DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/30/2025 was filed after the mailing date of the non-final office action on 10/1/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The claim language “An acylated oxyntomodulin peptide analog of the following Chemical Formula I” has been interpreted as “An acylated oxyntomodulin peptide analog consisting of the following Chemical Formula I” in light of the specification. Given the description of the specification and the claim language of claim 4, this is the broadest reasonable interpretation.
Claim Objections
Response to Arguments
Applicant’s arguments, see Applicant Reply page 7, para. 3, filed 12/30/2025, with respect to the objection to claim 9 have been fully considered and are persuasive. The objection to claim 9 has been withdrawn.
Claim Rejections - 35 USC § 112
Response to Arguments
Applicant’s arguments, see Applicant Reply page 7, para. 5, filed 12/30/2025, with respect to the rejections of claim 9 under USC 112(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made.
New Rejections
Claims 9 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating obesity, overweight, obesity- related inflammation, obesity-related gallbladder disease, obesity-induced sleep apnea, and diabetes accompanied by obesity, metabolic syndrome, hypertension, arteriosclerosis-inducing dyslipidemia, atherosclerosis, arteriosclerosis, coronary heart disease, stroke, or non-insulin dependent diabetes mellitus, does not reasonably provide enablement preventing obesity, overweight, obesity- related inflammation, obesity-related gallbladder disease, obesity-induced sleep apnea, and diabetes accompanied by obesity, metabolic syndrome, hypertension, arteriosclerosis-inducing dyslipidemia, atherosclerosis, arteriosclerosis, coronary heart disease, stroke, or non-insulin dependent diabetes mellitus. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
MPEP 2164.01(a) states: “In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is ‘reasonable’ or is ‘undue.’”
These factors include, but are not limited to:
The breadth of the claims;
Claims 9 and 10 are not particularly broad in terms of conditions to be treated, but the “preventing” refers to any action that suppresses or delays
the onset of a target disease.
The nature of the invention;
The nature of the invention is a method for preventing or treating a variety of conditions: obesity, overweight, obesity- related inflammation, obesity-related gallbladder disease, obesity-induced sleep apnea, and diabetes accompanied by obesity, metabolic syndrome, hypertension, arteriosclerosis-inducing dyslipidemia, atherosclerosis, arteriosclerosis, coronary heart disease, stroke, or non-insulin dependent diabetes mellitus.
The state of the prior art;
Hruby et al. (Hruby, et al. Pharmacoeconomics 33.7: 673-689 (2015)) discloses various degrees of obesity such as Class 1, class 2, class 3.
PNG
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502
1251
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(Hruby et al., page 674 Table 1).
Jastreboff et al. (Jastreboff, et al. New England Journal of Medicine 387.3: 205-216 (2022)) discloses the following results for a GLP-1/glucagon dual agonist: “At baseline, the mean body weight was 104.8 kg, the mean BMI was 38.0, and 94.5% of participants had a BMI of 30 or higher. The mean percentage change in weight at week 72 was −15.0% (95% confidence interval [CI], −15.9 to −14.2) with 5-mg weekly doses of tirzepatide, −19.5% (95% CI, −20.4 to −18.5) with 10-mg doses, and −20.9% (95% CI, −21.8 to −19.9) with 15-mg doses and −3.1% (95% CI, −4.3 to −1.9) with placebo (P<.0001 for all comparisons with placebo). The percentage of participants who had weight reduction of 5% or more was 85% (95% CI, 82 to 89), 89% (95% CI, 86 to 92), and 91% (95% CI, 88 to 94) with 5 mg, 10 mg, and 15 mg of tirzepatide, respectively, and 35% (95% CI, 30 to 39) with placebo; 50% (95% CI, 46 to 54) and 57% (95% CI, 53 to 61) of participants in the 10-mg and 15-mg groups had a reduction in body weight of 20% or more, as compared with 3% (95% CI, 1 to 5) in the placebo group.” (Jastreboff et al., page 205, para. 3).
Jastreboff2 et al. (Jastreboff, et al. New England Journal of Medicine 392.10: 958-971 (2025)) discloses the following results for a GLP-1/glucagon dual agonist: “ Fewer participants received a diagnosis of type 2 diabetes in the tirzepatide groups than in the placebo group (1.3% vs. 13.3%; hazard ratio, 0.07; 95% confidence interval [CI], 0.0 to 0.1; P<0.001). After 17 weeks off treatment or placebo, 2.4% of the participants who received tirzepatide and 13.7% of those who received placebo had type 2 diabetes (hazard ratio, 0.12; 95% CI, 0.1 to 0.2; P<0.001).” (Jastreboff2 et al., page 958, para. 3).
The level of one of ordinary skill;
One of ordinary skill in the art is high; typically a master’s level education or higher.
The level of predictability in the art;
The predictability of protein-protein interactions is low. A single point mutation can change the biophysical properties of a peptide: “In summary, we have shown that the structural changes in the fibrillar state of the Aβ42 peptide that are observed to occur upon introduction of single point mutations can be accompanied by changes in the dominance of the microscopic processes by which these aggregates are themselves formed.” (Bolognesi et al. ACS Chem Bio 9:2 (2013) page 381 col. 2 para. 3) and “In summary, while ovispirin-1 and novispirin G-10 both had solution structures that were helical and amphipathic in the presence of TFE, a relatively simple change in their primary structure (a single glycine–isoleucine exchange) had profound effects on their respective toxicities for human erythrocytes and epithelial cells.” (Sawai et al. Protein Eng. 15:3 (2002) page 232 col. 1 para. 3).
Furthermore, many sequences allowed by the current scope of the claims, result in non-functional aggregates. Wang (Wang, et al. MAbs. Vol. 1. No. 3. Taylor & Francis, (2009)) discloses a variety of aggregation prone motifs that occur in commercial antibodies (Wang, page 262, Table 2). The scope of the claims currently may incorporate such motifs and result in non-functional aggregates.
The amount of direction provided by the inventor and the existence of working examples; and The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Applicant does not provide data with respect to suppression of obesity (Claim 9) nor the suppression of non-insulin dependent diabetes mellitus (Claim 10).
Regarding claim 9, Hruby discloses the ranges of obesity as described above. Jastreboff discloses that subjects with an average BMI of 38 averaged a 15% reduction in mass, yielding an average resultant BMI of 32.3, which is still obese as disclosed by Hruby. Due to this result and lack of data in the specification, it would require an undue amount of experimentation for a person of ordinary skill in the art to determine if the claimed molecules can effectively prevent obesity.
Consequently, claim 9 is rejected.
Regarding claim 10, Jastreboff2 et al. discloses above that 1.3% of subjects developed type 2 diabetes while being treated with a GLP-1/glucagon dual agonist and 2.4% of subjects developed type 2 diabetes after treatment. Due to this result and lack of data in the specification, it would require an undue amount of experimentation for a person of ordinary skill in the art to determine if the claimed molecules can effectively prevent non-insulin dependent diabetes mellitus (type 2 diabetes).
Consequently, claim 10 is rejected.
Examiner Note: Examiner is aware of the dates of Jastreboff and Jastreboff2. However, these references are illustrative of properties that a GLP-1/glucagon dual agonist would possess either before or after the effective filing date of the application.
Closest Prior Art
Regarding claims 1-8, Carrington et al. discloses SEQ ID NO: 60, which is aligned against Applicant SEQ ID NO: 2 below:
SQ Sequence 32 AA;
Query Match 83.4%; Score 151; Length 32;
Best Local Similarity 90.3%;
Matches 28; Conservative 0; Mismatches 3; Indels 0; Gaps 0;
Qy 1 HXQGTFTSDXSKYLDXRRAQDFVQWLMNTKE 31
| ||||||| ||||| |||||||||||||||
Db 1 HSQGTFTSDYSKYLDSRRAQDFVQWLMNTKE 31
This sequence lacks sufficient identity to render Applicant SEQ ID NO: 2 obvious and also doesn’t include the side chain modifications. Consequently, claims 1-8 are free of the prior art.
Conclusion
Claims 9 and 10 are rejected.
Claims 1-8 are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Paul Bowles whose telephone number is (571)272-0919. The examiner can normally be reached Monday-Friday 8:30-5:00.
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/DAVID PAUL BOWLES/ Examiner, Art Unit 1654
/CHRISTINA BRADLEY/ Primary Examiner, Art Unit 1654
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