Snyders Heart Valve LLC v. St. Jude Medical S.C., Inc. et al

Filing 194

CLAIM CONSTRUCTION MEMORANDUM OPINION AND ORDER. Signed by Magistrate Judge Kimberly C Priest Johnson on 10/27/2017. (baf, )

IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF TEXAS
SHERMAN DIVISION
SNYDERS HEART VALVE LLC,
Plaintiff,
v.
ST. JUDE MEDICAL S.C., INC., ET AL.,
Defendant.

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Case No. 4:16-cv-00812-ALM-KPJ

CLAIM CONSTRUCTION MEMORANDUM OPINION AND ORDER
Before the Court are Plaintiff Snyders Heart Valve LLC’s (“Plaintiff” or “Snyders’”)
Opening Claim Construction Brief (Dkt. 163), Defendants St. Jude Medical S.C., Inc., St. Jude
Medical, LLC, and St. Jude Medical, Cardiology Division Inc.’s (collectively, “Defendants” or
“St. Jude”) Responsive Claim Construction Brief (Dkt. 168) 1 and Plaintiff’s Reply Claim
Construction Brief (Dkt. 172). Also before the Court are the parties’ July 24, 2017, Joint Claim
Construction and Prehearing Statement (Dkt. 153) and the parties’ September 15, 2017, Joint
Patent Local Rule 4-5(d) Claim Construction Chart (Dkt. 174).

The Court held a claim

construction hearing on September 28, 2017 (the “September 28 Hearing”), to determine the
proper construction of the disputed claim terms in United States Patents No. 6,540,782 (“the ’782
Patent”) and 6,821,297 (“the ’297 Patent”).
The Court issues this Claim Construction Memorandum Opinion and Order and hereby
incorporates by reference the claim construction hearing and transcript, as well as the

Some of the exhibits to Defendants’ Responsive Claim Construction Brief are filed under the docket entry numbered
169.
1

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demonstrative slides presented by the parties during the hearing. For the following reasons, the
Court provides the constructions set forth below.

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Table of Contents
I.

BACKGROUND ................................................................................................................. 4

II.

LEGAL STANDARD ......................................................................................................... 5

III.

ANALYSIS .......................................................................................................................... 8

A. AGREED CLAIM TERMS ............................................................................................... 8
B. DISPUTED CLAIM TERMS ............................................................................................ 9
1. “upstream region” and “downstream region” ........................................................... 9
2. “frame” ........................................................................................................................ 10
3. “frame element,” “u-shaped elements,” and “u-shaped frame elements” ............ 18
4. “peripheral anchor(s)” and “anchor” ....................................................................... 23
5. “central portion located along a centerline extending between the plurality of
peripheral anchors,” “central portion located along a centerline extending
between the plurality of peripheral anchors and between the upstream region and
the downstream region,” and “central portion of the frame/central portion
located between the plurality of peripheral anchors” ..................................................... 29
6. “band” .......................................................................................................................... 35
7. “valve element,” “flexible valve element,” and “flaps” ........................................... 41
8. “opening extending through at least one of said frame and said flexible valve
element/opening extending through at least one of said frame and the flexible
valve element” and “opening extends through the central portion of the frame
and the flexible valve element” .......................................................................................... 48
9. “releasable fastener” and “releasably attachable” .................................................. 52
10.
“incision” ................................................................................................................. 55
11.
“end of [an] instrument” ........................................................................................ 56
12.
“ejecting” ................................................................................................................. 56
13.
“flexibly resilient” ................................................................................................... 58
14.
“junction of the elements / junction of the frame elements” ............................... 61
15.
“valve element having a . . . concave downstream side” and “valve element
having a convex upstream side / valve element . . . having a convex upstream side” ... 62
16.
Preambles................................................................................................................. 64
IV. CONCLUSION ................................................................................................................. 69

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I.

BACKGROUND

Plaintiff brings suit alleging infringement of the ’782 Patent and the ’297 Patent. The ’782
Patent, titled “Artificial Heart Valve,” issued on April 1, 2003, and the Abstract of the ’782 Patent
states:
An artificial valve for repairing a damaged heart valve having a plurality of cusps
separating an upstream region from a downstream region. The artificial valve
includes a flexibly resilient frame sized and shaped for insertion in a position
between the upstream region and the downstream region. The frame has a plurality
of peripheral anchors for anchoring the frame in the position between the upstream
region and the downstream region and a central portion located between the
plurality of peripheral anchors. The valve also includes a flexible valve element
attached to the frame and to the central portion of the frame having an upstream
side facing the upstream region when the frame is anchored in the position between
the upstream region and the downstream region and a downstream side opposite
the upstream side facing the downstream region when the frame is anchored in the
position between the upstream region and the downstream region. The valve
element moves to an open position when fluid pressure in the upstream region is
greater than fluid pressure in the downstream region to permit downstream flow
from the upstream region to the downstream region. The valve element moves to
a closed position when fluid pressure in the downstream region is greater than fluid
pressure in the upstream region to prevent flow reversal from the downstream
region to the upstream region.
The ’297 Patent, titled “Artificial Heart Valve, Implementation Instrument and Method
Therefor,” issued on November 23, 2004, and the Abstract of the ’297 Patent states:
An artificial valve for repairing a damaged heart valve having a plurality of cusps
separating upstream and downstream regions. The artificial valve includes a
flexibly resilient frame with a plurality of peripheral anchors for anchoring the
frame in position between the regions. The frame includes a central portion located
between the anchors. The valve includes a flexible valve element attached to the
central portion of the frame having an upstream side and a downstream side
opposite the upstream side. The valve element moves to an open position when
fluid pressure in the upstream region is greater than fluid pressure in the
downstream region to permit downstream flow. The valve element moves to a
closed position when fluid pressure in the downstream region is greater than fluid
pressure in the upstream region to prevent flow reversal. The valve may be used in
beating heart procedures, avoiding cardiopulmonary bypass and cardioplegia.

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Both the ’782 Patent and the ’297 Patent claim priority to a provisional application filed
February 2, 2000. Plaintiff submits that “[t]his case focuses on the aortic valve, which is the
valve that is replaced by the accused products.” Dkt. 163 at 1.
Plaintiff has asserted: Claims 1, 2, 4–8, 10–13, 17–19, 21, 22, and 25–30 of the ’782 Patent;
and Claims 1–3, 8, 9, 17, 18, 20, 22, 23, 31–35, 37–39, and 45 of the ’297 Patent. See Dkt. 174,
Ex. 1 at 6–22.
II.

LEGAL STANDARD

Claim construction is a matter of law. Markman v. Westview Instruments, Inc., 52 F.3d
967, 979 (Fed. Cir. 1995). The purpose of claim construction is to resolve the meanings and
technical scope of claim terms. U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed.
Cir. 1997). When the parties dispute the scope of a claim term, “it is the court’s duty to resolve
it.” O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1362 (Fed. Cir. 2008).
“It is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the invention to
which the patentee is entitled the right to exclude.’” Phillips v. AWH Corp., 415 F.3d 1303, 1312
(Fed. Cir. 2005) (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d
1111, 1115 (Fed. Cir. 2004)). The Court examines a patent’s intrinsic evidence to define the
patented invention’s scope. Id. at 1313–14; Bell Atl. Network Servs., Inc. v. Covad Commc’ns
Group, Inc., 262 F.3d 1258, 1267 (Fed. Cir. 2001). Intrinsic evidence includes the claims, the rest
of the specification, and the prosecution history. Phillips, 415 F.3d at 1312–13; Bell Atl. Network
Servs., 262 F.3d at 1267. The Court gives claim terms their ordinary and customary meaning as
understood by one of ordinary skill in the art at the time of the invention. Phillips, 415 F.3d at
1312–13; Alloc, Inc. v. Int’l Trade Comm’n, 342 F.3d 1361, 1368 (Fed. Cir. 2003).

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Claim language guides the Court’s construction of claim terms. Phillips, 415 F.3d at 1314.
“[T]he context in which a term is used in the asserted claim can be highly instructive.” Id. Other
claims, asserted and unasserted, can provide additional instruction because “terms are normally
used consistently throughout the patent.” Id. Differences among claims, such as additional
limitations in dependent claims, can provide further guidance. Id.
“[C]laims ‘must be read in view of the specification, of which they are a part.’” Id. at 1315
(quoting Markman, 52 F.3d at 979). “[T]he specification ‘is always highly relevant to the claim
construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a
disputed term.’” Id. (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir.
1996)); Teleflex. Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002). In the
specification, a patentee may define his own terms, give a claim term a different meaning than it
would otherwise possess, or disclaim or disavow some claim scope. Phillips, 415 F.3d at 1316.
Although the Court generally presumes terms possess their ordinary meaning, this presumption
can be overcome by statements of clear disclaimer. See SciMed Life Sys., Inc. v. Advanced
Cardiovascular Sys., Inc., 242 F.3d 1337, 1343–44 (Fed. Cir. 2001). This presumption does not
arise when the patentee acts as his own lexicographer. See Irdeto Access, Inc. v. EchoStar Satellite
Corp., 383 F.3d 1295, 1301 (Fed. Cir. 2004).
The specification may also resolve ambiguous claim terms “where the ordinary and
accustomed meaning of the words used in the claims lack sufficient clarity to permit the scope of
the claim to be ascertained from the words alone.” Teleflex, 299 F.3d at 1325. For example, “[a]
claim interpretation that excludes a preferred embodiment from the scope of the claim ‘is rarely,
if ever, correct.’” Globetrotter Software, Inc. v. Elan Computer Group Inc., 362 F.3d 1367, 1381
(Fed. Cir. 2004) (quoting Vitronics, 90 F.3d at 1583). But, “[a]lthough the specification may aid

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the court in interpreting the meaning of disputed language in the claims, particular embodiments
and examples appearing in the specification will not generally be read into the claims.” Constant
v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1571 (Fed. Cir. 1988); accord Phillips, 415 F.3d
at 1323.
The prosecution history is another tool to supply the proper context for claim construction
because a patentee may define a term during prosecution of the patent. Home Diagnostics Inc. v.
LifeScan, Inc., 381 F.3d 1352, 1356 (Fed. Cir. 2004) (“As in the case of the specification, a patent
applicant may define a term in prosecuting a patent.”).

The well-established doctrine of

prosecution disclaimer “preclud[es] patentees from recapturing through claim interpretation
specific meanings disclaimed during prosecution.” Omega Eng’g Inc. v. Raytek Corp., 334 F.3d
1314, 1323 (Fed. Cir. 2003). “Indeed, by distinguishing the claimed invention over the prior art,
an applicant is indicating what the claims do not cover.” Spectrum Int’l v. Sterilite Corp., 164 F.3d
1372, 1378–79 (Fed. Cir. 1988) (quotation omitted). “As a basic principle of claim interpretation,
prosecution disclaimer promotes the public notice function of the intrinsic evidence and protects
the public’s reliance on definitive statements made during prosecution.” Omega Eng’g, 334 F.3d
at 1324. However, the prosecution history must show that the patentee clearly and unambiguously
disclaimed or disavowed the proposed interpretation during prosecution to obtain claim allowance.
Middleton Inc. v. 3M Co., 311 F.3d 1384, 1388 (Fed. Cir. 2002). Statements will constitute
disclaimer of scope only if they are “clear and unmistakable statements of disavowal.” See Cordis
Corp. v. Medtronic AVE, Inc., 339 F.3d 1352, 1358 (Fed. Cir. 2003). An “ambiguous disavowal”
will not suffice. Schindler Elevator Corp. v. Otis Elevator Co., 593 F.3d 1275, 1285 (Fed. Cir.
2010) (citation omitted).

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Although “less significant than the intrinsic record in determining the legally operative
meaning of claim language,” the Court may rely on extrinsic evidence to “shed useful light on the
relevant art.” Phillips, 415 F.3d at 1317 (quotation omitted). Technical dictionaries and treatises
may help the Court understand the underlying technology and the manner in which one skilled in
the art might use claim terms, but such sources may also provide overly broad definitions or may
not be indicative of how terms are used in the patent. Id. at 1318. Similarly, expert testimony may
aid the Court in determining the particular meaning of a term in the pertinent field, but “conclusory,
unsupported assertions by experts as to the definition of a claim term are not useful.” Id.
Generally, extrinsic evidence is “less reliable than the patent and its prosecution history in
determining how to read claim terms.” Id.
III.

ANALYSIS

A. AGREED CLAIM TERMS
Apart from terms presented in their briefing, the parties have reached agreement upon the
following constructions:
Term

Agreed Construction

“having a plurality of cusps”
(’782 Patent, Claims 1, 10, 17, 18, 28, 29, 30;
’297 Patent, Claims 1, 22, 31, 38)
“an artificial valve as set forth in claim 1”
(’297 Patent, Claims 17, 18, 20)

modifies “damaged heart valve,” not
“artificial valve”
“an artificial valve that meets all of the
limitations of claim 1 of the 297 Patent”

Dkt. 153 at 1; see Dkt. 174, Ex. 1 at 1.

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B. DISPUTED CLAIM TERMS
1. “upstream region” and “downstream region”
“upstream region”
(’782 Patent, Claims 1, 10, 17–20, 28–30; ’297 Patent, Claims 1, 8, 22, 28, 31, 34, 38)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“a region from which fluid flows to a
downstream region”

“side of the native heart valve leaflets from
which blood flows”

“downstream region”
(’782 Patent, Claims 1, 10, 17–20, 28–30; ’297 Patent, Claims 1, 8, 22, 28, 31, 34, 38)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“a region to which fluid flows from an
upstream region”

“side of the native heart valve leaflets to
which blood flows”

Dkt. 153 at 2; Dkt. 163 at 7; Dkt. 174, Ex. 1 at 1.
Plaintiff argues that “[t]he patents-in-suit use ‘upstream’ and ‘downstream’ in their
ordinary sense to mean two regions that have a relative relationship: fluid flows from the upstream
region to the downstream region.” Dkt. 163 at 7. In response, “St. Jude accepts Plaintiff’s
constructions of these terms.” Dkt. 168 at 42. Plaintiff’s reply brief acknowledges this agreement.
Dkt. 172 at 1; see Dkt. 174 at 1.
The Court therefore hereby construes these terms as set forth in the following chart:
Term

Construction

“upstream region”

“a region from which fluid flows to a
downstream region”

“downstream region”

“a region to which fluid flows from an
upstream region”

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2. “frame”
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“a structure designed to shape or support”

“a conical geodesic birdcage-shaped wire
structure”

Dkt. 153 at 2; Dkt. 163 at 9; Dkt. 168 at 22; Dkt. 174-1, Ex. 1 at 2. The parties submit that this
term appears in Claims 1–14, 17–22, and 25–30 of the ’782 Patent and Claims 1–4, 8–11, 16,
22–24, 28–32, 36, 38–40, and 46 of the ’297 Patent. Id.
a. The Parties’ Positions
Plaintiff argues that Defendants’ proposed construction is unwarranted because it “comes
from a description of a particular embodiment, that was contained in an appendix, that was
submitted with Dr. Snyders’ provisional patent application, and that ultimately led to the patentsin-suit.” Dkt. 153 at 9. Plaintiff also argues that Defendants’ proposal is inconsistent with the
prosecution history. Id.
Defendants respond that “the patentee identified the birdcage-shaped structure as
‘fundamental’ and ‘needed,’ and all embodiments show this specific frame.” Dkt. 168 at 23; see
id. at 24. Defendants also cite the prosecution history, in particular the provisional patent
application, as well as testimony of the named inventor. Id. at 24–25.
Plaintiff replies that “Dr. Snyders specifically chose not to include th[e] alleged disclaimer
in his non-provisional applications.” Dkt. 172 at 2. Moreover, Plaintiff argues, “[t]he alleged
disclaimers on which Defendants rely would not support Defendants’ proposed construction of
‘frame’ even if they had been included in Dr. Snyders’ patent specifications.” Id. at 3. For
example, Plaintiff argues that the patentee’s reference to a conical geodesic birdcage-shaped wire
structure “refers to a specific embodiment of Dr. Snyders’ invention.” Id. Plaintiff further argues
that Defendants are attempting to take Dr. Snyders’ deposition testimony out of context because
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Defendants’ counsel asked Dr. Snyders about specific embodiments rather than about the claims.
Id. at 5–6.
At the September 28 Hearing, Plaintiff also noted that a specific limitation as to the shape
of the claimed artificial valve is set forth in Claim 8 of the ’782 Patent, which explicitly recites “a
plurality of U-shaped elements joined together at a junction of the elements.”
b. Analysis
Claim 1 of the ’782 Patent, for example, recites in relevant part (emphasis added):
1. An artificial valve for repairing a damaged heart valve having a plurality of
cusps separating an upstream region from a downstream region, said artificial valve
comprising:
a flexibly resilient frame sized and shaped for insertion in a position
between the upstream region and the downstream region, the frame having a
plurality of peripheral anchors for anchoring the frame in the position between the
upstream region and the downstream region and a central portion located between
the plurality of peripheral anchors;
....
Defendants have not shown that this claim, or any of the other claims at issue, expressly
recites any limitation of a “conical geodesic birdcage-shaped wire structure.” Defendants have
emphasized Appendix B to the provisional application, which is incorporated by reference and to
which the patents-in-suit claim priority. See Dkt. 169-3, Ex. 3 at B-1; see also Columbia Univ. v.
Symantec Corp., 811 F.3d 1359, 1365–66 (Fed. Cir. 2016) (“provisional applications incorporated
by reference are ‘effectively part of the’ specification as though it was ‘explicitly contained
therein’”) (quoting Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed.
Cir. 2000)); X2Y Attenuators, LLC v. ITC, 757 F.3d 1358, 1362–63 (Fed. Cir. 2014) (“The
incorporated patents are effectively part of the host [patents] as if [they] were explicitly contained
therein. . . . As a result, the disclaimers of the incorporated patents are a part of the asserted
patents.”) (citations and internal quotation marks omitted).

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On one hand, the patentee referred to a “funnel” valve implemented with a “bird-cage,”
which the patentee also referred to as “the cage,” “the frame cage,” “the wire cage housing,” “the
wire cage framing apparatus,” or “the enclosing conical wire frame cage.” See, e.g., Dkt. 163-3,
Ex. 3 at B-5:12–14, B-6:2–8, B-7:1, B-9:17–21 & B-11:21–22. The patentee also explained that
such a shape can be advantageous:
This internal flexible funnel member when opened after exiting the introducer at
the native A-V valve site then presents itself in a geometric conical or “inverted
funnel” configuration in a close conforming relationship with the externally
supporting wire cage. Thus it is essentially congruent with that cage and with which
it is in contact in its greater circumferential surface. Such a congruency between
the outer wire cage and the internal flexible funnel element thus affords a certain
reinforcing effect from the flat wire caging to oppose excessive strain effects on the
flexible internal funnel member during its pressurized “open” mode of filling in the
functional state, and such a reinforcement will reduce the potential of stress related
fatigue problems for that flexing member.
Id. at B-7:8–20.
On the other hand, Appendix B discloses that “[i]n one embodiment, the valve is a selfseating stented atrioventricular funnel valve. . . .” Id. at B-1:6–7 (emphasis added). Thus, although
the patentee then described that “[t]he fundamental design of the stented funnel valve prosthesis
consists of a conical geodesic ‘bird- cage’ [sic] styled external supporting wire framework” (id. at
B-5:12–14), these details regarding the “funnel” valve embodiment are fairly read as describing
just that, an “embodiment.” See id. at B-1:6–7; see also id. at A-3:17–18 (“[t]he presently
described device”) (emphasis added). Indeed, the patentee also referred to specific wire shape,
size, and material, but these are plainly just examples as well. See id. at B-6:12–30.
On balance, the “conical geodesic birdcage-shaped wire structure” proposed by Defendants
would improperly import limitations from disclosed embodiments. See Constant, 848 F.2d at
1571; see also Phillips, 415 F.3d at 1323.

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Alternatively, even assuming for the sake of argument that a disclaimer were present, “it is
certainly possible that a clear and unmistakable disavowal in an incorporated patent is no longer
so when placed in the context of the disclosure of the host patent.” Id.; see MPHJ Tech. Invs.,
LLC v. Ricoh Ams. Corp., 847 F.3d 1363, 1369, 1376 (Fed. Cir. 2017) (even where the
“specification incorporates in full the . . . provisional application,” “it is the deletion from the . . .
[p]rovisional application that contributes understanding of the intended scope of the final
application”); see also id. at 1369 (regarding “the deleted one-step operation,” noting that “the . . .
Patent describes the single-step operation as ‘optional,’” but stating that “[t]hese statements that
single-step operation is ‘optional’ accord with the change from the . . . [p]rovisional to the final
patent”) (emphasis added).
Also of note, the word “geodesic” appears in the provisional application without
elaboration (see Dkt. 169-3, Ex. 3 at p. B-5:13) and does not appear in the specifications of the
patents-in-suit. Indeed, even the named inventor referred to “geodesic” as “kind of an architectural
term” and stated that his invention is “kind of like that.” Dkt. 168-33, Ex. 46, Deposition of Robert
Snyders taken August 1, 2017 (August 1, 2017 Snyders Depo.), at 138:13–24. At the September
28 Hearing, Defendants did not concede that “geodesic” would be confusing but did state that
other words could be used so long as the frame is required to come to a point. The potential for
confusion regarding the significance and meaning of the word “geodesic” demonstrates at least
one reason why “incorporation by references does not convert the invention of the incorporated
patent into the invention of the host patent.” X2Y, 757 F.3d at 1363 (citation and internal quotation
marks omitted).
Further, Defendants have argued that in the provisional application, in the specifications of
the patents-in-suit, and during prosecution of the patents-in-suit, the patentee distinguished the

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“stent-like” structures disclosed in “Bessler” (see Dkt. 169-3, Ex. 3 at A-3:9–13), “Andersen” (see
’782 Patent at 2:5–19; ’297 Patent at 2:9–23), “Teitelbaum” (see Dkt. 169-5, Ex. 5, Nov. 24, 2003
Amendment Under 37 C.F.R. § 1.111 at 14–15 (SJM00106556–57)), and “Stevens” (see Dkt. 1694, Ex. 4, July 10, 2002 Amendment in Response to Office Action Mailed April 10, 2002 at 10–11
(SJM00106436–37)).
In none of these instances, however, did the patentee make any definitive statement that
the claimed invention is limited to a “birdcage” shape, let alone a “conical geodesic birdcageshaped wire structure.” See Omega Eng’g, 334 F.3d at 1324 (“As a basic principle of claim
interpretation, prosecution disclaimer promotes the public notice function of the intrinsic evidence
and protects the public’s reliance on definitive statements made during prosecution.”) (emphasis
added). For example, Defendants have noted that the patentee stated: “The fundamental design of
the stented funnel valve prosthesis consists of a conical geodesic ‘bird- cage’ [sic] styled external
supporting wire framework fabricated of any biocompatible metallic material (e.g., stainless steel,
titanium, Nitinol, etc.) with an internally disposed and congruently fabricated unitary flexible
funnel-shaped member located within this cage. . . .” Dkt. 169-3, Ex. 3 at B-5:12–17 (emphasis
added). Defendants emphasized at the September 28 Hearing that whereas the patentee used “e.g.”
when referring to the “biocompatible metallic material,” no “e.g.” (or similar signal or language)
appears in relation to the “conical geodesic ‘birdcage’” framework. See id. This proposed
inference, however, does not rise to the level of a “definitive statement[].” See Omega Eng’g, 334
F.3d at 1324. As discussed above, these details regarding the “funnel” valve embodiment are fairly
read as describing just that, an “embodiment.” See Dkt. 169-3, Ex. 3 at B-1:6–7.
As another example, in the “Background of the Invention” section of the specification, the
patentee explained that Andersen “must be implanted by direct abdominal aortic incision and

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entry” and Bessler “does not describe the specific valve construction” but “[t]he Bessler procedure
includes excision, vacuum removal of the native valve, cardio pulmonary bypass and backflushing
of the coronary arterial tree.” ’782 Patent at 2:6–10 and 2:14–19. No relevant disclaimer is
apparent. See Ventana Med. Sys., Inc. v. Biogenex Labs., Inc., 473 F.3d 1173, 1181 (Fed. Cir.
2006) (“Such general statements, without more, will not be interpreted to disclaim every feature
of every prior art device discussed in the ‘BACKGROUND ART’ section of the patent.”).
As to the Teitelbaum reference discussed by the parties in their briefing and at the
September 28 Hearing, Defendants have not shown that the patentee ever distinguished Teitelbaum
based on the absence of a “birdcage-shaped” frame. See, e.g., Dkt. 169-5, Ex. 5, Nov. 24, 2003
Amendment Under 37 C.F.R. § 1.111 at 14–15 (SJM00106557) (“Teitelbaum does not disclose or
suggest a frame having a plurality of peripheral anchors, or a flexible valve element attached to
the frame.”).
Further, Defendants have cited testimony of the named inventor, Dr. Snyders, agreeing that
his valve used a geodesic birdcage design. See Dkt. 168-33, Ex. 46, Aug. 1, 2017 Snyders Depo.
at 138:14–139:5. In general, inventor testimony may be considered. See Phillips, 415 F.3d at
1317 (“Although we have emphasized the importance of intrinsic evidence in claim construction,
we have also authorized district courts to rely on extrinsic evidence, which consists of all evidence
external to the patent and prosecution history, including expert and inventor testimony,
dictionaries, and learned treatises.”) (citation and internal quotation marks omitted); see also
Gemalto S.A. v. HTC Corp., 754 F.3d 1364, 1371 (Fed. Cir. 2014) (considering inventor testimony
as to “the ordinary meaning of ‘programmable device’”).
Here, however, the cited testimony is of little, if any, relevance in these claim construction
proceedings. See Howmedica Osteonics Corp. v. Wright Med. Tech., Inc., 540 F.3d 1337, 1346–

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47 (Fed. Cir. 2008) (noting that inventor testimony is “limited by the fact that an inventor
understands the invention but may not understand the claims, which are typically drafted by the
attorney prosecuting the patent application”). Moreover, Defendants have not demonstrated that
Dr. Snyders was testifying about the claimed invention as opposed to a particular embodiment.
The same is true regarding other similar characterizations of the inventor’s “funnel valve.” See,
e.g., Dkt. 168-31, Ex. 44, Questionnaire at 6.
Finally, Defendants urged at the September 28 Hearing that the intrinsic and extrinsic
evidence consistently demonstrate that “there was ‘nothing in the context to indicate that the
patentee contemplated any alternative’ embodiment to the one presented.” Phillips, 415 F.3d at
1323 (quoting Snow v. Lake Shore & M.S. Ry. Co., 121 U.S. 617, 630 (1887)); see Inpro II
Licensing, S.A.R.L. v. T-Mobile USA, Inc., 450 F.3d 1350, 1355 (Fed. Cir. 2006) (“Although claims
need not be limited to the preferred embodiment when the invention is more broadly described,
neither do the claims enlarge what is patented beyond what the inventor has described as the
invention.”) (citation and internal quotation marks omitted); see also Retractable Techs., Inc. v.
Becton, Dickinson & Co., 653 F.3d 1296, 1305 (Fed. Cir. 2011) (“In reviewing the intrinsic record
to construe the claims, we strive to capture the scope of the actual invention, rather than strictly
limit the scope of claims to disclosed embodiments or allow the claim language to become
divorced from what the specification conveys is the invention.”) (citing Phillips, 415 F.3d at 1323–
24).
Defendants argued that what Dr. Snyders has referred to as the “funnel valve” is
coextensive with the claimed invention. See, e.g., Dkt. 168-16, Ex. 29 at 2 and 4; id., Dkt. 168-1,
Ex. 14 at 3. Nonetheless, “although the specification often describes very specific embodiments
of the invention, [the Federal Circuit has] repeatedly warned against confining the claims to those

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embodiments. In particular, [the Federal Circuit has] expressly rejected the contention that if a
patent describes only a single embodiment, the claims of the patent must be construed as being
limited to that embodiment.” Phillips, 415 F.3d at 1323. At the September 28 Hearing, Defendants
repeatedly urged that all that the named inventor ever invented or described was a “funnel” valve
with a “birdcage-shaped” frame. Although these arguments may perhaps bear upon requirements
of enablement or written description, Defendants have not persuasively demonstrated that these
arguments warrant limiting the claim scope to the specific features of particular disclosed
embodiments. See id.; see also id. at 1327 (“we have certainly not endorsed a regime in which
validity analysis is a regular component of claim construction”).2
Based on the foregoing, the Court hereby expressly rejects Defendants’ proposed
construction. No further construction is necessary. See U.S. Surgical, 103 F.3d at 1568 (“Claim
construction is a matter of resolution of disputed meanings and technical scope, to clarify and when
necessary to explain what the patentee covered by the claims, for use in the determination of
infringement. It is not an obligatory exercise in redundancy.”); see also O2 Micro, 521 F.3d at
1362 (“[D]istrict courts are not (and should not be) required to construe every limitation present
in a patent’s asserted claims.”); Summit 6, LLC v. Samsung Elecs. Co., Ltd., 802 F.3d 1283, 1291
(Fed. Cir. 2015).
The Court accordingly hereby construes “frame” to have its plain meaning.

2

Defendants also argued at the September 28 Hearing that the frame must be birdcage-shaped so as to be able to house
a unitary valve element. The parties’ disputes as to the “valve element” terms are addressed separately below.

Page 17 of 69

3. “frame element,” “u-shaped elements,” and “u-shaped frame elements”
“frame element”
(’782 Patent, Claims 18–22, 25, 26, 29; ’297 Patent, Claims 8–11, 16, 28–30)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“a part of a frame”

“one distinct component of the frame”
“u-shaped elements”
(’782 Patent, Claims 8, 13)

Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“parts that are generally shaped like a ‘U’”

“distinct components of the frame in the
shape of the letter U”

“u-shaped frame elements”
(’782 Patent, Claims 18, 29)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“parts of a frame that are generally shaped
like a ‘U’”

“distinct components of the frame in the
shape of the letter U”

Dkt. 153 at 2 and 3; Dkt. 163 at 10; Dkt. 168 at 29; Dkt. 174, Ex. 1 at 2.
a. The Parties’ Positions
Plaintiff submits that the ’297 Patent expressly discloses that “[t]he frame 20 may be of
unitary construction.” Dkt. 163 at 10 (citing ’297 Patent at 5:51-52).
Defendants respond that the disclosure that Plaintiff relies upon “was new matter added for
the first time in the ‘297 patent,” and “[a] patentee cannot use new matter in a continuation-in-part
application to broaden the meaning of claim terms in a parent patent.” Dkt. 168 at 29. Defendants
argue that their proposed construction “is consistent with both the plain meaning and the relevant
intrinsic record,” including the prosecution history. Id. at 30; see id. at 30–31. Further, as to “uPage 18 of 69

shaped,” Defendants argue that Plaintiff’s proposal of “generally” should be rejected because
“[t]he patentee did not claim ‘generally u-shaped,’” and “every embodiment in the patent shows
frame members that are clearly u-shaped.” Id. at 31.
Plaintiff replies: “The fact that the claimed frame elements are ‘elements’ indeed means
that they must be separate ‘parts’ of the frame. But it does not mean that [sic, they] must be
separate ‘components’ in the sense that they could not be formed from the same piece of material
as specifically described in the 297 Patent.” Dkt. 172 at 7.
b. Analysis
The parties present two disputes: (1) whether “elements” refers to distinct components; and
(2) whether “u-shaped” requires the shape of the letter “u” or instead encompasses shapes that are
“generally” shaped like the letter “u.”
The specification of the ’297 Patent discloses details regarding a possible “unitary”
construction:
In addition, the frame 20 may be of unitary construction. For instance, a small
diameter tube of Nitinol or other appropriate material may have longitudinal slits
extending from one end of the tube nearly to the opposite end, thereby forming
multiple portions cantilevered from one end. Such cantilevered portions may be
bent outward to form the frame of the artificial valve.
’297 Patent at 5:51–57.
Defendants argue that “the fact that new matter regarding ‘unitary’ frames was added to
the ’297 patent confirms that the invention as originally disclosed was a non-unitary frame.” Dkt.
168 at 30; see Goldenberg v. Cytogen, Inc., 373 F.3d 1158, 1168 (Fed. Cir. 2004) (“[N]ew-matter
content of the [continuation-in-part] patent is not available to construe the claims of the [parent]
patent, and the district court erred in relying on [it].”).

Page 19 of 69

The absence of this “unitary” disclosure in the earlier ’782 Patent does not demonstrate
that the ’782 Patent necessarily excluded unitary structures. See, e.g., Thorner v. Sony Computer
Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012) (“The words of a claim are generally given
their ordinary and customary meaning as understood by a person of ordinary skill in the art when
read in the context of the specification and prosecution history. . . . There are only two exceptions
to this general rule: 1) when a patentee sets out a definition and acts as his own lexicographer, or
2) when the patentee disavows the full scope of a claim term either in the specification or during
prosecution.”) (citing Phillips, 415 F.3d at 1313). Defendants have thus failed to demonstrate that
the ’782 Patent is limited to non-unitary embodiments. See Constant, 848 F.2d at 1571; see also
Phillips, 415 F.3d at 1323.
Defendants have also submitted dictionary definitions of “element” as referring to “a
distinct part” or “irreducible constituent” of a “composite” device. Dkt. 169-15, Ex. 49, MERRIAMWEBSTER’S COLLEGIATE DICTIONARY 373 (1995) (“a distinct part of a composite device”); Dkt.
169-16, Ex. 50, THE AMERICAN HERITAGE DICTIONARY OF THE ENGLISH LANGUAGE 594 (3d ed.
1992) (“A fundamental, essential, or irreducible constituent of a composite entity.”). In general,
“[a] claim construction that gives meaning to all the terms of the claim is preferred over one that
does not do so.” Merck & Co., Inc. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir.
2005).

Yet, “heavy reliance on the dictionary divorced from the intrinsic evidence risks

transforming the meaning of the claim term to the artisan into the meaning of the term in the
abstract, out of its particular context, which is the specification.” Phillips, 415 F.3d at 1321. Here,
Defendants have not identified any persuasive indication in the intrinsic evidence that the claims
use the word “elements” to require non-unitary “distinct components.”
As to the provisional patent application, the patentee stated:

Page 20 of 69

The fundamental design of the stented funnel valve prosthesis consists of a conical
geodesic “bird- cage” [sic] styled external supporting wire framework fabricated of
any biocompatible metallic material (e.g., stainless steel, titanium, Nitinol, etc.)
with an internally disposed and congruently fabricated unitary flexible funnelshaped member located within this cage also to be described later. This external
flat wire construction consists of any reasonable number of individual wire
elements crossing in their mid-length at the apical site of the framing cage to
develop into a curvilinear patterned series of equally spaced stents (i.e., 2 stents
derived from each wire length) to terminate at the expanding base of the device.
Thus a wire cage composed of 4 wire lengths would result in there being 8 separate
stenting elements, and these elements would then terminate individually in an
enclosed laminating treatment between the wrappings of a common encircling
stabilizer band fabricated of some type biocompatible flexible polymeric material
(e.g., silicone rubber, polyurethane, ePTFE, etc.).
Dkt. 169-3, Ex. 3 at B-5:12–29 (emphasis added); see id. at B-9:19–21 (joining of the distinct
components of the frame “is needed . . . to insure that [the valve element] does not collapse. . . .”).
This disclosure contemplates that the word “elements” does not require physically separate
components because “2 stents [are] derived from each wire length” such that “a wire cage
composed of 4 wire lengths would result in there being 8 separate stenting elements.” Id. at B5:22–24. In other words, each single wire comprises two “elements.” See id.
Further, even assuming for the sake of argument that these statements necessarily support
Defendants’ proposal of requiring distinct components, these details regarding the “funnel” valve
embodiment are fairly read as pertaining to a specific “embodiment” that should not be imported
into the claims. Id. at B-1:6–7; see Constant, 848 F.2d at 1571; see also Phillips, 415 F.3d at 1323.
Finally, Defendants have argued that the patentee distinguished the “Johnson,” “Stevens,”
and “Teitelbaum” references based on the disputed terms requiring distinct components. See Dkt.
169-4, Ex. 4, July 10, 2002 Amendment in Response to Office Action Mailed April 10, 2002 at 9–
12 (SJM00106435–38)). Upon review, no relevant definitive statements are apparent. See, e.g.,
id. at 9 (SJM00106435) (“Johnson does not disclose a plurality of U-shaped valve elements or a
band surrounding the frame and extending between adjacent elements to limit spacing between the
Page 21 of 69

adjacent elements.”); see also Omega Eng’g, 334 F.3d at 1324 (“As a basic principle of claim
interpretation, prosecution disclaimer promotes the public notice function of the intrinsic evidence
and protects the public’s reliance on definitive statements made during prosecution.”) (emphasis
added).
Therefore, the Court hereby expressly rejects Defendants’ proposed construction for
“frame elements.” No further construction is necessary as to that term. See U.S. Surgical, 103
F.3d at 1568 (“Claim construction is a matter of resolution of disputed meanings and technical
scope, to clarify and when necessary to explain what the patentee covered by the claims, for use
in the determination of infringement. It is not an obligatory exercise in redundancy.”); see also
O2 Micro, 521 F.3d at 1362 (“[D]istrict courts are not (and should not be) required to construe
every limitation present in a patent’s asserted claims.”); Summit 6, 802 F.3d at 1291.
As to Plaintiff’s proposal of “generally u-shaped,” however, Plaintiff has not sufficiently
justified introducing “generally,” which would tend to obscure rather than clarify the scope of the
disputed terms.
The Court therefore hereby construes these disputed terms as set forth in the following
chart:
Term

Construction

“frame element”

Plain meaning

“u-shaped elements”

“elements that are shaped like the letter U”

“u-shaped frame elements”

“elements of the frame that are shaped like
the letter U”

Page 22 of 69

4. “peripheral anchor(s)” and “anchor”
“peripheral anchor(s)”
(’782 Patent, Claims 1, 10, 28, 29; ’287 Patent, Claims 1, 22, 31, 38, 45)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

anchor(s):
structure(s) that secure or stabilize
something in place
an anchor can be integrated with a frame

“distinct structure(s) formed outside the
general shape of the frame and used to attach
the frame to the native anatomy”

peripheral:
located on the periphery
“anchor”
(’782 Patent, Claims 1, 6, 10, 19, 20, 28, 29; ’297 Patent, Claims 1, 22, 31, 38, 45)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“a structure that secures or stabilizes
something in place”
an anchor can be integrated with the frame

“distinct structure used to attach the frame to
the native anatomy”

Dkt. 153 at 2; Dkt. 163 at 10–11; Dkt. 168 at 32; Dkt. 174-1, Ex. 1 at 2.
a. The Parties’ Positions
Plaintiff argues that Defendants’ proposed constructions should be rejected because
“separate dependent claims add these requirements to the more broadly claimed ‘anchors.’ . . .”
Dkt. 163 at 12. Plaintiff also argues that its proposed interpretation is consistent with the
prosecution history. See id. at 12–13.
Defendants

respond

that

the

patents-in-suit

“define

and

claim

‘peripheral

anchors’/‘anchors’ separately from the ‘stenting’ (outward radial force) provided by the frame
itself.” Dkt. 168 at 33. Defendants also cite testimony of the named inventor. Id. Defendants

Page 23 of 69

contend that “one cannot call the same piece of metal both the ‘frame’ and the ‘peripheral anchor.’”
Id.
Plaintiff replies that, during prosecution, the examiner found that the term “peripheral
anchors” encompassed a stenting frame disclosed in a prior art reference, and “[a]fter the Examiner
rejected his argument, [Dr. Snyders] acquiesced in the examiner’s broader construction, and thus
amended his claims to give up other, unrelated claim scope.” Dkt. 172 at 7–8. Plaintiff also
submits that “SJM’s own documents describe stenting as anchoring.” Id. at 8. Finally, Plaintiff
argues that Defendants’ reliance on inventor deposition testimony and purported disclaimers
should be rejected for the same reasons discussed as to the term “frame” (addressed separately
above). Id. at 8.
b. Analysis
As a threshold matter, the parties have discussed the prosecution history, as well as the
examiner and the patentee’s respective interpretations of the “anchor” terms, but no definitive
statement is apparent (or, as the parties put it at the September 28 Hearing, there was no “meeting
of the minds”). See Dkt. 163-9, Ex. 9, Feb. 11, 2004 Office Action at 2 (SNYDERS_0000309)
(“Applicant’s arguments . . . have been fully considered but they are not persuasive. Applicant
contends Teitelbaum lacks a frame having a plurality of anchors. . . . Examiner disagrees because
frame element 12 is comprised of a plurality of self-expanding anchors.”); see Dkt. 163-9,, Ex. 10,
May 11, 2004 Amendment and Response to Office Action Under 37 C.F.R. § 1.116 at 14
(“Applicant appreciates the broad interpretation of the claims the Examiner has obviously
chosen.”); see also Omega Eng’g, 334 F.3d at 1324 (“As a basic principle of claim interpretation,
prosecution disclaimer promotes the public notice function of the intrinsic evidence and protects
the public’s reliance on definitive statements made during prosecution.”) (emphasis added).

Page 24 of 69

Turning to the claim language, Claim 1 of the ’782 Patent, for example, recites in relevant
part (emphasis added):
1. An artificial valve for repairing a damaged heart valve having a plurality of
cusps separating an upstream region from a downstream region, said artificial valve
comprising:
a flexibly resilient frame sized and shaped for insertion in a position
between the upstream region and the downstream region, the frame having a
plurality of peripheral anchors for anchoring the frame in the position between the
upstream region and the downstream region and a central portion located between
the plurality of peripheral anchors;
a band attached to the frame limiting spacing between adjacent anchors of
said plurality of peripheral anchors; . . .
In general, “[w]here a claim lists elements separately, the clear implication of the claim
language is that those elements are distinct component[s] of the patented invention.” Becton,
Dickinson & Co. v. Tyco Healthcare Grp., LP, 616 F.3d 1249, 1254 (Fed. Cir. 2010) (citations and
internal quotation marks omitted). Examples of “anchors 34” are illustrated in Figure 1 of the
patents-in-suit. See ’782 Patent at 5:14–17. As Defendants emphasized at the September 28
Hearing, the specification separately refers to “stenting elements 30” and “frame elements 30.”
See id. at 4:48–5:29.
Nonetheless, separately recited limitations do not necessarily require “wholly separate
structures.” See Powell v Home Depot U.S.A., Inc., 663 F.3d 1221, 1231–32 (Fed. Cir. 2011)
(Finding that “the disclosure in the specification cuts against Home Depot’s argument that the
[recited] ‘cutting box’ and ‘dust collection structure’ must be separate components” because “the
specification teaches that the cutting box may also function as a ‘dust collection structure’ to
collect sawdust and wood chips generated during the wood cutting process.”).

Page 25 of 69

Defendants’ reliance on Claims 1 and 8 of the ’297 Patent is unpersuasive.3 Although
dependent Claim 8, which depends from Claim 1, adds a requirement of frame elements “biased
outward” to hold the frame in position in an expanded configuration, Defendants have not shown
that any inconsistency arises when interpreting the “anchors” terms as encompassing anchors that
are integrated with the frame. Further of note, the specification discloses that “the stenting
elements 30 preferably are sufficiently resilient to hold the artificial valve 10M in position between
the cusps C of the native heart valve M after implantation. . . .” ’782 Patent at 4:65–5:1. Plaintiff
has also submitted that “SJM’s own documents describe stenting as anchoring.” Dkt. 172 at 8; see
Dkt. 173-1, Ex. 2 and Dkt. 173-2, Ex. 3.
As to the provisional patent application, Defendants have cited disclosures that “critical
fabrication requirements” include “secure fixation,” and “[i]t is proposed that the everting hooks
(estimated 110°–135° eversion) developed at the terminal end of each stenting arm beyond the
stabilizer band will be adequate for engaging the adjacent native valve structures . . . for such a
requisite fixation and stabilization.” Dkt. 169-3, Ex. 3 at B-13:21–31; see id. at B-6:12–16 (“The
terminal ends of each stent element just beyond the stabilizer band will be developed into a series
of everted hooklets for attachment to their designated sites of implantation (2-3 mm tissue
penetration depth) at the native valve location. . . .”). Upon review, no relevant definitive
statements are apparent. See Omega Eng’g, 334 F.3d at 1324 (“As a basic principle of claim
interpretation, prosecution disclaimer promotes the public notice function of the intrinsic evidence
and protects the public’s reliance on definitive statements made during prosecution.”) (emphasis
added). Further, the details provided regarding the “funnel” valve embodiment are fairly read as
part of just that, an “embodiment.” See Dkt. 169-3, Ex. 3. at B-1:6–7.

3

Claims 22 and 28 of the ‘297 Patent are similarly presented by Defendants. Dkt. 168 at 33 n.8.

Page 26 of 69

Defendants have also cited testimony of the named inventor. See Dkt. 168, Ex. 46, August
1, 2017 Snyders Depo. at 85:14–17 and 91:10–14; see also Dkt. 168-34, Ex. 47 at 432:21–24.
Here, however, the cited testimony is of little, if any, relevance in these claim construction
proceedings. See Howmedica, 540 F.3d at 1346–47 (noting that inventor testimony is “limited by
the fact that an inventor understands the invention but may not understand the claims, which are
typically drafted by the attorney prosecuting the patent application”). To whatever extent this
testimony is relevant, it is noteworthy that Dr. Snyders’ explained that “[t]he critical anchoring
mechanism is still the Superelastic Nitinol material. That’s what gives the stability.” Dkt. 172-1,
Ex. 1, Aug. 1, 2017 Snyders Depo. at 82:16–18. Defendants urged, at the September 28 Hearing,
that the claimed invention requires both an expanding stent and anchors. Any dispute between the
parties’ as to the meaning of Dr. Snyders’ testimony in this regard is of no apparent consequence,
however, because the claims here at issue expressly recite “anchor” limitations.
On balance, Defendants have not shown that the disputed terms necessarily refer to
structures that are separate from the frame. See Powell, 663 F.3d at 1231–32 (quoted above).
As to where the “anchors” are anchored, the parties do not appear to dispute that the
“anchors” are used to anchor the frame either to damaged native anatomy or to a damaged artificial
heart valve. At the September 28 Hearing, Plaintiff was amenable to a construction along the lines
of “structure on the periphery of the frame used to secure the frame” to the existing anatomy. To
whatever extent Defendants are arguing that the claim scope is limited to anchoring directly to
native anatomy (rather than potentially to a damaged artificial valve), Defendants have not
demonstrated that such a limitation is warranted. In short, surrounding claim language is
sufficiently clear regarding the structure to which the anchors are anchored.

Page 27 of 69

Finally, at the September 28 Hearing, the parties were unable to agree on whether an anchor
“secures,” as Plaintiff has proposed, or “attaches,” as Defendants have proposed. Defendants cited
disclosure of “attach” in the specification. See ’782 Patent at 5:14–15; see also id. at 5:59–62. On
balance, Defendants’ proposal of “attach” is more consistent with these disclosures as well as the
intrinsic evidence as a whole.
The Court therefore hereby construes these disputed terms as set forth in the following
chart:
Term

Construction

“peripheral anchor(s)”

“structure(s) on the periphery of the frame
that are used to attach the frame”

“anchor”

“structure used to attach the frame”

Page 28 of 69

5. “central portion located along a centerline extending between the plurality of
peripheral anchors,” “central portion located along a centerline extending
between the plurality of peripheral anchors and between the upstream region
and the downstream region,” and “central portion of the frame/central
portion located between the plurality of peripheral anchors”
“central portion located along a centerline extending between the plurality of peripheral
anchors”
(’297 Patent, Claims 1, 31)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

no construction necessary

“apex of the frame located along the central
axis of the valve”

“central portion located along a centerline extending between the plurality of peripheral
anchors and between the upstream region and the downstream region”
(’297 Patent, Claim 1)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

no construction necessary

“apex of the frame located along the central
axis of the valve”

“central portion of the frame/central portion located between the plurality of peripheral
anchors”
(’782 Patent, Claims 1, 6, 28, 30; ’297 Patent, Claims 1, 2, 4, 31, 38)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

no construction necessary

“apex of the frame”

Dkt. 153 at 2; Dkt. 163 at p. 13; Dkt. 168 at 26; Dkt. 174, Ex. 1 at 3.
a. The Parties’ Positions
Plaintiff argues: “Although the specific embodiments disclosed in the patent specification
show frames with apexes, see, e.g., [’782 Patent] at 7:1-3, nothing in the language of the asserted
claims, or what is taught in the specification, requires the frame to have an apex, let alone requires
Page 29 of 69

the ‘central portion’ to be the apex. Quite the contrary; the patents include dependent claims—not
asserted in this case—that specifically add the requirement that the artificial valve have an apex.”
Dkt. 163 at 14 (citing ’782 Patent at Cl. 9). Plaintiff also cites the prosecution history. See id. at
14–15.
Defendants respond that these disputed terms necessarily refer to structure because of “the
plain meaning of the term, the fact that every embodiment in the patents expressly defines the
‘central portion’ as the structure at the apex of the frame, the patentee’s explanation that such
apical structure is ‘needed,’ and the patentee’s clear disclaimer of tube-like stents during
prosecution.” Dkt. 168 at 26.
Plaintiff replies that Defendants improperly attempt to limit this disputed term to specific
disclosed embodiments. Dkt. 172 at 9. Plaintiff also argues that Defendants’ reliance on purported
disclaimers should be rejected for the same reasons discussed as to the term “frame” (addressed
separately above).
b. Analysis
Claim 1 of the ’782 Patent, for example, recites (emphasis added):
1. An artificial valve for repairing a damaged heart valve having a plurality of
cusps separating an upstream region from a downstream region, said artificial valve
comprising:
a flexibly resilient frame sized and shaped for insertion in a position
between the upstream region and the downstream region, the frame having a
plurality of peripheral anchors for anchoring the frame in the position between the
upstream region and the downstream region and a central portion located between
the plurality of peripheral anchors;
a band attached to the frame limiting spacing between adjacent anchors of
said plurality of peripheral anchors; and
a flexible valve element attached to the central portion of the frame and
adjacent the band, said valve element being substantially free of connections to the
frame except at the central portion of the frame and adjacent the band, said valve
element having an upstream side facing said upstream region when the frame is
anchored in the position between the upstream region and the downstream region
and a downstream side opposite the upstream side facing said downstream region
Page 30 of 69

when the frame is anchored in the position between the upstream region and the
downstream region, said valve element moving in response to a difference between
fluid pressure in said upstream region and fluid pressure in said downstream region
between an open position in which the element permits downstream flow between
said upstream region and said downstream region and a closed position in which
the element blocks flow reversal from said downstream region to said upstream
region, wherein the valve element moves to the open position when fluid pressure
in said upstream region is greater than fluid pressure in said downstream region to
permit downstream flow from said upstream region to said downstream region and
the valve element moves to the closed position when fluid pressure in said
downstream region is greater than fluid pressure in said upstream region to prevent
flow reversal from said downstream region to said upstream region.
As a threshold matter, the parties appear to agree that whereas some claims require that the
“central portion” must be “along a centerline,” others (such as above-reproduced Claim 1 of the
’782 Patent) do not. Plaintiff also “does not dispute that the claimed ‘centerline’ is the central axis
of the valve.” Dkt. 163 at 14; see id. (“Although replacing ‘centerline’ with ‘central axis’ does not
seem particularly helpful.”).
Plaintiff has cited prosecution history in which, Plaintiff argues, the examiner interpreted
“central portion” to mean “any centrally located portion of the frame 12” (see Dkt. 163-9-163-11,
Exs. 9–11), but regardless of how the examiner’s statements are interpreted, the applicability of
that prosecution history to the present dispute is not sufficiently clear, particularly in light of the
broader claim construction standard applied during prosecution. See, e.g., In re Bigio, 381 F.3d
1320, 1324 (Fed. Cir. 2004) (“During prosecution, . . . the PTO gives claims their broadest
reasonable interpretation.”) (citation and internal quotation marks omitted); see Phillips, 415 F.3d
at 1317 (“Yet because the prosecution history represents an ongoing negotiation between the PTO
and the applicant, rather than the final product of that negotiation, it often lacks the clarity of the
specification and thus is less useful for claim construction purposes.”).

Page 31 of 69

Plaintiff has also argued claim differentiation as to dependent Claim 9 of the ’782 Patent,
which depends from Claim 8, which in turn depends from Claim 1. Claim 9 of the ’782 Patent
explicitly recites an “apex” (emphasis added):
9. An artificial valve as set forth in claim 8 wherein said upstream side of the
flexible valve element is convex and has an apex which is attached to the frame at
the junction of the elements.
Claim 9 thus recites that “the flexible valve element . . . has an apex,” not that the frame
must have an apex. Also, Claims 8 and 9 recite additional limitations other than merely the apex.
The doctrine of claim differentiation thus carries little if any weight as to the present disputed
terms. See Wenger Mfg., Inc. v. Coating Mach. Sys., Inc., 239 F.3d 1225, 1233 (Fed. Cir. 2001)
(“Claim differentiation, while often argued to be controlling when it does not apply, is clearly
applicable when there is a dispute over whether a limitation found in a dependent claim should be
read into an independent claim, and that limitation is the only meaningful difference between the
two claims.”).
Nonetheless, turning to the Figures, the specification states that a “central portion” is
“generally designated by [reference numeral] 36” in Figure 2. ’782 Patent at 5:26–29 (emphasis
added). Indeed, Figures 2 and 3 illustrate reference numeral 36 using a lead line with an arrow at
the end thereof, which thus “indicate[s] the entire section towards which it points” rather than
being a “[l]ead line[] . . . between the reference character[] and the detail[] referred to.” 37
C.F.R. § 1.84(q) and (r); see MANUAL OF PATENT EXAMINING PROCEDURE § 608.02 at 600-90
(8th ed. Aug. 2001) (same). This intrinsic evidence weighs at least somewhat against limiting
the disputed “portion” to necessarily being an “apex.”
As to the provisional patent application, Defendants have cited disclosures regarding the
“apex of the cage.” Dkt. 169-3, Ex. 3 at B-6:2–8 and B-9:17–21. Upon review, no relevant

Page 32 of 69

definitive statements are apparent. See Omega Eng’g, 334 F.3d at 1324 (“As a basic principle of
claim interpretation, prosecution disclaimer promotes the public notice function of the intrinsic
evidence and protects the public’s reliance on definitive statements made during prosecution.”)
(emphasis added). Again, the details provided regarding the “funnel” valve embodiment are fairly
read as part of just that, an “embodiment.” See Dkt. 169-3 at B-1:6–7.
Defendants have also cited testimony of the named inventor. See Dkt. 168-33, Ex. 46,
Aug. 1, 2017 Snyders Depo. at 136:13–19, 200:24–201:18 and 221:2–14. Here, however, the cited
testimony is of little, if any, relevance in these claim construction proceedings. See Howmedica,
540 F.3d at 1346–47 (noting that inventor testimony is “limited by the fact that an inventor
understands the invention but may not understand the claims, which are typically drafted by the
attorney prosecuting the patent application”). Moreover, Defendants have not demonstrated that
Dr. Snyders was testifying about the claimed invention as opposed to a particular embodiment.
See Dkt. 168-33, Ex. 46, Aug. 1, 2017 Snyders Depo. at 136:13–19, 200:24–201:18 and 221:2–
14.
The apparent dispute instead turns upon the meaning of the constituent term “portion” as
used in the claims, such as above-reproduced Claim 1 of the ’782 Patent. In particular, the claim
recites “the frame having . . . a central portion located between the plurality of peripheral anchors.”
A fair reading of this recital is that, as Defendants have argued, the “central portion” must be part
of the structure of the frame rather than merely an empty space surrounded by the frame. See
Phillips, 415 F.3d at 1314 (“the ordinary meaning of claim language as understood by a person of
skill in the art may be readily apparent even to lay judges, and claim construction in such cases
involves little more than the application of the widely accepted meaning of commonly understood
words”).

Page 33 of 69

Likewise, this claim also recites that the flexible valve element is attached to the central
portion of the frame, thus again implying that the “central portion” must be structure rather than
empty space. ’782 Patent at Cl. 1 (“a flexible valve element attached to the central portion of the
frame and adjacent the band, said valve element being substantially free of connections to the
frame except at the central portion of the frame and adjacent the band”) (emphasis added); Phillips,
415 F.3d at 1314 (“[T]he claims themselves provide substantial guidance as to the meaning of
particular claim terms.”).
Finally, interpreting “central portion” as structure rather than empty space is also consistent
with the specification. See ’782 Patent at 7:3–6 (“As illustrated in FIG. 3, the flexible valve element
22 is attached to the central portion 36 of the frame 20 at a position substantially centered between
the anchors 34.”) (emphasis added); see also id. at ’782 Patent at 5:26–29 and Figs. 2 and 3.
Indeed, at the September 28 Hearing, Plaintiff acknowledged that the “central portion”
must be structural. Nonetheless, Plaintiff asserted that a dispute may remain because Defendants
are interpreting “along a centerline” as meaning “on” a centerline. Plaintiff argued that the phrase
“along a centerline” can encompass “parallel” to a centerline. Plaintiff analogized that a road can
be understood as running “along a beach” without actually running on top of the sand of the beach.
Instead, Plaintiff analogized, the road could follow “along” the shoreline at some distance.
Claim 1 of the ’297 Patent, for example, recites in relevant part (emphasis added):
1. An artificial valve for repairing a damaged heart valve having a plurality of
cusps separating an upstream region from a downstream region, said artificial valve
comprising:
a flexibly resilient frame sized and shaped for insertion in a position
between the upstream region and the downstream region, the frame having a
plurality of peripheral anchors for anchoring the frame in the position between the
upstream region and the downstream region and a central portion located along a
centerline extending between the plurality of peripheral anchors and between the
upstream region and the downstream region when said frame is inserted in the
position between the upstream region and the downstream region; . . .
Page 34 of 69

Plaintiff’s proposed interpretation of “along” as “parallel” is vague and lacks support in
either intrinsic or extrinsic evidence. Instead, the specification supports Defendants’ proposal that
“along a centerline” means at a position “on” the centerline (and Plaintiff “does not dispute that
the claimed ‘centerline’ is the central axis of the valve” (Dkt. 163 at 14). See, e.g., ’782 Patent at
7:3–6 (“As illustrated in FIG. 3, the flexible valve element 22 is attached to the central portion 36
of the frame 20 at a position substantially centered between the anchors 34.”) (emphasis added)
and Fig. 3.
The Court therefore hereby construes these disputed terms as set forth in the following
chart:
Term

Construction

“central portion located along a centerline
extending between the plurality of
peripheral anchors”

“central structural frame portion that is
located at a position on the central axis of
the valve between the plurality of
peripheral anchors”

“central portion located along a centerline
extending between the plurality of
peripheral anchors and between the
upstream region and the downstream
region”

“central structural frame portion that is
located at a position on the central axis of
the valve, between the plurality of
peripheral anchors, and between the
upstream region and the downstream
region”

“central portion of the frame/central
portion located between the plurality of
peripheral anchors”

“central structural frame portion that is
located between the plurality of peripheral
anchors”

6. “band”
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“a structure generally in the shape of a
circular strip or ring”
a band can be integrated with the frame

“tissue or material that encircles the frame
and binds the frame elements”

Page 35 of 69

Dkt. 153 at 2–3; Dkt. 163 at 15; Dkt. 168 at 35; Dkt. 174, Ex. 1 at 3. The parties submit that this
term appears in Claims 1, 10, 15–18, 23, 24, 27, 28, and 30 of the ’782 Patent and Claims 9, 10,
29, and 30 of the ’297 Patent. Dkt. 174-1, Ex. 1 at 3.
a. The Parties’ Positions
Plaintiff argues: “A band is a structure that has a circular strip or ring. Not every tissue or
material that surrounds something is a band.” Dkt. 163 at 15. Further, Plaintiff argues that “not
all ‘bands’ bind,” and “[w]hat the ‘band’ of the asserted claims is required to do is addressed by
other claim language that has not been proposed for construction.” Id.
Defendants respond that the “band” cannot be merely a portion of the frame because, for
example, the claims require that the “band” is “surrounding” or “attached to” the frame. Dkt. 168
at 35–36. Defendants submit that this interpretation is consistent with the specification and the
prosecution history. See id. at 36–37.
Plaintiff replies that “there is no logical reason why the claimed ‘band’ could not be part
of the frame.” Dkt. 172 at 10.
b. Analysis
Defendants have cited testimony of the named inventor as to whether the accused
instrumentality “has th[e] band.” See Dkt. 168, Ex. 46, Aug. 1, 2017 Snyders Depo. at 126:7–22.
On balance, however, the cited testimony is of little, if any, relevance in these claim construction
proceedings. See Howmedica, 540 F.3d at 1346–47 (noting that inventor testimony is “limited by
the fact that an inventor understands the invention but may not understand the claims, which are
typically drafted by the attorney prosecuting the patent application”). Moreover, the testimony
cited by Defendants does not clearly demonstrate that Dr. Snyders was testifying about the claimed
invention as opposed to a particular embodiment.

Page 36 of 69

Turning to the claims, “the claims themselves provide substantial guidance as to the
meaning of particular claim terms.” Phillips, 415 F.3d at 1314. Claim 1 of the ’782 Patent, for
example, recites in relevant part (emphasis added):
1. An artificial valve for repairing a damaged heart valve having a plurality of
cusps separating an upstream region from a downstream region, said artificial valve
comprising:
a flexibly resilient frame sized and shaped for insertion in a position
between the upstream region and the downstream region, the frame having a
plurality of peripheral anchors for anchoring the frame in the position between the
upstream region and the downstream region and a central portion located between
the plurality of peripheral anchors;
a band attached to the frame limiting spacing between adjacent anchors of
said plurality of peripheral anchors; and
a flexible valve element attached to the central portion of the frame and
adjacent the band, said valve element being substantially free of connections to the
frame except at the central portion of the frame and adjacent the band. . . .
The claim thus expressly recites “a band attached to the frame,” which implies that the
band is not part of the frame.4 See Becton, Dickinson, 616 F.3d at 1254 (“Where a claim lists
elements separately, ‘the clear implication of the claim language’ is that those elements are
‘distinct component[s]’ of the patented invention.”); see also id. at 1255–56 (regarding “spring
means connected to said hinged arm”: “If the hinged arm and the spring means are one and the
same, then the hinged arm must be ‘connected to’ itself and must ‘extend between’ itself and a
mounting means, a physical impossibility. A claim construction that renders asserted claims
facially nonsensical cannot be correct.”) (citation and internal quotation marks omitted). It is also
noteworthy that this interpretation is consistent with the specification. See ’782 Patent at 5:30–
6:23.
Defendants properly submit that the other Claims at issue are similar in this respect: “The Claims of the ’782 patent
recite a ‘band attached to the frame’ (Claims 1 and 28), a ‘band . . . positioned inside and attached to the frame’ (Claim
10), a ‘first band surrounding and attached to the frame’ (Claim 17), a ‘band surrounding the frame and extending
between adjacent [frame] elements’ (Claim 18), and a ‘first band surrounding the frame’ (Claim 30). The ’297 patent
similarly claims a ‘band extending around the frame elements’ (Claim 9). From this claim language, it is apparent
that the ‘band’ must be a structure separate from the frame.” Dkt. 168 at 36.
4

Page 37 of 69

Plaintiff’s reliance upon the Powell case, discussed above as to the “peripheral anchor(s)”
and “anchor” terms, is unavailing. 663 F.3d 1221. Here, the specification does not teach that the
“band” could be both integral with the frame and attached to the frame. See id. at 1231–32 (Fed.
Cir. 2011) (finding that “the disclosure in the specification cuts against Home Depot’s argument
that the [recited] ‘cutting box’ and ‘dust collection structure’ must be separate components”
because “the specification teaches that the cutting box may also function as a ‘dust collection
structure’ to collect sawdust and wood chips generated during the wood cutting process”). The
above-discussed context provided by surrounding claim language is therefore persuasive.
Also, the above-noted context provided by the claim language is more persuasive than the
prosecution history cited by Plaintiff, in which the examiner described the “Teitelbaum” reference.
Dkt. 163-9, Ex. 9, Feb. 11, 2004 Office Action at p. 3 (SNYDERS_0000310) (“Note the frame is
a wire mesh, which inherently includes a band (one of the wires) extending around the other frame
elements.”). No lexicography or clear interpretation is apparent in this prosecution history. See
Phillips, 415 F.3d at 1317 (“Yet because the prosecution history represents an ongoing negotiation
between the PTO and the applicant, rather than the final product of that negotiation, it often lacks
the clarity of the specification and thus is less useful for claim construction purposes.”); see also
Biogen, Inc. v. Berlex Labs., Inc., 318 F.3d 1132, 1140 (Fed. Cir. 2003) (“The court correctly
viewed the prosecution history not for the examiner’s or the applicant’s subjective intent, but as
an official record that is created in the knowledge that its audience is not only the patent examining
officials and the applicant, but the interested public.”).
On balance, the context provided by the claims is controlling. See Tempo Lighting, Inc. v.
Tivoli, LLC, 742 F.3d 973, 977 (Fed. Cir. 2014) (“In claim construction, this court gives primacy
to the language of the claims, followed by the specification.”); see also Aria Diagnostics, Inc. v.

Page 38 of 69

Sequenom, Inc., 726 F.3d 1296, 1300 (Fed. Cir. 2013) (“Claim construction focuses primarily on
the language of the claims.”) (citing Phillips, 415 F.3d 1303); Renishaw PLC v. Marposs Societa’
per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998) (“[T]he claims define the scope of the right to
exclude; the claim construction inquiry, therefore, begins and ends in all cases with the actual
words of the claim.”).
The Court therefore hereby expressly rejects Plaintiff’s interpretation that “a band can be
integrated with the frame.”
As to the remainder of the parties’ proposals, surrounding claim language specifies the
relevant configuration of the recited “band.” In other words, the parties’ proposals do not appear
to have any further incongruity that is not already addressed by other claim language. To whatever
extent Defendants are arguing that the “band” must encircle the outside of the frame rather than
the inside, such an interpretation would be inconsistent with Claim 10 of the ’782 Patent, which
recites “a band comprising an internal strip positioned inside and attached to the frame. . . .” The
submitted extrinsic dictionary definition of “band” does not compel otherwise. Dkt. 169-16, Ex.
50, THE AMERICAN HERITAGE DICTIONARY OF THE ENGLISH LANGUAGE 143 (3d. ed. 1992) (“A
thin strip of flexible material used to encircle and bind one object or to hold a number of objects
together”); see Phillips, 415 F.3d at 1321 (“heavy reliance on the dictionary divorced from the
intrinsic evidence risks transforming the meaning of the claim term to the artisan into the meaning
of the term in the abstract, out of its particular context, which is the specification”). The Court
therefore hereby expressly rejects any limitation that the “band” is limited to being positioned on

Page 39 of 69

the outside of the frame.5 Likewise, Defendants have not adequately supported their proposal of
“binds,” particularly in light of the context already provided by surrounding claim language.
Thus, in light of the foregoing findings, no further construction is necessary. See U.S.
Surgical, 103 F.3d at 1568 (“Claim construction is a matter of resolution of disputed meanings and
technical scope, to clarify and when necessary to explain what the patentee covered by the claims,
for use in the determination of infringement. It is not an obligatory exercise in redundancy.”); see
also O2 Micro, 521 F.3d at 1362 (“[D]istrict courts are not (and should not be) required to construe
every limitation present in a patent’s asserted claims.”); Summit 6, 802 F.3d at 1291.
The Court therefore hereby construes “band” to have its plain meaning.

Also, Defendants themselves have stated that “‘encircle’ does not necessarily mean encircle the exterior.” Dkt. 168
at 37. At the September 28 Hearing, Defendants confirmed their position that the recited “band” can go around the
inside of the frame, the outside of the frame, or both.
5

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7. “valve element,” “flexible valve element,” and “flaps”
“valve element”
(’782 Patent, Claims 1, 6, 7, 9, 10, 14, 17, 18, 24, 28–30; ’297 Patent, Claims 1, 2, 22, 31, 38)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

no construction necessary

“unitary piece of tissue or material that
collapses inwardly away from the frame to
allow forward fluid flow between the frame
and the unitary piece of tissue or material”

alternative:
a part of the valve

“flexible valve element”
(’782 Patent, Claims 1, 6, 7, 9, 10, 14, 17, 18, 24, 28–30; ’297 Patent, Claims 1, 2, 22, 31, 38)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

no construction necessary

“unitary piece of tissue or material that
collapses inwardly away from the frame to
allow forward fluid flow between the frame
and the unitary piece of tissue or material”

alternative:
a flexible part of the valve

“flaps”
(’782 Patent, Claims 7, 24)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

no construction necessary

“reversing cusps that collapse inwardly away
from the frame to allow forward fluid flow
between the frame and the reversing cusps”

Dkt. 153 at 3; Dkt. 163 at 16; Dkt. 168 at 14; Dkt. 174, Ex. 1 at 4.
a. The Parties’ Positions
Plaintiff argues: “The Court should not import that very detailed description of a specific
reversing-cusp design into the simple claim terms ‘valve element,’ ‘flexible valve element,’ and
‘flaps.’ The asserted claims simply do not include these requirements.” Dkt. 163 at 17.

Page 41 of 69

Defendants respond that “both the intrinsic and extrinsic records . . . provide that the valve
element must be a unitary piece of material that opens by collapsing inwardly.” Dkt. 168 at 15.
For example, Defendants submit that “[t]here is no embodiment that does not have a unitary,
inwardly collapsing valve element having reversing cusps.” Id. Defendants also argue that “[t]he
provisional patent application—to which almost all independent claims claim priority and which
is incorporated into the specifications by reference—repeatedly emphasizes the importance of this
‘unitary’ valve to the invention.” Id. at 16. Defendants urge that “[t]he patentee also expressly
distinguished and disparaged native-like multi-leaflet valves.” Id. at 17. Further, Defendants
argue that their proposed construction is consistent with the prosecution history as well as the
testimony of the named inventor. Id. at 18–21. Finally, Defendants argue: (1) “[a]s used in the
claims, ‘valve’ refers to the whole implant;” (2) “the patents make it clear that the ‘valve element’
refers to the entire valve member that alternately allows and blocks flow;” and (3) “[b]oth the
claims and the specifications show that what the patentee meant by ‘flaps’ was ‘reversing cusps.’”
Id. at 21–22.
Plaintiff replies: “[W]hat ‘element’ describes in this context is the relationship between the
‘valve element’ and the overall claimed artificial valve: the ‘valve element’ is a particular part of
the claimed artificial valve. Nothing about ‘valve element’ talks about what the valve element
itself must be made of, let alone requires that it be made from a single piece of tissue or material.”
Dkt. 172 at 10. As to disclosures in the specification cited by Defendants, Plaintiff argues that
“[n]othing about these statements disavows unitary or reversing-cusp valve elements.” Id. at 11.
Further, Plaintiff argues that Defendants’ reliance on purported disclaimers should be rejected for
the same reasons discussed as to the term “frame” (addressed separately above). Id.

Page 42 of 69

b. Analysis
Defendants submit: “The specifications of the patents, not just the provisional application,
state that the figures, including Figure 1, show ‘the present invention . . . in their entireties’—not
merely an embodiment of the invention.” Dkt. 168 at 15. Defendants have taken these words out
of context. The full statement is:
Referring now to the drawings and in particular to FIG. 1, artificial heart valves of
the present invention are designated in their entireties by the reference numbers
10A and 10M.
’782 Patent at 4:25–27; ’297 Patent at 4:61–63 (same). This passage does not state that Figure 1
illustrates the artificial heart valves of the present invention in their entireties. Rather, this passage
states that, in Figure 1, the entireties of the illustrated artificial heart valves are identified by the
reference numerals 10A (which indicates an artificial heart valve specifically configured for
repairing a damaged aortic valve “A”) and 10M (which indicates an artificial heart valve
specifically configured for repairing a damaged mitral valve “M”). See ’782 Patent at 4:25–31.
The specification also discloses, for example:
[T]he flexible valve element 22 is attached to the frame 20, and more particularly
to the band 40, at several attachment points 56 around the frame. Thus, the valve
element 22 forms flaps 58 extending between adjacent attachment points 56. Each
of the flaps 58 and a corresponding portion of the band 40 extending between
adjacent attachment points 56 defines an opening 60 though the valve when the
valve element 22 moves to the open position.
’782 Patent at 7:10–17. This disclosure regarding the flexible valve elements, and flaps formed
thereby, does not specify that the flexible valve element is necessarily of unitary construction, let
alone that unitary construction is an essential aspect of the disclosed invention. Even if such
disclosure were apparent, Defendants have not shown that those specific features should be
imported into the claims. See Constant, 848 F.2d at 1571; see also Phillips, 415 F.3d at 1323.

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Further, although the patentee distinguished prior art artificial heart valves (see ’782 Patent
at 2:5–19), Defendants have not shown that the patentee necessarily relied upon a “unitary” valve
element or “reversing cusps” in order to do so. See Retractable, 653 F.3d at 1305 (noting that “the
specifications do not disclose a body that consists of multiple pieces or indicate that the body is
anything other than a one-piece body,” but also noting that “[i]n distinguishing prior art syringes
comprised of multiple pieces, the specifications state that the prior art had failed to recognize a
retractable syringe that ‘can be molded as one piece outer body’”).
As to the provisional patent application, Defendants have cited disclosures regarding a
“unitary” valve element and a “reversed cusp” design:
The presently described device, to the contrary, derives its novel diminutive
features from the very elemental use of a unitary flap type flexible funnel member
that presents virtually no impaction of free forward flow mechanics for the funnel
valve prosthesis as pertains in the bulkier valve constructions as described above.
Its simplified method of providing an innovative “reversed cusp” enhancement
for device functionality is the essence of its capability for the diminutive
fabrication dimensions needed for transluminal or endothoracoscopic
implantation procedures.
Dkt. 169-3, Ex. 3 at A-3:9–26 (emphasis added); id. at A-4:10–15, A-7:13–20, B-5:12–18, B6:31–B-7:1, B-7:20–27, B-8:13–30 (discussing “‘reversing cusp’ flaps”), B-9:17–24 and B-20:24–
28.
Defendants have argued that what Dr. Snyders has referred to as the “funnel valve” is
coextensive with the claimed invention. See, e.g., Dkt. 168-16, Ex. 29 at 2 and 4; Dkt. 168-1, Ex.
14 at 3. Nonetheless, “although the specification often describes very specific embodiments of the
invention, [the Federal Circuit has] repeatedly warned against confining the claims to those
embodiments. In particular, [the Federal Circuit has] expressly rejected the contention that if a
patent describes only a single embodiment, the claims of the patent must be construed as being
limited to that embodiment.” Phillips, 415 F.3d at 1323. At the September 28 Hearing, Defendants
Page 44 of 69

repeatedly urged that all that the named inventor ever invented or described was a “funnel” valve
with a unitary valve member. Although these arguments may perhaps bear upon requirements of
enablement or written description, Defendants have not persuasively demonstrated that these
arguments warrant limiting the claim scope to the specific features of particular disclosed
embodiments. See id.; see also id. at 1327 (“we have certainly not endorsed a regime in which
validity analysis is a regular component of claim construction”).
On balance, the patentee’s statements pertained to particular “unitary,” “reversed cusp”
embodiments, and no relevant definitive statements are apparent that would justify imposing the
limitations proposed by Defendants. See Omega Eng’g, 334 F.3d at 1324 (“As a basic principle
of claim interpretation, prosecution disclaimer promotes the public notice function of the intrinsic
evidence and protects the public’s reliance on definitive statements made during prosecution.”)
(emphasis added). Again, the details provided regarding the “funnel” valve embodiment are fairly
read as part of just that, an “embodiment.” See Dkt. 169-3, Ex. 3 at B-1:6–7.
Alternatively, even assuming for the sake of argument that a disclaimer were present, “it is
certainly possible that a clear and unmistakable disavowal in an incorporated patent is no longer
so when placed in the context of the disclosure of the host patent.” X2Y, 757 F.3d at 1363; see
MPHJ, 847 F.3d at 1369, 1376 (even where the “specification incorporates in full the . . .
provisional application,” “it is the deletion from the . . . [p]rovisional application that contributes
understanding of the intended scope of the final application”); see also id. at 1369 (regarding “the
deleted one-step operation,” noting that “the . . . Patent describes the single-step operation as
‘optional,’” but stating that “[t]hese statements that single-step operation is ‘optional’ accord with
the change from the . . . [p]rovisional to the final patent”) (emphasis added).

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Defendants have further cited prosecution history of the ’782 Patent in which the patentee
distinguished the “Stevens” reference:
Stevens discloses a prosthetic valve comprising a cylindrical element (100) and at
least one cusp (95). However, Stevens does not disclose an artificial valve
comprising a band attached to a frame limiting spacing between adjacent anchors
of the frame or a flexible valve element attached to a central portion of the frame
and adjacent the band as recited in the claims.
Dkt. 169-4, Ex. 4, July 10, 2002 Amendment in Response to Office Action Mailed April 10, 2002
at 10 (SJM00106436). The prosecution history cited by Defendants contains no relevant definitive
statement that would support Defendants’ proposed “unitary” or “reversing cusps” limitations. See
Omega Eng’g, 334 F.3d at 1324 (“As a basic principle of claim interpretation, prosecution
disclaimer promotes the public notice function of the intrinsic evidence and protects the public’s
reliance on definitive statements made during prosecution.”) (emphasis added).
Defendants have also cited testimony of the named inventor. See Dkt. 168-33, Ex. 46,
Aug. 1, 2017 Snyders Depo. at 120:10–14, 120:19–121:10, 127:6–14, 143:16–25, 146:12–21 and
264:5–11. Here, however, the cited testimony is of little, if any, relevance in these claim
construction proceedings. See Howmedica, 540 F.3d at 1346–47 (noting that inventor testimony
is “limited by the fact that an inventor understands the invention but may not understand the claims,
which are typically drafted by the attorney prosecuting the patent application”). Moreover,
Defendants have not demonstrated that Dr. Snyders was testifying about the claimed invention as
opposed to a particular embodiment.
Defendants have also submitted dictionary definitions of “element” as referring to “a
distinct part” or “irreducible constituent” of a “composite” device. Dkt. 169-15, Ex. 49, MERRIAMWEBSTER’S COLLEGIATE DICTIONARY 373 (1995) (“a distinct part of a composite device”); Dkt.
169-16, Ex. 50, THE AMERICAN HERITAGE DICTIONARY OF THE ENGLISH LANGUAGE 594 (3d ed.

Page 46 of 69

1992) (“A fundamental, essential, or irreducible constituent of a composite entity.”). In general,
“[a] claim construction that gives meaning to all the terms of the claim is preferred over one that
does not do so.” Merck, 395 F.3d at 1372. Yet, “heavy reliance on the dictionary divorced from
the intrinsic evidence risks transforming the meaning of the claim term to the artisan into the
meaning of the term in the abstract, out of its particular context, which is the specification.”
Phillips, 415 F.3d at 1321. Here, Defendants have not identified any persuasive indication in the
intrinsic evidence that the claims use the word “element” to preclude a “valve element” from
having constituent parts.
Likewise, Defendants noted at the September 28 Hearing that whereas the preambles of
the claims recite “a plurality of cusps” as plural, the disputed terms recite “valve element” and
“flexible valve element” as singular. Although the disputed terms “valve element” and “flexible
valve element” are singular, these disputed terms appear in “comprising” claims that do not
prohibit the presence of additional elements. See, e.g., Genentech, Inc. v. Chiron Corp., 112 F.3d
495, 501 (Fed. Cir. 1997) (“‘Comprising’ is a term of art used in claim language which means that
the named elements are essential, but other elements may be added and still form a construct within
the scope of the claim.”).
Based on all of the foregoing, the Court hereby expressly rejects Defendants’ proposed
constructions. No further construction is necessary, particularly in light of the context provided
by surrounding claim language. See U.S. Surgical, 103 F.3d at 1568 (“Claim construction is a
matter of resolution of disputed meanings and technical scope, to clarify and when necessary to
explain what the patentee covered by the claims, for use in the determination of infringement. It
is not an obligatory exercise in redundancy.”); see also O2 Micro, 521 F.3d at 1362 (“[D]istrict

Page 47 of 69

courts are not (and should not be) required to construe every limitation present in a patent’s
asserted claims.”); Summit 6, 802 F.3d at 1291.
The Court accordingly hereby construes “valve element,” “flexible valve element,” and
“flaps” to have their plain meaning.
8. “opening extending through at least one of said frame and said flexible valve
element/opening extending through at least one of said frame and the flexible
valve element” and “opening extends through the central portion of the
frame and the flexible valve element”
“opening extending through at least one of said frame and said flexible valve element /
opening extending through at least one of said frame and the flexible valve element”
(’297 Patent, Claims 1, 22, 31, 38)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

no construction necessary

“small aperture in the structure of the frame
and/or the flexible valve element”

“opening extends through the central portion of the frame and the flexible valve
element”
(’297 Patent, Claim 2)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

no construction necessary

“small aperture in the structure of the frame
and the flexible valve element”

Dkt. 153 at 3; Dkt. 163 at 17–18; Dkt. 168 at 39; Dkt. 174, Ex. 1 at 4.
a. The Parties’ Positions
Plaintiff argues: (1) “nothing in the claim language speaks about the size of the opening;”
(2) “[c]hanging ‘opening’ to ‘aperture’ merely replaces a well-known word with a less-well known
word for no apparent reason, and would not be helpful to the jury;” and (3) “[t]he 297 patent

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describes a frame having an opening (212) that extends between (but not through) the frame
elements (230).” Dkt. 163 at 18–19. Plaintiff also cites the prosecution history. See id. at 19–20.
Defendants respond that “Plaintiff’s construction would cover any physical ‘opening’ in
an artificial heart valve implant—including the opening formed when the valve element opens to
allow blood flow.” Dkt. 168 at 39.
Plaintiff replies that “[a]s confirmed by the prosecution history,” the claimed “opening”
“covers the opening in the Teitelbaum frame.” Dkt. 172 at 13.
b. Analysis
As a threshold matter, Plaintiff has cited prosecution history in which the examiner
described the “Teitelbaum” reference:
Teitelbaum discloses in figures 3-4B an artificial heart valve comprising a flexibly
resilient frame (12) comprising anchors for maintaining the frame in position, a
flexible valve element (20) having convex upstream and concave downstream
sides, and an opening through the frame for receiving an implement such as a guide
(see Fig 2).
Dkt. 163-9, Ex. 9, Feb. 11, 2004 Office Action at 3 (SNYDERS_0000310) (emphasis added). On
balance, this prosecution history is not sufficiently clear so as to create any inconsistency with
Defendants’ proposed constructions. See Phillips, 415 F.3d at 1317 (“Yet because the prosecution
history represents an ongoing negotiation between the PTO and the applicant, rather than the final
product of that negotiation, it often lacks the clarity of the specification and thus is less useful for
claim construction purposes.”). Also of note, a broader claim construction standard was applied
during prosecution than is applicable here. See, e.g., In re Bigio, 381 F.3d at 1324 (“During
prosecution, . . . the PTO gives claims their broadest reasonable interpretation.”) (citation and
internal quotation marks omitted).
The specification discloses:

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An opening extends through at least one of the frame and the valve element for
receiving an implement.
***
In one embodiment, the post 310 mounts on the frame 220 (FIGS. 8, 14, 16 and 17)
and includes an opening 212 (FIG. 14) to allow an implement 214, such as a guide,
or guidewire, as depicted in FIG. 16 and described in detail below, to pass through
the valve 210. The opening 212 extends through at least one of the frame 220 and
the valve element 222 for receiving the implement 214 (FIGS. 8 and 16). Although
the opening 212 of the illustrated embodiment extends through the central portion
236 of the frame 220 and the valve element 222, it is envisioned that the opening
212 could extend through other portions of the artificial valve 210 without
departing from the scope of the present invention. After removal of the implement
214, it is envisioned the opening 212 may provide surface washing to reduce a
potential for blood to coagulate adjacent the downstream side (i.e., the concave side
252) of the valve element 222. It is further envisioned the opening 212 may be used
even where an implement 214 is not needed to reduce potential for blood to
coagulate adjacent the valve element 222. Although this opening 212 may have
other dimensions without departing from the scope of the present invention, in one
embodiment the opening has a width of between about 0.5 mm and about 1 mm,
and more preferably a width of about 1 mm.
’297 Patent at 3:1–3 and 13:1–24. On balance, these disclosures in the specification pertain to
specific features of particular disclosed embodiments that should not be imported into the claims.
See Constant, 848 F.2d at 1571; see also Phillips, 415 F.3d at 1323. Also, this disclosure expressly
notes that “it is envisioned that the opening 212 could extend through other portions of the artificial
valve 210 without departing from the scope of the present invention.” Id. at 13:10–13.
Moreover, Defendants’ proposal of a “small aperture in the structure” lacks sufficient
support in the intrinsic evidence and would tend to confuse rather than clarify the scope of the
claims. At the September 28 Hearing, Defendants argued that the specification explains these
disputed terms refer to an opening for a guide wire. Claim 1 of the ’297 Patent, for example,
recites: “an opening extending through at least one of said frame and said flexible valve element
for receiving an implement” (emphasis added). Nonetheless, Defendants’ proposal remains

Page 50 of 69

unclear and also is seemingly superfluous, at least in the case of the express recital in Claim 1 of
’297 Patent of “for receiving an implement.”
Defendants’ proposal would also appear to read out, for example, the embodiment
illustrated in Figure 14 of the ’297 Patent, in which “opening 212” is positioned between frame
elements rather than through any frame element. See ’297 Patent at 13:1–6 and Fig. 14.6 Further,
as to the term “opening extends through the central portion of the frame and the flexible valve
element,” the constituent term “central portion of the frame” is a separately disputed term
(addressed above). Finally, Defendants have argued that the usage of the phrase “not shown” in
the ’782 Patent (’782 Patent at 8:40–53) means that “‘openings’ that were shown in the ’782 Patent
are not the ‘opening’ subsequently claimed in the ‘297 Patent” (Dkt. 168 at 39–40), but the passage
cited by Defendants does not demonstrate any such disclaimer, and Defendants have not identified
any legal precedent to support their proposition. Moreover, what is disclosed as being “not shown”
is an “alternative embodiment,” not the “opening.” See ’782 Patent at 8:40–53.
The Court therefore hereby expressly rejects Defendants’ proposed constructions. No
further construction is necessary, particularly in light of the context provided by surrounding claim
language. See U.S. Surgical, 103 F.3d at 1568 (“Claim construction is a matter of resolution of
disputed meanings and technical scope, to clarify and when necessary to explain what the patentee
covered by the claims, for use in the determination of infringement. It is not an obligatory exercise
in redundancy.”); see also O2 Micro, 521 F.3d at 1362 (“[D]istrict courts are not (and should not
be) required to construe every limitation present in a patent’s asserted claims.”); Summit 6, 802
F.3d at 1291.

6

At the September 28, 2017 Hearing, Defendants clarified that Defendants are not seeking an interpretation that would
require the “openings” to be formed in a particular frame element.

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The Court accordingly hereby construes “opening extending through at least one of said
frame and said flexible valve element/opening extending through at least one of said frame
and the flexible valve element” and “opening extends through the central portion of the frame
and the flexible valve element” to have their plain meaning.
9. “releasable fastener” and “releasably attachable”
“releasable fastener”
(’297 Patent, Claims 3, 23)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“a fastener that is designed to be released
non-destructively”

“device that allows selective disengagement
and reengagement”

“releasably attachable”
(’297 Patent, Claims 34, 38)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“attached in a manner that can be unattached
nondestructively”

“allows selective disengagement and
reengagement”

Dkt. 153 at 3 and 4; Dkt. 163 at 20; Dkt. 168 at 40; Dkt. 174, Ex. 1 at 5.
a. The Parties’ Positions
Plaintiff argues: (1) “[i]nherent in the concept of ‘releasable’ is the idea that something is
designed to be unattached in a non-destructive manner;” (2) the ability to “reengage” after a release
“is not found in the terms ‘releasable fastener’ or ‘releasably attachable;’” and (3) although “one
form of ‘engaging’ something is to push against it,” “that X pushes against Y does not mean that
X is ‘fastened’ or ‘attached’ to Y.” Dkt. 163 at 21.
Defendants respond that surrounding claim language demonstrates that “releasable”
requires a capability of reengagement. Dkt. 168 at 40–41.
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Plaintiff replies that “SJM presents no argument that destructive releasing should count.”
Dkt. 172 at 14. Plaintiff also argues that, as to the separate recital that the fastener is “for
selectively connecting,” “[i]f anything, the fact that separate claim language adds this limitation
means that the ‘releasable fastener’ does not inherently include it.” Id.
b. Analysis
Claims 3 and 34 of the ’297 Patent, for example, recite (emphasis added):
3. An artificial valve as set forth in claim 2 further comprising a releasable fastener
mounted on the frame for selectively connecting the valve to an instrument.
***
34. A combination as set forth in claim 33 further comprising an installer received
within the hollow interior of the holder and releasably attachable to the artificial
heart valve for maneuvering the artificial heart valve from the hollow interior of the
holder into position between the upstream region and the downstream region.
The specification likewise discloses “releasable fastener[s]” and “releasably attachable”
installers:
The post 318 may additionally include a releasable fastener 314. For example, the
post 318 may include threads 320 (FIG. 16) for attaching the valve 210 to the
instrument 306. Either the inside or outside of the post 318 may be threaded, but
is preferably externally threaded, as shown in FIGS. 8 and 16. Preferably, the post
318 has an inner diameter ID of about 1.0 mm (FIG. 16) and an outer diameter OD
of about 2.0 mm. The post 318 is also preferably right-hand threaded, although
left-hand threads are contemplated as being within the scope of the present
invention.
***
The elongate manipulator 344 further includes a hollow interior 348 shaped and
sized to receive the installer 328. The installer is releasably attachable to the
artificial heart valve 210 for maneuvering the artificial heart valve from the hollow
interior 332 of the holder 276 into position between the upstream region and the
downstream region of the damaged heart H. In one embodiment, an end 352 of the
installer 328 includes an internally threaded portion 354 for threadably receiving
the externally threaded post 310 of the valve 210. This allows the user to push the
valve 210 from the holder 276 and selectively release the installer 328 from the post
310 of the valve by rotating the installer, thereby unscrewing the installer from the
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post. The installer 328 and elongate manipulator 344 may then be removed from
the surgical field. Preferably, the internally threaded portion 354 would have an
inner dimension ID" of about 2.0 mm to match the outer dimension OD of the
externally threaded post 310. In one embodiment, the end 352 of the installer 328
preferably has an outer dimension OD' of about 2.5 mm while the remaining portion
of the installer has an outer dimension OD" of about 2.0 mm.
***
Alternately, access to the aortic valve A is possible in a retrograde configuration
(e.g., from the femoral artery), as described above with respect to FIG. 5. Such an
installation would not include the use of a releasable fastener, but would
incorporate a plunger tip 80 and push rod 82 as set forth above.
’297 Patent at 13:25–35, 14:45–65 and 16:53–58 (emphasis added); see id. at 14:66–15:11
(disclosing “a different installer and post embodiment” that “includes a bayonet fastener 360 as
depicted in FIG. 17”); see also id. at Cls. 5 and 7.
These particular types of fasteners, however, are disclosed as examples. To the extent that
these examples might be implemented so as to enable both “disengagement and reengagement,”
as Defendants have proposed, such specific features from particular disclosed embodiments should
not be imported into the claims. See Constant, 848 F.2d at 1571; see also Phillips, 415 F.3d at
1323. Further, the extrinsic evidence cited by Defendants is of minimal, if any, weight in these
claim construction proceedings and is unpersuasive. See Dkt. 168-1, Ex. 14 at 23; see also Phillips,
415 F.3d at 1317 (“while extrinsic evidence can shed useful light on the relevant art, we have
explained that it is less significant than the intrinsic record in determining the legally operative
meaning of claim language) (citation and internal quotation marks omitted).
Nonetheless, Plaintiff has not adequately supported its proposal of requiring releasing
“non-destructively.” Plaintiff’s suggested analogy that “a page of a book is not ‘releasable’
because it can be ripped out” (Dkt. 163 at 20) is unpersuasive because its applicability to the
present dispute is unclear. For example, under Plaintiff’s apparent reasoning, a page of a

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perforated notebook might not be considered “releasable” because removing the page would
destroy the perforation. On balance, Plaintiff has not sufficiently explained or supported its
assertion that “[i]nherent in the concept of ‘releasable’ is the idea that something is designed to be
unattached in a non-destructive manner.” Id. The Court therefore hereby expressly rejects
Plaintiff’s proposal in that regard.
The Court accordingly hereby construes the disputed terms as set forth in the following
chart:
Term

Construction

“releasable fastener”

“fastener that allows for selectively
releasing”

“releasably attachable”

“attachable in a manner that can be
selectively released”

10. “incision”
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“a cut”

“surgical cut using a knife or scalpel”

Dkt. 153 at 3; Dkt. 163 at 21. The parties submit that this term appears in Claims 17, 18, and 20
of the ’297 Patent. Dkt. 174 at 1.
Plaintiff argues that Defendants’ proposed limitation should be rejected because the
specification “specifically describe[s] making an ‘incision’ in the context of a percutaneous,
transluminal method of implanting an artificial valve. . . .” Dkt. 163 at 21. Plaintiff also submits
that Defendants’ own documents refer to implanting a heart valve through an “incision” in the
femoral artery or a “puncture.” Id. at 22. In response, “St. Jude accepts Plaintiff’s construction of

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‘a cut.’” Dkt. 168 at 42. Plaintiff’s reply brief acknowledges this agreement. Dkt. 172 at 14; see
Dkt. 174, Ex. 1 at 1.
The Court therefore hereby construes “incision” to mean “a cut.”
11. “end of [an] instrument”
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

no construction necessary

“furthest extremity of the instrument”

alternative:
the end of the elongate [flexible]
instrument
Dkt. 153 at 3; Dkt. 163 at 23. The parties submit that this term appears in Claims “17, 28 [sic, 18],
[and] 20” of the ’297 Patent. Dkt. 174, Ex. 1 at 2.
Plaintiff submits that “SJM’s own documents confirm that in the context of TAVR, 7 ‘end
of [an] instrument’ does not mean the ‘furthest extremity’ of the instrument.” Dkt. 163 at 23. In
response, “St. Jude accepts Plaintiff’s proposal of no construction necessary.” Dkt. 168 at 42.
Plaintiff’s reply brief acknowledges this agreement. Dkt. 172 at 14.
As agreed-upon by the parties, therefore, the Court hereby finds as to “end of [an]
instrument”: “no construction necessary.”
12. “ejecting”
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“causing to come out”
this can be from any frame of reference

“causing to come out”8

7

“TAVR” appears to be an abbreviation for “transcatheter aortic valve replacement.”

8

Defendants previously proposed: “completely expelling, removing.” Dkt. 153 at 4.

Page 56 of 69

Dkt. 153 at 4; Dkt. 163 at 24; Dkt. 168 at 41; Dkt. 174-1, Ex. 1 at 5. The parties submit that this
term appears in Claims 28 and 29 of the ’782 Patent and Claims 17, 18, and 20 of the ’297 Patent.
Id.
a. The Parties’ Positions
Plaintiff argues that “nothing in the patents suggests that ‘ejecting’ requires ‘complete’
ejection,” and the specification “explain[s] that the valve can be ‘ejected’ and then recaptured by
the delivery instrument for re-positioning if necessary.” Dkt. 163 at 24 (citing ’297 Patent at 3:37–
50 and 20:42–21:25).
Defendants “accept[] Plaintiff’s construction, ‘causing to come out.’ But St. Jude does not
accept Plaintiff’s confusing and ambiguous gloss that ‘[t]his can be from any frame of reference,’
which Plaintiff evidently does not even offer as part of its proposed construction.” Dkt. 168 at 41.
Plaintiff replies that “[a]lthough it disagrees with this aspect of Snyders’ proposed
construction, SJM presents no argument responding to the reasons why Snyders’ position is
correct.” Dkt. 172 at 14.
b. Analysis
Defendants appear to no longer argue that “ejecting” requires causing to come out
completely. The only potential remaining issue might arise from Plaintiff’s assertion that “this can
be from any frame of reference.” Dkt. 174-1, Ex. 1 at 5. Plaintiff asserted, in its opening brief:
SJM’s proposed construction could arguably require the delivery instrument to be
held in place relative to the patient so that when the valve is ejected it moves with
respect to the patient. Snyders’ proposed construction would allow for that, but
would also allow the valve (instead of the instrument) to be held in place relative
to the patient, so that the valve could be ejected by withdrawing the end of the
instrument.
Dkt. 163 at 24.

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At the September 28 Hearing, Defendants did not articulate any substantive objection to
Plaintiff’s proposed interpretation. Rather, Defendants simply maintained that the additional
language proposed by Plaintiff is superfluous.
To resolve any confusion in this regard, the Court hereby finds that “ejecting” does not
exclude withdrawing an instrument while the valve remains stationary.

Such a reading is

supported by the specification. See ’782 Patent at 7:65–8:1 and Fig. 4.
With that understanding, the Court hereby construes “ejecting” to mean “causing to come
out.”
13. “flexibly resilient”
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“able to spring back to its original shape, on
its own, after being compressed”

“able to regain an original shape after being
compressed”

Dkt. 153 at 4; Dkt. 163 at 26; Dkt. 168 at 31. The parties submit that this term appears in Claims
1–5, 8, 10–13, 17, 21, and 28–30 of the ’782 Patent and Claims 1, 8, 22, 28, 31, 36, 38, and 46 of
the ’297 Patent. Dkt. 174-1, Ex. 1 at 31.
a. The Parties’ Positions
Plaintiff argues that Defendants’ proposal, which would encompass frames that must be
mechanically reopened, is inconsistent with disclosure “distinguish[ing] prior-art valves that must
be mechanically reopened (and that require the heart to be stopped while the valve is being reopened).” Dkt. 163 at 26 (citing ’782 Patent at 2:6–10). Plaintiff submits that “[t]he patents-insuit explain that the resiliency of the claimed valves means that they have a springiness that causes
them to expand outward on their own.” Dkt. 163 at 26 (citing ’782 Patent at 4:65–5:2, 5:51–52
and 9:48–49).

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Defendants respond that “[t]here is nothing in the specification, much less in the passages
Plaintiff cites, that says a flexibly resilient frame has to ‘spring back’ to its original shape ‘on its
own.’” Dkt. 168 at 32. Defendants argue that their proposed construction “is consistent with the
intrinsic record and aligns with the ordinary meaning for the term, and does so without introducing
extraneous limitations.” Id.
Plaintiff replies that “Dr. Snyders actually distinguished Anderson [on the ground] that it
must be expanded mechanically by inflating a balloon,” and “Dr. Snyders’ distinguishing of
Anderson confirms the plain meaning of ‘resilient,’ which refers to something that is itself able to
bounce back to its original shape after being compressed.” Dkt. 172 at 15.
b. Analysis
Claim 1 of the ’782 Patent, for example, recites in relevant part (emphasis added):
1. An artificial valve for repairing a damaged heart valve having a plurality of
cusps separating an upstream region from a downstream region, said artificial valve
comprising:
a flexibly resilient frame sized and shaped for insertion in a position between
the upstream region and the downstream region, the frame having a plurality of
peripheral anchors for anchoring the frame in the position between the upstream
region and the downstream region and a central portion located between the
plurality of peripheral anchors; . . .
The parties have not submitted any intrinsic evidence that defines or otherwise explains the
meaning of “resilient” as used here.
Defendants have submitted dictionary definitions of “resilient” as meaning “[c]apable of
returning to an original shape or position, as after having been compressed,” or “[t]he property of
a material that enables it to regain its original shape or position after being bent, stretched, or
compressed.” Dkt. 169-16, Ex. 50, THE AMERICAN HERITAGE DICTIONARY

OF THE

ENGLISH

LANGUAGE 1535 (3d ed. 1992); Dkt. 169-17, Ex. 51, WEBSTER’S II NEW COLLEGE DICTIONARY

Page 59 of 69

943 (1999). Neither of these definitions demands that something “resilient” must be able to regain
its original shape “on its own.”
Plaintiff has emphasized that the specification refers to enabling “‘beating heart’
procedures” (’782 Patent at 9:32-37), but Plaintiff has not identified any intrinsic evidence
demonstrating that such procedures necessarily require that the frame must regain its original shape
“on its own.” Instead, this disclosure refers to “the relatively small size of the valves and
instruments.” Id.
In the specification, the patentee distinguished the “Andersen” reference:
The Andersen device includes a heterologous pig valve mounted in an annular ring.
Due to the size of this device, it must be implanted by direct abdominal aortic
incision and entry. Further, the Andersen device requires a separate inflating
balloon for its deployment.
’782 Patent at 2:6–10 (emphasis added). The specification also discloses that a valve can expand
to fit a growing child:
It is envisioned that the valves of the present invention may be suitable for implant
in pediatric patients due to their small size and substantially unrestricted flow
characteristics. Further, because the valves adaptively expand, they are capable of
expanding to fit the growing child.
Id. at 9:45–49 (emphasis added).
On balance, however, Plaintiff has not demonstrated any disclaimer or lexicography or any
other sufficiently persuasive support for Plaintiff’s proposal of “on its own.” See, e.g., Thorner,
669 F.3d at 1365. In particular, neither distinguishing the use of a balloon nor providing an ability
of the frame to expand to fit a growing child necessarily precludes the use of any instrument or
device for returning the frame to an original shape. See, e.g., Liebel-Flarsheim Co. v. Medrad,
Inc., 358 F.3d 898, 908 (Fed. Cir. 2004) (“The fact that a patent asserts that an invention achieves

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several objectives does not require that each of the claims be construed as limited to structures that
are capable of achieving all of the objectives.”).
Nonetheless, the parties’ proposed constructions contain some common ground, in
particular as to being able to return to an “original shape” “after being compressed.” In light of
this, “some construction of the disputed claim language will assist the jury to understand the
claims.” TQP Dev., LLC v. Merrill Lynch & Co., Inc., No. 2:08-CV-471, 2012 WL 1940849, at *2
(E.D. Tex. May 29, 2012) (Bryson, J.).
The Court therefore hereby construes “flexibly resilient” to mean “able to return to an
original shape after being compressed.”
14. “junction of the elements / junction of the frame elements”
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“a structure where the elements
come together” / “a structure
where the frame elements come
together”

Plain and ordinary meaning
Alternatively:
“place where the frame elements are
joined”

Dkt. 153 at 4; Dkt. 163 at 27. The parties submit that this term appears in Claims 8, 9, 13, 14, and
18 of the ’782 Patent. Dkt. 174-1, Ex. 1 at 1.
“Snyders accepts SJM’s proposed alternative construction.” Dkt. 163 at 27; see Dkt. 172
at 15; see also Dkt. 174-1, Ex. 1 at 1.
The Court therefore hereby construes “junction of the elements / junction of the frame
elements” to mean “place where the frame elements are joined.”

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15. “valve element having a . . . concave downstream side” and “valve element
having a convex upstream side / valve element . . . having a convex upstream
side”
“valve element having a . . . concave downstream side”
(’782 Patent, Claims 10, 17, 18, 29; ’297 Patent, Claim 22)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“valve element having a downstream side that
bulges away from the downstream direction”

Plain and ordinary meaning
Alternatively “the downstream side of the
valve element is shaped like the inside surface
of a bowl”

“valve element having a convex upstream side / valve element . . . having a convex
upstream side”
(’782 Patent, Claims 10, 17, 18, 29; ’297 Patent, Claim 22)
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

“valve element having an upstream side that
bulges out in the upstream direction”

Plain and ordinary meaning
Alternatively “the upstream side of the valve
element is shaped like the exterior surface of
a bowl”

Dkt. 153 at 4; Dkt. 163 at 27; Dkt. 168 at 38; Dkt. 174-1, Ex. 1 at 5. Defendants submit that
these terms appear in Claims 10, 17, 18, and 29 of the ’782 Patent and Claim 22 of the ’297
Patent. Dkt. 168 at 38 n.12.
a. The Parties’ Positions
Plaintiff argues that “[t]he claims of the patents-in-suit use the words ‘concave’ and
‘convex’ to describe the claimed artificial valve in the same way those terms are used to describe
the curvature of native heart valves, and in the same way that those terms are generally used.” Dkt.
163 at 28. Plaintiff argues that Defendants’ alternative proposed constructions should be rejected

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because “not all concave and convex surfaces are shaped like the interior or exterior of a bowl.”
Id. at 29.
Defendants respond that “[t]here is no need to construe these terms” because “[t]he terms
‘convex’ and ‘concave’ are easily understood.” Dkt. 168 at 38. Defendants also argue that “it is
unclear how much complexity Plaintiff’s construction would allow for,” and Defendants submit
that Plaintiff cites no intrinsic evidence to support “leaving room for ‘more complicated surfaces.’”
Id. at 39 (quoting Dkt. 163 at 29).
Plaintiff replies that “SJM does not dispute that native heart valves have convex upstream
sides and concave downstream sides. . . . That is exactly what the claims require, not the opposite.”
Dkt. 172 at 15.
b. Analysis
On balance, the terms “concave” and “convex” are readily understandable in the context
of the claims and need not be construed. See Dkt. 169-16, Ex. 50, THE AMERICAN HERITAGE
DICTIONARY OF THE ENGLISH LANGUAGE 390 (3d. ed. 1992) (defining “concave” as “[c]urved like
the inner surface of a sphere”); id. at 412 (defining “convex” as “[h]aving a surface or boundary
that curves or bulges outward, as the exterior of a sphere”); Dkt. 169-17, Ex. 51, WEBSTER’S II
NEW COLLEGE DICTIONARY 232 (1999) (defining “concave” as “[c]urved like the inner surface of
a ball”); id. at 247 (defining “convex” as “[h]aving a surface or boundary that curves or bulges
outward, as the exterior of a sphere”); Dkt. 169-18, Ex. 52, TABER’S CYCLOPEDIC MEDICAL
DICTIONARY 426 (18th ed. 1997) (defining “concave” as “[h]aving a spherically depressed or
hollow surface”); id. at 439 (defining “convex” as “[c]urved evenly; resembling the segment of a
sphere”).

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In other words, construction would not serve to clarify the scope of the claims, as
demonstrated by the parties’ proposals of phrases such as “bulges away” and “shaped like the
inside surface of a bowl.” Further, the parties have not identified any intrinsic evidence that
provides any special meaning. In sum, no construction is appropriate or necessary as to these
terms. See Acumed LLC v. Stryker Corp., 483 F.3d 800, 806 (Fed. Cir. 2007) (“The resolution of
some line-drawing problems . . . is properly left to the trier of fact.”) (citing PPG Indus. v.
Guardian Indus. Corp., 156 F.3d 1351, 1355 (Fed. Cir. 1998) (“after the court has defined the
claim with whatever specificity and precision is warranted by the language of the claim and the
evidence bearing on the proper construction, the task of determining whether the construed claim
reads on the accused product is for the finder of fact”)); Eon Corp. IP Holdings v. Silver Spring
Networks, 815 F.3d 1314, 1318–19 (Fed. Cir. 2016) (citing PPG, 156 F.3d at 1355).9
The Court therefore hereby construes “valve element having a . . . concave downstream
side” and “valve element having a convex upstream side / valve element . . . having a convex
upstream side” to have their plain meaning.
16. Preambles
Plaintiff’s Proposed Construction

Defendants’ Proposed Construction

The preambles are limiting

The preambles are not limiting

Dkt. 153 at 4; Dkt. 163 at 29; Dkt. 174, Ex. 1 at 5. The parties submit that this dispute applies to
“all claims.” Id.

9

At the September 28 Hearing, the parties presented arguments regarding whether native heart valves have surfaces
that are “convex” or “concave,” which Defendants argued was significant because the patentee purportedly
distinguished the shape of the claimed invention from the shape of native heart valves. See, e.g., Dkt. 169, Ex. 3 at
B-20:23–28. For substantially the same reasons discussed as to Defendants’ other disclaimer arguments in the present
Claim Construction Memorandum Opinion and Order, Defendants have not persuasively demonstrated any disclaimer
in this regard. As a result, no relevant significance has been demonstrated as to whether native heart valves can be
characterized as having “concave” and “convex” surfaces.

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a. The Parties’ Positions
Plaintiff argues that the preambles are limiting because the bodies of the claims rely upon
the preambles for antecedent basis and for “essential structure.” Dkt. 163 at 30 (quoting Catalina
Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)).
Defendants respond that “[a]t most, . . . the preambles are limiting only to the extent
necessary to provide antecedent basis for [‘upstream region’ and ‘downstream region’].” Dkt. 168
at 42.
Plaintiff replies that “[e]verything included in the preambles is implicated by the
antecedent basis and essential structure arguments made by Snyders, such that the Court should
rule that the preambles as a whole are limiting.” Dkt. 172 at 15.
b. Analysis
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. 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 to state a purpose
or intended use for the invention.” Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d
1550, 1553 (Fed. Cir. 1997).
Catalina Mktg., 289 F.3d at 808; see, e.g., Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332,
1339 (Fed. Cir. 2003) (“When limitations in the body of the claim rely upon and derive antecedent
basis from the preamble, then the preamble may act as a necessary component of the claimed
invention.”). Also, “the purpose or intended use of the invention . . . is of no significance to claim
construction. . . .” See Pitney Bowes, 182 F.3d at 1305. This principle has sometimes been
characterized as “the presumption against reading a statement of purpose in the preamble as a
claim limitation.” Marrin v. Griffin, 599 F.3d 1290, 1294-95 (Fed. Cir. 2010); see Allen Eng’g

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Corp. v. Bartell Indus., 299 F.3d 1336, 1346 (Fed. Cir. 2002) (“Generally, the preamble does not
limit the claims.”).
Plaintiff appears to submit that Claim 1 of the ’782 Patent is representative of the present
dispute. Claim 1 of the ’782 Patent recites (emphasis added):
1. An artificial valve for repairing a damaged heart valve having a plurality of
cusps separating an upstream region from a downstream region, said artificial
valve comprising:
a flexibly resilient frame sized and shaped for insertion in a position
between the upstream region and the downstream region, the frame having a
plurality of peripheral anchors for anchoring the frame in the position between the
upstream region and the downstream region and a central portion located between
the plurality of peripheral anchors;
a band attached to the frame limiting spacing between adjacent anchors of
said plurality of peripheral anchors; and
a flexible valve element attached to the central portion of the frame and
adjacent the band, said valve element being substantially free of connections to the
frame except at the central portion of the frame and adjacent the band, said valve
element having an upstream side facing said upstream region when the frame is
anchored in the position between the upstream region and the downstream region
and a downstream side opposite the upstream side facing said downstream region
when the frame is anchored in the position between the upstream region and the
downstream region, said valve element moving in response to a difference between
fluid pressure in said upstream region and fluid pressure in said downstream region
between an open position in which the element permits downstream flow between
said upstream region and said downstream region and a closed position in which
the element blocks flow reversal from said downstream region to said upstream
region, wherein the valve element moves to the open position when fluid pressure
in said upstream region is greater than fluid pressure in said downstream region to
permit downstream flow from said upstream region to said downstream region and
the valve element moves to the closed position when fluid pressure in said
downstream region is greater than fluid pressure in said upstream region to prevent
flow reversal from said downstream region to said upstream region.
On one hand, recital of structure in a preamble does not necessarily mean that the preamble
is limiting. See, e.g., Marrin, 599 F.3d at 1294 (“the mere fact that a structural term in the preamble
is part of the claim does not mean that the preamble’s statement of purpose or other description is
also part of the claim”). For example, “it is generally not appropriate to limit claim language to
exclude particular devices because they do not serve a perceived purpose of the invention.”
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Praxair, Inc. v. ATMI, Inc., 543 F.3d 1306, 1325 (Fed. Cir. 2008) (citation and internal quotation
marks omitted).
Thus, at first blush, the recital of “[a]n artificial valve for repairing a damaged heart valve”
might be read as a non-limiting statement of purpose. See TomTom, Inc. v. Adolph, 790 F.3d 1315,
1323 (Fed. Cir. 2015) (“That the phrase in the preamble . . . provides a necessary structure for [the]
claim . . . does not necessarily convert the entire preamble into a limitation, particularly one that
only states the intended use of the invention.”); see also id. at 1314 (“It was therefore error for the
district court to use an antecedent basis rationale to justify converting this independent part of the
preamble into a new claim limitation.”); Georgetown Rail Equip. Co. v. Holland L.P., 867 F.3d
1229, 1236–37 (Fed. Cir. 2017) (“In the context of the entire patent, it is apparent that the term
‘mounted on a vehicle for movement along the railroad track’ is meant to describe the principal
intended use of the invention but not to import a structural limitation or to exclude from the reach
of the claims an assembly that does not include a vehicle mount.”).
Here, however, the preamble language is necessary to understand the structures recited in
the bodies of the claims. Deere & Co. v. Bush Hog, LLC is analogous:
Unlike non-limiting preamble terms, “rotary cutter deck” does not merely state a
name or a use for the claimed box section. Rather, the term describes a
“fundamental characteristic of the claimed invention” that informs one of skill in
the art as to the structure required by the claim. Poly-Am., L.P. v. GSE Lining Tech.,
Inc., 383 F.3d 1303, 1310 (Fed. Cir. 2004). For example, that the claim is drawn
to a “rotary cutter deck” informs the meaning of the “torsional stiffness”
limitation—the claimed structure must possess sufficient stiffness to withstand the
torsional loads imposed by the operation of a rotary cutter.
703 F.3d 1349, 1358 (Fed. Cir. 2012).
Here, the body of the claim refers to “the upstream region” and “the downstream region,”
which have their antecedent basis in the preamble’s recital of “an upstream region” and “a
downstream region.” Importantly, these regions are recited in the preamble not in isolation but
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rather with reference to “a damaged heart valve having a plurality of cusps separating an upstream
region from a downstream region.” In turn, this phrase is intertwined with the recital of “[a]n
artificial valve for repairing a damaged heart valve. . . .” Thus, because “the claim drafter cho[se]
to use both the preamble and the body to define the subject matter of the claimed invention, the
invention so defined, and not some other, is the one the patent protects.” Bell Commc’ns Research,
Inc. v. Vitalink Commc’ns Corp., 55 F.3d 615, 620 (Fed. Cir. 1995).
The preamble of Claim 1 of the ’782 Patent is therefore limiting in its entirety. See Proveris
Scientific Corp. v. Innovasystems, Inc., 739 F.3d 1367, 1373 (Fed. Cir. 2014) (“The phrase ‘the
image data’ clearly derives antecedent basis from the ‘image data’ that is defined in greater detail
in the preamble as being ‘representative of at least one sequential set of images of a spray plume.’”)
(emphasis added).
Claims 10, 17, 18, and 30 of the ’782 Patent, as well as Claims 1 and 22 of the ’297 Patent,
are similar to above-discussed Claim 1 of the ’782 Patent for purposes of this dispute as to the
preambles. Claims 28 and 29 of the ’782 Patent and Claims 31 and 38 of the ’297 Patent are also
similar to above-discussed Claim 1 of the ’782 Patent with respect to those preambles’ recitals of
“[a]n artificial valve for repairing a damaged heart valve having a plurality of cusps separating an
upstream region from a downstream region.”10 Claims 17, 18, and 20 of the ’297 Patent are also
similar because the preambles of those claims refer to “an artificial valve as set forth in claim 1.”
The Court accordingly hereby finds that the preambles of Claims 1, 10, 17, 18, and 30 of
the ’782 Patent and the preambles of Claims 1 and 22 of the ’297 Patent are limiting.

10

Plaintiff does not appear to have argued that any other portions of the preambles of these claims are limiting. See
Dkt. 163 at 29–30. Although Plaintiff asserts in its reply brief that “the preambles as a whole are limiting,” Plaintiff
has not presented any specific arguments other than as to the above-discussed recitals of “a damaged heart valve
having a plurality of cusps.” For example, Plaintiff has not presented any argument as to the recitals of “an instrument
for inserting the artificial valve between the upstream region and the downstream region” in Claims 28 and 29 of the
’782 Patent.

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The Court also hereby finds that the preambles of Claims 28 and 29 of the ’782 Patent
and Claims 31 and 38 of the ’297 Patent are limiting as to the recitals of “[a]n artificial valve
for repairing a damaged heart valve having a plurality of cusps separating an upstream
region from a downstream region.”
The Court further hereby finds that the preambles of Claims 17, 18, and 20 of the ’297
Patent are limiting as to the recitals of “an artificial valve as set forth in claim 1.”
IV.

CONCLUSION

The Court adopts the constructions set forth in this opinion for the disputed terms of the
patents-in-suit. The parties are ordered that they may not refer, directly or indirectly, to each
other’s claim construction positions in the presence of the jury. Likewise, the parties are ordered
.

to refrain from mentioning any portion of this opinion, other than the actual definitions adopted by
the Court, in the presence of the jury. Any reference to claim construction proceedings is limited
to informing the jury of the definitions adopted by the Court.
It is SO ORDERED.
SIGNED this 27th day of October, 2017.
.

____________________________________
KIMBERLY C. PRIEST JOHNSON
UNITED STATES MAGISTRATE JUDGE

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