DETAILED ACTION
The Office Action is in response to the Applicant's reply filed March 16, 2026 to the non-final rejection made on December 16, 2025.
Claims 1, 3, 6-8, 10-11, 13-16, 18-20 are currently pending and are examined on the merits herein.
Notice of Pre-AlA 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 .
Priority
This Application filed on 09/06/20204 has PRO 63/537,186 filed on 09/07/2023.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 7/15/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Response to Arguments
Applicant’s arguments over the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph of claims 1, 3, 6-8, 10-11, 13-16, and 18-20 are not persuasive. The rejection is herewith maintained. Applicant argues the Validated Investigator Global Assessment is analogous to the Système International d'Unités (conventionally known as "the metric system") and its units such as "meter," "kilogram," "liter," etc. See Simpson et al., (2022) The Examiner’s contention is that the criteria has evolved over time, the claims do not address which version of the VIGA is being used.
The rejection of claims 1,3-8,10-11,13-16 and 18-20 under 35 U.S.C. 103(a) as being unpatentable over Osborne 3 (US20200163944A1) in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2) is not persuasive. The rejection is herewith maintained.
The rejection of claims 1,3-8,10-11,13-16 and 18-20 under 35 U.S.C. 103(a) as being unpatentable over Osborne 4 (US20210161870A1) in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) is not persuasive. The rejection is herewith maintained.
The rejection of claims 1,3-8,10-11,13-16 and 18-20 under 35 U.S.C. 103(a) as being unpatentable over Osborne et al 5 (WO2021155173A1) in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2) is not persuasive. The rejection is herewith maintained.
The rejection of claims 1,3-8,10-11,13-16 and 18-20 under 35 U.S.C. 103(a) as being unpatentable over Osborne et al 6 (WO2022120213A1) in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2) is not persuasive. The rejection is herewith maintained.
The rejection of claims 1,3-8,10-11,13-16 and 18-20 under 35 U.S.C. 103(a) as being unpatentable over Osborne 8 ( US11992480B2) in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) is not persuasive. The rejection is herewith maintained.
The rejection of claims 1,3-8,10-11,13-16 and 18-20 under 35 U.S.C. 103(a) as being unpatentable over Osborne 9 ( 11129818 ) in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2) is not persuasive. The rejection is herewith maintained.
Applicant main arguments against Osborne3-6,8-9 and the ODP rejections are that the references do not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration, nor maintaining a vVIGA-AD score of zero or one for 124 days.
The Examiner respectfully reiterates that the prior art generally states the formulation is applied with a frequency between weekly to several times daily, preferably between every other day to three times daily, and most preferably one or two times daily. The combination of varying frequencies and the teaching of US11992480B2/ US20210161870A1 [0152] that the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated, renders obvious the change in regimen frequency at approximately 4 weeks. In fact, the references generally disclose day 29 (week 4) evaluation of the patients.
Further, the Examiner’s contention is that the data does not necessarily point to a requirement of administration for four weeks to achieve a Validated Investigator Global Assessment Scale for Atopic Dermatitis score of zero or one for 124 days. For example, claim 11 clearly recites administration once daily until the patient achieves a VIGA scale for AD score of zero. Applicant has not provided comparable data for treatments with other dosage regimens, that are rendered obvious over the teachings of Osborne. Additionally, the Examiner states the data in the specification relates to a specific formulation, not any 0.05% or 0.15% roflumilast topical composition as claimed.
The rejections are as below:
The following rejections are made:
Claim Rejections - 35 USC § 112
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 1, 3, 6-8, 10-11, 13-16, and 18-20 contains the trademark/trade name Validated Investigator Global Assessment. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112, second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a scale, accordingly, the identification/description is indefinite.
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.
Claim(s) 1,3-8,10-11,13-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne 3 (US20200163944A1) in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2).
Osborne 3 teaches a method for improving the therapeutic outcome of treatment with roflumilast, comprising topically administering a composition comprising hexylene glycol, diethylene glycol monoethyl ether, dicetyl phosphate, ceteth-10 phosphate and roflumilast to a patient in need of such treatment one or more times daily, wherein if said patient misses two consecutive doses, the plasma concentration of roflumilast decreases by less than 50%, wherein said patient is suffering from atopic dermatitis. The composition preferably contains roflumilast, salts of roflumilast, the N-oxide of roflumilast or salts thereof in an amount of 0.005-2% w/w, more preferably 0.05-1% w/w, and most preferably 0.1-0.5% w/w per dosage unit. [0054] Generally, the formulation is applied with a frequency between weekly to several times daily, preferably between every other day to three times daily, and most preferably one or two times daily. [0058]
While the reference teaches the use of the composition frequency between weekly to several times daily, preferably between every other day to three times daily, the reference does not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration. The reference does not discuss the Validated Investigator Global Assessment scale for atopic dermatitis score for 124 days or 52 weeks.
Simpson et al. teaches topic dermatitis (AD) is a common chronic, inflammatory skin disease with significant unmet medical need and several novel treatments under development. At present, numerous outcome measures are used in clinical trials of AD; however, in a recent systematic review, only two of these instruments, the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) indexwere considered adequately validated and recommended for use in clinical trials. As US regulators require a single‐item investigator global assessment (IGA) among clinical trial endpoints for AD, a validated measure suitable for use across AD clinical trials is needed. The validated Investigator Global Assessment for AD (vIGA‐AD™) was developed. The vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. It is scored from 0 (clear) to 4 (severe) based on four clinical features of AD lesions: erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account.
Osborne 8 teaches the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dosage regimen as needed, especially due to the teaching of evaluation thru 4 weeks showed improvement; and achieve a Validated Investigator Global Assessment scale for atopic dermatitis score of zero. The motivation comes from the teaching that treatment is achieved with Roflumilast skin formulation and that vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint and the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated. Therefore, a skilled artisan would have had reasonable expectation of achieving a Validated Investigator Global Assessment scale for atopic dermatitis score of zero when roflumilast is taught to successfully treat atopic dermatitis and improvement is seen at week 4.
Claims 1,3-8,10-11,13-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne 4 (US20210161870A1) in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2)..
Osborne 4 teaches a method of treating a patient suffering from atopic dermatitis with an atopic dermatitis-treating effective amount of roflumilast, wherein the improvement comprises: administering the roflumilast topically in a composition having a roflumilast release profile that produces in the patient a flattened plasma concentration time curve and a reduced Cmax relative to oral administration of an atopic dermatitis-treating effective amount of roflumilast in an oral composition, in a particular preferred embodiment, the concentration of roflumilast in the formulation is between 0.05 and 0.5%, such as 0.05%, 0.15%, 0.3%, and 0.5% w/w. claim 1, [0061]Generally, the formulation is applied with a frequency between weekly to several times daily, preferably between every other day to three times daily, and most preferably one or two times daily. [0090] Exemplified is Crodafos™ CES, containing the phosphate ester surfactants dicetyl phosphate and ceteth-10 phosphate, is utilized as a representative example of phosphate ester surfactants. [0098]
While the reference teaches the use of the composition frequency between weekly to several times daily, preferably between every other day to three times daily, the reference does not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration. The reference does not discuss the Validated Investigator Global Assessment scale for atopic dermatitis score for 124 days or 52 weeks.
Simpson et al. teaches topic dermatitis (AD) is a common chronic, inflammatory skin disease with significant unmet medical need and several novel treatments under development. At present, numerous outcome measures are used in clinical trials of AD; however, in a recent systematic review, only two of these instruments, the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) indexwere considered adequately validated and recommended for use in clinical trials. As US regulators require a single‐item investigator global assessment (IGA) among clinical trial endpoints for AD, a validated measure suitable for use across AD clinical trials is needed. The validated Investigator Global Assessment for AD (vIGA‐AD™) was developed. The vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. It is scored from 0 (clear) to 4 (severe) based on four clinical features of AD lesions: erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account.
Osborne 8 teaches the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dosage regimen as needed, especially due to the teaching of evaluation thru 4 weeks showed improvement; and achieve a Validated Investigator Global Assessment scale for atopic dermatitis score of zero. The motivation comes from the teaching that treatment is achieved with Roflumilast skin formulation and that vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint and the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated. Therefore, a skilled artisan would have had reasonable expectation of achieving a Validated Investigator Global Assessment scale for atopic dermatitis score of zero when roflumilast is taught to successfully treat atopic dermatitis and improvement is seen at week 4.
Claims 1,3-8,10-11,13-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne et al 5 (WO2021155173A1) in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2)..
Osborne 5 teaches a method for improving the therapeutic outcome of treatment with roflumilast, comprising topically administering a composition comprising hexylene glycol, diethylene glycol monoethyl ether, dicetyl phosphate, ceteth-10 phosphate and roflumilast to a patient in need of such treatment one or more times daily, wherein if said patient misses two consecutive doses, the plasma concentration of roflumilast decreases by less than 50%; wherein said patient is suffering from atopic dermatitis.. The composition preferably contains roflumilast, salts of roflumilast, the N-oxide of roflumilast or salts thereof in an amount of 0.005 - 2 % w/w, more preferably 0.05 - 1% w/w, and most preferably 0.1 - 0.5% w/w per dosage unit. The composition preferably contains hexylene glycol in an amount of between 0.1% and 20% w/w, more preferably between 0.25% and 8% w/w and most preferably between 0.5% and 2% w/w. Generally, the formulation is applied with a frequency between weekly to several times daily, preferably between every other day to three times daily, and most preferably one or two times daily.
While the reference teaches the use of the composition frequency between weekly to several times daily, preferably between every other day to three times daily, the reference does not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration. The reference does not discuss the Validated Investigator Global Assessment scale for atopic dermatitis score for 124 days or 52 weeks.
Simpson et al. teaches topic dermatitis (AD) is a common chronic, inflammatory skin disease with significant unmet medical need and several novel treatments under development. At present, numerous outcome measures are used in clinical trials of AD; however, in a recent systematic review, only two of these instruments, the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) indexwere considered adequately validated and recommended for use in clinical trials. As US regulators require a single‐item investigator global assessment (IGA) among clinical trial endpoints for AD, a validated measure suitable for use across AD clinical trials is needed. The validated Investigator Global Assessment for AD (vIGA‐AD™) was developed. The vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. It is scored from 0 (clear) to 4 (severe) based on four clinical features of AD lesions: erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account.
Osborne 8 teaches the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dosage regimen as needed, especially due to the teaching of evaluation thru 4 weeks showed improvement; and achieve a Validated Investigator Global Assessment scale for atopic dermatitis score of zero. The motivation comes from the teaching that treatment is achieved with Roflumilast skin formulation and that vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint and the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated. Therefore, a skilled artisan would have had reasonable expectation of achieving a Validated Investigator Global Assessment scale for atopic dermatitis score of zero when roflumilast is taught to successfully treat atopic dermatitis and improvement is seen at week 4.
Claim(s) 1,3-8,10-11,13-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne et al 6 (WO2022120213A1) in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2)..
Osborne 6 teaches a method for reducing facial redness and inflammation caused by treatment of moderate to severe atopic dermatitis, comprising topically administering to a subject in need of such treatment, a therapeutically effective amount of roflumilast or a pharmaceutically acceptable salt thereof, wherein said facial redness and inflammation is caused by a Malassezia spp infection. The composition preferably contains roflumilast, salts of roflumilast, the N- oxide of roflumilast or salts thereof in an amount of 0.005 - 2% w/w, more preferably 0.05 - 1% w/w, and most preferably 0.1 - 0.5% w/w per dosage unit. Generally, the formulation is applied with a frequency between weekly to several times daily, preferably between every other day to three times daily, and most preferably one or two times daily.
While the reference teaches the use of the composition frequency between weekly to several times daily, preferably between every other day to three times daily, the reference does not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration. The reference does not discuss the Validated Investigator Global Assessment scale for atopic dermatitis score for 124 days or 52 weeks.
Simpson et al. teaches topic dermatitis (AD) is a common chronic, inflammatory skin disease with significant unmet medical need and several novel treatments under development. At present, numerous outcome measures are used in clinical trials of AD; however, in a recent systematic review, only two of these instruments, the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) indexwere considered adequately validated and recommended for use in clinical trials. As US regulators require a single‐item investigator global assessment (IGA) among clinical trial endpoints for AD, a validated measure suitable for use across AD clinical trials is needed. The validated Investigator Global Assessment for AD (vIGA‐AD™) was developed. The vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. It is scored from 0 (clear) to 4 (severe) based on four clinical features of AD lesions: erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account.
Osborne 8 teaches the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dosage regimen as needed, especially due to the teaching of evaluation thru 4 weeks showed improvement; and achieve a Validated Investigator Global Assessment scale for atopic dermatitis score of zero. The motivation comes from the teaching that treatment is achieved with Roflumilast skin formulation and that vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint and the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated. Therefore, a skilled artisan would have had reasonable expectation of achieving a Validated Investigator Global Assessment scale for atopic dermatitis score of zero when roflumilast is taught to successfully treat atopic dermatitis and improvement is seen at week 4.
Claims 1,3-8,10-11,13-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne 8 ( US11992480B2) in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170).
Osborne 8 teaches a method for reducing gastrointestinal side effects of roflumilast relative to an oral roflumilast formulation marketed under the trademark DALIRESP®, comprising topically administering to said patient, a composition comprising (i) roflumilast in an amount of 0.05%-1% w/w and (ii) a phosphate ester surfactant blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in an amount of 1.0-25% w/w, wherein said patient is suffering from atopic dermatitis. Generally, the formulation is applied with a frequency between weekly to several times daily, preferably between every other day to three times daily, and most preferably one or two times daily. Osborne 8 teaches the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated.
While the reference teaches the use of the composition frequency between weekly to several times daily, preferably between every other day to three times daily, the reference does not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration. The reference does not discuss the Validated Investigator Global Assessment scale for atopic dermatitis score for 124 days or 52 weeks.
Simpson et al. teaches topic dermatitis (AD) is a common chronic, inflammatory skin disease with significant unmet medical need and several novel treatments under development. At present, numerous outcome measures are used in clinical trials of AD; however, in a recent systematic review, only two of these instruments, the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) indexwere considered adequately validated and recommended for use in clinical trials. As US regulators require a single‐item investigator global assessment (IGA) among clinical trial endpoints for AD, a validated measure suitable for use across AD clinical trials is needed. The validated Investigator Global Assessment for AD (vIGA‐AD™) was developed. The vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. It is scored from 0 (clear) to 4 (severe) based on four clinical features of AD lesions: erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dosage regimen as needed and achieve a Validated Investigator Global Assessment scale for atopic dermatitis score of zero. The motivation comes from the teaching that treatment is achieved with Roflumilast skin formulation and that vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. Therefore, a skilled artisan would have had reasonable expectation of achieving a Validated Investigator Global Assessment scale for atopic dermatitis score of zero when roflumilast is taught to successfully treat atopic dermatitis.
Claim(s) 1,3-8,10-11,13-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne 9 ( 11129818 ) in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2).
Osborne9 teaches a method for improving treatment adherence by improving delivery and extending the plasma half-life of a roflumilast composition, comprising (a) adding hexylene glycol, diethylene glycol monoethyl ether, dicetyl phosphate and ceteth-10 phosphate to a composition comprising roflumilast, (b) topically administering said composition to a patient in need of treatment with roflumilast, on a dosing regimen, and (c) continuing said dosing regimen after multiple administrations when said patient misses at least one dose, wherein the plasma half-life of said roflumilast remains at a therapeutically effective dose level, wherein the patient is suffering from atopic dermatitis. The amounts of exemplified are roflumilast 0.3% w/w white petrolatum 10.0% w/w isopropyl palmitate 5.0% w/w cetearyl alcohol, dicetyl 10.0% w/w phosphate and ceteth-10 phosphate hexylene glycol 2.0% w/w diethylene glycol monoethyl 25.0% w/w ether methylparaben 0.2% w/w propylparaben 0.05% w/w, and purified water q.s. ad 100 (47.25%), wherein the pH is adjusted to 5.5.
While the reference teaches the use of the composition frequency between weekly to several times daily, preferably between every other day to three times daily, the reference does not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration. The reference does not discuss the Validated Investigator Global Assessment scale for atopic dermatitis score for 124 days or 52 weeks.
Simpson et al. teaches topic dermatitis (AD) is a common chronic, inflammatory skin disease with significant unmet medical need and several novel treatments under development. At present, numerous outcome measures are used in clinical trials of AD; however, in a recent systematic review, only two of these instruments, the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) indexwere considered adequately validated and recommended for use in clinical trials. As US regulators require a single‐item investigator global assessment (IGA) among clinical trial endpoints for AD, a validated measure suitable for use across AD clinical trials is needed. The validated Investigator Global Assessment for AD (vIGA‐AD™) was developed. The vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. It is scored from 0 (clear) to 4 (severe) based on four clinical features of AD lesions: erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account.
Osborne 8 teaches the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dosage regimen as needed, especially due to the teaching of evaluation thru 4 weeks showed improvement; and achieve a Validated Investigator Global Assessment scale for atopic dermatitis score of zero. The motivation comes from the teaching that treatment is achieved with Roflumilast skin formulation and that vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint and the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated. Therefore, a skilled artisan would have had reasonable expectation of achieving a Validated Investigator Global Assessment scale for atopic dermatitis score of zero when roflumilast is taught to successfully treat atopic dermatitis and improvement is seen at week 4.
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 1,3-8,10-11,13-16 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of copending US11992480B2 in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) .
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to method for reducing gastrointestinal side effects of roflumilast relative to an oral roflumilast formulation marketed under the trademark DALIRESP®, comprising topically administering to said patient, a composition comprising (i) roflumilast in an amount of 0.05%-1% w/w and (ii) a phosphate ester surfactant blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in an amount of 1.0-25% w/w, wherein said patient is suffering from atopic dermatitis whereas the claims herein are drawn to a method of treating a patient suffering from atopic dermatitis comprising: topically administering to the patient a pharmaceutical composition comprising 0.05% or 0.15% roflumilast once a day for four weeks; and topically administering to the patient the pharmaceutical composition twice a week, wherein the twice weekly administration begins after the four weeks of once daily administration.
While the reference teaches the use of the composition frequency between weekly to several times daily, preferably between every other day to three times daily, the reference does not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration. The reference does not discuss the Validated Investigator Global Assessment scale for atopic dermatitis score for 124 days or 52 weeks.
Simpson et al. teaches topic dermatitis (AD) is a common chronic, inflammatory skin disease with significant unmet medical need and several novel treatments under development. At present, numerous outcome measures are used in clinical trials of AD; however, in a recent systematic review, only two of these instruments, the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) indexwere considered adequately validated and recommended for use in clinical trials. As US regulators require a single‐item investigator global assessment (IGA) among clinical trial endpoints for AD, a validated measure suitable for use across AD clinical trials is needed. The validated Investigator Global Assessment for AD (vIGA‐AD™) was developed. The vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. It is scored from 0 (clear) to 4 (severe) based on four clinical features of AD lesions: erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account.
Osborne 8 teaches the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dosage regimen as needed, especially due to the teaching of evaluation thru 4 weeks showed improvement; and achieve a Validated Investigator Global Assessment scale for atopic dermatitis score of zero. The motivation comes from the teaching that treatment is achieved with Roflumilast skin formulation and that vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint and the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated. Therefore, a skilled artisan would have had reasonable expectation of achieving a Validated Investigator Global Assessment scale for atopic dermatitis score of zero when roflumilast is taught to successfully treat atopic dermatitis and improvement is seen at week 4.
Claims 1,3-8,10-11,13-16 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending US 11129818 in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2)..
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to a method for improving treatment adherence by improving delivery and extending the plasma half-life of a roflumilast composition, comprising (a) adding hexylene glycol, diethylene glycol monoethyl ether, dicetyl phosphate and ceteth-10 phosphate to a composition comprising roflumilast, (b) topically administering said composition to a patient in need of treatment with roflumilast, on a dosing regimen, and (c) continuing said dosing regimen after multiple administrations when said patient misses at least one dose, wherein the plasma half-life of said roflumilast remains at a therapeutically effective dose level, wherein said patient is suffering from atopic dermatitis whereas the claims herein are drawn to a method of treating a patient suffering from atopic dermatitis comprising: topically administering to the patient a pharmaceutical composition comprising 0.05% or 0.15% roflumilast once a day for four weeks; and topically administering to the patient the pharmaceutical composition twice a week, wherein the twice weekly administration begins after the four weeks of once daily administration.
While the reference teaches the use of the composition frequency between weekly to several times daily, preferably between every other day to three times daily, the reference does not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration. The reference does not discuss the Validated Investigator Global Assessment scale for atopic dermatitis score for 124 days or 52 weeks.
Simpson et al. teaches topic dermatitis (AD) is a common chronic, inflammatory skin disease with significant unmet medical need and several novel treatments under development. At present, numerous outcome measures are used in clinical trials of AD; however, in a recent systematic review, only two of these instruments, the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) indexwere considered adequately validated and recommended for use in clinical trials. As US regulators require a single‐item investigator global assessment (IGA) among clinical trial endpoints for AD, a validated measure suitable for use across AD clinical trials is needed. The validated Investigator Global Assessment for AD (vIGA‐AD™) was developed. The vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. It is scored from 0 (clear) to 4 (severe) based on four clinical features of AD lesions: erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account.
Osborne 8 teaches the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dosage regimen as needed, especially due to the teaching of evaluation thru 4 weeks showed improvement; and achieve a Validated Investigator Global Assessment scale for atopic dermatitis score of zero. The motivation comes from the teaching that treatment is achieved with Roflumilast skin formulation and that vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint and the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated. Therefore, a skilled artisan would have had reasonable expectation of achieving a Validated Investigator Global Assessment scale for atopic dermatitis score of zero when roflumilast is taught to successfully treat atopic dermatitis and improvement is seen at week 4.
Claims 1,3-8,10-11,13-16 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-14 of copending US 17821051 in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2)..
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to method of inhibiting phosphodiesterase 4 in a patient, comprising topically administering an aerosol foam comprising roflumilast, cetearyl alcohol, dicetyl phosphate, ceteareth-10 phosphate in an oil in water emulsion and a propane/isobutane/butane propellant blend, to a patient in need thereof; wherein said oil in water emulsion has a viscosity of 4,000-11,000 cP, wherein said propellant and oil in water emulsion are in a ratio of about 1:8 to 1:6, wherein said aerosol foam is emitted from a container but collapses after application to the patient's skin, said roflumilast is in an amount of 0.05-2% by weight of the total composition, wherein said patient is suffering from atopic dermatitis whereas the claims herein are drawn to a method of treating a patient suffering from atopic dermatitis comprising: topically administering to the patient a pharmaceutical composition comprising 0.05% or 0.15% roflumilast once a day for four weeks; and topically administering to the patient the pharmaceutical composition twice a week, wherein the twice weekly administration begins after the four weeks of once daily administration.
While the reference teaches the use of the composition frequency between weekly to several times daily, preferably between every other day to three times daily, the reference does not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration. The reference does not discuss the Validated Investigator Global Assessment scale for atopic dermatitis score for 124 days or 52 weeks.
Simpson et al. teaches topic dermatitis (AD) is a common chronic, inflammatory skin disease with significant unmet medical need and several novel treatments under development. At present, numerous outcome measures are used in clinical trials of AD; however, in a recent systematic review, only two of these instruments, the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) indexwere considered adequately validated and recommended for use in clinical trials. As US regulators require a single‐item investigator global assessment (IGA) among clinical trial endpoints for AD, a validated measure suitable for use across AD clinical trials is needed. The validated Investigator Global Assessment for AD (vIGA‐AD™) was developed. The vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. It is scored from 0 (clear) to 4 (severe) based on four clinical features of AD lesions: erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account.
Osborne 8 teaches the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dosage regimen as needed, especially due to the teaching of evaluation thru 4 weeks showed improvement; and achieve a Validated Investigator Global Assessment scale for atopic dermatitis score of zero. The motivation comes from the teaching that treatment is achieved with Roflumilast skin formulation and that vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint and the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated. Therefore, a skilled artisan would have had reasonable expectation of achieving a Validated Investigator Global Assessment scale for atopic dermatitis score of zero when roflumilast is taught to successfully treat atopic dermatitis and improvement is seen at week 4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1,3-8,10-11,13-16 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 23-26, 28-33,36-42, 45-61,64 of copending application no. 17703543 in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2)..
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to a method for treating an epidermal barrier with decreased function, comprising topically administering a composition comprising a high Krafft temperature surfactant, a moisturizer and water to a patient in need of such treatment, wherein said composition does not include roflumilast or a keratolytic agent, wherein said patient is suffering from atopic dermatitis whereas the claims herein are drawn to a method of treating a patient suffering from atopic dermatitis comprising: topically administering to the patient a pharmaceutical composition comprising 0.05% or 0.15% roflumilast once a day for four weeks; and topically administering to the patient the pharmaceutical composition twice a week, wherein the twice weekly administration begins after the four weeks of once daily administration.
While the reference teaches the use of the composition frequency between weekly to several times daily, preferably between every other day to three times daily, the reference does not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration. The reference does not discuss the Validated Investigator Global Assessment scale for atopic dermatitis score for 124 days or 52 weeks.
Simpson et al. teaches topic dermatitis (AD) is a common chronic, inflammatory skin disease with significant unmet medical need and several novel treatments under development. At present, numerous outcome measures are used in clinical trials of AD; however, in a recent systematic review, only two of these instruments, the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) indexwere considered adequately validated and recommended for use in clinical trials. As US regulators require a single‐item investigator global assessment (IGA) among clinical trial endpoints for AD, a validated measure suitable for use across AD clinical trials is needed. The validated Investigator Global Assessment for AD (vIGA‐AD™) was developed. The vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. It is scored from 0 (clear) to 4 (severe) based on four clinical features of AD lesions: erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account.
Osborne 8 teaches the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dosage regimen as needed, especially due to the teaching of evaluation thru 4 weeks showed improvement; and achieve a Validated Investigator Global Assessment scale for atopic dermatitis score of zero. The motivation comes from the teaching that treatment is achieved with Roflumilast skin formulation and that vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint and the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated. Therefore, a skilled artisan would have had reasonable expectation of achieving a Validated Investigator Global Assessment scale for atopic dermatitis score of zero when roflumilast is taught to successfully treat atopic dermatitis and improvement is seen at week 4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1,3-8,10-11,13-16 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-7, 11-12, 14 of copending US 18345732 in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2)..
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to method of treating a patient suffering from inflammatory dermatoses comprising:
administering a topical pharmaceutical composition comprising roflumilast and an emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate, and
wherein said composition has a pH less than 7.5, said roflumilast is in an amount of 0.05-1% by weight of the total composition, wherein said patient is suffering from atopic dermatitis whereas the claims herein are drawn to a method of treating a patient suffering from atopic dermatitis comprising: topically administering to the patient a pharmaceutical composition comprising 0.05% or 0.15% roflumilast once a day for four weeks; and topically administering to the patient the pharmaceutical composition twice a week, wherein the twice weekly administration begins after the four weeks of once daily administration.
While the reference teaches the use of the composition frequency between weekly to several times daily, preferably between every other day to three times daily, the reference does not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration. The reference does not discuss the Validated Investigator Global Assessment scale for atopic dermatitis score for 124 days or 52 weeks.
Simpson et al. teaches topic dermatitis (AD) is a common chronic, inflammatory skin disease with significant unmet medical need and several novel treatments under development. At present, numerous outcome measures are used in clinical trials of AD; however, in a recent systematic review, only two of these instruments, the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) indexwere considered adequately validated and recommended for use in clinical trials. As US regulators require a single‐item investigator global assessment (IGA) among clinical trial endpoints for AD, a validated measure suitable for use across AD clinical trials is needed. The validated Investigator Global Assessment for AD (vIGA‐AD™) was developed. The vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. It is scored from 0 (clear) to 4 (severe) based on four clinical features of AD lesions: erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account.
Osborne 8 teaches the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dosage regimen as needed, especially due to the teaching of evaluation thru 4 weeks showed improvement; and achieve a Validated Investigator Global Assessment scale for atopic dermatitis score of zero. The motivation comes from the teaching that treatment is achieved with Roflumilast skin formulation and that vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint and the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated. Therefore, a skilled artisan would have had reasonable expectation of achieving a Validated Investigator Global Assessment scale for atopic dermatitis score of zero when roflumilast is taught to successfully treat atopic dermatitis and improvement is seen at week 4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1,3-8,10-11,13-16 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-7, 11-12, 14 of copending US 18353870 in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2)..
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to method of treating a patient suffering from inflammatory dermatoses comprising:
administering a topical pharmaceutical composition comprising roflumilast and an emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate, and
wherein said composition has a pH less than 7.5, said roflumilast is in an amount of 0.05-1% by weight of the total composition, wherein said patient is suffering from atopic dermatitis whereas the claims herein are drawn to a method of treating a patient suffering from atopic dermatitis comprising: topically administering to the patient a pharmaceutical composition comprising 0.05% or 0.15% roflumilast once a day for four weeks; and topically administering to the patient the pharmaceutical composition twice a week, wherein the twice weekly administration begins after the four weeks of once daily administration.
While the reference teaches the use of the composition frequency between weekly to several times daily, preferably between every other day to three times daily, the reference does not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration. The reference does not discuss the Validated Investigator Global Assessment scale for atopic dermatitis score for 124 days or 52 weeks.
Simpson et al. teaches topic dermatitis (AD) is a common chronic, inflammatory skin disease with significant unmet medical need and several novel treatments under development. At present, numerous outcome measures are used in clinical trials of AD; however, in a recent systematic review, only two of these instruments, the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) indexwere considered adequately validated and recommended for use in clinical trials. As US regulators require a single‐item investigator global assessment (IGA) among clinical trial endpoints for AD, a validated measure suitable for use across AD clinical trials is needed. The validated Investigator Global Assessment for AD (vIGA‐AD™) was developed. The vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. It is scored from 0 (clear) to 4 (severe) based on four clinical features of AD lesions: erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account.
Osborne 8 teaches the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dosage regimen as needed, especially due to the teaching of evaluation thru 4 weeks showed improvement; and achieve a Validated Investigator Global Assessment scale for atopic dermatitis score of zero. The motivation comes from the teaching that treatment is achieved with Roflumilast skin formulation and that vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint and the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated. Therefore, a skilled artisan would have had reasonable expectation of achieving a Validated Investigator Global Assessment scale for atopic dermatitis score of zero when roflumilast is taught to successfully treat atopic dermatitis and improvement is seen at week 4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1,3-8,10-11,13-16 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending US 18884931 in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2)..
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to method of treating a patient suffering from atopic dermatitis, the method comprising: topically administering to the patient a pharmaceutical composition comprising 0.05% to 0.30% roflumilast once daily, wherein the pharmaceutical composition reduces itch as measured by the WI-NRS in the patient within 48 hours following said topical administration, whereas the claims herein are drawn to a method of treating a patient suffering from atopic dermatitis comprising: topically administering to the patient a pharmaceutical composition comprising 0.05% or 0.15% roflumilast once a day for four weeks; and topically administering to the patient the pharmaceutical composition twice a week, wherein the twice weekly administration begins after the four weeks of once daily administration.
While the reference teaches the use of the composition frequency between weekly to several times daily, preferably between every other day to three times daily, the reference does not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration. The reference does not discuss the Validated Investigator Global Assessment scale for atopic dermatitis score for 124 days or 52 weeks.
Simpson et al. teaches topic dermatitis (AD) is a common chronic, inflammatory skin disease with significant unmet medical need and several novel treatments under development. At present, numerous outcome measures are used in clinical trials of AD; however, in a recent systematic review, only two of these instruments, the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) indexwere considered adequately validated and recommended for use in clinical trials. As US regulators require a single‐item investigator global assessment (IGA) among clinical trial endpoints for AD, a validated measure suitable for use across AD clinical trials is needed. The validated Investigator Global Assessment for AD (vIGA‐AD™) was developed. The vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. It is scored from 0 (clear) to 4 (severe) based on four clinical features of AD lesions: erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account.
Osborne 8 teaches the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dosage regimen as needed, especially due to the teaching of evaluation thru 4 weeks showed improvement; and achieve a Validated Investigator Global Assessment scale for atopic dermatitis score of zero. The motivation comes from the teaching that treatment is achieved with Roflumilast skin formulation and that vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint and the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated. Therefore, a skilled artisan would have had reasonable expectation of achieving a Validated Investigator Global Assessment scale for atopic dermatitis score of zero when roflumilast is taught to successfully treat atopic dermatitis and improvement is seen at week 4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1,3-8,10-11,13-16 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application Nos. 18/353,870 in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2)..
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘870 Application claims (see the claims submitted on October 12, 2023) a topical roflumilast composi-tion having a Cmax reduced “relative to an oral roflumilast formulation marketed under the trademark DALIRESP®.”
While the reference teaches the use of the composition frequency between weekly to several times daily, preferably between every other day to three times daily, the reference does not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration. The reference does not discuss the Validated Investigator Global Assessment scale for atopic dermatitis score for 124 days or 52 weeks.
Simpson et al. teaches topic dermatitis (AD) is a common chronic, inflammatory skin disease with significant unmet medical need and several novel treatments under development. At present, numerous outcome measures are used in clinical trials of AD; however, in a recent systematic review, only two of these instruments, the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) indexwere considered adequately validated and recommended for use in clinical trials. As US regulators require a single‐item investigator global assessment (IGA) among clinical trial endpoints for AD, a validated measure suitable for use across AD clinical trials is needed. The validated Investigator Global Assessment for AD (vIGA‐AD™) was developed. The vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. It is scored from 0 (clear) to 4 (severe) based on four clinical features of AD lesions: erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account.
Osborne 8 teaches the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dosage regimen as needed, especially due to the teaching of evaluation thru 4 weeks showed improvement; and achieve a Validated Investigator Global Assessment scale for atopic dermatitis score of zero. The motivation comes from the teaching that treatment is achieved with Roflumilast skin formulation and that vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint and the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated. Therefore, a skilled artisan would have had reasonable expectation of achieving a Validated Investigator Global Assessment scale for atopic dermatitis score of zero when roflumilast is taught to successfully treat atopic dermatitis and improvement is seen at week 4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not, in fact, been patented.
Claims 1,3-8,10-11,13-16 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 9,884,050 B1 9,895,359 B1 9,907,788 B1 10,105,354 B1 10,172,841 B2 10,940,142 B2 11,534,493 B2 11,793,796 B2 11,819,496 B2 12016848B2 in view of Simpson et al. (The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. PMID: 35442530; PMCID: PMC9804170) and Osborne 8 ( US11992480B2)..
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘050 patent claims (see, e.g., claim 10) a pharmaceutical composition comprising roflumilast, petrolatum, ceteraryl alcohol, dicetyl phosphate, and ceteth-10 phosphate, and it is described in the Patent specification as having utility in the treatment of inflammatory dermatosis (col. 9, ll. 34-35). Although the claims of the ‘050 Patent do not specifically recite the claimed pharma-cokinetic properties, i.e., the Cmax (claim 27), Tmax (claim 35), and AUC relative to the DALIRESP® composition (claim 44), these properties are nevertheless inherent for substantially the same reasons discussed above, mutatis mutandis. One would therefore have viewed the subject matter of the instant claims at not being patentably distinct from the subject matter claimed in the ‘050 Patent. See also claim 15 of the ‘359 Patent; claims 15-16 of the ‘788 Patent; claims 8 and 10 of the ‘354 Patent; claims 8 and 10 of the ‘841 Patent; claim 1 of the ‘142 Patent; claim 1 of the ‘818 Patent; claim 1 of the ‘493 Patent; claims 6 and 8 of the ‘796 Patent; and claim 9 of the ‘496 Patent.
While the reference teaches the use of the composition frequency between weekly to several times daily, preferably between every other day to three times daily, the reference does not specify the regimen of four weeks and topically administering twice a week after the four weeks once daily administration. The reference does not discuss the Validated Investigator Global Assessment scale for atopic dermatitis score for 124 days or 52 weeks.
Simpson et al. teaches topic dermatitis (AD) is a common chronic, inflammatory skin disease with significant unmet medical need and several novel treatments under development. At present, numerous outcome measures are used in clinical trials of AD; however, in a recent systematic review, only two of these instruments, the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) indexwere considered adequately validated and recommended for use in clinical trials. As US regulators require a single‐item investigator global assessment (IGA) among clinical trial endpoints for AD, a validated measure suitable for use across AD clinical trials is needed. The validated Investigator Global Assessment for AD (vIGA‐AD™) was developed. The vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint. It is scored from 0 (clear) to 4 (severe) based on four clinical features of AD lesions: erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account.
Osborne 8 teaches the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dosage regimen as needed, especially due to the teaching of evaluation thru 4 weeks showed improvement; and achieve a Validated Investigator Global Assessment scale for atopic dermatitis score of zero. The motivation comes from the teaching that treatment is achieved with Roflumilast skin formulation and that vIGA‐AD is a clinician‐rated scale to assess the overall severity of AD lesions at a given timepoint and the percentage of subjects with 75% and 90% improvement from baseline in TPSS×TPA at each study visit through week 4 were also evaluated. Therefore, a skilled artisan would have had reasonable expectation of achieving a Validated Investigator Global Assessment scale for atopic dermatitis score of zero when roflumilast is taught to successfully treat atopic dermatitis and improvement is seen at week 4.
Conclusion
No claims are allowed.
The arguments are not persuasive and the rejection is made FINAL.
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 extension fee 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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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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