Medtronic, Inc.v.Troy Norred

Patent Trial and Appeal Board

Jun 25, 2015

09712121 (P.T.A.B. Jun. 25, 2015)

Trials@uspto.gov Paper 41
Tel: 571-272-7822 Entered: June 25, 2015
UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

MEDTRONIC, INC., MEDTRONIC VASCULAR, INC., AND
MEDTRONIC COREVALVE, LLC,
Petitioner,
v.
TROY R. NORRED, M.D.,
Patent Owner.

Case IPR2014-00395
Patent 6,482,228 B1

Before SHERIDAN K. SNEDDEN, BARRY L. GROSSMAN, and
MITCHELL G. WEATHERLY, Administrative Patent Judges.
WEATHERLY, Administrative Patent Judge.
DECISION
Final Written Decision
35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
I. INTRODUCTION
A. Background
Medtronic, Inc., Medtronic Vascular, Inc., and Medtronic Corevalve,
LLC (collectively, “Medtronic”) filed a Petition (Paper 4, “Pet.”) requesting
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an inter partes review of claims 16 and 19–24 (the “challenged claims”) of
U.S. Patent No. 6,482,228 B1 (Exhibit 1001, “the ’228 patent”). 35 U.S.C.
§ 311. Troy R. Norred, M.D. (“Dr. Norred” or “Patent Owner”) timely filed
a Preliminary Response. Paper 11 (“Prelim. Resp.”). On June 27, 2014, we
instituted an inter partes review of all challenged claims, Paper 13 (“Dec.”
or “Institution Decision”), on the following grounds:
References Basis Claims Reviewed
U.S. Patent No. 5,957,949,
(“Leonhardt”) (Ex. 1004)
§ 102(b) 16 and 19–24
U.S. Patent No. 6,458,153 B1,
(“Bailey”) (Ex. 1006)
§ 102(e) 16 and 19–24
Dec. 20.
After we instituted review, Dr. Norred filed a Patent Owner Response,
Paper 18 (“PO Resp.”), in opposition to the Petition, and supported by the
declarations of Timothy T. Catchings, M.D. (Ex. 2295) and Troy R. Norred,
M.D. (Ex. 2293). Medtronic filed a Reply in support of the Petition, Paper
22 (“Reply”), supported by the Declaration of Alexander J. Hill, PhD
(Ex. 1026).
Dr. Norred also filed a Motion to Amend, Paper 17 (“Mot. Amend”),
seeking to substitute claim 25 for independent claims 16 and 20 and claim
26 for dependent claim 24 contingent upon our holding unpatentable any of
the original claims for which substituted claims were submitted. Mot.
Amend 1. Medtronic opposed the Motion to Amend. Paper 25 (“Amend
Opp.”). Dr. Norred filed a reply in support of its Motion to Amend. Paper
28 (“Amend Reply”).
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Oral argument was conducted on January 27, 2015. A transcript is
entered as Paper 40 (“Tr.”).
For the reasons expressed below, we conclude that Medtronic has
demonstrated, by a preponderance of evidence, that each of Leonhardt and
Bailey anticipates claims 16 and 19–24. Dr. Norred’s Motion to Amend is
denied.
B. Related Matters
Medtronic and Dr. Norred identified, as related proceedings, the co-
pending litigation titled Troy R. Norred, M.D. v. Medtronic, Inc., No. 2:13-
CV-02061 (D. Kan.). Pet. 1; Paper 11, 5. Two proceedings before the
Board involving the same parties, IPR2014-00110 and IPR2014-00111, also
are identified as related proceedings. Pet. 1; Paper 11, 5–6.
C. The ’228 Patent
The ’228 patent relates to a percutaneous aortic heart valve that is
placed by catheter and held in place with a stent system. Ex. 1001, 1:6–9,
1:29–31. Figures 10 and 11 of the ’228 patent are reproduced below.

Figures 10 and 11 illustrate a diagrammatic and plan view of
one embodiment of Dr. Norred’s cone-shaped aortic valve in a
closed position.
Id. at 2:31–34.
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Valve 66 consists of interconnected fingers 68, generally ring-shaped
base 70, and ring 72 secured to base 70. Id. at 4:54–64. Base 70 may be
seated against the root of the aortic valve. Id. at 5:17–19. Rim 78 of base 70
is made of a pliable biocompatible material and seals against the root of the
native aortic valve to reduce peri-valvular leaks. Id. at 5:18–20. Valve 66 is
anchored along the root of the aortic valve with connecting rods 80, which
are connected to ascending aortic stents 28. Id. at 5:21–23.
The ’228 patent describes additional embodiments of an aortic heart
valve in which the valve structures differ. See, e.g., id. at 4:5–52 (describing
umbrella valve 30 illustrated in Figures 6–9), 5:33–62 (describing trihedral
valve 82 illustrated in Figures 14–17), 5:63–6:8 (describing biological valve
100 illustrated in Figures 18 and 19). Nevertheless, the illustrated
embodiments of the aortic valves are held in place via a mechanical
attachment to a stent that seats against the aortic wall. See id. at 4:8–9,
5:21–23, 5:48–51, 6:3–7 (describing connecting rods that attach valves to
stent).
Claims 16 and 20, which are the only independent claims among the
challenged claims, recite:
16. An aortic valve for regulating a blood flow through
an aortic channel surrounded by an aortic wall upon placement
therein, said valve comprising:
a ring member having a circumference adapted to seat
about an aortic wall surrounding an aortic channel, said ring
including an aperture for blood flow therethrough;
a membrane having first and second spaced-apart open
ends, said membrane made of a material resistant to a fluid flow
therethrough; and
means for mounting said first open end of said membrane
about said ring aperture with said second open end displaced
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therefrom, said means moving said membrane second end
between a first open position to allow a blood flow
therethrough and a second closed position to preclude a blood
flow therethrough.
Ex. 1001, 7:59–8:12.
20. An aortic valve for controlling a blood flow through
an aortic channel upon placement therein, said valve
comprising:
a tissue valve having an interior member made of a tissue
material and presenting an opening movable between open and
closed positions;
a ring member surrounding said tissue valve, said ring
member having an outer circumference adapted to seat said ring
member about an aortic wall surrounding an aortic channel;
means for maintaining said ring member in said seated
position about the aortic wall,
said tissue valve interior member responsive to changes
of conditions within the aorta for movement of said opening
between a first closed position and a second open position.
Id. at 8:27–42.
II. ANALYSIS
A. Claim Interpretation
“A claim in an unexpired patent shall be given its broadest reasonable
construction in light of the specification of the patent in which it appears.”
37 C.F.R. § 42.100(b); accord In re Cuozzo Speed Techs., LLC, 778 F.3d
1271, 1278–82 (Fed. Cir. 2015). When applying that standard, we interpret
the claim language as it would be understood by one of ordinary skill in the
art in light of the specification. In re Suitco Surface, Inc., 603 F.3d 1255,
1260 (Fed. Cir. 2010). Thus, we give claim terms their ordinary and
customary meaning. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257
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(Fed. Cir. 2007) (“The ordinary and customary meaning is the meaning that
the term would have to a person of ordinary skill in the art in question.”
(internal quotation marks omitted)). Only terms which are in controversy
need to be construed, and then only to the extent necessary to resolve the
controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
(Fed. Cir. 1999).
Claim 19 recites a “means for maintaining said ring member in said
seat about the aortic wall.” Similarly, independent claim 20 and, thus, also
its dependent claims 21–24 recite “means for maintaining said ring member
in said seated position about the aortic wall.” In our Institution Decision, we
interpreted the “means for maintaining” recited in claims 19 and 20 under
35 U.S.C. § 112, ¶ 6. Dec. 12. Based on our review of the Specification, we
identified the combination of rods 104 interacting with stent 28 as the
structures for performing the recited “maintaining” function. We, therefore,
interpreted the “means for maintaining” as rods 104
1
interacting with stent
28 and equivalent structures. Id. at 12–13.
During the trial, Dr. Norred argued that the “means for maintaining”
refers not only to a stent, but also requires that the stent be configured to
extend into the ascending aorta. PO Resp. 10. Medtronic suggests that a
“more precise construction” is “rods 104 to interact with stent 28.” Reply 8
n.12. For the reasons expressed below, we maintain our previous
interpretation of “means for maintaining” as referring to the combination of

1
Other structures identified in the Specification for performing the
maintaining function are connecting rods 80 interacting with stent 28.
Ex. 1001, 5:47–50. We refer to connecting rods 104 throughout our analysis
for convenience.
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rods 104 interacting with stent 28 and their equivalent structures and we
reject both parties’ arguments for altering that interpretation.
It is well established that the use of the term “means” triggers a
rebuttable presumption that § 112, ¶ 6 governs the construction of the claim
term. Williamson v. Citrix Online, LLC, No. 2013-1130, 2015 WL 3687459,
at *7 (en banc) (Fed. Cir. June 16, 2015); Inventio AG v. ThyssenKrupp
Elevator Ams. Corp., 649 F.3d 1350, 1356 (Fed. Cir. 2011) (citing TriMed,
Inc. v. Stryker Corp., 514 F.3d 1256, 1259 (Fed. Cir. 2008)). Here, it is
clear, and there is no dispute among the parties, that the “means for
maintaining” is a “means plus function” phrase that is interpreted under
§ 112, ¶ 6.
The first step in the construction of a means-plus-function claim
element is to identify the particular claimed function. Micro Chem., Inc. v.
Great Plains Chem. Co., Inc., 194 F.3d 1250, 1258 (Fed. Cir. 1999). The
second step in the analysis is to look to the specification and identify the
corresponding structure for that function. Id. “The plain and unambiguous
meaning of paragraph six is that one construing means-plus-function
language in a claim must look to the specification and interpret that language
in light of the corresponding structure, material, or acts described therein,
and equivalents thereof, to the extent that the specification provides such
disclosure.” In re Donaldson Co., Inc., 16 F.3d 1189, 1193 (Fed. Cir. 1994)
(en banc). This is the “broadest reasonable interpretation” of “means-plus-
function” language. Id. at 1194–95. The structure disclosed in the written
description of the specification is the corresponding structure only if the
written description of the specification or the prosecution history clearly
links or associates that structure to the function recited in a means-plus-
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function claim limitation. B. Braun Med. Inc., v. Abbott Labs., 124 F.3d
1419, 1424 (Fed. Cir. 1997). Claim interpretation under § 112, ¶ 6 does not
“permit incorporation of structure from the written description beyond that
necessary to perform the claimed function.” Micro Chem, 194 F.3d at 1258.
The function recited in the “means for maintaining” of claims 19 and
20 is “maintaining said ring member in said seated position about the aortic
wall.”
2
Ex. 1001, 8:37–38 (emphasis added). Thus, the focus is on the “ring
member,” and a determination of the structure that maintains ring member
102 in a seated position about the aortic wall.
Based on Medtronic’s suggested “more precise” construction, the
parties’ constructions for the “means for maintaining” phrase appear to be
similar, but, in fact, are very different. Medtronic asserts that the challenged
claims are limited to an aortic valve. Reply 8 n.2 (“the claims are directed to
the ‘aortic valve’ and not a valve/stent combination”); see also Tr. 16:3–7
(“[t]he claims are all directed to a valve . . . [t]he claims are really directed to
the valve alone”). Thus, Medtronic’s proposed construction, including the
“more precise” suggestion in Medtronic’s Reply (Reply 8 n.2), does not
include the stent as an element of the “means for maintaining.”
Dr. Norred agrees that claim 16 is directed solely to the valve, but
maintains that claims 19–24, which recite the “means for maintaining,” are

2
Claim 19 recites substantially the same function using slightly different
phrasing as follows: “means for maintaining said ring member in said seat
about the aortic wall.” Ex. 1001, 8:25–26. We do not consider the different
phrasing to be material to our analysis.
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directed to the combination of a valve and stent. Tr. 37:25–38:4.
3

Dr. Norred asserts that “the rods cannot maintain the valve in place by itself.
It is the interaction with the stent system” that maintains the ring member in
a seated position about the aortic wall. Tr. 37:2–3. We are persuaded that
Dr. Norred’s construction is correct.
The Specification discloses rods that are part of the stent and rods that
connect the valve to the stent system. Stent system 28 comprises a small
slotted stainless steel tube or series of interconnected rods, which form an
expandable cylindrical lattice or scaffolding. Ex. 1001, 2:61–63. In the
context of the embodiment disclosed in Figures 18 and 19, the Specification
states that valve 100 (not ring 102) is anchored along the root of the aortic
valve with rods 104 connected to stents 28. Id. at 6:4–6, see also id. at 4:6–9
(valve 30 is anchored with rod 56 connected to stent struts 58), 5:21–23
(valve 66 is anchored with rods 80), 5:47–50 (valve 82 is anchored with
connecting rods, not shown). The Specification also states, generally, that
the valve is anchored “by a stent system,” and the rods connect the valve to
the stent. Ex. 1001, 1:30–31, 1:63–64. Thus, rods 104 on valve 100 and
stent system 28 are related inextricably in performing the function of
maintaining the valve, and hence the ring member, which is part of the
valve, anchored along the root of the aortic valve.

3
Q. “would you agree that Claim 16 is directed solely to the valve?
MR. KERNELL [counsel for Patent Owner]: Yeah. You know, I think
that’s fair that that is the valve as it’s maintained or that the valve that’s
implanted and that Claim 19 [and claims 20–24] adds the means for
maintaining, which is the stent system, the ascending aortic stent system.”
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The function recited in the “means for maintaining” in claims 19 and
20 is maintaining the ring member in a “seated position about the aortic
wall.” Ex. 1001, 8:37–38 (emphasis added). The written description in the
Specification distinguishes between seating and sealing. See, e.g., Ex. 1001,
5:16–20 (“Base 70 is seated against the root of the aortic valve . . . The rim
78 of base 70 is made of a pliable biocompatible material which seals
against the root of the native aortic valve.”) (emphasis added). In the written
description, ring 102 is described as “made of a pliable biocompatible
material which seals against the root of the native aortic valve 34.”
Ex. 1001, 6:1–9 (emphasis added). The Specification describes valve 100 as
“anchored” along the root of the aortic valve. Id. There is no explicit
disclosure about ring 102 seating about the aortic wall.
The claims themselves provide substantial guidance as to the meaning
of particular claim terms. Independent claim 20 states the ring member has
“an outer circumference” adapted “to seat” the ring member about an aortic
wall surrounding an aortic channel. Id. at 8:33–36 (emphasis added). Claim
24, dependent from claim 20, states that the ring member “contacts the wall
of the aortic channel and seals said ring against the aortic channel wall.” Id.
at 8:56–59 (emphasis added).
Dependent claims must further limit the claim from which they
depend. 35 U.S.C. § 112, ¶ 4 (“a claim in dependent form shall contain a
reference to a claim previously set forth and then specify a further limitation
of the subject matter claimed. A claim in dependent form shall be construed
to incorporate by reference all the limitations of the claim to which it
refers.”); Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (“the
presence of a dependent claim that adds a particular limitation gives rise to a
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presumption that the limitation in question is not present in the independent
claim”). Thus, the presumption is that a ring member that seals, as recited in
claim 24, is different from a ring member that seats, as recited in claim 20.
In describing the general relationship of the valve and stent system,
the Specification states that when the valve/stent combination is in position,
an angioplasty balloon inflates to expand the stent scaffolding and force the
stent system against the inner walls of the ascending aorta to anchor the
valve in place. Ex. 1001, 3:7–10. We construe the requirement to “seat” in
the “means for maintaining” clause in claim 20 to mean that the ring is
anchored, or forced, against the aortic wall. We decline to require that
seating and sealing are synonymous because the evidence of record does not
support such a construction.
Thus, based on the Specification, it is the combination of rods 104
interacting with stent system 28 that anchors valve 100 and seats ring
member 102. Without the stent, there is no structure to maintain the ring
member in seated position. Accordingly, it is rods 104 interacting with stent
system 28 that is the structure corresponding to the “means for maintaining”
called for in claims 19 and 20. This corresponding structure, and
equivalents thereof, is the broadest reasonable construction of the “means for
maintaining” the ring member in seated position. We are not persuaded to
modify this construction as suggested by either party.
B. The Challenges to the Claims
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros. v. Union Oil Co. of Cal., 814 F.2d 628, 631
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(Fed. Cir. 1987). With this standard in mind, we address each challenge
below.
Our Scheduling Order in this case cautioned Dr. Norred that “any
arguments for patentability not raised in the [Patent Owner Response] will
be deemed waived.” Paper 14, 2–3. The Board’s Trial Practice Guide,
furthermore, states that the Patent Owner Response “should identify all the
involved claims that are believed to be patentable and state the basis for that
belief.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766
(Aug. 14, 2012) Furthermore, as the Board has stated, our governing statute
and Rules “clearly place some onus on the patent owner, once trial is
instituted, to address the material facts raised by the petition as jeopardizing
patentability of the challenged claims.” Johnson Health Tech Co. Ltd. v.
Icon Health & Fitness, Inc., Case IPR2013-00463, slip op. at 12 (PTAB Jan.
29, 2015) (Paper 41).
In our Institution Decision, we concluded that Medtronic had made a
threshold showing that each of Leonhardt and Bailey taught all the
limitations of the challenged claims, sufficient for us to conclude that there
was a reasonable likelihood that Medtronic would prevail in showing that
the challenged claims were anticipated by each of Leonhardt and Bailey.
Dec. 10–12. We must now determine whether the preponderance of the
evidence of record supports a finding that each of Leonhardt and Bailey
anticipates the challenged claims. 35 U.S.C. § 316(e).
In the Patent Owner’s Response, Dr. Norred presents argument and
evidence to establish that both Leonhardt and Bailey fail to disclose the
“ring member” (required by claims 16 and 19–24) and “means for
maintaining” (required by claims 19–24). Dr. Norred does not present
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persuasive evidence or argument on the remaining elements of the claims,
that is, those elements other than the “ring member” and the “means for
maintaining.” Thus, the record now contains the same arguments and
evidence regarding the merits of Leonhardt’s and Bailey’s alleged
anticipation with regard to the remaining elements of the claims as it did at
the time of our Institution Decision. Thus, the preponderance of the
evidence of record developed at trial supports our conclusion that Medtronic
has set forth how these remaining limitations of the challenged claims are
taught by Leonhardt and Bailey. Accordingly, we do not address these
remaining limitations in our discussion below.
1. Anticipation of Claims 16 and 19–24 by Leonhardt
Leonhardt generally describes a percutaneously placed artificial valve
“to maintain bodily fluid flow in a single direction” to “be placed anywhere
flow control is desired.” Ex. 1004, 1:11–14. The aorta is among those
locations at which Leonhardt contemplates deploying its artificial valve. Id.
at 3:59–60, 9:64–10:21. Leonhardt’s Figures 3 and 4 are reproduced below.
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Figure 3 depicts Leonhardt’s
valve stent 20 fully deployed
with the aorta above the aortic
valve.
Leonhardt’s Figure 4 depicts a
partial sectional view of valve
stent 20 incorporating porcine
valve 22.
Id. at 3:59–62, 6:23–33.
Medtronic contends that Leonhardt discloses the claimed aortic valve
and provides claim charts that identify in detail how Leonhardt’s description
of its artificial heart valve discloses each element of all challenged claims.
Pet. 15–17, App. A-1. Dr. Norred argues that Medtronic’s showing that
Leonhardt anticipates claims 16 and 19–24 is deficient for two reasons, and
we address each in turn below.
a) Ring Member—Claims 16 and 19–24
(1) Claims 16 and 19–23
Dr. Norred contends that Leonhardt fails to disclose the claimed ring
member because Leonhardt’s stent 26 is not made of a pliable material. PO
Resp. 8–10. Even if we were to accept Dr. Norred’s contention that the
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claimed ring member must be made of a pliable material,
4
Dr. Norred’s
argument is unpersuasive. Leonhardt’s stent 12 is preferably formed of
superelastic nitinol wire. Ex. 1004, 3:48–56, 4:27–29, 4:63–5:2. Dr.
Norred’s expert witness, Dr. Catchings, testified that he considers nitinol to
be a pliable material. Ex. 1023, 195:8–10. Therefore, we find that
Leonhardt describes a ring member that is made of pliable material and
reject Dr. Norred’s argument that Leonhardt fails to teach the ring member
recited in claims 16 and 19–24.
(2) Claim 24
Claim 24 further recites that “said ring member contacts the wall of
the aortic channel and seals said ring against the aortic channel wall to
reduce blood flow therearound.” Ex. 1001, 8:56–59. Dr. Norred contends
that Leonhardt’s stent 26 is merely temporarily sealed to the wall of the aorta
using a light-activated bioadhesive and, therefore, fails to “seal” against the
aortic channel wall. PO Resp. 9. Dr. Norred reasons that the temporary
nature of Leonhardt’s seal is evident because the stent 26 may be
repositioned or removed after it is fully implanted. Id. (citing Ex. 1004, 3:4–
6, 3:27–30, 11:37–53).
We are not persuaded by Dr. Norred’s argument. Dr. Norred
identifies no basis for interpreting claim 24 such that its seal must be
permanent. A temporary seal is a seal within the meaning of “seal” as

4
The parties dispute whether the claims recite a “ring member” that must be
made from pliable material. We need not resolve that dispute here because
we find that Medtronic has identified a structure in each of Leonhardt and
Bailey as the claimed ring member and each of those structures is made of a
pliable material.
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recited in claim 24. Even if we were to conclude that claim 24 requires a
permanent seal, we remain unpersuaded by Dr. Norred’s argument. Claim
24 by its plain terms refers to a seal that “reduce[s] blood flow” around the
ring member. Leonhardt meets this limitation as well. For example,
Leonhardt describes that the stent is sized “to be approximately thirty
percent (30%) larger in diameter than the largest diameter of the tissue
against which the valve stent 20 (FIG. 3) will seal.” Ex. 1004, 5:3–5. The
seal that Leonhardt describes is precisely the type of seal recited in claim 24.
Accordingly, we reject Dr. Norred’s argument that Leonhardt fails to
describe the ring member recited in claim 24.
b) Means for Maintaining—Claims 19–24
Dr. Norred argues that Leonhardt fails to describe the “means for
maintaining.” PO Resp. 10–11. Dr. Norred’s argument is premised upon
our acceptance of his proposed limitation on the claimed “means for
maintaining” that would require the claimed means to be positioned in the
ascending aorta. For reasons expressed in part II.A above, we decline to
interpret the “means for maintaining” as being so limited. Even if we were
to accept Dr. Norred’s proposed interpretation, the argument would remain
unpersuasive because Leonhardt’s stent is “fully deployed within the aorta
above the aortic valve.” Reply 2 (citing Ex. 1004, 3:59–60, Fig. 3).
Accordingly, we reject Dr. Norred’s argument that Leonhardt fails to
describe the “means for maintaining” recited in claims 19–24.
2. Anticipation of Claims 16 and 19–24 by Bailey
Bailey generally describes a prosthetic cardiac valve comprising stent
support member 12, graft member 11 covering at least a portion of stent 12,
and biological xenograft valve flaps/leaflets 28. Pet. 20 (citing Ex. 1006,
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1:6–21, 28–38, 5:61–6:9, 7:58–8:19). Bailey’s Figures 1 and 2 are
reproduced below.

Bailey’s Figures 1 and 2 illustrate an embodiment of a
chamber-to-vessel valve stent in its fully deployed state with
Figure 2 having a portion of the outermost graft layer removed
to depict the valve apparatus within the stent.
Ex. 1006, 6:44–49. Bailey’s artificial valve is implanted in the location of
the natural aortic valve. Id. at 10:31–44, Figs. 6A, 6B. Bailey’s artificial
valve is held in place by two different anchor sections, proximal anchor
flange 22 and distal anchor portion 16. Id. at 5:61–6:7, 8:40–43.
Medtronic contends that Bailey discloses the claimed aortic valve and
provides claim charts that identify in detail how Bailey’s description of its
artificial heart valve discloses each element of all challenged claims.
Pet. 19–21, App. A-3. Dr. Norred argues that Medtronic’s showing that
Bailey anticipates claims 16 and 19–24 is deficient for three reasons, and we
address each in turn below.
a) Dr. Norred’s Alleged Priority of Invention over Bailey
Dr. Norred asserts that he conceived subject matter of the challenged
claims no later than December 21, 1998, and diligently reduced that subject
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matter to practice from that conception date until filing the application that
matured into the ’228 patent on November 14, 2000.
5
PO Resp. 12–30.
Dr. Norred bears the burden to establish the facts necessary to overcome
Bailey’s filing date. In re Facius, 408 F.2d 1396, 1403–04 (CCPA 1969)
(holding, in a prosecution context, that an earlier filed reference was prima
facie available as prior art and placing the burden on the party claiming prior
invention to overcome that reference). Dr. Norred may meet his burden by
providing evidence that the effective date of the reference is not “before the
invention by the applicant for patent,” that is, antedating the Bailey
reference. 35 U.S.C. § 102(e) (2000).
The application resulting in the issuance of Bailey was filed on
December 31, 1999, and Bailey issued on October 1, 2002. The application
that matured into the ’228 patent was filed on November 14, 2000. Bailey is
available as prior against the challenged claims under 35 U.S.C. § 102(e)(2)
as of December 31, 1999, unless Dr. Norred establishes that he conceived
the claimed subject matter before December 31, 1999, and diligently worked
to reduce that subject matter to practice until November 14, 2000.
6
We

5
Dr. Norred states that November 20, 2000, is the filing date of the
application leading to issuance of the ’228 patent. PO Resp. 21.
Nevertheless, that application was filed on November 14, 2000. Ex. 1001,
Cover Page.
6
The governing statute provides: “A person shall be entitled to a patent
unless . . .
(e) the invention was described in . . . (2) a patent granted on an
application for patent by another filed in the United States before the
invention by the applicant for patent.”
35 U.S.C. § 102(e) (2000).
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evaluate Dr. Norred’s arguments and evidence under the general standards
established in 37 C.F.R. § 1.131, which states:
When any claim of an application or a patent under
reexamination is rejected, the applicant or patent owner may
submit an appropriate oath or declaration to establish invention
of the subject matter of the rejected claim prior to the effective
date of the reference or activity on which the rejection is based.
37 C.F.R. § 1.131(a). The standards by which we evaluate Dr. Norred’s
asserted date of invention are stated in 37 C.F.R. § 1.131(b), which states:
The showing of facts for an oath or declaration under paragraph
(a) of this section shall be such, in character and weight, as to
establish reduction to practice prior to the effective date of the
reference, or conception of the invention prior to the effective
date of the reference coupled with due diligence from prior to
said date to a subsequent reduction to practice or to the filing of
the application.
37 C.F.R. § 1.131(b).
The required conception of the invention is the “formation in the mind
of the inventor, of a definite and permanent idea of the complete and
operative invention, as it is hereafter to be applied in practice.” Dawson v.
Dawson, 710 F. 3d 1347, 1352 (Fed. Cir. 2013); Coleman v. Dines, 754 F.2d
353, 359 (Fed. Cir. 1985) (citing Gunter v. Stream, 573 F.2d 77, 80 (CCPA
1978)). Based on that definition, our reviewing court has held that
“[c]onception is complete only when the idea is so clearly defined in the
inventor’s mind that only ordinary skill would be necessary to reduce the
invention to practice, without extensive research or experimentation,” and
that “[a]n idea is definite and permanent when the inventor has a specific,
settled idea, a particular solution to the problem at hand, not just a general
goal or research plan he hopes to pursue.” Id.
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Thus, conception requires more than accidental creation; there must
be evidence that the inventor appreciated that he made “something new.”
Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1063–64 (Fed. Cir.
2005). “The conception analysis necessarily turns on the inventor’s ability
to describe his invention with particularity. Until he can do so, he cannot
prove possession of the complete mental picture of the invention.”
Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir.
1994).
Proof of conception must be by “corroborating evidence which shows
that the inventor disclosed to others his ‘completed thought expressed in
such clear terms as to enable those skilled in the art’ to make the invention.”
Coleman, 754 F.2d at 359 (citing Field v. Knowles, 183 F.2d 593, 601
(CCPA 1950)); see also Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577
(Fed. Cir. 1996) (corroboration requirement “arose out of a concern that
inventors testifying in patent infringement cases would be tempted to
remember facts favorable to their case by the lure of protecting their patent
or defeating another’s patent”). The sufficiency of corroboration is
determined according to a “rule of reason.” Price v. Symsek, 988 F.2d 1187,
1195 (Fed. Cir. 1993). This, however, does not dispense with the
requirement that some independent evidence provide corroboration.
Coleman, 754 F.2d at 360. The requirement of “independent” corroboration
requires evidence other than the inventor’s testimony. In re NTP, Inc.,
654 F.3d 1279, 1291–92 (Fed. Cir. 2011).
Dr. Norred asserts that he conceived the invention “no later than
December 21, 1998.” PO Resp. 12 (citing Ex. 2203 and Ex. 2293 ¶ 27).
According to Dr. Norred, Exhibit 2203 “depicts each limitation set forth in
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claims 16 and 19 of the ‘228 Patent.” PO Resp. 13–19. Exhibit 2203 is a
sketch dated “12/21/98.” Exhibit 2203, annotated to identify more clearly
the labeled elements, is reproduced below.

Annotated Exhibit 2203 is a handmade sketch of a stent and
valve notarized as being signed by “Troy Norred” on December
21, 1998.
Dr. Norred states that Exhibit 2203 shows “the stent system as deployed in
the aorta, attached through connecting rods to the ring member.” PO Resp.
19.
Medtronic asserts that Exhibit 2203 “only identifies two elements of
an aortic device: (1) a ‘nitinol self-expanding stent’ that ‘expands to the
shape of the aorta and sinus;’ and (2) a ‘sutured bioprosthetic valve.’” Reply
7. According to Medtronic, Exhibit 2203 fails to show a ring member
surrounding a tissue valve (id.), or rods interacting with a stent to form the
“nitinol self
expanding stent”
“Aortic valve”
“One example sutured
bioprosthetic valve”
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“means for maintaining” structure discussed above. The ring member is
recited in claims 16 and 19–24, and the “means for maintaining” is recited in
claims 19–24.
After reviewing Exhibit 2203 and Dr. Norred’s supporting arguments,
we are not persuaded that the drawing supports Dr. Norred’s assertion that
he conceived the claimed valve as of December 21, 1998. Rather, we agree
with Medtronic that the sketch only identifies two elements of a device to be
inserted into the aorta: (1) a “nitinol self-expanding stent” that “expands to
the shape of the aorta and sinus;” and (2) a “sutured bioprosthetic valve.”
Reply 7. The detail in the sketch is insufficient to describe, for example, a
“ring member having a circumference adapted to seat about an aortic wall
surrounding an aortic channel” (claims 16 and 19) or a “ring member
surrounding said tissue valve, said ring member having an outer
circumference adapted to seat said ring member about an aortic wall”
(claims 20–24). The circle in the sketch that Dr. Norred identifies as the
ring member is described in the sketch itself as “a sutured bioprosthetic
valve.” Dr. Norred has testified that his invention was intended to “seal the
device against the root of the native valve upon placement without sutures.”
Ex. 2293 ¶ 61 (emphasis added). Dr. Norred also states that the invention of
the ’228 patent “relies on the stent system alone to anchor the device and
eliminate the need for sutures and other means of active fixation.” Id. ¶ 62
(emphasis added). According to Dr. Norred, if “sutures were necessary to
create a seal, then surgery would be necessary to create a seal, and my
invention could not serve the purpose for which it was intended.” Id. ¶ 61.
Dr. Norred’s testimony about eliminating the need for sutures and surgery is
consistent with the disclosure in the ’228 patent, which states that the
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disclosed invention is placed “percutaneously,” that is, without the need for
surgery. Ex. 1001, Abstract, 1:6–9. Accordingly, the sutured valve shown
in Exhibit 2203 does not provide persuasive evidence that Dr. Norred
conceived a valve, as of the creation of the sketch, that eliminates the need
for sutures that he states was his “invention.” The annotations on the sketch,
thus, appear to be inconsistent with Dr. Norred’s testimony that the sketch
illustrates a ring member. Because the sketch does not clearly show a ring
member, Dr. Norred’s contentions otherwise constitute uncorroborated
testimony created for this proceeding, more than fifteen years after the
sketch was made. Ex. 2293 ¶¶ 7, 86.
Dr. Norred bears the burden to establish the facts necessary to
overcome Bailey. In re Facius, 408 F.2d at 1403–1404 (holding that an
earlier filed reference was prima facie available as prior art and placing the
burden on the party claiming prior invention to overcome that reference).
Based on the totality of the evidence on which Dr. Norred relies, the
evidence does not establish that the subject matter recited in claims 16 and
19–24 was conceived prior to December 31, 1999. Thus, we conclude that
Bailey is prior art to the claims at issue under 35 U.S.C. § 102(e).
b) Ring Member—Claims 16 and 19–24
(1) Claims 16 and 19–23
Dr. Norred contends that Bailey fails to disclose the claimed ring
member because Bailey’s stent 12 is not made of a pliable material. PO
Resp. 33–35. Even if we were to accept Dr. Norred’s contention that the
claimed ring member must be made of a pliable material, Dr. Norred’s
argument is unpersuasive. Bailey’s stent 12 is preferably formed of
superelastic nitinol. Ex. 1006, 8:33–34. Dr. Norred’s expert witness, Dr.
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Catchings, testified that he considers nitinol to be a pliable material.
Ex. 1023, 195:8–10. Therefore, we find that Bailey describes a ring member
that is made of pliable material and reject Dr. Norred’s argument that Bailey
fails to teach the ring member recited in claims 16 and 19–23.
(2) Claim 24
Claim 24 further recites that “said ring member contacts the wall of
the aortic channel and seals said ring against the aortic channel wall to
reduce blood flow therearound.” Ex. 1001, 8:56–59. Dr. Norred contends
that Bailey’s stent (ring member) fails to seal against the aortic channel. PO
Resp. 34–35 (citing Ex. 1006, 10:15–24). Dr. Norred contends that Bailey
expressly contemplates the removal of struts from its stent body member 12,
which necessarily would destroy the seal against the aortic channel. PO
Resp. 34–35.
We are not persuaded by Dr. Norred’s argument. Claim 24 merely
requires a seal sufficient to reduce blood flow around the ring member,
which we read as being between the wall of the aortic channel and the ring
member. Dr. Norred cites no persuasive evidence that removing any of the
struts in Bailey’s stent would result in blood flowing between the remaining
struts in Bailey’s stent and the wall of the aorta or that Bailey describes
removing so many struts that the stent no longer has a circumference as
recited in the claims. In support of this argument, Dr. Norred cites a portion
of Bailey that reads:
Similarly, the stent struts of the CV valve stent 10 may
be oriented in such a manner as to create interstices of greater
or smaller area between adjacent struts, to accommodate a
particular patient anatomy. For example, where the stent struts
in the distal anchor section 16 would overly [sic] an artery
branching from the aorta, such as the coronary ostreum arteries,
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it may be desirable to either eliminate certain stent struts, or to
configure certain stent struts to define a greater interstitial area
to accommodate greater blood flow into the coronary ostreum.
Ex. 1006, 10:15–24. This passage merely indicates that portions of the stent
may be removed to allow blood to flow into the aorta through an artery that
discharges into the aorta. We see no indication that blood flowing through
the aorta would flow between the remaining portions of the stent and the
wall of the aorta. Accordingly, we reject Dr. Norred’s argument that Bailey
fails to describe the ring member recited in claim 24.
c) Means for Maintaining—Claims 19–24
Dr. Norred contends that Bailey fails to disclose the “means for
maintaining” that is recited in claims 19–24. PO Resp. 35–38. Dr. Norred
contends that Bailey’s stent 12 may only describe the “means for
maintaining” if “insubstantial differences” exist between Bailey’s stent and
the “means for maintaining.” PO Resp. 35 (citing Pacific Coast Marine
Windshields Ltd. v. Malibu Boats, LLC, 739 F.3d 694, 700 (Fed. Cir. 2014)).
Dr. Norred then argues that the presence in Bailey’s stent 12 of proximal
anchor flange 22 precludes a finding that Bailey’s stent 12 is a “means for
maintaining” because “the flange likely will pierce the aortic wall” and
create to other problems for the patient. PO Resp. 36–38.
Dr. Norred’s argument rests upon an incorrect formulation of the legal
standard for evaluating whether a structure in the prior art is the same or
equivalent to a structure claimed as a means-plus-function format. The
standard is not simply reduced to whether the two structures being compared
have “insubstantial differences.” The Federal Circuit described the test for
determining whether a claimed means for performing a function covers a
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structure in another device in the context of performing an infringement
analysis as follows:
“Literal infringement of a § 112, ¶ 6 limitation requires that the
relevant structure in the accused device perform the identical
function recited in the claim and be identical or equivalent” to
the structure identified in the written description as
corresponding to the recited function. . . . For the relevant
structure in the accused device to be equivalent to the structure
in the written description, differences between the two must be
insubstantial. . . . For example, the structure in the accused
device must perform the claimed function in substantially the
same way to achieve substantially the same result as the
structure in the written description.
JVW Enterprises, Inc. v. Interact Accessories, Inc., 424 F.3d 1324, 1333
(Fed. Cir. 2005) (citing Odetics, Inc. v. Storage Tech. Corp., 185 F.3d 1259,
1267 (Fed. Cir. 1999)). Accordingly, the inquiry is whether Bailey’s stent
12 performs the “maintaining” function in substantially the same way to
achieve substantially the same result.
Medtronic contends that Bailey’s stent meets these requirements
because Bailey’s stent 12 engages the tissue of the aortic wall to retain the
valve in position. Pet. 20, App. A-3 at 14 (citing Ex. 1006, 1:28–38, 5:61–
6:9, 7:58–8:19). These passages of Bailey indicate that stent 12 includes
distal anchor section 16, which “radially expands to contact the vascular
wall and retain the prosthesis in position.” Ex. 1006, 6:5–7. Bailey’s stent
12 also includes intermediate annular section 20 to which valve arms 24 are
connected. Ex. 1006, 9:25–29. We have determined that the “means for
maintaining” refers to connecting rods 104 interacting with stent 28 and
equivalent structures. The Specification describes stent system 28 as
maintaining the ring member in its seated position in the same manner as
Bailey’s distal anchoring portion 16 of Bailey’s stent 12, namely by
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expanding against the inner wall of the aorta. Ex. 1001, 3:7–10. The
Specification also describes rods 104 as being connected to stent 28 to assist
in maintaining the ring member in its seated position. Bailey’s intermediate
annular section 20 maintains valve body 26 in its intended location relative
to stent 12. Ex. 1006, Fig. 4.
III. MOTION FOR OBSERVATION
Dr. Norred’s Motion for Observation pertains to the testimony of
Alexander J. Hill, Ph.D. on cross-examination. We have considered Dr.
Norred’s observations (Paper 32) and Medtronic’s responses (Paper 34).
IV. MOTION TO AMEND
Because we have found claims 16 and 19–24 to be unpatentable as
anticipated by each of Leonhardt and Bailey, we turn to Dr. Norred’s Motion
to Amend Claims. In the Motion to Amend, Dr. Norred moves to substitute
claim 25 for challenged claims 16 and 20 and to substitute claim 26 for
challenged claim 19.
7
Proposed substitute claim 25 is shown below in
markup form as compared to the original claim 20
8
for which it is proposed
as a substitute.

7
In the markup of proposed claim 26, Dr. Norred refers to claim 19 as the
claim for which substitution is sought. The text of Dr. Norred’s Motion to
Amend states that proposed claim 26 is intended as a substitute for claim 24.
The marked up version of proposed claim 26 reflects changes from original
claim 19. We, therefore, understand the Motion to Amend to seek
substitution of claim 26 for claim 19.
8
Dr. Norred indicates in his Amend Reply that “[c]laim 16 is eliminated in
its entirety. Amend Reply 1. Therefore, we understand the Motion to
Amend to seek cancellation of claim 16 and substitution of proposed claim
25 for claim 20. Dr. Norred’s marked up version of proposed claim 25 does
not accurately reflect all changes between proposed claim 25 and original

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25. (Proposed substitute for claims 16 and 20) An aortic
valve for controlling a blood flow through an aortic channel
upon percutaneous placement therein, said valve comprising:
a tissue valve having an interior member made of a tissue
material and presenting an opening movable between open and
closed positions;
a ring member surrounding said tissue valve, said ring
member having a[[n]] pliable outer circumference adapted to
seat said ring member about against an aortic wall surrounding
an aortic channel and seal against a root of a native aortic valve;
and
means for maintaining said ring member in said seated
position about the aortic wall, a stent system having a plurality
of interconnected rods;
said ring member connected to one or more of said
plurality of interconnected rods;
said stent system anchoring said ring member in said
seated position against the aortic wall;
said tissue valve interior member responsive to pressure
changes [of conditions] within the aorta for movement of said
opening between said a first closed position and a second open
positions;
said aortic valve having a first collapsed configuration
for placement inside a catheter, and a second expanded
configuration when deployed from said catheter and
percutaneously placed.
26. (Proposed substitute for claim 19) The aortic valve as
claimed in claim 20 further comprising means for maintaining
said ring member in said seat about the aortic wall 25 wherein

claim 20. We have supplied a marked up version of proposed claim 25 that
accurately reflects all the differences between proposed claim 25 and
original claim 20.
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said stent system is expanded in the ascending aorta to anchor
said aortic valve in the aortic channel.
Mot. to Amend 1–2.
Proposed substitute claims may not enlarge the scope of original
patent claims. 35 U.S.C. § 316(d)(3); 37 C.F.R. § 42.121(a)(2)(ii). In this
regard, Medtronic argues that proposed claim 25 is broader in scope as
compared to original challenged claim 20. Amend Opp. 7. Medtronic
contends that the proposed changes replacing the “means for maintaining” in
claim 20 with “a stent system having a plurality of interconnected rods,”
broadens the claim by eliminating the connecting rods 104. Id.
Dr. Norred responds that the proposed change does not enlarge the
scope of claim 20 because claim 20 recites affirmatively “a plurality of
interconnected rods” along with a “stent system,” which are the structures
identified as performing the “maintaining” function in the “means for
maintaining.” Amend Reply, 1–2.
We are persuaded that Dr. Norred’s proposed amendment
impermissibly broadens the scope of claim 20. As discussed above, we
construed the phrase “means for maintaining” to mean “connecting rods 104
interacting with stent 28” and equivalents of those structures. The proposed
amendment now recites a “stent system having a plurality of interconnected
rods.” Mot. Amend 2. The Specification describes stent 28, which is merely
part of the structure that performs the maintaining function, as follows:
“The stent system 28 is made up of a small slotted stainless steel tube or
series of interconnected rods which form an expandable cylindrical lattice or
scaffolding.” Ex. 1001, 2:61–63. Accordingly, affirmatively reciting that
the stent system has “a plurality of interconnected rods” merely describes
what was already part of the stent system that is described in the ’228 patent.
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Proposed claim 25 would now cover devices that completely lacked the
separately described connecting rods 104, which were previously required as
part of the “means for maintaining.” Accordingly, we conclude that
proposed claim 25 impermissibly enlarges the scope of original claim 20.
Proposed claim 26 depends from proposed claim 25 and does not narrow the
improperly broadened limitation in proposed claim 25. For these reasons,
we deny Dr. Norred’s Motion to Amend.
V. CONCLUSION
We determine that Medtronic has demonstrated by a preponderance of
the evidence that claim 16 and 19–24 are unpatentable as anticipated by
Leonhardt under 35 U.S.C. § 102(b) and by Bailey under 35 U.S.C.
§ 102(e).
In addition, we determine that Dr. Norred has failed to demonstrate by
a preponderance of the evidence an entitlement to entry of the proposed
substitute claims 25 and 26. We, therefore, deny Dr. Norred’s Motion to
Amend.
VI. ORDER
For the reasons given, it is:
ORDERED that claims 16 and 19–24 of the ’228 patent are held
unpatentable;
FURTHER ORDERED that Dr. Norred’s Motion to Amend is denied;
FURTHER ORDERED that, pursuant to 35 U.S.C. § 318(b), upon
expiration of the time for appeal of this decision, or the termination of any
such appeal, a certificate shall issue canceling claims 16 and 19–24 in U.S.
Patent No. 6,482,228 B1; and
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FURTHER ORDERED that because 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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PETITIONER:
Jack Barufka
Evan Finkel
PILLSBURY WINTHROP SHAW PITTMAN LLP
jack.barufka@pillsburylaw.com
evan.finkel@pillsburylaw.com
PATENT OWNER:
James J. Kernell
David L. Marcus
BARTLE & MARCUS LLC
jjk@kcpatentlaw.com
dmarcus@bmlawkc.com