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 .
Claim Status: Claims 24-44 and 46-53 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 12, 2026 has been entered.
Allowable Subject Matter
Claims 49 and 50 are allowed.
Response to Arguments
Applicant's arguments filed on January 12, 2026 have been fully considered but they are not persuasive.
Re Claims 24 and 47, Applicant made an argument that Altshuler fails to provide any explanation how the handheld photocosmetic device would be handled for treating ophthalmic tissues. Applicant also mentioned that Altshuler does not disclose first and second light beams that respectively deliver the PBM light in at least two doses to the target tissue at different therapeutic wavelengths, each therapeutic wavelength selected to stimulate a therapeutic activity that produces different biological responses. Applicant argued that para. [0074] and [0165] is not a description of delivering light in first and second doses having respective first and second therapeutic wavelengths that are selected to stimulate identified first and second therapeutic activities. Additionally, Applicant disagreed that simply penetrating tissue at different depths represent different activities in the context of claim 24 and stated that it is the same activity just at different depths which is different than what is claimed.
Applicant also made an argument that disclosed wavelengths in Dotson are for treatment of cornea and not retina.
This argument has been considered but is not persuasive.
The following is the limitation at discussion: “wherein the least one light source is configured to produce at least first and second light beams that respectively deliver the PBM light in at least two doses to the target retinal tissue, the at least two doses delivering the PBM light at different therapeutic wavelengths, the first light beam in a first dose having a first therapeutic wavelength that is selected to stimulate an identified first therapeutic activity in the target retinal tissue, and the second light beam in a second dose having a second therapeutic wavelength that is selected to stimulate an identified second therapeutic activity in the target retinal tissue, wherein the second therapeutic wavelength differs from the first therapeutic wavelength by at least 25 nm, wherein the first light beam and the second light beam respectively stimulate the first therapeutic activity and the second therapeutic activity in the same target retinal tissue, and the second therapeutic activity produces a second therapeutic biological response according to a second biological process in the target retinal tissue that differs from a first therapeutic biological response produced by the first therapeutic activity according to a first biological process.”
The structural limitation required by this limitation is at least one light source that produces two different wavelengths used for photobiomodulation, where the two wavelengths differ by at least 25 nm. The rest of the limitation is a functional limitation on what each wavelength is capable of.
Altshuler discloses that 1) its device produces EMR to provide photobiomodulation (para. [0074], [0119]), that 2) EMR-treated tissue can be ophthalmic tissue including retinal tissue (para. [0074]), and that 3) a range of wavelengths by at least one light source that produces at least two light beams with two different wavelengths separated by 25 nm (para. [0095], [0096]). This disclosure meets all the structural limitations required by the above limitation.
Altshuler further discloses that different wavelengths and doses are used to penetrate the target tissue at different depths based on absorption and scattering characteristics of a tissue for wavelengths (para. [0116], [0118]). Applicant stated that simply penetrating tissue at different depths does not represent different activities but rather represents same activity at different depths. Examiner disagrees. Applicant has amended the claim such that the target tissue is retinal tissue. There are 8 different retinal layers with different types of cells. Therefore, if the light beam is penetrating retinal tissue at a different depth, it is certainly stimulating a different biological process because it is stimulating a different type of cells.
Given the structural limitation that Altshuler discloses with “the at least one light source”, Altshuler’s “at least one light source” is configured to produce two biological processes that are different using two different doses of wavelengths.
Dotson was further relied on to teach two light wavelengths producing two biological processes. Applicant argued that Dotson is for treatment of cornea and not retina.
Dotson discloses a method for promoting healing of retinal eye tissue exhibiting age-related macular degeneration (para. [0044]-[0047]) and further discloses a first wavelength between 580 nm to 680 nm and at least second wavelength between 850 to 950 nm (para. [0048]-[0049]). Red light (approximately 640 nm to 700 nm) has been found to decrease inflammation of tissue in the eye, increase ATP production, and reset cellular activity to cause abnormal cells to exhibit more normal behavior (para. [0035]).
Re Claims 24 and 47, Applicant made an argument that in Zacharias, the aiming light (visible light, 512 nm) and treatment light (NIR, 810 nm) cannot be considered as "two doses delivering the PBM light at different therapeutic wavelengths."
This argument has been considered but is not persuasive.
Zacharias discloses wavelengths in the range of 512 nm and 810 nm and discloses visible or infrared portion of electromagnetic spectrum to produce the therapeutic effect (para. [0078], The wavelength of the laser radiation produced by laser source 102 is typically in the visible or infrared portions of the electromagnetic spectrum to produce the therapeutic effect, although other wavelengths could be required for future treatments. Typical laser emission wavelengths selected for retinal treatment are 512 nm and 810 nm.), which overlaps with disclosed wavelength range for PBM in the instant specification (instant para. [0099] discloses wavelengths between 550 nm and 1064 nm or between 590 nm and 980 nm).
Re Claims 47, 48, and 53, Applicant made an argument that “Colbaugh’s use of diffusers in a sleep mask is not suggestive of diffusers deployed within a self-standing housing of a device as claimed in claim 24, wherein the self-standing housing includes an eyepiece or eyebox, a light source, a relay structure, and an actuator.”
This argument has been considered but is not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Altshuler as modified by Dotson and Luttrull have been relied on to disclose a self-standing housing includes an eyepiece or eyebox, a light source, a relay structure, and an actuator. Colbaugh has been relied on to teach the diffuser for the purpose of providing electromagnetic radiation to have a substantially uniform distribution and enhancing the comfort and/or usability of lighting module (para. [0030]). It would have been obvious to one of ordinary skill in the art to modify Altshuler as modified by Dotson and Luttrull to add one or more diffusers as taught by Colbaugh for disclosed purpose and benefits.
Applicant’s arguments with respect to claim(s) 24 have been considered but are moot because the new ground of rejection has been made necessitated by amendments.
Re Claim 24, Applicant argued that “Altshuler does not teach a self-standing housing having a relay structure and actuator disposed therein arranged to change a direction of first and second light beams relative to an eyepiece or eyebox such that the first and second light beams are redirected from the first eye of the patient to a target retinal tissue in a second eye of the patient without moving the self-standing housing”.
This argument has been considered but is moot. The new ground of rejection addresses the amended limitation.
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 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.
Claims 24, 43, 51, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Altshuler et al. (US 2008/0058783) in view of Dotson et al. (US 2013/0079759) and Luttrull et al. (US 2014/0330352), and Clapham et al. (US 2003/0004502).
Re Claims 24 and 51, Altshuler discloses a device for delivery of photobiomodulation (PBM) to a target retinal tissue of a first eye of a patient, the device comprising:
at least one light source (para. [0080], [0081], an EMR source 14 that generates EMR with one or more wavelengths in a desired range, fig. 1), a relay structure (para. [0081], an EMR delivery mechanism 20, fig. 1), and an actuator (para. [0081], [0082], a controller 26 can control the EMR delivery system 20. EMG delivery mechanism is an optical scanner that scans an EMR beam generated by the source 14 over a target region) disposed in an interior of the housing (fig. 1, handheld housing 12),
an eyepiece or eyebox through which PBM light from the device is delivered to the target retinal tissue of the first eye of the patient (para. [0074] discloses that the device is configured to treat ophthalmic tissue (e.g., retinal tissue), therefore the transmissive window 22 in fig. 1 and para. [0081] or a handheld housing 12 in para. [0080] and fig. 1 is considered as an eyepiece or eyebox);
at least one light source (para. [0080], [0081], an EMR source 14 that generates EMR with one or more wavelengths in a desired range, fig. 1) configured to produce at least first and second light beams that respectively deliver the PBM light in at least two doses to the target retinal tissue, the at least two doses delivering the PBM light at different therapeutic wavelengths, the first light beam in a first dose having a first therapeutic wavelength that is selected to stimulate an identified first therapeutic activity in the target retinal tissue and the second light beam in a second dose having a second therapeutic wavelength that is selected to stimulate an identified second therapeutic activity in the target retinal tissue, wherein the second therapeutic wavelength differs from the first therapeutic wavelength by at least 25 nm and the second activity in the target retinal tissue differs from the first activity (para. [0074] and [0165] discloses that disclosed method of EMR treatment can be applied for photodynamic therapy, photobiomodulation, and photostimulation to hard and soft tissues including ophthalmic tissue (e.g., conjuctiva, cornea, retinal tissue); para. [0080], [0096], [0095], Typical tunable wavelength bands cover a wavelength range of about 400 to about 1200 nm with a bandwidth in a range of about 0.1 to about 10 nm. the EMR source provides EMR with wavelengths that are less likely to cause retinal damage, e.g., wavelengths that are absorbed by water (e.g., wavelengths in a range of about 600-680 nm, or have a wavelength that is predominately red, or the spectrum of the light is in the range of or around the absorption peaks for water, for example, 970 nm, 1200 nm, 1470 nm, 1900 nm, 2940 nm); para. [0025], 300 nm to 1800 nm, para. [0148]; para. [0116], [0118], depending upon the wavelength(s) and fluence of an EMR beam, and the absorption and scattering characteristics of a tissue for the wavelength(s), an EMR beam may penetrate to certain depths before being initially or completely absorbed or dissipated – Altshuler discloses that different wavelengths and doses are used to penetrate the target tissue to certain depths. Therefore, different wavelengths targeting different depths would be considered different activities in the target tissue.) and wherein the PBM light in each of the first and second light beams has an irradiance at the target retinal tissue that is selected to facilitate healing and/or reverse or slow disease progression in the target retinal tissue (para. [0074], [0119], [0173] discloses photobiomodulation and photostimulation; para. [0072], [0074], [0075], When an amount of energy (usually at a particular wavelength) sufficient to initiate a certain photochemical reaction is delivered, the lattice is referred to herein as a lattice of “photochemical islets.” - Altshuler discloses that some dose of light produces chemical reaction; para. [0119], it is desirable to cause little or no damage while administering an effective amount of EMR at a specified wavelength (e.g., photobiostimulation));
wherein the relay structure includes one or more optical components that direct the first light beam and the second light beam from the at least one light source to the eyepiece or eyebox to deliver the PBM light in the at least two doses to the target retinal tissue of the first eye of the patient (para. [0081], an EMR delivery mechanism 20, fig. 1); and
wherein the actuator is configured to move at least a portion of the relay structure to change a direction of the first light beam and the second light beam relative to the eyepiece or eyebox and the first of the patient (para. [0081], [0082], a controller 26 can control the EMR delivery system 20. EMG delivery mechanism is an optical scanner that scans an EMR beam generated by the source 14 over a target region).
Altshuler is silent regarding the first light beam and the second light beam respectively stimulate the first therapeutic activity and the second therapeutic activity in the same target tissue, and the second therapeutic activity produces a second therapeutic biological response according to a second biological process in the target tissue that differs from a first therapeutic biological response produced by the first therapeutic activity according to a first biological process.
However, Dotson discloses an ophthalmic phototherapy device and associated phototherapy treatment method for promoting healing of damaged or diseased eye tissue (abstract). Dotson teaches the first light beam and the second light beam respectively stimulate the first therapeutic activity and the second therapeutic activity in the same target tissue, and the second therapeutic activity produces a second therapeutic biological response according to a second biological process in the target tissue that differs from a first therapeutic biological response produced by the first therapeutic activity according to a first biological process and wherein the PBM light in each of the first and second light beams has an irradiance at the target tissue that is selected to facilitate healing and/or reverse or slow disease progression in the target tissue (para. [0035], The particular wavelength used varies depending on the injury or eye condition being treated. For example, light in the yellow range (approximately 577 nm to 597 nm) has been shown to switch off collagenase production by down-regulating MMP production and to switch on new collagen production. In the field of opthamology, yellow light having a wavelength of approximately 590 nm has been found to be beneficial for treating corneal trauma when directed into a traumatized cornea. Red light (approximately 640 nm to 700 nm) has been found to decrease inflammation of tissue in the eye, increase ATP production, and reset cellular activity to cause abnormal cells to exhibit more normal behavior; para. [0044]-[0047], a method for promoting healing of retinal eye tissue exhibiting age-related macular degeneration; para. [0048], [0049], a first wavelength between 580 nm to 680 nm and at least second wavelength between 850 to 950 nm for retinal eye tissue).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Altshuler, by configuring the first light beam and the second light beam respectively stimulate the first therapeutic activity and the second therapeutic activity in the same target tissue, and the second therapeutic activity produces a second therapeutic biological response according to a second biological process in the target tissue that differs from a first therapeutic biological response produced by the first therapeutic activity according to a first biological process, wherein the PBM light in each of the first and second light beams has an irradiance at the target tissue that is selected to facilitate healing and/or reverse or slow disease progression in the target tissue, as taught by Dotson, for the purpose of healing of the retinal eye tissue (para. [0044]-[0049], para. [0035], The particular wavelength used varies depending on the injury or eye condition being treated. For example, light in the yellow range (approximately 577 nm to 597 nm) has been shown to switch off collagenase production by down-regulating MMP production and to switch on new collagen production. In the field of opthamology, yellow light having a wavelength of approximately 590 nm has been found to be beneficial for treating corneal trauma when directed into a traumatized cornea. Red light (approximately 640 nm to 700 nm) has been found to decrease inflammation of tissue in the eye, increase ATP production, and reset cellular activity to cause abnormal cells to exhibit more normal behavior).
Altshuler and Dotson are silent regarding a self-standing housing including an eyepiece or eyebox disposed on the housing, wherein the self-standing housing is arranged for placement on a floor, desk, cart, or table, the eyepiece or eyebox being arranged on the housing to position the at least one eye of the patient relative to the housing to receive the PBM light without moving the housing from the floor, desk, cart, or table.
However, Luttrull discloses an apparatus for retina phototherapy (abstract) and teaches a self-standing housing (para. [0019], system 10 consisting of a working surface 12 and a retina phototherapy device 14) including an eyepiece or eyebox (para. [0019], retina phototherapy device 14) disposed on the housing, wherein the self-standing housing is arranged for placement on a floor, desk, cart, or table (fig. 1), the eyepiece or eyebox being arranged on the housing to position the at least one eye of the patient relative to the housing to receive the PBM light without moving the housing from the floor, desk, cart, or table (para. [0030], FIGS. 6 and 7 illustrate a person positioned in the headrest assembly 18, with their chin in the chin rest 26 and forehead in the forehead rest 28. The ergonomic configuration of the extension arms 22 in the headrest assembly 18 and the barrel 36 of the device 14 are designed to accommodate any type of head, body, or face by effectively reaching out to the patient rather than having the patient “jam” into the device.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Altshuler as modified by Dotson, adding a self-standing housing to include the eyepiece or eyebox disposed on the housing, wherein the self-standing housing is arranged for placement on a floor, desk, cart, or table, the eyepiece or eyebox being arranged on the housing to position the at least one eye of the patient relative to the housing to receive the PBM light without moving the housing from the floor, desk, cart, or table, as taught by Luttrull, for the purpose of providing a stable base for the phototherapy device (para. [0023]) and headrest assembly (para. [0030]) and accommodating patients in a comfortable manner (para. [0002]).
Altshuler, Dotson, and Luttrull are silent regarding wherein the actuator is configured to move at least a portion of the relay structure to change a direction of the first light beam and the second light beam relative to the eyepiece or eyebox such that the first and second light beams are redirected from the first eye of the patient to a target retinal tissue in a second eye of the patient without moving the self-standing housing, wherein the actuator is configured to move the portion of the relay structure from at least a first position where the first and second light beams are directed to the first eye of the patient to a second position where the first and second light beams are directed to the second eye of the patient.
However, Clapham discloses a laser surgery system (abstract) and teaches a self-standing housing (fig. 3, base frame 18) and actuator is configured to move at least a portion of a relay structure to change a direction of the first light beam and the second light beam relative to the laser alignment system (fig. 3, laser alignment system 17) such that the first and second light beams are redirected from the first eye of the patient to a target retinal tissue in a second eye of the patient without moving the self-standing housing, wherein the actuator is configured to move the portion of the relay structure from at least a first position where the first and second light beams are directed to the first eye of the patient to a second position where the first and second light beams are directed to the second eye of the patient (para. [0073], [0074], the control system can also be programmed to automatically move to a second nominal position to align a second optical axis 82 (i.e. patient's second eye) with the laser beam axis 15. The control system can be programmed to automatically align the second optical axis with the laser beam axis immediately after treatment of the first eye or to directly align the second optical axis with the laser beam axis. Alignment can be accomplished by initially moving to the first nominal position (alignment with right eye) and then immediately moving to the second nominal position (alignment with the left eye).).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Atlshuler as modified by Dotsun and Luttrull, by configuring the actuator to move at least a portion of the relay structure to change a direction of the first light beam and the second light beam relative to the eyepiece or eyebox such that the first and second light beams are redirected from the first eye of the patient to a target retinal tissue in a second eye of the patient without moving the self-standing housing, wherein the actuator is configured to move the portion of the relay structure from at least a first position where the first and second light beams are directed to the first eye of the patient to a second position where the first and second light beams are directed to the second eye of the patient, as taught by Clapham, for the purpose of treatment of both eyes by only moving the laser optics (para. [0073], [0074]).
Re Claim 52, Altshuler discloses a patient interface arranged with respect to the eyepiece or eyebox to position the patient for irradiating the target retinal tissue of the first and second eyes of the patient with the PBM light (fig. 1, para. [0085], output window 22).
Re Claim 43, Altshuler as modified by Dotson and Luttrull discloses a method of delivering PBM to a target retinal tissue of a patient using the device of claim 24, the method comprising:
(i) positioning the patient relative to the eyepiece or eyebox using a patient interface surface of the device so that the first eye and the second eye of patient are positioned to receive the PBM light via the eyepiece or eyebox, wherein during delivery of the PBM light, the eyepiece or eyebox is set in a fixed position and is not moved relative to the patient (para. [0074], The disclosed device can be set in a fixed position and not moved relative to the patient while delivering the treatment; fig. 1, para. [0085], output window 22 reads on patient interface surface of the device); and
(ii) directing the PBM light of the first therapeutic wavelength and the second therapeutic wavelength from the device to the target retinal tissue of first and second eyes of the patient (para. [0095], [0074]).
Altshuler and Dotson are silent regarding a patient interface surface of the device that supports a head of the patient.
However, Luttrull discloses positioning the patient relative to the eyepiece or eyebox (fig. 6, para. [0022], retina phototherapy device 14) using a patient interface surface of the device that supports a head of the patient (fig. 6, para. [0022], a chin rest 26 and a forehead rest 28) so that the at least one eye of the patient is positioned to receive the treatment light via the eyepiece or eyebox (fig. 6, fig. 7), wherein during delivery of the treatment light, the eyepiece or eyebox is set in a fixed position and is not moved relative to the patient (fig. 1, para. [0021]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Altshuler as modified by Dotson and Luttrull, by positioning the patient relative to the eyepiece or eyebox using a patient interface surface of the device that supports a head of the patient so that the at least one eye of the patient is positioned to receive the PBM light via the eyepiece or eyebox, wherein during delivery of the PBM light the eyepiece or eyebox is set in a fixed position and is not moved relative to the patient, as taught by Luttrull, for the purpose of providing a stable base for the phototherapy device (para. [0023]) and headrest assembly (para. [0030]) and accommodating patients in a comfortable manner (para. [0002]).
MPEP 2112.02 discloses that under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.
Altshuler, Dotson, and Luttrull are silent regarding directing the PBM light of the first therapeutic wavelength and the second therapeutic wavelength from the device to the target retinal tissue of first and second eyes of the patient without moving the self-standing housing the device.
However, Clapham discloses a laser surgery system (abstract) and teaches a self-standing housing (fig. 3, base frame 18) and directing the PBM light of the first therapeutic wavelength and the second therapeutic wavelength from the device to the target retinal tissue of first and second eyes of the patient without moving the self-standing housing the device (para. [0073], [0074], the control system can also be programmed to automatically move to a second nominal position to align a second optical axis 82 (i.e. patient's second eye) with the laser beam axis 15. The control system can be programmed to automatically align the second optical axis with the laser beam axis immediately after treatment of the first eye or to directly align the second optical axis with the laser beam axis. Alignment can be accomplished by initially moving to the first nominal position (alignment with right eye) and then immediately moving to the second nominal position (alignment with the left eye).).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Atlshuler as modified by Dotsun, Luttrull, and Clapham, by directing the PBM light of the first therapeutic wavelength and the second therapeutic wavelength from the device to the target retinal tissue of first and second eyes of the patient without moving the self-standing housing the device, as taught by Clapham, for the purpose of treatment of both eyes by only moving the laser optics (para. [0073], [0074]).
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Altshuler et al. (US 2008/0058783) as modified by Dotson et al. (US 2013/0079759), Luttrull et al. (US 2014/0330352), and Clapham et al. (US 2003/0004502), and further in view of Colbaugh (US 2013/0053929).
Re Claim 53, Altshuler as modified by Dotson and Luttrull discloses the claimed invention substantially as set forth in claim 24.
Altshuler, Dotson, Luttrull, and Clapham are silent regarding one or more diffusers configured to diffuse the PBM light such that, prior to the PBM light reaching the at least one eye of the patient, an energy density profile of the PBM light does not have a substantial peak at any particular emission angle but is substantially evenly distributed among a range of emission angles.
Colbaugh discloses light therapy provided to a person’s eyes (para. [0026], [0027], figs. 4 and 5) and teaches one or more diffusers configured to diffuse the treatment light such that, prior to the PBM light reaching the at least one eye of the patient, an energy density profile of the treatment light does not have a substantial peak at any particular emission angle but is substantially evenly distributed among a range of emission angles (para. [0030], Housing 42 may further be configured to carry an optical diffuser on the outside of first set of radiation sources 44 and/or second set of radiation sources 46. This will help to diffuse the electromagnetic radiation emitted by the sources 44 and/or 46, and provide electromagnetic radiation having a substantially uniform distribution onto the eyelid of the subject. This may enhance the comfort and/or usability of lighting module 40 during rest and/or sleep by the subject.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Altshuler as modified by Dotson, Luttrull, and Clapham, by adding one or more diffusers configured to diffuse the PBM light such that, prior to the PBM light reaching the at least one eye of the patient, an energy density profile of the PBM light does not have a substantial peak at any particular emission angle but is substantially evenly distributed among a range of emission angles, as taught by Colbaugh, for the purpose of providing electromagnetic radiation having a substantially uniform distribution and enhancing the comfort and/or usability of lighting module (para. [0030]).
Claims 47 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Altshuler et al. (US 2008/0058783) in view of Dotson et al. (US 2013/0079759), Clapham et al. (US 2003/0004502), and Colbaugh (US 2013/0053929).
Re Claims 47 and 48, Altshuler discloses a device for delivery of photobiomodulation (PBM) to a target retinal tissue of first eye of a patient, the device comprising:
an eyepiece or eyebox through which PBM light from the device is delivered to the target retinal tissue of the first eye of the patient (para. [0074] discloses that the device is configured to treat ophthalmic tissue (e.g., retinal tissue), therefore the transmissive window 22 in fig. 1 and para. [0081] or a handheld housing 12 in para. [0080] and fig. 1 is considered as an eyepiece or eyebox);
a light engine disposed within a housing of the device and comprising at least one light source configured to produce at least first and second light beams that deliver PBM light in at least two doses of different therapeutic wavelengths to the same target retinal tissue, the first light beam in a first dose having a first therapeutic wavelength and the second light beam in a second dose having a second therapeutic wavelength (para. [0019], one or more rotatable mirrors and at least one optical fiber can be part of a light engine, para. [0080], [0081], an EMR source 14 that generates EMR with one or more wavelengths in a desired range, fig. 1), wherein the second therapeutic wavelength differs from the first therapeutic wavelength by at least 25 nm, and wherein the PBM light in each of the first and second light beams has an irradiance at the target tissue that stimulates different light sensitive factors in the target retinal tissue ((para. [0074] and [0165] discloses that disclosed method of EMR treatment can be applied for photodynamic therapy, photobiomodulation, and photostimulation to hard and soft tissues including ophthalmic tissue (e.g., conjuctiva, cornea, retinal tissue); para. [0080], [0096], [0095], the EMR source provides EMR with wavelengths that are less likely to cause retinal damage, e.g., wavelengths that are absorbed by water (e.g., wavelengths in a range of about 600-680 nm, or have a wavelength that is predominately red, or the spectrum of the light is in the range of or around the absorption peaks for water, for example, 970 nm, 1200 nm, 1470 nm, 1900 nm, 2940 nm); para. [0025], 300 nm to 1800 nm, para. [0148]; para. [0116], [0118], depending upon the wavelength(s) and fluence of an EMR beam, and the absorption and scattering characteristics of a tissue for the wavelength(s), an EMR beam may penetrate to certain depths before being initially or completely absorbed or dissipated - Altshuler discloses that different wavelengths and doses are used to penetrate the target tissue to certain depths. Therefore, different wavelengths targeting different depths would be considered stimulating different light sensitive factors/regions in the target tissue ) and wherein the PBM light has an irradiance at the target cell or tissue selected to stimulate the target cell or tissue and/or reverse or slow disease progression in the target cell or tissue (para. [0074], [0119], [0173] discloses photobiomodulation and photostimulation; para. [0072], [0074], [0075], When an amount of energy (usually at a particular wavelength) sufficient to initiate a certain photochemical reaction is delivered, the lattice is referred to herein as a lattice of “photochemical islets.” - Altshuler discloses that some dose of light produces chemical reaction; para. [0119], it is desirable to cause little or no damage while administering an effective amount of EMR at a specified wavelength (e.g., photobiostimulation));
one or more optical components disposed within the housing, wherein the one or more optical components are configured to direct the first light beam and the second light beam from the light engine to the eyepiece or eyebox to deliver PBM to the target cell or tissue of the first eye of the patient (para. [0081], EMR transmissive window 22, fig. 1); and
an actuator configured to move at least a part of the light engine within the housing relative to at least one optical component of the one or more optical components, to change a direction of at least one of the first light beam or the second light beam relative to both the housing and the first eye of the patient, wherein the actuator is configured and arranged to rotate a part of the light engine (para. [0019], piezoelectric scanner element and at least one stepper motor read on “actuator separate from the light engine”. The piezoelectric scanner element and at least one stepper motor can move one or more rotatable mirrors, which read on “a part of the light engine”, relative to EMR transmissive window, which is “one or more optical component”, to change a direction of the light beam; para. [0081], [0082], a controller 26 can control the EMR delivery system 20. EMG delivery mechanism is an optical scanner that scans an EMR beam generated by the source 14 over a target region. EMR delivery system 20 can be considered as a part of the light engine. A light engine can contain more than at least one light source. An optical scanner within the EMR delivery system 20 is moved relative to EMR transmissive window 22. The transmissive window can be considered as one or more optical components).
Altshuler is silent regarding the first light beam and the second light beam respectively stimulate an identified first therapeutic activity and an identified second therapeutic activity in the same target tissue, and the first therapeutic activity and the second therapeutic activity each produce a different therapeutic biological response in the target tissue according to respective different first and second biological processes, wherein the PBM light in each of the first and second light beams has an irradiance at the target tissue selected to stimulate the target tissue and/or reverse or slow disease progression in the target tissue.
However, Dotson discloses an ophthalmic phototherapy device and associated phototherapy treatment method for promoting healing of damaged or diseased eye tissue (abstract). Dotson teaches the first light beam and the second light beam respectively stimulate an identified first therapeutic activity and an identified second therapeutic activity in the same target tissue, and the first therapeutic activity and the second therapeutic activity each produce a different therapeutic biological response in the target tissue according to respective different first and second biological processes, wherein the PBM light in each of the first and second light beams has an irradiance at the target tissue selected to stimulate the target tissue and/or reverse or slow disease progression in the target tissue (para. [0035], The particular wavelength used varies depending on the injury or eye condition being treated. For example, light in the yellow range (approximately 577 nm to 597 nm) has been shown to switch off collagenase production by down-regulating MMP production and to switch on new collagen production. In the field of opthamology, yellow light having a wavelength of approximately 590 nm has been found to be beneficial for treating corneal trauma when directed into a traumatized cornea. Red light (approximately 640 nm to 700 nm) has been found to decrease inflammation of tissue in the eye, increase ATP production, and reset cellular activity to cause abnormal cells to exhibit more normal behavior.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Altshuler, by configuring the first light beam and the second light beam respectively stimulate an identified first therapeutic activity and an identified second therapeutic activity in the same target tissue, and the first therapeutic activity and the second therapeutic activity each produce a different therapeutic biological response in the target tissue according to respective different first and second biological processes, wherein the PBM light in each of the first and second light beams has an irradiance at the target tissue selected to stimulate the target tissue and/or reverse or slow disease progression in the target tissue, as taught by Dotson, for the purpose of treating injury or eye condition and inflammation of the eye tissue (para. [0035], The particular wavelength used varies depending on the injury or eye condition being treated. For example, light in the yellow range (approximately 577 nm to 597 nm) has been shown to switch off collagenase production by down-regulating MMP production and to switch on new collagen production. In the field of opthamology, yellow light having a wavelength of approximately 590 nm has been found to be beneficial for treating corneal trauma when directed into a traumatized cornea. Red light (approximately 640 nm to 700 nm) has been found to decrease inflammation of tissue in the eye, increase ATP production, and reset cellular activity to cause abnormal cells to exhibit more normal behavior.).
Altshuler and Dotson are silent regarding one or more diffusers configured to homogenize the PBM light in the first and second light beams and reduce non-uniformities in intensity of the first and second light beams prior to the PBM light reaching the at least one eye of the patient.
Colbaugh discloses light therapy provided to a person’s eyes (para. [0026], [0027], figs. 4 and 5) and teaches one or more diffusers configured to homogenize the light in the first and second light beams and reduce non-uniformities in intensity of the first and second light beams prior to the PBM light reaching the at least one eye of the patient (para. [0030], Housing 42 may further be configured to carry an optical diffuser on the outside of first set of radiation sources 44 and/or second set of radiation sources 46. This will help to diffuse the electromagnetic radiation emitted by the sources 44 and/or 46, and provide electromagnetic radiation having a substantially uniform distribution onto the eyelid of the subject. This may enhance the comfort and/or usability of lighting module 40 during rest and/or sleep by the subject.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Altshuler as modified by Dotson, by adding one or more diffusers within the housing of the device configured to homogenize the PBM light in the first and second light beams and reduce non-uniformities in intensity of the first and second light beams prior to the PBM light reaching the first and second eyes of the patient, as taught by Colbaugh, for the purpose of providing electromagnetic radiation having a substantially uniform distribution and enhancing the comfort and/or usability of lighting module (para. [0030]).
Altshuler, Dotson, and Colbaugh are silent regarding wherein the actuator is configured to move at least a part of the light engine within the housing relative to at least one optical component of the one or more optical components to change a direction of the first light beam and the second light beam relative to both housing and the patient such that the first and second light beams are redirected from the first eye of the patient to a target retinal tissue in a second eye of the patient without moving the housing of the device and the eyepiece or eyebox through which the PBM is delivered.
However, Clapham discloses a laser surgery system (abstract) and teaches a self-standing housing (fig. 3, base frame 18) and actuator is configured to move at least a part of the light engine (fig. 3, laser delivery optics 16) relative to at least one optical component of the one or more optical components (fig. 3, other components of laser delivery optics 16) to change a direction of the first light beam and the second light beam relative to the laser alignment system (fig. 3, laser alignment system 17) and the patient such that the first and second light beams are redirected from the first eye of the patient to a target retinal tissue in a second eye of the patient without moving the self-standing housing and the laser alignment system through which the PBM is delivered (para. [0073], [0074], the control system can also be programmed to automatically move to a second nominal position to align a second optical axis 82 (i.e. patient's second eye) with the laser beam axis 15. The control system can be programmed to automatically align the second optical axis with the laser beam axis immediately after treatment of the first eye or to directly align the second optical axis with the laser beam axis. Alignment can be accomplished by initially moving to the first nominal position (alignment with right eye) and then immediately moving to the second nominal position (alignment with the left eye).).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Atlshuler as modified by Dotsun and Colbaugh, by configuring the actuator to move at least a part of the light engine within the housing relative to at least one optical component of the one or more optical components to change a direction of the first light beam and the second light beam relative to both housing and the patient such that the first and second light beams are redirected from the first eye of the patient to a target retinal tissue in a second eye of the patient without moving the housing of the device and the eyepiece or eyebox through which the PBM is delivered, as taught by Clapham, for the purpose of treatment of both eyes by only moving the laser optics (para. [0073], [0074]).
Claims 24-26, 28, 29, 32, 35, 36, 39, 40, 41, 43, 44, 46 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Zacharias (US 2008/0015553) in view of Dotson et al. (US 2013/0079759), Luttrull et al. (US 2014/0330352), and Clapham et al. (US 2003/0004502).
Re Claim 24, Zacharias discloses a device for delivery of photobiomodulation (PBM) to a target retinal tissue of first eye of a patient, the device comprising:
at least one light source (fig. 2, para. [0083], LED or solid state LASER), a relay structure (para. [0084], fig. 2, fig. 4, laser delivery system 120 reads on relay structure; para. [0104], figs. 8A, 8B, a refractive dual-axis beam steering mechanism. A frame 558 holds a pair of spherical or aspherical lenses of opposing dioptric power. A lens 572 of opposing positive dioptric power is mounted on a movable lens holder 560. Combined operation of piezoelectric actuators 580 and 590 allows relative XY displacement of lens 572 relative to lens 570 in all directions – lens 572 reads on a relay structure), and an actuator (fig. 3, para. [0101], motion/position controller circuit 62, para. [0065], [0085], [0087]-[0090], [0119], processor/controller aligns beam steering mechanism 128; para. [0076], microprocessor 300, Processor/controller 10 is connected by suitable data conductors to the sensors and actuators required for operation of system 100) disposed in an interior of a housing (fig. 2),
an eyepiece or eyebox through which PBM light from the device is delivered to the target cell or tissue of the first eye of the patient (para. [0089], [0099], [0016], lens 134 reads on eyepiece);
wherein the at least one light source (fig. 2, para. [0083], LED or solid state LASER), configured to produce the first light beam in a first dose having a first therapeutic wavelength to stimulate a first activity in the target retinal tissue and a second light beam in a second dose having a second therapeutic wavelength to stimulate a second activity in the target cell or tissue, wherein the second therapeutic wavelength differs from the first therapeutic wavelength by at least 25 nm (para. [0078], wavelength for retinal treatment are 512 nm and 810 nm) and the second activity in the target cell or tissue differs from the first activity (para. [0078], visible or infrared portion of electromagnetic spectrum to produce the therapeutic effect, Typical laser emission wavelengths selected for retinal treatment are 512 nm and 810 nm; para. [0082] discloses that wavelength is adjusted according to treatment preferences – This discloses that different wavelengths produces different treatment effects, which reads on different activities; para. [0084]);
a relay structure that, includes one or more optical components that direct the first light beam and the second light beam from the at least one light source to the eyepiece or eyebox to deliver the light in at least two doses to the target retinal tissue of the first eye of the patient (para. [0084], fig. 2, fig. 4, laser delivery system 120 reads on relay structure; para. [0104], figs. 8A, 8B, a refractive dual-axis beam steering mechanism. A frame 558 holds a pair of spherical or aspherical lenses of opposing dioptric power. A lens 572 of opposing positive dioptric power is mounted on a movable lens holder 560. Combined operation of piezoelectric actuators 580 and 590 allows relative XY displacement of lens 572 relative to lens 570 in all directions – lens 572 reads on a relay structure); and
an actuator configured and arranged to move at least a portion of the relay structure to change a direction of the first light beam and the second light beam relative to the eyepiece or eyebox, the actuator, and the at least one eye of the patient (fig. 3, para. [0101], motion/position controller circuit 62, para. [0065], [0085], [0087]-[0090], [0119], processor/controller aligns beam steering mechanism 128; para. [0076], microprocessor 300, Processor/controller 10 is connected by suitable data conductors to the sensors and actuators required for operation of system 100).
Zacharias discloses that controller is configured to modulate the laser power between zero and a selected maximum power along the pattern path using input (para. [0120], [0081]), which means the power level can be adjusted to deliver non-destructive and non-ablative light. Zacharias further discloses that laser source is selected to deliver dose of laser radiation typically with the maximum RMS power above 2.5 watts. Zacharias also discloses that aiming light source is preferably a low power visible light source at light levels compatible with safe standards of aiming light at retina (para. [0083])
Zacharias discloses wavelengths in the range of 512 nm and 810 nm and discloses visible or infrared portion of electromagnetic spectrum to produce the therapeutic effect (para. [0078]), which overlaps with disclosed wavelength range for PBM in the instant specification (instant para. [0099] discloses wavelengths between 550 nm and 1064 nm or between 590 nm and 980 nm).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to configure Zacharias’s at least one light source to produce at least first and second light beams that deliver PBM light in at least two doses to the target retinal tissue, the at least two doses having different therapeutic wavelengths, wherein the PBM light in each of the first and second light beams has an irradiance at the target cell or tissue that facilitates healing and/or reverses or slows disease progression in the target cell or tissue, for the purpose of providing both photocoagulation and photobiomodulation yielding predictable results without alteration to the Zacharias’ device with the benefit of providing two treatments for one price and one equipment, treating more people with different conditions, and increasing income with various uses of the device.
Zacharias is silent regarding the first light beam and the second light beam respectively stimulate the first therapeutic activity and the second therapeutic activity in the same target tissue, and the second therapeutic activity produces a second therapeutic biological response according to a second biological process in the target tissue that differs from a first therapeutic biological response produced by the first therapeutic activity according to a first biological process.
However, Dotson discloses an ophthalmic phototherapy device and associated phototherapy treatment method for promoting healing of damaged or diseased eye tissue (abstract). Dotson teaches the first light beam and the second light beam respectively stimulate the first therapeutic activity and the second therapeutic activity in the same target tissue, and the second therapeutic activity produces a second therapeutic biological response according to a second biological process in the target tissue that differs from a first therapeutic biological response produced by the first therapeutic activity according to a first biological process and wherein the PBM light in each of the first and second light beams has an irradiance at the target tissue that is selected to facilitate healing and/or reverse or slow disease progression in the target tissue (para. [0035], The particular wavelength used varies depending on the injury or eye condition being treated. For example, light in the yellow range (approximately 577 nm to 597 nm) has been shown to switch off collagenase production by down-regulating MMP production and to switch on new collagen production. In the field of opthamology, yellow light having a wavelength of approximately 590 nm has been found to be beneficial for treating corneal trauma when directed into a traumatized cornea. Red light (approximately 640 nm to 700 nm) has been found to decrease inflammation of tissue in the eye, increase ATP production, and reset cellular activity to cause abnormal cells to exhibit more normal behavior; para. [0044]-[0047], a method for promoting healing of retinal eye tissue exhibiting age-related macular degeneration; para. [0048], [0049], a first wavelength between 580 nm to 680 nm and at least second wavelength between 850 to 950 nm for retinal eye tissue).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Altshuler, by configuring the first light beam and the second light beam respectively stimulate the first therapeutic activity and the second therapeutic activity in the same target tissue, and the second therapeutic activity produces a second therapeutic biological response according to a second biological process in the target tissue that differs from a first therapeutic biological response produced by the first therapeutic activity according to a first biological process, wherein the PBM light in each of the first and second light beams has an irradiance at the target tissue that is selected to facilitate healing and/or reverse or slow disease progression in the target tissue, as taught by Dotson, for the purpose of healing of the retinal eye tissue (para. [0044]-[0049], para. [0035], The particular wavelength used varies depending on the injury or eye condition being treated. For example, light in the yellow range (approximately 577 nm to 597 nm) has been shown to switch off collagenase production by down-regulating MMP production and to switch on new collagen production. In the field of opthamology, yellow light having a wavelength of approximately 590 nm has been found to be beneficial for treating corneal trauma when directed into a traumatized cornea. Red light (approximately 640 nm to 700 nm) has been found to decrease inflammation of tissue in the eye, increase ATP production, and reset cellular activity to cause abnormal cells to exhibit more normal behavior.).
Zacharias and Dotson are silent regarding a self-standing housing including an eyepiece or eyebox disposed on the housing, wherein the self-standing housing is arranged for placement on a floor, desk, cart, or table, the eyepiece or eyebox being arranged on the housing to position the at least one eye of the patient relative to the housing to receive the PBM light without moving the housing from the floor, desk, cart, or table.
However, Luttrull discloses an apparatus for retina phototherapy (abstract) and teaches a self-standing housing (para. [0019], system 10 consisting of a working surface 12 and a retina phototherapy device 14) including an eyepiece or eyebox (para. [0019], retina phototherapy device 14) disposed on the housing, wherein the self-standing housing is arranged for placement on a floor, desk, cart, or table (fig. 1), the eyepiece or eyebox being arranged on the housing to position the at least one eye of the patient relative to the housing to receive the PBM light without moving the housing from the floor, desk, cart, or table (para. [0030], FIGS. 6 and 7 illustrate a person positioned in the headrest assembly 18, with their chin in the chin rest 26 and forehead in the forehead rest 28. The ergonomic configuration of the extension arms 22 in the headrest assembly 18 and the barrel 36 of the device 14 are designed to accommodate any type of head, body, or face by effectively reaching out to the patient rather than having the patient “jam” into the device.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotson, adding a self-standing housing to include the eyepiece or eyebox disposed on the housing, wherein the self-standing housing is arranged for placement on a floor, desk, cart, or table, the eyepiece or eyebox being arranged on the housing to position the at least one eye of the patient relative to the housing to receive the PBM light without moving the housing from the floor, desk, cart, or table, as taught by Luttrull, for the purpose of providing a stable base for the phototherapy device (para. [0023]) and headrest assembly (para. [0030]) and accommodating patients in a comfortable manner (para. [0002]).
Zacharias, Dotson, and Luttrull are silent regarding wherein the actuator is configured to move at least a portion of the relay structure to change a direction of the first light beam and the second light beam relative to the eyepiece or eyebox such that the first and second light beams are redirected from the first eye of the patient to a target retinal tissue in a second eye of the patient without moving the self-standing housing, wherein the actuator is configured to move the portion of the relay structure from at least a first position where the first and second light beams are directed to the first eye of the patient to a second position where the first and second light beams are directed to the second eye of the patient.
However, Clapham discloses a laser surgery system (abstract) and teaches a self-standing housing (fig. 3, base frame 18) and actuator is configured to move at least a portion of a relay structure to change a direction of the first light beam and the second light beam relative to the laser alignment system (fig. 3, laser alignment system 17) such that the first and second light beams are redirected from the first eye of the patient to a target retinal tissue in a second eye of the patient without moving the self-standing housing, wherein the actuator is configured to move the portion of the relay structure from at least a first position where the first and second light beams are directed to the first eye of the patient to a second position where the first and second light beams are directed to the second eye of the patient (para. [0073], [0074], the control system can also be programmed to automatically move to a second nominal position to align a second optical axis 82 (i.e. patient's second eye) with the laser beam axis 15. The control system can be programmed to automatically align the second optical axis with the laser beam axis immediately after treatment of the first eye or to directly align the second optical axis with the laser beam axis. Alignment can be accomplished by initially moving to the first nominal position (alignment with right eye) and then immediately moving to the second nominal position (alignment with the left eye).).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotsun and Luttrull, by configuring the actuator to move at least a portion of the relay structure to change a direction of the first light beam and the second light beam relative to the eyepiece or eyebox such that the first and second light beams are redirected from the first eye of the patient to a target retinal tissue in a second eye of the patient without moving the self-standing housing, wherein the actuator is configured to move the portion of the relay structure from at least a first position where the first and second light beams are directed to the first eye of the patient to a second position where the first and second light beams are directed to the second eye of the patient, as taught by Clapham, for the purpose of treatment of both eyes by only moving the laser optics (para. [0073], [0074]).
Re Claim 52, Altshuler discloses a patient interface arranged with respect to the eyepiece or eyebox to position the patient for irradiating the target retinal tissue of the first and second eyes of the patient with the PBM light (para. [0089], optional lens 134).
Re Claim 25, Zacharias discloses a programmable controller operatively coupled to the actuator and at least one light source, wherein the programmable controller is configured and arranged to control movement of the relay structure by the actuator, for at least one of the first light beam and the second light beam: a light energy emission; a light energy density; a light energy duration; a light energy frequency; a light energy area; a light energy sequence; or any combination thereof (fig. 9, figs. 10A, 10B, control panel; para. [0067], a processor/controller 10; para. [0083], power modulation, [0085], beam profiler has the capability of changing the laser energy distribution pattern; fig. 3, para. [0101], motion/position controller circuit 62, para. [0065], [0085], [0087]-[0090], [0119], processor/controller aligns beam steering mechanism 128; para. [0076], microprocessor 300, Processor/controller 10 is connected by suitable data conductors to the sensors and actuators required for operation of system 100).
Re Claim 26, Zacharias discloses an aperture, wherein the device is configured to direct the first light beam and the second light beam through the aperture, to the relay structure and the relay structure is thereafter configured to direct the first light beam and the second light beam through the eyepiece or eyebox to provide PBM to the target retinal tissue of the first eye and the second eye of the patient (para. [0084], fig. 2, fig. 4, a light guide 114 reads on aperture, laser delivery system 120 reads on relay structure, para. [0089], [0099], [0016], lens 134 reads on eyepiece; para. [0104], figs. 8A, 8B, a refractive dual-axis beam steering mechanism. A frame 558 holds a pair of spherical or aspherical lenses of opposing dioptric power. A lens 572 of opposing positive dioptric power is mounted on a movable lens holder 560. Combined operation of piezoelectric actuators 580 and 590 allows relative XY displacement of lens 572 relative to lens 570 in all directions – lens 572 reads on a relay structure).
Re Claim 28, Zacharias discloses that the at least one light source comprises an LED, a lamp, a laser, or any combination thereof (fig. 2, laser delivery system; para. [0083], LED or solid state LASER).
Re Claim 29, Zacharias discloses that the at least one light source is configured and arranged to emit a pulsed light beam comprising a plurality of pulses having a temporal pulse width, wherein the temporal pulse width is in a range from 0.1 milliseconds to 150 seconds (para. [0190]-[0192], pulses of therapeutic laser power, duration of each pulse set to between 5 and 1000 milliseconds, preferably between 10 and 50 milliseconds).
Re Claim 32, Zacharias discloses that one or both of the first therapeutic wavelength and the second therapeutic wavelength are in a range of 590 nm ± 10% of 590 nm, 670 nm 10% of 670 nm, 810 nm 10% of 810 nm, or 1064 nm± 10% of 1064 nm (para. [0078], wavelength for retinal treatment are 512 nm and 810 nm).
Re Claims 35 and 36, Zacharias as modified by Dotson discloses the claimed invention substantially as set forth in claim 24.
Zacharias discloses that the laser treatment system allows procedures such as pan-retinal photo-coagulation and segmental photocoagulation (abstract) and further discloses the first therapeutic wavelength is near-infrared wavelength and is in a range from 800 nm to 900 nm (para. [0078], wavelength for retinal treatment are 512 nm and 810 nm).
Zacharias discloses that the one or more optical components of the relay structure are configured to direct the third light beam from the at least one light source to the eyepiece or eyebox to provide PBM to the target tissue of the at least one eye of the patient (para. [0084], fig. 2, fig. 4, para. [0065], beam splitter/reflector 138 and retinal focusing optics 132).
Zacharias also discloses an actuator configured and arranged to move at least a portion of the relay structure to change a direction of at least one of the first light beam or the second light beam relative to the eyepiece or eyebox, the actuator, and the at least one eye of the patient (fig. 3, para. [0101], motion/position controller circuit 62, para. [0065], [0085], [0087]-[0090], [0119], processor/controller aligns beam steering mechanism 128; para. [0076], microprocessor 300, Processor/controller 10 is connected by suitable data conductors to the sensors and actuators required for operation of system 100). Zacharias discloses a relay structure that, includes one or more optical components that direct the first light beam and the second light beam from the at least one light source to the eyepiece or eyebox to deliver the light in at least two doses to the target cell or tissue of the at least one eye of the patient (para. [0084], fig. 2, fig. 4, laser delivery system 120 reads on relay structure; para. [0104], figs. 8A, 8B, a refractive dual-axis beam steering mechanism. A frame 558 holds a pair of spherical or aspherical lenses of opposing dioptric power. A lens 572 of opposing positive dioptric power is mounted on a movable lens holder 560. Combined operation of piezoelectric actuators 580 and 590 allows relative XY displacement of lens 572 relative to lens 570 in all directions – lens 572 reads on a relay structure).
Zacharias is silent regarding the at least one light source is configured and arranged to produce a third light beam that delivers in PBM light in a third dose to the target tissue, the third dose having a third therapeutic wavelength that is selected to stimulate an identified third therapeutic activity in the target tissue, wherein the third therapeutic wavelength differs from the first therapeutic wavelength and the second therapeutic wavelength by at least 25 nm, and wherein the third light beam stimulates the third therapeutic activity in the same target tissue as the first therapeutic activity and the second therapeutic activity and produces a therapeutic biological response in the target tissue according to a third biological process that differs from the therapeutic biological response produced by at least one of the first therapeutic activity or the second therapeutic activity according to the first or second biological process, wherein the first therapeutic wavelength, the second therapeutic wavelength and the third therapeutic wavelength are each selected from a yellow wavelength, a red wavelength, or a near-infrared wavelength, and wherein the second therapeutic wavelength is in a range from 600 nm to 700 nm, and the third wavelength is in a range from 550 nm to 650 nm, wherein the first therapeutic wavelength is in a range of 850 ± 30 nm, the second therapeutic wavelength is in a range of 660 nm ± 30 nm, and the third wavelength is in a range of 590 ± 30 nm.
However, Dotson discloses an ophthalmic phototherapy device and associated phototherapy treatment method for promoting healing of damaged or diseased eye tissue (abstract). Dotson teaches the at least one light source is configured and arranged to produce a third light beam that delivers in PBM light in a third dose to the target tissue, the third dose having a third therapeutic wavelength that is selected to stimulate an identified third therapeutic activity in the target tissue, wherein the third therapeutic wavelength differs from the first therapeutic wavelength and the second therapeutic wavelength by at least 25 nm, and wherein the third light beam stimulates the third therapeutic activity in the same target tissue as the first therapeutic activity and the second therapeutic activity and produces a therapeutic biological response in the target tissue according to a third biological process that differs from the therapeutic biological response produced by at least one of the first therapeutic activity or the second therapeutic activity according to the first or second biological process, wherein the first therapeutic wavelength, the second therapeutic wavelength and the third therapeutic wavelength are each selected from a yellow wavelength, a red wavelength, or a near-infrared wavelength (para. [0035], The particular wavelength used varies depending on the injury or eye condition being treated. For example, light in the yellow range (approximately 577 nm to 597 nm) has been shown to switch off collagenase production by down-regulating MMP production and to switch on new collagen production. In the field of opthamology, yellow light having a wavelength of approximately 590 nm has been found to be beneficial for treating corneal trauma when directed into a traumatized cornea. Red light (approximately 640 nm to 700 nm) has been found to decrease inflammation of tissue in the eye, increase ATP production, and reset cellular activity to cause abnormal cells to exhibit more normal behavior; para. [0037], wavelengths in the red and near-infrared spectrums are selected to suppress inflammation of the eye tissue – If the third therapeutic wavelength is either red or near-infrared light, then it has different therapeutic activity from the therapeutic activity from orange light; para. [0048], a first wavelength between approximately 580 nm to 680 nm, and preferably approximately 670 nm, as well as at least a second wavelength between approximately 850 nm to 950 nm).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias, by configuring the at least one light source is configured and arranged to produce a third light beam that delivers in PBM light in a third dose to the target tissue, the third dose having a third therapeutic wavelength that is selected to stimulate an identified third therapeutic activity in the target tissue, wherein the third therapeutic wavelength differs from the first therapeutic wavelength and the second therapeutic wavelength by at least 25 nm, and wherein the third light beam stimulates the third therapeutic activity in the same target tissue as the first therapeutic activity and the second therapeutic activity and produces a therapeutic biological response in the target tissue according to a third biological process that differs from the therapeutic biological response produced by at least one of the first therapeutic activity or the second therapeutic activity according to the first or second biological process, wherein the first therapeutic wavelength, the second therapeutic wavelength and the third therapeutic wavelength are each selected from a yellow wavelength, a red wavelength, or a near-infrared wavelength, as taught by Dotson, for the purpose of treating a traumatized cornea and decreasing inflammation of eye tissue (para. [0035], The particular wavelength used varies depending on the injury or eye condition being treated. For example, light in the yellow range (approximately 577 nm to 597 nm) has been shown to switch off collagenase production by down-regulating MMP production and to switch on new collagen production. In the field of opthamology, yellow light having a wavelength of approximately 590 nm has been found to be beneficial for treating corneal trauma when directed into a traumatized cornea. Red light (approximately 640 nm to 700 nm) has been found to decrease inflammation of tissue in the eye, increase ATP production, and reset cellular activity to cause abnormal cells to exhibit more normal behavior; para. [0037], wavelengths in the red and near-infrared spectrums are selected to suppress inflammation of the eye tissue).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotson, to configure Zacharias’s at least one light source to produce at least first, second, and third light beams that deliver PBM light in at least three doses to the target cell or tissue, the at least three doses having different therapeutic wavelengths, wherein the PBM light in each of the first, second, and third light beams has an irradiance at the target cell or tissue that facilitates healing and/or reverses or slows disease progression in the target cell or tissue, for the purpose of providing both photocoagulation and photobiomodulation yielding predictable results without alteration to the Zacharias’ device with the benefit of providing two treatments for one price and one equipment, treating more people with different conditions, and increasing income with various uses of the device.
Zacharias, Dotson, and Colbaugh are silent regarding wherein the actuator is configured to move at least a portion of the relay structure to change a direction of the first, second, and third light beam relative to the eyepiece or eyebox such that the first, second and third light beams are redirected from the first eye of the patient to a target retinal tissue in the second eye of the patient without moving the housing.
However, Clapham discloses a laser surgery system (abstract) and teaches a self-standing housing (fig. 3, base frame 18) and actuator is configured to move at least a portion of a relay structure to change a direction of light beams relative to the laser alignment system (fig. 3, laser alignment system 17) such that the light beams are redirected from the first eye of the patient to a target retinal tissue in a second eye of the patient without moving the self-standing housing, wherein the actuator is configured to move the portion of the relay structure from at least a first position where the light beams are directed to the first eye of the patient to a second position where the first and second light beams are directed to the second eye of the patient (para. [0073], [0074], the control system can also be programmed to automatically move to a second nominal position to align a second optical axis 82 (i.e. patient's second eye) with the laser beam axis 15. The control system can be programmed to automatically align the second optical axis with the laser beam axis immediately after treatment of the first eye or to directly align the second optical axis with the laser beam axis. Alignment can be accomplished by initially moving to the first nominal position (alignment with right eye) and then immediately moving to the second nominal position (alignment with the left eye).).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotsun and Colbaugh, by configuring the actuator to move at least a portion of the relay structure to change a direction of the first, second, and third light beam relative to the eyepiece or eyebox such that the first, second and third light beams are redirected from the first eye of the patient to a target retinal tissue in the second eye of the patient without moving the housing, as taught by Clapham, for the purpose of treatment of both eyes by only moving the laser optics (para. [0073], [0074]).
Re Claim 39, Zacharias discloses a beam positioning mechanism operably coupled to the actuator to move at least a portion of the relay structure to change the direction of the first light beam and the second light beam relative to the eyepiece or eyebox, the actuator, and the first or second eye of the patient (fig. 3, para. [0101], motion/position controller circuit 62, para. [0065], [0085], [0087]-[0090], [0119], processor/controller aligns beam steering mechanism 128).
Re Claim 40, Zacharias discloses a biomedical sensor operatively coupled to the programmable controller and configured and arranged to provide real-time feedback information to the programmable controller regarding the first or second eye of the patient (para. [0098], retinal imaging, para. [0123], processor/controller 10 can receive an input from imaging device 860 to add further processing power to protect sensitive zones of the retina in automatic fashion).
Re Claim 41, Zacharias discloses that the programmable controller is configured and arranged to regulate emission of light from the at least one light source in accordance with the feedback information (para. [0098], retinal imaging, para. [0123], processor/controller 10 can receive an input from imaging device 860 to add further processing power to protect sensitive zones of the retina in automatic fashion).
Re Claim 43, Zacharias as modified by Dotson and Luttrull discloses a method of delivering PBM to a target tissue of at least one eye of a patient using the device of claim 24, the method comprising:
(i) positioning the patient relative to the eyepiece or eyebox using a patient interface surface of the device so that the first eye and the second eye of the patient is positioned to receive the PBM light via the eyepiece or eyebox, wherein during delivery of the PBM light the eyepiece or eyebox is set in a fixed position and is not moved relative to the patient; and (para. [0089], optional lens 134 reads on patient interface; fig. 4, The disclosed device can be set in a fixed position and not moved relative to the patient while delivering the treatment); and
(ii) directing light of at least one of the first therapeutic wavelength or the second therapeutic wavelength from the device to the first eye and the second eye of the patient (para. [0078], para. [0072], [0073]).
Zacharias and Dotson are silent regarding a patient interface surface of the device that supports a head of the patient.
However, Luttrull discloses positioning the patient relative to the eyepiece or eyebox (fig. 6, para. [0022], retina phototherapy device 14) using a patient interface surface of the device that supports a head of the patient (fig. 6, para. [0022], a chin rest 26 and a forehead rest 28) so that the at least one eye of the patient is positioned to receive the treatment light via the eyepiece or eyebox (fig. 6, fig. 7), wherein during delivery of the treatment light, the eyepiece or eyebox is set in a fixed position and is not moved relative to the patient (fig. 1, para. [0021]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotson and Luttrull, by positioning the patient relative to the eyepiece or eyebox using a patient interface surface of the device that supports a head of the patient so that the at least one eye of the patient is positioned to receive the PBM light via the eyepiece or eyebox, wherein during delivery of the PBM light the eyepiece or eyebox is set in a fixed position and is not moved relative to the patient, as taught by Luttrull, for the purpose of providing a stable base for the phototherapy device (para. [0023]) and headrest assembly (para. [0030]) and accommodating patients in a comfortable manner (para. [0002]).
MPEP 2112.02 discloses that under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.
Zacharias, Dotson, and Luttrull are silent regarding directing the PBM light of the first therapeutic wavelength and the second therapeutic wavelength from the device to the target retinal tissue of first and second eyes of the patient without moving the self-standing housing the device.
However, Clapham discloses a laser surgery system (abstract) and teaches a self-standing housing (fig. 3, base frame 18) and directing the PBM light of the first therapeutic wavelength and the second therapeutic wavelength from the device to the target retinal tissue of first and second eyes of the patient without moving the self-standing housing the device (para. [0073], [0074], the control system can also be programmed to automatically move to a second nominal position to align a second optical axis 82 (i.e. patient's second eye) with the laser beam axis 15. The control system can be programmed to automatically align the second optical axis with the laser beam axis immediately after treatment of the first eye or to directly align the second optical axis with the laser beam axis. Alignment can be accomplished by initially moving to the first nominal position (alignment with right eye) and then immediately moving to the second nominal position (alignment with the left eye).).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotsun, Luttrull, and Clapham, by directing the PBM light of the first therapeutic wavelength and the second therapeutic wavelength from the device to the target retinal tissue of first and second eyes of the patient without moving the self-standing housing the device, as taught by Clapham, for the purpose of treatment of both eyes by only moving the laser optics (para. [0073], [0074]).
Re Claim 44, Zacharias discloses (iii) actuating the actuator to move at least a portion of the relay structure, thereby changing the direction of at least one of the first light beam and the second light beam relative to the eyepiece or eyebox, the actuator, and the first eye and the second eye of the patient (fig. 3, para. [0101], motion/position controller circuit 62, para. [0065], [0085], [0087]-[0090], [0119], processor/controller aligns beam steering mechanism 128; para. [0076], microprocessor 300, Processor/controller 10 is connected by suitable data conductors to the sensors and actuators required for operation of system 100; fig. 2).
Re Claim 46, Zacharias discloses that the at least one light source is comprised in a light engine (para. [0083], fig. 2, laser source 102; para. [0077], laser source 102 can be incorporated inside laser delivery system 120), and wherein the actuator is configured to rotate a part of the light engine to change the direction of at least one of the first light beam or the second light beam relative to the eyepiece or eyebox, the actuator, and the first or second eye of the patient (para. [0100], pattern steering mechanism 136).
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Zacharias (US 2008/0015553) as modified by Dotson et al. (US 2013/0079759), Clapham et al. (US 2003/0004502) and Luttrull et al. (US 2014/0330352) and further in view of Colbaugh (US 2013/0053929).
Re Claim 53, Zacharias as modified by Dotson, Clapham and Luttrull discloses the claimed invention substantially as set forth in claim 24.
Zacharias, Dotson, and Luttrull are silent regarding one or more diffusers configured to diffuse the PBM light such that, prior to the PBM light reaching the at least one eye of the patient, an energy density profile of the PBM light does not have a substantial peak at any particular emission angle but is substantially evenly distributed among a range of emission angles.
Colbaugh discloses light therapy provided to a person’s eyes (para. [0026], [0027], figs. 4 and 5) and teaches one or more diffusers configured to diffuse the treatment light such that, prior to the PBM light reaching the at least one eye of the patient, an energy density profile of the treatment light does not have a substantial peak at any particular emission angle but is substantially evenly distributed among a range of emission angles (para. [0030], Housing 42 may further be configured to carry an optical diffuser on the outside of first set of radiation sources 44 and/or second set of radiation sources 46. This will help to diffuse the electromagnetic radiation emitted by the sources 44 and/or 46, and provide electromagnetic radiation having a substantially uniform distribution onto the eyelid of the subject. This may enhance the comfort and/or usability of lighting module 40 during rest and/or sleep by the subject.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotson, Clapham, and Luttrull, by adding one or more diffusers within the self-standing housing configured to diffuse the PBM light such that, prior to the PBM light reaching the first and second eyes of the patient, an energy density profile of the PBM light does not have a substantial peak at any particular emission angle but is substantially evenly distributed among a range of emission angles, as taught by Colbaugh, for the purpose of providing electromagnetic radiation having a substantially uniform distribution and enhancing the comfort and/or usability of lighting module (para. [0030]).
Claims 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Zacharias (US 2008/0015553) in view of Dotson et al. (US 2013/0079759), Colbaugh (US 2013/0053929), and Clapham et al. (US 2003/0004502).
Re Claim 47, Zacharias discloses a device for delivery of photobiomodulation (PBM) to a target tissue of at least one eye of a patient, the device comprising:
an eyepiece or eyebox through which PBM light from the device is delivered to the target tissue of the at least one eye of the patient (para. [0089], [0099], [0016], lens 134 reads on eyepiece);
a light engine disposed within a housing of the device and comprising at least one light source (para. [0077], laser source 102 can be incorporated inside laser delivery system 120, fig. 2, para. [0083], LED or solid state LASER; para. [0112], mirror 130 is also part of the light engine), configured and arranged to produce a first light beam in a first dose having a first therapeutic wavelength and a second light beam in a second dose having a second therapeutic wavelength, wherein the second therapeutic wavelength differs from the first therapeutic wavelength by at least 25 nm and wherein the light in each of the first and second light beams has an irradiance at the target cell or tissue that stimulates different light sensitive factors in the target cell or tissue (para. [0078], wavelength for retinal treatment are 512 nm and 810 nm; para. [0078], visible or infrared portion of electromagnetic spectrum to produce the therapeutic effect, Typical laser emission wavelengths selected for retinal treatment are 512 nm and 810 nm; para. [0082] discloses that wavelength is adjusted according to treatment preferences – This discloses that different wavelengths produces different treatment effects, which reads on stimulating different light sensitive factors in the target cell or tissue; para. [0084]);
one or more optical components disposed within the housing, wherein the one or more optical components are configured and arranged to direct the first light beam and the second light beam from the light engine to the eyepiece or eyebox to deliver PBM to the target cell or tissue of the at least one eye of the patient (para. [0084], fig. 2, fig. 4, para. [0065], beam splitter/reflector 138 and retinal focusing optics 132); and
an actuator configured and arranged to move a part of the light engine within the housing relative to at least one optical component of the one or more optical components to change a direction of at least one of the first light beam or the second light beam relative to both the housing and the at least one eye of the patient (fig. 3, para. [0101], motion/position controller circuit 62, para. [0065], [0085], [0087]-[0090], [0119], processor/controller aligns beam steering mechanism 128; para. [0076], microprocessor 300, Processor/controller 10 is connected by suitable data conductors to the sensors and actuators required for operation of system 100. fig. 2, Para. [0087], [0097], [0112], mirror 130 is considered “a part of the light engine”, which moves relative to beam splitter 138 and focusing optics 132, which are one or more optical components, by an actuator involved in system related beam steering mechanism 128).
Zacharias discloses that controller is configured to modulate the laser power between zero and a selected maximum power along the pattern path using input (para. [0120], [0081]), which means the power level can be adjusted to deliver non-destructive and non-ablative light. Zacharias further discloses that laser source is selected to deliver dose of laser radiation typically with the maximum RMS power above 2.5 watts. Zacharias also discloses that aiming light source is preferably a low power visible light source at light levels compatible with safe standards of aiming light at retina (para. [0083])
Zacharias discloses wavelengths in the range of 512 nm and 810 nm and discloses visible or infrared portion of electromagnetic spectrum to produce the therapeutic effect (para. [0078]), which overlaps with disclosed wavelength range for PBM in the instant specification (instant para. [0099] discloses wavelengths between 550 nm and 1064 nm or between 590 nm and 980 nm).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to configure Zacharias’s at least one light source to produce at least first and second light beams that deliver PBM light in at least two doses of different therapeutic wavelengths to the target cell or tissue, wherein the PBM light in each of the first and second light beams has an irradiance at the target cell or tissue that stimulates different light sensitive factors in the target cell or tissue, for the purpose of providing both photocoagulation and photobiomodulation yielding predictable results without alteration to the Zacharias’ device with the benefit of providing two treatments for one price and one equipment, treating more people with different conditions, and increasing income with various uses of the device.
Zacharias is silent regarding the first light beam and the second light beam respectively stimulate the first therapeutic activity and the second therapeutic activity in the same target cell or tissue, and the first activity and the second activity each produce a different therapeutic biological response in the target tissue according to respective different first and second biological processes.
However, Dotson discloses an ophthalmic phototherapy device and associated phototherapy treatment method for promoting healing of damaged or diseased eye tissue (abstract). Dotson teaches the first light beam and the second light beam respectively stimulate the first therapeutic activity and the second therapeutic activity in the same target tissue, and the first activity and the second activity each produce a different therapeutic biological response in the target tissue according to respective different first and second biological processes, wherein the PBM light in each of the first and second light beams has an irradiance at the target tissue that is selected to facilitate healing and/or reverse or slow disease progression in the target tissue (para. [0035], The particular wavelength used varies depending on the injury or eye condition being treated. For example, light in the yellow range (approximately 577 nm to 597 nm) has been shown to switch off collagenase production by down-regulating MMP production and to switch on new collagen production. In the field of opthamology, yellow light having a wavelength of approximately 590 nm has been found to be beneficial for treating corneal trauma when directed into a traumatized cornea. Red light (approximately 640 nm to 700 nm) has been found to decrease inflammation of tissue in the eye, increase ATP production, and reset cellular activity to cause abnormal cells to exhibit more normal behavior.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Altshuler, by configuring the first light beam and the second light beam respectively stimulate the first therapeutic activity and the second therapeutic activity in the same target cell or tissue, and the first activity and the second activity each produce a different therapeutic biological response in the target tissue according to respective different first and second biological processes, wherein the PBM light in each of the first and second light beams has an irradiance at the target tissue that is selected to facilitate healing and/or reverse or slow disease progression in the target tissue, as taught by Dotson, for the purpose of healing of the eye tissue (para. [0035], The particular wavelength used varies depending on the injury or eye condition being treated. For example, light in the yellow range (approximately 577 nm to 597 nm) has been shown to switch off collagenase production by down-regulating MMP production and to switch on new collagen production. In the field of opthamology, yellow light having a wavelength of approximately 590 nm has been found to be beneficial for treating corneal trauma when directed into a traumatized cornea. Red light (approximately 640 nm to 700 nm) has been found to decrease inflammation of tissue in the eye, increase ATP production, and reset cellular activity to cause abnormal cells to exhibit more normal behavior.).
Zacharias and Dotson are silent regarding one or more diffusers configured to homogenize the PBM light in the first and second light beams and reduce non-uniformities in intensity of the first and second light beams prior to the PBM light reaching the at least one eye of the patient.
Colbaugh discloses light therapy provided to a person’s eyes (para. [0026], [0027], figs. 4 and 5) and teaches one or more diffusers configured to homogenize the light in the first and second light beams and reduce non-uniformities in intensity of the first and second light beams prior to the PBM light reaching the at least one eye of the patient (para. [0030], Housing 42 may further be configured to carry an optical diffuser on the outside of first set of radiation sources 44 and/or second set of radiation sources 46. This will help to diffuse the electromagnetic radiation emitted by the sources 44 and/or 46, and provide electromagnetic radiation having a substantially uniform distribution onto the eyelid of the subject. This may enhance the comfort and/or usability of lighting module 40 during rest and/or sleep by the subject.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotson, by adding one or more diffusers within the housing of the device configured to homogenize the PBM light in the first and second light beams and reduce non-uniformities in intensity of the first and second light beams prior to the PBM light reaching the first and second eyes of the patient, as taught by Colbaugh, for the purpose of providing electromagnetic radiation having a substantially uniform distribution and enhancing the comfort and/or usability of lighting module (para. [0030]).
Zacharias, Dotson, and Colbaugh are silent regarding wherein the actuator is configured to move at least a part of the light engine within the housing relative to at least one optical component of the one or more optical components to change a direction of the first light beam and the second light beam relative to both housing and the patient such that the first and second light beams are redirected from the first eye of the patient to a target retinal tissue in a second eye of the patient without moving the housing of the device and the eyepiece or eyebox through which the PBM is delivered.
However, Clapham discloses a laser surgery system (abstract) and teaches a self-standing housing (fig. 3, base frame 18) and actuator is configured to move at least a part of the light engine (fig. 3, laser delivery optics 16) relative to at least one optical component of the one or more optical components (fig. 3, other components of laser delivery optics 16) to change a direction of the first light beam and the second light beam relative to the laser alignment system (fig. 3, laser alignment system 17) and the patient such that the first and second light beams are redirected from the first eye of the patient to a target retinal tissue in a second eye of the patient without moving the self-standing housing and the laser alignment system through which the PBM is delivered (para. [0073], [0074], the control system can also be programmed to automatically move to a second nominal position to align a second optical axis 82 (i.e. patient's second eye) with the laser beam axis 15. The control system can be programmed to automatically align the second optical axis with the laser beam axis immediately after treatment of the first eye or to directly align the second optical axis with the laser beam axis. Alignment can be accomplished by initially moving to the first nominal position (alignment with right eye) and then immediately moving to the second nominal position (alignment with the left eye).).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotsun and Colbaugh, by configuring the actuator to move at least a part of the light engine within the housing relative to at least one optical component of the one or more optical components to change a direction of the first light beam and the second light beam relative to both housing and the patient such that the first and second light beams are redirected from the first eye of the patient to a target retinal tissue in a second eye of the patient without moving the housing of the device and the eyepiece or eyebox through which the PBM is delivered, as taught by Clapham, for the purpose of treatment of both eyes by only moving the laser optics (para. [0073], [0074]).
Re Claim 48, Zacharias discloses that the actuator is configured and arranged to rotate a part of the light engine (fig. 2, Para. [0087], [0097], [0112], mirror 130 is considered “a part of the light engine”, which is rotated by an actuator involved in system related beam steering mechanism 128).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Zacharias (US 2008/0015553) as modified by Dotson et al. (US 2013/0079759), Clapham et al. (US 2003/0004502), and Luttrull et al. (US 2014/0330352), and further in view of Knopp et al. (US 2002/0173778).
Re Claim 42, Zacharis as modified by Dotson, Clapham, and Luttrull discloses the claimed invention substantially as set forth in claim 24.
Zacharias are silent regarding a patient interface that includes a forehead rest, a chin rest, or both a forehead rest and a chin rest.
However, Knopp discloses a laser workstation (abstract, fig. 9A) and teaches a patient interface that includes a forehead rest, a chin rest, or both a forehead rest and a chin rest (fig. 9C, 9B, para. [0108]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotson and Luttrull, by configuring the device to have a laser workstation with a patient interface that includes a forehead rest, a chin rest, or both a forehead rest and a chin rest, as taught by Knopp, for the purpose of fixing the position of the patient’s head while patient comfortably rest their head on the patient interface and allowing surgeon/user a freedom to move (para. [0108]).
Claims 30, 31, and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Zacharias (US 2008/0015553), as modified by Dotson et al. (US 2013/0079759), Clapham et al. (US 2003/0004502), and Luttrull et al. (US 2014/0330352), and further in view of Palanker (US 2013/0204235).
Re Claim 30, Zacharias as modified by Dotson, Clapham, and Luttrull discloses the claimed invention substantially as set forth in claim 24.
Zacharias discloses that the laser treatment system allows procedures such as pan-retinal photo-coagulation and segmental photocoagulation (abstract) and further discloses the first therapeutic wavelength is in a range from 800 to 900 nm (para. [0078], wavelength for retinal treatment are 512 nm and 810 nm).
Zacharias is silent regarding the second therapeutic wavelength in a range from 600 to 700 nm.
However, Palanker discloses a laser treatment system for eye configured for pan retinal photocoagulation treatment (para. [0028]) and discloses that the beam generated by laser source may be continuous or pulsed at a duration from about 1 ms to about 1 second, may have a power from about 30 mW to about 2 W and may have a wavelength in the visible spectrum (e.g., 532 nm, 561 nm, 577 nm, 647 nm, 659 nm, or 670 nm) or a wavelength in the non-visible spectrum (e.g., 810 nm) (para. [0038]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotson, Clapham, and Luttrull, by configuring the second therapeutic wavelength to be in a range of 600 to 700 nm, as taught by Palanker, for the purpose of delivering pan retinal photocoagulation treatment (para. [0028]) and producing lighter and smaller lesions to limit damage to the ganglion cell layer and never fiber layer of the eye (para. [0006]).
Re Claim 31, Zacharias as modified by Dotson, Clapham, and Luttrull discloses the claimed invention substantially as set forth in claim 24.
Zacharias discloses that the laser treatment system allows procedures such as pan-retinal photo-coagulation and segmental photocoagulation (abstract) and further discloses the first therapeutic wavelength is in a range from 800 to 900 nm (para. [0078], wavelength for retinal treatment are 512 nm and 810 nm).
Zacharias is silent regarding the second therapeutic wavelength in a range from 550 to 650 nm.
However, Palanker discloses a laser treatment system for eye configured for pan retinal photocoagulation treatment (para. [0028]) and discloses that the beam generated by laser source may be continuous or pulsed at a duration from about 1 ms to about 1 second, may have a power from about 30 mW to about 2 W and may have a wavelength in the visible spectrum (e.g., 532 nm, 561 nm, 577 nm, 647 nm, 659 nm, or 670 nm) or a wavelength in the non-visible spectrum (e.g., 810 nm) (para. [0038]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotson, Clapham, and Luttrull, by configuring the second therapeutic wavelength to be in a range from 550 to 650 nm, as taught by Palanker, for the purpose of delivering pan retinal photocoagulation treatment (para. [0028]) and producing lighter and smaller lesions to limit damage to the ganglion cell layer and never fiber layer of the eye (para. [0006]).
Re Claim 33, Zacharias as modified by Dotson, Clapham, and Luttrull discloses the claimed invention substantially as set forth in claim 24.
Zacharias discloses that the laser treatment system allows procedures such as pan-retinal photo-coagulation and segmental photocoagulation (abstract) and further discloses the therapeutic wavelengths are 512 nm and 810 nm (para. [0078], wavelength for retinal treatment are 512 nm and 810 nm).
Zacharias is silent regarding the first therapeutic wavelength or the second therapeutic wavelength in a range of: (i) 850 nm ± 30 nm; (ii) 660 nm ± 30 nm; or (iii) 590 nm ± 30 nm.
However, Palanker discloses a laser treatment system for eye configured for pan retinal photocoagulation treatment (para. [0028]) and discloses that the beam generated by laser source may be continuous or pulsed at a duration from about 1 ms to about 1 second, may have a power from about 30 mW to about 2 W and may have a wavelength in the visible spectrum (e.g., 532 nm, 561 nm, 577 nm, 647 nm, 659 nm, or 670 nm) or a wavelength in the non-visible spectrum (e.g., 810 nm) (para. [0038]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotson, Clapham, and Luttrull, by configuring the first therapeutic wavelength or the second therapeutic wavelength to be in a range of: (i) 850 nm ± 30 nm; (ii) 660 nm ± 30 nm; or (iii) 590 nm ± 30 nm, as taught by Palanker, for the purpose of delivering pan retinal photocoagulation treatment (para. [0028]) and producing lighter and smaller lesions to limit damage to the ganglion cell layer and never fiber layer of the eye (para. [0006]).
Re Claim 34, Zacharias as modified by Dotson, Clapham, and Luttrull discloses the claimed invention substantially as set forth in claim 24.
Zacharias discloses that the laser treatment system allows procedures such as pan-retinal photo-coagulation and segmental photocoagulation (abstract) and further discloses that the first therapeutic wavelength is 810 nm ± 10% of 810 nm (para. [0078], wavelength for retinal treatment are 512 nm and 810 nm).
Zacharias is silent regarding the second therapeutic wavelength in a range of 670 nm ± 10% of 670 nm.
However, Palanker discloses a laser treatment system for eye configured for pan retinal photocoagulation treatment (para. [0028]) and discloses that the beam generated by laser source may be continuous or pulsed at a duration from about 1 ms to about 1 second, may have a power from about 30 mW to about 2 W and may have a wavelength in the visible spectrum (e.g., 532 nm, 561 nm, 577 nm, 647 nm, 659 nm, or 670 nm) or a wavelength in the non-visible spectrum (e.g., 810 nm) (para. [0038]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotson, Clapham, and Luttrull, by configuring the second therapeutic wavelength in a range of 670 nm ± 10% of 670 nm, as taught by Palanker, for the purpose of delivering pan retinal photocoagulation treatment (para. [0028]) and producing lighter and smaller lesions to limit damage to the ganglion cell layer and never fiber layer of the eye (para. [0006]).
Claims 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Zacharias (US 2008/0015553) as modified by Dotson et al. (US 2013/0079759), Clapham et al. (US 2003/0004502) and Luttrull et al. (US 2014/0330352), and further in view of Koifmann (US 2015/0234207).
Re Claims 37 and 38, Zacharias as modified by Dotson, Clapham, and Luttrull discloses the claimed invention substantially as set forth in claims 24 and 35
Zacharias discloses that the laser treatment system allows procedures such as pan-retinal photo-coagulation and segmental photocoagulation (abstract) and further discloses the first therapeutic wavelength is near-infrared wavelength and is in a range from 800 nm to 900 nm (para. [0078], wavelength for retinal treatment are 512 nm and 810 nm).
Zacharias is silent regarding the first therapeutic wavelength is in a range of 850 ± 30 nm, the second therapeutic wavelength is in a range of 660 nm ± 30 nm, and the third wavelength is in a range of 590 ± 30 nm.
Dotson further discloses the first therapeutic wavelength in a range from 800 nm to 900 nm, the second therapeutic wavelength is in a range from 600 nm to 700 nm, and the third wavelength is in a range from 550 nm to 650 nm, wherein the first therapeutic wavelength is in a range of 850 ± 30 nm, the second therapeutic wavelength is in a range of 660 nm ± 30 nm, and the third wavelength is in a range of 590 ± 30 nm, but is silent regarding the first therapeutic activity producing first biological response that differs from the second therapeutic activity producing second biological response.
However, Koifman discloses that photobiomodulation with near infrared light is protective against bright-light-induced retinal degeneration. The protective effect involves a reduction of cell death and inflammation. Photobiomodulation has the potential to become an important treatment modality for the prevention or treatment of light-induced stress in the retina (para. [0075], [0007], near infrared light range spectrum (750 nm or greater)). Near infrared light range spectrum (750 nm or greater) reads on a range from 800 nm to 900 nm.
Koifman discloses the biological process from the near infrared light range (para. [0075]) which is different from the biological process from the red light as disclosed by Dotson (para. [0035], Red light (approximately 640 nm to 700 nm) has been found to decrease inflammation of tissue in the eye, increase ATP production, and reset cellular activity to cause abnormal cells to exhibit more normal behavior).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotson, Clapham, and Luttrull, by configuring the first therapeutic wavelength in a range from 800 nm to 900 nm, the second therapeutic wavelength is in a range from 600 nm to 700 nm, and the third wavelength is in a range from 550 nm to 650 nm, wherein the first therapeutic wavelength is in a range of 850 ± 30 nm, the second therapeutic wavelength is in a range of 660 nm ± 30 nm, and the third wavelength is in a range of 590 ± 30 nm, as taught by Koifman and Dotson, for the purpose of treating a traumatized cornea and decreasing inflammation of eye tissue (Dotson, para. [0035]), and preventing and treating light-induced stress in the retina and reduction of cell death and inflammation (Koifman, para. [0075]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Zacharias (US 2008/0015553) as modified by Dotson et al. (US 2013/0079759), Clapham et al. (US 2003/0004502), and Luttrull et al. (US 2014/0330352), and further in view of Shazly et al. (US 2011/0098692) and Buczek et al. (US 2008/0246920).
Re Claim 27, Zacharias as modified by Dotson, Clapham, and Luttrull discloses the claimed invention substantially as set forth in claim 24.
Zacharias discloses a laser source with wavelength selection 204 function (para. [0082]), but is silent regarding a reflective filter configured to substantially pass light having the first therapeutic wavelength and substantially reflect light having the second therapeutic wavelength, wherein the device is configured to direct the first light beam and the second light beam to the reflective filter and to direct the light having the first therapeutic wavelength and the light having the second therapeutic wavelength through the eyepiece or eyebox to provide PBM to the target cell or tissue of said at least one eye.
Shazly discloses a laser treatment system configured to perform pan-retinal photocoagulation (para. [0048]) and teaches a plurality of laser diode assemblies (para. [0061]) where the laser unit can emit energy at a wavelength of about 405±20 nm, about 445±20 nm, about 635±20 nm, about 658±20 nm, and/or about 520±20 nm (para. [0006], [0010]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotson, Clapham, and Luttrull, by adding a plurality of light sources that generate individual wavelengths disclosed in Zacharias and Shazly, as taught by Shazly, for the purpose of providing a plurality of wavelength simultaneously for the pan-retinal photocoagulation (para. [0048], [0008]).
Shazly is silent regarding a reflective filter configured and arranged to substantially pass light having the first therapeutic wavelength and substantially reflect light having the second therapeutic wavelength, wherein the device is configured and arranged to direct the first light beam and the second light beam to the reflective filter and to direct the light having the first therapeutic wavelength and the light having the second therapeutic wavelength through the eyepiece or eyebox to provide PBM to the target cell or tissue of said at least one eye.
However, Buczek discloses a multi-LED ophthalmic illuminato and teaches a reflective filter configured to substantially pass light having of first wavelength and substantially reflect light of second wavelength, wherein the device is configured to direct a first light beam and a second light beam to the reflective filter and to direct the light of the first wavelength and the light of the second wavelength to the target cell or tissue of said at least one eye (abstract, para. [0021], [0022], [0023], wavelength range, fig. 1; para. [0031], [0032], fig. 2, [0037], [0038], controller 100).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zacharias as modified by Dotson, Clapham, Luttrull and Shazly, by including a reflective filter configured and arranged to substantially pass light having the first therapeutic wavelength and substantially reflect light having the second therapeutic wavelength, wherein the device is configured and arranged to direct the first light beam and the second light beam to the reflective filter and to direct the light having the first therapeutic wavelength and the light having the second therapeutic wavelength through the eyepiece or eyebox to provide PBM to the target cell or tissue of said at least one eye, as taught by Buczek, for the purpose of collimating the light produced by at least one of light sources (abstract, para. [0022]).
Conclusion
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, March 17, 2026
Examiner, Art Unit 3792