Ex Parte Hoffman et al

Board of Patent Appeals and Interferences

Nov 27, 2007

10387966 (B.P.A.I. Nov. 27, 2007)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DENNIS ROBERT HOFFMAN,
EILEEN ELIZABETH BIRCH, JULIA ANNE BOETTCHER, and
DEBORAH ANN SCHADE
__________

Appeal 2007-4463
Application 10/387,966
Technology Center 1600
__________

Decided: November 27, 2007
__________

Before DEMETRA J. MILLS, LORA M. GREEN, and RICHARD M.
LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal from the Examiner’s final rejection of
claims 1-39. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

STATEMENT OF THE CASE
The claims are directed to methods for enhancing the visual
development of term infants comprising administering docosahexaenoic acid
(“DHA”) and docosahexaenoic acid (“AA” or “ARA”) to term infants who
have been weaned from breast milk.
Appeal 2007-4463
Application 10/387,966

Claims 1-39 are pending (Appeal Br. 21). The claims stand rejected
under 35 U.S.C. § 103(a) as obvious over Birch (Pediatric Res. 44(2): 201-
209, 1998) and Carlson (Pediatric Res. 39(5): 882-888, 1996) (Answer 4).
We select claim 1 as representative of the claimed subject matter for the
purpose of deciding this appeal. Claim 1 reads as follows:
A method for enhancing the visual development of term
infants, the method comprising:
a) breast-feeding the term infants from birth to an age of
from about 1.5 months to about 6.5 months;
b) weaning the infants to formula; and
c) administering to those infants a visual development
enhancing amount of DHA and ARA from the time of weaning.

CLAIM INTERPRETATION
Claim 1 is directed to a “method for enhancing visual development of
term infants” comprising a) breast-feeding infants from birth to “an age of
from about 1.5 months to about 6.5 months”; b) weaning the infants; and c)
“administering to those infants a visual development enhancing amount of
DHA and ARA from the time of weaning.”
The preamble of claim 1 states that the method is “for enhancing the
visual development of term infants.” In other words, the purpose of
administering DHA and AA is to enhance an infant’s visual development. It
is well-established that claim language which states a purpose and intended
result of a claimed method does not limit the scope of the claim. Bristol-
Myers Squibb Co. v. Ben Venue Laboratories Inc., 246 F.3d 1368, 1372

1 “Appeal Br.” refers to the Applicant’s Brief on Appeal date stamped
November 13, 2006.
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(Fed. Cir. 2001). Thus, we treat the method’s purpose to enhance visual
development as non-limiting.
Claim 1 also recites that term infants are breast-fed “from birth to an
age of from about 1.5 months to about 6.5 months.” We interpret this to
mean that the breast-feeding period can be from birth to any time point that
falls within the range of “from about 1.5 to 6.5 months.” For example,
breast feeding from birth to 1.5 months of age would meet the limitations of
claim 1.
The DHA and AA are administered to the infants in step c) from “the
time of weaning.” This phrase does not limit the period of time during
which the infants are administered the DHA and AA supplement. Thus, we
interpret step c) to be open-ended, covering administration, for example, for
as little as a day or to a year of age from the time of weaning.

FINDINGS OF FACT
Birch
1. Birch describes feeding terms infants formula supplemented with DHA
and AA to determine their effect on visual acuity (Birch, Abstract;
Answer 4).
2. Visual acuity was measured using sweep evoked potential (VEP) (Birch,
Abstract).
3. Term infants were (a) breast fed from birth through at least 17 weeks of
age or (b) formula-fed from birth to 17 weeks of age with supplemented
formula and thereafter with an unsupplemented commercial formula (Birch,
at p. 203. col. 1).
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4. Birch concludes that supplementation of term infant formula with DHA
(0.35%) or with DHA (0.36%) and AA (0.72%) “during the first 17 weeks
of life yields clear differences in . . . sweep VEP acuity throughout the first
year of life” (Birch, at p. 207, col. 1).
5. There were no significant differences between the DHA diet group and
the DHA and AA diet group, suggesting “that the dietary supply of DHA
(and not AA) is the specific factor which is associated with optimal visual
acuity maturation” (Birch, at p. 207, col. 1).
6. In an earlier study by Carlson (see below) which “used lower levels” of
DHA or DHA + AA, a “preferential looking visual acuity advantage” was
observed at early but not later test ages (Birch, at p. 208, col. 1). Birch states
that several differences between the studies may account for the discrepant
results, including lower levels of DHA, infant age when testing was
completed, and the particular testing protocols for visual acuity (Birch, at p.
208, col. 1).
7. Birch concludes that “early dietary intake of DHA and AA appear
necessary for optimal development of the human brain and eye” (Birch,
at p. 208, col. 2).
Carlson
8. Carlson reports the effect of feeding term infants formula with or without
DHA and AA (Carlson, Abstract; at p. 883, col. 2).
9. Visual acuity was measured using cards with black and white gratings
(“grating acuity”) (Carlson, at pp. 883-884).
10. At two months, breast-fed infants and infants fed the DHA (0.1%) and
AA (0.43%) supplemented formula had higher visual acuity than infant fed
standard formula without DHA and AA (Carlson, Abstract).
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11. The effect of diet was transitory; the effect on visual acuity was not
observed at 4, 6, 9, and 12 months (Carlson, at p. 886, col. 1).
12. Carlson reports that mothers may decide to stop breast-feeding (Carlson,
at p. 883).
Level of ordinary skill in the art
13. The Examiner finds that the “determination and experimentation with
different groups of infants using the same compounds as [the] prior art for
the same purpose as [the] prior art is . . . within the skill of the artisan”
(Final Rejection2 2).
Reason to combine the references
14. Persons of skill in the art would have been motivated to supplement
infant formula with DHA and AA when feeding infants who had been
weaned from breast milk at time before 17 weeks of age based on Birch’s
teachings about the advantages of DHA and AA supplementation (Findings
of Fact (“FF”) 4, 7).
ANALYSIS
Claim 1 is a “method for enhancing visual development of term
infants” that comprises three steps: a) breast-feeding infants from birth to
“an age of from about 1.5 months to about 6.5 months”; b) weaning the
infants; and c) “administering to those infants a visual development
enhancing amount of DHA and ARA from the time of weaning.”
The Examiner finds that each of Birch and Carlson describe feeding
term infants a formula supplemented with DHA and AA to enhance visual
acuity (FF 1, 8) as recited in step c) of claim 1. Claim 1 requires the infants

2 The “Final Rejection” refers to the Office action mailed Aug. 23, 2006.
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to be breast-fed from birth until an “age of from about 1.5 months to about
6.5 months,” followed by administering DHA and AA. In Birch’s study,
however, infants are not breast-fed prior to supplementation (FF 3). Rather,
they are fed with the DHA and AA supplemented formula from birth (FF 3).
However, Birch teaches that supplementing with DHA or DHA and AA
“during the first 17 weeks of life yields clear differences in . . . sweep VEP
acuity throughout the first year of life” (Birch, at p. 207, col. 1; FF 4). Birch
also teaches that “early dietary intake of DHA and AA appear necessary for
optimal development of the human brain and eye” (Birch, at p. 208, col. 2;
FF 7). Thus, if the infants were to be weaned from breast milk any time
before 17 weeks of age,3 Birch’s teaching would have motivated persons of
skill in the art to have supplemented their formula with DHA and AA to
enhance brain and eye development (FF 14) – meeting the limitations of
steps b) and c) of claim 1. Such determination would have been
commensurate with the level of ordinary skill in the art (FF 13).
To establish obviousness, a reason must be provided as to why
persons of ordinary skill in the art would have made the claimed subject
matter. KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007). In this
case, we are in agreement with the Examiner that there was adequate reason
to have combined the teachings of Birch and Carlson.
As reported by Carlson, mothers may decide to stop breast-feeding
(FF 12). In such cases, we are persuaded that Birch’s teaching that DHA
and AA supplementation improves visual acuity (Birch, at p. 207, col. 1; FF
4) and is “necessary for optimal development of the human brain and eye”

3 17 weeks is roughly equivalent to about 4 months.
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(Birch, at p. 208, col. 2; FF 7) would have prompted persons of ordinary
skill in the art to have provided DHA and AA to infants weaned before
about 4 months (17 weeks) – which falls between the claimed “age of from
about 1.5 months to about 6.5 months” as recited in claim 1.
Appellants contend that neither “of the cited references . . . suggest
that DHA and ARA can enhance visual development in an infant that has
been weaned from breast-milk to formula” (Appeal Br. 6). They argue that
Birch teaches that only DHA contributes to enhanced visual acuity, and thus
is “an unambiguous teaching away” from administering “a combination of
both DHA and ARA for enhancing visual development” (Appeal Br. 8).
Appellants also contend that “Carlson found DHA, and not ARA, to be the
essential dietary” fatty acid in its study (Appeal Br. 8-9).
We do not find Birch and Carlson to “teach away” from administering
the combination of DHA and AA. “A reference . . . teache[s] away only
when a person of ordinary skill, upon [examining] the reference, would be
discouraged from following the path set out in the reference, or would be led
in a direction [different] from the path that was taken by the applicant.” In
re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Both Birch and Carlson
administer DHA and AA (FF 1, 8) – and thus teach the same combination
recited in claim 1. Neither ascribes any negative benefit to administering the
combination. In fact, Appellants admit that Carlson teaches that AA may be
necessary in its formula to prevent fatty acid imbalances (Appeal Br. 8).
Birch expressly states that both “DHA and AA appear necessary for optimal
development of the human brain and eye” (Birch, at p. 208, col. 2; FF 7).
Thus, we do not find that either Carlson or Birch would have discouraged
persons of skill in the art to have administered a combination of DHA and
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AA. The fact that AA may be included for a purpose different from
enhancing visual development – such as to prevent fatty acid imbalances or
to elicit optimal brain development – does not change our conclusion. We
have interpreted the claim preamble “for enhancing visual development of
term infants” to be non-limiting. Thus, any reason for administering the
combination of DHA and AA to term infants would meet the limitations of
claim 1.
Appellants also contend that persons of ordinary skill in the art would
not have been motivated to have supplemented with DHA since Carlson
teaches that its effect on visual acuity was transient (Appeal Br. 10).
We are not convinced by this argument that the Examiner erred. First,
Carlson does teach a higher visual acuity at two months of age in infants fed
formula supplemented with DHA and AA (FF 10). Thus, persons of
ordinary skill in the art would have been motivated to feed infants weaned at
two months or before – an age that falls within “about 1.5 months” as recited
in claim 1 – with the Carlson’s supplement comprising DHA and AA to
achieve this increase in visual acuity, even if it may prove to be transitory.
Secondly, Birch recognizes that its results showing the persistence of
the DHA effect until one year of age differs from Carlson’s results, but
states that the discrepancy may be explained by differences in levels of DHA
and AA and the testing protocol for visual acuity (FF 6). Compare Carlson’s
0.1% DHA and 0.43% AA (FF 10) to Birch’s 0.36% DHA and 0.72% AA
(FF 4); compare Carlson’s grating acuity (FF 9) to Birch’s VEP (FF 2) as a
measure of visual acuity. Thus, we do not agree that Carlson’s transient
effect on visual acuity with DHA and AA would have discouraged persons
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of ordinary skill from administering the same combination to infants since
Birch shows persistence of the effect at higher doses.
Appellants argue that “the references focus on supplementation during
the early period of life and do not indicate that post-weaning
supplementation would provide any benefit at all” (Appeal Br. 12).
Claim 1 recites that term infants are breast-fed “from birth to an age
of from about 1.5 months to about 6.5 months.” We interpreted this to mean
that the breast-feeding period can be from birth to any time from about 1.5 to
6.5 months, including from birth to 1.5 or 2 months (see supra at p. 2-3).
While neither Birch nor Carlson describes breast-feeding following by DHA
and AA supplementation, persons of ordinary skill in the art would have
recognized from Birch’s teaching about the advantages of early
supplementation with DHA and AA that infants weaned from breast milk
any time prior to 17 weeks would benefit from supplementation, providing
the motivation to have done so (FF 14). The Examiner finds, and we agree,
that making such determination would have been within the skill of the
ordinary artisan (FF 13).
Appellants assert that
Carlson found “no overall effect of diet on visual acuity.”
Accordingly, any overall improvement of visual acuity in the
present application would indicate unexpected results over
Carlson. The present invention illustrates dramatic
improvements over the results found in Carlson
(Appeal Br. 13 (reference omitted)).
We do not find this argument persuasive. As discussed above, despite
Carlson’s results with lower dosages, Birch shows that increased amounts of
DHA and AA have a persistent effect on visual acuity (FF 4) and are
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necessary for optimal brain and eye development (FF 7). Thus, the skilled
worker would have expected DHA and AA to effect development.
Appellants also contend:
The present invention additionally provides unexpected results
over the results shown in Birch. Birch found no improvement in
VEP between LCPUFA-supplemented infants and control
infants at 26 weeks of age. Birch attributed this result to a
“plateau effect” of visual development in infants. Birch found
that infant visual development plateaus from about 25-35
weeks. Birch, p. 207. In contrast to the teaching of Birch,
however, the present invention teaches that DHA and ARA
supplementation according to the method of the present
invention can actually increase VEP acuity at 26 weeks of age
and that there is no plateau effect at 26 weeks of age.
(Appeal Br. 14).
According to Birch, the prior art teaches that there “is initial rapid
development of VEP acuity during the first 15-20 wk of life, followed by a
plateau, which extends from about 25-35 wk, and then a slower period of
visual development” to adult levels (Birch, at p. 207, col. 2). Birch states
that it “is easiest to detect differences among groups during rapid periods of
change and most difficult during a developmental plateau. Thus, it would be
expected that the clearest differences among groups would emerge at the 6-,
17-, and 52-wk time periods” (id.).
Appellants show “good agreement between” their results and those of
Birch at 17- and 52-weeks (Specification 50: 24-25). “It is only at 26 weeks
that there is a significant difference in the outcomes of the 2 studies”
(Specification 50: 25-26). They argue that this “is a surprising and
unexpected benefit that the present invention provides over Birch” (Appeal
Br. 14).
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We do not find this data persuasive. Evidence of unexpected results
must be commensurate with the full scope of the claim. In re Harris, 409
F.3d 1339, 1344 (Fed. Cir. 2005). In this case, the evidence provided by
Appellants is based on an example in which infants were weaned at 6 weeks
of age and then maintained on a supplement containing DHA and AA until
one year of age (Specification 32: 1-6; 33: 15-30). The amount of DHA and
AA was 0.36% and 0.72%, respectively (Specification 33: 15-20).
However, the claims are not limited to these amounts nor to administering
the supplement to infants until one year of age. According to step c) of
claim 1, the DHA and AA are administered “from the time of weaning.” We
have interpreted this step to be open-ended, covering, for example,
administration for as little as a day or to a year of age (see supra at pp. 2-3).
Appellants have not provided evidence that other amounts of DHA and AA
administered for periods less than 26 weeks4 would result in enhanced
acuity at 26 weeks of age. Thus, the showing is not commensurate with the
broader scope of claim 1.
In addition to this, having concluded that it would have been obvious
to have administered DHA and AA to infants who had been weaned from
breast milk, we consider the increase in visual acuity at 26 weeks to be the
recognition of a latent advantage of an obvious invention. “Mere
recognition of latent properties in the prior art does not render nonobvious

4 Birch administered DHA and AA until 17 weeks of age (FF 3). Thus, the
relevant period for the showing would be from 17 to 26 weeks of age. The
upper limit is 26 weeks because that it is when the “unexpected benefit” is
observed (Appeal Br. 14).
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an otherwise known invention.” In re Baxter Travenol Labs., 952 F.2d 388,
392 (Fed. Cir. 1991).
For the foregoing reasons, we affirm the rejection of claim 1. Claims
2-39 fall with claim 1 because separate reasons for their patentability were
not presented. See 37 C.F.R. § 41.37(c)(1)(vii).

TIME PERIOD
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

APJ initials:

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