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
Applicant’s amendment to the claims, filed 07/08/2026, regarding the rejection under U.S.C. 112(b), has been fully considered and is persuasive. The rejection under U.S.C. 112(b) has been withdrawn.
Applicant’s arguments regarding the rejection under U.S.C. 103 have been fully considered and are not persuasive.
Applicant’s first argument, that Para. 0057 of Levatter only is directed to control of the device and not treatment steps, is unpersuasive. While Levatter does teach various methods that call for the discontinuing the biologic for UV treatment (which Levatter notes is for the purpose of minimizing time on the biologic due to potential long term consequences of biologic use, Para. 0033 “Injectable biologics are known to cause undesirable side effects, including hormonal imbalance, internal organ damage, elevated blood pressure, allergic reactions, and cancer. Therefore, the biologics would ideally be limited to minimal doses and short-term treatment. However, such restrictive use of the biologics is heretofore thought impossible because the reduction in doses or discontinuation of medication is known to cause recrudescence of the psoriasis condition, even to a more severe degree than prior to the treatment”) Levatter also mentions in other areas that the treatment can be concurrent. Para. 0020 states “In some embodiments, a method of treating psoriasis comprises identifying a patient on a biologic regimen treating psoriasis and after the biologic regiment reduces the severity of the psoriasis, administering UV phototherapy to the subject. In some embodiments, the method further comprises, after the biologic reduces severity of the psoriasis, instructing the patient to discontinue the biologic regimen” and Para. 0040, “In some other embodiments, however, UV phototherapy may be administered before discontinuing the administration of the biologics (e.g., to treat problematic lesions, as a supplement to the biologics). Once the supplemental purpose is achieved, the biologic is discontinued, and UV phototherapy is applied to maintain equilibrium” (emphasis added). As such, Levatter does teach the amended limitations of “while the parenterally administered biologic is active in the subject” and “within a time frame in which the administration of the at least one biologic impacts the phototherapy treatment or the phototherapy treatment impacts the parenterally administered biologic”.
Applicant’s second argument, that the combination of Brooks and Levatter is improper as Brooks does not teach the usage of their UV phototherapy with a biologic, only with drugs used to prevent phototoxicity, is likewise unpersuasive. Brooks and Levatter are both directed to the treatment of psoriasis using UV phototherapy (Para. 0005 for Brooks, Abstract for Levatter). Levatter also teaches that drugs other than biologics can be used alongside or to replace the biologic depending on the need of the patient (Para. 0032, “The examples listed above may also be combined with or substituted with/replaced by one or more of, steroids, vitamins, coal tar, retinoid, calcipotriene, tazarotene, psoralens, anthralin, acitretin, methotrexate, cyclosporine, non-biologic pharmaceutical drugs, and the like, whether now known or developed in the future”). The Examiner also notes that the two drugs listed by Brooks, clobetasol spray and calcitriol ointment, are not merely drugs to reduce phototoxicity, but are used as standalone drugs to treat psoriasis even not in combination with UV therapy. All of this combined shows that one of ordinary skill would find it proper to combine Brooks and Levatter, as two inventions that combine UV treatment and drug application to treat psoriasis.
Appilcant’s final argument, that Korman does not teach an intensity of 60 mW/cm2, is acknowledged in the rejection of Claim 39, as the Examiner points to the Titanium Metals Corp. of America v. Banner, where it was held that even if values do not overlap, if the values are close enough that one would expect them to have the same properties it is therefore obvious. As Applicant has not pointed to any inaccuracies in this argument, the rejection is maintained.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 35, 37-38, and 40-44 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application 20180140867 awarded to Brooks et al, hereinafter Brooks, and further in view of U.S. Patent Application 20110002918 awarded to Levatter, hereinafter Levatter.
Regarding Claim 35, Brooks teaches method for localized treatment of a skin condition (abstract), the method comprising the steps of: administering a therapeutically effective amount of at least one biological drug to the subject (Para. 0069, “calcitriol ointment”); utilizing a dosimetry device, comprising an optical matrix comprising a plurality of regions, each region configured to allow varying percentages of UVB light to pass therethrough, to transmit varying percentages of the UVB light to an area of the subject’s skin (Para. 0014, “In an embodiment, the present invention is directed to a dosimetry device that is connectable to a phototherapy apparatus for applying targeted phototherapy to a treatment area (e.g., on diseased skin tissue). The device comprises a housing and an optical matrix arranged within the housing that includes a plurality of at least one of absorptive, reflective and/or partially transmissive regions, which each permit a different intensity of light (expressed as percentages of an incident of a light beam) and/or range of light to pass therethrough. In an embodiment, the light that is dispensed from a phototherapy apparatus is UVB light”); assessing a response of the treated area to the varying percentages of the UVB light transmitted thereto; determine an optical dose of UVB light based on the response of the treated area to the varying percentages of UVB light and the biological drug administered (Para. 0020, “In an embodiment, the method can further comprise the step of analyzing the treatment area subsequent to transmitting the varying percentages of the UVB light to the treatment area through the optical matrix to assess the minimum blistering dose of the treatment area); and applying the optimal dose of UVB light to the treatment area (Para. 0054, “In an embodiment in FIGS. 3A and 3B, the sensitivity matrix 24 is comprised of a plurality of regions 26, 28, 30, 32, 34, 36, 38, 40, 42 that are each designated to allow a prescribed intensity of light to pass therethrough to assess an individual's minimum blistering dose tolerance and in turn optimally treat a patient at their maximum tolerable dose”). Brooks does not teach wherein the drug administered is a parenterally administered biologic, or wherein the steps are performed essentially simultaneously and repeated.
However, in the art of UV phototherapy for dermatological purposes (abstract), Levatter teaches the usage of a parenterally administered biologic (Para. 0034) that is administered alongside the phototherapy and active during the usage of the phototherapy, affecting the needed dosage of the phototherapy (Para. 0040, Para. 0057), and wherein the steps are repeated at least once (Fig. 3c).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brooks by Levatter, i.e. by using the UV phototherapy device of Brooks in the combined UV/biologic system of Levatter, for the predictable purpose of combining known prior art elements in similar manners to the same purpose.
Regarding Claim 37, Brooks modified by Levatter makes obvious the method of Claim 35. Levatter further teaches wherein the transmission of light passing through the regions ranges from about 20% in one region up to about 100% in another region (Para. 0015, “In an embodiment, the optical matrix can include five regions. In an embodiment, the intensity of light passing through the regions can range from about 20% in one region up to about 100% in another region”).
Regarding Claim 38, Brooks modified by Levatter makes obvious the method of Claim 35. Levatter further teaches wherein the UVB light is UVB laser light having a wavelength of about 290-320 nm (Para. 0016, “The reflective coatings can be configured for an output UVB light of about 308 nm”).
Regarding Claim 40, Brooks modified by Levatter makes obvious the method of Claim 35. Brooks does not teach wherein the administering of the biological drug and the applying of the maximum tolerable dose of UVB light is repeated 1-5 times a week.
However, Levatter teaches administering a maximum tolerable dose of UVB is repeated 1-5 times a week (Para. 0010).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brooks by Levatter, i.e. by performing the method 1-5 times a week, for the predictable purpose of combining the prior art elements according to known methods to yield predictable result of improving psoriasis treatment.
Regarding Claims 41-42, Brooks modified by Levatter makes obvious the method of Claim 35. Brooks does not teach wherein the administering of the therapeutically effective amount of the at least one biological drug is initiated at least 2 days prior to the transmitting of the varying percentages of UVB light to a treatment area and the assessment of the response of the treated area to the varying percentages of the UVB light transmitted thereto, or wherein the at least one biological drug is selected from a group consisting of: alefacept, etanercept, adalimumab, infliximab, ustekinumab and any combination thereof.
However, Levatter teaches wherein the administering of the therapeutically effective amount of the at least one biological drug is initiated at least 2 days prior to the transmitting of the varying percentages of UVB light to a treatment area and the assessment of the response of the treated area to the varying percentages of the UVB light transmitted thereto (Para. 0043, “In some embodiments, the phototherapy may begin at least one or more hours, one or more days, or one or more weeks after discontinuing administration of the biologics” The Examiner notes that if the biologics are discontinued a week before the treatment, that they must have been administered either a week before or even earlier), wherein the biological drug is either alefacept, etanercept, adalimumab, infliximab, or ustekinumab (Para. 0010)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brooks by Levatter, i.e. by administering of the therapeutically effective amount of the at least one of the noted biological drugs is initiated at least 2 days prior to the transmitting of the varying percentages of UVB light to a treatment area and the assessment of the response of the treated area to the varying percentages of the UVB light transmitted thereto, for the predictable purpose of combining the prior art elements according to known methods to yield predictable result of improving psoriasis treatment.
Regarding Claim 43, Brooks modified by Levatter makes obvious the method of Claim 35. Levatter further teaches wherein the skin condition is selected from vitiligo, psoriasis, leukoderma, atopic dermatitis, and alopecia areata (Para. 0003).
Regarding Claim 44, modified by Levatter makes obvious the method of Claim 43. Levatter further teaches wherein the skin condition is vitiligo or psoriasis (Para. 0003).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application 20180140867 awarded to Brooks et al, hereinafter Brooks as applied to the claims above, and further in view of U.S. Patent Application 20110002918 awarded to Levatter, hereinafter Levatter, further in view of U.S. Patent Application 20020173833 awarded to Korman et al, hereinafter Korman.
Regarding Claim 39, Brooks modified by Levatter makes obvious the method of Claim 35, wherein the UVB light is UVB laser light having a wavelength of about 308 nm (Para. 0016, “The reflective coatings can be configured for an output UVB light of about 308 nm”). Brooks does not teach an intensity of 60 mW/cm2.
However, in the art of phototherapy, Korman teaches treating psoriasis at a wavelength of 310 nm and an intensity of 50 mW/cm2 (Para. 0146).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brooks by Korman, i.e. by operating the method of Brooks at an intensity of 60 mW/cm2, for the predictable purpose of combining the prior art elements according to known methods to yield predictable result of improving psoriasis treatment, since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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/JLM/
Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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