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 .
Priority
This application is a national stage entry under 35 USC 371 of PCT/CN2023/107768 filed 17 July 2023, which claims the benefit of foreign priority from Chinese Application no. 202210832712.4 filed 15 July 2022.
Response to Amendment
The preliminary amendment filed 15 January 2025 has been acknowledged. Claims 1-15 and 17-21 are pending, wherein claims 17-21 are new.
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.
Claim(s) 1, 2, 6-8, 11-15, and 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (Chinese Reference no. CN 114272519 – disclosed by Applicant – English Translation provided by USPTO) in view of He et al. (US Publication no. 2021/0402205).
In regard to claim 1, Wang discloses a light irradiation control method for myopia physiotherapy (page 2, the invention provides a method and device; page 5, “A medical device applying light energy to the eye, comprising a light energy source 20. image capture device 30 and processing control unit 40, the light energy source 20 at least a portion of the light is directed to the eye of the user 10, image capture device 30 is configured to obtain the eye image information, processing control unit 40 processing the eye image information to obtain the user using condition related information. The medical device 1 of the invention can be used for treating but not limited to myopia), comprising:
acquiring an ocular surface image of a user (page 5, image capture device 30 obtains the eye image information; also see page 7, in the paragraph beginning “Specifically,…” which discusses the image capture device);
analyzing the ocular surface image to determine state information of a pupil (page 7, in the paragraph beginning “Specifically,…”, the eye information is sent to processing control unit 40 to calculate the pupil diameter, which the pupil diameter is a state information of the pupil); and
controlling, based on the state information of the pupil (i.e., pupil diameter) and a light irradiation in-eye light power of the user (page 10, paragraph beginning “In this embodiment…” teaches that the processing control unit 40 receives the eye 10 information transmitted by the image capturing device 30, real-time analyzing the user eye 10 information in the user using process and obtaining the light energy source 20 enters into the user eye 10 of the eye effective power; when the eye effective power is greater than or equal to the set value, the processing control unit 40 controls the eye power, the processing control unit 40 controls the light to stop entering the user eye 10, which can accurately control the light energy source to irradiate the treatment time of the eyes of the user; wherein the “eye effective power” is construed to be the recited “light irradiation in-eye light power”), light irradiation on a fundus of the user (page 15, the paragraph beginning “Further, the light energy source 20…”, the light improves the blood circulation in the fundus).
Wang is considered to substantially teach the invention as claimed, however does not teach that the light energy source is adapted to output light in the red wavelength to irradiate the fundus to treat myopia. He et al. expressly teaches that direct irradiation of the eye fundus with red light through the pupil is found to prevent, delay, inhibit and even reverse myopia (para 20). In view of this, modification of the light energy source of Wang to output red light when treating myopia is considered to have been obvious to one of ordinary skill in the art since He et al. explicitly teaches that light in the red wavelength range will more effectively and safely play the photophysical and photochemical effects, improve the metabolic rate and blood circulation of the eye fundus and in turn promote the remodeling of fibroblasts to prevent, delay, inhibit and even reverse myopia.
In regard to claim 2, Wang teaches that acquiring the ocular surface image of the user includes: acquiring the ocular surface image of the user by at least one positioning camera before and/or during red-light irradiation on the fundus of the user (page 11, paragraph beginning “Specifically, the light energy source…” teaches that the image capture device 30 is a camera for clearly and stably shooting the human eye information).
In regard to claim 4, Wang teaches that the state information of the pupil includes a pupil size (page 7, the paragraph beginning “Specifically, when…” teaches that the processing control unit 40 calculates the pupil diameter from the information from the image capture device 30, the pupil diameter is the pupil size).
In regard to claim 5, Wang teaches that the state information of the pupil further includes a distance of the pupil relative to a red-light irradiation assembly (page 14, paragraph beginning “image capture device 30” teaches that the position of the eye is obtained and entered into a reference coordinate system with the medical device, wherein the eye position is considered to encompass the distance parameter, wherein the eye position is used to control adjustment of the light source).
In regard to claim 6, Wang teaches that the state information of the pupil further includes a position and/or direction of the pupil relative to the red-light irradiation assembly (page 14, paragraph beginning “image capture device 30” teaches that the position of the eye is obtained and entered into a reference coordinate system with the medical device, wherein the eye position is considered to encompass the distance parameter, wherein the eye position is used to control adjustment of the light source).
In regard to claim 7, Wang teaches that the configuration for moving the red-light irradiation assembly (light energy source 20) in at least one moving direction in response to a shift in the position and/or direction of the pupil relative to the red-light irradiation assembly, to provide vertical red-light irradiation on the fundus (page 12, paragraph beginning “Further, in the embodiment…” teaches a position adjusting unit 110 comprising a motor 111 to move light energy source 20 in a variety of directions according the needs of the user).
In regard to claim 8, Wang in view of He et al. teaches that controlling, based on the state information of the pupil and the red-light irradiation in-eye light power of the user, red-light irradiation on the fundus of the user includes: determining a light source power of the red-light irradiation assembly based on the pupil size and the red-light irradiation in-eye light power of the user; and controlling the red-light irradiation on the fundus of the user based on the light source power of the red-light irradiation assembly (page 10 of Wang, paragraph beginning “In this embodiment…” teaches that the processing control unit 40 receives the eye 10 information transmitted by the image capturing device 30, real-time analyzing the user eye 10 information in the user using process and obtaining the light energy source 20 enters into the user eye 10 of the eye effective power; when the eye effective power is greater than or equal to the set value, the processing control unit 40 controls the eye power, the processing control unit 40 controls the light to stop entering the user eye 10, which can accurately control the light energy source to irradiate the treatment time of the eyes of the user; wherein the “eye effective power” is construed to be the recited “light irradiation in-eye light power”).
In regard to claim 8, Wang in view of He et al. teaches that controlling, based on the state information of the pupil and the red-light irradiation in-eye light power of the user, red-light irradiation on the fundus of the user further includes:
determining the light source power of the red-light irradiation assembly based on the pupil size (Wang, page 7, the paragraph beginning “Specifically, when…” teaches that the processing control unit 40 calculates the pupil diameter from the information from the image capture device 30, the pupil diameter is the pupil size), the a distance of the pupil relative to the red-light irradiation assembly (Wang, page 14, paragraph beginning “image capture device 30” teaches that the position of the eye is obtained and entered into a reference coordinate system with the medical device, wherein the eye position is considered to encompass the distance parameter, wherein the eye position is used to control adjustment of the light source), and the red-light irradiation in-eye light power of the user (page 10, paragraph beginning “In this embodiment…” teaches that the processing control unit 40 receives the eye 10 information transmitted by the image capturing device 30, real-time analyzing the user eye 10 information in the user using process and obtaining the light energy source 20 enters into the user eye 10 of the eye effective power; when the eye effective power is greater than or equal to the set value, the processing control unit 40 controls the eye power, the processing control unit 40 controls the light to stop entering the user eye 10, which can accurately control the light energy source to irradiate the treatment time of the eyes of the user; wherein the “eye effective power” is construed to be the recited “light irradiation in-eye light power”).
In regard to claim 12, Wang substantially teaches the invention as claimed except that the light source power of the red-light irradiation assembly ranges from 0. 1mw to 1. 7mw. He et al., as relied on above, irradiates the fundus to treat myopia with a red light and a power of 1.07-1.47 mW at a distance of 100 mm from the eye (para 22). Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the invention described by Wang and He et al. to output red light with a power in the range of 0. 1mw to 1. 7mw since He et al. expressly teaches that this is the effective range of power to provide the intended result to delay, inhibit, or reverse myopia.
In regard to claim 13, Wang substantially teaches the invention as claimed except that the spectrum of the light source is narrow-band red-light or infrared light, with a center wavelength within the range of 630nm to 850nm, and a width (full width at half maximum) less than 20nm. He et al., as relied on above, irradiates the fundus to treat myopia with a red light at a wavelength range of 650 +/- 10 nm (para 22). Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the invention described by Wang and He et al. to output red light in the wavelength range of 630nm to 850nm, and a width (full width at half maximum) less than 20nm since He et al. expressly teaches that this is the effective range of power to provide the intended result to delay, inhibit, or reverse myopia.
In regard to claim 14, Wang discloses a light irradiation control device for myopia physiotherapy (processing control unit 40, page 5, paragraph beginning “As shown in FIG. 1…”), comprising:
a processor (processor 401, page 6, paragraph beginning “Further, the light energy source…”); and
a memory having program instructions for controlling red-light irradiation on a fundus stored thereon which, when executed by a processor, cause to implement (page 6, paragraph beginning “Further, the light energy source…”):
acquiring an ocular surface image of a user (page 5, image capture device 30 obtains the eye image information; also see page 7, in the paragraph beginning “Specifically,…” which discusses the image capture device);
analyzing the ocular surface image to determine state information of a pupil (page 7, in the paragraph beginning “Specifically,…”, the eye information is sent to processing control unit 40 to calculate the pupil diameter, which the pupil diameter is a state information of the pupil); and
controlling, based on the state information of the pupil (i.e., pupil diameter) and a light irradiation in-eye light power of the user (page 10, paragraph beginning “In this embodiment…” teaches that the processing control unit 40 receives the eye 10 information transmitted by the image capturing device 30, real-time analyzing the user eye 10 information in the user using process and obtaining the light energy source 20 enters into the user eye 10 of the eye effective power; when the eye effective power is greater than or equal to the set value, the processing control unit 40 controls the eye power, the processing control unit 40 controls the light to stop entering the user eye 10, which can accurately control the light energy source to irradiate the treatment time of the eyes of the user; wherein the “eye effective power” is construed to be the recited “light irradiation in-eye light power”), light irradiation on a fundus of the user (page 15, the paragraph beginning “Further, the light energy source 20…”, the light improves the blood circulation in the fundus).
Wang is considered to substantially teach the invention as claimed, however does not teach that the light energy source is adapted to output light in the red wavelength to irradiate the fundus to treat myopia. He et al. expressly teaches that direct irradiation of the eye fundus with red light through the pupil is found to prevent, delay, inhibit and even reverse myopia (para 20). In view of this, modification of the light energy source of Wang to output red light when treating myopia is considered to have been obvious to one of ordinary skill in the art since He et al. explicitly teaches that light in the red wavelength range will more effectively and safely play the photophysical and photochemical effects, improve the metabolic rate and blood circulation of the eye fundus and in turn promote the remodeling of fibroblasts to prevent, delay, inhibit and even reverse myopia.
In regard to claim 15, Wang discloses an apparatus for myopia physiotherapy, comprising:
a positioning camera configured to capture an ocular surface of a user to generate an ocular surface image (page 5, image capture device 30 obtains the eye image information; also see page 7, in the paragraph beginning “Specifically,…” which discusses the image capture device);
a light irradiation assembly configured to irradiate light on a fundus of the user to implement myopia physiotherapy (light energy source 20, page 6, paragraph beginning “Further, the light energy source 20…”);
and a light irradiation control device for myopia physiotherapy which is connected to the positioning camera and the red-light irradiation assembly (processing control unit 40, page 5, paragraph beginning “As shown in FIG. 1…”; and page 6, paragraph beginning “Further, the light energy source 20…”), respectively, and configured to control the light irradiating the fundus by
acquiring an ocular surface image of a user (page 5, image capture device 30 obtains the eye image information; also see page 7, in the paragraph beginning “Specifically,…” which discusses the image capture device);
analyzing the ocular surface image to determine state information of a pupil (page 7, in the paragraph beginning “Specifically,…”, the eye information is sent to processing control unit 40 to calculate the pupil diameter, which the pupil diameter is a state information of the pupil); and
controlling, based on the state information of the pupil (i.e., pupil diameter) and a light irradiation in-eye light power of the user (page 10, paragraph beginning “In this embodiment…” teaches that the processing control unit 40 receives the eye 10 information transmitted by the image capturing device 30, real-time analyzing the user eye 10 information in the user using process and obtaining the light energy source 20 enters into the user eye 10 of the eye effective power; when the eye effective power is greater than or equal to the set value, the processing control unit 40 controls the eye power, the processing control unit 40 controls the light to stop entering the user eye 10, which can accurately control the light energy source to irradiate the treatment time of the eyes of the user; wherein the “eye effective power” is construed to be the recited “light irradiation in-eye light power”), light irradiation on a fundus of the user (page 15, the paragraph beginning “Further, the light energy source 20…”, the light improves the blood circulation in the fundus).
Wang is considered to substantially teach the invention as claimed, however does not teach that the light energy source is adapted to output light in the red wavelength to irradiate the fundus to treat myopia. He et al. expressly teaches that direct irradiation of the eye fundus with red light through the pupil is found to prevent, delay, inhibit and even reverse myopia (para 20). In view of this, modification of the light energy source of Wang to output red light when treating myopia is considered to have been obvious to one of ordinary skill in the art since He et al. explicitly teaches that light in the red wavelength range will more effectively and safely play the photophysical and photochemical effects, improve the metabolic rate and blood circulation of the eye fundus and in turn promote the remodeling of fibroblasts to prevent, delay, inhibit and even reverse myopia.
In regard to claim 17, Wang teaches that the state information of the pupil includes a pupil size (page 7, the paragraph beginning “Specifically, when…” teaches that the processing control unit 40 calculates the pupil diameter from the information from the image capture device 30, the pupil diameter is the pupil size).
In regard to claim 18, Wang teaches that the state information of the pupil further includes a distance of the pupil relative to a red-light irradiation assembly (page 14, paragraph beginning “image capture device 30” teaches that the position of the eye is obtained and entered into a reference coordinate system with the medical device, wherein the eye position is considered to encompass the distance parameter, wherein the eye position is used to control adjustment of the light source).
In regard to claim 19, Wang teaches that the state information of the pupil further includes a position and/or direction of the pupil relative to the red-light irradiation assembly (page 14, paragraph beginning “image capture device 30” teaches that the position of the eye is obtained and entered into a reference coordinate system with the medical device, wherein the eye position is considered to encompass the distance parameter, wherein the eye position is used to control adjustment of the light source).
In regard to claim 20, Wang substantially teaches the invention as claimed except that the light source power of the red-light irradiation assembly ranges from 0. 1mw to 1. 7mw. He et al., as relied on above, irradiates the fundus to treat myopia with a red light and a power of 1.07-1.47 mW at a distance of 100 mm from the eye (para 22). Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the invention described by Wang and He et al. to output red light with a power in the range of 0. 1mw to 1. 7mw since He et al. expressly teaches that this is the effective range of power to provide the intended result to delay, inhibit, or reverse myopia.
In regard to claim 21, Wang substantially teaches the invention as claimed except that the spectrum of the light source is narrow-band red-light or infrared light, with a center wavelength within the range of 630nm to 850nm, and a width (full width at half maximum) less than 20nm. He et al., as relied on above, irradiates the fundus to treat myopia with a red light at a wavelength range of 650 +/- 10 nm (para 22). Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the invention described by Wang and He et al. to output red light in the wavelength range of 630nm to 850nm, and a width (full width at half maximum) less than 20nm since He et al. expressly teaches that this is the effective range of power to provide the intended result to delay, inhibit, or reverse myopia.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (Chinese Reference no. CN 114272519 – disclosed by Applicant – English Translation provided by USPTO) in view of He et al. (US Publication no. 2021/0402205), further in view of He et al. (Chinese Reference no. CN 112220447 – disclosed by Applicant – English Translation provided by USPTO – hereinafter He ‘447).
In regard to claim 3, Wang in view of He et al. is considered to substantially describe the invention as claimed, however neither reference teaches that analyzing the ocular surface image to determine the state information of the pupil includes: analyzing the ocular surface image by a neural network model to determine the state information of the pupil. He ‘447 is directed to a fundus camera to ascertain pupil size in a manner similar to Wang. He ‘447 explicitly teaches using a neural network and using acquired data to train the neural network to identify characteristics of the pupil (page 6, paragraph starting “The method for identifying pupil image…” and at other areas of the disclosure teach that acquired data is used to train a neural network for detection of the position and size of the pupil in the image). In view of this, it is considered to have been obvious to one of ordinary skill in the art to modify the invention described by Wang in view of He et al. to employ neural network based pupil image analysis to determine the state of the pupil since He ‘447 explicitly teaches use of neural network in such manner to permit automated and accurate determination of pupil size and location for controlling an illumination beam to irradiate the fundus. The modification would have been the use of a known technique by a known system to predictably automate an image analysis process.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (Chinese Reference no. CN 114272519 – disclosed by Applicant – English Translation provided by USPTO) in view of He et al. (US Publication no. 2021/0402205) and He et al. (Chinese Reference no. CN 112220447 – disclosed by Applicant – English Translation provided by USPTO – hereinafter He ‘447), further in view of Tedford et al. (US Publication no. 2016/0067086).
In regard to claim 9, Wang in view of He et al. is considered to substantially describe the invention as claimed, however neither reference teaches that the light source of the red-light irradiation assembly includes a non-homogenized light beam, and determining the light source power of the red-light irradiation assembly based on the pupil size and the red-light irradiation in-eye light power of the user includes: determining the light source power based on the pupil size, the red-light irradiation in-eye light power of the user, and a power-annulus radius correspondence relationship of the non- homogenized light beam.
Wang teaches that the light source power is based on the pupil size (page 7) and the red-light irradiation in-eye light power of the user (page 10). He et al. discuss red light irradiation. Neither teach the power-annulus radius correspondence relationship of the beam. He ‘447 as relied on above provides teaching for a fundus camera that determines a pupil size to control irradiation of the fundus also teaches obtaining a relationship between the annular illumination beam size and the radius of the pupil (page 7, paragraph beginning “In the actual application scene…” teaches that this relationship is critical since it impacts the ability of the irradiated light beam to enter the pupil). Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the invention of Wang in view of He et al. to adjust performance of the light energy source to account for the relationship between the annulus of the light beam and the radius of the pupil since He ‘447 explicitly teaches that this relationship ensures that the irradiated light can enter the pupil.
Wang in view of He et al. and He ‘447 describe the invention as claim except for using a non-homogenized light beam. Tedford et al. describes non-invasive photobiomodulation treatment of ocular structures which includes a pupil diameter measurement (para 101). Tedford et al. teaches that light beam with a non-homogenized (I.e., gaussian) light profile may be used in the treatment process (para 119 and 149). The irradiance at the emission surface is selected to provide the desired irradiances at the target tissue. The irradiance of the light beam is preferably controllably variable so that the emitted light energy can be adjusted to provide a selected irradiance at the tissue being treated. In view of this, it is considered to have been obvious to one of ordinary skill in the art to modify the light energy sources of Wang, He et al., and He ‘447 to be non-homogenized light source since Tedford et al. explicity teaches use of a non-homogenized light source to allow control of the irradiance at the tissue being treated.
In regard to claim 10, Wang in view of He et al. is considered to substantially describe the invention as claimed, however neither reference teaches that the light source of the red-light irradiation assembly includes homogenized light beam, and determining the light source power of the red-light irradiation assembly based on the pupil size and the red-light irradiation in-eye light power of the user includes: determining the light source power based on the pupil size, the red-light irradiation in-eye light power of the user, and a power-annulus radius correspondence relationship of the homogenized light beam.
Wang teaches that the light source power is based on the pupil size (page 7) and the red-light irradiation in-eye light power of the user (page 10). He et al. discuss red light irradiation. Neither teach the power-annulus radius correspondence relationship of the beam. He ‘447 as relied on above provides teaching for a fundus camera that determines a pupil size to control irradiation of the fundus also teaches obtaining a relationship between the annular illumination beam size and the radius of the pupil (page 7, paragraph beginning “In the actual application scene…” teaches that this relationship is critical since it impacts the ability of the irradiated light beam to enter the pupil). Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the invention of Wang in view of He et al. to adjust performance of the light energy source to account for the relationship between the annulus of the light beam and the radius of the pupil since He ‘447 explicitly teaches that this relationship ensures that the irradiated light can enter the pupil.
Wang in view of He et al. and He ‘447 describe the invention as claim except for using a homogenized light beam. Tedford et al. describes non-invasive photobiomodulation treatment of ocular structures which includes a pupil diameter measurement (para 101). Tedford et al. teaches that light beam with a homogenized (I.e., top hat) light profile may be used in the treatment process (para 119 and 149). The irradiance at the emission surface is selected to provide the desired irradiances at the target tissue. The irradiance of the light beam is preferably controllably variable so that the emitted light energy can be adjusted to provide a selected irradiance at the tissue being treated. In view of this, it is considered to have been obvious to one of ordinary skill in the art to modify the light energy sources of Wang, He et al., and He ‘447 to be homogenized light source since Tedford et al. explicitly teaches use of a homogenized light source to allow control of the irradiance at the tissue being treated.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Broach et al. (US Publication no. 2025/0295935) is directed to techniques to treating myopia using red light and using fundus cameras, however, fails as prior art due to defective priority date.
Kushida et al. (US Publication no. 20240261590) describes a light irradiation system, however does not emit red light wavelengths.
He et al. (CN 115245631 – disclosed by Applicant) is directed to system and techniques for treating myopia using red light and basing irradiance of light on pupil size. However, fails as prior art due to defective priority date.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 19 July 2026
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