DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment and
Status of the Claims
2. Applicant’s amendment and response, submitted April 20, 2026, and supplemental response of May 15, 2026, have been reviewed by the examiner and entered of record in the file.
3. Claims 1, 3, and 34 are amended, claims 25 and 28 are canceled, and claim 34 is newly added.
4. Claims 3, 18, 26, 27, and 31-33 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
5. Claims 1, 4, 7, 8, 21-24, 29, 30, and 34 are under examination and are the subject of this office action.
Information Disclosure Statement
6. The information disclosure statements (IDS) submitted on April 2, 2026 and May 19, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner, please refer to the signed copies of Applicant’s PTO-1449 forms, attached herewith.
Oath/Declaration
7. The Declaration submitted under 37 CFR 1.132 by Dr. Iris Kopeloff, demonstrating the unexpectedly beneficial results described in the ADORING 3 trial, in particular the length of the claimed remittive period, is sufficient to overcome the previous obviousness rejection over Peppers et al., in view of Dermavant Clinical Study Protocol, further in view of Kraus and Lee.
8. The 1.132 Declaration has been recorded.
Specification
9. The title of the invention is objected to because it is not descriptive of the recited invention. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested:
“Remittive Effects of Tapinarof in the Treatment of Atopic Dermatitis.”
New Claim Objections
10. Claim 1 is objected to because of the following informalities:
The verb tense should be consistent throughout the claim, i.e., the term “stop” in step (b) (line 6) should be replaced with the term “stopping” to be consistent with the term “applying” in step (a).
Previous Claim Rejections – 35 USC § 112(b)
11. Claims 1, 4, 7, 8, 21-24, 29 and 30 were previously rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 was previously rejected as being unclear regarding the recitation following the “wherein” clause after step “c.”
In view of Applicant’s amendment to claim 1 to delete the recitation of “while applying… [language omitted]” and replace with the limitation “during the initial period of time and the further period of time,” the previous indefiniteness rejection is overcome and is withdrawn.
12. The rejection of claims 4, 7, 8, 21-24, 29 and 30 as depending from and including all of the limitations of rejected claim 1 is also withdrawn.
New Claim Rejections - 35 USC § 112(b)
13. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
14. Claims 1, 4, 7, 8, 21-24, 29, 30 and 34 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
15. Claim 1 recites the limitation "the affected areas" in line 4. There is insufficient antecedent basis for this limitation in the claim because there is no prior recitation of an affected area in the claim. It is suggested that the “the” after “composition to” and prior to “affected” be deleted.
16. Claim 21 depends from claim 1 and recites the limitation "…wherein the subject’s itch numeric rating scale…[language omitted]" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim because there is no prior recitation of an itch numeric rating scale of the subject in claim 1.
17. Claim 22 depends from claim 1 and recites the limitation "…wherein the subject’s itch numeric rating scale…[language omitted]" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim because there is no prior recitation of an itch numeric rating scale of the subject in claim 1.
18. Claim 23 depends from claim 1 and recites the limitation "…wherein the subject’s Eczema Area and Severity Index (EASI) score…[language omitted]" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim because there is no prior recitation of an Eczema Area and Severity Index (EASI) score of the subject in claim 1.
19. Claim 24 depends from claim 1 and recites the limitation "…wherein the subject’s Eczema Area and Severity Index (EASI) score…[language omitted]" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim because there is no prior recitation of an Eczema Area and Severity Index (EASI) score of the subject in claim 1.
20. Claim 29 depends from claim 1 and recites the limitation "…wherein the subject’s itch numeric rating scale…[language omitted]" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim because there is no prior recitation of an itch numeric rating scale of the subject in claim 1.
21. Claim 30 depends from claim 1 and recites the limitation "…wherein the subject’s Eczema Area and Severity Index (EASI) score…[language omitted]" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim because there is no prior recitation of an Eczema Area and Severity Index (EASI) score in claim 1.
22. Claims 4, 7, 8, 21-24, 29, 30 and 34 are also rejected under 35 USC 112(b) as being dependent upon and including all of the limitations of rejected claim 1.
Previous Claim Rejections – 35 USC § 103
23. Claims 1, 4, 7, 8, 21-24, 29, 30 and 34 were previously rejected under 35 U.S.C. 103 as being unpatentable over Peppers et al., Journal of Am Acad Dermatol (published online July 3, 2018), in view of Dermavant Clinical Study Protocol, (available December 16, 2019, cited on Applicant’s IDS of January 6, 2025), and further in view of Kraus and Lee, U.S. 20200147001 A1 (published May 14, 2020).
24. In view of Applicant’s persuasive arguments and the Declaration submitted under 37 CFR 1.132 by Dr. Iris Kopeloff, demonstrating the unexpectedly beneficial results described in the ADORING 3 trial, in particular the length of the instantly claimed remittive period, the previous obviousness rejection is withdrawn.
New Claim Rejections – 35 USC § 112(a)
25. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
26. Claims 1, 4, 7, 8, 21-24, 29, 30 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
27. Claim 1 is rejected on the ground that it recites elements without support in the original disclosure:
In step (a), the initial period of time of “about 8 weeks to about 48 weeks,” isn’t associated with an absolute IGA score of 0 for termination of treatment in the disclosure. The Specification at paragraph [0273] defines the period of time to achieve an IGA score of 0:
“In certain embodiments, the subject achieved a IGA score of 0 or 1 at least once over a 52 week period of time. In certain embodiments, the subject achieved a IGA score of 0 at least once over a 52 week period of time. In certain embodiments, the subject achieved a IGA score of 0 or 1 at least once over a 44 week period of time. In certain embodiments, the subject achieved a IGA score of 0 at least once over a 44 week period of time. In certain embodiments, the subject did not experience worsening during a 52 week period of time.”
Thus, there is no absolute “until the subject has an IGA score of 0” over the recited period of “about 8 weeks to about 48 weeks” or indication of termination.
And, regarding termination, the originally filed claims stop administration after applying tapinarof topical cream for an initial period of time of “at least 8 weeks” until the subject has an IGA score of 0. There is no top range for this amount (i.e., no upper limit), which does not meet the description requirement, because there is no indication that termination occurs in the time period claimed and therefore the claim reads literally on embodiments outside of the range described in paragraph [0273].
In step (b), the remittive period of time of “about 2 months to about 3 months,” isn’t associated with the subject maintaining an IGA score of < 2 in the disclosure. The Specification defines the remittive period of time to achieve an IGA score < 2 in several paragraphs, for example in paragraph [0009]:
“stop treating the subject with tapinarof for a remittive period of time of about 1 month to about 7 months, wherein the remittive period of time is the time wherein the subject maintains an IGA score < 2;”
and in paragraph [0010]:
“In certain embodiments, the remittive period is greater than 3 months and up to about 7 months. In an embodiment, the remittive period is about 4 months.”
Thus, there is no absolute “wherein the subject maintains an IGA score < 2” over the recited period of “about 2 months to about 3 months” in the Specification.
In step (c), following the remittive period, the original claims have a conditional that is missing from the claim but has support in the specification at paragraphs [0240]-[0241]:
“stopping treatment of the subject with tapinarof for a remittive period of time of about 1 month to about 7 months, wherein the remittive period of time is the time wherein the subject has an IGA score <2, and
[0241] if, after the remittive period of time, the subject has an IGA score of ≥2, further applying a thin layer of 1.0% tapinarof topical cream composition to the affected areas of the subject once a day for a further period of time until the subject has an IGA score of 0;”; and
In step (c), the recited “about 8 weeks to about 16 weeks” [emphasis added] isn’t associated with the subject achieving an IGA score of 0 in the disclosure. The Specification defines the further period of time to achieve an IGA score of 0 in several paragraphs, for example in paragraph [0077]:
“In certain embodiments the further period of time is about 8 weeks to 16 weeks. In certain embodiments the further period of time is about 8 weeks, about 9 weeks, about 10 weeks, about 11 weeks, about 12 weeks, about 13 weeks, about 14 weeks, about 15 weeks, or about 16 weeks,”.
Thus there is no defined further period of time of from “about 8 weeks [up to] about 16 weeks”.
See Waldemar Link, GmbH & Co. v. Osteonics Corp., 32 F.3d 556, 559, 31 USPQ2d 1855, 1857 (Fed. Cir. 1994); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111, 1114 (Fed. Cir. 1991)(A written-description question often arises when an applicant, after filing a patent application, subsequently adds "new matter" not present in the original application.); In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).
See also Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1328, 56 USPQ2d 1481, 1487 (Fed. Cir. 2000) ("[T]he specification does not clearly disclose to the skilled artisan that the inventors... considered the... ratio to be part of their invention.... There is therefore no force to Purdue’s argument that the written description requirement was satisfied because the disclosure revealed a broad invention from which the [later-filed] claims carved out a patentable portion"). See also General Hosp. Corp. v. Sienna Biopharmaceuticals, Inc., 888 F.3d 1368, 1372, 126 USPQ2d 1556, 1560 (Fed. Cir. 2018) (written description support for the claimed concentration is lacking where the specification discloses a range of optical densities and several discrete values in the range with no explicitly defined maximum concentration; and even if the specification may be read to convert each disclosed value into a range, there is insufficient written description for the entire claimed range where the disclosed range minimally overlaps with the claimed range). Compare Union Oil of Cal. v. Atl. Richfield Co., 208 F.3d 989, 997, 54 USPQ2d 1227, 1232-33 (Fed. Cir. 2000) (Description in terms of ranges of chemical properties which work in combination with ranges of other chemical properties to produce an automotive gasoline that reduces emissions was found to provide an adequate written description even though the exact chemical components of each combination were not disclosed and the specification did not disclose any distinct embodiments corresponding to any claim at issue. "[T]he Patent Act and this court’s case law require only sufficient description to show one of skill in the . . . art that the inventor possessed the claimed invention at the time of filing.").
28. Claims 4, 7, 8, 21-24, 29, 30 and 34 are rejected under 35 USC 112(a) as being dependent upon and including all of the limitations of rejected claim 1.
Conclusion
29. In conclusion, claims 1, 3, 4, 7, 8, 18, 21-24, 26, 27, 29, 30 and 31-34 are present in the application. Claims 3, 18, 26, 27, and 31-33 are withdrawn. Claims 1, 4, 7, 8, 21-24, 29, 30 and 34 are rejected. No claim is presently allowed.
30. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANET L COPPINS/Examiner, Art Unit 1628
/Rayna Rodriguez/Primary Examiner, Art Unit 1628
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