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 17/765,354
This Office Action is responsive to the remarks and claims of 9/9/2025.
Claims 1-4, 6, 9-10, and 12-15 are examined on the merits.
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Claims 5, 7, and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.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.
Priority
The instant application is a national stage entry of PCT/CN2020/118945, and also claims foreign priority to CN201910943781.0.
The effective filing date is 09/30/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/9/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicants’ claim amendments and Remarks of 9/9/2025 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
In regard to the enablement rejection, Applicants submit a declaration showing the efficacy of sodium ferulate in preventing aortic dissection. The declaration by Baohong Jiang describes the experimental procedure and methods for evaluating the preventive efficacy of sodium ferulate (SF) in preventing aortic dissection (AD). The experimental results that no AD was seen in the SF group. Maximum tension of blood vessels was also measured. It is unclear how this measurement (and the related metrics of elasticity and fragility) relates to the diseases of claims 1 and 12. This rejection is maintained because there is no discussion for how arterial dissection is correlated/related to the other artery diseases of claim 1. The declaration (which only discusses aortic dissection) is not commensurate in scope with all of base claims 1 and 12 (which also includes aneurysm and intramural hematoma).
In regard to anticipatory rejection, this rejection is withdrawn. Examiner was unaware that arterial dissection was a medically recognized term. Applicants clarify this with references Bossone, Etminan, and Peng.
In regard to the obviousness rejection, this rejection is withdrawn for the same reason as the anticipatory rejection is withdrawn.
Response to Amendments
Claim Rejections - 35 USC § 112- Maintained
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6, 9-10, and 12-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
The nature of the invention: The nature of the invention pertains to preventing and/or treating an artery disease by administering a pharmaceutical composition comprising a compound of formula I.
The breadth of the claims: The breadth of the claims is drawn to a pharmaceutical composition comprising a compound of formula I.
The state of the prior art: The elected species of a compound of formula I is known (see prior art rejection below).
The relative skill of those in the art: The relative skill of the artisan would be a medical professional.
The predictability or unpredictability of the art: HARRIOT (as referenced in PTO-892) discloses that there are idiopathic types of artery disease (title) which has complex multiple faceted pathogeneses (introduction). Thus, it would be difficult to prevent all artery disease. The art of preventing artery disease is unpredictable.
The amount of direction or guidance presented: Examiner reviewed the instant Specification. No guidance is presented in the Instant Specification on how to prevent artery disease. Applicants do not show any data or evidence that the composition of the claims had been tested.
The presence or absence of working examples: No working examples are shown in the Instant Specification. Applicants do not show any data or evidence that the composition of the claims had been tested. Applicants do not provide guidance for how the instant composition would be effective in preventing artery disease. Lack of a working example is a factor to be considered, especially in a case involving an unpredictable art. See MPEP § 2164.02.
The quantity of experimentation necessary: The quantity of experimentation would be “undue” because of the amount of time and resources needed to experimentally prove that the instant composition does prevent artery disease.
For the reasons above, especially the lack of a working example or guidance from the specification, a person of ordinary skill in the art would have to engage in undue experimentation to create an effective preventative artery disease treatment, with no assurance of success.
Thus, claims 1-4, 6, 9-10, and 12-15 are rejected as lacking enablement.
Claim Rejections - 35 USC § 102 -New
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.
Claim(s) 1-4, 6, 9-10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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).
HAN anticipates that Ojeoksan (OJS) contains ferulic acid (3.1 HPLC analysis of OJS). HAN anticipates that OJS is part of a pharmaceutical composition or a formulation (mice food in Methods). This anticipates a food material from claim 12.
HAN further anticipates the OJS diet lowered vascular dysfunction and inflammatory processes and prevented the development of early and advanced atherosclerosis (conclusions).
HAN anticipates that Atherosclerosis is characterized as a chronic inflammatory disease of the arterial wall (introduction).
UPMC is relied upon for the beneficial teaching that aortic dissection is a tear in the inner layer of the aorta (the major artery carrying blood out of the heart) and is caused by atherosclerosis (page 1). Therefore, preventing atherosclerosis also prevents the artery disease of arterial dissection of claims 1 and 10.
Ferulic acid is the elected species of formula I, which anticipates claims 1-4, 6, and 9.
Claim(s) 1-4, 6, 9-10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HAN (Han et al., “The Inhibitory Effect Of Ojeoksan on Early and Advanced Atherosclerosis”, Nutrients, September 6, 2018) as evidenced by University of Michigan Health (“What is arteriosclerotic aortic disease?”, University of Michigan Health, May 1, 2013).
HAN anticipates that Ojeoksan (OJS) contains ferulic acid (3.1 HPLC analysis of OJS). HAN anticipates that OJS is part of a pharmaceutical composition or a formulation (mice food in Methods). This anticipates a food material from claim 12.
HAN further anticipates the OJS diet lowered vascular dysfunction and inflammatory processes and prevented the development of early and advanced atherosclerosis (conclusions).
HAN anticipates that Atherosclerosis is characterized as a chronic inflammatory disease of the arterial wall (introduction).
University of Michigan Health is relied upon for the beneficial teaching that atherosclerosis is a major cause of abdominal aortic aneurysm (age 1). Therefore, preventing atherosclerosis also prevents the artery disease of aortic aneurysm of claims 1 and 10.
Ferulic acid is the elected species of formula I, which anticipates claims 1-4, 6, and 9.
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.
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