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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09 Feb 2026 has been entered.
This Office action is responsive to Applicant’s submission filed on 09 Feb 2026, in which the previously submitted amendment filed 26 Nov 2025 is entered, claims 4, 14, and 21 are amended to change the scope and breadth of the claim, and new claim 22 is added.
This application is a domestic application, filed 06 Oct 2023; claims benefit as a CON of 17/176,285, filed 16 Feb 2021, issued as PAT 11,826,378; and claims benefit of foreign priority document EP 20157761.6, filed 17 Feb 2020. This foreign priority document is in English.
Claims 1-14 and 16-22 are pending in the current application and are examined on the merits herein.
Rejections Withdrawn
Applicant’s amendment, filed 09 Feb 2026, with respect that claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite has been fully considered and is persuasive, as amended claim 14 does not recite the indicated exemplary claim language.
This rejection has been withdrawn.
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.
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.
Amended Claims 1-2, 5-11, 14, 16, 18, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over LAURING et al. (WO 2017/155841 A1, published 14 Sep 2017, provided by Applicant in IDS filed 30 Jan 2024) in view of Nair et al. (Drug Dev. Res., 2018, 18(79), p373-382, provided by Applicant in IDS filed 30 Jan 2024).
LAURING et al. teaches the use of certain SGLT-2 inhibitors, such as ertugliflozin or a pharmaceutically acceptable salt or a co-crystal thereof, for treating, reducing the risk of and/or preventing heart failure, myocardial infarction, cardiovascular disease or cardiovascular death in animals without type 2 or type I diabetes mellitus, or in animals with pre-diabetes, or in animals with type 2 or type I diabetes mellitus or pre-diabetes (abstract; page 4, lines 15-20), addressing claims 1-2 and where the method is characterized by lower levels of cardiac mortality and/or morbidity addressing claim 14. LAURING et al. teaches the embodiments where the SGLT-2 inhibitor is a glucopyranosyl-substituted benzene derivative
PNG
media_image1.png
147
267
media_image1.png
Greyscale
(page 2, line 15-25) or the specific SGLT2 inhibitor known as ertugliflozin, (page 4, lines 1-10) addressing limitations of claims 5-6. In one embodiment the ertugliflozin can exist as a co-crystal with L-proline (page 12, lines 5-10; page 40, line 5), addressing claims 7 and 16. In one embodiment the method is for treating a cardiovascular disease such as heart failure in an animal. (page 4, lines 15-20) The term animal includes humans and companion animals such as dogs, cats, and horses. (page 10, lines 25-30) LAURING et al. teaches the example of a dose administered once daily of 5 mg or 15 mg ertugliflozin to an animal, preferably a human (page 37, lines 10-15), addressing claim 11. In working examples the composition is formulated for oral administration (page 43, line 35; page 47, lines 10-15), addressing claim 9.
LAURING et al. does not specifically disclose the method of treatment of the cardiac disease of heart failure in a feline animal comprising administering the SGLT2 inhibitor to the feline animal and wherein the one or more SGLT-2 inhibitors are to be administered at a daily dose of 0.01 mg/kg bodyweight to 10 mg/kg bodyweight (claim 1); a daily dose of 0.5 mg/kg bodyweight to 10 mg/kg bodyweight (claim 21); or a daily dose of 0.5 mg/kg bodyweight to 1 mg/kg bodyweight (claim 22).
Nair et al. teaches appropriate translation and determination of the maximum recommended starting dose in human is a vital task in new drug development and research. Allometric scaling is the most frequently used approach for dose extrapolation based on normalization of dose-to-body surface area. The concept of estimating the first-in-human dose, interspecies scaling between species and the factors influencing the dose escalation were reviewed. (page 373, abstract) Nair et al. teaches the use of body surface area to translate dose between species is a classical approach, primarily because of the excellent correlation between the plasma volume/total circulating plasma protein in normal adults with the body surface area than determined with either height or weight. (page 376, left column, section 3.7) Nair et al. teaches translation of an animal equivalent dose (AED) based on a human dose is known. (page 377, left column, section 3.9) Nair et al. teaches data for dose conversion based on animal and human, where the human is estimated having average body weight 60 kg, and the dose conversion to cats is by multiplying the human dose in mg/kg by 1.9. (page 375, table 1)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine LAURING et al. in view of Nair et al. in order to select from within the teachings of LAURING et al. the method of treating the cardiac disease of heart failure in a cat comprising administering the SGLT2 inhibitor ertugliflozin and to convert the suggested human dose to a cat dose based on known conversion values taught by Nair et al. One of ordinary skill in the art would have been motivated to pick and choose to combine the teachings of LAURING et al. with a reasonable expectation of success because LAURING et al. teaches the animal treated includes companion animals such as cats. One of ordinary skill in the art would have been motivated to combine LAURING et al. in view of Nair et al. with a reasonable expectation of success because LAURING et al. teaches the method of treating the cardiac disease of heart failure in a cat comprising administering the SGLT2 inhibitor ertugliflozin is encompassed within the scope of the invention and provides guidance for picking and choosing the disease and animal treated according to the method taught therein, and Nair et al. teaches the translation of an animal equivalent dose (AED) based on a human dose is known. Regarding the dosage, LAURING et al. teaches the example of a dose administered once daily of 5 mg or 15 mg ertugliflozin to an animal, preferably a human, and the teachings of Nair et al. provides guidance to one of ordinary skill in the art to convert this to a dose of approximately 0.16 mg/kg or 0.475 mg/kg in a cat. Regarding claims 21 and 22, the teachings of LAURING et al. and Nair et al. suggest it would have been obvious to one of ordinary skill in the art to select the optimal or workable dose range through routine experimentation using the exemplary doses as a starting point. See also MPEP 2144.04, for example at I. providing “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close” and at II. providing ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)’ In this case LAURING et al. in view of Nair et al. suggest a dosage of 0.475 mg/kg in a cat that is close to the close to the claimed range, and LAURING et al. suggests the dose administered to be effective to perform the method as claimed.
Response to Applicant’s Remarks:
Applicant’s amendment and remarks, entered 09 Feb 2026, have been fully considered and not found to be persuasive.
Applicant again notes that LAURING et al. describes embodiments of the method of treatment wherein the subject is a human, and does not describe specific embodiments of the method of treatment of animals other than humans. Applicant further notes that the dosages within LAURING et al. are in amounts typically described for their preferred embodiments of the method of treatment wherein the subject is a human, and LAURING et al. discusses species-specific pathologies for their preferred embodiments wherein the subject is a human but does not describe species-specific pathologies known for cats. However, as detailed in the rejection of record, LAURING et al. specifically describes the invention as encompassing the treatment of animals such as cats. MPEP 2123 at II. provides “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).” In this case the examples or preferred embodiments of the method of treatment wherein the subject is a human does not teach away from the broader disclosure of non-exemplified or non-preferred embodiments taught within LAURING et al.
Applicant again remarks that appropriate translation and determination of the dose in humans from or to other animals is complex, and different factors such as pharmacokinetic different affect different mammal species. However, MPEP 2143.02 provides “Obviousness does not require absolute predictability, but at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976)” In this case Nair et al. itself and as a representative of the state of the pharmaceutical arts recognizing the applicability of animal models as equivalent models for humans suggests at least some degree of predictability would have been expected by one of ordinary skill in the art. Further, as detailed in the rejection of record, the combined teachings of the cited prior art are relied upon to suggest selecting the optimal or workable dose range through routine experimentation using the exemplary doses as a starting point. The conclusion of obviousness made in the rejection of above does not rely on absolute predictability, such as the disclosed human dose being absolutely predictive of the exact dose in a different animal species through a simple calculation. The complexity of the dose translation does not necessarily mean that it would not have been routine experimentation in this case.
As detailed above, LAURING et al. specifically describes the invention as encompassing the treatment of animals such as cats. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007) provides “[A] person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.” In this case, this embodiment taught within LAURING et al. and Nair et al. teaching the appropriate translation and determination of the dose in humans from or to other animals suggests this embodiment would have been within the technical grasp of one of ordinary skill in the art. If this leads to the success implied by LAURING et al. in describing this alternative embodiment of their invention, then it is likely that this embodiment of the method was the product not of innovation but of ordinary skill and common sense.
Amended Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over LAURING et al. (WO 2017/155841 A1, published 14 Sep 2017, provided by Applicant in IDS filed 30 Jan 2024) in view of Nair et al. (Drug Dev. Res., 2018, 18(79), p373-382, provided by Applicant in IDS filed 30 Jan 2024) as applied to claims 1-2, 5-11, 14, 16, 18, and 21, further in view of Ferasin et al. (Journal of Veterinary Cardiology, 2015, 17, pS173-S189, cited in PTO-892).
LAURING et al. in view of Nair et al. teaches as above.
LAURING et al. in view of Nair et al. does not specifically teach the one or more cardiac diseases comprises a clinical sign of heart failure selected from the group consisting of dyspnoea, tachypnoea, pleural effusion, pulmonary oedema, feline aortic thromboembolism (FATE) (claim 20).
Ferasin et al. teaches acute heart failure in cats represents a complex clinical situation in feline practice and this review has been designed to focus on the description of acute heart failure in cats, the diagnostic approach and clinical management of acutely decompensated feline cardiac patients (page S173, abstract). Ferasin et al. teaches as observed in humans and other animal species, the cardinal manifestations of HF in cats are dyspnoea and fatigue, which often limit exercise tolerance and interaction. However, exercise intolerance is frequently unnoticed in domestic cats because of their common sedentary life style. Consequently, signs of fluid retention (congestive failure) are often the only abnormalities observed by the owners, such as tachypnoea/dyspnoea secondary to pulmonary oedema and/or pleural effusion and abdominal enlargement caused by ascites (page S174, left column, paragraph 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine LAURING et al. in view of Nair et al. further in view of Ferasin et al. in order to select the subject treated to have clinical sign of heart failure. One of ordinary skill in the art would have been motivated to combine LAURING et al. in view of Nair et al. further in view of Ferasin et al. with a reasonable expectation of success because LAURING et al. teaches a method for treating heart failure, cardiovascular disease or cardiovascular death in animals such as cats, and Ferasin et al. teaches known clinical sign of heart failure in cats include tachypnoea/dyspnoea secondary to pulmonary oedema and/or pleural effusion, suggesting it would have been obvious to one of ordinary skill in the art to select the animal treated to have known clinical signs of the disease.
Response to Applicant’s Remarks:
Applicant’s amendment and remarks, entered 09 Feb 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks regarding LAURING et al. in view of Nair et al. are addressed as above.
Amended Claims 1-2, 5-12, 14, 16-18, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over LAURING et al. (WO 2017/155841 A1, published 14 Sep 2017, provided by Applicant in IDS filed 30 Jan 2024) in view of Nair et al. (Drug Dev. Res., 2018, 18(79), p373-382, provided by Applicant in IDS filed 30 Jan 2024) and Reiche et al. (US 2015/0164856, published 18 Jun 2015, provided by Applicant in IDS filed 30 Jan 2024).
LAURING et al. teaches as above. LAURING et al. teaches the mode of action of SGLT-2 inhibitors is independent of insulin secretion, that the effects of the SGLT-2 inhibitor empagliflozin on cardiovascular morbidity and mortality in animals with type 2 diabetes at high cardiovascular risk are significantly lower rates of death from cardiovascular causes, hospitalization for heart failure, and death from any cause, and the biomarker effects of SGLT-2 inhibitors in diabetics are similar to those in non-diabetics. (LAURING et al. page 1, lines 25-35) LAURING et al. teaches since the biomarker effects of SGL T-2 inhibitors in diabetics are similar to those in non-diabetics, the effects on cardiovascular morbidity and mortality in animals type 2 diabetes at high cardiovascular risk attributed to SGLT-2 inhibitors may extend to animals without type 2 diabetes but still are at high cardiovascular risk.(page 2, lines 15-20)
LAURING et al. does not specifically teach the method of treatment of the cardiac disease of heart failure in a feline animal comprising administering the SGLT2 inhibitor empagliflozin administered at a daily dose of 0.01 mg/kg bodyweight to 10 mg/kg bodyweight (claim 1); a daily dose of 0.5 mg/kg bodyweight to 10 mg/kg bodyweight (claim 21); or a daily dose of 0.5 mg/kg bodyweight to 1 mg/kg bodyweight (claim 22). LAURING et al. does not specifically teach the co-crystal of the SGLT2 inhibitor, L-proline and crystalline water. (claim 17)
Nair et al. teaches as above.
Reiche et al. teaches one or more SGLT2 inhibitors or pharmaceutically acceptable forms thereof for use in the treatment and/or prevention of a metabolic disorder in a feline animal. (abstract) Reiche et al. discloses the one or more SGLT2 inhibitors is 1-cyano-2-(4-cyclopropyl-benzyl)-4-(B-D-glucopyranos-1-yl)-benzene or a pharmaceutically acceptable form thereof, referred to as compound A, (page 2, paragraphs 22-23) or the compound named velagliflozin. Reiche et al. discloses the pharmaceutically acceptable form of the one or more SGLT2 inhibitors may be a crystalline complex between the one or more SGLT2 inhibitors and one or more amino acids, such as proline, preferably L-proline, (page 2, paragraph 25; page 11, paragraph 156; page 12, paragraphs 172-183) addressing limitations of claims 7 and 16. In a preferred embodiment the crystalline complex, in the particular the 1:1 complex of said SGLT2 inhibitor with L-proline, is a hydrate, (page 12 paragraphs 176-178) addressing limitations of claim 17. Reiche et al. discloses the compound administered in dosages of 0.1 to 3.0 mg/kg body weight per day, preferably from 0.2 to 2.0 mg/body weight per day, more preferably from 0.1 to 1 mg/body weight per day, (page 2, paragraph 27; page 15, paragraph 220) addressing limitations of claims 10 and 12. Reiche et al. discloses the working example of pharmacokinetic study of compound A administered to overnight fasted cats at a dose of 0.01 mg/kg, 0.1 mg/kg and 1 mg/kg. (page 16, paragraph 245)
It would have been obvious to one of ordinary skill in the art before the time the invention was filed to combine LAURING et al. in view of Nair et al. and Reiche et al. in order to select the method of treating the cardiac disease of heart failure in a cat comprising administering the SGLT2 inhibitor as a crystalline complex with L-proline or the SGLT2 inhibitor velagliflozin and to convert the suggested human dose to a cat dose based on known conversion values taught by Nair et al. One of ordinary skill in the art would have been motivated to combine LAURING et al. in view of Nair et al. and Reiche et al. with a reasonable expectation of success because LAURING et al. teaches the method of treating the cardiac disease of heart failure in a cat comprising administering an SGLT2 inhibitor and provides guidance for picking and choosing the disease and animal treated according to the method taught therein, suggests the mechanism of action to reduce cardiovascular morbidity and mortality is by SGLT2 inhibition, and suggests the SGLT2 inhibitor empagliflozin is also known to reduce cardiovascular morbidity and mortality; Nair et al. teaches the translation of an animal equivalent dose (AED) based on a human dose is known; and Reiche et al. teaches effective administration of SGLT2 inhibitor such as ertugliflozin, empagliflozin, or velagliflozin to a feline animal. Regarding the dosage, LAURING et al. teaches the example of a dose administered once daily of 5 mg or 15 mg ertugliflozin to an animal, preferably a human, Nair et al. provides guidance to one of ordinary skill in the art to convert this to a dose of approximately 0.16 mg/kg or 0.475 mg/kg in a cat, and Reiche et al. provides guidance for a similar dosage in a cat for effective administration of SGLT2 inhibitor. Therefore one of ordinary skill in the art would have had a reasonable expectation of success to substitute known equivalent SGLT2 inhibitors in order to reduce cardiovascular morbidity and mortality such as for the method of treating the cardiac disease of heart failure in a cat. See MPEP 2144.06 at II providing “An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)” In this case the SGLT-2 inhibitor empagliflozin is known to reduce cardiovascular morbidity and mortality in animals with type 2 diabetes at high cardiovascular risk and that the mechanism of action for this is by SGLT-2 inhibition, suggesting that substituting equivalent SGLT-2 inhibitors would have been obvious to one of ordinary skill in the art.
Response to Applicant’s Remarks:
Applicant’s amendment and remarks, entered 09 Feb 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks regarding LAURING et al. in view of Nair et al. are addressed as above.
Amended Claims 3-4, 13, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over LAURING et al. (WO 2017/155841 A1, published 14 Sep 2017, provided by Applicant in IDS filed 30 Jan 2024) in view of Nair et al. (Drug Dev. Res., 2018, 18(79), p373-382, provided by Applicant in IDS filed 30 Jan 2024) and Reiche et al. (US 2015/0164856, published 18 Jun 2015, provided by Applicant in IDS filed 30 Jan 2024) as applied to claims 1-2, 5-12, 14, 16-18, and 21-22, and further in view of Kaplan et al. (Heart Failure Reviews, 2018, 23, p419-437, provided by Applicant in IDS filed 30 Jan 2024) and Freeman et al. (Cardiol. Res., 2017, 8(4), p139-142, provided by Applicant in IDS filed 30 Jan 2024).
LAURING et al. in view of Nair et al. and Reiche et al. teaches as above. LAURING et al. further teaches regarding biomarker effects of SGLT-2 inhibitors both diabetic and non-diabetic populations experience increases in urinary glucose excretion and an osmotic diuretic effect. (LAURING et al. page 2, lines 1-5)
LAURING et al. in view of Nair et al. and Reiche et al. does not specifically teach the method where the one or more cardiac diseases is hypertrophic cardiomyopathy or heart failure due to hypertrophic cardiomyopathy. (claims 3-4) LAURING et al. in view of Nair et al. and Reiche et al. does not specifically teach the method wherein the one or more SGLT-2 inhibitors are to be administered before, after or concomitantly with administering one or more other active pharmaceutical ingredients as claimed (claim 13 and 19).
Kaplan et al. teaches although interest in the study of various SGLT isoforms and the effect of their inhibition on cardiovascular function extends over the past 20 years, an explanation of the effects observed clinically based on available experimental data is not forthcoming. (abstract) Kaplan et al. teaches an exciting aspect of sodium-glucose cotransporter 2 inhibitors (SGLT2i) therapeutic effect in type 2 diabetes (T2D) patients is potential direct cardioprotection independently of glycemic control. SGLT2i, empagliflozin (Empa), is the first drug to display significant cardioprotection in clinical trials with a clear reduction in CV mortality and hospitalization due to heart failure within the first 3 months of initiating the treatment. Speculations on the basis of such effects included a role for the observed reduction of BP, body weight, and increased diuretic effects. (page 420, right column, paragraph 2; page 421, EMPA-REG Outcome Trial Summary) Kaplan et al. teaches some potential molecular mechanisms through which SGLT2i can facilitate this cardioprotective effect. (page 422, figure 1) Diabetes is associated with 2- to 4-fold increase in the risk for cardiovascular disease. Heart failure is preceded by metabolic and mitochondrial dysfunction, oxidative stress, and cardiac myocytes death that are exacerbated in T2D patients with no defined mechanisms. (page 422, left column, paragraph 2) Metabolically, one possible explanation for SGLT2 inhibition-mediated cardioprotective effects is ketone bodies formation. Multiple experimental studies showed that β-hydroxybutyrate, a ketone body, competes with FFA and glucose entry into cardiac mitochondrial metabolic oxidation with higher energy efficiency and lower myocardial oxygen consumption. (page 426, right column) There is consensus that SGLT2i direct effects on the myocardium (Table 1) are independent of SGLT2i-mediated systemic effects (Table 2), and together direct and systemic effects potentiate SGLT2 inhibition cardioprotective outcomes (Fig. 1). Kaplan et al. teaches exploring the effects of these drugs in pre-diabetic or non-diabetic individuals with other forms of metabolic impairment and at high risk of CVD is also warranted. (page 430, paragraph spanning left and right column)
Freeman et al. teaches hypertrophic cardiomyopathy (HCM) is a common disease in pet cats. The similarity to human HCM, the rapid progression of disease, and the defined and readily determined endpoints of feline HCM make it an excellent natural model that is genotypically and phenotypically similar to human HCM. (page 139, abstract) HCM occurs spontaneously and frequently in pet cats, and the feline disease is remarkably similar to the human disease. The most common presentations in cats are sudden death or syncope, congestive heart failure (CHF), and arterial thromboembolism (ATE). Once diagnosed with HCM, most cats eventually die from CHF, sudden death, or ATE, while a smaller proportion remains subclinical. (page 140, paragraph spanning left and right columns). As in humans, despite advances in the understanding of HCM, no preclinical therapy has demonstrated the ability to slow disease progression or reduce ventricular hypertrophy in cats. The most commonly employed therapies include cardioprotective strategies. (paragraph spanning pages 140-141) In cats with HCM and congestive heart failure (CHF), the above-mentioned treatments are expanded to include diuretics, such as furosemide. (page 141, left column, paragraph 2) Freeman et al. teaches studying HCM in cats with naturally occurring disease can enhance translational efficiency and effectiveness between basic science research and human clinical trials. At the same time, discoveries in humans can spur advances in the treatment of cats with this disease. (page 141, right column, paragraph 3)
It would have been obvious to one of ordinary skill in the art before the time the invention was filed to combine LAURING et al. in view of Nair et al. and Reiche et al. further in view of Kaplan et al. and Freeman et al. in order to modify the method of treatment to be the treatment of cardiac diseases in a feline that is a non-diabetic cat. One of ordinary skill in the art would have been motivated to combine LAURING et al. in view of Nair et al. and Reiche et al. further in view of Kaplan et al. and Freeman et al. further in view of Kaplan et al. and Freeman et al. with a reasonable expectation of success because all of LAURING et al., Reiche et al., and Kaplan et al. are drawn to methods of treatment with an SGLT2 inhibitor; both LAURING et al. and Reiche et al. teaches the method of treatment of a feline animal using the SGLT2 inhibitor; Reiche et al. teaches the method of treatment of a feline animal using the SGLT2 inhibitor velagliflozin; both LAURING et al. and Kaplan et al. suggests SGLT2 inhibitors act by direct cardioprotection independently of glycemic control, teach exploring the effects of these drugs in non-diabetic individuals, and teach SGLT2 inhibitors have diuretic effects; and Freeman et al. teaches HCM is a common disease in pet cats, is similar to human HCM, suggests advances in the treatment can be shared between human and cats, and teaches in cats with HCM and congestive heart failure (CHF), the above-mentioned treatments are expanded to include diuretics, such as furosemide. Therefore one of ordinary skill in the art would have put together the teachings of LAURING et al. in view of Nair et al. and Reiche et al. further in view of Kaplan et al. and Freeman et al. like pieces of a puzzle to arrive at a method of treating a cardiac diseases of HCM and congestive heart failure in a feline that is a non-diabetic cat.
Response to Applicant’s Remarks:
Applicant’s amendment and remarks, entered 09 Feb 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks regarding LAURING et al. in view of Nair et al. are addressed as above.
Applicant notes that Kaplan describes the cardioprotective effect of the SGLT2 inhibitor empagliflozin in clinical trials for human patients. However Reiche et al. as relied upon in the above rejection teaches one or more SGLT2 inhibitors or pharmaceutically acceptable forms thereof for use in the treatment and/or prevention of a metabolic disorder in a feline animal. This teaching in combination with the teaching of LAURING et al. that certain SGLT-2 inhibitors can be used for treating heart failure or cardiovascular disease in animals without type 2 or type I diabetes mellitus reasonably suggests to one of ordinary skill in the art that the activity of SGLT2 inhibitors applies to both humans and other animals such as cats. Therefore one of ordinary skill in the art would have reasonable expected the teachings of Kaplan to be applicable to humans and other animals such as cats based on these combined teachings of the prior art.
Applicant appears to interpret the reliance on the teachings of Freeman et al. as forming the nexus between human clinical trials of Kaplan et al. and cats. However, as discussed above regarding LAURING et al. in view of Nair et al., the primary reference LAURING et al. teaches the invention as encompassing the treatment of animals such as cats, and the examples or preferred embodiments of the method of treatment wherein the subject is a human does not teach away from the broader disclosure of non-exemplified or non-preferred embodiments taught within LAURING et al. In this case the teachings of Freeman et al. are relied upon to explain why one of ordinary skill in the art would have selected the treatment of specifically HCM in cats as a type of cardiovascular disease treated within the scope of LAURING et al. With respect to the combination of the teachings of Freeman et al. and the above cited prior art, the teachings of Reiche et al. and Kaplan et al. are relied on to support the finding that one of ordinary skill in the art would have had a reasonable expectation of success in selecting the treatment of specifically HCM in cats as a type of cardiovascular disease treated within the scope of LAURING et al. because of the expectation that SGLT2 inhibitors would have been expected to have a cardioprotective effect including in cats.
Applicant again remarks that the examiner's conclusion of obviousness is based upon improper hindsight reasoning. As previously discussed, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As detailed in the rejection of record, the teachings are “put together… like pieces of a puzzle to arrive at a method of treating a cardiac diseases of HCM and congestive heart failure in a feline that is a non-diabetic cat“ based on the chain of reasoning set forth therein. That chain of reasoning relies only on knowledge that was taught by the cited prior art and was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, therefore such a reconstruction is proper.
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.
Amended Claims 1-14, 16, 18-19, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,826,378 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because Reference claims 1-17 of the reference patent are drawn to a method of treatment of one or more of hypertrophic cardiomyopathy (HCM) and heart failure due to hypertrophic cardiomyopathy (HCM) in the feline animal comprising administering to the feline animal Velagliflozin administered to the feline animal at a dose of 0.01 mg/kg bodyweight to 10 mg/kg bodyweight. Reference claims 3 and 6 recites the dose of 0.1 mg/kg bodyweight to 1 mg/kg bodyweight corresponding to claim 12. Reference claim 7 corresponds to claim 18. Reference claims 8-9 correspond to claim 9. Reference claim 10-11 correspond to claims 7 and 16. Reference claim 12 corresponds to claim 11. Reference claim 13 corresponds to claim 14. Reference claims 14-16 correspond to claims 13 and 19.
Regarding claims 21-22, Reference claims 3 and 6 recites the dose of 0.1 mg/kg bodyweight to 1 mg/kg bodyweight. It would have been obvious to one of ordinary skill in the art to select the optimal or workable dose range through routine experimentation using the claimed dose range as a starting point. See also MPEP 2144.04, for example at I. providing “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)” and at II. providing ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)’ In this case the claimed range lies inside the ranges disclosed in the Reference claims, and further it would have been routine experimentation for one of ordinary skill in the relevant art as shown herein to discover the optimum or workable range.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 09 Feb 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks note a terminal disclaimer can be filed, however as no terminal disclaimer is currently of record it is proper to maintain this rejection.
Amended Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,826,378 (reference patent) in view of Reiche et al. (US 2015/0164856, published 18 Jun 2015, provided by Applicant in IDS filed 30 Jan 2024).
Reference claims 1-17 recite as above.
Reference claims 1-17 do not specifically recite the method wherein the co-crystal of the SGLT2 inhibitor, L-proline and crystalline water. (claim 17)
Reiche et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-17 in view of Reiche et al. in order to select the crystalline complex between Velagliflozin and L-proline to be the co-crystal of the SGLT2 inhibitor, L-proline and crystalline water. One of ordinary skill in the art would have been motivated to combine Reference claims 1-17 in view of Reiche et al. with a reasonable expectation of success because both Reference claims 1-17 in view of Reiche et al. teach the method comprising Velagliflozin administered to cats, both Reference claims 1-17 in view of Reiche et al. teach the Velagliflozin can be a co-crystal with L-proline, and Reiche et al. teaches in a preferred embodiment the crystalline 1:1 complex of Velagliflozin with L-proline is a hydrate, providing guidance to select the crystalline complex between Velagliflozin and L-proline of the method of Reference claims 1-17 to be the co-crystal hydrate.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 09 Feb 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks note a terminal disclaimer can be filed, however as no terminal disclaimer is currently of record it is proper to maintain this rejection.
Amended Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,826,378 (reference patent) in view of Ferasin et al. (Journal of Veterinary Cardiology, 2015, 17, pS173-S189, cited in PTO-892).
Reference claims 1-17 recite as above as applied to claims 1-14, 16, 18-19, and 21.
Reference claims 1-17 do not specifically teach the one or more cardiac diseases comprises a clinical sign of heart failure selected from the group consisting of dyspnoea, tachypnoea, pleural effusion, pulmonary oedema, feline aortic thromboembolism (FATE) (claim 20).
Ferasin et al. teaches acute heart failure in cats represents a complex clinical situation in feline practice and this review has been designed to focus on the description of acute heart failure in cats, the diagnostic approach and clinical management of acutely decompensated feline cardiac patients (page S173, abstract). Ferasin et al. teaches as observed in humans and other animal species, the cardinal manifestations of HF in cats are dyspnoea and fatigue, which often limit exercise tolerance and interaction. However, exercise intolerance is frequently unnoticed in domestic cats because of their common sedentary life style. Consequently, signs of fluid retention (congestive failure) are often the only abnormalities observed by the owners, such as tachypnoea/dyspnoea secondary to pulmonary oedema and/or pleural effusion and abdominal enlargement caused by ascites (page S174, left column, paragraph 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-17 in view of Ferasin et al. in order to select the subject treated to have clinical sign of heart failure. One of ordinary skill in the art would have been motivated to combine Reference claims 1-17 in view of Ferasin et al. with a reasonable expectation of success because Reference claims 1-17 recite a method for treating heart failure due to hypertrophic cardiomyopathy (HCM) in the feline animal, and Ferasin et al. teaches known clinical sign of heart failure in cats include tachypnoea/dyspnoea secondary to pulmonary oedema and/or pleural effusion, suggesting it would have been obvious to one of ordinary skill in the art to select the animal treated to have known clinical signs of the disease.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 09 Feb 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks note a terminal disclaimer can be filed, however as no terminal disclaimer is currently of record it is proper to maintain this rejection.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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, Scarlett Goon can be reached at (571)270-5241. 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.
/JONATHAN S LAU/Primary Examiner, Art Unit 1693
Prosecution Insights