Stryker Corporationv.Orthophoenix, LLC

Patent Trial and Appeal Board

Feb 24, 2016

09918942 (P.T.A.B. Feb. 24, 2016)

Trials@uspto.gov Paper 27
Tel: 571-272-7822 Entered: February 24, 2016

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________
STRYKER CORPORATION,
Petitioner,

v.

ORTHOPHOENIX, LLC,
Patent Owner.
_______________

Case IPR2014-01519
Patent 6,623,505 B2
_______________

Before JOSIAH C. COCKS, RICHARD E. RICE, and
SCOTT A. DANIELS, Administrative Patent Judges.

RICE, Administrative Patent Judge.

FINAL WRITTEN DECISION
35 U.S.C. § 318(a) and 37 C.F.R. § 42.73

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I. INTRODUCTION
A. Background/Summary
Stryker Corporation (“Petitioner”) filed a Petition (Paper 1, “Petition”
or “Pet.”) for inter partes review of claims 1–12 of U.S. Patent
No. 6,623,505 B2 (Ex. 1001, “the ’505 Patent”). We instituted an
inter partes review as to all claims. Paper 7 (“Dec.”), 19. After institution,
Orthophoenix, LLC (“Patent Owner”) filed a Patent Owner Response (Paper
14, “PO Resp.”), to which Petitioner filed a Reply (Paper 17, “Pet. Reply”).
The grounds for trial were as follows:

References Basis Claims Challenged
Valley1 § 102(b) 1–12
Valley § 103(a) 1–12
Reiley2 and Anderson3 § 103(a) 1–3, 5–7, and 9–11

Petitioner relied on the first and second declarations of
Neil J. Sheehan. (Exs. 1002, 1041). Patent Owner relied on the declaration
of Gamal Baroud, Ph.D. (Ex. 2018).

1 U.S. Patent No. 5,766,151 filed June 7, 1995, issued June 16, 1998
(Ex. 1007).
2 International Publication No. WO 95/20362, published Aug. 3, 1995
(Ex. 1006).
3 U.S. Patent No. 4,706,670, issued November 17, 1987 (Ex. 1005).
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Patent Owner filed Observations on the cross-examination of
Mr. Sheehan (Paper 19), to which Petitioner filed a Response (Paper 24).
A consolidated Oral Hearing for this proceeding and case IPR2014-
01535 was held on November 4, 2015. A transcript of the Hearing has been
entered in the record. Paper 26 (“Tr.”).
We have jurisdiction under 35 U.S.C. § 6(c). The evidentiary
standard is a preponderance of the evidence. See 35 U.S.C. § 316(e);
37 C.F.R. § 42.1(d). This Final Written Decision is issued pursuant to
35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
For the reasons explained below, we determine that Petitioner has
shown by a preponderance of the evidence that claims 1, 2, 4–6, 8–10,
and 12 are unpatentable as anticipated by Valley and claims 1–12 are
unpatentable as obvious over Valley; however, Petitioner has not shown by a
preponderance of the evidence that claims 1–3, 5–7, and 9–11 are
unpatentable as obvious over Reiley and Anderson.
B. Related Proceedings
Petitioner and Patent Owner are parties to a federal district court case
involving the ’505 Patent (Orthophoenix, LLC. v. Stryker Corp., No. 13-
1628-LPS (D. Del.)). Pet. 1. They also are parties to an inter partes review
of U.S. Patent No. 6,280,456 B1, which is related to the ’505 Patent. See
IPR2014-01535, Paper 1.
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C. The ’505 Patent
The ’505 Patent relates “to expandable structures, which, in use, are
deployed in interior body regions of humans and other animals.” Ex. 1001,
1:12–14. Figures 19 and 20 of the ’505 Patent are reproduced below.

Figures 19 and 20 depict side section views of expandable structure
110 at different stages of manufacture. Id. at 3:41–51, 10:14–59. As
depicted in Figure 19, expandable structure 110 includes inner catheter
tube 120, which is slidable within outer catheter tube 118, and located a
distance d1 beyond the outer catheter tube. Id. at 3:41–45, 10:19–32. At
this stage, the proximal end of expandable structure 110 has been bonded to
the distal end of outer catheter tube 118, and the distal end of expandable
structure 110 is bonded to the distal end of inner catheter tube 120. Id. at
3:41–45, 10:32–36. Figure 20 shows the expandable structure of Figure 19
at a later stage, after sliding the inner catheter tube a distance d2 (shorter
than d1) from the end of outer catheter tube 118. Id. at 3:46–47, 10:40–43.
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At that stage, the relative position of the outer and inner catheter tubes 118
and 120 are secured against further movement, for example, by adhesive.
Id. at 10:46–49.
In another embodiment, materials selected for the inner catheter tube
and the expandable body are more compliant (i.e., more elastic) than the
materials selected for the outer catheter tube, such that, during expansion,
the expandable body and the inner catheter tube are capable of increasing in
length relative to the outer catheter tube. Id. at 11:15–39, Fig. 21. Figure 21
of the ’505 Patent is reproduced below.

Figure 21 depicts expandable structure 300, including inner catheter
tube 304, expandable body 306, and outer catheter tube 302. Id. at 10:60–
11:7. Materials selected for inner catheter tube 304 and expandable body
306 are more compliant than materials selected for outer catheter tube 302.
Id. at 11:15–18. “Due to the differential selection of materials, the lack of
compliance of the outer catheter tube 302 at the proximal body end 314 is
counterpoised during expansion of the body 306 against the compliance of
the inner catheter tube 304 at the distal body end 316.” Id. at 11:27–31.
The ’505 Patent describes passing a stiffening member or stylet
through an interior lumen of the expandable structure. Id. at 12:35–40.
Figures 26 and 27 of the ’505 Patent are reproduced below.
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Figure 26 is a side view of expandable structure 604. Id. at 4:3–6,
12:35–47. Figure 27 is a side view of expandable structure 604, after
deployment in targeted interior body region 610. Id. at 4:7–12, 12:48–63.
As shown in Figure 26, lumen 602 of inner catheter tube 600 accommodates
the passage of stiffening member or stylet 606. Id. at 12:36–39, Fig. 26. As
shown in Figure 27, the stylet includes distal region 612, which has a
preformed bend that deflects expandable structure 604 and the distal end of
inner catheter tube 600 relative to the axis of guide sheath 608 as the stylet is
advanced free of the guide sheath and into targeted interior region 610. Id.
at 12:48–58, Fig. 27.
D. Illustrative Claims
Claims 1, 5, and 9 are independent. Claims 1 and 3 are illustrative
and are reproduced below:
1. A device for deployment into bone
comprising
an outer catheter tube having a distal end,
an inner catheter tube extending at least in
part within the outer catheter tube and having a
distal end region that extends at least in part beyond
the distal end of the outer catheter tube,
an inflatable structure having a proximal end
secured to the outer catheter tube and a distal end
secured to the inner catheter tube, the inflatable
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structure extending outside and beyond the outer
catheter tube and at least partially enclosing the
inner catheter tube, and
a flow passage between the outer and inner
catheter tubes communicating with the inflatable
structure and adapted to convey an inflation
medium into the inflatable structure to inflate the
inflatable structure.

3. A device according to claim 1 wherein
the inflatable structure is adapted and configured to
compress cancellous4 bone upon inflation of the
inflatable structure in bone.

Id. at 15:62–16:9, 16:15–18.
II. ANALYSIS
A. Claim Construction and Person of Ordinary Skill in the Art
In an inter partes review, claim terms in an unexpired patent are given
their broadest reasonable interpretation in light of the specification of the
patent in which they appear. 37 C.F.R. § 42.100(b); see also In re Cuozzo
Speed Techs., LLC, 793 F.3d 1268, 1278, 1279 (Fed. Cir. 2015) (“We
conclude that Congress implicitly approved the broadest reasonable
interpretation standard in enacting the AIA” and “the standard was properly
adopted by PTO regulation.”), cert. granted sub nom. Cuozzo Speed Techs.
LLC v. Lee, 84 U.S.L.W. 3218 (Jan. 15, 2016) (No. 15-446). Under that

4 With reference to Figures 1 and 2, the Specification states that vertebral
body 26 includes an exterior formed from compact cortical bone 28, which
encloses “interior volume 30 of reticulated cancellous, or spongy, bone 32
(also called medullary bone or trabecular bone).” Id. at 4:57–61, Figs. 1, 2.
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standard, a claim term generally is given its ordinary and customary
meaning, as would be understood by one of ordinary skill in the art in the
context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249,
1257 (Fed. Cir. 2007). While our claim interpretation cannot be divorced
from the specification and the record evidence, see Microsoft Corp. v.
Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015) (quoting In re NTP,
Inc., 654 F.3d 1279, 1288 (Fed. Cir. 2011)), we must be careful not to
import limitations from the specification that are not part of the claim
language. See Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870,
875 (Fed. Cir. 2004). Any special definition for a claim term must be set
forth in the specification with reasonable clarity, deliberateness, and
precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
The parties do not agree on the level of ordinary skill in the art.
Petitioner’s expert, Mr. Sheehan, testifies to the following definition of a
person of ordinary skill:
A person of ordinary skill in the relevant art would have a
mechanical engineering degree, industrial design degree, or
similar technical degree, or equivalent work experience, and at
least 5 years of working in the area of medical device design,
including experience with catheters carrying an expandable or
inflatable structure, such as a typical balloon catheter.

Ex. 1002 ¶ 31. In contrast, Dr. Baroud testifies:

Based on my experience, a person of ordinary skill in the
art would have had advanced training in mechanical and
biomechanical engineering and would have had specific
experience with the mechanics and properties of bones as well as
more specifically, with the field of bone augmentation. Bone
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augmentation includes bone strengthening, increasing osseous
dimensions as well as verterbroplasty and kyphoplasty.

Ex. 2018 ¶ 13. We credit Mr. Sheehan’s definition over that of Dr. Baroud.
As the field of the ’505 Patent is expandable structures, Ex. 1001, 1:12–14, a
relevant technical degree or equivalent work experience involving the design
of expandable structures, whether in bone or vasculature, is all that the level
of ordinary skill would have required. See Ex. 1041 ¶ 28.
1. The Preambles of Claims 1, 5, and 9
The preambles of claims 1 and 5 each recite: “A device for
deployment into bone.” The preamble of claim 9 recites: “A system for
treating bone.” The parties disagree as to whether the preambles are claim
limitations. Compare Pet. 14–15 with PO Resp. 13–15.
“Whether to treat a preamble as a limitation is a determination
‘resolved only on review of the entire[] . . . patent to gain an understanding
of what the inventors actually invented and intended to encompass by the
claim.”’ Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,
808 (Fed. Cir. 2002) (quoting Corning Glass Works v. Sumitomo Elec.
U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989)). “In general, a preamble
limits the invention if it recites essential structure or steps, or if it is
‘necessary to give life, meaning, and vitality’ to the claim.” Id. (quoting
Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir.
1999)). “Conversely, a preamble is not limiting ‘where a patentee defines a
structurally complete invention in the claim body and uses the preamble only
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to state a purpose or intended use for the invention.”’ Id. (quoting Rowe v.
Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)).
In this case, Patent Owner argues that “when read in the context of the
claim, the preamble requires the claimed device to possess structure and
properties compatible with, i.e., designed and constructed for, use in bone
and thus forecloses interpretations of the claim inconsistent with suitability
of the claimed device for such use.” PO Resp. 13–14 (citing In re Stencel,
828 F.2d 751, 754 (Fed. Cir. 1987)). Patent Owner asserts that “the words
of the preamble ‘for deployment into bone’ or ‘for treating bone’ serve to
limit the prior art against which patentability is measured to devices
designed and constructed for deployment in bone.” Id. Patent Owner
further asserts that “[w]ithout significant modification of mechanical and
structural properties of the balloons, bone catheters outfitted with bone
balloons cannot be used in blood vessels, nor can blood vessel catheters
outfitted with vascular balloons be used in bone. Id. (citing Ex. 2018 ¶¶ 21–
22.
Patent Owner also argues that “claims 5 and 9 state within the claim
body that the claimed inflatable structure is sized and configured for passage
within a cannula into bone, and claims 7 and 11 indicate within the claim
body that the inflatable structure is adapted and configured for compression
of cancellous bone. Id. at 14–15. Patent Owner further argues that “[i]n
each case the claim body references the bone recited in the preamble.” Id.
at 15.
We have considered Patent Owner’s arguments, but agree with
Petitioner that the preambles of claims 1, 5, and 9 each “merely state the
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intended use for the claimed device and system.” Pet. Reply 3. As
Petitioner argues, the body of each of these claims describes “structurally
complete . . . inventions (e.g., outer and inner catheter tubes, an inflatable
structure, and a flow passage between the tubes).” Id. We also agree with
Petitioner that nothing in the Specification or prosecution history of the
’505 Patent supports interpreting the claim preambles as limitations. See id.
at 5; Ex. 1001, 4:28–40, 5:31–43, 11:50–12:25, Figs. 22, 23; Ex. 1016, 79–
83, 94–101. Indeed, contrary to Patent Owner’s arguments, the
Specification describes “vasculature” as “present[ing] an environment well
suited to receive the benefits of the invention.” Ex. 1001, 4:30–32.
We recognize that claims 5 and 9 each recite “the inflatable structure
being sized and configured for passage within a cannula into bone”
(emphasis added). As we stated in the Institution Decision, however, we are
not persuaded that the term “bone” in the preamble provides any distinct
definition of the term “bone” in the body of the claim. Dec. 7. For that
reason, the preamble is not necessary to give meaning to, or define, the term
“bone” in the body of the claim. See Catalina Mktg. Int’l, 289 F.3d at 808.
The Federal Circuit’s decision in Stencel is distinguishable. In that
case, the claim related to a driver device intended for use with a particular
threaded lobed collar. 828 F.2d at 752. The Federal Circuit determined that
the driver was limited by language defining the structure of the collar on
which it acted. Id. at 754. The body of the claim recited “the collar” and the
preamble defined the collar as “a threaded collar . . . having plastically
deformable lobes.” Id. at 752–53, 754. In contrast, here, the preamble does
not assist to define the term “bone” in the body of the claim.
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Accordingly, we maintain our determination in the Institution
Decision that the body of each of claims 1, 5, and 9 fully and intrinsically
sets forth all of the limitations of the claim, and that the preambles are not
claim limitations. Dec. 8.
2. “Wherein the inflatable structure is adapted and
configured to compress cancellous bone upon
inflation of the inflatable structure in bone”
Patent Owner contends the phrase “wherein the inflatable structure is
adapted and configured to compress cancellous bone upon inflation of the
inflatable structure in bone,” recited in claims 3, 7, and 11, requires “a
device having a structure and properties not only suitable for the claimed use
but specifically designed and constructed to perform the claimed function
and thus constitute[s] a limitation.” PO Resp. 15 (citing In re Giannelli,
739 F.3d 1375, 1379 (Fed. Cir. 2014)). Patent Owner further argues that the
recited phrase means “that the inflatable structure must be designed and
constructed to compress cancellous bone upon inflation in a manner that
creates uniform and predictable compression in the cancellous bone[,] but
must not apply so much pressure as to compromise the structural integrity of
the bone.” Id. at 16 (emphasis added; citing Ex. 2018 ¶¶ 21–22).
Dr. Baroud testifies in support of Patent Owner’s claim construction that
“the inflatable structure must be designed and constructed to compress
cancellous bone upon inflation in a manner that creates a relatively uniform
and predictable compression in the cancellous bone.” Ex. 2018 ¶ 21
(referencing his discussion of Figures 17–20 of the ’505 Patent); see id.
¶¶ 28–29. Petitioner disagrees, and asserts that the disputed phrase merely
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requires an inflatable structure that is capable of compressing cancellous
bone upon inflation. Pet. 15–16; Pet. Reply 8.
In Giannelli, cited by Patent Owner, the claims at issue required a
“first handle portion adapted to be moved from a first position to a second
position by a pulling force . . . in a rowing motion.” 739 F.3d at 1379
(emphasis added). Recognizing that the claim term “adapted to” can mean
“made to,” “designed to,” or “configured to,” as well as “capable of” or
“suitable for,” the Federal Circuit gave the term the first, narrower meaning
because the written description “ma[de] clear” that the claimed machine was
“designed or constructed to be used as a rowing machine whereby a pulling
force is exerted on the handles.” Id. The Federal Circuit explained that the
patent specification described “how the position of the handles relative to the
primary and secondary lever arms and the resistance mechanism renders
them ‘adapted’ to be moved by the user’s pulling force.” Id. Based on its
claim interpretation, the Federal Circuit determined that the relevant
question for patentability in that case was whether the apparatus disclosed in
the prior art was “made to,” “designed to,” or “configured to,” allow the user
to perform a rowing exercise by pulling on the handles as claimed. Id.
at 1381.
In this case, unlike Giannelli, the claim interpretation issue does not
revolve about the meaning of “adapted to,” but rather the term “adapted and
configured to.” By inclusion of “configured,” the term “adapted and
configured to” expressly invokes the narrower meaning of “adapted to”
considered by the Federal Circuit in Giannelli, i.e., “made to,” “designed
to,” or “configured to.” Giannelli, 739 F.3d at 1379, 1381 (emphasis
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added). Further, interpreting “adapted and configured to” more broadly to
mean “capable of” or “suitable for” would render “configured” superfluous
in the term “adapted and configured to.” See Bicon, Inc. v. Straumann Co.,
441 F.3d 945, 950 (Fed. Cir. 2006) (stating that “claims are interpreted with
an eye toward giving effect to all terms in the claim”).
The phrase “wherein the inflatable structure is adapted and configured
to compress cancellous bone upon inflation of the inflatable structure in
bone,” however, does not indicate how the inflatable structure should be
designed or constructed to perform the recited function of compressing
cancellous bone upon inflation, or specify any particular manner of
performing that function. That the Specification describes embodiments
designed or constructed to compress cancellous bone as recited in the claims
does not justify reading limitations from those embodiments into the claims,
contrary to Patent Owner’s argument. See PO Resp. 5–9 (citing Ex. 1001,
9:24–67, 10:14–59, Figs. 17, 18, 19), 15–16; Tr. 34:15–36:16. Accordingly,
we do not agree with Patent Owner that “adapted and configured to,” in
claims 3, 7, and 11, means that “that the inflatable structure must be
designed and constructed to compress cancellous bone upon inflation in a
manner that creates uniform and predictable compression in the cancellous
bone[,] but must not apply so much pressure as to compromise the structural
integrity of the bone.” See PO Resp. 16. Nor do we agree with Patent
Owner’s argument at the Oral Hearing that the inflatable structure must have
tapered ends. See Tr. 36:14–16.
We determine that the broadest reasonable interpretation consistent
with the Specification of an “inflatable structure [that] is adapted and
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configured to compress cancellous bone upon inflation of the inflatable
structure in bone” is an inflatable structure that is designed or made to
compress cancellous bone upon inflation of the inflatable structure in bone.
B. Asserted Anticipation of Claims 1–12 by Valley
To anticipate a patent claim under 35 U.S.C. § 102, “a single prior art
reference must expressly or inherently disclose each claim limitation.”
Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1334 (Fed. Cir. 2008).
Under the principles of inherency, if the prior art necessarily functions in
accordance with, or includes, the claimed limitations, it anticipates, even
though artisans of ordinary skill may not have recognized the inherent
characteristics or functioning of the prior art. MEHL/Biophile Int’l Corp. v.
Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999) (citation omitted); In re
Cruciferous Sprout Litig., 301 F.3d 1343, 1349–50 (Fed. Cir. 2002).
In this case, Petitioner challenges claims 1–12 as anticipated by
Valley. Pet. 47–55. As discussed below, we are persuaded that Valley
anticipates claims 1, 2, 4–6, 8–10, 12, but not claims 3, 7, and 11.
1. Overview of Valley
Valley “relates to a catheter based system for isolating the heart and
coronary blood vessels of a patient from the remainder of the arterial system
and for infusing a cardioplegic agent into the patient’s coronary arteries to
induce cardioplegic arrest in the heart.” Ex. 1007, 1:43–48. Figure 8A of
Valley shows coaxial catheters and a deflated balloon. Id. at Fig. 8A. We
refer to Petitioner’s colorized, cropped version of Figure 8A, which is
reproduced below:
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Pet. 48; Ex. 1002 ¶ 74.
As illustrated in Petitioner’s Figure 8A, the distal end of balloon 410
(shown in blue) extends outside and beyond the distal end of outer catheter
tube 404 (shown in red), and the balloon encloses a portion of inner catheter
tube 402 (shown in green). See Pet. 48. The proximal end of balloon 410 is
attached to the distal end of outer tube 404, and the distal end of balloon 410
is attached to the distal end of inner tube 402, with the inner catheter tube
extending beyond the distal end of the outer catheter tube. See id. Inner
tube 402 is moveable in relation to outer tube 404. Ex. 1007, 24:27–30,
24:67–25:17.
2. Analysis―Claims 1, 2, 4–6, 8–10, and 12
Upon review of the arguments and evidence presented by the parties,
we determine that Petitioner has shown by a preponderance of the evidence
that Valley anticipates claims 1, 2, 4–6, 8–10, and 12. We are persuaded
that Petitioner―through claim charts and the testimony of Mr.
Sheehan―has shown sufficiently that Valley discloses each limitation of
claims 1, 2, 4–6, 8–10, and 12. See Pet. 47–55; Ex. 1002 ¶¶ 74–93.
Patent Owner argues that the balloon catheter device of Valley does
not meet the preamble requirements of independent claims 1, 5, and 9 for
“deployment into bone” or “treating bone.” PO Resp. 20. We disagree with
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Patent Owner’s argument because, as discussed above, the preambles of
claims 1, 5, and 9 are not claim limitations. See supra section II.A.1.
With respect to claims 5 and 9, we determine that Valley discloses,
inherently, an inflatable structure that is “sized and configured for passage
within a cannula into bone,” as recited in those claims. See Ex. 1002 ¶ 88.
In this regard, we credit Mr. Sheehan’s testimony:
The balloon of Valley is capable of insertion into the
disclosed introducer sheath, which is a cannula. A person of
ordinary skill would understand that the collapsed balloon of
Valley is sized and configured for passage within a cannula that
could be used in bone. While the disclosed catheter of Valley
focuses on use in vasculature, one of ordinary skill in the art
would understand that such a cannula, like the disclosed balloon
catheter, would also be used for entry into bone. Furthermore,
given that the architecture of vasculature is generally smaller
than that of bone, it would follow that anything sized for a
vasculature application would not be subject to any dimensional
limitations vis‐à‐vis bone. Accordingly, a person of ordinary
skill would understand that if the inflatable structure of Valley is
capable of passing within the cannula of Valley for entry into the
vascular system, the inflatable structure of Valley is also capable
of passage within a cannula into bone.
Id.
Patent Owner does not dispute the testimony of Mr. Sheehan that a
person of ordinary skill in the art would have understood that the collapsed
balloon of Valley is sized and configured for passage within a cannula that
could be used in bone. See id. Rather, Patent Owner challenges
Mr. Sheehan’s credibility based on his admission during cross-examination
that he had never designed a balloon catheter device for use in bone.
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PO Resp. 19–20 (quoting Ex. 2017, 10:15–11:7). Although Mr. Sheehan
has not designed a balloon catheter for use in bone, we find that
Mr. Sheehan’s experience designing balloon catheters for use in other body
regions qualifies him to opine on the challenged claims of the ’505 Patent.
See Ex. 2017, 9:13–10:14.5
For the reasons given, we conclude that Petitioner has shown by a
preponderance of the evidence that Valley anticipates independent claims 1,
5, and 9. Patent Owner presents arguments only as to independent claims 1,
5, and 9 and relies on those arguments as to dependent claims 2, 4, 6, 8, 10,
and 12. Having considered Petitioner’s arguments and Mr. Sheehan’s
testimony with respect to dependent claims 2, 4, 6, 8, 10, and 12, we are
persuaded that Petitioner has shown by a preponderance of the evidence that
Valley also anticipates those claims. See Pet. 47–55; Ex. 1002 ¶¶ 74–93.
3. Analysis―Claims 3, 7, and 11
Upon review of the arguments and evidence presented by the parties,
we determine that Petitioner has not shown by a preponderance of the
evidence that Valley anticipates claims 3, 7, and 11.
Claims 3, 7, and 11 each recite that “the inflatable structure is adapted
and configured to compress cancellous bone upon inflation of the inflatable
structure in bone.” As discussed above, this phrase requires an inflatable

5 We note that Patent Owner’s declarant, Dr. Baroud, testified that he has
never designed any type of balloon catheter, whether for use in vasculature
or bone. Ex. 1040, 96:5–16.
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structure that is designed or made to compress cancellous bone upon
inflation of the inflatable structure in bone. See supra Section II.A.2.
In arguing that Valley discloses this limitation, Petitioner asserts that
“a person of ordinary skill in the art would understand that [Valley’s]
disclosure of nondistensible materials, including polyethylene and PET,6 is
consistent with balloons that can compress cancellous bone as disclosed in
the 505 patent.” Pet. 52 (citing Ex. 1002 ¶¶ 81–83). We are not persuaded
by this argument because it improperly relies on the ’505 Patent disclosure
as evidence of what would have been known to those of ordinary skill in the
art at the time of the invention. See W.L. Gore & Assocs. v. Garlock, Inc.,
721 F.2d 1540, 1547 (Fed. Cir. 1983) (identifying as error the lower court’s
attribution of “that which only the inventor taught . . . to the prior art”).
In the Patent Owner Response, Patent Owner argues that the Valley
balloon is not designed to compress cancellous bone as required by the
claims because “[p]ressures typically required to compress various types of
cancellous bone are much higher than those described in Valley.”
PO Resp. 20 (citing Ex. 2018 ¶¶ 23–25), 23. Patent Owner argues that “at
the pressure specified in the ’505 patent, 250–500 psi, the balloon in Valley
will most likely rupture or be punctured by individual trabeculae of the
cancellous bone.” Id. at 20–21 (citing Ex. 2018 ¶ 26). Patent Owner also
argues that “[t]he balloon in Valley is designed to operate in soft
vasculature, a preexisting cavity, and all of Valley’s teachings are specific to
vascular applications.” Id. at 21 (citing Ex. 1007, 5:29–67, 6:1–10). Patent

6 Polyethylene terephthalate. See Ex. 1002 ¶ 82.
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Owner further argues that “the balloon in Valley is formed from elastomeric
materials which are by nature soft and comparatively atraumatic when
pressed against an anatomic structure such as [a] blood vessel.” Id. (citing
Ex. 1007, 21:32–46; Ex. 2018 ¶ 27).
In the Reply, Petitioner argues that Valley’s balloons “fall squarely
within” the teaching of the ’505 Patent of materials and thicknesses that can
withstand pressures up to 250–500 psi. Pet. Reply 9 (citing Ex. 1001,
12:64–13:4; Ex. 1002 ¶ 83; Ex. 1041 ¶¶ 5–6; Ex. 1040, 48:21–49:22).
Petitioner argues that materials (“polyethylene, polyurethane, and
polyethylene terephthalate (PET)”) and wall thicknesses (“0.090 to
0.130 mm”) disclosed in Valley are capable of withstanding pressures up to
250–500 psi. Id. at 9–10 (citing Ex. 1007, 8:25–32, 21:64–65). Petitioner
also argues that Valley discloses “inelastic materials.” Id. at 9 n.5 (citing
Ex. 1007, 8:29–32).
We are not persuaded that Valley discloses, expressly or inherently,
an inflatable structure that is designed or made to compress cancellous bone,
as required under our claim interpretation. See supra Section II.A.2.
Petitioner’s arguments in the Reply depend on improperly combining
elements from distinct Valley embodiments. See Net MoneyIN v. VeriSign,
Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008) (“[I]t is not enough [for
anticipation] that the prior art reference discloses part of the claimed
invention, which an ordinary artisan might supplement to make the whole, or
that it includes multiple, distinct teachings that the artisan might somehow
combine to achieve the claimed invention.”) (citing In re Arkley, 455 F.2d
586, 587 (CCPA 1972) (“[T]he [prior art] reference must clearly and
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unequivocally disclose the claimed [invention] or direct those skilled in the
art to the [invention] without any need for picking, choosing, and combining
various disclosures not directly related to each other by the teachings of the
cited reference.”)).
For balloon wall thicknesses from 0.090 mm to 0.130 mm, Petitioner
cites Valley’s disclosure relating to the embodiment depicted in Figure 6A.
Pet. Reply 10 (citing Ex. 1007, 21:64–65). In that embodiment,
“balloon 210 is preferably made from an elastomeric material such as latex,
silicone, or polyurethane.” Ex. 1007, 22:9–12 (emphasis added); see also id.
at 8:26–28 (again describing latex, silicone, and polyurethane as elastomeric
materials). Even if a balloon formed from polyurethane and having a wall
thickness within the range disclosed in Valley would withstand pressures of
250–500 psi, as Petitioner argues (Pet. Reply 9–10), we agree with Patent
Owner that Petitioner has failed to show sufficiently that any balloon made
from an elastomeric material, such as polyurethane, can be used to compress
cancellous bone. See PO Resp. 21.
For balloons made from “inelastic” materials such as polyethylene or
PET, Petitioner relies upon other Valley embodiments. Pet. Reply 9 n.5
(citing Ex. 1007, 8:29–32, describing polyethylene and PET as
nondistensible balloon materials). We are not persuaded, however, that
Valley discloses a wall thickness for a balloon made from an “inelastic”
material such as polyethylene or PET. In the Reply, Petitioner extrapolates
the wall thickness range of 0.090 mm–0.130 mm, which Valley discloses for
balloons made from elastomeric materials, to balloons made from “inelastic”
materials such as polyethylene and PET. Id. at 9–10 (citing Ex. 1007,
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21:64–65), n.5. Petitioner has not pointed to any teaching in Valley
supporting such extrapolation.
Mr. Sheehan’s testimony that a balloon capable of compressing
cancellous bone “can be formed” from materials disclosed in Valley also is
insufficient to prove inherency. See Ex. 1002 ¶ 82. That is, for inherency,
Mr. Sheehan’s testimony would need to establish that a Valley balloon, as
designed or made, necessarily functions to compress cancellous bone upon
inflation of the balloon in bone. See MEHL/Biophile Int’l, 192 F.3d at 1365
(“Under the principles of inherency, if the prior art necessarily functions in
accordance with, or includes, the claimed limitations, it anticipates.”).
Petitioner argues, based on calculations performed by Dr. Baroud on
cross-examination, that “the Valley balloons are capable of withstanding
pressures above 250 psi.” Pet. Reply 14 (citing Ex. 1007, 5:37, Figs. 8B, 11,
13; Ex. 1041 ¶ 13; Ex. 1040, 137:18–138:5, 140:19–141:23). As discussed
above, however, to the extent Dr. Baroud’s calculations pertain to balloons
made from nondistensible materials such as polyethylene and PET, the
calculations are based on wall thicknesses that have not been shown to be
disclosed by Valley. Further, Dr. Baroud testified that his calculations show
a capability of withstanding pressures above 250 psi “with a safety factor
of 2” or “roughly 2” (see Ex. 1040, 138:5, 141:22–23), but that “a safety
factor of at least 5” was required for medical devices because of the potential
for variations in materials and the need for safety in such devices. Id.
at 118:4–119:25.
Petitioner also argues that Dr. Baroud testified on cross-examination
that pressures well below 250 psi are capable of compressing cancellous
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bone, including pressures as low as 50 psi. Id. at 12–13 (citing Ex. 1040,
81:20–84.2). For the reasons discussed above, we are not persuaded that a
Valley balloon, as designed or made, necessarily functions to compress
cancellous bone at those pressures.
For the reasons given, we conclude that Petitioner has not shown by a
preponderance of the evidence that Valley anticipates claims 3, 7, and 11.
C. Asserted Obviousness of Claims 1–12 over Valley
A claim is unpatentable for obviousness under 35 U.S.C. § 103(a) if
the differences between the subject matter sought to be patented and the
prior art are such that the subject matter as a whole would have been obvious
at the time the invention was made to a person having ordinary skill in the
art to which the subject matter pertains. See KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 406 (2007). A patent claim composed of several elements,
however, is not proved obvious merely by demonstrating that each of its
elements was known, independently, in the prior art. Id. at 418. In
analyzing the obviousness of a combination of prior art elements, it can be
important to identify a reason that would have prompted one of skill in the
art to combine the elements in the way the claimed invention does. Id. A
precise teaching directed to the specific subject matter of a challenged claim
is not necessary to establish obviousness. Id. Rather, “any need or problem
known in the field of endeavor at the time of invention and addressed by the
patent can provide a reason for combining the elements in the manner
claimed.” Id. at 420. The question of obviousness is resolved on the basis
of underlying factual determinations, including: (1) the scope and content of
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the prior art; (2) any differences between the claimed subject matter and the
prior art; (3) the level of skill in the art; and (4) objective evidence of
nonobviousness, i.e., secondary considerations, if in evidence.7 See Graham
v. John Deere Co., 383 U.S. 1, 17–18 (1966).
Upon review of the arguments and evidence presented by the parties,
we determine that Petitioner has shown by a preponderance of the evidence
that claims 1–12 would have been obvious over Valley and the knowledge
of a person of ordinary skill in the art. Petitioner contends, and we agree,
that it would have been obvious to use the Valley catheter in bone. See Pet.
55 n.11 (citing Ex. 1002 ¶¶ 110–114). We credit Dr. Sheehan’s testimony
that “[i]n designing a catheter with an inflatable structure for use within a
bone lumen, a person of ordinary skill in the art would [have] look[ed] to
prior art balloon catheters, especially those utilized in vasculature.”
Ex. 1002 ¶ 111. We also credit Dr. Sheehan’s testimony, with regard to the
level of skill in the art, that “with the advent of balloon-assisted
vertebroplasty,8 or vertebral kyphoplasty, in the late 1980s, it became well-
known . . . that balloon catheter designs originally conceived for
cardiovascular purposes could be used in bone.” Id. ¶ 16.
Dr. Sheehan further testifies that “Reiley illustrates that a person of
ordinary skill would have used the balloon catheter disclosed in Valley to

7 Patent Owner does not assert any secondary considerations in the Patent
Owner Response.
8 A procedure involving injecting bone cement into a vertebral body after
creating a cavity in the bone using a balloon catheter. Id. at 5 n.5.
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treat bone.” Id. ¶ 112. As explained by Dr. Sheehan, Reiley teaches
modifying a coaxial intravascular catheter with inner and outer tubing,
similar to the catheter disclosed in Valley, to compress cancellous bone. Id.
(citing Ex. 1006, Abstract, 4:21–25). We credit Dr. Sheehan’s testimony
that:
Either the knowledge of a person of ordinary skill in the
art or the explicit disclosure of Reiley teach[es] the use of the
balloon catheter disclosed in Valley “for deployment into bone,”
“for treating bone,” or “to compress cancellous bone upon
inflation of the inflatable structure in bone,” or “within a cannula
into bone.”
Id. ¶ 113.
While Valley does not disclose a balloon that is designed or made to
compress cancellous bone, as required by claims 3, 7, and 11 (see supra
Section II.B.3), we credit Dr. Sheehan’s testimony that a person of ordinary
skill in the art would have been motivated to modify Valley’s balloon for use
in bone and, more particularly, to design or make a balloon for use in
compressing cancellous bone. With respect to Patent Owner’s argument that
Valley discloses balloons made from elastomeric materials, such as
polyurethane, which cannot be used to compress cancellous bone,
Dr. Sheehan explains that Valley also discloses “nondistensible materials,
which as the name implies are the opposite of elastic.” Ex. 1041 5 n.1.
With respect to Patent Owner’s argument that Valley’s balloons cannot
withstand the higher pressures required to compress cancellous bone,
Dr. Sheehan explains that increasing the wall thickness of a balloon or
balloon catheter at the time of the invention was routine and well-known.
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Id. ¶ 12. We credit Dr. Sheehan’s testimony on these issues and conclude
that modifying Valley’s balloon to design or make a balloon for use in
compressing cancellous bone would have been within the skill in the art, and
the result would have been predictable.
In opposition, Patent Owner repeats its arguments with respect to
anticipation, discussed supra in Section II.B. PO Resp. 23. Patent Owner
also argues that:
Modifying Valley for bone would fundamentally change the
principle of operation of Valley by forcing the balloon in Valley
to operate at significantly higher pressures, thereby risking
damage to the vasculature or making the balloon susceptible to
rupture if it were inserted into bone and by completely altering
the shape of the balloon upon expansion to enable it to uniformly
compress a cavity. Plas-Pak Indus., Inc. v. Sulzer Mixpac AG,
No. 2013007786, 2014 WL 2033101 (P.T.A.B. Jan 17, 2014).
Id. at 23–24. We are not persuaded that modifying Valley for bone would
have changed its principle of operation. As Dr. Sheehan explains, increasing
the wall thickness of a balloon or balloon catheter at the time of the
invention was routine and well-known. See Ex. 1041 ¶ 12. No credible
evidence supports the argument that a Valley balloon made from a
nondistensible material, such as polyethylene or PET, and having a wall
thickness designed or made to compress cancellous bone, would be
“susceptible to rupture if it were inserted into bone.” See PO Resp. at 23–
24. Further, Petitioner’s argument with respect to “altering the shape of the
balloon upon expansion to enable it to uniformly compress a cavity” is not
commensurate with the scope of the claims, which do not require uniformly
compressing a cavity.
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Based on the arguments and evidence of record, including the
evidence and arguments discussed above in connection with Petitioner’s
challenge to claims 1–12 as anticipated by Valley (see supra Section II.B),
we conclude that Petitioner has shown by a preponderance of the evidence
that Valley renders obvious claims 1–12 in view of the knowledge of a
person of ordinary skill in the art.
D. Asserted Obviousness of Claims 1–12 over Reiley and Andersen
Petitioner challenges claims 1–12 as obvious over Reiley and
Anderson. Upon review of the arguments and evidence presented by the
parties, we determine that Petitioner has not shown by a preponderance of
the evidence that claims 1–12 would have been obvious over Reiley and
Andersen.
1. Overview of Reiley and Andersen
Reiley discloses an inflatable balloon-like device for use in treating
bone conditions. Ex. 1006, 1:9–11. According to Reiley, prior art methods
disclosed balloon devices that are inserted and inflated in bone to compact
cancellous bone and to enlarge the cavity in the bone. Id. at 2:9–16. Reiley
discloses that while prior art methods are adequate for the fixation of bone, it
has been found that the compacting of cancellous bone against the inner
surface of the cortical wall can be “significantly improved with the use of
inflatable devices that incorporate additional engineering features not
heretofore described and not properly controlled with prior inflatable
devices.” Id. at 2:32–3:5. Reiley further discloses that “[a] need has
therefore arisen for improvements in the shape, construction and size of
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inflatable devices for use with the foregoing apparatus and method.” Id.
at 3:6–8.
Anderson, according to Petitioner, “discloses the well‐known balloon
catheter design of a ‘coaxial catheter with a flexible inner tubing and an
outer tubing.’” Pet 32–33 (citing Ex. 1005, 2:17–18). Petitioner’s colorized
version of Figure 4a of Andersen is reproduced below.

According to Petitioner, colorized Figure 4a depicts an inflatable
balloon portion (shown in blue) formed at the distal end of the outer tubing
(shown in red) and anchored to the distal end of the inner tubing (shown in
green). Id. at 33 (citing Ex. 1005, 2:19–22; Ex. 1002 ¶ 105). Petitioner
asserts that “Figure 4a shows the inflatable structure extending outside
and beyond the outer catheter tube and at least partially enclosing the
inner catheter tube.” Id. (citing Ex. 1002 ¶¶ 105, 108).
2. Analysis
Petitioner argues that Anderson discloses the limitations of
independent claims 1, 5, and 9. Pet. 44. In particular, Petitioner argues that
the portion of the outer tubing shown in red (in colorized Figure 4a above)
corresponds to “an outer catheter tube having a distal end (emphasis
added),” as recited in the claims. Id. at 34. Petitioner also argues that the
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inflatable balloon portion (shown in blue) corresponds to “an inflatable
structure having a proximal end secured to the outer catheter tube and a
distal end secured to the inner catheter tube, the inflatable structure
extending outside and beyond the outer catheter tube and at least partially
enclosing the inner catheter tube” (emphasis added), as recited in the claims.
Id. at 35.
Patent Owner contends that Petitioner erroneously depicts the outer
catheter tube (shown in red) as having a distal end that is coterminous with
the proximal end of the balloon portion (shown in blue). PO Resp. 25.
Patent Owner argues that Anderson itself “treats the balloon as part of the
outer catheter tube and therefore actually has the distal end of the outer
catheter tube extending past the balloon—to the ‘left’ of the balloon in
Fig. 4a.” Id. (citing Ex. 2018 ¶¶ 32–35). Patent Owner further argues:
“Thus, the distal end of the outer catheter tube is NOT in the position shown
by Mr. Sheehan (Ex. 1002, claim chart at ¶ 108) in red, but at position 25 in
FIG. 4(a). Id. at 26–27.
In the Reply, Petitioner provides a second colorized version of
Figure 4a. Pet. Reply 21. Petitioner’s second colorized Figure 4a is
reproduced below:

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Petitioner argues, referencing the figure above, that “Andersen depicts
an inflatable structure (blue) extending outside and beyond the outer catheter
tube (red).” Id. Petitioner further argues that the blue area circled in orange
is a part of the balloon portion, as evidenced by Anderson’s disclosure that
“[a]n inflatable balloon portion is formed at the distal end of the outer tubing
and is anchored to the distal end of the inner tubing.” Id. at 21–22 (citing
Ex. 1005, 2:19–23; Ex. 1002 ¶¶ 105, 108; Ex. 1041 ¶¶ 18–21). Petitioner
also relies on Anderson’s disclosure that “[n]eck 26 [shown in purple in the
second colorized figure above] is sealed to the distal end of the balloon
portion I of the shaft 4.” Id. at 22 (citing Ex. 1005, 5:26–34; Ex. 1002
¶¶ 105, 108; Ex. 1041 ¶ 21).
We have considered all of Petitioner’s arguments, but conclude that
Petitioner has not shown sufficiently that Anderson teaches an inflatable
balloon structure that extends “outside and beyond the outer catheter tube,”
as required by independent claims 1, 5, and 9. As Patent Owner argues,
Anderson divides the length of catheter shaft 4 into three portions, including
“balloon portion I” and “movable shaft portion II,”9 which are identified as
elements “I” and “II” in Figure 4a. See PO Resp. 28; Ex. 1005, 4:53–56,
Fig. 4a. Even assuming, as Petitioner argues, that Anderson teaches that
balloon portion I can extend into the blue area circled in orange on
Petitioner’s second colorized Figure 4a, the balloon portion still would be a

9 Anderson discloses that the balloon and other portions of the outer tubing
are divided into segments that exhibit different behavior when the catheter is
internally pressurized, such that a balloon portion becomes shorter in length
and a moving portion becomes larger. Ex. 1005, 2:22–29.
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part of catheter shaft 4 and, as such, would not extend outside and beyond
catheter shaft 4, as the claims require.
In a footnote in the Reply, Petitioner argues that even if Andersen
does not disclose an inflatable structure extending outside and beyond the
outer catheter tube, “Reiley discloses balloon catheters where the inflatable
structure extends outside and beyond the outer catheter tube,” and a skilled
artisan “would have known how to integrate” Anderson’s coaxial catheter
design with the balloon catheters disclosed in Reiley. Pet. Reply 23 n.15
(citing Ex. 1006 at Figs. 1–4, 6, 8, 10, 12, 15; Ex. 1041 ¶ 25). Petitioner’s
argument is beyond the scope of a proper reply. See 37 C.F.R. § 42.23(b)
(“A reply may only respond to arguments raised in the corresponding
opposition or patent owner response.”). Moreover, Petitioner’s new
argument does not provide articulated reasoning with rational underpinning
sufficient to support a legal conclusion of obviousness. See KSR, 550 U.S.
at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). In particular,
Petitioner has not articulated any reason why a skilled person would have
integrated Anderson’s coaxial catheter design with a known balloon catheter
where the inflatable structure extends outside and beyond the outer catheter
tube.
For the reasons given, we conclude that Petitioner has not shown by a
preponderance of the evidence that independent claims 1, 5, and 9 would
have been obvious over Reiley and Andersen. In arguing that dependent
claims 2–4, 6–8, and 10–12 would have been obvious over Reiley and
Anderson, Petitioner does not present any additional arguments with respect
to the limitations of the independent claims. Pet. 41–47; Ex. 1002 ¶¶ 102–
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109. Accordingly, for the same reasons as discussed above in connection
with the independent claims, Petitioner has not shown by a preponderance of
the evidence that dependent claims 2–4, 6–8, and 10–12 would have been
obvious over Reiley and Andersen.
III. CONCLUSION
For the foregoing reasons, we determine that Petitioner has shown by
a preponderance of the evidence that claims 1–12 are unpatentable.
III. ORDER
In view of the foregoing, it is hereby:
ORDERED that claims 1–12 of U.S. Patent No. 6,623,505 B2 are
unpatentable.
This is a Final Written Decision. Parties to the proceeding seeking
judicial review of the decision must comply with the notice and service
requirements of 37 C.F.R. § 90.2.

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For Petitioner:
Sandra A. Frantzen
sfrantzen@mcandrews-ip.com

Deborah A. Laughton
dlaughton@mcandrews-ip.com

Robert F. Kappers
rkappers@mcandrews-ip.com

For Patent Owner:
Tarek N. Fahmi
tarek.fahmi@ascendalaw.com

Michael A. Davitz
michael.davitz@ascendalaw.com