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 .
DETAILED ACTION
Acknowledgement is made of applicant’s amendment which was received by the office on December 29, 2025. Claims 1-28 and 30 are currently pending and under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-28 and 30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1, 22 and 30 have been amended to recite “subsequent to an expiration of the first treatment period and independent of the subject experiencing erythema”, however the disclosure does not provide support for the amended claim language “and independent of the subject experiencing erythema”. The original disclosure recites pausing treatment for a pause period, see para. [0031]-[0032] of published application US 2023/0405350, but there is no recitation whether the pause period is independent of the subject experiencing erythema. Therefore, the claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 2-21, 23-28 and 31 directly or indirectly depend from claims 1 or claim 22 and are rejected to for the reasons stated above regarding claims 1 and 22.
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.
Claim(s) 1-5, 8-9, 11-19, and 21-28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Mohammad (Mohammad et al, The Vitiligo Working Group recommendations for narrowband ultraviolet B light phototherapy treatment of vitiligo, Journal of the American Academy of Dermatology) in view of Moffat (US 2018/0353770) and Moffat ‘292 (US 2020/0376292) (all previously cited).
In reference to at least claim 1
Mohammad teaches
A method of treating an autoimmune condition or other chronic condition in a subject with a pause and reset phototherapy protocol that establishes a first treatment period of a predetermined duration, comprising (see "hold dose," in the Moderate & Severe Erythema rows of the Cairo University study, Table 1, p. 882);
administering ultraviolet B (UVB) therapy for a first set of phototherapy treatments having escalating dosage levels over time (first of multiple sets of treatments with 20% escalating dosage levels over time, see Table 1, p. 881), wherein the first set of phototherapy treatments are defined by a pause and reset phototherapy protocol that establishes a first treatment period of a predetermined duration (the first set of phototherapy treatments constitutes the set of treatments occurring 2-3x/week until phototherapy treatments are paused and then reset, p. 882, 884);
subsequent to an expiration of the first treatment period pausing treatment for a pause period, wherein the pause period has a length of time that is based on the pause and reset phototherapy protocol (pausing treatment for a predetermined period that is part of the pause and reset phototherapy protocol, Moderate Erythema, Table 1, p. 882), administering UVB therapy for a second set of phototherapy treatments having escalating dosage levels over time (second of multiple sets of treatments with 20% escalating dosage levels over time, Table 1, p. 881), wherein the second set of phototherapy treatments are defined by a pause and reset phototherapy protocol (wherein the second set of treatments constitutes the set of treatments occurring 2-3x/week after the first time phototherapy treatments are paused, p. 882, Bright red asymptomatic erythema or symptomatic erythema, p.884).
However, Mohammad does not teach treating a non-dermatological autoimmune condition or other chronic non- dermatological condition in a subject or subsequent to an expiration of the first treatment period and independent of the subject experiencing erythema, pausing treatment for a pause period that has a length of time that is based on the pause and reset therapy protocol, wherein the length of time is at least about two weeks.
Moffat which teaches systems and methods for targeted UVB phototherapy for autoimmune disorders and other indications discloses that it is known to use UVB phototherapy to treat various autoimmune dermatologic disorders including psoriasis, atopic dermatitis, vitiligo, chronic urticaria, lichen planus, cutaneous T cell lymphoma, pityriasis lichenoides, parapsoriasis, pityriasis rosea, pruritus, seborrheic dermatitis, actinic prurigo, and alopecia areata (“Ultraviolet phototherapy has been used to treat various autoimmune dermatologic disorders including psoriasis, atopic dermatitis, vitiligo, chronic urticaria, lichen planus, cutaneous T cell lymphoma, pityriasis lichenoides, parapsoriasis, pityriasis rosea, pruritus, seborrheic dermatitis, actinic prurigo, and alopecia areata”, para. [0049]). Moffat further discloses treating a non-dermatological autoimmune condition or other chronic non- dermatological condition (“Considering the immune response from UV phototherapy is not just local, but systemic, autoimmune conditions in other systems of the body are expected to respond to the same or similar immune-modulating biological mechanisms that work in the skin. Phototherapy using UVB can produce vitamin D3 and calcitriol as well as initiate an immune response that leads to the production of ACTH, MSH and BE, all of which have been shown to have a positive impact on several non-dermal autoimmune conditions.”, para. [0049]; “ A targeted UVB phototherapy device that maximizes immune response, calcitriol production and vitamin D.sub.3 production is expected have multiple biological mechanisms of benefit for autoimmune conditions.”, para. [0112]; “Thus, the present disclosure provides systems and methods for an endogenous alternative for synthetic ACTH therapy used for MS and arthritis treatment and/or an endogenous alternative to relieve inflammatory pain related to many autoimmune conditions based on maximum dermal beta endorphin production.”, para. [0114]) in a subject using UVB phototherapy (“The system 3200 can emit high intensity focused UVB radiation to provide therapeutic effects on autoimmune disorders or other indications,”, para. [0078]-[0079], [0090]). Moffat further discloses that providing phototherapy optimizes serum vitamin D levels while preventing adverse events such a gastrointestinal adverse event associated with supplementation (“Cutaneous vitamin D production is most useful form of delivery to optimize serum vitamin D level while preventing adverse events associated with supplementation.”, para. [0038]-[0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Mohammad to expand the applications to include other chronic non- dermatological conditions, as taught by Moffat, in order to provide UVB phototherapy to treat other chronic non- dermatological conditions that optimizes serum vitamin D levels using cutaneous vitamin D production while preventing adverse events such an overdose risk, malabsorption and gastrointestinal adverse events associated with supplementation.
Moffat ‘292 discloses administering ultraviolet B (UVB) therapy (UVB, [0033]) for treating non-dermatological autoimmune conditions (“Vitamin D and UVR can boost innate immune function, with antimicrobial actions helping to fight infections and anti-inflammatory properties having a role in the prevention and treatment of inflammatory diseases like fibromyalgia, rheumatoid arthritis and osteoarthritis.”, [0032]) and that phototherapy treatment usually consists of three exposures per week for at least three months, and then a frequency of once every one to two weeks is used for maintenance, i.e. a pause period between treatment periods can include two weeks during a maintenance period which is independent of experiencing erythema (para. [0045], [0147]). Moffat ‘292, further discloses that dosage can be modified based on information regarding medications from the user in which treatment is prevented for a specified period of time such as a number of days, weeks or months, i.e. pausing for at least about two weeks between treatment periods which is independent of experiencing erythema (para. [0137]) or recent UV exposure, i.e. a pause period for at least about two weeks between treatment periods which is independent of experiencing erythema (para. [0138]) to prevent or avoid erythema or discomfort ([0125], [0155]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Mohammad modified by Moffat to include after the first treatment period independent of the subject experiencing erythema, pausing treatment for a pause period that has a length of time that is based on a therapy protocol, wherein the length of time is at least about two weeks, as taught by Moffat ‘292, in order to prevent or avoid erythema or discomfort.
In reference to at least claim 2
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 1. Mohammad further discloses wherein the first set of phototherapy treatments are delivered over a first period of time (the first set of phototherapy treatments are delivered over a first period of time until the onset of Moderate/Severe Erythema, p. 881-882, Table 1), wherein the first period of time is defined by the pause and reset phototherapy protocol (the endpoint of the first period of time is defined by a stopping condition in the pause/reset protocol of Cairo University, p. 882, Table 1). Moffat ‘292 further discloses wherein the length of time of the pause period is less than the first period of time (based on information regarding medication treatment is prevented for a specified period of time such as a number of days, weeks or months, para. [0137] or recent UV exposure, para. [0138]).
In reference to at least claim 3
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 1. Mohammad further discloses wherein the second set of phototherapy treatments are delivered over a second period of time (wherein the second set of treatments are delivered over a second period after the first treatment period and pause period, Table 1, p. 881-882) and wherein the first period of time is substantially the same as the second period of time (first and second periods are substantially the same when erythema onset occurs after a similar number of sessions, Table 1, p. 881-882).
In reference to at least claim 4
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 1. Mohammad further discloses wherein the first set of phototherapy treatments and the second set of phototherapy treatments each comprise less than 30 phototherapy treatments (wherein if erythema onset takes less than 30 phototherapy treatments, the first and second set of treatments comprise less than 30 treatments, Moderate/Severe Erythema, Table 1, p. 882).
In reference to at least claim 5
Mohammad modified by Moffat renders obvious a method according to claim 1. Moffat ‘292 further discloses wherein the first period of time has a ratio to the first pause period in the range of 2:1 to 12:1 (treatment is prevented for a specified period of time such as a number of days, weeks or months, para. [0137]-[0138]).
In reference to at least claim 8
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 1. Moffat further discloses wherein the non-dermatological condition is atherosclerosis (“Exposing at least 30% of a patient's total skin surface area to a focused UV range (298 nm-307 nm) during a single phototherapy session would allow efficacious treatment of autoimmune disorders in various systems of the body including nervous, digestive, endocrine, integumentary, cardiovascular, muscular, and skeletal.”, para. [0079]).
In reference to at least claim 9
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 1. Moffat further discloses wherein the non-dermatological condition is multiple sclerosis (“There are more than 80 types of autoimmune disorders, some of the more common including Multiple Sclerosis (“MS”),”, para. [0003]; “Exposing at least 30% of a patient's total skin surface area to a focused UV range (298 nm-307 nm) during a single phototherapy session would allow efficacious treatment of autoimmune disorders in various systems of the body including nervous, digestive, endocrine, integumentary, cardiovascular, muscular, and skeletal.”, para. [0079]).
In reference to at least claim 11
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 1. Moffat further discloses wherein the non-dermatological condition is asthma (“Exposing at least 30% of a patient's total skin surface area to a focused UV range (298 nm-307 nm) during a single phototherapy session would allow efficacious treatment of autoimmune disorders in various systems of the body including nervous, digestive, endocrine, integumentary, cardiovascular, muscular, and skeletal.”, para. [0079]).
In reference to at least claim 12
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 1. Moffat further discloses wherein the non-dermatological condition is irritable bowel disease (“Exposing at least 30% of a patient's total skin surface area to a focused UV range (298 nm-307 nm) during a single phototherapy session would allow efficacious treatment of autoimmune disorders in various systems of the body including nervous, digestive, endocrine, integumentary, cardiovascular, muscular, and skeletal.”, para. [0079]).
In reference to at least claim 13
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 1. Moffat further discloses wherein the non-dermatological condition is vasculitis (“Exposing at least 30% of a patient's total skin surface area to a focused UV range (298 nm-307 nm) during a single phototherapy session would allow efficacious treatment of autoimmune disorders in various systems of the body including nervous, digestive, endocrine, integumentary, cardiovascular, muscular, and skeletal.”, para. [0079]).
In reference to at least claim 14
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 1. Moffat further discloses wherein the non-dermatological condition is Parkinson’s (“Exposing at least 30% of a patient's total skin surface area to a focused UV range (298 nm-307 nm) during a single phototherapy session would allow efficacious treatment of autoimmune disorders in various systems of the body including nervous, digestive, endocrine, integumentary, cardiovascular, muscular, and skeletal.”, para. [0079]).
In reference to at least claim 15
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 1. Moffat ‘292 further discloses wherein the length of time of the pause period is less than about four weeks (treatment is prevented for a specified period of time such as a number of days, weeks or months, para. [0137]-[0138]).
In reference to at least claim 16
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 1. Mohammad further discloses wherein further comprising: subsequent to administering UVB therapy for the second set of phototherapy treatments, pausing treatment for a second pause period (subsequent to administering therapy for the second set, pausing treatment for a second pause period until erythema subsides/for a fixed period of 2 sessions, Table 1, p. 882), wherein the second pause period has a length of time that is based on the pause and reset phototherapy protocol (wherein the second pause period can be 2 sessions long, i.e., a length of time predefined by the pause and reset protocol, p. 882); and administering UVB therapy for a third set of phototherapy treatments having escalating dosage levels over time, wherein the third set of phototherapy treatments are defined by a pause and reset phototherapy protocol (administering therapy for a third set of treatments following the second pause period, wherein dosage levels escalate 20% each time, and the third set is defined by a stopping condition in the pause and reset protocol, Table 1, p. 882).
In reference to at least claim 17
Mohammad modified by Moffat renders obvious a method according to claim 16. Mohammad further discloses wherein the pause period is a first pause period, and wherein the second pause period has the same length as the first pause period (the second and first pause periods have the same length, 2 sessions, or the time to onset of erythema, Table 1, p. 882).
In reference to at least claim 18
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 16. Mohammad further discloses wherein the pause period is a first pause period, and wherein the second pause period has a different length than the first pause period (if the erythema is less quickly resolved during the second pause period, the second pause period may be longer than the first pause period, Table 1, p. 882).
In reference to at least claim 19
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 1. Mohammad further discloses administering a disease-modifying therapy (DMT) in conjunction with the administration of the first set of phototherapy treatments and the second set of phototherapy treatments (in conjunction with phototherapy administering DMTs such as oral antioxidants and pulse corticosteroids and topical treatments, Table II, p. 885).
In reference to at least claim 21
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 1. Moffat further discloses wherein the non-dermatological condition is rheumatoid arthritis (“There are more than 80 types of autoimmune disorders, some of the more common including Multiple Sclerosis (“MS”), Rheumatoid Arthritis (“RA”),”, para. [0003]; “Exposing at least 30% of a patient's total skin surface area to a focused UV range (298 nm-307 nm) during a single phototherapy session would allow efficacious treatment of autoimmune disorders in various systems of the body including nervous, digestive, endocrine, integumentary, cardiovascular, muscular, and skeletal.”, para. [0079]).
In reference to at least claim 22
Mohammad teaches
A method of treating a chronic condition in a subject, comprising: administering ultraviolet B (UVB) therapy for a first set of phototherapy treatments, the first set of phototherapy treatments having a first initial dosage level and a first final dosage level and wherein the first set of phototherapy treatments is administered over a first treatment period of a predetermined duration (first set of UVB phototherapy treatments, Table 1, p. 881-882), wherein the first initial dosage level is less than the first final dosage level (because dosage levels escalate, first initial/final dosage levels are lesser and greater respectively, Table 1, p. 881); and in conjunction with the administration of the first set of phototherapy treatments, administering a disease-modifying therapy (DMT) to the subject for treatment of the chronic dermatological condition (in conjunction with phototherapy administering DMTs such as oral antioxidants and pulse corticosteroids and topical treatments, Table II, p. 885).
Subsequent to an expiration of the first treatment period pausing treatment for a pause period, wherein the pause period has a length of time that is based on the pause and reset phototherapy protocol (pausing treatment for a predetermined 2-session period that is part of the pause and reset phototherapy protocol, Moderate Erythema, Table 1, p. 882), administering UVB therapy for a second set of phototherapy treatments having escalating dosage levels over time (second of multiple sets of treatments with 20% escalating dosage levels over time, Table 1, p. 881), and in conjunction with the administration of the second set of phototherapy treatments, administering the DMT to the subject for treatment of the chronic dermatological condition (in conjunction with phototherapy administering DMTs such as oral antioxidants and pulse corticosteroids and topical treatments, Table II, p. 885).
However, Mohammad does not teach treating a non-dermatological autoimmune condition or other chronic non- dermatological condition in a subject or subsequent to an expiration of the first treatment period and independent of the subject experiencing erythema, pausing treatment for a pause period that has a length of time that is based on the pause and reset therapy protocol, wherein the length of time is at least about two weeks.
Moffat which teaches systems and methods for targeted UVB phototherapy for autoimmune disorders and other indications discloses that it is known to use UVB phototherapy to treat various autoimmune dermatologic disorders including psoriasis, atopic dermatitis, vitiligo, chronic urticaria, lichen planus, cutaneous T cell lymphoma, pityriasis lichenoides, parapsoriasis, pityriasis rosea, pruritus, seborrheic dermatitis, actinic prurigo, and alopecia areata (“Ultraviolet phototherapy has been used to treat various autoimmune dermatologic disorders including psoriasis, atopic dermatitis, vitiligo, chronic urticaria, lichen planus, cutaneous T cell lymphoma, pityriasis lichenoides, parapsoriasis, pityriasis rosea, pruritus, seborrheic dermatitis, actinic prurigo, and alopecia areata”, para. [0049]). Moffat further discloses treating a non-dermatological autoimmune condition or other chronic non- dermatological condition (“Considering the immune response from UV phototherapy is not just local, but systemic, autoimmune conditions in other systems of the body are expected to respond to the same or similar immune-modulating biological mechanisms that work in the skin. Phototherapy using UVB can produce vitamin D3 and calcitriol as well as initiate an immune response that leads to the production of ACTH, MSH and BE, all of which have been shown to have a positive impact on several non-dermal autoimmune conditions.”, para. [0049]; “ A targeted UVB phototherapy device that maximizes immune response, calcitriol production and vitamin D.sub.3 production is expected have multiple biological mechanisms of benefit for autoimmune conditions.”, para. [0112]; “Thus, the present disclosure provides systems and methods for an endogenous alternative for synthetic ACTH therapy used for MS and arthritis treatment and/or an endogenous alternative to relieve inflammatory pain related to many autoimmune conditions based on maximum dermal beta endorphin production.”, para. [0114]) in a subject using UVB phototherapy (“The system 3200 can emit high intensity focused UVB radiation to provide therapeutic effects on autoimmune disorders or other indications,”, para. [0078]-[0079], [0090]). Moffat further discloses that providing phototherapy optimizes serum vitamin D levels while preventing adverse events such a gastrointestinal adverse event associated with supplementation (“Cutaneous vitamin D production is most useful form of delivery to optimize serum vitamin D level while preventing adverse events associated with supplementation.”, para. [0038]-[0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Mohammad to expand the applications of to include other chronic non- dermatological conditions, as taught by Moffat, in order to provide UVB phototherapy to treat other chronic non- dermatological conditions that optimizes serum vitamin D levels using cutaneous vitamin D production while preventing adverse events such an overdose risk, malabsorption and gastrointestinal adverse events associated with supplementation.
Moffat ‘292 discloses administering ultraviolet B (UVB) therapy (UVB, [0033]) for treating non-dermatological autoimmune conditions (“Vitamin D and UVR can boost innate immune function, with antimicrobial actions helping to fight infections and anti-inflammatory properties having a role in the prevention and treatment of inflammatory diseases like fibromyalgia, rheumatoid arthritis and osteoarthritis.”, [0032]) and that phototherapy treatment usually consists of three exposures per week for at least three months, and then a frequency of once every one to two weeks is used for maintenance, i.e. a pause period between treatment periods can include two weeks during a maintenance period which is independent of experiencing erythema (para. [0045], [0147]). Moffat ‘292 further discloses that dosage can be modified based on information regarding medications from the user in which treatment is prevented for a specified period of time such as a number of days, weeks or months, i.e. pausing for at least about two weeks between treatment periods which is independent of experiencing erythema (para. [0137]) or recent UV exposure, i.e. a pause period for at least about two weeks between treatment periods which is independent of experiencing erythema (para. [0138]) to prevent or avoid erythema or discomfort ([0125], [0155]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Mohammad modified by Moffat to include after the first treatment period independent of the subject experiencing erythema, pausing treatment for a pause period that has a length of time that is based on a therapy protocol, wherein the length of time is at least about two weeks, as taught by Moffat ‘292, in order to prevent or avoid erythema or discomfort.
In reference to at least claim 23
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 22. Moffat further discloses wherein the non-dermatological condition is rheumatoid arthritis (“There are more than 80 types of autoimmune disorders, some of the more common including Multiple Sclerosis (“MS”), Rheumatoid Arthritis (“RA”),”, para. [0003]; “Exposing at least 30% of a patient's total skin surface area to a focused UV range (298 nm-307 nm) during a single phototherapy session would allow efficacious treatment of autoimmune disorders in various systems of the body including nervous, digestive, endocrine, integumentary, cardiovascular, muscular, and skeletal.”, para. [0079]).
In reference to at least claim 24
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 22. Moffat further discloses wherein the non-dermatological condition is multiple sclerosis (“There are more than 80 types of autoimmune disorders, some of the more common including Multiple Sclerosis (“MS”),”, para. [0003]; “Exposing at least 30% of a patient's total skin surface area to a focused UV range (298 nm-307 nm) during a single phototherapy session would allow efficacious treatment of autoimmune disorders in various systems of the body including nervous, digestive, endocrine, integumentary, cardiovascular, muscular, and skeletal.”, para. [0079]).
In reference to at least claim 25
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 22. Moffat further discloses wherein the non-dermatological condition is inflammatory bowel disease (“There are more than 80 types of autoimmune disorders, some of the more common including Multiple Sclerosis (“MS”), Rheumatoid Arthritis (“RA”), Type 1 Diabetes mellitus (“T1D”), Ulcerative Colitis (“UC”), Crohn's Disease (“CD”), Celiac and Lupus.”, para. [0003]; “Exposing at least 30% of a patient's total skin surface area to a focused UV range (298 nm-307 nm) during a single phototherapy session would allow efficacious treatment of autoimmune disorders in various systems of the body including nervous, digestive, endocrine, integumentary, cardiovascular, muscular, and skeletal.”, para. [0079]).
In reference to at least claim 26
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 22. Moffat further discloses wherein the non-dermatological condition is ulcerative colitis (“There are more than 80 types of autoimmune disorders, some of the more common including Multiple Sclerosis (“MS”), Rheumatoid Arthritis (“RA”), Type 1 Diabetes mellitus (“T1D”), Ulcerative Colitis (“UC”), Crohn's Disease (“CD”), Celiac and Lupus.”, para. [0003]; “Exposing at least 30% of a patient's total skin surface area to a focused UV range (298 nm-307 nm) during a single phototherapy session would allow efficacious treatment of autoimmune disorders in various systems of the body including nervous, digestive, endocrine, integumentary, cardiovascular, muscular, and skeletal.”, para. [0079]).
In reference to at least claim 27
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 22. Moffat further discloses wherein the non-dermatological condition is Crohn’s disease (“There are more than 80 types of autoimmune disorders, some of the more common including Multiple Sclerosis (“MS”), Rheumatoid Arthritis (“RA”), Type 1 Diabetes mellitus (“T1D”), Ulcerative Colitis (“UC”), Crohn's Disease (“CD”), Celiac and Lupus.”, para. [0003]; “Exposing at least 30% of a patient's total skin surface area to a focused UV range (298 nm-307 nm) during a single phototherapy session would allow efficacious treatment of autoimmune disorders in various systems of the body including nervous, digestive, endocrine, integumentary, cardiovascular, muscular, and skeletal.”, para. [0079]).
In reference to at least claim 28
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 22. Moffat further discloses wherein the non-dermatological condition is diabetes type 1 (“There are more than 80 types of autoimmune disorders, some of the more common including Multiple Sclerosis (“MS”), Rheumatoid Arthritis (“RA”), Type 1 Diabetes mellitus (“T1D”), Ulcerative Colitis (“UC”), Crohn's Disease (“CD”), Celiac and Lupus.”, para. [0003]; “Exposing at least 30% of a patient's total skin surface area to a focused UV range (298 nm-307 nm) during a single phototherapy session would allow efficacious treatment of autoimmune disorders in various systems of the body including nervous, digestive, endocrine, integumentary, cardiovascular, muscular, and skeletal.”, para. [0079]).
In reference to at least claim 30
Mohammad teaches
A method of treating an autoimmune condition or other chronic condition in a subject with a pause and reset phototherapy protocol, comprising (see "hold dose," in the Moderate & Severe Erythema rows of the Cairo University study, Table 1, p. 882);
administering ultraviolet B (UVB) therapy for a first set of phototherapy treatments having escalating dosage levels over time (first of multiple sets of treatments with 20% escalating dosage levels over time, see Table 1, p. 881), wherein the first set of phototherapy treatments are defined by a pause and reset phototherapy protocol that established a first treatment period of a predetermine duration (the first set of phototherapy treatments constitutes the set of treatments occurring until phototherapy treatments are paused and then reset, p. 882, 884);
subsequent to an expiration of the first treatment period pausing treatment for a pause period, wherein the pause period has a length of time that is based on the pause and reset phototherapy protocol (pausing treatment for a predetermined 2-session period that is part of the pause and reset phototherapy protocol, Moderate Erythema, Table 1, p. 882),
and administering UVB therapy for a second set of phototherapy treatments having escalating dosage levels over time (second of multiple sets of treatments with 20% escalating dosage levels over time, Table 1, p. 881), wherein the second set of phototherapy treatments are defined by a pause and reset phototherapy protocol (wherein the second set of treatments constitutes the set of treatments occurring 2-3x/week after the first time phototherapy treatments are paused due to Moderate/Severe Erythema, p. 882, Bright red asymptomatic erythema or symptomatic erythema, p.884).
However, Mohammad does not teach treating Multiple Sclerosis in a subject or subsequent to an expiration of the first treatment period and independent of the subject experiencing erythema, pausing treatment for a pause period that has a length of time that is based on the pause and reset therapy protocol, wherein the length of time is at least about two weeks.
Moffat which teaches systems and methods for targeted UVB phototherapy for autoimmune disorders and other indications discloses that it is known to use UVB phototherapy to treat various autoimmune dermatologic disorders including psoriasis, atopic dermatitis, vitiligo, chronic urticaria, lichen planus, cutaneous T cell lymphoma, pityriasis lichenoides, parapsoriasis, pityriasis rosea, pruritus, seborrheic dermatitis, actinic prurigo, and alopecia areata (“Ultraviolet phototherapy has been used to treat various autoimmune dermatologic disorders including psoriasis, atopic dermatitis, vitiligo, chronic urticaria, lichen planus, cutaneous T cell lymphoma, pityriasis lichenoides, parapsoriasis, pityriasis rosea, pruritus, seborrheic dermatitis, actinic prurigo, and alopecia areata”, para. [0049]). Moffat further discloses treating a non-dermatological autoimmune condition or other chronic non- dermatological condition (“There are more than 80 types of autoimmune disorders, some of the more common including Multiple Sclerosis (“MS”),”, para. [0003]; “Considering the immune response from UV phototherapy is not just local, but systemic, autoimmune conditions in other systems of the body are expected to respond to the same or similar immune-modulating biological mechanisms that work in the skin. Phototherapy using UVB can produce vitamin D3 and calcitriol as well as initiate an immune response that leads to the production of ACTH, MSH and BE, all of which have been shown to have a positive impact on several non-dermal autoimmune conditions.”, para. [0049]; “ A targeted UVB phototherapy device that maximizes immune response, calcitriol production and vitamin D.sub.3 production is expected have multiple biological mechanisms of benefit for autoimmune conditions.”, para. [0112]; “Thus, the present disclosure provides systems and methods for an endogenous alternative for synthetic ACTH therapy used for MS and arthritis treatment and/or an endogenous alternative to relieve inflammatory pain related to many autoimmune conditions based on maximum dermal beta endorphin production.”, para. [0114]) in a subject using UVB phototherapy (“The system 3200 can emit high intensity focused UVB radiation to provide therapeutic effects on autoimmune disorders or other indications,”, para. [0078]-[0079], [0090]). Moffat further discloses that providing phototherapy optimizes serum vitamin D levels while preventing adverse events such a gastrointestinal adverse event associated with supplementation (“Cutaneous vitamin D production is most useful form of delivery to optimize serum vitamin D level while preventing adverse events associated with supplementation.”, para. [0038]-[0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Mohammad to expand the applications of to include other chronic non- dermatological conditions including Multiple Sclerosis, as taught by Moffat, in order to provide UVB phototherapy to treat other chronic non- dermatological conditions that optimizes serum vitamin D levels using cutaneous vitamin D production while preventing adverse events such an overdose risk, malabsorption and gastrointestinal adverse events associated with supplementation.
Moffat ‘292 discloses administering ultraviolet B (UVB) therapy (UVB, [0033]) for treating non-dermatological autoimmune conditions (“Vitamin D and UVR can boost innate immune function, with antimicrobial actions helping to fight infections and anti-inflammatory properties having a role in the prevention and treatment of inflammatory diseases like fibromyalgia, rheumatoid arthritis and osteoarthritis.”, [0032]) and that phototherapy treatment usually consists of three exposures per week for at least three months, and then a frequency of once every one to two weeks is used for maintenance, i.e. a pause period between treatment periods can include two weeks during a maintenance period which is independent of experiencing erythema (para. [0045], [0147]). Moffat ‘292 further discloses that dosage can be modified based on information regarding medications from the user in which treatment is prevented for a specified period of time such as a number of days, weeks or months, i.e. pausing for at least about two weeks between treatment periods which is independent of experiencing erythema (para. [0137]) or recent UV exposure, i.e. a pause period for at least about two weeks between treatment periods which is independent of experiencing erythema (para. [0138]) to prevent or avoid erythema or discomfort ([0125], [0155]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Mohammad modified by Moffat to include after the first treatment period independent of the subject experiencing erythema, pausing treatment for a pause period that has a length of time that is based on a therapy protocol, wherein the length of time is at least about two weeks, as taught by Moffat ‘292, in order to prevent or avoid erythema or discomfort.
Claim(s) 6, 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Mohammad in view of Moffat and Moffat ‘292, in further view of Gao (Gao M-Z, Wei V-Y, Xu Q-W, Ji R, Han Z-J, Jiang T-W. Elevated serum YKL-40 correlates with clinical characteristics in patients with polymyositis or dermatomyositis. previously cited).
In reference to at least claims 6-7 and 10
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 1. Moffat ‘292 further discloses wherein the length of time of the pause period is based on a metric of the subject] (based on information regarding medication treatment is prevented for a specified period of time such as a number of days, weeks or months, para. [0137] or recent UV exposure, para. [0138]).
However, Mohammad does not teach wherein the length of time of the pause period is based on measured YKL-40 levels of the subject.
Gao teaches Based on measured YKL-40 levels of the subject (measured YKL-40 levels indicate subject state, see Abstract, Gao).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Mohammad modified by Moffat to incorporate the metric of measured YKL- 40 levels, as taught by Gao, in order to substantiate externally evaluated estimates of the subject's autoimmune condition severity, to more precisely determine when to terminate the pause period.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Mohammad in view of Moffat and Moffat ‘292 in further view of Hecht (US 20190309044, previously cited).
In reference to at least claim 20
Mohammad modified by Moffat and Moffat ‘292 renders obvious a method according to claim 1. Mohammad further discloses wherein the administration of the first set of phototherapy treatments and the second set of phototherapy treatments (see first and second sets of phototherapy treatments, Table 1, p. 881-882, rejection of claim 1).
Mohammad does not teach administering glatiramer acetate in conjunction with the administration of the first set of phototherapy treatments and the second set of phototherapy treatments.
Hecht, which teaches phototherapeutic methods and thus exists in the applicant's field of endeavor, teaches administering glatiramer acetate in conjunction (glatimer acetate, [0007; 0317]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Mohammad with the addition of glatimer acetate, as taught by Hecht, in order to augment and more precisely modulate phototherapeutic effectiveness with variable application of an intermediary agent.
Double Patenting
In view of the approval of the terminal disclaimer filed on 12/29/2025, see approval 12/29/2025, the double patenting rejections made against the claims in the office action of 7/30/2025 have been withdrawn.
Response to Arguments
Double Patenting
As stated above, in view of the approval of the terminal disclaimer filed on 12/29/2025, see approval 12/29/2025, the double patenting rejections made against the claims in the office action of 7/30/2025 have been withdrawn.
Claim Rejections – 35 USC 103
In regards to applicant’s arguments about Mohammad disclosing a pause period, see pg. 7-8 of response filed 12/29/2025, applicant’s arguments with respect to claim(s) 1,22 and 30 have been considered but are moot because the new ground of rejection does not rely on Mohammad for teaching a pause period that is independent of the subject experiencing erythema. The rejections have been amended to include reference to Moffat ‘292 for disclosing such features, see 103 rejection above.
Applicant argues “the Examiner mischaracterizes the nature of the pause in Mohammad by describing it as a "predetermined 2-session period." This is contrary to the teachings of the reference”, see pg. 7-8 of response filed 12/29/2025. As stated above, the new ground of rejection does not rely on Mohammad for teaching a pause period that is independent of the subject experiencing erythema. The rejections have been amended to include reference to Moffat ‘292 for disclosing such features, see 103 rejection above.
Applicant argues “Moffat teaches away from Mohammad. Moffat's entire disclosure is directed to systems that deliver a targeted, sub-erythemal dose of UVB radiation within a specific wavelength range (298-307 nm) with the explicit goal of producing "significant efficacy without side effects" (Moffat, para. [0082]). The very purpose of Moffat is to prevent the erythema that Mohammad's protocol is designed to react to. A person of ordinary skill in the art, guided by Moffat's teachings to develop a safe and effective therapy for non-dermatological conditions, would be motivated to avoid protocols that depend on the occurrence of adverse events, and would thus be taught away from the reactive, side-effect-driven methodology of Mohammad. The proposed combination is therefore illogical and based on hindsight., see pg. 8 of response filed 12/29/2025. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As an initial matter, Mohammad is the base reference which is being modified with Moffat to show that utilizing ultraviolet phototherapy protocols to treat other non-dermatologic autoimmune disorders would have been obvious. As disclosed by Moffat treatment protocols for treating autoimmune dermatologic disorders were known in the art and have been shown to provide systemic immune-modulating biological mechanisms, see para. [0048]-[0049]. Therefore it would have been well within the knowledge of one having ordinary skill in the art to look at art that discusses using ultraviolet phototherapy for treating autoimmune dermatologic disorders for potential treatment options that may aid in treating other autoimmune non-dermatologic disorders. There is nothing within Mohammad which discredits or teaches away from the combination with Moffat as several treatment protocols are disclosed.
Applicant argues “Finally, a person of ordinary skill in the art would recognize that a pause of "at least about two weeks" is not an obvious modification for managing phototherapy-induced erythema. It is understood in the art that severe, blistering burns from properly administered NB-UVB phototherapy are exceedingly rare.¹ Standard erythema is a short-term event that typically resolves in 3 to 7 days.² A skilled artisan would therefore have no clinical motivation or reason to design a protocol with a mandatory pause period of two weeks or more, as such a long duration is unnecessary for managing the expected and common clinical outcomes. Arriving at the claimed pause duration would require looking beyond the teachings of the art and the knowledge of one skilled in the art and instead is relying on impermissible hindsight” see pg. 9 of response filed 12/29/2025. As stated above, the new ground of rejection does not rely on Mohammad for teaching a pause period that is independent of the subject experiencing erythema. The rejections have been amended to include reference to Moffat ‘292 for disclosing such features, see 103 rejection above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JG/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796