DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Preliminary amendment filed on 07/30/2024 has been entered. Claim 3 is cancelled. Claims 1, 2, and 4-25 are pending in this application and are currently under examination.
Priority
This is US Application No. 18/666,922 filed on 05/17/2024 and claims foreign priority of EP 23175200.7 filed on 05/24/2023.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
Fourteen information disclosure statements (IDS) filed on 09/18/2024, 08/08/2025, 01/29/2026, 03/25/2026, and 06/09/2026 with appropriate assertion under 37 CFR 1.98 have been considered.
Claim Objections
Claims 1, 2, 5, 8, 11, and 21 are objected to because of the following informalities: In claim 1, insert the missing phrase “in need thereof,” immediately after the recitation “a non-human mammal” (line 2) because not everyone requires the treatment. In claim 2, delete the excessive recitation “particular” (line 6). In claim 5, change the incorrect recitation “is as” (line 5) to “is a”. In claim 8, change the incorrect recitation “The one or more SGLT-2 inhibitors or pharmaceutically acceptable forms thereof in combination with telmisartan or pharmaceutically acceptable forms thereof for use according to claim 1” (lines 1 to 3) to “The method according to claim 1” to comply with the preceding claim; replace the incorrect recitation “derivative of the formula” (for formulas (1), (12), (14), and (15)), which means derivatizing the formula, with “derivative having the formula”; change the incorrect recitation “represented by” (a total of 20 occurrences), which means one of many, to “having”; delete the excessive label “(7-1)” next to structure of formula (12); insert the phase “of the formula (14)” immediately after the recitation “wherein R” (line 3 in the (14) paragraph) to differentiate from the preceding “R” in formula (12); change the incorrect recitation “tert. Butyl” (line 4 in the (14) paragraph) to “tert-butyl”; insert the phrase “of the formula (15) immediately after the recitation “R1” (line 4 in the (15) paragraph) to differentiate from the preceding “R1” in formula (1); insert the phrase “of the formula (18) immediately after the recitation “R3” (line 4 in the (18) paragraph) to differentiate from the preceding “R3” in formula (1); change the incorrect conjunction “and” (line 1 on page 9) before the last substituent in the (18) paragraph to “or” because the “and” indicates a combination of all substituents; replace the burry structure of formula (20) with a legible structure; and change the incorrect structure “
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“, which is not Rongliflozin, in the (21) paragraph to “
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”. In claim 11, spell out abbreviated “CDK” (line 6) to “chronic kidney disease (CKD)”. In claim 21, spell out the abbreviated “SDMA” (line 7) to “symmetric dimethyl arginine (SDMA)”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, and 4-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of one or more renal diseases and/or hypertension in a non-human mammal in need thereof, does not reasonably provide enablement for prevention of one or more renal diseases and/or hypertension in a non-human mammal in need thereof. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or to use the invention commensurate in scope with these claims. Claims 2, 4, 5, 8-10, 15-20, 22, and 23 depend from claim 1.
Applicants claim a method of prevention of one or more renal diseases and/or hypertension in a non-human mammal (or a cat or dog; or provides a preventive therapeutic effect), recited in claims 1, 6, 7, 11-14, 21, and 24. However, no limiting definition of “preventing" or “prevention” is given in the instant Specification. In the absence of a limiting definition by the Applicants, "prevention" as described according to the Institute for International Medical Education (pages 15 and 16, also listed in IDS filed on 06/09/2026), is a preventive measure, such as preserving physical fitness in primary prevention and effective intervention to correct departures from good health in secondary prevention. More specifically, tertiary prevention, which is most relevant as used in the context of the instant invention, "consists of the measures available to reduce or eliminate long-term impairments and disabilities, [and to] minimize suffering caused by existing departures from good health". Thus, the claimed method of prevention of one or more renal diseases and/or hypertension in a non-human mammal as interpreted by a skilled practitioner of the medical or pharmaceutical arts would be to reduce for long-term the occurrence of or to eliminate one or more renal diseases and/or hypertension in a non-human mammal by the method.
The Applicant's attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: The rejected invention is drawn to A method of prevention and/or treatment of one or more renal diseases and/or hypertension in a non-human mammal (or a cat or dog) comprising administering (or provides a preventive and/or therapeutic effect) to the nonhuman mammal a pharmaceutical composition comprising one or more SGLT-2 inhibitors or a pharmaceutically acceptable form thereof to the non-human mammal (claims 1, 6, 7, 11-14, 21, and 24).
Relative skill of those in the art: The relative skill of those in the art is from biomedical field (see the cited reference below).
Breadth of claims: The claim is extremely broad in that it encompasses the prevention of one or more renal diseases in a non-human mammal using the claimed method.
State of the prior art/Predictability or unpredictability of the art: There is no teaching or suggestion in the state of the prior art that application of certain pharmaceutical method can prevent one or more renal diseases in a non-human mammal. Adeghate et al. (EXPERT OPINION ON INVESTIGATIONAL DRUGS 2019, VOL. 28, NO. 9, 811–820, also listed in IDS filed on 06/09/2026) disclosed that SGLT1 and 2 inhibitors cause significant reductions in body weight, blood pressure, and HbA1c level. SGLT2-induced reduction in cardiovascular and renal events in T2DM patients with well-established CVD and kidney disease, is an added advantage for this class of hypoglycemic agents. Canagliflozin showed a significantly lower risk of cardiovascular illness coupled with a marked reduction in the rate of hospitalization for heart and kidney failure. Empagliflozin can reduce cardiovascular death risks by as much as 38% and delay the progression of chronic kidney disease in T2DM patients with or without cardiac failure. Ertugliflozin was safe in patients with chronic renal disease. Moreover, infections of the urinary and genital tracts were not markedly different between treated and placebo groups (page 812. Left col., Article Highlights; page 813, right col., para. 1-3). One of skilled artisan would understand that contemporary treatment or management of renal diseases and/or hypertension by SGLT-2 inhibitors is to minimize disease progression or symptoms, not to prevent, renal diseases and/or hypertension.
Amount of guidance/Existence of working examples: It is worth noting that there are no working examples in the instant application to show that the claimed method is effective for preventing one or more renal diseases and/or hypertension in a non-human mammal as recited in the claim. The exemplary embodiments of the Specification merely present: EXAMPLE 1 and 3 (cats) and EXAMPLE 2 and 4 (dogs): The results of the clinical field trial show a significant and clinically relevant delay in progression of renal disease and/or hypertension, delay of onset of hypertension with renal disease (p. 43/58 to 46/58).
Quantity of experimentation: In order to practice the full scope of the invention, one skilled in the art would need to undertake a novel and extensive research program to show that a preventive measure can be achieved after applying the claimed method. Furthermore, one of ordinary skill in the art would need to test a representative number of animals before one of ordinary skill in the art would be able to conclude that any method can be used to prevent one or more renal diseases and/or hypertension in a non-human mammal. Because this research would have to be exhaustive, and because it would involve such a wide and unpredictable scope of use in prevention of one or more renal diseases and/or hypertension in a non-human mammal, it would constitute an undue and unpredictable experimental burden.
Lack of a working example is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art. See MPEP § 2164. Genetech, 108 F.3d at 1366, states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable".
Therefore, in view of the Wands factors as discussed above, including the amount of guidance provided and the predictability of the art and the lack of working examples to practice the full scope of the claimed invention herein, a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-9 and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 7, 9, and 21, the phrase "such as", “i.e.”, or “e.g.” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). To advance the prosecution, the broadest reasonable interpretation is given to the genus before the recitation “such as”, “i.e.”, or “e.g.”.
Claim 7 recites “elevated blood pressure (BP) induced by medicaments, by glucocorticoids, mineralocorticoids, erythropoiesis-stimulating agents, ephedrine and/or high dose sodium chloride” (lines 7-9), in which the conjunction “and” would combine the broad recitation “medicaments” and narrow recitation, for example, “glucocorticoids”, and would be confusing. Applicant is advised to change the recitation “and/or” (last line) to “or”.
Claim 8 recites “derivative” (in the fourth line from the end of (1) and (18) paragraphs), in which the “derivative” is not defined and thus the metes and bounds of the term is not clear. Applicant is advised to change the recitation to “a structural derivative”.
Claim Rejections - 35 USC § 102/103
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.
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.
(I) Claims 1, 2, and 4-24 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hadd et al. (WO 2021/092341published on May 14, 2021, hereinafter referred to as Hadd ‘341, also listed in IDS filed on 09/18/2024).
With regard to structural limitations “a method comprising administering (orally or parentally; or once or twice per day; or before, after or concomitantly with one or more other active ingredients or ACE inhibitors) to a non-human mammal (or a feline or cat; or a canine or dog) in need treatment of one or more renal diseases (or glomerulopathy, polycystic kidney disease, chronic kidney disease, or proteinuria) or hypertension (or systemic hypertension; or associated with chronic kidney disease) a pharmaceutical composition comprising one or more SGLT-2 inhibitors (or a glucopyranosyl-substituted benzene derivative having the formula (1); or Velagliflozin (
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), Dapagliflozin, Canagliflozin, Empagliflozin, Luseogliflozin, Tofogliflozin, Ipragliflozin, Ertugliflozin, Atigliflozin, Remogliflozin, Sotagliflozin, Sergliflozin, Bexagliflozin, or Janagliflozin; or at a dose of 0.01 to 10 mg/kg bodyweight; or consisting of velagliflozin one or twice per day at a dose of 0.01 to 1 mg/kg bodyweight) or a pharmaceutically acceptable form thereof (or a crystalline complex with one or more amino acid or proline) in combination with telmisartan (or at a dose of about 0.01 to about 10 mg/kg of bodyweight; or one or twice per day; or further comprising measuring the systolic blood pressure (SBP))” (claims 1, 2, 4-20, and 22-24):
Hadd ‘341 disclosed a method of using sodium-glucose linked transporter (SGLT) inhibitors in the management of hypertension, renal disease (e.g., chronic kidney disease) or heart failure in companion animals (in particular, felines and canines). SGLT inhibitors are atigliflozin, bexagliflozin, canagliflozin, dapagliflozin, empagliflozin, enavogliflozin, ertugliflozin, henagliflozin, ipragliflozin, janagliflozin, licogliflozin, luseogliflozin, mizagliflozin, remogliflozin, sergliflozin, sotagliflozin, tianagliflozin and tofogliflozin. In addition, velagliflozin is being developed for the management of animal forms of diabetes and related morbidities. The use of all conformational or optical isomers and other mixtures of such isomers, as well as solvates, hydrates, isomorphs, polymorphs, co-crystals and tautomers are within the scope. In some embodiments, the compound that inhibits an SOLT or the prodrug thereof has a structure selected from the group consisting of:
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. Feline and canine CKD are managed pharmacologically by very similar strategies. The angiotensin II receptor blocker (ARB) telmisartan produced a reduction in the urinary protein to creatinine ratio that was significant at all time points. The management of feline CKD recommended by IRIS emphasizes control of hypertension in stage 1 disease by the CCB amlodipine or the ARB telmisartan. Other medications predominantly consist of ACE inhibitors and ARBs, which respectively prevent the formation of angiotensin II and block its effect on angiotensin II receptor 1. These medications reduce blood pressure and are renoprotective (pages 27/97 to 28/97, [0114, 0116]; page 45/97 to 48/97, [0157, 0160]; pages 13/97 to 15/97, [0048, 0049, 0053]). In some aspects, provided herein are methods for the treatment of chronic kidney disease (CKD) in a companion animal, comprising administering to a subject in need thereof a therapeutically effective amount of a compound that inhibits a sodium-dependent glucose transporter (SGLT) or a prodrug thereof. In some embodiments, the companion animal is preselected to have heart failure. In some embodiments, the companion animal is preselected to be hypertensive. Said treating can decrease the amount of symmetric dimethylarginine (SDMA) in the blood of the companion animal. Companion animals include domestic animals preferably including canines (dogs), felines (cats), equidae (horses). In some embodiments, the therapeutically effective amount administered to a canine is a total daily dosage of about 10-4,000 μg kg-1 of the compound that inhibits an SGLT or the prodrug thereof or a total daily dosage selected from the group consisting of about 50 μg kg-1, 100 μg kg-1, 200 μg kg-1, 400 μg kg-1, 800 μg kg-1, 1,000 μg kg-1. In some embodiments, the therapeutically effective amount is one-time daily. In some embodiments, the therapeutically effective amount is two-times (twice) daily. In some embodiments, the therapeutically effective amount is an oral liquid dosage form. Combination therapy is also contemplated herein. In some embodiments, a companion animal with heart failure, hypertension, or chronic kidney disease receives an additional therapeutic agent. The additional therapeutic agent includes, angiotensin-converting enzyme inhibitors (ACE inhibitors, such as enalapril, lisinopril and benazepril); angiotensin receptor blockers (such as valsartan and telmisartan). Administration of a compound can be achieved in various ways, including oral, buccal, parenteral, intravenous, intradermal (e.g., subcutaneous, intramuscular), transdermal. (pages 54/97 to 55/97, [0171, 0174, 0178]; pages 58/97 to 61/97, [0189, 0191, 0198, 0199, 0201, 0203]). Doses of bexagliflozin in the form of a proline co-crystal consisting of two moles of L-proline for every mole of bexagliflozin. The co-crystal was dissolved in 10% PEG400 and administered by oral gavage. (page 67/97 to 68/97, [0222]). Proteinuria is a manifestation of renal disease and the degree of proteinuria is a measure of disease severity. A meta-analysis of the effects of the SGLT2 inhibitors canagliflozin, dapagliflozin or empagliflozin that showed that SGLT2 inhibition decreased the likelihood of dialysis, transplantation, or death from renal disease by 33% compared to placebo. Exemplary etiology of CKD includes, cardiovascular diseases, hypertension, diabetes, glomerulonephritis, polycystic kidney diseases, and kidney graft rejection (pages 11/97 to 12/97, [0040, 0044]; page 27/97, [0110]). A subject's blood pressure is recorded as the systolic pressure (heart contraction) in mm Hg followed by the diastolic pressure (heart relaxation) in mm Hg (page 27/97, [0111]).
Thus, these teachings of Hadd ‘341 anticipate Applicant’s claims 1, 2, and 4-24 because (a) the same gliflozin compounds and therapeutically effective amounts along with angiotensin II receptor blocker (ARB) telmisartan are used clinically or routinely for treating chronic kidney disease or associated hypertension in a cat or dog, and (b) co-crystal of the gliflozin compound is also disclosed and exemplified by bexagliflozin in the form of a proline co-crystal, and thus teachings of Hadd ‘341 meet all structural limitation of claimed method would also achieve the intended results, including “one or more of the following clinical and/or biochemical parameters: improved renal efficiency, characterized by a reduction of proteinuria…delayed onset of hypertension… higher quality of life”, required by claim 21. Or, in an alternative, an effective amount of telmisartan is readily optimized according to clinical practice.
(II) Claims 1, 2, 4, 6-8, 11, 15, 16-19, and 21-25 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Jia et al. (WO 2022/036506, published on February 24, 2022, English version of the family US 2023/0346817 was used here, hereinafter referred to as Jia ‘506, also listed in IDS filed on 09/18/2024).
With regard to structural limitations “a method comprising administering (orally or parentally; or once or twice per day; concomitantly with one or more other active ingredients or ACE inhibitors) to a non-human mammal (or a canine or dog) in need treatment of one or more renal diseases (or chronic kidney disease, or proteinuria) or hypertension (or systemic hypertension; or associated with chronic kidney disease) a pharmaceutical composition comprising one or more SGLT-2 inhibitors (or a glucopyranosyl-substituted benzene derivative having the formula (1); or Dapagliflozin, Canagliflozin, Empagliflozin, Luseogliflozin, Tofogliflozin, Ipragliflozin, Ertugliflozin, Atigliflozin, Remogliflozin, Sotagliflozin, Bexagliflozin, or Janagliflozin; or at a dose of 0.01 to 10 mg/kg bodyweight) or a pharmaceutically acceptable form thereof in combination with telmisartan (or at a dose of about 0.01 to about 10 mg/kg of bodyweight; or one or twice per day; or further comprising measuring the systolic blood pressure (SBP))” (claims 1, 2, 4, 6-8, 11, 15, 16-19, and 22-24), and “a pharmaceutical composition comprising one or more SGLT2 inhibitors or pharmaceutically acceptable forms thereof in combination with telmisartan, wherein the pharmaceutical composition is a fixed-dose-combination (FDC) of the one or more SGL T-2 inhibitors or pharmaceutically acceptable forms thereof and telmisartan; and the FDC is a solid or a liquid formulation” (claim 25):
Jia ‘506 disclosed a composition of an SGLT-2 inhibitor and an angiotensin receptor blocker and use thereof. The composition is used for the treatment of diabetes with hypertension, while benefiting the patient's kidney; or delaying the deterioration of renal failure in patients with chronic kidney disease (CKD) and preventing cardiovascular (CV) and renal death. In addition, the composition is at a fixed dose (page 3/13, [0006]; page 5/13, [0052]). Table 13 (active ingredient B: dapagliflozin):
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. The self-made formulations of Examples 41 and 42 and reference formulation were subjected to PK research in Beagle dogs. The Cmax Ratio and AUC0-24 Ratio of the self-made formulation and the original formulation in beagle dogs are both in the range of 80%-125%, indicating that the self-made formulation and the original formulation are bioequivalent in beagle dogs (pages 10/13 to 13/13, [0080, 0085, 0087, and 0088]). The SGLT-2 inhibitor is selected from the group consisting of dapagliflozin (active ingredient B), canagliflozin, empagliflozin, ipragliflozin, luseogliflozin, tofogliflozin, ertugliflozin, janagliflozin, bexagliflozin, sotagliflozin, henagliflozin, tianagliflozin, remogliflozin, alligliflozin, remogliflozin etabonate, and a mixture thereof. Recent clinical trials of SGLT-2 inhibitors have demonstrated that the systolic blood pressure of patients with diabetes decreased by 4 mmHg. In a case of using the common antihypertensive drugs for monotherapy, the systolic blood pressure decreased by 9.1 mmHg. The angiotensin II receptor antagonist is selected from the group consisting of irbesartan, candesartan, valsartan, telmisartan, losartan, iprasartan, olmesartan, and azilsartan; or cocrystal (page 3/13, [0009, 0004, and 0028]).
Thus, these teachings of Jia ‘506 anticipate Applicant’s claims 1, 2, 4, 6-8, 11, 15, 16-19, and 21-25 because the SGLT-2 inhibitor, for example, dapagliflozin (active ingredient B) is formulated with angiotensin II receptor blocker (ARB) telmisartan for treating chronic kidney disease or associated hypertension in a dog, and thus teachings of Jia ‘506 meet all structural limitation of claimed method would also achieve the intended results, including “one or more of the following clinical and/or biochemical parameters: improved renal efficiency, characterized by a reduction of proteinuria…delayed onset of hypertension… higher quality of life”, required by claim 21. Or, an effective amount of a SGLT-2 inhibitor and an effective amount of telmisartan are readily optimized according to clinical practice.
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, 2, 6, 7-22, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7-13, 16-18, and 21-25 of copending Application No. 18/666,911 (Applicant: BOEHRINGER INGELHEIM VETMEDICA GMBH, claim set of 08/02/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because Appl ‘911 claims “A method of prevention and/or treatment of one or more cardiac diseases in a non-human mammal comprising administering to the non-human mammal a pharmaceutical composition comprising one or more SGLT-2 inhibitors or pharmaceutically acceptable forms thereof in combination with pimobendane and/or telmisartan or pharmaceutically acceptable forms thereof (or achieving a therapeutic effect for the non-human mammal that is characterized by… prevention of hypertension; or the pharmaceutical composition is a fixed-dose-combination (FDC) of the one or more SGLT-2 inhibitors or pharmaceutically acceptable form thereof and pimobendan and/or telmisartan or pharmaceutically acceptable forms thereof, and the FDC is a solid formulation or a liquid formulation)” (claims 1, 24, and 25), reading on or overlapping with claims 1, 21, and 25 of this Application and would achieve the same intended results recited in claim 22 of this Application. Also, claims 2, 7-13, 16-18, and 21-23 of Appl ‘911 read on claims 2, 6, and 7-20 of this Application, respectively. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YIH-HORNG SHIAO whose telephone number is (571)272-7135. The examiner can normally be reached Mon-Thur, 08:30 am to 07:00 pm EST.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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