CTNF 18/781,034 CTNF 86777 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. DETAILED ACTION Claims 21-33 are pending in the application. Claims 21-33 are rejected. Information Disclosure Statement The Examiner has considered the Information Disclosure Statement(s) filed on February 6 th , 2025. Double Patenting 08-33 AIA 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 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. 08-34 AIA Claim s 21, 22 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-20 of U.S. Patent No. 10,150,779 . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite the compound of instant claim 21. The compound of instant claim 21 is recited in claim 10 of the patent. Furthermore, claim 13 of the patent recites an analogous composition relative to instant claim 22. Regarding instant claim 33, claim 19 of the patent recites an analogous method . 08-36 AIA Claim s 21-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-20 of U.S. Patent No. 10,150,779 in view of U.S. Patent No. 4,868,301 by Mylari et al . The claims of the ‘779 patent recite the compound of instant claim 21. The compound of instant claim 21 is recited in claim 10 of the patent. Furthermore, claims 13, 14, 16, and 19 of the patent recite analogous compositions or methods relative to instant claims 22, 23, 30 and 33. Regarding instant claims 26-29, claim 17 of the patent recites each of the conditions relative to a diabetic subject. Regarding instant claims 24 and 31, the claims of the patent do not recite a specific dosage; however, a person having ordinary skill in the art would have been motivated to apply dosages known to be useful with analogous compounds. For instance, Mylari et al. teach compounds of the following general formula: PNG media_image1.png 235 526 media_image1.png Greyscale . The Mylari et al. further disclose that the compounds are useful as aldose reductase inhibitors where, for instance, the following compound is disclosed in column 13 as example 16 (3-(5-trifluoromethylbenzothiazole-2-ylmethyl)-4-oxo-3H-phthalazin-1-ylacetic acid, which is also known as zopolrestat) PNG media_image2.png 243 416 media_image2.png Greyscale . The prior art compound differs from the instant claims based on the phthalazine structure being replaced with a thieno[3,4-d]pyridazine type structure in formula (I). Regarding dosages, Mylari et al. teach in column 9 (lines 1-14) that dosages can range from 0.5 to 25 mg/kg, which overlaps with instant claims 24 and 31. Regarding the mode of administration recited in instant claim 23, Mylari et al. teach modes of administration including oral. Regarding the frequency of instant claim 25, a person having ordinary skill in the art in seeking to develop simplified or optimized dosing regimens would have been motivated to test different dosing frequencies where a person of ordinary skill in the art would have been motivated to include once per day for simplification . 08-34 AIA Claim s 21, 22 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-23 of U.S. Patent No. 10,647,726 . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite the compound of instant claim 21. The compound of instant claim 21 is recited in claim 15 of the patent. Furthermore, claim 20 of the patent recites an analogous composition relative to instant claim 22 . Regarding instant claim 33, this utility is disclosed in column 8, lines 53-59 of the ‘726 patent. With respect to the fact that the claims of the ‘726 patent are drawn to compounds and compositions while the instant claims are drawn to methods of treating, Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co . 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations . 08-36 AIA Claim s 21-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-23 of U.S. Patent No. 10,647,726 in view of U.S. Patent No. 4,868,301 by Mylari et al. (herein Mylari et al.) and in further view of U.S. Patent No. 6,579,879 by Mylari et al. (herein Mylari et al. ‘879). The claims of the ‘726 patent recite the compound of instant claim 21. The compound of instant claim 21 is recited in claim 15 of the ‘726 patent. Furthermore, claim 20 of the ‘726 patent recites an analogous composition relative to instant claim 22. The claims of the ‘726 patent do not recite utilities; however, a person having ordinary skill in the art would have at least been motivated to apply the compounds of the ‘726 patent in utilities for structurally analogous compounds. For instance, Mylari et al. teach compounds of the following general formula: PNG media_image1.png 235 526 media_image1.png Greyscale . The Mylari et al. further disclose that the compounds are useful as aldose reductase inhibitors where, for instance, the following compound is disclosed in column 13 as example 16 (3-(5-trifluoromethylbenzothiazole-2-ylmethyl)-4-oxo-3H-phthalazin-1-ylacetic acid, which is also known as zopolrestat) PNG media_image2.png 243 416 media_image2.png Greyscale . The prior art compound differs from the instant claims based on the phthalazine structure being replaced with a thieno[3,4-d]pyridazine type structure in formula (I). Regarding utilities, Mylari et al. teach treatment of diabetic complications including retinopathy and neuropathy as embraced by instant claims 26 and 27. Regarding dosages, Mylari et al. teach in column 9 (lines 1-14) that dosages can range from 0.5 to 25 mg/kg, which overlaps with instant claims 24 and 31. Regarding the mode of administration recited in instant claim 23, Mylari et al. teach modes of administration including oral. Regarding the frequency of instant claims 25 and 32, a person having ordinary skill in the art in seeking to develop simplified or optimized dosing regimens would have been motivated to test different dosing frequencies where a person of ordinary skill in the art would have been motivated to include once per day for simplification. Regarding instant claim 30, a person having ordinary skill in the art would have at least been motivated to treat subjects most frequently affected by the conditions of Mylari et al., which would include humans. As an additional teach regarding utility of aldose reductase inhibitors, Mylari et al. ‘879 teach application of aldose reductase inhibitors to (abstract) “treat or prevent diabetic complications such as diabetic neuropathy, diabetic retinopathy, diabetic nephropathy, diabetic cardiomyopathy,…”. Accordingly, a person having ordinary skill in the art in seeking to apply the compounds of the ‘726 patent would have been motivated to treat the conditions of instant claims 26-29, which are taught by Mylari et al. ‘879 . 08-34 AIA Claim s 21 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-23 of U.S. Patent No. 10,870,658 . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite the compound of instant claim 21. The compound of instant claim 21 is recited in claim 20 of the patent. Regarding instant claim 22, it is obvious to add a carrier to an obvious compound. Ex parte Douros , 163 USPQ 667 (PTO Bd. App. 1968) . 08-36 AIA Claim s 21-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-23 of U.S. Patent No. 10,870,658 in view of U.S. Patent No. 4,868,301 by Mylari et al. (herein Mylari et al.) and in further view of U.S. Patent No. 6,579,879 by Mylari et al. (herein Mylari et al. ‘879). The compound of instant claim 21 is recited in claim 20 of the patent. Regarding instant claim 22, it is obvious to add a carrier to an obvious compound. Ex parte Douros , 163 USPQ 667 (PTO Bd. App. 1968). The claims of the ‘658 patent are drawn to methods of inhibiting aldose reductase in a subject having neuropathy but where the claims of the patent do not specify oral administration. A person having ordinary skill in the art would have at least been motivated to apply the methods of the ‘658 patent in similar embodiments for structurally analogous compounds. For instance, Mylari et al. teach compounds of the following general formula: PNG media_image1.png 235 526 media_image1.png Greyscale . Mylari et al. further disclose that the compounds are useful as aldose reductase inhibitors where, for instance, the following compound is disclosed in column 13 as example 16 (3-(5-trifluoromethylbenzothiazole-2-ylmethyl)-4-oxo-3H-phthalazin-1-ylacetic acid, which is also known as zopolrestat) PNG media_image2.png 243 416 media_image2.png Greyscale . The prior art compound differs from the instant claims based on the phthalazine structure being replaced with a thieno[3,4-d]pyridazine type structure in formula (I). Regarding utilities, Mylari et al. teach treatment of diabetic complications including retinopathy and neuropathy as embraced by instant claims 26 and 27. Regarding dosages, Mylari et al. teach in column 9 (lines 1-14) that dosages can range from 0.5 to 25 mg/kg, which overlaps with instant claims 24 and 31. Regarding the mode of administration recited in instant claim 23, Mylari et al. teach modes of administration including oral. Regarding the frequency of instant claims 25 and 32, a person having ordinary skill in the art in seeking to develop simplified or optimized dosing regimens would have been motivated to test different dosing frequencies where a person of ordinary skill in the art would have been motivated to include once per day for simplification. Regarding instant claim 30, a person having ordinary skill in the art would have at least been motivated to treat subjects most frequently affected by the conditions of Mylari et al., which would include humans. As an additional teach regarding utility of aldose reductase inhibitors, Mylari et al. ‘879 teach application of aldose reductase inhibitors to (abstract) “treat or prevent diabetic complications such as diabetic neuropathy, diabetic retinopathy, diabetic nephropathy, diabetic cardiomyopathy,…”. Accordingly, a person having ordinary skill in the art in seeking to apply the methods of the ‘658 patent would have been motivated to treat the conditions of instant claims 26-29, which are taught by Mylari et al. ‘879 and taught to be complications for diabetic subjects . 08-34 AIA Claim s 21 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-24 of U.S. Patent No. 11,498,925 . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite the compound of instant claim 21. The compound of instant claim 21 is recited in claim 20 of the patent. Regarding instant claim 22, it is obvious to add a carrier to an obvious compound. Ex parte Douros , 163 USPQ 667 (PTO Bd. App. 1968) . 08-36 AIA Claim s 21-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-24 of U.S. Patent No. 11,498,925 in view of U.S. Patent No. 4,868,301 by Mylari et al. (herein Mylari et al.) and in further view of U.S. Patent No. 6,579,879 by Mylari et al. (herein Mylari et al. ‘879). The compound of instant claim 21 is recited in claim 20 of the ‘925 patent. Regarding instant claim 22, it is obvious to add a carrier to an obvious compound. Ex parte Douros , 163 USPQ 667 (PTO Bd. App. 1968). The claims of the ‘925 patent are drawn to methods of inhibiting aldose reductase in a subject having neuropathy, nephropathy or cardiomyopathy but where the claims of the patent do not specify oral administration. A person having ordinary skill in the art would have at least been motivated to apply the methods of the ‘658 patent in similar embodiments for structurally analogous compounds. For instance, Mylari et al. teach compounds of the following general formula: PNG media_image1.png 235 526 media_image1.png Greyscale . Mylari et al. further disclose that the compounds are useful as aldose reductase inhibitors where, for instance, the following compound is disclosed in column 13 as example 16 (3-(5-trifluoromethylbenzothiazole-2-ylmethyl)-4-oxo-3H-phthalazin-1-ylacetic acid, which is also known as zopolrestat) PNG media_image2.png 243 416 media_image2.png Greyscale . The prior art compound differs from the instant claims based on the phthalazine structure being replaced with a thieno[3,4-d]pyridazine type structure in formula (I). Regarding utilities, Mylari et al. teach treatment of diabetic complications including retinopathy and neuropathy as embraced by instant claims 26 and 27. Regarding dosages, Mylari et al. teach in column 9 (lines 1-14) that dosages can range from 0.5 to 25 mg/kg, which overlaps with instant claims 24 and 31. Regarding the mode of administration recited in instant claim 23, Mylari et al. teach modes of administration including oral. Regarding the frequency of instant claims 25 and 32, a person having ordinary skill in the art in seeking to develop simplified or optimized dosing regimens would have been motivated to test different dosing frequencies where a person of ordinary skill in the art would have been motivated to include once per day for simplification. Regarding instant claim 30, a person having ordinary skill in the art would have at least been motivated to treat subjects most frequently affected by the conditions of Mylari et al., which would include humans. As an additional teach regarding utility of aldose reductase inhibitors, Mylari et al. ‘879 teach application of aldose reductase inhibitors to (abstract) “treat or prevent diabetic complications such as diabetic neuropathy, diabetic retinopathy, diabetic nephropathy, diabetic cardiomyopathy,…”. Accordingly, a person having ordinary skill in the art in seeking to apply the methods of the ‘658 patent would have been motivated to treat the conditions of instant claims 26-29, which are taught by Mylari et al. ‘879 and taught to be complications for diabetic subjects . 08-34 AIA Claim s 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-26 of U.S. Patent No. 12,077,547 . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite the compound of instant claim 21. The compound of instant claim 21 is recited in claim 22 of the patent. Regarding instant claim 22, claim 22 of the patent recites an oral dose form comprising, for instance, a buffer. Regarding instant claims 23-25, claims 24-26 of the patent recite analogous methods . 08-34 AIA Claim s 21-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-26 of U.S. Patent No. 12,077,547 in view of U.S. Patent No. 4,868,301 by Mylari et al. (herein Mylari et al.) and in further view of U.S. Patent No. 6,579,879 by Mylari et al. (herein Mylari et al. ‘879) . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite the compound of instant claim 21. The compound of instant claim 21 is recited in claim 22 of the patent. Regarding instant claim 22, claim 22 of the patent recites an oral dose form comprising, for instance, a buffer. Regarding instant claims 23-25, claims 24-26 of the patent recite analogous methods. The claims of the ‘547 patent are drawn to methods of inhibiting aldose reductase in a subject but where the claims of the patent do not specify the conditions of instant claims 26-29. A person having ordinary skill in the art would have at least been motivated to apply the methods of the ‘547 patent in similar embodiments for structurally analogous compounds. For instance, Mylari et al. teach compounds of the following general formula: PNG media_image1.png 235 526 media_image1.png Greyscale . Mylari et al. further disclose that the compounds are useful as aldose reductase inhibitors where, for instance, the following compound is disclosed in column 13 as example 16 (3-(5-trifluoromethylbenzothiazole-2-ylmethyl)-4-oxo-3H-phthalazin-1-ylacetic acid, which is also known as zopolrestat) PNG media_image2.png 243 416 media_image2.png Greyscale . The prior art compound differs from the instant claims based on the phthalazine structure being replaced with a thieno[3,4-d]pyridazine type structure in formula (I). Regarding utilities, Mylari et al. teach treatment of diabetic complications including retinopathy and neuropathy as embraced by instant claims 26 and 27. Regarding instant claim 30, a person having ordinary skill in the art would have at least been motivated to treat subjects most frequently affected by the conditions of Mylari et al., which would include humans. As an additional teach regarding utility of aldose reductase inhibitors, Mylari et al. ‘879 teach application of aldose reductase inhibitors to (abstract) “treat or prevent diabetic complications such as diabetic neuropathy, diabetic retinopathy, diabetic nephropathy, diabetic cardiomyopathy,…”. Accordingly, a person having ordinary skill in the art in seeking to apply the methods of the ‘547 patent would have been motivated to treat the conditions of instant claims 26-29, which are taught by Mylari et al. ‘879 and taught to be complications for diabetic subjects. The limitations of instant claims 31 and 32 are recited in claims 25 and 26 of the ‘547 patent. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626 Application/Control Number: 18/781,034 Page 2 Art Unit: 1626 Application/Control Number: 18/781,034 Page 3 Art Unit: 1626 Application/Control Number: 18/781,034 Page 4 Art Unit: 1626 Application/Control Number: 18/781,034 Page 5 Art Unit: 1626 Application/Control Number: 18/781,034 Page 6 Art Unit: 1626 Application/Control Number: 18/781,034 Page 7 Art Unit: 1626 Application/Control Number: 18/781,034 Page 8 Art Unit: 1626 Application/Control Number: 18/781,034 Page 9 Art Unit: 1626 Application/Control Number: 18/781,034 Page 10 Art Unit: 1626 Application/Control Number: 18/781,034 Page 11 Art Unit: 1626 Application/Control Number: 18/781,034 Page 12 Art Unit: 1626
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