MEDTRONIC, INC.

Patent Trials and Appeals Board

Nov 22, 2021

2021002704 (P.T.A.B. Nov. 22, 2021)

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.
14/163,413 01/24/2014 Mark T. MARSHALL C00005612.USU1 9322
27581 7590 11/22/2021
Medtronic, Inc. (CVG)
8200 Coral Sea Street NE.
MS: MVC22
MINNEAPOLIS, MN 55112
EXAMINER
WEI, CHARLES M
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
11/22/2021 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.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MARK T. MARSHALL

Appeal 2021-002704
Application 14/163,413
Technology Center 3700
____________

Before MICHAEL J. FITZPATRICK, JEREMY M. PLENZLER, and
LISA M. GUIJT, Administrative Patent Judges.

FITZPATRICK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant, Medtronic Inc.,1 appeals under 35 U.S.C. § 134(a) from the
Examiner’s final decision rejecting claims 12–18 and 21. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42.
Appellant identifies itself as the sole real party in interest. Appeal Br. 1.
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Application 14/163,413

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STATEMENT OF THE CASE
The Specification
The Specification relates to subcutaneous extravascular implantation
of medical leads. Spec. ¶3. The Specification explains that components of,
for example, a sub-cutaneous implantable cardioverter defibrillator (“SubQ
ICD”) system must be placed at different positions around the heart.
Spec. ¶6. Thus, according to Appellant, in the prior art, surgical
implantation of a SubQ ICD required multiple points of incision, “which
increases the risk of infection, complexity of the procedure, surgical
duration, and cost.” Id. Appellant’s claimed invention seeks to accomplish
the placement of leads using a single point of incision. Id. ¶7.
The Claims
Claims 12–18 and 21 are rejected. Final Act. 1. No other claims are
pending. Id. Claim 12 is the sole independent claim on appeal and is
reproduced below.
12. A medical system, comprising:
a first medical device having a first handle, a proximal
end, a distal end, and a lumen therethrough, the distal end of the
first medical device being deflectable; and
a second medical device slideably receivable within the
lumen of the first medical device, the second medical device
having a second handle, a proximal portion, a distal portion
having a major axis, the second medical device including a tube
configured to create a pathway sized to receive a medical lead,
the second handle sized to be received within the first handle;
the first medical device including an actuator, the actuator
including a rotatable collar configured to deflect the first medical
device to an angle up to 90 degrees;
the distal portion of the second medical device being
slideable out through the distal end of the first medical device,
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Application 14/163,413

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the distal portion of the second medical device being configured
to extend longitudinally at an angle substantially orthogonal to
the major axis for a distance away from a distal most end of the
first medical device when the distal end of the first medical
device is deflected and the distal portion of the second medical
device is slid out through the distal end of the first medical
device; and
the distal portion of the second medical device defines a
substantially rigid longitudinal column axis when the distal end
of the first medical device is deflected and the distal portion of
the second medical device is slid out through the distal end of the
first medical device.
Appeal Br. Claims App.
The Examiner’s Rejections
The following rejections, all pursuant to 35 U.S.C. § 103, are before
us:
1. claims 12, 13, 16, 17, and 21 as unpatentable over Kraus2 and
Fleischhackor3 (Final Act. 3);
2. claims 14 and 15 as unpatentable over Kraus, Fleischhackor,
and Bardy4 (id. at 5); and
3. claim 18 as unpatentable over Kraus, Fleischhackor, and
Schwartz5 (id. at 6).
DISCUSSION
Rejection 1
The Examiner found that Kraus discloses all of the subject matter of
claim 12 “except wherein the first medical device includes an actuator, the

2 US 6,641,564 B1, issued Nov. 4, 2003 (“Kraus”).
3 US 5,395,329, issued Mar. 7, 1995 (“Fleischhackor”).
4 US 7,274,962 B2, issued Sept. 25, 2007 (“Bardy”).
5 US 5,437,288, issued Aug. 1, 1995 (“Schwartz”).
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Application 14/163,413

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actuator including a rotatable collar configured to deflect the first medical
device to an angle up to 90 degrees.” Final Act. 3–4 (citing Kraus at 6:15–
47, Figs. 1, 2, 3A, 3B); see also Ans. 4 (additionally citing Kraus at Fig. 13).
The Examiner found that “Fleischhackor teaches a flexible catheter having a
steering mechanism with a rotatable collar (fig. 1, element 24), in order to
permit precise control of the movement of the catheter body (col. 7, II. 45-
47).” Final Act. 4. The Examiner concluded: “It would have been obvious
to one having ordinary skill in the art before the effective filing date of the
claimed invention to modify the device of modified [Kraus] with a steering
mechanism, in order to permit precise control of movement.” Id.
As discussed below, we determine the Examiner failed to establish a
prima facie rejection.
Claim 12 includes limitations directed to deflections in both of the
recited medical devices. Those limitations are:
(1) “the first medical device including an actuator, the actuator
including a rotatable collar configured to deflect the first medical
device to an angle up to 90 degrees”; and
(2) “the distal portion of the second medical device being
configured to extend longitudinally at an angle substantially
orthogonal to the major axis for a distance away from a distal
most end of the first medical device when the distal end of the
first medical device is deflected and the distal portion of the
second medical device is slid out through the distal end of the
first medical device.”
Appeal Br. Claims App. The Examiner finds that Kraus discloses the former
limitation, which the Examiner construes as requiring a deflection of merely
a single degree. See Final Act. 4 (“Examiner notes that one degree is an ‘an
angle up to 90 degrees’ because one degree is less than 90 degrees.
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Application 14/163,413

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Therefore, a [first medical] device capable of any amount of deflection is
‘configured to deflect . . . to an angle up to 90 degrees.’”).
The Examiner’s construction would be reasonable given the language
of the first limitation alone. However, claim 12 also recites that the second
device is within the lumen of the first device and that, when the first medical
device is deflected, the distal end of the second medical device extends at
“an angle substantially orthogonal.” Thus, the claim effectively requires the
actuator being configured to deflect both medical devices “at an angle
substantially orthogonal.” The Examiner does not show that Kraus in view
of Fleischhackor satisfies these requirements of the claim.
To be clear, the Examiner finds that Kraus’s flexible needle
(corresponding to the second medical device) can be deflected 90 degrees
such that it could “extend orthogonally at an angle substantially orthogonal
to the major axis,” as recited in claim 12. However, the Examiner does not
find that Kraus’s dilator 120 (corresponding to the first medical device) can
be deflected 90 degrees. Nor does the Examiner find that Fleischhackor’s
“steering catheter handle,” which provides “controlled bending of the
catheter tip” and thus “precise control of the movement of the catheter body”
(Fleischhackor 7:43–47), can effectuate 90 degree turns. Instead, the
Examiner construes the claim to require an actuator configured to deflect the
first medical device by a mere one degree. Final Act. 4. That construction
is erroneous.
Accordingly, we reverse the Examiner’s rejection of claims 12, 13,
16, 17, and 21 over Kraus and Fleischhackor.
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Rejections 2 and 3
Claims 14, 15, and 18 ultimately depend from claim 12. Appeal Br.
Claims App. The Examiner applies an additional reference, either Bardy or
Schwartz, in regards to the additional limitations recited in these claims.
Final Act. 5–6. The Examiner does not apply the additional reference in a
manner that could cure the deficiency in the rejection of claim 12 noted
above. Thus, for essentially the same reason, we likewise reverse the
Examiner’s rejection of claims 14 and 15 over Kraus, Fleischhackor, and
Bardy and the Examiner’s rejection of claim 18 over Kraus, Fleischhackor,
and Schwartz.

DECISION SUMMARY
In summary:

Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
12, 13, 16,
17, 21
103 Kraus,
Fleischhackor
12, 13, 16,
17, 21
14, 15 103 Kraus,
Fleischhackor,
Bardy
14, 15
18 103 Kraus,
Fleischhackor,
Schwartz
18
Overall
Outcome
12–18, 21

REVERSED