Ex Parte Fichot et al

Patent Trial and Appeal Board

May 12, 2016

12741985 (P.T.A.B. May. 12, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
121741,985 05/07/2010
29157 7590
K&L Gates LLP-Chicago
P.O. Box 1135
CHICAGO, IL 60690
05/16/2016
FIRST NAMED INVENTOR
Marie-Claire Fichot
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
3712036-1074 1213
EXAMINER
HANLEY, SUSAN MARIE
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
05/16/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
USpatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARIE-CLAIRE FICHOT
and NORBERT SPRENGER
Appeal2013-007454
Application 12/741,985
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a
synthetic nutritional composition. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as Nestec S.A. (see App. Br.
2).
Appeal2013-007454
Application 12/741,985
Statement of the Case
Background
The Specification teaches that "the co-administration of sialylated
oligosaccharides and N-acetyl-lactosamine and/ or oligosaccharides
containing N-acetyl-lactosamine is particularly effective in the prevention of
secondary infections following viral infections such as influenza" (Spec. 3, 1.
26 to 4, 1. 2).
The Claims
Claims 1 and 3-11 are on appeal. Claim 1 is representative and reads
as follows:
1. A synthetic nutritional composition suitable for use in the
prevention of secondary infections following a viral infection
characterised by neuraminidase activity, the composition
comprising a sialylated oligosaccharide selected from the group
consisting of 3' sialyllactose, 6' sialyllactose and a combination
thereof and a component selected from the group consisting of
N-acetyl-lactosamine, an oligosaccharide containing N-acetyl-
lactosamine, and a combination thereof.
The Issues
A. The Examiner rejected claims 1 and 3-11 under 35 U.S.C. § 103(a) as
obvious over Sprenger,2 Morrow,3 and Prieto4 (Ans. 2-8)5.
2 Sprenger et al., WO 2007/101675 Al, published Sept. 13, 2007.
3 Morrow et al., US 2007/0275881 Al, published Nov. 29, 2007.
4 Prieto et al., US 6,045,854, issued Apr. 4, 2000.
5 We recognize that the Examiner sets forth two rejections over the same
prior art, referencing the prior art in different orders (see Ans. 2-8).
However, "where a rejection is predicated on two references each containing
pertinent disclosure which has been pointed out to the applicant, we deem it
to be of no significance, but merely a matter of exposition, that the rejection
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Application 12/741,985
B. The Examiner rejected claims 1 and 3-11 on the ground of
obviousness type double patenting over claims 1 and 5-11 of US 12/281,448
(now issued as US 9,005,682), Prieto, Sprenger, and Morrow (Ans. 8-11).
C. The Examiner rejected claims 1 and 3-11 on the ground of
obviousness type double patenting over claim 1 of US 12/278,918 (now
issued as US 8,361,530), Prieto, Sprenger, and Morrow (Ans. 11-14).
A. 35 U.S.C. § 103(a) over Sprenger, Prieto, and Morrow
The Examiner finds it obvious to "combine the infant formulae of
Prieto and Sprenger ... because both formulae have beneficial health effects
for infants. Since the composition components are known, it is considered
prima facie obvious to combine them into a single composition useful for the
very same purpose, e.g., improving infant health" (Ans. 7).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Sprenger, Prieto, and Morrow
render claims 1, 4, 8, and 9 obvious?
Findings of Fact
1. Sprenger teaches "a probiotic and a prebiotic mixture which is
specifically designed to enhance the efficiency and the efficacy of the
probiotic and to food products comprising said preparation" (Sprenger 1, 11.
5-7).
is stated to be on A in view of B instead of on B in view of A, or to term one
reference primary and the other secondary." In re Bush, 296 F.2d 491, 496
(CCPA 1961)
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Application 12/741,985
2. Sprenger teaches that "in some cases breast feeding is
inadequate or unsuccessful for medical reasons or the mother chooses not to
breast feed. Infant formulae have been developed for these situations"
(Sprenger 2, 11. 30-32).
3. Sprenger teaches that a "pre biotic is a non-digestible food
ingredient that beneficially affects the host by selectively stimulating the
growth and/or activity of one or a limited number of bacteria in the colon,
and thus improves host health" (Sprenger 3, 11. 6-9).
4. Sprenger teaches
a prebiotic mixture comprising 5-70 wt% of at least one N-
acetylated oligosaccharide selected from the group comprising
GalNAca 1,3Gala 1,4Glc and Gal~ 1,6GalNAca 1,3Gal~ 1,4Glc,
20-95 wt% of at least one neutral oligosaccharide selected from
the group comprising Gal~l,6Gal, Gal~l,6Gal~l,4Glc
Gal~ 1,6Gal~l,6Glc, Gal~ 1,3Gal~ 1,3Glc, Gal~ 1,3Gal~ 1,4Glc,
Gal~ 1,6Gal~ 1,6Gal~ 1,4Glc, Gal~ 1,6Gal~ 1,3Gal~ 1,4Glc
Gal~ 1,3Gal~ 1,6Gal~ 1,4Glc and Gal~ 1,3Gal~ l ,3Gal~ l ,4Glc
and 5-50 wt% of at least one sialylated oligosaccharide selected
from the group comprising NeuAca2,3Gal~l,4Glc and
NeuAca2,6Gal~ 1,4Glc.
(Sprenger 4, 1. 32 to 5, 1. 6).
5. Sprenger teaches that the "sialylated oligosaccharides 3'sialyl-
lactose and 6'sialyl-lactose may be isolated by chromatographic or filtration
technology from a natural source such as animal milks" (Sprenger 10, 11. 30-
31). Sprenger teaches a composition with "3 wt% ofNeuAca2,3Gal~l,4Glc
and NeuAca2,6Gal~l,4Glc[.] It may ... be added directly to a food product
such as an infant formula" (Sprenger 15, 11. 29-31 ).
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Application 12/741,985
6. Prieto teaches that "oligosaccharides can inhibit the binding of
bacteria to epithelial cells, acting as decoys by competing with cell
receptors. Additionally, oligosaccharides protect infants from viral and
bacterial infections of the respiratory, gastrointestinal, and urogenital tracts"
(Prieto, col. 1, 11. 59---64 ).
7. Prieto teaches that "[p ]neumococcal attachment was inhibited
by both high and low molecular weight fractions, specifically lactose-N-
tetraose ... and lactose-N-neotetraose" (Prieto, col. 1, 11. 54--57).
8. Prieto teaches "a synthetic nutritional formulation that contains
at least one of the following oligosaccharides in the recited concentration
ranges ... from about 100 to about 900 mg/L of Lacto-N-neoTetraose ...
or from about 120 to about 2800 mg/L of lacto-N-tetraose" (Prieto, col. 2, 11.
32--44).
9. Prieto teaches that the "oligosaccharides used in the nutritional
formulation of this invention can be prepared in any manner, preferably, by
chemical synthesis" (Prieto, col. 5, 11. 9-11).
10. Prieto teaches a "ready-to-feed infant formulation containing
the oligosaccharides 3-fucosyllactose, lacto-N-fucopentaose III, lacto-N-
fucopentaose II, difucosyllactose, 2' fucosyllactose, lacto-N-fucopentaose I,
Lacto-N-neo Tetraose, lacto-N-fucopentaose V and lacto-N-tetraose" (Prieto,
col. 9, 11. 44--48).
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR!nt'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "If a person of
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Application 12/741,985
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability." Id. at 417.
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 2-8; FF 1-8) and agree that the
claims are rendered obvious by Sprenger, Prieto, and Morrow. We address
Appellants' arguments below.
Claim 1
Appellants contend that they "surprisingly found that the co-
administration of sialylated oligosaccharides and N-acetyl-lactosamine
and/or oligosaccharides containing N-acetyl-lactosamine is particularly
effective in the prevention of secondary infections following viral infections
such as influenza" (App. Br. 6).
We do not find this argument persuasive because no evidence of this
asserted "surprising" result is provided, either in the Specification or in a
Declaration. The only example in the Specification is limited to an
exemplary composition with no results provided (Spec. 14). "It is well
settled that unexpected results must be established by factual evidence.
Mere argument or conclusory statements ... [do] not suffice." In re Soni,
54 F.3d 746, 750 (Fed. Cir. 1995).
Appellants contend that "[ d]ue to the different origin and different
structure, the skilled artisan would not have been motivated to modify Prieto
with Sprenger. In contrast to BMOs [bovine milk oligosaccharides], Prieto
only notes that human milk oligosaccharides have known beneficial
biological effects" (App. Br. 8).
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We are not persuaded. Both Sprenger and Prieto are directed towards
addition of components to infant formula (FF 2, 10), and both Sprenger and
Prieto suggest the addition of these components to improve host health (FF
3, 6). Combining these components in a single formula to improve infant
health is consistent with Wrigley, where the Federal Circuit found a "strong
case of obviousness based on the prior art references of record. [The claim]
recites a combination of elements that were all known in the prior art, and all
that was required to obtain that combination was to substitute one well-
known ... agent for another." Wm. Wrigley Jr. Co. v. Cadbury Adams USA
LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012). We agree with the Examiner
that "[s]ince the composition components are known, it is considered prima
facie obvious to combine them into a single composition useful for the very
same purpose, e.g., improving infant health" (Ans. 4). We note that
Appellants provide no evidence rebutting the teachings in Sprenger that
sialyllactoses improve health and are desirable additions to infant formula
(FF 1-5).
Appellants contend that "the Examiner relied on hindsight
reconstruction of the claimed invention to arrive at the claimed composition.
Indeed, only with a hindsight reconstruction of Appellants' claimed
invention is the Examiner able to even attempt to piece together the
teachings of the prior art to arrive at independent Claim 1" (App. Br. 8).
While we are fully aware that hindsight bias often plagues
determinations of obviousness, Graham v. John Deere Co., 383 U.S. 1, 36
(1966), we are also mindful that the Supreme Court has clearly stated that
the "if a technique has been used to improve one device, and a person of
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Application 12/741,985
ordinary skill in the art would recognize that it would improve similar
devices in the same way, using the technique is obvious unless its actual
application is beyond his or her skill." KSR, 550 U.S. at 417.
That is precisely the rejection at issue here, where Sprenger suggests
the incorporation of sialyllactose into infant formula because the addition
"beneficially affects the host ... and thus improves host health" (FF 3) and
where Prieto teaches the incorporation ofN-acetyl-lactosamines such as
lactose-N-tetraose and lactose-N-neotetraose (FF 7) "in order protect infants
from viral and bacterial infections of the respiratory, gastrointestinal, and
urogenital tracts" (FF 6). The combination of two different ingredients, both
taught to improve infant health when incorporated into infant formula (FF 3,
6), does not represent hindsight. Rather, the use of the combination of
sialyllactose and N-acetyl-lactosamines to improve infant formula is nothing
"more than the predictable use of prior art elements according to their
established functions." KSR, 550 U.S. at 417. Cf In re Gee, 614 Fed. Appx.
495, 498 (Fed. Cir. 2015).
Claims 4 and 8
Appellants contend that the "ratio between 3' sialyllactose and 6'
sialyllactose was not recognized as a result effective variable for preventing
secondary infections following a viral infection characterized by
neuramidase activity" (App. Br. 9). Appellants contend that "the amount of
sialylated oligosaccharide was not recognized as a result effective variable
for preventing secondary infections following a viral infection characterized
by neuramidase activity" (App. Br. 10).
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Application 12/741,985
We do not find these arguments persuasive because Sprenger teaches
ranges for the amount of sialyllactose that may be added to the infant
formula (FF 4), thus evidencing that the amounts may be optimized within
the claimed range. Moreover, Sprenger evidences a 1: 1 ratio of 3' and 6'
sialyllactose, a value within the claimed range (FF 5). See In re Peterson,
315 F.3d 1325, 1329 (Fed. Cir. 2003) ("A prima facie case of obviousness
typically exists when the ranges of a claimed composition overlap the ranges
disclosed in the prior art.") Appellants provide no evidence of any
secondary consideration such as unexpected results for the specific range
required by claims 4 and 8.
Claim 9
Appellants contend that "the amount ofN-acetyl-lactosamine was not
recognized as a result effective variable for preventing secondary infections
following a viral infection characterized by neuramidase activity" (App. Br.
11).
We do not find this argument persuasive because Prieto teaches
ranges for the amounts ofN-acetyl-lactosamine, specifically teaching the use
of "from about 100 to about 900 mg/L ofLacto-N-neoTetraose ... or from
about 120 to about 2800 mg/L of lacto-N-tetraose" (FF 8), ranges that
overlap the amounts required by claim 9. Peterson, 315 F.3d at 1329.
Appellants provide no evidence of any secondary consideration such as
unexpected results for the specific range required by claim 9.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
Sprenger, Prieto, and Morrow render claims 1, 4, 8, and 9 obvious.
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B. and C. Obviousness-type Double Patenting
Appellants do not argue the double patenting rejections. We therefore
summarily affirm the obviousness-type double patenting rejections. See
Manual of Patent Examining Procedure§ 1205.02 ("If a ground of rejection
stated by the examiner is not addressed in the appellant's brief, that ground
of rejection will be summarily sustained by the Board.")
SUMMARY
In summary, we affirm the rejection of claim 1, 4, 8, and 9 under 35
U.S.C. § 103(a) as obvious over Sprenger, Morrow, and Prieto. Claims 3,
5-7, 10, and 11 fall with claim 1.
We affirm the rejection of claims 1 and 3-11 on the ground of
obviousness type double patenting over claims 1 and 5-11 of US 12/281,448
(now issued as US 9,005,682), Prieto, Sprenger, and Morrow.
We affirm the rejection of claims 1 and 3-11 on the ground of
obviousness type double patenting over claim 1 of US 12/278,918 (now
issued as US 8,361,530), Prieto, Sprenger, and Morrow.
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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