Ex Parte Yuksel et al

Board of Patent Appeals and Interferences

Jan 9, 2012

09983537 (B.P.A.I. Jan. 9, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
09/983,537 10/24/2001 K. Umit Yuksel 29026-0345 9541
7590 01/09/2012
SUTHERLAND ASBILL & BRENNAN LLP
999 Peachtree Street, NE
Atlanta, GA 30309-3996
EXAMINER
PHILOGENE, PEDRO
ART UNIT PAPER NUMBER
3733
MAIL DATE DELIVERY MODE
01/09/2012 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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte K. UMIT YUKSEL, STEVEN P. WALSH,
and KIRBY S. BLACK
__________

Appeal 2010-007310
Application 09/983,537
Technology Center 3700
__________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
isolated transplantable bioprosthetic. The Examiner rejected the claims as
anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

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Statement of the Case
Background
“[T]he present invention relates to bioprosthetic devices comprised of
an exterior biological tissue member which at least partly defines a cavity,
and a proteinaceous biopolymer which fills the cavity, and intercalates [and]
is chemically bound (linked) to the surrounding biological tissue member.”
(Spec. 5, ll. 7-11).
The Claims
Claims 1 and 3-19 are on appeal. Claim 1 is representative and is
reproduced below:
1. An isolated transplantable bioprosthetic comprised
of an exterior biological tissue member which at least
partly defines a cavity, and a proteinaceous biopolymeric
material which fills the cavity, intercalates the
surrounding biological tissue member, and is chemically
bound to the tissue of the surrounding biological tissue
member.

The issue

The Examiner rejected claims 1 and 3-19 under 35 U.S.C. § 102(b) as
anticipated by Rhee ‘5001 (Ans. 3-5).
The Examiner finds that “Rhee et al disclose an isolated transplantable
bioprosthetic comprising of an exterior biological tissue member” (Ans. 3).
The Examiner finds that Rhee teaches a “biopolymeric material . . .which
fills the cavity and replaces the nucleus pulposus, intercalates or inserts
between this surrounding biological tissue member” (Ans. 3-4). The

1 Rhee et al., US 5,874,500, issued Feb. 23, 1999.
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Examiner finds that with “respect to the Rhee disclosing proteinacerous [sic]
biopolymeric material, page 9, line 22 of applicant’s [s]pecification discloses
a cross-linked polymer, such as those in U.S. 6,051,648, which is a
continuation of Rhee et al (5,874,500), are suitable as proteinacerous [sic]
biopolymeric material” (Ans. 4).
Appellants contend that “[w]hile it is true that Rhee ‘500 does
disclose . . . that the cross-linked synthetic polymer may be injected into an
invertebral disc as a replacement for the natural nucleus pulposus, Rhee ‘500
. . . makes it quite clear that the disc is in vivo” (App. Br. 3). Appellants
contend that “Rhee ‘500 does not disclose at all an isolated (read: ex vivo)
transplantable bioprosthetic” (App. Br. 3).
Appellants contend that the Examiner
cannot acknowledge that the term ‘isolated transplantable’ is
sufficient to exclude in vivo tissue of a human patient for
purpose of satisfying 35 USC §101 on the one hand, and
then assert that the claims read on in vivo tissue of a human
patient for purpose of asserting an art-based rejection,
especially an anticipation rejection under 35 USC §102(b).

(App. Br. 4).
Appellants contend that “Rhee et al ‘500 teach directly away from the
use of a proteinaceous biopolymeric material such as that embraced by the
presently pending claims” (App. Br. 5).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s finding that Rhee ‘500 anticipates claim 1?

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Findings of Fact
1. The Specification teaches that the “bioprosthetic device is a
bioprosthetic vertebral disc having a fibrillar outer annulus which surrounds
and defines an interior cavity and is formed by removal of at least a
substantial portion of the natural gelatinous core therefrom” (Spec. 5, ll. 11-
14).
2. The Specification teaches that the “cavity defined by the
fibrillar outer annulus may then be filled with a flowable biopolymeric
material which is then allowed to at least partly solidify in situ (e.g., most
preferably by in situ cross-linkage reaction) to form a proteinaceous
biopolymer within the cavity” (Spec. 5, ll. 15-18).
3. The Specification teaches that:
Virtually any suitable proteinaceous biopolymer may be
employed in the practice of the present invention. In this
regard, the term “proteinaceous biopolymer” and like terms
mean a polymeric or copolymeric material which contains
one or more units in the polymer chain comprised of natural,
synthetic or sequence-modified proteins or polypeptides, and
mixtures and blends of such polymeric and/or copolymeric
materials.

(Spec. 7, ll. 1-7).
4. The Specification teaches, in Example 3, that it “was found that
(1) the removal of the nucleus reduced the overall height of the material, as
well as the compressibility, (2) the filling with the biomaterial restored the
disc height and the compressibility” (Spec. 12, ll. 22-25).
5. The Specification teaches, in Example 1, that:
A formulation formed of a protein solution (serum albumin)
and a cross linker (gluteraldehyde) was contained in the
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separate chambers of a delivery device. When the device is
triggered, the two components are expelled from their
respective chambers into a mixing tip that combines the two
solutions and mixes them as they travel over the static
mixing elements present in the tip.

(Spec. 11, ll. 4-11).
6. Rhee ‘500 teaches that for
compositions intended for use in tissue augmentation,
fibrillar collagen is preferred because it tends to form
stronger crosslinked gels having greater long-term
persistency in vivo than those prepared using nonfibrillar
collagen. In general, the collagen is added to the first
synthetic polymer, then the collagen and first synthetic
polymer are mixed thoroughly to achieve a homogeneous
composition. The second synthetic polymer is then added
and mixed into the collagen/first synthetic polymer mixture,
where it will covalently bind to primary amino groups or
thiol groups on the first synthetic polymer and primary
amino groups on the collagen, resulting in the formation of a
homogeneous crosslinked network.

(Rhee ‘500, col. 13, ll. 14-25).
7. Rhee ‘500 teaches that “it may also be desirable to incorporate
proteins such as albumin” (Rhee ‘500, col. 13, ll. 31-32).
8. Rhee ‘500 teaches that the “compositions of the present
invention may be administered before, during or after crosslinking of the
first and second synthetic polymer” (Rhee ‘500, col. 13, ll. 39-41).
9. Rhee ‘500 teaches that:
In order to administer the composition prior to crosslinking,
the first synthetic polymer and second synthetic polymer
may be contained within separate barrels of a dual-
compartment syringe. In this case, the two synthetic
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polymers do not actually mix until the point at which the
two polymers are extruded from the tip of the syringe needle
into the patient's tissue. This allows the vast majority of the
crosslinking reaction to occur in situ.

(Rhee ‘500, col. 13, ll. 50-57).
10. Rhee ‘500 teaches that the “crosslinked polymer compositions
can also be used as a replacement material for the nucleus pulposus of a
damaged intervertebral disk. As such, the nucleus pulposus of the damaged
disk is first removed, then the crosslinked polymer composition is injected
or otherwise introduced into the center of the disk” (Rhee ‘500, col. 18, ll.
50-55).
11. Rhee ‘500 teaches that the “composition may either be
crosslinked prior to introduction into the disk, or allowed to crosslink in
situ” (Rhee ‘500, col. 18, ll. 55-57).
12. Rhee ‘500 teaches that “[e]lectrophilic groups on the second
synthetic polymer may also react with primary amino groups on lysine
residues of collagen molecules within the patient’s own tissue, providing for
‘biological anchoring’ of the compositions with the host tissue” (Rhee ‘500,
col. 18, l. 66 to col. 19, l. 3).
13. Rhee ‘500 teaches that “when collagen from a xenogeneic
source, such as bovine collagen, is used, atelopeptide collagen is generally
preferred, because of its reduced immunogenicity” (Rhee ‘500, col. 12, ll. 3-
6).
Principles of Law
It is well settled that during examination, the PTO must interpret
terms in a claim using “the broadest reasonable meaning of the words in
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their ordinary usage as they would be understood by one of ordinary skill in
the art, taking into account whatever enlightenment by way of definitions or
otherwise that may be afforded by the written description contained in the
applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
1997).
“A single prior art reference that discloses, either expressly or
inherently, each limitation of a claim invalidates that claim by anticipation.”
Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir.
2005). In Cruciferous Sprout, the court stated “[i]t is well settled that a prior
art reference may anticipate when the claim limitations not expressly found
in that reference are nonetheless inherent in it.” In re Cruciferous Sprout
Litigation, 301 F.3d 1343, 1349 (Fed. Cir. 2002).
Analysis
Claim interpretation is at the heart of patent examination because
before a claim is properly interpreted, its scope cannot be compared to the
prior art. In this case, the limitations in claim 1 which are at issue are the
requirements for an “isolated” transplantable bioprosthetic and a
“proteinaceous biopolymeric material” (Claim 1).
During prosecution, claim terms are given their broadest reasonable
interpretation as they would be understood by persons of ordinary skill in the
art in the light of the Specification. Therefore, we first turn to the
Specification to determine whether “proteinaceous biopolymeric material”
and “isolated” have any specified definitions.

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“proteinaceous biopolymeric material”
The Specification expressly defines “proteinaceous biopolymeric
material”. The Specification teaches that “the term ‘proteinaceous
biopolymer’ and like terms mean a polymeric or copolymeric material which
contains one or more units in the polymer chain comprised of natural,
synthetic or sequence-modified proteins or polypeptides, and mixtures and
blends of such polymeric and/or copolymeric materials” (Spec. 7, ll. 1-7; FF
3).
Thus, when the Specification uses the term “proteinaceous
biopolymeric material” in the context of Claim 1, the Specification is
reasonably understood as encompassing any polymer or copolymer which
contains natural, synthetic, or sequence-modified proteins, or blends of these
components with other polymers (FF 3). We recognize that Appellants have
argued other interpretations of “proteinaceous biopolymeric material” (see
Ans. 4-5), but the express definition of the Specification controls this
inquiry. (See Serrano v. Telular Corp., 111 F.3d 1578, 1582 (Fed. Cir.
1997)(“The inventors’ definition and explanation of the meaning of the word
… as evidenced by the specification, controls the interpretation of that claim
term).
“isolated”
Appellants do not identify, and we do not find, a specific teaching in
the Specification which defines or explains the term “isolated”. Appellants
contend that “Rhee ‘500 does not disclose at all an isolated (read: ex vivo)
transplantable bioprosthetic” (App. Br. 3).
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While Appellants contend that “isolated” should be read as “ex vivo”,
there is no support for such a reading in the Specification. The “isolated
transplantable bioprosthetic” claimed is composed of two parts, “an exterior
biological tissue member which at least partly defines a cavity” and “a
proteinaceous biopolymeric material which fills the cavity” (see Claim 1).
Both Appellants Specification and Rhee ‘500 teach that the “proteinaceous
biopolymeric material” is composed of material which is “ex vivo” and
which is prepared outside the patient’s body (FF 3-5, 8-10).
However, the only disclosure of “an exterior biological tissue member
which at least partly defines a cavity” in Appellants’ Specification is where
the “bioprosthetic device is a bioprosthetic vertebral disc having a fibrillar
outer annulus which surrounds and defines an interior cavity and is formed
by removal of at least a substantial portion of the natural gelatinous core
therefrom” (Spec. 5, ll. 11-14; FF 1). This is precisely the same cavity
taught by Rhee ‘500 who teaches that the “crosslinked polymer
compositions can also be used as a replacement material for the nucleus
pulposus of a damaged intervertebral disk. As such, the nucleus pulposus of
the damaged disk is first removed, then the crosslinked polymer composition
is injected or otherwise introduced into the center of the disk” (Rhee ‘500,
col. 18, ll. 50-55; FF 10).
We agree with the Examiner that the term “isolated” in Claim 1
cannot be reasonably interpreted to exclude the only disclosed embodiment;
that of a vertebral disc found in the Specification (and in Rhee ‘500) (Ans. 4;
FF 1, 10). Appellants do not identify any teaching in the Specification
which supports their interpretation of “isolated” as “ex vivo”. The only
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reasonable interpretation of “isolated” in this context is that the term is
intended to exclude the naturally present gelatinous material in the nucleus
pulposis of the intervertebral disc from the claim, while including
proteinaceous biopolymeric materials which differ from the natural
gelatinous material. See In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989)
(“[D]uring patent prosecution when claims can be amended, ambiguities
should be recognized, scope and breadth of language explored, and
clarification imposed.”)
Anticipation
Rhee teaches a bioprosthetic where “crosslinked polymer
compositions can also be used as a replacement material for the nucleus
pulposus of a damaged intervertebral disk. As such, the nucleus pulposus of
the damaged disk is first removed, then the crosslinked polymer composition
is injected or otherwise introduced into the center of the disk” (Rhee ‘500,
col. 18, ll. 50-55; FF 10). After the nucleus pulposis is removed from the
disc, the disc is an exterior biological tissue member which partly defines a
cavity (FF 10). Rhee ‘500 teaches a proteinaceous biopolymeric material
which fills the cavity (FF 10). Rhee ‘500 teaches that the biopolymeric
material is chemically bound to the surrounding tissue, teaching that
“[e]lectrophilic groups on the second synthetic polymer may also react with
primary amino groups on lysine residues of collagen molecules within the
patient’s own tissue, providing for ‘biological anchoring’ of the
compositions with the host tissue” (Rhee ‘500, col. 18, l. 66 to col. 19, l. 3;
FF 12).

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Appellants contend that the Examiner
cannot acknowledge that the term ‘isolated transplantable’ is
sufficient to exclude in vivo tissue of a human patient for
purpose of satisfying 35 USC §101 on the one hand, and
then assert that the claims read on in vivo tissue of a human
patient for purpose of asserting an art-based rejection,
especially an anticipation rejection under 35 USC §102(b).

(App. Br. 4).
We are not persuaded. The issue is simply whether “isolated” is
reasonably interpreted as limited to “ex vivo” or whether it encompasses the
use of a damaged intervertebral disc with the nucleus pulposis removed as a
cavity for the bioprosthetic as taught by Rhee ‘500 (FF 10-12). In light of
our claim interpretation above and the teachings of the Specification (FF 1,
2, 4), we find that Rhee ‘500 properly anticipates the limitation.
Appellants contend that “Rhee et al ‘500 teach directly away from the
use of a proteinaceous biopolymeric material such as that embraced by the
presently pending claims” (App. Br. 5).
We are not persuaded. Rhee ‘500 specifically teaches that “when
collagen from a xenogeneic source, such as bovine collagen, is used,
atelopeptide collagen is generally preferred, because of its reduced
immunogenicity” (Rhee ‘500, col. 12, ll. 3-6; FF 13). Thus, Rhee ‘500
teaches the use of “proteinaceous biopolymeric material” which expressly
satisfies the requirements of the definition in the Specification as discussed
above (FF 3, 5-9, 13).
Conclusion of Law
The evidence of record supports the Examiner’s finding that Rhee
‘500 anticipates claim 1.
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SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C. §
102(b) as anticipated by Rhee ‘500. Pursuant to 37 C.F.R. § 41.37(c)(1), we
also affirm the rejection of claims 3-19 as these claims were not argued
separately.

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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