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 4/24/2026. Currently claims 1-14, 16-22 and 25-35 pending with claims 31-32 withdrawn based on previous restriction.
Response to Arguments
Applicant’s arguments, see pg. 9-10, filed 4/24/2026, with respect to the rejection(s) of:
claim(s) 1-3, 7-9, 11, 17, 19-22 and 33-35 under 35 USC 103 as being unpatentable over Zhou in view of Butzloff
claim(s) 30 under 35 USC 103 as being unpatentable over Zhou in view of Butzloff in view of Luttrull in view of Sims
claim(s) 18 under 35 USC 103 as being unpatentable over Zhou in view of Butzloff in view of Kubota II
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 Therefore, the rejection has been withdrawn.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 Xia et al (WO 2019109125).
Additionally, dependent claims 12-13 which previously were dependent on claim 4 and were indicated as allowable subject matter in the previous non-final office action based on their dependency to claim 4 have been amended in the most recent set of claim amendments to depend on claim 1 only. This amendment raises a new ground of rejection in view of Xia as well .
Applicant’s arguments, see pgs. 9-10, filed 4/24/2026, with respect to the previous rejections of:
Claim(s) 5-6, 16, 27-29 under 35 USC 103 as being unpatentable over Zhou in view of Butzloff
Claim(s) 14 under 35 USC 103 as being unpatentable over Zhou in view of Butzloff in view of Luttrull in view of Sims
Claim(s) 25-26 under 35 USC 103 as being unpatentable over Zhou in view of Butzloff in view of Bahmani have been fully considered and are persuasive based on the amendments to the claims. The previous prior art rejections of claims 5-6, 14, 25-29 has been withdrawn.
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) 1-3, 7-9, 11-13, 18-22, 30, 33 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al (WO 2019109125) hereafter known as Xia
Independent claim:
Regarding claim 1:
A system for applying ocular light therapy to an eye of a subject [see abstract… “An ophthalmic treatment device for photobiomodulation of a retina” and Fig. 1 and Fig. 6], the system comprising:
one or more light sources configured to apply ocular photo-bio-stimulation light to a retina of the eye of the subject, wherein at least some of the ocular photo-bio stimulation light is transmitted towards the eye of the subject, and wherein light wavelengths of the ocular photo-bio-stimulation light are within a range of one or more of, 450nm - 500nm, 480nm +/- 30nm, 500nm +/- 30nm, 530nm +/- 20nm, 575nm +/-30nm, 600nm- 700nm, 700nm - 730nm, or 830nm +/- 30nm [see Fig. 1 element 12 and para 43… “The treatment device 11 consists of a treatment light source 12 which emits treatment light radiation in a treatment beam 12a at a wavelength range from about 600nm to about 1000nm, that is the say, in the red to near infrared region. A suitable treatment light source is a laser, a light emitting diode (LED), a lamp, or any alternative sources at 600nm - 1000nm radiation.”]; and
one or more optics located between the one or more light sources and the eye of the subject [see Fig. 1 and 4 elements 16-17 and para 46… “The uniform beam is delivered to a beam delivery and viewing module 16 which directs the beam through an optional contact lens 17 to the eye 18 of a patient.”],
wherein the one or more optics are configured to form an area on the retina comprising one or more of, an image, a part of an image, a shadow, filtered light, reduced ocular photo-bio-stimulation light, a darker color tone compared to the ocular photo-bio-simulation light, no light, or black, to protect a fovea of the eye of the subject from ocular photo-bio-stimulation light transmitted towards the fovea [see Fig. 5-6 and para 54… “In one embodiment the beam shaping element includes a mask. The mask is located in the collimating path of the light beam to block the central part of the light beam thus forming an annular profile as shown in FIG 5. The mask may be optically opaque materials to the light in the range of 600nm - 1000nm. The size of the mask is designed so that the inner diameter of the annular beam is greater than the diameter of the fovea or the optic disc of an eye to be treated.” A greater diameter indicates at least some of the macula closest to the fovea is protected],
However, it is not explicitly clear how far the mask embodiment disclosed by Fig. 5 of Xia that blocks actually extends into the periphery of the retina relative to the light. Therefore, this embodiment fails to explicitly discloses “and wherein a higher amount of ocular photo-bio-stimulation illumination or a higher intensity of the ocular photo-bio-stimulation light is applied to a peripheral retinal area of the eye of the subject compared to a central retina of the eye of the subject”.
Xia further discloses a zoom module that can affect the size of the light and the use of beam shaping elements that change the mask’s sizes and shapes in other embodiments [see para 52-53… “The zoom module 40 controls the spot size of the treatment light” and “The one or more beam shaping elements 42a may have various designs to shape the treatment light beam to an annular shape with a central void of various shapes and sizes.”] and that the scope of the disclosure includes variations of the embodiments indicating the scope of the disclosure includes combinations of different embodiments and their features [see para 71… “The above description of various embodiments of the present invention is provided for purposes of description to one of ordinary skill in the related art. It is not intended to be exhaustive or to limit the invention to a single disclosed embodiment. As mentioned above, numerous alternatives and variations to the present invention will be apparent to those skilled in the art of the above teaching. Accordingly, while some alternative embodiments have been discussed specifically, other embodiments will be apparent or relatively easily developed by those of ordinary skill in the art.”]
It would have been obvious to adjust the size and shape of Xia’s mask relative to the light so that at least part of the periphery of the retina is not covered by the mask (i.e. thereby reciting “and wherein a higher amount of ocular photo-bio-stimulation illumination or a higher intensity of the ocular photo-bio-stimulation light is applied to a peripheral retinal area of the eye of the subject compared to a central retina of the eye of the subject”) because this is a subcombination of different combinations of Xia’s embodiments disclosed within the scope of Xia.
Dependent claims:
Regarding claims 2-3, see rejection to claim 1 above which cites Figs. 5-6 and para 54 of Xia [see… “In one embodiment the beam shaping element includes a mask. The mask is located in the collimating path of the light beam to block the central part of the light beam thus forming an annular profile as shown in FIG 5. The mask may be optically opaque materials to the light in the range of 600nm - 1000nm. The size of the mask is designed so that the inner diameter of the annular beam is greater than the diameter of the fovea or the optic disc of an eye to be treated.” ] which discloses a mask (i.e. at the very least reduced light) being applied to the fovea as recited by claim 2. Also this mask is at least a masking fixation target that provides a fully protective area over the fovea as recited by claim 3.
Regarding claim 7, see para 22 of Xia [see “The annular treatment light beam profile preferably has a central void with a diameter of 1.0mm to 2.5mm and most preferably 1.5mm to 2.0mm. The outer diameter of the annular profile is preferably 4.5mm to 10mm and most suitably 4.5mm to 6.0mm.”] disclose the masking fixation target includes a profile with an outer diameter of 4.5-6 mm which recites this claim.
Regarding claim 8, see Fig. 1 and 4 which show an instrument [see element 11] with a lens [see element 30] as recited as claimed.
Regarding claim 9, para 16 of Xia [see “Further to the power measurement, the profiles of LED light projected on the paper target through the aperture and lens are significantly different at the settings with and without using the diffuser.”] discloses the device as having a diffuser which makes the device capable of having diffuser light enter the eye depending on how the device is used.
Regarding claim 11, see para 22 of Xia [see “The annular treatment light beam profile preferably has a central void with a diameter of 1.0mm to 2.5mm and most preferably 1.5mm to 2.0mm. The outer diameter of the annular profile is preferably 4.5mm to 10mm and most suitably 4.5mm to 6.0mm.”] disclose the masking fixation target includes a profile with an outer diameter of 4.5-6 mm which recites this claim.
Regarding claim 12-13, see Figs. 5-7 and rejection to claim 1 above which disclose a ring of light (i.e. annular light ring) surrounding the macula including the extending beyond an outer edge of the macula as recited in these claims.
Regarding claim 18, see Para 56 [see “The beam shaping element 42a, in another embodiment, may be a LCD array, or a micro mirror, or a number of alternative spatial light modulators.”] which discloses the device includes spatial light modulators capable of modulating light as claimed.
Regarding claim 19, see para 54 of Xia [see “the beam shaping element includes a mask. The mask is located in the collimating path of the light beam to block the central part of the light beam thus forming an annular profile as shown in FIG 5. The mask
may be optically opaque materials to the light in the range of 600nm - 1000nm.”] which discloses this claim.
Regarding claim 20, see para 64 of Xia [see “Persons skilled in the art will appreciate that there are a number of ways to control the duration of exposure for light treatment. In one simple technique the treatment light control includes a timer with a start button that initiates irradiation. Irradiation ceases at the end of the selected time. The same outcome is achieved by moving a beam block into the path of the treatment beam after a period determined by a timer.”] discloses fixed timed exposure (i.e. masking fixation target or filtering fixation target is fixed) as recited by this claim.
Regarding claim 21, see para 48 of Xia [see “The optical path for the Operator 19 is through binoculars 29, safety filter (not shown) and objective lens 30 to the eye 18 of the patient (and possible through optional contact lens 17). The light path is through the delivery head 26 and objective lens 30 (and possible through optional contact lens 17) to the eye 18. The aiming beam path is also through the delivery head 26 and objective lens 30 (and possible through optional contact lens 17) to the eye 18. An illumination light beam (not shown) from the slit lamp 25 is directed by one or more mirrors 27 to provide illumination to the eye 18.”] and para 58 of Xia [see “The objective lens 30 focusses the light beam 11 a onto the patient's retina 181 through the contact lens 17 which is temporarily adhered to the patient's eye with a high viscosity topical gel such as Genteal Gel (available from Novatis).”] which discloses an option contact lens which is understood to cable of being worn and therefore capable of being worn during, before or after application of light
Regarding claim 22, see Para 43 [… “Referring to FIG 1 there is a shown a block diagram of a treatment device 11 suitable for low level light therapy, such as photobiomodulation for treatment of ophthalmic disorders including diabetic retinopathy (DR), diabetic macular edema (DME) and age related macular degeneration (AMO). The treatment device 11 consists of a treatment light source 12 which emits treatment light radiation in a treatment beam 12a at a wavelength range from about 600nm to about 1000nm, that is the say, in the red to near infrared region.”] which demonstrates capability to treat either wet or dry macular degeneration.
Regarding claim 30, see Figs. 5-6 which discloses a masking fixation target is at least capable of moving within a radius of an arc of the eye as claimed.
Regarding claim 33, see para 43 of Xia [see “A suitable treatment light source is a laser, a light emitting diode (LED), a lamp, or any alternative sources at 600nm - 1000nm radiation.”] which discloses one or more LEDs as claimed.
Regarding claim 35, see rejection to claim 1 above which cites Figs. 5-6 and para 54 of Xia [see… “In one embodiment the beam shaping element includes a mask. The mask is located in the collimating path of the light beam to block the central part of the light beam thus forming an annular profile as shown in FIG 5. The mask may be optically opaque materials to the light in the range of 600nm - 1000nm. The size of the mask is designed so that the inner diameter of the annular beam is greater than the diameter of the fovea or the optic disc of an eye to be treated.” ] which discloses the optics comprise or support a masking fixation target.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xia as applied to claim 1 above, and further in view of Butzloff et al (US 20180345034) hereafter known as Butzloff.
Xia discloses the invention substantially as claimed including all the limitations of claims 1 as outlined above.
However, Xia fails to disclose “wherein the one or more light sources provide an ocular photo-bio-stimulation light intensity of 500 lux or more, and wherein the ocular photo-bio-stimulation light upon striking the retina of the subject has a light intensity of 300 lux or more.” as claimed.
Butzloff discloses in the analogous art of ophthalmological light treatments [see para 2… “This invention relates to treatment ocular disorders, in general, and to treatment of myopia, in particular.” And see abstract… “Illumination apparatus, ocular apparatus, and ocular method for treating at least one eye.”] light emitting diodes (i.e. photo-bio-stimulation light sources) with an illumination that has upper range of 30000 lux [see Figs. 5-8 element(s) 40 and para 46… “one therapeutic illuminator panel arrangement 40” and para 43… “Light source 27 may be a stand-alone panel, which may consist of an array of surface mounted light emitting diodes (SMD), or an array of chip-mounted optical output devices (COB).” And para 8… “the illuminator is configured to provide illuminance values from about 2,000 lux to about 30,000 lux”] that strike the retina with at least 300 lux with a wavelength of 640-690 nm for the purpose of helping treat myopia and macular degeneration which Butzloff discloses is often associated with myopia [see abstract… “Illuminator illuminates eyes with 100 lux of monochromatic red light of 640 nm to 690 nm. Illuminator controls progressive myopia leading to excessive axial elongation in a juvenile or to ameliorate macular degeneration in an aging adult.” And para 5… “Further, adults with extreme myopia can be prone to myopic macular degeneration later in life.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Xia’s system to include using a light source that includes diodes capable of illuminance value of up 30000 lux that can produce 640-690 nm and at least 300 lux as the light source (i.e. thereby reciting the light source as claimed,) because this will increase the versality of the device to treat additional related eye conditions.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xia as applied to claim 1 above, and further in view of Zhou et al (US 20220107508) hereafter known as Zhou.
Xia discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, Xia fails to disclose “wherein the ocular light therapy is utilized or applied in combination with one or more of, the subject wearing a myopia control lens or lenses, admission of atropine to the subject, admission of an oral medication to the subject, admission of a medication to the subject, or orthokeratology.” as recited by claim 34.
Zhou discloses in the analogous art of ophthalmological light therapy [see para 8… “In accordance with the present invention, micro-reticles and corresponding micro-lenses are distributed around the paracentral and/or peripheral region of a spectacle lens or lens combination with each micro-lens arranged in between its corresponding micro-reticle and the pupil of a wearer's eye. The micro-lens refracts the light rays from the micro-reticle such that when the micro-reticle is presented to the wearer's eye, at least along one direction, a sharply focused line of the reticle image is formed either substantially on the paracentral and/or peripheral retina (i.e. within focus as perceived by a wearer's eye) or in front of the paracentral and/or peripheral retina (i.e. myopically defocused within a desired range as perceived by the wearer's eye).”] that the use of Atropine is a known way to treat myopia [see para 82… “All children are at risk of developing myopia which emerges between the ages of 4 to 10 and continue to progress until up to 25 years of age. There are several approaches to prevent progression of myopia during this period, including pharmaceutical (i.e. low dose Atropine) and optical (i.e. specially designed contact lenses).”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Xia to include a configuration that uses Atropine similarly to that discussed by Zhou with treatment because will allow for the treatment of myopia in addition to other conditions thereby increasing the versatility Xia’s device.
Allowable Subject Matter
Claims 4-6, 10, 14, 16, 25-29 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 4 and 10:
Claim 4 is broadest claim of this group of claims. Claim 4 recites a system for applying ocular light therapy to an eye of a subject. The closest prior art is Xia. Xia discloses the invention substantially as claimed including all the limitations of claims 1 and 3 as outlined above. However, Xia fails to disclose “the fully protective area is partially or completely surrounded by a blended protective area” as claimed. Furthermore, nothing in the prior art when viewed with Xia obviates this deficiency. It is important to note that the allowability is not based on the missing limitation alone, but rather the missing limitation in combination with all the limitations of claim 4 together (including those limitations recited through dependency), which defines the invention over the prior art. Therefore, the combination of claimed limitations recited by claim 4 is neither anticipated, nor obviated in view of the prior art.
Regarding claims 5-6, 14, 16, 25-29:
Claim 27 is broadest claim of this group of claims. Claim 27 recites a system for applying ocular light therapy to an eye of a subject. The closest prior art is Xia. Xia discloses the invention substantially as claimed including all the limitations of claims 1 as outlined above. However, Xia fails to disclose “a fine-tuned fixation target is located or configured to appear to be located within an outer perimeter of the masking fixation target or the filtering fixation target.”. Furthermore, nothing in the prior art when viewed with Xia obviates this deficiency. It is important to note that the allowability is not based on the missing limitation alone, but rather the missing limitation in combination with all the limitations of claim 27 together (including those limitations recited through dependency), which defines the invention over the prior art. Therefore, the combination of claimed limitations recited by claim 27 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
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