DSM IP ASSETS B.V.

Patent Trials and Appeals Board

Jan 25, 2022

2021003571 (P.T.A.B. Jan. 25, 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. 15/542,091 07/07/2017 Shuen Ei CHEN GPK-4662-3432 8729 23117 7590 01/25/2022 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 01/25/2022 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 2021-003571 Application 15/542,091 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 poultry feed and method of using that feed with poultry 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. Appellant identifies the real party in interest as DSM IP Assets B.V. (Appeal Br. 3.) Appeal 2021-003571 Application 15/542,091 2 STATEMENT OF THE CASE Appellant’s Specification states that “[r]eproductive efficiency and the incidence of pathogenic disorders [in poultry] are directly influenced by the extent of ovary development and nutrition in poultry.” (Spec. 1.) Appellant’s Specification further indicates that “[t]he liver is a key organ in egg production” and “[t]he skeletal system is intimately associated with egg production.” (Id. at 1-2.) Appellant’s Specification teaches that 25- Hydroxyvitamin D3 (25-OH D3) and canthaxanthin have been used in feeding poultry for various reasons, including to improve egg quality and poultry fertility. (Id. at 2-3.) Appellant’s Specification also teaches that Vitamin C and Vitamin E have been used in feeding poultry, including to improve bone health, as has 25-OH D3. (Id.) Appellant’s invention “relates to the combination of 25- hydroxyvitamin D (‘25-OH D3’ and/or ‘25-OH D2’) and antioxidants/anti- inflammatories (ascorbic acid, Vitamin E and canthaxanthin) for use in poultry feed.” (Spec. 1.) Claims 1, 3, 4, and 6-8 are on appeal. Claims 1 and 7, reproduced below, are illustrative of the claimed subject matter: 1. A poultry feed comprising a supra-physiological dose of 25- Hydroxy vitamin D, ascorbic acid , Vitamin E and canthaxanthin for promoting ovarian health, wherein ovarian health is indicated by at least one indicia of ovarian health selected from the group consisting of: reduced ovarian degeneration, occurrence of ovarian degeneration at a later onset, no occurrence of ovarian degeneration; reduction in the amount of ovarian tumors, reduction in size of ovarian tumors, reduction in both size and number of ovarian tumors, occurrence of ovarian tumors at a later onset, and no occurrence of ovarian tumors. Appeal 2021-003571 Application 15/542,091 3 7. A method of promoting ovarian health in poultry, wherein ovarian health is indicated by at least one indicia of ovarian health selected from the group consisting of: reduced ovarian degeneration, occurrence of ovarian degeneration at a later onset, no occurrence of ovarian degeneration; reduction in the amount of ovarian tumors, reduction in size of ovarian tumors, reduction in both size and number of ovarian tumors, occurrence of ovarian tumors at a later onset, and no occurrence of ovarian tumors; comprising feeding poultry a feed comprising a supra- physiological dose of 25-Hydroxy vitamin D, ascorbic acid , Vitamin E and canthaxanthin. (Appeal Br. 20-21 (Claims App.) The prior art relied upon by the Examiner is: Name Reference Date 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 The following grounds of rejection by the Examiner are before us on review: Claims 1, 3, 4, and 6 under 35 U.S.C. § 103(a) as unpatentable over Barella and Hernandez. Claims 1, 3, 4, and 6-8 under 35 U.S.C. § 103(a) as unpatentable over Rodriguez, Barella, and Hernandez. DISCUSSION Obviousness: Claims 1, 3, 4, and 6 The Examiner found that Barella teaches a composition that is administered to “humans, pets or farm animals including birds and fish” Appeal 2021-003571 Application 15/542,091 4 where the composition includes lycopene in combination with vitamin E and vitamin C, and 25-hydroxyvitamin D3. (Final Action 3 (citing Barella ¶¶ 8, 54-56).) The Examiner further found that Barella teaches that the composition is “for treatment of non-cancerous symptoms and/or pathologies associated with androgen signaling” where “[e]xamples of pathologies which are associated with androgen signaling include polycystic ovary syndrome and ovarian hyperstimulation syndrome.” (Id. (citing Barella ¶¶ 1, 52).) The Examiner recognized that Barella’s composition is not taught to include canthaxanthin but found that addition of that ingredient to the composition would have been obvious in light of the teachings of Hernandez. (Id.) In particular, the Examiner found that Hernandez teaches “the use of canthaxanthin and 25-hydroxyvitamin D3 for improving breeder hatchability and fertility and lowering embryo mortality in poultry” and that “[i]t is also advantageous for the composition to comprise Vitamin E and selenium.” (Id. (citing Hernandez 3:19-22, Abstr.).) The Examiner noted that Hernandez teaches the ingredients “can be added as a formulated powder to a premix containing other materials, vitamins, amino acids and trace elements, which is added to regular animal food.” (Id. (citing Hernandez 3:6-10).) The Examiner explained that “[i]t would have been obvious to one of ordinary skill in the art at the time the invention was filed to add canthaxanthin to the composition of Barella et al. to improve breeder hatchability and fertility and lower embryo mortality in poultry as taught by Hernandez et al.” (Final Action 3-4.) The Examiner also explained that “[t]here would have been a reasonable expectation of success since Appeal 2021-003571 Application 15/542,091 5 Hernandez et al. specifically teach an effective combination of 25-OH D3 with canthaxanthin, Vitamin E, and selenium for promoting ovarian health while Barella et al. teach the combination of 25-OH D3, Vitamin E and Vitamin C for treatment of polycystic ovary syndrome which results in infertility.” (Id. at 4.) In addition, the Examiner found that “[t]he prior art of Barella et al. and Hernandez et al. are directed to treating ovarian health instead of a mineral deficiency and thus read on supraphysiological dose.” (Id.) We agree with the Examiner’s findings and conclusion of obviousness. According to Appellant, the Examiner’s rejection is in error because “Barella’s disclosure would not have caused a person having ordinarily skill in the art to select a combination of Vitamin E, Vitamin C, and 25-Hydroxyvitamin D based on the permutations and combinations of one or more of the optional ingredients within this indiscriminate list [of paragraph 56].” (Appeal Br. 13.) According to Appellant, Barella “is focused entirely on a carotenoid - lycopene - that is not recited in the claims” and “Barella is unrelated to ovarian health in poultry.” (Appeal Br. 9-10.) Appellant further argues that “Barella does not teach or suggest that 25-Hydroxyvitamin D would or could affect or enhance the combination of lycopene and Vitamin E and/or Vitamin C” “ either as part of the basal diet or as a supplemental to the basal diet.” (Id. at 13-14.) Thus, according to Appellant, “there is no reason or rationale to select the recited components based on Barella’s disclosure.” (Id. at 14.) We do not find Appellant’s arguments persuasive. First, that Barella includes lycopene in its composition is not evidence demonstrating patentability of the claimed composition, which is stated to be one Appeal 2021-003571 Application 15/542,091 6 “comprising . . . 25-Hydroxyvitamin D, ascorbic acid, Vitamin E and canthaxanthin.” “‘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.” Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997). Second, whether or not Barella is concerned with ovarian health is not relevant to whether the composition claim is patentable over the prior art. The patentability of composition claims depends on the claimed composition, not on the use or purpose of that composition. Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Thus, whether or not Barella describes its suggested composition for promoting ovarian health is immaterial. What matters is whether the prior art suggests the combination of compositional elements. Even so, we agree with the Examiner that Barella is concerned with a composition that treats androgen signaling pathologies, including polycystic ovary syndrome (pcos) in subjects such as “farm animals including birds.” (Barella ¶¶ 52-54.) The Examiner explains, and Appellant does not dispute, that “[p]olycystic ovary syndrome is when ovaries develop follicles and fail to release eggs regularly. Thus the ovaries are not working properly, i.e., ovarian degeneration.” (Ans. 5.) Thus, we agree with the Examiner that Barella is concerned with a composition to promote ovarian health in poultry. Third, it is immaterial that Barella does not teach that 25- Hydroxyvitamin D3 would or could affect or enhance the combination of lycopene and Vitamin E and/or Vitamin C. Barella specifically states that these three ingredients may be co-administered with a number of other ingredients. This alone suggests the combination of 25-hydroxyvitamin D3 Appeal 2021-003571 Application 15/542,091 7 with lycopene, vitamin E and vitamin C. “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); see also Merck & Co. Inc. v. Biocraft Laboratories, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (That a reference “discloses a multitude of effective combinations does not render any particular formulation less obvious.”); see also id. at 807 (species claim held obvious where it recited one of 1200 possible combinations of embodiments disclosed by reference and where reference suggested no preference for claimed embodiment). Appellant further argues that the rejection is in error because “even if a person having ordinarily skill in the art would have created a composition based on those three components (either with or without lycopene), Barella does not teach or suggest that canthaxanthin would or could be used in a combination of Vitamin E, Vitamin C, and 25-Hydroxyvitamin D.” (Appeal Br. 14.) We do not find this argument persuasive of non-obviousness as the rejection is based on a combination of Barella and Hernandez. “In determining whether obviousness is established by combining the teachings of the prior art, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations omitted). Barella teaches that the composition that includes lycopene can also include other carotenoids. (See Barella ¶ 56.) Barella also teaches that 25- Hydroxyvitamin D3 may be included in the composition. (Id.) In short, Barella suggests that a number of carotenoids can be used together with lycopene, vitamin E, and vitamin C, and that the carotenoid lycopene can be Appeal 2021-003571 Application 15/542,091 8 used in conjunction with 25-hydroxyvitamin D3. Hernandez teaches the use of canthaxanthin and 25-hydroxyvitamin D3 for improving breeder hatchability and fertility (i.e., promoting ovarian health) and lowering embryo mortality in poultry, where the ingredients can be part of a premix that also includes vitamin E and selenium. (Hernandez 3.) Thus, one of ordinary skill in the art would have reasonably expected from the combination of teachings of Barella and Hernandez that lycopene, canthaxanthin, vitamin E, vitamin C, and 25-hydroxyvitamin D3 can be combined into a single composition absent evidence to the contrary and for the purpose of achieving the advantages each reference teaches. Appellant has not provided any evidence to indicate one of ordinary skill in the art would have had reason to expect that the claimed ingredients, which are taught to be able to be used in feeding poultry, could not be combined for use in a single composition. Appellant’s arguments that “Hernandez is unrelated to the addition of supra physiological amounts of Vitamin E or Vitamin C (which is not administered at all)” and that it does not address ovarian health (Appeal Br. 15) are also not persuasive of non-obviousness. First, improving fertility may be deemed to be promoting ovarian health. And even if not, the fact that Hernandez does not address the intended use of the composition is immaterial for the reasons addressed above in the discussion of the Barella reference. Catalina, 289 F.3d at 809. As for the required “supra physiological” dose of the combination of ingredients, we note that according to Appellant’s Specification this dosage is achieved simply by “not acting to remedy a vitamin or other nutrient deficiency.” (Spec. 6.) As the Examiner noted, neither Barella nor Appeal 2021-003571 Application 15/542,091 9 Hernandez is concerned with administering the components described to remedy a vitamin or nutrient deficiency. Barella states that the compounds “may be provided as the active ingredient in . . . animal feed compositions.” (Barella ¶ 58.) Thus, the amounts suggested to be included in composition by these references meet the requirements of a “supra physiological” dose. Moreover, Appellant has not provided any evidence that the combination of ingredients in the amounts suggested by the prior art would not inherently produce the intended result recited in the claim if the combination of ingredients were used in the intended manner. In light of the foregoing, we affirm the Examiner’s rejection of claims 1, 3, 4, and 6 under 35 U.S.C. § 103(a) as unpatentable over Barella and Hernandez. Obviousness: Claims 7 and 8 The Examiner’s findings regarding Barella and Hernandez are discussed above. The Examiner found that Rodriguez teaches compositions and methods for preventing the development of epithelial ovarian cancer and “Example 10 addressed the effect of administration of Vitamin D[, a term that includes 25-hydroxyvitamin D3,] on human ovarian epithelial cells, resulting in a significant increase in apoptosis” of those cells. (Final Action 4 (citing Rodriguez ¶¶ 19, 155, Abstr.).) The Examiner further found that “[c]omparison was completed on a chicken ovarian cancer model. See Example 13.” (Id.) According to the Examiner, “the chicken ovarian cancer model was used to test the efficacy of 25-hydroxyviatmin D3 which then could be extrapolated to actual poultry populations.” (Ans. 6.) The Appeal 2021-003571 Application 15/542,091 10 Examiner found that “[t]he prior art of Barella and Hernandez . . . make obvious the additional ingredients to provide additional therapeutic benefit when treating ovarian cancer with 25-hdyroxyvitamin D3,” which is taught and/or suggested by Rodriguez. (Id.) We agree with the Examiner’s findings and conclusion of obviousness. Appellant argues the Examiner’s rejection is in error because “there is no reason or rationale why a person having ordinary skill in the art would generate the claimed methods based on Rodriguez, which involves a poultry model for identifying compounds for administration to humans and which involves feed restriction.” (Appeal Br. 16.) Appellant further argues that because Rodriguez teaches administration of Vitamin D to cultured poultry cells, one of ordinary skill in the art would have had no reason or rationale to include it in a poultry feed based on Rodriguez, “let alone [in] a supra- physiological amount.” (Id. at 16-17.) We do not find these arguments persuasive. As the Examiner pointed out, one of ordinary skill in the art would have found it obvious to extrapolate the chicken ovarian cancer model used to test the efficacy of 25-hydroxyvitamin D3 in preventing ovarian cancer “to actual poultry populations.” (Ans. 6.) We also agree with the Examiner that one of ordinary skill in the art would have found it obvious to include in a poultry feed, as an additive, lycopene, canthaxanthin, vitamin E, and vitamin C, and 25-hydroxyvitamin D for the additional benefits taught by Barella (lycopene, vitamin E, and vitamin C to prevent pcos, and which can be co-administered with 25-hydroxyvitamin D, as well as other carotenoids) and Hernandez (canthaxanthin and 25-hydroxyvitamin D administered to Appeal 2021-003571 Application 15/542,091 11 improve hatchability, fertility and lower embryo mortality during the first phase of embryo development). Moreover, as discussed above, a “supra physiological” dose of the combination of ingredients, according to the Specification, is achieved simply by “not acting to remedy a vitamin or other nutrient deficiency.” (Spec 6.) Each of the references are concerned with achieving a benefit other than remedying a vitamin or nutrient deficiency. Consequently each either teaches or suggests inclusion of ingredients that are in supra physiological amounts to be provided to poultry. With respect to claim 8, Appellant argues that the cited art does not teach or suggest feeding poultry an unrestricted diet (i.e., ad libitum) or that the combination of 25-Hydroxyvitamin D, ascorbic acid, Vitamin E and canthaxanthin amount given to the poultry is “a supra-physiological amount.” (Appeal Br. 18.) Appellant argues that the chickens referred to in Hernandez “are prone to hyperphagia, i.e., excessive eating” and Hernandez does not teach or suggest such chickens “would or could be fed ad libitum.” (Id.) Appellant further argues “[t]he fact that Rodriguez teaches a feed additive does not indicate that such a feed additive would be fed to poultry in an unrestricted diet.” (Id.) We do not find Appellant’s arguments persuasive. First, as discussed above, Rodriguez supports a conclusion of obviousness of a method of promoting ovarian health, by preventing ovarian cancer, in poultry of any type by administration of a composition that includes a supra-physiological dose of 25-hydroxyvitamin D3. Barella teaches that the composition of lycopene, vitamin E, and vitamin C to prevent pcos, which can be co-administered with 25- Appeal 2021-003571 Application 15/542,091 12 hydroxyvitamin D, as well as other carotenoids, may be provided as part of the animal feed to farm animals that are birds (Barella ¶¶ 54, 58). There is no indication, nor does Appellant argue, that the composition cannot be administered to poultry who are fed ad libitum or that the prevention of pcos would not be achieved with the lycopene composition that also included vitamin E, vitamin C, 25-hydroxyvitamin D, as well as other carotenoids when provided to poultry who are fed ad libitum. And although Hernandez describes the benefit of canthaxanthin and 25-hydroxyvitamin D as improving hatchability, fertility and lowering embryo mortality during the first phase of embryo development in breeder poultry who are likely not fed ad libitum, there is no indication that the composition would not achieve similar benefits in poultry who are fed ad libitum. Consequently, we agree with the Examiner that the method recited in claim 8 requiring poultry feeding to be ad libitum would have been obvious from the cited references. In light of the foregoing, we affirm the Examiner’s rejection of claims 1, 3, 4, and 6-8 under 35 U.S.C. § 103(a) as unpatentable over Rodriguez, Barella, and Hernandez. Appeal 2021-003571 Application 15/542,091 13 DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3, 4, 6 103 Barella, Hernandez 1, 3, 4, 6 1, 3, 4, 6-8 103 Rodriguez, Barella, Hernandez 1, 3, 4, 6-8 Overall Outcome 1, 3, 4, 6-8 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) (2020). AFFIRMED