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 .
Priority
This application is a CON of PCT/US2024/025627 filed 04/22/2024. PCT/US2024/025627 has PRO 63/497,502 filed 04/21/2023.
Claim Status
Claims 1-13, 18, 20-21 are pending. Claims 1, 18, 20 are amended. claims 14-17, 19 are canceled. Claims 1-13, 18, 20-21 are being examined on the merits in this office action.
Information Disclosure Statement
The information disclosure statements submitted on 04/20/2026 has been considered by the examiner.
Claim Rejections - 35 USC § 112 – Maintained and Updated
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13, 18, 20-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 18, 20 recites the limitation "relative to baseline", which is not defined in the Specification or adequately described in the pending claim scope. Thus, it is unclear what the “baseline” is, or if the baseline is a form of “control” if the control is a positive or negative control. Examiner notes that it is unclear what the baseline rate if hypoglycemia events refers to. Therefore, the failure to identify the exact metes and bounds of the “baseline” renders the pending claim scope indefinite. For the purpose of applying prior art, the claims are understood to be fully satisfied by administering the formulation comprising Avexitide once daily (QD), at a dose of about 20 mg to about 120 mg, wherein the pharmaceutical formulation comprises Avexitide at a concentration between about 2 mg/mL and about 250 mg/mL, in a subject that has previously undergone a surgery.
Claims 2-13, and 21 depend from an indefinite base claim and fail to clarify the issue of the independent claim. Accordingly, claims 2-13, and 21 are rejected as indefinite.
Claim Rejections - 35 USC § 102 – Maintained and Updated
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-13, 18, 20-21 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Craig et al. (US20210338780A1 – hereinafter “Craig”).
Claim Interpretation
The claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 211 l.0l(IV), describing how Applicant may act as their own lexicographer).
The claims recite “…the method comprises…”. "Comprising" is an open-ended transitional term (see, e.g., MPEP § 2111.03(1)), wherein additional steps or components are not excluded. However, "'[c]omprising' is a term of art used in claim language which means that the named elements are essential" (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
The claims recite “…rate of hypoglycemia events…” which as stated in the instant specification is defined as “..number of episodes below a defined glucose level, for example, for example, 70 mg/L, 54 mg/dL, or 40 mg/dL” (See [0050]). Examiner notes that for the purpose of applying prior art, a reference that teaches reducing the rates or incidents of hypoglycemia, would read on the limitation.
Further, the claims recite the wherein clause “….wherein the rate of hypoglycemia events in the subjects is reduced by at least about 40% relative to baseline”. Examiner notes that this limitation recites an intended or expected results, which is understood to be fully satisfied by the positively recited method steps set forth at instant claim 1 (i.e., subcutaneously administering Avexitide in a "buffered liquid formulation" to a patient in need of decreasing the rate of hypoglycemia events MPEP §2111.04(1). Examiner notes that for the purpose of applying prior art, the wherein clause recited in claim 1 is deemed fully satisfied by the subcutaneous administration of Avexitide at the recited dose, formulated at the recited concentration and administered to the recited patient population.
Further, claims 18 recite Level 2 hypoglycemia events. These are terms of the art and Examiner is interpreting them as follows:
Level 2 hypoglycemia l is a glucose alert level of <54 mg/dL
Regarding claim 1, Craig teaches a method of treating hypoglycemia comprising administering subcutaneously a formulation comprising avexitide at a concentration of between 2-90 mg/mL (claim 1), wherein the avexitide is administered at a total daily dose from about 40 mg to about 120 mg; or from 60 mg-120 mg QD, or a total daily dose of about 90 mg QD (claim 7-8; [0007]), wherein the subject has previously had one or more of Roux-en-Y gastric bypass surgery, vertical sleeve gastrectomy (VSG), biliopancreatic diversion (BPD), upper-GI procedure, gastrectomy, esophagectomy, Nissen fundoplication, gastric bypass surgery (claim 5), wherein the method reduces the rate of hypoglycemia [0015, 0024, 0033]. Craig teaches that the mean rates of hypoglycemia in the subject are reduced from between about 30%-60% for avexitide as compared to a control [0169-0171, 0179]. Craig teaches that treatment with avexitide therapy results in a reduction in the rate of hypoglycemia and/or a reduction in the rate of severe hypoglycemia as compared to baseline or placebo or other control (e.g., as compared to the subject's rate of hypoglycemia and/or rate of severe hypoglycemia, e.g., as measured by self-blood glucose monitoring or continuous glucose monitoring) [0073]. Examiner notes that Craig teaches that “Severe hypoglycemia,” as used herein, is defined as hypoglycemic symptoms confirmed by self-blood glucose monitoring (SBGM) glucose≤54 mg/dL [0044]. Examiner notes that this teachings of Craig read on the wherein clause. Further, Examiner notes that Craig teaches administering the instant formulation, comprising the instant active ingredient (avexitide) at ranges that include the instant concentration range and instant dose range and administered to the instant patient population (i.e. subjects that have previously undergone surgery). Craig thus teaches all the steps of the claimed method thus anticipating the claim. Examiner notes that since Craig teaches all the steps of the claimed invention, the result of decreasing hypoglycemia at the instant rate constitute an expected result and would naturally flow.
Regarding claim 2, Craig teaches that post-bariatric hypoglycemia subjects have exaggerated postprandial secretion and/or action of GLP-1 due to altered nutrient transit after bariatric surgery [0004] and that wherein peak GLP-1 and glucagon levels are higher in the subject as compared to a control (claim 47; [0141]).
Regarding claim 3, Craig teaches wherein the formulation is administered subcutaneously (claim 1; [0006, 0031, 0037, 0056-0064]).
Regarding claim 4, Craig teaches wherein the formulation is a buffered liquid formulation comprising avexitide (claim 1; [0006, 0037, 0063-0065]).
Regarding claims 5-6, Craig teaches that the formulation comprises a sodium acetate buffer (claim 31; [0012]), wherein the sodium acetate is at a concentration including 10 mM [0075-00776].
Regarding claim 7, Craig teaches that the avexitide is at a concentration including 100 mg/mL [0056, 0066].
Regarding claims 8-9, Craig teaches that the formulation has a pH above 5.0 and up to about 6. [0074], or a pH of about 5.5 [0012].
Regarding claims 10-12, Craig teaches that the buffered formulation comprises a tonicity modifier, wherein the tonicity modifier is mannitol, wherein the mannitol is at a concentration of about 40-50 mg/ml (claims 32-33; [0079-0081, 0126-0127]).
Regarding claim 13, Craig teaches wherein the avexitide is administered at a total daily dose is about 90 mg; or about 90 mg QD (claim 9), wherein the avexitide is administered less than 30 days (claim 1) or a period of 14 days [0219, 0228, 0258].
Regarding claims 18, and 20, Examiner notes that MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the method step of claim 1 and is given little patentable weight. Additionally, Examiner notes that Craig teaches that the mean rates of hypoglycemia in the subject are reduced from between about 30%-60% for avexitide as compared to a control [0169-0171, 0179]. Craig teaches that treatment with avexitide therapy results in a reduction in the rate of hypoglycemia and/or a reduction in the rate of severe hypoglycemia as compared to baseline or placebo or other control (e.g., as compared to the subject's rate of hypoglycemia and/or rate of severe hypoglycemia, e.g., as measured by self-blood glucose monitoring or continuous glucose monitoring) [0073]. Examiner notes that Craig teaches that “Severe hypoglycemia,” as used herein, is defined as hypoglycemic symptoms confirmed by self-blood glucose monitoring (SBGM) glucose≤54 mg/dL [0044]. Craig further teaches treatment with avexitide therapy results in a reduction in the rate of hypoglycemia and/or a reduction in the rate of severe hypoglycemia as compared to baseline or placebo or other control [0073], that wherein rates of hypoglycemia are an SBGM glucose level<70 mg/dL or SBGM glucose level<55 mg/dL is reduced by between about 4-57% as compared with a control [0170-0175].
Regarding claim 21, Craig teaches administering the formulation at a dose of 45 mg BID (claim 8, 20, 67; [0047, 0056-0060]), wherein the avexitide is administered less than 30 days (claim 1) or a period of 14 days [0219, 0228, 0258].
Response to Arguments
Applicant's arguments filed 04/20/2026 have been fully considered but they are not persuasive.
Applicant Arguments
Applicant argues that the wherein clause is a limiting element. Applicant argues that the independent claim 1 has been amended to recite “wherein the rate of level 2 hypoglycemia events is reduced by at least about 40%” and that the clause sets forth a specific measurable therapeutic outcome and that the claim is directed to administering avexitide in a manner that achieves a defined clinical efficacy endpoint. Applicant argues that the office dependence on inherency is improper.
Applicant argues that Craig does not disclose each and every element of amended claim 1 and that Craig “severe hypoglycemia” includes categories of events beyond those encompassed by Level 2 hypoglycemia.
Examiner’s Response
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that Craig teaches the instant invention, and specifically teaches the instant active ingredient, administered to the instant patient population, at the instant dosage and concentration. Examiner notes that MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the method step of claim 1 and is given little patentable weight. Further, Examiner adds that the wherein clause simply recites an appreciated property of the claimed method. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (See MPEP 2112 (I)). Additionally, Examiner notes that Craig teaches that the mean rates of hypoglycemia in the subject are reduced from between about 30%-60% for avexitide as compared to a control [0169-0171, 0179]. Craig teaches that treatment with avexitide therapy results in a reduction in the rate of hypoglycemia and/or a reduction in the rate of severe hypoglycemia as compared to baseline or placebo or other control (e.g., as compared to the subject's rate of hypoglycemia and/or rate of severe hypoglycemia, e.g., as measured by self-blood glucose monitoring or continuous glucose monitoring) [0073]. Examiner notes that Craig teaches that “Severe hypoglycemia,” as used herein, is defined as hypoglycemic symptoms confirmed by self-blood glucose monitoring (SBGM) glucose≤54 mg/dL [0044]. Examiner notes that the disclosures of Craig read on the wherein clause. The arguments are unpersuasive and the rejection is maintained.
Double Patenting – Maintained and Updated
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 1-6, 8-13, 18, 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10, 14-16 of U.S. Patent No. US10660937B2 in view of Craig et al. (US20210338780A1 – hereinafter “Craig”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite a method of method for treating a patient with hyperinsulinemic hypoglycemia, the method comprising administering to the patient in need thereof a therapeutically effective amount of exendin(9-39), wherein the therapeutically effective amount is 2-100 mg of exendin(9-39) administered to the patient by subcutaneous injection once per day (claim 1), wherein the exendin(9-39) is administered at a concentration of 20-45 mg/ml (claim 2), wherein the patient has previously had bariatric surgery (claim 3), wherein the bariatric surgery is Roux-en-Y gastric bypass, vertical sleeve gastrectomy, placement of an endosleeve device, duodenal mucosal resurfacing, partial bypass of the duodenum, vagal nerve blockade, or pyloroplasty, wherein the gastrointestinal surgery is gastrectomy, Nissen Fundoplication, or esophagectomy (claim 4-6).
Even though the claims of the patent recite the instant method steps, the claims do not explicitly recite that the method decreases the rate of hypoglycemia events. However, it is known in the art that the instant method steps are known to reduce the rate of hypoglycemia events or episodes as taught by Craig et al.
Craig teaches a method of treating hypoglycemia comprising administering subcutaneously a formulation comprising avexitide at a concentration of between 2-90 mg/mL (claim 1), wherein the avexitide is administered at a total daily dose from about 40 mg to about 120 mg; or from 30 mg-60 mg BID, or from 60 mg-120 mg QD (claim 7-8), wherein the subject has previously had one or more of Roux-en-Y gastric bypass surgery, vertical sleeve gastrectomy (VSG), biliopancreatic diversion (BPD), upper-GI procedure, gastrectomy, esophagectomy, Nissen fundoplication, gastric bypass surgery (claim 5), wherein the method reduces the rate of hypoglycemia [0015, 0024, 0033]. Craig teaches that the mean rates of hypoglycemia in the subject are reduced from between about 30%-60% for avexitide as compared to a control [0169-0171, 0179].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent and use the method steps to reduce the rate of hypoglycemia events since Craig teaches that the same method steps of the patent are effective in reducing the rate of hypoglycemia events. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the method of the patent to reduce the rate of hypoglycemia events since Craig teaches that the same method steps of the patent are effective in reducing the rate of hypoglycemia events. The claims of the patent render obvious the instant claims.
Regarding claim 2, Craig teaches that post-bariatric hypoglycemia subjects have exaggerated postprandial secretion and/or action of GLP-1 due to altered nutrient transit after bariatric surgery [0004] and that wherein peak GLP-1 and glucagon levels are higher in the subject as compared to a control (claim 47; [0141]). It would have been obvious to use the method in subjects with elevated GLP-1.
Regarding claim 3, the claims of the patent recite that exendin(9-39) administered to the patient by subcutaneous injection once per day (claim 1).
Regarding claim 4, Craig teaches wherein the formulation is a buffered liquid formulation comprising avexitide (claim 1; [0006, 0037, 0063-0065]). It would have been obvious to modify the claims of the patent and administer formulation as a buffered liquid formulation.
Regarding claims 5-6, Craig teaches that the formulation comprises a sodium acetate buffer (claim 31; [0012]), wherein the sodium acetate is at a concentration including 10 mM [0075-00776]. It would have been obvious to modify the claims of the patent and administer formulation that comprises sodium acetate at the concentrations taught by Craig.
Regarding claims 8-9, Craig teaches that the formulation has a pH above 5.0 and up to about 6. [0074], or a pH of about 5.5 [0012]. It would have been obvious to modify the claims of the patent and administer formulation at the pH taught by Craig.
Regarding claims 10-12, Craig teaches that the buffered formulation comprises a tonicity modifier, wherein the tonicity modifier is mannitol, wherein the mannitol is at a concentration of about 40-50 mg/ml (claims 32-33; [0079-0081, 0126-0127]). It would have been obvious to modify the claims of the patent and administer formulation comprising mannitol and the concentration taught by Craig.
Regarding claim 13, the claims of the patent recite administering the formulation at a dose of 2-100 mg once per day (claim 1).
Regarding claims 18, 20, Examiner notes that MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the method step of claim 1 and is given little patentable weight. Additionally, Examiner notes that Craig teaches that the mean rates of hypoglycemia in the subject are reduced from between about 30%-60% for avexitide as compared to a control [0169-0171, 0179]. Further, Craig teaches that “Severe hypoglycemia,” as used herein, is defined as hypoglycemic symptoms confirmed by self-blood glucose monitoring (SBGM) glucose ≤54 mg/dL, that severe hypoglycemia can also be a severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery and teaches that the rate of severe hypoglycemia is reduced [0044]. Craig further teaches treatment with avexitide therapy results in a reduction in the rate of hypoglycemia and/or a reduction in the rate of severe hypoglycemia as compared to baseline or placebo or other control [0073], that wherein rates of hypoglycemia are an SBGM glucose level<70 mg/dL or SBGM glucose level<55 mg/dL is reduced by between about 4-57% as compared with a control [0170-0175]. Craig teaches wherein the mean percent time with glucose values<70 mg/dL, <55 mg/dL, and <40 mg/dL for the subject is reduced by between about 4-57% as compared with a control [0175-0177]. Examiner notes that disclosures of Craig read on level 1-3 hypoglycemia events or episodes and thus render obvious the instant claims.
Regarding claim 21, the claims of the patent recite administering the formulation at a dose of 20 mg to 50 mg (claim 14), once per day or twice per day (claim 1).
Claims 1-6, 8-13, 18, 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 14-21, 24, 28-29 of U.S. Patent No. US10993992B2 in view of Craig et al. (US20210338780A1 – hereinafter “Craig”).
The claims of the patent recite a method for treating hyperinsulinemic hypoglycemia in a subject, the method comprising subcutaneously administering to the subject in need thereof an isotonic solution comprising a therapeutically effective amount of exendin(9-39) and at least one of an antimicrobial preservative, a tonicity adjusting agent, or a buffer; wherein the therapeutically effective amount is 2-100 mg of exendin(9-39); and wherein the exendin(9-39) is administered at a concentration of 20-45 mg/ml (claim 1, 10, 21, 31), wherein the exendin(9-39) is administered once per day (claim 15), wherein the patient has previously had bariatric surgery (claim 17), wherein the bariatric surgery is Roux-en-Y gastric bypass, vertical sleeve gastrectomy, placement of an endosleeve device, duodenal mucosal resurfacing partial bypass of the duodenum, vagal nerve blockade, or pyloroplasty, wherein the patient has previously had gastrointestinal surgery, wherein the gastrointestinal surgery is gastrectomy, Nissen Fundoplication, or esophagectomy (claims 18-20).
Even though the claims of the patent recite the instant method steps, the claims do not explicitly recite that the method decreases the rate of hypoglycemia events. However, it is known in the art that the instant method steps are known to reduce the rate of hypoglycemia events or episodes as taught by Craig et al.
Craig teaches a method of treating hypoglycemia comprising administering subcutaneously a formulation comprising avexitide at a concentration of between 2-90 mg/mL (claim 1), wherein the avexitide is administered at a total daily dose from about 40 mg to about 120 mg; or from 30 mg-60 mg BID, or from 60 mg-120 mg QD (claim 7-8), wherein the subject has previously had one or more of Roux-en-Y gastric bypass surgery, vertical sleeve gastrectomy (VSG), biliopancreatic diversion (BPD), upper-GI procedure, gastrectomy, esophagectomy, Nissen fundoplication, gastric bypass surgery (claim 5), wherein the method reduces the rate of hypoglycemia [0015, 0024, 0033]. Craig teaches that the mean rates of hypoglycemia in the subject are reduced from between about 30%-60% for avexitide as compared to a control [0169-0171, 0179].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent and use the method steps to reduce the rate of hypoglycemia events since Craig teaches that the same method steps of the patent are effective in reducing the rate of hypoglycemia events. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the method of the patent to reduce the rate of hypoglycemia events since Craig teaches that the same method steps of the patent are effective in reducing the rate of hypoglycemia events. The claims of the patent render obvious the instant claims.
Regarding claim 2, Craig teaches that post-bariatric hypoglycemia subjects have exaggerated postprandial secretion and/or action of GLP-1 due to altered nutrient transit after bariatric surgery [0004] and that wherein peak GLP-1 and glucagon levels are higher in the subject as compared to a control (claim 47; [0141]). It would have been obvious to use the method in subjects with elevated GLP-1.
Regarding claim 3, the claims of the patent recite that exendin(9-39) administered to the patient by subcutaneously (claim 1).
Regarding claim 4, the claims of the patent recite wherein the formulation comprises a buffer (claim 1).
Regarding claims 5-6, Craig teaches that the formulation comprises a sodium acetate buffer (claim 31; [0012]), wherein the sodium acetate is at a concentration including 10 mM [0075-00776]. It would have been obvious to modify the claims of the patent and administer formulation that comprises sodium acetate at the concentrations taught by Craig.
Regarding claims 8-9, Craig teaches that the formulation has a pH above 5.0 and up to about 6. [0074], or a pH of about 5.5 [0012]. It would have been obvious to modify the claims of the patent and administer formulation at the pH taught by Craig.
Regarding claims 10-12, the claims of the patent recite that the formulation comprises a tonicity agent (claim 1) such as mannitol (claim 2). Further, Craig teaches that the buffered formulation comprises a tonicity modifier, wherein the tonicity modifier is mannitol, wherein the mannitol is at a concentration of about 40-50 mg/ml (claims 32-33; [0079-0081, 0126-0127]). It would have been obvious to modify the claims of the patent and administer formulation comprising mannitol and the concentration taught by Craig.
Regarding claims 18, 20, Examiner notes that MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the method step of claim 1 and is given little patentable weight. Additionally, Examiner notes that Craig teaches that the mean rates of hypoglycemia in the subject are reduced from between about 30%-60% for avexitide as compared to a control [0169-0171, 0179]. Further, Craig teaches that “Severe hypoglycemia,” as used herein, is defined as hypoglycemic symptoms confirmed by self-blood glucose monitoring (SBGM) glucose ≤54 mg/dL, that severe hypoglycemia can also be a severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery and teaches that the rate of severe hypoglycemia is reduced [0044]. Craig further teaches treatment with avexitide therapy results in a reduction in the rate of hypoglycemia and/or a reduction in the rate of severe hypoglycemia as compared to baseline or placebo or other control [0073], that wherein rates of hypoglycemia are an SBGM glucose level<70 mg/dL or SBGM glucose level<55 mg/dL is reduced by between about 4-57% as compared with a control [0170-0175]. Craig teaches wherein the mean percent time with glucose values<70 mg/dL, <55 mg/dL, and <40 mg/dL for the subject is reduced by between about 4-57% as compared with a control [0175-0177]. Examiner notes that disclosures of Craig read on level 1-3 hypoglycemia events or episodes and thus render obvious the instant claims.
Regarding claim 21, the claims of the patent recite administering the formulation at a dose of 2-100 mg (claim 1, 10, 21, 31), twice per day (claim 4, 31).
Claims 1-6, 8-12, 18, 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 14-21, 24, 28-29 of U.S. Patent No. US10993991B2 in view of Craig et al. (US20210338780A1 – hereinafter “Craig”).
The claims of the patent recite a method for treating reating hyperinsulinemic hypoglycemia in a subject, the method comprising subcutaneously administering to the subject in need thereof an isotonic solution comprising a therapeutically effective amount of exendin(9-39) and at least one of an antimicrobial preservative, a tonicity adjusting agent, or a buffer; wherein the therapeutically effective amount is 10-30 mg of exendin(9-39); and wherein the exendin(9-39) is administered at a concentration of 4-20 mg/ml (claim 1, 10, 21, 24), wherein the exendin(9-39) is administered once per day (claim 4, 15), wherein the patient has previously had bariatric surgery (claims 6-9, 17-20).
Even though the claims of the patent recite the instant method steps, the claims do not explicitly recite that the method decreases the rate of hypoglycemia events. However, it is known in the art that the instant method steps are known to reduce the rate of hypoglycemia events or episodes as taught by Craig et al.
Craig teaches a method of treating hypoglycemia comprising administering subcutaneously a formulation comprising avexitide at a concentration of between 2-90 mg/mL (claim 1), wherein the avexitide is administered at a total daily dose from about 40 mg to about 120 mg; or from 30 mg-60 mg BID, or from 60 mg-120 mg QD (claim 7-8), wherein the subject has previously had one or more of Roux-en-Y gastric bypass surgery, vertical sleeve gastrectomy (VSG), biliopancreatic diversion (BPD), upper-GI procedure, gastrectomy, esophagectomy, Nissen fundoplication, gastric bypass surgery (claim 5), wherein the method reduces the rate of hypoglycemia [0015, 0024, 0033]. Craig teaches that the mean rates of hypoglycemia in the subject are reduced from between about 30%-60% for avexitide as compared to a control [0169-0171, 0179].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent and use the method steps to reduce the rate of hypoglycemia events since Craig teaches that the same method steps of the patent are effective in reducing the rate of hypoglycemia events. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the method of the patent to reduce the rate of hypoglycemia events since Craig teaches that the same method steps of the patent are effective in reducing the rate of hypoglycemia events. The claims of the patent render obvious the instant claims.
Regarding claim 2, Craig teaches that post-bariatric hypoglycemia subjects have exaggerated postprandial secretion and/or action of GLP-1 due to altered nutrient transit after bariatric surgery [0004] and that wherein peak GLP-1 and glucagon levels are higher in the subject as compared to a control (claim 47; [0141]). It would have been obvious to use the method in subjects with elevated GLP-1.
Regarding claim 3, the claims of the patent recite that exendin(9-39) administered to the patient by subcutaneously (claim 1, 10, 21, 24).
Regarding claim 4, the claims of the patent recite wherein the formulation comprises a buffer (claim 1).
Regarding claims 5-6, Craig teaches that the formulation comprises a sodium acetate buffer (claim 31; [0012]), wherein the sodium acetate is at a concentration including 10 mM [0075-00776]. It would have been obvious to modify the claims of the patent and administer formulation that comprises sodium acetate at the concentrations taught by Craig.
Regarding claims 8-9, Craig teaches that the formulation has a pH above 5.0 and up to about 6. [0074], or a pH of about 5.5 [0012]. It would have been obvious to modify the claims of the patent and administer formulation at the pH taught by Craig.
Regarding claims 10-12, the claims of the patent recite that the formulation comprises a tonicity agent (claim 1) such as mannitol (claim 2). Further, Craig teaches that the buffered formulation comprises a tonicity modifier, wherein the tonicity modifier is mannitol, wherein the mannitol is at a concentration of about 40-50 mg/ml (claims 32-33; [0079-0081, 0126-0127]). It would have been obvious to modify the claims of the patent and administer formulation comprising mannitol and the concentration taught by Craig.
Regarding claim 13, the claims of the patent recite administering the formulation at a dose of 2-100 mg once per day (claim 1, 15).
Regarding claims 18, 20, Examiner notes that MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the method step of claim 1 and is given little patentable weight. Additionally, Examiner notes that Craig teaches that the mean rates of hypoglycemia in the subject are reduced from between about 30%-60% for avexitide as compared to a control [0169-0171, 0179]. Further, Craig teaches that “Severe hypoglycemia,” as used herein, is defined as hypoglycemic symptoms confirmed by self-blood glucose monitoring (SBGM) glucose ≤54 mg/dL, that severe hypoglycemia can also be a severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery and teaches that the rate of severe hypoglycemia is reduced [0044]. Craig further teaches treatment with avexitide therapy results in a reduction in the rate of hypoglycemia and/or a reduction in the rate of severe hypoglycemia as compared to baseline or placebo or other control [0073], that wherein rates of hypoglycemia are an SBGM glucose level<70 mg/dL or SBGM glucose level<55 mg/dL is reduced by between about 4-57% as compared with a control [0170-0175]. Craig teaches wherein the mean percent time with glucose values<70 mg/dL, <55 mg/dL, and <40 mg/dL for the subject is reduced by between about 4-57% as compared with a control [0175-0177]. Examiner notes that disclosures of Craig read on level 1-3 hypoglycemia events or episodes and thus render obvious the instant claims.
Regarding claim 21, the claims of the patent recite administering the formulation at a dose of 2-100 mg (claim 1, 10, 21, 31), twice per day (claim 4, 31).
Claims 1-13, 18, 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 13-17, 21-30 of U.S. Patent No. US11020484B2 in view of Craig et al. (US20210338780A1 – hereinafter “Craig”).
The claims of the patent recite a method for treating or preventing hyperinsulinemic hypoglycemia in a subject, comprising administering to the subject the liquid pharmaceutical formulation of claim 1 (claim 21), wherein the subject has previously had an upper-gastrointestinal procedure (claim 22), wherein the subject has previously had a bariatric procedure (claim 23), wherein the method comprises subcutaneously administering to the subject the liquid pharmaceutical formulation comprising exendin (9-39) at a dosage of about 30 mg to about 75 mg once daily (QD) (claim 24), wherein the exendin (9-39) or the pharmaceutically acceptable salt thereof is at a concentration of about 45 mg/ml or about 90 mg/ml (claims 26-27).
Even though the claims of the patent recite the instant method steps, the claims do not explicitly recite that the method decreases the rate of hypoglycemia events. However, it is known in the art that the instant method steps are known to reduce the rate of hypoglycemia events or episodes as taught by Craig et al.
Craig teaches a method of treating hypoglycemia comprising administering subcutaneously a formulation comprising avexitide at a concentration of between 2-90 mg/mL (claim 1), wherein the avexitide is administered at a total daily dose from about 40 mg to about 120 mg; or from 30 mg-60 mg BID, or from 60 mg-120 mg QD (claim 7-8), wherein the subject has previously had one or more of Roux-en-Y gastric bypass surgery, vertical sleeve gastrectomy (VSG), biliopancreatic diversion (BPD), upper-GI procedure, gastrectomy, esophagectomy, Nissen fundoplication, gastric bypass surgery (claim 5), wherein the method reduces the rate of hypoglycemia [0015, 0024, 0033]. Craig teaches that the mean rates of hypoglycemia in the subject are reduced from between about 30%-60% for avexitide as compared to a control [0169-0171, 0179].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent and use the method steps to reduce the rate of hypoglycemia events since Craig teaches that the same method steps of the patent are effective in reducing the rate of hypoglycemia events. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the method of the patent to reduce the rate of hypoglycemia events since Craig teaches that the same method steps of the patent are effective in reducing the rate of hypoglycemia events. The claims of the patent render obvious the instant claims.
Regarding claim 2, Craig teaches that post-bariatric hypoglycemia subjects have exaggerated postprandial secretion and/or action of GLP-1 due to altered nutrient transit after bariatric surgery [0004] and that wherein peak GLP-1 and glucagon levels are higher in the subject as compared to a control (claim 47; [0141]). It would have been obvious to use the method in subjects with elevated GLP-1.
Regarding claim 3, the claims of the patent recite that exendin(9-39) administered to the patient by subcutaneously (claim 17, 24-26, 29-30).
Regarding claim 4, the claims of the patent recite wherein the formulation comprises a buffer (claim 1-6).
Regarding claims 5-6, the claims of the patent recite that the composition comprises a buffer such as sodium acetate at a concentration of about 10 mM (claims 1-5).
Regarding claim 7, the claims of the patent recite wherein the exendin (9-39) or the pharmaceutically acceptable salt thereof is at a concentration of about 10 mg/ml to about 120 mg/ml (claim 13).
Regarding claims 8-9, the claims of the patent recite wherein the pH is about 5.5 (claim 7).
Regarding claims 10-12, the claims of the patent recite that the formulation comprises a tonicity modifier (claim 8) such as mannitol (claim 9), wherein the tonicity modifier is present in an amount from about 20 mg/ml to about 60 mg/ml (claim 10).
Regarding claim 13, the claims of the patent recite administering the formulation at a dose of 90 mg QD (claim 25).
Regarding claims 18, 20, Examiner notes that MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the method step of claim 1 and is given little patentable weight. Additionally, Examiner notes that Craig teaches that the mean rates of hypoglycemia in the subject are reduced from between about 30%-60% for avexitide as compared to a control [0169-0171, 0179]. Further, Craig teaches that “Severe hypoglycemia,” as used herein, is defined as hypoglycemic symptoms confirmed by self-blood glucose monitoring (SBGM) glucose ≤54 mg/dL, that severe hypoglycemia can also be a severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery and teaches that the rate of severe hypoglycemia is reduced [0044]. Craig further teaches treatment with avexitide therapy results in a reduction in the rate of hypoglycemia and/or a reduction in the rate of severe hypoglycemia as compared to baseline or placebo or other control [0073], that wherein rates of hypoglycemia are an SBGM glucose level<70 mg/dL or SBGM glucose level<55 mg/dL is reduced by between about 4-57% as compared with a control [0170-0175]. Craig teaches wherein the mean percent time with glucose values<70 mg/dL, <55 mg/dL, and <40 mg/dL for the subject is reduced by between about 4-57% as compared with a control [0175-0177]. Examiner notes that disclosures of Craig read on level 1-3 hypoglycemia events or episodes and thus render obvious the instant claims.
Regarding claim 21, the claims of the patent recite administering the formulation at a dose including 45 mg twice daily (BID) (claim 26).
Claims 1-13, 18, 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 13-17, 21-30 of U.S. Patent No. US11738086B2 in view of Craig et al. (US20210338780A1 – hereinafter “Craig”).
The claims of the patent recite a method for treating hyperinsulinemic hypoglycemia (HH) in a subject, the method comprising administering to the subject a liquid pharmaceutical formulation comprising exendin (9-39) or a pharmaceutically acceptable salt thereof and a tonicity modifier in a physiologically acceptable buffer having a pH in the range of 5.1 to 6; wherein the liquid pharmaceutical formulation is formulated for oral, intravenous, buccal, rectal, parenteral, intraperitoneal, intradermal, intramuscular, subcutaneous, or inhalational administration (claim 1), wherein the method comprises administering to the subject the liquid pharmaceutical formulation comprising exendin (9-39) at a daily dosage of about 30 mg to 90 mg (claim 2), once per day (QD) or twice per day (BID) (claim 3), wherein the exendin (9-39) or the pharmaceutically acceptable salt thereof is at a concentration of about 10 mg/ml to about 120 mg/ml (claim 19-22), wherein the subject has previously had an upper-gastrointestinal procedure, wherein the subject has previously had a bariatric procedure (6-7).
Even though the claims of the patent recite the instant method steps, the claims do not explicitly recite that the method decreases the rate of hypoglycemia events. However, it is known in the art that the instant method steps are known to reduce the rate of hypoglycemia events or episodes as taught by Craig et al.
Craig teaches a method of treating hypoglycemia comprising administering subcutaneously a formulation comprising avexitide at a concentration of between 2-90 mg/mL (claim 1), wherein the avexitide is administered at a total daily dose from about 40 mg to about 120 mg; or from 30 mg-60 mg BID, or from 60 mg-120 mg QD (claim 7-8), wherein the subject has previously had one or more of Roux-en-Y gastric bypass surgery, vertical sleeve gastrectomy (VSG), biliopancreatic diversion (BPD), upper-GI procedure, gastrectomy, esophagectomy, Nissen fundoplication, gastric bypass surgery (claim 5), wherein the method reduces the rate of hypoglycemia [0015, 0024, 0033]. Craig teaches that the mean rates of hypoglycemia in the subject are reduced from between about 30%-60% for avexitide as compared to a control [0169-0171, 0179].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent and use the method steps to reduce the rate of hypoglycemia events since Craig teaches that the same method steps of the patent are effective in reducing the rate of hypoglycemia events. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the method of the patent to reduce the rate of hypoglycemia events since Craig teaches that the same method steps of the patent are effective in reducing the rate of hypoglycemia events. The claims of the patent render obvious the instant claims.
Regarding claim 2, Craig teaches that post-bariatric hypoglycemia subjects have exaggerated postprandial secretion and/or action of GLP-1 due to altered nutrient transit after bariatric surgery [0004] and that wherein peak GLP-1 and glucagon levels are higher in the subject as compared to a control (claim 47; [0141]). It would have been obvious to use the method in subjects with elevated GLP-1.
Regarding claim 3, the claims of the patent recite that exendin(9-39) administered to the patient by subcutaneously (claim 1, 4-5, 23).
Regarding claim 4, the claims of the patent recite wherein the formulation comprises a buffer (claim 1, 9-12).
Regarding claims 5-6, the claims of the patent recite that the composition comprises a buffer such as sodium acetate at a concentration of about 10 mM (claims 9-11).
Regarding claim 7, the claims of the patent recite wherein the exendin (9-39) or the pharmaceutically acceptable salt thereof is at a concentration of about 10 mg/ml to about 120 mg/ml (claim 19).
Regarding claims 8-9, the claims of the patent recite wherein the pH is about 5.5 (claim 12-13).
Regarding claims 10-12, the claims of the patent recite that the formulation comprises a tonicity modifier (claim 14) such as mannitol (claim 15), wherein the tonicity modifier is present in an amount from about 20 mg/ml to about 60 mg/ml (claim 16).
Regarding claim 13, the claims of the patent recite administering the formulation at a dose of 90 mg QD (claim 2).
Regarding claims 18, 20, Examiner notes that MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the method step of claim 1 and is given little patentable weight. Additionally, Examiner notes that Craig teaches that the mean rates of hypoglycemia in the subject are reduced from between about 30%-60% for avexitide as compared to a control [0169-0171, 0179]. Further, Craig teaches that “Severe hypoglycemia,” as used herein, is defined as hypoglycemic symptoms confirmed by self-blood glucose monitoring (SBGM) glucose ≤54 mg/dL, that severe hypoglycemia can also be a severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery and teaches that the rate of severe hypoglycemia is reduced [0044]. Craig further teaches treatment with avexitide therapy results in a reduction in the rate of hypoglycemia and/or a reduction in the rate of severe hypoglycemia as compared to baseline or placebo or other control [0073], that wherein rates of hypoglycemia are an SBGM glucose level<70 mg/dL or SBGM glucose level<55 mg/dL is reduced by between about 4-57% as compared with a control [0170-0175]. Craig teaches wherein the mean percent time with glucose values<70 mg/dL, <55 mg/dL, and <40 mg/dL for the subject is reduced by between about 4-57% as compared with a control [0175-0177]. Examiner notes that disclosures of Craig read on level 1-3 hypoglycemia events or episodes and thus render obvious the instant claims.
Regarding claim 21, the claims of the patent recite administering the formulation at a dose including 45 mg twice daily (BID) (claim 5).
Claims 1, 3-4, 7, 13, 18, 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 88-89, 90, 94, 100, 105, 117 of copending Application No. 17/285,039. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application recite method of reducing the mean percent time spent in hypoglycemia by a human subject diagnosed with post-bariatric hypoglycemia (PBH), the method comprising subcutaneously administering to the human subject having a glucose value[[s]] of <70 mg/dL at least 60 mg of avexitide once daily for at least 14 days to reduce in the human subject the mean percent time spent in hypoglycemia by about 4-26% (claim 88), wherein the avexitide is administered to the human subject as a buffered liquid formulation comprising avexitide at a concentration from 2 mg/ml to 180 mg/ml (claim 89), wherein the subject has previously had one or more of vertical sleeve gastrectomy (VSG), biliopancreatic diversion (BPD), upper-GI procedure, gastrectomy, esophagectomy, Nissen fundoplication, gastric bypass surgery (claim 94), wherein the avexitide is administered to the subject at a dose of 90 mg to 120 mg QD (claim 100), wherein the method results in one or more of the following in the subject reduced rate of hypoglycemia events (claim 105).
The claims of the copending application recite a method of decreasing the rate of hypoglycemia events in a subject, wherein the method comprises administering a pharmaceutical formulation comprising avexitide or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical formulation is administered once daily (QD) and the avexitide in the pharmaceutical formulation is at a dose of about 20 mg to about 120 mg, wherein the pharmaceutical formulation comprises avexitide at a concentration between about 2 mg/mL and about 250 mg/mL, wherein the subject has previously undergone a surgery selected from the group consisting of Roux-en-Y gastric bypass, vertical sleeve gastrectomy, gastrectomy,esophagectomy, and Nissen fundoplication, and wherein the rate of hypoglycemia events in the subject is reduced by at least about 10% relative to baseline (claim 1).
The claims of the copending application anticipate the instant claims.
Regarding claim 3, the claims of the copending application recite wherein formulation subcutaneously administered (claim 88).
Regarding claim 4, the claims of the copending application recite a buffered liquid formulation (claim 89).
Regarding claim 7, the claims of the copending application recite that the buffered liquid formulation comprising avexitide at a concentration from 2 mg/ml to 180 mg/ml (claim 89).
Regarding claim 13, the claims of the copending application recite wherein the avexitide is administered to the subject at a dose of 90 mg to 120 mg QD (claim 100).
Regarding claim 14-20, the claims of the copending application recite wherein the method results in reduced rate of hypoglycemia events (claim 105), wherein administration of avexitide reduces the mean percent time spent in hypoglycemia by about 26% (claim 117).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 04/20/2026 have been fully considered but they are not persuasive.
Applicant Arguments
Applicant argues that the independent claim 1 has been amended to recite “wherein the rate of level 2 hypoglycemia events is reduced by at least about 40%” and that the clause sets forth a specific measurable therapeutic outcome and that the claim is directed to administering avexitide in a manner that achieves a defined clinical efficacy endpoint. Applicant argues that the office dependence on inherency is improper.
Examiner’s Response
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that the claims of the patent recite the instant invention, specifically recite the instant active ingredient, administered to the instant patient population, at the instant dosage and concentration. Examiner notes that all the claims of the patent recite the instant method. Examiner notes that MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the method step of claim 1 and is given little patentable weight. Further, Examiner adds that the wherein clause simply recites an appreciated property of the claimed method. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (See MPEP 2112 (I)). Additionally, Examiner notes that Craig teaches that the mean rates of hypoglycemia in the subject are reduced from between about 30%-60% for avexitide as compared to a control [0169-0171, 0179]. Craig teaches that treatment with avexitide therapy results in a reduction in the rate of hypoglycemia and/or a reduction in the rate of severe hypoglycemia as compared to baseline or placebo or other control (e.g., as compared to the subject's rate of hypoglycemia and/or rate of severe hypoglycemia, e.g., as measured by self-blood glucose monitoring or continuous glucose monitoring) [0073]. Examiner notes that Craig teaches that “Severe hypoglycemia,” as used herein, is defined as hypoglycemic symptoms confirmed by self-blood glucose monitoring (SBGM) glucose≤54 mg/dL [0044]. Examiner notes that the disclosures of Craig read on the wherein clause. The arguments are unpersuasive and the rejection is maintained.
Conclusion
No claims are allowed. Due to new grounds of rejection to include claim 90 of the copending application 17/285,039, this rejection in Non-Final.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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