Ex Parte Angstrom et al

Patent Trial and Appeal Board

Dec 23, 2013

10518297 (P.T.A.B. Dec. 23, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JONAS ANGSTROM, SUSANN TENEBERG,
JUHANI SAARINEN, TERO SATOMAA, JARI NATUNEN,
HALINA MILLER-PODRAZA, KARL-ANDERS KARLSSON,
MAAN ABUL-MILH, and NIAMH ROCHE1
__________

Appeal 2012-006592
Application 10/518,297
Technology Center 1600
__________

Before TONI R. SCHEINER, ERICA A. FRANKLIN, and
SUSAN L. C. MITCHELL, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the rejection of claims
directed to a method of treating or preventing a gastrointestinal infection.
The Examiner has rejected the claims as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).

1 Appellants identify the Real Party-In-Interest as Nestec LTD. (App. Br. 2.)

Appeal 2012-006592
Application 10/518,297
2

STATEMENT OF THE CASE
Claims 92, 94-97, and 106-115 are pending and on appeal. Claims
76-91 and 98-104 have been withdrawn from consideration, while claims
1-75, 93, and 105 have been canceled (App. Br. 4).
In addition, we note that Appellants elected the species 2,3'-sialyl
lactose and lacto-N-neo-tetraose for examination on the merits, with
traverse, in the Response to Election/Restriction dated December 5, 2007.
Accordingly, it is our understanding that the claims have been examined
only to the extent they read on the elected species.
The Examiner relies on the following evidence:
Zopf et al. (“Zopf II”) US 5,883,079 Mar. 16, 1999
Prieto et al. US 6,083,934 Jul. 4, 2000
Vanmaele et al. WO 00/51644 A1 Sep. 8, 2000
Finke et al. CA 2 394 090 A1 Jun. 14, 2001
David Zopf & Stephen Roth, Oligosaccharide anti-infective agents, 347 THE
LANCET 1017-1021 (1996) (“Zopf I”).
K.L. Pickering & A.L. Morrow, Factors in Human Milk that Protect against
Diarrheal Disease, 21 INFECTION 355-357 (1993).
Claims 92, 97, 106, and 110-115 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Finke.
Claims 92, 94-96, and 106-115 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Finke, Zopf II, Pickering, Vanmaele, Prieto,
and Zopf I.
Claim 92 is reproduced in full in Appellants’ Claim Appendix.
However, given Appellants’ election of species, claim 92 is representative to
the extent it is directed to:
Appeal 2012-006592
Application 10/518,297

3
A method of treatment for a gastrointestinal infection or
treatment in order to prevent the development of said infection,
wherein a pharmaceutically or therapeutically effective amount
of a composition containing purified fraction(s) of at least two
compounds being or containing a pathogen inhibiting
oligosaccharide sequence is administered to a subject in need of
such treatment; wherein the purified fraction(s) is/are purified
or isolated oligosaccharide fraction(s) from natural or synthetic
sources; and wherein said oligosaccharide sequence is selected
from the pathogen receptors as defined in the formula
. . .
[2,3'-sialyl lactose and lacto-N-neo-tetraose], and
wherein said composition is not human milk.
(App. Br. 25.)
FINDINGS OF FACT
The following findings of fact (FF) are supported by a preponderance
of the evidence of record.
1. According to Finke, oligosaccharides in milk play “important
roles in humans for the specific and unspecific defense against infections”
(Finke 1: 23-24). For example, “[o]ligosaccharides from human milk
constitute a substrate source for bifido bacteria. Thus, they support the
normal intestinal flora necessary for the function of the gastro-intestinal
tract, and repress pathogenic germs” (id. at 1: 26-28).
2. In addition, Finke teaches that “[o]ligoraccharides prevent the
adhesion of pathogenic germs and/or substances such as bacteria, toxins and
eukaryotic parasites, in that they act as specific receptor analogues, the first
step of an infection being thereby prevented” and “an anti-adhesive action of
oligosaccharides against the most diverse pathogenic micro-organisms could
be shown” in in-vitro assays (Finke 2: 2-6).
Appeal 2012-006592
Application 10/518,297

4
3. Finke discloses “mixture[s] of oligosaccharides obtained from
one or several animal milks . . . [and] the use of said oligosaccharide
mixture[s] for combating disorders of gastro-intestinal functions” (Finke 1:
8-11), and for “prophylaxis against such gastro-intestinal infections” (id. at
8: 2-3).
4. According to Finke, “the total spectrum of the oligosaccharides
present in the oligosaccharide mixture has to differ from that of the animal
milk or milks, from which the oligosaccharide fractions were obtained”
(Finke 4: 13-15), so that “there is not obtained a mixture that corresponds to
the original mixture present in an animal milk or present in several animal
milks” (id. at 4: 11-13).
5. Finke teaches that “[t]he relationship of neutral to sialylated
(acidic) oligosaccharides . . . is about 10:1 in mature human milk” (Finke 1:
20-21), while the ratio of neutral oligosaccharides to acidic oligosaccharides
is 90-60:10-40% by weight in its inventive compositions (id. at 6: 6-7).
6. Finke’s working examples exemplify seven different
compositions, each of which comprises an acidic oligosaccharide fraction
and a neutral oligosaccharide fraction, isolated from various milk sources.
In Example 4, the main components of the acidic fraction include 2,3'- and
2,6'-sialyl lactoses, and in Example 5, the neutral fraction comprises lacto-
N-neo-tetraose and lacto-N-neo-hexose.
DISCUSSION
I.
The Examiner rejected claims 92, 97, 106, and 110-115 as
unpatentable over Finke.
Appeal 2012-006592
Application 10/518,297

5
The Examiner finds that Finke discloses oligosaccharide mixtures
comprising acidic and neutral oligosaccharide fractions, useful for treating
or preventing gastrointestinal infection (Ans. 6). The Examiner further finds
that Finke teaches that “[s]uitable acidic oligosaccharides include 2,3'-sialyl
lactose . . . and suitable neutral oligosaccharides include lacto-N-neo-
tetraose” (id.).
The Examiner concedes that “Finke does not teach an example
wherein 2,3'-sialyl lactose and lacto-N-neo-tetraose are administered
together” (id.). However, the Examiner concludes that it would have been
obvious for one of ordinary skill in the art to administer an acidic
oligosaccharide, e.g., 2,3'-sialyl lactose, together with a neutral
oligosaccharide, e.g., lacto-N-neo-tetraose, to treat or prevent disorders of
the gastrointestinal tract, given Finke’s disclosure that “the combination of
an acidic and a neutral oligosaccharide [from various milk sources] is
particularly effective” (id. at 7) “for supporting normal intestinal flora and
repressing pathogenic germs, and preventing adhesion of germs” (id. at 6-7).
Appellants contend that Finke “is silent regarding the fact that each of
lacto-N-neo-tetraose and 2,3'-sialyl lactose are specific receptor analogues”
(App. Br. 15), and “selects milk oligosaccharides only on the basis of
whether they are acidic or neutral and combines those fractions in ratios that
are . . . similar to the ratio of acidic/neutral oligosaccharides found in human
milk” (id.). Appellants contend that:
Lacto-N-neo-tetraose and 2,3'-sialyllactose fall within [a]
much narrower group of oligosaccharides that act as pathogen
receptors (e.g., receptor analogues). This narrower group
obviously includes members from the broad genus of neutral
and acidic oligosaccharides disclosed by Finke, but this
narrower group also excludes many oligosaccharides within the
Appeal 2012-006592
Application 10/518,297

6
broad genus of neutral and acidic oligosaccharides present in
milk that may or may not have other functions that improve the
immune response to pathogenic microorganisms.
Based on the teachings of Finke, one of ordinary skill in
the art would have to blindly pick and choose among all neutral
oligosaccharides and all acidic oligosaccharides present in
animal milk(s) without knowing which oligosaccharides
function as receptor analogues to gastrointestinal infection-
causing microorganisms to arrive at the present claims.
(Id. at 16.)
Appellants’ argument is not persuasive. Finke combines acidic and
neutral oligosaccharide fractions from various milk sources at various ratios,
for the express purpose of approximating and/or improving on the anti-
infective properties of human milk (FF 3), and specifically exemplifies each
of the oligosaccharides required by the claims (FF 6), albeit not together in
the same composition. Nevertheless, we agree with the Examiner that it
would have been obvious for one of ordinary skill in the art to administer
any of Finke’s acidic oligosaccharides, e.g., 2,3'-sialyl lactose, together with
any of Finke’s neutral oligosaccharides, e.g., lacto-N-neo-tetraose, to treat or
prevent disorders of the gastrointestinal tract, given Finke’s disclosure.
While Finke may not expressly state that these particular oligosaccharides
are specific receptor analogues, or that they exhibit other specific protective
mechanisms, the law does not require that they be combined for the reason
or advantage contemplated by the inventor, as long as some suggestion to
combine the elements is provided by the prior art as a whole. In re Beattie,
974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig, 539 F.2d 1300, 1304
(CCPA 1976).
Moreover, “[t]he combination of familiar elements according to
known methods is likely to be obvious when it does no more than yield
Appeal 2012-006592
Application 10/518,297

7
predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416
(2007). “What matters is the objective reach of the claim. If the claim
extends to what is obvious, it is invalid under § 103.” Id. at 419; see also
Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989)
(“That the [prior art] patent discloses a multitude of effective combinations
does not render any particular formulation less obvious.”); In re Corkill, 771
F.2d 1496, 1500 (Fed. Cir. 1985) (affirming obviousness rejection of claims
in light of prior art teaching that “hydrated zeolites will work” in detergent
formulations, even though “the inventors selected the zeolites of the claims
from among ‘thousands’ of compounds”).
Appellants further contend:
[T]he disclaimer of Finke excluding original animal milk
combinations excludes the combination of individual
components of the specific examples, as such composition is
realized to be a natural animal milk composition, when
considering all possible animals and natural variations of
animal milk oligosacchrides. This teaching combined with an
infinite functional disclaimer renders it impossible to define any
saccharide ratio being definitely taught by Finke. . . .
Because of the disclaimer, it is impossible to know if these are
meant to be combinable. According to Finke, any combination
of these would require knowledge beyond one of ordinary skill
in the art. . . . Considering the variety of human milk, it is not
an easy task to formulate a composition, which certainly differs
from any human milk.
(App. Br. 17.)
We are not persuaded. The “disclaimer” cited by Appellants is merely
an acknowledgement that Finke’s inventive compositions are not intended to
encompass products of nature (FF 4). Appellants have not shown that
combining an acidic component from one of Finke’s examples with a basic
Appeal 2012-006592
Application 10/518,297

8
component from another example would somehow replicate the exact
composition of natural human milk, or milk from any other species, for that
matter. “Attorney’s argument in a brief cannot take the place of evidence.”
In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974).
The rejection of claim 92 as unpatentable over Finke is affirmed. The
rejection is affirmed with respect to claims 97, 106, and 110-115 as well, as
they were not separately argued. See 37 C.F.R. § 41.37(c)(1)(vii).
II.
Claims 92, 94-96, and 106-115 stand rejected as unpatentable over
Finke, Zopf II, Pickering, Vanmaele, Prieto, and Zopf I.
The Examiner finds that Finke, relied on as discussed above, “teaches
the treatment of bacterial gastrointestinal infections generally, and the cited
references teach particular bacteria which are known to be treatable using
oligosaccharides, particularly the elected species and oligosaccharides
comprising Galβ (1-4)GlcNAc” (Ans. 9). The Examiner concludes that “the
skilled artisan could predict that the bacterial infections taught by the cited
references could be treated using Finke's oligosaccharide composition” (id.).
Appellants contend that “the cited references or the knowledge in the
art provide no reason or rational that would allow one of ordinary skill in the
art to arrive at the present claims” (App. Br. 22). Appellants contend that:
Zopf I and Pickering do not add a great deal beyond Finke that
some oligosaccharides can act as receptor analogs for certain
pathogens, other than suggesting specific pathogens that may be
inhibited in their ability to adhere to certain tissues or protected
against with oligosaccharides. Zopf I and Pickering give no
guidance as to which oligosaccharide structures are effective to
treat or prevent gastrointestinal infections. Additionally,
although Vanmaele, Prieto and Zopf II are directed to
gastrointestinal disorders, the skilled artisan would have no
Appeal 2012-006592
Application 10/518,297

9
reasonable expectation of success in arriving at the present
claims in view of the oligosaccharides disclosed in the cited
references. Accordingly, the combinations of references do not
render the present invention obvious.
(Id.)
This argument is not persuasive for the same reasons discussed above.
Accordingly, the rejection of claim 92 as unpatentable over Finke,
Zopf II, Pickering, Vanmaele, Prieto, and Zopf I is affirmed. The rejection
is affirmed with respect to claims 94-96, and 10-115 as well, as they were
not separately argued. See 37 C.F.R. § 41.37(c)(1)(vii).
SUMMARY
The rejection of claims 92, 97, 106, and 110-115 as unpatentable over
Finke is affirmed.
The rejection of claims 92, 94-96, and 106-115 as unpatentable over
Finke, Zopf II, Pickering, Vanmaele, Prieto, and Zopf I is affirmed.
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

lp