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 . 1
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 21 November 2025 has been entered.
Status of Claims
Claims 1-2, 6, 13, 16, 19, 22, 25, 32, and 41-45 are pending. Claims 32 and 41-45 are withdrawn. Claims 1-2, 6, 13, 16,19, 22 and 25 are under examination, as they read upon elected Group I and species, a skin wound and a composition comprising about 0.01% of [the sesquiterpene/terpene/terpenoid compound] thujopsene2 as active ingredient, dimethyl sulfoxide (DMSO) as a pharmaceutically acceptable carrier, buffer as a diluent, paraffin as an excipient, and/or an antioxidant as an additive.
Response to Arguments
Applicant’s arguments as supported by the Nov 11 2025 Kim Declaration and amendment of claim 1 limiting the amount of thujopsene to about 0.001 v/v% to about 0.04%, filed Nov 21 2025 with respect to the rejection of Claims 1-2, 6, 13, 16,19, 22 and 25 under 35 U.S.C. 103 over WO 2011034591 A1 (Labuda WO 591) in view of Chen et al. J. Ess. Oil-Bear. Plants. (2020) 25:3, pages 482-494 (abstract only), have/has been fully considered and are persuasive.
Of note, paragraphs 5-12 of the Kim Declaration highlights experimental data to demonstrate wound healing where “the claimed composition comprising about 0.001 v/v% to about 0.04 v/v% of thujopsene can upregulate gene expression of FLG, HBD-3, LL-37, OR2AT4, and SIR Tl in skin cells and increase protein levels of FLG, HBD-3, LL-37, OR2AT4, and SIR Tl in human skin, without exhibiting toxicity to skin cells.” See paragraph 13 of the Nov 2025 Kim Declaration. It is noted that that the claimed range of thujopsene (about 0.001 v/v% to about 0.04 v/v%) is far narrower and just slightly lower than the generic range taught by Labuda WO 591 (where its topical terpene compositions/ formulations contain 0.05 to 50% by weight of terpene). See paragraph 48. Further, the claimed range of thujopsene is far lower than value of the example of Formula III of Labuda WO 591 that teaches 1% terpene by weight with 99 % liponeate oil as a carrier. See paragraph 49.
The rejection of claims 1-2, 6, 13, 16,19, 22 and 25 has been withdrawn.
Applicant's response filed Nov 11 2025, with regard to requesting the double patenting rejection of claims 1-2, 6, 16, 19, 22 and 25 over claims 1-12 of U.S. Patent No. 12,011,420 have been fully considered but they are not persuasive. See below maintained rejection.
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 1-2, 6, 13, 16, 19, 22 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,011,420. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Prior art and conflict patent and patent applications, comprising thujopsene as an active ingredient, will teach the claimed invention, so long as the prior art recites the basic claim elements of
• Administration to a subject in need (afflicted with a skin disease/condition such as the elected species of skin wounds)
• a therapeutically effective amount of a composition comprising
• of about 0.001 v/v% to about 0.04 v/v% v/v of thujopsene
will teach the claimed invention.
Reference patent claim 1 is directed to a method for treating a viral infection caused by a poxvirus in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a composition comprising at least about 10% of thujopsene.
Regarding the method of claim 1 and treating a subject in need afflicted with a skin wound, or preventing such skin wound, the reference patent teaches the treatment of small pox (variola) virus (see claim 4), where official notice is given that small pox causes skin wounds that appear as a rash and develop into pus filled bumps (pustules) that scab over into skin wounds. Reference patent claim 12 teaches topical or transdermal administration which would be applicable to treating pox infections of the skin that result in skin wounds (small pox pustules).
Note while reference patent claim 1 notes a value of 10% thujopsene, higher than the claimed range of about 0.001 v/v% to about 0.04 v/v%, it is pointed out that reference claim 13 teaches a species of composition comprising thujopsene, at a concentration of from about 0.0010% to about 0.04%.
It would be routine for a PHOSITA to optimize the reference patent concentrations into v/v% as claimed in light of the teachings of claim 13, in light of reference claim 2 that note percentages of 30, 50, 70 or 90% thujopsene.
Regarding examined claim 6 requiring a purity of at least 80, 90 or 95%, reference patent claim 3 discloses a thujopsene purity of at least about 95%.
Regarding claim 13 and the limitations of a chronic wound, it would be routine for a PHOSITA to treat chronic wounds, such as sores (bed, pressure) in the same way to treat small pox burst pustule wounds that fester and/or scab over.
Regarding claim 16, and the limitation of increased expression of FLG or inhibition of IL-4, the reference patent claims teach the claimed thujopsene comprising formulation as claimed, for the treatment of skin wounds.
The reference patent methods uses the same compositions having the same ingredients as those of the instant claims, so it is a reasonable conclusion that the pharmacological properties, with regard to increased FLG expression and IL-4 inhibition, would also be the same. See MPEP 2112.
Regarding claim 19 and 22, the reference patent claims 11-12 teach the limitations word for word, wherein the therapeutically effective amount of the composition is administered one to five times a day and wherein the therapeutically effective amount of the composition is administered for at least about 5 days, about 7 days, about 15 days, about 21 days, about 24 days, about 28 days, or about 30 days.
Regarding claim 25 and the limitation of at most about 0.01 v/v %, about 0.02 v/v %, about 0.03 v/v %, about 0.04 v/v % of thujopsene, reference patent claim 13 teaches wherein the therapeutically effective amount of the composition is at a concentration of from about 0.0010% to about 0.04% of therapeutically effective amounts of composition. While the reference patent doesn’t specifically recite the v/v % limitation of the claims, given the nature of formulating thujopsene into pharmaceutically acceptable carriers as per claim 25, it would be routine for a PHOSITA to optimize the reference patent concentrations into v/v% as claimed.
Conclusion and Correspondence
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 This application claims priority to Oct 12 2022 and was published as US 20240130979.
2 CAS Reg. No. 470-40-6 (1aS,4aS,8aS)-1,1a,4,4a,5,6,7,8-Octahydro-2,4a,8,8-tetramethylcyclopropa[d]naphthalene (ACI)
NSC 44707, Sesquichamene, Thujopsen, Thujopsene, (-)-, Widdrene
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