DSM IP Assets B.V.

Patent Trials and Appeals Board

Jan 26, 2022

2021003948 (P.T.A.B. Jan. 26, 2022)

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. 15/542,500 07/10/2017 Shuen Ei CHEN GPK-4662-3438 8407 23117 7590 01/26/2022 NIXON & VANDERHYE, PC 901 NORTH GLEBE ROAD, 11TH FLOOR ARLINGTON, VA 22203 EXAMINER WORSHAM, JESSICA N ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 01/26/2022 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 SHUEN EI CHEN and THAU KIONG CHUNG Appeal 2021-003948 Application 15/542,500 Technology Center 1600 Before RICHARD M. LEBOVITZ, TAWEN CHANG, 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 food suitable for a companion animal, and a method of administering that food to the animal to ameliorate the amount of weight gain. 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. Appellant identifies the real party in interest as DSM IP Assets B.V. (Appeal Br. 3.) Appeal 2021-003948 Application 15/542,500 2 STATEMENT OF THE CASE Appellant’s Specification states that Hyperphagia and therefore adiposity can occur in companion animals including dogs and cats. Overfeeding-induced diseases which can result include metabolic disorders including diabetes and cardiovascular problems. Pet owners do not always regulate the volume of food which is offered to the animal, and some animals will eat past the point of satiation. (Spec. 1.) Appellant’s Specification indicates that “[t]here is a need to reduce or ameliorate the metabolic and hormonal dysregulations as a result of hyperphagia in companion animals in order to ameliorate, prevent or treat impaired glucose regulation, insulin actions, cardiomyopathies, and ultimately ascites and sudden death.” (Id. at 2.) Appellant’s invention is directed to the combination of 25-Hydroxyvitamin D (25-OH D3 and/or 25-OH D2) and antioxidants/anti-inflammatories to ameliorate adverse metabolic conditions when animals are fed ad libitium. (Id. at 3.) Claims 1-14 are on appeal. Claims 1 and 11, reproduced below, are illustrative of the claimed subject matter: 1. A food suitable for a companion animal comprising a combination comprising a supra-physiological amount, for the companion animal, of 25-Hydroxy vitamin D (25-OH D), Vitamin C, Vitamin E and at least one carotenoid selected from the group consisting of: astaxanthin, cryptoxanthin, beta- carotene, lutein, zeaxanthin, and canthaxanthin. 11. A method of ameliorating the amount of weight gained by a companion animal which is fed ad libitum comprising: administering a food comprising a supra-physiological amount of 25-OH D, at least one carotenoid selected from the group consisting of: astaxanthin, cryptoxanthin, beta-carotene, lutein, Appeal 2021-003948 Application 15/542,500 3 zeaxanthin, and canthaxanthin, Vitamin C and Vitamin E to the animal. (Appeal Br. 21, 23.) The prior art relied upon by the Examiner is: Name Reference Date Tritsch et al. US 7,632,518 B2 Dec. 15, 2009 Rodriguez US 2003/0125229 A1 July 3, 2003 Barella et al. US 2006/0069151 A1 Mar. 30, 2006 Hernandez et al. WO 2010/057811 A2 May 27, 2010 Jaume Amengual et al. Beta-Carotene Reduces Body Adiposity of Mice via BCMO1, 6:6 e20644 PLOS one, 1-13 2011 DSM DSM Vitamin Supplementation Guidelines 2011 for domestic animals, 12th ed. 2011 The following grounds of rejection by the Examiner are before us on review: Claims 1-4 and 11-14 under 35 U.S.C. § 102(a)(1) as anticipated by Barella. Claims 1, 2, and 4 under 35 U.S.C. § 102(a)(1) as anticipated by Tritsch. Claims 1-14 under 35 U.S.C. § 103 as obvious over Barella, Tritsch, DSM, and Amengual. Appeal 2021-003948 Application 15/542,500 4 DISCUSSION Anticipation: Barella The Examiner found that Barella discloses a composition which can be added to food administered to pets, where the composition includes lycopene, Vitamins C and E, as well as including beta-carotene (i.e., canthaxanthin) and Vitamin D. (Final Action 3 (citing Barella ¶¶ 8, 54-56, 58).) In addition, the Examiner found that Barella teaches the composition can be used to treat obesity. (Id. (citing Barella claim 7).) The Examiner also found that “[s]ince the formulation is administered as a food [and there is no specific dosing regimen disclosed,] it is assumed the population can eat ad libitum.” (Id.) We agree with the Examiner’s findings and conclusions. Appellant argues claim 1 and claim 11 separately. Claim 1 First, we address claim 1 and Appellant’s arguments directed to that claim. Claim 1 requires a food “comprising” 25-OH D, Vitamins C and E, and “at least one” carotenoid “selected from the group consisting of” six enumerated carotenoids. With respect to carotenoids (Appeal Br. 8), we agree with the Examiner that even though lycopene is not one of the named carotenoids of the Markush group, the claims do not preclude the presence of lycopene (Ans. 4). The claim construction issue is almost identical to the situation presented in Amgen Incorporated v. Amneal Pharmaceuticals LLC, 945 F.3d 1368 (Fed. Cir. 2020). The issue here is whether all carotenoids present in the prior art composition are subject to the specific Markush carotenoid limitation. Just as in Amgen, the answer is no. There is nothing in Appellant’s claim indicating that every carotenoid in the claimed food Appeal 2021-003948 Application 15/542,500 5 must be within the Markush group. Amgen, Inc. v. Amneal Pharms. LLC, 945 F.3d 1368, 1378 (Fed. Cir. 2020) (distinguishing from the Markush language interpreted in Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350 (Fed. Cir. 2016)). Instead, as noted, the claim recites “at least one” carotenoid and does not indicate that the “only” carotenoids in the claimed food are those listed in the group. Moreover, importantly, the transition term used to indicate what components make up the claimed food, is the open-ended term “comprising.” “The term ‘comprising’ is the standard transition term used to make clear that the claim does not preclude the presence of components or steps that are in addition to, though not inconsistent with, those recited in the limitations that follow.” Amgen, 945 F.3d at 1378-79; Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) (“‘Comprising’ is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.”). Thus, Appellant’s claim language does not preclude a finding of anticipation where a prior art composition includes a carotenoid that is not one of the enumerated carotenoids in the Markush group. For this reason, we do not agree with Appellant (Appeal Br. 8) that because lycopene is not recited in Appellant’s claim, Barella cannot be found to anticipate. We next turn to the required “supra-physiological” amounts of the recited components of the food of claim 1. We disagree with Appellant that this term is “define[d]” in the Specification (Reply Br. 4). Rather, we understand the Specification to indicate by example what would be a “supra- physiological amount.” In particular, the Specification states that a combination of 25-OH D, carotenoid, Vitamin E and ascorbic acid (i.e., Appeal 2021-003948 Application 15/542,500 6 Vitamin C) when “added to a basal diet which contains all the necessary ingredients for complete nutrition” “provides a supra-physiological amount.” (Spec. 5.) We understand this to mean that a teaching in the prior art indicating a composition is a supplement that may be added by way of a premix to animal feed is sufficient to indicate the components of the premix provide a supra-physiological amount of the ingredients to the animal feed. In other words, the premix acts as a supplement to an otherwise nutritionally complete animal feed.2 Barella teaches that the compounds in the lycopene, Vitamin C, Vitamin E composition “optionally together with compounds (a) to (pp)” may be used to treat non-cancerous symptoms and/or pathologies (Barella ¶¶ 1, 57 (“medical treatment of subjects”)) and may be part of a food premix, which is added to animal feed. (Barella ¶¶ 56-58.) In other words, the lycopene, Vitamin C, Vitamin E, “together with compounds (a) to (pp)” are not provided in a composition to satisfy nutritional requirements. Thus, we agree with the Examiner that Barella teaches providing the claimed compounds in a composition that provides a supra-physiological amount of those ingredients. 2 The Examiner refers to a definition of supra-physiological from Merriam- Webster as meaning “greater than normally present” and determines that “any amount administered would be greater than what is normally present.” (Ans. 4-5.) We do not rely on the Examiner’s definition in arriving at our decision. However, we note that in rejecting Appellant’s claims for anticipation the Examiner also relies on the fact that Barella teaches the composition is used to treat various disorders and is used as a food or food premix. (Final Action 3.) These are the findings that we rely on in arriving at our conclusion that the Examiner has made out a prima facie case of anticipation. Appeal 2021-003948 Application 15/542,500 7 The fact that beta-carotene and 25-OH D3 are provided in a list of other ingredients (ingredients (a) to (pp)) that may be included optionally together with the lycopene, Vitamin C, and Vitamin E (Appeal Br. 10-14) does not establish the composition as claimed is not anticipated. Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1376 (Fed. Cir. 2005) (“This court rejects the notion that one of these ingredients cannot anticipate because it appears without special emphasis in a longer list.”) This is particularly true because Barella identifies beta-carotene (o) and 25-OH D3 (u) as preferred ingredients to use together with lycopene and Vitamins C and E. (Barella ¶¶ 24, 30, 59.) “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put into the last opening in a jig-saw puzzle. It is not invention.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 335 (1945). It is also immaterial that Barella does not teach that 25-OH D3 “would or could affect or enhance the combination” of lycopene and Vitamin E and Vitamin C (Appeal Br. 13-14), because Barella specifically states that these three ingredients may be co-administered with the other ingredients provided in paragraphs 56 and 59. Appellant agrees that Barella teaches lycopene can be administered to pets, but argues that it does not teach either expressly or inherently providing a supra-physiological amount of the claimed compounds to pets that does not include lycopene. (Appeal Br. 9-10.) We do not find this argument persuasive for reasons discussed above, namely that the claims do not exclude a composition that includes the carotenoid lycopene. Appeal 2021-003948 Application 15/542,500 8 Thus, we affirm the Examiner’s rejection of claim 1 as anticipated by Barella. Dependent claims 2-4 have not been argued separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv). Claim 11 Claim 11 requires administering the food composition as recited in claim 1 to a companion animal that is fed ad libitum. The intended purpose of that method is to ameliorate the amount of weight gained by the animal. The only additional argument beyond the composition arguments noted above that Appellant makes regarding this method is that Barella does not expressly or inherently direct a person to unrestricted feeding of a companion animal, and thus, it can only be said that “Barella might involve unrestricted feeding.” (Appeal Br. 15.) According to Appellant that unrestricted feeding is only a possibility and therefore insufficient to establish anticipation by inherency, which requires the characteristic to necessarily flow from the teachings of the prior art. (Id.) We do not find Appellant’s argument persuasive because, as the Examiner noted, Barella teaches that the composition can be provided as a therapeutic by way of a feed additive, and Barella does not require restrictive feeding. (See Ans. 5.) The Examiner therefore had reasonable basis to find that Barella describes providing the composition for ad libitum feeding or set meal feeding. Appellant did not rebut the Examiner’s finding by providing objective evidence for the assertion that “companion animals are fed a restricted diet - and not an unrestricted, ad libitum diet” (Reply Br. 6). While it is true that some may choose to feed a companion animal on a timed schedule, Appellant did not establish that such is necessary. The Examiner had reasonable basis to find that Barella inherently embraces both Appeal 2021-003948 Application 15/542,500 9 because it does not require restrictive feeding. Moreover, the fact that Barella embraces both feeding types does not preclude finding anticipation. See, e.g., In re Petering, 301 F.2d 676, 681-82 (CCPA 1962) (disclosure of small genus (20 members in Petering) can anticipate claim directed to any single member of the genus). Thus, we affirm the Examiner’s rejection of claim 11 as being anticipated by Barella. Dependent claims 12-14 have not been argued separately and therefore fall with claim 11. 37 C.F.R. § 41.37(c)(1)(iv). Anticipation: Tritsch The Examiner found that Tritsch discloses a composition to be added to food that can be administered as a premix with animal food to dogs or cats which composition incudes 25-OH D3, carotenoids, and Vitamin E, and teaches that additional suitable vitamins can be added, including Vitamin C. (Final Action 4 (citing Tritsch Abstr., Example 7, and 8:13-28, 56-59).) The Examiner further found that since Tritsch does “not disclose a specific dosing regimen, the feed is considered ad libitum.” (Id.) We agree with the Examiner’s finding of anticipation by Tritsch. As the Examiner noted, Tritsch, like Barella, teaches a composition that can be used as a premix for canine or feline animal feed. (Tritsch Example 7, 8:56- 60.) In addition, Tritsch teaches that the composition provides nutritional supplementation or is an additive to the feed, not that it provides the only source of nutrition. (Id. 3:6-7, 8:56-60.) In other words, the components in the Tritsch composition that are provided as supplementation or as an additive are not serving to “merely meet nutritional requirements” of a Appeal 2021-003948 Application 15/542,500 10 vitamin/nutrition deficiency. (Spec. 5.) Consequently, we conclude that the composition provides for supra-physiological amounts. Moreover, Tritsch describes a composition including 25-OH D3, Vitamin E, and carotenoids (id. at Example 7), and notes that suitable carotenoids include CAROPHYLL Red3, and astaxanthin and combinations thereof (id. at 8:24-27). Additionally, Tritsch teaches that other nutritional additives can be provided to the composition including vitamins like Vitamin C. (Id. at 8:5-17; see also claims 6-9.) Thus, we agree with the Examiner that Tritsch describes a composition within the scope of the claimed food. Appellant argues that the rejection is in error because Tritsch does not teach how to pick from the possible combinations of nutrients that would produce the surprising effects of the present application, nor does it teach supra-physiological dose of the components. (Appeal Br. 16.) We do not find Appellant’s arguments persuasive. The supra-physiological argument fails for the reason just discussed. As for the picking of possible combinations to achieve the effects described in the application, we note that anticipation can be established when all of the components of the claimed composition are shown in a single prior art reference, In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009); it is not required that the prior art teach what the effect of the composition is when used. Cf. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990) (“[A]pparatus claims cover what a device is, not what a device does.”); In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (“It is well settled that the recitation of 3 CAROPHYLL Red is DSM’s brand of canthaxanthin. (See DSM 2.) Appeal 2021-003948 Application 15/542,500 11 a new intended use for an old product does not make a claim to that old product patentable.”). And as discussed above, Tritsch teaches a premix composition as including 25-OH D3, Vitamin E, and carotenoids, and notes that suitable carotenoids include CAROPHYLL Red and astaxanthin and combinations thereof, and also explains that other vitamins can be added, such as Vitamin C. Although Tritsch, like Barella, includes a number of vitamins that can be added, this does not preclude a finding of anticipation where Tritsch teaches that any one of the 12 listed vitamins is suitable. Perricone, 432 F.3d at 1376; Sinclair, 325 U.S. at 335. Thus, we affirm the Examiner’s rejection of claim 1 as being anticipated by Tritsch. Dependent claims 2 and 4 have not been argued separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv). Appellant also makes the same additional argument with respect to method claim 11 that it made for the Barella-based rejection. We do not address this last argument as the Examiner did not reject claim 11 as being anticipated by Tritsch. Obviousness: Barella, Tritsch, DSM, Amengual Addressing dependent claims 5-10, the Examiner found that Barella does not teach the claimed amounts of 25-OH D3, Vitamin D, Vitamin C, Vitamin E, and beta-carotene. (Final Action 5.) The Examiner also found that Tritsch does not teach a specific dosing regimen. (Id.) The Examiner found that DSM teaches “that sows should receive vitamin supplements” that include 0.05 mg/kg 25-OH D3, 200-300 mg/kg Vitamin C, 100-150 mg/kg Vitamin E, and 300 mg/kg beta-carotene. (Id. at 6.) The Examiner further found that “[a]lthough DSM is directed to swine, Appeal 2021-003948 Application 15/542,500 12 Barella et al. teach that similar formulations are effective in both farm animals and pets.” (Id. at 7.) The Examiner also found that Amengual teaches that “[c]irculating beta-carotene levels are inversely correlated with risk of human type 2-diabetes, which is associated with obesity” and that “[r]educed levels of beta-carotene are commonly found in obese children.” (Id. at 6 (citing Amengual 9).) The Examiner determined that It would have been obvious to one of ordinary skill in the art at the time the invention was filed to administer a composition comprising 25-OHD, a carotenoid, Vitamin C and Vitamin E to a companion animal to alleviate weight gain because Barella et al. teach administration of these components to combat obesity, Tritsch et al. teach administration of these components to companion animals is known, and Amengual specifically teach the correlation between beta-carotene levels and obesity. In addition, it would have been well within the purview of the skilled artisan to modify the amounts of each ingredient based on the known effective values taught by DSM to optimize the formulation. (Final Action 6-7.) Appellant argues that the rejection is in error because neither DSM nor Amengual provides the disclosure absent from Barella and Tritsch regarding including supra-physiological amounts and feeding the companion animal ad libitum. (Appeal Br. 19.) However, for the reasons discussed above, we do not agree with Appellant that Barella or Tritsch fail to teach supra-physiological amounts or ad libitum feeding of companion animals. Consequently, we affirm the Examiner’s rejection of claims 1-14 as being obvious from Barella, Tritsch, DSM and Amengual. Appeal 2021-003948 Application 15/542,500 13 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-4, 11-14 102 Barella 1-4, 11-14 1, 2, 4 102 Tritsch 1, 2, 4 1-14 103 Barella, Tritsch, DSM, Amengual 1-14 Overall Outcome 1-14 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