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 .
DETAILED ACTION
The amendments and arguments filed Aug. 7, 2026 are acknowledged and have been fully considered. Claims 3, 5-8, 10, and 12 are now pending and are now under consideration. Claims 1, 2, 4, 9, 11, and 13 are cancelled; claims 3 and 10 are amended.
OBJECTIONS/REJECTIONS WITHDRAWN
The rejections of claims 3, 5-8, 10, and 12 under 35 U.S.C. 103 over JAYNES and SIRCAR are withdrawn in light of the claim amendments.
OBJECTIONS/REJECTIONS MAINTAINED
The double patenting rejections of record have been maintained as no action regarding these rejections has been taken by applicants at this time.
Priority
The examiner acknowledges the certified translation for Korean application (KR 10-2021-0084286) filed on 06/28/2021, to which benefit of priority has been claimed. The certified translation was received Aug. 7, 2026 and has been made of record in the file wrapper.
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 obviousness-type 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); and 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
US Patent Application 18/574,665
Claims 3, 5-8, 10, and 12 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 12-18 of copending Application 18/574,665 in view of Al-Goblan (Al-Goblan, A. S., et al. Diabetes Metab. Syndr. Obes. (2014), 4(7); 587-591). Although the conflicting claims are not identical, they are not patentably distinct from each other because the scope of the '665 claims anticipates or renders obvious that of the instant claims. SEQ ID NO: 1 is identical between the two cases, and the two cases have the same effective filing date. The difference between the two claim sets is that the '665 claims recite a method of treating obesity instead of diabetes. However, the link between diabetes and obesity is well-known in the art. For example, Al-Goblan reports on the mechanisms linking diabetes and obesity (title; abstract). Al-Goblan teaches that body mass index (obesity) has a strong relationship to diabetes and insulin resistance, and the two conditions are often occur together (abstract; pgs. 588-590; conclusions). Since these two conditions are so closely linked, and since they often occur together, treatment of one renders treatment of the other obvious, and thus the entire scope of the instant claims is an obvious variation of the '665 claims.
Response to Arguments
Applicants' arguments have been fully considered but are not persuasive. Applicants argue that the treatment of obesity does not render the treatment of diabetes obvious (response, pgs. 6-7).
The examiner has cited evidence in the art (i.e., Al-Goblan) that establishes obesity has a strong relationship to diabetes and insulin resistance, and the two conditions often occur together. While applicants opine that treatment of obesity could not have been predicted to have a therapeutic effect on diabetes, this statement is unsupported by evidence, and is refuted by Al-Goblan. Obesity and diabetes are well-known to be closely linked and treatment of one often has a therapeutic effect on the other. The teachings of Al-Goblan suggest this to one of ordinary skill in the art.
Applicants argue that the obesity and diabetes are different conditions and are measured in different ways (response, pgs. 6-7).
The fact that obesity and diabetes are different conditions is not in dispute. Rather, the issue is these two different conditions are closely linked, often occur together, and are not patentably distinct in this case. Further, applicants' argument is not supported by the teachings of the specification. For example, at par. [0002], applicants teach:
"In this regard, it is known that when body fat increases due to obesity, a symptom in which insulin sensitivity decreases is shown, and in particular, the accumulation of abdominal fat is associated with glucose intolerance. Moreover, it is known that in patients with type 2 diabetes, the more obese the patient is, the more severe insulin resistance becomes because obesity and insulin resistance are closely correlated." (instant specification par. [0002]; emphasis added)
Moreover, applicants teach that the peptide is effective in both diabetic and obese mouse models (instant par. [0051]). Applicants actually tested the effect of the peptide in a mouse model of obesity (instant pars. [0055]-[0056], [0071]; Figs. 4-5; Example 2). Similarly, in the '665 case, applicants teach that the peptides were effective in a mouse model with diabetes-induced weight gain (pars. [0047], [0060], [0064]; Figs. 7 and 11 of the '665 application). Likewise, in the '665 application applicants actually tested the peptides in a diabetic mouse model ([0080]; Fig. 7 of the '665 application). Therefore, both the '665 application and the instant application demonstrate that applicants knew that diabetes and obesity were so closely linked that the effect of the peptides should be tested in a mouse model of the other condition.
Thus, it is disingenuous for applicants to now argue that obesity and diabetes are not closely linked and should be considered to be patentably distinct. Based on applicants' own teachings one would understand that a decrease in obesity correlates with a decrease in insulin resistance. Indeed, Al-Goblan confirms that these two conditions are known to be closely associated in the art. In fact, Al-Goblan teaches that both type 2 diabetes and obesity are associated with insulin resistance (p. 589, 1st col.). Treating one of the two conditions in a subject having both would treat the other, and treatment of either diabetes or obesity renders treatment of the other condition obvious.
Summary/Conclusion
Claims 3, 5-8, 10, and 12 are rejected; claims 1, 2, 4, 9, 11, and 13 are cancelled.
THIS ACTION IS MADE FINAL. Applicants are 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 extension fee 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 date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin S Orwig whose telephone number is (571)270-5869. The examiner can normally be reached Mon.-Fri. 7AM-4PM (with alternate Fridays off). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Engle can be reached Mon.-Fri. at (571)276660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kevin S Orwig/
Primary Examiner, Art Unit 3991
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