Ex Parte Jandacek et al

Board of Patent Appeals and Interferences

Jun 1, 2012

10699351 (B.P.A.I. Jun. 1, 2012)

MOD PTOL-90A (Rev.06/08)

APPLICATION NO./
CONTROL NO.
FILING DATE FIRST NAMED INVENTOR /
PATENT IN REEXAMINATION
ATTORNEY DOCKET NO.
10/699,351 10/31/2003 Jandacek, Ronald James

EXAMINER
THE PROCTER & GAMBLE COMPANY
Global Legal Department - IP
Sycamore Building - 4th Floor
299 East Sixth Street
CINCINNATI OH 45202
Gembeh, Shirley
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE

06/01/2012 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.

UNITED STATES DEPARTMENT OF COMMERCE
U.S. Patent and Trademark Office
Address : COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________________________________________________________________________________

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RONALD JAMES JANDACEK,
WILLIAM RANDALL FRANCIS,
GARY ROBERT KELM, and BRYN HIRD
__________

Appeal 2011-012288
Application 10/699,351
Technology Center 1600
__________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
composition comprising a stiffening agent, lipase inhibitor and foam. The
Examiner rejected the claims as obvious. We have jurisdiction under 35
U.S.C. § 6(b). We reverse.

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Statement of the Case
Background
“The present invention relates to compositions comprising a stiffening
agent, wherein the compositions are useful for stiffening unabsorbed dietary
fat and oil present in the gastrointestinal tract, thereby reducing
gastrointestinal side effects and separation of these substances from fecal
matter” (Spec 1, ll. 13-15).
The Claims
Claims 1, 3, 5-7, and 9-12 are on appeal. Claim 1 is representative
and reads as follows:
1. A composition comprising:
(a) a stiffening agent having a complete melting point of
about 33°C or greater which is selected from the group
consisting of R-COOR', R-OR', R-CONR'R", R-NR'R",
salts thereof, and mixtures thereof, wherein:
(i) R is selected from the group consisting of alkyl
radicals having from about 14 to about 24 carbon
atoms, alkenyl radicals having from about 14 to
about 24 carbon atoms, alkynyl radicals having
from about 14 to about 24 carbon atoms,
heteroalkyl radicals having from about 14 to
about 24 carbon atoms, heteroalkenyl radicals
having from about 14 to about 24 carbon atoms,
and heteroalkynyl radicals having from about 14
to about 24 carbon atoms; and
(ii) R' and R" are each, independently, selected from
the group consisting of hydrogen, alkyl radicals,
alkenyl radicals, alkynyl radicals, heteroalkyl
radicals, heteroalkenyl radicals, and
heteroalkynyl radicals; and
(b) a lipase inhibitor; and
(c) a non-digestible, non-absorbable, open-celled high
internal phase emulsion (HIPE) foam.
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The issue

The Examiner rejected claims 1, 3, 5-7, and 9-12 under 35 U.S.C. §
103(a) as obvious over de Smidt,
1
Maeder,
2
and Park
3
(Ans. 6-8).
The Examiner finds that de Smidt teaches “a pharmaceutical
composition comprising (i) a glyceride ester (thus R-OR' which is per
definition as recited by instant claim 1 is a stiffening agent) . . . wherein R is
(12-20 carbon atoms; see col. 3, line 60), having a melting point of 37°C
(i.e., greater than 33°C and (ii) a lipase inhibitor” (Ans. 6). The Examiner
finds that Maeder teaches “a pharmaceutical composition containing a lipase
inhibitor, a fatty acid having a melting point equal or greater than 37°C, (see
col. 1 lines 7-21), wherein the fatty acid is selected from behenic acid” (Ans.
7). The Examiner finds that Park teaches “a non-digestible, non-absorbable,
open-celled HIPE foam compositions and methods of orally administering
said forms compositions for the treatment of obesity” (Ans. 7).
The Examiner finds it obvious “to expand the teachings of de Smidt to
include a non-digestible, non-absorbable, open-celled HIPE foam in the drug
delivery foam compositions disclosed by Park et al. for formulation of a
composition for reducing fat absorption or for treating obesity, as taught by
de Smidt” (Ans. 7).
Appellants contend that “de Smidt does not teach or suggest the
stiffening agent as recited in independent claim 1. Maeder fails to remedy
the deficiency of de Smidt and teaches only fatty acids and fatty acid salts,

1
de Smidt et al., US 6,703,369 B1, issued Mar. 9, 2004.
2
Maeder et al., US 6,730,319 B2, issued May 4, 2004.
3
Park et al., US 5,750,585, issued May 12, 1998.
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particularly sodium and potassium salts thereof, as a second component in
addition to a lipase inhibitor” (App. Br. 4)
Appellants contend that “de Smidt, Maeder, and Park do not teach or
suggest a non-digestible, nonabsorbable, open-celled high internal phase
emulsion (HIPE) foam as recited in claim” (App. Br. 4). Appellants contend
that “the hydrogels of Park are prepared by introducing a gas into a
monomer solution comprising at least one hydrophilic olefin monomer
compound. The hydrogels of Park are not formed from an emulsification
process using hydrophobic monomers. . . .Thus, the compositions of Park
and the present invention are not the same” (App. Br. 4).
Appellants contend that the ordinary artisan “would have no
motivation to select the use of a pharmaceutical composition that provides
exactly the opposite effect i.e. solid to liquid that the current invention
sought to reverse i.e. liquid to non-liquid with the present invention” (App.
Br. 5).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that de Smidt, Maeder, and Park render
the composition of claim 1 obvious?
Findings of Fact
1. de Smidt teaches that “[l]ipase inhibitors include lipstatin and
orlistat. . . . Its use for the control or prevention of obesity and
hyperlipidemia is described” (de Smidt, col. 1, ll. 10-17).
2. de Smidt teaches a “pharmaceutical composition comprising at
least one inhibitor of lipases and at least one fatty acid ester of polyols,
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characterized in that the fatty acid ester has a melting point above the body
temperature, e.g., >37°C.” (de Smidt, col. 2, ll. 44-48).
3. de Smidt teaches that the “term „glyceride ester‟ refers to an
ester of glycerol. According to the present invention, an ester may contain
one to three, preferably one or three C12 to C20 fatty acid(s) moieties per
glycerol moiety” (de Smidt, col. 3, ll. 58-61).
4. de Smidt teaches that the “fatty acid moieties in the fatty acid
ester of the polyols have, independently from each other, twelve or more
carbon atoms, preferably twelve to twenty carbon atoms” (de Smidt, col. 3, l.
66 to col. 4, l. 1).
5. de Smidt teaches that the “glyceride ester is present in an
amount varying between 0.5 and 90% of the total weight of the composition
. . . the lipase inhibitor is present in an amount varying from 1 to 50%,
preferably from 5 to 30%, of the total weight of the composition” (de Smidt,
col. 4, ll. 38-62).
6. Maeder teaches that “[o]rlistat (tetrahydrolipstatin) is a well
known example for a lipase inhibitor. . . . Orlistat is useful in the control or
prevention of obesity and hyperlipidemia” (Maeder, col. 4, ll. 48-61).
7. Maeder teaches a “pharmaceutical composition comprising a) a
solid pharmaceutically active compound which has a melting point ≥37° C.
and b) a fatty acid or a fatty acid salt or a mixture of a fatty acid and a fatty
acid salt, and c) optionally additional pharmaceutically acceptable
excipients” (Maeder, col. 3, ll. 31-38).
8. Maeder teaches that “the fatty acid or a fatty acid salt or the
mixture of a fatty acid and a fatty acid salt may be selected from . . . the
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group of a consisting of lauric acid, myristic acid, palmitic acid, stearic acid,
arachidic acid and behenic acid” (Maeder, col. 5, ll. 37-43).
9. Park teaches that
the hydrogel foams can be used to control the appetite of
healthy people who desire to reduce the volume of food they
take. The presence of bulky hydrogel foams will reduce the
space in the stomach and thus the amount of food that can be
ingested. The extended presence of hydrogel foams in the
stomach will slow down the emptying of food into the
intestine. Thus, the hydrogel foams of the present invention
can also be used as a therapy for obesity.

(Park, col. 15, ll. 22-30).
10. Park teaches that “hydrogel foams of the present invention are
prepared by introducing a gas into an monomer solution comprising at least
one hydrophilic olefin monomer compound, about 0.1 to about 10% by
weight of a multiolefin-functional crosslinking agent and a surfactant, during
polymerization (Park, col. 3, ll. 50-54).
11. Park teaches that the “polymerization reaction is conducted in
an aqueous solution; however nonaqueous solvents, preferably water
miscible non-aqueous solvents . . . can also be used to form the hydrogel
foams” (Park, col. 3, ll. 55-60).
12. Park teaches that “hydrogel foam can be prepared that is
bioerodible and will disintegrate upon exposure to enzymatic digestion”
(Park, col. 4, ll. 63-64).
13. The Specification teaches that “polymeric foams useful herein
are prepared by polymerization of the oil phase of certain water-in-oil
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emulsions having a relatively high ratio of water phase to oil phase,
commonly known in the art as „HIPE.‟” (Spec. 23, ll. 20-22).
14. The Specification defines an HIPE foam, teaching that as “used
herein, a polymeric foam material which results from the polymerization of
such emulsions is referred to herein as a „HIPE foam‟” (Spec. 23, ll. 22-23).
Principles of Law
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993).
“Inherency ... may not be established by probabilities or possibilities.
The mere fact that a certain thing may result from a given set of
circumstances is not sufficient.” MEHL/Biophile Int'l. Corp. v. Milgraum,
192 F.3d 1362, 1365 (Fed. Cir. 1999).
Analysis
Appellants contend that “the hydrogels of Park are prepared by
introducing a gas into a monomer solution comprising at least one
hydrophilic olefin monomer compound. The hydrogels of Park are not
formed from an emulsification process using hydrophobic monomers. . . .
Thus, the compositions of Park and the present invention are not the same”
(App. Br. 4).
The Examiner responds that Appellants‟ argument that the “hydrogels
of Park are not formed from an emulsification process using hydrophobic
monomers is found not persuasive because how Park formulates or makes
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the open celled high internal phase emulsion bears no relevant to the issue
here” (Ans. 10). The Examiner contends that the “claims are not directed to
a process of making a HIPE but to using a HIPE, how it is prepared plays no
role in this rejection and the Board should not consider Appellant‟s
argument” (Ans. 10).
We find that Appellants have the better position. Claim 1 requires a
“high internal phase emulsion (HIPE) foam”. The Specification teaches that
“polymeric foams useful herein are prepared by polymerization of the oil
phase of certain water-in-oil emulsions having a relatively high ratio of
water phase to oil phase, commonly known in the art as „HIPE.‟” (Spec. 23,
ll. 20-22; FF 13). The Specification then defines a HIPE foam, teaching that
as “used herein, a polymeric foam material which results from the
polymerization of such emulsions is referred to herein as a „HIPE foam‟”
(Spec. 23, ll. 22-23; FF 14).
Thus, in order to satisfy the requirement in claim 1 for a HIPE foam,
the foam must be identical to a foam which results from the polymerization
of a water-in-oil emulsion (FF 13-14).
The Examiner asserts that “Park et al. teach a non-digestible, non-
absorbable, open-celled HIPE foam compositions” (Ans. 7). However, a
review of Park does not bear out this assertion, since Park never teaches the
use of an emulsion, but rather only teaches the use of water miscible agents
(FF 10-11). Thus, the foam of Park is formed from different starting
materials than the instantly claimed foam (FF 10, 11, 13, 14).
In order to properly invoke the inherency doctrine, the Examiner must
provide evidence or reasoning to suggest that the product being claimed is
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necessarily identical to the product of the prior art, and that the products are
identical insofar as shown by the available evidence. MEHL, 192 F.3d at
1365. Here, the Examiner has failed to provide any evidentiary basis or
scientific reasoning which would demonstrate that the gas blown aqueous
foam of Park is structurally identical to the HIPE foam claimed, where the
HIPE foam is composed of a polymerized emulsion. The evidence of
record in Park and the Specification suggests that these are different
chemical compositions composed of different components which result in
different foams, the claimed HIPE foam and Park‟s foam which is not an
HIPE foam (FF 10, 11, 13, 14).
Conclusion of Law
The evidence of record does not support the Examiner‟s conclusion
that de Smidt, Maeder, and Park render the composition of claim 1 obvious.

SUMMARY
In summary, we reverse the rejection of claims 1, 3, 5-7, and 9-12
under 35 U.S.C. § 103(a) as obvious over de Smidt, Maeder, and Park.

REVERSED
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