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
Regarding the 112b rejections, applicant’s amendments and related arguments have overcome these rejections and the previous 112b rejections are hereby withdrawn. It is noted that applicant’s amendments have created new 112b issues and grammatical issues; see 112b rejection and claim objections below.
Regarding the 103 rejection, applicant’s amendments and related arguments have been fully considered, but are not persuasive. Applicant points to Par 0063 of King as teaching that only the first/initial administration of JAKi and phototherapy treatments are simultaneous. Without getting into a debate as to what King intended/meant by “initially” in the context of Par 0063, the examiner points to 2 explicit examples in King that clearly/explicitly teach the continued simultaneous administration of both phototherapy and JAKi treatments, as claimed. Par 0163 states “Treatment was begun with tofacitinib, 5mg, twice daily and full-body narrowband UV-B (400-500 mJ) twice weekly. After 3 months of treatment, there was nearly complete repigmentation of her face (FIG. 5B)”. Par 0164 states “Treatment was begun with tofacitinib, 5mg, twice daily and narrowband UV-B (360-500 mJ) 2 to 3 times weekly to only the face. After 3 months of treatment, there was about 50% repigmentation of the face, and, after 6 months, about 75% facial repigmentation”. These examples make it clear that on the days when phototherapy is delivered (either twice or three times a week), the JAKi treatment was also delivered “essentially simultaneous” (shortly before and/or after the phototherapy, i.e. JAKi is administered twice on the same day as phototherapy), and this essentially simultaneous administration of both JAKi and phototherapy is repeated 2 to 3 times a week for at least 3 months to 6 months. While there may days in between this repeated simultaneous treatment where the administration of both treatments is not simultaneously, i.e. 4-5 days a week where the time between the application of JAKi and phototherapy is too long/far apart to be considered simultaneous, this is not precluded by the current claim language. In fact, applicant’s own invention encompasses both simultaneous and sequential administration of the two treatments (“According to some embodiments, the treatments may be provided sequentially during part of the regimen and simultaneously during other parts of the regimen”). Stated differently, the claims do not require only simultaneous administration. While repeated simultaneous administration of both treatments is required, this does not preclude additional/unclaimed sequential administrations. Therefore, when the BRI of the current claims is established and the entirety of the King reference is considered, it’s clear to a POSITA that the reference teaches the continued simultaneous administration of both phototherapy and JAKi treatments, as claimed.
Furthermore, it is emphasized that it is unclear what is meant by “essentially simultaneously”; see 112b below. For examination purposes, the examiner contends that as long as the phototherapy is delivered on the same day as the JAKi treatment, it meets the claim language.
Therefore, applicant’s amendments and related arguments are not persuasive and the examiner is substantially maintaining the previous 103 rejection, with updated claim mapping to address the amendments; see 103 below for details.
Claim Objections
Claim 1 is objected to because of the following informalities: the limitation “utilizing a dosimetry device, comprising an optical matrix comprising a plurality of regions, each one of the regions configured to allow varying percentages of UVB light to pass therethrough and to transmit varying percentages of the UVB light to a treatment area of skin of the subject” is grammatically incorrect and should read “utilizing a dosimetry device, comprising an optical matrix comprising a plurality of regions, each one of the regions configured to allow varying percentages of UVB light to pass therethrough to transmit varying percentages of the UVB light to a treatment area of skin of the subject”, specifically the “and” is deleted. Appropriate correction is required.
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.
Claim 44 is 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.
Applicant’s amendments to change mW to mW/cm2 is not supported by the specification. First, as pointed out by the previous rejection, it’s unclear if “intensity of 60 mW” was meant to refer to intensity or power, as mW relates to power not intensity. It remains unclear which one (power or intensity) applicant had possession of. It is seemingly applicant’s position that the “intensity” part of the previous claim was correct and the mW was the incorrect portion of the claim. However, there is no way to ascertain which portion of the claim was in error, based on applicant’s original specification. It could just as easily be that “intensity” was wrong, and the claim should’ve said “power of 60 mW”. Therefore, the change to mW/cm2 is not supported. Furthermore, even if it’s clear that the “mW” was the error (which, again, is not necessarily the case), there are a number of units that can be used to measure intensity, as it only requires power/area. As commonly understood, there are numerous units that can designate area, e.g. m2 or in2. While cm2 is the most common within the laser treatment art, it is not necessarily true that even if the claim language relates to intensity that it was necessarily measured in cm2 as currently claimed. Therefore, this is considered new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 41-52 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “essentially simultaneous” in claim 41 is a relative term which renders the claim indefinite. The term “essentially simultaneous” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is noted that the specification provides “non-limiting” examples of “e.g. 0-5 hours” as encompassing “essentially simultaneous” and similarly provides “non-limiting” examples of sequentially “as a day before, a day after, a week before or a week after”, but this does not provide sufficient details/explanation as to the definitive scope of this term. Specifically, while the non-limiting examples provide some context to the term, it remains unclear when the two treatments are close enough to be considered “essentially simultaneous” and when they become far enough apart to be considered “sequential”. For examination purposes, as long as the JAKi and phototherapy treatment are administered on the same day, the claim language of “essentially simultaneous” is met.
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.
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 41-43 and 45-52 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0140867 to Levatter (submitted by applicant on their IDS) in view of WO 2018/200786 to King (submitted by applicant on their IDS) OR US 2020/0069965 to King (which is the 371 app of the King WIPO).
Regarding the King references, it is noted that the WIPO qualifies as prior art under 102(a)(1) while the PGPub qualifies as prior art under 102(a)(2), and both references are being used interchangeably in the current rejection. For citation purposes, the examiner is using citations from the PGPub only, as it has paragraphs.
[Claim 41 and 51-52] Levatter discloses a method for localized treatment of a skin condition (“The excimer phototherapy system 70 is designed to provide phototherapy for various dermatoses including psoriasis, vitiligo, leukoderma, atopic dermatitis” Par 0064), the method comprising the steps of:
a. administering a therapeutically effective amount of a dermatological treatment compound (at least Pars 0069-70 discuss using a dermatological treatment compound in combination with the phototherapy);
b. 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 (Abstract and at least Pars 0012-21 and 0048; dosimetry device 20; Fig. 3A);
c. assessing a response of the treated area to the varying percentages of the UVB light transmitted thereto (“An assessment can then be made as to the maximum tolerable dose of phototherapy that can be applied to the individual's skin in order to place a skin condition into remission” Abstract; at least Pars 0012-21 and 0054);
d. determining an optimal dose of UVB light, based on the response of the treated area to the varying percentages of UVB light and to the dermatological treatment compound (at least Pars 0002, 0012-21, 0044 and 0048. The examiner contends that based on Pars 0069-70, the dermatological treatment compound is combined with or applied before the phototherapy. Therefore any assessment of the response to phototherapy and determining of an optimal dose of the light, when a treatment compound is applied with or before the phototherapy, necessarily/inherently is based on the response of both the light and the compound); and
e. applying the optimal dose of UVB light to the treatment area (Abstract, at least Pars 0012-21 and 0067).
Levatter is discussed above, including explicitly disclosing the treatment of vitiligo (Par 0064) and the use of additional medicaments/compositions combined with phototherapy (Pars 0069-70), but fails to explicitly teach the use of a janus kinase inhibitor. However, in the same field of endeavor, King discloses the known benefits of the combined application of both janus kinase inhibitor and phototherapy to treat vitiligo (Abstract; at least Pars 0006-15 and 0063-66). Therefore, it would have been obvious to modify the method taught by Levatter to first include the application of janus kinase inhibitor, as taught by King, as a known dermatological treatment component that when combined with phototherapy is known to promote repigmentation in areas of affected by vitiligo. Based on Levatter’s explicitly teaching that “phototherapy treatment of diseased psoriatic plaque can be combined with the use of a topical spray and/or ointment” or the use of photosensitizing agents to increase sensitivity of cells to UV light (Pars 0069-70), it would be obvious to substitute either of these compounds/medicaments for the janus kinase inhibitor of King, as a simple substitution of one known dermatological treatment compound used in phototherapy for another to obtain predictable results, to treat vitiligo. Specifically, a POSITA would choose the specific dermatological treatment compound, based on the condition/disease being treated, and since it’s known from King that janus kinase inhibitor is known to provide beneficial results in the treatment of vitiligo when combined with phototherapy, it would be obvious to use janus kinase inhibitor in the method of Levatter when treating vitiligo.
Additionally King fails to explicitly the essentially simultaneous application of the JAKi and phototherapy treatments, as well as failing to teach the repeating these simultaneous treatments at least once. However, King discloses “treatment was begun with tofacitinib, 5mg, twice daily and full-body narrowband UV-B (400-500 mJ) twice weekly. After 3 months of treatment, there was nearly complete repigmentation of her face (FIG. 5B), 75% or greater repigmentation of her neck, chest, forearms, and shins, and only minimal freckling of the dorsal hands” (Par 0163) and “treatment was begun with tofacitinib, 5mg, twice daily and narrowband UV-B (360-500 mJ) 2 to 3 times weekly to only the face. After 3 months of treatment, there was about 50% repigmentation of the face, and, after 6 months, about 75% facial repigmentation” (Par 0164). As explained above, in the response to arguments section, this clearly teaches continuous/repeated simultaneous administration of both JAKi and phototherapy treatments. Specifically, on the 2-3 days a week when phototherapy is applied, the claim language is met, due to the fact that the JAKi treatment is also applied twice on these days, i.e. essentially simultaneous (see 112b rejection above). This simultaneous administration of both JAKi and phototherapy treatments is then repeated 2-3 times a week for 3-6 months. Therefore, it would have been obvious to modify the method taught by Levatter to not only use JAKi specifically (as addressed in the rationale, above), but to additionally administer both JAKi and phototherapy treatments in a continuous/repeated, essentially simultaneous manner, as King explicitly teaches that such a regimen/schedule provides effective treatment of vitiligo.
[Claim 42] Levatter discloses determining a maximum tolerable dose of the light (Abstract; at least Pars 0012-21, 0044 and 0054). King discloses determining an optimal amount of the JaKi (“pharmaceutically effective amount” and “effective amount”; at least Pars 0048, 0057, 0094, 0101-103 and 0133-142). The examiner contends that in the combination of Levatter and King, it would be obvious to determine the optimal dose of both the light and the compound/Jaki, based on the teachings of both Levatter and King.
[Claim 43] Levatter discloses “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” (Par 0015).
[Claim 45] King discloses “Treatment was begun with tofacitinib, 5mg, twice daily and full-body narrowband UV-B (400-500 mJ) twice weekly” (Par 0163); this equates to administrating the JaKi 10 times a week and the phototherapy 2 times a week. However King goes on to disclose “in other embodiments, the compositions of the invention are administered to the patient in range of dosages that include, but are not limited to, once every day, every two days, every three days to once a week, and once every two weeks. It is readily apparent to one skilled in the art that the frequency of administration of the various combination compositions of the invention varies from individual to individual depending on many factors including, but not limited to, age, disease or disorder to be treated, gender, overall health, and other factors. Thus, the invention should not be construed to be limited to any particular dosage regime and the precise dosage and composition to be administered to any patient is determined by the attending physical taking all other factors about the patient into account” (Par 0101). Therefore King teaches or suggests applying both the JaKi and phototherapy 1-5 times a week. It would be obvious to modify the phototherapy of Levatter to use this specific schedule/regimen, as this has been found to provide effective results for the treatment of vitiligo.
[Claim 46] As discussed above, in relation to claim 45, King discloses the repeated/continued application of both JaKi and phototherapeutic light (Pars 0163-164). Therefore, in the combination of Levatter and King, it would be obvious to repeat/duplicate the assessment and determination of an optimal dose, as well, in order to maintain the most effective dose throughout the course of the entire treatment period. This is considered a duplication of parts or routine optimization; see MPEP 2144.04 and 2144.05. Furthermore, the examiner contends that how often this assessment is repeated is routine optimization. It is emphasized that there is no evidence that repeating assessment “at least every two weeks” provides any unexcepted results or has any criticality. It would therefore, be obvious for a POSITA to choose the desired frequency of the repeated assessment based on the specific patient, treatment, and situation, at hand.
[Claim 47] King discloses “an effective amount of the therapeutic compound necessary to achieve a therapeutic effect may vary according to factors such as the state of the disease or disorder in the patient; the age, sex, and weight of the patient; and the ability of the therapeutic compound to treat a disease or disorder contemplated in the invention. Dosage regimens may be adjusted to provide the optimum therapeutic response.” (Par 0094) and “The amount of a compound and/or composition of the invention that constitutes a “therapeutically effective amount” will vary depending on the compound, the disease state and its severity, the age of the patient to be treated, and the like. The therapeutically effective amount can be determined routinely by one of ordinary skill in the art having regard to his own knowledge and to this disclosure” (Par 0057). Therefore, King explicitly teaches routinely adjusting/varying the dosage of JaKi. The examiner contends that in the combination of Levatter and King, it would be obvious to continually/routinely/repeatedly adjust the therapeutically effective amount of Jaki, based on repeated assessments of the response, as this merely a duplication of the method.
[Claim 48] King discloses “it is readily apparent to one skilled in the art that the frequency of administration of the various combination compositions of the invention varies from individual to individual depending on many factors including, but not limited to, age, disease or disorder to be treated, gender, overall health, and other factors. Thus, the invention should not be construed to be limited to any particular dosage regime and the precise dosage and composition to be administered to any patient is determined by the attending physical taking all other factors about the patient into account” (Par 0101). Therefore, King establishes that when or how often JaKi is administered is a result effective variable. Therefore, it would have been obvious to one of ordinary skill in the art to choose/try when to administer the Jaki and phototherapy based on the factors taught by King, as this is a mere optimization of result effective variable. It is emphasized that applicant has no criticality for the claimed timing/schedule, as the specification states “According to some embodiments, the treatments may be provided essentially simultaneously. As a non-limiting example, the JAK inhibitor may be administered shortly (e.g. 0-5 hours) before (or after) the phototherapy. According to some embodiments, the treatments may be provided sequentially. As a non-limiting example, the JAK inhibitor may be administered before or after (a day before, a day after, a week before or a week after) the phototherapy. According to some embodiments, the treatments may he provided sequentially during part of the regimen and simultaneously during other parts of the regimen. As a non-limiting example, the JAK inhibitor may initially be provided alone (e.g. for a week prior to the phototherapy) whereafter the treatments are provided essentially simultaneously (e.g. administration of the JAKi shortly before the phototherapy)”.
[Claims 49 and 50] King discloses “in various embodiments, the at least one Janus kinase inhibitor is selected from the group consisting of tofacitinib, ruxolitinib, oclacitinib, baricitinib, filgotinib, gandotinib, lestaurtinib, momelotinib, pacritinib, upadacitinib (ABT-494), peficitinib, cucurbitacin I, CHZ868, fedratinib, cerdulatinib, ATI-50001, Leo-124429, or a salt or solvate thereof.
In various embodiments, the at least one Janus kinase inhibitor is tofacitinib or a salt or solvate thereof In various embodiments, the subject is administered about 5-20 mg/day of tofacitinib.
In various embodiments, the at least one Janus kinase inhibitor is ruxolitinib or a salt or solvate thereof. In various embodiments, the subject is administered about 5-50 mg/day of ruxolitinib” Pars 0008-10. Therefore, it would have been obvious to use the specific janus kinase inhibitor and dosage, taught by King, in the phototherapy method taught by Levatter, as these are specific compounds and dosages that are known to provide effective results in treating vitiligo.
Claims 44 is rejected under 35 U.S.C. 103 as being unpatentable over Levatter and King as applied to claim 41 above, and further in view of US 2002/0013609 to Spencer.
Both Levatter and King disclose the use of UVB light which has a wavelength of 290-320 nm (See at least Pars 0006 and 0016-21 of Levatter and Pars 0011, 0059 and 0088), but both references are silent regarding an intensity of 60 mW/cm2. However, in the same field of endeavor, Spencer discloses a method for the treatment of vitiligo (title/abstract) that includes application of UVB light at a setting of not more than 120 mwatts (Par 0028) and a spot size of 10 x 10 mm (Par 0029), i.e. 100 mm2 which is equivalent to 1 cm2. Therefore the resulting intensity is at most 120 mW/cm2. Therefore, it would have been obvious to one of ordinary skill in the art to modify the method taught by Levatter and King to apply phototherapeutic light at an intensity of less than 120 mW/cm2, including 60 mW/cm2, as taught by Spencer, as this is an intensity range that is known in the art to be effective for treating vitiligo. Furthermore, “in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.” 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 Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796