Ex Parte Gaonkar et al

Patent Trial and Appeal BoardOct 25, 2017

12479444 (P.T.A.B. Oct. 25, 2017)

United States Patent and Trademark Office UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O.Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 12/479,444 06/05/2009 Anilkumar Ganapati Gaonkar 9610-94198-US 1459 109813 7590 10/25/2017 Fitch, Even, Tabin & Flannery, LLP 120 South LaSalle Street Suite 1600 Chicago, IL 60603-3406 EXAMINER PROSSER, ALISSAJ ART UNIT PAPER NUMBER 1619 MAIL DATE DELIVERY MODE 10/25/2017 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ANILKUMAR GANAPATI GAONKAR, AHMAD AKASHE, LES LAWRENCE, AMADO R. LOPEZ, RONALD L. MEIBACH, DANA SEBESTA, JAMES D. WHITE, YAN WANG, and LESLIE G. WEST Appeal 2017-001526 Application 12/479,4441 Technology Center 1600 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and DAVID COTTA, Administrative Patent Judges. COTTA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving “an ester- containing functional ingredient which is microencapsulated by an enteric matrix.” Specification 11. The Examiner rejected the claims on appeal as obvious under 35 U.S.C. § 103(a). We reverse. 1 According to Appellants, the real party in interest is Kraft Foods Group Brands LLC, which is a subsidiary of Kraft Heinz Foods Company. App. Br. 3. Appeal 2017-001526 Application 12/479,444 STATEMENT OF THE CASE Claims 1—13, 15—17, 47, and 48 are on appeal. Claim 1 is illustrative and reads as follows: 1. A composition comprising: a functional ingredient; a non-active carrier; and an enteric matrix microencapsulating the functional ingredient and non-active carrier and comprising a food grade enteric polymer, wherein the functional ingredient comprises at least about 10% esterified essential oils that are configured to hydrolyze into parent, non-esterified essential oils and at least one non- esterified functional component, wherein the esterified essential oils have a microencapsulation efficiency that is at least about 50% greater than the microencapsulation efficiency of the parent, non-esterified essential oils and the non-esterified functional component has an increased microencapsulation efficiency than when in a comparable enteric matrix, wherein the esterified essential oils comprise esters of thymol. App. Br. 23. The Examiner rejected claims 1—13, 15—17, 47 and 48 under 35 U.S.C. § 103(a) as unpatentable over the combination of Enan,2 Evans,3 and Lis-Balchin4 as evidenced by SIDS.5 2 Enan, WO 2008/003007 A2, published Jan. 3, 2008 (“Enan”). 3 Evans et al., Quantitative Structure-Activity Relationships and Carminative Activity, 67(2) Journal of Pharmaceutical Sciences 277-278 (1978) (“Evans”). 4 Lis-Balchin et al., Studies on the Mode of Action of the Essential Oil of Lavender (Lavandula Angustifolia P. Miller), 13 Phytotherapy Research 540-542 (1999) (“Lis-Balchin”). 5 Swiss Agency for the Environment, Forests and Landscape, SIDS Initial Assessment Report for SIAM 14 (2002) (“SIDS”). 2 Appeal 2017-001526 Application 12/479,444 ANALYSIS In rejecting claim 1 as obvious, the Examiner relied upon Enan as disclosing encapsulated esterified essential oils. Final Act.6 4. The Examiner acknowledged that Enan did not disclose, inter alia, that the essential oils comprised esters of thymol as required by the pending claims. Id. at 5. With respect to this element, the Examiner found that Evans disclosed that linalol (linalool) and thymol possess antispasmodic and carminative activity and that “[t]he carminative activity is related to solubility and the oxygen of carbonyl ester groups is assumed to be the center of biological activity so the order of increasing influence is O < OH < C=0 (alcohol< ester).” Id. at 6. Based on this disclosure, the Examiner concluded that it would have been obvious to include esters of thymol in Enan’s composition. The Examiner explained: Evans concluded that] the carminative activities of alcohols (e.g., linalol, thymol) and esters are largely due to their solubilities, however, other factors are involved, the principal one being the nature of the oxygenated groups in the molecule such that the order of increasing influence is O < OH (alcohol) < C=0 (ester). This teaching provides motivation for the ordinary artisan to include and to optimize the amount of esters in the formulation of Enan comprising linalol and thymol in order to reap the expected benefit of improved carminative activity. Ans. at 9. Appellants argue, inter alia, that Evans does not support the general conclusion that esters have greater carminative activity than alcohols because, “[i]n Evans, ‘there is no comparison between a generic compound 6 Office Action mailed September 22, 2015 (“Final Act.”). 3 Appeal 2017-001526 Application 12/479,444 ‘X’ and an esterified form of compound ‘X’, let alone between thymol and a thymol ester.’” App. Br. 17. Instead, Evans compares “compounds having different functional groups, some of which include alcohols, esters, and other functional groups.” Id. Moreover, Appellants assert, Enan is directed to anti-parasitic compositions, and the evidence shows that esterified forms of thymol have lower anti-parasitic activities than the parent non-esterified forms. Id. at 18 (citing Second Akashe Decl. H 9 and 15). Further, Appellants argue that thymol acetate has 50% less solubility than non- esterified thymol and because the carminative activity of thymol is influenced by its solubility, “one skilled in the art reading Evans would not replace thymol with a thymol ester.” Id. at 20 (citing Second Akashe Decl. 116). In addition, Appellants argue that unexpected results demonstrate the claimed composition to be non-obvious. Appellants assert: “It was unexpectedly discovered that that esterified forms of essential oils, such as esterified forms of thymol, linalool and the like, have a higher microencapsulation efficiency, higher retention, and overall higher payload when compared to microencapsulation of the same non-esterified forms.” First Akashe Decl. 19 (footnote omitted). This is a close case. Evans does suggest that esters may have greater carminative activity than alcohols. See, Evans 278 (“The contribution of the carbonyl group to carminative activity must be greater than either hydroxyl or ether, because the ID50 values of this group were lower. Therefore, it was assumed that the carbonyl oxygen of esters, rather than the ether oxygen, was the center of biological activity.”). See also, id. Other factors are involved [in carminative activity], the principal one being the nature of the oxygenated groups in the 4 Appeal 2017-001526 Application 12/479,444 molecule,. . . [wjhere two such groups are present in one molecule, carminative activity is almost exclusively influenced by only one of them. The order of increasing influence is 0<0H Hydrophobic Compounds 5 Appeal 2017-001526 Application 12/479,444 “Figure 2 is a chart comparing the microencapsulation efficiency between two experiments, with one experiment including a functional ingredient that does not contain at least 30 percent esters, the second experiment including a functional ingredient that includes at least 30 percent esters of linalool and thymol.” Spec. 110; see also, id. 176 (“As shown in Figure 2, it is evident that the use of some esterified components in the essential oil blend led to about a 130% increase in payload retention, the payload retention increase seen in both the esterified and non-esterified components of the functional ingredient.”); and First Akashe Decl. ]Hf 9-11 (discussing same). We assess obviousness based on a preponderance of the evidence. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Here, considering the relatively weak suggestion provided by Evans to use an esterified form of thymol together with Appellants’ evidence of unexpected results, we find that the Examiner’s rejection is not supported by a preponderance of the evidence. Accordingly we reverse the Examiner’s rejection of claims 1—13, 15-17,47, and 48. SUMMARY For the reasons set forth herein, we reverse the Examiner’s rejection of 1—13, 15—17, 47, and 48 under 35 U.S.C. § 103(a) as unpatentable over the combination of Enan, Evans, and Lis-Balchin as evidenced by SIDS. REVERSED 6