Colibri Heart Valve LLC

Patent Trials and Appeals Board

May 5, 2021

IPR2020-01453 (P.T.A.B. May. 5, 2021)

Trials@uspto.gov Paper: 13
571-272-7822 Date: May 5, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

MEDTRONIC COREVALVE LLC,
Petitioner,
v.
COLIBRI HEART VALVE LLC,

IPR2020-01453
Patent 8,900,294 B2

Before ERICA A. FRANKLIN, JAMES A. TARTAL, and
ERIC C. JESCHKE
FRANKLIN, Administrative Patent Judge.
DECISION
Denying Petitioner’s Request for Rehearing
37 C.F.R. § 42.71

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Patent 8,900,294 B2
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I. INTRODUCTION
Medtronic CoreValve LLC (“Petitioner”) requests a rehearing of the
Decision Denying Institution (“Decision”) of an inter partes review of
claims 1–4 of U.S. Patent No. 8,900,294 B2 (Ex. 1001, “the ’294 patent”)
entered on March 5, 2021 (Paper 11, “Dec.”). Paper 12 (“Reh’g Req.”).
In the Petition (Paper 2, “Pet.”) Petitioner raised the following
challenges to those claims:
Claims Challenged 35 U.S.C. § Reference(s)
1–4 103(a)1 Garrison2
1–4 103(a) Garrison, Leonhardt3
1–4 103(a) Garrison, Cox4
1–4 103(a) Garrison, Leonhardt, Cox
1–3 103(a) DiMatteo, Limon5
4 103(a) DiMatteo, Limon, Gabbay6
4 103(a) DiMatteo, Limon, Phelps7

1 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
Stat. 284, 287–88 (2011), amended 35 U.S.C. § 103, effective March 16,
2013. Because the application from which the ’294 patent issued has an
effective filing date prior to March 16, 2013, the pre-AIA version of § 103
applies.
2 Garrison et al., US 6,425,916 B1, issued Jul. 30, 2002 (“Garrison,”
Ex. 1005).
3 Leonhardt et al., US 5,957,949, issued Sept. 28, 1999 (“Leonhardt,”
Ex. 1006).
4 Cox, US 5,713,950, issued Feb. 3, 1998 (“Cox,” Ex. 1021).
5 Limon et al., US 6,077,295, issued Jun. 20, 2000 (“Limon,” Ex. 1008).
6 Gabbay, US 7,025,780 B2, issued Apr. 11, 2006 (“Gabbay,” Ex. 1009).
7 Phelps et al., WO 00/15147, published Mar. 23, 2000 (“Phelps,” Ex. 1010).
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As in the Decision, we refer to the first four grounds including
Garrison as the “Garrison grounds,” and the three grounds including
DiMatteo as the “DiMatteo grounds.” Petitioner also relied on the
Declaration of William J. Drasler, Ph.D. (Ex. 1002) for its patentability
challenges. Colibri Heart Valve LLC (“Patent Owner”) filed a Preliminary
Response to the Petition. Paper 6.
Upon consideration of the Petition, Preliminary Response, and
evidence of record, we determined that Petitioner failed to demonstrate a
reasonable likelihood that it would prevail in showing the unpatentability of
at least one challenged claim. Dec. 2. In the Rehearing Request, Petitioner
seeks a reconsideration of that determination. See Reh’g Req. 1.
II. DISCUSSION
“When rehearing a decision on petition, a panel will review the
decision for an abuse of discretion.” 37 C.F.R. § 42.71(c). “The burden of
showing a decision should be modified lies with the party challenging the
decision. The request must specifically identify all matters the party
believes the Board misapprehended or overlooked, and the place where each
matter was previously addressed in a motion, an opposition, or a reply.” Id.
§ 42.71(d). Because Petitioner has not met its burden, as discussed below,
the Rehearing Request is denied.
Independent claim 1 recites a method of controlled release of a
percutaneous replacement heart valve at a location of a native heart valve in
a patient. Ex. 1001, 13:38–14:37. The method comprises, in part, obtaining
a replacement heart valve device and a delivery and implantation system,
wherein the replacement heart valve device includes “a valve residing
entirely within an inner channel of the stent member and attached to a
proximal portion of the stent member.” Id. at 13:41–14:3. As in the
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Decision, we refer to the limitation requiring the valve to be “attached to a
proximal portion of the stent member” as the “attachment limitation.”
Dec. 13, 22. In the Decision, we determined that Petitioner failed to
demonstrate that the cited prior art teaches or suggests that attachment
limitation. In the following discussion, we address Petitioner’s rehearing
contentions regarding that determination for the Garrison grounds and the
DiMatteo grounds, in turn.
A. The Garrison Grounds
Petitioner asserts that the Decision “overlooks and does not address
Garrison’s Figures, which, as explained in the Petition and by Dr. Drasler,
teach that the valve is attached to a proximal portion from the perspective of
a POSITA [a person of ordinary skill in the art].” Reh’g Req. 10. Petitioner
argues in the Rehearing Request that Garrison’s Figures 9, 10, and 14 depict
to a POSITA that the valve is attached to the proximal end of posts 32. Id. at
12–13. Petitioner also refers to the testimony of Dr. Drasler that the valve is
attached to a proximal portion of the stent member because it is attached, by
suture, to posts 32. Id. (citing Ex. 1002 ¶¶ 70, 91–93). According to
Petitioner, “[r]egardless of whether Garrison separately discusses how the
valve is attached to posts 32, the Figures themselves demonstrate to a
POSITA that the limitation is met.” Id. at 14. Petitioner asserts further that
Garrison’s description of the valve’s base as being sutured to the stent does
not preclude the valve from also being attached to the posts 32. Id. at 14–15.
We disagree with Petitioner’s assertion that our Decision overlooks
and does not address Garrison’s Figures. Indeed, in the Decision we set
forth, describe, and discuss Garrison’s Figures 10 and 11, as well as
Petitioner’s first and second annotated versions of Garrison’s Figure 10,
Petitioner’s annotated version of Garrison’s Figure 11, and Petitioner’s
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annotated version of Garrison’s Figure 14. Dec. 11–16. In the Decision, we
also address Petitioner’s contention and Dr. Drasler’s testimony that
Garrison’s valve is attached to the post portion of the stent member. Id. at
17–20. In doing so, we noted in the Decision, as we do again here, that
Petitioner’s contention that the valve in Garrison’s Figure 10 is attached to
the post was based upon Petitioner’s assertion that Garrison disclosed that
the valve is sutured to the post. Id. at 14–15, 17–18; Pet. 29 (citing
Ex. 1005, 5:42–50). We did not find that assertion to be supported by
Garrison’s disclosure. The disclosure in Garrison referenced by Petitioner
states,
The posts 32 support a valve portion 38 which performs the
functions of the patient's malfunctioning native valve. Referring
to FIGS. 10 and 11, the valve portion 38 is preferably a stentless
tissue valve such as a tri-leaflet 39 45 stentless porcine valve.
The valve portion 38 has a base 41 which is secured to the
support structure 26 with sutures (not shown). The valve portion
38 may be stored separately from support structure 26 and
attached to the support structure 26 before the procedure.
Ex. 1005, 5:42–50 (emphasis added). As we explained in the Decision,
the disclosure in Garrison that Petitioner relies upon describes
only that the base of the valve is secured to the support
structure/stent with sutures.” Id. (citing Ex. 1005, 5:42–50)
(“The valve portion 38 has a base 41 which is secured to the
support structure 26 with sutures . . . .”). Garrison describes the
posts by merely stating, “[p]osts 32 support a valve portion 38.”
Id. at 5:42 (emphasis added). Critically missing in the Petition is
any showing by Petitioner that Garrison’s use of the term
“support” means “attach.” Petitioner does not even allege as
much. Instead, Petitioner mistakenly relies on Garrison as
disclosing that the valve is sutured to the posts of the support
structure. But, as may be plainly seen in the disclosure relied
upon by Petitioner that is not the case.
Dec. 17–18.
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Similarly, we addressed Dr. Drasler’s opinion that the valve portion in
Garrison is attached to the posts. Id. at 17 (citing Ex. 1002 ¶ 92). The
rationale that Dr. Drasler provides for his opinion that the valve is attached
to, and not merely supported by, the posts is his assertion that, “[a]s
illustrated in Figures 10-11 and 14, the valve portion (annotated in blue) is
supported by the posts via sutures (not shown) described as used to secure
the valve to the support structure (Garrison 5:42–47) at the proximal portion
of the supporting structure (annotated in red).” Ex. 1002 ¶ 92. Thus,
Dr. Drasler relies not on what is shown in Garrison’s figures, but in his
mistaken belief that the quoted language from Garrison set forth above
describes that the valve is secured to the posts via sutures. Id. (citing Ex.
1005, 5:42–47). As we discuss above, and in the Decision, Garrison does
not describe the valve being secured to the posts via sutures, or by any other
means. Dec. 17–18.
B. The DiMatteo Grounds
Petitioner does not dispute our determination that it failed to show
sufficiently for institution that DiMatteo discloses a replacement heart valve
attached to a proximal portion of the stent member. Dec. 25; see Reh’g Req.
5–6. Rather, Petitioner contends that we erred in determining that Petitioner
did not adequately explain why a POSITA would have been motivated to
modify DiMatteo’s valve/stent configuration to attach the valve to the
proximal portion of the stent instead of maintaining the attachment at what
DiMatteo depicts as a more central portion of the stent. Reh’g Req. 6.
To begin, Petitioner asserts that “the Decision erred as a matter of law
in requiring Petitioner to demonstrate that the benefits of attachment to the
proximal portion must be ‘unique’ relative to the other options.” Id. (citing
Dec. 25–26). We disagree as that argument mischaracterizes the Decision.
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In the Decision, we considered Petitioner’s and Dr. Drasler’s position that a
skilled artisan would have been motivated to attach DiMatteo’s valve to the
stent’s proximal portion. Dec. 25. According to Petitioner and Dr. Drasler,
a POSITA would have made that modification “to implant the valve in the
direction of desired fluid flow for delivery via certain paths,” and “to
achieve the advantageous result of more easily recovering the valve/stent
after partial deployment—otherwise the bulkier portion with the valve would
be deployed first.” Pet. 49–50 (citing Ex. 1002 ¶¶ 166–168). That was the
extent of Petitioner’s discussion in the Petition regarding a motivation for
modifying DiMatteo’s valve/stent configuration.
Upon considering that asserted basis for the proposed modification of
DiMatteo, we explained that such alleged motivation was inadequately
explained. Dec. 25. Our statement that Petitioner and Dr. Drasler “have not
explained why attaching the valve to the proximal portion of the stent, as
opposed to a central portion, would uniquely allow implantation of the valve
in the direction of desired fluid flow or provide the advantage of an easy
recovery of the device,” was not an application of some heightened standard
for obviousness motivation. Id. at 25–26. Rather, it was a finding focused
on the rationale relied upon by Petitioner and Dr. Drasler for modifying
DiMatteo, i.e., to obtain an advantage or benefit from doing so. Thus, it is
misleading for Petitioner to allege that the Board erred in requiring
Petitioner to demonstrate the benefits of attaching the valve to the proximal
portion of the stent, as our analysis focused on the rationale that Petitioner
relied on for its proposed obviousness modification.
Further, Petitioner asserts that the Board overlooked and did not
address Petitioner’s and Dr. Drasler’s explanation of how attaching the valve
to the stent’s proximal portion advantageously facilitates an easier recovery
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Patent 8,900,294 B2
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of the valve/stent after partial deployment, i.e., “otherwise the bulkier
portion with the valve would be deployed first.” Reh’g. Req. 8–9. We
disagree. The explanation in the Petition that Petitioner asserts we
overlooked is limited to Petitioner’s assertion that “a POSITA would have
been motivated to attach the valve to the stent’s proximal portion to achieve
the advantageous result of more easily recovering the valve/stent after partial
deployment—otherwise the bulkier portion with the valve would be
deployed first.” Pet. 50 (citing Ex. 1002 ¶ 168).
As Petitioner acknowledges in the Rehearing Request, that “full
passage from the Petition is cited in the Decision’s summary of Petitioner’s
arguments.” Reh’g. Req. 10 (citing Dec. 23). Yet, Petitioner takes issue
with how we referred back to that statement subsequently in our Decision by
quoting only a portion of it and using an ellipses for the end of the passage.
Id. (citing Dec. 25). That manner of referring to Petitioner’s assertion does
not demonstrate that we overlooked Petitioner’s assertion that “the bulkier
portion with the valve would be deployed first,” which we expressly quoted
earlier. Nor does it demonstrate that we erred in determining that Petitioner
and Dr. Drasler failed to adequately support that contention for institution.
For additional clarity, we note here that it is unclear what Petitioner
and Dr. Drasler meant by their statement in the Petition that “otherwise the
bulkier portion with the valve would be deployed first.” Pet. 50. The term
“first” is a relative term that remains undefined in the Petition and
Dr. Drasler’s testimony. Dr. Drasler’s testimony that “with the non-valve
end of the stent partially deployed, the operator could confirm the accuracy
of the placement of the prosthesis, and recover the valve/stent if needed for
repositioning,” Ex. 1002 ¶168, appeared to be based on an assumption that
the only alternative to a proximal valve/stent attachment is a distal
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valve/stent attachment. However, as we discuss in the Decision, “DiMatteo
does not refer to proximal and distal halves of its stent.” Dec. 25. Rather,
DiMatteo’s stent may be considered to have a central portion between the
proximal and distal portions. Id. And DiMatteo’s figures appears to depict
the valve attachment at a more central portion of the stent. See id.; Ex. 1007,
Figs. 19–20. Thus, Petitioner and Dr. Drasler’s explanation for why
attaching the valve to the stent’s proximal portion achieves “the
advantageous result of more easily recovering the valve/stent after partial
deployment—otherwise the bulkier portion with the valve would be
deployed first,” Pet. 50, was insufficient and unpersuasive for institution, see
Dec. 25 (“Petitioner and Dr. Drasler, however, have not adequately
explained or supported such alleged motivation.”).

III. CONCLUSION
Because Petitioner has not demonstrated that we misapprehended or
overlooked matters raised in the Petition, we conclude Petitioner has not
shown that the Board abused its discretion in denying institution of the
challenged claims. See 37 C.F.R. § 42.71(d).

IV. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that Petitioner’s Request for Rehearing is denied.

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For PETITIONER:

James L. Davis, Jr.
James.l.davis@ropesgray.com

Scott McKeown
Scott.mckeown@ropesgray.com

Cassandra Roth
Cassandra.roth@ropesgray.com

For PATENT OWNER:

Sarah Spires
sspires@skkiermontderby.com