DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-17 are pending and under consideration.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show a clear graph in FIG. 9, FIG.10, FIG.11 and FIG. 15 as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 1-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barnett et al. (Diabetes Care 29: 1818-1825, 2006) in view of Gelber et al (US Pub. No. 20060153778) and Cheatham et al (US Pub. No. 20060239934).
It is noted to applicants that the administered formulation to an overweight diabetes is same, therefore, the outcome of the treatment would be the same whether the prior art measure the weight of a subject after treatment or not (see Nguyen et al. Obes. Surg. 2011, 21: 351-355).
The instantly claimed invention is broadly drawn to a method of improving post-prandial blood glucose homeostasis in an overweight patient with type 2 diabetes currently being treated with a suppressor of hepatic glucose output, said method comprising: administering an ultrarapid acting insulin (URAI) preparation with at least one established meal; wherein said treatment results in weight loss or reduced weight gain as compared to treatment with a suppressor of hepatic glucose output alone (claim 1), wherein said URAI is administered by inhalation (claim 2), wherein the URAI is a dry powder (claim 3), wherein the URAI comprises 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine and X is fumaryl (claims 4-5), wherein the insulin comprises human recombinant insulin (claims 6-7), wherein the dry powder is crystalline and is in a cartridge (8, 12), wherein said cartridge comprises 4, 8, or 12 units of insulin (claim 13), wherein said crystalline dry powder is administered using an inhaler (claim 14), wherein said treatment results in weight loss as compared to treatment with a suppressor of hepatic glucose output alone (claim 15), and wherein said treatment results in reduced weight gain as compared to treatment with a suppressor of hepatic glucose output alone (claim 16).
Barnett et al. teach selecting a patient population having type 2 diabetes using a criterion of Hba1C (A1C) (page 1818, Research Design and Methods; page 1819, left column). They teach administering inhaled insulin (Exubera) dry powder formulation and inhaler system developed by Pfizer and teach administering the formulation within 10 min before meals (page 1819, middle column). They teach that the administration of inhaled insulin controls blood glucose better than metformin alone or when metformin is used with a sulfonyl urea (e.g., Glibenclamide) (see Table-1).They teach administering a dose of inhaled insulin which comes in 1 mg and 3 mg doses and each mg is about 2.5-3.0 units of subcutaneously injected insulin (page 1819, middle column), therefore, the dosages are in the range of 1 to 32 subcutaneous equivalent units. This suggests using insulin by inhalation in subject who were on metformin and/or sulfonyl urea. Barnett et al do not teach to use insulin-FDKP as an ultrarapid insulin and they do not teach inhaled insulin preparation comprising FDKP associated with insulin or insulin-FDKP.
Gelber et al teach that the administration of Technosphere dry powder glargine to a subject reduced HbA1c level in a dose dependent manner [0104]. They teach administering insulin-FDKP in patients with type 2 diabetes by inhalation (in lungs) of Technosphere/Insulin (TI) [103]. Gelber et al teach that the study has demonstrated that Technosphere pulmonary insulin (insulin-FDKP), when used in patients with an adequate glycemic control previously only diet and exercise alone or on oral agent therapy, safely and significantly improved glycemic control and with no evidence of overall impact on pulmonary function [0113].
Cheatham et al teach that the administration of Technosphere dry powder glargine to a subject provides glycemic control when administered from 10 minutes before to 30 minutes after the beginning of a meal (Example 6). Cheatham et al teach that Technosphere/Insulin markedly improved post-prandial glucose control compared to prandial SC while total serum insulin concentrations were comparable between both treatments [0190]. They teach administering insulin-FDKP (i.e., ultrarapid insulin) in patients with type 2 diabetes by inhalation of Technosphere/Insulin (TI) [0192].
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 an ultrarapid insulin which is inhalable insulin as taught by Gelber et al and in the form of dry powder as taught by Cheatham et al to replace the rapid insulin taught by Bernett et al and to use a functionally equivalent in inhalable form of insulin as taught by Bernett et al., and diabetic patients are in general overweight or obese, unless claim indicates that the treatment is for non-obese subject. One would have been motivated to do so because both Gelber et al and Cheatham et al teach treating hyperglycemia in type 2 diabetic (in general obese, overweight) subject using insulin-FDKP inhalable formulation which is fast acting insulin and it has peak blood concentration faster than subcutaneously administered insulin. Further, one would have a reasonable expectation of success in using insulin-FDKP inhalable formulation in the form of dry powder because both Gelber et al and Cheatham et al teach treating hyperglycemia in type 2 diabetic subject using the same. Therefore, the instantly claimed invention would have been obvious over the combined teachings of the prior art.
Claim 17 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barnett et al. (Diabetes Care (Diabetes Care 29: 1818-1825, 2006) in view of Gelber et al (US Pub. No. 20060153778) and Cheatham et al (US Pub. No. 20060239934) as applied to claims 1-16 above, and further in view of Glaesner et al. (US Pub. No. 20060252693 A1).
The instantly claimed invention is broadly drawn to a method of improving post-prandial blood glucose homeostasis in an overweight patient with type 2 diabetes currently being treated with a suppressor of hepatic glucose output, said method comprising: administering an ultrarapid acting insulin (URAI) preparation with at least one established meal; wherein said treatment results in weight loss or reduced weight gain as compared to treatment with a suppressor of hepatic glucose output alone (claim 1) and further comprising administering a GLP-1 agonist.
The teachings of Barnett et al., Gelber et al. and Cheatham et al are summarized as set forth above. Neither Barnett et al., Gelber et al. nor Cheatham et al teaches administering a GLP-1 agonist with inhalable insulin treatment as taught above.
Glaesner et teach administering a GLP-1 agonist to treat a subject having type-2 diabetes and obesity (see claim 80).
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 GLP-1 agonist as taught by Glaesner et al with an ultrarapid insulin which is inhalable insulin as taught by Gelber et al., Cheatham et al and Bernett et al for treating a type-2 diabetic subject with obesity. One would have been motivated to do so because both Glaesner et al teach treating diabetes and obesity with GLP-1 agonist which is same patient population as set forth above. Further, one would have a reasonable expectation of success in using GLP-1 agonist for treating type-2 diabetes as being treated with insulin-FDKP inhalable formulation in the form of dry powder because the subject population of type 2 diabetic subject is same for both treatments. Therefore, the instantly claimed invention would have been 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 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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8 and 10-12 of U.S. Patent No. 8,119,593. Although the claims at issue are not identical, they are not patentably distinct from each other because a method of improving post-prandial blood glucose homeostasis in an overweight patient with type 2 diabetes currently being treated with a suppressor of hepatic glucose output, said method comprising: administering an ultrarapid acting insulin (URAI) preparation with at least one established meal; wherein said treatment results in weight loss or reduced weight gain as compared to treatment with a suppressor of hepatic glucose output alone, wherein the suppressor of hepatic glucose is metformin, wherein the ultrarapid acting insulin preparation is administered by inhalation, wherein the ultrarapid acting insulin preparation is a dry powder and wherein ultrarapid acting insulin preparation comprises a fumaryl diketopiperazine (FDKP) associated with insulin. A method of treating diabetes type 2, comprising: selecting a patient with diabetes type 2 currently being treated with a suppressor of hepatic glucose output and an insulin secretagogue; discontinuing treatment with the insulin secretagogue; and routinely administering an ultrarapid acting insulin (URAI) preparation with at least one established meal, wherein the insulin secretagogue is a sulfonylurea, wherein the URAI preparation is not administered by injection, wherein the URAI preparation is administered by inhalation, and wherein the URAI preparation is administered by inhalation into the lungs are taught in claims 1-3, 8 and 10-12 of U.S. Patent No. 8,119,593.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,7-13 of U.S. Patent No. 8,623,817. Although the claims at issue are not identical, they are not patentably distinct from each other because a method of improving post-prandial blood glucose homeostasis in an overweight patient with type 2 diabetes currently being treated with a suppressor of hepatic glucose output, said method comprising: administering an ultrarapid acting insulin (URAI) preparation with at least one established meal; wherein said treatment results in weight loss or reduced weight gain as compared to treatment with a suppressor of hepatic glucose output alone, wherein the suppressor of hepatic glucose is metformin, wherein the ultrarapid acting insulin preparation is administered by inhalation, wherein the ultrarapid acting insulin preparation is a dry powder and wherein ultrarapid acting insulin preparation comprises a fumaryl diketopiperazine (FDKP) associated with insulin. A method of treating diabetes type 2, comprising: selecting a patient with diabetes type 2 currently being treated with a suppressor of hepatic glucose output and an insulin secretagogue; discontinuing treatment with the insulin secretagogue; and routinely administering an ultrarapid acting insulin (URAI) preparation with at least one established meal, wherein the insulin secretagogue is a sulfonylurea, wherein the URAI preparation is not administered by injection, wherein the URAI preparation is administered by inhalation, and wherein the URAI preparation is administered by inhalation into the lungs are taught in claims 1, 7-13 of U.S. Patent No. 8,119,593.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8 and 10-12 of U.S. Patent No. 8,119,593 in view of Glaesner et al. (US Pub. No. 20060252693 A1).
The teachings of claims 1-3, 8 and 10-12 of U.S. Patent No. 8,119,593 are set forth above. Claims 1-3, 8 and 10-12 of U.S. Patent No. 8,119,593 do not teach to further administer GLP-1 agonist with the URAI to a subject having type-2 diabetes.
Glaesner et teach administering a GLP-1 agonist to treat a subject having type-2 diabetes and obesity (see claim 80).
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 GLP-1 agonist as taught by Glaesner et al with an ultrarapid insulin which is inhalable insulin as taught claims 1-3, 8 and 10-12 of U.S. Patent No. 8,119,593. One would have been motivated to do so because both Glaesner et al teach treating diabetes and obesity with GLP-1 agonist which is same patient population as set forth above. Further, one would have a reasonable expectation of success in using GLP-1 agonist for treating type-2 diabetes as being treated with insulin-FDKP inhalable formulation in the form of dry powder because the subject population of type 2 diabetic subject is same for both treatments. Therefore, the instantly claimed invention would have been obvious over the combined teachings of the prior art.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,7-13 of U.S. Patent No. 8,623,817 in view of Glaesner et al. (US Pub. No. 20060252693 A1).
Glaesner et teach administering a GLP-1 agonist to treat a subject having type-2 diabetes and obesity (see claim 80).
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 GLP-1 agonist as taught by Glaesner et al with an ultrarapid insulin which is inhalable insulin as taught claims 1 and 7-13 of U.S. Patent No. 8,623,817. One would have been motivated to do so because both Glaesner et al teach treating diabetes and obesity with GLP-1 agonist which is same patient population as set forth above. Further, one would have a reasonable expectation of success in using GLP-1 agonist for treating type-2 diabetes as being treated with insulin-FDKP inhalable formulation in the form of dry powder because the subject population of type 2 diabetic subject is same for both treatments. Therefore, the instantly claimed invention would have been obvious over the combined teachings of the prior art.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8-11 of U.S. Patent No. 11,998,591. Although the claims at issue are not identical, they are not patentably distinct from each other because a method of improving post-prandial blood glucose homeostasis in an overweight patient with type 2 diabetes currently being treated with a suppressor of hepatic glucose output, said method comprising: administering an ultrarapid acting insulin (URAI) preparation with at least one established meal; wherein said treatment results in weight loss or reduced weight gain as compared to treatment with a suppressor of hepatic glucose output alone, wherein the suppressor of hepatic glucose is metformin, wherein the ultrarapid acting insulin preparation is administered by inhalation, wherein the ultrarapid acting insulin preparation is a dry powder and wherein ultrarapid acting insulin preparation comprises a fumaryl diketopiperazine (FDKP) associated with insulin. A method of treating diabetes type 2, comprising: selecting a patient with diabetes type 2 currently being treated with a suppressor of hepatic glucose output and an insulin secretagogue; discontinuing treatment with the insulin secretagogue; and routinely administering an ultrarapid acting insulin (URAI) preparation with at least one established meal, wherein the insulin secretagogue is a sulfonylurea, wherein the URAI preparation is not administered by injection, wherein the URAI preparation is administered by inhalation, and wherein the URAI preparation is administered by inhalation into the lungs and the method further comprising administering a GLP-1 agonist are taught in claims 1-6 and 8-11 of U.S. Patent No. 11,998,591.
Conclusion
No claim is allowed.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
