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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/18/2025 has been entered.
Priority
The instant application is a national stage entry of PCT/US2019/048184 (filed 08/24/2019), which claims priority to US provisional application 62/751,404 (filed 10/26/2018), and also claims priority to US provisional application 62/722,766 (filed 8/24/2018).
The instant application find support from US provisional application 62/722,766. Therefore, the effective filing date is 8/24/2018.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/18/2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Current Status of 17/271,045
The rejections of record have been withdrawn.
Claims 1, 3-8, 42-44, 53, 57-59 and 61-62 have been examined on the merits.
Applicants elected atorvastatin (elected statin). Claim 60 is withdrawn due to being drawn to a nonelected species of statin.
The claims filed 12/18/2025 have been used in this Office Action.
Response to Arguments
Applicants’ claim amendments and Remarks of 12/18/2025 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
In regard to the 103 rejection, this rejection is withdrawn. Applicants remarks with Examiner’s reply are summarized below:
It was known that chronic use of statin therapies in patients leads to an increase in HbA1c levels, which worsens existing diabetic conditions.
Applicants submit that Bempedoic acid unexpectedly protects against statin-associated increases in HbA1c levels (Figure 2 from the instant specification).
Applicants submit that the surprising effect to be indicative of the ability of bempedoic acid to prevent worsening of diabetes in a subject receiving statin therapy (because diabetes would worsen glycemic control).
Examiner sees that at 12 weeks, the placebo group had an increase of 0.04% and at 52 weeks the placebo group had an increase of 0.15%. The treated group at 12 weeks had a decrease of 0.15% and at 52 weeks the treated group had a decrease of 0.01%.
Examiner was unsure of the scale of the percentages, which may or may not have impacted unexpected results; however, literature in this art confirmed that without treatment or lifestyle changes, untreated or poorly managed Type 2 diabetes can cause HbA1c levels to rise, potentially increasing by 0.5% or more over a short period.
Applicants have shown that bempedoic acid has unexpected and surprising results.
Applicants submits that the Office incorrectly asserts that if a therapy decreases LDL-C levels, then it also decreases HbA1c levels. Applicants instead submit there is a correlation between HbA1c levels and LDL-C levels.
Examiner has reviewed appendix A2, B3, C4, and D5.
By Applicants’ own admission, there is a correlation between HbA1c levels and LDL-C levels. Correlation in the broadest sense is a measure of an association between variables.
Applicants submit that HbA1c level observed with statin use appears to be dose dependent and that statins reduce LDL-C in a dose dependent way.
Ezetimibe has no effect on HbA1c levels. Ezetimibe does not cause any loss of glycemic control relative to placebo (when administered alone or with a statin).
Bempedoic acid is not a statin nor a cholesterol absorption inhibitor (type of drug ezetimibe is).
Applicants submit that lowering LDL-C levels does not guarantee a change in HbA1c levels and each therapy should be evaluated separately.
Applicants further submit Appendix C and D to show that two different treatments lowered LDL-C levels, but did not change HbA1c levels.
Examiner understands that lowering LDL-C levels does not guarantee a change in HbA1c levels.
Response to Amendment
Claim Rejections - 35 USC § 102
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, 3-8, 43-44, 53, 57-59, and 61-62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ballantyne (Ballantyne et al., “Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: A randomized, placebo-controlled study”, Atherosclerosis, June 12, 2018) as evidenced by CDC (“A1c test for Diabetes and Prediabetes”, CDC, May 15, 2024)
Ballantyne anticipates a method of administering bempedoic acid and ezetimibe to patients with existing diabetes receiving statin therapy (who are in need of LDL-C lowering) (title). Instant claim 1 recites the open limitation of “comprising”, which allows for both bempedoic acid and ezetimibe to be administered.
Ballantyne anticipates that safety assessments were conducted and HbA1c levels were measured (page 197). Ballantyne does not describe that increased levels of HbA1c were part of the treatment-emergent AEs (page 197 and Table 2). The Supplement for Ballantyne describes that HbA1c levels were tested at -5 weeks, 0 weeks, and 12 weeks (page 87). Subject exclusion included patients who had more than or equal to 10% HbA1c (page 196). This is a method of decreasing the likelihood of increasing levels of HbA1c.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Chemical properties are inherent to their compounds. See MPEP 2112 (II). Products of identical chemical composition can not have mutually exclusive properties. A chemical composition, ezetimibe, and its properties, reducing mesangial expansion, are inseparable. See MPEP 2112.01 (II).
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
This anticipates claims 1, 44, and 53 (human subject).
Ballantyne states that type 2 diabetes subjects had to have a history of statin intolerance (section 2.1), which inherently anticipates that subjects have had type 2 diabetes for some amount of time long enough to be diagnosed and be taking medication prior to entering into the study. There is at least one patient from the 181 patients (figure 2) that fits this criteria. This anticipates claims 4 and 5.
Ballantyne anticipates type 2 diabetes (title). This anticipates claim 2.
Ballantyne discloses that Subject exclusion included patients who had more than or equal to 10% HbA1c (page 196). CDC is relied upon for the beneficial teaching that for most people with type 2 diabetes, a HbA1c level is 7% or less (page 2). Since the patients from Ballantyne are diabetic, this means the subjects has a HbA1c level between 5-10% or 7-10%. This anticipates claims 6 and 62.
Ballantyne anticipates bempedoic acid dose of 180 mg per day (page 197). This anticipates claim 43.
Ballantyne anticipates a mean fasting LDL-C baseline of 127.6 mg/dL (page 197). Ballantyne anticipates patients were required to have a fasting LDL-C of equal to or greater than 100 mg/dL at screening (section 2.1). This anticipates claims 7 and 8.
Ballantyne anticipates the statin therapy is one of the following rosuvastatin 5mg, atorvastatin 10mg, simvastatin 10mg, lovastatin 20mg, pravastatin 40mg, fluvastatin 40mg, or pitavastatin 2mg (Section 2.1). This anticipates claims 57-59.
Ballantyne anticipates an ezetimibe dose of 10 mg (section 2.2). This anticipates claim 61.
Conclusion
Claim 42 is objected to for depending on a rejected base claim. No claims are allowed as currently written.
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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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.
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/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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