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
Applicant’s election without traverse of 1, 3-7, 9-11, 12-20, 27, 28, 32-41 in the reply filed on 06/16/2026 is acknowledged.
Claim 42 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/16/2026.
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.
Claim(s) 1, 3-7, 9-11, 12-20, 27, 28, 32-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miyake, Cardiovascular Research (2009) 83, 436–443; Ungvari, Circulation Research Volume 123, Issue 7, 14 September 2018; Pages 849-867; Shimazu, Science 339,211 214(2013; Morales, Redox Biology Volume 29, January 2020, 101395; Kim, Aging (Albany NY). 2019 Feb 27;11(4):1283–1304; Han, Mol Cell. 2018 Sep 20;71(6):1064-1078; Chen, Circ Res. 2016 Oct 28;119(10):1076-1088, further in view of Lochmann, WO 2020147978 & Young-Min Han Experimental & Molecular Medicine (2020) 52:548–555.
Miyake titled “Pharmacological treatment of abdominal aortic aneurysm” teaches
[T]he pathological features of abdominal aortic aneurysm AAA are characterized by chronic aortic wall inflammation, destruction of the elastic media, neovascularization, and depletion of vascular smooth muscle cells (VSMC). Recent studies have revealed that a number of molecular mediators and extracellular matrix-degrading proteinases contribute to the pathological process of aortic wall degradation, and the histological changes in the aneurysm wall are thought to result from complex interactions among these factors. Miyake at page 437 column B association of oxidative stress with the formation of AAA. Miyake teaches many options for Pharmacological therapy for AAA, starting at column A of page 438. For example, Miyake at column B page 439, anti-inflammatory agents are expected to be useful for treating AAA. Similarly, Ungvari teaches that oxidative stress, vascular inflammation and cellular senescence play role in vascular aging (see throughout). Miyake and Ungvari do not specifically teach β-hydroxybutyrate (the active ingredient in the claimed method), this commercially available compound is well-known as an exogenous ketone supplement. According to Morales, [T]he ketone body β-hydroxybutyrate is no longer viewed simply as a metabolic intermediate, as it regulates a broad range of physiological processes at cellular and systemic levels. Particularly, β-hydroxybutyrate functions as a stress response molecule and orchestrates an antioxidant defense program to maintain redox homeostasis in response to environmental and metabolic challenges, such as ischemia. This property of β-hydroxybutyrate might be key for the beneficial effect of calorie restriction on stress response and disease processes. The secondary references of Shimazu, Morales, Kim, Han and Chen further teach the biochemical property underlying AAA. Thus according to Shimazu, titled ‘Suppression of Oxidative Stress by β-Hydroxybutyrate, an Endogenous Histone Deacetylase Inhibitor’, treatment of mice with β-hydroxybutyrate conferred substantial protection against oxidative stress. Likewise, Kim titled ‘Anti‐inflammatory action of β‐hydroxybutyrate..’ teaches anti-inflammatory action of β-hydroxybutyrate and that β-hydroxybutyrate reduced oxidative stress. Han, teaches that β-Hydroxybutyrate prevents vascular senescence (see title) and Chen, vascular smooth muscle links vascular senescence and inflammation to abdominal aortic aneurysm AAA (see title).
Taken together, the cited prior art references teach the inherent biochemical properties of β-hydroxybutyrate and how these are inexorably linked to treatment of AAA. Dependent claims 3-16 are drawn to (ester) derivatives of β‐hydroxybutyric acid (R=H). The enzymatic hydrolysis of these derivatives to release hydroxybutyrate is well-known in the art. For example, see Lochmann pages 30, 31, 40 which includes the species of instant claim 16 and Young-Min Han Figures at page 549 (the esterase activity) releasing hydroxybutyrate. Dependent claims 32-39 are ‘reaching-through’ claims drawn to the underlying inherent biochemical properties of β‐hydroxybutyric acid. Similarly, Applicant admitted to prior art at page 20 [0078] teaches detecting and/or treating a subject having an aneurysm or at risk for developing an aneurysm corresponding to limitation of claim 41 for patient selection. Applicant is encouraged use word search techniques in the cited references for the plethora of possibilities. To find a specific word/limitation on a webpage or document:
Press Ctrl + F (Windows) or Cmd + F (Mac).
Type the word in the search bar that appears.
Press Enter to jump through each highlighted instance on the page
Thus the limitation of claim 34, ‘Marfan syndrome’ is found in the section under ACE inhibitors of the cited Miyake.
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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.
/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
Prosecution Insights