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 .
Current Status of 17/859,609
The rejections of record are withdrawn, below.
This Office Action is responsive to the amended claims of 9/17/2025.
Claims 4, 6, 20, and 21 are examined on the merits.
Claims 1-3 and 9-10 are still withdrawn.
This Office Action is made second non-final in order to make the 103 rejection below.
Priority
This application does not claim priority to any application.
The effective filing date is the filing date, which is 7/7/2022.
Response to Arguments
Applicants’ claim amendments and Remarks of 9/17/2025 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
Claims 5, 7-8, and 11-19 have been canceled. Claim 4 has been amended.
In regard to the 102 rejection, this rejection is withdrawn because Applicants amended claim 4 from comprising to consisting of. Park’s shiunko ointment contains other ingredients.
Response to Amendment
Claim Rejections - 35 USC § 103- New
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) 4, 6, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Afzal (Afzal and Al-Oriquat, “Shikonin Derivatives, Chemical Investigations of Arnebia Deceumbens”, Agric. Biol. Chem., 1986), in view of Papageorgiou (Papageorgiou et al., “The Chemistry and Biology of Alkannin Shikonin, and Related Naphthazarin Natural Products”, Angewandte Chemie, 1999), in view of OAKBEND (“What is a Diabetic Ulcer?”, OakBend Medical Center, August 4, 2017), in view of YADAV (Yadav et al., “Review of Shikonin and Derivatives: Isolation, Chemistry, Biosynthesis, Pharmacology and Toxicology”, Front. Pharmacol., July 1, 2022) and in view of Park (Park et al, “Wound healing effects of deoxyshikonin isolated from jawoongo: In vitro and in vivo studies”, Journal of Ethnopharmacology, 2017).
Park teaches the wound healing effects of deoxyshikonin were assessed in a mouse model of cutaneous wounds (abstract).
Park teaches that deoxyshikonin-treated groups showed accelerated wound closure compared with the controls in a mouse model of cutaneous wounds (abstract).
OAKBEND teaches that treatment for diabetic ulcers begin with cleaning the wound, applying proper wound dressings to allow the ulcer to drain and heal (page 2). Additional optional steps include administering antibiotics, applying non-removeable casts, and amputation (page 2). This helps teach that a method for accelerated wound closure would also be/be helpful in a treatment for diabetic ulcers.
Park teaches that the mice were treated with deoxyshikonin topically (page 136). This helps teach claims 6 and 21.
YADAV teaches that the roots of Arnebia decumbens were dried, powdered, and firstly extracted with hexane, and the resulting extract was purified over silica gel eluting with ethyl acetate and petroleum ether as part of a method to extract shikonin (page 6). YADAV also teaches that deoxyshikonin were the most thermally unstable compared to other derivatives (page 19). Table 1 shows Natural sources of shikonin and its derivatives (including Arnbeia Decumbens).
Afzal teaches a method for preparing a powder from the roots (“air-dried plant roots”) of arnebia decumbens and extracting shikonin derivatives (including shikonin) from the powder (title and page 1651).
The artisan would have been motivated to use OAKBEND’s teachings that the treatment for diabetic ulcers includes letting them heal (page 2). The artisan would expect that a method for accelerating wound closure would also be a treatment for diabetic ulcers. This helps teach the methods of treating diabetic ulcers of claims 4 and 20.
Park used standard deoxyshikonin from Sigma-Aldrich (Materials and Methods), but also discusses it can be derived from Lithospermi Radix (LR, the dried root of Lithospermum erythrorhizon) (abstract). Furthermore, YADAV teaches that the roots of Arnebia decumbens were dried, powdered, before extracting shikonin derivatives (page 6). It would have been obvious to have either made deoxyshikonin synthetically (Park abstract) or extract other known shikonin derivatives from the Arnebia decumbens root (YADAV page 6; Afzal title and page 1651). Therefore, the Examiner interprets Deoxyshikonin from PARK’s ointment to be equivalent to the product of shikonin derivatives of claims 4 and 20.
The artisan would have found it obvious to substitute deoxyshikonin from Arnebia Decumbens (Afzal page 1651) for Park’s deoxyshikonin from Lithospermi Radix. The artisan would have been motivated and expected to use Afzal’s mushroom species (arnebia decumbens) instead of Park’s mushroom species (Lithospermi Radix) because both have the same derivative (Deoxyshikonin). Because chemical properties are inherent to their compounds (See MPEP 2112 (II)), the artisan would have had a reasonable expectation of success in substituting deoxyshikonin from one source with deoxyshikonin from another source. This teaches claim 4. It is suggested that Applicants submit data that the type of mushroom from the instant claims is critical.
While using Afzal’s deoxyshikonin from Arnebia decumbens and method of preparation, Papageorgiou is relied upon for the beneficial things that and that aceytlshikonin also comes from the roots of arnebia decumbens (15 on page 277).
The artisan would have expected that Azfal’s preparation of deoxyshinonsin would also include aceytlshikonin. This teaches claims 4 and 20.
Park teaches that the mice were treated with deoxyshikonin topically (page 136). The artisan would also be motivated and expected to use the route of delivery known to be effective (i.e. topically) for administering the shikonin derivatives of claims 4 and 20. This teaches claims 6 and 21.
Conclusion
No claims are allowed currently.
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/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625