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The rejections of record are withdrawn, below.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 05/11/2026.
Claims 4, 6, 20, and 21 are examined on the merits.
Claims 1-3 and 9-10 are still withdrawn.
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 05/11/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
In regard to the 103 rejection, this rejection is withdrawn. Applicants remarks with Examiner’s reply is summarized below:
Claim 4 has been amended to remove deoxyshikonin, shikonin, and isovalerate from the group of shikonin derivatives.
The 103 rejection no longer covers the scope of the instant claims.
Claim 4 also has been amended to add the limitation that extracting shikonin derivatives from the powder using isooctane.
Response to Amendment
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.
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) 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over GUO (Guo et al., “Pharmacological properties and derivatives of shikonin-A review in recent years”, Pharmacological Research, November 2019) in view of OAKBEND (“What is a Diabetic Ulcer?”, OakBend Medical Center, August 4, 2017).
GUO teaches Shikonin effectively enhanced the wound-healing process in damaged skin tissues and teaches a topical treatment with shikonin (section 4). This helps teach claims 20-21.
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. This helps teach claims 20-21.
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 (GUO section 4) also be a treatment for diabetic ulcers. This teaches method of treating diabetic ulcers of claim 20.
The artisan would be motivated and expected to use the route of delivery known to be effective (i.e. topically) for administering the shikonin derivatives of claim 20 (and because GUO also topically administers the compound). This teaches claim 21.
Claim(s) 4, and 6, 20- 21 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Mussawi (Abdulameer Al-Mussawi, “Isolation and Identification of Shikonin From Arnebia Decumbens L. and its Antibacterial Activity”, Journal of Applied Science’s Research, 2010) and in view of GUO (Guo et al., “Pharmacological properties and derivatives of shikonin-A review in recent years”, Pharmacological Research, November 2019) in view of OAKBEND (“What is a Diabetic Ulcer?”, OakBend Medical Center, August 4, 2017).
Claims 20 and 21 are taught above.
Al-Mussawi teaches that the roots of Arnebia decumbens L. (50g) were air-dried and then powdered; the powder was extracted with hexane (preparation of Plant Extract on page 1452). Al-Mussawi teaches that the concentrated extract was purified by column chromatography (page 1452). This helps teach claim 4.
Chromforum teaches Isooctane as a replacement for hexane in chromatography (page 1).
KADHOM also teaches replacing hexane with isooctane (section 3.2) because Isooctane has less health hazards for humans (table 1). This helps teach claim 4.
The artisan would have been motivated to replace hexane and instead use isooctane in Al-Mussawi’s method of extracting shikonin from the powered roots of Arnebia decumbens (page 1452). The artisan would have been motivated to replace one non-polar alkane solvent with another, especially due to hexane’s known health hazards (Kadhom section 3.2 and table 1), in order to improve safety. Replacing hexane in order to use isooctane was known (Chromforum). The artisan would have expected Al-Mussawi’s method of extracting shikonin from the powered roots of Arnebia decumbens to also work with a different non-polar alkane solvent. This helps teach claim 4.
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 shikonin (from Al- Mussawi’s method) to be effective in accelerating wound closure and treating diabetic ulcers (as shikonin is in GUO section 4). This teaches claim 4.
The artisan would be motivated and expected to use the route of delivery known to be effective (i.e. topically) for administering the shikonin derivatives of claim 4 (and because GUO also topically administers the compound). This teaches claim 6.
Conclusion
No claims are allowed as currently written.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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, Andrew Kosar can be reached at 571-272-0913. 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.
/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
Prosecution Insights