Ex Parte Zimmer

Board of Patent Appeals and Interferences

Feb 1, 2010

10454708 (B.P.A.I. Feb. 1, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOHN PAUL ZIMMER
__________

Appeal 2009-013134
Application 10/454,708
Technology Center 1600
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Decided: February 1, 2010
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Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to an infant
formula. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

Appeal 2009-013134
Application 10/454,708

Statement of the Case
Background
“Lutein and zeaxanthin are naturally occurring xanthophylls (plant
pigments that are a sub-class of carotenoids) found in commonly consumed
foods such as spinach, kale, corn and oranges” (Spec. 1: 11-13).
The Claims
Claims 2-6 and 8-10 are on appeal. Claim 2 is representative and
reads as follows:
2. An infant formula composition in liquid form
comprising lutein and zeaxanthin in an amount of 6 to 230
mcg/L.

The prior art

The Examiner relies on the following prior art references to show
unpatentability:
Khachik, F. et al., Identification, Quantification, and Relative
Concentrations of Carotenoids and Their Metabolites in Human Milk and
Serum, 69 ANALYTICAL CHEMISTRY 1873-1881 (1997).

Schweigert, F. et al., Improved Extraction Procedure for Carotenoids from
Human Milk, 70 INT. J. VITAM. NUTR. RES. 79-83 (2000).

The issue
The Examiner rejected claims 2-6 and 8-10 under 35 U.S.C. § 103(a)
as obvious over Khachik and Schweigert (Ans. 3-4).
The Examiner finds that “Khachik discloses the various carotenoids
found in human milk and serum; including lutein and zeaxanthin
metabolites” (Ans. 3). The Examiner finds that “Khachik concludes that as
many of the 34 carotenoids described as present in human milk, should be
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included in infant formula” (Ans. 3). The Examiner finds that “Schweigert
discloses the results of a study to determine the concentration of various
carotenoids from human milk” (id. at 4). The Examiner finds that
“applicant's claimed ranges encompass the ranges found in natural human
breast milk” (id.). The Examiner concludes that it would have been obvious
“to follow the Khachik advice, i.e., provide the carotenoids including lutein
and zeaxanthin in an infant formula; in an amount found in natural breast
milk because it is common sense that an infant formula should resemble
human milk as much as possible” (id.).
Appellant argues that “there is no suggestion in Khachik, et al. to use
lutein and zeaxanthin in infant formula. Khachik, et al. is directed to
methodology for detecting and measuring concentrations of carotenoids and
their metabolites in human milk and serum, not to an infant formula
composition” (App. Br. 9). Appellant argues that Khachik “shows that the
serum content of various carotenoids is many times higher than the milk
content. Therefore, Khachik, et al. teaches away from supplementing an
infant formula with the amounts of carotenoids found in human milk” (id. at
10). Appellant argues that Schweigert “is not directed to infant formula, and
does not suggest adding lutein and zeaxanthin to infant formula” (id. at 11).
Appellant also argues that
[t]he Examiner errs in seeking to combine this teaching with
that of Khachik, et al., since Khachik, et al. teaches that the
carotenoid amounts in human serum, not milk, should be
used (Khachik, et al. page 1881), and Schweigert, et al. does
not provide the amounts found in human serum.

(App. Br. 12.)
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Appellant argues that “[a]n invention that is as clearly motivated and
obvious as the Examiner alleges would not have gone undiscovered for half
a century in a highly competitive industry that sells billions of dollars worth
of formula globally every year” (Reply Br. 5).
In view of these conflicting positions, we frame the obviousness issue
before us as follows:
Has Appellant demonstrated that the Examiner erred in concluding
that it would have been obvious to include lutein and zeaxanthin in an
amount of 6 to 230 mcg/L in infant formula?
Findings of Fact (FF)
1. Khachik teaches that “[b]reast milk carotenoids provide an
important source of vitamin A for the infant and may contribute significantly
to protection of the nursing infant from respiratory and gastrointestinal
infection. Thus, the carotenoids of human milk are important for developing
and maintaining good health of infants” (Khachik 1873, col. 1).
2. Khachik teaches that “[i]n recent years, the protective role of
carotenoid-rich fruits and vegetables in prevention of cancer, heart disease,
and advanced age-related macular degeneration has become more evident
from several epidemiological studies” (Khachik 1873, col. 2).
3. Khachik teaches that “[i]n our opinion, the most interesting
metabolites of carotenoids in serum and milk are the oxidative metabolites
of lutein and zeaxanthin” (Khachik 1879, col. 1).
4. Khachik teaches that
it appears that carotenoids, in addition to their antioxidant
mechanism of action, may also exert their potential
biological activity in prevention of certain diseases by other
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mechanisms. These are (1) enhancement of the activity of
the cellular communication, (2) stimulation of the activity of
the phase II enzymes (detoxification enzymes), and (3) anti-
inflammatory/immune-related properties.

(Khachik 1881, col. 1.)
5. Khachik teaches that “[w]e postulate that this wide spectrum of
carotenoids and metabolites functions in concert; as a result, their presence
in serum and breast milk promotes the health of the mother and infant”
(Khachik 1881, col. 1).
6. Khachik teaches that “in many instances, because of certain
health-related problems, mothers are unable to breast-feed and rely on infant
formula to provide adequate nutrition for their child. Currently, most infant
formula is fortified with vitamins, nutrients, and, in some cases, β-carotene”
(Khachik 1881, col. 1).
7. Khachik teaches that “[w]e believe, since most of the prominent
carotenoids described in this report are currently available from natural
sources, the infant formula can be modified to include as many dietary
carotenoids as possible” (Khachik 1881, col. 1).
8. Khachik teaches that “selection of a mixture of carotenoids for
human studies should be carefully designed and should closely resemble the
relative distribution of these compounds in human serum” (Khachik 1881,
col. 1-2).
9. Khachik teaches the distribution of carotenoids in serum and
breast milk in Table 2, reproduced below:
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“The quantitative distribution of carotenoids in serum and breast milk of
three lactating mothers is shown in Table 2” (Khachik 1880, col. 1).
10. Schweigert teaches that “human milk is a rich source of a verity
of carotenoids which differ in its chemical composition” (Schweigert 79,
col. 1).
11. Schweigert teaches that in “human milk samples lutein,
zeaxanthin . . . were observed” (Schweigert 80, col. 2).
12. Schweigert teaches that the concentration of lutein in human
was 48 ng/ml (which is equivalent to µg/L) and the amount of zeaxanthin
was 12.1 ng/ml (Schweigert 81, table 1 description).
Principles of Law
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
The Supreme Court has emphasized that “the [obviousness] analysis need
not seek out precise teachings directed to the specific subject matter of the
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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.” KSR Int'l Co.
v. Teleflex Inc., 550 U.S. 398, 418 (2007).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
Id. at 416. “If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability.” Id. at 417. As also noted by the
Court in KSR, “[a] person of ordinary skill is also a person of ordinary
creativity, not an automaton.” Id. at 421.
Analysis
Khachik teaches that “carotenoids of human milk are important for
developing and maintaining good health of infants” (Khachik 1873, col. 1;
FF 1). Khachik teaches that lutein and zeaxanthin are carotenoids present in
milk (FF 3). Khachik teaches that “[w]e believe, since most of the
prominent carotenoids described in this report are currently available from
natural sources, the infant formula can be modified to include as many
dietary carotenoids as possible” (Khachik 1881, col. 1; FF 7). Khachik
teaches that “selection of a mixture of carotenoids for human studies should
be carefully designed and should closely resemble the relative distribution of
these compounds in human serum” (Khachik 1881, col. 1-2; FF 8).
Schweigert teaches that in “human milk samples lutein, zeaxanthin . .
. were observed” (Schweigert 80, col. 2; FF 11). Schweigert teaches specific
amounts of lutein and zeaxanthin found in human milk (FF 12).

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Applying the KSR standard of obviousness to the findings of fact, we
agree with the Examiner that it would have been obvious to follow the
suggestion of Khachik that “infant formula can be modified to include as
many dietary carotenoids as possible” (Khachik 1881, col. 1; FF 7). Since
Khachik teaches that lutein and zeaxanthin are carotenoids found in human
breast milk and serum, inclusion of these carotenoids in infant formula
would have obvious selections based on Khachik’s general teaching and
would have predictably been expected to improve infant health (FF 1-8).
We also agree with the Examiner that the ordinary artisan, in selecting the
amounts of lutein and zeaxanthin to be added, would select “an amount
found in natural breast milk because it is common sense that an infant
formula should resemble human milk as much as possible” (Ans. 4). Such a
combination is merely a “predictable use of prior art elements according to
their established functions.” KSR, 550 U.S. at 417.
Appellant argues that “there is no suggestion in Khachik, et al. to use
lutein and zeaxanthin in infant formula. Khachik, et al. is directed to
methodology for detecting and measuring concentrations of carotenoids and
their metabolites in human milk and serum, not to an infant formula
composition” (App. Br. 9). We are not persuaded. Khachik expressly
teaches that “infant formula can be modified to include as many dietary
carotenoids as possible” (Khachik 1881, col. 1; FF 7). Khachik expressly
teaches that human breast milk contains lutein and zeaxanthin (FF 3, 9). We
therefore agree with the Examiner that “there is [an] explicit disclosure by
Khachik to include the claimed carotenoids in an infant formula” (Ans. 5).
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Appellant argues that Khachik “shows that the serum content of
various carotenoids is many times higher than the milk content. Therefore,
Khachik, et al. teaches away from supplementing an infant formula with the
amounts of carotenoids found in human milk” (App. Br. 10). Appellant
argues that
[t]he Examiner errs in seeking to combine this teaching with
that of Khachik, et al., since Khachik, et al. teaches that the
carotenoid amounts in human serum, not milk, should be
used (Khachik, et al. page 1881), and Schweigert, et al. does
not provide the amounts found in human serum.

(App. Br. 12.) We are not persuaded. We appreciate that Khachik teaches
that “selection of a mixture of carotenoids for human studies should be
carefully designed and should closely resemble the relative distribution of
these compounds in human serum” (Khachik 1881, col. 1-2; FF 8).
However, this teaching refers to the relative distribution of the carotenoids,
not their absolute amounts (see FF 8). Thus, Khachik is teaching that
carotenoids, such as lutein and zeaxanthin, which are found in serum should
be used, but does not teach a specific amount of carotenoid to be added.
Even if this teaching was a suggestion to use the amounts in serum, this does
not teach away from using the amounts in human milk. See In re Fulton,
391 F.3d 1195, 1201 (Fed. Cir. 2004) (“The prior art's mere disclosure of
more than one alternative does not constitute a teaching away from any …
alternatives because such disclosure does not criticize, discredit, or
otherwise discourage the solution claimed ….”).
Additionally, we agree with the Examiner’s reason for using amounts
found in breast milk and formula since “it is widely accepted that infant
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formula would mimic human breast milk as closely as possible” (Ans. 5).
This is consistent with the express teaching of Khachik that “[w]e believe,
since most of the prominent carotenoids described in this report are currently
available from natural sources, the infant formula can be modified to include
as many dietary carotenoids as possible” (Khachik 1881, col. 1; FF 7). The
ordinary artisan of ordinary creativity would have reasonably used amounts
of carotenoids found in human breast milk in the formulation of infant
formula.
We are not persuaded by Appellant’s argument that “[a]n invention
that is as clearly motivated and obvious as the Examiner alleges would not
have gone undiscovered for half a century in a highly competitive industry
that sells billions of dollars worth of formula globally every year” (Reply Br.
5). This appears to be an argument for the secondary consideration of long-
felt need. Establishing long-felt need requires objective evidence that an art-
recognized problem existed in the art for a long period of time without
solution. In particular, first, the evidence must show that the need was a
persistent one that was recognized by those of ordinary skill in the art. In re
Gershon, 372 F.2d 535, 539 (CCPA 1967). Appellant has presented no such
evidence in this case, and therefore this argument is insufficient to establish
long-felt need, because there is no need which is supported by evidence. See
In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (attorney's arguments
cannot take the place of evidence).

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Conclusions of Law
Appellant has not demonstrated that the Examiner erred in concluding
that it would have been obvious to include lutein and zeaxanthin in an
amount of 6 to 230 mcg/L in infant formula.
SUMMARY
In summary, we affirm the rejection of claim 2 under 35 U.S.C. §
103(a) over Khachik and Schweigert. Pursuant to 37 C.F.R. §
41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 3-6 and 8-10 as
these claims were not argued separately.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).
AFFIRMED

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