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 .
Status of the Claims
Claims 1-5, 8-17, 20, 22, and 23 are pending. Acknowledgment is made of the amendment of claims 1, 3, 5, 8, 9, 11, and 13-17, the cancellation of claims 6, 7, 19, and 21, and the addition of new claims 22 and 23, in the reply filed 06/30/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/03/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objections/Rejections
Applicant’s amendment to the claims, filed 06/30/2026, overcomes the objection to claims 1, 8, 9, and 17 for minor informalities. The objection to claims 1, 8, 9, and 17 has been withdrawn.
Applicant’s amendment to the claims, filed 06/30/2026, overcomes the rejection of claims 1-17 and 19-21 under 35 U.S.C. 112(a) for scope of enablement. The rejection of claims 1-17 and 19-21 has been withdrawn.
Applicant’s amendment to the claims, filed 06/30/2026, overcomes the rejection of claims 1-17 and 19-21 under 35 U.S.C. 112(b) for indefiniteness. The rejection of claims 1-17 and 19-21 has been withdrawn.
Maintained/Modified Rejections
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 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.
Claims 1-5, 8-13, 15-17, 20, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Kley et al. (US 10,603,300 B2), published 31 March 2020.
Kley et al. teaches in claims 1, 3, 6-8, and 13-15 a method of treating hypertension, including the slowed progression or remission of hypertension, in a dog comprising orally administering an SGLT2 inhibitors, wherein the SGLT2 inhibitor is 1-cyano-2-(4-cyclopropyl-benzyl)-4-(β-D-glucopyranos-1-yl)-benzene, in combination with insulin, at a dosage of 0.01 to 1.0 mg/kg bodyweight once per day, as in instant claims 1, 10-13, 20, and 22.
Kley et al. teaches, in claims 9-11, that the method comprises a crystalline complex between the SGLT2 inhibitor and L-proline, as in instant claim 8. It is taught, in claim 7, that the patient has pre-diabetes, which would indicate that the patient does not yet have diabetes, as in instant claim 9. It is also taught, in column 15 lines 22-23, that in one embodiment, the canine is not suffering from diabetes.
Regarding claims 15 and 23, the decrease in SBP value would be an inherent property of the method taught by the prior art, since the same composition is being administered to the same patients, and products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. See MPEP 2112. Additionally, Kley et al. teaches in claim 3 that the method slows progression or causes remission of hypertension, which would indicate a decrease in SBP.
Kley et al. teaches treatment in a canine, rather than a feluine. Kley et al. fails to specify that the hypertension is secondary hypertension associate with chronic kidney disease or idiopathic hypertension. Kley et al. fails to teach that the hypertension is non-refractory to treatment with ACE inhibitors or that the patient suffers from target organ damage risk. Kley et al. fails to teach that the method further comprises measurement of the SBP.
Regarding the instant claims, it would be prima facie obvious to one of ordinary skill in the art to treat a feline suffering from hypertension with Velagliflozin, since Kley et al. teaches the exact same treatment method of hypertension with Velagliflozin, with the only difference that the treatment method is for a canine rather than a feline. One of ordinary skill in the art would be motivated to use the existing method taught by Kley et al. as a starting point to treat hypertension in other animals, including felines, since the method is known to treat canines. One of ordinary skill in the art would also have a reasonable expectation of success using the known method to treat other similar mammals, such as felines, since the results would be expected to be the same in the treatment of similar mammals.
Regarding instant claims 2-5 and 17, Kley et al. teaches the treatment of hypertension, including the remission and slowed progression of hypertension. Kley et al. also teaches the treatment of renal dysfunction in claim 3, which is taught cause other disorders/consequences. It is well-known in the art that chronic kidney disease causes high blood pressure, as in instant claims 2 and 3. It is also well-known that hypertension may cause target organ damage.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to treat any type of hypertension, including hypertension secondary to chronic kidney disease, idiopathic hypertension, and hypertension where the patient is at risk for target organ damage, using the methods taught by Kley et al. because the prior art teaches the treatment of hypertension, which would encompass those specific types of hypertension that are well-known in the art.
One would have a reasonable expectation of success in treating any specific scenario of hypertension using the method taught by Kley et al., since it is not limited to treating a specific type of hypertension.
Regarding claim 16, it would be prima facie obvious to one of ordinary skill in the art to test the SBP of the patient being treated for hypertension by the method taught by Kley et al. This would be routine experimentation for one such as a medical doctor in order to determine administration amounts and to evaluate which patients need such treatment.
One of ordinary skill in the art would routinely evaluate the SBP of a patient who is being treated for hypertension using the method taught by the prior art.
Applicant Argues:
Applicant argues that the administration of Velagliflozin to a canine in order to treat hypertension does not render obvious the same method in order to treat hypertension in a feline. Applicant states that metabolism differs in different species, and that treatment methods are not readily transferable.
Examiner Responds:
Applicant's arguments have been fully considered but they are not persuasive. One of ordinary skill in the art would be motivated to use the prior art method as a starting point when treating a different mammal, such as a feline, for hypertension, since it is common in the art to use known treatment methods on different mammals in order to treat the same conditions. Applicant has taken a prior art method of treatment and only changed the specific mammal being treated by the method, which is not patentably new.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kley et al. (US 10,603,300 B2) as applied to claims 1-5, 8-13, 15-17, 20, 22, and 23 above, and further in view of Reiche et al. (US 10,555,958 B2), published 11 February 2020.
Kley et al. teaches a method of treating hypertension in a canine comprising orally administering the SGLT2 inhibitor is 1-cyano-2-(4-cyclopropyl-benzyl)-4-(β-D-glucopyranos-1-yl)-benzene, in combination with insulin, at a dosage of 0.01 to 1.0 mg/kg bodyweight once per day. See above rejection.
Kley et al. fails to teach the co-administration of two SGLT2 inhibitors.
Reiche et al. teaches, in claims 1 and 2, a method of treating hypertension in an equine animal comprising administering one or more SGLT2 inhibitors, wherein one of the SGLT2 inhibitors is 1-cyano-2-(4-cyclopropyl-benzyl)-4-(β-D-glucopyranos-1-yl)-benzene. The method is taught, in claims 9 and 11, to be administered once daily at a dose of 0.02 to 1.0 mg/kg bodyweight.
Therefore, it would be prima facie obvious to use two SGLT2 inhibitors in the method taught by Kley et al., since Reiche et al. teaches the co-administration of two SGLT2 inhibitors in the same composition with the same administration technique and dosage as Kley et al.
One would have a reasonable expectation of success in co-administering another SGLT2 inhibitor in the method taught by Kley et al., since Reiche et al. teaches the same composition used for the same purpose with the co-administration of 1-cyano-2-(4-cyclopropyl-benzyl)-4-(β-D-glucopyranos-1-yl)-benzene and another SGLT2 inhibitor. One would expect the composition to have the same results of treating hypertension with the addition of another SGLT2 inhibitor, as taught by Reiche et al.
Applicant Argues:
Applicant argues that the administration of Velagliflozin to a canine or equine in order to treat hypertension does not render obvious the same method in order to treat hypertension in a feline. Applicant states that metabolism differs in different species, and that treatment methods are not readily transferable.
Examiner Responds:
Applicant's arguments have been fully considered but they are not persuasive. One of ordinary skill in the art would be motivated to use the prior art methods as a starting point when treating a different mammal, such as a feline, for hypertension, since it is common in the art to use known treatment methods on different mammals in order to treat the same conditions.
Nonstatutory 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 1-5, 9-17, 20, 22, and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14, and 27 of U.S. Patent No. 10,220,017 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘017 teaches, in claims 1, 14, and 27, a method of treating hypertension in an equine or canine animal comprising administering a liquid pharmaceutical composition comprising one or more SGLT-2 inhibitor of formula (I). It would be obvious to use this method to treat hypertension in a feline, since treatment of hypertension is taught for canine and equine animals, and the treatment method of administering Velagliflozin is also taught to be used in feline animals, as in instant claims 1, 9, 10, 14, 20, 22, and 23.
Claim 27 teaches the treatment of renal dysfunction and diabetes in addition to hypertension. It would be obvious to one of ordinary skill in the art to treat any type of hypertension using the methods taught in Patent ‘017, as in instant claims 2-5 and 17.
Regarding claims 11-13 and 16, MPEP 2144.05 II A states: “‘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)”. Therefore, the amounts and administration techniques in the instant claims are not inventive over the prior art, since the same composition is being administered to the same patients, and this would be considered routine experimentation.
Regarding claim 15, the decrease in SBP value would be an inherent property of the method taught by the prior art, since the same composition is being administered to the same patients, and products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. See MPEP 2112.
Applicant Argues:
Applicant claims that the treatment of hypertension in a feline is not taught in Patent ‘017.
Examiner Responds:
The method of treating hypertension in canine and equine animals renders obvious the treatment of hypertension in feline animals, especially since the patent teaches that the method of administering Velagliflozin can be used in felines to treat related disorders.
Claims 1-5, 9-17, 20, 22, and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 6, 8, and 9 of U.S. Patent No. 10,555,958 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘958 teaches, in claims 1, 2, and 6, a method of treating hypertension in an equine animal comprising orally administering one or more SGLT2 inhibitors, wherein one of the SGLT2 inhibitors is 1-cyano-2-(4-cyclopropyl-benzyl)-4-(β-D-glucopyranos-1-yl)-benzene, as in instant claims 1, 9, 10, 14, 20, 22, and 23. It is taught, in claims 8 and 9, that the dose is 0.01 to 100 μg/kg bodyweight once per day, as in instant claims 11-13.
It would be obvious to one of ordinary skill in the art to treat any type of hypertension in any non-human mammal, including felines, using the methods taught in Patent ‘958, as in instant claims 2-5 and 17.
Regarding claim 16, MPEP 2144.05 II A states: “‘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)”. Therefore, the administration techniques in the instant claim are not inventive over the prior art, since the same composition is being administered to the same patients, and this would be considered routine experimentation.
Regarding claim 15, the decrease in SBP value would be an inherent property of the method taught by the prior art, since the same composition is being administered to the same patients, and products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. See MPEP 2112.
Applicant Argues:
Applicant argues that the method of treating an equine animal for hypertension cannot be construed as similar to treating a feline animal for hypertension using the same method.
Examiner Responds:
Applicant's arguments have been fully considered but they are not persuasive. One of ordinary skill in the art would be motivated to use the prior art method as a starting point when treating a different mammal, such as a feline, for hypertension, since it is common in the art to use known treatment methods on different mammals in order to treat the same conditions.
Claims 1-5, 8-17, 20, 22, and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, 9-11, 13, and 14 of U.S. Patent No. 10,603,300 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘300 teaches, in claims 1, 3, 7, 13, and 14, a method of treating hypertension in a dog comprising orally administering, once per day, one or more SGLT2 inhibitors, wherein one of the SGLT2 inhibitors is 1-cyano-2-(4-cyclopropyl-benzyl)-4-(β-D-glucopyranos-1-yl)-benzene, at a dose of 0.1 to 1.0 mg/kg bodyweight, as in instant claims 1, 9-14, 20, 22, and 23. It is taught in claims 9-11 that the method comprises a crystalline complex between a SGLT2 inhibitor and L-proline, as in instant claim 8.
It would be obvious to one of ordinary skill in the art to treat any type of hypertension in any non-human mammal, including felines, using the methods taught in Patent ‘300, as in instant claims 2-5 and 17.
Regarding claim 16, MPEP 2144.05 II A states: “‘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)”. Therefore, the administration techniques in the instant claim are not inventive over the prior art, since the same composition is being administered to the same patients, and this would be considered routine experimentation.
Regarding claim 15, the decrease in SBP value would be an inherent property of the method taught by the prior art, since the same composition is being administered to the same patients, and products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. See MPEP 2112.
Applicant Argues:
Applicant argues that Patent ‘300 teaches the treatment of a metabolic disorder in a canine which does not include the treatment of hypertension, and does not include the treatment of felines.
Examiner Responds:
As recited above, reference claim 3 teaches the treatment of hypertension in a canine. One of ordinary skill in the art would be motivated to use the prior art method as a starting point when treating a different mammal, such as a feline, for hypertension, since it is common in the art to use known treatment methods on different mammals in order to treat the same conditions.
Claims 1-5, 8-17, 20, 22, and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, 11, and 12 of U.S. Patent No. 10,688,116 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘116 teaches, in claims 1, 8, 11, and 12, a method of treating hypertension in an equine animal comprising orally administering one or more SGLT2 inhibitors, wherein one of the SGLT2 inhibitors is 1-cyano-2-(4-cyclopropyl-benzyl)-4-(β-D-glucopyranos-1-yl)-benzene, once per day at a dose of 0.3 to 0.4 mg/kg bodyweight, as in instant claims 1, 9-14, 20, 22, and 23. It is taught in claim 6 that the method comprises a crystalline complex between the SGLT2 inhibitor and proline, as in instant claim 8.
It would be obvious to one of ordinary skill in the art to treat any type of hypertension in any non-human mammal, including felines, using the methods taught in Patent ‘116, as in instant claims 2-5 and 17.
Regarding claim 16, MPEP 2144.05 II A states: “‘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)”. Therefore, the administration techniques in the instant claim are not inventive over the prior art, since the same composition is being administered to the same patients, and this would be considered routine experimentation.
Regarding claim 15, the decrease in SBP value would be an inherent property of the method taught by the prior art, since the same composition is being administered to the same patients, and products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. See MPEP 2112.
Applicant Argues:
Applicant argues that the method of treating an equine animal for hypertension cannot be construed as similar to treating a feline animal for hypertension using the same method.
Examiner Responds:
Applicant's arguments have been fully considered but they are not persuasive. One of ordinary skill in the art would be motivated to use the prior art method as a starting point when treating a different mammal for hypertension, since it is common in the art to use known treatment methods on different mammals in order to treat the same conditions.
Claims 1-5, 9-17, 20, 22, and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 19, and 28 of U.S. Patent No. 10,709,683 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘638 teaches, in claims 1, 4, 19, and 28, a method of treating hypertension in a dog or cat comprising orally administering one or more SGLT2 inhibitors, wherein one of the SGLT2 inhibitors is 1-cyano-2-(4-cyclopropyl-benzyl)-4-(β-D-glucopyranos-1-yl)-benzene, once per day, as in instant claims 1, 9, 10, 14, 20, 22, and 23.
It would be obvious to one of ordinary skill in the art to treat any type of hypertension using the methods taught in Patent ‘638, as in instant claims 2-5 and 17.
Regarding claims 11-13 and 16, MPEP 2144.05 II A states: “‘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)”. Therefore, the amounts and administration techniques in the instant claims are not inventive over the prior art, since the same composition is being administered to the same patients, and this would be considered routine experimentation.
Regarding claim 15, the decrease in SBP value would be an inherent property of the method taught by the prior art, since the same composition is being administered to the same patients, and products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. See MPEP 2112.
Applicant Argues:
Applicant claims that the treatment of hypertension in a feline is not taught in Patent ‘683.
Examiner Responds:
The method of treating hypertension in canine and equine animals renders obvious the treatment of hypertension in feline animals, especially since the patent teaches that the method of administering Velagliflozin can be used in felines to treat related disorders.
Claims 1-5, 8-17, 20, 22, and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7-13 of U.S. Patent No. 11,433,045 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘045 teaches, in claims 1, 7, and 11-13, a method of treating hypertension in a dog comprising orally administering, once per day, one or more SGLT2 inhibitors, wherein one of the SGLT2 inhibitors is 1-cyano-2-(4-cyclopropyl-benzyl)-4-(β-D-glucopyranos-1-yl)-benzene, at a dose of 0.01 to 1.0 mg/kg bodyweight, as in instant claims 1, 9-14, 20, 22, and 23. It is taught in claims 8-10 that the method comprises a crystalline complex between a SGLT2 inhibitor and L-proline, as in instant claim 8.
It would be obvious to one of ordinary skill in the art to treat any type of hypertension in any non-human mammal, including felines, using the methods taught in Patent ‘045, as in instant claims 2-5 and 17.
Regarding claim 16, MPEP 2144.05 II A states: “‘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)”. Therefore, the administration techniques in the instant claim are not inventive over the prior art, since the same composition is being administered to the same patients, and this would be considered routine experimentation.
Regarding claim 15, the decrease in SBP value would be an inherent property of the method taught by the prior art, since the same composition is being administered to the same patients, and products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. See MPEP 2112.
Applicant Argues:
Applicant argues that Patent ‘045 teaches the treatment of a metabolic disorder in a canine which does not include the treatment of hypertension, and does not include the treatment of felines.
Examiner Responds:
As recited above, reference claim 1 teaches the treatment of hypertension in a canine. One of ordinary skill in the art would be motivated to use the prior art method as a starting point when treating a different mammal, such as a feline, for hypertension, since it is common in the art to use known treatment methods on different mammals in order to treat the same conditions.
Claims 1-5, 9-17, 20, 22, and 23 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claim 1, 2, and 35 of copending Application No. 18/321,117 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘117 teaches, in claims 1, 2, and 35, a method of treating hypertension in a dog or cat comprising administering two SGLT-2 inhibitors, wherein at least one SGLT-2 inhibitor is velagliflozin, as in instant claims 1, 9, 10, 14, 20, 22, and 23.
It would be obvious to one of ordinary skill in the art to treat any type of hypertension using the methods taught in Patent ‘017, as in instant claims 2-5 and 17.
Regarding claims 11-13 and 16, MPEP 2144.05 II A states: “‘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)”. Therefore, the amounts and administration techniques in the instant claims are not inventive over the prior art, since the same composition is being administered to the same patients, and this would be considered routine experimentation.
Regarding claim 15, the decrease in SBP value would be an inherent property of the method taught by the prior art, since the same composition is being administered to the same patients, and products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. See MPEP 2112.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant Argues:
Applicant holds the provisional rejection in abeyance.
Examiner Responds:
The provisional rejection is not the final remaining rejection, and therefore is not withdrawn.
Claims 1-5, 9-17, 20, 22, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17, 18, 20, and 21 of copending Application No. 18/594,627 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘627 teaches, in claims 17, 18, 20, and 21, a method of treating hypertension in a cat or dog, including situational hypertension, secondary hypertension, and idiopathic hypertension, wherein the secondary hypertension is associated with chronic kidney disease, comprising orally administering one or more SGLT-2 inhibitors (selected from those in claim 20), at a dose of 0.1 to 10 mg/kg bodyweight, as in instant claims 1-4, 9-11, 13, 14, 20, 22, and 23.
It would be obvious to one of ordinary skill in the art to treat any type of hypertension using the methods taught in Application ‘627, as in instant claims 5 and 17.
Regarding claims 12 and 16, MPEP 2144.05 II A states: “‘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)”. Therefore, the amounts and administration techniques in the instant claims are not inventive over the prior art, since the same composition is being administered to the same patients, and this would be considered routine experimentation.
Regarding claim 15, the decrease in SBP value would be an inherent property of the method taught by the prior art, since the same composition is being administered to the same patients, and products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. See MPEP 2112.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant Argues:
Applicant holds the provisional rejection in abeyance.
Examiner Responds:
The provisional rejection is not the final remaining rejection, and therefore is not withdrawn.
Claims 1-5, 8-17, 20, 22, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 7, 8, 13, 14, 16-18, and 24 of copending Application No. 18/666,911 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘911 teaches, in claims 1, 2, 7, 13, 14, 16-18, and 24, a method of treating hypertension in a feline or canine comprising orally administering one or more SGLT-2 inhibitors (selected from those in claim 7) once or twice per day at a dose of 0.01 to 4 mg/kg, as in instant claims 1, 9-14, 20, 22, and 23. It is taught, in claim 8, that the method comprises a crystalline complex between the one or more SGLT-2 inhibitors and proline, as in instant claim 8.
It would be obvious to one of ordinary skill in the art to treat any type of hypertension using the methods taught in Application ‘911, as in instant claims 2-5 and 17.
Regarding claim 16, MPEP 2144.05 II A states: “‘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)”. Therefore, the amounts and administration techniques in the instant claims are not inventive over the prior art, since the same composition is being administered to the same patients, and this would be considered routine experimentation.
Regarding claim 15, the decrease in SBP value would be an inherent property of the method taught by the prior art, since the same composition is being administered to the same patients, and products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. See MPEP 2112.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant Argues:
Applicant holds the provisional rejection in abeyance.
Examiner Responds:
The provisional rejection is not the final remaining rejection, and therefore is not withdrawn.
Claims 1-5, 8-17, 20, 22, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 6-9, 15-17, and 22-24 of copending Application No. 18/666,922 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘922 teaches, in claims 1, 2, 6-8, and 15-17, a method of treating hypertension, to include idiopathic hypertension and secondary hypertension associated with chronic kidney disease, in a canine or feline comprising orally administering one or more SGLT-2 inhibitors (selected from claim 8), at a dose of 0.01 to 1.0 mg/kg, once or twice daily, as in instant claims 1-4, 9-14, 20, 22, and 23.
Reference claim 9 corresponds to instant claim 8. Reference claim 22 corresponds to instant claim 15. Reference claim 23 corresponds to instant claims 5 and 16. Reference claim 24 corresponds to instant claim 17.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant Argues:
Applicant holds the provisional rejection in abeyance.
Examiner Responds:
The provisional rejection is not the final remaining rejection, and therefore is not withdrawn.
Claims 1-5, 8-17, 20, 22, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, 10, and 11 of copending Application No. 19/208,239 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘239 teaches, in claims 1-3, 10, and 11, a method of treating hypertension in an equine animal comprising orally administering, once per day, one or more SGLT2 inhibitors (selected from claims 2 or 3), at a dose of 0.01 to 5 mg/kg bodyweight, as in instant claims 1, 9-14, 20, 22, and 23. Reference claim 8 corresponds to instant claim 8.
It would be obvious to one of ordinary skill in the art to treat any type of hypertension in any non-human mammal, including felines, using the methods taught in Patent ‘116, as in instant claims 2-5 and 17.
Regarding claim 16, MPEP 2144.05 II A states: “‘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)”. Therefore, the administration techniques in the instant claim are not inventive over the prior art, since the same composition is being administered to the same patients, and this would be considered routine experimentation.
Regarding claim 15, the decrease in SBP value would be an inherent property of the method taught by the prior art, since the same composition is being administered to the same patients, and products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. See MPEP 2112.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant Argues:
Applicant holds the provisional rejection in abeyance.
Examiner Responds:
The provisional rejection is not the final remaining rejection, and therefore is not withdrawn.
Conclusion
Claims 1-5, 8-17, 20, 22, and 23 are rejected.
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.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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