Ex Parte Beck et alDownload PDFPatent Trial and Appeal BoardDec 28, 201612064886 (P.T.A.B. Dec. 28, 2016) Copy Citation 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. 12/064,886 07/15/2008 Markus Beck ES-4662-743 3781 23117 7590 12/30/2016 NIXON & VANDERHYE, PC 901 NORTH GLEBE ROAD, 11TH FLOOR ARLINGTON, VA 22203 EXAMINER PALLAY, MICHAEL B ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 12/30/2016 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): PTOMAIL@nixonvan.com pair_nixon @ firsttofile. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARKUS BECK, HANSJOERG GRASS, BRUNO LEUENBERGER, MARKUS NOWOTNY, CHRISTIAN SCHAFER, and KARL MANFRED VOELKER1 Appeal 2015-007744 Application 12/064,886 Technology Center 1600 Before DONALD E. ADAMS, ERIC B. GRIMES, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. NEWMAN, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims to a tablet that includes formulations of fat-soluble active ingredients and a protective colloid. The Examiner entered final rejections for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify the Real Party in Interest as DSM IP Assets B.V. (TE Heerlen, Netherlands). Br. 3. Appeal 2015-007744 Application 12/064,886 STATEMENT OF THE CASE Background “The present invention relates to novel formulations of a fat-soluble active ingredient with high bioavailability of said fat-soluble active ingredient as well as to their manufacture and use as [a] dietary supplement, food, feed, personal care product and/or pharmaceutical.” Spec. 1:3—5. The Claims Claims 34—57 are on appeal. Independent claims 34, 36, 38, and 40 are illustrative and reads as follows: 34. A tablet having high bioavailability containing 0.1 to 25 weight-% of lutein, 65 to 75 weight-% of a protective colloid, 2 to 5 weight-% of an anti-oxidant and 10 to 25 weight-% of com starch, based on the total weight of the tablet wherein the protective colloid is modified food starch or a mixture of modified food starch and sugar, and wherein the tablet when dissolved, dispersed or diluted in/with water has an extinction El/1 at a wavelength in the range of from 200 to 800 nm of > 380, wherein said tablet has an extmsion loss of fat-soluble active ingredient of less than or equal to 30%. 36. A tablet having high bioavailability containing 5 to 15 weight-% of lycopene, 55 to 75 weight-% of a protective colloid, and 2 to 5 weight-% of an anti-oxidant and 10 to 25 weight-% of com starch, based on the total weight of the tablet wherein the protective colloid is modified food starch or a mixture of modified food starch and sugar, and wherein the tablet when dissolved, dispersed or diluted in/with water has an extinction El/1 at a wavelength in the range of from 200 to 800 nm of > 380, wherein said tablet has an extmsion loss of fat- soluble active ingredient of less than or equal to 30%. 38. A tablet having high bioavailability containing 1 to 30 weight-% of P-carotene, 20 to 75 weight-% of a protective 2 Appeal 2015-007744 Application 12/064,886 colloid, 2 to 5 weight-% of an anti-oxidant and 10 to 25 weight- % of com starch, based on the total weight of the tablet wherein the protective colloid is modified food starch or a mixture of modified food starch and sugar, and wherein the tablet when dissolved, dispersed or diluted in/with water has an extinction El/1 at a wavelength in the range of from 200 to 800 nm of > 380, wherein said tablet has an extmsion loss of fat-soluble active ingredient of less than or equal to 30%. 40. A tablet having high bioavailability containing from 1 to 20 weight-% of zeaxanthin, 50 to 90 weight-% of a protective colloid, 2 to 5 weight-% of an anti-oxidant, and 10 to 25 weight-% of com starch, based on the total weight of the tablet wherein the protective colloid is modified food starch or a mixture of modified food starch and sugar, and wherein the tablet when dissolved, dispersed or diluted in/with water has an extinction El/1 at a wavelength in the range of from 200 to 800 nm of > 380, wherein said tablet has an extmsion loss of fat- soluble active ingredient of less than or equal to 30%. The Issue The Examiner rejected claims 34—57 under 35 U.S.C. § 103(a) as obvious over Beck.2 (Non-final Act., mailed Aug. 15, 2014, at 2— 8). The Examiner finds that Beck teaches “pharmaceutical compositions comprising a and/or P-zeacarotene in a colloidal solution that may be converted into a solid for use as a colorant” and that can be prepared “in a manner known for the preparation of carotenoid and fat soluble vitamin compositions.” Id. at 3. The Examiner finds Beck teaches “[fjurther coloring agent carotenoids such as P-carotene, 8’-apo-P-carotenal, lutein, 2 WO 03/022071 A2, published Mar. 20, 2003 (“Beck”) 3 Appeal 2015-007744 Application 12/064,886 zeaxanthin, lycopene, astaxanthin, canthaxanthin, and mixtures thereof may be added to the composition to achieve an intermediate color hue.” Id. The Examiner finds Beck discloses use of “modified food starch[] as a protective hydrocolloid in the composition,” and that “gelatin, pectin, gum arabic, mixtures thereof, and other substances may be used.” Id. The Examiner also finds “[sjugars such as sucrose, invert sugar, glucose, fructose, lactose, maltose, and saccharose may be present in the composition.” Id. The Examiner finds Appellants’ Specification defines a formulation as having “high bioavailability if the extinction coefficient El/1 is >380 at a wavelength in the range of from 200 to 800 nm.” Id. at 4. Using this definition, the Examiner finds that Beck’s Example 1 discloses a composition in which the El/1 coefficient is 1640 at a wavelength of 438 nm, and concludes that the composition of Example 1 is inherently bioavailable. Id. at 3^4. The Examiner finds Beck discloses a composition as follows: comprising about 0.1 to about 30 wt.%, preferably about 1 to about 20 wt.% of zeacarotene (i.e., a fat-soluble active ingredient). . . about 1 to about 90 wt.%, preferably about 5 to about 70 wt.% of a protective hydrocolloid; 0 to about 50 wt.% of a starch ... 0 to about 20 wt.% of fat-soluble antioxidants; and 0 to about 70 wt.%, preferably 0 to about 40 wt.% of mono- or disaccharides (i.e., sugar). Id. at 4. The Examiner also finds Example 1 of Beck discloses a composition “comprising 3.5 - 3.8 wt.% zeacarotene and 33 wt.% com starch.” Id. The Examiner finds that it would have been obvious 4 Appeal 2015-007744 Application 12/064,886 to substitute lutein, lycopene, P-carotene or zeaxanthin for the zeacarotene in the compositions of Beck ... or to add lutein, lycopene, P-carotene or zeaxanthin to the compositions of Beck [] in concentrations as disclosed in Beck for the zeacarotene, which overlap with the claimed concentrations of lutein, lycopene, P-carotene, or zeaxanthin, with a reasonable expectation of success. Id. at 4—5. The Examiner finds the skilled artisan would have been “motivated to do so in order to achieve other color hues as suggested by Beck [], given that Beck [] discloses zeacarotene, lutein, lycopene, P-carotene, and zeaxanthin all as coloring agent[] carotenoids that may be contained in the composition.” Id. at 5. The Examiner finds that Beck discloses compositions in which the protective hydrocolloid is modified food starch, maltodextrin, gelatin, or mixtures thereof . . . protective hydrocolloid is preferably about 5-70 wt.% of the composition . . . and sugar is preferably 0 to about 40 wt.% of the composition . . . Thus, the ratio of protective hydrocolloid (e.g., modified food starch) to sugar is about 70:0 to about 5:40, which broadly overlaps the claimed ratio ranges. Id. The Examiner finds “[w]ith respect to the claimed extrusion loss of fat-soluble active ingredient, although Beck [] does not explicitly disclose such extrusion loss, such is a latent property that would flow naturally from following the teachings of Beck [] as discussed herein.” Id. at 5—6. The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that claims 34, 36, 38, and 40 are obvious over Beck? 5 Appeal 2015-007744 Application 12/064,886 Findings of Fact 1. The Specification discloses: “If the extinction coefficient El/1 is at a wavelength in the range of from 200 to 800 nm >380 the formulation is one with high bioavailability.” Spec. 3:1—2. 2. Beck discloses: The use of a-zeacarotene, P-zeacarotene or a mixture of both as a colouring agent for food or pharmaceutical compositions. For addition to the food or pharmaceutical composition or otherwise incorporation therein during its preparation the zeacarotene (mixture) is generally first formulated to a solid or liquid colorant composition in the form of a stable water- soluble or dispersible powder, an aqueous colloidal solution or oil-in-water dispersion of such a powder, an oil-in-water dispersion of the zeacarotene (mixture), or an oil-soluble dispersion of the zeacarotene (mixture) in a triglyceride. In a solid colorant composition the zeacarotene (mixture) is generally finely dispersed in a matrix or carrier. Such colorant compositions may be prepared by homogenizing, in an aqueous or colloidal solution of a carrier and optionally one or more water-soluble excipients and/or adjuvants, a solution or dispersion of the zeacarotene (mixture) and optionally one or more fat-soluble excipients and/or adjuvants in a triglyceride or an organic solvent, or in a mixture of both triglyceride and organic solvent, and, if required, converting the so obtained dispersion into a solid composition. The colorant compositions, their processes of preparation and the food or pharmaceutical 6 Appeal 2015-007744 Application 12/064,886 compositions which comprise the zeacarotene (mixture) as the colouring agent are further aspects of this invention. Beck, Abstract. 3. Beck discloses: Pharmaceutical compositions such as tablets or capsules in which the zeacarotene is used as a colouring agent are also within the scope of the present invention. The colouration of tablets can be accomplished by adding the zeacarotene in form of a liquid or solid colorant composition separately to the tablet coating mixture or by adding a colorant composition comprising the zeacarotene to one of the components of the tablet coating mixture. Id. at 8:11-17. 4. Beck discloses: [I]t has been found that cc-zeacarotene and P-zeacarotene, each individually or a combination of both in any relative proportion . . . can be used to impart a yellow to greenish-yellow colour to food products such as beverages, sweet products and dairy products, and to pharmaceutical compositions, such as tablets and capsules. Id. at 1:23-2:3. 5. Beck discloses “[i]n order to achieve an intermediate colour hue, such compositions may optionally contain one or more further colouring agents, e.g. one or more further carotenoids such as P- carotene, canthaxanthin, 8’-apo-P-carotenal, ethyl 8’-apo-P- carotenoate, lycopene, astaxanthin, lutein and zeaxanthin.” Beck 2:16-20. 7 Appeal 2015-007744 Application 12/064,886 6. Beck teaches: The protective hydrocolloid or carrier which may be present in and used to prepare the colorant compositions of the present invention is for example and more particularly a polysaccharide gum, e.g. gum arabic; a modified food starch, e.g. sodium octenyl succinyl starch; a pectin, e.g. sugar beet pectin; a maltodextrin; a protein, e.g. a gelatin, particularly fish, swine or bovine gelatin, a plant protein or a milk protein; a ligninsulphonate; or any mixture of these substances. Preferably, sodium octenyl succinyl starch or a gelatin is used as the protective hydrocolloid or carrier. Id. at 4:27-32. 7. Beck discloses: “Examples of mono- and disaccharides which may be present in the compositions of the present invention are sucrose, invert sugar, glucose, fructose, lactose, maltose, saccharose and sugar alcohols, and examples of the oligo- and polysaccharides are starch and starch hydrolysates.” Id. at 5:4—7. 8. Beck discloses: Typically, a powder colorant composition according to the present invention comprises about 0.1 to about 30 wt.%, preferably about 1 to about 20 wt.%, of the zeacarotene; 0 to about 20 wt.%, preferably about 0.5 to about 10 wt.%, of one or more fat-soluble antioxidants; 0 to about 50 wt.%, preferably about 0.5 to about 30 wt.%, of a triglyceride; about 1 to about 90 wt.%, preferably about 5 to about 70 wt.%, of a protective hydrocolloid; 0 to about 70 wt.%, preferably 0 to about 40 wt.%, of one or more mono- or disaccharides; 8 Appeal 2015-007744 Application 12/064,886 0 to about 50 wt.%, preferably 0 to about 35 wt.%, of a starch; 0 to about 70 wt.%, preferably 0 to about 40 wt.%, of a starch hydrolysate; 0 to about 10 wt.%, preferably 0 to about 5 wt.%, of a water-soluble antioxidant; 0 to about 5 wt.%, preferably about 1 to about 3 wt.%, of silicic acid; and 0 to about 10 wt.%, preferably about 1 to about 5 wt.%, of water, the weight percentages of all these ingredients totalling 100. Id. at 6:5—18. 9. Beck discloses Example 1 in which the colorant composition comprises “3.5—3.8 wt% P-zeacarotene”, “33 wt% com starch,” that “the powder was [] dispersed in deionized water” and in which “an extinction of 1.64 at a wavelength of 438 nm was calculated [E(l%, 1 cm) = 1640].” Id. at 9:1-10:15. Principles of Law “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. Wrigley found a “strong case of obviousness based on the prior art references of record. [The claim] recites a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to substitute one well-known ... agent for another.” Wm. 9 Appeal 2015-007744 Application 12/064,886 WrigleyJr. Co. v. Cadbury Adams USALLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012). Analysis The Examiner provides sound reasoning for rejecting the appealed claims over Beck. We adopt the Examiner’s findings of fact regarding the scope and content of the prior art as our own (Non-final Act. 3—8; FF 1—9) and affirm the rejection. We address Appellants’ arguments below. Appellants argue Beck does not disclose “a mixture of modified food starch with sugar.” Br. 9. This argument is not persuasive with regard to the independent claims because each independent claim recites “wherein the protective colloid is modified food starch or a mixture of modified food starch and sugar,” (emphasis added). Accordingly, Beck’s disclosure of modified food starch as a protective hydrocolloid (FF 6) meets this limitation. With regard to dependent claims 35, 37, 39 and 41, which specify “wherein the protective colloid is a mixture of modified food starch and sugar,” the Examiner states although Beck et al. does not specifically characterize sugar as a protective colloid, Beck et al. does characterize modified food starch as a protective hydrocolloid [], and the composition of 10 Appeal 2015-007744 Application 12/064,886 Beck et al. includes sugar . . . such combination inherently has the property of being a protective colloid. Non-final Act. 8. We find the Examiner has the better position as Appellants fail to explain why the Beck composition containing modified food starch and sugar does not act as a protective colloid. Appellants argue “BECK is silent about bioavailability of any of their compositions. The focus of BECK is to provide a composition which gives a yellow to greenish-yellow color to food products and pharmaceutical compositions.” Br. 9. This argument is not persuasive given Appellants’ definition of bioavailability of a composition, upon which the Examiner relies: “If the extinction coefficient El/1 is at a wavelength in the range of from 200 to 800 nm >380 the formulation is one with high bioavailability” and Beck’s disclosure of compositions in Example 1 having, for instance, an extinction coefficient El/1 of 1640 at a wavelength of 438 nm. FF 1 and 9. Appellants argue, however, that these solutions are based on a mixture of gelatin and sucrose as the protective colloid, [do] not use modified food starch or its mixture with sugars as the protective colloid [and] the E 1/1 values given in BECK only apply for compositions of a or P-carotene, but not of any other colorant/carotenoid. Due to the differences in the combinations of protective colloid ingredient and fat-soluble active ingredient, the combinations may render a difference in bioavailability of the formulations, and thus the bioavailability of the compositions in BECK may not inherently be the same as the claimed formulations. Br. 10. Appellants provide no evidence in support of this argument, to demonstrate the compositions of Beck do not have high bioavailability. 11 Appeal 2015-007744 Application 12/064,886 Without evidence, this attorney argument is unpersuasive. See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the place of evidence.”). Appellants also argue that Beck’s disclosure of other carotenoids (e.g., zeacarotene, lutein, lycopene, P-carotene, and zeaxanthin) is for the purpose of coloring food “but not for the reason of having high bioavailability.” Br. 10-11. We are not persuaded by Appellants’ arguments. The test for obviousness before us is what the teachings of Beck would have suggested to one of ordinary skill in the art. See In re Keller, 642 F.2d 413, 425 (CCPA 1981) (citing cases). Moreover, it is well settled that “the law does not require that the references be combined for the reasons contemplated by the inventor.” In re Beattie, 91A F.2d 1309, 1312 (Fed. Cir. 1992) (citing cases). Appellants argue that although Beck may disclose the other carotenoids, it does not disclose any amounts of these carotenoids for use in a composition. Br. 11. Appellants additionally argue that Beck discloses use of these other carotenoids only in conjunction with zeacarotenoids, but does not teach or suggest replacing zeacarotene with any of lutein, lycopene, P-carotene, or zeaxanthin. See id. We are not persuaded. Beck teaches that “one or more further carotenoids such as P-carotene, canthaxanthin, 8’-apo-P-carotenal, ethyl 8’- apo-P-carotenoate, lycopene, astaxanthin, lutein and zeaxanthin” can be added to a mixture to achieve different coloring hues and specifically that Beck’s “compositions may optionally contain one or more further carotenoids.” FF 5. Claims 34, 36, 38, and 40 use the broad functional 12 Appeal 2015-007744 Application 12/064,886 word “containing” and provide ranges for the claimed components. None of these claims excludes other carotenoids from being added to the composition. We further agree with the Examiner that Beck’s teachings render obvious the simple substitution of lutein, lycopene, a carotene (such as P-carotene), or zeaxanthin for zeacarotene in the Beck compositions, as such substitutions are “the combination of familiar elements according to known methods,” yielding "predictable results.” KSR, 550 U.S. at 417. Appellants further argue that Beck does not “mention extrusion loss of the tablets” and that, due to having different “fat-soluble active ingredients [and] protective colloids,” that “even if one of ordinary skill in the art were to derive the extrusion loss of BECK’s composition, the advantages of using a fat-soluble active ingredient with high bioavailability to reduce extrusion loss may not necessarily be obvious.” Br. 11—12. We are not persuaded. As discussed above, one of skill in the art need not make the claimed composition for the same reason as the inventor to render it obvious. In re Beattie, 974 F.2d at 1312. Appellants have provided no evidence that the compositions of Beck do not provide the claimed prevention of extrusion loss, or any evidence that the claimed compositions prevent extrusion loss to an unexpectedly superior level. See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the place of evidence.”). Absent such evidence, we agree with the Examiner that the compositions of Beck, made within the ranges recited by claims 34, 36, 38 and 40, would inherently demonstrate the same properties as the claimed compositions, including “an extrusion loss of a fat-soluble active ingredient of less than or equal to 30%.” Moreover, that the claimed 13 Appeal 2015-007744 Application 12/064,886 compositions have the added advantage of precluding extrusion loss does not otherwise render the composition patentable as mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Prindle, 297 F.2d 251, 254 (CCPA 1962). Accordingly, we affirm the rejection of obviousness of claims 34, 36, 38 and 40. With regard to claims 35, 37, 39 and 41, Appellants argue “BECK does not teach or suggest having a mixture of modified food starch and sugar as the protective colloid in its compositions” and that Beck does not render the weight ratios claimed in any of the claims obvious. Br. 15—20. The Examiner responds that Beck discloses compositions in which the protective hydrocolloid is . . . modified food starch, maltodextrin, gelatin, or mixtures thereof... is preferably about 5-70 wt.% of the composition . . . and sugar is preferably 0 to about 40 wt.% of the composition []. Thus, the ratio of protective hydrocolloid (e.g., modified food starch) to sugar is about 70:0 to about 5:40, which broadly overlaps the claimed ratio ranges. Moreover, a calculation of the ratio of protective colloid to sugar in the composition of Example 6 of Beck et al. results in a ratio of about 1.6: 1, given 31.2 g gelatin (i.e., protective hydrocolloid) and 55.2 g maltodextrin (i.e., protective hydrocolloid) and 55.2 g sucrose (i.e., sugar) (i.e., (31.2g + 55.2g) / 55.2g), which overlaps with the ratio ranges in claims 35, 39, and 41 of 1:1 to 5:1, 1:1 to 100:1, and 1:1 to 5:1. Thus, it would have been prima facie obvious ... to make the composition of Beck et al. with a weight ratio of modified food starch to sugar of about 1.6:1, with a reasonable expectation of success, given that Beck et al. discloses that modified food starch can be used as a protective hydrocolloid 14 Appeal 2015-007744 Application 12/064,886 and given that Beck et al. discloses an example wherein the weight ratio of protective hydrocolloid to sugar is about 1.6:1. Ans. 2—3. To the extent the range is not directly suggested for claim 37, the Examiner states that it would have been prima facie obvious ... to optimize the content of modified food starch protective hydrocolloid and sugar in the composition of Beck et al., and to prepare the composition with the claimed weight ratio, including adding more modified food starch given that such is a preferred protective colloid, with the predictable result of optimizing such excipients and/or adjuvants in the composition in order to obtain stable hydrocolloid-protected particles, as suggested by Beck et al., with a reasonable expectation of success. Id. at 6—7. We find the Examiner has the better position, as Appellants have not provided data or other information proving the claimed weight ratios do not fall within the broad ranges calculated by the Examiner, or that the amounts claimed are critical. Our reviewing court has held that “the existence of overlapping or encompassing ranges shifts the burden to the applicant to show that his invention would not have been obvious.” In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003). We therefore affirm the rejection of claims 35, 37, 39 and 41. Conclusion of Law We affirm the rejection of claims 34-40 as obvious over Beck. Appellants have raised no arguments with regard to claims 42—57 and thereby waive their arguments regarding those claims. We therefore also affirm the rejection of claims 42—57 under 35 U.S.C. § 103(a) as 15 Appeal 2015-007744 Application 12/064,886 unpatentable over Beck. See Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (“In the event of such a waiver, the PTO may affirm the rejection of the group of claims that the examiner rejected on that ground without considering the merits of those rejections.”). SUMMARY We affirm the rejection of claims 34—57 under 35 U.S.C. § 103(a) as obvious over Beck. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 16 Copy with citationCopy as parenthetical citation