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 .
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Claims 14-22 are withdrawn from further consideration for reasons set forth in the restriction requirement, 37 CFR 1.142(b).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.
Double Patenting
Response to Arguments
Applicant argues the rejection under U.S. Patent No. 9896495, in view of WO2021094259A1 (Published 2021] does not apply to claims 11-12 in the non-final office action. Applicant is correct because the double patenting rejection is made under U.S. Patent No. 9896495 in view of Behary et al. [previously cited and attached] (see non-final office action pg 11-13). The secondary reference WO2021094259A1 was not needed to reject claims 11-12 of the claim listing filed March 12th, 2026.
Applicants’ arguments, see pg 4, filed July 22nd, 2026, with respect to the rejection of claims 1-6, and 8-13 under double patenting have been fully considered and are persuasive. Therefore, the rejection of claims 1-6, 8, and 11-13 are 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patenting as being unpatentable over claims 1-2, 9, and 11 of U.S. Patent No. 9896495, in view of WO2021094259A1 is withdrawn. However, upon further consideration, a new grounds of rejection is made in view of the amendments to claims 1, 5-6, and 8-10.
Applicants’ arguments, see pg 5, filed July 22nd, 2026, with respect to the rejection of claims 2-4 and 7 under double patenting have been fully considered and are persuasive. Therefore, the rejection of claims 2, 3, 4, and 7 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over claims 1-6, 14, and 17 of U.S. Patent No. 12391737 in view of U.S. Patent No. 9896495 (Published 2018) is withdrawn. However, upon further consideration, a new ground of rejection is made in view of the amendments to claim 7.
Applicant notes that claim 1 has been amended to add the limitations of claims 11-12 and claims 11-12 are cancelled. Applicants’ arguments, see pg 6, filed July 22nd, 2026, with respect to claims 11-12 have been fully considered and are persuasive. The rejection of claims 11-12 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 [previously cited and attached] has been withdrawn.
Applicant’s arguments, see pg 8, filed July 22nd, 2026, with respect to the rejection(s) of claims 2 and 3 under on the ground of provisional 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 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicants’ arguments filed July 22nd, 2026 on pg 6 have been fully considered but they are not persuasive. Applicants’ arguments are anticipatory of the present double patenting rejection and are therefore addressed. Applicant traverses the argument that the combination of any GLP-1/GCG agonist and any PYY-agonist would not be expected to act synergistically, as taught by Behary et al because:
Compound I does not have very close structural similarities to oxyntomodulin and Compounds B, E, and K do not have very close structural similarities to PYY. A prima facie case of obviousness only exists when chemical compounds have very close structural similarities and similar utilities [MPEP 2144.09]. Furthermore, the utilities of Compounds B, E, and K are different from PYY because PYY is nonselective and Compounds B, E, and K are selective for the neuropeptide Y2 receptor.
Behary taught combinations of three functionalities: GLP-1, oxyntomodulin (GLP-1/GCG), and PYY, while applicant’s claims relating to synergy require only GLP-1 GCG dual agonism and PYY.
These arguments are not persuasive because:
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the case for obviousness is not built on the rationale that Behary et al.’s compounds and the instant compounds have structural similarities. The instant GLP-1/glucagon dual agonist and NPY2 agonist compounds are taught by U.S. Patent No. 9896495 and WO2021094259A1. The case for obviousness is built on the fact that Behary et al.’s teaches that the genus of GLP-1/GCG dual agonism combined with PYY agonism attains a synergistic effect.
"Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967) [MPEP 716.02(c)(II)].
From Behary et al’s teachings, one of ordinary skill in the art would expect a compound that causes GLP-1/GCG agonism combined with a compound that causes NPY2 agonism to be synergistic. Therefore, the fact that U.S. Patent No. 9896495’s GLP-1/glucagon dual agonists and WO2021094259A1’s PYY agonists create a synergistic effect is evidence of obviousness.
Behary et al state 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]. OXM is a dual agonist of GLP-1/glucagon, so Behary et al. teach that the dual agonism of GLP-1 and glucagon combined with PYY agonism has a synergistic effect. Furthermore, even though Behary et al. reduce to practice GLP-1, oxyntomodulin (GLP-1/GCG), and PYY, the same receptors are being targeted. Thus, there still exists a motivation for one of ordinary skill in the art to a GLP-1/GCG dual agonist and a PYY agonist taught by U.S. Patent No. 9896495 and WO2021094259A1, respectively with a reasonable expectation of attaining a synergistic effect.
Thus, claims 1 and 5-10 are rejected on the grounds of nonstatutory double patenting.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5-6, and 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9896495, in view of WO2021094259A1 and Behary et al [previously cited and attached].
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]. 9896495 does not teach that the glucagon analogs and PYY receptor agonists are long-acting agonists and specifically claim compounds B or E 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 18-19]. The PYY analog compound 117 corresponds to instant compound B and 23 to E [pg 52-125].
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.
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 that is the same as Compound I. 9896495 and WO2021094259A1 do not teach that GLP-1/glucagon and PYY agonism have a synergistic effect.
Behary et al. introduce 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 state 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]. This means that a GLP-1/glucagon dual agonist combined with PYY has synergistic effect.
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 B, or E, wherein the combination therapy has a synergistic effect as measured by reduction of food intake or body weight because there is a reasonable expectation that such a combination therapy would be successful at treating obesity and obesity-related conditions and since they are all proven target receptors with known efficacy and GLP-1, glucagon and PYY agonism combined has a synergistic effect.
Regarding claim 5, 9896495 does not claim Compound B. 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]. Thus, it was obvious to claim the method according to claim 1, wherein the long acting NPY2 agonist is Compound B,
Regarding claim 6, 9896495 does not claim Compound E. 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]. Thus, it was obvious to claim the method according to claim 1, wherein the long acting NPY2 agonist is Compound E,
Regarding claim 8, 9896495 does not claim administration once a week. 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. Therefore, prior to the effective filing date, it was obvious to claim the method according to claim 1, wherein the combination therapy is administered once per week.
Regarding claim 9, 9896485 claim a method of preventing or treating obesity, morbid obesity, morbid obesity prior to surgery, obesity linked inflammation, obesity linked gallbladder disease, obesity induced sleep apnea, diabetes, metabolic syndrome, hypertension, atherogenic dyslipidimia, atherosclerois, arteriosclerosis, coronary heart disease, peripheral artery disease, stroke, or microvascular disease by administering instant Compound I [claim 8]. Thus, it was obvious to claim the method according to claim 1, wherein the obesity-related condition comprises one or more of type 2 diabetes, liver disease, kidney disease, or cardiovascular disease.
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.
Claims 1, 7, and 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12391737 in view of U.S. Patent No. 9896495 and Behary et al.
Regarding claim 1, 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 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]. 12391737 and 9896495 do not teach a synergistic effect on food intake due to the combine agonism of GLP-1, glucagon and PYY.
Behary et al. introduce 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, 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 Compound K, wherein the combination therapy has a synergistic effect as measured by reduction of food intake or body weight because they is a reasonable expectation that such a combination therapy would be successful at treating obesity and obesity-related conditions and have a synergistic effect since they are all proven target receptors with known efficacy and GLP-1, glucagon and PYY agonism combined has a synergistic effect.
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.
Regarding claim 9, 12391737 claims a method for treating obesity or an obesity-related condition or disease, the method comprising administering to a patient in need thereof a pharmaceutically effective amount of a PYY analogue wherein the obesity or the obesity-related condition or disease is selected from the group consisting of type 2 diabetes, hypertension, dyslipidemia, sleep apnea and cardiovascular disease [claim 13]. Therefore, it would have been obvious to claim the method according to claim 1, wherein the obesity-related condition comprises one or more of type 2 diabetes, liver disease, kidney disease, or cardiovascular disease.
Regarding claim 10, 12391737 claims a method for treating atherogenic dyslipidemia, hepatic steatosis, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), kidney failure or atherosclerosis, the method comprising administering to a patient in need thereof a pharmaceutically effective amount of a PYY analogue [claim 15]. Therefore, it would have been obvious to claim the method of claim 9, wherein the liver disease is NAFLD (non- alcoholic fatty liver disease) or NASH (non-alcoholic steatohepatitis).
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12391737 in view of U.S. Patent No. 9896495 and Behary et al, as applied to claims 1, 7, and 9-10, in further view of WO2021094259A1.
12391737 instant compound K and a method for treating obesity or obesity-related conditions or diseases [claims 1-6 and 14]. 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]. Behary et al. teach the synergist effect of GLP-1, glucagon, and PYY combined agonism, 12391737, 9896495, and Behary et al. do not claim or teach administration once a week.
WO2021094259A1 states that the PYY analogs of their 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. Therefore, prior to the effective filing date, it was obvious to claim the method according to claim 1, wherein the combination therapy is administered once per week.
Claim Rejections - 35 USC § 103
Response to Arguments
Applicant believes that the rejection of claims 11-12 under 35 USC § 103 as unpatentable over Haebel et al (WO2021094259A1), in view of Riber et al (US9896495B2) is not applicable. Applicant is correct because the rejection is made under Haebel et al. and Riber et al in further view of Behary et al.
Applicants’ arguments filed July 22nd, 2026 on pg 6 have been fully considered but they are not persuasive. Applicant traverses the argument that the combination of any GLP-1/GCG agonist and any PYY-agonist would not be expected to act synergistically, as taught by Behary et al because:
Compound I does not have very close structural similarities to oxyntomodulin and Compounds B, E, and K do not have very close structural similarities to PYY. A prima facie case of obviousness only exists when chemical compounds have very close structural similarities and similar utilities [MPEP 2144.09]. Furthermore, the utilities of Compounds B, E, and K are different from PYY because PYY is nonselective and Compounds B, E, and K are selective for the neuropeptide Y2 receptor.
Behary taught combinations of three functionalities: GLP-1, oxyntomodulin (GLP-1/GCG), and PYY, while applicant’s claims relating to synergy require only GLP-1 GCG dual agonism and PYY.
These arguments are not persuasive because:
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the case for obviousness is not built on the rationale that Behary et al’s compounds and the instant compounds have structural similarities and utilities. The instant GLP-1/glucagon dual agonist and NPY2 agonist compounds are taught by Riber et al. and Haebel et al, respectively. The case for obviousness is built on the fact that Behary et al.’s teaches that the genus of GLP-1/GCG dual agonism combined with PYY agonism attains a synergistic effect.
"Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967) [MPEP 716.02(c)(II)].
From Behary et al’s teachings, one of ordinary skill in the art would expect a compound that causes GLP-1/GCG agonism combined with a compound that causes NPY2 agonism to be synergistic. Therefore, the fact that U.S. Patent No. Riber et al’s GLP-1/glucagon dual agonists and Haebel et al’s PYY agonists create a synergistic effect is evidence of obviousness.
Behary et al state 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]. Furthermore, even though Behary et al. reduce to practice GLP-1, oxyntomodulin (GLP-1/GCG), and PYY, the same receptors are being targeted. Thus, there still exists a motivation for one of ordinary skill in the art to a GLP-1/GCG dual agonist and a PYY agonist taught by Riber et al. and Haebel et al, respectively with a reasonable expectation of attaining a synergistic effect.
Thus, the rejection of claims 1, 5-6, and 8-10 under 35 U.S.C. 103 is maintained.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5-6, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Haebel et al (WO2021094259A1), in view of Riber et al (US9896495B2: Published 2018) and Behary et al. [previously cited and attached].
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]. The PYY analog compound 117 corresponds to instant compound B and 23 to E [pg 52-125].
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].
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 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]. 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 their glucagon analogs are long-acting.
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 the same as instant Compound I. Habel and Riber et al. do not teach a synergistic effect in food intake.
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, 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 claims 5 and 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.
Conclusion
Claims 1-13 are rejected on the grounds of nonstatutory double patenting. Claims 1, 5-6, and 8- 10 are rejected under 35 U.S.C. 103.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SACHI JAUHARI/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
