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 .
Election/Restrictions
Applicants elected ferulic acid and arterial dissection, which reads on claims 1-4, 6, 9-10, and 12-15.
Claims 5, 7, and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/21/2025.
Response to Arguments
Applicants’ claim amendments and Remarks of 04/10/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
Applicants have amended claims 1-2, and 12.
In regard to the enablement rejection, this rejection is withdrawn as Applicants have deleted “prevented” from claims 1 and 12.
In regard to the anticipatory rejection over Han as evidenced by UPMC, this rejection is withdrawn as Applicants have deleted “prevented” from claims 1 and 12.
In regard to the anticipatory rejection over Han as evidenced by University of Michigan Health, this rejection is withdrawn as Applicants have deleted “prevented” from claims 1 and 12.
In regard to the obviousness rejection, this rejection is XXXX. Applicants’ remarks with Examiner’s reply are summarized below:
The instant claims only recite treating an artery disease.
Applicants submit that there is no evidence that Han’s mice are suffering from the recited artery disease.
HAN teaches Apolipoprotein-E gene-deficient mice (ApoE -/- mice), which are animal models of hyperlipidemia, atherosclerosis, hypertension, endothelial dysfunctions (page 2). An artisan would be motivated to take the teachings from an animal model and administer the same treatment to a human.
Applicants submit that there are notable distinctions between (i) the recited artery disease and (ii) vascular dysfunction/inflammatory/atherosclerosis, regarding causes, symptoms, and treatments.
Without evidence to support this, these statements are attorney opinion.
Additionally, Kithcart discloses that the majority of Peripheral artery disease (PAD) is caused by atherosclerosis (Medical Management of Patients With PAD). Examiner still thinks that in treating/preventing atherosclerosis, this would be helpful in ameliorating artery diseases. Furthermore, on page 10 of the Nonfinal of 01/09/2026,
Applicants submit that the two types of disorders (atherosclerosis vs. recited artery disease) differ entirely in lesion layer, key molecular mechanisms, and pathological progression. Therefore, the artisan would not have effected success in preventing or treating aortic medial degeneration.
Without evidence to support this, these statements are attorney opinion.
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) 1-4, 6, 9-10, 12-13, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over HAN (Han et al., “The Inhibitory Effect Of Ojeoksan on Early and Advanced Atherosclerosis”, Nutrients, September 6, 2018) as evidenced by UPMC (“Aortic Dissection”, UMPC, last reviewed by a medical professional on 2024-10-01) in view of GIM (Gim et al., “”Ferulic acid regulates the AKT/GSK-3B/CRMP-2 Signaling pathway in a middle cerebral artery occlusion animal model”, Lab Anim Res., June 24, 2013) and MAGUIRE (Maguire et al., “Matrix Metalloproteinase in Abdominal Aortic Aneurysm and Aortic Dissection”, Pharmaceuticals, August 6, 2019) and in view of MA (Ma et al., “Salvianolic Acids: Potential Source of Natural Drugs for the Treatment of Fibrosis Disease and Cancer”, Front Pharmacol. February 19, 2019).
Claim(s) 1-4, 6, 9-10, and 12 are taught above.
HAN teaches the OJS diet lowered vascular dysfunction and inflammatory processes (conclusions). HAN also teaches that OJS prevented the development of early and advanced atherosclerosis (conclusions).
GIM teaches that “Ferulic acid is a component of the plants Angelica sinensis (Oliv.) Diels ” of claim 13 (Abstract).
It would have been obvious for an artisan to use Ferulic acid derived from Angelica sinensis. Chemical properties are inherent to their compounds. Products of identical chemical composition can not have mutually exclusive properties. A chemical composition, Ferulic acid regardless of which plant it was extracted or derived from, and its properties are inseparable. See MPEP 2112.01 (II). This teaches claim 13.
MAGUIRE teaches that the initiators of Aortic Dissection (AD) (the aorta is the largest artery) include smoking and arterial hypertension, whilst key pathophysiological features of AD include chronic inflammation (abstract).
MAGUIRE teaches that salvianolic acid A has been shown to improve vascular integrity (section 8).
MA teaches that salvianolic acids are anti-inflammatory (Salvianolic Acids).
MAGUIRE and MA do not teach Ferulic acid.
The artisan would have been motivated to use salvianolic acid A to treat/prevent artery dissection. MAGUIRE teaches that salvianolic acid A has been shown to improve vascular integrity (section 8). An artisan would expect that this would be helpful for artery dissection, which lacks vascular integrity. Additionally, because Aortic Dissection (a type of artery dissection) is initiated by inflammation (MAGUIRE abstract), that an anti-inflammatory compound (like salvianolic acid A) would be helpful in treating artery dissection (MA Salvianolic Acids).
The artisan would have been motivated to add another compound (salvianolic acid A) to a composition useful in preventing artery dissection/lowering inflammation (HAN conclusion). HAN teaches a pharmaceutical composition or a formulation comprising ferulic acid (the elected species of a compound of formula I) with a pharmaceutically acceptable carrier (mice food) (HAN methods and conclusion). This teaches claim 14’s part a and part c. Salvianolic acid A is also useful in treating artery dissection and has anti-inflammatory properties (see above). ”It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). This teaches claims 14 and 15.
Conclusion
No claims are allowed.
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.
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.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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