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 .
Claim Status
Applicant’s amendment filed November 30, 2023 has been received and entered.
Claims 1-4 and 6-15 have been amended.
Claim 5 has been canceled.
Claims 16-20 have been added.
Claims 1-4 and 6-20 are pending and under consideration.
Priority
This application is a 371 of PCT/KR2022/009449 filed June 30, 2022, which claims the benefit of Republic of Korea Application No. 10-2021-0086014 filed June 30, 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
However, support for the claimed invention cannot be determined because the foreign priority documents provided for Application No. 10-2021-0086014 are not in English. Applicant cannot rely upon the certified copy of the foreign priority application to overcome any prior art rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216. Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Accordingly, the PCT/KR2022/009449 filing date of June 30, 2022 will be used for the purpose of applying prior art.
Information Disclosure Statements
The information disclosure statements (IDSs) submitted on 11/30/2023, 6/18/2025, 9/26/2025, and 1/21/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1-2, 6-7, and 19-20 are objected to because of the following informalities:
Claims 1-2 and 7 - should recite SEQ ID NOs: with lowercase “s”.
Claim 2 is drawn to a conjugate comprising a peptide represented by the formula X - L - F.
Claim 2 (line 9) further recites that “- represents covalent linkages between X and L and between L and F, respectively”. It is suggested that the claim be amended to read “the dash (-) represents covalent linkages between X and L and between L and F, respectively”.
Claim 6 is grammatically incorrect. It is suggested that the claim be amended to read “…wherein the subject is a diabetic patient that is overweight or obese”.
Claims 19-20 recite “the sodium-glucose cotransporter 2 (SGLT-2 inhibitor)”, however, the full term for the acronym SGLT-2 was fully defined in claim 1. Therefore, the claims should read “the SGLT-2 inhibitor”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 2, 4, and 9-14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 2 (line 5) recites X represents a peptide including an amino acid sequence of any one of SEQ ID NOs: 1 to 102. The term “including an amino acid sequence” makes it unclear as to whether X comprises only a peptide having an amino acid sequence of SEQ ID NO: 1 to 102, or if the amino acid sequence of one of SEQ ID NO: 1 to 102 comprises a part of the amino acid sequence of X. For the purposes of examination, X is interpreted as comprising the amino acid sequence of one of SEQ ID NOs: 1 to 102, with no additional amino acids.
Claims 10-14 are included in the rejection as they depend from claim 2 and fail to clarify the issue.
Claim 2 recites the term “long-acting conjugate”, which is a relative term which renders the claim indefinite. The term “long-acting conjugate” 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. Specifically, the specification discloses that the long-acting conjugate has a biocompatible material conjugated to the peptide, and may exhibit an increased duration of efficacy, as compared with the peptide to which the biocompatible material is not conjugated [pg. 22 (last par.) - pg. 23]. For the purposes of examination, a long-acting conjugate will be interpreted as meaning a conjugated peptide having an increased half-life than the parent peptide.
Claim 4 recites the SGLT-2 inhibitor is any one or more selected from empagliflozin, dapagliflozin, canagliflozin, remogliflozin, remogliflozin etabonate, sergliflozin, ipragliflozin, tofogliflozin, luseogliflozin, sotagliflozin, bexagliflozin, atigliflozin, and ertugliflozin. However, the claim depends from claim 1 which only allows for a single SGLT-2 inhibitor, reciting the therapeutic peptide is administered with a sodium-glucose cotransporter 2 (SGLT-2 inhibitor).
Claim 9 recites the peptide has a ring formed between amino acid residues. The claim is ambiguous as to where such ring may be formed. The specification discloses the ring may be formed between amino acids at positions 16 and 20, but is not limited thereto. The specification further discloses the ring may be formed between amino acid side chains. Thus, one of ordinary skill would not be able to determine whether or not they were infringing on the claims as written.
Claim 12 recites the immunoglobulin Fc region is a dimer consisting of two polypeptide chains, wherein one end of L is linked to only one polypeptide chain of the two polypeptide chains. The claim language is confusing and makes it hard to envision the structure. It is suggested the claim be amended to read “…the immunoglobulin Fc region is a dimer consisting of two polypeptide chains, wherein one of the two polypeptide chains is linked to one end of L.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
WRITTEN DESCRIPTION
Claims 1-4 and 6-20 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See MPEP § 2163.
Claim 1 is drawn to drawn to a method for treating metabolic syndrome, liver disease, lung disease, or respiratory infections in a subject in need thereof, comprising administering a pharmaceutically effective amount of a peptide selected from any one SEQ ID NOs: 1 to 102 and an SGLT-2 inhibitor.
Claim 4 limits the SGLT-2 inhibitor to one or more of empagliflozin, dapagliflozin, canagliflozin, remogliflozin, remogliflozin etabonate, sergliflozin, ipragliflozin, tofogliflozin, luseogliflozin, sotagliflozin, bexagliflozin, atigliflozin, and ertugliflozin.
The claims encompass a large genus of structurally distinct molecules that block SGLT-2 protein.
The specification discloses that SGLT-2 inhibitors are a class of medicine used as blood glucose level lowering agents, and are an oral diabetes treatment mainly used to control blood glucose in type 2 diabetes patients by inhibiting glucose reabsorption by the kidneys and excreting glucose, resulting in a blood glucose lowering effect [pg. 3, lines 1-5].
The instant specification only demonstrates the results for 1 type of SGLT-2 inhibitors administered with a single peptide with the amino acid sequence of SEQ ID NO: 42.
It is well understood in the art that SGLT-2 inhibitors share the common function of blocking SGLT-2 in the kidneys, thereby forcing glucose to be excreted in the urine. However, Padda et al. (Treasure Island (FL): StatPearls Publishing; Updated 2025 Sep 15, https://www.ncbi.nlm.nih.gov/books/ NBK576405/) teaches that SGLT-2 inhibitors differ significantly in selectivity, approved indications, dosing, and kidney function requirements. Despite substantial clinical advantages, therapy requires attention to safety considerations such as volume depletion, genital infections, diabetic ketoacidosis, and potential lower extremity complications. Optimizing patient outcomes depends on appropriate selection, dosing, monitoring, and interprofessional strategies that enhance adherence and long-term care [pg. 1]. FDA-approved SGLT-2 inhibitors include the following:
Canagliflozin inhibits both SGLT-2 in the kidneys and SGLT-1 in the intestines which slightly delays glucose absorption. It is approved for type 2 diabetes and reducing the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in adults with T2DM and established cardiovascular disease (CVD), as well as reducing the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with T2DM and diabetic nephropathy [pg. 2].
Dapagliflozin is highly selective for SGLT-2 and is approved for type 2 diabetes, and reducing the risk of cardiovascular death and urgent heart failure visits in adults with heart failure, irrespective of ejection fraction status. It is also approved for treating chronic kidney disease (CKD) [pg. 2-3].
Empagliflozin is highly selective for SGLT-2 and is approved for type 2 diabetes, reducing cardiovascular death in adults with cardiovascular disease, and treating both preserved and reduced ejection fraction heart failure. It is also approved for treating chronic kidney disease (CKD) [pg. 3-4].
Ertugliflozin is highly selective for SGLT-2 and is primarily used to improve glycemic control in adults with type 2 diabetes. Unlike other SGLT2 inhibitors, ertugliflozin’s current FDA-approved indications are limited to glycemic management, without additional cardiovascular or renal risk-reduction claims [pg. 4].
Bexagliflozin is highly selective for SGLT-2 and its primary FDA approval is as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes [pg. 4].
Sotagliflozin is a dual SGLT1/SGLT2 inhibitor, approved in the U.S. and indicated to reduce the risk of cardiovascular death, hospitalization, and urgent heart failure visits in adults with heart failure, including those with preserved or reduced ejection fraction, or cardiovascular risk factors such as T2DM or CKD [pg. 4-5].
Applicant has only demonstrated the effect of a single SGLT-2 inhibitor, empagliflozin. Therefore, the properties of one SGLT-2 inhibitor cannot be applied to other SGLT-2 inhibitors, as the properties of the claimed SGLT-2 inhibitors are not predictive of the full genus of inhibitors.
The instant application has not provided a sufficient description showing possession of the necessary functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus of SGLT-2 inhibitors encompassing various structures, specificities and functions. Further, the Court has interpreted 35 U.S.C. § 112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe, Inc., 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002). In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 48 USPQ2d 1398 (Fed Cir. 1997)).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with
reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession
of the invention. The invention is, for purposes of the 'written description’ inquiry, whatever is now
claimed." (See Vas-Cath, p. 1117). The specification does not "clearly allow persons of ordinary skill in
the art to recognize that [he or she] invented what is claimed." (See Vas-Cath, p. 1116). Also, it is noted that the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., Inc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Meeting the written description threshold requires showing that the applicant was in “possession” of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support
need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein
v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning —
i.e., what the written description and knowledge in the art would lead one to speculate as to modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Ariad points out, the written description requirement also
ensures that when a patent claims a genus by function, the specification recites sufficient materials to
accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3.
Given the claimed broadly class of SGLT-2 inhibitors, in the absence of sufficient disclosure of relevant identifying characteristics, the patentee must establish “a reasonable structure-function correlation” either within the specification or by reference to the knowledge of one skilled in the art with functional claims. There is insufficient written description of the required kind of structure- identifying information about the corresponding makeup of the claimed SGLT-2 inhibitors to demonstrate possession. Also, see Amgen Inc. v. Sanofi, Aventisub LLC, No. 2017-1480 (Fed. Cir. 2017). Thus, one of skill in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d 1559, 43, USPQ2d 1398.
Claims 2-4 and 6-20 are included in the rejection because they depend from a rejected claim and fail to resolve the issue.
ENABLEMENT
Claims 1-4 and 6-20 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the enablement requirement because the specification, while being enabling for treating obesity and diabetes by administering a long-acting conjugate comprising a peptide with the amino acid sequence of SEQ ID NO: 42 in combination with empagliflozin, does not reasonably provide enablement for treating metabolic syndrome, liver disease, lung disease, or respiratory infections, comprising administering a pharmaceutically effective amount of any peptide selected from SEQ ID NOs: 1 to 102 in combination with any SGLT-2 inhibitor as broadly claimed.
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
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 in 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). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
The nature of the invention and (5) The breadth of the claims:
Claim 1 is drawn to a method for treating metabolic syndrome, liver disease, lung disease, or respiratory infections in a subject in need thereof, comprising administering a pharmaceutically effective amount of a peptide selected from any one SEQ ID NOs: 1 to 102 and any SGLT-2 inhibitor.
The claim is broad and inclusive of all types of metabolic syndrome, liver disease, lung disease, and respiratory infections. The breadth of the claim exacerbates the complex nature of the subject matter to which the present claims are directed. The claims are extremely broad due to the vast number of possible diseases represented by the terms “treating metabolic syndrome, liver disease, lung disease, or respiratory infections”.
Claim 3 further limits the metabolic syndrome to diabetes, obesity, hyperlipidemia, and dyslipidemia.
Regarding metabolic syndrome, Fahed et al. (Int J Mol Sci, 2022; 23(2):786) teaches it is not a disease per se, but a cluster of metabolic dysregulations including insulin resistance, atherogenic dyslipidemia, central obesity, and hypertension [Abstract, Introduction]. The pathogenesis of metabolic syndrome encompasses multiple genetic and acquired entities that fall under insulin resistance and chronic low-grade inflammation. However, many aspects of this metabolic syndrome are still not completely understood [Abstract].
Regarding liver disease, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (https://www.niddk.nih.gov/health-information/liver disease; accessed online 26 June 2026) teaches there are many kinds of liver diseases and conditions. Some, like hepatitis, are caused by viruses. Others can be the result of drugs or drinking too much alcohol [Introduction].
Types of liver disease include: Alagille syndrome, autoimmune hepatitis, biliary atresia, cirrhosis, hepatitis A, hepatitis B, hepatitis C, hepatitis D, hepatitis E, viral hepatitis, nonalcoholic fatty liver disease (NASH), porphyria, primary biliary cirrhosis, primary sclerosing cholangitis, and Wilson disease [Liver Disease Topics].
Regarding lung diseases, Hoffman et al. (https://www.webmd.com/lung/lung-diseases-overview; 2025) teaches they are some of the most common medical conditions in the world. Lung diseases encompass any condition that affects the lungs. There are many causes of lung diseases, including smoking, environmental factors, infections, and genetics [Introduction].
Lung diseases can be subdivided into different categories depending on the location of the disease:
Lung diseases affecting the airways
Asthma
COPD
Bronchitis
Emphysema
Cystic fibrosis
Lung diseases affecting the alveoli
Pneumonia
Tuberculosis
Emphysema
Pulmonary Edema
Lung cancer
Acute respiratory distress syndrome (ARDS)
Pneumoconiosis
Lung diseases affecting the interstitium
Interstitial lung disease (ILD), including sarcoidosis, pulmonary fibrosis, and autoimmune disease
Pneumonia
Emphysema
Pulmonary Edema
Lung diseases affecting blood vessels
Pulmonary embolism
Pulmonary hypertension
Lung diseases affecting the pleura
Pleural effusion
Pneumothorax
Mesothelioma
Lung diseases affecting the chest wall
Obesity hypoventilation syndrome
Neuromuscular disorders
Regarding respiratory infections, Dasaraju et al. (Baron S, editor. Medical Microbiology. 4th edition. Galveston (TX): University of Texas Medical Branch at Galveston; 1996) teaches respiratory infections can be separated into upper and lower respiratory infections, and encompass many infections with different etiologies [General Concepts].
Upper respiratory infections - mostly viral
Common cold
Sinusitis
Pharyngitis
Epiglottitis
Laryngotracheitis
Lower respiratory infections - viral or bacterial
Bronchitis
Bronchiolitis
Pneumonia
(2) The state of the prior art and (4) The predictability or unpredictability of the art:
The state of the art with regard to treating metabolic syndrome is complex, with many methods focusing on management of the disorder. For example, Fahed et al. (2022) teaches adherence to the Mediterranean diet has been shown to decrease the risk of, and even revert metabolic syndrome [Section 3.1]. Additionally, nutraceuticals, including several plant extracts, spices (e.g., curcumin), herbs, and essential oil extracts (e.g., coconut oil), as well as probiotics have been shown to have benefit in the management of patients with metabolic syndrome [Sections 3.2, 3.4-3.6]. Fahed et al. (2022) also teaches butyrate supplementation may help in management of metabolic syndrome, as butyrate is produced by bacteria in the colon, and microbiota taken from lean subjects show increased comparative levels of bacteria that produce butyrate and after transferring them to subjects with metabolic syndrome, the insulin sensitivity is improved [Section 3.3]. Fahed et al. (2022) also teaches drugs that can be used for the management of metabolic syndrome, including statins that reduce inflammation and anti-hyperglycemic agents such as DPP-4 inhibitors and GLP-1 receptor agonists [Sections 3.6-3.7].
The current state of the art regarding the treatment of liver disease is that pharmacological interventions form the backbone of liver disease management. Wazir et al. (Cureus, 2023; 15(12): e49920. DOI 10.7759/cureus.49920) teaches regarding medications alleviating symptoms of liver disease, the pharmacological arsenal is vast. Despite the strides made in pharmacological interventions, challenges persist in balancing the efficacy of medications with potential adverse effects [pg. 7].
Wazir further teaches lifestyle modifications, particularly dietary changes, are pivotal in supporting liver health. A well-balanced diet can mitigate the impact of liver diseases and promote overall well-being. For individuals with liver diseases, especially those with ALD, reducing or eliminating alcohol consumption is paramount. Nutritional interventions are particularly relevant in conditions such as NAFLD, where dietary choices significantly impact disease progression. Further, engaging in regular physical activity contributes to weight management, reducing the risk of NAFLD and its progression to more severe forms, such as NASH. Physical activity enhances insulin sensitivity, a crucial factor in managing liver diseases. Improved insulin sensitivity reduces the risk of metabolic complications associated with liver conditions such as cirrhosis [pg. 7]. Lastly, in cases where liver diseases progress to an advanced stage and no other therapeutic options remain, liver transplantation can be a lifesaving intervention for conditions such as end-stage liver disease, acute liver failure, or certain liver cancers [pg. 8].
The current treatments for lung disease depends on the specific condition, with the primary goal of relieving symptoms, slowing disease progression, and improving quality of life. The National Heart, Lung, and Blood Institute (NHLBI) (https://www.nhlbi.nih.gov/health/lung-treatments; 2022) teaches a range of treatments for lung diseases. For example, oxygen therapy can be administered with conditions such as asthma, pneumonia, or COPD that cause blood oxygen levels to be too low [pg. 1]. Pulmonary rehabilitation that includes exercise training, health education, and breathing techniques for people who have certain lung conditions, such as cystic fibrosis, COPD, or have had a lung transplant [pg. 2-3]. NHLBI also teaches that thoracentesis to remove excess fluid from the pleural space can make breathing easier for patients with pneumonia or sarcoidosis [pg. 3-4]. More aggressive treatment such as tracheostomy may be required for patients on ventilators or conditions that block the upper airways, such as pneumonia and stroke [pg. 4-5]. Lastly, lung transplant may be necessary when other treatment options fail [pg. 5-6].
Treatment of respiratory infections is dependent on type and location. Dasaraju et al. (1996) teaches upper and lower respiratory viral infections are treated symptomatically, while bacterial infections are treated with antibiotics. Upper respiratory infections include the common cold, sinusitis, and epiglottitis. Treatment for the common cold is comprised of decongestants, antipyretics, fluids, and bed rest [pg. 3]. Sinusitis infections can be treated with analgesics and moist heat over the affected sinus pain and a decongestant to promote sinus drainage. However, antimicrobial therapy with amoxicillin-clavulanate or a cephalosporin may be necessary [pg. 3]. Epiglottitis is the most serious upper respiratory infection and is considered a medical emergency, especially in children. Patients need to be intubated to maintain an open airway as soon as the first sign of respiratory distress is detected and antibacterial therapy directed at H. influenzae is administered. Dasaraju also teaches that H. influenzae type b infections can be prevented with vaccination early in life [pg. 7].
Lower respiratory viral infections are treated with supportive measures. Respiratory syncytial virus infections in infants may be treated with antivirals such as ribavirin. Amantadine and rimantadine are available for chemoprophylaxis or treatment of influenza type A viruses. Selected groups of patients with chronic bronchitis may receive benefit from use of corticosteroids, bronchodilators, or prophylactic antibiotics [pg. 8]. Treatment for pneumonia is dependent on the causative organism, which can be viral or bacterial in nature. The pneumococcal vaccine should be given to patients at high risk for developing pneumococcal infections, including asplenic patients, the elderly and any patients immunocompromised through disease or medical therapy [pg. 9-10].
Given the lack of predictability in the treatment of metabolic syndrome, liver disease, lung disease, and respiratory infections, the skilled artisan would have to engage in undue experimentation to first identify individuals to which the instant method would apply and treat patients with the specific metabolic syndrome, liver disease, lung disease, or respiratory infection.
6) the amount of direction or guidance provided by the inventor; 7) the existence of working examples;
The instant claims are directed to a treatment comprising administering a peptide selected from SEQ ID NO: 1 to SEQ ID NO: 102 in combination with an SGLT-2 inhibitor. However, the instant specification sets forth only one in vivo example testing the blood glucose lowering effect of the long-acting conjugate of SEQ ID NO: 42 in combination with empagliflozin administered to DIO/STZ rats, which are models of obesity and diabetes [Example 2, pg. 73]. Treatment resulted in reduced glucose levels and reduced body weight [Fig. 1].
No other models for metabolic syndrome (i.e., hyperlipidemia or dyslipidemia), or liver disease, lung disease, or respiratory infection were treated with the disclosed peptides, administered alone or part of a long-acting conjugate in combination with an SGLT-2 inhibitor.
Furthermore, Table 2 of the instant specification demonstrates the results for the in vitro activity of the triple agonists against compared to native peptide agonists at the GLP-1, glucagon and GIP receptors. Of the 102 instantly claimed unconjugated peptides, only a select number demonstrate agonist activity. For example, the peptides of SEQ ID NOs: 13 and 18-20 of the present application have < 0.1 %, < 0.1 %, and < 0.1 % in vitro activity compared to the native peptide agonists at the GLP-1, glucagon and GIP receptors, respectively. Thus, these peptides are not triple GLP-1, glucagon, and GIP receptor agonists. Many of the other instantly claimed peptides demonstrate weak triple agonist activity. Only a handful of the instantly claimed peptides can be considered true triple GLP-1, glucagon, and GIP receptor agonists, including the peptides recited in claims 7 and 18 having an amino acid sequence of SEQ ID NOs: 21, 22, 42, 43, 50, 77, and 96.
However, when the peptides of SEQ ID NOs: 21, 22, 42, 43, 50, 77, and 96 were conjugated, the activities toward one or more receptor were significantly reduced [Table 3]. For example, the activity of the peptide of SEQ ID NO: 21 has 0.1 %, 1.6 %, and 0.1 % in vitro activity compared to the native peptide agonists at the GLP-1, glucagon and GIP receptors, respectively, which has significantly less agonist activity versus the unconjugated peptide.
As such, it would be hard to envision peptides with little to no agonist activity towards the receptors for GLP-1, glucagon, or GIP would be effective in any treatment, including the treatment of metabolic syndrome, liver disease, lung disease, and respiratory infections as broadly claimed.
Therefore, the only embodiment that is enabled is treatment of diabetes and obesity comprising administration of a long-acting conjugate of SEQ ID NO: 42 in combination with an SGLT-2 inhibitor. One of skill in the art would be required to engage in extensive, difficult experimentation to first develop criteria for identification of specific types of metabolic syndrome, liver disease, lung disease, and respiratory infections to which the method can apply which is known to be unpredictable as indicated above. This required experimentation is undue.
In conclusion, the claimed invention does not provide enablement for treatment of metabolic syndrome, liver disease, lung disease, and respiratory infections by administration of an unconjugated peptide comprising an amino acid sequence of SEQ ID NO: 1 to 102 in combination with an SGLT-2 inhibitor. Thus for the reasons outlined above, the specification is not considered to be enabling for one skilled in the art to make and use the claimed invention as the amount of experimentation required is undue, due to the broad scope of the claims, the lack of guidance and working examples provided in the specification. Therefore, the specification is not representative of the instant claims and the specification is not fully enabled for the instant claims. In view of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention.
Claims 2-4 and 6-20 are included in the rejection as they depend from or otherwise require all the limitation of a rejected claim and fail to resolve the issues.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 and 6-20 are rejected under 35 U.S.C. 103 as being unpatentable over Oh et al. (WO 2017/116205; cited IDS 11/30/2023) (“Oh”) in view of Bossart et al. (WO 2018/100134) (“Bossart”). An English ESPACENET machine translation (attached) of WO 2017/116205 was used in making the following rejection(s). As such, page numbers refer to those printed on the bottom margin of the translated document.
The instant claims are drawn to a method for treating metabolic syndrome, liver disease, lung disease, or respiratory infections in a subject in need thereof, comprising administering a pharmaceutically effective amount of a peptide selected from any one SEQ ID NOs: 1 to 102 and an SGLT-2 inhibitor, wherein the peptide is in the form of a long-acting conjugate with the formula X-L-F, wherein X represents a peptide including an amino acid sequence of any one of SEQ ID NOS: 1 to 102; L represents a linker containing ethylene glycol repeating units; F represents an immunoglobulin Fc region; and the dash (-) represents covalent linkages between X and L and between L and F, respectively. The metabolic syndrome is any one or more selected from the group consisting of diabetes, obesity, hyperlipidemia, and dyslipidemia and the peptide includes any one amino acid sequence of SEQ ID NOS: 21, 22, 42, 43, 50, 77, and 96, wherein the peptide is C-terminally amidated, has a ring formed between amino acid residues, wherein the immunoglobulin Fc region is aglycosylated and is an IgG4 Fc region consisting of two polypeptide chains, wherein in the conjugate, L is linked to F and X by covalent linkages formed by reacting one end of L with an amine group or thiol group of F and reacting the other end of L with an amine group or thiol group of X, respectively, wherein L is polyethylene glycol with a formula weight of 1 kDa to 100 kDa. The SGLT-2 inhibitor is any one or more selected from the group consisting of empagliflozin, dapagliflozin, canagliflozin, remogliflozin, remogliflozin, etc. The peptide, or the peptide conjugate and the SGLT-2 inhibitor are administered simultaneously, separately, sequentially, or reverse sequentially.
Oh teaches methods for treating metabolic syndrome comprising administering a pharmaceutical composition [pg. 93] comprising a conjugate of peptides having activity against glucagon receptors, GLP-1 (glucagon-like peptide-1) receptors, and GIP (glucose-dependent insuliontropic polypeptide) receptors [pg. 6] (instant claim 1 (partial)). The conjugate is represented by the formula X-L-F [pg. 7], wherein X is a peptide characterized as being a peptide comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 1 to 102 [pg. 26], L is a non-peptide linker comprising polyethylene glycol [pg. 28], and F is a substance that can increase the half-life of X [pg. 7] (instant claims 1-2, 14). Exemplary peptides are selected from the group consisting of SEQ ID NOs: 21, 22, 42, 43, 50, 64 to 77, and 96 to 102. [pg. 63] (instant claims 7, 18).
Oh further teaches the peptide comprises a ring formed between the 16th and 20th amino acid from the N-terminus [pg. 7] (instant claim 9). Further, the N- and C-terminals of chemically synthesized peptides are charged, therefore the N-terminal may be acetylated and/or the C-terminal may be amidated to remove these charges [pg. 43] (instant claim 8). Additionally, F and X may be bonded to each other through L by a covalent chemical bond [pg. 67]. The linker has a molecular weight in the range of 1 to 100 kDa and both ends of the linker may be bonded to an amine or thiol group of F, and an amine or thiol group of X [pg. 72] (instant claims 13, 15). Oh also teaches the immunoglobulin Fc region may be in a dimeric form, and one molecule of X may be covalently connected to one of the dimeric Fc regions by a non-peptide linker [pg. 76] (instant claim 12 (partial)). Genetic engineering methods using microorganisms can be used to remove immunoglobulin Fc sugar chains via aglycosylation resulting in significantly reduced or eliminated antibody dependent cytotoxicity or complement-dependent cytotoxicity of the pharmaceutical in vivo [pg. 80] (instant claim 10). More specifically, the immunoglobulin Fc region is an IgG4 Fc region, and the immunoglobulin Fc region is a non-glycosylated Fc region. The polypeptide encoding a short-chain immunoglobulin Fc region of the same origin forms a bond with a short-chain polypeptide of a different origin when forming a dimer [pg. 81] (instant claims 11-12 (partial)).
Oh further teaches the conjugate can be used to treat metabolic syndrome, which is characterized by impaired glucose tolerance, hypercholesterolemia, dyslipidemia, obesity, diabetes, hypertension, atherosclerosis, arteriosclerosis, or coronary heart disease [pg. 29] (instant claims 3, 6, 16).
The peptide amino acid sequences of SEQ ID NOs: 1 to 102 disclosed by Oh are 100% identical to the instantly claimed peptides of SEQ ID NOs: 1 to 102.
Oh does not teach combining one of the peptides of SEQ ID NOs: 1 to 102 with an SGLT-2 inhibitor.
Bossart teaches GLP-1/glucagon/GIP receptor agonists and their medical use for the treatment of disorders of metabolic syndrome, including diabetes and obesity [pg. 1, lines 7-9]. The trigonal agonists for the GLP-1, GIP and glucagon receptors, can be widely combined with other pharmacologically active compounds [pg. 30, lines 30-34], such as SGLT2 inhibitors, for example: canaglifozin, dapagliflozin, remoglifozin, sergliflozin, empagliflozin, ipragliflozin, tofogliflozin, luseogliflozin, sotagliflozin, ertuglifozin, among others [pg. 32, lines 15-19] (instant claims 1 (partial), 4, 17). The active ingredient combinations can be used especially for a synergistic improvement in action. They can be applied either by separate administration of the active ingredients to the patient or in the form of combination products in which a plurality of active ingredients are present in one pharmaceutical preparation. When the active ingredients are administered by separate administration of the active ingredients, this can be done simultaneously or successively [pg. 31, lines 5-11] (instant claims 19-20).
One of ordinary skill in the art would be motivated to combine one of the GLP-1/glucagon/GIP receptor agonist peptides disclosed by Oh with an SGLT-2 inhibitor given that Bossart teaches the synergistic effects of combining a trigonal GLP-1/glucagon/GIP receptor agonist and an SGLT-2 inhibitor for treating symptoms of metabolic syndrome. The skilled artisan would have a reasonable expectation of success in substituting the GLP-1/glucagon/GIP receptor agonist peptides taught by Bossart with one of the peptides disclosed by Oh, because Oh teaches the peptides are effective in the treatment of symptoms of metabolic syndrome, such as diabetes and obesity. The addition of an SGLT-2 inhibitor increases the therapeutic benefit of the GLP-1/glucagon/GIP peptide in a synergistic manner as evidenced by Bossart.
Section 2144.06 of the MPEP provides guidance as to obviousness of art recognized equivalents for the same purpose. The court has held that it is obvious to combine two elements each of which is taught by the prior art to be useful for the same purpose. No specific teaching or suggestion is needed for combination – the idea of combining them flows logically from their having been individually taught in the prior art as useful for the same purpose. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that if a technique has been used to improve one method, and a person of ordinary skill would recognize that it would be used in similar methods in the same way, using the technique is obvious unless its application is beyond that person’s skill. It would be obvious to apply a known technique to a known product to be used in a known method that is ready for improvement to yield predictable results. Therefore, the instant invention was prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention in view of the combined references.
Double Patenting
Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
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.
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Claims 1-4 and 6-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 18-19 of U.S. Application No. 17/792,228 in view of Oh et al. (WO 2017/116205; cited IDS 11/30/2023) (“Oh”) and further in view of Bossart et al. (WO 2018/100134) (“Bossart”).
Copending claim 1 is drawn to a method for treating lung disease, comprising a pharmaceutical composition comprising an amino acid sequence of any one of SEQ ID NOS: 1 to 102. Copending claim 2 recites the peptide can be in the form of a long-acting conjugate with the formula X-L-F, wherein X is one of SEQ ID NOs: 1 to 102, L is a linker comprising an ethylene glycol repeat unit; F is an immunoglobulin Fc region, and a dash is a covalent bond. Copending claims 4-5 further limit the peptide to amino acid sequences of SEQ ID NOs: 21, 22, 42, 43, 50, 64, 66, 67, 70, 71, 76, 77, 96, 97, and 100 and SEQ ID NOs: 21, 22, 42, 43, 50, 77, and 96, respectively. Copending claims 3 and 6 recite the peptide is C-terminally amidated and comprises a ring between amino acid residues 16 and 20. Copending claim 7 is drawn to an ethylene glycol linker. Copending claims 8 and 19 recite the Fc region is an IgG Fc region, which is a dimer consisting of two polypeptide chains. Copending claims 9-12 and 18 are drawn to lung diseases caused by respiratory infections, such as viral respiratory infections.
The peptides of SEQ ID NOs: 1 to 102 disclosed by the copending application are 100% identical to the instantly claimed peptides. Therefore, the claims of the copending application read on the administration of a conjugated peptide with an instantly claimed amino acid sequence of SEQ ID NO: 1 to 102 for the treatment of lung disease. However, the copending application does not disclose the peptides are administered in combination with an SGLT-2 inhibitor or that the combination therapy can also be used to treat symptoms of metabolic syndrome, such as diabetes and obesity.
However, Oh teaches the identical conjugated peptides for treating metabolic syndrome (i.e., diabetes and obesity) as recited in the instant claims, wherein the conjugate is represented by the formula X-L-F [pg. 7], wherein X is a peptide characterized as being a peptide comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 1 to 102 [pg. 26], L is a non-peptide linker comprising polyethylene glycol [pg. 28]. Exemplary peptides are selected from the group consisting of SEQ ID NOs: 21, 22, 42, 43, 50, 64 to 77, and 96 to 102. [pg. 63]. Oh further teaches the immunoglobulin Fc region is an IgG4 Fc region, and the immunoglobulin Fc region is a non-glycosylated Fc region [pg. 81].
Oh does not teach combining one of the peptides of SEQ ID NOs: 1 to 102 with an SGLT-2 inhibitor or provide dosing information.
Bossart teaches trigonal GLP-1/glucagon/GIP receptor agonists and their medical use for the treatment of disorders of the metabolic syndrome, including diabetes and obesity [pg. 1, lines 7-9]. The trigonal agonists for the GLP-1, GIP and glucagon receptors, can be widely combined with other pharmacologically active compounds [pg. 30, lines 30-34], such as SGLT2 inhibitors, for example: canaglifozin, dapagliflozin, remoglifozin, sergliflozin, empagliflozin, ipragliflozin, tofogliflozin, luseogliflozin, sotagliflozin, ertuglifozin, among others [pg. 32, lines 15-19]. The active ingredient combinations can be used especially for a synergistic improvement in action. They can be applied either by separate administration of the active ingredients to the patient or in the form of combination products in which a plurality of active ingredients are present in one pharmaceutical preparation. When the active ingredients are administered by separate administration of the active ingredients, this can be done simultaneously or successively [pg. 31, lines 5-11].
Therefore, it would have been obvious to one of ordinary skill in the art that the treatment method disclosed by the copending application could be applied to patients with symptoms of metabolic syndrome (i.e., diabetes or obesity) as evidenced by Oh that uses the identical peptides for the treatment of metabolic syndrome. It would also be obvious to one of ordinary skill that the treatment method disclosed by the copending claims can be combined with an SGLT-2 inhibitor because Bossart teaches when an SGLT-2 inhibitor is administered with a GLP-1/glucagon/GIP receptor agonist the therapeutic benefit of the triagonist increases in a synergistic fashion. Therefore, the combination of prior art elements according to known methods would be expected to yield predictable results with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Similarly, claims 1-4 and 6-20 are rejected or provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over one or more claims of the U.S. Patent Nos. or copending Application Nos. listed below in view of Oh et al. (WO 2017/116205; cited IDS 11/30/2023) (“Oh”) and further in view of Bossart et al. (WO 2018/100134) (“Bossart”).
Application No.
Brief Description of the Invention
Pertinent Claims
17/414682
A method for treatment of liver disease comprising administering a peptide selected from SEQ ID NOs: 1 to 102
1-4, 6, 8-13, 15-20, 22, 24-29, 31-33
17/700055
A peptide having agonist activities to GLP-1, GIP, and glucagon receptors for treatment of metabolic syndrome
4-15, 18-22
17/917846
A method for treating hyperlipidemia comprising administering a peptide having agonist activities to GLP-1, GIP, and glucagon receptors
1-13, 15-16
18/031958
A method for treating sequalae following a respiratory infectious disease comprising administering a peptide selected from SEQ ID NOs: 1 to 102
1-12, 15-16
18/040869
A method for treatment of non-alcoholic liver disease comprising administering a peptide selected from SEQ ID NOs: 21, 22, 31, 32, 37, 42, 43, 50, 53, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 75, 76, 77, 79, 96, 97, 98, 99, 100, 101, or 102
1, 6, 8-9, 13-16
18/041151
A method for lowering blood pressure associated with metabolic syndrome comprising administering a peptide selected from SEQ ID NOs: 1, 22, 27, 30 to 32, 34, 36, 37, 42, 43, 50 to 56, 58, 64 to 79, 83, 86, 91, 93, and 96 to 102
27-28, 31-41, 44-45
Patent No.
Brief Description of the Invention
Pertinent Claims
10,370,426
A peptide having activities to GLP-1, GIP, and glucagon receptors for treatment of metabolic syndrome
1-16
10,400,020
A peptide conjugate having activities to GLP-1, GIP, and glucagon receptors for treatment of metabolic syndrome
1-24
10,981,967
A peptide conjugate comprising SEQ ID NOs: 1 to 102 having activities to GLP-1, GIP, and glucagon receptors for treatment of metabolic syndrome
1-37
11,332,508
A peptide conjugate comprising SEQ ID NOs: 1 to 102 having activities to GLP-1, GIP, and glucagon receptors for treatment of metabolic syndrome
1-34
The above-listed copending applications and issued patents at a minimum read on GLP-1/GIP/glucagon receptor agonists for the treatment of metabolic syndrome and/or liver disease and respiratory disease comprising administering a peptide selected from SEQ ID NOs: 1 to 102. It is noted that one of the issued patents does not recite a long-acting conjugate of the recited peptides, or all of the properties of said peptides. These deficiencies are remedied by Oh.
Oh teaches the peptides for treating metabolic syndrome (i.e., diabetes and obesity) as recited in the instant claims, wherein the peptide is a conjugate represented by the formula X-L-F [pg. 7], wherein X is a peptide characterized as being a peptide comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 1 to 102 [pg. 26], L is a non-peptide linker comprising polyethylene glycol [pg. 28]. Exemplary peptides are selected from the group consisting of SEQ ID NOs: 21, 22, 42, 43, 50, 64 to 77, and 96 to 102. [pg. 63]. Oh further teaches the immunoglobulin Fc region is an IgG4 Fc region, and the immunoglobulin Fc region is a non-glycosylated Fc region [pg. 81].
Additionally, none of the copending applications or the issued patents recite the GLP-1/GIP/glucagon receptor agonist peptides are administered in combination with an SGLT-2 inhibitor. This deficiency is remedied by Bossart.
Bossart teaches trigonal GLP-1/glucagon/GIP receptor agonists and their medical use for the treatment of disorders of the metabolic syndrome, including diabetes and obesity [pg. 1, lines 7-9]. The trigonal agonists for the GLP-1, GIP and glucagon receptors can be widely combined with other pharmacologically active compounds [pg. 30, lines 30-34], such as SGLT2 inhibitors, for example: canaglifozin, dapagliflozin, remoglifozin, sergliflozin, empagliflozin, ipragliflozin, tofogliflozin, luseogliflozin, sotagliflozin, ertuglifozin, among others [pg. 32, lines 15-19]. The active ingredient combinations can be used especially for a synergistic improvement in action. They can be applied either by separate administration of the active ingredients to the patient or in the form of combination products in which a plurality of active ingredients are present in one pharmaceutical preparation. When the active ingredients are administered by separate administration of the active ingredients, this can be done simultaneously or successively [pg. 31, lines 5-11].
Therefore, it would have been obvious to one of ordinary skill in the art that the treatment methods disclosed by the copending applications or issued patents could be applied to patients with symptoms of metabolic syndrome (i.e., diabetes or obesity) as evidenced by Oh that uses the identical peptides for the treatment of metabolic syndrome. It would also be obvious to one of ordinary skill that the treatment method disclosed by the copending claims can be combined with an SGLT-2 inhibitor because Bossart teaches when an SGLT-2 inhibitor is administered with a GLP-1/glucagon/GIP receptor agonist the therapeutic benefit of the triagonist increases in a synergistic fashion. Therefore, the combination of prior art elements according to known methods would be expected to yield predictable results with a reasonable expectation of success.
Note, the rejections over the claims of copending applications 17/414682, 17/700055, 17/917846, 18/031958, 18/040869, and 18/041151 are provisional nonstatutory double patenting rejections.
Conclusion
No claim is allowed.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MAUREEN VARINA DRISCOLL/ Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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