Ex Parte Johnson et alDownload PDFPatent Trial and Appeal BoardJan 14, 201512014327 (P.T.A.B. Jan. 14, 2015) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte ELIZABETH J. JOHNSON and D. MAX SNODDERLY1 __________ Appeal 2012-006318 Application 12/014,327 Technology Center 1600 __________ Before LORA M. GREEN, MELANIE L. McCOLLUM, and ROBERT A. POLLOCK, Administrative Patent Judges. McCOLLUM, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a nutritional supplement and to methods for enhancing lutein transport and carotenoid absorption. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE Claims 1, 4–6, 9–16, and 18–24 are pending and on appeal (App. Br. 4). The claims are set forth in Appendix A of the Appeal Brief (id. at 14–16). We will focus on claim 1, which reads as follows: 1 Appellants identify the real parties in interest as Trustees of Tufts College and The Schepens Eye Research Institute (App. Br. 4). Appeal 2012-006318 Application 12/014,327 2 1. A nutritional supplement composition for improving memory and cognitive abilities in mammals comprising synergistic amounts of lutein and docosahexanaenoic acid (DHA) in amounts effective for reducing small low density lipoproteins in serum and enhancing transport of lutein to a subject’s brain to produce an improvement in cognitive function by increasing absorption of lutein, wherein the synergistic amounts comprise about 700 to 1000 mg of DHA and about 10 to 15 mg of lutein. Claims 1, 4–6, 9–16, and 18–24 stand rejected under 35 U.S.C. § 103(a) as obvious over Gorenbein et al. (US 6,200,601 B1, Mar. 13, 2001) in view of Gorsek (US 6,649,195 B1, Nov. 18, 2003), Romero et al. (US 2006/0205826 A1, Sept. 14, 2006), and Birch et al. (US 7,413,759 B2, Aug. 19, 2008) (Ans. 5). The Examiner relies on Gorenbein for teaching “the use of DHA, lutein in a nutritional supplement for correcting, improving, preventing or delaying various visual disorders, such as macular degeneration,” “amounts of DHA within the claimed range,” and “1-6 mg/day lutein” (id.). The Examiner relies on Gorsek for teaching “the use of 20 mg lutein in nutritional supplement” (id.). The Examiner relies on Romero for teaching “the use of carotenoids, such as lutein for the treatment of cognitive disorders” (id.). The Examiner relies on Birch for teaching “the use of DHA for improving cognitive function” (id.). The Examiner concludes that it would have been obvious “to use lutein and DHA for the improvement of cognitive function motivated by the teachings of Romero and Birch, which teach the use of DHA and lutein individually for the treatment of cognitive dysfunction” (id. at 5–6). Appeal 2012-006318 Application 12/014,327 3 FINDINGS OF FACT 1. Gorenbein discloses “a nutritional supplement useful for preventing visual disorders and for improving vision,” comprising “DHA, antioxidants including at least lutein, and anthocyanosides” (Gorenbein, col. 1, l. 66, to col. 2, l. 2). 2. In particular, Gorenbein discloses that the nutritional supplement “preferably contains about 25 to 900, preferably 25 to 140, mg/day of DHA” (id. at col. 2, ll. 45–47). 3. In addition, Gorenbein discloses that the nutritional supplement “preferably contains about 1 to 6 mg/day of lutein” (id. at col. 2, ll. 61–63). 4. Gorsek “relates to a composition for maintaining healthy eyesight” (Gorsek, col. 1, ll. 6–8). 5. In particular, Gorsek discloses a composition comprising 20 mg lutein (id. at col. 3, l. 45). 6. Romero “relates generally to the use of carotenoids to provide neuroprotective effects and, more specifically, to the use of lutein and other carotenoids to treat or ameliorate cognitive decline and provide other neuroprotection functions” (Romero ¶ 1). 7. In particular, Romero states that its “invention consists of the administration of carotenoids to subjects who are suffering from or at risk to develop cognitive decline” (id. at ¶ 12). 8. Birch relates “to baby-food compositions comprising docosahexaenoic acid (DHA) and to methods of using the compositions to improve the health and development of an infant including enhancing cognitive ability” (Birch, col. 1, ll. 28–33). Appeal 2012-006318 Application 12/014,327 4 ANALYSIS Gorenbein discloses “a nutritional supplement useful for preventing visual disorders and for improving vision,” containing “about 25 to 900 . . . mg/day of DHA” and “about 1 to 6 mg/day of lutein” (Findings of Fact (FF) 1–3). Gorsek discloses “a composition for maintaining healthy eyesight,” comprising 20 mg of lutein (FF 4–5). In view of these disclosures, we conclude that it would have been prima facie obvious to include lutein in amounts between 6 and 20 mg, including amounts within the claimed range of about 10 to 15 mg. “[W]here there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness.” Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004). In this regard, we note that a “range” in the prior art can be shown by reference to multiple prior art patents. See, e.g., id. at 1320–21 (separate prior art patents disclosed weight plates having one, two, or four elongated handles; the court stated that the “key feature of the . . . patent [at issue], the fact that there are three elongated handles, falls within a range disclosed by the prior art.”). Appellants argue, however, that the applied references “provide no teachings or suggestions for . . . a composition comprising amounts effective for reducing small low density lipoproteins in serum” (App. Br. 10). However, it is the Examiner’s position that reducing small low density lipoproteins in serum is an inherent effect of compositions comprising the claimed amounts of DHA and lutein (Ans. 6). “‘[I]t is elementary that the mere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not cause a claim drawn to those Appeal 2012-006318 Application 12/014,327 5 things to distinguish over the prior art.’” In re Best, 562 F.2d 1252, 1254–55 (CCPA 1977) (quoting In re Swinehart, 439 F.2d 210, 212–13 (CCPA 1971)). In addition, where “the claimed and prior art products are identical or substantially identical . . . the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product.” Id. at 1255. “Whether the rejection is based on ‘inherency’ under 35 U.S.C. § 102, on ‘prima facie obviousness’ under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same.” Id. In the present case, we conclude that the substantial similarity between the claimed composition and the composition suggested by the applied references is sufficient to shift the burden to Appellants to demonstrate that the composition suggested by the applied references does not inherently reduce small low density lipoproteins in serum. Appellants have not met this burden. Appellants also argue that “one of ordinary skill in the art would not have any reason to modify the teachings of Gorenbein, Gorsek, Romero or Birch to recreate the nutritional supplement of the claimed invention” (App. Br. 12). However, the “normal desire of scientists or artisans to improve upon what is already generally known” provides a reason to use amounts within a range disclosed in the prior art. In re Peterson, 315 F.3d 1325, 1329–30 (Fed. Cir. 2003). In addition, Appellants argue that they “have shown that administration of DHA and lutein unexpectedly act in concert to reduce lipoproteins in the blood” (App. Br. 9). However, “when unexpected results Appeal 2012-006318 Application 12/014,327 6 are used as evidence of nonobviousness, 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). Gorenbein discloses a nutritional supplement comprising both DHA and lutein (FF 1). In addition, as noted by the Examiner, Appellants have not shown that the claimed amounts are critical for achieving the allegedly unexpected result (Ans. 6). Appellants also argue that “there are no teachings or suggestions in any of the cited prior art for amounts of lutein and DHA effective for improving cognitive function by decreasing memory acquisition time or increasing memory retention time, as in claims 4-5” (App. Br. 10). However, as with claim 1, we conclude that the substantial similarity between the claimed composition and the composition suggested by the applied references is sufficient to shift the burden to Appellants to demonstrate that the composition suggested by the applied references does not inherently increase memory retention time or improve cognitive function by decreasing memory acquisition time. Appellants have not met this burden. In addition, Appellants argue: There are also no teachings or suggestions that administering lutein and DHA occurs prior to onset of cognitive impairment (claim 9), prevents or delays the onset of a memory disorder in the subject (claim 13), increases serum carotenoid concentration levels between about 100 nmol/L to about 1µmol/L compared to serum carotenoid concentrations levels in the absence of DHA (claim 19), increases HDL and HDL subfractions of blood (claim 20), increases transport of lutein to a subject’s brain (claim 21), or increases memory in the subject (claim 22). Appeal 2012-006318 Application 12/014,327 7 (Id.) However, as with claims 1, 4, and 5, we conclude that the substantial similarity between the claimed composition and the composition suggested by the applied references is sufficient to shift the burden to Appellants to demonstrate that administering the composition suggested by the applied references would not inherently provide the results recited in claims 13 and 19–22. Appellants have not met this burden. Claim 9 recites administering lutein and DHA to a subject “prior to onset of cognitive impairment” (id. at 14). As noted by the Examiner, Gorenbein “differs from the claimed invention in . . . the use of the claimed components for the improvement of cognitive disorders” (Ans. 5). However, Romero discloses “the use of lutein . . . to treat or ameliorate cognitive decline” (FF 6). In particular, Romero discloses administering its composition to subjects “at risk to develop cognitive decline” (FF 7). Birch discloses that, at least for infants, DHA enhances cognitive ability (FF 8). Thus, we conclude that it would have been obvious to administer the composition suggested by Gorenbein and Gorsek to a subject “prior to onset of cognitive impairment” in an effort to prevent visual disorders and/or improve vision, as well as to prevent or delay cognitive decline. CONCLUSION The evidence supports the Examiner’s conclusion that claim 1 would have been obvious. Claims 6, 12, 14–16, and 18 have not been separately argued and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). The evidence also supports the Examiner’s conclusion that claims 4, 5, 9, 13, and 19–22 would have been obvious. Claims 10, 11, 23, and 24 have not been separately argued and therefore fall with claims 4 and 5. Id. Appeal 2012-006318 Application 12/014,327 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). AFFIRMED cdc Copy with citationCopy as parenthetical citation