Ex Parte Chew et alDownload PDFPatent Trial and Appeal BoardJul 27, 201610764215 (P.T.A.B. Jul. 27, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. 10/764,215 132446 7590 Mars Petcare Theresa Shearin FILING DATE 01/23/2004 07/29/2016 315 Cool Springs Blvd. Franklin, TN 37067 FIRST NAMED INVENTOR Boon Peng Chew 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 ATTORNEY DOCKET NO. CONFIRMATION NO. IAM0043 US 9145 EXAMINER ANDERSON, JAMES D ART UNIT PAPER NUMBER 1629 NOTIFICATION DATE DELIVERY MODE 07/29/2016 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): mars.patents@effem.com theresa.shearin@effem.com becca.barnett@effem.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BOON PENG CHEW, MICHAEL GRIFFIN HAYEK, and JEAN SOON PARK Appeal2014-004739 Application 10/764,215 Technology Center 1600 Before DEMETRA J. MILLS, ULRIKE W. JENKS, and RYAN H. FLAX, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal2014-004739 Application 10/764,215 STATEMENT OF CASE The present invention is directed to methods and compositions which are useful for attenuating inflammation, enhancing the immune response, or enhancing longevity in a companion animal, wherein astaxanthin is utilized. Spec. 1. The following claim is representative. 1. A composition comprising astaxanthin, wherein the composition is a nutritionally balanced pet food wherein said composition attenuates inflammation, enhances immune response, enhances longevity, or combinations thereof; wherein said composition is selected from the group consisting of dog food compositions, cat food compositions and combinations thereof. Cited References Hayek us 6, 133,323 Oct. 17, 2000 Jyonouchi et al, Immunomodulating 14ctions of Carotenoids: Enhancement of In Vivo and In Vitro Antibody Production to T-Dependent Antigens, 21 NUTRITION AND CANCER 47-58 (1994) ("Jyonouchi 1994"). Jyonouchi, et al., "Effect of Carotenoids on In Vitro Immunoglobulin Production by Human Peripheral Blood Mononuclear Cells: Astaxanthin, a Carotenoid Without Vitamin A Activity, Enhances In Vitro Immunoglobulin Production in Response to a T-Dependent Stimulant and Antigen," NUTRITION AND CANCER 171-182 (1995). ("Jyonouchi 1995a"). Jyonouchi, et al., Astaxanthin, a Carotenoid without Vitamin A Activity, Augments Antibody Responses in Cultures Including T-helper Cell Clones and Suboptimal Does of Antigen] '2, 125AM. INST. OF NUTRITION 1483-1492, 1995. ("Jyonouchi 1995b"). 2 Appeal2014-004739 Application 10/764,215 Chew et al., A Comparison of the Anticancer Activities of Dietary fl- Carotene, Canthaxanthin and Astaxanthin in Mice In Vivo, 19 ANTICANCER RESEARCH 1849-1854 (1999). (Chew 1999a). Chew et al., Dietary fl-Carotene and Axtaxanthin but not Canthaxanthin Stimulate Splenocyte Function in Mice, 19 ANTICANCER RESEARCH 5223- 5228 ( 1999). ("Chew l 999b"). Kim et al., Modulation of Humoral and Cell-Mediated Immune Responses by Dietary Lutein in Cats, 73 VETERINARY IMMUNOLOGY AND IMMUNOPATHOLOGY 331-341 (2000). ("Kim"). Naguib, Antioxidant Activities of Astaxanthin and Related Carotenoids, 48 J. AGRIC. FOOD CHEM. 1150-1154 (2000). Terao, 24 LIPIDS 659-661 (1989). Additional Appellants cited references Gugger et al., fl-Carotene Uptake and Tissue Distribution in Ferrets (Mustela putoriusfuro), 122 J. NUTRI. 115-119 (1992) ("Gugger"). Grounds of Rejection Claims 1, 2, 4, and 6-9 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Hayek. FINDINGS OF FACT The Examiner's findings of fact are set forth in the Answer at pages 3-14. PRINCIPLES OF LAW In making our determination, we apply the preponderance of the evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 3 Appeal2014-004739 Application 10/764,215 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Office). "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). In KSR, the Supreme Court rejected a rigid application of a teaching-suggestion- motivation test in the obviousness determination. The Court emphasized that "the [obviousness] analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418. When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 301 (CCP,,L\ .. 1982); see also l\1PEP § 2144.06. All that is required is a reasonable expectation of success, not absolute predictability of success. See In re 0 'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988). Obviousness analysis We agree with the Examiner's fact finding, statement of the rejection and responses to Appellants' arguments as set forth in the Answer. We find that the Examiner has provided evidence to support a prima facie case of obviousness. We provide the following additional comment to the Examiner's argument set forth in the Final Rejection and Answer. 4 Appeal2014-004739 Application 10/764,215 The Examiner finds that: Hayek teaches a pet food supplement and process for enhancing immune response and improving the overall health of companion animals such as cats and dogs, and more particularly to a pet food supplement and process which includes beneficial amounts of beta-carotene in the animal's diet (col. 1, lines 10-15). Ans. 4. The Examiner further finds that: Hayek teaches that carotenoids are naturally-occurring plant pigments which are absorbed in varying degrees by different species. Common carotenoids include beta-carotene, lycopene, lutein, zeaxanthin, and astaxanthin. These carotenoids are known to play an important role in modulating the immune system and enhancing the health of these species (col. 1, lines 16-22). Id. The Examiner concludes that, "[i]t would have been obvious to one of ordinary skill in the art to modify the compositions comprising beta-carotene taught by Hayek to generate a composition comprising another known carotenoid such astaxanthin for use in a pet food composition for a companion animal to enhance immune response." Ans. 7. In response, Appellants argue that the Examiner has not established a reasonable expectation of success from the substitution of astaxanthin for beta-carotene. App. Br. 2. In particular, the Appellants argue that Hayek does not "actually say that the carotenoids are interchangeable." App. Br. 3. Appellants rely on their Specification which discloses that: Although much is known about the carotenoids, it is difficult to extrapolate from what is known about the effects of one carotenoid in an animal to determine the effects that another carotenoid may have in the same animal. It is also difficult to 5 Appeal2014-004739 Application 10/764,215 determine what the effect of a single carotenoid may be in one animal based upon previous findings in a different type of animal. Carotenoid absorption and metabolism have been determined to be species-specific. Carotenoid absorption and metabolism have been determined to be species-specific. Cattle and horses, for example, absorb beta-carotene, while goats and sheep do not absorb carotenoids at all. (Schweigert, F.J., 1998). After a 1931 study demonstrated that a large proportion of beta- carotene provided to cats was not absorbed, many believed that cats were unable to utilize beta-carotene until, Chew et al. (2000) determined that domestic cats readily absorb beta- carotene, and Schweigert et al. (2002) demonstrated that this absorption is not accompanied by conversion of beta-carotene to vitamin A, indicating that the effects of beta-carotene in cats are not due to its function as a vitamin A precursor. Even within a single animal, the carotenoids can exhibit differential patterns of absorption. Lutein and zeaxanthin are found concentrated in the human retina, while beta-carotene is generally thought to be absent from retinal tissue due to its inability to cross the blood retinal barrier. Page 2, lines 4-20 of the Specification as originally filed. Appellants also rely on the disclosures ofNaguib, Gugger, and Jyonouchi 1995 in support of patentability, which are argued as showing differences in carotenoid activity. App. Br. 5. In response, the Examiner argues that: Appellants' citation of pertinent prior art knowledge is incomplete and omits essential prior art knowledge that supports the Examiner's position. In relying only on citation of prior art discussing differences in carotenoids and omitting prior art demonstrating similarities of different carotenoids, Appellants present an incomplete picture of the common knowledge of those skilled in the art. 6 Appeal2014-004739 Application 10/764,215 Ans. 11. The Examiner argues that, in addition to Hayek, the Kim, Jyonouchi 1995, Naguib, Jyonouchi 1994, Chew 1999a, and Chew 1999b references support a finding of unpatentability based on obviousness. The Examiner argues that "the totality of the evidence of record does not support Appellants' position that the skilled artisan would not reasonably expect astaxanthin to have similar immunomodulatory activity as beta-carotene." Ans. 13 (emphasis original). We find that the Examiner has the better argument and that the preponderance of the evidence supports a finding of unpatentability based on obviousness. To begin, the claims do not require conversion ofbeta- carotene to vitamin A. It is well known from Chew (2000) (quoted and cited in Spec. at 2, as reproduced above) that cats are able to absorb beta-carotene, lutein and astaxanthin, showing increases in antibody responses upon their administration and therefore similar immune responses. Chew (2000), p. 1912, col. 2. Upon administration of these carotenoid forms, no further processing is required by cats. In response to the Examiner's prima facie case of obviousness, Appellants provide no further evidence supporting that one of ordinary skill in the art would understand that cats do not absorb astaxanthin. Gugger, cited by Appellants, describes different types of carotenoid absorption in primarily non-pet companion animals, so the relevance of Gugger is questioned. Appellant argues that "Jyonouchi et al. reported that astaxanthin, but not beta-carotene, enhanced IgM and IgA production by human peripheral blood mononuclear cells and human cord blood mononuclear cells in response to T-dependent antigen in vitro." See Jyonouchi et al.., 23 NUTR CANCERl 71-183 (1995) ("Jyonouchi 1995a"). 7 Appeal2014-004739 Application 10/764,215 Br. 4. However, Fig. 2 of Jyonouchi l 995a, show that both B-carotene and astaxanthin increased IgM production, but astaxanthin increased IgM production more significantly. Therefore, both B-carotene and astaxanthin increased the immune response. Appellants argue "that astaxanthin may reduce the risk of certain diseases of the eye, while canthaxanthin was reported to cause adverse effects on the retina." Br. 5. Canthaxanthin was not mentioned in the background section at col. 1 of Hayek as a carotenoid known to modulate the immune system. Furthermore, the Examiner cites multiple references on pages 11-12 of the Answer, showing similarities between carotenoids, to which Appellants do not provide comment. Based on the evidence of record, Appellants have not rebutted the Examiner's prima facie case of obviousness by establishing lack of a reasonable expectation of success on the evidence of record. All that is required is a reasonable expectation of success, not absolute predictability of success. See 0 'Farrell, 853 F.2d at 903. The balance and preponderance of the evidence supports the Examiner's position and the obviousness rejection is affirmed. CONCLUSION OF LAW The cited references support the Examiner's obviousness rejection, which is affirmed for the reasons of record. All pending, rejected claims fall. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § l.136(a). AFFIRMED 8 Copy with citationCopy as parenthetical citation