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 .
Detailed Action
This office action is a response to applicant’s communication submitted February 25, 2026, wherein claims 112, 113, 116, and 119 are canceled and new claim 124 is introduced. This application is a continuation of US application 17/184746, now US patent 11903955, filed February 25, 2021, which is a continuation of US application 16/812745, now US patent 10973836, filed March 9, 2020, which claims benefit of provisional applications 62/985407, filed March 5, 2020, 62/969181, filed February 3, 2020, 62/960756, filed January 14, 2020, 62/946625, filed December 11, 2019, 62/930673, filed November 5, 2019, and 62/893849, filed August 30, 2019.
Claims 108-111, 114, 115, 117, 118, and 120-124 are pending in this application.
Claims 108-111, 114, 115, 117, 118, and 120-124 as amended are examined on the merits herein.
Withdrawn Rejections
The rejections of claims 117-119, 122, and 123 for claiming the same invention as claims 1, 6, 17, 18, and 22 of US patent 1097836, of claims 108-116 and 120-121 for claiming the same invention as claims 1, 6, 17, 18, and 22 of US patent 10973836 in view of Bindra in view of Preiss, of claims 117-119, 122, and 123 for claiming the same invention as claims 1, 6, 17, 18, and 22 of US patent 11903955, and of claims 108-110, 112-116, and 120-121 for claiming the same invention as claims 1, 6, 17, 18, and 22 of US patent 11903955 in view of Bindra in view of Preiss, are withdrawn in view of the terminal disclaimer submitted February 25, 2026.
The following rejections of record in the previous action are maintained:
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 114 and 115 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. These claims depend from claim 108, which is directed to a method of preventing and/or delaying the incidence of diabetes in a patient. However, claim 114 includes as its sole additional limitation the requirement that the incidence of diabetes is reduced relative to a standard of care agent. These claims do not specify at what time the incidence of diabetes is measured, so any method that successfully prevents or delays diabetes would reasonably be considered to achieve the effect of “reducing the incidence” at a reasonably selected time point. Furthermore claim 114 does not specify the standard of care agent that the effect is measured against, and therefore cannot be said to meaningfully narrow the scope of the claims. Regarding claim 115, this claim further depends on claim 114 and specifies that the therapy results in a hazard ratio of less than 1 compared to the placebo or standard of care agent. However, all that a hazard ratio of less than 1 means is that the condition is less likely with the treatment than with the placebo or standard of care agent, which is a limitation already present in the base claim, merely stated in a different manner. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to Arguments: Applicant’s arguments, submitted February 25, 2026, with respect to the above grounds of rejection, have been fully considered and not found to be persuasive to remove the rejection. Specifically, Applicant argues that the specification defines “standard of care heart failure agent” as being specifically defined in the present specification, for example paragraphs 114 and 140-148. Looking to paragraph 114 of the specification as originally filed, this paragraph includes the statement, “As used herein, "standard of care HF agents" include at least one standard of care HF agent, for example, at least two or at least three or more medications or medication classes, other than SGLT2 inhibitors, that are used to treat HF, for instance, HFrEF.” This sentence defines “standard of care HF agent” in a tautological manner as an agent used to treat heart failure. While this paragraph then includes a list of exemplary standard of care HF agents Angiotensin-converting enzyme (ACE) inhibitors; Angiotensin receptor blockers (ARBs); beta blockers; mineralocorticoid receptor agents like mineralocorticoid receptor antagonists (MRA), and neprilysin inhibitors, this is merely an exemplary list, and is then followed by a further list of more exemplary agents that could also be considered to be standard of care HF agents. Neither of these exemplary listings are actually described in such a way as to be a strict definition of the term “standard of care HF agent” that would limit the scope of this term as used in present claim 114. Paragraphs 140-148 of the specification similarly recite a list of exemplary standard of care agents but do not clearly define the term in a way that would limit the definition of this term to narrower than the broadest definition “medications or medication classes, other than SGLT2 inhibitors, that are used to treat HF, such as HFrEF,” appearing in claims 114 and 140. Therefore as discussed in the body of the rejection, claim 114 allows for comparison to any other possible therapeutic agent which could be used to treat HFrEF. Being better than some undefined arbitrary standard does not serve to narrow the scope of the claim. Therefore claim 114 fails to further limit the scope of claim 108. Regarding claim 115, Applicant’s response does not address this claim individually, in particular that one skilled in the art would interpret the limitations, “the incidence of diabetes is reduced,” and “a hazard ratio of less than 1,” as meaning the same thing, rendering the claims identical in scope.
For these reasons the rejection is maintained.
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.
Claims 108-111, 114, 115, 117, 118, 120-122, and 124 are rejected under 35 U.S.C. 103 as being unpatentable over Bindra et al. (US pre-grant publication 2014/0243262, of record in previous action) in view of Preiss et al. (Reference of record in previous action)
Independent claim 108 is directed to a method of preventing and/or delaying the incidence of diabetes in a patient suffering from heart failure with reduced ejection fraction, (HFrEF) comprising administering a therapeutically effective amount of dapagliflozin to the patient, wherein the patient does not have type 2 diabetes at the time of initiating therapy. As described in the present specification, HFrEF is defined as a left ventricular ejection fraction of 40% or less. (p. 4 paragraph 13 of the specification) Further as discussed under 35 USC 112(d) dependent claims 115-116 do not further limit base claim 108 and therefore have the same scope.
Bindra et al. discloses oral pharmaceutical formulations comprising dapagliflozin. (pp. 1-2 paragraph 8) These pharmaceutical compositions can be administered to a subject in order to delay the onset or progression of type 2 diabetes or other SGLT2-related conditions such as metabolic syndrome. (p. 3 paragraphs 22-24) Bindra et al. differs from the claimed method in that it does not specifically describe delaying the onset or progression of type 2 diabetes in a patient suffering from heart failure with reduced ejection fraction.
However, Preiss et al. discloses a study of the development of diabetes in patients suffering from chronic heart failure. (p. 916 left column first paragraph) The patients specifically are described as having a left ventricular ejection fraction of less than 0.40, indicating HFrEF. (p. 916 left column second paragraph) OF these patients, 6.7% developed diabetes during the study period, coming to 27.8 per 1000 patient-years. (p. 917 middle column second paragraph) Preiss et al. further suggests identifying high-risk individuals within the population of CHF patients and applying treatment to reduce progression to diabetes.
It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to administer the dapagliflozin-containing pharmaceutical dosage unit described by Bindra et al. to a nondiabetic patient suffering from HFrEF, in order to reduce the development of diabetes in said patient. One of ordinary skill in the art would have seen the disclosure of Preiss et al. as specifically suggesting looking for ways to reduce progression in this patient population and would have seen Bindra’s therapeutic agent as being useful for this purpose based on the disclosed indications described by Bindra.
Regarding claim 109, Bindra et al. suggests administering the dapagliflozin or dapagliflozin propylene glycol hydrate in a dosage of about 0.5-100 mg in single or divided doses. (p. 11 paragraph 123) Bindra et al. further exemplifies a 10 mg tablet as a dosage form for dapagliflozin. (p. 18 example 8) One of ordinary skill in the art would have therefore considered the dosage of dapagliflozin to be a result-effective variable, and would have found it to be obvious to determine the optimal dosage for this compound, for example at the value of 10 mg exemplified in the disclosure, rendering claim 109 obvious.
Regarding claims 110 and 111, A1c was seen to be associated with the development of diabetes, and therefore to be a risk factor to be taken into consideration. (p. 197 left column first paragraph) IT would have been obvious to one of ordinary skill in the art at the time of the invention to specifically identify the patient’s A1c level as part of the process of determining their risk of progression to diabetes. In particular this is especially true for claim 111, as an elevated A1c level would indicate increased risk of progression.
Regarding independent claim 117, this claim is directed to a method of preventing and/or delaying a fatal cardiovascular event in a patient with HFrEF who does not have type 2 diabetes, comprising administering dapagliflozin to the patient. This claim differs from claim 108 in that the condition being prevented or delayed is a fatal cardiovascular even rather than development of diabetes, however, in addition to the teachings of Bindra and Preiss described above, Preiss et al. describes diabetes as being a predictor of cardiovascular morbidity and mortality in patients with heart failure. (p. 915 right column first paragraph) Therefore it stands to reason that delaying or preventing the development of diabetes is reasonably considered to additionally accomplish delay or prevention of a fatal cardiovascular event in a portion of patients suffering from HFrEF. Therefore it would have been obvious to one of ordinary skill in the art to administer dapagliflozin to this patient population for the purpose of preventing or delaying cardiovascular death, according to claim 117 and also dependent claim 119.
Regarding claim 118, this claim recites the same dosage as claim 109 and is obvious for the same reasons given with respect to claim 109, in view of the fact that as discussed under 35 USC 112(d) this claim does not actually limit the scope of base claim 117.
Regarding claims 120-121, while the cited references do not specifically describe the claimed time ranges, Preiss et al. discloses that patients were followed for a median of 2.8 years. (p. 917 center column second paragraph) This indicates that delays of up to 24 months (2 years) are reasonably possible if the development of diabetes is prevented.
Regarding claim 122, p. 916 table 1 of Preiss discloses that about 50% of patients being studies had already suffered a myocardial infarction, indicating that this is a common finding in patients with HFrEF. Given the desirability of preventing diabetes and further cardiovascular events in these patients, it would have been obvious to one of ordinary skill in the art at the time of the invention to administer therapy as quickly as possible, for example immediately after such an event. Therefore the further limitation described by claim 122 is obvious.
Regarding claim 124, this claim requires that the method reduces worsening of heart failure symptoms in the patient during a period of 12-36 months. As discussed previously, Preiss discloses that diabetes is associated with wore outcomes in heart failure. (p. 919 left column last paragraph) Furthermore the study described by Preiss observed the development of new diabetes cases among the study population over a median follow up of 2.8 years, or 33.6 months. (p. 917 center column second paragraph) Since the development of diabetes would be expected to lead to a worsening of heart failure symptoms, it is reasonable to conclude that a treatment that delays or prevents the incidence of diabetes during this time, such as that described by Bindra, would reduce any worsening of heart failure symptoms during this time that would be attributable to the development or progression of diabetes.
Therefore the invention taken as a whole is prima facie obvious.
Response to Arguments: Applicant’s arguments, submitted February 25, 2026, with respect to the above grounds of rejection, have been fully considered and not found to be persuasive to remove the rejection. Applicant argues that the Office acknowledges that Bindra does not disclose the use of dapagliflozin in delaying the onset of diabetes. However, this statement is in error, and appears to be a misquotation of the statement earlier in the office action that Bindra “does not specifically describe delaying the onset or progression of type 2 diabetes in a patient suffering from heart failure with reduced ejection fraction.” This statement does not state or imply that Bindra does not teach delaying the onset or progression of type 2 diabetes in any patient, merely that the reference does not teach doing so for the specific subset of patients having heart failure with reduced ejection fraction. In fact, p. 3 paragraph 23 of Bindra includes the sentence, “In another embodiment, the invention provides the pharmaceutical formulation of the invention for use in delaying the progression or onset of type II diabetes.” Therefore it is clear that Bindra does in fact describe such a therapeutic effect as being achievable with dapagliflozin.
Applicant further argues that Bindra makes no mention of cardiovascular disease, and therefore one of ordinary skill in the art would not have a motivation to apply it to the disclosure of Preiss. Additionally, Applicant asserts that the fact that Preiss does not discuss the use of SGLT2 inhibitors for treating heart failure further means that Preiss does not suggest administering dapagliflozin to heart failure patients to reduce the risk of developing diabetes. However, the relevant fact in this case is that, as remarked upon in the body of the rejection, Preiss specifically describes that it would be desirable to identify patients with heart failure at risk of diabetes and take steps to reduce that risk. In this context, one of ordinary skill in the art would have taken “steps to reduce this risk,” as referring not only to specific agents mentioned in the disclosure of Preiss, but also to any therapies known in the art to have this effect, including the use of dapagliflozin as described by Bindra.
Claim 123 is rejected under 35 U.S.C. 103 as being unpatentable over Bindra et al. in view of Preiss et al. as applied to claims 108-111, 114, 115, 117, 118, 120-122, and 124 above, and further in view of Wang et al. (Reference of record in 1/11/2024 PTO-1449)
The disclosures of Bindra and Preiss are discussed above. Bindra in view of Preiss does not specifically describe a process wherein the patient suffers from acute decompensated heart failure. However, Wang et al. discloses that there is a large population of patients with acute decompensated heart failure in need of improved treatment. (p. 401 left column first three paragraphs) Wang et al. further discloses a population of patients having decompensated heart failure and reduced ejection fraction. (p. 401 right column first paragraph and “study designs and study population”) It would have been obvious to one of ordinary skill in the art at the time of the invention to apply the treatment protocol described by Bindra in view of Preiss to patients having acute decompensated heart failure as described by Wang et al. One of ordinary skill in the art would have been motivated to treat this patient population because they are a subset of the broader population of patients having HFrEF described by the primary reference.
Therefore the invention taken as a whole is prima facie obvious.
Response to Arguments: Applicant’s arguments, submitted February 25, 2026, with respect to the above grounds of rejection, have been fully considered and not found to be persuasive to remove the rejection. Applicant does not argue separately against this rejection, but rather relies upon the fact that claim 123 depends from claim 117, arguing that claim 123 is therefore patentable for the same reasons given with respect to the base claim. Therefore this argument is found to be not persuasive for the same reasons given previously with respect to the earlier rejection above.
Conclusion
No claims are allowed in this action. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREA OLSON whose telephone number is (571)272-9051. The examiner can normally be reached M-F 6am-3:00pm.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 4/30/2026
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