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 .
DETAILED ACTION
Status of the Claims
Claims 1, 3, 4, 12, 14-15, 21-27, and 29-34 are pending. Claims 3-4 and 26-27 are withdrawn from further consideration as being directed towards a nonelected invention. Claims 1, 12, 14-15, 21-25, and 29-34 are examined on their merits.
Information Disclosure Statement
The Information Disclosure Statements filed on May 19th 2026 and April 2nd 2026 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
35 U.S.C. § 102 Rejection Overcome by 102(b)(2)(C) Exception
Applicant argues in the response filed on June 5th 2026 that Kraus (US20200147000A1) does not serve as art because
Kraus was published less than one year before the effective filing date of the claimed invention.
Both Kraus and the present application were owned by Dermavant Sciences GmbH as of the effective filing date, and therefore Kraus is excepted as prior art under 35 U.S.C. § 102(b)(2)(C).
Applicant’s argument is found persuasive. Kraus does not serve as prior art and all 102 rejections are withdrawn.
35 U.S.C. § 102 Rejection Overcome by 102(b)(2)(C) Exception
As the 103 rejections were also over Kraus, they are withdrawn for the same reasons.
35 U.S.C. § 112(b) Rejections Overcome by Argument
Applicant argues in the response filed on June 5th 2026 that the phrase “wherein the remittive period of time is the time wherein the subject maintains a PGA score <2” fully and clearly defines the amount of time between the two application phases of the tapinarof. Applicant’s argument is found persuasive. As the subject’s PGA score is clearly used to define the remittive period between applications, the corresponding 112(b) rejection is withdrawn.
35 U.S.C. § 112(b) Rejections Maintained
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.
The rejection of claims 1, 21-25, and 29, as well as their dependent claims, 12-15 and 30-34 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 is maintained.
Applicant argues in the response filed on June 5th 2026 that the “wherein” clauses define the scope of the claimed method to wherein only methods that achieve these results fall within the claim scope, and that the results define clear measurable objective boundaries that would inform one of ordinary skill in the art of the metes and bounds of the claim.
Applicant’s argument is found not persuasive.
The method of claim 1 is fully described by:
The composition administered (a 1.0% tapinarof cream)
The method of administration (topical)
The patient population (a subject with plaque psoriasis)
The dosing regimen (once a day for 3-12 months, until the subject has a PGA score of 0, followed by a break of 3-7 months until the subject’s PGA score is ≥2, followed by a reapplication until the subject’s PGA score is zero)
It is unclear how the “wherein” clauses as recited by applicant further limit any of the above limitations that describe the metes and bounds of the method. Applicant has not provided any evidence or even any suggestion that the recited results are limiting to any of ‘the composition administered, the method of administration, the patient population, or the dosing regimen,’ but has only stated that the metes and bounds of the method are defined by the results achieved by the method.
Furthermore, the courts have found that ‘functional-result’ clauses are generally considered to be non-limiting unless said results introduce a material condition or functional change that alters how the method is performed. See MPEP § 2111.04.
As it is unclear how the results described in any of 1, 21-25, 29, or their dependent claims further limit the methods described in the claims, the claims remain indefinite, and the 112(b) rejections over claims 1, 21-25, and 29, as well as their dependent claims, 12, 14-15 and 30-34 are maintained.
35 U.S.C. § 112(b) Rejections Reiterated
Claims 1, 21-25, and 29, as well as their dependent claims, 12, 14-15 and 30-34 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.
Claim 1 and its dependent claims are indefinite for the following phrases,
“wherein the 1.0% tapinarof topical cream composition does not prolong the QTc interval in the subject while applying the 1.0% tapinarof topical cream”
“wherein the plasma concentration of tapinarof in the subject is below 50 pg/mL while applying the 1.0% tapinarof topical cream”
“wherein no tachyphylaxis occurs when further applying the thin layer of 1.0% tapinarof topical cream composition to the affected areas of the subject once a day for the initial period of time and the further period of time”
because one of ordinary skill in the art could not reasonably determine the metes and bounds of claim 1 from the claim language.
Regarding the phrase, “wherein the 1.0% tapinarof topical cream composition does not prolong the QTc interval in the subject while applying the 1.0% tapinarof topical cream,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of treating plaque psoriasis. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. the lack of prolongation in the subject’s QTc interval). The claim language is repeated (specification, pg. 21-23) but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. One of ordinary skill in the art therefore could not reasonably determine how the phrase limits the method of treating plaque psoriasis of claim 1.
Regarding the phrase, “wherein the plasma concentration of tapinarof in the subject is below 50 pg/mL while applying the 1.0% tapinarof topical cream,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of treating plaque psoriasis. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. the subject’s low plasma concentration of tapinarof). The claim language is repeated (specification, pg. 17-19), and the described results are demonstrated (specification, pg. 135-136), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. One of ordinary skill in the art therefore could not reasonably determine how the phrase limits the method of treating plaque psoriasis of claim 1.
Regarding the phrase, “wherein no tachyphylaxis occurs when further applying the thin layer of 1.0% tapinarof topical cream composition to the affected areas of the subject once a day for the initial period of time and the further period of time,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of treating plaque psoriasis. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. the subject’s low plasma concentration of tapinarof). The described results are demonstrated (Figure 6), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. One of ordinary skill in the art therefore could not reasonably determine how the phrase limits the method of treating plaque psoriasis of claim 1.
Claim 21 is indefinite for the phrase, “wherein the subject’s itch numeric rating scale is improved by about 1 to 5 points at the end of the initial time period,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 1. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. an improvement on the subject’s itch numeric rating scale). Said rating scale is described in the specification (specification, pg. 49, paragraph [0139]), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. As one of ordinary skill in the art could not reasonably determine how claim 21 further limits the method of claim 1, claim 21 is indefinite.
Claim 22 is indefinite for the phrase, “wherein the subject’s itch numeric rating scale is improved by about 4 points at the end of the initial period of time,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 1. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. an improvement on the subject’s itch numeric rating scale). Said rating scale is described in the specification (specification, pg. 49, paragraph [0139]), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. As one of ordinary skill in the art could not reasonably determine how claim 22 further limits the method of claim 1, claim 22 is indefinite.
Claim 23 is indefinite for the phrase, “wherein the subject’s Psoriasis Area and Severity Index (PASI) score is improved by at least 75% at the end of the initial period of time,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 1. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. an improvement on the subject’s PASI score). Said rating scale is described in the specification (specification, pg. 37, paragraph [0110]; specification, pg. 118, paragraph [0359]), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. As one of ordinary skill in the art could not reasonably determine how claim 23 further limits the method of claim 1, claim 23 is indefinite.
Claim 24 is indefinite for the phrase, “wherein the subject’s Psoriasis Area and Severity Index (PASI) score is improved by at least 90% at the end of the initial period of time,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 1. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. an improvement on the subject’s PASI score). Said rating scale is described in the specification (specification, pg. 37, paragraph [0110]; specification, pg. 120, paragraph [0361]), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. As one of ordinary skill in the art could not reasonably determine how claim 24 further limits the method of claim 1, claim 24 is indefinite.
Claim 25 is indefinite for the phrase, “wherein the subject’s percent body surface area (BSA) affected is decreased,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 1. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. a decrease in the affected body surface area). Said improvements are described in the specification (specification, pg. 36, paragraph [0109]; specification, pg. 114, paragraph [0351]), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. As one of ordinary skill in the art could not reasonably determine how claim 25 further limits the method of claim 1, claim 25 is indefinite.
Claim 29 is indefinite for the phrase, “wherein the subject’s Dermatology Life Quality Index (DLQI) score is improved from baseline at the end of the initial period of time,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 1. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. an improvement on the subject’s DLQI score). Said rating scale is described in the specification (specification, pg. 39, paragraph [0112]; specification, pg. 121, paragraph [0365]), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. As one of ordinary skill in the art could not reasonably determine how claim 29 further limits the method of claim 1, claim 29 is indefinite.
Allowable Subject Matter
Claims 1, 12, 14-15, 21-25, and 29-34 are free of the prior art.
Applicant has developed a method for treating plaque psoriasis via administration of 1.0% tapinarof topical cream in a 3-step method:
Applying a thin layer of about 1.0% topical tapinarof cream once a day for about 12-52 weeks, until the subject has a PGA score of 0
Stopping treatment for a period of 1-7 months wherein the PGA score stays below 2
Applying the treatment once daily until the subject has a PGA score of 0
Applicant’s method is free of the art, with the closest art being the preliminary studies that justified applicant’s method. See Robbins (Robbins et al., Phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of plaque psoriasis, Journal of the American Academy of Dermatology, Volume 80, Issue 3, 2019, Pages 714-721). Said preliminary studies, however, do not justify the remittive period (step 2) of applicant’s method. Said remittive period is found in Kraus (US20200147000A1). However, Kraus is disqualified as art as a 102(b)(2)(C) exception. Thus, applicant’s method, and especially the dosing regimen described within, is free of the art.
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 12, 14-15, 21-25, and 29-34 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening 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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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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