CTNF 18/257,756 CTNF 89000 DETAILED ACTION Claims 83-101 are pending and being examined on the merits in this office action. Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority The filing receipt dated 3/13/2024 has the following priority information: PNG media_image1.png 66 498 media_image1.png Greyscale Specification 06-31 AIA Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01. Claim Objections 07-29-01 AIA Claim s 89-97, 102 and 103 are objected to because of the following informalities: Claims 89-96, 102 and 103 should be amended to depend from claim 88, as claim 1 has been canceled. Claim 97 should be amended to remove the parentheticals, quotation marks, “e.g.” claim language, “including” phrasing, as well as multiple instances of the term “or”. Claim 97 should be amended at last line to recite “ cholecystitis cholescystitis ”. Claim 102 should be amended to recite “synthesizing the polypeptide by solid-phase or liquid-phase methodology, [[and]] isolating and purifying the polypeptide . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 89-103 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. The metes and bounds of claims 89-96, 102 and 103 are deemed to be indefinite. The claims depend from claim 1 which is canceled in the amendment filed 2/08/2024. Further regarding claim 96, the term “a disease or disorder associated with amylin receptor activity” is a relative term which renders the claim indefinite. The term “a disease or disorder associated with amylin receptor activity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is further noted “associated with amylin receptor activity”- encompasses direct interaction – agonist or antagonist, as well as indirect interactions (upstream or downstream of receptor binding). Because claims 97-101 depend from indefinite claim 96 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112(b). The metes and bounds of claim 97 are deemed to be indefinite due to multiple instances of alternative claim language: wherein the disease or disorder is obesity, metabolic disease, an obesity-related condition, eating disorder, Alzheimer's disease, hepatic steatosis (" fatty liver ") , kidney failure, arteriosclerosis (e.g. atherosclerosis ) , cardiovascular disease, macrovascular disease, microvascular disease, diabetic heart (including diabetic cardiomyopathy and heart failure as a diabetic complication ) , coronary heart disease, peripheral artery disease or stroke, cancer, dumping syndrome, hypertension e.g. pulmonary hypertension, or dyslipidemia e.g . atherogenic dyslipidemia, cholescystitis, or short bowel syndrome. See also MPEP § 2173.05(d), for recitation of “e.g.” claim language. Regarding claim 97, the use of parenthetical phrases render the claims indefinite because it is unclear whether the limitations following the phrases or in parentheses are part of the claimed invention. See MPEP § 2173.05(d). Because claims 98 and 99 depend from indefinite claim 97 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112(b). The metes and bounds of claim 98 are deemed to be indefinite due to recitation of alternative claim language: wherein the obesity-related condition is overweight, morbid obesity, obesity prior to surgery, obesity-linked inflammation, obesity-linked gallbladder disease, sleep apnea and respiratory problems, hyperlipidemia, degeneration of cartilage, osteoarthritis, or reproductive health complications of obesity or overweight such as infertility. See also MPEP § 2173.05(d), for recitation of “such as” claim language. 07-34-03 AIA The term “ reproductive health complications of obesity ” in claim 98 is a relative term which renders the claim indefinite. The term “ reproductive health complications of obesity ” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. 07-34-03 AIA The term “ disease states associated with elevated blood glucose levels ” in claim 99 is a relative term which renders the claim indefinite. The term “ disease states associated with elevated blood glucose levels ” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of claim 99 are deemed to be indefinite due to recitation of alternative claim language: wherein the metabolic disease is diabetes, type 1 diabetes, type 2 diabetes, gestational diabetes, pre-diabetes, insulin resistance, impaired glucose tolerance (IGl), disease states associated with elevated blood glucose levels, metabolic disease including metabolic syndrome, or hyperglycemia e.g. abnormal postprandial hyperglycemia. See also MPEP § 2173.05(d), for recitation of “e.g.” claim language . 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 07-31-03 AIA Claims 96-101 are r ejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for d iabetes, obesity, hyperglycemia, impaired insulin tolerance, and certain eating disorders such as binge-eating d oes not reasonably provide enablement for a ll forms of recited diseases, including but limited to, Alzheimer’s, cardiovascular disease, hypertension, cancer, osteoarthritis, anorexia (another eating disorder), and asthma (another respiratory disorder) much less prevention of any disease. T he specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to p ractice t he invention commensurate in scope with these claims. As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright , 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc. , 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson , 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc. 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc. , 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc. , 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC , 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). Pursuant to In re Wands , 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck , 20 USPQ2d 1438, 1444. The analysis is as follows: (1)Breadth of claims. The claims are directed to a method of treating and/or preventing a disease or disorder associated with amylin receptor activity in a subject, comprising administering a therapeutically effective amount of the polypeptide or a pharmaceutically acceptable salt thereof of claim 1 to the subject in need thereof. Claim 1 recites a Markush grouping of peptides of SEQ ID NOs:10-12, 15, 17-21, 24, 25, 33, 40, 44, 48, 66, 70, 80, 129, and 156. (a) Scope of the diseases covered. The specification does not expressly define “a disease or disorder associated with amylin receptor activity in a subject”. Dependent claim 97 recites that the disease or disorder is e.g., obesity, metabolic disease, an obesity-related condition an obesity-related condition, eating disorder, Alzheimer's disease, coronary heart disease, peripheral artery disease or stroke, or cancer. Claim 98 recites wherein the obesity-related condition is overweight, morbid obesity, obesity prior to surgery, obesity-linked inflammation, obesity-linked gallbladder disease, sleep apnea and respiratory problems, hyperlipidemia, degeneration of cartilage, osteoarthritis, or reproductive health complications of obesity or overweight such as infertility. Claim 99 recites wherein the metabolic disease is diabetes, type 1 diabetes, type 2 diabetes, gestational diabetes, pre-diabetes, insulin resistance, impaired glucose tolerance (IGl), disease states associated with elevated blood glucose levels, metabolic disease including metabolic syndrome, or hyperglycemia e.g. abnormal postprandial hyperglycemia. (2) The nature of the invention and predictability in the art: The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher , 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). (3) Direction or Guidance: That provided is limited. Example 1 discloses synthesis of lapidated pramlintide analogues. Example 2 discloses in vitro binding assays. Example 3 discloses thioflavin T fibrillation assays (assessment of peptide stability). Example 4 discloses pharmacokinetic analysis of peptide half-lives in rats. The specification does not include an Example 5. Example 6 discloses assessment of food intake in a rat model. Data is found in Table 9. It is not clear if the peptide numbering also correlates with SEQ ID NO. With the exception of a reduction in food intake, no examples of treatment were reduced to practice. No examples of preventing any disease or disorder were reduced to practice. In order to prevent a disease or disorder, the skilled artisan must first be able to recognize which patient(s) are at risk of developing a disease or disorder, and the amount of the claimed peptide/dosing schedule in order to prevent a disease or disorder. Accordingly, there the specification provides limited guidance as to amounts/routes of administration/dosing regimens for treatment/prevention of all the diseases and disorders that fall within the instant claim scope. (4) State of the Prior Art: Boyle et al ( Mol Metab 8 :203-210 (2018)) is a review article discussing amylin. Amylin is a pancreatic b-cell hormone that produces effects in several different organ systems. One of its best-characterized effects is the reduction in eating and body weight seen in preclinical and clinical studies. Amylin activates specific receptors, a portion of which it shares with calcitonin gene-related peptide (CGRP). Amylin’s role in the control of energy metabolism relates to its satiating effect, but recent data indicate that amylin may also affect hedonic aspects in the control of eating [e.g., binge eating], including a reduction of the rewarding value of food. Recently, several amylin-based peptides have been characterized. Pramlintide (Symlin ) is currently the only one being used clinically to treat type 1 and type 2 diabetes. However other amylin analogs with improved pharmacokinetic properties are being considered as anti-obesity treatment strategies (abstract). Metabolic disease (Encyclopedia Britannica, accessed 2/12/2020 at URL: britannica.com/science/metabolic-disease; pp. 1-17 (2019)) defines a metabolic disease as any of the diseases or disorders that disrupt normal metabolism, the process of converting food to energy on a cellular level. Thousands of enzymes participating in numerous interdependent metabolic pathways carry out this process (p. 1). Metabolic diseases affect the ability of the cell to perform critical biochemical reactions that involve the processing or transport of proteins (amino acids), carbohydrates (sugars and starches), or lipids (fatty acids). Id . Metabolic diseases are typically hereditary, yet most persons affected by them may appear healthy for days, months, or even years. The onset of symptoms usually occurs when the body’s metabolism comes under stress—for example, after prolonged fasting or during a febrile illness. For some metabolic disorders, it is possible to obtain prenatal diagnostic screening. Id . Food is broken down in a series of steps by cellular enzymes (proteins that catalyze the conversion of compounds called substrates) into products with a different biochemical structure. These products then become the substrate for the next enzyme in a metabolic pathway (p. 2). If an enzyme is missing or has diminished activity, the pathway becomes blocked, and the formation of the final product is deficient, resulting in disease. Id . Low activity of an enzyme may result in the subsequent accumulation of the enzyme’s substrate, which may be toxic at high levels. In addition, minor metabolic pathways that usually lie dormant may be activated when a substrate accumulates, possibly forming atypical, potentially toxic, products. Each cell in the body contains thousands of metabolic pathways . Id . Metabolic disorders can include, but are not limited to, disorders of amino acid metabolism, urea cycle defects, amino acid transport disorders, organic acidemias, disorders of carbohydrate metabolism, disorders of lipid metabolism, mitochondrial disorders, lysosomal storage disorders, peroxisomal disorders, purine and pyrimidine disorders, porphyrias (pp. 5-16). Cornier et al. ( Endo. Rev. 29 :777-822 (2008)) is a review article discussing metabolic syndrome. Metabolic syndrome (MetS) is a clustering of components that reflect over-nutrition, sedentary lifestyles, and resultant excess adiposity. The MetS includes the clustering of abdominal obesity, insulin resistance, dyslipidemia, and elevated blood pressure and is associated with other comorbidities including the prothrombotic state, proinflammatory state, nonalcoholic fatty liver disease, and reproductive disorders (abstract). MetS is not a single disease. Id . Treatment of MetS involves lifestyle modification (diet, exercise) and treatment for underlying/associated conditions, e.g., diabetes, weight loss, high blood pressure, dyslipidemia, (pp. 797-803). Alzheimer’s disease causes progressive cognitive deterioration is characterized by beta amyloid deposits and neurofibrillary tangles in the cerebral cortex and subcortical gray matter (Alzheimer’s disease, Merck Manual, accessed 11/2/2023 at URL merckmanuals.com/professional/neurologic-disorders/delirium-and-dementia/alzheimer-disease, pp. 1-9). Alzheimer’s disease is the most common cause of dementia (p. 2). Most cases of Alzheimer disease are sporadic, with late onset (≥ 65 years) and unclear etiology. Risk of developing the disease is best predicted by age. However, about 5 to 15% of cases are familial; half of these cases have an early (presenile) onset (< 65 years) and are typically related to specific genetic mutations. At least 5 distinct genetic loci, located on chromosomes 1, 12, 14, 19, and 21, influence initiation and progression of Alzheimer disease. Mutations in genes for the amyloid precursor protein, presenilin I, and presenilin II may lead to autosomal dominant forms of Alzheimer disease, typically with early onset. In affected patients, the processing of amyloid precursor protein is altered, leading to deposition and fibrillar aggregation of beta-amyloid; beta-amyloid is the main component of neuritic (senile) plaques, which consist of degenerated axonal or dendritic processes, astrocytes, and glial cells around an amyloid core. Beta-amyloid may also alter kinase and phosphatase activities in ways that eventually lead to hyperphosphorylation of tau (a protein that stabilizes microtubules) and formation of neurofibrillary tangles. Other genetic determinants include the apolipoprotein (apo) E (epsilon) alleles. Apo E proteins influence beta-amyloid deposition, cytoskeletal integrity, and efficiency of neuronal repair. Risk of Alzheimer disease is substantially increased in people with two epsilon-4 alleles and may be decreased in those who have the epsilon-2 allele. For people with two epsilon-4 alleles, risk of developing Alzheimer disease by age 75 is about 10 to 30 times that for people without the allele (pp. 2-3). Cholinesterase inhibitors modestly improve cognitive function and memory in some patients. Other treatments include an N -methyl-d-aspartate (NMDA) receptor antagonist and monoclonal antibodies specific for beta-amyloid oligomers (pp. 6-7). The instant further claim scope encompasses genetically inherited diseases, including but not limited to phenylketonuria Hafid et al ( Transl Pediatr 8(1): 304-317 (2019)). There is no reasonable, technical basis for effective treatment of genetically caused metabolic diseases such as phenylketonuria with the claimed polypeptides based on the knowledge in the art, including known causes of such metabolic diseases and the known effects of pramlintide and its analogs. (6) Skill of those in the art: MPEP 2141.03 states (in part)" A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR International Co. V. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id . Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. At 1396, 82 USPQ2d at 1396. The "hypothetical person having ordinary skill in the art' to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art." Ex parte Hiyamizu , 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner's definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering). In the instant case, the skill in the art high with respect to physicians and scientists. The level of skill in the art (physicians and scientists) would be high. (7) The quantity of experimentation needed: Owing especially to factors 1-6 the quantity is expected to be high. MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright , 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here. Double Patenting 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The 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 88, 90, and 95-103 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12371464 (hereinafter referred to as “the ‘464 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. The instant application and the ‘464 parent share priority to Prov Appl No 63/125996, earliest effective filing date of 12/16/2020. Regarding instant claims 88 and 90, claims 1 and 2 of the ‘464 patent discloses polypeptide or a pharmaceutically acceptable salts comprising the amino acid sequence of SEQ ID NO:15. SEQ ID NO:15 of the ‘464 patent has 100% identity with instant SEQ ID NO: 15. Regarding claim 95, claims 1, 2, and 6 of the ‘464 patent discloses a pharmaceutical composition comprising the polypeptide or a pharmaceutically acceptable salt of claim 1 (e.g., instant SEQ ID NO:15) and pharmaceutically acceptable excipient. Regarding claims 96-101, the instant claims are directed to a method of treating comprised of administering the patented peptide of SEQ ID NO:15. It would have been obvious to one of ordinary skill in the art at the time the invention was made that the peptide of the ‘464 patent could be used in a method for treating and/or preventing a disease or disorder associated with amylin receptor activity. The ‘464 patent disclosed, but did not claim the method of a disease or disorder associated with amylin receptor activity (coll. 29-30, 33-34). The instant case is analogous to Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010), where the courts ruled that obviousness-type double patenting exist between previously-disclosed, but newly-claimed utility. Therefore, the instant claims 96-101 are not patentably distinct from the issued claims of the ‘464 patent. Regarding claim 103, the instant claim is directed to a method of producing the polypeptide. Claims 1 and 2 of the ‘464 disclose instant SEQ ID NO:15. The ‘464 patent disclosed, but did not claim the method of a preparing the peptide (Example 1). The instant case is analogous to Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010), where the courts ruled that obviousness-type double patenting exist between previously-disclosed, but newly-claimed. Therefore, the instant claim 102 is not patentably distinct from the issued claims of the ‘464 patent. Regarding claim 103, claims 1, 2, and 7 of the ‘464 patent discloses a kit comprising the polypeptide or pharmaceutically acceptable salt of claim 1 (e.g., instant SEQ ID NO:15), optionally further comprising instructions for use. Claims 88, 90, and 95-103 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 94, 96, and 98-125 of copending Application No 19052168 (hereinafter referred to as “the ‘168 application”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. The instant application and the ‘168 application share priority to Prov Appl No 63/125996, earliest effective filing date of 12/16/2020. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Regarding claims 88, 90, 95, and 103, claims 94 (obesity-related condition), 98, 102 (inhibiting or reducing weight gain, promoting weight loss, reducing food intake, and/or producing excessive body weight), 103, 111 (obesity), 112, 118 (metabolic disease), 120 of the ‘168 application recite administering SEQ ID NO:15. SEQ ID NO:15 of the ‘168 application has 100% identity with instant SEQ ID NO: 15. Regarding claim 97-99, claims 94 (obesity-related condition), 98, 102 (inhibiting or reducing weight gain, promoting weight loss, reducing food intake, and/or producing excessive body weight), 103, 111 (obesity), 112, 118 (metabolic disease), 120 of the ‘168 application recite administering SEQ ID NO:15 to treat the disease. Regarding claim 100, claims 107, 108, 116, and 124 of the ‘168 application recite wherein the pharmaceutical composition is administered by subcutaneous injection. Regarding claim 101, claims 109, 110, 117, and 125 of the ‘168 application recite wherein the composition is administered by self-administration. Claims 88-101 and 103 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-24, 26, 27, 29, 30, 36, 38, 42, 48-50 of copending Application No. 19212361 (hereinafter referred to as “the ‘361 application”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. SEQ ID NOs:6, 9-11, 17, 18, 22 of the ‘361 application claims which have 100% identity with instant SEQ ID NOs: 10, 15, 17, 18, 33, 40, 70, respectively. Regarding claim 88-94, claims 1, 11, and 15 of the ‘361 application recite amylin receptor agonists of SEQ ID NOs:9-11 (100% identity with instant SEQ ID NOs: 15, 17, and 18). Regarding claim 95, claims 1, 4, 11, 15, and 49 of the ‘361 application recite a composition comprising a AMYR agonist and a GLP-1R antagonist. Claim 15 of the ‘361 application recites SEQ ID NOs:9-11 which have 100% identity with instant SEQ ID Nos. 15, 17 and 18. Regarding claim 97-99, claims 1 (treating and/or preventing a disease or disorder), 11, 23 (treating and/or preventing a disease or disorder), 36 (reducing weight gain, promoting weight loss, reducing food intake, increasing satiety, improving glycemic and/or metabolic control), 38 (reducing fat-mass specific body weight) of the ‘361 application recite administering a AMYR agonist. Claims 15 and 24 recite SEQ ID NOs:9-11 which have 100% identity with instant SEQ ID Nos. 15, 17 and 18. Regarding claim 100, claims 1, 11, 15, and 42 of the ‘361 application of the ‘361 application recite that the peptide is administered by subcutaneous injection. Regarding claim 101, claims 1, 11, 15, and 42 of the ‘361 application recite that the peptide is administered orally or by subcutaneous injection. Self-administration is deemed to be routine in the art. Regarding claim 103, claims 1, 4, 11, 15, 49, and 50 of the ‘361 application recite a kit comprising a AMYR agonist and a GLP-1R antagonist. Claim 15 of the ‘361 application recites SEQ ID NOs:9-11 which have 100% identity with instant SEQ ID Nos. 15, 17 and 18. Relevant Prior Art SEQ ID NOs: 10-12, 15, 17, 18-20, 44, 48, and 66 comprise the same modifications from pramlintide at the following position: Arg replacing Val at pramlintide position 17; C18 diacid-linked acyl group from a lysine epsilon group at the N-terminus; and either αMePhe replacing Phe at position 23 or Aib replacing Asn at position 21. SEQ ID NO:21 differs from pramlintide with a C18 diacid-linked acyl group from a lysine epsilon group at the N-terminus; and αMePhe replacing Phe at position 23; and Arg replacing Asn at position 35. SEQ ID NOs:24 and 25 differ from pramlintide with a C18 diacid-linked acyl groups from a lysine epsilon group at the N-terminus; and αMePhe replacing Phe at position 23; and Arg replacing Asn at position 31. SEQ ID NO:33 differs from pramlintide with a C18 diacid-linked acyl group from a lysine epsilon group at the N-terminus; an extra Lys at the N-terminus, and Dab replacing Asn at position 15. SEQ ID NOs:40, 70, and 80 differs from pramlintide with a C18 diacid-linked acyl group from a lysine epsilon group at the N-terminus; an extra Lys at the N-terminus, and Aib replacing Asn at position 21. SEQ ID NOs:70 and 80 further comprise Arg or Aib replacing Asn at position 31. SEQ ID NO:33 differs from pramlintide with a C18 diacid-linked acyl group from a lysine epsilon group at the N-terminus; an extra Lys at the N-terminus, and Dab replacing Asn at position 14. SEQ ID NO:129 differs from pramlintide with a C18 diacid-linked acyl group from a lysine epsilon group at the N-terminus; an extra Lys at the N-terminus, and Aib replacing Val at position 17. SEQ ID NO:156 differs from pramlintide with a C18 diacid-linked acyl group from a lysine epsilon group at the N-terminus; an extra Lys at the N-terminus, Dab replacing Asn at position 14; and Aib replacing Val at position 17. The closest prior art to the instant peptides is Schaffer et al (U.S. 20110105394) and Hansen (U.S. 2009/0099085). The references teach amylin derivatives, respectively. SEQ ID NOs: 10-12, 15, 17, 18-20, 44, 48, and 66 differ from SEQ ID NO:28 of Shaffer which is Asn, and at the denoted αMePhe or Aib residues, respectively. SEQ ID NO:21 differs from SEQ ID NO:17 of Hansen with an extra Lys at the N-terminus, αMePhe instead of Asn at position 21, and Asn instead of Arg at position 35. SEQ ID NOs:24 and 25 differ from SEQ ID NO:6 of Hansen with an extra Lys at the N-terminus and αMePhe instead of Asn at position 21. SEQ ID NO:33 differs from SEQ ID NO:14 of Hansen with an extra Lys at the N-terminus, and Dab replacing Asn at position 14. SEQ ID NO:40 differs from SEQ ID NO:10 of Hansen with an extra Lys at the N-terminus, Aib at position 21, and Glu instead of Asn at position 31. SEQ ID NO:44 differs from SEQ ID NO:28 of Schaffer with Aib instead of Asn at position 21, and Glu instead of Asn at position 31. SEQ ID NO:48 differs from SEQ ID NO:20 of Schaffer with an extra Lys the N-terminus and Aib instead of Asn at position 21. SEQ ID NO:66 differs from SEQ ID NO:28 of Schaffer with an extra Lys at the N-terminus and Aib instead of Asn at position 21. SEQ ID NO:70 differs from SEQ ID NO:6 of Hansen with an extra Lys at the N-terminus and Aib instead of Asn at position 21. SEQ ID NO:80 differs from SEQ ID NO:10 of Hansen with an extra Lys at the N-terminus and Aib instead of Asn at position 31. SEQ ID NO:129 differs from SEQ ID NO:6 of Hansen with an extra Lys at the N-terminus, and Aib instead of Val at position 17. SEQ ID NO:156 differs from SEQ ID NO:6 of Hansen with an extra Lys at the N-terminus, Dab replacing Asn at position 14,and Aib instead of Val at position 17. Conclusion No claims are allowed. Claims 83-101 are pending and are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KRISTINA M HELLMAN/Examiner, Art Unit 1654 Application/Control Number: 18/257,756 Page 2 Art Unit: 1654 Application/Control Number: 18/257,756 Page 3 Art Unit: 1654 Application/Control Number: 18/257,756 Page 4 Art Unit: 1654 Application/Control Number: 18/257,756 Page 5 Art Unit: 1654 Application/Control Number: 18/257,756 Page 6 Art Unit: 1654 Application/Control Number: 18/257,756 Page 7 Art Unit: 1654 Application/Control Number: 18/257,756 Page 8 Art Unit: 1654 Application/Control Number: 18/257,756 Page 9 Art Unit: 1654 Application/Control Number: 18/257,756 Page 10 Art Unit: 1654 Application/Control Number: 18/257,756 Page 11 Art Unit: 1654 Application/Control Number: 18/257,756 Page 12 Art Unit: 1654 Application/Control Number: 18/257,756 Page 13 Art Unit: 1654 Application/Control Number: 18/257,756 Page 14 Art Unit: 1654 Application/Control Number: 18/257,756 Page 15 Art Unit: 1654 Application/Control Number: 18/257,756 Page 16 Art Unit: 1654 Application/Control Number: 18/257,756 Page 17 Art Unit: 1654 Application/Control Number: 18/257,756 Page 18 Art Unit: 1654 Application/Control Number: 18/257,756 Page 19 Art Unit: 1654 Application/Control Number: 18/257,756 Page 20 Art Unit: 1654