Ex Parte Ranganathan

Board of Patent Appeals and Interferences

Jul 28, 2010

10936262 (B.P.A.I. Jul. 28, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/936,262 09/08/2004 Natarajan Ranganathan KBI-0027 7800
7590 07/28/2010
Licata & Tyrrell P.C.
66 E. Main Street
Marlton, NJ 08053
EXAMINER
HOFFMAN, SUSAN COE
ART UNIT PAPER NUMBER
1655
MAIL DATE DELIVERY MODE
07/28/2010 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte NATARAJAN RANGANATHAN
__________

Appeal 2010-003915
Application 10/936,262
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and STEPHEN WALSH,
Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
composition for reducing nitrogenous waste products in the blood. The

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

Appeal 2010-003915
Application 10/936,262

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Patent Examiner rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.

STATEMENT OF THE CASE
The invention concerns a composition comprising prebiotic and
probiotic components. (Spec. p. 4, ll. 28-29). The Specification states that
the composition of the invention “can be added to a food product, dietary
supplement, medical food or pharmaceutical product which, upon ingestion,
will promote a healthy intestinal microenvironment and assist in the
elimination of nitrogenous waste products that can build up in concentration
in the circulating blood.” (Id. at p. 4, ll. 30-35).
Claims 1, 3 and 4 are on appeal. Claim 1 is representative and reads
as follows:
1. A composition for reducing nitrogenous waste products in the blood
comprising at least one probiotic component and at least one non-digestive
prebiotic component, wherein the prebiotic component is not an excipient
and is 20% to 70% of the total weight of the composition, the probiotic
component is 20% to 70% of the total weight of the composition, the at least
one probiotic component is Streptococcus thermophilus, and wherein said
composition reduces plasma creatinine concentrations by 13% to 29%.

The Examiner rejected claims 1, 3 and 4 under 35 U.S.C. § 103(a) as
being unpatentable over Cavaliere Vesely2 and Ohkuma.3

2 US Patent No. 5,716,615 issued to Renata Maria Anna Cavaliere Vesely, et
al., Feb. 10, 1998.
3 US Patent No. 5,358,729 issued to Kazuhiro Ohkuma, et al., Oct. 25, 1994.
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Application 10/936,262

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Claims 3 and 4 have not been argued separately and therefore stand or
fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS
The Issue
The Examiner’s position is Cavaliere Vesely taught that compositions
comprising Streptococcus thermophilus are useful in treating constipation
and for lowering cholesterol levels. (Ans. 3). The Examiner found that
Cavaliere Vesely also disclosed using S. thermophilus in amounts from 10%
to 95% of the total weight of the composition. (Id.).
The Examiner found that Ohkuma taught that “compositions
comprising indigestible dextrin (synonymous with pyrodextrin) are also
useful in treating constipation and lowering cholesterol.” (Id.).
Additionally, the Examiner found that Ohkuma disclosed examples which
included dextrin in compositions from about 24.27% to about 68.7% of the
total weight of the composition. (Id. at 4).
According to the Examiner, the combined references show that it was
well known in the art at the time of the invention to use each of the claimed
ingredients to treat constipation and to lower cholesterol levels. (Id.).
Therefore, the Examiner concluded that it would have been obvious to a
person of ordinary skill in the art at the time the invention was made to
combine the ingredients, known to be useful for the same purpose, into a
single composition for the same use. (Id.). The Examiner also determined
that the references disclosed using S. thermophilus and dextrin in amounts
that overlap with the claimed amounts, and a skilled artisan would have been
motivated to use the disclosed amounts in formulating the combined
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product. (Id. at 5). The Examiner additionally found that “it would have
been customary for an artisan of ordinary skill to determine the optimal
amount of each ingredient to add in order to best achieve the results desired
by the reference within the broad ranges taught in the references.” (Id.).
Appellant contends that “the Examiner has failed to establish the
obviousness of a composition with the claimed components at the claimed
amounts.” (App. Br. 8). According to Appellant, “it is unclear how one
skilled in the art could derive the optimal amount of a particular component
when the intended use is different [than] that of the present invention.” (Id.).
Appellant asserts that Cavaliere Vesely disclosed optionally including
excipients, such as maltodextrin, in amounts of 1 to 10% , and that this
disclosure does “not support a conclusion that excipients such as
maltodextrin are critical variables which can be optimized to arrive at the
claimed invention.” (Id. at 9). According to Appellant, “the Examiner has
not provided sufficient rationale as to why one of ordinary skill in the art
would have used the indigestible dextrin of Ohkuma et al. in an amount of
20% to 70% of the total weight of a composition described by Cavaliere
Vesely et al.” (Id. at 10).
The issue with respect to this rejection is whether it would have been
obvious to one of ordinary skill in the art at the time the invention was made
to combine the known elements of the prior art, in their disclosed amounts,
and for their known, similar function to arrive at the claimed composition.

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Findings of Fact
1. Cavaliere Vesely disclosed a pharmaceutical composition comprising
S. thermophilus, Lactobacillus and Bifidobacteria. (Cavaliere Vesely
Abstract; col. 2, ll. 30-56).
2. The instant Specification recognized S. thermophilus, Lactobacillus
and Bifidobacteria as probiotic components. (See Spec. p. 6, ll. 11-32).
3. Cavaliere Vesely disclosed adding S. thermophilus to its composition
in an amount of 10 to 95% by weight of total composition. (Cavaliere
Vesely col. 2, ll. 31-32).
4. Cavaliere Vesely disclosed that its composition is useful to treat
conditions including constipation and hypercholesteremia. (Id. at col. 2, ll.
23-26).
5. Ohkuma disclosed an indigestible dextrin composition. (Ohkuma
Abstract).
6. Ohkuma stated that “[h]eat-treated starch (pyrodextrin) will
hereinafter be referred to merely as ‘dextrin.’” (Id. at col. 4, ll. 26-27).
7. The instant Specification recognized pyrodextrin as a prebiotic
component. (Spec. at p. 11, l. 35 - p.12, l. 2).
8. Ohkuma disclosed examples of its composition comprising dextrin in
amounts ranging from about 24.27% to about 68.7 %. (Ohkuma col. 38,
Table 37, col. 40, Table 42).
9. Ohkuma disclosed that its compositions are useful to alleviate
constipation and lower total cholesterol. (Id. at Ex. 8, col. 26, ll. 1-44; Ex.
10, col. 27, ll. 1-63).

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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 Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
“It is prima facie obvious to combine two compounds each of which is
taught by the prior art to be useful for the same purpose, in order to form a
third composition which is to be used for the very same purpose.” In re
Kerkhoven, 626 F.2d 846, 850 (CCPA 1980). “[E]ven a slight overlap in
range establishes a prima facie case of obviousness.” In re Peterson,
315 F.3d 1325, 1329 (Fed. Cir. 2003).
“[I]t is not necessary in order to establish a prima facie case of
obviousness that there be a suggestion in or expectation from the prior art
that the claimed compound or composition will have the same or a similar
utility as one newly discovered by applicant.” In re Dillon, 919 F.2d 688,
693 (Fed. Cir. 1990) (emphasis in original).
“[B]y definition, any superior property must be unexpected to be
considered as evidence of non-obviousness.” Pfizer, Inc. v. Apotex, Inc.,
480 F.3d 1348, 1371 (Fed. Cir. 2007). The existence of unexpected results
is a question of fact and the party asserting such existence has the burden of
proving the results are, in fact, unexpected. In re Geisler, 116 F.3d 1465,
1469-70 (Fed. Cir. 1997).

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Analysis
We are not persuaded by Appellant’s contention that the Examiner has
not provided sufficient rationale for combining Ohkuma’s non-digestive
prebiotic component, i.e., indigestible dextrin, with Cavaliere Vesely’s
probiotic composition comprising S. thermophilus, Lactobacillus and
Bifidobacteria, in the claimed amounts, to yield the claimed composition.
(See App. Br. 8-10). A reason to combine teachings need not be expressly
stated in the prior art references. In re Kahn, 441 F.3d 977, 989 (Fed. Cir.
2006). There need only be articulated reasoning with rational underpinnings
to support a reason to combine the teachings. Kahn, 441 F.3d at 988.
Here, the Examiner explained that Cavaliere Vesely and Ohkuma each
disclosed components that were known to be useful for alleviating
constipation and for lowering total cholesterol. (Ans. 4). Therefore, the
Examiner reasoned that the ordinary skill in the art at the time of the
invention would have suggested combining the prior art components into a
single composition to achieve their additive effect. (Id.).
Further, the Examiner found that Cavaliere Vesely expressly disclosed
the range amount of S. thermophilus to use in a composition, and that
Ohkuma similarly expressly disclosed the range amount of indigestible
dextrin to use in a composition. (Id.). Thus, the Examiner reasoned that the
skilled artisan would be motivated by these disclosures to incorporate these
components into a single composition according to their respectively
disclosed range amounts. (Id.). According to the Examiner, it would have
been customary for the artisan to determine the optimal amount of each
ingredient, within the disclosed ranges, to best achieve a composition that
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alleviates constipation and lowers cholesterol, as taught by the references.
(Id.).
The Examiner’s reasoning is consistent with the teachings of the prior
art (see FF 1-9) and Appellant has not established otherwise with persuasive
evidence. The Examiner’s simple combination of the known elements of the
prior art in a known manner was a predictable variation that could have been
implemented by a person of ordinary skill. See KSR Int’l Co., 550 U.S. at
416-17; see also Kerkhoven, 626 F.2d at 850. Therefore, we find that the
evidence of record supports a conclusion that the Examiner rationally
determined that it would have been obvious to a person of ordinary skill in
the art at the time the invention was made to combine Ohkuma’s prebiotic
component with Cavaliere Vesely’s probiotic composition.
To the extent that Appellant challenges the Examiner’s rejection by
asserting that claimed amounts of the prebiotic and probiotic components
would not have been obvious to a person of ordinary skill in the art at the
time the invention was made (see App. Br. 8-10) we remain unpersuaded.
Cavaliere Vesely disclosed adding S. thermophilus to its composition in an
amount of 10 to 95% by weight of total composition. (FF-3). This disclosed
range overlaps the claimed range for the probiotic component of 20-70%.
(See Claim 1). Additionally, Ohkuma disclosed compositions comprising
dextrin in amounts ranging from about 24.27% to about 68.7 % (FF-8)
which also overlaps the claimed range for the prebiotic component (see
Claim 1). Such overlap in the range amounts disclosed in the prior art as
compared to the claimed ranges establishes a prima facie case of
obviousness. See Peterson, 315 F.3d at 1329.
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This result is unchanged by the Examiner’s reasoning that a skilled
artisan would have optimized the disclosed amounts of the prior art
components because the Examiner expressly stated that such optimization
would be “within the broad ranges taught in the references.” (Ans. 5). The
broad ranges of these components disclosed in the prior art rendered the
claimed amounts obvious.
Further, we find Appellant’s assertion that Cavaliere Vesely does not
support a conclusion that its excipients such as maltodextrin can be
optimized (see App. Br. 9) to be misdirected. The Examiner’s combination
did not rely upon optimizing an excipient disclosed in Cavaliere Vesely.
Instead, as the Examiner explained, the combination involved adding
Ohkuma’s prebiotic dextrin to Cavaliere Vesely’s probiotic composition.
(Ans. 3, 4, 7).
In the Reply, Appellant asserts that “the cited references are not
reasonably pertinent to the problem with which Appellant was concerned.”
(Reply Br. 2). According to Appellant, the claimed elements “interact to
produce a ‘new or different function,’ which is neither taught nor obvious in
view of the combined teachings of the cited references.” (Id. at 3).
This argument is also unpersuasive. While the combined prior art is
directed to a different purpose than the intended use of the claims, both the
claims and the combined prior art are directed to a composition comprising
the same elements. “[I]t is not necessary in order to establish a prima facie
case of obviousness that there be a suggestion in or expectation from the
prior art that the claimed compound or composition will have the same or a
similar utility as one newly discovered by applicant.” Dillon, 919 F.2d at
693. Appellant has not rebutted the Examiner’s prima facie showing that the
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claims defining a composition would have been obvious. See Pfizer, Inc.,
480 F.3d at 1371; Geisler, 116 F.3d at 1469-70.

CONCLUSION OF LAW
It would have been obvious to one of ordinary skill in the art at the
time the invention was made to combine the known probiotic and prebiotic
components of the prior art, in their disclosed amounts, and for their known,
similar function to arrive at the claimed composition.
SUMMARY
We affirm the rejection of claims 1, 3 and 4 under 35 U.S.C. § 103(a)
as being unpatentable over Cavaliere Vesely and Ohkuma.
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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