Ex Parte Clark et al

Patent Trial and Appeal Board

Jun 7, 2017

13673452 (P.T.A.B. Jun. 7, 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.
13/673,452 11/09/2012 Christopher J. Clark 2001.1493101 3302
11050 7590 06/09/2017
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
SIMPSON, SARAH A
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
06/09/2017 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 CHRISTOPHER J. CLARK, BRIAN JOSEPH TISCHLER,
DENNIS A. PEIFFER, TIMOTHY J. LEY, and THYNA M. CHAU
Appeal 2015-007556
Application 13/673,452
Technology Center 3700
Before LINDA E. HORNER, MICHAEL L. HOELTER, and
BRENT M. DOUGAL, Administrative Patent Judges.
HORNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Boston Scientific Scimed, Inc. (Appellant)1 seeks our review under
35 U.S.C. § 134(a) of the Examiner’s decision, as set forth in the Final
Office Action dated August 7, 2014 [hereinafter “Final Act.”], rejecting
claims 1 and 3-16.2 We have jurisdiction under 35 U.S.C. § 6(b).
1 Boston Scientific Scimed, Inc. is the applicant as provided in 37 C.F.R.
§ 1.46 and the real party in interest. Appeal Brief 2 (February 9, 2015)
(hereinafter “Br.”). Boston Scientific Scimed, Inc. is a wholly owned
subsidiary of Boston Scientific Corp. Id.
2 In the event of further prosecution of this application before the Examiner,
we note that dependent claim 3 depends improperly from canceled claim 2.
Appeal 2015-007556
Application 13/673,452
We REVERSE.
CLAIMED SUBJECT MATTER
Appellant’s claimed subject matter relates to “devices for occluding a
body lumen” such as “the left atrial appendage of the heart.” Spec. 1,11. 9-
11. Claims 1 and 16 are independent. Claim 1 is illustrative of the subject
matter on appeal and is reproduced below.
1. An occlusion device comprising:
a framework comprising a proximal portion, a middle
portion, and a distal portion, wherein:
the proximal portion comprises a first hub that
has a fixed first diameter;
the middle portion has a second diameter and
comprises a plurality of beams extending from the first
hub to a distal portion, wherein each of the plurality of
beams is connected to an adjacent beam by a first
circumferentially extending column of strut pairs, and
wherein the middle portion of the framework is
movable between a first configuration wherein the
second diameter is not greater than the first diameter
and a second configuration wherein the second
diameter is greater than the first diameter; and
the distal portion has a third diameter, wherein
the third diameter is not greater than the first diameter
in the first configuration; and
a biocompatible covering disposed over at least a part
of the framework.
Br. 22 (Claims App.). Independent claim 16 similarly recites “[a]n
occlusion device” comprising a framework and a biocompatible covering
disposed over at least a part of the framework. Id. at 24.
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Appeal 2015-007556
Application 13/673,452
EVIDENCE
The Examiner relies upon the following evidence in the Final Office
Action:
Palmer et al. (“Palmer”) US 6,660,021 B1
McGuckin, Jr. et al. US 2005/0015111 Al
(“McGuckin”)
Bosma et al. (“Bosma”)
Case et al. (“Case”)
Sokolov et al. (“Sokolov”)
Gilson et al. (“Gilson”)
US 6,989,021 B2
US 2007/0021826 Al
US 2010/0063533 Al
US 2010/0228281 Al
REJECTIONS
Dec. 9, 2003
Jan. 20, 2005
Jan. 24, 2006
Jan. 25, 2007
Mar. 11,2010
Sept. 9,2010
The Final Office Action includes the following rejections:
1. Claims 1,3,4, 6-11, 13, and 15 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Sokolov, Palmer, and McGuckin.
2. Claim 5 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Sokolov, Palmer, McGuckin, and Case.
3. Claim 12 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Sokolov, Palmer, McGuckin, and Bosma.
4. Claim 14 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Sokolov, Palmer, McGuckin, and Gilson.
5. Claim 16 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Sokolov and Palmer.
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Appeal 2015-007556
Application 13/673,452
ANALYSIS
As noted above, all of the claims are directed to an “occlusion
device.” Each of the grounds of rejection is based on the Examiner’s finding
that “Sokolov discloses an occlusion device.”3 See, e.g., Final Act. 3. The
Examiner explains that “[gjiving the claims their broadest reasonable
interpretation in light of the specification, the examiner has interpreted ‘an
occlusion device’ to be a device capable of at least partially clogging and/or
blocking a vessel.” Ans. 10—11. The Examiner finds that the filter of
Sokolov is, therefore, capable of occluding a vessel. Id. The Examiner
points to the disclosure in paragraph 51 of Sokolov, which teaches that the
size of the hooks 40 for migration resistance and the number of anchor
members 30 may be determined by calculating the force applied to each
hook when the filter 1 is fully occluded. Id. The Examiner explains that
based on this disclosure “the filter 1 of Sokolov is capable of being fully
occluded” and that when fully occluded “blood, emboli or debris in the
vessel would not be able to pass through the filter and instead the filter
would clog and/or block the vessel.” Id.
Appellant contends the Examiner erred in rejecting the claims because
Sokolov fails to disclose an occlusion device. Br. 10. In particular,
Appellant argues that the Examiner’s definition of “occlusion device” is
3 We do not understand the Examiner to have found that either Palmer or
McGuckin discloses an occlusion device. See, e.g., Final Act. 4-5
(Examiner finding that “Palmer teaches a filter device” and “McGuckin
teaches a filter”).
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Appeal 2015-007556
Application 13/673,452
unreasonably broad when that term is construed as one having ordinary skill
in the art would understand it in view of the Specification. Br. 9-10.
Appellant asserts that “[i]n medicine, an ‘occlusion’ has been defined as ‘the
blockage or closing of a blood vessel or hollow organ. Id. at 9 (quoting
Concise Oxford English Dictionary Luxury Edition, Oxford University
Press, New York, NY, Stevenson et al. Eds., 12th Ed., 2011, p. 989).
Appellant argues that the Specification uses the term “occlusion device”
consistently with this definition. Br. 8-9.
As Appellant points out, the Specification describes that the occlusion
device can be used to treat atrial fibrillation by occluding the left atrial
appendage of the heart. Spec. 1,11. 9-26. The Specification describes in the
background of the invention that “[treatment of [atrial fibrillation] may
include surgically closing the [left atrial appendage], epicardial [left atrial
appendage] ligation, or delivering a device or mechanism across or into the
[left atrial appendage] in order to occlude it” Id. at 11. 27-29 (emphasis
added). “[W]hen the device [of Figure 1] is properly positioned within the
[left atrial appendage] the occlusion device forms a seal with the walls of the
[left atrial appendage] in order to prevent emboli or blood clots from passing
back into the blood stream.” Id. at 2,11. 5-8 (emphasis added). The
Specification describes that known occlusion devices have frameworks that
may be compromised by distortive forces exerted by the left atrial
appendage and allow some material to exit the left atrial appendage and re­
enter the bloodstream. Id. at 11. 8-15. The Specification describes that the
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Application 13/673,452
occlusion device of the present invention, by contrast, does not allow flow
past the device:
When an occlusion device of the present disclosure is properly
positioned within the [left atrial appendage], the occlusion device
may have sufficient circumferential and/or radial strength [to]
form a seal with the wall of the [left atrial appendage] (and resist
the distortive forces that the [left atrial appendage] may exert on
the occlusion device) in order to, for example, prevent emboli or
blood clots from passing back into the blood stream.
Spec. 6,11. 13-21. Thus, the Specification describes the occlusion device of
the invention as a device that seals to the walls of the left atrial appendage
and prevents flow past the device.
Based on the description in the Specification and the ordinary
meaning of “occlusion,” one having ordinary skill in the art would
understand an “occlusion device” to mean a device that completely blocks or
obstructs a blood vessel or hollow organ so as to prevent anything from
passing in, out, or through it. This understanding is consistent with the
definition of “occlusion” proffered by Appellant. The Examiner has not
cited to any evidence that supports the Examiner’s broader interpretation of
“occlusion device” as “a device capable of at least partially clogging and/or
blocking a vessel.” Ans. 11. For these reasons, we agree with Appellant
that the Examiner’s interpretation of “occlusion device” to allow passage of
flow past the device is unreasonably broad.
The Examiner’s finding that the filter of Sokolov is an occlusion
device is based on the Examiner’s unreasonably broad definition of
“occlusion device” to allow flow past the device. Ans. 11. As noted by
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Application 13/673,452
Appellant (Br. 11), Sokolov’s filter is specifically designed to allow blood
flow past the filter even when the filter is filled with emboli. Sokolov,
para. 7 (“there is a need for a blood filter which . . . will not complete block
blood flow if filled with emboli”); id. at para. 8 (“A preferred device
provides for filtration of emboli in a blood vessel without the captured
emboli causing . . . total blockage of blood flow”); id. at para. 14 (“the filter
basket can be smaller in cross section than the blood vessel so a full filter
does not clog the blood vessel”); id. at para. 41 (“FIGS. 1-15A illustrate
various embodiments of blood filters which filter emboli in a blood vessel of
a subject such that the captured emboli tend not to cause increased pressure
on the blood vessel walls or total blockage of blood flow).4 Thus, Sokolov’s
filter, even when modified as proposed by the Examiner, would not
completely block or obstruct a blood vessel or hollow organ so as to prevent
anything from passing in, out, or through it, and thus would not function as
an occlusion device.
The Examiner further stated that all of the structural limitations in the
body of the claim following the preamble can be found in the combination of
Sokolov, Palmer, and McGuckin, and thus “the filtering device may also be
an occlusion device.” Ans. 11 (citing Kropa v. Robie, 187 F.2d 150 (CCPA
4 We further agree with Appellant that, for the reasons pointed out on page
14 of the Brief, the Examiner misunderstood the reference in paragraph 51
of Sokolov to the filter being “fully occluded.” See Ans. 11. When this
paragraph is read in the context of the entirety of Sokolov, it is clear that
Sokolov’s filter 1 does not completely block or obstruct the blood vessel
and, thus, is not an occlusion device.
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Application 13/673,452
1951)). Appellant contends that “the phrase ‘occlusion device’ further
defines the structure of the recited subject matter.” Br. 13.
As to the effect of the preamble, “a claim preamble has the import that
the claim as a whole suggests for it.” Bell Communications Research, Inc. v.
Vitalink Communications Corp., 55 F.3d 615, 620 (Fed. Cir. 1995). “Where
a patentee uses the claim preamble to recite structural limitations of his
claimed invention, the PTO and courts give effect to that usage.” Rowe v.
Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). “Conversely, 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, the
preamble is not a claim limitation.” Id. “The determination of whether
preamble recitations are structural limitations or mere statements of purpose
or use ‘can be resolved only on review of the entirety of the patent to gain an
understanding of what the inventors actually invented and intended to
encompass by the claim.’” Id. (quoting Corning Glass Works v. Sumitomo
Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989)). “The inquiry
involves examination of the entire patent record to determine what invention
the patentee intended to define and protect.” Id.
As noted in our review of the Specification discussed supra,
Appellant’s Specification evinces a particular and distinct structural meaning
for “occlusion device” that distinguishes it from “filters” or other devices
that allow blood to flow past the device when it is placed in a blood vessel or
hollow organ. In particular, as discussed in detail supra, an “occlusion
device” must be capable of forming a seal with the walls of the blood vessel
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Application 13/673,452
or hollow organ in which it is placed in order to prevent emboli or blood
clots from passing back into the blood stream. Thus, we conclude that the
claim preamble gives “life and meaning” to the invention claimed based on
“a review of the entirety of the [Specification] to gain an understanding of
what the inventors actually invented and intended to encompass by the
claims.” Corning Glass Works, 868 F.2d at 1257. Accordingly, we agree
with Appellant that the phrase “occlusion device” recited in the preamble
imparts meaning to the structure recited in the body of the claim, and for the
reasons stated supra, the Examiner misconstrued this phrase in the preamble.
For these reasons, we do not sustain the Examiner’s rejections of the
claims, which are based on an unreasonably broad interpretation of the claim
language.
DECISION
The rejections of claims 1 and 3-16 under 35 U.S.C. § 103(a) are
reversed.
REVERSED
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