DETAILED ACTION
Claims 1-35 are pending and under consideration on the merits.
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 .
Status of the Rejections
The claim objections are withdrawn in view of the amendment.
The 103 rejections are maintained.
The double patenting rejection over 19/027,546 is withdrawn in view of the abandonment of the copending application, and the remaining rejections are maintained, and a new rejection is added in view of the filing of a new copending application.
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.
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 1-10,12-31, and 33-35 are rejected under 35 U.S.C. 103 as unpatentable over Rothstein et al. (J Am Acad Dermatol (Vol. 76, Number 6)(June 2017) 1054-1060; of record in IDS).
As to claims 1-10,12-31, and 33-35, Rothstein discloses a method of treating vitiligo and depigmentation comprising topically administering to patients a cream (claims 10 and 31) comprising 1.5% ruxolitinib phosphate (claims 12 and 33) to the affected skin area twice daily as recited by base claims 1, 15, and 18 for 20 weeks, which is below the “at least 52 weeks” duration recited by base claims 1 and 15 (Abstract, “Study design” section on page 1055, and footnote 7 on page 1060).
As to claims 7, 18, and 28, the patients were screened and determined to have nonsegmental vitiligo (see “Patient demographics” section on page 1056).
Regarding claims 6, 13, 19, 27, and 34, some patients had more than 0.5% of the face affected with vitiligo as recited by the claims (see “Patient demographics” section on page 1056), and Rothstein teaches that the patients had a minimum of 1% of the total body surface affected by vitiligo and that no more than 10% of body surface area should be treated (Abstract and last paragraph of “Study design” section on page 1055).
Regarding claims 9 and 30, the median age of the patient was 52, which is within the recited range (Abstract).
As to claims 8, 14, 29, and 35, the Rothstein method does not comprise administering any other agents for the treatment of vitiligo, nor laser or any other kind of phototherapy.
As to claims 1-10,12-31, and 33-35, Rothstein does not further expressly disclose that the duration of treatment is at least about 52 weeks as recited by claims 1, 15, and 24, nor a step of reinitiating the treatment after discontinuation as recited by claims 4 and 15, wherein the discontinuation was for about 6 months (claim 22), and wherein the patient loses repigmentation after the discontinuation (claim 15) for 100-195 days as recited by claim 16, or that the patient previously responded to treatment with the ruxolitinib composition but then depigmented after discontinuation of treatment as recited by claim 18. Nor does Rothstein expressly disclose continuing topical administration after 52 weeks in those cases when the patient does not achieve a 90% or greater improvement in Face Vitiligo Area Scoring Index as recited by claim 24 and wherein the addition treatment lasts for another 52 weeks (claim 26). Nor does Rothstein expressly disclose that the repigmenting is durable for at least 100 days (claim 1) or about 6 months or about 1 year after discontinuation of treatment as recited by claims 2 and 3, or that the repigmenting occurred within the time periods recited by claim 23. Nor does Rothstein expressly disclose that at least 3% non-facial body surface area is affected by vitiligo as recited by claims 6, 13, 27, and 34. Nor does Rothstein expressly disclose the degree of improvement in Face Vitiligo Area Scoring Index (F-VASI90) recited by claims 1, 5, 15, 17, and 20. Nor does Rothstein expressly disclose continuing treatment for an additional duration when the patient does not achieve a 90% or greater improvement in the F-VASI90 as recited by claim 24, and when the additional treatment duration is 52 weeks (claim 26) and results in an increase in the F-VASI90 as recited by claim 25.
As to claims 1-10, 12-31, and 33-35, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Rothstein method by modifying the length of time of treatment to be within the ranges of claims 1, 15, and 21, and then to reinitiate topical administration after discontinuation as recited by claims 4 and 15, wherein the discontinuation lasts for about 6 months as recited by claim 22, and further to continue the topical administration beyond the initial 52 weeks when the patient does not achieve a 90% or more improvement in F-VASI90 as recited by claim 24, such as an additional 52 weeks of treatment as recited by claim 26 or when the patient responds to the treatment but then depigments after discontinuation of treatment as per claim 18, because the skilled artisan would have recognized that the length of treatment of vitiligo with a therapeutic agent will affect the degree of therapeutic efficacy of the treatment (see, e.g., Figures 1 and 2 of Rothstein showing that the VASI index score of the study subjects increased as a function of the time of treatment with the ruxolitinib), such that the skilled artisan would have had a motivation to vary the length of treatment to arrive at an optimal period of time producing the best therapeutic results, and the skilled artisan further would have had a motivation to discontinue the treatment after a period of time in which no further improvement was observed, and further to restart the treatment after a period of time if the patient’s F-VASI90 score starts to deteriorate again, so as to once again raise said score. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 6, 13, 27, and 34, it further would have been prima facie obvious to practice the Rothstein method by selecting patients having at least 3% non-facial body surface area affected by the vitiligo, because Rothstein discloses that some patients had more than 0.5% of the face affected with vitiligo and that up to 10% of the body surface area can be treated, such that the skilled artisan would have recognized that an amount of 3% of total non-face surface area could be treated without exceeding the 10% maximum total surface area that should be treated.
The method of Rothstein as modified supra will result in the patient achieving an F-VASI90 score within the ranges of claims 1, 5, 15, 17 and 20 at the recited time periods, and result in repigmenting within a time period recited by claim 23, and that is durable for the time periods recited by claims 1-3, as well as a loss of repigmentation within the time period of claim 16 after discontinuation, because it comprises the same steps of topically administering the same composition in the same concentration for twice a day as recited by the claims.
Claims 11 and 32 are rejected under 35 U.S.C. 103 as unpatentable over Rothstein et al. (J Am Acad Dermatol (Vol. 76, Number 6)(June 2017) 1054-1060; of record in IDS) as applied to claims 1-10, 12-31, and 33-35 above, and further in view of Lipari et al. (US Pat. Pub. 2017/0266289).
The teachings of Rothstein are relied upon as discussed above, but Rothstein does not further expressly disclose that the cream is an oil in water emulsion as recited by claims 11 and 32.
Lipari discloses topical formulations comprising active ingredients (Abstract), wherein the active ingredient may be one that is effective to treat vitiligo (paragraph 42), wherein the formulation may be in the form of an oil in water cream (paragraphs 24-25).
As to claims 11 and 32, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Rothstein method by selecting a cream that is in the form of an oil in water emulsion, because Rothstein nowhere teaches any limits on the type of cream disclosed therein that would exclude oil in water emulsions, and Rothstein teaches that pharmaceutical creams comprising an active ingredient for the treatment of vitiligo may be in the form of an oil in water emulsion, such that the skilled artisan reasonably would have expected that the cream used in the Rothstein method of treating vitiligo via topical administration of a cream comprising an active for the treatment of vitiligo could be in the form of an oil in water emulsion. Such a modification is merely the combining of known prior art elements according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Response to Applicant’s Arguments
Applicant argues that Rothstein does not teach administering the composition for at least about 52 weeks and achieving a 90% or more improvement in F-VASI, and wherein the improvement is durable for at least 100 days after discontinuing topical administration as required by the claims. Applicant argues that Rothstein teaches a mean improvement of 76% in VASI scores, with improvement becoming observable at about week 4, and that at week 20 the rate of improvement slowed and began to plateau, and that there was no indication that extending the treatment period would achieve the claimed level of improvement. Applicant further notes that Rothstein states that they “cannot comment on what occurs when patients stop treatment,” but pointed to an instance where the response to oral treatment was rapidly lost after discontinuing administration.
In response, the fact that the Rothstein study lasted for only 20 weeks, along with the fact that Rothstein states they are unable to comment on what would happen after treatment was stopped, would have provided a motivation to the skilled artisan to extend the treatment duration beyond the 20 weeks to determine what was the optimal treatment period, and further would have motivated the skilled artisan to stop treatment and determine what happens to the observed improvement, in order to fill in the missing gaps of the Rothstein study. Additionally, the fact that Rothstein notes that it was known that in a case in which the subject was orally administered ruxolitinib, improvement was rapidly lost, would have provided the skilled artisan with an additional reason to continue the treatment beyond 20 weeks in order to prevent the observed improvement from being lost. While Rothstein does not teach a 90% or more improvement in F-FASI that is maintained for at least 100 days after discontinuing topical administration, such a result would have flowed naturally from following the motivation to extend the treatment as discussed above, because the Rothstein method comprises the topical administration of the same active in the same amount recited by the claims for the treatment of the same disorder (vitiligo). See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc.v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) (“The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.”).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-35 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. Appl No. 19/027,546.
The reference claims recite a method of treating vitiligo comprising topically administering to an affected skin area of a patient diagnosed with vitiligo a pharmaceutical composition comprising 1.5% ruxolitinib phosphate on a free base basis twice per day, wherein the patient is 18-75 years old and is not administered any other agents for vitiligo treatment, wherein the composition is a cream such as an oil in water emulsion, wherein the patient has at least 0.5% facial surface area and at least 3% nonfacial surface area affected by vitiligo, and wherein the Vitiligo Area Scoring Index is improved by at least 75%. The reference claims do not recite administering laser or any phototherapy.
The reference claims do not recite that the duration of treatment is at least about 52 weeks as recited by claims 1, 15, and 24, nor a step of reinitiating the treatment after discontinuation as recited by claims 4 and 15, wherein the discontinuation was for about 6 months (claim 22), and wherein the patient loses repigmentation after the discontinuation (claim 15) for 100-195 days as recited by claim 16, or that the patient previously responded to treatment with the ruxolitinib composition but then depigmented after discontinuation of treatment as recited by claim 18, nor continuing topical administration after 52 weeks in those cases when the patient does not achieve a 90% or greater improvement in Face Vitiligo Area Scoring Index as recited by claim 24 and wherein the addition treatment lasts for another 52 weeks (claim 26, nor continuing treatment for an additional duration when the patient does not achieve a 90% or greater improvement in the F-VASI90 as recited by claim 24, and when the additional treatment duration is 52 weeks (claim 26) and results in an increase in the F-VASI90 as recited by claim 25, but it would have been prima facie obvious to make these modifications because the skilled artisan would have recognized that the length of treatment of vitiligo with a therapeutic agent will affect the degree of therapeutic efficacy of the treatment, such that the skilled artisan would have had a motivation to vary the length of treatment to arrive at an optimal period of time producing the best therapeutic results, and the skilled artisan further would have had a motivation to discontinue the treatment after a period of time in which no further improvement was observed, and further to restart the treatment after a period of time if the patient’s F-VASI90 score starts to deteriorate again, so as to once again raise said score. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The reference claims also do not recite that the repigmenting is durable for at least 100 days (claim 1) or about 6 months or about 1 year after discontinuation of treatment as recited by claims 2 and 3, or that the repigmenting occurred within the time periods recited by claim 23, but the reference method as modified supra will result in repigmenting within a time period recited by claim 23, and that is durable for the time periods recited by claims 1 and 2-3, as well as a loss of repigmentation within the time period of claim 16 after discontinuation, because it comprises the same steps of topically administering the same composition in the same concentration for twice a day as recited by the claims.
Claims 1-35 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. Appl No. 18/245,019.
The reference claims recite a method of treating vitiligo comprising topically administering to an affected skin area of a patient diagnosed with vitiligo a pharmaceutical composition comprising 1.5% ruxolitinib phosphate on a free base basis twice per day, wherein the patient is 18-75 years old and is not administered any other agents for vitiligo treatment, wherein the composition is a cream such as an oil in water emulsion, wherein the Vitiligo Area Scoring Index is improved by at least 75%, wherein the method does not comprise administering laser or any phototherapy, wherein the patient has at least 0.5% facial surface area and at least 3% nonfacial surface area affected by vitiligo, wherein the duration of treatment is at least 52 weeks, and wherein the repigmenting is durable for at least 6 months.
The reference claims do not recite a step of reinitiating the treatment after discontinuation, wherein the discontinuation was for about 6 months, and wherein the patient loses repigmentation after the discontinuation for 100-195 days, or that the patient previously responded to treatment with the ruxolitinib composition but then depigmented after discontinuation of treatment, nor continuing topical administration after 52 weeks in those cases when the patient does not achieve a 90% or greater improvement in Face Vitiligo Area Scoring Index and wherein the addition treatment lasts for another 52 weeks, nor continuing treatment for an additional duration when the patient does not achieve a 90% or greater improvement in the F-VASI90, and when the additional treatment duration is 52 weeks and results in an increase in the F-VASI90, but it would have been prima facie obvious to make these modifications because the skilled artisan would have recognized that the length of treatment of vitiligo with a therapeutic agent will affect the degree of therapeutic efficacy of the treatment, such that the skilled artisan would have had a motivation to vary the length of treatment to arrive at an optimal period of time producing the best therapeutic results, and the skilled artisan further would have had a motivation to discontinue the treatment after a period of time in which no further improvement was observed, and further to restart the treatment after a period of time if the patient’s F-VASI90 score starts to deteriorate again, so as to once again raise said score. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The reference method will result in repigmenting within a time period recited by claim 23, as well as a loss of repigmentation within the time period of claim 16 after discontinuation, because it comprises the same steps of topically administering the same composition in the same concentration for twice a day as recited by the claims.
Claims 1-35 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. No. 12,233,067.
The reference claims recite a method of treating nonsegmental vitiligo comprising topically administering to an affected skin area of a patient clinically diagnosed with vitiligo a pharmaceutical composition comprising 1.5% ruxolitinib phosphate on a free base basis twice per day, wherein the patient is at least 12 years old, wherein the composition is a cream such as an oil in water emulsion, wherein the Vitiligo Area Scoring Index is improved by at least 75%, wherein the method does not comprise administering laser or any phototherapy, wherein the patient has at least 0.5% facial surface area and at least 3% nonfacial surface area affected by vitiligo but not exceeding a total of 10%, wherein the duration of treatment is at least 52 weeks. The reference method does not recite administering any other agents for vitiligo treatment.
The reference claims do not recite a step of reinitiating the treatment after discontinuation, wherein the discontinuation was for about 6 months, and wherein the patient loses repigmentation after the discontinuation for 100-195 days, or that the patient previously responded to treatment with the ruxolitinib composition but then depigmented after discontinuation of treatment, nor continuing topical administration after 52 weeks in those cases when the patient does not achieve a 90% or greater improvement in Face Vitiligo Area Scoring Index and wherein the addition treatment lasts for another 52 weeks, nor continuing treatment for an additional duration when the patient does not achieve a 90% or greater improvement in the F-VASI90, and when the additional treatment duration is 52 weeks and results in an increase in the F-VASI90, but it would have been prima facie obvious to make these modifications because the skilled artisan would have recognized that the length of treatment of vitiligo with a therapeutic agent will affect the degree of therapeutic efficacy of the treatment, such that the skilled artisan would have had a motivation to vary the length of treatment to arrive at an optimal period of time producing the best therapeutic results, and the skilled artisan further would have had a motivation to discontinue the treatment after a period of time in which no further improvement was observed, and further to restart the treatment after a period of time if the patient’s F-VASI90 score starts to deteriorate again, so as to once again raise said score. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The reference method will result in repigmenting within a time period recited by claim 23, as well as a loss of repigmentation within the time period of claim 16 after discontinuation, wherein the repigmenting is durable for at least 6 months, because it comprises the same steps of topically administering the same composition in the same concentration for twice a day as recited by the claims.
Claims 1-35 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. No. 11,590,138 and in view of Rothstein et al. (J Am Acad Dermatol (Vol. 76, Number 6)(June 2017) 1054-1060) where indicated below.
The teachings of the cited secondary reference are relied upon as discussed above.
The reference claims recite a method of treating nonsegmental vitiligo comprising topically administering to an affected skin area of a patient clinically diagnosed with vitiligo a pharmaceutical composition comprising 1.5% ruxolitinib or a salt thereof on a free base basis twice per day, wherein the patient is at least 12 years old, wherein the composition is a cream such as an oil in water emulsion, wherein the Vitiligo Area Scoring Index is improved by at least 25%, wherein the method does not comprise administering any phototherapy, wherein the patient has at least 0.5% facial surface area and at least 3% nonfacial surface area affected by vitiligo, wherein the duration of treatment is at least 52 weeks. The reference method does not recite administering any other agents for vitiligo treatment.
The reference claims do not recite a step of reinitiating the treatment after discontinuation, wherein the discontinuation was for about 6 months, and wherein the patient loses repigmentation after the discontinuation for 100-195 days, or that the patient previously responded to treatment with the ruxolitinib composition but then depigmented after discontinuation of treatment, nor continuing topical administration after 52 weeks in those cases when the patient does not achieve a 90% or greater improvement in Face Vitiligo Area Scoring Index and wherein the addition treatment lasts for another 52 weeks, nor continuing treatment for an additional duration when the patient does not achieve a 90% or greater improvement in the F-VASI90, and when the additional treatment duration is 52 weeks and results in an increase in the F-VASI90, but it would have been prima facie obvious to make these modifications because the skilled artisan would have recognized that the length of treatment of vitiligo with a therapeutic agent will affect the degree of therapeutic efficacy of the treatment, such that the skilled artisan would have had a motivation to vary the length of treatment to arrive at an optimal period of time producing the best therapeutic results, and the skilled artisan further would have had a motivation to discontinue the treatment after a period of time in which no further improvement was observed, and further to restart the treatment after a period of time if the patient’s F-VASI90 score starts to deteriorate again, so as to once again raise said score. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The reference method will result in repigmenting within a time period recited by claim 23, as well as a loss of repigmentation within the time period of claim 16 after discontinuation, wherein the repigmenting is durable for at least 6 months, because it comprises the same steps of topically administering the same composition in the same concentration for twice a day as recited by the claims.
Although the reference claims do not specify that the ruxolitinib salt is the phosphate salt, it would have been prima facie obvious to use this salt in light of Rothstein’s teaching that ruxolitinib phosphate is a suitable salt for use in a method of treatment of vitiligo.
Claims 1-35 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. No. 11,602,536.
The reference claims recite a method of treating nonsegmental vitiligo comprising topically administering to an affected skin area of a patient clinically diagnosed with vitiligo a pharmaceutical composition comprising 1.5% ruxolitinib phosphate on a free base basis twice per day, wherein the patient is 18-75 years old, wherein the composition is a cream such as an oil in water emulsion, wherein the Vitiligo Area Scoring Index is improved by at least 75%, wherein the method does not comprise administering any laser or phototherapy, wherein the patient has at least 0.5% facial surface area and at least 3% nonfacial surface area affected by vitiligo, wherein the duration of treatment is at least 52 weeks. The reference method does not recite administering any other agents for vitiligo treatment.
The reference claims do not recite a step of reinitiating the treatment after discontinuation, wherein the discontinuation was for about 6 months, and wherein the patient loses repigmentation after the discontinuation for 100-195 days, or that the patient previously responded to treatment with the ruxolitinib composition but then depigmented after discontinuation of treatment, nor continuing topical administration after 52 weeks in those cases when the patient does not achieve a 90% or greater improvement in Face Vitiligo Area Scoring Index and wherein the addition treatment lasts for another 52 weeks, nor continuing treatment for an additional duration when the patient does not achieve a 90% or greater improvement in the F-VASI90, and when the additional treatment duration is 52 weeks and results in an increase in the F-VASI90, but it would have been prima facie obvious to make these modifications because the skilled artisan would have recognized that the length of treatment of vitiligo with a therapeutic agent will affect the degree of therapeutic efficacy of the treatment, such that the skilled artisan would have had a motivation to vary the length of treatment to arrive at an optimal period of time producing the best therapeutic results, and the skilled artisan further would have had a motivation to discontinue the treatment after a period of time in which no further improvement was observed, and further to restart the treatment after a period of time if the patient’s F-VASI90 score starts to deteriorate again, so as to once again raise said score. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The reference method will result in repigmenting within a time period recited by claim 23, as well as a loss of repigmentation within the time period of claim 16 after discontinuation, wherein the repigmenting is durable for at least 6 months, because it comprises the same steps of topically administering the same composition in the same concentration for twice a day as recited by the claims.
Claims 1-35 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. No. 11,590,138.
The reference claims recite a method of treating nonsegmental vitiligo comprising topically administering to an affected skin area of a patient clinically diagnosed with vitiligo a pharmaceutical composition comprising 1.5% ruxolitinib phosphate on a free base basis twice per day, wherein the patient is 12 or more years old, wherein the composition is a cream such as an oil in water emulsion, wherein the Vitiligo Area Scoring Index is improved by at least 90%, wherein the method does not comprise administering any laser or phototherapy, wherein the patient has at least 0.5% facial surface area and at least 3% nonfacial surface area affected by vitiligo, wherein the duration of treatment is at least 52 weeks. The reference method does not recite administering any other agents for vitiligo treatment.
The reference claims do not recite a step of reinitiating the treatment after discontinuation, wherein the discontinuation was for about 6 months, and wherein the patient loses repigmentation after the discontinuation for 100-195 days, or that the patient previously responded to treatment with the ruxolitinib composition but then depigmented after discontinuation of treatment, nor continuing topical administration after 52 weeks in those cases when the patient does not achieve a 90% or greater improvement in Face Vitiligo Area Scoring Index and wherein the addition treatment lasts for another 52 weeks, nor continuing treatment for an additional duration when the patient does not achieve a 90% or greater improvement in the F-VASI90, and when the additional treatment duration is 52 weeks and results in an increase in the F-VASI90, but it would have been prima facie obvious to make these modifications because the skilled artisan would have recognized that the length of treatment of vitiligo with a therapeutic agent will affect the degree of therapeutic efficacy of the treatment, such that the skilled artisan would have had a motivation to vary the length of treatment to arrive at an optimal period of time producing the best therapeutic results, and the skilled artisan further would have had a motivation to discontinue the treatment after a period of time in which no further improvement was observed, and further to restart the treatment after a period of time if the patient’s F-VASI90 score starts to deteriorate again, so as to once again raise said score. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The reference method will result in repigmenting within a time period recited by claim 23, as well as a loss of repigmentation within the time period of claim 16 after discontinuation, wherein the repigmenting is durable for at least 6 months, because it comprises the same steps of topically administering the same composition in the same concentration for twice a day as recited by the claims.
Response to Applicant’s Arguments
Applicant advances the same arguments made against the 103 rejection, specifically, that the rejections do not provide sufficient evidence of a motivation to extend the treatment time for at least 52 weeks, and wherein a durable response lasts for at least 100 days.
In response, In response, the fact that the Rothstein study lasted for only 20 weeks would have provided a strong motivation to the skilled artisan to extend the treatment duration beyond the 20 weeks to determine what was the optimal treatment period for obtaining maximum improvement, and the fact that Rothstein state they are unable to comment on what would happen after treatment was stopped further would have motivated the skilled artisan to stop treatment and determine what happens to the observed improvement, in order to fill in the missing gaps of the Rothstein study. Additionally, the fact that Rothstein notes that it was known that in a case in which the subject was orally administered ruxolitinib, improvement was rapidly lost, would have provided the skilled artisan with an additional reason to continue the treatment beyond 20 weeks in order to prevent the observed improvement from being lost. While Rothstein does not teach a 90% or more improvement in F-FASI that is maintained for at least 100 days after discontinuing topical administration, such a result would have flowed naturally from following the motivation to extend the treatment as discussed above, because the Rothstein method comprises the topical administration of the same active in the same amount recited by the claims for the treatment of the same disorder (vitiligo). See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc.v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) (“The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.”).
New Rejection
Claims 1-35 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. Appl. No. 19/333,201 and in view of Rothstein et al. (J Am Acad Dermatol (Vol. 76, Number 6)(June 2017) 1054-1060) where indicated below.
The teachings of the cited secondary reference are relied upon as discussed above.
The reference claims recite a method of treating nonsegmental vitiligo comprising topically administering to an affected skin area of a patient clinically diagnosed with vitiligo a pharmaceutical composition comprising 1.5% ruxolitinib phosphate on a free base basis twice per day, wherein the patient is 18-75 years old, wherein the composition is a cream such as an oil in water emulsion, wherein the Vitiligo Area Scoring Index is improved by at least 75%, wherein the method does not recite administering any laser or phototherapy, wherein the patient has at least 0.5% facial surface area and at least 3% nonfacial surface area affected by vitiligo, wherein the treatment continues for 52 weeks. The reference method does not recite administering any other agents for vitiligo treatment.
The reference claims do not recite a step of reinitiating the treatment after discontinuation, wherein the discontinuation was for about 6 months, and wherein the patient loses repigmentation after the discontinuation for 100-195 days, or that the patient previously responded to treatment with the ruxolitinib composition but then depigmented after discontinuation of treatment, nor continuing topical administration after 52 weeks in those cases when the patient does not achieve a 90% or greater improvement in Face Vitiligo Area Scoring Index and wherein the addition treatment lasts for another 52 weeks, nor continuing treatment for an additional duration when the patient does not achieve a 90% or greater improvement in the F-VASI90, and when the additional treatment duration is 52 weeks and results in an increase in the F-VASI90, but it would have been prima facie obvious to make these modifications because, since the Rothstein study lasted for only 20 weeks, there would have been a strong motivation to the skilled artisan to extend the treatment duration beyond the 20 weeks to determine what was the optimal treatment period for obtaining maximum improvement. The skilled artisan would have recognized that the length of treatment of vitiligo with a therapeutic agent will affect the degree of therapeutic efficacy of the treatment, such that the skilled artisan would have had a motivation to vary the length of treatment to arrive at an optimal period of time producing the best therapeutic results, and the skilled artisan further would have had a motivation to discontinue the treatment after a period of time in which no further improvement was observed, and further to restart the treatment after a period of time if the patient’s F-VASI90 score starts to deteriorate again, so as to once again raise said score. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The reference method will result in repigmenting within a time period recited by claim 23, as well as a loss of repigmentation within the time period of claim 16 after discontinuation, wherein the repigmenting is durable for at least 6 months, because it comprises the same steps of topically administering the same composition in the same concentration for twice a day as recited by the claims.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600