Ex Parte 7789909 et al

Patent Trial and Appeal Board

Jul 30, 2014

95001615 (P.T.A.B. Jul. 30, 2014)

UNITED STATES PATENT AND TRADEMARKOFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
95/001,615 06/13/2011 7789909 1737.407REX0 4324
30452 7590 07/31/2014
EDWARDS LIFESCIENCES CORPORATION
LEGAL DEPARTMENT
ONE EDWARDS WAY
IRVINE, CA 92614
EXAMINER
WILLIAMS, CATHERINE SERKE
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
07/31/2014 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

MEDTRONIC, INC.
Requester, Respondent

v.

EDWARDS LIFESCIENCES AG1
Patent Owner, Appellant
____________________

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Technology Center 3900
____________________

Before STEVEN D.A. McCARTHY, DANIEL S. SONG and
BRETT C. MARTIN, Administrative Patent Judges.

SONG, Administrative Patent Judge

DECISION ON APPEAL

Claim 3 of the '909 patent is subject to reexamination and stands
rejected (Right of Appeal Notice3 (hereinafter "RAN") 1). Remaining
claims 1, 2 and 4-20 of the '909 patent have been cancelled (id.). The

1 Edwards Lifesciences AG is the Patent Owner and the real party in interest
(Appeal Brief of Patent Owner (hereinafter "App. Br.") 1).
2 Patent US 7,789,909 B2 (hereinafter "the '909 patent") issued September 7,
2010 to Andersen et al.
3 The Examiner's Answer incorporates the RAN by reference. Hence, we
cite to the RAN herein.
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Patent Owner appeals under 35 U.S.C. §§ 134(b) and 315 from the
Examiner's rejections (App. Br. 4). We have jurisdiction under 35 U.S.C.
§§ 134(b) and 315.
In addition to its Appeal Brief and Rebuttal Brief (hereinafter "Reb.
Br."), the Patent Owner also relies on the declaration of Mr. Anthony C.
Lunn. The Requester relies on its Respondent Brief (hereinafter "Resp.
Br.") as well as the declarations of Mr. Jeffrey W. Allen and the declaration
of Mr. John C. Hay.
We AFFIRM the Examiner's rejections.

The '909 patent is directed to a system for implanting a valve
prosthesis (Abstract). Claim 3 depends from canceled claim 2, which
depends from canceled independent claim 1. Claim 3, incorporating the
language of claims 1 and 2, reads as follows (Claims App'x, italics added):
3. (Original) [The system of claim 2,] A system for replacing
the function of a natural heart valve in a human body by a
catheterization technique, comprising:
an elongate catheter having an opening configured for
receiving a guide wire, the catheter sized for advancement into
a human heart without opening the thoracic cavity;
a self-expandable stent constructed to be radially
compressible and re-expandable, the stent having a top end, a
bottom end and a metallic outer surface configured to contact
native tissue in the human heart; and
a collapsible and re-expandable elastical valve
comprising three flaps formed of biological tissue, the elastical
valve attached to an interior portion of the stent for folding and
expanding together with the stent, the elastical valve located
between the top and bottom ends of the stent, the elastical valve
having three commissural points sutured to the stent, the
elastical valve configured to allow blood to flow in one
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direction such that blood is capable of flowing through the stent
from the bottom end toward the top end;
wherein the stent and elastical valve are radially
compressible from an expanded condition to a compressed
condition for advancement through a small inlet opening into a
body channel, the stent having a compressed outer diameter of
10 mm or less for placement inside a tubular wall of a cap along
a distal end portion of the catheter and wherein the stent is
radially self-expandable upon ejection from the cap to a re-
expanded condition comprising a re-expanded outer diameter
of approximately 27 mm or more such that at least a portion of
the stent contacts native tissue in the human heart for securing
the stent in the human heart without suturing the stent to native
tissue, the stent configured for supporting the elastical valve in
the human heart for replacing the function of a natural aortic
valve without open heart surgery and wherein the catheter is
detachable from the stent and elastical valve such that the
catheter can be removed from the human body and the small
inlet opening can be closed such that the patient can resume a
substantially normal life[.];
[2. (Canceled) The system of claim 1,] wherein the stent is
configured to re-expand along an entire length of the stent[.];
wherein the elastical valve is sized to be positioned in the
human heart between the coronary ostia and the left ventricle
for replacing the function of the natural aortic valve.

Claim 3 stands rejected under 35 U.S.C. § 102(b) as anticipated by:
1. WO 01/49213 A2 to Bailey, published July 12, 2001
(hereinafter "Bailey"); and
2. WO 91/17720 to Andersen, published November 28, 1991
(hereinafter "Andersen").
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ISSUE
The dispositive issue raised in the appeal is whether the '909 patent is
entitled to the benefit of earlier filed U.S. patent applications listed on the
face of the '909 patent; and priority to the Danish application number
1246/90 (collectively the “prior filed applications”).

PRINCIPLES OF LAW
Under 35 U.S.C. § 120, an application for patent is entitled to a claim
for priority, or "benefit," of an earlier filed patent application when the
claimed invention is disclosed in the previously filed application in the
manner provided by 35 U.S.C. § 112. See 35 U.S.C. § 120 (2010).
35 U.S.C. § 112 states:
The specification shall contain a written description of the
invention, and of the manner and process of making and using
it, in such full, clear, concise, and exact terms as to enable any
person skilled in the art to which it pertains, or with which it is
most nearly connected, to make and use the same . . . .
35 U.S.C. § 112 (2010).
The "test for sufficiency [under § 112] is whether the disclosure of the
application relied upon reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date."
Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir.
2010) (en banc); see also Noelle v. Lederman, 355 F.3d 1343, 1348 (Fed.
Cir. 2004) ("the test to determine if an application is to receive the benefit of
an earlier filed application is whether a person of ordinary skill in the art
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would recognize that the applicant possessed what is claimed in the later
filed application as of the filing date of the earlier filed application.").
"[I]t is the specification itself that must demonstrate possession. And
while the description requirement does not demand any particular form of
disclosure, . . . or that the specification recite the claimed invention in haec
verba, a description that merely renders the invention obvious does not
satisfy the requirement." Ariad Pharm. v. Eli Lilly, 598 F.3d at 1352
(citations omitted). Further, compliance with the written description
requirement is a question of fact, which must be resolved on a case-by-case
basis. See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir.
1991).

ANALYSIS
The Patent Owner does not dispute that Bailey and Andersen disclose
each and every limitation of claim 3. Rather, the Patent Owner argues that
the '909 patent is entitled to the May 18, 1990 priority date based on the
prior filed applications4 so that neither Bailey nor Andersen is prior art and
the rejections are improper (App. Br. 4, 20).

4 As to the prior filed applications, the Patent Owner states:
Each of the parent U.S. applications, the Danish priority
application, and the Andersen PCT share the same written
description with the exception of the 'Cross-Reference to
Related Applications' section added to the U.S. applications.
Thus, for the convenience of the Board, this brief cites to
portions of the Andersen PCT application to show written
description and enablement in the priority documents.
(App. Br. 5, fn.1).
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The Examiner finds that claim 3 is "not entitled to benefit of the prior
filed applications and are not entitled to claim priority before October 10,
2002" so that both Bailey and Andersen are prior art (RAN 5, 7). In
particular, the Examiner finds that:
The priority benefit is not being afforded to the claims
under reexamination because the earlier filed US applications
do not meet the written description and enablement
requirements of 35 USC 112 first paragraph in order to satisfy
35 U.S.C. 120. The earlier US filed applications do not
"convey to one skilled in the art that the inventor had
possession at that time of the later claimed subject matter". See
MPEP § 2163.02. Furthermore, one reasonably skilled in the
art could not have made or used the invention from the
disclosures in the earlier filed applications coupled with
information known in the art without undue experimentation.
See MPEP § 2164.01.
(RAN 10).
Specifically, the Examiner finds that the prior filed applications5 lack
written description and enabling disclosure for the limitations reciting that
the stent has "a compressed outer diameter of 10 mm or less" and "a re-
expanded outer diameter of approximately 27 mm or more" now recited in
claim 3 of the '909 patent (RAN 12, 17).

5 The Examiner makes clear that:
no rejections under 35 USC 112 first paragraph are being
adopted or made by the examiner. The scope of
reexamination does not include 35 USC 112 determinations
of the claims. The written description and enablement
requirements of 35 USC 112 are only being addressed with
regard to the earlier filed US application specification in order
to determine if the earlier filed application specification
satisfies the requirements of 35 USC 120.
(RAN 10-11, emphasis in original).
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Written Description Issue
The Patent Owner asserts that "[t]he recited ranges of compression to
10 mm or less and re-expansion to 27 mm or more are not open-ended but
rather are strictly limited by the anatomy of the human body." (App. Br. 6).
According to the Patent Owner, "one skilled in the art would have
understood the practical limitation on the ranges for the compressed and re-
expanded diameters necessary for delivering and implanting a valve
prosthesis at the location recited in claim 3." (App. Br. 7).
The Examiner disagrees and finds that compression to a specific range
and re-expansion to a specific range as asserted by the Patent Owner are not
disclosed. The Examiner finds that:
The lower and upper limits as offered by patent owner, is at
most a possibility one skilled in the art may achieve from
knowledge of human anatomy but is not necessarily present. . . .
In fact, patent owner's arguments and the knowledge of one
skilled in the art lend more to establishing the minimum
compression and minimum expansion needed for the prosthesis
to be deployed and function within the human anatomy rather
than establishing a defined limit to the claimed open ended
compression and expansion.
(RAN 12).
We agree with the Examiner and address the Patent Owner's
arguments infra.

10 mm or Less
The Patent Owner asserts that the limitation "10 mm or less" is not
open-ended but rather "under a proper interpretation, . . . requires
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compression to the range of about 10 mm to about 6 mm" (App. Br. 12) and
that the claim does not encompass smaller compression diameters such as 4
mm (App. Br. 10). The Patent Owner argues that when a person of ordinary
skill considers the recited use of a catheterization technique, design
constraints, and knowledge that "the diameters of the common femoral
arteries" range from 7.8 to 12 mm for adults, such a person of ordinary skill
"would not have interpreted the claimed valve prosthesis to be compressible
to a minimum catheter size as that would create unnecessary complications"
(App. Br. 9-10, citing Horejs et al., "Normal Aortoiliac Diameters by CT,"
12(4) J. Computer Assisted Tomography 602, 602-603, Tables 1-2 (1988)).
Such complications are said to include damaging the valve tissue or
impairing post-deployment function (App. Br. 11-12).
However, we agree with the Examiner's finding that "the prior
disclosures do not limit the body channel through which the catheter and
compressed prosthesis are inserted." (RAN 13). As the Examiner finds,
nothing limits the claims to catheterization through the femoral artery, and
"one skilled in the art would understand that insertion routes other than the
femoral artery are possible for carrying out the invention." (Id.).
In the above regard, as the Requester argued in rebuttal to the Patent
Owner's assertions, claim 3 "does not include a limitation that the valve
prosthesis is compressible to a size suitable for a transfemoral approach, and
no smaller," and is not limited to the femoral artery, but instead, "simply
uses the term body channel." (Resp. Br. 4). As also noted by the Requester,
"the specification itself never identifies any specific access vessel, such as
the femoral artery" (id.) and the Patent Owner does not persuasively dispute
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the Requester's assertion that there are other vessels such as the brachial
artery, which has a diameter ranging from 4.11 mm to 5.30 mm, such vessels
requiring compression of the valve prostheses to a diameter of about 4 mm
which is less than 6 mm (id. at 6).
The Patent Owner argues that the two prior art references noted in the
Background sections of the prior filings disclose inserting the valve
prosthesis through the femoral artery (App. Br. 10; see also Reb. Br. 3).
According to the Patent Owner, "there is no need to provide support for
other delivery techniques that are not outlined in the patent specification."
(App. Br. 11). While those noted prior art references may disclose delivery
through the femoral artery, that does not mean that a person of ordinary skill
in the art would view the prior filings as disclosing that the femoral artery
must be used to deliver the prosthesis at the exclusion of other vessels that
may be smaller, especially considering that "femoral artery" is not explicitly
mentioned in the specifications of the prior filings.
We also agree with the Examiner's further position that "one skilled in
the art would have understood that an even smaller compression would still
meet the functional requirements of the claim" requiring installation by
catheterization (RAN 13). As explained by the Examiner:
While patent owner argues that anatomical dimensions
would place a limit on the compression, this argument is
flawed. The inner diameter of the femoral artery would instead
guide one skilled in the art as to the upper bounds of
compression needed in order to traverse the prosthesis through
the artery to the deployment site. Accordingly one must design
the stent to compress to a smaller diameter than the inner
diameter of the artery. This anatomical dimension, i.e. design
constraint, actually provides the upper boundary regarding the
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compression and not the lower boundary. Anything able to
compresses to a smaller diameter would work; anything
compressed to a larger diameter will not. Therefore, patent
owner has not provided any disclosure or knowledge in the art
that would lead one skilled in the art to understand at what
point "or less" has been reached and diameters below 6mm are
encompassed by the open ended claimed range of "10mm or
less".
(RAN 16).
While the Patent Owner asserts that damage to the valve tissue would
occur when compressed under 6 mm and that the prosthesis would be
inoperable, these assertions do not appear to be supported by persuasive
objective evidence (see also Resp. Br. 6).

27 mm or More
The Patent Owner also asserts that the limitation "27 mm or more" is
not open-ended, but "requires re-expansion to a range of about 27mm to
about 33 mm" because of the recited position, and thus, does not encompass
larger re-expansion diameters (App. Br. 15). The Patent Owner asserts that
"[t]he anatomical dimension of a human's heart in the region between the
coronary ostia and the left ventricle" was well known to one of ordinary skill
in the art and that it was also well known that "the annulus of an aortic valve
in an adult human ranges from 24 to 33 mm with a mean of 26.4 mm." (Id.
at 7, 13, citing Decl. of Lunn ¶ 32). The Patent Owner asserts that
"[a]ccordingly, the maximum re-expanded outer diameter of the valve
prosthesis recited in claim 3 would be about 33 mm" which is "only about 3
mm bigger than the working example disclosed." (Id. at 13-14).
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However, as found by the Examiner, "[i]f anything, human anatomy
merely provides the smallest expansion required in order to fill the inner
diameter of the aorta." (RAN 13). As explained by the Examiner, such
teachings establish the minimum re-expansion size instead of a maximum
re-expansion size, and a stent that is capable of expanding beyond the known
anatomical dimensions of the aorta, "even the specific region as claimed,
would expand to fill the aorta in that region and function as claimed." (Id. at
13-14). Hence, we again agree with the Examiner's finding that claim 3
does not preclude the stent from having such re-expansion capability, even if
the stent is not fully re-expanded during use within the aorta (id. at 15-16).
The Patent Owner also argues that "[a] valve prosthesis designed for a
33 mm annulus cannot be expanded to 40 mm because it would destroy the
elastical valve mounted inside and the prosthesis would fail to function
properly." (App. Br. 15). However, claim 3 does not limit the installation to
"the annulus of an aortic valve in an adult human" (id. at 13). Instead, the
claim merely recites that "at least a portion of the stent contacts native tissue
in the human heart" and that the elastical valve is "positioned in the human
heart between the coronary ostia and the left ventricle." As pointed out by
the Requester in rebuttal to the Patent Owner's assertions, "[c]laim 3 does
not recite that the stent contacts the native tissue between the coronary ostia
and the left ventricle," but "merely describes the intended position of the
valve, not the engagement point of the stent." (Resp. Br. 7, citing Decl. of
Hay ¶ 10). The Patent Owner does not persuasively dispute the Requester's
assertion that "a valve can be positioned between the coronary ostia and the
left ventricle without the stent engaging the anatomy between the coronary
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ostia and the left ventricle," and because the recited area is not limited to the
aortic annulus, it also includes the aortic root, which has a diameter as large
as 47 mm (id. at 7, 8).
The Patent Owner points out that prior filings state that "it is obvious
to modify the valve prosthesis depending on the desired use" so that there is
support for different sizes and it was not necessary to disclose every possible
size "since anatomical dimensions were well-known." (App. Br. 16).
However, vague statements as to obviousness of modifying the valve
prostheses do not establish possession of the invention now claimed. Ariad
Pharm. v. Eli Lilly, 598 F.3d at 1351. In addition, a description that merely
renders the invention obvious does not satisfy the written description
requirement. Id. at 1352.
The Patent Owner also noted that "[t]he '909 patent in reexamination
is expired" and, thus, the Board should "construe the claims by giving more
weight to the prosecution history than provided for under the broadest
reasonable interpretation standard." (App. Br. 5, citing SAP America Inc. v.
Versata Development Group Inc., 107 USPQ 2d 1097, fn.6 (PTAB 2013)).
In this regard, the Patent Owner points out that the original examiner did not
reject claim 3 under 35 U.S.C. § 112, first paragraph, and that it is the Patent
Office's policy to give full faith and credit to the action of a previous
examiner unless there is a clear error in the previous action (id. at 5, citing
MPEP § 706.04).
However, issues raised in the appeal are not with respect to the '909
patent's compliance with 35 U.S.C. § 112, but rather, whether there is
adequate written descriptive support in the prior applications to establish that
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claim 3 is entitled to the asserted benefit and priority. In view of the above,
we find that claim 3 of the '909 patent is not entitled to the asserted benefit
and priority because the earlier filings lack sufficient written description to
demonstrate possession of the subject matter of claim 3.

Enablement Issue
The Examiner also finds that "the priority application fails to provide
enablement for the open ended claim range of '10mm or less' and
'approximately 27mm or more'." (RAN 17-18). In this regard, the Examiner
finds that the claim ranges include "dimensions that are inoperable" and
require undue experimentation to "ascertain the workable limit of the open
ended claim ranges." (Id. at 18-19). The Patent Owner submits arguments
disputing the Examiner's findings (App. Br. 17-18).
Because we find that claim 3 of the '909 patent is not entitled to the
asserted benefit and priority due to lack of sufficient written description in
the earlier filings, it is unnecessary to reach the enablement issue.

CONCLUSION
The Examiner's rejections of claim 3 are AFFIRMED.

Requests for extensions of time in this inter partes reexamination
proceeding are governed by 37 C.F.R. § 1.956. In the event neither party
files a request for rehearing within the time provided in 37 C.F.R. § 41.79,
and this decision becomes final and appealable under 37 C.F.R. § 41.81, a
party seeking judicial review must timely serve notice on the Director of the
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United States Patent and Trademark Office. See 37 C.F.R. §§ 90.1 and
1.983.

AFFIRMED

peb

PATENT OWNER:

EDWARDS LIFESCIENCES CORPORATION
Legal Department
One Edwards Way
Irvine, CA 92614

THIRD PARTY REQUESTOR:

MEDTRONIC CARDIOVASCULAR
c/o IP Legal Dept.
3576 Unocal Place
Santa Rosa, CA 95403