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 .
Response to Arguments
1. Applicant's arguments filed 02/02/2026 have been fully considered but they are not persuasive.
The Applicant argues that it would not be obvious to one having ordinary skill in the art to combine the teachings of Ibrahim and Vassao since Vassao is not related to light application to the eye. The Examiner respectfully disagrees. While Vassao does not teach applying light to the eye of a user, it is not relied upon for this portion of the teaching. Ibrahim is used to teach that green spectrum light is applied to the eye after surgery to reduce chronic pain. They are silent regarding also emitting green spectrum light before surgery to treat chronic pain. This is where the Examiner relies upon the art of Vassao. They teach a treatment for chronic pain wherein green light can be applied before and after surgery in order to reduce post-operative pain and swelling and aid in recovery. While they do not teach treating the eye, they teach that it is known in the art to apply green spectrum light before and after a surgery to better aid in recovery and treatment of chronic pain. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.
The Applicant next argues that the art of Ibrahim does not concern itself with postoperative pain, but rather only with chronic pain. The Examiner respectfully disagrees. Looking at Par. 0100 of Ibrahim, it states: “To investigate neuronal changes that may have occurred in sensory neurons following green LED exposure, pharmacological profiling of neuronal populations was performed. DRG cultures were prepared from rats after exposure to green LED for eight hours daily for five days or control conditions and their functional profiling performed with by Ca.sup.2+ imaging as described recently (see, e.g., Moutal A, Chew L A, Yang X, Wang Y, Yeon S K, Telemi E, Meroueh S, Park K D, Shrinivasan R, Gilbraith K B, Qu C, Xie J Y, Patwardhan A, Vanderah T W, Khanna M, Porreca F, Khanna R. (S)-Lacosamide inhibition of CRMP2 phosphorylation reduces postoperative and neuropathic pain behaviors through distinct classes of sensory neurons identified by constellation pharmacology. Pain 2016)” Par. 0030 also teaches using light therapy post-surgery to treat neuropathic pain.
The Applicant further argues that Ibrahim does not teach inducing a reduction in microglia activation. The Examiner points to Par. 0045 which teaches “A reduction in the number of membrane-localized proteins in dorsal horn green LED exposed rats was also observed, which likely correlates with decreased signaling capabilities of neurons. The findings also uncovered proteins enriched in tissues from green LED exposed rats that have are reported to be linked to antinociception.” One of these proteins that is being reduced is Cathepsin B which is expressed in the microglia, Thus the green LED would decrease the presence of microglia since it is decreasing the protein it produces. Further, the art of Ibrahim teaches the same structure and light application (green LED light) as the Applicant, therefore, it would be capable of the claimed function. If there is something other than the application of green LED for a determined time and duration for a plurality of days that reduces the microglia activation, then the Examiner recommends putting it in the claims.
The Applicant argues that the art of Van de Vin would not teach wherein the light received at the subject's visual system is operable to reduce release of at least tumor necrosis factor alpha (TNFa) since it does not disclose applying light in the green wavelength, as required by the present application. The Examiner respectfully disagrees. While Van de Vin does teach that light in the blue wavelength is used to reduce TNFa, they also state that “decrease in inflammatory cytokine expression and secretion is observed with light at other wavelengths”. They go on to teach that a combination of wavelengths could also be used, which Par. 0310-0311 describes as being a combination of green LED. This portion of the rejection still stands.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
2. Claim(s) 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ibrahim (US 20190160304 A1).
In regards to claim 19, A method for reducing microglial activation in a subject (Par. 0045 and Table 2 teaches reducing inflammation caused from microglial) comprising:
using a light source operable in a green range of wavelengths to administer light in the green range of wavelengths to allow the light to be received at the subject's visual system for a first time period and according to a pre-arranged schedule of administrations; and using the light source to administer, for a second time and subsequent periods according to the prearranged schedule of administrations, light in the green range of wavelengths to allow the light to be received at the subject's visual system (Par. 0009 and 0011 teach applying light in the green spectral range to the eye of a subject for a determined time and duration for a plurality of days; i.e. a first and second number of days).
wherein the light received by the subject's visual system during the first and the second time periods is operable to induce a reduction in microglia activation compared to microglia activation prior to administering the light for the second time period (Par. 0045 and Table 2)
In regards to claim 20, Ibrahim discloses the method of claim 19, wherein the light received at the subject's visual system is operable to regulate inflammation by inducing the reduction microglia activation (Par. 0045 and Table 2).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
3. Claim(s) 1-2, 5-6, 8-9, 11-12, 15-17, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable Ibrahim (US 20190160304 A1) in view of Vassao (NPL: Pre-Conditioning and Post-Operative Photobiomodulation Therapy by a Novel Light Patch System for Knee Arthroplasty: A Protocol for a Phase 1 StudY)
In regards to claim 1, Ibrahim discloses a method of reducing post-operative pain of a subject (Abstract teaches treating chronic pain of a subject), comprising:
administering, daily, according to a first pre-arranged schedule of administrations, light with one or more wavelengths in the range between approximately 515 nm and approximately 535 nm to a visual system of the subject; and administering, daily, for a second number of days and according to a second pre-arranged schedule of administrations, light with one or more wavelengths in the range between approximately 515 nm and approximately 535 nm to the visual system of the subject wherein the light is administered for a time period during each day of the light administration (Par. 0009 and 0011 teach applying light in the range if 450-570nm to the eye of a subject for a determined time and duration for a plurality of days; i.e. a first and second number of days).
While Ibrahim teaches applying light to the subject after surgery to reduce chronic pain, they do not disclose applying light both before and after surgery. However, in the same field of endeavor, Vassao teaches a system for treating pain in a subject (Abstract) wherein light in the 450-650nm range is applied to a subject both before and after surgery (Fig 1 and Experimental Procedures teaches applying PBM light to a subject before and after a surgical procedure. Table 1 also shows that the wavelength of the applied light is between 450-650nm), in order reduce post-operative pain and swelling and aiding recovery (Background).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Ibrahim and modified them by having the light applied both before and after surgery, as taught and suggested by Vassao, in order reduce post-operative pain and swelling and aiding recovery (Background of Vassao).
In regards to claim 2, the combined teachings of Ibrahim and Vassao disclose the method of claim 1, wherein the first number of days is 56 or less, the second number of days is 84 or less, and the time period is between 1 minute and 24 hours (Table 1 of Vassao teaches applying the light pre-operatively for 7 days and then post-operatively for 7 days).
In regards to claim 5, the combined teachings of Ibrahim and Vassao disclose the method of claim 1, except for wherein the administering comprises administering light of 0.001 lux to 1000 lux (Par. 0011 of Ibrahim teaches using a range of 4-1000 lux).
In regards to claim 6, the combined teachings of Ibrahim and Vassao disclose the method of claim 1, further comprising administering an opioid or non-opioid pain relief medication to the subject after the surgery, wherein said opioid or non-opioid pain relief medication is administered at a reduced dose compared to a standard dose of the pain relief medication for the subject (Par. 0059 of Ibrahim teaches using a non-opioid pain relieving medication with the light).
In regards to claim 8, the combined teachings of Ibrahim and Vassao disclose the method of claim 1, wherein for at least two days for which said administering is performed during them there is at least one day between the two days during which no said administering is performed (Table 1 of Vassao teaches that after surgery the light is applied every other day).
In regards to claim 9, the combined teachings of Ibrahim and Vassao disclose the method of claim 1, wherein said administering includes contacting an eye of the subject with a material that allows light between approximately 515 nm and approximately 535 nm to enter the visual system of the subject, and wherein the material is a material that is configured to filter out light of a wavelength that is not between approximately 515 nm and approximately 535 nm (Par. 0049 of Ibrahim teaches using a material to filter out the undesired wavelengths).
In regards to claim 11, Ibrahim discloses a method of enhancing pain sensitivity of a subject (Abstract), comprising:
administering, daily, on the subject and according to a first pre-arranged schedule of administrations, light with one or more wavelengths in the range between approximately 650 nm and approximately 670 nm to a visual system of the subject; and administering, daily, for a second number of days according to a second pre-arranged schedule of administrations, light with one or more wavelengths in the range between approximately 650 nm and approximately 670 nm to the visual system of the subject, wherein the light is administered for a time period during each day of the light administration ((Par. 0009 and 0011 teach applying light in the range if 450-570nm to the eye of a subject for a determined time and duration for a plurality of days; i.e. a first and second number of days).
Ibrahim discloses the claimed invention except for the range being 650-670nm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use this wavelength range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
While Ibrahim teaches applying light to the subject after surgery to reduce chronic pain, they do not disclose applying light both before and after surgery. However, in the same field of endeavor, Vassao teaches a system for treating pain in a subject (Abstract) wherein light in the 450-650nm range is applied to a subject both before and after surgery (Fig 1 and Experimental Procedures teaches applying PBM light to a subject before and after a surgical procedure. Table 1 also shows that the wavelength of the applied light is between 450-650nm), in order reduce post-operative pain and swelling and aiding recovery (Background).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Ibrahim and modified them by having the light applied both before and after surgery, as taught and suggested by Vassao, in order reduce post-operative pain and swelling and aiding recovery (Background of Vassao).
In regards to claim 12, the combined teachings of Ibrahim and Vassao disclose the method of claim 11, wherein the first number of days is 56 or less, the second number of days is 84 or less, and the time period is between 1 minute and 24 hours (Table 1 of Vassao teaches applying the light pro-operatively for 7 days and then post-operatively for 7 days).
In regards to claim 15, the combined teachings of Ibrahim and Vassao disclose the method of claim 11, wherein the administering comprises administering light of 0.001 lux to 1000 lux (Par. 0011 of Ibrahim teaches using a range of 4-1000 lux).
In regards to claim 16, the combined teachings of Ibrahim and Vassao disclose the method of claim 11, wherein for at least two days for which said administering is performed, during them there is at least one day between the at least two days during which no said administering is performed (Table 1 of Vassao teaches that after surgery the light is applied every other day).
In regards to claim 17, the combined teachings of Ibrahim and Vassao disclose the method of claim 11, wherein said administering includes contacting an eye of the subject with a material that allows light between approximately 650 nm and approximately 670 nm to enter the visual system of the subject, wherein the material is a material that is configured to filter out light of a wavelength that is not between approximately 650 nm and approximately 670 nm (Par. 0049 of Ibrahim teaches using a material to filter out the undesired wavelengths).
In regards to claim 21, Ibrahim discloses the method of claim 19, except for wherein the first time period occurs prior to a surgery on the subject, and the second time period occurs after the surgery on the subject.
While Ibrahim teaches applying light to the subject after surgery to reduce chronic pain, they do not disclose applying light both before and after surgery. However, in the same field of endeavor, Vassao teaches a system for treating pain in a subject (Abstract) wherein light in the 450-650nm range is applied to a subject both before and after surgery (Fig 1 and Experimental Procedures teaches applying PBM light to a subject before and after a surgical procedure. Table 1 also shows that the wavelength of the applied light is between 450-650nm), in order reduce post-operative pain and swelling and aiding recovery (Background).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Ibrahim and modified them by having the light applied both before and after surgery, as taught and suggested by Vassao, in order reduce post-operative pain and swelling and aiding recovery (Background of Vassao).
4. Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable Ibrahim and Vassao, and in further view of Van de Vin (US 20220280807 A1).
In regards to claim 22, the combined teachings of Ibrahim and Vassao disclose the method of claim 21, except for wherein the light received at the subject's visual system is operable to reduce release of at least tumor necrosis factor alpha (TNFa) during postoperative neuroinflammation.
However, in the same field of endeavor, Van de Vin discloses using light therapy to treat CNS disorders (Abstract) wherein the light is used to reduce tumor necrosis factor alpha (TNFa) (Par. 0285) in order to regulate inflammation in the brain (Par. 0285).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Ibrahim and Vassao and modified them by having the light educe tumor necrosis factor alpha (TNFa), as taught and suggested by Van de Vin, in order to regulate inflammation in the brain (Par. 0285 of Van de Vin).
5. Claim(s) 25-27 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable Ibrahim in view of Van de Vin (US 20220280807 A1).
In regards to claim 25, Ibrahim discloses a method for treating a subject, comprising: operating a light source in a green range of wavelengths; and administering light in the green range of wavelengths to the subject for a first time period and according to a pre-arranged schedule of administrations; wherein the light in the green range of wavelengths has one or more wavelengths in the range between approximately 515 nm and approximately 535 nm (Fig 1 and Experimental Procedures teaches applying PBM light to a subject before and after a surgical procedure; i.e. for a first and second time period. Table 1 also shows that the wavelength of the applied light is between 450-650nm, since green light is in the range of 500-570 this light system would cover this). Ibrahim does not disclose wherein the light is used to treat/reduce astrocytes activation, However, in the same field of endeavor, Van de Vin discloses using light therapy to treat CNS disorders (Abstract) wherein the light is used to to treat/reduce astrocytes activation (Par. 0285) in order to regulate inflammation in the brain (Par. 0285).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Ibrahim and Vassao and modified them by having the light treat/reduce astrocytes activation, as taught and suggested by Van de Vin, in order to regulate inflammation in the brain (Par. 0285 of Van de Vin).
In regards to claim 26, the combined teachings of Ibrahim and Van de Vin disclose the method of claim 25, wherein the light received at the subject's visual system is operable to reverse changes in the molecular expression or morphology of astrocytes indicative of a reactive state of the astrocytes (Par. 0285 of Van de Vin).
In regards to claim 27, the combined teachings of Ibrahim and Van de Vin disclose the method of claim 26, wherein the changes in molecular expression or morphology of astrocytes are induced due to an infection, wherein the infection is associated with a human immunodeficiency virus (Par. 0003 of Van de Vin).
In regards to claim 29, the combined teachings of Ibrahim and Van de Vin disclose the method of claim 25, wherein the light received at the subject's visual system is operable to reduce pain, wherein the first time period is a first number of hours less than equal to eight, and the pre-arranged schedule of administrations consists of administrations over a plurality of consecutive days (Abstract and Par. 0008-0011 of Ibrahim).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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