DETAILED ACTION
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 .
Claim Status
Claims 1-18 are pending.
Priority
This application is filed 11/14/2024, and claims the benefit of domestic priority as below:
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Information Disclosure Statements
No IDS(s) received.
Abstract
The abstract of the disclosure is objected to because the abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. Currently, the abstract has 44 words.
The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. Examiner requests to satisfy the abstract requirement. See MPEP § 608.01(b).
Claim interpretation
Claims are interpreted in accordance with the broadest reasonable interpretation (BRI) standard
consistent with the specification (See MPEP 2111).
According to the specification, the terms “chronic heart failure” and “congestive heart failure” are interpreted equally (page 14, line 31); the term “empagliflozin” is interpreted as “the SGLT2 inhibitor 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene” (page 13, lines 25-28); and the term “the patient” is interpreted as “a patient with chronic heart failure” (page 1, lines 5-9).
With respect to Claim 1, since the claim relates to a method of treatment, the preamble, “a method for reducing the risk of cardiovascular death and/or reducing the risk of hospitalization for heart failure in a patient with chronic heart failure”, is given patentable weight. Furthermore, the requirement set forth in the preamble is interpreted as being inherently satisfied because empagliflozin is administered to the claimed patient population under the claimed treatment conditions, as such administration results in the mitigation of the specified risks. Accordingly, the claim 1 is interpreted as a method wherein empagliflozin is administered to a patient with chronic heart failure (“…administering empagliflozin to the patient”) with the recited reduction in the risk of cardiovascular death and/or hospitalization for heart failure being a therapeutic result of such administration.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5-7, 9-11, 13, 17 and 18 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Broedl et al. (US 2014/0303097 A1, pub'd 10/09/2014).
The published date of the applied reference satisfies the requirements of 35 USC 102 (a)(1). For the requirements of 35 USC 102 (a)(2), the applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Broedl teaches that
a method of preventing, reducing the risk of or delaying the occurrence of a cardiovascular event in a patient with type 1 or type 2 diabetes mellitus or with pre-diabetes, said method comprising administering empagliflozin (i.e., 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene), optionally in combination with one or more other therapeutic substances, to the patient wherein the patient with type 1 or type 2 diabetes mellitus or with pre-diabetes has one or more cardiovascular risk factors selected from A), B), C) and D) (paragraph [0054]-[0055]). In the disclosed method, the cardiovascular event includes cardiovascular death and heart failure requiring hospitalization, and cardiovascular risk factor A) includes previous or existing congestive heart failure. In view of the claim interpretation and the instant specification (page 14 line 31), congestive heart failure and chronic heart failure are treated equally. Consistent with the claim interpretation above, where Broedl discloses administration of empagliflozin to the claimed patient population under the claimed treatment conditions, the recited reduction in the risk of cardiovascular death and/or hospitalization for heart failure is inherently met because such risk reduction necessarily results from the disclosed administration. Thus, Broedl teaches the limitations, as required by claims 1, 6, and 10.
a patients with or at risk of cardiovascular disease, particularly in those type 1 or type 2 diabetes patients being at risk of cardiovascular events, such as type 1 or type 2 diabetes patients with one or more risk factors selected from previous or existing vascular disease … congestive heart failure (e.g. NYHA class I, II, III or IV, e.g. left ventricular function <40% ), as required by claim 3 (paragraph [0218] and [0296]);
SGLT-2 inhibitors, in particular empagliflozin, for treating and/or preventing collagen deposition and/or vessel wall thickening (e.g. in diabetes or non-diabetes patients), as required by claim 7 (paragraph [0211]);
as stated in item (2) above, cardiovascular risk patients having congestive heart failure with a left ventricular function <40%, thereby, teaching a patient with reduced ejection fraction, as required by claim 5 (paragraph [0296]), and LVEF of smaller or equal than 40%, as required by claim 13 (paragraph [0296]);
a preferred dosage of the SGLT2 inhibitor empagliflozin is 10 mg or 25 mg per day, that fall within the claimed range of 1 mg to 25 mg, as required by claim 9 (paragraph [0382]);
administration of a combination comprising a certain SGLT-2 inhibitor (particularly empagliflozin) and one or more other active substances selected from antidiabetic substances that lower blood pressure, antiplatelet agents, anticoagulant agents, and other cardiovascular medications, that fall within the claimed group, as required by claim 11 (paragraph [0402]);
empagliflozin is administered orally once daily (10 mg/daily or 25 mg /daily), as required by claim 17 (Example 3); and
administration of empagliflozin in combination with one or more cardiovascular medications, including angiotensin receptor blockers (ARBs), angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, or a diuretic, that fall within the claimed group, as required by claim 18 (paragraph [0138]).
Claim Rejections - 35 USC § 103
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.
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.
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.
Claim(s) 2, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Broedl et al. (US 2014/0303097 A1, pub'd 10/09/2014), in view of Scheen (EMPA-REG OUTCOME : Empagliflozin reduces mortality in patients with type 2 diabetes at high cardiovascular risk, Rev. Med. Liège, 70(11), 583-589, pub'd 09/17/2015).
As discussed above in 35 USC 102, Broedl teaches the limitations of claim 1, including administration of empagliflozin to patients having chronic heart failure/heart failure and identifies cardiovascular death and heart failure requiring hospitalization as cardiovascular outcomes to be prevented or reduced. (see 35 USC 102 and claim interpretation).
With respect to claims 2 and 12, claim 2 recites that the risk of hospitalization for heart failure is the risk of first hospitalization for heart failure and claim 12 recites that the risk of first and/or recurrent hospitalization for heart failure is reduced.
Broedl fails to teach the risk of hospitalization for heart failure is the risk of first hospitalization for heart failure.
Scheen teaches that empagliflozin (10 or 25 mg/day) reduces hospitalizations for heart failure by 35% and cardiovascular mortality by 38% compared with placebo in patients with type 2 diabetes mellitus and known cardiovascular(abstract).
It would have been obvious to a PHOSITA at the time of the invention to administer empagliflozin to patients with chronic heart failure, particularly patients with pre-diabetes or type II diabetes mellitus taught by Broedl for the purpose of reducing cardiovascular death and hospitalization for heart failure. A PHOSITA would have been motivated to apply the demonstrated reduction in heart failure hospitalization taught by Sheen to the heart failure patients identified by Broedl in order to reduce hospitalization for heart failure, including first hospitalization. A PHOSITA would have had a reasonable expectation of success because Scheen clinically demonstrated a substantial reduction in heart failure hospitalization following administration of the same drug, empagliflozin, in an overlapping cardiovascular risk population.
Claim(s) 4, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Broedl et al. (US 2014/0303097 A1, pub'd 10/09/2014), and Scheen (EMPA-REG OUTCOME : Empagliflozin reduces mortality in patients with type 2 diabetes at high cardiovascular risk, Rev. Med. Liège, 70(11), 583-589, pub'd 09/17/2015) as applied to claims 2 and 12 above, and further in view of Tsuchihashi-Makaya (Characteristics and outcomes of hospitalized patients with heart failure and reduced vs preserved ejection fraction, JCARE-CARD, Circ. J. 73(10), 1893-900, pub’d 07/31/2009).
With respect to claims 4 and 14-16, claim 4 recites that the patient is a patient with preserved ejection fraction, and the claims 14-16 recite that the patient is a patient with reduced ejection fraction showing a left ventricular ejection fraction (LVEF) of greater than 40%, greater than 50% or in a range from 40 % to 49%.
The combination of Broedl and Scheen fails to teach a patient with preserved ejection fraction and a left ventricular ejection fraction (LVEF) of greater than 40%, greater than 50% or in a range from 40 % to 49%.
Tsuchihashi-Makaya teaches that 1) heart failure with preserved ejection fraction is common; 2) comparing the characteristics, treatments, and outcomes in heart failure patients with reduced and preserved ejection fraction (Abstract); 3) preserved ejection fraction as defined as an EF ≥50% and reduced ejection fraction as an EF <40% (Abstract). The preserved EF group had a mean LVER of 62.4% (table 1), and the study showed 278 patients (16%) having an EF between 40% and 50%, thereby recognizing an intermediate EF heart failure population (results); and 4) the comorbidity of diabetes and heart failure, reporting that 29.8% of heart failure patients had diabetes mellitus, including 33.3% of patients with reduced ejection fraction and 29.4% of patients with preserved ejection fraction (table 1).
A PHOSITA would have been motivated to include the preserved and intermediate EF heart failure populations taught by Tsuchihashi-Makaya among the heart failure patients treated according to Broedl and Scheen because Tsuchihashi-Makaya further teaches that preserved EF patients represented a common heart failure population having similarly high mortality and rehospitalization burdens and identifies a need for effective management. A PHOSITA would have had a reasonable expectation of success of achieving reduction in the claimed cardiovascular risks because Broedl identifies congestive heart failure as a cardiovascular risk condition suitable for empagliflozin treatment, Scheen teaches cardiovascular benefits of empagliflozin, and Tsuchihashi-Makaya identifies preserved and intermediate EF patients as recognized subpopulations within the same heart failure disease.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Broedl et al. (US 2014/0303097 A1, pub'd 10/09/2014), and Scheen (EMPA-REG OUTCOME : Empagliflozin reduces mortality in patients with type 2 diabetes at high cardiovascular risk, Rev. Med. Liège, 70(11), 583-589, pub'd 09/17/2015) as applied to claims 2 and 12 above, and further in view of Barnett et al. (Efficacy and safety of empagliflozin added to existing antidiabetic treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial., Lancet Diabetes Endocrinol., 2(5), 369-84, pub’d 01/24/2014).
With respect to claim 8, the claim recites that the patient has an eGFR equal to or greater
than 20 ml/min/1.73m2 or eGFR equal to or greater than 30 ml/min/1.73m2.
The combination of Broedl and Scheen fails to teach the patient has an eGFR equal to or greater
than 20 ml/min/1.73m2 or eGFR equal to or greater than 30 ml/min/1.73m2.
Barnett teaches 1) administration of empagliflozin to patients with type 2 diabetes mellitus and chronic kidney disease (abstract); 2) administered empagliflozin 25 mg once daily for 52 weeks to patients with stage 3 chronic kidney disease having an eGFR of ≥30 to ≤60 mL/min/1.73m2 (abstract); and 3) that empagliflozin reduced HbA1c and is well tolerated in patients with stage 2 or stage 3 chronic kidney disease (abstract). Thus, Barnett teaches administration of empagliflozin to patients having an eGFR of at least 30 mL/min/1.73 m2, which satisfies one of the alternatives recited in claim 8.
A PHOSITA would have been motivated to include heart failure patients having the renal function characteristic taught by Barnett among the patients treated according to Broedl and Scheen because Barnett teaches that patients with type 2 diabetes mellitus and chronic kidney disease having an eGFR of ≥30 to ≤60 mL/min/1.73m2 are suitable candidates for empagliflozin treatment. A PHOSITA would have had a reasonable expectation of success in achieving reduction in the claimed cardiovascular risks because Barnett shows that empagliflozin is tolerated in patients having stage 2 or stage 3 chronic kidney disease, including patients having an eGFR of ≥30 to ≤60 mL/min/1.73m2.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,813,275 B2 in view of Broedl et al. (US 2014/0303097 A1, pub'd 10/09/2014), Scheen (EMPA-REG OUTCOME : Empagliflozin reduces mortality in patients with type 2 diabetes at high cardiovascular risk, Rev. Med. Liège, 70(11), 583-589, pub'd 09/17/2015), Tsuchihashi-Makaya (Characteristics and outcomes of hospitalized patients with heart failure and reduced vs preserved ejection fraction, JCARE-CARD, Circ. J. 73(10), 1893-900, pub’d 07/31/2009), and Barnett et al. (Efficacy and safety of empagliflozin added to existing antidiabetic treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial., Lancet Diabetes Endocrinol., 2(5), 369-84, pub’d 01/24/2014).
The claims of the ‘275 patent claims broadly encompass a method for reducing the risk of cardiovascular death and/or hospitalization for heart failure in a patient with heart failure, said method comprising administering a therapeutically effective amount of empagliflozin to the patient (claim 1). The empagliflozin is administered in a total daily amount of 10 mg or 25 mg (claims 2 and 6). The patient has type 2 diabetes mellitus (claim 3) and reducing the risk of cardiovascular death and hospitalization for heart failure (claims 4 and 5).
The instant claims differ from the ‘275 patent in so far as they require administration to a patient having chronic heart failure.
The teachings of Broedl, Sheen, Tsuchihashi-Makaya, and Barnett are as discussed supra in the 35 U.S.C. 102 and 35 U.S.C. 103 rejection and are herein incorporated by reference in their entirety.
It would have been prima facie obvious to one of ordinary skill in the art to administer empagliflozin to patients having chronic heart failure in the methods of the ‘275 patent in view of the combined teachings of Broedl, Sheen, Tsuchihashi-Makaya, and Barnett for the same reasons discussed supra in the 35 U.S.C. 102 and 35 U.S.C. 103 rejection, which reasons are herein incorporated by reference in their entirety.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,918,596 B2 in view of Broedl et al. (US 2014/0303097 A1, pub'd 10/09/2014), Scheen (EMPA-REG OUTCOME : Empagliflozin reduces mortality in patients with type 2 diabetes at high cardiovascular risk, Rev. Med. Liège, 70(11), 583-589, pub'd 09/17/2015), Tsuchihashi-Makaya (Characteristics and outcomes of hospitalized patients with heart failure and reduced vs preserved ejection fraction, JCARE-CARD, Circ. J. 73(10), 1893-900, pub’d 07/31/2009), and Barnett et al. (Efficacy and safety of empagliflozin added to existing antidiabetic treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial., Lancet Diabetes Endocrinol., 2(5), 369-84, pub’d 01/24/2014).
The claims of the ‘596 patent claims broadly recite 1) administrating empagliflozin to a patient with a previous or existing myocardial infarction to reduce the risk of heart failure or hospitalization for heart failure (claims 1 and 7); 2) reducing the risk of hospitalization for heart failure (claims 6, 11 and 12); and 3) administration of 10 mg or 25 mg of empagliflozin, including 10 mg once daily (claims 2-5 and 8-10).
The instant claims require chronic heart failure, whereas the cited claims of the ‘596 patent require a history of myocardial infraction. The respective patient populations are not mutually exclusive and encompass patients having both a history of myocardial infraction and chronic heart failure. (Broedl’s specification [0023]). In addition, the limitation of “reducing the risk of cardiovascular death and/or reducing the risk of hospitalization for heart failure” in the instant claim 1 is corresponded to the limitation as “the risk of heart failure or hospitalization for heart failure” in ‘596’s claim 1.
The teachings of Broedl, Sheen, Tsuchihashi-Makaya, and Barnett are as discussed supra in the 35 U.S.C. 102 and 35 U.S.C. 103 rejection and are herein incorporated by reference in their entirety.
It would have been prima facie obvious to one of ordinary skill in the art to administer empagliflozin to patients having chronic heart failure in the methods of the ‘596 patent in view of the combined teachings of Broedl, Sheen, Tsuchihashi-Makaya, and Barnett for the same reasons discussed supra in the 35 U.S.C. 102 and 35 U.S.C. 103 rejection, which reasons are herein incorporated by reference in their entirety.
Art of Record but not Applied
US 7,723,309 B2 which recites administering a therapeutically effective amount of an SGLT2 inhibiting compound to a patient with chronic heart failure. Thus, 309 patent addresses the same patient population and a related therapeutic method as the instant claims. However, 309 patent claims the (R)-tetrahydrofuran-3-yloxy compound, whereas the instant claims require empagliflozin, which is the corresponding (S)-configured compound. Accordingly, ‘309 patent does not provide a sufficient basis for an obviousness type double patenting rejection.
US 10,406,172 B2 which the administration of a single-formulation tablet containing empagliflozin, linagliptin, and metformin for the treatment of diabetic complications, including cardiomyopathy and heart failure. Additionally, the '172 patent addresses a broader range of diseases or disorders associated with diabetic complications. Accordingly, ‘172 patent does not provide a sufficient basis for an obviousness type double patenting rejection.
Conclusion
Claims 1-18 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEONG JONG KIM whose telephone number is (571)272-6918. The examiner can normally be reached 7:00am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEONG JONG KIM/ Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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