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 .
Election/Restrictions
Applicants’ election of group I (Claims 1-21) in the reply filed 8 May 2026 is acknowledged.
Applicants’ election of a single and specific subject population to administer treatment to being type-2 diabetics and a single and specific route of administration for the method of reducing the incidence of hypoglycemia in the reply filed 8 May 2026 is acknowledged.
Claims 2, 5, 12, 14, 19 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on 8 May 2026.
Claims 1, 3-4, 6-11, 13, 15-18 and 20 are under consideration.
Status of Claims
The claim listing filed 8 May 2026 is pending. Applicant elected, without traverse, Group I, claims 1, 3-4, 6-11, 13, 15-18 and 20. Claim 22 has been canceled. Claims 2, 5, 12, 14, 19 and 21 are withdrawn from further consideration for the reasons set forth above, 37 CFR 1.142(b). Claim 13 has been canceled. Claims 1-4, 6-13, 15-20 are being examined on the merits in this office action.
The search was expanded to include the limitation of the subject being a type-1 diabetic (claims 2, 12, and 19).
The species election as set forth in the species election requirement mailed 17 November 2026 is maintained.
Priority
The present application claims benefit under 35 U.S.C. 119(e) to U.S. Provisional Application No. 63/340,723 filed 11 May 2022. Applicants claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365 (c) is acknowledged regarding claims 1-4, 6-13, 15-17.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/340,723, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 18-20 are drawn to a method of reducing the incidence of hypoglycemia in an insulin requiring subject who is administered insulin either via regular doses of insulin or via continuous subcutaneous infusion comprising administering to the subject C-peptide when the subject is exercising or before the subject begins exercising. U.S. Provisional Application No. 63/340,723 does not reference reducing the incidence of hypoglycemia in an insulin-requiring subject when or before the subject starts exercising. Accordingly, claims 18-20 are not entitled to the benefit of the prior-filed provisional application. Claims 18-20 are still entitled to the benefit of the effective filing date of the instant application (11 May 2023).
Information Disclosure Statement
The Information Disclosure Statements (IDSs) submitted on 09 January 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the examiner.
35 USC § 101
Examiner does not reject claims 1, 3-4, 6-11, 13, 15-18 and 20 under 35 U.S.C 101 due to the results of the following subject matter eligibility test using the generic claim, claims 1, 9 and 18:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes. The dependent claims are drawn to methods of reducing the incidence of hypoglycemia in an insulin-requiring subject who is administered insulin either via regular doses of insulin or via continuous subcutaneous infusion comprising administering to the subject C-peptide.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon or an abstract idea?
Yes. The claim is directed to a method of using a natural product (C-peptide). The closest natural counterpart to the instant invention as claimed would be the peptide, C-peptide. According to Orci et al. (“Conversion of proinsulin to insulin occurs coordinately with acidification of maturing secretory vesicles.” J Cell Biol. 1986 Dec;103(6 Pt 1):2273-81. doi: 10.1083/jcb.103.6.2273. PMID: 3536964; PMCID: PMC2114621.), proinsulin is a single polypeptide chain formed by two subunits, the A chain, the B chain and the two are joined together via the C-peptide (pg. 2273, [Abstract] “Proinsulin is a single polypeptide chain composed of the B and A subunits of insulin joined by the C-peptide region.”).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Yes. The claim recites the limitation "A method of reducing the incidence of hypoglycemia … comprising administering to the subject C-peptide…". The administration of C-peptide is not routine and conventional, therefore making the administration step the “significantly more” needed to make the claims eligible subject matter under 35 U.S.C 101.
Therefore, claims 1, 9 and 18 of the instant application, and in turn their dependent claims, recite a method of using a natural product with elements that amount to significantly more than the judicial exception and are exempt this rejection.
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.
Claims 1-2, 4 and 8 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Johansson et al., hereafter “Johansson” (“Influence of combined C-peptide and insulin administration on renal function and metabolic control in diabetes type 1.” J Clin Endocrinol Metab. 1993;77(4):976–981., as cited in the IDS filed 09 January 2024).
Regarding claim 1, Johansson teaches the delivery of C-Peptide through a continuous subcutaneous infusion pump together with the patients’ regular insulin therapy to type-1 diabetics (pg. 976, “Subjects and Methods: Eighteen type 1 diabetic patients between 18 and 26 yr of age participated in the study. … Both groups received SC infusions of insulin and C-peptide, as applicable, using insulin pumps …”). Johansson also teaches that pancreatic β-cells are almost totally destroyed in patients with type 1 diabetes (pg. 976 “Insulin and C-peptide are synthesized in equimolar amounts in pancreatic β-cells (l), which are almost totally destroyed in patients with type 1 diabetes.”).
Regarding the limitation “a method for reducing the incidence of hypoglycemia”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art peptide is capable of performing the intended use, then it meets the claim. The administration method used as described in Johansson is the same administration method described in the instant claim; thus it is interpreted as being sufficient for reducing the incidence of hypoglycemia as described in the instant claim. The teachings of Johansson include the same step, the same compound and the same patient population.
Regarding claim 2, Johansson teaches the patient population being type-1 diabetics (pg. 976, “Subjects and Methods: Eighteen type 1 diabetic patients between 18 and 26 yr of age participated in the study.”).
Regarding claim 4, Johansson teaches the delivery of C-Peptide using continuous subcutaneous infusion (pg. 976, “received SC infusions of insulin and C-peptide, as applicable, using insulin pumps …”).
Regarding claim 8, Johansson teaches the delivery of C-Peptide using an insulin pump (pg. 976, “received SC infusions of insulin and C-peptide, as applicable, using insulin pumps …”).
Claims 9-12 and 17 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Johansson et al., hereafter “Johansson” (“Influence of combined C-peptide and insulin administration on renal function and metabolic control in diabetes type 1. J Clin Endocrinol Metab. 1993;77(4):976–981., as cited in the IDS filed 09 January 2024).
Regarding claim 9, Johansson teaches the delivery of C-Peptide through a continuous subcutaneous infusion pump together with the patients’ regular insulin therapy to type-1 diabetics (pg. 976, “Subjects and Methods: Eighteen type 1 diabetic patients between 18 and 26 yr of age participated in the study. … Both groups received SC infusions of insulin and C-peptide, as applicable, using insulin pumps …”). Johansson also teaches that pancreatic β-cells are almost totally destroyed in patients with type 1 diabetes (pg. 976 “Insulin and C-peptide are synthesized in equimolar amounts in pancreatic β-cells (l), which are almost totally destroyed in patients with type 1 diabetes.”).
Regarding the limitation “a method for reducing the incidence of hypoglycemia”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art peptide is capable of performing the intended use, then it meets the claim. The administration method used as described in Johansson is the same administration method described in the instant claim; thus it is interpreted as being sufficient for reducing the incidence of hypoglycemia as described in the instant claim. The teachings of Johansson include the same step, the same compound and the same patient population.
The only difference between the teaching of Johansson and the instant application is Johansson does not explicitly teach a molar dose ratio of C-Peptide to insulin being greater than 1:1.
It would be obvious to artisan to arrive at molar ratio because it is routine optimization.
Regarding claim 10, Johansson teaches the delivery of C-Peptide through a continuous subcutaneous infusion pump together with the patients’ regular insulin therapy to type-1 diabetics (pg. 976, “Subjects and Methods: Eighteen type 1 diabetic patients between 18 and 26 yr of age participated in the study. … Both groups received SC infusions of insulin and C-peptide, as applicable, using insulin pumps …”).
The only difference between the teaching of Johansson and the instant application is Johansson does not explicitly teach a molar dose ratio of C-Peptide to insulin being about 1.5:1.
It would be obvious to artisan to arrive at molar ratio because it is routine optimization.
Regarding claim 11, Johansson teaches the delivery of C-Peptide through a continuous subcutaneous infusion pump together with the patients’ regular insulin therapy to type-1 diabetics (pg. 976, “Subjects and Methods: Eighteen type 1 diabetic patients between 18 and 26 yr of age participated in the study. … Both groups received SC infusions of insulin and C-peptide, as applicable, using insulin pumps …”).
The only difference between the teaching of Johansson and the instant application is Johansson does not explicitly teach a molar dose ratio of C-Peptide to insulin being about than 2:1.
It would be obvious to artisan to arrive at molar ratio because it is routine optimization.
Regarding claim 12, Johansson teaches the patient population being type-1 diabetics (pg. 976, “Subjects and Methods: Eighteen type 1 diabetic patients between 18 and 26 yr of age participated in the study.”).
Regarding claim 17, Johansson teaches the delivery of C-Peptide using an insulin pump (pg. 976, “received SC infusions of insulin and C-peptide, as applicable, using insulin pumps …”).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Johansson et al., hereafter “Johansson” (“Influence of combined C-peptide and insulin administration on renal function and metabolic control in diabetes type 1.” J Clin Endocrinol Metab. 1993;77(4):976–981., as cited in the IDS filed 09 January 2024), as applied to claim 1 above, and in further view of Prentki and Nolan, hereafter “Prentki” (“Islet beta cell failure in type 2 diabetes.” J Clin Invest. 2006 Jul;116(7):1802-12. doi: 10.1172/JCI29103. PMID: 16823478; PMCID: PMC1483155.).
Regarding claim 3, Johansson teaches the delivery of C-Peptide through a continuous subcutaneous infusion pump together with the patients’ regular insulin therapy to type-1 diabetics (pg. 976, “Subjects and Methods: Eighteen type 1 diabetic patients between 18 and 26 yr of age participated in the study. … Both groups received SC infusions of insulin and C-peptide, as applicable, using insulin pumps …”). Johansson also teaches that pancreatic β-cells are almost totally destroyed in patients with type 1 diabetes (pg. 976 “Insulin and C-peptide are synthesized in equimolar amounts in pancreatic β-cells (l), which are almost totally destroyed in patients with type 1 diabetes.”).
Johansson does not teach the subject being a type-2 diabetic.
Prentki teaches that the natural history of type-2 diabetes (T2D) entails deterioration in β cell function (pg. 1802,“Furthermore, the natural history of T2D entails progressive deterioration in β cell function …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johansson’s teachings with the teachings of Prentki because Johansson teaches the method of administering C-peptide to insulin requiring subjects with destroyed β-cells, while Prentki teaches that deterioration of β-cell function is included in the natural history of type-2 diabetes. One of ordinary skill in the art would have been motivated before the effective filing date of the instant invention would have had a reasonable expectation of success because Johansson teaches the administration of C-peptide to patients with β-cells that are almost totally destroyed, something that is important to those suffering from hypoglycemia and that deterioration of β-cell function is natural in T2D.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Johansson et al., hereafter “Johansson” (“Influence of combined C-peptide and insulin administration on renal function and metabolic control in diabetes type 1. J Clin Endocrinol Metab. 1993;77(4):976–981., as cited in the IDS filed 09 January 2024), as applied to claim 1 above, and in further view of Orci et al. hereafter “Orci” (“Conversion of proinsulin to insulin occurs coordinately with acidification of maturing secretory vesicles.” J Cell Biol. 1986 Dec;103(6 Pt 1):2273-81. doi: 10.1083/jcb.103.6.2273. PMID: 3536964; PMCID: PMC2114621.).
Regarding claim 6, Johansson teaches the delivery of C-Peptide through a continuous subcutaneous infusion pump together with the patients’ regular insulin therapy to type-1 diabetics (pg. 976, “Subjects and Methods: Eighteen type 1 diabetic patients between 18 and 26 yr of age participated in the study. … Both groups received SC infusions of insulin and C-peptide, as applicable, using insulin pumps …”). Johansson also teaches that pancreatic β-cells are almost totally destroyed in patients with type 1 diabetes (pg. 976 “Insulin and C-peptide are synthesized in equimolar amounts in pancreatic β-cells (l), which are almost totally destroyed in patients with type 1 diabetes.”).
Johansson does not teach the C-peptide being a part of a larger peptide.
Orci teaches that proinsulin is a single polypeptide chain formed by two subunits, the A chain, the B chain and the two are joined together via the C-peptide (pg. 2273, [Abstract] “Proinsulin is a single polypeptide chain composed of the B and A subunits of insulin joined by the C-peptide region.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johansson’s teachings with the teachings of Orci because Johansson teaches the method of administering C-peptide to insulin requiring subjects with destroyed β-cells, while Orci teaches that C-peptide is a part of a larger molecule (proinsulin). One of ordinary skill in the art would have been motivated before the effective filing date of the instant invention would have had a reasonable expectation of success because Johansson teaches the administration of C-peptide to patients with β-cells that are almost totally destroyed, something that is important to those suffering from hypoglycemia and that deterioration of β-cell function, while Orci teaches that proinsulin contains C-peptide, making it a part of a larger molecule.
Regarding claim 7, Orci teaches that proinsulin is a single polypeptide chain formed by two subunits, the A chain, the B chain and the two are joined together via the C-peptide (pg. 2273, [Abstract] “Proinsulin is a single polypeptide chain composed of the B and A subunits of insulin joined by the C-peptide region.”).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Johansson et al., hereafter “Johansson” (“Influence of combined C-peptide and insulin administration on renal function and metabolic control in diabetes type 1. J Clin Endocrinol Metab. 1993;77(4):976–981., as cited in the IDS filed 09 January 2024) , as applied to claim 9 above, and in further view of Prentki and Nolan, hereafter “Prentki” (“Islet beta cell failure in type 2 diabetes.” J Clin Invest. 2006 Jul;116(7):1802-12. doi: 10.1172/JCI29103. PMID: 16823478; PMCID: PMC1483155.).
Regarding claim 13, Johansson teaches the delivery of C-Peptide through a continuous subcutaneous infusion pump together with the patients’ regular insulin therapy to type-1 diabetics (pg. 976, “Subjects and Methods: Eighteen type 1 diabetic patients between 18 and 26 yr of age participated in the study. … Both groups received SC infusions of insulin and C-peptide, as applicable, using insulin pumps …”). Johansson also teaches that pancreatic β-cells are almost totally destroyed in patients with type 1 diabetes (pg. 976 “Insulin and C-peptide are synthesized in equimolar amounts in pancreatic β-cells (l), which are almost totally destroyed in patients with type 1 diabetes.”).
Johansson does not teach the subject being a type-2 diabetic.
Prentki teaches that the natural history of type-2 diabetes (T2D) entails deterioration in β cell function (pg. 1802,“Furthermore, the natural history of T2D entails progressive deterioration in β cell function …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johansson’s teachings with the teachings of Prentki because Johansson teaches the method of administering C-peptide to insulin requiring subjects with destroyed β-cells, while Prentki teaches that deterioration of β-cell function is included in the natural history of type-2 diabetes. One of ordinary skill in the art would have been motivated before the effective filing date of the instant invention would have had a reasonable expectation of success because Johansson teaches the administration of C-peptide to patients with β-cells that are almost totally destroyed, something that is important to those suffering from hypoglycemia and that deterioration of β-cell function is natural in T2D.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Johansson et al., hereafter “Johansson” (“Influence of combined C-peptide and insulin administration on renal function and metabolic control in diabetes type 1. J Clin Endocrinol Metab. 1993;77(4):976–981., as cited in the IDS filed 09 January 2024), as applied to claim 9 above, and in further view of Orci et al. hereafter “Orci” (“Conversion of proinsulin to insulin occurs coordinately with acidification of maturing secretory vesicles.” J Cell Biol. 1986 Dec;103(6 Pt 1):2273-81. doi: 10.1083/jcb.103.6.2273. PMID: 3536964; PMCID: PMC2114621.).
Regarding claim 15, Johansson teaches the delivery of C-Peptide through a continuous subcutaneous infusion pump together with the patients’ regular insulin therapy to type-1 diabetics (pg. 976, “Subjects and Methods: Eighteen type 1 diabetic patients between 18 and 26 yr of age participated in the study. … Both groups received SC infusions of insulin and C-peptide, as applicable, using insulin pumps …”). Johansson also teaches that pancreatic β-cells are almost totally destroyed in patients with type 1 diabetes (pg. 976 “Insulin and C-peptide are synthesized in equimolar amounts in pancreatic β-cells (l), which are almost totally destroyed in patients with type 1 diabetes.”).
Johansson does not teach the C-peptide being a part of a larger peptide.
Orci teaches that proinsulin is a single polypeptide chain formed by two subunits, the A chain, the B chain and the two are joined together via the C-peptide (pg. 2273, [Abstract] “Proinsulin is a single polypeptide chain composed of the B and A subunits of insulin joined by the C-peptide region.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johansson’s teachings with the teachings of Orci because Johansson teaches the method of administering C-peptide to insulin requiring subjects with destroyed β-cells, while Orci teaches that C-peptide is a part of a larger molecule (proinsulin). One of ordinary skill in the art would have been motivated before the effective filing date of the instant invention would have had a reasonable expectation of success because Johansson teaches the administration of C-peptide to patients with β-cells that are almost totally destroyed, something that is important to those suffering from hypoglycemia and that deterioration of β-cell function, while Orci teaches that proinsulin contains C-peptide, making it a part of a larger molecule.
Regarding claim 16, Orci teaches that proinsulin is a single polypeptide chain formed by two subunits, the A chain, the B chain and the two are joined together via the C-peptide (pg. 2273, [Abstract] “Proinsulin is a single polypeptide chain composed of the B and A subunits of insulin joined by the C-peptide region.”).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Johansson et al., hereafter “Johansson” (“Influence of combined C-peptide and insulin administration on renal function and metabolic control in diabetes type 1. J Clin Endocrinol Metab. 1993;77(4):976–981., as cited in the IDS filed 09 January 2024) and Villines (“Exercise-induced hypoglycemia: Signs and prevention.” Medical News Today. (2022, January 13). https://www.medicalnewstoday.com/articles/exercise-induced-hypoglycemia-what-to-know).
Regarding claim 18, Johansson teaches the delivery of C-Peptide through a continuous subcutaneous infusion pump together with the patients’ regular insulin therapy to type-1 diabetics (pg. 976, “Subjects and Methods: Eighteen type 1 diabetic patients between 18 and 26 yr of age participated in the study. … Both groups received SC infusions of insulin and C-peptide, as applicable, using insulin pumps …”). Johansson also teaches that pancreatic β-cells are almost totally destroyed in patients with type 1 diabetes (pg. 976 “Insulin and C-peptide are synthesized in equimolar amounts in pancreatic β-cells (l), which are almost totally destroyed in patients with type 1 diabetes.”).
Regarding the limitation “a method for reducing the incidence of hypoglycemia”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art peptide is capable of performing the intended use, then it meets the claim. The administration method used as described in Johansson is the same administration method described in the instant claim; thus it is interpreted as being sufficient for reducing the incidence of hypoglycemia as described in the instant claim. The teachings of Johansson include the same step, the same compound and the same patient population.
Johansson does not teach the administration of C-peptide being before or while the subject is exercising.
Villines teaches that exercise induced hypoglycemia (EIH) is a condition where a person’s blood glucose drops because of the glucose demand caused by exercising (pg. 1, “Exercise-induced hypoglycemia (EIH) refers to low blood sugar levels that occur during or after exercise, which can happen because exercise increases the body’s energy demands and glucose usage.”). Villines also teaches that an individual is more likely to experience EIH if they have an insulin sensitivity or take insulin (pg. 2,“ An individual is more likely to experience EIH if they … have insulin sensitivity or take insulin …”). In addition to the teachings above, Villines teaches that to prevent EIH in diabetics to take medications to control their blood glucose before exercising (pg. 3, “The American Diabetes Association (ADA) recommends that people who take diabetes medications to control their blood glucose check their blood glucose levels before exercising.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johansson’s teachings with the teachings of Villines because Johansson teaches the method of administering C-peptide to insulin requiring subjects, while Villines teaches that exercise induced hypoglycemia is an issue insulin requiring subjects have. One of ordinary skill in the art would have been motivated before the effective filing date of the instant invention would have had a reasonable expectation of success because Johansson teaches the administration of C-peptide to patients with β-cells that are almost totally destroyed, something that is important to those suffering from hypoglycemia, while Villines teaches that exercise induced hypoglycemia is an issue insulin requiring subjects have and that hypoglycemic preventative measures should be taken before exercising. The combination of references is a would have been readily apparent and deemed to be a mere (A) Combining prior art elements according to known methods to yield predictable results (see MPEP 2143(I)).
Regarding claim 19, Johansson teaches the patient population being type-1 diabetics (pg. 976, “Subjects and Methods: Eighteen type 1 diabetic patients between 18 and 26 yr of age participated in the study.”).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Johansson et al., hereafter “Johansson” (“Influence of combined C-peptide and insulin administration on renal function and metabolic control in diabetes type 1. J Clin Endocrinol Metab. 1993;77(4):976–981., as cited in the IDS filed 09 January 2024) and Villines, Z. (2022, January 13). Exercise-induced hypoglycemia: Signs and prevention. Medical News Today. https://www.medicalnewstoday.com/articles/exercise-induced-hypoglycemia-what-to-know), as applied to claim 18 above, and in further view of Orci et al. hereafter “Orci” (“Conversion of proinsulin to insulin occurs coordinately with acidification of maturing secretory vesicles.” J Cell Biol. 1986 Dec;103(6 Pt 1):2273-81. doi: 10.1083/jcb.103.6.2273. PMID: 3536964; PMCID: PMC2114621.).
Regarding claim 20, Johansson teaches the delivery of C-Peptide through a continuous subcutaneous infusion pump together with the patients’ regular insulin therapy to type-1 diabetics (pg. 976, “Subjects and Methods: Eighteen type 1 diabetic patients between 18 and 26 yr of age participated in the study. … Both groups received SC infusions of insulin and C-peptide, as applicable, using insulin pumps …”). Johansson also teaches that pancreatic β-cells are almost totally destroyed in patients with type 1 diabetes (pg. 976 “Insulin and C-peptide are synthesized in equimolar amounts in pancreatic β-cells (l), which are almost totally destroyed in patients with type 1 diabetes.”). Villines teaches that exercise induced hypoglycemia (EIH) is a condition where a person’s blood glucose drops because of the glucose demand caused by exercising (pg. 1, “Exercise-induced hypoglycemia (EIH) refers to low blood sugar levels that occur during or after exercise, which can happen because exercise increases the body’s energy demands and glucose usage.”). Villines also teaches that an individual is more likely to experience EIH if they have an insulin sensitivity or take insulin (pg. 2,“ An individual is more likely to experience EIH if they … have insulin sensitivity or take insulin …”). In addition to the teachings above, Villines teaches that to prevent EIH in diabetics to take medications to control their blood glucose before exercising (pg. 3, “The American Diabetes Association (ADA) recommends that people who take diabetes medications to control their blood glucose check their blood glucose levels before exercising.”).
Johansson and Villines do not teach the subject being a type-2 diabetic.
Prentki teaches that the natural history of type-2 diabetes (T2D) entails deterioration in β cell function (pg. 1802,“Furthermore, the natural history of T2D entails progressive deterioration in β cell function …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johansson’s and Villines’ teachings with the teachings of Prentki because Johansson teaches the method of administering C-peptide to insulin requiring subjects and that β cells are and Villines teaches that exercise induced hypoglycemia is an issue insulin-requiring subjects have, while Prentki teaches that deterioration of β-cell function is included in the natural history of type-2 diabetes. One of ordinary skill in the art would have been motivated before the effective filing date of the instant invention would have had a reasonable expectation of success because Johansson teaches the administration of C-peptide to patients with β-cells that are almost totally destroyed, something that is important to those suffering from hypoglycemia and that deterioration of β-cell function is natural in T2D.
Status of Claims
Claims 1-2, 4, 8-12, and 17 rejected under 35 U.S.C. 102(a)(1). Claims 3, 6-7, 13, 15-16 and 18-20 are rejected under 35 U.S.C. 103.
No claims are allowed.
Conclusion
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/Daliyah M. Brown/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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