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 This application is a national stage application of PCT/IL2022/050613, filed June 8, 2022, which claims benefit of provisional application 63/208108, filed June 8, 2021. Claims 1-18 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted December 6, 2023 is acknowledged wherein claims 10, 13, and 16-18 are amended . Claim Objections Claim 1 is objected to because of the following informalities: the claim refers to a treatment that “reduces the severing of acne or rosacea relapse.” This appears to be a typographical error , with the intended wording referring to the severity of relapse. Appropriate correction is required. 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 appl icant regards as his invention. Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: a subject to whom the topical composition is administered. Claims 10, 11, 13, and 14 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. Claims 10 and 13 refer to a method in which the claimed therapy is administered during, before, or after an acne or rosacea treatment. Claims 11 and 14 refer to a step of administering an anti-acne or anti-rosacea agent. Since the stated purpose of the therapeutic agents recited in the method of independent claim 1 is to treat or reduce the relapse of acne or rosacea, it is unclear whether the anti-acne or anti-rosacea therapy referred to in these claims includes the therapy with a PDE4 inhibitor, JAK inhibitor, or AhR modulator which is described in the base claim 1, or whether it is by necessity an additional therapeutic agent or treatment besides this first active agent. Therefore these claims are indefinite. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claims 1- 5 and 16-18 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Welgus et al . (US pre-grant publication 2020/0155524, cited in PTO-1449) Independent claim 1 is directed to a method of reducing the rate or severity of acne relapse or rosacea relapse, comprising administering a topical composition comprising a PDE4 (Phosphodissterase 4) inhibitor, a JAK (Janus kinase) inhibitor, an AhR (aryl hydrocarbon receptor) modulator, or a combination thereof. Dependent claims 2 and 3 further require that the agent be a specific PDE4 inhibitor, such as roflumilast. Welgus et al. discloses a topical formulation of a PDE4 inhibitor having an improved pharmacokinetic profile . (P. 2 paragraph 15) In some embodiments the PDE4 inhibitor is roflumilast. (p. 3 paragraph 32) These formulations have reduced side effects, resulting in greater patient compliance and reduced cessation of treatment, (p. 3 paragraph 35) benefits which would furthermore be expected to reduce the incidence of relapse in patients being treated, since treatment is more likely to be properly adhered to. In addition, the pharmacokinetic profile of the PDE4 inhibitor is extended to a flat, constant peak over extended periods of time, allowing the treatment to remain efficacious even if a dose is occasionally missed, another factor reducing the incidence or severity of relapse. (p. 3 paragraphs 37-38) These therapeutic formulations are used to treat a variety of different conditions including acne and rosacea. (p. 7 paragraph 68) Therefore administering this topical formulation as described by Welgus et al. anticipates claims 1-3. Additionally regarding claim 16, p. 4 paragraph 48 describes the topical formulation as a an ointment, cream, gel, spray, or foam. Regarding claims 17-18, these claims refer to an intended outcome of treatment. Since the therapeutic methods de s cribed by Welgus et al. involve administering the same compound to the same subject to treat the same condition as those described in Applicant’s disclosure, they are reasonably expected to produce the same effects, thereby anticipating these claims as well. Regarding claims 4-5, p. 6 paragraph 65 describes the compositions as including additional active agents including JAK inhibitors. Claims 1 , 7- 12 , and 17-18 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Cote-Sierra et al . (PCT international publication WO2016/092493, Reference included with PTO-892) Independent claim 1 is directed to a method of reducing the rate or severity of acne relapse or rosacea relapse, comprising administering a topical composition comprising a PDE4 (Phosphodissterase 4) inhibitor, a JAK (Janus kinase) inhibitor, an AhR (aryl hydrocarbon receptor) modulator, or a combination thereof. Dependent claims 7 and 8 further require that the agent be a specific AhR modulator, such as tapinarof, which according to the Drugbank entry for this molecule (Reference included with PTO-892) is 3,5-dihydroxy-4-isopropylstilbene. Cote-Sierra et al. discloses a method of treating acne by daily topical application of the anti-inflammatory compound 3,5-dihydroxy-4-isopropyl-trans-stilbene, which is the claimed compound tapinarof. (p. 3 seventh-tenth paragraphs) This method of treatment would, by treating acne, reasonably be considered to also reduce the likelihood and severity of any relapse, thereby anticipating the present claims. Regarding claim 9, the compound can be administered in an amount of 0.5%. (p. 7 sixth paragraph) Regarding claims 10 and 11 Cote-Sierra discloses treatment with additional anti-acne agents. (p. 8 fifth paragraph) Regarding claim 12, Cote-Sierra describes various topical anti-acne agents such as azelaic acid, retinoic acid derivatives, and topical antibiotics. Regarding claims 17-18, these claims refer to an intended outcome of treatment. Since the therapeutic methods described by Cote-Sierra et al. involve administering the same compound to the same subject to treat the same condition as those described in Applicant’s disclosure, they are reasonably expected to produce the same effects, thereby anticipating these claims as well. Claims 1, 5, 6, 12-14, 17, and 18 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Howell et al . (PCT international publication WO2019/191679, Reference included with PTO-892) Independent claim 1 is directed to a method of reducing the rate or severity of acne relapse or rosacea relapse, comprising administering a topical composition comprising a PDE4 (Phosphodissterase 4) inhibitor, a JAK (Janus kinase) inhibitor, an AhR (aryl hydrocarbon receptor) modulator, or a combination thereof. Dependent claims 7 and 8 further require that the agent be a specific AhR modulator, such tofacitinib, abrocitinib, or ruxolitinib. Howell et al. discloses a method of treating a human subject having, suspected of having, or at risk of developing an inflammatory skin disease and having altered expression of certain genes, comprising administering to the subject a therapy comprising a JAK inhibitor. (p. 2 lines 18-24) The JAK inhibitor is preferably topically administered. (p. 4 lines 23-24) In a specific embodiment the JAK inhibitor is ruxolitinib. (p. 8 lines 9-10) Diseases treatable in this manner include rosacea and acne. (p. 8 lines 17-21) Regarding claims 12-14, Howell et al. discloses administering additional active agents including retinoids in combination with the JAK inhibitor. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claim s 4, 10-15, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Welgus et al . (US pre-grant publication 2020/0155524, cited in PTO-1449) The disclosure of Welgus et al. is discussed above. Welgus et al. does no t specifically disclose an embodiment wherein the concentration of the PDE4 inhibitor is between 0.05-0.1%. However, Welgus et al. does describe a concentration range, which in one embodiment is 0.05-1%. (p. 4 paragraph 45) Since this range encompasses the claimed range of 0.05-0.1%, it would have been obvious to one of ordinary skill in the art at the time of the invention to determine the appropriate concentration at which to include the PDE4 inhibitor ins the disclosed composition, thereby rendering the claimed range obvious. Regarding claims 10-15, p. 6 paragraph 65 further describes administering additional agents depending on the condition to be treated, including for example antibiotics such as erythromycin. It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to include these or other active agents for the treatment of acne or rosacea in the composition and to determine the appropriate amount of time during which to administer the composition, in view of the suggestion of the art. Regarding claims 17 and 18, while as discussed previously these claim s are seen to be anticipated by Welgus, because the therapeutic results would be necessarily achieved by administering the disclosed therapeutic agent to the disclosed subject, even assuming for the sake of argument that the therapeutic method described by Welgus would not have inherently produced these effects, it would still have been obvious to one of ordinary skill in the art at the time of the invention to attempt to reduce both the likelihood and severity of relapse for the condition being treated, such as acne or rosacea. One of ordinary skill in the art would have found this to be particularly relevant in view of the description of the disclosed formulations as having an improved pharmacokinetic property that is described as useful to maintain the efficacy of the treatment. For these reasons the invention taken as a whole is prima facie obvious. Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Welgus as applied to claim s 1-5 and 16-18 above, and further in view of Cote-Sierra et al . (PCT international publication WO2016/092493, Reference included with PTO-892) The disclosure of Welgus et al. is discussed above. While Welgus et al. does not specifically disclose a method further comprising administering ab AhR modulator to the subject, Cote-Sierra et al. discloses a method of treating acne in a subject comprising topically administering to the subject 3,5-dihydroxy-4-isopropyl-trans-stilbene. (p. 3 last four paragraphs) As disclosed by the Drugbank entry for Tapinarof (Reference included with PTO-892) This is the structure for the claimed compound tapinarof. This compound can be preferably applied in a concentration of 0.5 w/w% for example. (p. 7 sixth paragraph) It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize tapinarof as an additional active agent in the compositions described by Cote-Sierra et al. One of ordinary skill in the art would have found it to be obvious to combine these active agents as they are both described as being useful for the same purpose, namely the treatment of acne. Therefore the invention taken as a whole is prima facie obvious. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer . Claims 1- 14 and 16-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6 -9, 12, 13, 17, 18, of copending Application No. 17/779151, (reference application , US pre-grant publication 2023 / 0000786 , cited in PTO-892, herein referred to a as ‘151 ). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘151 anticipate the presently claimed invention . Specifically, claim 1 of ‘151 claims a topical composition comprising tapinarof and a PDE4 inhibitor in amounts substantially overlapping the concentration ranges recited in present claims 4 and 9. Dependent claims 6-9 further specify the inclusion of additional active ingredients including a retinoid, benzoyl peroxide, and a JAK inhibitor selected from several of the same compounds recited in present claim 5. Claim 12 of ‘151 specifies that the topical composition is selected from one of a number of forms as recited in present claim 16. Claim 13 of ‘151 furthermore claims a method of treating, preventing, or alleviating a skin disorder comprising administering topically a pharmaceutical composition according to the aforementioned claims to a subject in need thereof. Treating, preventing, or alleviating a disorder would reasonably be considered to produce an effect of preventing or ameliorating relapse as recited in present claims 1, 17, and 18. Claims 17 and 18 of ‘151 further specify that the skin disorder is acne or rosacea, thereby anticipating the present claims. Regarding present claims 4 and 9, these claims require ranges for the concentration of AhR modulator and PDE4 inhibitor which are not specifically anticipated by the ranges recited in claim 1 of ‘151. However the ranges of 0.25-3.0 recited in claim 1 of ‘151 substantially overlap with the presently claimed ranges, rendering claims 4 and 9 obvious. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion No claims are allowed in this action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ANDREA OLSON whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9051 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 6am-3:00pm . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Scarlett Y Goon can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-5241 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ANDREA OLSON/ Primary Examiner, Art Unit 1693 3/16/2026