MEDTRONIC, INC.

Patent Trials and Appeals Board

Jun 19, 2020

13749489 - (D) (P.T.A.B. Jun. 19, 2020)

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.
13/749,489 01/24/2013 Michael D. Baudino P0038473.USU2
(134.054301
4512
64619 7590 06/19/2020
MEDTRONIC, INC. (NEURO/MRG)
710 MEDTRONIC PARKWAY NE
MS-LC340
MINNEAPOLIS, MN 55432-5604
EXAMINER
PHAM, MINH DUC GIA
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
06/19/2020 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):
ptodocketing@mrgs.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 MICHAEL D. BAUDINO

Appeal 2019-006792
Application 13/749,489
Technology Center 3600
___________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
The Examiner rejected the claims under 35 U.S.C. § 112 as lacking a
written description and under 35 U.S.C. § 103 as obvious. Pursuant to 35
U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject
the claims. 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,
Inc. Appeal Br. 2.
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Application 13/749,489

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STATEMENT OF THE CASE
This is the second time an appeal in this application has been before
the Board. A decision in the first appeal was entered June 19, 2018 (“Dec.
App.”). The appealed rejections were affirmed in the decision and a new
ground of rejection under 37 C.F.R. § 41.50(b) was entered. Prosecution was
reopened and the claims were again finally rejected over the same prior art
in the first appeal. Final Act. (Oct. 16, 2018).
The claims stand finally rejected by the Examiner as follows:
1. Claims 1–17 and 21 under 35 U.S.C. § 112(a) or 35 U.S.C. § 112
(pre-AIA), first paragraph, as failing to comply with the written description
requirement. Final Act. 2.
2. Claims 1, 2, 10, and 15 under pre-AIA 35 U.S.C. § 103(a) as
obvious in view of Boling (U.S. Pat. No. 7,146,222 B2, issued Dec. 5, 2006)
(“Boling”) and Desai et al. (U.S. Pat. Appl. Publ. No. 2011/0054581 Al,
published Mar. 3, 2011) (“Desai”). Final Act. 4.
3. Claims 1, 2, 6, 9–17, and 21 under pre-AIA 35 U.S.C. § 103(a) as
obvious in view of Erickson et al. (U.S. Pat. Appl. Publ. No. 2005/0209667
A1, published Sep. 22, 2005) (“Erickson”) and Desai. Final Act. 6.
4. Claims 3–5, 7, and 8 under pre-AIA 35 U.S.C. § 103(a) as obvious
in view of Erickson, Desai, and Colvin (U.S. Pat. Appl. Publ. No.
2006/0247749 Al, published Nov. 2, 2006) (“Colvin”). Final Act. 9.
Claim 1, the only independent claim on appeal, is reproduced below:
1. An implantable medical lead comprising:
a proximal end portion including a plurality of contacts
and having a proximal end; and
a distal end portion including an array of electrodes and
having a distal end for tunneling and a generally flat body
extending proximally from the distal end, each of the electrodes
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of the array being discretely electrically coupled to one of the
plurality of contacts and the array of electrodes being exposed
through a surface of the generally flat body along an array
length,
wherein the body of the distal end portion is sufficiently
stiff to be pushed through subcutaneous tissue without use of an
introducer and without use of a stylet.

WRITTEN DESCRIPTION REJECTION
Claim 1 is directed to an implantable medical lead “wherein the body
of the distal end portion is sufficiently stiff to be pushed through
subcutaneous tissue without use of an introducer and without use of a
stylet.” The phrase “without use of a stylet” was added by amendment on
Aug. 16, 2018. In response to the amendment, the Examiner rejected the
claims as lacking written description. Final Act. 2. The Examiner stated that
there is “no mention of exclusion or prohibition of using a stylet” in the
Specification. Id. at 3. The Examiner also found that a stylet is used in an
embodiment described in the Specification to facilitate implantation into
subcutaneous tissue. Id.
We reverse this rejection.
To satisfy the written description requirement of 35 U.S.C. § 112, the
inventor must “convey with reasonable clarity to those skilled in the art that,
as of the filing date sought, he or she was in possession of the invention.”
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563–64 (Fed. Cir. 1991)
(emphasis omitted). “One shows that one is ‘in possession’ of the invention
by describing the invention, with all its claimed limitations . . . .” Lockwood
v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (emphasis
omitted).
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As recognized by the Examiner, the Specification describes
embodiments which describe a lead containing a stylet. Spec. 10:10–15.
However, the Specification also describes an embodiment where the lead is
made of a material which imparts the requisite stiffness and facilitates its
ability to be pushed through subcutaneous tissue as required by claim 1.
Spec. 7:3–21 (“If the lead body is too thin and is made of a material or
materials having relatively low modulus of elasticity, the ability of the lead
to be pushed through subcutaneous tissue may be compromised, while lead
having thicker lead bodies made of the same material may be readily pushed
through subcutaneous tissue.”). This embodiment is not described as
containing a stylet. Accordingly, the rejection describes an embodiment
where the lead “is sufficiently stiff to be pushed through subcutaneous tissue
. . . without use of a stylet” and therefore demonstrates that the inventor had
possession of the claimed embodiment with all its limitations. The written
description rejection of claims 1, and dependent claims 2–17 and 21, is
reversed.

REJECTION BASED ON BOLING AND DESAI
The Examiner found that Boling describes an implantable lead with
the features of claim 1. Ans. 4–5. The Examiner found that Figure 7 of
Boling shows a core member 180 at its proximal end which “would provide
the lead with rigidity to be pushed through brain tissues.” Id. at 5. The
Examiner further found that Desai describes a lead with a tip portion that is
“sufficiently stiff to be pushed through subcutaneous tissue without use of an
introducer and without use of a stylet” as required by the rejected claim. Id.
The Examiner found that it would be within the skill of the ordinary skilled
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worker to use Desai’s material to make Boling’s lead because “both
inventions are concerned with the same field of endeavor.” Id.
Appellant argues that the embodiments disclosed in Boling do not
describe the implantable lead as sufficiently stiff to be pushed through
subcutaneous tissue without use of an introducer and without use of a stylet
as recited in claim 1. Appeal Br. 8. Appellant states that Boling uses a stylet
to impart rigidity. Id. (quoting also from the previous Decision (Dec. App. 4)
which made this finding). Appellant also argues that Boling does not teach
that core member 180 provides sufficient stiffness for the lead to be pushed
through brain tissue. Appeal Br. 8. Appellant states that the Examiner did
not give sufficient reason to combine Boling with Desai. Id. at 11.
Appellant’s argument is persuasive.
Boling describes a core member 180 at the distal portion of the lead
100. Boling, col. 8, ll. 4–8. While Boling describes core member 180 as
being a solid structure, and made of a metal, Boling does not disclose that its
purpose is to impart rigidity to the lead so that the lead may be pushed
through brain tissue. Id. at col. 8, ll. 9–29.
Boling describes the lead as “flexible.” Id. at col. 6, ll. 49–53. Boling
characterizes the lead 100 as having “sufficient flexibility where it exits the
cortex 330 to avoid adverse pressure effects on the brain or any portion of
the lead 100.” Id. at col. 18, ll. 39–41. To insert the lead into the brain,
Boling describes using a stylet which “provides rigidity and serves to ‘push’
the lead 100 through the soft brain tissue.” Id. at col. 19, ll. 3–8. Thus, the
stylet, not the core member, is described by Boling as providing the stiffness
to the lead enabling it to be pushed through tissue. Because Boling teaches
that the lead is flexible, e.g., to avoid adverse pressure effects on the brain,
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and uses a stylet to push the flexible lead through brain tissue, we fail to see
the Examiner’s logic that one of ordinary skill in the art would have had
reason to use Desai’s material to make the distal end portion of the lead stiff.
Ans. 5.
“An examiner bears the initial burden of presenting a prima facie case
of obviousness.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
2011). As that burden was not met here, we are compelled to reverse the
obviousness rejection of claim 1, and dependent claims 2, 10, and 15 that
depend from claim 1 and incorporate all its limitations.

REJECTION BASED ON ERICKSON AND DESAI
The Examiner found Erickson describes an implantable lead with the
features of the lead of claim 1. Final Act. 6. The Examiner acknowledged
that Erickson does not disclose the limitation “wherein the body of the distal
end is sufficiently stiff to be pushed through subcutaneous tissue without use
of an introducer and stylet.” Id. However, the Examiner found that Desai
describes a lead made with a material that would possess the same stiffness.
Id. The Examiner determined it would have been obvious to one of ordinary
skill in the art to have modified Erickson with the material in Desai “since
both invention are concerned with the same field of endeavor, namely
electrical stimulation leads configured to be implanted within the patient
with known biocompatible materials.” Id. at 7.
Appellant argues that Erickson teaches that “lead body does not have
a great deal of stiffness, stating that a stylet may be used as a stiffening
member for handling and placing the lead.” Appeal Br. 15. Appellant also
argues that Desai, on the other hand, describes a harder lead to enable it to
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be pushed to the fixation site. Id. at 15–16. Appellant contends that the
Examiner did not provide an adequate reason as “why one of skill in the
medical device arts or medicine would make the lead of Erickson et al.
stiffer.” Id. at 15.
We agree with Appellant. Erickson describes a flexible electrode and
specifically teaches it is “formed so as to not otherwise significantly impair
the inherent flexibility of the paddle structure.” Erickson ¶ 48. Erickson
discloses that, in certain embodiments, the invention includes “providing the
body of the lead with at least one waisted region that effectively increases
the flexibility of the body.” Id. ¶ 15. Another object of Erickson is described
as including “certain features [in the lead] to increase the flexibility of such
lead, thus enhancing the steerability of such lead.” Id. ¶ 18. To drive the lead
forward, Erickson describes using a stylet. Id. ¶ 65. Based on Erickson’s
repeated requirement of a flexible lead (see also id. ¶¶ 40, 68, 69), we are
not persuaded by the Examiner’s argument that one of ordinary skill in the
art would have had a reason to make it stiffer using the materials in Desai.
Because the Examiner did not meet the burden of establishing prima facie
obviousness of the claims, we reverse the rejection of claim 1, and
dependent claims 2, 6, 9–17, and 21 that depend from claim 1 and
incorporate all its limitations.

REJECTION FURTHER BASED ON COLVIN
The Examiner further cited Colvin to meet limitations in the
dependent claims 3–5, 7, and 8. Final Act. 10. Because Colvin does not
make up for the deficiencies in Erickson and Desai, the rejection of these
claims is reversed.
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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–17, 21 112 Written
Description
1–17, 21
1, 2, 10, 15 103 Boling, Desai 1, 2, 10, 15
1, 2, 6, 9–
17, 21
103 Erickson, Desai 1, 2, 6, 9–
17, 21
3–5, 7, 8 103 Erickson, Desai,
Colvin
3–5, 7, 8
Overall
Outcome
1–17, 21

REVERSED