COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION

Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA . DETAILED ACTION Status of the Claims The Examiner acknowledges receipt of Applicants’ Response, filed 18 May 2026. Applicants did not amend the claims. Consequently, claims 25 – 43 remain available for substantive examination. Information Disclosure Statements The Examiner has considered the Information Disclosure Statement (IDS) filed 18 May 2026, which is now of record in the file. REJECTIONS MAINTAINED Rejections Pursuant to 35 U.S.C. § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections pursuant to 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 rejection of claims 25 – 39 pursuant to 35 U.S.C. § 102(a)(1) as anticipated by US 10,322,117 to Rodgers, A. and S. MacMahon, issued 18 June 2019 (“Rodgers ‘117”), is hereby maintained. Rodgers ‘117 discloses pharmaceutical compositions that are useful for the treatment of hypertension comprising an angiotensin II receptor blocker, a diuretic, and a calcium channel blocker (see Abstract), wherein the diuretic is indapamide, and the dose of the indapamide is about 0.625 mg, the calcium channel blocker is amlodipine besylate at a dose of about 1.25 mg, and the angiotensin II receptor blocker is telmisartan at a dose of the of about 10 mg (see Col. 2, ll. 10 – 22), wherein the dose of telmisartan is from about 8 mg to about 12 mg, the dose of indapamide is from about 0.5 mg to about 0.75 mg, and the dose of amlodipine besylate is from about 1 mg to about 1.5 mg (see Col. 2, ll. 25 – 28), wherein the dose of telmisartan is from about 16 mg to about 24 mg, the dose of indapamide is from about 1 mg to about 1.5 mg, and the dose of amlodipine besylate is from about 2 mg to about 3 mg, or the dose of telmisartan is about 20 mg, the dose of indapamide is about 1.25 mg, and the dose of amlodipine besylate is about 2.5 mg (see Col. 3, ll. 16 – 22), wherein the dose of telmisartan is from about 12 mg to about 16 mg, the dose of indapamide is from about 0.75 mg to about 1.0 mg, and the dose of amlodipine besylate is from about 1.5 mg to about 2 mg, or the dose of telmisartan is about 13 .2 mg, the dose of indapamide is about 0.825 mg, and the dose of amlodipine besylate is about 1.65 mg (see Col. 20, ll. 5 – 11), wherein the dose of telmisartan is from about 16 mg to about 30 mg, the dose of indapamide is from about 1 mg to about 1.875 mg, and the dose of amlodipine besylate is from about 2 mg to about 3.75 mg, wherein the pharmaceutical composition is in the form of pill, tablet, or capsule suitable for oral administration (see Col. 3, ll. 28 – 31), and wherein the pharmaceutical compositions are used for treating hypertension in human subjects, resulting in a systolic blood pressure (SBP) of less than about 140 mmHg, or less than about 135 mmHg, representing a reduction of systolic blood pressure (SBP) of about 10 mmHg, or greater (see Col. 38, l. 9 – Col. 41, l. 5). Consequently, Rodgers ‘117 discloses each and every limitation of the claims at issue, rendering them anticipated pursuant to 35 U.S.C. § 102(a)(1). Rejection Pursuant to 35 U.S.C. § 103 The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 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. The rejection of claims 25 - 43 pursuant to 35 U.S.C. § 103, as being obvious over Rodgers ‘117, in view of WO 2011/149438 A1 to Bilgic, M., et al., published 1 December 2011, identified on the Information Disclosure Statement (IDS) filed 1 December 2025, cite no 021 (FOR) (“Bilgic WO ‘438”), is hereby maintained. The Invention As Claimed Applicants claim a method of treating a subject having hypertension, the method comprising administering to the subject a pharmaceutical composition comprising telmisartan, indapamide, and amlodipine besylate, wherein said pharmaceutical composition is not administered in a subject who is prescribed aliskiren, wherein the pharmaceutical composition is formulated for oral administration, in the form of a pill, tablet, or a capsule, wherein treating the subject results in a reduction of systolic blood pressure (SBP) in the subject of about 10 mmHg, or greater, or of about 5 mmHg, or greater, wherein the treating the subject results in a reduction in SBP or DBP that is greater than the reduction obtained with the full lowest hypertension therapeutic dose of any one of telmisartan, indapamide, or amlodipine besylate in the pharmaceutical composition, wherein treating the subject results in greater long-term tolerability and reduced risk of side effects when compared to treatment with the full lowest hypertension therapeutic dose of any one of telmisartan, indapamide, or amlodipine besylate in the pharmaceutical composition, wherein a dose of the indapamide is about 0.625 mg, wherein a dose of the amlodipine besylate is about EQ 1.25 mg base, wherein a dose of the telmisartan is about 10 mg, wherein a dose of the indapamide is about 0.625 mg, a dose of amlodipine besylate is about EQ 1.25 mg base, and a dose of the telmisartan is about 10 mg, wherein a dose of the indapamide is about 1.25 mg, wherein a dose of the amlodipine besylate is about EQ 2.5 mg base, wherein a dose of the telmisartan is about 20 mg, wherein a dose of the indapamide is about 1.25 mg, a dose of the amlodipine besylate is about EQ 2.5 mg base, and a dose of the telmisartan is about 20 mg, wherein a dose of the indapamide is about 2.5 mg, wherein a dose of amlodipine besylate is about EQ 5 mg base, wherein a dose of telmisartan is about 40 mg, and wherein a dose of the indapamide is about 2.5 mg, a dose of the amlodipine besylate is about EQ 5 mg base, and a dose of the telmisartan is about 40 mg. The Teachings of the Cited Art The teachings of Rodgers ‘117 are set forth above. With respect to claims 25 – 39, a disclosure that anticipates also renders the claim obvious under §103, for anticipation is the epitome of obviousness. The reference does not explicitly a method for treating hypertension by oral administration of a composition comprising telmisartan, indapamide, and amlodipine besylate at loadings reading on all of loadings recited in the instant claims. The teachings of Bilgic WO ‘438 remedy that deficiency. Bilgic WO ‘438 discloses a combination of antihypertensive active agents and use of the combinations to treat hypertension (see Abstract), wherein the combination comprises indapamide (a diuretic), amlodipine (a calcium channel blocker), and telmisartan (an angiotensin receptor antagonist) (see p. 1, ll. 5 – 7), wherein a pharmaceutical composition comprises the combination of antihypertensive active agent formulated in the same dosage form (see p. 3, ll. 25 – 26), wherein the composition comprising the active agents telmisartan, amlodipine, and indapamide are prepared to be administered by the oral route (see p. 4, ll. 5 – 6), wherein the oral dosage forms can be in solid dosage forms such as a tablet, a capsule, enteric coated or modified release tablets, prolonged release tablets, and delayed release tablets, among others (see p. 4, ll. 10 – 11), wherein the total amount of active agents in the formulation is in the range of 0.5% to 95%, preferably in the range of 1 % to 90%, in proportion to total amount of substances in the pharmaceutical formulation (see p. 4, ll. 15 – 17), wherein one dose of the pharmaceutical composition comprises 10 - 300 mg telmisartan, 2.5 - 25 mg amlodipine, and 0.1 - 10 mg indapamide (see p. 4, ll. 20 – 22), wherein, in an exemplified embodiment, telmisartan is present in the dosage form at 35% wgt, amlodipine is present at 15% wgt, and indapamide is present at 5% wgt, with the remaining mass of the dosage form in excipients (see Ex. 1, p. 8). The reference does not expressly disclose administration of dosage forms comprising compositions of telmisartan, indapamide, and/or amlodipine besylate to treat patients with hypertension. The teachings of Rodgers ‘117 remedy that deficiency. Application of the Cited Art to the Claims It would have been prima facie obvious before the filing date of the claimed invention to treat subjects with hypertension by administering a composition comprising telmisartan, indapamide, and amlodipine besylate in a solid oral dosage form to the subject, wherein the dose of the indapamide is about 0.625 mg, the calcium channel blocker is amlodipine besylate at a dose of about 1.25 mg, and the angiotensin II receptor blocker is telmisartan at a dose of the of about 10 mg (see Col. 2, ll. 10 – 22), wherein the dose of telmisartan is from about 8 mg to about 12 mg, the dose of indapamide is from about 0.5 mg to about 0.75 mg, and the dose of amlodipine besylate is from about 1 mg to about 1.5 mg (see Col. 2, ll. 25 – 28), wherein the dose of telmisartan is from about 16 mg to about 24 mg, the dose of indapamide is from about 1 mg to about 1.5 mg, and the dose of amlodipine besylate is from about 2 mg to about 3 mg, or the dose of telmisartan is about 20 mg, the dose of indapamide is about 1.25 mg, and the dose of amlodipine besylate is about 2.5 mg (see Col. 3, ll. 16 – 22), wherein the dose of telmisartan is from about 12 mg to about 16 mg, the dose of indapamide is from about 0.75 mg to about 1.0 mg, and the dose of amlodipine besylate is from about 1.5 mg to about 2 mg, or the dose of telmisartan is about 13 .2 mg, the dose of indapamide is about 0.825 mg, and the dose of amlodipine besylate is about 1.65 mg (see Col. 20, ll. 5 – 11), wherein the dose of telmisartan is from about 16 mg to about 30 mg, the dose of indapamide is from about 1 mg to about 1.875 mg, and the dose of amlodipine besylate is from about 2 mg to about 3.75 mg, wherein human subjects are treated for hypertension by administration of the composition, as taught by Rodgers ‘117, wherein one dose of the pharmaceutical composition can comprise 10 - 300 mg telmisartan, 2.5 - 25 mg amlodipine, and 0.1 - 10 mg indapamide, as taught by Bilgic WO ‘438. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of Rodgers ‘117 as to the clinical effectiveness of a combination dosage form in treating hypertension, resulting in a reduction in systolic blood pressure of 10 mmHg, or greater (see Col. 40, ll. 55 – 67), and by the teachings of Bilgic WO ‘438 as to the availability of solid dosage forms comprising a broad range of loadings effective in the treatment of hypertension. With respect to the limitation recited in claim 25 directed to the composition not being administered to a subject “who is prescribed aliskiren,” the Examiner notes that the cited references are silent on treating a subject for hypertension who is prescribed aliskiren, giving rise to the reasonable presumption that the treated subjects are not prescribed aliskiren. With respect to claims 28 – 31, which claims recite limitations directed to the clinical effects of administering the composition used in the method of the invention, it is the Examiner’s position that administration of oral dosage forms according to the cited art, the compositions comprising the same antihypertensive active agents, at the same mass loadings, would necessarily result in clinical effects that would read on the limitations in question. In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 25 - 43 would have been obvious within the meaning of 35 USC § 103. Obviousness-Type 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp. Claim 25 - 43 are provisionally rejected on the basis of nonstatutory obviousness-type double patenting as being unpatentable over co-pending claims 1, 12, and 13 of U.S. application Serial Number 19/383,124 (“the ‘124 application”), in view of Bilgic WO ‘438 and Rodgers ‘117. The instant claims have been described supra. Claims 1, 12, and 13 of the ‘124 application are directed to a pharmaceutical composition for a treatment of hypertension, the pharmaceutical composition comprising (a) telmisartan; (b) indapamide; and (c) amlodipine besylate, wherein a dose of the telmisartan is about 30 milligrams (mg) to about 50 mg, a dose of the indapamide is about 1.875 mg to about 3.125 mg, and a dose of the amlodipine besylate is about EQ 3.75 mg base to about EQ 6.25 mg base, wherein the composition is used to treat at least one, or both, of hypertension and dyslipidemia in a subject in need thereof. The claims do not disclose the use of pharmaceutical compositions to treat subjects with hypertension wherein the three active ingredients are present in the compositions at loadings reading on the loadings recited in the pending claims. The teachings of Bilgic WO ‘438 and Rodgers ‘117, as set forth above, remedy that deficiency. Thus, it would have been prima facie obvious to treat a subject with hypertension with a composition (a) telmisartan; (b) indapamide; and (c) amlodipine besylate, wherein a dose of the telmisartan is about 30 milligrams (mg) to about 50 mg, a dose of the indapamide is about 1.875 mg to about 3.125 mg, and a dose of the amlodipine besylate is about EQ 3.75 mg base to about EQ 6.25 mg base, according to the enumerated claims of the ‘124 application, wherein the compositions comprise 10 - 300 mg telmisartan, 2.5 - 25 mg amlodipine, and 0.1 - 10 mg indapamide, as taught by Bilgic WO ‘438. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of the cited references as to the clinical efficacy of compositions comprising the three anti-hypertensive active agents across a range of loadings. A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date pursuant to 35 U.S.C. § 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, Applicants may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions. This is a provisional obviousness-type double patenting rejection. Claim 25 - 43 are directed to an invention not patentably distinct from claims 1 and 4 – 6 of commonly assigned U.S. Patent No. 10,369,156. (“the ‘156 patent”), in view of Bilgic WO ‘438 and Rodgers ‘117. Although the claims at issue are not identical, they are not patentably distinct from each other because the identified claims of the ‘156 patent are directed to a pharmaceutical composition comprising (a) irbesartan; (b) hydrochlorothiazide; (c) amlodipine besylate; and ( d) atenolol; wherein the dose of irbesartan is about 37 .5 mg, the dose of hydrochlorothiazide is about 6.25 mg, the dose of amlodipine besylate is about 1.25 mg, and the dose of atenolol is about 12.5 mg, wherein (a), (b), (c) and (d) are provided in one formulation, wherein the composition is used to treat hypertension in a subject in need thereof, where the treatment results in a reduction of systolic blood pressure (SBP) of about 10 mm Hg, or greater, or about 5 mm Hg, or greater. The claims do not disclose use of a composition to treat hypertension comprising telmisartan and indapamide, as well as the amlodipine besylate. The teachings of Bilgic WO ‘438 and Rodgers ‘117, as set forth above, remedy those deficiencies. Thus, it would have been prima facie obvious to treat hypertension in subjects in need thereof by administering the composition according to the enumerated claims, wherein the composition further comprises telmisartan and indapamide, or to replace irbesartan with telmisartan as the angiotensin II receptor blocker (ARB), and to replace hydrochlorothiazide with indapamide as the diuretic. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of the cited references as to the clinical efficacy of compositions comprising the three anti-hypertensive active agents across a range of loadings. Claims 25 - 43 are directed to an invention not patentably distinct from claims 1 and 11 – 15 of commonly assigned U.S. Patent No. 10,799,487. (“the ‘487 patent”), in view of Bilgic WO ‘438 and Rodgers ‘117. Although the claims at issue are not identical, they are not patentably distinct from each other because the identified claims of the ‘487 patent are directed to a pharmaceutical composition comprising (a) telmisartan; (b) indapamide; and (c) amlodipine besylate; wherein a dose of telmisartan is from about 16 mg to about 24 mg, a dose of indapamide is from about 1 mg to about 1.5 mg, and a dose of amlodipine besylate is from about 2 mg to about 3 mg, wherein the composition is used to treat hypertension in a subject in need thereof, wherein the treatment results in a systolic blood pressure (SBP) of less than about 140 mmHg, wherein the treatment results in a reduction of systolic blood pressure (SBP) of about 10 mmHg or greater, wherein the treatment results in a diastolic blood pressure (DBP) of less than about 90 mmHg, and wherein the treatment results in a reduction of diastolic blood pressure (DBP) of about 5 mmHg, or greater. The claims do not disclose the use of pharmaceutical compositions to treat subjects with hypertension wherein the three active ingredients are present in the compositions at loadings reading on the loadings recited in the pending claims. The teachings of Bilgic WO ‘438 and Rodgers ‘117, as set forth above, remedy that deficiency. Thus, it would have been prima facie obvious to treat a subject with hypertension with a composition (a) telmisartan; (b) indapamide; and (c) amlodipine besylate, wherein a dose of the telmisartan is about 16 milligrams (mg) to about 24 mg, a dose of the indapamide is about 1 mg to about 1.5 mg, and a dose of the amlodipine besylate is about 2 mg to about 3 mg, according to the enumerated claims of the ‘487 patent, wherein the compositions comprise 10 - 300 mg telmisartan, 2.5 - 25 mg amlodipine, and 0.1 - 10 mg indapamide, as taught by Bilgic WO ‘438, and are effective in treating hypertension, according to the teachings of Rodgers ‘117. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of the cited references as to the clinical efficacy of compositions comprising the three anti-hypertensive active agents across a range of loadings. Claims 25 - 43 are directed to an invention not patentably distinct from claims 1, 9, and 10 of commonly assigned U.S. Patent No. 11,478,462 (“the ‘462 patent”), in view of Bilgic WO ‘438 and Rodgers ‘117. Although the claims at issue are not identical, they are not patentably distinct from each other because the identified claims of the ‘462 patent are directed to a pharmaceutical composition comprising (a) telmisartan; (b) hydrochlorothiazide; and (c) amlodipine besylate; wherein the dose of telmisartan is from about 8 mg to about 12 mg, the dose of hydrochlorothiazide is from about 5 mg to about 7.5 mg, and the dose of amlodipine besylate is from about 1 mg to about 1.5 mg; and wherein the pharmaceutical composition is free of beta-blockers, wherein the composition is used in a method to treat a subject in need of treatment for hypertension, wherein the treatment results in a systolic blood pressure (SBP) of less than about 140 mmHg, a reduction of systolic blood pressure (SBP) of about 10 mmHg or greater, a diastolic blood pressure (DBP) of less than about 90 mmHg, a reduction of diastolic blood pressure (DBP) of about 5 mmHg, or greater, or combinations thereof. The claims do not disclose treatment of hypertension with a composition comprising indapamide as the diuretic, in addition to amlodipine besylate and telmisartan. The teachings of Bilgic WO ‘438 and Rodgers ‘117 remedy that deficiency. Thus, it would have been prima facie obvious to treat a subject with hypertension by administration of the compound of the ‘462 patent, wherein the composition further comprises indapamide, or comprises indapamide in place of hydrochlorothiazide as the diuretic, the component actives at loadings according to the teachings of Bilgic WO ‘438 and Rodgers ‘117. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of the cited references as to the clinical efficacy of compositions comprising the three anti-hypertensive active agents across a range of loadings. Claims 25 - 43 are directed to an invention not patentably distinct from claims 1, 11, and 12 of commonly assigned U.S. Patent No. 12,285,415 (“the ‘415 patent”), in view of Bilgic WO ‘438 and Rodgers ‘117. Although the claims at issue are not identical, they are not patentably distinct from each other because the identified claims of the ‘415 patent are directed to a pharmaceutical composition comprising: (a) telmisartan; (b) indapamide; and (c) amlodipine besylate, wherein the dose of the telmisartan is from about 8 mg to about 12 mg, wherein the dose of indapamide is from about 0.5 mg to about 0.75 mg, wherein the dose of amlodipine besylate is from about 1 mg to about 1.5 mg, wherein the composition is used in a method to treat hypertension, or hypertension and hyper lipidemia, in subjects in need thereof. The claims do not disclose the use of pharmaceutical compositions to treat subjects with hypertension wherein the three active ingredients are present in the compositions at loadings reading on the loadings recited in the pending claims. The teachings of Bilgic WO ‘438 and Rodgers ‘117, as set forth above, remedy that deficiency. Thus, it would have been prima facie obvious to treat a subject with hypertension with a composition (a) telmisartan; (b) indapamide; and (c) amlodipine besylate, wherein a dose of the telmisartan is about 8 milligrams (mg) to about 12 mg, a dose of the indapamide is about 0.5 to about 0.75, and a dose of the amlodipine besylate is about 1 mg to about 1.5 mg, according to the enumerated claims of the ‘487 patent, wherein the compositions comprise 10 - 300 mg telmisartan, 2.5 - 25 mg amlodipine, and 0.1 - 10 mg indapamide, as taught by Bilgic WO ‘438, and are effective in treating hypertension, according to the teachings of Rodgers ‘117. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of the cited references as to the clinical efficacy of compositions comprising the three anti-hypertensive active agents across a range of loadings. Claims 25 - 43 are directed to an invention not patentably distinct from claims 1, 9, and 10 of commonly assigned U.S. Patent No. 12,521,380 (“the ‘380 patent”), in view of Bilgic WO ‘438 and Rodgers ‘117. Although the claims at issue are not identical, they are not patentably distinct from each other because the identified claims of the ‘415 patent are directed to a pharmaceutical composition comprising: (a) telmisartan; (b) indapamide; and (c) amlodipine besylate, wherein the dose of the telmisartan is from about 8 mg to about 12 mg, wherein the dose of indapamide is from about 0.5 mg to about 0.75 mg, wherein the dose of amlodipine besylate is from about 1 mg to about 1.5 mg, wherein the composition is used in a method to treat hypertension, or hypertension and dyslipidemia, in subjects in need thereof. The claims do not disclose the use of pharmaceutical compositions to treat subjects with hypertension wherein the three active ingredients are present in the compositions at loadings reading on the loadings recited in the pending claims. The teachings of Bilgic WO ‘438 and Rodgers ‘117, as set forth above, remedy that deficiency. Thus, it would have been prima facie obvious to treat a subject with hypertension with a composition (a) telmisartan; (b) indapamide; and (c) amlodipine besylate, wherein a dose of the telmisartan is about 8 milligrams (mg) to about 12 mg, a dose of the indapamide is about 0.5 to about 0.75, and a dose of the amlodipine besylate is about 1 mg to about 1.5 mg, according to the enumerated claims of the ‘380 patent, wherein the compositions comprise 10 - 300 mg telmisartan, 2.5 - 25 mg amlodipine, and 0.1 - 10 mg indapamide, as taught by Bilgic WO ‘438, and are effective in treating hypertension, according to the teachings of Rodgers ‘117. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of the cited references as to the clinical efficacy of compositions comprising the three anti-hypertensive active agents across a range of loadings. Response to Applicants’ Arguments The Examiner has considered the arguments submitted with the Response filed 18 May 2026 but does not find them persuasive. Applicants’ arguments rest on the proviso recited in claim 25 that the composition administered in the method of the invention “is not administered in a subject who is prescribed aliskiren.” The rejection of record takes the position that the primary reference, Rodgers ‘117, is silent as to administration of the disclosed composition to subjects who have been prescribed aliskiren and that, consequently, the silence gives rise to a presumption that the subjects treated with the disclosed composition of Rodgers ‘117 have not been prescribed aliskiren. In response, Applicants cite to an opinion of the Court of Appeals for the Federal Circuit in IBM v. Iancu, No. 2018-1065 et al. (Fed.Cir. Apr. 1, 2019), for the proposition that “mere silence in a prior art reference does not necessarily teach a limitation.” The Examiner would first note that the case Applicants are citing is a non-precedential opinion, a category in which a majority of Federal Circuit opinions fall. The key impact of such characterization is that, although the holding in the case resolves the specific dispute between the parties, the opinions do not establish binding legal precedent for future cases. It is the Examiner’s position that Applicants’ use of the case is apparently trying to do just that. Perhaps more importantly, Applicants are also failing to address other relevant law. See, for example, AC Technologies S.A. v. Amazon.com, Inc., 912 F.3d 1358, 1367 (Fed. Cir. 2019) (“[A] reference need not state a feature's absence in order to disclose a negative limitation.”), and Süd-Chemie, Inc. V. Multisorb Techs., Inc., 554 F.3d 1001, 1004-05 (Fed. Cir. 2009) (affirming finding that a prior art reference disclosed “uncoated” films where it did not describe the film as coated and did not suggest necessity of coatings). In looking more closely at Süd-Chemie, the opinion states that “Süd-Chemie contends that because Komatsu [US 4,487,791] does not specifically refer to the films as ‘uncoated,’ it fails to teach the purportedly critical requirement of the '942 patent that both the laminate and microporous films be uncoated.” Id., at 1004. Süd-Chemie further, and perhaps most importantly, states that “Süd-Chemie draws the wrong inference from Komatsu's failure to specifically refer to the films as uncoated. As noted, Komatsu plainly teaches that containers can be made of films that are heat sealed without the use of adhesives, and thus without coatings. Moreover, Süd-Chemie has not offered any evidence that a reference to a microporous or laminate film would be understood by one of skill in the art as contemplating a film with an adhesive coating attached. The district court was thus correct to characterize Komatsu as teaching the use of uncoated films, and not to interpret Komatsu as disclosing only films coated with adhesives.” Id., at 1005 (emphasis added). In the instant case, the primary Rodgers ‘117 reference does not overtly teach that the disclosed compositions are not to be administered to a subject who has been prescribed aliskiren. However, as the above cases establish, the inquiry does not start and end there. In looking to the entire disclosure, would one of ordinary skill in the art come to the conclusion that treating hypertension would require prescribing additional anti-hypertensive medications, such as aliskiren? It is the Examiner’s position that Rodgers ‘117 adequately informs the skilled practitioner that the disclosed combination of telmisartan, indapamide, and amlodipine besylate are effective in treating hypertension and, most critically, that there is no necessity to require the prescription of additional medications, such as aliskiren, for that treatment to be clinically effective. Further, being prescribed aliskiren is merely an instruction to use. With respect to the double patenting rejections, Applicants rely solely on the arguments discussed above with respect to the teachings of Rodgers ‘117. Consequently, in light of the above discussion, Applicants’ arguments are unpersuasive and claims 25 – 43 stand rejected. NO CLAIM IS ALLOWED. THIS ACTION IS MADE FINAL. Applicants are reminded of the extension of time policy as set forth in 37 CFR § 1.136(a). PNG media_image1.png 18 19 media_image1.png Greyscale 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 Response 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 extension fee 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. CONCLUSION Any inquiry concerning this communication or any other communications from the Examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The Examiner can normally be reached on M - F 8:30 a.m. - 5:00 p.m. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see <http://pair-direct.uspto.gov>. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. 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. /DANIEL F COUGHLIN/ Examiner, Art Unit 1619 /DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619