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
Status of Application
1. Applicants’ arguments/remarks filed 11 November 2025 are acknowledged. Claims 1-6, 8-9, and 11-15 are currently pending. Claims 7 and 10 are cancelled. Claims 12-15 were previously withdrawn. Claims 1 and 11 are amended. Claims 1-6, 8-9, and 11 are examined on the merits within.
Withdrawn Rejections
2. Applicants’ arguments filed 11 November 2025, with respect to the 35 U.S.C. 103 Rejections have been fully considered and are persuasive. The 35 U.S.C. 103 Rejections of Betancourt Villamizar et al. (WO 2016/189345) in view of Reising et al. (US 2012/0251621), (Koike et al. (US 2003/0054082), Pasupuleti (US 20140170128), Komorowski (US Patent 11865121), and Harpe et al. (US 20010016580) and Betancourt Villamizar et al. (WO 2016/189345) in view of Reising et al. (US 2012/0251621), Koike et al. (US 2003/0054082), Pasupuleti (US 20140170128), Komorowski (US Patent 11865121) and Harpe et al. (US 20010016580) as applied to claims 1-3, 5-6, 8-9 and 11 above and further in view of Cain et al. (JP 2008031177), Okuyama et al. (US 20080146664), and Hernandez et al. (WO 2013086243) has been withdrawn. However, upon a further review, a new rejection is made in view of Betancourt Villamizar et al. (WO2016/189345) in view of Koike et al. (US 2003/0054082), Komorowski (US Patent 11865121), and Hernandez et al. (WO 2013086243). The Double Patenting Rejection over U.S. Patent No. 10,716,820 has been withdrawn in view of the claim amendments.
New Rejections
Claim Rejections – 35 U.S.C. 103
3. 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.
4. Claim(s) 1-3, 5-6, 8-9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Betancourt Villamizar et al. (WO2016/189345) in view of Koike et al. (US 2003/0054082), Komorowski (US Patent 11865121), and Hernandez et al. (WO 2013086243).
Betancourt Villamizar et al. teach compositions containing natural oil such as canola oil and flax seed oil with phytosterols that make up at least 98%. See abstract, claims 1-7, Example Table 1. The composition further includes a natural antioxidant from 0.1 to 0.2% which may be tocopherol and rosemary extract. See paragraph [0004] and claim 9. The compositions are used for treating oxidative stress and cardiovascular disorders. See abstract.
With respect to claim 11, which recite product-by-process limitations, the Examiner notes “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
The amendments to the claim recite for “treating or preventing diabetes or prediabetes” however this limitation is regarded as intended use of the composition. It must be noted that the recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art is capable of performing the intended use, then it meets the claim. In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Circ. 1997) MPEP 2111.02.
Betancourt Villamizar et al. teach rosemary extract as antioxidant and tocopherol but does not disclose the antioxidant selected from coconut extract derivatives, canola oil derivatives and combinations thereof, polyphenol of plant origin, a chromium compound, the amount of phytosterol from 20 to 30% by weight or palmitoleic acid.
Koike et al. teach oil or fat compositions which may include antioxidants such as vitamin A, C, E, and polyphenols. See abstract and para [0028]. Examples of polyphenols include natural anti-oxidant components such as catechin (e.g., plant derived and coconut extract derivative) and flavonoids and may be from 0.02-2 % by weight, particularly 0.05-1 % in view of effects and coloring. See paragraph [0030]. Koike et al. teach phytosterol in amount of 0.05 wt % or more (claim 5). Koike et al. teach that from the viewpoint of the effect of reducing cholesterol, the food or pharmaceutical of the present invention contains a phytosterol in an amount of 0.05% or more, particularly 0.3% or more. No particular limitation is imposed on the upper limit of the amount of the phytosterol, and the amount preferably falls within a range of 0.05-20%. Examples of the phytosterol include a sitosterol, ß sitosterol, stigmastanol, campesterol, a sitostanol, ß sitostanol, stigmastanol, campestanol, and cycloartenol, as well as esters thereof, such as fatty acid esters, ferulic acid esters, and cinnamic acid esters (para 0049).
Komorowski teach chromium present from about 0.0001-3 wt % or 0.01 to about 1 wt % a range that overlaps with the instant claims. Dietary supplementation of chromium to normal individuals has been reported to lead to improvements in glucose tolerance, serum lipid concentrations, including high-density lipoprotein cholesterol, insulin and insulin binding. The chromium complex includes those such as chromium picolinate and chromium chloride (see col. 3, lines 8-55 and col. 6, lines 10-15).
Hernandez et al. teach palmitoleic acid and that it may have protective effects against some cardiovascular disease risk factors. Higher concentration of circulating cis-palmitoleic acid is associated with lower LDL cholesterol, higher HDL cholesterol, and lower total HDL cholesterol ratio (para 0006). The amount may be at least 30, 40, 45 % (para 0034).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to use palmitoleic acid in the composition of Betancourt Villamizar et al. to provide additional cardiovascular benefit as taught by Hernandez et al. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to further include a chromium compound in the composition of Betancourt Villamizar et al. and to include amounts that overlap. One would have been motivated to do so because of its effects on glucose from the blood and achieving rapid clearance and improvements of risk of cardiovascular disease. One would have been motivated to do so because dietary supplementation of chromium to normal individuals has been reported to lead to improvements in glucose tolerance, serum lipid concentrations, including high-density lipoprotein cholesterol, insulin and insulin binding. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Applicants have not provided any criticality to the amounts. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the amount of phytosterol in the compositions of Betancourt Villamizar et al. for the purpose of reducing cholesterol as taught by Koike et al. It would have further been prima facie obvious to include polyphenols such as catechin in Betancourt Villamizar et al. for the purposes of its natural anti- oxidant components. Combinations of two or more species of anti-oxidants may be used which are inclusive of vitamins and polyphenols.
Allowable Subject Matter
5. Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicants’ arguments filed 11 November 2025 have been fully considered but they are not persuasive.
6. Applicants argued, “The prior art does not guide one to select coconut extract derivatives or canola oil derivatives as suitable antioxidants. The ‘345 is directed to treating oxidative stress and is silent regarding any treatment of diabetes. ‘082 addresses a different technical problem, reducing body fat or visceral fat to treat obesity. One of ordinary skill would not consider the teachings of ‘243 to be relevant. The compositions of the present application do not comprise glycerol phospholipids of palmitoleic acid but instead the free acid. One would not be able to determine the mentioned effects are attributed to palmitoleic acid since the effects are due to all of the components and interactions among them. The compositions as claimed provide functional properties that are not anticipated by the prior art. None of the prior art address glycemia levels or insulin activity.”
In response to applicants’ arguments, with regards to the treatment of diabetes, the claims are directed to a composition, wherein the intended use of the composition is treatment of diabetes or pre-diabetes. Since this limitation is regarded as intended use of the composition, it is given little patentable weight. It must be noted that the recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed.Cir. 1997) MPEP § 2111.02. The ‘082 reference was provided to make obvious use of catechins because these are known antioxidants and the ‘345 shows the effective use of antioxidants. As stated by Applicant, catechins are components of coconut extract derivatives. The prior art of ‘082 is relevant due to the fact that it is a combination of ingredients used to treat a human which is similar to the ‘345 reference. The claims do not preclude glycerol phospholipids as components of the composition. Thus it is unnecessary to show which effects are caused by which agent as long as the combination of ingredients are made obvious by the prior art. In response to applicants’ argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., glycemia levels, insulin activity, etc.) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Thus these rejections are maintained.
Conclusion
7. Applicants’ 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
8. No claims are allowed at this time.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615