Prosecution Insights
Last updated: August 18, 2026
Application No. 17/266,897

TRI-PEPTIDES AND TREATMENT OF METABOLIC, CARDIOVASCULAR AND INFLAMMATORY DISORDERS

Final Rejection §103§DP
Filed
Feb 08, 2021
Priority
Aug 10, 2018 — provisional 62/717,546 +1 more
Examiner
DABKOWSKI, ERINNE R
Art Unit
1654
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Regents of the University of Michigan
OA Round
7 (Final)
56%
Grant Probability
Moderate
8-9
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allowance Rate
396 granted / 710 resolved
-4.2% vs TC avg
Strong +69% interview lift
Without
With
+69.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
57 currently pending
Career history
785
Total Applications
across all art units

Statute-Specific Performance

§101
6.5%
-33.5% vs TC avg
§103
29.6%
-10.4% vs TC avg
§102
14.7%
-25.3% vs TC avg
§112
32.7%
-7.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 710 resolved cases

Office Action

§103 §DP
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 amendment to the claims filed after non-final office action on May 26, 2026 is acknowledged. Claims 37 was amended, claims 1-36, 39-40, 43-49, 54-56 are canceled and 37-38, 41-42, 50-53 are pending in the instant application. The restriction was deemed proper and made final previous office action. Claim 38 remain withdrawn as being drawn to a non-elected species/invention. Claims 37, 41-42, 50-53 are examined on the merits of this office action. Maintained/Revised Rejection Claim Rejections - 35 USC § 103 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. Claim(s) 37, 41-42, 50-53 remain rejected under 35 U.S.C. 103 as being unpatentable over Chen (WO2012109561) in view of Patel (Curr Diabetes Rev 2014;10(4):238-50), Bhatt (HepatoBiliary Surg Nutr 2015;4(2):101-108) and Armstrong (Lancet 2016; 387: 679–90). *All references cited previously. Chen teaches a method of treating obesity and metabolic syndrome in subjects comprising administering GGL (also referred to diapin, see Example 2, see abstract, claims 1-2). Chen teaches using animal models of obesity and diabetes (ob/ob and db/db). Chen specifically teaches that diapin stimulated GLP-1 secretion, insulin secretion and lowers blood glucose levels (see Figures 7-10). Chen teaches “The amount of the composition administered is therapeutically effective to achieve at least one of the following: reducing blood glucose levels, stimulating insulin secretion, stimulating GLP-1 secretion, reducing insulin resistance, and improving glycemic control” (see paragraph 0066). Chen teaches administration of additional therapeutic agents for treatment of metabolic syndrome or diabetes (see paragraph 0075) and in particular a DPP4 inhibitor and TZD (see paragraph 0075, lines 10-11). Chen does not specifically provide an example of treating patients with fatty liver disease. Bhatt teaches that insulin resistance appears to be a critical contributing factor to NAFLD (see page 103, left column, first paragraph). Bhatt teaches “ Elevated circulating free fatty acid levels, in part related to diminished suppression of adipose tissue lipolysis by insulin, result in increased delivery of free fatty acids to the liver. The synthesis of excess triglyceride in the liver is driven by this supply of fatty acids and the accumulation of excess liver fat is further exacerbated by impaired hepatic fatty acid oxidation secondary to insulin resistance. When glucose levels are elevated in the context of prediabetes or overt diabetes, this provides further substrate for triglyceride synthesis. Additionally, impaired very low density lipoprotein (VLDL) secretion, which commonly occurs with insulin resistance, further contributes to hepatic fat accumulation. Insulin resistance is not only a factor in obesity and diabetes, but also may be an underlying mechanism for NAFLD even in non-obese individuals without diabetes, as noted in a euglycemic insulin clamp study” (see page 103, left column). Bhatt teaches “A recent small study from Japan showed improved steatosis and NASH histology (lower NAS score) following liraglutide treatment in overweight or obese subjects with prediabetes (37). This was associated with improved glucose tolerance and a small decrease in BMI” (see GLP-1 analogs section). Armstrong teaches use of Liraglutide (GLP-1 agonist) in patients with NASH and with or without diabetes (see Method, Abstract OC-016). Armstrong teaches that both patients with diabetes and without diabetes and NASH achieved the primary endpoint and resolution of NASH (see page 686, right column, second paragraph). It would have been obvious before the effective filing date of the claimed invention to treat patients with fatty liver disease, including NAFLD and NASH, in non-diabetic subjects with the compositions of Chen. One of ordinary skill in the art would have been motivated to do so given that lowering glucose levels, improving glucose utilization, reducing insulin resistance and increasing GLP-1 secretion would be beneficial in treating patients with fatty liver disease regardless of diabetes status. Bhatt teaches that insulin resistance is a critical contributing factor to NAFLD, even in non-obese, non-diabetic individuals, and that improving insulin sensitivity ameliorates hepatic steatosis and fibrosis. Armstrong teaches that treatment with a GLP-1 agonist , liraglutide, improved NASH outcomes and achieved resolution of NASH in both diabetic and non-diabetic patients. Given that Chen’s GGL peptide stimulates GLP-1 secretion, improves insulin secretion, and reduces insulin resistance, a person of ordinary skill in the art would have had a reasonable expectation of success in using GGL or GGdL to treat NASH or NAFLD in non-diabetic subjects with similar beneficial results. Regarding claim 53, Chen does not specifically provide an example using additional therapeutics (TZD or DPP4 inhibitor). However, MPEP states “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). But see In re Geiger, 815 F.2d 686, 2 USPQ2d 1276 (Fed. Cir. 1987) (“Based upon the prior art and the fact that each of the three components of the composition used in the claimed method is conventionally employed in the art for treating cooling water systems, the board held that it would have been prima facie obvious, within the meaning of 35 U.S.C. 103, to employ these components in combination for their known functions and to optimize the amount of each additive....Appellant argues... hindsight reconstruction or at best,... obvious to try’.... We agree with appellant.”). One of ordinary skilled in the art would have been motivated to combine the two each known (DPP4 inhibitors, TZD) to be useful for the same purpose (treating diabetes, obesity, improving glucose utilization), with a reasonable expectation that at least here will be an additive effect. Regarding the limitations of “decreases hepatic triglyceride levels” (claim 41); hepatic cholesterol (see claim 42); stabilization or reduction in NAFLD activity score (claim 50); slowing the progression of the steatosis component or inflammation of NAS, which is a SCORE (claim 51); wherein NAS is different by no less than 1.5 points...(claim 52); Claims 41, 42, 50, 51 and 52 simply express the intended results of the process step (administering the tripeptide) positively recited. MPEP 2111.04 (I). Chen in view of Bhatt and Armstrong teach the same method of the instant claims including the same subject population and therapeutic and thus, these effects will inherently be achieved. Please note that the claims do not require that the patients have NASH or any specific NAS (NAFLD Score) which BRI, can be zero. Furthermore, Chen teaches administering the peptide which is the treatment. Claim 37 has no effective amount or mode of administration recited, so any dose or route of administration would result in the results claimed. Regarding amended claim 37, Applicant has further recited that administration of the claimed tripeptide “reduces the abundance of Clostridium in the gut microbiota of the subject and reduces hepatic expression of CCL5.” These additional limitations do not recite a different treatment method, composition, dosage, route of administration, patient population, or therapeutic protocol from that rendered obvious by the combination of Chen, Bhatt, and Armstrong. Rather, the limitations merely recite additional biological effects resulting from administration of the same tripeptide to treat the same disease in the same subject population. Because the prior art teaches the same method of treatment, any biological effects that necessarily result from practicing that method are inherent characteristics of the prior art method. The discovery or recognition of previously unappreciated biological mechanisms or properties resulting from an otherwise obvious method does not render the method patentable. Furthermore, where the claimed and prior art methods are the same or substantially identical, the Office can reasonably require Applicant to demonstrate that the prior art method does not inherently possess the recited characteristics. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Applicant has not identified any material distinction in the claimed treatment method that would reasonably be expected to produce a different biological outcome than the method rendered obvious by the cited prior art. Response to Applicant’s Arguments Applicant argues that amended claim 37 now recites a “fundamentally different mechanism of action,” namely reducing the abundance of Clostridium in the gut microbiota and reducing hepatic expression of CCL5, and therefore the Examiner’s rationale, which relies on GLP-1 secretion and insulin sensitization, no longer applies. Applicant’s Arguments have been fully considered but not found persuasive. The obviousness rejection is not predicated upon any single biological mechanism by which the tripeptide achieves therapeutic benefit. Rather, the rejection is based upon the combined teachings of Chen, Bhatt and Armstrong, which collectively teach administering the identical tripeptide to treat metabolically related disorders and provide motivation to administer the peptide to subjects suffering from NAFLD/NASH, including non-diabetic subjects, with a reasonable expectation of success. Amended claim 37 continues to recite administration of the same tripeptide to the same disease population for the same therapeutic purpose. The amendment does not require a different composition, dosage, formulation, route of administration, patient population, or treatment protocol. Instead, the amendment merely recites additional biological effects allegedly resulting from administration of the known treatment. Discovery or recognition of a previously unappreciated biological mechanism or property of an otherwise obvious method does not render the method patentable (see MPEP2112). Applicant argues that none of the cited references teaches reducing Clostridium abundance or hepatic CCL5 expression and therefore the prima facie case fails. Applicant’s Arguments have been fully considered but not found persuasive. The rejection is based upon administration of the same therapeutic tripeptide to treat the same disease state. Applicant has not identified any material difference between the claimed administration and the administration suggested by the prior art combination. Where the claimed and prior art methods are the same or substantially identical, the Office may reasonably conclude that properties or biological effects necessarily resulting from practicing the prior art method are inherent. See In re Best, 562 F.2d 1252 (CCPA 1977). Accordingly, because the same treatment method is taught by the prior art, any biological effects that necessarily result from practicing that method, including modulation of biomarkers or gut microbiota, do not distinguish the claimed method merely because such effects were not previously recognized. Applicant has not provided persuasive evidence demonstrating that practicing the prior art method would fail to produce the recited biological effects. Applicant argues that the specification demonstrates that Clostridium reduction and CCL5 reduction are newly discovered mechanisms of action. Applicant’s argument has been fully considered but not found persuasive. Evidence contained in Applicant’s own specification regarding the biological mechanism by which the claimed treatment operates does not establish patentability over an otherwise obvious treatment method. The claims remain directed to administration of the same tripeptide for treatment of the same disease. Merely discovering or describing the biological pathway through which an otherwise obvious treatment functions does not impart patentability to the known treatment method. Applicant argues that the specification demonstrates unexpected results because DT-109 performs better than glycine or leucine individually. Applicant’s argument has been fully considered but not found persuasive. The closest prior art relied upon in the rejection is Chen, which already teaches the identical tripeptide rather than glycine or leucine individually. Unexpected results must be shown relative to the closest prior art, not relative to compounds that are not relied upon in the rejection. Moreover, the evidence cited by Applicant concerns improvements in HDL, LDL, body composition, hepatic DAG, and related physiological endpoints. Such evidence does not establish that the newly added claim limitations requiring reduction of Clostridium abundance and hepatic CCL5 expression constitute unexpected results over the cited prior art combination. Accordingly, the evidence is not commensurate in scope with the asserted distinction over the prior art and is insufficient to outweigh the prima facie case of obviousness. Applicant argues that claims 41-42 and 50-52 recite measurable physiological outcomes rather than intended results. Applicant’s arguments have been fully considered but not found persuasive. As explained in the previous Office Action, these claims recite results obtained from administration of the therapeutic peptide rather than additional affirmative treatment steps. The prior art teaches administering the same tripeptide to the same patient population for the same therapeutic purpose. To the extent the recited physiological outcomes necessarily result from practicing the obvious treatment method, such outcomes constitute inherent characteristics of the prior art method and do not patentably distinguish the claims. Applicant argues that Chen does not teach treating liver disease and therefore the cited combination is not the same method, making inherency inapplicable. Applicant’s arguments have been fully considered but not found persuasive. Obviousness is based upon the combined teachings of the cited references, not Chen alone. Chen teaches the claimed tripeptide and its therapeutic administration. Bhatt teaches that insulin resistance is a principal contributor to NAFLD, including in non-diabetic subjects, and Armstrong teaches successful treatment of NAFLD/NASH in diabetic and non-diabetic patients by improving the same metabolic abnormalities. As set forth in the rejection, one of ordinary skill in the art would have been motivated to administer Chen’s tripeptide to treat NAFLD/NASH with a reasonable expectation of success. Applicant has not identified any material distinction between the claimed administration and the administration rendered obvious by the cited combination other than newly recited biological consequences of performing the same treatment. 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 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 37, 41-42, 50-53 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28, 30, 38-41 of co-pending Application No.18/163773 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because: The instant application claims A method for treating liver disease in a mammalian subject in need thereof comprising administering to the subject at least one tripeptide selected from Gly-Gly-Leu or Gly-Gly-dLeu, or a pharmaceutically acceptable salt thereof, wherein the mammalian subject does not have diabetes, and wherein the mammalian subject has liver disease and wherein the liver disease is fatty liver, steatohepatitis, non-alcoholic fatty liver disease (NAFLD), or non-alcoholic steatohepatitis (NASH)....” (claim 37). The co-pending application further claims reduction in TG (claim 41); decrease in hepatic cholesterol (claim 42); functional properties including reduction in NAS score (Claims 50-52), an additional therapeutic including GLP-1 (claim 53 ) treatment for the prevention delay or reduction in arteriosclerosis (which Applicants claim as a complication of atherosclerosis). The copending application claims “A method of treating atherosclerosis, the method comprising administering to a subject in need thereof, a therapeutically effective amount of a glycine-containing tripeptide molecule Gly-Gly-Leu or Gly-Gly-dLeu, or a pharmaceutically acceptable salt thereof, wherein the subject has atherosclerosis and does not have diabetes, wherein the administering increases hepatic expression of fatty acid oxidation genes.....wherein the administering reduces atherosclerotic plaque burden in the aorta, wherein the administering reduces plasma LDL cholesterol levels, wherein the administering reduces hepatic triglyceride content and hepatic total cholesterol levels in the subject.”. The copending application further claims wherein the subject has CKD, stroke, atherosclerosis, PAD, CAD or aneurysm (see claim 3); and administering an additional therapeutic such as a GLP-1 or variant thereof (see claim 38). The co-pending application doesn’t specifically claim treating liver disease (NASH, NAFLD or steatopheptitis). It would have been an obvious variant of the invention claimed in the co-pending application to treat liver disease including fatty liver disease and NAFLD. The co-pending application claims recite administering the same compound for reducing plasma LDL cholesterol levels, reducing hepatic total cholesterol and triglyceride content, all of which would have been beneficial in treating fatty liver disease, including NAFLD, in non-diabetic subjects. A person of ordinary skill would have reasonably expected that a therapy capable of reducing liver triglycerides, LDL and hepatic total cholesterol would be beneficial at treating fatty liver disease. Accordingly, the present claims do no define a patentably distinct use of the same peptide. The properties of instant claims 50-52 would inherently occur as a result of practicing the method of Co-pending Application No.18/163773 (same patient population, fatty liver disease (NAFLD) and administering the same drug. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Response to Applicant’s Arguments Regarding the obviousness-type double patenting rejections, Applicant merely requests that the rejections be held in abeyance pending identification of allowable subject matter. Such a request does not traverse the merits of the rejections or present arguments responsive thereto. Accordingly, the obviousness-type double patenting rejections are maintained. Claims 37, 41-42, 50-53 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 53-55, 57, 59-64 of co-pending Application No.18/020908(reference application) in view of Armstrong (see above reference). Although the claims at issue are not identical, they are not patentably distinct from each other because: The instant application claims A method for treating liver disease in a mammalian subject in need thereof comprising administering to the subject at least one tripeptide selected from Gly-Gly-Leu or Gly- Gly-dLeu, or a pharmaceutically acceptable salt thereof, wherein the mammalian subject does not have diabetes, and wherein the mammalian subject has liver disease and wherein the liver disease is fatty liver, steatohepatitis, non-alcoholic fatty liver disease (NAFLD), or non-alcoholic steatohepatitis (NASH)....” (claim 37). The co-pending application further claims reduction in TG (claim 41); decrease in hepatic cholesterol (claim 42); functional properties including reduction in NAS score (Claims 50-52), an additional therapeutic including GLP-1 (claim 53 ) treatment for the prevention delay or reduction in arteriosclerosis (which Applicants claim as a complication of atherosclerosis). The copending application claims “A method of treating steatohepatitis in a subject, comprising administering a pharmaceutically effective amount of at least one N-acyl amino acid product to the subject, wherein the N-acyl amino acid product has a fatty acid component and an amino acid component” (see claim 14). The copending application further claims wherein the amino acid component is glycine- glycine-leucine or glycine-glycine-D-leucine (which is the peptide of the instant claims) (claim 14); wherein the steatohepatitis is non-alcoholic steatohepatitis, alcoholic liver disease or alcoholic steatohepatitis (claim 62); wherein the treating results in the subject in decreased liver fat, decreased inflammatory status, decreased injured hepatocytes and decreased atherosclerotic plaques (see claim 62). The properties of instant claims 41-42, 50-52 would inherently occur as a result of practicing the method of Co-pending Application No. 18/020908 (same patient population, fatty liver disease (NAFLD) and administering the same drug. Co-pending Application No.18/020908 is silent to including an additional therapeutic. However, Armstrong teaches use of Liraglutide (GLP-1 agonist) in patients with NASH and with or without diabetes (see Method, Abstract OC-016). Armstrong teaches that both patients with diabetes and without diabetes and NASH achieved the primary endpoint and resolution of NASH (see page 686, right column, second paragraph). MPEP states “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). But see In re Geiger, 815 F.2d 686, 2 USPQ2d 1276 (Fed. Cir. 1987) (“Based upon the prior art and the fact that each of the three components of the composition used in the claimed method is conventionally employed in the art for treating cooling water systems, the board held that it would have been prima facie obvious, within the meaning of 35 U.S.C. 103, to employ these components in combination for their known functions and to optimize the amount of each additive....Appellant argues... hindsight reconstruction or at best,... obvious to try’.... We agree with appellant.”). One of ordinary skilled in the art would have been motivated to combine the two each known (GLP-1 agonists) to be useful for the same purpose (treating diabetes, obesity, improving glucose utilization, NASH), with a reasonable expectation that at least there will be an additive effect. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Response to Applicant’s Arguments Regarding the obviousness-type double patenting rejections, Applicant merely requests that the rejections be held in abeyance pending identification of allowable subject matter. Such a request does not traverse the merits of the rejections or present arguments responsive thereto. Accordingly, the obviousness-type double patenting rejections are maintained. Claim Objection Claim 37 is objected to for the following informality: an acronym should be spelled out in its first instance. For example, CCL5 should be C-C motif chemokine ligand 5 (CCL5). Conclusion No claims are allowed. THIS ACTION IS MADE FINAL. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ERINNE R DABKOWSKI/Primary Examiner, Art Unit 1654
Read full office action

Prosecution Timeline

Show 8 earlier events
Apr 22, 2025
Final Rejection mailed — §103, §DP
Jul 22, 2025
Request for Continued Examination
Jul 24, 2025
Response after Non-Final Action
Aug 08, 2025
Non-Final Rejection mailed — §103, §DP
Nov 10, 2025
Response Filed
Feb 26, 2026
Non-Final Rejection mailed — §103, §DP
May 26, 2026
Response Filed
Jul 14, 2026
Final Rejection mailed — §103, §DP (current)

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Prosecution Projections

8-9
Expected OA Rounds
56%
Grant Probability
99%
With Interview (+69.0%)
2y 10m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 710 resolved cases by this examiner. Grant probability derived from career allowance rate.

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