Ex Parte 6063776 et al

Board of Patent Appeals and Interferences

Mar 9, 2011

90010459 (B.P.A.I. Mar. 9, 2011)

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.
90/010,459 03/19/2009 6063776 090084 7635
7590 03/09/2011
EDMUND J. SEASE
801 GRAND AVENUE
SUITE 3200
DES MOINES, IA 50209
EXAMINER
HUANG, EVELYN MEI
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
03/09/2011 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 WASHINGTON UNIVERSITY,
Patent Owner & Appellant
____________

Appeal No. 2011-001507
Reexamination Control No. 90/010,459
Patent No. 6,063,776
Technology Center 3900
____________

Before ROMULO H. DELMENDO, MICHAEL P. TIERNEY, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL1

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”
shown on the PTOL-90A cover letter attached to this decision.
Appeal No. 2011-001507
Reexamination Control No. 90/010,459
Patent No. 6,063,776

2
This is a decision on the appeal by the Patent Owner of U.S. Patent
No. 6,063,776 from the Patent Examiner’s rejections of claims 17-32 in an
ex parte reexamination proceeding. The Board’s jurisdiction for this appeal
is under 35 U.S.C. §§ 6(b), 134(b), and 306. We reverse.

BACKGROUND
U.S. Patent No. 6,063,776 (hereinafter “the ‘776 patent”) issued May
16, 2000. The named inventor is Richard E. Ostlund, Jr. A request for an ex
parte reexamination of claims 17-19 was filed March 19, 2009, pursuant to
35 U.S.C. §§ 302-307 and 37 C.F.R § 1.510. Reexamination was ordered.
During the reexamination proceeding, claims 20-40 were added (Suppl.
App. Br.2 1). In a Final Rejection dated September 24, 2009, claims 17-32
were rejected and claims 33-40 deemed patentable. The final rejection of
claims 17-32 was appealed by the Patent Owner. An oral hearing was held
on February 16, 2011.
The claims are directed to a water-soluble composition for reducing
cholesterol. The composition comprises “an aqueous homogenous micellar
mix” of two components: a plant sterol and an emulsifier. The ‘776 patent
exemplifies sitostanol as the plant sterol and lecithin as the emulsifier (see
Examples 1 and 2 at cols. 5-6). Claims 18, 23, 26, and 31, respectively, are
directed to these specific components. According to the patent, the claimed
composition is highly bioavailable and reduces cholesterol absorption by
humans (col. 4, ll. 35-46 & col. 9, ll. 46-49).

2 “Suppl. App. Br.” refers to the Appeal Brief filed by the Patent Owner on
May 6, 2010.
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Patent No. 6,063,776

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The claims stand rejected by the Examiner as follows:
1. Claims 17-19 under 35 U.S.C. § 102(b) as anticipated by
Redziniak3 (Ans. 7);
2. Claims 20-22, 24-30, and 32 under 35 U.S.C. § 102(b) as
anticipated by Redziniak, or alternatively, under 35 U.S.C. § 103(a) as
obvious in view of Redziniak (id. at 8); and
3. Claims 23 and 31 under 35 U.S.C. § 103(a) as obvious in view of
Redziniak and Straub4 (id. at 10).
Claims 17 and 23 are representative and read as follows:
Claim 17. A water-soluble composition for reducing
cholesterol absorption comprising:
an aqueous homogenous micellar mix of a plant sterol
and an emulsifier wherein the mole ratio of the plant
stero1:emulsifier is about 1:01 to about 1:10

Claim 23. The water soluble composition of claim 17
wherein the plant sterol is sitostanol.

(Supp. App. Br. 14, Claims App’x.)

MICELLAR MIX

Legal Principles
“During reexamination, as with original examination, the PTO must
give claims their broadest reasonable construction consistent with the
specification . . . . Therefore, we look to the specification to see if it provides
a definition for claim terms, but otherwise apply a broad interpretation.” In

3 U.S. Patent No. 4,508,703 issued Apr. 2, 1985.
4 U.S. Patent No. 5,244,887 issued Sept. 14, 1993.
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re ICON Health and Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007).
Nevertheless, “this interpretation must be consistent with the one that those
skilled in the art would reach.” In re Cortright, 165 F.3d 1353, 1358 (Fed.
Cir. 1999).
Findings of Fact (FF)
FF1
According to the ‘776 patent:
The phytosterol-emulsifier complex is prepared by high shear
mixing, for example by vortexing, mixing, sonicating or
passing through a small orifice of a phytosterol:emulsifier
mixture in water. The dispersed material is then either used as
is or dried, for example, by lyophilization or spray-drying. The
complex can be used in liquid form prior to any drying, or it
can be dried as indicated, and then on contact with liquid it
again forms an aqueous vesicular complex which can enter
directly into the intestinal micellar phase. No fat is used as a
carrier, and surprisingly the system, even when dried, does not
change its physical structure from the micelles that contain
vesicles, the majority of which contain some plant sterol and
some lecithin.
(Col. 4, ll. 1-13 (emphasis added); see also col. 4, l. 66 to col. 5, l. 8.)

FF2
White, in the textbook titled Principles of Biochemistry,5 defines
“micelles” as follows: “Micelles are stable colloidal aggregates which are
formed by amphiphiles above a very narrow concentration range, called the
critical micelle concentration (cmc), which differs for various amphiphiles.”
(Page 65.)

5 PRINCIPLES OF BIOCHEMISTRY (Abraham White et al. eds., 6th ed. 1978).
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FF3
Figure 3.1 of White is reproduced below:

Figure 3.1 shows the structures of surfactants in an aqueous media,
where the micelles are described as “globular structures in three
dimensions,” with the hydrophilic head group shown as a circle and the
hydrophobic tail as a line squiggle.

FF4
In describing what happens when amphiphilic biological lipids are
dissolved in water, White writes:
“If dry phosphoglyceride is placed in water and becomes swollen, the
predominant structures are not micelles but multilamellar structures which
appear to be extended sheets or enclosed vesicles” (p. 66). A micrograph is
shown of the swollen phosphoglycerides, which White states is a “lipid
bilayer” (p. 67).

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Patent No. 6,063,776

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FF5
A micelle is also defined in the IUPAC (International Union of Pure
and Applied Chemistry) Compendium of Chemical Terminology:6
Surfactants in solution are often association colloids, that is,
they tend to form aggregates of colloidal dimensions, which
exist in equilibrium with the molecules or ions from which they
are formed. Such aggregates are termed micelles.

FF6
Dr. Richard E. Ostlund, Jr., the sole inventor of the ‘776 patent,
testified in his first written declaration, dated December 12, 2008 (“Ostlund
1 Decl.”) that
“Micellar mix” refers to a mix of micelles, which . . . are small
units of supramolecular structure . . . in which molecules
associate with each other without covalent chemical bonding.
An example of a generalized scheme for a micelle is shown
below:

6 IUPAC COMPENDIUM OF CHEMICAL TERMINOLOGY (Alan D. McNaught &
Andrew Wilkinson eds., 2d ed. 1997).
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This figure shows a micelle in aqueous solution, with a “head”
that is “hydrophilic” (literally water-loving) and a “tail” that is
“hydrophobic” (literally water-fearing) [not apparent from
figure]. Because of its hydrophilic exterior, such a micelle is
capable of dissolving in water, even though its interior may be
hydrophobic. Micelles can come in different forms, such as
vesicles or flattened sheets. Importantly, micelles are
distinguished from liposomes (which typically contain a core of
aqueous solution).
(¶ 37.)

FF7
Dr. Ostlund, in footnote 5 of the Ostlund 1 Declaration, wrote:
“Supramolecular structure refers to a structure of greater complexity than a
molecule and often consisting of more than one molecule.”

FF8
Dr. William Stenson, a professor of medicine who has worked in the
field of gastroenterology for more than 30 years, testified in his written
declaration (Stenson Decl. dated Oct. 20, 2009) that the terms “liposomes”
and “micelles” were “recognized in the art as of the time of filing of Ostlund
May 26, 1998 as completely different physical states.” (¶ 4.)

FF9
Dr. Stenson further stated:
I have read the definition provided by Dr. Ostlund (Declaration
I, para. 35) for micelles as, “small units of supramolecule
structure in which molecules associate with each other without
covalent bonding that is not readily separated back into the pure
components and having a similar composition throughout”.
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This was then, and is now the plain ordinary meaning of the
term “micelles”.
(¶ 5.)

FF10
Figure 3.3 of White is reproduced below:

Figure 3.3 of White shows a “phosphoglyceride bilayer found in
vesicles.” (Page 68.)

Analysis
The dispute in this appeal centers around the meaning of the phrase
“micellar mix,” one of the components of the claimed “water-soluble
composition for reducing cholesterol absorption.” Thus, we begin our
analysis by construing “micellar mix.”
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Patent No. 6,063,776

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The Patent Owner acknowledged that the ‘776 patent does not define
“micellar” or “micelle” (Suppl. App. Br. 4), the noun form from which
“micellar” is derived. In the context of the ‘776 patent, however, the
inventor made clear to one skilled in the relevant art that the term “micellar
mix” contains micelles (FF1). There is adequate evidence in this record that
the term “micelle” was a term utilized in chemistry to describe a distinct
physical state of surfactant (lipid) molecules having hydrophilic head groups
and hydrophobic tails. Several definitions of “micelle” have been
introduced as evidence (FFs 2, 3, 5, 6, & 9). The common feature of these
definitions, illustrated in both White and the Ostlund 1 Declaration, is of a
group of surfactant molecules organized into a “monolayer” ball-like
structure with the head groups on the outside and the tails on the inside (FF3
& FF6; compare reproduced illustrations). White distinguishes the micellar
structure from bilayer and multilayer (“multilamellar” or “lamellar”)
structures (FF4 & FF10). We therefore interpret the phrase “micellar mix”
to require surfactant molecules organized into a ball-like structure to form a
micelle. A micelle is a distinctly different structure than a liposome. Our
interpretation does not limit the micellar mix to containing only micelles, but
necessarily requires their presence.

Appeal No. 2011-001507
Reexamination Control No. 90/010,459
Patent No. 6,063,776

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REJECTIONS 1-3 OVER REDZINIAK
Issue
The issue in the rejections citing the Redziniak patent is whether
Redziniak described or suggested a composition comprising a “micellar
mix” as that term would be properly interpreted by one of ordinary skill in
the art in the light of the written description of the ‘776 patent.

Legal Principles
The Examiner bears the burden of establishing a prima facie case of
unpatentability. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Under 35 U.S.C. § 102 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). “To establish inherency, the extrinsic evidence must
make clear that the missing descriptive matter is necessarily present in the
thing described in the reference . . . . Inherency, however, 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.” In re
Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (internal quotation marks and
citations omitted).

Findings of Fact (FF)
The following disclosure appears in Redziniak:
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FF11
The present invention relates generally to hydrated lipidic
lamellar phases and to a method for obtaining the same, and
also to compositions intended particularly for pharmaceutical,
cosmetic or like uses and comprising said lipidic lamellar
phases.
(Col. 1, ll. 7-11.)

FF12
According to M. M. RIEGER . . . , one of the conditions for the
amphiphilic lipid to be capable of forming lamellar phases
rather than only micellar clusters is that the dimensions of its
hydrophobic portion be at least as important as that of its
hydrophilic portion.
(Col. 1, ll. 24-30.)

FF13
“Such lipids are capable of forming bimolecular lipidic layers
(lamellae or bilayers) . . . .” (Col. 1, ll. 31-32.)

FF14
The liposome is a particular configuration of a lamellar phase
appearing in the form of a lipidic spherule composed of one or
several concentric bilayers alternating with aqueous
compartments. The liposomes are dispersed in an aqueous
medium and form a highly hydrated lamellar phase.
(Col. 1, ll. 41-46.)

FF15
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The purpose of the present invention is to . . . [provide] a new
method for obtaining hydrated lipidic lamellar phases, and more
particularly a new method for obtaining a pulverulent mixture
of amphiphilic lipidic constituents with, possibly, hydrophobic
or partially hydrophobic constituents. This method is of great
simplicity and allows continuous production of large quantities
of mixtures and therefore of hydrated lipidic lamellar phases or
of liposomes . . . .
(Col. 3, ll. 48-58.)

FF16
Various examples in Redziniak describe forming liposomes (col. 9, ll.
48-50 & 64-65; col. 10, ll. 53-54) and lamellar structures (col. 11, l. 6).

FF17
Redziniak describes atomizing a mixture of amphiphilic lipids to
produce a pulverant mixture that disperses to produce a lamellar phase (col.
4, ll. 1-8).
Analysis
The term “micellar mix,” as recited in the claims, plainly requires the
presence of micelles (see supra p. 9). The Examiner did not make findings
on whether Redziniak described micelles, but rather interpreted the claims to
encompass compositions with liposomes, and found that Redziniak
described liposomes (Ans. 7-9, 13, & 15-16).
The liposomes in Redziniak’s composition (FF15 & FF16) do not
describe the claimed “micellar mix” because liposomes are structurally
different from micelles. Liposomes are expressly described in the prior art
as bi- or multi-layer (lamellar) structures (FF14 & FF15), a fact undisputed
Appeal No. 2011-001507
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Patent No. 6,063,776

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by the Examiner. Redziniak describes the purpose of its invention as to
make “lamellar” structures, such as liposomes (FF15) – both of which
comprise multiple lipid layers and which therefore are structurally different
from the “monolayer” ball-like micelles (FFs 4, 6, 8, 12, & 14). Redniziak’s
examples consistently describe forming liposomes and lamellar phases
(FF16 & FF17). The Examiner acknowledged that micelles might not be
formed by Redziniak:
Indeed, Dr. Ostlund’s conclusion that micelles are not formed
in Redziniak’s composition is totally expected in view of the
state of the prior art at the time of the invention (White and
Ramsammy, as discussed supra). This is especially so because
Redziniak has confirmed the existence of liposomes (vesicles)
in the opalescent liquid by electron microscopy (Redziniak,
column 10, Example 10, lines 48-52).
(Ans. 18.)
While there is some apparent evidence (albeit disputed) that “micellar
mix” includes bilayer or multilayer lipid structures,7 the presence of micelles
is required by the claims. Consequently, the pertinent question is whether
the Examiner established that Redziniak described or suggested micelles in
its composition. As no persuasive findings on this pivotal issue were made,
we conclude that the Examiner did not meet the burden of establishing that
Redziniak described or suggested a micellar mix. Oetiker, 977 F.2d at 1445.
The Examiner argued that micelles were not formed by Dr. Ostlund
because lecithin produces liposomes under the condition set forth in the ‘776

7 For example, there is evidence that the term “vesicle” recited in the ‘776
patent (FF1) would be understood to encompass bi- or multilayer structures
(FF4 & FF10). Nonetheless, it was not necessary for us to determine
whether “vesicles” includes bilayer or multilayer lipid structures.
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Patent No. 6,063,776

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patent (Ans. 17-18). The Examiner also characterized the conditions for
making liposomes in Redziniak as “essentially the same as described” in the
‘776 patent (id. at 18).
The factual basis underpinning the Examiner’s reasoning does not
outweigh the evidence that micelles were formed in the ‘776 patent. Dr.
Ostlund in his written declaration testified that the procedures followed in
the ‘776 patent produced micellar mixes; he provided additional
experimental evidence of this (Ostlund 1 Decl. 7: ¶ 20, 13: ¶ 37 (last line on
page), & 14: ¶ 39); Ostlund 2 Decl. 3: ¶ 4 & 5: ¶ 8, dated Aug. 5, 2009). Dr.
Stenson agreed that a micellar mix was formed both in the ‘776 patent and in
the experiments following the methods of the ‘776 patent conducted by Dr.
Ostlund in his declaration (Stenson Decl. ¶ 19).
The Examiner did not adequately address Dr. Ostlund’s testimony and
experimental evidence that a micellar mix comprising micelles was formed,
but instead focused on the experiment in which Dr. Ostlund purported to
carry out Redziniak’s Example 10. The latter experiment was not relevant to
whether micelles were produced in the ‘776 patent and whether the claims
were properly interpreted to include micelles.
The Examiner also did not establish that Redziniak’s method was the
same as the method described in the ‘776 patent. According to Dr. Ostlund,
the micellar mix was formed in the ‘776 patent “by mixing [the lecithin and
sitostanol] in solvent, drying, sonicating in water and lyophilizing” (Ostlund
2 Decl. 2: ¶ 3; FF1). However, Redziniak used an atomization technique in
making its liposomes (FF17; Ostlund 2 Decl. 3: ¶ 4).
Appeal No. 2011-001507
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Patent No. 6,063,776

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The Examiner also incorrectly stated that the issue was not “whether
the Redziniak process forms micelles.” (Ans. 23.) The claim, when
properly interpreted, comprises micelles and therefore it was necessary that
Redziniak disclosed or suggested them. Because the Examiner did not
establish that Redziniak necessarily or inherently described micelles
(Robertson, 169 F.3d at 745), nor that Redziniak suggested a composition
comprising micelles, we are compelled to reverse all the rejections of claims
17-32.

REVERSED

bim

FOR PATENT OWNER:

EDMUND J. SEASE
801 GRAND AVENUE
Appeal No. 2011-001507
Reexamination Control No. 90/010,459
Patent No. 6,063,776

16
SUITE 3200
DES MOINES, IA 50209

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