Ex Parte Johnson et al

Patent Trial and Appeal Board

Jan 14, 2015

12014327 (P.T.A.B. Jan. 14, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte ELIZABETH J. JOHNSON and D. MAX SNODDERLY1
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Appeal 2012-006318
Application 12/014,327
Technology Center 1600
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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).
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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).
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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).
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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
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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
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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).
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(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.
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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

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