Steven Zaver et al.

Patent Trials and Appeals Board

Sep 17, 2019

14714488 - (D) (P.T.A.B. Sep. 17, 2019)

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.
14/714,488 05/18/2015 Steven Zaver H-KN-02072US01 5205
77218 7590 09/17/2019
Medtronic Vascular - APV Division
c/o IP Legal Department
3576 Unocal Place
Santa Rosa, CA 95403
EXAMINER
ORKIN, ALEXANDER J
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
09/17/2019 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):
rs.docketingapv@medtronic.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte STEVEN ZAVER, SENGKHAM SIRIVONG,
CHRISTOPHER QUINN, EARL SLEE, and LINDA ANDERSON
__________

Appeal 2017-010761
Application 14/714,488
Technology Center 3700
__________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

PAULRAJ, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 21–34 on obviousness grounds. We
have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 We use the word “Appellant” to refer to “Applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as Medtronic
plc of Dublin, Ireland, which is the parent entity of the assignee of record,
Covidien LP. (Appeal Br. 3.)
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STATEMENT OF THE CASE
Background
“The present invention relates to embolic protection systems, and,
more particularly, to embolic protection systems for use in blood vessels.”
(Spec. ¶ 2.) “Embolic protection devices can remove emboli from the
bloodstream by filtering debris from blood, by occluding blood flow
followed by aspiration of debris, or can cause blood flow reversal to effect
removal of debris.” (Id. ¶ 4.) However, “[d]ifficulties can arise where
embolic protection devices are not properly deployed within the anatomy,”
and also “when recovering an embolic protection device.” (Id. ¶¶ 5–6.)
“Accordingly, a need exists for an embolic protection device having
improved radiopacity that is inexpensive, durable, provides visibility to the
appropriate regions of the device, and which uses technology that does not
compromise the performance of the device.” (Id. ¶ 8.)
The Claims
Claims 21–34 are on appeal. Independent claim 21 is representative,
and reads as follows:
21. A device comprising:
a filter element comprising a mesh including a filament,
the filter element being configured to expand from a collapsed
configuration when the filter element is restrained to an
expanded configuration when the filter element is unrestrained,
wherein the filter element defines a cavity including a proximal
facing opening in the expanded configuration;
a bead of radiopaque material attached to the filament of
the mesh;
an elongate support member;
a proximal marker disposed on the elongate support
member and slideable with respect to the elongate support
member; and
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a distal marker disposed on the elongate support member
and slideable with respect to the elongate support member,
wherein the mesh of the filter is attached to the proximal and
distal markers,
wherein the elongate support member comprises a stop
between the proximal and distal markers that limits the
movement of proximal and distal markers.

The Issues
The Examiner rejected the claims as follows:
Claims 21–34 under 35 U.S.C. § 103(a) as being unpatentable
over the combination of Clubb2 and Goicoechea.3 The
Examiner additionally relies upon Linder4 and Brady5 as
evidentiary references in support of the rejection.

FINDINGS OF FACT
FF1. Clubb teaches a device for filtering emboli having a mesh
filter element being expandable from a collapsed
configuration when restrained to an expanded configuration
when unrestrained having a proximal, distal, and central
portion creating a proximal facing cavity having a perimeter,
an elongate support member, and a radiopaque band
attached to the mesh. (Clubb, Abstract, ¶¶ 29, 63.)

FF2. Clubb teaches that the material used for the filter mesh may
be a nickel-titanium alloy (“nitinol”). (Id. ¶¶ 34, 36.)

FF3. Clubb teaches that “[t]he material comprising the filter is
preferably at least partially radiopaque,” and “[t]his material

2 Clubb et al., US 2004/0153118 A1, published Aug. 5, 2004.
3 Goicoechea et al., US 6,165,213, issued Dec. 26, 2000.
4 Linder et al., US 2005/0096692 A1, published May 5, 2005.
5 Brady et al., US 2006/0241681 A1, published Oct. 26, 2006.
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can be made radiopaque by plating, or by using core wires,
tracer wires, or fillers that have good X-ray absorption
characteristics compared to the human body.” (Id. ¶ 37.)

FF4. As shown in Fig. 4(a), Goicoechea teaches an endoluminal
prosthesis wherein “a radiopaque marker may typically
comprise a gold or platinum wire 17 crimped onto an end of
stent 16. Alternatively, the radiopaque marker may be a
tube 17a disposed around a length of wire on the stent, also
as shown in FIG. 4(a).” (Goicoechea, 10:53–57, Fig. 4(a).)

FF5. Linder teaches an embolic protection device with a filter
assembly wherein:
[b]ands 120 of a radiopaque material can be added to at
least one of struts 116 of filter basket 112. The bands,
120, may be made from cut tubing of a radiopaque
material, or optionally be made from a section of
helically wound coil of a radiopaque material.
Optionally, a band 124 of radiopaque material, similar to
band 120, can also be added at the proximal junction of
filter basket 112 and guide member 102. This band 124
can optionally surround at least a portion of body 122
and can be encapsulated in an adhesive filet to provide a
smooth transition in outer diameters. The radiopaque
substances can include, but not limited to, barium
sulphate, bismuth subcarbonate, titanium dioxide,
combinations thereof, or other radiopaque substances.

(Linder ¶ 53.)
FF6. Brady teaches a support frame for an embolic protection
device that includes a radiopaque core wherein “[i]deally the
radiopaque core is provided as a core embedded within at
least one support element.” The radiopaque core may be in
powder form or liquid form, and/or include a radiopaque
element that comprises a wire, and be made of mercury,
gold, or platinum. (Brady ¶¶ 110–112.)

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FF7. Brady further teaches that the device may include filaments
with a radiopaque core embedded therein, and also a jacket
around the filaments made at least partially of a radiopaque
material. (Id. ¶¶ 130–131.)

PRINCIPLES OF LAW
“[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” . . . however, the
analysis need not seek out precise teachings directed to the
specific subject matter of the challenged claim, for a court can
take account of the inferences and creative steps that a person
of ordinary skill in the art would employ.
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (citation omitted).

ANALYSIS
Rejection Based on Clubb and Goicoechea, as evidenced by Linder and
Brady
With respect to claims 21–29, 32, and 33, the Examiner finds that
Clubb discloses a device satisfying most of the claim elements with the
exception that Clubb “is silent about the radiopaque bead attached to the
filament of the mesh.” Final Act. 3. The Examiner, however, relies upon
Clubb’s disclosure that the filter can be radiopaque. Id. The Examiner
further relies upon Goicoechea as teaching a similar device with a
radiopaque element in the form of a plurality of beads defining a through
hole into which the filament extends, wherein the bead is mechanically
crimped onto the filament or formed over the filament. Id. (citing
Goicoechea, Fig. 4(a), 10:50–60). The Examiner further contends that
Goicoechea teaches that the bead comprises a tubular marker band, and
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comprises a platinum alloy. Id. Based on these teachings, the Examiner
asserts that “[i]t would have been obvious to one of ordinary skill [in] the art
at the time of the invention to substitute the bead of Goicoechea with the
device (radiopaque mechanism) of Clubb in order for using an alternative
mechanism to monitor the device during delivery.” Id. at 3–4.
With respect to claim 30, the Examiner contends that Clubb teaches
the bead is integral with the braided filament. Id. at 4 (citing Clubb ¶ 37).
With respect to claim 31, the Examiner contends that Clubb discloses the
mesh comprises a polymer film defining holes and the filament is applied to
the polymer film. Id. (citing Clubb ¶¶ 4, 36). With respect to claim 34, the
Examiner contends that Clubb discloses that the plurality of elements are
metal filaments. Id. (citing Clubb ¶ 36).
Appellant makes several arguments as to why the Examiner failed to
make a prima facie case of obviousness. Although Appellant has presented
arguments under different groupings of the claims, we focus our analysis on
claims 21 and 32 as our analysis for these independent claims applies to all
the claims on appeal. In particular, we are persuaded that the Examiner has
failed to establish that one of ordinary skill in the art would have found it
obvious to substitute the radiopaque mechanism taught by Clubb with the
radiopaque marker taught by Goicoechea in order to arrive at the claimed
bead of radiopaque material attached to the filament of the mesh.6 See
Appeal Br. 7–9.

6 In a prior appeal in the parent application, we were persuaded by
Appellant’s argument that “‘because Clubb discloses a filter that is made
from a radiopaque material, there would have been no apparent reason,
absent access to Appellant’s disclosure, to modify the filter to include an
additional radiopaque element.’” See Ex Parte Zaver, Appeal No. 2012-
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Under the Manual of Patent Examining Procedure (“MPEP”), one
exemplary rationale that may support a conclusion of obviousness is the
“[s]imple substitution of one known element for another to obtain
predictable results.” See MPEP §§ 2141, 2143. In this case, however, the
Examiner has not shown that one of ordinary skill in the art would have
considered the substitution of the at least partially radiopaque material of
Clubb’s filter with the radiopaque marker taught by Goicoechea to be a
“[s]imple substitution” that would lead to “predictable results,” or that the
different means to achieve radiopacity taught by the references would have
been considered equivalent in the art. Nor has the Examiner pointed to any
particular advantage to be gained by using Goicoechea’s radiopaque markers
in lieu of, or in addition to, Clubb’s partially radiopaque filter material. The
Examiner’s stated reason for making the substitution, in order to “us[e] an
alternative mechanism to monitor the device during delivery,” is merely
conclusory, and does not provide the requisite articulated reasoning with
rational underpinning to support the legal conclusion of obviousness.
We have also considered the Examiner’s reliance on the teachings of
Linder and Brady. The Examiner cites these references as allegedly
showing that the radiopaque mechanisms of Clubb and Goicoechea are
“similar or known” substitutions. Ans. 3. Linder teaches that radiopaque
bands 120, 124 that are similar to Goicoechea’s radiopaque tubes may be
positioned at different parts of a filter assembly. FF5. Brady teaches that a

005308, 2014 WL 6807802, at *1 (PTAB Dec. 2, 2014). Unlike in the prior
appeal, however, we recognize that the Examiner relies upon a substitution
rationale rather than a rationale to modify Clubb’s filter to include an
additional radiopaque element.
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radiopaque core or radiopaque elements in the form of a wire or a jacket
may be used in an embolic protection device. FF6. However, neither
reference suggests that the use of the radiopaque mechanisms taught therein
would have been considered a similar or known substitution for a
mechanism in which the filter material itself is made of at least a partially
radiopaque material, as taught in Clubb. Nor does either reference identify
any other advantage in using beads as the radiopaque material.
Accordingly, we are persuaded that the Examiner has not made a
prima facie case of obviousness for any of claims on appeal, which all
require at least one bead of radiopaque material attached to the filament of
the mesh.

CONCLUSION
We reverse the rejection of claims 21–34 under 35 U.S.C. § 103(a) as
being unpatentable over the combination Clubb and Goicoechea, as
evidenced by Linder and Brady.

Claims
Rejected
Basis Affirmed Reversed
21–34 § 103 Clubb,
Goicoechea, Linder,
Brady
21–34

REVERSED