Ex Parte Burgher et al

Board of Patent Appeals and Interferences

Jan 6, 2009

10681489 (B.P.A.I. Jan. 6, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ANITA MARIA BURGHER,
SUSAN MARIE KAUP, and CHARLES FRANCIS KUHLMAN
__________

Appeal 2008-5439
Application 10/681,489
Technology Center 1600
__________

Decided: January 06, 2009
__________

Before ERIC GRIMES, LORA M. GREEN, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

Opinion for the Board filed by Administrative Patent Judge GREEN.
Opinion Dissenting filed by Administrative Patent Judge GRIMES.
GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 1-3 and 5-7. We have jurisdiction under
35 U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to an infant formula. Claim 1 is
representative of the claims on appeal, and reads as follows:
1. An infant formula composition comprising 3.2 mg/L to 15.4 mg/L of
CMP; 1.8 mg/L to 11.0 mg/L of UMP; 2.4 mg/L to 8.0 mg/L of GMP; 0.1
mg/L to 2.2 mg/L of IMP; and 2.5 mg/L to 13.2 mg/L of AMP.
The Examiner relies on the following reference:
Gil US 5,066,500 Nov. 19, 1991
We affirm.

ISSUE
The Examiner finds that claims 1-3 and 5-7 are anticipated by Gil.
Appellants contend that Gil does not teach how much nucleotide is
present in the infant formulas therein; and also contend that Gil does not
anticipate the amount of GMP required by the claims on appeal.
Thus, the issue on Appeal is: Does Gil does teach how much
nucleotide is present in the infant formulas therein; and does Gil anticipate
the amount of GMP required by the claims on appeal?

FINDINGS OF FACT
FF1 The Examiner rejects claims 1-3 and 5-7 under 35 U.S.C. § 102(b) as
being anticipated by Gil.
FF2 The Examiner finds that Gil
teaches an infant formula adding on a liquid basis, per dl:
• 0.28-2.62 mg of uridine phosphate,
• 0.04- 0.5 mg of guanosine phosphate,
• 0.64-1.43 mg of adenosine phosphate,
• 0.53- 1.53 [mg] of cytidine phosphate and
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• 0-0.29 mg of inosine phosphate (col. 5, line 66-col 6 line
5; and claim 12).

(Ans. 3-4 (see Gil, col. 5, l. 67-col. 6, l. 5; see also col. 10, Table I).)
FF3 The Examiner finds further that Gil teaches that “the terms uridine
phosphate, guanosine phosphate, etc [are] intended to refer collectively to
mono, di and/or tri phosphates but that for reasons known to those skilled in
the art, the 5'-monophosphates are preferred.” (Ans. 3.)
FF4 According to the Examiner, Gil teaches that the “supplementation of
nucleotides to infant formulas of Gil [ ] gives a better physiological fatty
acid tissue membrane to newborns, an improved cell immunity and better
intestinal repair to those patients with intestinal diseases.” (Id. at 4.)
FF5 Gil discloses “infant formulas and clinical nutrition products enriched
with nucleosides, nucleotides or mixes of these two classes of compounds.”
(Gil, col. 4, ll. 66-68.)
FF6 Gil teaches that “[i]n general, infant formulas tend to have a
composition qualitatively and quantitatively as similar as possible to human
milk.” (Col. 1, ll. 62-64.)
FF7 Specifically, Gil teaches:
[O]ne embodiment of the present invention provides for a
nutritionally balanced diet formulation which comprises a
source of amino nitrogen, carbohydrates, edible fats, minerals,
vitamins and a nucleoside/nucleotide composition containing at
least one of:
a) uridine, uridine phosphate or a mixture thereof;
b) guanosine, guanosine phosphate or a mixture thereof;
c) adenosine, adenosine phosphate or a mixture thereof;
d) cytidine, cytidine phosphate or a mixture thereof; or
e) inosine, inosine phosphate or a mixture thereof.
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Thus, the formulation must contain at least one of the
fifteen different possible components in an amount (based on
100 grams of dry product) equal to 1 mg.

(Col. 5, ll. 21-34).
FF8 Gil teaches that the “content of nucleosides and/or nucleotides in the
infant formulas of the present invention are in the range of those for human
milk. An exemplary nucleoside and/or nucleotide mixture for infant
formulas not containing cow’s milk, according to the invention, is shown in
Table I [i.e., the amount found by the Examiner in FF2].” (Col. 8, l. 65-col.
9, l. 2).
FF9 Thus, Gil teaches that the formula may contain only nucleoside,
only nucleotide, or a mixture thereof. Therefore, Gil discloses infant
formulas (Cols. 9-10, ll. 7-18) comprising (per deciliter) a mixture of
0.28-2.62 mg of uridine phosphate,
0.04-0.5 mg of guanosine phosphate,
0.64-1.43 mg of adenosine phosphate,
0.53-1.53 mg of cytidine phosphate and
0-0.29 mg of inosine phosphate
FF10 A comparison of the amount of nucleotide required by the claimed
formula to the formula of Gil is set forth below.
nucleotide Claim 1 in mg/dl1 Claim 2 in mg/dl Gil in mg/dl
From Table I
CMP 0.32-1.54 0.42-1.16 0.53-1.53
UMP 0.18-1.10 0.24-0.83 0.28-2.62

1 The claimed amounts are in “mg/L”. These values were converted to
deciliters (“dl”) by dividing by 10.
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GMP 0.24-0.8 0.24-0.6 0.04-0.5
IMP 0.01-0.22 0.01-0.17 0.00-0.29
AMP 0.25-1.32 0.33-0.99 0.64-1.43

FF11 Thus the claimed ranges do not substantially deviate from the ranges
disclosed by Gil, e.g., , overlapping at least one end of the range and very
close to the numerical value disclosed by Gil for the other end of the range.

PRINCIPLES OF LAW
“It is well settled that a claim is anticipated if each and every
limitation is found either expressly or inherently in a single prior art
reference.” Celeritas Techs. Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354,
1361 (Fed. Cir. 1998). In addition, “[a]nticipation does not require the
actual creation or reduction to practice of the prior art subject matter;
anticipation requires only an enabling disclosure.” Schering Corp. v.
Geneva Pharmaceuticals, 339 F.3d 1373, 1380 (Fed. Cir. 2003).
Anticipation has been found even when a prior art range “does not
exactly correspond to [the] claimed range,” but the prior art range “does not
significantly deviate from, [the] claimed ranges.” See Perricone v. Medicis
Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005) (court found that a
claimed range of 0.025 to 5% did not significantly deviate from a prior art
range of 0.01 to 20%). We recognize that in Perricone, the prior art range
“entirely encompasse[d]” the claimed ranges. But the court cited Atlas
Powder Co. v. Ireco Inc., 190 F.3d 1342, 1346 (Fed. Cir. 1999) for the
proposition that “[w]hen a patent claims a chemical composition in terms of
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ranges of elements, any single prior art reference that falls within each of the
ranges anticipates the claim.” Perricone, 432 F.3d at 1377. Thus, we
interpret the court’s holding in Perricone as resting on the amount of
deviation between the prior art range and the claimed range, and not
specifically requiring that the prior art range completely encompass the
claimed range. See, e.g., Atofina v. Great Lakes Chemical Corp., 441 F.3d
991, 999 (Fed. Cir. 2006) (finding that a disclosed temperature range of 100
to 500°C did not anticipate the claimed temperature range of 330 to 450°C,
even though the prior art range encompassed the claimed range, because
“[g]iven the considerable difference between the claimed range and the
range in the prior art, no reasonable fact finder could conclude that the prior
art describes the claimed range with sufficient specificity to anticipate this
limitation of the claim.”).

ANALYSIS
Appellants argue that Gil “teaches the supplementation of infant
formula with nucleosides and/or nucleotides, specifically 0.28-2.8 mg/dl
uridine and/or uridine phosphate, 0.04-0.50 mg/dl guanosine and/or
guanosine phosphate, 0.64-1.43 mg/dl adenosine and/or adenosine
phosphate, 0.53-1.53 mg/dl cytidine and/or cytidine phosphate, and 0-0.29
mg/dl inosine and/or inosine phosphate.” (App. Br. 4-5). According to
Appellants, Gil does not teach an infant formula containing the claimed
ranges of nucleotides, but instead in Gil, “nucleosides and nucleotides are
lumped together without clearly stating how much of each is included.” (Id.
at 5.) Appellants assert further that Gil does “not state that any minimum
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amount of nucleotide is required,” and in fact teaches that “nucleosides are
more effective that nucleotides.” (Id.)
Moreover, Appellants assert, Gil does state the “concentrations of
CMP, GMP, AMP, UMP and IMP in human milk, including a range of 0.04-
0.21 mg/dl GMP, and further states that the patented invention uses
nucleosides/nucleotides in the range that they are present in human milk.”
(Id.) Appellants argue that teaching of Gil would require the formula of Gil
to contain 0.04 to 0.21 mg/dl GMP, whereas the formula of claim 1 requires
0.24 to 0.80 mg/dl (i.e., 2.4 mg/L to 8.0 mg/L), and thus Gil suggests using
less GMP than is required by the formula of claim 1 (id.).
Appellants’ arguments are not convincing. Gil makes clear that when
the reference is referring to nucleosides and nucleotides, the formula or
dietary supplement can contain all nucleosides, all nucleotides, or a mixture
of both (FF8). Thus Gil anticipates formulas containing only nucleotides as
required by the instant claims (FF9).
Moreover, while Gil may have a preferred range of 0.04-0.21 mg/dl of
GMP, the reference clearly teaches a range of 0.04-0.5 mg/dl of GMP (FF9),
which is not substantially different from the range required in claim 1 of
0.24-0.8 mg/dl (2.4 mg/L to 8.0 mg/L) GMP (FF10-11), and Appellants do
not point out why the overlapping range disclosed by Gil would not
anticipate the range of GMP required by claim 1.
We thus affirm the rejection as to claim 1. As Appellants do not
argue claims 5 and 6 separately from claim 1, the rejection is also affirmed
as to those claims. 37 C.F.R. § 41.37(c)(1)(vii).
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As to claims 2 and 3, Appellants argue that the ranges of GMP
required by the claims are even farther from the preferred range of Gil of
0.04-0.21 mg/dl (App. Br. 6). But, as discussed above, while that range may
be preferred by Gil, Gil clearly teaches a range of 0.04-0.5 mg/dl of GMP
(FF9), and Appellants do not present any argument or reasoning as to why
that broader range would not anticipate the ranges required by claims 2 and
3.
As to claim 7, Appellants argue that the claim requires feeding the
formula of claim 1 to a preterm infant, and as Gil does not teach the formula
of claim 1, the reference cannot teach feeding the formula of claim 1 to
infants (App. Br. 6). However, we have found that Gil anticipates the
formula of claim 1, and the reference also anticipates feeding the formula to
preterm infants (Answer 4; Gil, col. 13, ll. 53-57). The rejection is therefore
also affirmed as to claim 7.
CONCLUSIONS OF LAW
Thus, we find that Gil does teach how much nucleotide is present in
the infant formulas therein; and Gil also anticipates the amount of GMP
required by the claims on appeal.
The rejection of claims 1-3 and 5-7 under 35 U.S.C. § 102(b) is
therefore affirmed.
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TIME LIMITS
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

dm

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GRIMES, Administrative Patent Judge, dissenting.
I respectfully dissent. I agree with my colleagues that Gil discloses
compositions that have the same ingredients, in similar amounts, to those of
the claims on appeal. In my view, however, the facts of this case do not
support a finding of anticipation.
The majority relies on Perricone v. Medicis Pharm. Corp., 432 F.3d
1368 (Fed. Cir. 2005), concluding that the claimed ranges in this case, as in
Perricone, do not deviate significantly from the ranges disclosed in the prior
art. Ante at 5-6. The claims in Perricone were directed to methods of
treating skin using a composition containing fatty acid esters of ascorbic
acid. 432 F.3d at 1373. The claims recited different amounts of fatty acid
esters, ranging “from an ‘effective’ amount in claim 1 to particular specific
ranges in other claims (e.g., ‘up to 10% by weight,’ ‘063 patent, claim 2;
‘from about 0.025% to about 5% by weight,’ ‘063 patent, claim 3; ‘from
about 0.025% to about 10% by weight,’ ‘063 patent, claim 22).” Id. at 1377.
The prior art reference in Perricone disclosed topical application of a
composition comprising a fatty acid ester of ascorbic acid in an amount of
0.01 to 20% by weight. See id. The court held that the prior art range
“entirely encompasses, and does not significantly deviate from, [the]
claimed ranges,” and that the prior art compositions met the limitations of
the claims on appeal. Id.
Perricone must be contrasted with Atofina v. Great Lakes Chemical
Corp., 441 F.3d 991 (Fed. Cir. 2006), which was decided only three months
later. The claims in Atofina were directed to a method of making difluoro-
methane: “Claim 1 requires that the process be conducted in the presence of
0.1 to 5 moles of oxygen per 100 moles of methylene chloride, at a
temperature of between 330 and 450 °C.’” 441 F.3d at 993.
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The prior art reference in Atofina disclosed a similar process carried
out at a temperature between 100° C and 500° C and using 0.001 to 1.0%
oxygen to methylene chloride (rather than 0.1 to 5% as claimed). Id. at 994,
999. The Atofina court held that
the prior art . . . discloses a temperature range of 100 to 500 °C
which is broader than and fully encompasses the specific
temperature range claimed . . . of 330 to 450 °C. Given the
considerable difference between the claimed range and the
range in the prior art, no reasonable fact finder could conclude
that the prior art describes the claimed range with sufficient
specificity to anticipate this limitation.
Id. at 999.
That is, Perricone held that a prior art range of 0.01 to 20%
anticipated, among others, a claimed range of 0.025% to about 5% because it
fully encompassed the claimed range and did not deviate from it
significantly. The claimed range in Perricone made up about 25% of the
prior art range.2 And Atofina held that a prior art range of 100 to 500° C that
fully encompassed a claimed range of 330 to 450° C did not anticipate
because there was a “considerable difference” between the two ranges. The
claimed range in Atofina made up 30% of the prior art range.3
The Atofina court cited Perricone (see 441 F.3d at 999) but did not
explain why the facts of the two cases resulted in different outcomes. The
cases provide no general principle, for example, for determining whether
Gil’s disclosure of a composition comprising 0 to 0.29 mg/dl of IMP
anticipates the limitation of claim 1 requiring 0.01 to 0.22 mg/dl of IMP.

2 (5 – 0.025)/(20 – 0.01) x 100 = 24.9%.
3 120/400 x 100 = 30%.
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Reconciling Perricone and Atofina can be left for another day, however,
since the other ranges disclosed by Gil do not fully encompass the ranges
recited in the claims.
In my view, that fact makes this case more similar to Atofina than to
Perricone. Besides addressing the difference in temperature ranges, the
Atofina court also addressed the difference between the prior art’s disclosure
of a 0.001 to 1.0% ratio of oxygen to methylene chloride, compared to the
claimed range of 0.1 to 5%. 441 F.3d at 1000. The court held that the prior
art range did not anticipate: “Once again, although there is a slight overlap,
no reasonable fact finder could determine that this overlap describes the
entire claimed range with sufficient specificity to anticipate this limitation of
the claim.” Id.
Here, as discussed in detail by the majority, most of the ranges
disclosed by Gil overlap the ranges recited in the claims:4
• for UMP, claim 1 recites 0.18-1.10 mg/dl, while Gil discloses 0.28-
2.62 mg/dl;
• for GMP, claim 1 recites 0.24-0.8 mg/dl, while Gil discloses 0.04-
0.5 mg/dl;
• for AMP, claim 1 recites 0.25-1.32 mg/dl, while Gil discloses 0.64-
1.43 mg/dl.

4 Gil’s CMP range of 0.53-1.53 mg/dl is entirely within claim 1’s range of
0.32-1.54 mg/dl, which the Atofina court implied would suffice to anticipate
that limitation. See 441 F.3d at 999 (“Titanium Metals stands for the
proposition that an earlier species reference anticipates a later genus
claim.”).
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The claimed and prior art ranges here are closer than those in Atofina,
where the claimed composition could have a ratio of oxygen to methylene
chloride five times higher than what was disclosed in the prior art. See 441
F.3d at 1000. Nonetheless, the critical question under Atofina, as I
understand it, is whether the prior art range “describes the entire claimed
range with sufficient specificity to anticipate this limitation.” 441 F.3d at
999.
In this case, the prior art composition can include 2.5 times as much
UMP as allowed by claim 1 (2.62 compared to 1.10 mg/dl), while claim 1
can include 1.5 times as much GMP (0.8 compared to 0.5 mg/dl) and less
than half the AMP (0.25 compared to 0.64 mg/dl) as the prior art
composition.
I cannot say that the ranges disclosed in Gil describe each of the
ranges recited in claim 1 with sufficient specificity to anticipate them.
“Under 35 U.S.C. § 102, every limitation of a claim must identically appear
in a single prior art reference for it to anticipate the claim.” Gechter v.
Davidson, 116 F.3d 1454, 1457 (Fed. Cir. 1997). In my view, therefore,
Atofina requires reversal of the rejection on appeal.

dm
Wyeth
Patent Law Group
5 Giralda Farms
Madison, NJ 07940

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