DETAIL ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 1-13, in the reply filed on March 12th, 2026 is acknowledged.
Claims 14-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 12th, 2026.
Applicant’s election without traverse of compound E in the reply filed on March 12th, 2026 is also acknowledged.
Claims Status
Claims 14-22 are withdrawn from further consideration for reasons set forth in the restriction requirement, 37 CFR 1.142(b). Claims 1-13 are examined on the merits in this office action.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, filed on October 4th, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 13th, 2024 and March 12th, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 8, and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 9, and 11 of U.S. Patent No. 9896495, in view of WO2021094259A1 (Published 2021] [instant compounds A-J], all by applicant.
9896495 claims a method of preventing weight gain or promoting weight loss as part of a combination therapy using glucagon analogs together with an agent for treatment of obesity, wherein the agent is a peptide YY receptor agonist [claims 1, 9 and 11]. 9896495 does not teach that the glucagon analogs and PYY receptor agonists are long-acting agonists.
WO2021094259A1, claims PYY analogs that are NPY2 receptor agonists administered as part of a combination therapy together with an agent for treatment of obesity, wherein the agent for obesity is a glucagon-GLP 1 dual agonist [pg 2 line 6 and claims 18-19]. WO2021094259A1 specifies that
“Long in-vivo half-life is also a beneficial property for agents to reduce food intake in overweight or obese patients. Compounds with a long-acting profile (as compared to the very short in-vivo half-life of native (human) PYY) reducing the frequency of administration are desirable” [pg 18 line 11]
and that “In one aspect, the invention relates to PYY analogues with extended half-live, e.g. with longer half-life than the half-life of hPYY (3-36)” [pg 18 line 19].
While WO2021094259A1 does support an embodiment where the PYY analogs are long-acting, it does not support that the glucagon analogs are long-acting.
In the claims dependent to claim 1, the applicant goes on the claim instant compound I as the long-acting GLP-1/glucagon receptor dual agonist [instant claim 2]. One of the GluGLP-1 dual agonists, SEQ ID NO:61, that 9896495 claims has the same structure as instant compound I [Col 22 line 34 and claim 2].
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40, 100 USPQ2d 1433, 1440 (Fed. Cir. 2011) [MPEP 2114].
The functional limitation- a long-acting GLP-1/glucagon receptor agonist- is an inherent characteristic of 9896495’s SEQ ID NO:61 because the structure is a dependent embodiment [instant claim 2] of the limitation in claim 1.
Therefore, it would have been obvious for the applicant to claim a method for treatment or prevention of obesity or an obesity-related condition, comprising treating a patient in need thereof with a combination therapy comprising administering a long-acting GLP-1/glucagon receptor dual agonist and a long acting NPY2 receptor agonist because the long-acting GLP-1/glucagon receptor dual agonist of 9896495 in conjunction with the long-acting NPY2 receptor agonists of WO2021094259A1 are all treatments for obesity and target receptors with known efficacy.
Regarding claim 2, 9896495 claims a GluGLP-1 dual agonist of SEQ ID: 61 that has the same structure as instant compound I [Col 22 line 34 and claim 2]. 9896495 claims a method of preventing weight gain or promoting weight loss as part of a combination therapy using glucagon analogs together with an agent for treatment of obesity, wherein the agent is a peptide YY receptor agonist [claim 11]. 9896495 does not specifically claim compounds A-L as the peptide YY receptor agonist.
WO2021094259A1, claims PYY analogs that are NPY2 receptor agonists administered as part of a combination therapy together with an agent for treatment of obesity, wherein the agent for obesity is a glucagon-GLP 1 dual agonist [pg 2 line 6 and claims 1-2 and 18-19]. The PYY analog compound 106 corresponds to instant compound A, 117 to B, 234 to C, 74 to D. 23 to E, 14 to F, 171 to G, 231 to H and 53 to J [pg 52-125].
Therefore, it would have been obvious for the applicant to claim a method where the long-acting GLP-1/glucagon receptor dual agonist is instant compound I and the long acting NPY2 receptor agonist is selected from the group consisting of Compound A-J because they is a reasonable expectation that such a combination therapy would be successful at treating obesity and obesity-related conditions since they are all proven target receptors with known efficacy.
Regarding claims 3-4, WO2021094259A1 claims PYY analogs that are NPY2 receptor agonists administered as part of a combination therapy together with an agent for treatment of obesity, such as a glucagon-GLP-1 dual agonist [pg 2 line 6 and claims 1-2 and 18-19]. The PYY analog compound 117 corresponds to B and 23 to E [pg 87 and 55].
Regarding claim 5, WO2021094259A1 claims PYY analogs that are NPY2 receptor agonists administered as part of a combination therapy together with an agent for treatment of obesity, such as a glucagon-GLP-1 dual agonist [pg 2 line 6 and claims 1-2 and 18-19]. The PYY analog compound 117 corresponds to B [pg 87]
Regarding claim 6, WO2021094259A1 claims PYY analogs that are NPY2 receptor agonists administered as part of a combination therapy together with an agent for treatment of obesity, such as a glucagon-GLP-1 dual agonist [pg 2 line 6 and claims 1-2 and 18-19]. The PYY analog compound 23 corresponds to E [pg 55].
Regarding claim 8, WO2021094259A1 states that the PYY analogs of the invention are most suitable for once weekly administration [pg 18 line 20]. Thus, WO2021094259A1 makes obvious that the best mode for the invention is using it once a week and an artisan of ordinary skill could reasonably deduce that a GLP-1/glucagon agonist and a PYY analog would be successful with this mode if administered together.
Regarding claim 9, WO2021094259A1 claims a PYY analog used as part of a combination therapy together with an agent for the treatment of obesity or obesity-related conditions, such as type 2 diabetes, hypertension, dyslipidemia, sleep apnea and cardiovascular disease, wherein the agent is a glucagon-GLP- 1 dual agonist [claims 9 and 11]. Thus, a method of treating an obesity-related condition such as type 2 diabetes, liver disease, or cardiovascular disease is anticipated.
Regarding claim 10, WO2021094259A1 claims PYY analogue used as part of a combination therapy together with an obesity agent like glucagon-GLP- 1 dual agonist for the treatment of atherogenic dyslipidemia, hepatic steatosis, NAFLD, NASH, kidney failure or atherosclerosis [claims 15 and 19]. As such, a method of treating a liver disease, such as NAFLD and NASH is anticipated.
Regarding claim 13, WO2021094259A1 that factors such as age, weight of the patient, route of administration, and severity of disease will be used to determine a pharmaceutically effective amount [pg 39 line 7]. 9896495. also states that a composition typically comprises a therapeutically effective amount of a compound of the invention [Col 23 line 43]. Therefore, it is obvious to one of ordinary skill that a therapeutically effective amount of both the GLP-1/glucagon dual agonist and NPY2 agonist would be necessary when combined.
Claims 2, 3, 4, and 7 are also rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 14, and 17 of U.S. Patent No. 12391737 in view of U.S. Patent No. 9896495 (Published 2018).
Regarding claim 2, 12391737 claims a PYY analog that is the same as instant compound K and is used in a method for treating obesity or obesity-related conditions or diseases [claims 1-6 and 14]. 12391737 also claims a method for treating obesity or obesity-related conditions or diseases wherein the PYY analogue is administered as part of a combination therapy together with an agent for treatment of diabetes, obesity, dyslipidemia or hypertension [claim 14 and 17]. 12391737 details that the combination therapy may have a glucagon-GLP-1 dual agonist from WO2015055801A1 (priority application of US9896495B2) [Col 27 line 9]. However, 12391737 does not specifically claim instant compound I as an agent for treatment of diabetes, obesity, dyslipidemia or hypertension.
9896495 claims a GluGLP-1 dual agonist of SEQ ID: 61 that has the same structure as instant compound I [Col 22 line 34 and claim 2]. 9896495 also claims a method of preventing weight gain or promoting weight loss as part of a combination therapy using glucagon analogs together with an agent for treatment of obesity, wherein the agent is a peptide YY receptor agonist [claims 1, 9 and 11].
Therefore, it would have been obvious to the applicant to combine instant compound K with instant compound I in a method for treatment or prevention of obesity and/or an obesity-related condition because both compounds have shown efficacy in such treatments and there would have been a reasonable expectation of success.
Regarding claim 3, 12391737 claims a PYY analog that is the same as instant compound K and a method for treating obesity or obesity-related conditions or diseases wherein the PYY analog is administered as part of a combination therapy together with an agent for treatment of diabetes, obesity, dyslipidemia or hypertension [claim 1-6, 14 and 17]. 9896495 claims a GluGLP-1 dual agonist of SEQ ID: 61 that has the same structure as instant compound I [Col 22 line 34 and claim 2]. Therefore, it would have been obvious to the applicant to combine instant compound K with instant compound I in a method for treatment or prevention of obesity and/or an obesity-related condition.
Regarding claim 4, 12391737 claims a PYY analog that is the same as instant compound K and a method for treating obesity or obesity-related conditions or diseases wherein the PYY analog is administered as part of a combination therapy together with an agent for treatment of diabetes, obesity, dyslipidemia or hypertension [claim 1-6, 14 and 17]. 9896495 claims a GluGLP-1 dual agonist of SEQ ID: 61 that has the same structure as instant compound I [Col 22 line 34 and claim 2]. Therefore, it would have been obvious to the applicant to combine instant compound K with instant compound I in a method for treatment or prevention of obesity and/or an obesity-related condition.
Regarding claim 7, 12391737 claims a PYY analog that is the same as instant compound K and a method for treating obesity or obesity-related conditions or diseases wherein the PYY analog is administered as part of a combination therapy together with an agent for treatment of diabetes, obesity, dyslipidemia or hypertension [claim 1-6, 14 and 17]. 9896495 claims a GluGLP-1 dual agonist of SEQ ID: 61 that has the same structure as instant compound I [Col 22 line 34 and claim 2]. Therefore, it would have been obvious to the applicant to combine instant compound K with instant compound I in a method for treatment or prevention of obesity and/or an obesity-related condition.
Claims 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 and 11 of U.S. Patent No. 9896495 in view of Behary et al (Behary, P., Tharakan, G., Alexiadou, K., Johnson, N., Wewer Albrechtsen, N. J., Kenkre, J., Cuenco, J., Hope, D., Anyiam, O., Choudhury, S., Alessimii, H., Poddar, A., Minnion, J., Doyle, C., Frost, G., Le Roux, C., Purkayastha, S., Moorthy, K., Dhillo, W., Holst, J. J., … Tan, T. M. (2019). Combined GLP-1, Oxyntomodulin, and Peptide YY Improves Body Weight and Glycemia in Obesity and Prediabetes/Type 2 Diabetes: A Randomized, Single-Blinded, Placebo-Controlled Study. Diabetes care, 42(8), 1446–1453).
9896495 claims a method of preventing weight gain or promoting weight loss as part of a combination therapy using glucagon analogs together with an agent for treatment of obesity, wherein the agent is a peptide YY receptor agonist [claim 9 and 11]. 9896495 does not teach the combination therapy having a synergistic effect or that the glucagon analogs are long-acting agonists.
In the claims dependent to claim 1, the applicant goes on the claim instant compound I as the long-acting GLP-1/glucagon receptor dual agonist [instant claim 2]. One of the GluGLP-1 dual agonists, SEQ ID NO:61, that 9896495 claims has the same structure as instant compound I [Col 22 line 34 and claim 2].
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40, 100 USPQ2d 1433, 1440 (Fed. Cir. 2011) [MPEP 2114].
The functional limitation- a long-acting GLP-1/glucagon receptor agonist- is an inherent characteristic of 9896495’s SEQ ID NO:61 because the structure is a dependent embodiment [instant claim 2] of the limitation in claim 1.
Behary et al introduces oxyntomodulin (OXM) as a dual agonist of the GLP-1 and glucagon receptors and peptide YY (PYY), which acts to reduce appetite and food intake postprandially [pg 2 pgh 2]. Behary et al states that combinations of GLP-1 and PYY, OXM and PYY, and GLP-1 and glucagon have synergistic effects on food intake [pg 2 pgh 2]. Therefore, prior to the effective filing date, it is would have been obvious to the inventor that their long-acting GLP-1/glucagon agonist and long-acting NPY2 agonist would work synergistically because the GLP-1/glucagon dual agonist, OXM, and a neuropeptide Y receptor agonist, PYY, also have a synergistic effect.
Regarding claim 12, the synergistic effect Behary stated was measured by a reduction in food intake [pg 2 pgh 2]. It would have been obvious to a person of ordinary skill in the art that the synergistic effect of the GLP-1/glucagon dual agonist and neuropeptide Y2 agonist would be measured by a reduction of food intake.
Claims 2 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-7, 9-11 and 17 of copending Application No. 19,250,242 in view of U.S. Patent No. 9896495 (Published 2018).
Application No. 19,250,242 is a continuation of parent patent U.S. Patent No. 12391737. 19250242 claims PYY analogs, of which compound 84 is the same as instant compound L [claims 1-2, 5-7, and 9-11 and pg 74]. According to base claim 1, X6 is Glu, X8 is Pro, X9 is Glu, X10 is Glu, X11 is Asp, X12 is Ala, X13 is Thr, X14 is Pro, X15 is Glu, X16 is Glu, X17 is Ile, X18 is Gln, X19 is Arg, X20 is Tyr, X21 is Tyr, X22 is Val, X23 is Ala, X27 is Tyr, X28 is Tyr, X29 is Asn, X30 is Trp, X32 is Thr, and X33 is Arg in instant compound L. 19250242 also claims a method of using the PYY analogs for treating obesity or obesity-related conditions or diseases [claim 17]. 19250242 does not claim a combination therapy using a long-acting GLP-1/glucagon dual agonist.
9896495 claims a GluGLP-1 dual agonist of SEQ ID: 61 that has the same structure as instant compound I [Col 22 line 34 and claim 2]. 9896495 claims a method of preventing weight gain or promoting weight loss as part of a combination therapy using glucagon analogs together with an agent for treatment of obesity, wherein the agent is a peptide YY receptor agonist [claims 1, 9 and 11].
Therefore, it would have been obvious to the applicant to combine instant compound L with instant compound I in a method for treatment or prevention of obesity and/or an obesity-related condition because both compounds have shown efficacy in such treatments and there would have been a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
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.
Claims 1-6 and 8-13 are rejected under 35 U.S.C. 103 as being obvious over Haebel et al (WO2021094259A1), in view of Riber et al (US9896495B2: Published 2018).
The applied references have a common assignee with the instant application. Based upon the publication date of the references, they constitutes prior art under 35 U.S.C. 102(a)(1) and the 102(b)(1)(A) exception does not apply.
Haebel et al. claims PYY analogs that are NPY2 receptor agonists administered as part of a combination therapy together with an agent for treatment of obesity, wherein the agent for obesity is a glucagon-GLP 1 dual agonist [pg 2 line 6 and claims 18-19]. Haebel specifies that
“Long in-vivo half-life is also a beneficial property for agents to reduce food intake in overweight or obese patients. Compounds with a long-acting profile (as compared to the very short in-vivo half-life of native (human) PYY) reducing the frequency of administration are desirable” [pg 18 line 11]
and that “In one aspect, the invention relates to PYY analogues with extended half-live, e.g. with longer half-life than the half-life of hPYY (3-36)” [pg 18 line 19].
While Haebel does support an embodiment where the PYY analogs are long-acting in the combination therapy, it does not support that the glucagon GLP-1 dual agonists are long-acting.
Riber et al claims a method of preventing weight gain or promoting weight loss as part of a combination therapy using glucagon analogs together with an agent for treatment of obesity, wherein the agent is a peptide YY receptor agonist [claims 1, 9 and 11]. Riber does not specify that they glucagon analogs are long-acting.
However, in the claims dependent to claim 1, the applicant goes on the claim instant compound I as the long-acting GLP-1/glucagon receptor dual agonist [instant claim 2]. One of the GluGLP-1 dual agonists, SEQ ID NO:61, that Riber et al claims has the same structure as instant compound I [Col 22 line 34 and claim 2]. The MPEP states:
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40, 100 USPQ2d 1433, 1440 (Fed. Cir. 2011) [MPEP 2114].
The functional limitation- a long-acting GLP-1/glucagon receptor agonist- is an inherent characteristic of Riber’s SEQ ID NO:61 because the structure is a dependent embodiment [instant claim 2] of the limitation in claim 1.
Therefore, it would have been obvious for the applicant to use a method for treatment or prevention of obesity or an obesity-related condition, comprising treating a patient in need thereof with a combination therapy comprising administering a long-acting GLP-1/glucagon receptor dual agonist and a long acting NPY2 receptor agonist because the long-acting GLP-1/glucagon receptor dual agonist of Riber in conjunction with the long-acting NPY2 receptor agonists of Haebel are all treatments for obesity and target receptors with known efficacy.
Regarding claim 2, Haebel claims PYY analogs that are NPY2 receptor agonists administered as part of a combination therapy together with an agent for treatment of obesity, such as a glucagon-GLP-1 dual agonist [pg 2 line 6 and claims 18-19]. The PYY analog compound 106 corresponds to instant compound A, 117 to B, 234 to C, 74 to D. 23 to E, 14 to F, 171 to G, 231 to H and 53 to J [pg 52-125]. Haebel details that the glucagon-GLP-1 dual agonist may be described in WO2011/006497, W02014/041195, W02015/055801, W02015/055802, or WO2016/166289 [pg 41 line 4]. However, Haebel et al does not specify a which publication listed above to choose from or the compound from the patent application publication.
US9896495B2 (Riber et al), the granted patent of parent publication WO2015055801A1, listed in Haebel et al., claims a GluGLP-1 dual agonist of SEQ ID: 61 that has the same structure as instant compound I [Col 22 line 34 and claims 2, 16, and 19]. Therefore, it would have been obvious to a person of ordinary skill art prior to the effective filing date to use the PYY analogs and patent publications given by Haebel and choose from finite number of GluGLP-1 dual agonists taught by Riber et al. There exists a reasonable expectation of success because all three receptors are proven targets for obesity and obesity-related diseases and Riber et al and Haebel et al have already shown instant compound I and compound A-L efficacy at targeting the GLP-1/glucagon and NPY2 receptors, respectively.
Regarding claims 3-6, instant compounds B and E are disclosed as compounds 117 and 23, respectively in Haebel (see above rejection) [pg 87 and 55].
Regarding claim 8, Haebel states that the PYY analogs of the invention are most suitable for once weekly administration [pg 18 line 20]. Thus, Haebel makes obvious that the best mode for the invention is using it once a week and an artisan of ordinary skill could reasonably deduce that any invention comprising a PYY analog would be successful with this mode.
Regarding claim 9, Haebel claims a PYY analog used as part of a combination therapy together with an agent for treatment of diabetes, obesity, dyslipidemia or hypertension, wherein the agent for obesity agent is a glucagon-GLP- 1 dual agonist [claims 18-19]. Thus, a method of treating an obesity-related condition such as type 2 diabetes, liver disease, or cardiovascular disease is obvious.
Regarding claim 10, Haebel claims PYY analogue used as part of a combination therapy together with an obesity agent like glucagon-GLP- 1 dual agonist for the treatment of atherogenic dyslipidemia, hepatic steatosis, NAFLD, NASH, kidney failure or atherosclerosis [claims 15 and 19]. As such, a method of treating a liver disease, such as NAFLD and NASH is obvious.
Regarding claim 13, Haebel et al states that factors such as age, weight of the patient, route of administration, and severity of disease will be used to determine a pharmaceutically effective amount [pg 39 line 7]. Riber et al. also states that a composition typically comprises a therapeutically effective amount of a compound of the invention [Col 23 line 43]. Therefore, it is obvious to one of ordinary skill that a therapeutically effective amount of both compounds would be necessary when combined.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being obvious over Haebel et al (WO2021094259A1), in view of Riber et al (US9896495B2: Published 2018), in further view of Behary et al (Behary, P., Tharakan, G., Alexiadou, K., Johnson, N., Wewer Albrechtsen, N. J., Kenkre, J., Cuenco, J., Hope, D., Anyiam, O., Choudhury, S., Alessimii, H., Poddar, A., Minnion, J., Doyle, C., Frost, G., Le Roux, C., Purkayastha, S., Moorthy, K., Dhillo, W., Holst, J. J., … Tan, T. M. (2019). Combined GLP-1, Oxyntomodulin, and Peptide YY Improves Body Weight and Glycemia in Obesity and Prediabetes/Type 2 Diabetes: A Randomized, Single-Blinded, Placebo-Controlled Study. Diabetes care, 42(8), 1446–1453).
Haebel teaches NPY2 receptor agonists administered as part of a combination therapy together with an agent for treatment of obesity, wherein the agent for obesity is a glucagon-GLP 1 dual agonist. Riber et al teaches instant compound I, which is a long-acting GLP-1/glucagon dual agonist. Habel and Riber do not teachs a synergisitic effect.
Behary et al introduces oxyntomodulin (OXM) as a dual agonist of the GLP-1 and glucagon receptors, which reduces food intake and increases energy expenditure (10), leading to weight loss [pg 2 pgh 2]. Peptide YY (PYY) acts to reduce appetite and food intake postprandially. Behary et al states that combinations of GLP-1 and PYY, OXM and PYY, and GLP-1 and glucagon have synergistic effects on food intake [pg 2 pgh 2].
Therefore, prior to the effective filing date, it would have been obvious that a long-acting GLP-1/glucagon dual agonist and NPY2R agonist would have had a synergistic effect measured by a reduction in food intake because Behary showed that a GLP-1/glucagon dual agonist, OXM, and a neuropeptide Y receptor agonist, PYY, also had a synergistic effect, measured by a reduction in food intake.
Summary
Claims 1-13 are rejected on the grounds of nonstatutory double patenting. Claims 1-6, 8- 13 are rejected under 35 U.S.C. 103.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SACHI JAUHARI whose telephone number is (571)272-3769. The examiner can normally be reached Mon-Fri 9-4.
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/SACHI JAUHARI/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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