The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 34-38 are presented for examination.
A request for continued examination under 37 C.F.R. §1.114, including the fee set forth in 37 C.F.R. §1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 C.F.R. §1.114, and the fee set forth in 37 C.F.R. §1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 C.F.R. §1.114. Applicant's submission filed on November 11, 2025 has been entered.
Claims 34-38 are pending and under examination. Claim 34 is amended. Claims 39-46 are cancelled.
Applicant’s arguments, filed November 11, 2025, have been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Status of Rejections in the July 24, 2025 Final Action
In reply to the rejection of claims 34-38 under 35 U.S.C. §112(b) (pre-AIA second paragraph), as set forth at p.6-7 of the previous Office Action dated July 24, 2025, Applicant now amends claim 34 to clearly require the administration of both pemafibrate (or salt thereof) and pitavastatin (or salt or solvate thereof) to the recited patient. Accordingly, the rejection is now hereby withdrawn.
In reply to the rejection of claims 45-46 under 35 U.S.C. §112(b) (pre-AIA second paragraph), as set forth at p.7-9 of the previous Office Action dated July 24, 2025, Applicant now cancels claims 45-46. Accordingly, the rejection is now hereby withdrawn.
In reply to the rejection of claims 34-44 under 35 U.S.C. §102(a)(1) as being anticipated by Yokote et al. (“Abstract 12384: Novel Approach to Residual Risk, K-877, a Potent and Selective PPAR-a Modulator (SPPARMa), Added-On to Pitavastatin in Japanese Patients with Dyslipidemia”, Circulation, 2015; 132:A12384, cited on the 01/20/22 PTO-892), citing to Ishibashi et al. (“Effects of K-877, a Novel Selective PPARa Modulator (SPPARMa), in Dyslipidaemic Patients: A Randomized, Double Blind, Active- and Placebo-Controlled, Phase 2 Trial”, Atherosclerosis, 206; 249:36-43, cited on the 01/20/22 PTO-892) and Halperin et al. (“Dyslipidemia and the Risk of Incident Hypertension in Men”, Hypertension, 2006; 47:45-50) as factual evidence, as set forth at p.9-14 of the previous Office Action dated July 24, 2025, Applicant now amends claim 34 to specifically require “treating hypertension in a patient in need thereof” – thus, implicitly requiring the patient to exhibit a “need” for treatment of hypertension - which distinguishes over the patient population of dyslipidemic subjects in Yokote et al., and cancels claims 39-44. Accordingly, the rejection is now hereby withdrawn.
In reply to the rejection of claims 34, 39 and 44 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 8,426,455 B2, citing to PubChem (“Pemafibrate”, CID 11526038) and Halperin et al. (“Dyslipidemia and the Risk of Incident Hypertension in Men”, Hypertension, 2006; 47:45-50) as factual evidence, as set forth at p.16-19 of the previous Office Action dated July 24, 2025, Applicant now amends claim 34 to specifically require that the patient have a “need” for “treating hypertension”, which distinguishes over the hyperlipidemia patient population of the patent claims, and further cancels claims 39 and 44. Accordingly, the rejection is now hereby withdrawn.
In reply to the rejection of claims 34, 39 and 44 on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,446,282 B2, as set forth at p.19-21 of the previous Office Action dated July 24, 2025, Applicant now amends claim 34 to specifically require that the patient have a “need” for “treating hypertension”, which distinguishes over the renally impaired dyslipidemic patient population of the patent claims, and further cancels claims 39 and 44. Accordingly, the rejection is now hereby withdrawn.
Upon reconsideration of the subject matter as newly amended, however, new grounds for rejection are necessitated and set forth infra.
Claim Rejections - 35 USC § 112(b) (Pre-AIA Second Paragraph)
(New Grounds of Rejection)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
(1) Claims 34-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Applicant’s claim 34 recites “[a] method of treating hypertension in a patient in need thereof” via “administering a) pemafibrate or a salt thereof; and b) pitavastatin, a salt thereof or a solvate thereof, to a patient in need thereof; to thereby reduce hypertension in the patient”.
The “need” of the patient recited in the active step of the method is not clearly set forth. Applicant fails to explicitly refer back to the “patient in need thereof” of the preamble (such as by reciting “the patient in need thereof”) – instead reciting “a patient in need thereof”. As a result, it is unclear if the patient is in need of hypertension treatment, or has another unidentified need.
Clarification is required.
There is also a lack of antecedent basis for the limitation directed to “the patient” as recited at l.6 of the claim. It is unclear if “the patient” refers to “the patient” of the preamble of the claim or “the patient” of the active step of the claim (which is additionally indefinite for failing to identify the patient’s “need” for the reasons above).
Clarification is required.
As Applicant’s claims 35-38 fail to remedy these points of ambiguity in claim 34, they must also be rejected for the same reasons applied thereto.
For these reasons, the claims fail to meet the tenor and express requirements of 35 U.S.C. §112(b) (pre-AIA second paragraph) and are, thus, properly rejected.
Claim Rejections - 35 USC § 102 (New Grounds of Rejection)
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(2) Claim 34 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshida et al. (“Combination Therapy with Pemafibrate (K-877) and Pitavastatin Improves Vascular Endothelial Function in DAHL/Salt-Sensitive Rats”, Circulation, 2018 November; 138(Suppl.1), Abstract Only, cited by Applicant on the 02/14/22 IDS),
citing to Wilson et al. (“Effects of Lipid-Lowering Agents in the Dahl Salt-Sensitive Rat”, Hypertension, 1998; 31(1):225-231, cited on the 06/14/23 PTO-892) as evidence.
Yoshida et al. teaches an experimental study of five groups of DAHL/salt-sensitive rats to determine the effect of the combination of pemafibrate and pitavastatin on endothelial function, which are: (i) normal diet (ND) with normal salt level and no drug (group 1); (ii) high-fat diet (HFD) with high salt level and no drug (group 2); (iii) HFD with high salt level and treated with pitavastatin (0.3 mg/kg) (group 3); (iv) HFD with high salt level and treated with pemafibrate (0.5 mg/kg) (group 4); and (v) HFD with high salt level and treated with pemafibrate (0.5 mg/kg) and pitavastatin (0.3 mg/kg) (group 5) (abstract). Yoshida et al. teaches that treatment was continued for 12 weeks duration, after which vessel endothelial function was assessed (abstract). Yoshida et al. teaches that the rats of group 5 demonstrated a significant improvement in vessel endothelial function as compared to group 2, and that systolic blood pressure was significantly lower than that of groups 2, 3 and 4 (abstract). Yoshida et al. teaches that the combination of pemafibrate therapy with pitavastatin therapy improved vessel endothelial function in DAHL/salt-sensitive rats fed HFD with high salt level and that this therapeutic effect may be a beneficial strategy for preventing progression of atherosclerosis (abstract).
Wilson et al. is cited as extraneous factual evidence demonstrating that the DAHL/salt-sensitive rat is a model of salt-sensitive hypertension when fed a high salt diet (col.1, para.1, p.225), thereby establishing that the subject of Yoshida’s study constitutes a subject in need of treatment for hypertension, as required by claim 34.
In claim 34, Applicant recites “[a] method for treating hypertension in a patient in need thereof” via the administration of pemafibrate (or salt thereof) with pitavastatin (or a salt or solvate thereof).
As Yoshida et al. teaches the effect of pemafibrate and pitavastatin therapy to significantly reduce hypertension and improve vessel endothelial function, Yoshida’s teachings meet the recited therapeutic objective of “treating hypertension” as instantly claimed.
MPEP §2131.01 states that “[n]ormally, only one reference should be used in making a rejection under 35 U.S.C. 102”, but that it is proper to apply a second reference when the extra reference is cited for the purpose of “show[ing] that a characteristic not disclosed in the reference is inherent”.
Therefore, instant claim 34 is properly anticipated under AIA 35 U.S.C. §102(a)(1).
Claim Rejections - 35 USC § 103 (New Grounds of Rejection)
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(3) Claims 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida et al. (“Combination Therapy with Pemafibrate (K-877) and Pitavastatin Improves Vascular Endothelial Function in DAHL/Salt-Sensitive Rats”, Circulation, 2018 November; 138(Suppl.1), Abstract Only, cited by Applicant on the 02/14/22 IDS) in view of Reagan-Shaw et al. (“Dose Translation from Animal to Human Studies Revisited”, FASEB J, 2008; 22(3):659-661, cited on the 06/14/23 PTO-892),
citing to Wilson et al. (“Effects of Lipid-Lowering Agents in the Dahl Salt-Sensitive Rat”, Hypertension, 1998; 31(1):225-231, cited on the 06/14/23 PTO-892) as evidence.
Yoshida et al. teaches an experimental study of five groups of DAHL/salt-sensitive rats to determine the effect of the combination of pemafibrate and pitavastatin on endothelial function, which are: (i) ND with normal salt level and no drug (group 1); (ii) HFD with high salt level and no drug (group 2); (iii) HFD with high salt level and treated with pitavastatin (0.3 mg/kg) (group 3); (iv) HFD with high salt level and treated with pemafibrate (0.5 mg/kg) (group 4); and (v) HFD with high salt level and treated with pemafibrate (0.5 mg/kg) and pitavastatin (0.3 mg/kg) (group 5) (abstract). Yoshida et al. teaches that treatment was continued for 12 weeks duration, after which vessel endothelial function was assessed (abstract). Yoshida et al. teaches that the rats of group 5 demonstrated a significant improvement in vessel endothelial function as compared to group 2, and that systolic blood pressure was significantly lower than that of groups 2, 3 and 4 (abstract). Yoshida et al. teaches that the combination of pemafibrate therapy with pitavastatin therapy improved vessel endothelial function in DAHL/salt-sensitive rats fed HFD with high salt level and that this therapeutic effect may be a beneficial strategy for preventing progression of atherosclerosis (abstract).
Wilson et al. is cited as extraneous factual evidence demonstrating that the DAHL/salt-sensitive rat is a model of salt-sensitive hypertension when fed a high salt diet (col.1, para.1, p.225), thereby establishing that the subject of Yoshida’s study constitutes a subject in need of treatment for hypertension, as required by the instant claims.
Yoshida et al. differs from the instant claims only insofar as it does not explicitly teach the amount of pemafibrate is about 0.01-10 mg or about 0.1-0.4 mg, in terms of the free form of pemafibrate once or more per day (claims 35-36), or the amount of pitavastatin is from 0.001-160,000 parts by mass, or 0.05-12,000 parts by mass, per 1 part by mass of pemafibrate or its salt calculated as the free form of pemafibrate (claims 37-38).
Reagan-Shaw et al. teaches that the average weight of a rat is 0.15 kg (Table 1, p.660).
Here, Yoshida et al. teaches the administration of pemafibrate (0.5 mg/kg) with pitavastatin (0.3 mg/kg) to DAHL/salt-sensitive hypertensive rats.
As Reagan-Shaw et al. teaches that the average body weight of a rat is 0.15 kg, such dosage amounts are equivalent to:
(i) (0.5 mg/kg pemafibrate) * (0.15 kg average weight of a rat) = 0.075 mg pemafibrate; and
(ii) (0.3 mg/kg pitavastatin) * (0.15 kg average weight of a rat) = 0.045 mg pitavastatin.
Such dosages as described by Yoshida et al., therefore, meet Applicant’s claimed range of “about 0.01 to 10 mg in terms of the free form of pemafibrate” (claim 35), and “about 0.1 to 0.4 mg in terms of the free form of pemafibrate once or more per day” (claim 36). Though the amount of 0.075 mg pemafibrate is just outside of the “about 0.1 to 0.4 mg” range of claim 36, Applicant fails to define the amount of variation tolerated by the term “about” as used in the instant claims and, therefore, such amount is understood to meet this claimed range of “about 0.1 to 0.4 mg”. Also, though Yoshida et al. does not explicitly teach the frequency per day of the administration, it must be noted that such quantity is administered “once” per day on any one day it is administered, thereby meeting this “once or more per day” requirement of claims 35-36.
Additionally, the determination of the amount of pitavastatin per 1 part by mass of pemafibrate calculated as the free form of pemafibrate using these average dosage amounts is:
(0.075 mg pemafibrate)/(0.045 mg pitavastatin) = (1 mg pemafibrate)/(x mg pitavastatin), where x is 0.6 mg, which also meets Applicant’s instantly claimed ranges of 0.001 to 160,000 parts by mass pitavastatin per 1 part by mass pemafibrate calculated as the free form of pemafibrate (claim 37) or 0.05 to 12,000 parts by mass per 1 part by mass of pemafibrate calculated as the free form of pemafibrate (claim 38).
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Applicant’s Arguments
In reply, Applicant traverses the previously applied rejections in view of the submitted amendments and arguments (Remarks, p.4-8).
Applicant’s traversal and amendments have been fully and carefully considered, and the previously applied rejections have been withdrawn as indicated above.
Upon further reconsideration of the claimed subject matter as amended, however, new grounds for rejection are necessitated and are set forth infra.
For these reasons supra, rejection of claims 34-38 is proper.
Conclusion
Rejection of claims 34-38 is proper.
No claims of the present application are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Leslie A. Royds Draper whose telephone number is (571)272-6096. The examiner can normally be reached Tuesday to Thursday (08:30 AM to 05:00 PM).
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/Leslie A. Royds Draper/Primary Examiner, Art Unit 1629
November 19, 2025