Ex Parte Allan et al

Patent Trial and Appeal Board

Aug 10, 2017

13482880 (P.T.A.B. Aug. 10, 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.
13/482,880 05/29/2012 James Calvin Allan P0040228.USU2/1111-382 1001
27581 7590
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
EXAMINER
TURCHEN, ROCHELLE DEANNA
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
08/14/2017 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):
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES CALVIN ALLAN, ERIK C. GRISWOLD,
WILLIAM J. HAVEL, STEVEN L.WALDHAUSER, KELLY M. WIEN,
KENDRA YASGER, RUDOLPH A. BEASLEY, JON D. SCHELL, and
DON H. TRAN1
Appeal 2016-006105
Application 13/482,880
Technology Center 3700
Before DONALD E. ADAMS, RICHARD J. SMITH, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
for intravascular implantation of an implantable medical device. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 According to Appellants, the real party in interest is Medtronic, Inc.
(Appeal Br. 3.)
Appeal 2016-006105
Application 13/482,880
STATEMENT OF THE CASE
Claims on Appeal
Claims 1—21 are on appeal. (Claims Appendix, Appeal Br. 16—21.)
Claim 1, the only independent claim, is illustrative and reads as follows
(emphasis added):
1. A method for intravascular implantation of an implantable
medical device within a patient comprising:
positioning a distal end of an elongated outer sheath forming an inner
lumen with a distal opening adjacent a target site within a vasculature of the
patient;
partially deploying the implantable medical device from the distal
opening, wherein the implantable medical device includes an expandable
fixation element with a looped element expandable from a collapsed position
to an expanded position, wherein, in the expanded position, the looped
element is configured to simultaneously contact opposite sides of the interior
of the vasculature to secure the implantable medical device within the
vasculature, wherein at least a portion of the expandable fixation element
assumes the expanded position when the implantable medical device is
partially deployed from the distal opening;
advancing the distal end of the outer sheath within the vasculature
with the implantable medical device partially deployed from the distal
opening; and
monitoring at least one of the vasculature and the portion of the
expandable fixation element for deflection to determine when a size of the
portion of the expandable fixation element corresponds to a size of the
vasculature.
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Appeal 2016-006105
Application 13/482,880
Examiner’s Rejections
1. Claims 1—15 and 21 stand rejected under pre-AIA 35 U.S.C. § 103(a)
as unpatentable over Rafiee,2 Lenker,3 and Zaver.4 (Ans. 3—9.)
2. Claims 16 and 18—20 stand rejected under pre-AIA 35 U.S.C. § 103(a)
as unpatentable over Rafiee, Lenker, Zaver, and Kassab.5 (Id. at 9—10.)
3. Claim 17 stands rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Rafiee, Lenker, Zaver, and Greenland.6 (Id. at 10.)
DISCUSSION
Rejection No. 1
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejection under pre-AIA 35 U.S.C. § 103(a).
Analysis
The issue turns on the step of “monitoring at least one of the
vasculature and the portion of the expandable fixation element for deflection
to determine when a size of the portion of the expandable fixation element
corresponds to a size of the vasculature.” (Appeal Br. 16.)
The obviousness rejection is based on the Examiner’s position that
Rafiee teaches “[t]he use of contrast dye in conjunction with fluoroscopy
provides the visualization of both the vasculature and the device,” and that
“the use of contrast dye and fluoroscopy as disclosed by Rafiee [] in
paragraph [0061] discloses the limitation ‘monitoring at least one of the
2 Rafiee et al., US 2009/0192601 Al, pub. July 30, 2009 (“Rafiee”).
3 Lenker et al., US 6,350,278 Bl, issued Feb. 26, 2002 (“Lenker”).
4 Zaver et al., US 2007/0135826 Al, pub. June 14, 2007 (“Zaver”).
5 Kassab et al., US 2008/0300672 Al, pub. Dec. 4, 2008 (“Kassab”).
6 Greenland et al., US 2008/0071178 Al, pub. Mar. 20, 2008 (“Greenland”).
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Application 13/482,880
vasculature and the portion of the expandable fixation element for deflection
. . as set forth and evidenced by the present invention.” (Ans. 12—13.)
The Examiner supports that position by reference to Appellants’ claims 2
and 3, and paragraph 185 of Appellants’ Specification. (Id. at 11—12.) In
particular, the Examiner points to the recitation in claim 2 that the
monitoring step may include using fluoroscopy to view at least one of the
vasculature and the portion of the expandable fixation element, and the
recitation in claim 3 that the monitoring step may also include injecting a
contrast dye within the vasculature. (Id. )
Appellants argue that paragraph 61 of Rafiee “actually discloses
visualization of dye flow blockage to determine placement of device 500,”
and that “[t]he Examiner has failed to demonstrate that flow blockage [per
Rafiee] would necessarily result in deflection of at least one of the
vasculature and the portion of the expandable fixation element.” (Appeal
Br. 7.) Moreover, according to Appellants, “neither image methods
including fluoroscopy and contrast dyes, nor monitoring for flow blockage,
necessarily involves ‘monitoring at least one of the vasculature and the
portion of the expandable fixation element for deflection,’ as recited in
claim 1.” (Id. at 8.) Appellants argue further that claims 2 and 3 and the
Specification
clearly describe monitoring at least one of the vasculature and
the portion of the expandable fixation element for deflection,
which is different from other methods of fluoroscopy
visualization that monitor for other things such as, for example,
flow blockage, as described [by] Rafiee. Appellants’]
description that monitoring for deflection may include using
fluoroscopy or injecting a contrast dye would not have led one of
ordinary skill in the art to equate the feature of “monitoring at
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Application 13/482,880
least one of the vasculature and the portion of the expandable
fixation element for deflection,” in claim 1 with either using
fluoroscopy or injecting a contrast dye. Again, a person of
ordinary skill in the art would understand that, even though
monitoring for deflection may include using fluoroscopy and
injecting contrast dyes, it does not follow that all methods using
fluoroscopy and injecting contrast d[y]es necessarily involve
monitoring for deflection.
(Reply Br. 5.)
We find that Appellants have the better position. A prima facie case
for obviousness “requires a suggestion of all limitations in a claim.” CFMT,
Inc. v. Yieldup Inti Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003). We find
that Appellants have persuasively argued that the Examiner has not
established a suggestion in the prior art of the method of claim 1,
particularly the step of monitoring at least one of the vasculature and the
portion of the expandable fixation element for deflection. Moreover, while
imaging or visualization techniques may well be taught by Rafiee, the
method step at issue requires “monitoring ... for deflection,” and we are not
persuaded that such step is taught or suggested by Rafiee.
Accordingly, because the Examiner has failed to present a prima facie
case of obviousness, the rejection of claim 1 is reversed. Dependent claims
2—15 and 21 stand with claim 1.
Rejection Nos. 2 and 3
Claims 16—20 depend, directly or indirectly, from claim 1, and are
therefore nonobvious because claim 1 is nonobvious. See In re Fine, 837
F.2d 1071, 1076 (Fed. Cir. 1988). Accordingly, the rejections of claims 16—
20 are reversed.
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Conclusions of Law
A preponderance of evidence of record fails to support the Examiner’s
rejection of claim 1 for obviousness. Dependent claims 2—15 and 21 stand
with claim 1.
A preponderance of evidence of record fails to support the Examiner’s
rejections of claims 16—20 for obviousness.
SUMMARY
We reverse the rejections of all claims on appeal.
REVERSED
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