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 .
Claims 1-19 are pending and under examination.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 4-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richardson et al (WO 2010/021879).
The instantly claimed invention is broadly drawn to a method of treating hyperglycemia in a patient with a Body Mass Index (BMI) of over 25 kg/m2; the method comprising: administering by inhalation an initial dose of an ultra-rapid acting insulin formulation taken at mealtime and a second dose of between 10% to 100% of said initial dose taken 30 to 150 minutes after beginning the meal (claim 1), wherein the patient regularly has a pre-meal blood glucose level greater than 100 mg/dL (claim 4), wherein the pre-meal blood glucose of the patient for a next meal is regularly greater than 140 mg/dL (claim 5), wherein the initial dose is provided in 4, 8, or 12 unit cartridges comprising the ultrarapid acting insulin formulation (claim 6-7), wherein the second dose is provided in 4, 8, or 12 unit cartridges comprising the ultrarapid acting insulin formulation (claim 8). The method of claim 1, wherein the initial dose is taken at mealtime. The method of claim 1, wherein said second dose is administered if the subject’s blood glucose level 30 to 150 minutes after beginning the meal is greater than 140 mg/dL. The method of claim 1, wherein the second dose is taken 60-150 minutes after beginning a meal (claim 11). The method of claim 11, wherein the second dose is taken 90-150 minutes after beginning a meal (claim 12). The method of claim 1, wherein the second dose is between 25% to 100% of the initial dose. The method of claim 1, wherein the ultrarapid acting insulin formulation comprises 3,6-di(succinyl-4-aminobutyl)-, 3,6-di(maleyl-4-aminobutyl)-, 3,6-di(glutaryl-4-aminobutyl)-, 3,6-di(malonyl-4-aminobutyl)-, 3,6-di(oxalyl-4-aminobutyl)-, or 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine, wherein the ultrarapid acting insulin formulation comprises 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine (claim 13-15). The method of claim 15, wherein the ultrarapid acting insulin comprises human insulin, wherein administration is by inhalation (claim 16-17).
The method of claim 17, wherein administration by inhalation comprises use of a breath-powered inhaler (claim 18), and wherein the pre-meal blood glucose is determined with continuous blood glucose monitoring (claim 19).
Richardson et al. teach treating both type of type 1 and type 2 diabetes using an ultrarapid insulin (see paragraph 0021). They teach that a dose can be determined based on meal, or it can be standard dose that is not adjusted with meal or it can be a split dose wherein said split dose formulation is administered at the beginning of the meal and at a subsequent point in time [0021]. Regarding claim 14-15, they teach that the insulin formulation is insulin-FDKP and is administered by pulmonary inhalation [0021]. They teach that the administration of ultrarapid insulin is done to mimic the meal related insulin response and it can be done within 10 min of meal or at least 5, 10, 15, 20, 30 before meal and second split dose can be between 30 and 120 min after beginning the meal [0022], this meets the limitations of claim 5 and claims 6-8. They teach that insulin-FDKP can be in cartridge having 7.5-120 IU or 15-90 IU and they teach to deliver insulin dosages preferable 6-48 IU [0023]. Regarding claims 2-5, they teach delivering insulin subcutaneous equivalent (subQ eq) units and it can be 4, 8, 12 units [0023]. This is well known in the art that diabetic subjects have fasting blood glucose level of about 126 mg/dL (see paragraph 0091, 00191] which is greater than 100 mg/dl as recited in preamble of claim 1. Regarding claim 9, they teach that if the blood glucose level after 60-120 minutes is greater than 140 mg/dl then to administer a secondary dose of the ultra-rapid insulin which is about 25%-100% of the initial dose [0158]. Regarding claims 11-13, they teach that the ultra-rapid insulin is insulin-FDKP which is the same ultra-rapid insulin as being instantly claimed. They teach that an ultrarapid insulin is 3, 6,-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine [00113, 00116]. Regarding claim 18, they teach determining blood glucose and determining pre-meal blood glucose utilizing 7-point self-monitoring blood glucose (SMBG) over a time period [00145]. Therefore, the instantly claimed invention is implicitly or explicitly anticipated by the prior art.
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.
Claim(s) 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Richardson et al. (WO 2010/021879) in view of Boss et al. (US Pub. No. 20100035795).
The instantly claimed inventio is broadly drawn to a method of treating hyperglycemia in a patient with a Body Mass Index (BMI) of over 25 kg/m2; the method comprising: administering by inhalation an initial dose of an ultra-rapid acting insulin formulation taken at mealtime and a second dose of between 10% to 100% of said initial dose taken 30 to 150 minutes after beginning the meal (claim 1), wherein the patient is currently taking metformin (claim 2), wherein the patient is currently taking a GLP-1 agonist (claim 3),wherein the patient regularly has a pre-meal blood glucose level greater than 100 mg/dL (claim 4), wherein the pre-meal blood glucose of the patient for a next meal is regularly greater than 140 mg/dL (claim 5), wherein the initial dose is provided in 4, 8, or 12 unit cartridges comprising the ultrarapid acting insulin formulation (claim 6-7), wherein the second dose is provided in 4, 8, or 12 unit cartridges comprising the ultrarapid acting insulin formulation (claim 8). The method of claim 1, wherein the initial dose is taken at mealtime. The method of claim 1, wherein said second dose is administered if the subject’s blood glucose level 30 to 150 minutes after beginning the meal is greater than 140 mg/dL. The method of claim 1, wherein the second dose is taken 60-150 minutes after beginning a meal (claim 11). The method of claim 11, wherein the second dose is taken 90-150 minutes after beginning a meal (claim 12). The method of claim 1, wherein the second dose is between 25% to 100% of the initial dose. The method of claim 1, wherein the ultrarapid acting insulin formulation comprises 3,6-di(succinyl-4-aminobutyl)-, 3,6-di(maleyl-4-aminobutyl)-, 3,6-di(glutaryl-4-aminobutyl)-, 3,6-di(malonyl-4-aminobutyl)-, 3,6-di(oxalyl-4-aminobutyl)-, or 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine, wherein the ultrarapid acting insulin formulation comprises 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine (claim 13-15). The method of claim 15, wherein the ultrarapid acting insulin comprises human insulin, wherein administration is by inhalation (claim 16-17).
The method of claim 17, wherein administration by inhalation comprises use of a breath-powered inhaler (claim 18), and wherein the pre-meal blood glucose is determined with continuous blood glucose monitoring (claim 19).
The teachings of Richardson et al. are set forth above. Richardson et al. do not teach that patient is currently taking metformin and/or GLP-1.
Boss et al. tach that a typical progression of first oral antidiabetic agent used is metformin as a suppressor of hepatic glucose output [0016]. They teach that the use of metformin is not associated with weight gain or hypoglycemia. They teach that if hyperglycemia is not controlled with metformin then a secretagogue can be added [0016]. This is well known that metformin is the first line of medicine used for treating hyperglycemia [0181]. They teach that if adequate glycemic control is not attained with metformin (Step 1) then addition of second agent like GLP-1, insulin or sulfonyl urea should be considered [0182].
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a patient population being treated with metformin and/or a GLP-1 agonist as taught by Boss et al to administer inhalable insulin as taught by Richardson et al. Additionally, one would have been motivated to do so because Boss et al teach that the treatment of a diabetic patient with metformin is the first step and then to add on a GLP-1 or insulin for further controlling hyperglycemia (see paragraph [0182]). Further, one would have a reasonable expectation of success in using metformin or GLP- 1 treat a patient having hyperglycemia because it is routine in the art and as taught by Richardson et al. Therefore, the instantly claimed invention is obvious over the combined teachings of the prior art.
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 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.
Claims 1, 4-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8-11 of U.S. Patent No. 11,013,788. Although the claims at issue are not identical, they are not patentably distinct from each other because treating diabetes comprising treating a subject with a pre-meal blood glucose level greater than 100 mg/dL comprising: administering by inhalation a split dose of up to 48 units of an ultrarapid acting insulin formulation, the split dose including an initial dose taken at mealtime and a second dose of between 10% to 100% of said initial dose taken 30 to 150 minutes after beginning a meal; wherein when pre-meal blood glucose of the subject for a next meal is greater than 100 mg/dL. The method of claim 1, wherein said second dose is administered if the subject's blood glucose level 30 to 150 minutes after beginning the meal at is greater than 140 mg/dL (claim 6). The method according to claim 1, wherein said second dose is taken 60-150 minutes after beginning a meal (claim 7). The method according to claim 7, wherein said second dose is taken 90-150 minutes after beginning a meal (claim 8). The method according to claim 1, wherein said second dose is between 25% to 100% of the initial dose (claim 9). The method according to claim 1, wherein said pre-meal blood glucose is greater than 120 mg/dl (claim 10). The method according to claim 1, wherein said ultrarapid acting insulin formulation comprises 3,6-di(succinyl-4-am inobutyl)-, 3,6-di(maleyl-4-am inobutyl)-, 3,6-di(glutaryl-4- aminobutyl)-, 3,6-di(malonyl-4-aminobutyl)-, 3,6-di(oxalyl-4-am inobutyl)-, or 3,6- di(fumaryl-4-aminobutyl)-2,5-diketopiperazine (claim 11). The method according to claim 11, wherein said ultrarapid acting insulin formulation comprises 3,6-di(fumaryl-4-aminobutyl)-2, 5-diketopiperazine (claim 12). The method of claim 12, wherein said ultrarapid acting insulin comprises human insulin (claim 13). The method of claim 13, wherein administration is by inhalation (claim 14) are taught in claims 1-6 and 8-11 of US Pat. No. 11,013,788. The instant claims do not require that the secondary dose produces an undesirably lesser, non-proportional reduction in blood glucose of claim 7 of US Pat. No. 11,013,788.
Claims 1, and 4-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-12 of U.S. Patent No. 10,307,464. Although the claims at issue are not identical, they are not patentably distinct from each other because treating diabetes comprising treating a subject with a pre-meal blood glucose level greater than 100 mg/dL comprising: administering by inhalation a split dose of up to 48 units of an ultrarapid acting insulin formulation, the split dose including an initial dose taken at mealtime and a second dose of between 10% to 100% of said initial dose taken 30 to 150 minutes after beginning a meal; wherein when pre-meal blood glucose of the subject for a next meal is greater than 100 mg/dL. The method of claim 1, wherein said second dose is administered if the subject's blood glucose level 30 to 150 minutes after beginning the meal at is greater than 140 mg/dL (claim 6). The method according to claim 1, wherein said second dose is taken 60-150 minutes after beginning a meal (claim 7). The method according to claim 7, wherein said second dose is taken 90-150 minutes after beginning a meal (claim 8). The method according to claim 1, wherein said second dose is between 25% to 100% of the initial dose (claim 9). The method according to claim 1, wherein said pre-meal blood glucose is greater than 120 mg/dl (claim 10). The method according to claim 1, wherein said ultrarapid acting insulin formulation comprises 3,6-di(succinyl-4-am inobutyl)-, 3,6-di(maleyl-4-am inobutyl)-, 3,6-di(glutaryl-4- aminobutyl)-, 3,6-di(malonyl-4-aminobutyl)-, 3,6-di(oxalyl-4-am inobutyl)-, or 3,6- di(fumaryl-4-aminobutyl)-2,5-diketopiperazine (claim 11). The method according to claim 11, wherein said ultrarapid acting insulin formulation comprises 3,6-di(fumaryl-4-aminobutyl)-2, 5-diketopiperazine (claim 12). The method of claim 12, wherein said ultrarapid acting insulin comprises human insulin (claim 13). The method of claim 13, wherein administration is by inhalation (claim 14) are taught in claims 1-7 and 9-12 of US Pat. No. 10,307,464. The instant claims do not require that the secondary dose produces an undesirably lesser, non-proportional reduction in blood glucose of claim 8 of US Pat. No. 10,307,464.
Claims 1, 4-6, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,597,374. Although the claims at issue are not identical, they are not patentably distinct from each other because treating diabetes comprising treating a subject with a pre-meal blood glucose level greater than 100 mg/dL comprising: administering by inhalation a split dose of up to 48 units of an ultrarapid acting insulin formulation, the split dose including an initial dose taken at mealtime and a second dose of between 10% to 100% of said initial dose taken 30 to 150 minutes after beginning a meal; wherein when pre-meal blood glucose of the subject for a next meal is greater than 100 mg/dL. The method of claim 1, wherein said second dose is administered if the subject's blood glucose level 30 to 150 minutes after beginning the meal at is greater than 140 mg/dL (claim 6) are taught in 1-9 of U.S. Patent No. 9,597,374.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-12 of U.S. Patent No. 10,307,464 in view of Richardson et al (WO 2010/021879). Although the claims at issue are not identical, they are not patentably distinct from each other because treating diabetes comprising treating a subject with a pre-meal blood glucose level greater than 100 mg/dL comprising: administering by inhalation a split dose of up to 48 units of an ultrarapid acting insulin formulation, the split dose including an initial dose taken at mealtime and a second dose of between 10% to 100% of said initial dose taken 30 to 150 minutes after beginning a meal; wherein when pre-meal blood glucose of the subject for a next meal is greater than 100 mg/dL. The method of claim 1, wherein said second dose is administered if the subject's blood glucose level 30 to 150 minutes after beginning the meal at is greater than 140 mg/dL (claim 6). The method according to claim 1, wherein said second dose is taken 60-150 minutes after beginning a meal (claim 7). The method according to claim 7, wherein said second dose is taken 90-150 minutes after beginning a meal (claim 8). The method according to claim 1, wherein said second dose is between 25% to 100% of the initial dose (claim 9). The method according to claim 1, wherein said pre-meal blood glucose is greater than 120 mg/dl (claim 10). The method according to claim 1, wherein said ultrarapid acting insulin formulation comprises 3,6-di(succinyl-4-am inobutyl)-, 3,6-di(maleyl-4-am inobutyl)-, 3,6-di(glutaryl-4- aminobutyl)-, 3,6-di(malonyl-4-aminobutyl)-, 3,6-di(oxalyl-4-am inobutyl)-, or 3,6- di(fumaryl-4-aminobutyl)-2,5-diketopiperazine (claim 11). The method according to claim 11, wherein said ultrarapid acting insulin formulation comprises 3,6-di(fumaryl-4-aminobutyl)-2, 5-diketopiperazine (claim 12). The method of claim 12, wherein said ultrarapid acting insulin comprises human insulin (claim 13). The method of claim 13, wherein administration is by inhalation (claim 14) are taught in claims 1-7 and 9-12 of US Pat. No. 10,307,464. US Pat. No. 10,307,464 does not recite the limitations of claims 2-4 and 15-18. Richardson et al. teach treating both type of type 1 and type 2 diabetes using an ultrarapid insulin (see paragraph 0021). Richardson et al teach that the administration of ultrarapid insulin is done to mimic the meal related insulin response and it can be done within 10 min of meal or at least 5, 10, 15, 20, 30 before meal and second split dose can be between 30 and 120 min after beginning the meal [0022], this meets the limitations of claim 5 and claims 6-8. They teach that insulin-FDKP can be in cartridge having 7.5-120 IU or 15-90 IU and they teach to deliver insulin dosages preferable 6-48 IU [0023]. Regarding claims 2-5, they teach delivering insulin subcutaneous equivalent (subQ eq) units and it can be 4, 8, 12 units [0023]. Richardson et al. teach treating both type of type 1 and type 2 diabetes using an ultrarapid insulin (see paragraph 0021). They teach that a dose can be determined based on meal, or it can be standard dose that is not adjusted with meal or it can be a split dose wherein said split dose formulation is administered at the beginning of the meal and at a subsequent point in time [0021]. Regarding claim 14-15, they teach that the insulin formulation is insulin-FDKP and is administered by pulmonary inhalation [0021]. Regarding claim 18, they teach determining blood glucose and determining pre-meal blood glucose utilizing 7-point self-monitoring blood glucose (SMBG) over a time period [00145]. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to treat a subject having type 1 or type 2 diabetes using initial dose comprising up to 12 units, wherein said pre-meal BG is determined with continuous blood glucose monitoring as taught by Richardson et al for in treating a diabetic subject using a split dose of ultrarapid insulin as taught by claims 1-7 and 9-12 of U.S. Patent No. 10,307,464.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8-11 of U.S. Patent No. 11,013,788 in view of Richardson et al. (WO 2010/021879). Although the claims at issue are not identical, they are not patentably distinct from each other because treating diabetes comprising treating a subject with a pre-meal blood glucose level greater than 100 mg/dL comprising: administering by inhalation a split dose of up to 48 units of an ultrarapid acting insulin formulation, the split dose including an initial dose taken at mealtime and a second dose of between 10% to 100% of said initial dose taken 30 to 150 minutes after beginning a meal; wherein when pre-meal blood glucose of the subject for a next meal is greater than 100 mg/dL. The method of claim 1, wherein said second dose is administered if the subject's blood glucose level 30 to 150 minutes after beginning the meal at is greater than 140 mg/dL (claim 6). The method according to claim 1, wherein said second dose is taken 60-150 minutes after beginning a meal (claim 7). The method according to claim 7, wherein said second dose is taken 90-150 minutes after beginning a meal (claim 8). The method according to claim 1, wherein said second dose is between 25% to 100% of the initial dose (claim 9). The method according to claim 1, wherein said pre-meal blood glucose is greater than 120 mg/dl (claim 10). The method according to claim 1, wherein said ultrarapid acting insulin formulation comprises 3,6-di(succinyl-4-am inobutyl)-, 3,6-di(maleyl-4-am inobutyl)-, 3,6-di(glutaryl-4- aminobutyl)-, 3,6-di(malonyl-4-aminobutyl)-, 3,6-di(oxalyl-4-am inobutyl)-, or 3,6- di(fumaryl-4-aminobutyl)-2,5-diketopiperazine (claim 11). The method according to claim 11, wherein said ultrarapid acting insulin formulation comprises 3,6-di(fumaryl-4-aminobutyl)-2, 5-diketopiperazine (claim 12). The method of claim 12, wherein said ultrarapid acting insulin comprises human insulin (claim 13). The method of claim 13, wherein administration is by inhalation (claim 14) are taught in claims 1-6 and 8-11 of US Pat. No. 11,013,788. The instant claims do not require that the secondary dose produces an undesirably lesser, non-proportional reduction in blood glucose of claim 7 of US Pat. No. 11,013,788. US Pat. No. 11,013,788 does not recite the limitations of claims 2-4 and 15-18. Richardson et al. teach treating both type of type 1 and type 2 diabetes using an ultrarapid insulin (see paragraph 0021). Richardson et al teach that the administration of ultrarapid insulin is done to mimic the meal related insulin response and it can be done within 10 min of meal or at least 5, 10, 15, 20, 30 before meal and second split dose can be between 30 and 120 min after beginning the meal [0022], this meets the limitations of claim 5 and claims 6-8. They teach that insulin-FDKP can be in cartridge having 7.5-120 IU or 15-90 IU and they teach to deliver insulin dosages preferable 6-48 IU [0023]. Regarding claims 2-5, they teach delivering insulin subcutaneous equivalent (subQ eq) units and it can be 4, 8, 12 units [0023]. Richardson et al. teach treating both type of type 1 and type 2 diabetes using an ultrarapid insulin (see paragraph 0021). They teach that a dose can be determined based on meal, or it can be standard dose that is not adjusted with meal or it can be a split dose wherein said split dose formulation is administered at the beginning of the meal and at a subsequent point in time [0021]. Regarding claim 14-15, they teach that the insulin formulation is insulin-FDKP and is administered by pulmonary inhalation [0021]. Regarding claim 18, they teach determining blood glucose and determining pre-meal blood glucose utilizing 7-point self-monitoring blood glucose (SMBG) over a time period [00145]. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to treat a subject having type 1 or type 2 diabetes using initial dose comprising up to 12 units, wherein said pre-meal BG is determined with continuous blood glucose monitoring as taught by Richardson et al for in treating a diabetic subject using a split dose of ultrarapid insulin as taught by claims 1-6 and 8-11 of U.S. Patent No. 11,013,788.
Claims 1 and 3-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8-11 of U.S. Patent No. 11,931,404. Although the claims at issue are not identical, they are not patentably distinct from each other because treating hyperglycemia in a patient with a Body Mass Index (BMI) of over 25 kg/m2; the method comprising: administering by inhalation an initial dose of an ultra-rapid acting insulin formulation taken at mealtime and a second dose of between 10% to 100% of said initial dose taken 30 to 150 minutes after beginning the meal (claim 1), wherein the patient is currently taking a GLP-1 agonist (claim 3),wherein the patient regularly has a pre-meal blood glucose level greater than 100 mg/dL (claim 4), wherein the pre-meal blood glucose of the patient for a next meal is regularly greater than 140 mg/dL (claim 5), wherein the initial dose is provided in 4, 8, or 12 unit cartridges comprising the ultrarapid acting insulin formulation (claim 6-7), wherein the second dose is provided in 4, 8, or 12 unit cartridges comprising the ultrarapid acting insulin formulation (claim 8). The method of claim 1, wherein the initial dose is taken at mealtime. The method of claim 1, wherein said second dose is administered if the subject’s blood glucose level 30 to 150 minutes after beginning the meal is greater than 140 mg/dL. The method of claim 1, wherein the second dose is taken 60-150 minutes after beginning a meal (claim 11). The method of claim 11, wherein the second dose is taken 90-150 minutes after beginning a meal (claim 12). The method of claim 1, wherein the second dose is between 25% to 100% of the initial dose. The method of claim 1, wherein the ultrarapid acting insulin formulation comprises 3,6-di(succinyl-4-aminobutyl)-, 3,6-di(maleyl-4-aminobutyl)-, 3,6-di(glutaryl-4-aminobutyl)-, 3,6-di(malonyl-4-aminobutyl)-, 3,6-di(oxalyl-4-aminobutyl)-, or 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine, wherein the ultrarapid acting insulin formulation comprises 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine (claim 13-15). The method of claim 15, wherein the ultrarapid acting insulin comprises human insulin, wherein administration is by inhalation (claim 16-17). The method of claim 17, wherein administration by inhalation comprises use of a breath-powered inhaler (claim 18), and wherein the pre-meal blood glucose is determined with continuous blood glucose monitoring (claim 19) are taught by claims 1-19 of U.S. Patent No. 11,931,404.
Conclusion
No claim is allowed.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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