Ex Parte Myint et al

Board of Patent Appeals and Interferences

May 24, 2012

11268786 (B.P.A.I. May. 24, 2012)

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.
11/268,786 11/08/2005 Khin Myint 9910/605 US 5013
32642 7590 05/25/2012
STOEL RIVES LLP - SLC
201 SOUTH MAIN STREET, SUITE 1100
ONE UTAH CENTER
SALT LAKE CITY, UT 84111
EXAMINER
CARTER, TARA ROSE E
ART UNIT PAPER NUMBER
3733
MAIL DATE DELIVERY MODE
05/25/2012 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 KHIN MYINT, ERIK O. MARTZ,
BENJAMIN F. CARTER and RONALD BURKE
__________

Appeal 2011-002655
Application 11/268,786
Technology Center 3700
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a multi-
lumen mold for formation of an intervertebral prosthesis. The Examiner
rejected the claims as anticipated and as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.

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Application 11/268,786

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Statement of the Case
Background
“The present invention relates to a method and apparatus for filling an
intervertebral disc space with an in situ curable biomaterial using a multi-
lumen mold” (Spec. 3, l. 27 to 4, l. 1).
The Claims
Claims 1-41 are on appeal. Claim 1 is representative and reads as
follows:
1. A multi-lumen mold for in situ formation of a
prosthesis in an annulus located in an intervertebral disc
space of a patient, the annulus having at least two openings
formed by minimally invasive techniques and at least a
portion of the nucleus pulposus removed to form a nuclear
cavity, the multi-lumen mold comprising:
a mold shaped to insert into the nuclear cavity, the
mold having at least one interior cavity;
at least a first lumen having a distal end fluidly
coupled to the interior cavity of the flexible mold at a first
location;
at least a second lumen having a distal end fluidly
coupled to the interior cavity of the flexible mold at a second
location, the first and second lumens extending out through
the respective openings in the annulus when the mold is
positioned in the nuclear cavity; and
a curable biomaterial delivered into the flexible mold
through at least one of the lumens.

The issues
A. The Examiner rejected claims 1-3 under 35 U.S.C. § 102(a) as
anticipated by Suddaby
1
(Ans. 3-4).

1
Suddaby, L., US 2005/0027358 A1, published Feb. 3, 2005.
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B. The Examiner rejected claims 20-22, 40, and 41 under 35 U.S.C. §
103(a) as obvious over Suddaby and Stalcup
2
(Ans. 4-6).
C. The Examiner rejected claims 4-8, 11, 18, 19, 23-28, 32-34, 38, and
39 under 35 U.S.C. § 103(a) as obvious over Suddaby, Stalcup, and Bao
3

(Ans. 6-8).
D. The Examiner rejected claims 4-10, 12-17, 24, 29-31, and 35-37 under
35 U.S.C. § 103(a) as obvious over Suddaby, Stalcup, and Belef
4
(Ans. 8-
12).
A. 35 U.S.C. § 102(a) over Suddaby
The Examiner finds that:
Suddaby discloses a multi-lumen mold for in situ formation
of a prosthesis in an annulus located in an intervertebral disc
space of a patient, the annulus having at least two openings
(see fig. 5) formed by minimally invasive techniques and at
least a portion of the nucleus pulposus removed to form a
nuclear cavity (para. 14), the multi-lumen mold comprising:
a mold (10+20) shaped to insert into the nuclear cavity; at
least a first lumen having a distal end fluidly coupled to the
flexible mold at a first location (see fig. 5); at least a second
lumen having a distal end fluidly coupled to the flexible
mold at a second location (see fig. 5), the first and second
lumens extending out through the respective openings in the
annulus when the mold is positioned in the nuclear cavity
(see figs. 5 and 6); and a curable biomaterial (e.g. 12 or 22)
delivered into the flexible mold through at least one of the
lumens (see figs. 5 and 6).

(Ans. 4).

2
Stalcup et al, US 6,332,894 B1, issued Dec. 25, 2001.
3
Bao et al., US 2003/0220649 A1, published Nov. 27, 2003.
4
Belef et al., US 2002/0147497 A1, published Oct. 10, 2002.
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Appellants “submit that Suddaby discloses two separate balloons 10,
20 filled with different materials 12, 22, and therefore, does not disclose two
lumens fluidly coupled to the same interior cavity of a mold” (App. Br. 6).
Appellants contend that there “is no fluid communication between the
interior cavities of the molds 10 and 20 or their respective fill tubes” (App.
Br. 6).
Appellants contend that “[n]owhere in Suddaby is there any disclosure
of two lumens fluidly coupled to the same interior cavity of a mold.
Therefore, the two-balloon system of Suddaby does not anticipate claim 1 or
the claims that depend therefrom” (App. Br. 6).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s finding that Suddaby anticipates claim 1?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
1. Suddaby teaches “a prosthetic nuclear replacement for a
damaged intervertebral disc, and a surgical procedure for implanting the
construct in the intervertebral disc space” (Suddaby 1 ¶ 0001).
2. Suddaby teaches to “provide an intervertebral disc nuclear
replacement prosthesis that simultaneously restores sufficient disc space
height and mobility to provide a semblance of functional normalcy and to
reduce or eliminate abnormal stresses on adjacent intervertebral segments”
(Suddaby 1 ¶ 0012).
3. Suddaby teaches an embodiment where “two balloons, one
inside the other, are inserted into the disc. Using volume measuring and
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filling techniques similar to those described above, the inner balloon 10 is
filled with a first liquid material 12, and the chamber 18 formed between the
inner balloon 10 and the outer balloon 20 is filled with a second hardenable
material 22 in liquid form” (Suddaby 2 ¶ 0032).
4. Figure 5 of Suddaby is reproduced below:

“FIG. 5 shows a dual compartment balloon in which an inner and an outer
compartment are insufflated with materials having different elastomeric
properties when in their hardened states” (Suddaby 2 ¶ 0025).
5. Suddaby teaches that the “first liquid material 12 is preferably
hardenable, but to a substantially lesser hardness that the outer material, so
that [the] cured construct is relatively soft on the inside, and relatively harder
on the outside, like a natural disc” (Suddaby 2-3 ¶ 0032).
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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
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).
Analysis
Suddaby teaches a multi-lumen mold (FF 4) where the mold is
shaped to insert into the cavity of an intervertebral disc space nuclear cavity
(FF 1-2). Suddaby teaches a first lumen fluidly coupled to the mold at a first
location and a second lumen fluidly coupled to the mold at a second
location, where the first and second lumens extend out of the annulus (FF 1-
4). Suddaby teaches a curable biomaterial delivered into the flexible mold
(FF 5).
Appellants “submit that Suddaby discloses two separate balloons 10,
20 filled with different materials 12, 22, and therefore, does not disclose two
lumens fluidly coupled to the same interior cavity of a mold” (App. Br. 6).
Appellant contends that there “is no fluid communication between the
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interior cavities of the molds 10 and 20 or their respective fill tubes” (App.
Br. 6).
We are not persuaded. As correctly argued by the Examiner, claim 1
does not require that the first and second lumen are connected to the same
interior cavity. Claim 1 expressly claims a “mold having at least one interior
cavity”. We can therefore reasonably interpret the claim as permissive of
having two interior cavities based on this claim language. Claim 1 does not,
however, incorporate any requirement that there is fluid communication
between interior cavities. “[L]imitations are not to be read into the claims
from the specification.” In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir.
1993).
Conclusion of Law
The evidence of record supports the Examiner’s finding that Suddaby
anticipates claim 1.
B. 35 U.S.C. § 103(a) over Suddaby and Stalcup
The Examiner finds that Suddaby teaches the steps of claim 20 other
than “the step of removing the lumens comprises cutting said lumens” (Ans.
5). The Examiner finds that “Stalcup teaches cutting lumens after use in
order to remove the lumens from the surgical site and allow the surgeon to
close the incision in the annulus (col. 3. lines 60-65)” (Ans. 5). The
Examiner finds it obvious to “modify the step of removing the lumens of
Suddaby in view of Stalcup in order to remove the lumens from the surgical
site and allow the surgeon to close the incision in the annulus” (Ans. 6).
Appellants contend that “Suddaby teaches away from permitting fluid
communication between the interior cavities of the balloons 10 and 20 (or
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their respective fill tubes) and mixing of the first and second fill materials”
(App. Br. 7).
We find that the Examiner has the better position. Claim 20 requires
“positioning a mold in the annular cavity so that first and second lumens
fluidly coupled to an interior cavity in the mold extend through the first and
second openings in the annulus”. However, claim 20 does not require that
there is a single interior cavity which is fluidly coupled to both the first and
second lumens. Claim 20 is permissive of multiple interior cavities where
the first lumen is coupled to a first cavity and the second lumen is coupled to
a second cavity. Therefore, Suddaby does not teach away as Appellants
contend, but rather teaches the use of a first and second lumen (FF 3-4).
C. 35 U.S.C. § 103(a) over Suddaby, Stalcup, and Bao
The Examiner finds that “Suddaby and Stalcup teach the claimed
invention” except for certain dependent claim limitations (Ans. 6). The
Examiner finds that Bao teaches these limitations (Ans. 7-8). The Examiner
finds it obvious “to modify Suddaby and Stalcup in view of Bao in order to
ensure the mold is retained in the desired area” (Ans. 8).
The Examiner provides sound fact-based reasoning for combining
Bao with Suddaby and Stalcup. We adopt the fact finding and analysis of the
Examiner as our own. Appellants argue the underlying obviousness
rejection, but Appellants do not identify any material defect in the
Examiner's reasoning for combining Bao with Suddaby and Stalcup. Since
Appellants only argue the underlying rejection which we affirmed above, we
affirm this rejection for the reasons stated by the Examiner.

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D. 35 U.S.C. § 103(a) over Suddaby, Stalcup, and Belef
The Examiner finds that “Suddaby and Stalcup teaches the claimed
invention” except for certain dependent claim limitations (Ans. 8). The
Examiner finds that Bao teaches these limitations (Ans. 10-11). The
Examiner finds it obvious to “create the multi-lumen mold of Suddaby and
Stalcup with the securing member, the tension member, and the securing
structure, in view of Belef, in order to provide a mechanism for sealing the
mold after it has been filled” (Ans. 11).
The Examiner provides sound fact-based reasoning for combining
Belef with Suddaby and Stalcup. We adopt the fact finding and analysis of
the Examiner as our own. Appellants argue the underlying obviousness
rejection, but Appellants do not identify any material defect in the
Examiner's reasoning for combining Belef with Suddaby and Stalcup. Since
Appellants only argue the underlying rejection which we affirmed above, we
affirm this rejection for the reasons stated by the Examiner.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C. §
102(a) as anticipated by Suddaby. Pursuant to 37 C.F.R. § 41.37(c)(1), we
also affirm the rejection of claims 2 and 3 as these claims were not argued
separately.
We affirm the rejection of claims 20-22, 40, and 41 under 35 U.S.C. §
103(a) as obvious over Suddaby and Stalcup.
We affirm the rejection of claims 4-8, 11, 18, 19, 23-28, 32-34, 38,
and 39 under 35 U.S.C. § 103(a) as obvious over Suddaby, Stalcup, and Bao.
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Application 11/268,786

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We affirm the rejection of claims 4-10, 12-17, 24, 29-31, and 35-37
under 35 U.S.C. § 103(a) as obvious over Suddaby, Stalcup, and Belef.
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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