DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 22 June 2026 has been entered.
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 22 June 2026 wherein Claims 1 and 8 – 10 are amended, Claim 11 is previously cancelled, and Claims 16 – 20 are newly added. Therefore, Claims 1 – 10 and 12 – 20 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 8 – 11, filed 22 June 2026, with respect to the rejection(s) of independent claim(s) 1, 8, 9, and 10 and their respective dependent claims under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Friedman et al. (US 2016/0310758 A1), Chao et al. (US 2019/0168020 A1), and Rogers (US 2007/0288071 A1).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 8 – 10, 12, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al. (US 2016/0310758 A1) (hereinafter referred to as “Friedman”) and Chao et al. (US 2019/0168020 A1) (hereinafter referred to as “Chao”), as evidenced and motivated by Rogers (US 2007/0288071 A1).
Friedman is cited in the Notice of References Cited form dated 21 November 2024.
Rogers is cited in the Notice of References Cited form dated 23 January 2026.
With regards to claim 1, Friedman discloses (see Fig. 4) a non-invasive cornea and sclera strengthening system (200) (see [0049] “photoactivation device 200 that is configured to activate a photosensitizer, such as riboflavin, that has been applied to eye tissue according to an antimicrobial treatment”) adapted to:
irradiate violet light toward an eye, without ablating a corneal epithelium of the eye (see [0037], [0044], and [0077]); and
administer an administration agent to elicit crosslinking of collagen fibers constituting corneal tissue or scleral tissue of the eye (see [0037] “other approaches avoid epithelial debridement,” [0044] “When photosensitizers (e.g., riboflavin) are applied to the cornea, the subsequent application of photoactivating light (e.g., UVA light) may result in cross-linking activity,” and [0077] “It is understood, however, that alternative embodiments may call for cross-linking activity (to modify biomechanical properties) in addition to antimicrobial treatment. As such, the model based on the photochemical kinetic reactions allows these alternative embodiments to generate ROS and/or other radicals for the desired antimicrobial effect and desired cross-linking activity”),
wherein the non-invasive cornea and sclera strengthening system is further adapted to
irradiate the violet light onto a surface of the eye within a range of 0.1 to 1 mW/cm2, inclusive (see [0052] “The number of photoactivating light sources 204 may be limited to the number required to provide the desired low dose of photoactivating light, e.g., delivered at an irradiance of approximately 0.3 mW/cm2”).
However, Friedman is silent with regards to the system being adapted to:
irradiate violet light in wavelengths within a range of 360 nm to 400 nm, inclusive, and
irradiate the violet light onto the eye within a range of three to five hours, inclusive, per day for a plurality of consecutive days.
Nonetheless, a second embodiment of Friedman further teaches (Figs. 1a – 1b) wherein the system is adapted to irradiate the violet light in wavelengths within a range of 360 nm to 400 nm, inclusive (see [0023] “The photoactivating light sources 106 may be light emitting diodes (LED's) that can emit selected wavelengths of light, e.g., 365 nm, 450 nm, etc.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the wavelength that the system of Friedman is capable of providing in view of a teaching of the second embodiment of Friedman such that the system is adapted to irradiate the violet light in wavelengths within a range of 360 nm to 400 nm, inclusive. One of ordinary skill in the art would have been motivated to make this modification, as Friedman teaches that this specific wavelength achieves the desired photochemical kinetic reactions, antimicrobial effects, and cross-linking (see [0023] and [0077] of Friedman).
However, neither embodiment of Friedman teaches that the system is adapted to:
irradiate the violet light onto the eye within a range of three to five hours, inclusive, per day for a plurality of consecutive days.
Nonetheless Chao, which is within the analogous art of light source apparatuses and wearable apparatuses (see abstract and title), teaches a system adapted to:
irradiate violet light in wavelengths within a range of 360 nm to 400 nm, inclusive, (see [0026] “Moreover, the wavelength of the monochromatic light falls in a range of 380 nm to 780 nm, and an irradiance (intensity) of the monochromatic light entering the eyes of the user falls in a range of 30 μW/cm2 to 200 μW/cm2”) and
irradiate the violet light onto the eye within a range of three to five hours, inclusive, per day for a plurality of consecutive days (see [0026] “A frequency of light illumination ranges from three times a day to once a week. A duration of light illumination each time is 0.5 hours to 4 hours. A total course of light illumination falls in a range of 1 day to 3 months.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the duration of irradiation per day that the system of Friedman is adapted to provide in view of a teaching of Chao such that the system is adapted to irradiate the violet light onto the eye within a range of three to five hours, inclusive, per day for a plurality of consecutive days. One of ordinary skill in the art would have been motivated to make this modification because Rogers teaches that low irradiance treatment generally provides a treatment level that is sufficient to initiate a photodynamic effect, which can then be continued over a desired period of time to achieve the desired treatment level in the target tissue, without causing damage to the surrounding tissue (see [0024] of Rogers). Here, the irradiance duration can be tailored such that it is about three to four hours long per day in order to reach the desired treatment level in the target tissue to initiate the photodynamic effect each day. Alternatively, one of ordinary skill in the art would have been motivated to make this modification because Chao teaches that this duration of irradiation and length of treatment is designed to take into account vision, psychology, physiological effect, and biological effect of the human body, to achieve a treatment of the human body (see [0004], [0036], of Chao).
The system of Friedman modified in view of a teaching of Chao as further evidenced and motivated by Rogers will hereinafter be referred to as the system of Friedman, Chao, and Rogers.
With regards to claim 2, the system of Friedman, Chao, and Rogers teaches the claimed invention of claim 1, and Friedman further teaches wherein the non-invasive cornea and sclera strengthening system (200) comprises a facially-oriented type device (see [0051] “the photoactivation device 200 in FIG. 4 resembles a pair of eyeglasses”) that is adapted to irradiate the violet light in a direction of the eye (see [0055]), and
wherein the facially-oriented type device comprises one or more devices from among eyeglasses (see [0051] “the photoactivation device 200 in FIG. 4 resembles a pair of eyeglasses”) with a light source (204) (see [0055] “light sources 204”), a liquid crystal display with a light source, a desk lamp, a handy light source, a table-top installed-type light source, a personal computer mounted-type light source, and a mobile terminal mounted-type light source.
With regards to claim 8, Friedman discloses (see Figure 4) a non-invasive cornea and sclera strengthening system (200) (see [0049] “photoactivation device 200 that is configured to activate a photosensitizer, such as riboflavin, that has been applied to eye tissue according to an antimicrobial treatment”) adapted to irradiate violet light toward an eye without ablating a corneal epithelium to strengthen a tissue of a cornea or a sclera, at a timing after administration of an administration agent, used for strengthening the tissue of the cornea or the sclera, to the eye (see [0037] “other approaches avoid epithelial debridement,” [0044] “When photosensitizers (e.g., riboflavin) are applied to the cornea, the subsequent application of photoactivating light (e.g., UVA light) may result in cross-linking activity,” and [0077] “It is understood, however, that alternative embodiments may call for cross-linking activity (to modify biomechanical properties) in addition to antimicrobial treatment. As such, the model based on the photochemical kinetic reactions allows these alternative embodiments to generate ROS and/or other radicals for the desired antimicrobial effect and desired cross-linking activity”),
wherein the non-invasive cornea and sclera strengthening system is adapted to irradiate the violet light onto a surface of the eye within a range of 0.1 to 1 mW/cm2, inclusive (see [0052] “The number of photoactivating light sources 204 may be limited to the number required to provide the desired low dose of photoactivating light, e.g., delivered at an irradiance of approximately 0.3 mW/cm2”).
However Friedman is silent with regards to the non-invasive cornea and sclera strengthening system being adapted to:
irradiate violet light in wavelengths within a range of 360 nm to 400 nm, inclusive, and
wherein the non-invasive cornea and sclera strengthening system is adapted to irradiate the violet light onto the eye within a range of three to five hours, inclusive, per day for a plurality of consecutive days.
Nonetheless, a second embodiment of Friedman further teaches (Figs. 1a – 1b) wherein the system is adapted to irradiate the violet light in wavelengths within a range of 360 nm to 400 nm, inclusive (see [0023] “The photoactivating light sources 106 may be light emitting diodes (LED's) that can emit selected wavelengths of light, e.g., 365 nm, 450 nm, etc.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the wavelength that the system of Friedman is capable of providing in view of a teaching of the second embodiment of Friedman such that the system is adapted to irradiate the violet light in wavelengths within a range of 360 nm to 400 nm, inclusive. One of ordinary skill in the art would have been motivated to make this modification, as Friedman teaches that this specific wavelength achieves the desired photochemical kinetic reactions, antimicrobial effects, and cross-linking (see [0023] and [0077] of Friedman).
However, neither embodiment of Friedman teaches the following:
wherein the non-invasive cornea and sclera strengthening system is adapted to irradiate the violet light onto the eye within a range of three to five hours, inclusive, per day for a plurality of consecutive days.
Nonetheless Chao, which is within the analogous art of light source apparatuses and wearable apparatuses (see abstract and title), teaches a system adapted to:
irradiate violet light in wavelengths within a range of 360 nm to 400 nm, inclusive, (see [0026] “Moreover, the wavelength of the monochromatic light falls in a range of 380 nm to 780 nm, and an irradiance (intensity) of the monochromatic light entering the eyes of the user falls in a range of 30 μW/cm2 to 200 μW/cm2”) and
irradiate the violet light onto the eye within a range of three to five hours, inclusive, per day for a plurality of consecutive days (see [0026] “A frequency of light illumination ranges from three times a day to once a week. A duration of light illumination each time is 0.5 hours to 4 hours. A total course of light illumination falls in a range of 1 day to 3 months.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the duration of irradiation per day that the system of Friedman is adapted to provide in view of a teaching of Chao such that the system is adapted to irradiate the violet light onto the eye within a range of three to five hours, inclusive, per day for a plurality of consecutive days. One of ordinary skill in the art would have been motivated to make this modification because Rogers teaches that low irradiance treatment generally provides a treatment level that is sufficient to initiate a photodynamic effect, which can then be continued over a desired period of time to achieve the desired treatment level in the target tissue, without causing damage to the surrounding tissue (see [0024] of Rogers). Here, the irradiance duration can be tailored such that it is about three to four hours long per day in order to reach the desired treatment level in the target tissue to initiate the photodynamic effect each day. Alternatively, one of ordinary skill in the art would have been motivated to make this modification because Chao teaches that this duration of irradiation and length of treatment is designed to take into account vision, psychology, physiological effect, and biological effect of the human body, to achieve a treatment of the human body (see [0004], [0036], of Chao).
With regards to claim 9, Friedman discloses (see Figure 4) a non-invasive cornea and sclera strengthening method, comprising the step of:
using a non-invasive cornea and sclera strengthening system (200) (see [0049] “photoactivation device 200 that is configured to activate a photosensitizer, such as riboflavin, that has been applied to eye tissue according to an antimicrobial treatment”) capable of setting an irradiance of violet light onto a surface of an eye, without ablating a corneal epithelium of the eye, within a range of 0.1 to 1 mW/cm2, inclusive, (see [0037] “other approaches avoid epithelial debridement,” [0044] “When photosensitizers (e.g., riboflavin) are applied to the cornea, the subsequent application of photoactivating light (e.g., UVA light) may result in cross-linking activity,” [0052] “The number of photoactivating light sources 204 may be limited to the number required to provide the desired low dose of photoactivating light, e.g., delivered at an irradiance of approximately 0.3 mW/cm2, “and [0077] “It is understood, however, that alternative embodiments may call for cross-linking activity (to modify biomechanical properties) in addition to antimicrobial treatment. As such, the model based on the photochemical kinetic reactions allows these alternative embodiments to generate ROS and/or other radicals for the desired antimicrobial effect and desired cross-linking activity”) and
setting a time of irradiation of the violet light onto the eye per day at a timing after administration of an administration agent used for strengthening a tissue of a cornea or a sclera to the eye, irradiating the violet light by the non-invasive cornea and sclera strengthening system onto the eye to elicit crosslinking of collagen fibers constituting corneal tissue or scleral tissue of the eye (see [0037], [0044], [0052], and [0077]).
Nonetheless, a second embodiment of Friedman further teaches (Figs. 1a – 1b) wherein the system is adapted to irradiate the violet light in wavelengths within a range of 360 nm to 400 nm, inclusive (see [0023] “The photoactivating light sources 106 may be light emitting diodes (LED's) that can emit selected wavelengths of light, e.g., 365 nm, 450 nm, etc.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the wavelength that the non-invasive cornea and sclera strengthening system of the non-invasive cornea and sclera strengthening method of Friedman is capable of providing in view of a teaching of the second embodiment of Friedman such that the non-invasive cornea and sclera strengthening system is adapted to irradiate the violet light in wavelengths within a range of 360 nm to 400 nm, inclusive. One of ordinary skill in the art would have been motivated to make this modification, as Friedman teaches that this specific wavelength achieves the desired photochemical kinetic reactions, antimicrobial effects, and cross-linking (see [0023] and [0077] of Friedman).
However neither embodiment of Friedman teaches that the system of the non-invasive cornea and sclera strengthening method:
setting a time of irradiation of the violet light onto the eye within a range of three to five hours, inclusive per day, and
irradiating the violet light by the non-invasive cornea and sclera strengthening system onto the eye within the range of three to five hours, inclusive per day for a plurality of consecutive days.
Nonetheless Chao, which is within the analogous art of light source apparatuses and wearable apparatuses (see abstract and title), teaches a system within a method adapted to:
irradiate violet light in wavelengths within a range of 360 nm to 400 nm, inclusive, (see [0026] “Moreover, the wavelength of the monochromatic light falls in a range of 380 nm to 780 nm, and an irradiance (intensity) of the monochromatic light entering the eyes of the user falls in a range of 30 μW/cm2 to 200 μW/cm2”) and
setting a time of irradiation of the violet light onto the eye within a range of three to five hours, inclusive per day (see [0026]),
irradiate the violet light onto the eye within a range of three to five hours, inclusive, per day for a plurality of consecutive days (see [0026] “A frequency of light illumination ranges from three times a day to once a week. A duration of light illumination each time is 0.5 hours to 4 hours. A total course of light illumination falls in a range of 1 day to 3 months.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the duration of irradiation per day that the system of the method of Friedman is adapted to provide in view of a teaching of Chao such that the method further comprises setting a time of irradiation of the violet light onto the eye within a range of three to five hours, inclusive per day, and irradiating the violet light by the non-invasive cornea and sclera strengthening system onto the eye within the range of three to five hours, inclusive per day for a plurality of consecutive days. One of ordinary skill in the art would have been motivated to make this modification because Rogers teaches that low irradiance treatment generally provides a treatment level that is sufficient to initiate a photodynamic effect, which can then be continued over a desired period of time to achieve the desired treatment level in the target tissue, without causing damage to the surrounding tissue (see [0024] of Rogers). Here, the irradiance duration can be tailored such that it is about three to four hours long per day in order to reach the desired treatment level in the target tissue to initiate the photodynamic effect each day. Alternatively, one of ordinary skill in the art would have been motivated to make this modification because Chao teaches that this duration of irradiation and length of treatment is designed to take into account vision, psychology, physiological effect, and biological effect of the human body, to achieve a treatment of the human body (see [0004], [0036], of Chao).
With regards to claim 10, Friedman discloses (see Figure 4) a non-invasive cornea and sclera strengthening method, comprising the step of:
using a non-invasive cornea and sclera strengthening system (200)(see [0049] “photoactivation device 400 that is configured to activate a photosensitizer, such as riboflavin, that has been applied to eye tissue according to an antimicrobial treatment”) capable of setting an irradiance of violet light onto a surface of an eye, without ablating a corneal epithelium, at a timing after administration of an administration agent, used for strengthening a tissue of a cornea or a sclera, to the eye, within a range of 0.1 to 1 mW/cm2, inclusive (see [0037] “other approaches avoid epithelial debridement,” [0044] “When photosensitizers (e.g., riboflavin) are applied to the cornea, the subsequent application of photoactivating light (e.g., UVA light) may result in cross-linking activity,” [0052] “The number of photoactivating light sources 204 may be limited to the number required to provide the desired low dose of photoactivating light, e.g., delivered at an irradiance of approximately 0.3 mW/cm2,” and [0077] “It is understood, however, that alternative embodiments may call for cross-linking activity (to modify biomechanical properties) in addition to antimicrobial treatment. As such, the model based on the photochemical kinetic reactions allows these alternative embodiments to generate ROS and/or other radicals for the desired antimicrobial effect and desired cross-linking activity”), and setting a time of irradiation of the violet light onto the eye and irradiating the violet light onto the eye to elicit crosslinking of collagen fibers constituting corneal tissue or scleral tissue of the eye (see [0037], [0044], [0052], and [0077]).
However Friedman is silent with regards to the following:
the irradiance of violet light in wavelengths is within a range of 360 nm to 400 nm, inclusive, and
setting a time of irradiation of the violet light onto the eye within a range of three to five hours, inclusive per day, and
irradiating the violet light by the non-invasive cornea and sclera strengthening system onto the eye within the range of three to five hours, inclusive per day for a plurality of consecutive days.
Nonetheless, a second embodiment of Friedman further teaches (Figs. 1a – 1b) wherein the non-invasive cornea and sclera strengthening system is adapted to irradiate the violet light in wavelengths within a range of 360 nm to 400 nm, inclusive (see [0023] “The photoactivating light sources 106 may be light emitting diodes (LED's) that can emit selected wavelengths of light, e.g., 365 nm, 450 nm, etc.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the wavelength that the non-invasive cornea and sclera strengthening system of the non-invasive cornea and sclera strengthening method of Friedman is capable of providing in view of a teaching of the second embodiment of Friedman such that the non-invasive cornea and sclera strengthening system is adapted to irradiate the violet light in wavelengths within a range of 360 nm to 400 nm, inclusive. One of ordinary skill in the art would have been motivated to make this modification, as Friedman teaches that this specific wavelength achieves the desired photochemical kinetic reactions, antimicrobial effects, and cross-linking (see [0023] and [0077] of Friedman).
However neither embodiment of Friedman teaches that the non-invasive cornea and sclera strengthening system of the non-invasive cornea and sclera strengthening method is adapted to:
setting a time of irradiation of the violet light onto the eye within a range of three to five hours, inclusive per day, and
irradiating the violet light by the non-invasive cornea and sclera strengthening system onto the eye within the range of three to five hours, inclusive per day for a plurality of consecutive days.
Nonetheless Chao, which is within the analogous art of light source apparatuses and wearable apparatuses (see abstract and title), teaches a system within a method adapted to:
irradiate violet light in wavelengths within a range of 360 nm to 400 nm, inclusive, (see [0026] “Moreover, the wavelength of the monochromatic light falls in a range of 380 nm to 780 nm, and an irradiance (intensity) of the monochromatic light entering the eyes of the user falls in a range of 30 μW/cm2 to 200 μW/cm2”) and
setting a time of irradiation of the violet light onto the eye within a range of three to five hours, inclusive per day (see [0026]),
irradiate the violet light onto the eye within a range of three to five hours, inclusive, per day for a plurality of consecutive days (see [0026] “A frequency of light illumination ranges from three times a day to once a week. A duration of light illumination each time is 0.5 hours to 4 hours. A total course of light illumination falls in a range of 1 day to 3 months.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the duration of irradiation per day that the system of the method of Friedman is adapted to provide in view of a teaching of Chao such that the method further comprises setting a time of irradiation of the violet light onto the eye within a range of three to five hours, inclusive per day, and irradiating the violet light by the non-invasive cornea and sclera strengthening system onto the eye within the range of three to five hours, inclusive per day for a plurality of consecutive days. One of ordinary skill in the art would have been motivated to make this modification because Rogers teaches that low irradiance treatment generally provides a treatment level that is sufficient to initiate a photodynamic effect, which can then be continued over a desired period of time to achieve the desired treatment level in the target tissue, without causing damage to the surrounding tissue (see [0024] of Rogers). Here, the irradiance duration can be tailored such that it is about three to four hours long per day in order to reach the desired treatment level in the target tissue to initiate the photodynamic effect each day. Alternatively, one of ordinary skill in the art would have been motivated to make this modification because Chao teaches that this duration of irradiation and length of treatment is designed to take into account vision, psychology, physiological effect, and biological effect of the human body, to achieve a treatment of the human body (see [0004], [0036], of Chao).
With regards to claim 12, the system of Friedman, Chao, and Rogers teaches the claimed invention of claim 1, and Friedman further teaches (Fig. 4) wherein the non-invasive cornea and sclera strengthening system (200) comprises at least one of eyeglasses (see [0051] “As shown in FIG. 4, the photoactivation device 200 includes a body 202. The body 202 may be shaped and worn like an eyeglasses frame”) or a soft contact lens.
With regards to claim 16, the system of Friedman, Chao, and Rogers teaches the claimed invention of claim 1, the non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers further wherein the plurality of consecutive days comprises at least seven days (see [0026] of Chao and the rejection of Claim 1 above).
Claim(s) 3, 6, and 13 – 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friedman, Chao, and Rogers as applied to claims 1 and 12 above, and further in view of Ivri (US 2016/0199225 A1).
Ivri is cited in the Notice of References Cited form dated 21 November 2024.
With regards to claim 3, the system of Friedman, Chao, and Rogers teaches the claimed invention of claim 1, and Friedman further teaches (Fig. 4) wherein the non-invasive cornea and sclera strengthening system (200) comprises a facially-oriented type device (see [0051] “the photoactivation device 200 in FIG. 4 resembles a pair of eyeglasses”) that is adapted to irradiate the violet light in a direction of the eye (see [0055]).
However, the system of Friedman, Chao, and Rogers is silent with regards to an administrating device configured to administer the administration agent is integrated with the facially-oriented type device.
Nonetheless Ivri, which is within the analogous art of micro-droplet delivery devices and methods (see abstract), teaches (Figs. 1 – 5A) an administrating device (100; see [0048]) configured to administer the administration agent (120; see [0048]) is integrated with the facially-oriented type device (502; see Figs. 5-5A and [0031] – [0032] and [0064] – [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers in view of a teaching of Ivri such that an administrating device configured to administer the administration agent is integrated with the facially-oriented type device. One of ordinary skill in the art would have been motivated to make this modification, as Ivri teaches a means for delivering an administrative agent to the eye without causing the blinking reflex (see [0043] of Ivri). One of ordinary skill would utilize the administrating device of Ivri in order to deliver the administrative agent such that the patient does not blink away the administrative agent.
With regards to claim 6, the system of Friedman, Chao, and Rogers teaches the claimed invention of claim 1, however, Friedman is silent with regards to wherein the non-invasive cornea and sclera strengthening system is adapted to carry out administration of the administration agent periodically or continuously.
Nonetheless Ivri, which is within the analogous art of micro-droplet delivery devices and methods (see abstract), teaches (Figs. 1A – 5A) the non-invasive cornea and sclera strengthening system (100; see [0048]) is adapted to carry out administration of the administration agent periodically or continuously (see [0059] “continuously dispensing droplet of 500 pL at a frequency of 33 Hz”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers in view of a teaching of Ivri such that the non-invasive cornea and sclera strengthening system is adapted to carry out administration of the administration agent periodically or continuously. One of ordinary skill in the art would have been motivated to make this modification because Ivri teaches a means for delivering an administrative agent to the eye without causing the blinking reflex (see [0043] of Ivri). One of ordinary skill would utilize the administrating device of Ivri in order to deliver the administrative agent such that the patient does not blink away the administrative agent.
With regards to claim 13, the system of Friedman, Chao, and Rogers teaches the claimed invention of claim 12, and Friedman further teaches wherein the non-invasive cornea and sclera strengthening system (200) comprises:
the eyeglasses (see [0051] “As shown in FIG. 4, the photoactivation device 200 includes a body 202. The body 202 may be shaped and worn like an eyeglasses frame”).
However, Friedman is silent with regards to the system further comprising:
an administrating device configured to administer the administration agent that is integrated with the eyeglasses.
Nonetheless Ivri, which is within the analogous art of micro-droplet delivery devices and methods (see abstract), teaches (Figs. 1A – 5A) the non-invasive cornea and sclera strengthening system comprises:
the eyeglasses (502; see [0064] and Figs. 5-5A), and
an administrating device (100; see [0048]) configured to administer the administration agent that is integrated with the eyeglasses (see Figs. 5 – 5A and [0064]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers in view of a teaching of Ivri such that the non-invasive cornea and sclera strengthening system further comprises the eyeglasses; and an administrating device configured to administer the administration agent that is integrated with the eyeglasses. One of ordinary skill in the art would have been motivated to make this modification, as Ivri teaches a means for delivering an administrative agent to the eye without causing the blinking reflex (see [0043] of Ivri). One of ordinary skill would utilize the administrating device of Ivri in order to deliver the administrative agent such that the patient does not blink away the administrative agent.
With regards to claim 14, the system of Friedman, Chao, and Rogers teaches the claimed invention of claim 12, however, Friedman is silent with regards to wherein the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent to the eye by sustained release from an eyeglass frame of the eyeglasses or sustained release from the soft contact lens.
Nonetheless Ivri, which is within the analogous art of micro-droplet delivery devices and methods (see abstract), teaches (Figs. 1A – 5A) the non-invasive cornea and sclera strengthening system (100; see [0048]) is adapted to administer the administration agent (120; see [0065]) to the eye by sustained release from an eyeglass frame (501; see [0064]) of the eyeglasses (502; see Figs. 5 – 5A and [0047], [0059], and [0064]) or sustained release from the soft contact lens.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers in view of a teaching of Ivri such that the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent to the eye by sustained release from an eyeglass frame of the eyeglasses or sustained release from the soft contact lens. One of ordinary skill in the art would have been motivated to make this modification, as Ivri teaches a means for delivering an administrative agent to the eye without causing the blinking reflex (see [0043] of Ivri). One of ordinary skill would utilize the administrating device of Ivri in order to deliver the administrative agent such that the patient does not blink away the administrative agent.
The non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers modified in view of a teaching of Ivri will hereinafter be referred to as the non-invasive cornea and sclera strengthening system of Friedman, Chao, Rogers, and Ivri.
With regards to claim 15, the non-invasive cornea and sclera strengthening system of Friedman, Chao, Rogers, and Ivri teaches the claimed invention of claim 14, however, Friedman is silent with regards to wherein the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent to the eye by sustained release from a mist spraying device disposed on the eyeglass frame.
Nonetheless Ivri, which is within the analogous art of micro-droplet delivery devices and methods (see abstract), teaches (Figs. 1A – 5A) the non-invasive cornea and sclera strengthening system (100; see [0048]) is adapted to administer the administration agent (120; see [0064]) to the eye by sustained release from a mist spraying device (110; see [0047], [0059], and [0064]) disposed on the eyeglass frame (501; see [0064] and see Figs. 5 – 5A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the non-invasive cornea and sclera strengthening system of Friedman, Chao, Rogers, and Ivri in view of a further teaching of Ivri such that the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent to the eye by sustained release from a mist spraying device disposed on the eyeglass frame. One of ordinary skill in the art would have been motivated to make this modification, as Ivri teaches a means for delivering an administrative agent to the eye without causing the blinking reflex (see [0043] of Ivri). One of ordinary skill would utilize the administrating device of Ivri in order to deliver the administrative agent such that the patient does not blink away the administrative agent.
Claim(s) 4, 5, 7, and 17 – 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friedman, Chao, and Rogers as applied to claims 1 and 16 above, and further in view of Liu et al. (US 2008/0181967 A1) (hereinafter referred to as “Liu”).
Liu is cited in the Notice of References Cited form dated 21 November 2024.
With regards to claim 4, the non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers teaches the claimed invention of claim 1, however, Friedman is silent with regards to wherein the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent to the eye by one or two or more methods selected from eye drops, eye ointment, sustained release from an eyeglass frame, or sustained release from a contact lens.
Nonetheless Liu, which is within the analogous art of contact lens (see [0012] and [0118]), teaches the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent (see [0118] “riboflavin”) to the eye by one or two or more methods selected from eye drops, eye ointment, sustained release from an eyeglass frame, or sustained release from a contact lens (see [0012] and [0118]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers in view of a teaching of the Liu such that the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent to the eye by one or two or more methods selected from eye drops, eye ointment, sustained release from an eyeglass frame, or sustained release from a contact lens. One of ordinary skill in the art would have been motivated to make this modification, as Liu teaches that riboflavin is a crosslinking agent that increases the mechanical strength of the eye and a contact lens is a means for delivering the riboflavin to the eye (see [0012], [0115], and [0118] of Liu). Therefore, one of ordinary skill in the art would be motivated to use contact lens to release the administration to the eye in order to increase the mechanical strength of the eye.
The non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers modified in view of a teaching of Liu will hereinafter be referred to as the non-invasive cornea and sclera strengthening system of Friedman, Chao, Rogers, and Liu.
With regards to claim 5, the non-invasive cornea and sclera strengthening system of Friedman, Chao, Rogers, and Liu teaches the claimed invention of claim 4, and Liu further teaches wherein the contact lens is adapted to transmit the violet light (see [0012] and [0118] “exposing the lens to ultraviolet light (UVA)” of Liu).
With regards to claim 7, the non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers teaches the claimed invention of claim 1, however, Friedman is silent with regards to wherein the non-invasive cornea and sclera strengthening system is adapted to treat at least one from among keratoconus, corneal ectasia, corneal infection, bullous keratopathy, and ametropia.
Nonetheless Liu, which is within the analogous art of contact lens (see [0012] and [0118]), teaches the non-invasive cornea and sclera strengthening system is adapted to treat at least one from among keratoconus, corneal ectasia, corneal infection, bullous keratopathy, and ametropia (see [0115] “Such a condition can be, for instance, keratoconus or corneal ectasia”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers in view of a teaching of Liu such that the non-invasive cornea and sclera strengthening system is adapted to treat at least one from among keratoconus, corneal ectasia, corneal infection, bullous keratopathy, and ametropia. One of ordinary skill in the art would have been motivated to make this modification because Liu teaches that this crosslinking agent can be used to facilitate crosslinking of collagens in the eye for treating keratoconus or corneal ectasia (see [0115] of Liu).
With regards to claim 17, the non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers teaches the claimed invention of claim 16, however, Friedman is silent with regards to wherein the non-invasive cornea and sclera strengthening system comprises at least one of: eyeglasses or a soft contact lens, and the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent to the eye by sustained release from an eyeglass frame of the eyeglasses or sustained release from the soft contact lens.
Nonetheless Liu, which is within the analogous art of contact lens (see [0012] and [0118]), teaches wherein the non-invasive cornea and sclera strengthening system comprises at least one of: eyeglasses or a soft contact lens (see [0012] and [0118]), and the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent (see [0118] “riboflavin”) to the eye by sustained release from an eyeglass frame of the eyeglasses or sustained release from the soft contact lens (see [0012] and [0118]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers in view of a teaching of the Liu such that wherein the non-invasive cornea and sclera strengthening system further comprises at least one of: eyeglasses or a soft contact lens, and the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent to the eye by sustained release from an eyeglass frame of the eyeglasses or sustained release from the soft contact lens. One of ordinary skill in the art would have been motivated to make this modification, as Liu teaches that riboflavin is a crosslinking agent that increases the mechanical strength of the eye and a contact lens is a means for delivering the riboflavin to the eye (see [0012], [0115], and [0118] of Liu). Therefore, one of ordinary skill in the art would be motivated to use contact lens to release the administration to the eye in order to increase the mechanical strength of the eye.
The non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers modified in view of a teaching of Liu will hereinafter be referred to as the non-invasive cornea and sclera strengthening system of Friedman, Chao, Rogers, and Liu.
With regards to claim 18, the non-invasive cornea and sclera strengthening system of Friedman, Chao, and Roger teaches the claimed invention of claim 1, however Friedman is silent with regards to wherein the non-invasive cornea and sclera strengthening system comprises at least one of: eyeglasses or a soft contact lens, and the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent to the eye by sustained release from an eyeglass frame of the eyeglasses or sustained release from the soft contact lens.
Nonetheless Liu, which is within the analogous art of contact lens (see [0012] and [0118]), teaches wherein the non-invasive cornea and sclera strengthening system comprises at least one of: eyeglasses or a soft contact lens (see [0012] and [0118]), and the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent (see [0118] “riboflavin”) to the eye by sustained release from an eyeglass frame of the eyeglasses or sustained release from the soft contact lens (see [0012] and [0118]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers in view of a teaching of the Liu such that wherein the non-invasive cornea and sclera strengthening system further comprises at least one of: eyeglasses or a soft contact lens, and the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent to the eye by sustained release from an eyeglass frame of the eyeglasses or sustained release from the soft contact lens. One of ordinary skill in the art would have been motivated to make this modification, as Liu teaches that riboflavin is a crosslinking agent that increases the mechanical strength of the eye and a contact lens is a means for delivering the riboflavin to the eye (see [0012], [0115], and [0118] of Liu). Therefore, one of ordinary skill in the art would be motivated to use contact lens to release the administration to the eye in order to increase the mechanical strength of the eye.
The non-invasive cornea and sclera strengthening system of Friedman, Chao, and Rogers modified in view of a teaching of Liu will hereinafter be referred to as the non-invasive cornea and sclera strengthening system of Friedman, Chao, Rogers, and Liu.
With regards to claim 19, the non-invasive cornea and sclera strengthening system of Friedman, Chao, Rogers, and Liu teaches the claimed invention of claim 18, however Friedman is silent with regards to wherein the non-invasive cornea and sclera strengthening system comprises the soft contact lens, and the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent to the eye by sustained release from the soft contact lens.
Nonetheless Liu, which is within the analogous art of contact lens (see [0012] and [0118]), teaches the non-invasive cornea and sclera strengthening system comprises the soft contact lens (see [0012] and [0118]), and the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent (see [0118] “riboflavin”) to the eye by sustained release from the soft contact lens.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the non-invasive cornea and sclera strengthening system of Friedman, Chao, Rogers, and Liu in view of a further teaching of the Liu such that wherein the non-invasive cornea and sclera strengthening system comprises the soft contact lens, and the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent to the eye by sustained release from the soft contact lens. One of ordinary skill in the art would have been motivated to make this modification, as Liu teaches that riboflavin is a crosslinking agent that increases the mechanical strength of the eye and a contact lens is a means for delivering the riboflavin to the eye (see [0012], [0115], and [0118] of Liu). Therefore, one of ordinary skill in the art would be motivated to use contact lens to release the administration to the eye in order to increase the mechanical strength of the eye.
With regards to claim 20, the non-invasive cornea and sclera strengthening system of Friedman, Chao, Rogers, and Liu teaches the claimed invention of claim 17, however Friedman is silent with regards to wherein the non-invasive cornea and sclera strengthening system comprises the soft contact lens, and the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent to the eye by sustained release from the soft contact lens.
Nonetheless Liu, which is within the analogous art of contact lens (see [0012] and [0118]), teaches the non-invasive cornea and sclera strengthening system comprises the soft contact lens (see [0012] and [0118]), and the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent (see [0118] “riboflavin”) to the eye by sustained release from the soft contact lens.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the non-invasive cornea and sclera strengthening system of Friedman, Chao, Rogers, and Liu in view of a further teaching of the Liu such that wherein the non-invasive cornea and sclera strengthening system comprises the soft contact lens, and the non-invasive cornea and sclera strengthening system is adapted to administer the administration agent to the eye by sustained release from the soft contact lens. One of ordinary skill in the art would have been motivated to make this modification, as Liu teaches that riboflavin is a crosslinking agent that increases the mechanical strength of the eye and a contact lens is a means for delivering the riboflavin to the eye (see [0012], [0115], and [0118] of Liu). Therefore, one of ordinary skill in the art would be motivated to use contact lens to release the administration to the eye in order to increase the mechanical strength of the eye.
Conclusion
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
08/24/2026
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