Ex Parte Salahieh et al

Patent Trial and Appeal Board

May 31, 2017

13290369 (P.T.A.B. May. 31, 2017)

United States Patent and Trademark Office
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.
13/290,369 11/07/2011 Amr Salahieh 2001.1545102 3084
11050 7590 06/02/2017
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
GANESAN, SUBA
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
06/02/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AMR SALAHIEH, BRIAN D. BRANDT,
ROBERT A. GESHLIDER, DWIGHT P. MOREJOHN, and TOM SAUL
Appeal 2015-005776
Application 13/290,369
Technology Center 3700
Before STEFAN STAICOVICI, WILLIAM A. CAPP, and
SEAN P. O’HANLON, Administrative Patent Judges.
O’HANLON, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Amr Salahieh et al. (Appellants)1 appeal under 35 U.S.C. § 134 from
the Examiner’s April 25, 2014 final decision rejecting claims 1—15. We
have jurisdiction over this appeal under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 According to Appellants, the real party in interest is Sadra Medical, Inc., a
subsidiary of Boston Scientific Corporation. Appeal Br. 2.
Appeal 2015-005776
Application 13/290,369
SUMMARY OF THE INVENTION
Appellants’ disclosure is directed to “methods and apparatus for
endovascularly replacing a heart valve with a replacement valve using an
expandable and retrievable anchor.” Spec. 12. Claim 1, reproduced below
from page 25 (Claims Appendix) of the Appeal Brief, is illustrative of the
claimed subject matter:
1. An apparatus for endovascularly replacing a patient’s
heart valve, the apparatus comprising:
an expandable anchor supporting a replacement valve;
a delivery catheter adapted to deliver the anchor and
replacement valve to a vicinity of the heart, and
an anchor actuation element reversibly coupled to a
proximal end of the anchor and adapted to apply a distally-
directed force on the proximal end of the anchor;
wherein the anchor and replacement valve are adapted
for percutaneous delivery and deployment to replace the
patient’s heart valve, wherein the anchor and the replacement
valve are further adapted to permit blood flow through the
replacement valve and to prevent blood backflow through the
replacement valve after the replacement valve at least partially
exits the catheter and before the anchor completely exits the
catheter.
REJECTIONS
Claim 15 stands rejected under 35U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement.
Claims 1—10 and 13 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Leonhardt (US 5,957,949, iss. Sept. 28, 1999) and
De Paulis (US 6,352,554 B2, iss. Mar. 5, 2002).
2
Appeal 2015-005776
Application 13/290,369
Claims 14 and 15 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Leonhardt, De Paulis, and Pease (US 2003/0055495 Al,
pub. Mar. 20, 2003).
Claims 1, 2, 5, 6, and 11—15 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Beyersdorf (US 2002/0193871 Al, pub. Dec. 19,
2002) and Gabbay (US 2002/0032481 Al, pub. Mar. 14, 2002).
ANALYSIS
Written Description Rejection
The Examiner finds that claim 15 fails to satisfy the written
description requirement because although “[t]he [Specification describes
proximal anchor actuation elements that do not extend through a center
opening (e.g., para. 39),” “[t]he [Specification does not describe an anchor
actuation element that both 1) is reversibly coupled to a distal end of the
anchor and 2) does not extend through a center opening of the replacement
valve.” Final Act. 6; see also Ans. 9.
“The test for determining compliance with the written description
requirement is whether the disclosure of the application as originally filed
reasonably conveys to the artisan that the inventor had possession at that
time of the later claimed subject matter, rather than the presence or absence
of literal support in the specification for the claim language.” In re Kaslow,
707 F.2d 1366, 1375 (Fed. Cir. 1983). Based on our review, we agree with
Appellants that the Specification, as originally filed, provides the required
support for the claim recitations under discussion. Appeal Br. 6—10. More
specifically, we note, for example, that the Specification describes, and,
thus, shows Appellants’ possession of: posts 32 being part of anchor 30 and
3
Appeal 2015-005776
Application 13/290,369
being attached to the distal end of anchor 30 (Spec. 33, 35); control wires
112 being anchor actuation elements and being reversibly coupled to posts
32 {id. 33, 39); and control wires 112 being part of the deployment
system, with no part of the deployment system passing through a center
opening of the replacement valve {id. H 39 40).
Accordingly, we do not sustain the rejection of claim 15 as failing to
comply with the written description requirement.
Obviousness Based on Leonhardt and De Paulis
We note that the Examiner relies on De Paulis only regarding claim 8,
and relies on Leonhardt alone regarding claims 1—7, 9, 10, and 13. See Final
Act. 7—9. The Examiner finds that Leonhardt discloses an apparatus
substantially as recited in independent claim 1, including, inter alia, an
expandable anchor (stent 26),2 which supports a replacement valve (valve
22), a delivery catheter (sheath 106), and an anchor actuation element (push
rod 112 and suture loops 174) reversibly coupled to a proximal end of the
anchor. Id. at 7. According to the Examiner, “the push rod actuates the
valve by providing a stationary force on the valve while the sheath is
withdrawn.” Id. at 3; see also Ans. 10. The Examiner further finds that
“Leonhardt discloses that the anchor and the replacement valve are
monitored for proper function and patency . . . after the replacement valve at
least partially exits the catheter . . . and before the anchor completely exits
the catheter.” Final Act. 7 (citing Leonhardt, 10:53—60, 11:23—36, 11:37—
12:16, Fig. 9A). The Examiner reasons:
2 Parentheticals refer to the terminology of the cited references.
4
Appeal 2015-005776
Application 13/290,369
Because permitting blood flow through the replacement valve
and preventing blood backflow through the replacement valve
are obvious characteristics of “proper function and patency” of
a heart valve, it would have been obvious (if not inherent) to
one of ordinary skill in the art at the time the invention was
made to have utilized the invention of Leonhardt to specifically
permit blood flow and prevent blood backflow while
monitoring the prosthetic valve’s function and patency.
Id. at 7—8. The Examiner further reasons that “[t]his would have occurred
using known methods and would have yielded predictable results to a person
of ordinary skill in the art at the time the invention was made.” Id. at 8.
Appellants traverse, first arguing that “[t]he Examiner erroneously
equated Leonhardt’s push rod 112 and suture loops 174 to the presently
recited anchor actuation elements” because neither the push rod nor the
suture loops actuate Leonhardt’s valve stent. Appeal Br. 10-12. Rather,
according to Appellants, “Leonhardt discloses a valve stent 20 that is self-
actuating and may be further actuated by expansion of expansion balloon
154.” Id. at 12 (citing Leonhardt, 10:55—11:9, Lig. 9B). Appellants further
allege error in the Examiner’s determination that Leonhardt’s push rod
actuates the valve despite the fact that the push rod remains stationary (while
the sheath is withdrawn). Id. at 13; see also Reply Br. 3^4.
We are not persuaded by Appellants’ arguments. Initially, we note
that claim 1 requires the anchor actuation element be “adapted to apply a
distally-directed force on the proximal end of the anchor,” but claim 1 does
not require that the anchor actuation element otherwise be adapted to interact
with the anchor. Appeal Br. 25 (Claims App.). Thus, Appellants’
arguments regarding actuation of the anchor are not commensurate in scope
with claim 1, and, therefore, are unpersuasive. To the extent Appellants
5
Appeal 2015-005776
Application 13/290,369
argue that the recited anchor actuation element must actively foreshorten the
anchor (see id. at 15), this argument is also not commensurate in scope with
claim 1.
We further note that Appellants identify “fingers, tubes, [and] posts”
as being examples of anchor actuation elements. Spec. 139. Appellants
have failed to persuasively explain why Leonhardf s push rod, which
appears to be equivalent to a finger, tube, or post, does not also qualify as an
anchor actuation element.
Regarding Appellants’ assertion that construing Leonhardf s
stationary push rod as an actuation element “remove[s] all meaning from
‘actuation’” (Appeal Br. 13), Appellants do not direct us to, nor do we find,
any indication in the Specification that the claim term “actuation” was used
outside of its ordinary meaning. If a divergent specialized usage were
intended, such a meaning was required to be clearly explained in the
Specification. See Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582
(Fed. Cir. 1996) (“[A] patentee may choose to be his own lexicographer and
use terms in a manner other than their ordinary meaning, as long as the
special definition of the term is clearly stated in the patent specification or
file history.”). Thus, we construe “actuation” according to its ordinary and
customary meaning.
We note that one dictionary defines “actuation” as “to put into
mechanical action or motion.” (See, e.g., http://www.merriam-
webster.com/dictionary/actuation (last visited May 22, 2017)). As correctly
note by the Examiner, Leonhardf s push rod exerts a distally-directed force
on the proximal end of valve stent 20 by virtue of its remaining stationary—
6
Appeal 2015-005776
Application 13/290,369
and maintaining valve stent 20 stationary—while sheath 106 is withdrawn.
See, e.g., Final Act. 2—3; Leonhardt 8:23—27, 10:53—58, 11:10-15. Thus,
Leonhardt’s push rod causes the valve stent to be put into mechanical action
or motion (self-expansion), and, thus, actuates the valve stent. As such,
Leonhardt’s push rod corresponds to the recited anchor actuation element.
Appellants’ arguments fail to apprise us of error.
Appellants also argue that “[t]he Examiner’s interpretation of
Leonhardt is contrary to the apparent teachings of Leonhardt’s figures,”
asserting that because “no push rod [is] shown in Figs. 9B, 9C, and 9D,”
Leonhardt’s push rod is “apparently withdrawn” after the outer sheath 106 is
withdrawn from the distal end of valve stent 20. Appeal Br. 14 (emphasis
omitted). This argument is unpersuasive in view of Leonhardt’s written
description. See, e.g., Leonhardt 11:10—15.
Accordingly, for the foregoing reasons, we sustain the rejection of
claim 1, and of its dependent claims 2—10 and 13, which Appellants do not
argue separately, as being unpatentable over Leonhardt and De Paulis.
Obviousness Based on Leonhardt, De Paulis, and Pease
With respect to the rejection of claims 14 and 15, which depend from
claim 1, Appellants rely on the arguments presented above in regard to the
rejection of claim 1, and assert that Pease does not remedy the alleged
shortcomings of Leonhardt and De Paulis. Appeal Br. 16. Accordingly, for
the same reasons as discussed above, we also sustain the rejection of claims
14 and 15 as being unpatentable over Leonhardt, De Paulis, and Pease.
7
Appeal 2015-005776
Application 13/290,369
Obviousness Based on Beyersdorf and Gabbay
The Examiner finds that Beyersdorf discloses an apparatus
substantially as recited in claim 1, including, inter alia, an expandable
anchor (anchoring element 100), which supports a replacement valve, and a
delivery catheter, but does not disclose an anchor actuation element or an
intermediate valve deployment stage. Final Act. 10—11. The Examiner
reasons that “it is fully expected that the [Beyersdorf] catheter system used
to deploy the valve stent includes some form of push mechanism to either
eject the stent or to maintain the stent stability while a sheath is withdrawn,
as this is a usual and typical means of prosthesis delivery.” Id.
Alternatively, the Examiner finds that Gabbay teaches an anchor actuation
element (plunger mechanism 210) reversibly coupled to a proximal end of
an anchor and adapted to apply a distally-directed force on the proximal end
of the anchor, and reasons that it would have been obvious to one of
ordinary skill to use Gabbay’s anchor actuation element to deploy
Beyersdorf s stent “as an obvious expedient,” which “would have occurred
using well known methods and would have yielded highly predictable
results.” Id. at 11. The Examiner further finds that Gabbay demonstrates
that an intermediate valve deployment stage, “where the replacement valve
has at least partially exited the catheter and before the anchor has completely
exited the catheter,” is a “well-known technique of retracting the catheter
sheath to allow the prosthetic to expand,” and reasons that “[i]t would have
been an obvious expedient to deliver the Beyersdorf valve in accordance
with the catheter retraction technique taught by Gabbay.” Id.
The Examiner further finds that “Beyersdorf and Gabbay are both
silent as to whether the valve is adapted to permit blood flow through the
8
Appeal 2015-005776
Application 13/290,369
replacement valve and to prevent blood backflow through the replacement
valve in this intermediate deployment stage.” Id. at 12. However, the
Examiner finds that “this limitation is functional language,” and because
“[t]he Beyersdorf prosthetic valve is likely located near end 17 . . . and
because of the stent’s long length, it is fully expected that the valve will be
expanded and functional while the proximal end of the stent remains within
the catheter.” Id. Continuing, the Examiner determines that “[t]he leaflets
of Beyersdorf are not restrained and are fully expected to function once the
distal end of the stent deploys” and that “it would have been obvious to one
of ordinary skill in the art at the time the invention was made to have
provided the prosthetic valve of Beyersdorf in view of Gabbay with the
ability to function once expanded, regardless of whether the distal stent has
finished being deployed.” Id. The Examiner further determines that
Beyersdorf s “anchor and replacement valve are adapted to permit blood
flow through the replacement valve and around the catheter after the
replacement valve at least partially exits the catheter and before the anchor
completely exits the catheter.” Id. (citing Beyersdorf 24—25). The
Examiner also determines that “this limitation is functional language,”
which does not distinguish the claim because “Beyersdorf in view of Gabbay
includes all of the same structure as [Appellants’] claimed device.” Id.', see
also Ans. 13.
Appellants traverse, arguing, inter alia, that “the claim recitations
identified by the Examiner as being functional do actually distinguish the
present claims structurally from the cited [references]” (Appeal Br. 21
9
Appeal 2015-005776
Application 13/290,369
(emphasis omitted)), and that “the Examiner repeatedly relied on
unsupported allegations in support of the . . . rejection” {id. at 22).
We are persuaded of error in the determination that the “adapted to”
recitations are merely functional language. See Final Act. 12. “[T]he phrase
‘adapted to’ generally means ‘made to,’ ‘designed to,’ or ‘configured to,’ though it
can also be used more broadly to mean ‘capable of or ‘suitable for.’” In re Man
Mach. Interface Techs. LLC, 822 F.3d 1282, 1286 (Fed. Cir. 2016) (citing In re
Giannelli, 739 F.3d 1375,1379 (Fed. Cir. 2014)). In Giannelli, the court looked to
the written description of the application and determined that the phrase “adapted
to” in view of the specification, has a narrower meaning than “capable of’ or
“suited for.” Giannelli, 739 F.3d at 1379. See also Aspex Eyewear, Inc. v.
Marchon Eyewear, Inc., 672 F.3d 1335, 1349 (Fed. Cir. 2012) (holding that
“adapted to” required elements to be “designed or configured to accomplish the
specified objective, not simply that they can be made to serve that purpose”). In
this case, we likewise look to Appellants’ Specification to discern the meaning of
“adapted to.”
The Specification sets forth that it is the braided and self-expanding nature
of the anchor and the positioning of the seal around the anchor that render the
anchor and replacement valve adapted to permit blood flow through the
replacement valve and to prevent blood backflow through the replacement
valve when the valve is in the so-called intermediate deployment stage when
only a part of the replacement valve has exited the catheter. See Spec.
1174—75. Thus, the Specification and claims use “adapted to” to describe
the construction of the recited apparatus, rather than simply a functional
characteristic thereof. The relevant question, therefore, is whether the
10
Appeal 2015-005776
Application 13/290,369
apparatus described in Beyersdorf, in view of Gabbay, is constructed
(designed) to permit blood flow through the replacement valve and to
prevent blood backflow through the replacement valve when only a part of
the replacement valve has exited the catheter. See Giannelli at 1380. The
Examiner’s rejection does not address this question.
We are further persuaded of error in the reliance on unsupported
assertions. See, e.g., Final Act. 12. As our reviewing court has explained,
“section 103 requires a fact-intensive comparison of the claimed process
with the prior art rather than the mechanical application of one or another
per senile.” In re Ochiai, 71 F.3d 1565, 1571 (Fed. Cir. 1995); see also
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“[R] ejections on
obviousness grounds cannot be sustained by mere conclusory statements;
instead, there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.”) (quoting In
re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). The rejection does not meet
these requirements. Specifically, the Examiner’s determinations that “zY is
fully expected that the [Beyersdorf] valve will be expanded and functional
while the proximal end of the stent remains within the catheter” and “[t]he
leaflets of Beyersdorf are not restrained and are fully expected to function
once the distal end of the stent deploys” (Final Act. 12 (emphasis added))
are conclusory and do not apprise Appellants of any basis for such
assertions. Thus, the Examiner has failed to set forth an articulated
reasoning in support of the rejection as required. We further note that the
Examiner did not set forth what structure within the Beyersdorf apparatus is
determined to be “leaflets.”
11
Appeal 2015-005776
Application 13/290,369
Accordingly, for the foregoing reasons, we do not sustain the rejection
of claim 1 and its dependent claims 2, 5, 6, and 13—15 as being unpatentable
over Beyersdorf and Gabbay. Each of independent claims 11 and 12
contains similar recitations as claim 1 (see Appeal Br. 27—28 (Claims
App.)), and we do not sustain the rejection of these claims as being
unpatentable over Beyersdorf and Gabbay for same reasons as with respect
to the rejection of claim 1.
DECISION
The Examiner’s decision to reject claim 15 as failing to comply with
the written description requirement is reversed.
The Examiner’s decision to reject claims 1—10 and 13 as being
unpatentable over Leonhardt and De Paulis is affirmed.
The Examiner’s decision to reject claims 14 and 15 as being
unpatentable over Leonhardt, De Paulis, and Pease is affirmed.
The Examiner’s decision to reject claims 1, 2, 5, 6, and 11—15 as
being unpatentable over Beyersdorf and Gabbay is reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED-IN-PART
12