is provided and fails to disclose the amount of time the light is applied. Therefore, Tuan fails to disclose “and wherein the ocular photo-bio- stimulation light is applied to the subject’s eye for 60 minutes or less during the ocular light therapy session” and fails to fully disclose “providing a myopia control lens worn by the subject for more than 60 minutes per day one or more of, before the ocular light therapy session, during the ocular light therapy session, or after the ocular light therapy session”.
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”] that the application of a myopically defocused image [see para 65… “The virtual images created by these displays will be myopically defocused and will be placed symmetrically in the four sectors (nasal-inferior, nasal-superior, temporal-inferior and temporal-superior), in some embodiments.”] for an interval of 15 minutes repeated at hourly intervals throughout the day for an overall period of 15 minutes to 12 hours per day are a known time parameters for treatment of myopia [see para 64… “The projected image may have a duration as short as 15 minutes, repeated throughout the day at hourly intervals, for example. The projected image may be continuous over a time within a range from 15 minutes to 12 hours per day.”]
Since Tuan is directed to treating myopia but is silent as to the time for the application of the lighted myopic images and Kubota discloses a known time for displaying lighted images is a light therapy session of 15 minutes (i.e. 60 minutes or less during the ocular light therapy session) and to repeat this light therapy session every hour for a total use of between 15 minutes to 12 hours per day, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Tuan to apply the lighted images similar to that of Kubota as this is a known application time for applying myopia defocused light.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Tuan in view of Kubota by applying the device for 15 minutes each session every hour for a total of 2 hours a day because this is a subset of 15 minutes to 12 hours per day (i.e. providing a myopia control lens worn by the subject for more than 60 minutes per day one or more of, before the ocular light therapy session, during the ocular light therapy session, or after the ocular light therapy session).
Claim 5:
Tuan in view of Kubota discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
Tuan in view of Kubota also discloses light sources that 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 Kubota fails to explicitly disclose “wherein light wavelengths of the ocular photo-bio-stimulation light are with a range of one or more of, 480nm +/- 30nm, 500nm — 550nm, or 600nm — 700nm.
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 Kubota by using a range of one or more 450nm – 500 nm, 500nm — 550nm or 600nm — 700nm because these are subranges of ranges of light of 400-700nm disclosed by Tuan.
Regarding claims 9 and 27:
Tuan in view of Kubota discloses the invention substantially as claimed including all the limitations of claim 1.
However, Tuan in view of Kubota is silent as to the intensity and if the light modulates at a specific frequency. Therefore, Tuan in view of Kubota fails to disclose “wherein an intensity of the ocular photo-bio-stimulation light is 500 lux or greater when measured at the one or more ocular photo-bio-stimulation light sources, and wherein the ocular photo-bio-stimulation light is 400 lux or greater when it strikes the retina of the subject’s eye” as recited by claim 9, “wherein the one or more ocular photo-bio-stimulation light sources modulate within a range of one of: 5Hz to 15 Hz, 10Hz to 20Hz, or 40Hz +/- 20Hz” as recited by claim 27.
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”] further known parameters used include a dynamic image with modulation frequency of 1- 500 Hz [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 Kubota is silent as to many of the details of the fixation target images, and Kubota discloses 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’s femtoprojector 420B (i.e. light source) to have the images move with a modulation frequency between 1-500 Hz and 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 Kubota by using an intensity of 5000 lux (i.e. understood to recite claim 9) and 5-15 Hz (i.e. claim 27) as these are subsets of intensities and frequencies of light disclosed by Tuan in view of Kubota for addressing myopia in the eye.
Regarding claims 12, 16 and 22, see Figs. 1-4 of Tuan and para 28 [see “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. FIG. 4 is similar to FIGS. 1 and 3 except that the configuration of femtoprojectors is different. The system of FIG. 4 includes two central projectors: one 420A is focused on the retina, and the other 420B is focused before the retina at the dashed line 464.”] which discloses a contact lens (i.e. a myopia control lens) with femtoprojectors (element 420B--- light source) through the front of which light is transmitted as recited by claim 12, light source attached to or supported by lens or optic as recited by claim 16, control lens is housed within eyewear as recited by claim 22.
Regarding claim 13:
Tuan in view of Kubota discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, Tuan in view of Kubota does not explicitly disclose wherein the ocular photo-bio-stimulation light is applied when the subject is not wearing eyewear comprising the myopia control lens. Instead, Tuan in view of Kubota discloses using a myopia control lens that includes eyewear [see Fig. 4 element 110 of Tuan].
At the time the invention was filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to use a myopia control lens that is a lens that is not part of eyewear because applicant has not disclosed that specifically using a myopia control lens that is not part of eyewear provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Tuan in view of Kubota’s myopia control lens as part of a contact lens, and applicant’s invention, to perform equally well with either the lenses taught by Tuan in view of Kubota’s myopia control lens or the claimed myopia control lens that is not part eyewear (i.e. subject is not wearing eyewear comprising the myopia control lens ) because both lenses would perform the same function of applying the myopia control equally well. Therefore, it would have been prima facie obvious to modify Tuan in view of Kubota to obtain the invention as specified in claim 13 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Tuan in view of Kubota.
Regarding claim 14:
Tuan in view of Kubota discloses the invention substantially as claimed including all the limitations of claim 1.
However, Tuan in view of Kubota is silent as to where the device is worn or used. Therefore, Tuan in view of Kubota fails to disclose “wherein the myopia control lens is worn by the subject outdoors and in sunlight”.
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 Kubota by wearing the myopia control lens outdoors during the day (i.e. in sunlight) because there are only a limited number of places to where the device (inside during the day, inside during the night, outside during the day or outside during the night) and this is one of those limited number of choices.
Regarding claim 15:
Tuan in view of Kubota discloses the invention substantially as claimed including all the limitations of claim 1.
However, Tuan in view of Kubota is silent as to if the device is worn or used before or after treatment. Therefore, Tuan in view of Kubota fails to disclose “wherein the myopia control lens is: worn by the subject before a regiment of ocular light therapy sessions are completed, worn by the subject before the ocular photo-bio-simulation light is applied to the retina of the subject's eye, worn by the subject while the ocular photo-bio-simulation light is being applied to the retina of the subject's eye, worn by the subject after a regiment of ocular light therapy sessions are completed, or worn by the subject after the ocular photo-bio-simulation light is finished being applied during the light therapy session” as recited by claim 15.
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 Kubota by wearing the myopia control lens after a regiment of ocular light therapy sessions because there are only a limited number of times when to use the device (before treatment, during treatment or after treatment) and this is one of those limited number of choices.
Regarding claim 18, see para 28 of Tuan [see “The femtoprojector 420B projects images with central myopic defocus.”]
Regarding claim 19, see 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.”] which discloses the femtoprojectors including the light source as including a light diode array.
Regarding claim 20-21: see Figs. 3-4 element 110 which shows the myopia control lens is a contact lens and/or myopia control contact lens as recited by these claims.
Claim(s) 2-3 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuan in view of Kubota as applied to claim 1 above, and further in view of Zhou et al (US 20220107508) hereafter known as Zhou.
Tuan in view of Kubota discloses the invention substantially as claimed including all the limitations of claim 1. Tuan in view of Kubota also discloses the light sources all 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 Kubota fails to disclose “including an optical stop, wherein the optical stop is configured to cast or impart one or more of a full protective image, a shadow, an umbra, a penumbra, a dark color toned spot, or a black spot, over the all or the portion of the macula of the subject's eye, and wherein the casted or imparted one or more of the full protective image, the shadow, the umbra, the penumbra, the dark color toned spot, or the black spot, are operative to protect the all or the portion of the macula of the subject's eye from the applied ocular photo-bio-stimulation light” as recited by claim 2, “wherein the optical stop comprises a fixation target on one side of the optical stop or wherein the fixation target is located in front of the optical stop on a side closer to” as recited by claim 3 or “including an optical stop comprising or forming a fixation target, wherein the optical stop, the fixation target, or both, are configured to protect the entire fovea and/or the all or the portion of the macula” as recited by claim 23.
Zhao discloses in the analogous art of controlling myopia progression [see abstract… “Spectacles that control myopia progression have a central zone that achieves foveal vision correction and distributed micro-reticle(s) and corresponding micro-lens(es) around the paracentral and/or peripheral zone of the spectacle.”] a known way to control the progression of myopia [see abstract… “Spectacles that control myopia progression”] includes a configuration of a myopia control lenses [see Fig. 4A-4B element 402 and para 96… “spectacle lens 402” and abstract… “Spectacles that control myopia progression”] that includes micro reticle lights (i.e. fixation target) [see Fig. 4A-4B element 402 and para 96… “On the front surface 404, micro-reticles 408 are positioned deposited or embedded”] that are on one side of and paired with corresponding micro-lenses (i.e. optical stops) [see Fig. 4A-4B element 410 and para 96… “micro-lenses 410 imprinted or molded or embedded there”] to project a protective image onto the paracentral retina (i.e. striking border of the macula which is at least the portion of a macula) [see para 97… “The relative position of each micro-reticle and micro-lens pair is such that light rays from a micro-reticle will be focused by its corresponding micro-lens to create a virtual micro-reticle image” and “the light rays from the micro-reticle that pass through the eye pupil to form a real reticle image that lands substantially on the paracentral and/or peripheral retina (as shown in FIG. 4B)”].
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 Kubota by including on Tuan in view of Kubota’s lens micro reticles paired with micro-lenses that project a protective image onto the paracentral region of the retina similarly to that disclosed by Zhou because this is the combination of two independent ways to control myopia progression and the combination of two independent ways to control myopia would be expected to lead to improved treatment (and if not provide the same level of treatment) than only using either individual independent way of controlling myopia progression alone.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Tuan in view of Kubota in view of Zhou by using a dark color from the range of one or more using a range of one or more of, 400nm-700nm for all the light sources including the micro-reticles (i.e. thereby reciting claims 2, 3 and 23) because these are subranges of ranges of lights of 400-700nm disclosed by the primary reference of Tuan.
Claim(s) 10-11 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuan in view of Kubota as applied to claims 1 above, and further in view of Kubota et al (US 20220413318) hereafter known as Kubota II.
Regarding claims 10-11 and 26
. Tuan in view of Kubota discloses the invention substantially as claimed including all the limitations of claims 1 above.
However, Tuan in view of Kubota fails to disclose “forming one or more of, a full protective image and/or a blended protective image, on the retina of the subject's eye, configured to cover the all or the portion of the macula of the subject's eye.” as recited by claim 10, “wherein the blended protective image is partially or completely surrounded by the ocular photo-bio-stimulation light, and wherein the ocular photo-bio-stimulation light is configured to strike an optic nerve head of the subject’s eye and an additional area of the retina of the subject’s eye” as recited by claim 11 or “the method further comprising: protecting an entire fovea and/or the all or the portion of the macula and/or fovea of the subject's eye by way of casting or imparting a full protective image, a blended protective image, or both, that cover the entire fovea and/or the part or all or the portion of the macula of the subject's eye” as recited by claim 26
Kubota II discloses in the analogous art of ophthalmic light stimulation [see abstract… “An apparatus to treat refractive error of the eye comprises one or more optics configured to project stimuli comprising out of focus images onto the peripheral retina outside the macula.”] a known fixation target includes a design that includes black crosses (i.e a blended protective image) that are surrounded by light over part or all of a macula of the retina of the eye of the user (i.e. completely surrounded by photo-bio-stimulation light), [see Fig. 7 And paras 98-99… “FIG. 7 shows a plurality of stimuli 702 and an image 704 on a display 706 as seen by a user.” And “the stimuli comprise a light pattern 708 on a dark background 710, e.g. a black and white pattern. In some embodiments, the stimuli comprise a polychromatic pattern on a darker background, such as a white or nearly white stimulus on a gray background or substantially black background. In some embodiments, each of the stimuli comprises a dark inner region and one or more light outer regions on a dark background, e.g. a dark cross through a white circular region a dark background. Stimuli may be selected based on their global contrast factor, their polarity (e.g., white or polychromatic on black background, versus, black on white or polychromatic background).” And para 181… “Also, constriction of the pupil can be decreased by providing the stimulus to the peripheral regions of the retina while maintaining substantially lower illumination amounts of the fovea and macula during stimulation.”] as an effective stimulus for treating refractive errors of the eye [see para 102… “the polychromatic flower scene may be less effective as a stimulus than an annular array of white circles on a black background with a black cross segmenting the circular icon, although other stimuli may be used.” and abstract… “An apparatus to treat refractive error of the eye comprises one or more optics configured to project stimuli comprising out of focus images onto the peripheral retina outside the macula.”]
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 Kubota by including a fixation target that includes a pattern with a black crosses on a background similarly to that disclosed by Kubota II focused on the central part of the retina (i.e. reciting claims 10-11 and 26), because Tuan is silent as to all the exact details of the fixation target pattern and Kubota II discloses this is a known effective pattern for treating refractive errors of the eye.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuan in view of Kubota as applied to claim 1 above, and further in view of Bahmani et al (US 20200108272) hereafter known as Bahmani.
Tuan in view of Kubota discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, Tuan in view of Kubota fails to disclose “providing one or more of, an alarm, an auditory alarm, a visual alarm, a light, a speaker, haptic feedback or haptic alerts, an automatic off, an automatic timed switch, an eye tracker, a sensor for sensing
blink rate of the subject, a sensor for sensing pupil diameter of the subject, a distance sensor, an ultrasonic sensor, an infrared sensor, a light sensor, a time of light sensor, a Light Detection and Ranging (LiDAR) sensor, an optical camera-based sensor, a camera, a Complementary MetalOxide-Semiconductor (CMOS) camera sensor, a Charge-Coupled Device (CCD) camera sensor, a radar-based sensor, a controller, a distance measurement sensor, software, memory, a timer, a capability to store in memory or communicate a time of applied ocular light therapy, wireless communication, wired communication, biofeedback, one or more sensor, or eye tracking” as recited by claim 28
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. one or more sensors) to determine a gaze direction and automatically turn of the light if the light is not positioned correctly to a user’s gaze 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 Kubota by including and using electrooculogram or electroretinograph to determine a user’s gaze to turn off the light if the individual is not looking at the target similar to that disclosed by Bahmani (i.e. reciting claim 28) 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) 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuan in view of Kubota in view of Zhou.
Independent claim:
Regarding claim 30:
A method for treating one or more pathologies of a subject, using ocular photo-bio-stimulation light the method [see Figs. 1-4 and claim 12…. “A method of controlling eye focusing disorders in a patient” and claim 14…. “where the diagnosed eye focusing disorder is myopia and the first group projects light into the patient's eye with peripheral myopic defocus” and para 5… “Similarly in the presence of myopic defocus—images formed before the retina rather than on it—the eyeball grows proportionally shorter to meet the image.”] comprising:
treating a subject with ocular photo-bio-stimulation light during an ocular light
therapy session, wherein the ocular photo-bio-stimulation light is provided by one or more ocular photo-bio-stimulation light sources [see Fig. 4 and para 28… “The system of FIG. 4 includes two central projectors: one 420A is focused on the retina, and the other 420B is focused before the retina at the dashed line 464. The femtoprojector 420B projects images with central myopic defocus. All of the central projectors are aimed in the central field of view; i.e. at the fovea and its surroundings. In fact, the central projectors 420 may all be aimed at exactly the same area of the retina.” 420B diode (i.e. light) and is understood to provide photo-bio-stimulation light to the retina]; and
wherein the method is operative to treat the one or more pathologies of the subject [see para 28… “one 420A is focused on the retina, and the other 420B is focused before the retina at the dashed line 464. The femtoprojector 420B projects images with central myopic defocus.” And para 5… “Similarly in the presence of myopic defocus—images formed before the retina rather than on it—the eyeball grows proportionally shorter to meet the image.” The myopic light shortens the eyeball (i.e. stopping axial elongation which leads to slowing or stopping myopia progression (i.e. treating a pathology). Also as there is a protective image provided by fixation target the retina is protected as claimed.].
However, Tuan is silent to the amount of time the light is applied and fails to disclose using an optical stop. Therefore, Tuan fails to disclose “and wherein the ocular photo-biostimulation light treatment lasts for 60 minutes or less during an ocular light therapy session” or “protecting all or a portion of a macula of an eye of the subject from all or some of the ocular photo-bio-stimulation light by using an optical stop located between the one or more ocular photo-bio-stimulation light sources and the subject's eye, and wherein the optical stop is configured to form, cast, or impart, a protective image or shadow over the all or the portion of the macula of the subject's eye”
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”] that the application of a myopically defocused image [see para 65… “The virtual images created by these displays will be myopically defocused and will be placed symmetrically in the four sectors (nasal-inferior, nasal-superior, temporal-inferior and temporal-superior), in some embodiments.”] for an interval of 15 minutes repeated at hourly intervals throughout the day for an overall period of 15 minutes to 12 hours per day are a known time parameters [see para 64… “The projected image may have a duration as short as 15 minutes, repeated throughout the day at hourly intervals, for example. The projected image may be continuous over a time within a range from 15 minutes to 12 hours per day.”]
Zhao discloses in the analogous art of controlling myopia progression [see abstract… “Spectacles that control myopia progression have a central zone that achieves foveal vision correction and distributed micro-reticle(s) and corresponding micro-lens(es) around the paracentral and/or peripheral zone of the spectacle.”] a known way to control the progression of myopia [see abstract… “Spectacles that control myopia progression”] includes a configuration of a myopia control lenses [see Fig. 4A-4B element 402 and para 96… “spectacle lens 402” and abstract… “Spectacles that control myopia progression”] that includes micro reticle lights [Fig. 4A-4B element 402 and para 96… “On the front surface 404, micro-reticles 408 are positioned deposited or embedded”] that are paired with micro-lenses [see Fig. 4A-4B element 410 and para 96… “micro-lenses 410 imprinted or molded or embedded there”] to project an image onto the paracentral retina (i.e. striking the border of the macula which is at least a portion of a macula) [see para 97… “The relative position of each micro-reticle and micro-lens pair is such that light rays from a micro-reticle will be focused by its corresponding micro-lens to create a virtual micro-reticle image” and “the light rays from the micro-reticle that pass through the eye pupil to form a real reticle image that lands substantially on the paracentral and/or peripheral retina (as shown in FIG. 4B)”].
Since Tuan is directed to treating myopia but is silent as to the time for the application of the lighted images and Kubota discloses a known time for displaying lighted images is a light therapy session of 15 minutes (i.e. 60 minutes or less during the ocular light therapy session) and to repeat this light therapy session every hour for a total use of between 15 minutes to 12 hours per day, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Tuan to apply the lighted images similar to that of Kubota as this is a known application time for applying myopia defocused light.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Tuan in view of Kubota by applying the device 15 minutes each session every hour for a total of 2 hours because this is a subset of 15 minutes to 12 hours per day (i.e. wherein the ocular photo-biostimulation light treatment lasts for 60 minutes or less during an ocular light therapy session).
Finally, 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 Kubota by including on Tuan in view of Kubota’s lens micro reticle lights paired with micro-lenses to project a protective image onto the paracentral region of the retina (i.e. understood to include the border of the macula) similarly to that disclosed by Zhou (i.e. thereby reciting “protecting all or a portion of a macula of an eye of the subject from all or some of the ocular photo-bio-stimulation light by using an optical stop located between the one or more ocular photo-bio-stimulation light sources and the subject's eye, and wherein the optical stop is configured to form, cast, or impart, a protective image or shadow over the all or the portion of the macula of the subject's eye”) because this is the combination of two independent ways to control myopia progression and the combination of two independent ways to control myopia would be expected to lead to improved treatment an (and if not provide the same level of treatment) than one only using either individual independent way of controlling myopia progression alone.
Regarding claim 31, see rejection to claim 30 which disclose treating myopia.
Allowable Subject Matter
Claims 4, 6-8, 29 and 32 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Please note allowability is dependent on the interpretation and overcoming these rejections.
The following is a statement of reasons for the indication of allowable subject matter:
Claims 4, 6 and 8 are broadest of the allowable subject matter claims. Claim 4, 6 and 8 all recite a method for slowing or stopping myopia progression of a subject’s eye.
With respect to claim 4, the closest prior art is Tuan in view of Kubota in view of Zhou. Tuan in view of Kubota in view of Zhou discloses the invention substantially as claimed including all the limitations of claims 1-2 as outlined above. However, Tuan in view of Kubota in view of Zhou fails to disclose “wherein the full protective image, the shadow, the umbra, the penumbra, the dark color toned spot, or the black spot, are surrounded by and located within an outside perimeter of a blended protective image, shadow, umbra, or penumbra”. Furthermore, nothing in the prior art when viewed with Tuan in view of Kubota in view of Zhou obviates this deficiency. It is important to note that the combination of all the limitations together, not just the missing limitation(s) is what defines the invention over the prior art. Therefore, claim 4 is neither anticipated, nor obviated in view of the prior art.
With respect to claim 6, the closest prior art is Tuan in view of Kubota in view of Zhou. Tuan in view of Kubota in view of Zhou discloses the invention substantially as claimed including all the limitations of claims 1-3 as outlined above. However, Tuan in view of Kubota in view of Zhou fails to disclose “wherein the optical stop, the fixation target, or combinations of both, comprise a fine-tuned fixation target, wherein the fine-tuned fixation target forms a fine-tuned fixation target image or shadow on one or more of, the entire fovea of the subject's eye, the all or the portion of the macula of the subject's eye, or the retina of the subject's eye, and wherein the fine-tuned fixation target is optionally of a color tone or shade that is a different color tone or shade or a contrasting color tone or shade compared to the ocular photo-bio-stimulation light.” as recited by claim 6. Furthermore, nothing in the prior art obviates these deficiencies. It is important to note that the combination of all the limitations together, not just the missing limitation(s) is what defines the invention over the prior art. Therefore, claim 6 is neither anticipated, nor obviated in view of the prior art.
With respect to claim 8, the closest prior art is Tuan in view of Kubota in view of Zhou. Tuan in view of Kubota in view of Zhou discloses the invention substantially as claimed including all the limitations of claims 1-3 as outlined above. However, Tuan in view of Kubota in view of Zhou fails to disclose “wherein a distance of the optical stop, the fixation target, or both, to the subject's eye is adjustable along a Z axis or a line of sight of the subject” as recited by claim 8. Furthermore, nothing in the prior art obviates these deficiencies. It is important to note that the combination of all the limitations together, not just the missing limitation(s) is what defines the invention over the prior art. Therefore, claim 8 is neither anticipated, nor obviated in view of the prior art.
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