NESTEC SA

Patent Trials and Appeals BoardAug 16, 2021

2020006620 (P.T.A.B. Aug. 16, 2021)

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. 15/430,729 02/13/2017 Brian M. Zanghi 12688-US-CNT 7934 69099 7590 08/16/2021 Nestle Purina Petcare Global Resources, Inc Checkerboard Square Intellectual Property Patents ST. LOUIS, MO 63164 EXAMINER THAKOR, DEVANG K ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 08/16/2021 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): USpatentmail@nestle.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BRIAN M. ZANGHI, ARLEIGH J. REYNOLDS, and RONDO P. MIDDLETON Appeal 2020-006620 Application 15/430,729 Technology Center 1600 Before TAWEN CHANG, TIMOTHY G. MAJORS, and RACHEL H. TOWNSEND, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims to a supplement for dogs as being obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as NESTEC SA. (Appeal Br. 3.) Appeal 2020-006620 Application 15/430,729 2 STATEMENT OF THE CASE Claims 1, 4, and 7–10 are on appeal. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A canine pre-exercise supplement comprising: a. about 35% to about 60% protein or amino acids, comprising one or more structural proteins including animal muscle; one or more bioavailable proteins including whey, partially hydrolyzed soy and hydrolyzed amino acids, or any combination thereof; and one or more branched chain amino acids including L-leucine; b. about 20% to about 38% fat, comprising at least one source of medium chain triglycerides; and c. about 5% to about 25% carbohydrate, wherein the canine pre-exercise supplement provides the canine with between about 1.2 g/kg BW and about 2.0 g/kg BW total nutrition. (Appeal Br. 20.) The prior art relied upon by the Examiner is: Name Reference Date Hallinan et al. US 3,115,409 Dec. 24, 1963 Christensen et al. US 4,784,860 Nov. 15, 1988 Torney et al. US 2003/0194423 A1 Oct. 16, 2003 Clark et al. US 2004/0197465 A1 Oct. 7, 2004 Franzen et al. EP 0026985 A1 Apr. 15, 1981 Ellen Kienzle and Anna Rainbird Maintenance Energy Requirement of Dogs: What is the Correct Value for the Calculation of Metabolic Body Weight in Dogs?, 121 J Nutr. S39–40 1991 Appeal 2020-006620 Application 15/430,729 3 The following grounds of rejection are before us on review: Claims 1, 4, 7, 8, and 10 under 35 U.S.C. § 103 as being unpatentable over Clark, Hallinan, Franzen, Torney, and Kienzle Claim 9 under 35 U.S.C. § 103 as being unpatentable over Clark, Hallinan, Franzen, Torney, Kienzle, and Christensen DISCUSSION Obviousness: Claim 1 Regarding the preamble recitation of “pre-exercise supplement,” the Examiner found that such is an intended use of the composition and does not patentably distinguish the composition from the prior art. (Final Action 5.) Regarding the compositional elements, the Examiner found that Clark teaches a dog food containing high protein and low-carbohydrates, including a specific example that has 59% protein, 25% fat, and 10.65% carbohydrate. (Final Action 3 (citing Clark ¶¶ 3, 6, and Example 1).) The Examiner found that Clark does not teach the specific categories of protein claimed, i.e., structural protein, bioavailable protein, and branched chain amino acids, and does not teach that the fat includes at least one source of medium chain triglycerides. (Id.) However, the Examiner found the foregoing would have been obvious selections based on the teachings of Hallinan, Franzen, and Torney. In particular, the Examiner found that Hallinan teaches beef heart muscle is a protein material for use in pet foods. (Id. (citing Hallinan 2:65–70).) The Examiner further found that Hallinan teaches that maintaining the proper acidity in pet food is useful for reducing incidence of kidney stones and that food-grade whey is a suitable pH adjuster for that purpose. (Id. (citing Hallinan 1:28–30, 3:15–16).) The Examiner found that Franzen teaches L-leucine, which is a branched-chain Appeal 2020-006620 Application 15/430,729 4 amino acid, is an ingredient that is added to dog food to improve its palatability. (Final Action 4 (citing Franzen Abstr. and Disclosure of Invention).) The Examiner found that Torney teaches coconut oil is a suitable lipid source for pet food and provides nutritional value as well as palatability. (Id. (citing Torney ¶ 68).) The Examiner determined from the foregoing teachings that one having ordinary skill in the art would have found it obvious “to include beef heart muscle, whey, and L-leucine in the composition of Clark to provide a protein source, acidity, and palatability.” (Id.) Regarding the claimed nutritional amount to be provided by the composition, i.e., 1.2 g/kg BW and about 2.0 g/kg BW, the Examiner found the following. The Examiner stated that Clark’s Example 1 composition would provide 2107.45 kJ based on a carbohydrate or protein energy content of 4 kcal/g and a fat energy content of 9 kcal/g, and 1 kJ=.239 kcal. (Final Action 4.) The Examiner further found that “Kienzle teaches that the maintenance energy requirement for Labradors is approximately 600 kJ/kg (Table 1); therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to feed the dogs 28.47 g/kg BW per day.” (Id. at 4–5.) The Examiner determined that it would have been obvious to formulate the composition of Clark as modified with the specified proteins and fat above “to provide the canine with less than 28.47 g/kg BW of nutrition” because one of ordinary skill in the art would break up the per day amount into more than one serving because “dogs would not just be eating once a day.” (Id. at 5.) The Examiner, thus, concluded that the claimed nutritional range would have been obvious. Appeal 2020-006620 Application 15/430,729 5 Appellant argues that the rejection is in error because the prior art does not teach the claimed composition. (Appeal Br. 13.) We do not find that argument persuasive as Appellant does not identify any error in the Examiner’s rejection as to why it would have been obvious from the prior art teachings to modify the high protein composition of Clark to include beef heart muscle, whey, and L-leucine, as well as including coconut oil. We agree with the Examiner’s findings of facts regarding the teachings of the references as set forth above. We also agree with the Examiner that objective teachings from the prior art would have lead one of ordinary skill in the art to combine the relevant teachings from Clark, Hallinan, Franzen, and Torney and thereby arrive at the claimed composition. As such, the Examiner has established a prima face case of obviousness. In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992). Contrary to Appellant’s assertion (Appeal Br. 17), the Examiner has not relied on “only hindsight” in rejecting the claimed composition.2 Clark provides a teaching of a canine composition including protein, fat, and carbohydrate in percentage amounts that are within the ranges claimed, and Hallinan provides a reason to select beef heart (a well-known beef by- product known to be used in making pet food) as a protein in a canine formula as well as including whey in such a formula (to maintain a pH that 2 Appellant’s analysis of the references individually (Appeal Br. 12–13) does not persuade us of non-obviousness. “Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Appeal 2020-006620 Application 15/430,729 6 will provide for proper acidity to minimize the incidence of kidney stones). Franzen provides a reason to include L-leucine in a pet food (to provide palatability), and Torney provides a reason to include coconut oil as part of the lipid component of a pet food (for palatability). Appellant also argues that the claimed composition has unexpected results, namely an increase in serum concentration of leucine at 30 minutes. (Appeal Br. 14.) We do not find the foregoing argument persuasive. In particular, Appellant’s evidence concerning the increase in serum concentration of leucine at 30 minutes is based on a single formulation (“the test formula”) as follows (with amounts being based on a percentage of the test formula): Beef Hearts 60.5 L-Leucine 0.9 Soy Grits 80-0 5.0 Coconut Oil 7.2 Soy Protein Modified (SPI 1510) 5.5 Whey Protein Concentrate 6.0 Glycerine 5.0 GDL NE 1.2 Flavor Smoke P-50 0.3 Calcium Propionate 0.12 Salt 1.5 Phosphoric Acid 0.5 Caramel Coloring 0.75 Garlic Powder 0.5 Soy Protein Isolate 2.0 TG Gelatin 1.5 Soy Lecithin 2.0 Sorbic Acid 0.28 PMX Naturox Plus 0.1 Vitamin Mix 0.125 Appeal 2020-006620 Application 15/430,729 7 (Spec. ¶ 69 (Table 1).) According to Appellant’s Specification, this test formula contains “44% crude protein on as-fed basis” (Id. ¶ 68), apparently derived from the following ingredients of the formulation: Beef Hearts, Soy Protein Modified, Whey Protein Concentrate, and Soy Protein Isolate. There is no indication in the Specification of the fat percentage of this test formula or the carbohydrate percentage. Thus, it is not clear that this composition is one that meets the percentage fat and carbohydrate limitations of claim 1, even if, as Appellant asserts, the claim includes compositional elements found in the test formula (Appeal Br. 15). In re Fenn, 639 F.2d 762, 765 (CCPA 1981) (“Although it is well settled that comparative test data showing an unexpected result will rebut a prima facie case of obviousness, the comparative testing must be between the claimed invention and the closest prior art.”) Nevertheless, even assuming the test formula meets all of the limitations of claim 1, the feeding study that Appellant indicates demonstrates a 12.2% increase serum appearance of the amino acid at 30 minutes3 is based only on this single formulation. One data point is insufficient to ascertain a trend “which would allow [one having ordinary skill in the art] to reasonably extend the probative value thereof.” In re Kollman, 595 F.2d 48, 56 (Fed. Cir. 1979). Appellant has not provided a basis to support the conclusion that other embodiments falling within the claim will behave in the same manner. In re Kao, 639 F.3d 1057, 1068 3 We assume without determining for ourselves that the percentage is accurate, although Appellant does not explain in the Appeal Brief or in the Specification how this percentage increase is calculated. (See Spec. ¶¶ 72– 73.) Appeal 2020-006620 Application 15/430,729 8 (Fed. Cir. 2011). In particular, Appellant’s claim does not require a particular amount of whey protein be included in the composition, only that 35% to about 60% protein generally is to be included. The test formula, however, included 6% whey protein as well as including 5.5% soy protein modified and 2.0% soy protein isolate as part of the 44% crude protein on as-fed basis. Appellant has not provided scientific explanation or reason to expect that the presence of any amount of bioavailable proteins in a formulation that includes 35 to 60% protein generally would result in a similar increase in appearance of L-leucine at 30 minutes after ingestion, or even that a formulation not including each of whey protein, soy protein modified, and soy protein isolate would achieve a similar increase. Moreover, it does not appear that the comparative composition in the feed study, i.e., the “Control food” (Spec. ¶ 70), is the closest prior art, which would be the high protein composition disclosed in Example 1 of Clark that had 59% Protein (from corn gluten meal, poultry meal, pork protein isolate, and dry egg), 25% fat (from the same sources as protein), and 9.8% nitrogen free extract (NFE) carbohydrate plus 0.85% fiber. (Clark ¶¶ 21–23 (noting that the same pet food as in Comparative Example 2 was used for Example 1).) Appellant acknowledges that the Control food was composed of a chicken and rice dry kibble containing “at least 30%” crude protein targeted to contain 31% crude protein on an as-fed basis. (Appeal Br. 16.) Such composition does not include a protein isolate or egg as does the Example 1 composition of Clark. Furthermore, the 31% crude protein is a much lower percentage of protein than in the Clark exemplified composition, besides not including a protein that is well known to be more readily digestible than chicken and rice protein, i.e., egg protein. Thus, we Appeal 2020-006620 Application 15/430,729 9 disagree with Appellant’s suggestion that Clark’s exemplified formula is not significantly different from the control formulation. (Appeal Br. 16–17.) “[W]hen unexpected results are used as evidence of non-obviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).4 In addition to the foregoing, “by definition, any superior property must be unexpected to be considered evidence of non-obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). We are not persuaded by Appellant’s data that the increased serum appearance of the amino acid L-leucine at 30 minutes after ingestion is an unexpected result. Indeed, we note that the Specification does not even identify the results as unexpected. (Spec. ¶ 73 (“The data specifically demonstrate that the test food formula is superior in its ability to significantly enhance the delivery of L-Leu”).) The only assertion that the claimed composition provides unexpected results is Appellant’s argument in the brief. “Attorneys’ argument is no substitute for evidence.” Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989); In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the place of evidence.”). The test formula is composed of different categories of digestible proteins such as whey and beef heart, which are known to be digested at different rates. Whey is well known to be a quickly digested protein. We 4 Even if the exemplification in Clark is not a commercialized product, we conclude that it is the closest prior art to which a composition within the scope of claim 1 should have been compared. See In re Merchant, 575 F.2d 865, 869 (CCPA 1978) (“In In re Wright . . . , failure of a particular reference to constitute the commercial standard did not diminish its position as the closest prior art.”) Appeal 2020-006620 Application 15/430,729 10 note that the serum L-leucine is greater with the group fed the Control food after 60 minutes than in the group fed the test formula, thus supporting the conclusion that the greater serum L-leucine at 30 minutes post ingestion is simply the result of providing a more easily/quickly digestible protein in combination with a protein that is digested more slowly. Expected beneficial results are not evidence of non-obviousness. See In re Skoner, 517 F.2d 947, 950 (CCPA 1975). “While a “marked superiority” in an expected property may be enough in some circumstances to render a compound patentable, a “mere difference in degree” is insufficient. In re Papesch, 50 CCPA 1084, 315 F.2d 381, 392 (CCPA 1963); In re Hoch, 57 CCPA 1292, 428 F.2d 1341, 1344 n. 5 (CCPA 1970) (explaining that unexpected “differences in properties” can mean “significant difference in degree of the same property” amounting to a “marked superiority” for purposes of evaluating unexpected results) (quotation omitted).” Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014). Appellant has not provided sufficient data or other evidence to establish the 12.2% difference is not simply a difference in degree that would be expected. Appellant’s argument that the difference in “results [demonstrated in the Specification] cannot be explained based on the disclosures of the prior art” (Appeal Br. 17) does not persuade us of non-obviousness. Even if none of the cited references by the Examiner in the rejection indicate whey is more easily digestible than beef protein, or that the presence of such a protein in pet food would result in amino acids being present in serum faster than with the same amount of a slower to digest protein, the prior art, nevertheless, suggests inclusion of whey (Hallinan) in a pet food Appeal 2020-006620 Application 15/430,729 11 composition that also includes dry egg (Clark). “In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007). The “discovery that a claimed composition possesses a property not disclosed for the prior art subject matter, does not by itself defeat a prima facie case.” In re Dillon, 919 F.2d 688, 693 (Fed. Cir. 1990); see also In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.”). Appellant also argues that the claimed composition “is superior in its ability to reduce protein catabolism.” (Appeal Br. 14–15.) We do not find Appellant’s argument persuasive because, similar to the discussion above regarding the serum L-leucine demonstration, it is not apparent that the test food composition for the protein catabolism demonstration meets all of the limitations of claim 1, and Appellant has not provided a comparison to the closest prior art, i.e., the pet food composition or Example 1 of Clark that meets the protein, fat and carbohydrate percentages claimed. Thus, for the foregoing reasons, we affirm the Examiner’s rejection of claim 1 as being obvious over Clark, Hallinan, Franzen, Torney, and Kienzle. Claims 4, 7, 8, and 10 have not been argued separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv). Regarding claim 9, Appellant argues that “Christensen does not cure the deficiencies” of the references relied on to reject claim 1. (Appeal Br. 18.) Because we do not agree that the Examiner’s rejection is deficient as to Appeal 2020-006620 Application 15/430,729 12 claim 1, we do not find Appellant’s argument persuasive regarding claim 9. Thus, we affirm the Examiner’s rejection of claim 9 as being obvious over Clark, Hallinan, Franzen, Torney, Kienzle, and Christensen. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 4, 7, 8, 10 103 Clark, Hallinan, Franzen, Torney, Kienzle 1, 4, 7, 8, 10 9 103 Clark, Hallinan, Franzen, Torney, Kienzle, Christensen 9 Overall Outcome 1, 4, 7–10 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED