Ex Parte Tricarico et alDownload PDFPatent Trial and Appeal BoardMar 31, 201713028176 (P.T.A.B. Mar. 31, 2017) 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. ALLTE-31385/US-2/ORD 8213 EXAMINER TARAZANO, DONALD LAWRENCE ART UNIT PAPER NUMBER 1791 MAIL DATE DELIVERY MODE 13/028,176 02/15/2011 7590119996 Alltech, Inc. Legal Department - Intellectual Property 3031 Catnip Hill Pike Nicholasville, KY 40356 Juan M. Tricarico 04/03/2017 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 JUAN M. TRICARICO, KARLA. DAWSON, and JAMES D. JOHNSTON1 Appeal 2016-001607 Application 13/028,176 Technology Center 1700 Before TERRY J. OWENS, RAE LYNN P. GUEST, and CHRISTOPHER L. OGDEN, Administrative Patent Judges. OGDEN, Administrative Patent Judge. DECISION ON APPEAL Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s decision2 finally rejecting claims 14—20, 22, 23, 26, 27, 29, 30, and 32—34 in the above-identified application. We have jurisdiction pursuant to 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify Alltech, Inc. as the real party in interest. Appeal Br. 3, May 29, 2015. 2 Final Office Action, April 6, 2015 [hereinafter Action]; Examiner’s Answer, Sept. 23, 2015 [hereinafter Answer], Appeal 2016-001607 Application 13/028,176 BACKGROUND Appellants’ invention is directed to methods of administering dietary supplement compositions, comprising protein derived from yeast3 extract, to ruminant animals (e.g., cattle). Spec. 1. Independent claim 14 is representative: 14. A method of increasing amino acid and protein absorption within the intestine in a ruminant comprising providing a dietary supplement composition comprising about 6.5-7.8% nitrogen, about 40-50 % crude protein, and about 0.5% to about 1.5%) ammonia on a dry matter basis, wherein the crude protein is derived from yeast extract, and wherein said composition is made up of dried particles of 0.100-0.500 mm in size, wherein the particles have no applied protective barrier, and administering the dietary supplement composition to the ruminant under conditions such that the components of the dietary supplement composition are intestinally available, wherein the dietary supplement composition increases the amount of amino acid and protein that escape ruminal fermentation in the rumen of the ruminant administered the dietary supplement composition compared to the amount of amino acid and protein that escape ruminal fermentation in the rumen of a ruminant not administered the dietary supplement composition. Appeal Br. 29 (emphasis of key disputed limitations added). Claims 15 and 26 are also independent, and comprise similar limitations. Id. at 29, 30-31. The Examiner maintains the rejection of claims 14—20, 22, 23, 26, 27, 29, 30, and 32—34 under 35 U.S.C. § 103(a) as being unpatentable over 3 According to the Specification, “[t]he invention is not limited to any particular type of yeast or yeast strain.” Spec. 4. 2 Appeal 2016-001607 Application 13/028,176 Linton4 in view of Merry,5 Ferguson,6 Scott,7 Roth,8 Parker,9 10and Wasserman.10 See Action 2—15. In the Appeal Brief, Appellants argue claims 14—17, 19, 20, 22, 26, 27, 29, and 32 as a group. See Appeal Br. 9-23. Appellants also separately argue claim 18, claim 23, and the group of claims 30, 33, and 34. See id. at 23—27. Therefore, consistent with 37 C.F.R. § 41.37(c)(l)(iv) (2016), we limit our discussion to claims 14, 18, 23, and 30. Claims 15—17, 19, 20, 22, 26, 27, 29, and 32 stand or fall with claim 14, and claims 33 and 34 stand or fall with claim 30. DISCUSSION Claim 14 The Examiner finds that Linton teaches a method of providing an animal feed supplement that is “a colloidal mixture of spent brewer’s yeast in water.” Action 3. The Examiner cites Merry, Ferguson, Scott, Roth, Parker, and Wasserman as teaching the numerical limitations in claim 14. See id. 4—7. For example, the Examiner finds that Wasserman teaches microbial fermentations of Saccharomyces fragilis with nitrogen and crude protein levels within the range of claim 14; therefore, the Examiner finds “that the 4 Linton et al., U.S. Patent 4,055,667 (issued Oct. 25, 1977). 5 Merry et al., U.S. Patent 3,829,564 (issued Aug. 13, 1974). 6 Ferguson et al., U.S. Patent 3,619,200 (issued Nov. 9, 1971). 7 Scott et al., U.S. Patent 3,925,560 (issued Dec. 9, 1975). 8 Roth et al., U.S. Patent 4,199,561 (issued Apr. 22, 1980). 9 Parker, U.S. Patent 2,921,854 (issued Jan. 19, 1960). 10 Aaron E. Wasserman, Amino Acid and Vitamin Composition of Saccharomyces Fragilis Grown in Whey, 44 Dairy Sci. 379 (1961). 3 Appeal 2016-001607 Application 13/028,176 ammonia in the prior art would, likewise, fall within the claimed ranges.” Id. at 7. According to the Examiner, Wasserman teaches compositions containing brewer’s yeast in which nitrogen values are 7.8—8.9%, and teaches that crude protein levels may be obtained by multiplying the nitrogen values by 6.25; thus, Wasserman teaches a crude protein range from 48.75—55.6%. Id. at 6—7 (citing Wasserman 381 & Tbl. 1). Because Wasserman “use[s] the same type of yeast, brewer’s yeast, and since the crude protein and nitrogen ranges of the prior art and the claimed invention [are] the same or overlapping or touching,” the Examiner finds that “the ammonia in the prior art[] would, likewise, fall within the claimed ranges.” Id. at 7. Appellants argue that the Examiner erred in using Wasserman because the nitrogen values that the Examiner relied on are for “whole cell preparations” rather than for yeast extracts. See Appeal Br. 13—14 (citing Wasserman 381). Appellants contrast the whole cell preparation nitrogen values with material 2, an extract of S. fragilis with a nitrogen content of 9.58%, which would correspond to a protein content of 60% (9.59x6.25). See id. at 14. Appellants argue that the material 2 values are higher than the corresponding whole cell value for S. fragilis corresponding to material 1 (showing 7.97% nitrogen, which would correspond to 7.97x6.25=49.8% protein) and are outside the range of claim 14. See id. at 13—14. We do not find these arguments persuasive of reversible error. To the extent that whole cell nitrogen results may vary for S. fragilis based on whether the sample is a whole cell sample or an extract, Appellants have not shown how this would affect the Examiner’s findings regarding brewer’s yeast in both Wasserman and Linton. The Examiner finds that Linton 4 Appeal 2016-001607 Application 13/028,176 discloses a protein content of about 37% for a supplement based on brewer’s yeast. See Action 3 (citing Linton 12:10—55). The Specification does not define the term “about,” and we find nothing in the Specification that is inconsistent with interpreting the crude protein range in claim 14 to include about 37% protein. Thus, based on the preponderance of the evidence on this record, we determine that the broadest reasonable interpretation of the phrase “about 40-50% crude protein,” consistent with the Specification, includes about 37%. We also note that Wasserman teaches that “[t]he total nitrogen contents of the yeast will vary” based on factors such as the choice of media. See Wasserman 383. For example, Wasserman states that “A frag ills growing in whey alone may have a nitrogen content of 4.9%, whereas in the media containing 1% (NFL^SCL, the growing cells may contain 8.2% N.” Id. Thus, Wasserman teaches a broader range of total nitrogen content for S. fragilis than just the two values measured for materials 1 and 2. This broader range substantially overlaps the range in claim 14, which does not specify the conditions under which the yeast is grown. Appellants also argue that “it is known in the art that ammonia levels can significantly vary and are not fixed for all brewers’ yeast slurries.” Appeal Br. 14. As evidence of this, Appellants submit J.D. Steckley et al., Brewer’s Yeast Slurry, I. Composition as Affected by Length of Storage, Temperature, and Chemical Treatment, 62 J. Dairy Sci. 941 (1979) [hereinafter Steckley]. Appellants argue that Steckley shows that the ammonia level of yeast slurries increases upon storage unless the slurries are chilled to such low temperatures as 4 °C during the storage period. Appeal Br. 14—15 (citing Steckley 943, Fig. 5). Appellants note that Linton teaches 5 Appeal 2016-001607 Application 13/028,176 that yeast slurries should be “stable” for 30 days, including at ambient temperatures. Id. (citing Linton 2:54—63, 6:24—36, 7:14—17). Thus, Appellants argue that because of the instability of the ammonia content during storage, “the nitrogen and crude protein information provided by Wasserman on brewers’ yeast does not permit any presumptions to be made about specific ammonia levels that may be inherent to brewers’ yeast in Linton at the time of administration to a ruminant.” Id. at 15 (citing Par Pharm., Inc. v. TWIPharms., Inc., 773 F.3d 1186, 1195-96 (Fed. Cir. 2014)). We do not find these arguments persuasive of reversible error. Claim 14 does not specify any particular storage temperature, or require any storage period before administration to the animal. It would be within the scope of claim 14 to administer the supplement to the animal immediately after preparation or after a period of chilled storage. Although Linton teaches a benefit for long storage at ambient temperatures, Appellants do not persuasively argue that Linton teaches away from either immediate administration or cold storage. As Appellants acknowledge, Steckley teaches that with no storage time, the ammonia content is 1.5%, and if the yeast is kept in cold storage, the ammonia content remains low. See Appeal Br. 14 (citing Steckley 943, Fig. 5). Next, regarding the claim 14 limitation that “the particles have no applied protective barrier,” the Examiner finds that “Linton teaches that the yeast particles are not coated” because it teaches a colloidal mixture of spent brewer’s yeast in water. Action 8. The Examiner also finds that Merry, Scott, Ferguson, and Roth teach “that particle size is important in bypassing the rumen, thus preserving the protein and amino acid[] nutrients in the yeast.” Id.', see also Answer 16—17. Thus, the Examiner shows that particle 6 Appeal 2016-001607 Application 13/028,176 size, at least in part, performs the function of protecting proteins during passage through the rumen. Appellants argue that Linton is silent about whether the particles are coated or uncoated, and that Merry, Ferguson, Roth, and Scott teach away from leaving the particles uncoated. See Appeal Br. 16. According to Appellants, these secondary references teach “that a protective coating is necessary for the supplements as sized therein to avoid or reduce degradation of such supplement particles in the rumen.” Id. Appellants argue that the nutrients can only be protected by the combination of the protective coating and the small particle size. See id. at 17. We do not find these arguments persuasive of reversible error. First, while Linton does not positively disclose that the particles have no protective coating, Appellants have pointed to no persuasive reason why a person of ordinary skill in the art would have understood that the particles are coated, given that Linton gives details about preparing the supplement but no coating is mentioned. Thus, it was known in the art to use small particle sized nutrients without a protective coating as claimed. Second, Linton’s lack of teaching of a protective particle coating would have suggested to a person of ordinary skill in the art that the coating was not critical and could be eliminated. See In re Thompson, 545 F.2d 1290, 1294 (CCPA 1976) (eliminating the cost of an additional step would have been sufficient motivation for doing so). According to Appellants’ Specification, the invention “takes advantage of one or more of the following’'’ factors in order to ensure that the protein rich supplement can escape ruminal fermentation and provide effective nutrition for the animal: 1) the composition of the material (e.g., having a specific nitro gen and/or amino acid profile; 2) the fine particle size ... of the 7 Appeal 2016-001607 Application 13/028,176 material (e.g., that allows it to partition into the ruminal liquid fraction; 3) the relatively low fractional rate of degradation of the material (e.g., 0.175 h_1); and/or 4) the relatively high fractional rate of liquid outflow from the rumen (e.g., 0.12 h_1). Spec. 13—14 (emphasis added). However, the Examiner has shown that the composition and particle size are already present in Linton without the additional use of a coating, which is a teaching that is consistent with Appellants’ Specification. The remaining two factors (3 and 4) are not recited in claim 14. Appellants have not disputed the Examiner’s finding that Merry, Scott, Roth, and Ferguson teach that small particle size may result in ready passage through the rumen. See Answer 16—17; Reply 3. Although Merry, Scott, Roth, and Ferguson teach in favor of particle coatings, we weigh those teachings against the teachings of Linton, which includes data, in the absence of a coating, indicating improvements in milk quality and average daily milk production for dairy cows. See Action 3 (citing Linton 15:1—19); see also In re Young, 927 F.2d 588, 591 (Fed. Cir. 1991) (when there are apparently conflicting teachings, all the references must be considered for their power to suggest solutions to an artisan of ordinary skill). Thus, based on the preponderance of the evidence on this record, we determine that claim 14 simply omits a particle coating which the prior art teaches is not necessary when there is a small particle size. Appellants also argue that the Specification demonstrates unexpected results over the prior art. See Appeal Br. 20—23 (citing Examples 1 and 2; Figs. 3, 7). According to Appellants, the Examples demonstrate that increases in energy-corrected milk (ECM) production, fat- corrected milk (FCM) production, milk fat content, milk yield, and protein yield were obtained in dairy cattle fed the inventive dietary supplement composition as compared to the control (no 8 Appeal 2016-001607 Application 13/028,176 supplement, basal diet only), while not affecting dry matter in take or blood metabolites BHBA and NEFA. Id. at 20-21 (citing Spec. 25—26, 31, Figs. 3, 7). Appellants argue that Example 2 further “shows that the unexpected improvements were achieved using the supplement composition even though a protein source in the basal diet amount had been correspondingly reduced.” Id. at 22. We do not find Appellants’ evidence persuasive of unexpected results. Such evidence must be commensurate with the scope of the claims. See In re Peterson, 315 F.3d 1325, 1330—31 (Fed. Cir. 2003). However, the data from the two examples cited by Appellants does not show that the effect is unique to the particle size, ammonia content, the absence of a protective barrier, or any other particular limitations in claim 14. Further, “when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter TravenolLabs., 952 F.2d 388, 392 (Fed. Cir. 1991). The Examples only compare the results to feed with no supplements, which is not sufficient to show an unexpected improvement over the use of any of the prior art supplements. For the above reasons, we find no reversible error in the Examiner’s decision to reject 14, and we affirm the Examiner’s rejection. For the same reasons, we affirm the rejection of claims 15—17, 19, 20, 22, 26, 27, 29, and 32. Claim 18 Claim 18 requires that “the dietary supplement composition is administered to the ruminant to provide 1.5%—2.5% of the ruminant’s total daily dry matter intake.” Appeal Br. 30. The Examiner finds that “[o]ne of 9 Appeal 2016-001607 Application 13/028,176 ordinary skill in the art would recognize that the average dairy cow consumes at least about 13 kg dm [dry matter] per day.” Action 9. Based on this, the Examiner calculates that in Linton, “the maximum contribution of yeast to the dry matter consumed per day is about 8%.” Id. (citing Linton 3:13—15, 8:30—31, 15:12—16). Alternatively, the Examiner calculates that in Linton, there would be 0.3—1.7% yeast in the feed per day. Id. Appellants argue that the Examiner’s value of 13 kg dry matter per day is too low, and cites Appellants’ Specification for a value of 23 kg dry matter per day. See Appeal Br. 24. Based on that higher value, Appellants argue that the percent of the supplement in the ruminant’s daily dry matter intake as taught by Linton would be outside the scope of claim 18. See id. at 24—25. Appellants also argue that “the yeast in Linton’s supplement is used in combination with other kinds of nutrients,” and therefore, “the increased milk production indicated at column 15, lines 4—7 of Linton should not be attributed solely to the yeast component.” Id. at 25. We do not find these arguments persuasive of reversible error. The Specification uses 23 kg of dry matter per day as an example for calculating the amount of dietary supplement composition intake. Spec. 5. However, the Specification does not state that this amount of dry matter is typical for a cow, and Appellants do not point to any persuasive evidence that the animals in Linton would have been fed at that higher rate, feed rates likely vary and Appellants have no shown that the Examiner’s finding is erroneous or untenable. As to Appellants’ argument that all of Linton’s increased milk production cannot be attributed solely to the yeast component, Appellants have not explained how this would alter the Examiner’s calculation of the 10 Appeal 2016-001607 Application 13/028,176 amount of yeast in the ruminant’s total daily dry matter intake, so as to take it outside the scope of claim 18. Thus, we find no reversible error in the Examiner’s rejection of claim 18. Claim 23 Claim 23 requires that the “crude protein contains about 40-45% soluble protein and about 55—60% insoluble protein.” Appeal Br. 30. The Examiner finds that Wasserman teaches a ratio of soluble to insoluble protein of 45:55, calculated from the total and combined extractable amino acid content in Wasserman’s Table 2. Action 10. Appellants argue that “Wasserman states that the protein fraction was not pure protein, and that the results were affected by the presence of extraneous nonprotein nitrogen and carbohydrate compounds.” Appeal Br. 26 (citing Wasserman 382,11. 3—14, 383,11. 20-27). Thus, Appellants argue that the soluble to insoluble ratio cannot be calculated from Table 2 of Wasserman. See id. We do not find this argument persuasive of reversible error. To the extent that the raw numbers in Table 2 of Wasserman may be affected by other nitrogen sources in the sample, Appellants have not pointed to any persuasive evidence or reason why this would affect the ratio of soluble to insoluble protein such that the supplement falls outside the scope of claim 23. Thus, we find no reversible error in the Examiner’s rejection of claim 23. Claim 30 Claim 30 requires that “the composition is made up of dried particles of 0.100-0.250 mm in size.” Appeal Br. 31. The Examiner cites Merry, 11 Appeal 2016-001607 Application 13/028,176 Ferguson, Scott, and Roth as teaching particles with the size of 0.1 to 1 mm. See Action 12—14. Because this range overlaps that of claim 30, the Examiner determines that a prima facie case of obviousness has been established. See id. The Examiner also cites Parker as teaching particles “on the order of 4—20 microns in diameter.” Id. at 12 (citing Parker 1:31— 35).11 Appellants argue that the particles in Parker are not the final product, and that they are later aggregated to produce larger aggregate particles. See Appeal Br. 27. Despite this,12 Appellants do not point to evidence to rebut the Examiner’s prima facie case of obviousness based on the overlapping particle size ranges taught by Merry, Ferguson, Scott, and Roth. See Appeal Br. 27. Consequently, Appellants’ arguments do not persuade us that the Examiner reversibly erred in rejecting claim 30. For the same reasons, we find no reversible error in the Examiner’s rejection of claims 33 and 34. 11 We further note that Linton teaches a particle size of 325 mesh (44 microns or 0.044 mm), which is significantly smaller than the recited particle size. See Linton 13:54. Appellants have shown no criticality to the claimed particles size range, particularly to the lower end of the claimed particle size range and, to the contrary, specifically indicates that the particle size ranges are not critical. See Spec. 5:2—5 (describing a size as small as 0.0625 mm and stating that “larger and smaller particles sizes may also be used”). 12 We note that Parker teaches a final product size of 150-60 mesh (about 0.1 to 0.25 mm), with most of the products having a 60 mesh size (0.25 mm), falling squarely within the range recited in claim 30. See Parker 4:59-65, 5:10-15. 12 Appeal 2016-001607 Application 13/028,176 DECISION The Examiner’s decision is affirmed. No time period for taking any subsequent action in connection with this appeal maybe extended. See 37 C.F.R. § 1.136(a)(l)(iv) (2016). AFFIRMED 13 Copy with citationCopy as parenthetical citation