TriVascular, Inc.v.Shaun Samuels

Patent Trial and Appeal Board

Dec 3, 2014

08870745 (P.T.A.B. Dec. 3, 2014)

Trials@uspto.gov Paper 45
Tel: 571-272-7822 Entered: December 3, 2014

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________
TRIVASCULAR, INC.,
Petitioner,

v.

SHAUN L.W. SAMUELS,
Patent Owner.
_______________

Case IPR2013-00493
Patent 6,007,575
_______________

Before TONI R. SCHEINER, RICHARD E. RICE, and
SCOTT E. KAMHOLZ, Administrative Patent Judges.

RICE, Administrative Patent Judge.

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

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I. INTRODUCTION
A. Background
Petitioner TriVascular, Inc. (“TriVascular”) filed a Petition (Paper 1,
“Pet.”) requesting an inter partes review of claims 1–24 of U.S. Patent
No. 6,007,575 (Ex. 1001, “the ’575 Patent”). We instituted trial for claims
1, 2, and 4–24: claims 1, 2, 6–15, and 18–24 as obvious over Samuels ’851
1

and Todd;
2
and claims 1, 4–6, 9–11, 13, 14, 16, 17, and 19–21 as obvious
over Lazarus
3
and Todd. Decision to Institute (Paper 10, “Dec.”) 26.
Patent Owner Shaun L.W. Samuels (“Dr. Samuels”) filed a Request
for Rehearing (Paper 13, “Req. Reh’g”). We denied the Request. Decision
on Request for Rehearing (Paper 15).
Dr. Samuels filed a Patent Owner Response (Paper 19, “Resp.”) and a
contingent Motion to Amend (Paper 21). TriVascular filed a Reply
(Paper 28, “Reply”) and an Opposition to the Motion to Amend (Paper 27).
Dr. Samuels filed a Reply to the Opposition (Paper 29).
In his Response (Paper 19), Dr. Samuels relied upon his own
declaration (Ex. 2002) and the declaration of Timothy W.I. Clark, M.D.
(Ex. 2003). In its Reply (Paper 28), TriVascular relied upon deposition
testimony of Dr. Samuels (Ex. 1020) and Dr. Clark (Ex. 1021).

1
US 5,423,851 (Ex. 1002).
2
US 5,423,745 (Ex. 1008).
3
US 5,693,088 (Ex. 1004).
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Oral argument was conducted on September 3, 2014. A transcript is
entered as Paper 44 (“Tr.”).
We have jurisdiction under 35 U.S.C. § 6(c). This final written
decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
TriVascular has not proved that claims 1, 2, and 4–24 are
unpatentable.
We dismiss as moot Dr. Samuels’s Motion to Amend.
B. The ’575 Patent
The ’575 Patent relates to an inflatable intraluminal stent that can be
affixed to the interior surface of a tubular structure within the human body as
a means of treating conditions such as stenosis. Ex. 1001, 2:28–31. The
device features an inflatable cuff with a “friction-enhancing” outer surface.
Id. at 2:35–36. Figure 1 of the ’575 Patent is reproduced below:

Figure 1 is a perspective view of “an embodiment of the inflatable
intraluminal stent of the present invention.” Id. at 2:62–63, 3:24–25. As
illustrated in Figure 1, stent 5 includes lumen 15, which is defined by
inflatable cuff 17 having inner surface 19 and outer surface 23. Id. at 3:26–
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31. Outer surface 23 includes “a number of inflatable ridges 25 disposed
about its circumference.” Id. at 3:32–33.
Claim 1 is illustrative of the claimed subject matter and is reproduced
below.
1. An inflatable intraluminal stent adapted to
be secured to the interior of a tubular structure
within the human body comprising:
a) an inflatable and deflatable cuff of
generally hollow cylindrical continuation having a
collapsible lumen, an inner surface, an inlet, an
outlet and a friction enhancing outer surface, said
friction-enhancing outer surface featuring
inflatable protrusion(s) including at least one
circumferential ridge disposed about the inflatable
cuff, said friction-enhancing outer surface
engaging the interior of the tubular structure
without penetration to prevent the cuff from
moving in a longitudinal direction with respect to
the tubular structure when said cuff is in a fully
inflated condition;
b) means for injecting an inflation material
into said cuff to inflate it; and
c) a valve integral with the inflatable cuff for
permitting entry of the inflation material from the
means for injecting and thereafter sealing said cuff
to prevent deflation.

Id. at 6:47–67.
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II. DISCUSSION
A. Claim Construction
In an inter partes review, claim terms in an unexpired patent are
interpreted according to their broadest reasonable construction in light of the
specification of the patent in which they appear. 37 C.F.R. § 42.100(b);
Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14,
2012). Claim terms are given their 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). 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).
1. “Friction-enhancing outer surface”
We determined, for purposes of instituting inter partes review, that
the broadest reasonable interpretation consistent with the Specification of a
“friction-enhancing outer surface” is an outer surface with features that
increase its capability to engage or grip another surface. Dec. 8 (citing
Ex. 1001, 2:35–37, 3:64–67). We maintain this interpretation because
neither party has contested it, and we discern no evidence in the full record
compelling a different interpretation.
2. “Circumferential ridge disposed about the inflatable cuff”
We determined, for purposes of instituting inter partes review, that
the broadest reasonable interpretation consistent with the Specification of a
“circumferential ridge disposed about the inflatable cuff” is a raised strip
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disposed circumferentially about the outer surface of the inflatable cuff.
Id. at 9 (citing Ex. 1001, 3:32–33, 54, Figs. 1, 2; Ex. 1014 (WEBSTER’S
NINTH NEW COLLEGIATE DICTIONARY (1986)), 1014 (“ridge”)). We
maintain this interpretation because neither party has contested it, and we
discern no evidence in the full record compelling a different interpretation.
3. “Means for” terms
Petitioner proposes claim constructions for each of the following
“means for” terms, which Petitioner contends are means-plus-function
limitations governed by 35 U.S.C. § 112 ¶ 6: “means for injecting an
inflation material into said cuff to inflate it,” recited in claim 1; “means for
inflating the cuff with inflation material in fluid communication with said
inflation port,” recited in claim 14; “means for inflating the plurality of cuffs
with inflation material,” recited in claim 23; and “means for securing an
intraluminal medical device to the inner surfaces of the cuffs,” recited in
claim 24.
4
Pet. 7–9. Dr. Samuels does not contest the applicability of § 112
¶ 6 to these limitations, and does not contest the proposed constructions. We
determine that express construction of these limitations is not required for
this decision.
4. “When said cuff is in a fully inflated condition”
and “when the cuff is fully inflated”
Petitioner argues that the claim terms “when said cuff is in a fully
inflated condition,” in claim 1 (emphasis added), and “when the cuff is fully

4
We note that claim 20 recites similarly “means for securing an intraluminal
medical device to the inner surface of the cuff.”
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inflated,” in claim 14 (emphasis added), each mean “when the cuff is
inflated to the extent that the cuff is affixed to the lumen of the tubular
structure but not inflated to the extent that it penetrates the tubular
structure.” Pet. 11 (emphasis added). We determine that express
construction of these claim terms is not required for this decision.
5. “Inflatable protrusions”
Each of the independent claims recites “said friction-enhancing outer
surface featuring inflatable protrusion(s) including at least one
circumferential ridge disposed about the inflatable cuff” (emphasis added).
Petitioner did not propose a claim construction for “inflatable protrusions” in
the Petition.
Dr. Samuels contends that “inflatable protrusions” are protrusions that
contain fluid and are themselves inflatable. Resp. 5–8. In support of that
claim construction, Dr. Samuels argues that ridges 25, as described in the
Specification, are protrusions that “are themselves in fluid communication
with the inflatable chamber 27 of cuff 17.” Id. at 5–6 (citing Ex. 1001,
3:54–56, Fig. 2).
TriVascular argues that “inflatable protrusions can be ‘solid’
structures such as barbs or[,] in the case of [] some of the prior art examples,
solid circumferential ridges.” Reply 10 (citing Clark. Dep., Ex. 1021,
135:6–16 (discussing Samuels ’851 (Ex. 1002))). TriVascular’s proposed
claim construction, however, does not accord with the plain meaning of
“inflatable” as used in the Specification, i.e., expandable by being filled with
fluid. See, e.g., Ex. 1001, Abstr. 3–4, 3:55 (“inflatable chamber”), 1:30
(“inflatable balloon”), 2:33, 38, 3:30 (“inflatable cuff”), 3:33–34 (“inflatable
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ridges”). Under the plain meaning of “inflatable” as used in the
Specification, solid ridges are not “inflatable,” because they are not capable
of being filled with fluid. See Resp. 5–8; In re Zletz, 893 F.2d 319, 321
(Fed. Cir. 1989) (holding that the words of the claim must be given their
plain meaning unless the plain meaning is inconsistent with the
specification).
Further, under TriVascular’s proposed claim construction, there is no
meaningful difference between “protrusions” disposed on an inflatable cuff
and “inflatable protrusions” disposed on an inflatable cuff. See Tr. 10:7–14.
Trivascular’s proposed claim construction, therefore, fails to give any
meaning to “inflatable” in “inflatable protrusions,” and by not giving effect
to all words of the claim, runs afoul of a cardinal rule of claim construction.
See Bicon, Inc. v. Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006)
(“[C]laims are interpreted with an eye toward giving effect to all terms in the
claim,” so that physical structures and characteristics described specifically
in a claim are not rendered “merely superfluous.”).
TriVascular relies on the prosecution history of the ’575 Patent. See
Reply 5–7. TriVascular views the prosecution history through the lens of its
contention that Samuels ’851,
5
which was applied as anticipatory prior art by
the Examiner,
6
discloses “inflatable protrusions” in the form of solid
barbs 18. See id. Based on the premise that the only “inflatable protrusions”

5
We provide an overview of Samuels ’851 in section II.B.1 infra.
6
See Non-Final Act., mailed Nov. 16, 1998, Ex. 1012, 70–75.
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disclosed in Samuels ’851 are solid barbs, TriVascular argues that
Dr. Samuels, by not traversing the Examiner’s rejection over Samuels ’851
but instead amending the claims, acted inconsistently with his claim
construction in this proceeding. Reply 6–7 (citing Am’t, dated Mar. 16,
1999, Ex. 1012, 81–89). TriVascular, however, has not persuaded us that
the premise of its argument is correct. Indeed, the argument is inconsistent
with TriVascular’s assertion in this proceeding, discussed below, that the
recesses of Samuels ’851 (not just the solid barbs) constitute “inflatable
protrusions.” See, e.g., Pet. 27 (Claim Chart I, element 1a-3), 40–41 (Claim
Chart II, element 1a-3, incorporating information from Chart I); Tr. 13:22–
15:6.
Finally, TriVascular contends that Dr. Samuels’s proposed
construction of “inflatable protrusions” is inconsistent with dependent
claims 2 and 15, which incorporate the “inflatable protrusions” limitation of
claims 1 and 14, respectively, and recite additionally “wherein the friction
enhancing outer surface is a coarse surface.” Reply 7–9. TriVascular relies
on the embodiment illustrated in Figure 3 of the ’575 Patent, which has an
outer surface “made coarse by a combination of raised portions 31 and
lowered portions 33.” Id. at 8 (citing Ex. 1001, 3:60–67, Fig. 3). In essence,
TriVascular argues that the coarse surface described in the Specification is
solid and, therefore, “inflatable protrusions” must encompass solid
protrusions in order for claims 2 and 15 to encompass the embodiment
illustrated in Figure 3. Id. at 7–9. TriVascular’s analysis is unpersuasive
because it fails to explain how claims 1, 2, 14, and 15 would encompass the
embodiment illustrated in Figure 3, even if “inflatable protrusions” were
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construed to encompass solid protrusions. For example, even under
TriVascular’s proposed construction, the embodiment illustrated in Figure 3
would not satisfy the claim requirement for “at least one circumferential
ridge.” We are not persuaded of any inconsistency in the scope of claims 1,
2, 14, and 15 under Dr. Samuels’s proposed claim construction.
Accordingly, applying the standard of broadest reasonable
interpretation consistent with the Specification, we determine that “inflatable
protrusions” are protrusions that are themselves inflatable, i.e., expandable
by being filled with fluid.
B. Obviousness Analysis
To prevail in its challenges to the patentability of claims 1, 2, and 4–
24, TriVascular must prove a proposition of unpatentability by a
preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
A claim is unpatentable 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. KSR, 550 U.S. 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
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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.
We analyze the instituted grounds of unpatentability in accordance
with the above-stated principles.
1. Asserted Obviousness of Claims 1, 2, 6–15,
and 18–24 over Samuels ’851 and Todd
We instituted a review based on TriVascular’s contention that the
combination of Samuels ’851 and Todd renders obvious claims 1, 2, 6–15,
and 18–24 under 35 U.S.C. § 103(a). Upon consideration of the parties’
arguments and evidence, we determine that TriVascular has not
demonstrated that those claims would have been obvious over Samuels ’851
and Todd, for the reasons explained below.
a. Overview of Samuels ’851
Samuels ’851 discloses inflatable balloon cuff 10, which can be used
to affix a medical device within a tubular structure of the body. Ex. 1002,
2:35–37. Figures 1 and 2 of Samuels ’851, which are reproduced below,
illustrate cuff 10 before and after inflation, respectively:
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Id., Figs. 1 & 2.
Figures 1 and 2 are pre- and post-deployment perspective views of
cuff 10, respectively.
As illustrated in Figure 1, cuff 10 includes a plurality of reinforced
recesses 12, each of which is bonded to individual barb 18 such that, before
inflation, individual barbs 18 lie beneath outer surface 14 of cuff 10. Id. at
2:40–42, 59–61. “When the cuff 10 is fully inflated,” as illustrated in
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Figure 2, “the recesses 12 pop out to allow the barbs 18 to engage the wall of
a tubular structure within the body.” Id. at 2:62–64.
b. Overview of Todd
Todd is directed to balloon catheters that are “designed for secure
placement and sealing within body passageways.” Ex. 1008, 3:67–4:2. In a
preferred embodiment, “[g]ripping means project[] from the outer surface of
the balloon for securely gripping the walls of the body passageway to secure
the catheter in place.” Id. at 6:50–52. In this regard, Todd discloses:
A seal within the body passageway is also formed. This
important gripping aspect of the present invention may
comprise at least one irregularity in the outer surface of the
balloon.

Id. at 6:52–56. The gripping means disclosed in Todd comprise “a plurality
of protuberances that project outwardly from the outer surface of
balloon 26.” Id. at 6:57–59. As defined expressly in Todd, “[t]he term
‘protuberance’ refers to a projection from the outer surface of a balloon that
assists in the retention of that balloon in a body passageway of a patient.”
Id. at 6:62–65. “The protuberances are soft enough to grip the walls of the
body passageway without damaging the tissues.” Id. at 6:65–67. Figures 7
and 8 of Todd illustrate various configurations of protuberances. Id. at 6:6–
7:2. Figure 7 is reproduced below.
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Id., Fig. 7.
Figure 7 is a perspective view of inflatable balloon 26 illustrating
“protuberances in the form of an outwardly projecting spiral ridge 48 wound
about the exterior surface of balloon 26.” Id. at 7:35–37. “When inflated,
the spiral ridge 48 contacts and tightly grips the walls of a body passageway
in which it is inserted.” Id. at 7:37–39.
Figure 8 is reproduced below.

Id., Fig. 8.
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Figure 8 is a perspective view of inflatable balloon 26 illustrating
“protuberances . . . in the form of outwardly projecting annular rings 52
wound about the exterior surface of balloon 26.” Id. at 7:41–43.
TriVascular contends that Todd discloses friction-enhancing,
inflatable balloon protuberances, including “inflatable ridges.” Pet. 22
(citing Ex. 1008, Figs. 5–9), 41 & 51 (claim chart) (quoting Ex. 1008, 7:35–
39, citing Ex. 1008, Fig. 7). At oral argument, TriVascular clarified its
analysis of Todd’s disclosure, and asserted that the protuberances disclosed
in Todd are hollow, and themselves inflatable. Tr. 6:5–12:20. TriVascular
cited in support of its position the statement in column 7 of Todd that:
“When inflated, the spiral ridge 48 contacts and tightly grips the walls of a
body passageway in which it is inserted.” Id. at 6–7; Ex. 1008, 7:37–39
(emphasis added); see Pet. 40–41 (Claim Chart II, element 1a-3, quoting
Ex. 1008, 7:35–39). TriVascular, however, has not provided a declaration,
or any other evidence, to establish that a person of ordinary skill in the art
would understand Todd to disclose protuberances that are hollow, and
themselves inflatable.
Dr. Samuels does not agree that Todd discloses “inflatable
protrusions.” Resp. 12. Dr. Samuels asserts that “the region between the
inner and outer surfaces of balloon 26 of Todd is solid . . . and any provided
roughened surfaces or protuberances are also solid.” Id. (citing Ex. 1008,
Figs. 4 & 8; Ex. 2004).
On the record before us, TriVascular has failed to show that Todd
discloses “inflatable protrusions,” i.e., protrusions that are expandable by
being filled with fluid. See section II.A.5 supra. The protuberances
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disclosed in Todd project outwardly “from the outer surface” of inflatable
balloon 26. See Ex. 1008, 6:58–59, 62–63. As such, the protuberances are
disposed on the exterior surface of the inflatable balloon, and are not in fluid
communication with the balloon’s inner chamber 32. See Resp. 12; Ex.
1008, 7:15–16, Figs. 2, 4 & 5 (describing knobs 40 as solid structures on the
outer surface of the balloon), 7:32–34, Fig. 6 (describing “cross-hatched
pattern 44 projecting outwardly from the exterior surface of balloon 26”),
7:35–39, Fig. 7 (describing “outwardly projecting spiral ridge 48 wound
about the exterior surface of balloon 26”), 7:40–46, Fig. 8 (describing
“outwardly projecting annular rings 52 wound about the exterior surface of
balloon 26”). Todd discloses expansion means in fluid communication with
inner chamber 32 for inflating balloon 26 (id. at 7:53–60), but does not
disclose expansion means for inflating the protuberances, either separately
or in conjunction with inflation of the balloon. Todd discloses, simply, that
“when balloon 26 is inflated, the gripping means [i.e., the protuberances] on
the exterior of the balloon contact and grip the walls of the body
passageway.” Id. at 8:14–16.
Trivascular has not persuaded us, moreover, that a person of ordinary
skill in the art would have understood Todd’s statement “[w]hen inflated, the
spiral ridge 48 contacts and tightly grips the walls of a body passageway in
which it is inserted” (id at 7:37–39 (emphasis added)), to teach or suggest
that spiral ridge 48 is expandable by being filled with fluid. See Tr. 6–7.
Other than that isolated statement, there is no suggestion, indication, or hint
in Todd that any of the disclosed protuberances is hollow such that it can be
filled with fluid and inflated. To the contrary, as discussed above, Todd
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discloses that all of the protuberances, including spiral ridge 48, are formed
on the exterior surface of the balloon. In light of that disclosure, a person of
ordinary skill in the art would understand that spiral ridge 48 is not in fluid
communication with the inner chamber of the balloon and, therefore, cannot
be filled with fluid via the expansion means used to inflate the balloon.
TriVascular has failed to explain why, in the context of Todd’s whole
disclosure, the statement “[w]hen inflated, the spiral ridge 48 . . .” (Ex. 1008,
7:37–39) would not have been understood by a person of ordinary skill in
the art as, simply, a specific example of the broader (and repeated)
disclosure in Todd that “when balloon 26 is inflated, the gripping means on
the exterior of the balloon contact and grip the walls of the body
passageway” (id. at 8:14–16). See also id. at 4:19–21 (“When the balloon is
inflated, the gripping means come into contact with the walls of the body
passageway.”), 6:48–52 (“Once . . . the balloon is inflated, the catheter is
held in place by gripping means projecting from the outer surface of the
balloon for securely gripping the walls of the body passageway . . . .”).
c. Analysis of Claims 1, 2, 6–15, and 18–24
TriVascular contends that it would have been “an obvious
modification to take the friction-enhancing features of [Todd] and modify
Samuels ’851 while maintaining its basic intent and purpose.” Pet. 22.
TriVascular asserts that a common purpose of the “inflatable protrusions and
barbs” of Samuels ’851 and the “ridges” of Todd is “to firmly secure the
stent in one position in the lumen of the tubular structure.” Reply 12.
Therefore, substitution of Todd’s ridges for the barbs of Samuels ’851,
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TriVascular argues, “would have been an obvious modification carried out
with predictable success.” Id.
Dr. Samuels counters that “no proper apparent reason has been
presented by [Tri-Vascular] for the proposed combination.” Resp. 14.
Dr. Samuels also argues that Tri-Vascular “has not explained how the
combination would have inflatable circumferential ridges,” and that “Todd
lacks any inflatable circumferential ridges.” Id. at 16.
For the reasons discussed below, we determine that TriVascular has
not shown that the combination of Samuels ’851 and Todd satisfies the
requirement of independent claims 1, 14, and 23 for “inflatable protrusion(s)
including at least one circumferential ridge disposed about the inflatable
cuff.”
In its Petition, TriVascular contends that recesses 12 of Samuels ’851
satisfy the requirement of independent claims 1, 14, and 23 for “inflatable
protrusion(s) including at least one circumferential ridge disposed about the
inflatable cuff.” See, e.g., Pet. 27 (Claim Chart I, element 1a-3), 40–41
(Claim Chart II, element 1a-3, incorporating information from Chart I);
Tr. 13:22–15:6. TriVascular has not explained sufficiently, however, why a
person of ordinary skill in the art would have known to include the recesses
of Samuels ’851 in the proposed combination of Samuels ’851 and Todd.
As discussed above, recesses 12 of Samuels ’851 function to project
barbs 18 into surrounding tissue when inflatable balloon cuff 10 is filled
fully with fluid. See section II.B.1.a supra. In its Reply, TriVascular asserts
that the “inflatable protrusions and barbs” of Samuels ’851 serve the same
purpose as the “ridges” of Todd, but proposes, without elaboration, to
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substitute just the barbs of Samuels ’851 with the ridges of Todd. See
Reply 12. At oral argument, TriVascular was unable to explain why anyone
would use the recesses of Samuels ’851 in the proposed combination of
Samuels ’851 and Todd. See Tr. 12:21–17:15.
We determine that Trivascular has not provided a sufficient rationale
to support substituting the ridges of Todd for just the barbs of Samuels ’851.
See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[T]here must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness.”).
TriVascular also contends that it would have been obvious to
eliminate both the recesses and barbs of Samuels ’851, and to substitute “a
circumferential ridge, similar to the one that is in Todd.” See Tr. 15:24–
17:15. TriVascular asserts three reasons why combining the references in
that fashion would satisfy the requirement for “inflatable protrusion(s)
including at least one circumferential ridge disposed about the inflatable
cuff”: (1) the ridges are “inflatable” in the combination simply because they
are riding on an inflatable cuff; (2) the ridges in Todd are themselves
inflatable; and (3) use of ridges that are themselves inflatable would have
been obvious, as they would take up less volume and be easier to insert in
blood vessels than ridges that are not themselves inflatable. See id. at
17:16–18:14. None of those reasons is persuasive. The first reason is not
persuasive because it does not satisfy the requirement for “inflatable
protrusions,” i.e., protrusions that are expandable by being filled with fluid.
See section II.A.5 supra. The second reason is not persuasive because we do
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not agree that Todd discloses ridges that are themselves inflatable. See
section II.B.1.b supra.
Lastly, the third reason is not persuasive because TriVascular has not
established that a person of ordinary skill in the art would have known to
use, on an inflatable cuff, circumferential ridges that are themselves
inflatable. The evidence is to the contrary. See, e.g., Ex. 2002 (Samuels
Decl.) ¶ 4.c (“No one else in the medical field, to the best of my knowledge,
ever proposed or suggested an inflatable ridge-based sealing arrangement
prior to my invention, ever.”); Ex. 1020 (Samuels Dep.), 138:20–140:7
(affirming testimony in ¶ 4.c of Samuels Decl.), 187:11–14 (testifying that
inflatable ridges were not known in the medical field); Ex. 2003 (Clark
Decl.) ¶ 8 (“[B]eing able to reduce the overall diameter by just deflating the
fluid chamber and, correspondingly, the ridges is an intriguing concept, one
which was not known, to the best of my knowledge, in the medical field
prior to Samuels ’575.”); Ex. 1021 (Clark Dep.), 82:19–21 (“I’m not aware
of any inflatable protrusions to support an endograft prior to Samuels
[’575].”).
Upon consideration of the parties’ arguments and evidence, we
determine that Petitioner has not demonstrated that independent claims 1,
14, and 23, and their dependent claims 2, 6–13, 15, 18–22, and 24, are
unpatentable for obviousness over Samuels ’851 and Todd.
2. Asserted Obviousness of Claims 1, 4–6, 9–11,
13, 14, 16, 17, and 19–21 over Lazarus and Todd
We instituted a review based on TriVascular’s contention that the
combination of Lazarus and Todd renders obvious claims 1, 4–6, 9–11, 13,
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14, 16, 17, and 19–21 under 35 U.S.C. § 103(a). Upon consideration of the
parties’ arguments and evidence, we determine that TriVascular has not
demonstrated that those claims would have been obvious over Lazarus and
Todd, for the reasons explained below.
a. Overview of Lazarus
Lazarus relates to grafts that can be positioned intraluminally for
repair of vascular defects such as aneurysms. Ex. 1004, 11–14. Figures 3
and 4 of Lazarus are reproduced below:

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Figure 3 depicts intraluminal vascular graft 10, including attachment
means 16 in the form of inflatable toroidal collars 50. Id. at 10:20–22,
15:15–18. Figure 4 is an enlarged view of a section of the inflatable collar
illustrating inflation conduit 56 and closeable valve 58. Id. at 10:23, 15:15–
18. Lazarus teaches that the intraluminal graft can be deployed within a
vessel of the body to form a tight seal between the inflatable collar and the
vessel wall, without use of potentially-damaging hooks or barbs. Id., Abstr.,
1:57–63, 15:24–28.
b. Analysis of Claims 1, 4–6, 9–11,
13, 14, 16, 17, and 19–21
TriVascular relies upon Lazarus for all limitations of independent
claims 1 and 14, except “inflatable protrusion(s) including at least one
circumferential ridge disposed about the inflatable cuff,” for which
TriVascular relies on Todd. Pet. 22–23, 40–41 (Claim Chart II, element 1a-
3). As a reason to combine Lazarus and Todd, TriVascular asserts:
A POSA looking to make an intraluminal device for treating
aneurysms would look to Lazarus ’088 and modify it with the
teachings of [Todd] to arrive at the Samuels ’575 recited
claims. A review of the claim charts provides a clear blueprint
for such obvious modification.
Id. at 23. TriVascular further asserts that “[i]t would have been an
obvious modification to use [Todd’s] circumferential ridges to
facilitate the seal” between the intraluminal graft of Lazarus and a
vessel of the body. Reply 15.
Dr. Samuels disagrees and argues that TriVascular has not provided
an apparent reason to modify Lazarus. Resp. 22. Dr. Samuels also argues
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that TriVascular has not explained how the combination of Lazarus and
Todd would have inflatable circumferential ridges, and that TriVascular
relies improperly on Todd “to meet the limitations of inflatable protrusion(s)
including at least one circumferential ridge.” Id. at 24.
We agree with Dr. Samuels that Trivascular has failed to establish that
the combination of Lazarus and Todd includes the claim limitation
“inflatable protrusions.” As discussed previously, Trivascular has failed to
persuade us that Todd discloses “inflatable protrusions.” See section
II.B.1.b supra. Moreover, forming the non-inflatable protuberances
disclosed in Todd on the inflatable collar of Lazarus would not satisfy the
requirement for “inflatable protrusions” because the protuberances would
not be expandable by being filled with fluid, or be themselves inflatable.
See section II.A.5 supra. TriVascular has not established, furthermore, that
a person of ordinary skill in the art would have known to use, on an
inflatable collar, protrusions that are themselves inflatable. See Ex. 2002
¶ 4.c; Ex. 1020, 138:20–140:7, 187:11–14; Ex. 2003 ¶ 8; Ex. 1021, 82:19–
21.
Upon consideration of the parties’ arguments and evidence, we
determine that TriVascular has not demonstrated that independent claims 1
and 14, and their dependent claims 4–6, 9–11, 13, 16, 17, and 19–21, are
unpatentable as obvious over Lazarus and Todd.
III. CONCLUSION
TriVascular has not proved, by a preponderance of the evidence, that
claims 1, 2, and 4–24 of the ’575 Patent are unpatentable. TriVascular has
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not proved that claims 1, 2, 6–15, and 18–24 would have been obvious over
Samuels ’851 and Todd, or that claims 1, 4–6, 9–11, 13, 14, 16, 17, and 19–
21 would have been obvious over Lazarus and Todd. Accordingly, Dr.
Samuels’s Motion to Amend, which is contingent on claims 1, 14, and 23
being found unpatentable, is moot.
IV. ORDER
For the reasons given, it is
ORDERED that claims 1, 2, and 4–24 of U.S. Patent No. 6,007,575
are not determined to be unpatentable; and
FURTHER ORDERED that Dr. Samuels’s Motion to Amend is
dismissed as moot.

This is a final 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 the PETITIONER:

Daniel A. Scola, Jr.
dscola@hbiplaw.com

Michael I. Chakansky
mchakansky@hbiplaw.com

For the PATENT OWNER:

Everett Diederiks
ediederiks@dwpatentlaw.com

James D. Petruzzi
jpetruzzi@masonpetruzzi.com