DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
If the status of the application as subject to AIA or pre-AIA is incorrect, any correction of the statutory basis (e.g., changing from AIA to pre-AIA ) for a rejection under 35 U.S.C. §§ 102 and/or 103 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.
Status of the Claims
The listing of claims filed 27 November 2024 via preliminary amendment has been examined. Claims 1, 2, 8–17, and 19–26 are pending. Claims 3–7 and 18 are canceled. Claims 8–13, 15, and 19–26 are amended.
Benefit of Earlier Filing Date
The instant application was filed on 27 November 2024 and claims the benefit of an earlier filing date of U.S. Prov. Pat. App. Serial No. 63/604,571, filed 30 November 2023. Applicant’s claim is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 14 August 2025 and 30 July 2026 are acknowledged and have been considered.
Third-Party Submission
The third-party submission under 37 C.F.R. § 1.290 submitted 30 March 2026 is acknowledged and has been considered.
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 11 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 11 recites the broad limitation “diabetes” followed by a narrower statement of the limitation, “(e.g., type 1 diabetes type 2 diabetes, gestational diabetes, and maturity-onset diabetes of the young).”
A broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c),(d).
The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 26 is rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Le et al., Food Chemistry (2020), 329, 126650, 10 pages (“Le”).
Le discloses the use of food grade tripropionin purchased from Sigma-Aldrich Co. Ltd. (Le, p.2, §2.1).
Le discloses the formation of an oil-in-water emulsion comprising tripropionin and the emulsion was subjected to in vitro gastrointestinal digestion. (Id., §§1.2 and 2.3).
Thus, Le discloses a composition comprising isolated tripropionin and a carrier.
Claim Rejections - 35 U.S.C. § 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.
Graham v. John Deere Co., 383 U.S. 1, 17 (1966); MPEP § 2141(II).
Claims 1–17 and 19–26 are rejected under 35 U.S.C. § 103 as being unpatentable over WO2020/127178 (“Blanchard”) [IDS] and WO2014/020344 (“Frost”) [IDS] in view of Qian et al., BMC Public Health (2010), 10:139, (8 pages) (“Qian”) and Halpern et al., Pharmaceuticals (2010), 3, 2398–2415 (“Halpern”).
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
Blanchard discloses compositions prepared by a transesterification reaction between tripropionin and other short chain fatty acid derivatives of glycerol, such as trihexanoin, triheptanoin, etc. (Blanchard, pp.11–12). The transesterification reaction, tripropionin, and the resulting compounds are shown below.
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Blanchard discloses the composition comprises less than 10% tripropionin. (Id., claim 8).
Blanchard states the compounds are useful as a dietary source of propionic acid, which is liberated from the compounds by lipase in the gastrointestinal tract. (Id., p.2).
Blanchard discloses formulating the compositions for oral administration, including a capsule, tablet, or liquid. (Id., pp.7, 14, 18).
Blanchard discloses the compositions can include a carrier. (Id., pp.14–15).
Blanchard discloses administering the compound to treat diseases like obesity, metabolic disease, diabetes, and diseases treatable by increasing ketone levels. (Id., p.8–10).
Blanchard discloses the subject may be human. (Id., p.19).
Frost states: “It is predicted that up to 58% of the world’s adult population will be overweight or obese by 2030.” (Frost, p.1).
Frost states: “The current standards for both men and women accepted as ‘normal’ are a BMI of 20-24.9 kg/m2.” (Id., p.6).
Frost states: “In one commonly used convention, a BMI of 25.0 kg/m2 to 29.9 kg/m2 is overweight, while a BMI of 30 kg/m2 or greater is obese.” (Id., p.9).
Frost states: “[S]upplementing the diet with inulin propionate ester leads to decreased fatty acid output from the adipose tissue, leading to improved insulin sensitivity. This makes propionate esters a viable dietary treatment for diabetes.” (Id., p.11).
Frost discloses giving human subjects 10g of propionate inulin ester via oral administration to reduce food intake. (Id., pp.11–12).
Frost discloses that daily oral administration of propionate inulin ester “reduced food intake, prevented weight gain and increased weight loss after 16 weeks.” (Id., p.12).
Qian discloses a case study of subjects having impaired fasting glucose. (Qian, p.1).
Qian discloses that fasting glucose is correlated with BMI. (Id.).
Qian discloses that BMI was a predictor of impaired fasting glucose. (Id., p.7).
Halpern discloses combinations of drugs for the treatment of obesity. (Halpern, p.2398).
Halpern states: “Orlistat is a synthetic hydrogenated derivative of lipstatin which partially inhibits the gastric lipase, pancreatic lipase and carboxyl ester lipase enzymes. These enzymes work hydrolyzing the dietary triglycerides into fatty acids and monoglycerides, which are subsequently absorbed by the mucosal cells of the gastrointestinal (GI) tract. Orlistat reduces the absorption of ingested fat by 30%, increasing its excretion in the feces.” (Id., p.2402.).
Halpern states: “Since the mechanisms of action of these two medications are very distinct, their combined use was evaluated in some studies.” (Id.).
Halpern discloses combinations with orlistat and sibutramine and with metformin. (Id., pp.2402–03).
Ascertaining the differences between the prior art and the claims at issue
Blanchard and Frost do not disclose administering a lipase inhibitor (e.g., orlistat) with the active ingredient. Halpern is relied on for that element.
Blanchard and Frost do not disclose the “fasting glucose greater than 100 mg/dL.” Qian is relied on for that element.
Blanchard and Frost do not disclose nutritional information (protein, digestible carbohydrate, or fat content) for the inactive ingredients in the compositions.
Blanchard and Frost do not disclose the caloric density of the compositions.
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant application includes experiments comparing a composition comprising tripropionin with a composition comprising glycerol. (Spec., p.16).
The instant application does not include any experiments comparing a composition comprising tripropionin with a composition comprising other prodrugs of propionate.
The instant application includes a prophetic example for administering a lipase inhibitor (orlistat) with the active ingredient. (Id., p.20) There is no data for the proposed study.
The instant application does not include any data related to the concentration of tripropionin in an amount of at least 5% w/w of the composition.
The instant application does not include any comparative data related to: “the composition has a caloric density no greater than 0.15 kcal/g” and “the composition has a caloric density of at least 0.4 kcal/g,”
The instant application does not include any comparative data related to the inactive ingredients: “at least 5% of total calories in the composition is protein,” “at least 5% of total calories in the composition is digestible carbohydrate,” or “at least 5% of total calories in the composition is fat.”
The question of obviousness
Based on the above factors, it would have been prima facie obvious for a person having ordinary skill in the art prior to the filing of the instant application to combine the teachings of Blanchard, Frost, Qian, and Halpern to arrive at the claimed method because: Blanchard and Frost disclose an oral administration of compounds capable of releasing propionate in the distal digestive track of a human; i.e., prodrugs analogous to tripropionin, which also releases propionate in vivo; Frost discloses a patient population identified by BMI and a dosage for obtaining a desired amount of propionate in the patient; Qian establishes a correlation between fasting glucose and obesity; and Halpern establishes that combination therapy with a lipase inhibitor for the treatment of obesity is known in the art.
There is no indication in the instant specification that the inactive ingredients responsible for the claimed limitations (“at least 5% of total calories in the composition is protein,” “at least 5% of total calories in the composition is digestible carbohydrate,” or “at least 5% of total calories in the composition is fat”) involve more than a routine selection of common excipients.
One of ordinary skill in the art would have been motivated to combine the teachings of the cited references because they are analogous to one another and each directed to the treatment of obesity, and a majority of the world’s population will likely be overweight or obese in the near future, which indicates an urgency to combining known elements of treating obesity. There would have been a reasonable expectation of success at arriving at the claimed invention by combining the teachings of the cited references because the compositions in the instantly claimed method are prodrugs that predictably release propionate in the gastrointestinal tract.
Although Blanchard and Frost do not use the terms “reducing adiposity and/or improving glucose homeostasis,” the cited references disclose reducing body weight and improving insulin sensitivity in the subject—characteristics recited in instant claim 2—that are indicative of reducing adiposity and/or improving glucose homeostasis in instant claim 1.
Although Blanchard and Frost do not disclose certain characteristics of the subject, such as a “fasting glucose greater than 100 mg/dL” as recited in instant claim 10; one of ordinary skill in the art would appreciate that some of the overweight, obese, and/or diabetic subjects discussed in the cited references would possess that characteristic because fasting glucose is correlated with BMI per the disclosures in Qian.
The examples in the instant specification have been considered for potential evidence of nonobviousness, but the experiment does not compare the composition in the claimed method with other prodrugs of propionate. In other words, there is no comparative data showing an unexpected result for the composition in the claimed method relative to close prior art.
Conclusion
No claims are allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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