Medtronic, Inc.

Patent Trials and Appeals Board

Nov 25, 2020

2020002606 (P.T.A.B. Nov. 25, 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.
14/962,485 12/08/2015 Ronald A. DRAKE C0010473.USU2 6481
27581 7590 11/25/2020
Medtronic, Inc. (CVG)
8200 Coral Sea Street NE.
MS: MVC22
MINNEAPOLIS, MN 55112
EXAMINER
RODJOM, KATHERINE MARIE
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
11/25/2020 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):
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 RONALD A. DRAKE,
KEVIN R. SEIFERT,
LESTER O. STENER, and
AMY E. THOMPSON-NAUMAN

Appeal 2020-002606
Application 14/962,485
Technology Center 3700
____________

Before JENNIFER D. BAHR, JOHN C. KERINS, and
MICHAEL L. HOELTER, Administrative Patent Judges.

HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–8, 12–14, 19, and 20, which

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. 3.
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constitute all the claims pending in this application. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART the Examiner’s rejections of these claims.
CLAIMED SUBJECT MATTER
The disclosed subject matter “relates to implant tools and techniques
for implanting implantable medical leads or other implantable components
in extravascular locations.” Spec. ¶ 1. Apparatus claims 1 and 12 are
independent. Claim 1 is illustrative of the claims on appeal and is
reproduced below.
1. An implant tool for implanting an implantable medical
lead, implantable catheter or other implantable component
within a patient, the implant tool comprising:
an open channel delivery tool that includes:
a delivery tool handle, and
a delivery tool shaft, the delivery tool shaft having:
a proximal end adjacent to the delivery tool
handle, and
a distal end, and the delivery tool shaft
defining:
an arc-shaped open channel that is open
along an entire section of the delivery tool shaft
which extends from near the proximal end to the
distal end,
wherein a cross-section of the entire delivery tool
shaft along the entire section is arc-shaped; and
a bore-in mechanism configured to interact with the open
channel delivery tool.
EVIDENCE
Name Reference Date
Jones et al. US 5,755,697 May 26, 1998
Merdan US 2002/0068912 A1 Jun. 6, 2002
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Schulman et al. (“Schulman”) US 2006/0253181 A1 Nov. 9, 2006
Assell et al. (“Assell”) US 2007/0066977 A1 Mar. 22, 2007
Gerber US 2008/0103572 A1 May 1, 2008
Brannon US 2010/0268024 A1 Oct. 21, 2010
REJECTIONS
Claims 1–8, 12–14, 19, and 20 are rejected under 35 U.S.C.
§ 102(a)(1) as anticipated by Assell.
Claim 1 is rejected under 35 U.S.C. § 102(a)(1) as anticipated by
Schulman.
Claims 1 and 4–8 are rejected under 35 U.S.C. § 103 as unpatentable
over Schulman and Gerber.
Claims 1–3, 12–14, 19, and 20 are rejected under 35 U.S.C. § 103 as
unpatentable over Jones and Merdan.
ANALYSIS
The rejection of claims 1–8, 12–14, 19, and 20
as anticipated by Assell
Independent claim 1 recites a “delivery tool shaft having . . . an arc-
shaped open channel that is open along an entire section of the delivery tool
shaft.” Claim 1 further recites, “wherein a cross-section of the entire
delivery tool shaft along the entire section is arc-shaped.” Independent
claim 12 contains similar language.
The Examiner references Assell’s “delivery tool (1012)” as having a
shaft with “an open channel (1024/1036) that is open along an entire section
of the shaft.” Final Act. 4; see also Ans. 4 (“Assell teaches the tube (1012),
interpreted as the claimed ‘delivery tool shaft’”). The Examiner also finds
that the cross-section of the entire delivery tool shaft “is arc-shaped (arc
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shape formed by open channel 1024/1036 – Figs. 11A, 20A).” Final Act. 4;
see also Ans. 4.
Assell discloses tube 1012 having a “lumen or portal 1024” formed
longitudinally in a wall thereof. Assell ¶ 119, see also Assell Figs. 11A, B,
20 A, B. Assell specifically teaches that the wall surface of “tube 1012 is
milled or otherwise formed with a groove or tract 1036 that provides a
lumen 1024” therein. Assell ¶ 119. “In another embodiment, portal 1024 is
formed by molding or extrusion.” Assell ¶ 119. There is no indication that
groove 1036 extends all the way through the wall of tube 1012. Thus, while
the Examiner may be correct that lumen/groove 1024/1036 itself is open and
arc-shaped (see Final Act. 4; Ans. 6), there is no indication that, as per claim
1 (claim 12 is similar), “the entire delivery tool shaft along the entire section
is arc-shaped” because tube 1012 remains fully circumscribed or unbroken,
but with a grooved wall. See Assell Figs. 11A–13B, 20A, B.
Appellant explains, “a cross-section of the entire cannula tube 1012 is
not arc-shaped. Rather, the cross-section of cannula tube 1012 is round.”
Appeal Br. 7 (referencing Assell Fig 12A); see also Reply Br. 3–6.
For example, an interpretation of this claim language which
characterizes cannula tube 1012 as having an arc-shaped cross-
section due to portal 1024 is not reasonable, since portal 1024
represents a small indent in a wall of cannula tube 1012 and
does not cause the cross-section of cannula tube 1012 as a
whole to have an arc-shaped cross-section.
Appeal Br. 8; see also id. at 9; Reply Br. 3.
The Examiner replies that “[t]he circumference of the cannula tube is
clearly interrupted by the presence of the drill wire lumen or portal (1024),
thus creating the arc-shaped cross section.” Ans. 4. But, an irregularity in
the wall of the tube does not detract from the fact that the tube’s perimeter
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remains intact (i.e., 360 degrees) along its length. Additionally, even the
Examiner’s annotations depict tube 1012 with an unbroken enclosure (albeit
having a grooved sidewall). See Ans. 5. We thus disagree with the
Examiner’s finding that Assell’s grooved tube results in the tube having an
open or arc-shaped cross-section. See Ans. 5. Accordingly, we reverse the
Examiner’s rejection of claims 1–8, 12–14, 19, and 20 as being anticipated
by Assell.
The rejection of claim 1
as anticipated by Schulman
Claim 1 additionally recites, “a bore-in mechanism configured to
interact with the open channel delivery tool.” The Examiner has determined
that “‘bore-in mechanism’ has/have been interpreted under 35 U.S.C. 112(f)
or pre-AIA 35 U.S.C. 112, sixth paragraph” and that “the corresponding
structure may be found in paragraphs [0042]–[0045] and [0063]–[0067] of
Applicant’s specification.” Final Act. 3. Appellant’s Specification
preferentially describes bore-in mechanism 60 as a helical shape surrounding
a lumen through which the tool’s shaft passes. See Spec. ¶¶ 42, 44.
Paragraph 63 of Appellant’s Specification further discusses how the “bore-in
mechanism may be fixed at the distal end during the boring and traversing
process” and of “moving shaft 54 through the lumen of bore-in mechanism
60.” Paragraph 64 further explains that “the procedure described above can
be performed using a more conventional tunneling tool,” such as rods or
sheaths.
In rejecting claim 1, the Examiner equates Schulman’s needle 30 to
the recited bore-in mechanism. See Final Act. 7; Ans. 9. Appellant
disagrees with this correlation because “a person having ordinary skill in the
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art would not have characterized needle 30 of Schulman as being a ‘bore-in
mechanism.’” Appeal Br. 13; see also Reply Br. 8. Appellant contends that
“‘bore’ is defined by Merriam-Webster as ‘to pierce with a turning or
twisting movement of a tool,’” and that Schulman’s needle does not meet
this criteria.2 Appeal Br. 13; see also Reply Br. 8. Further, “[s]ince the
Examiner is interpreting ‘bore-in mechanism’ under 35 U.S.C. § 112, sixth
paragraph, Schulman must disclose actual performance of the alleged recited
function, boring in.” Appeal Br. 15; see also Reply Br. 8. In other words,
“[t]he Examiner has not established that Schulman's needle 30 is the same
as, or is a structural equivalent of, any of the example bore-in mechanisms
described in Appellant's disclosure.” Appeal Br. 15.
The Examiner contends that Schulman’s “needle (30) is fully capable
of being turned or twisted” (Ans. 9), but the Examiner does not explain how
a shaft will pass through Schulman’s needle so that the needle can be
deemed equivalent to the recited “bore-in mechanism” discussed in
Appellant’s Specification. See above. Accordingly, and based on the record
presented, we do not sustain the Examiner’s rejection of claim 1 as being
anticipated by Schulman.
The rejection of claims 1 and 4–8
as unpatentable over Schulman and Gerber
Appellant argues claims 1 and 4–8 together. See Appeal Br. 16–19.
We select claim 1 for review, with claims 4–8 standing or falling with claim
1. See 37 C.F.R. § 41.37(c)(1)(iv).

2 As per the Examiner, “[t]he term ‘bore’ is interpreted as a hole or hollow
passage and a bore-in mechanism may be any tool capable of forming a hole
or hollow passage.” Ans. 9.
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Here, the Examiner appears to be presenting an alternate interpretation
of Schulman from that above, stating that “Schulman fails to disclose a bore-
in mechanism,” and relying on Gerber for such structure. Final Act. 8; see
also Ans. 10. Appellant disagrees, stating that Schulman is directed to
placing electrodes “without causing any physical damage or injury thereto.”
Appeal Br. 17 (referencing Schulman ¶ 28); see also Reply Br. 9, 11.
Gerber, on the other hand and according to Appellant, is designed to pierce
through tissue and that “[p]iercing tissue and advancing a lead through tissue
represent ways of damaging tissue.”3 Appeal Br. 18. Thus, a skilled person
“would not have modified lead 18 of Schulman with the threaded fixation
structure 70 of Gerber . . . because the threaded fixation structure 70 would
cause damage to element 34 of Schulman.” Appeal Br. 19.
The Examiner contends that Appellant’s argument is premised on “a
narrow characterization of Schulman” because Schulman more specifically
teaches inserting a lead “adjacent to or in contact with the desired
neuromuscular pathway or (organ) 34.” Ans. 10 (referencing Schulman
¶ 19). In other words, Schulman teaches a desire to not damage the target
tissue, not that no injury of any kind is to occur. See Schulman ¶ 28 (“to
insure satisfactory electrical contact with element 34 without causing any
physical damage or injury thereto”). Hence, Appellant’s characterization of

3 Gerber also teaches that is some embodiments, “the thread structure may
not engage the adjacent tissue” until desired, and that “a sheath may be
configured to cover [Gerber’s] elongate member and thread structure,”
which may “be removed to allow the threaded fixation structure to contact
the adjacent tissue.” Gerber ¶ 28. Hence, it appears that Gerber also teaches
a desire to minimize or avoid damaging tissue.
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the teachings of Schulman is faulty, which undercuts the premise of
Appellant’s arguments, rendering them equally faulty.
Further, the Examiner explains that “[a] reference does not teach away
if it merely expresses a general preference for an alternative from amongst
options available to the ordinarily skilled artisan, and the reference does not
discredit or discourage investigation into the invention.” Ans. 11
(referencing In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
Appellant also addresses Schulman’s teaching of advancing the
electrode to a desired location and contends that Gerber teaches a like
objective. See Reply Br. 10–11. Consequently, since Schulman already
discloses this operation, “the disclosed objective of threaded fixation
structure 70 of Gerber is not necessary for the techniques disclosed by
Schulman.” Reply Br. 11. However, the Examiner did not rely on Gerber
based on acquiring a desired location, but instead “for the purpose of
securely attaching the lead to the target tissue within the patient.” Final Act.
8. As such, we are not persuaded the Examiner failed to provide articulated
reasoning with rational underpinning or that such reasoning fails to support
the Examiner’s conclusion of obviousness. See KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 418 (2007).
Accordingly, and based on the record presented, we are not persuaded
that the Examiner improperly combined Schulman and Gerber. We sustain
the Examiner’s rejection of claims 1 and 4–8.
The rejection of claims 1–3, 12–14, 19, and 20
as unpatentable over Jones and Merdan
For both independent claims 1 and 12, the Examiner identifies the
recited delivery tool as Jones’ “catheter 48,” but acknowledges that “Jones
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fails to disclose the delivery tool (catheter 48) comprises an arc-shaped open
channel as claimed.” Final Act. 9. The Examiner relies on Merdan for such
disclosure and reasons that it would have been obvious “to modify the
delivery tool (catheter 48) of Jones to include a support member having an
arc-shaped open channel” as disclosed by Merdan. Final Act. 9–10.
Appellant contends that if such a modification were to occur, “the
resulting device would not amount to ‘an open channel delivery tool that
includes . . . an arc-shaped open channel that is open along an entire section
of the delivery tool shaft.’” Appeal Br. 20. This is because “the gap
described by Merdan does not represent an open channel, since it is an
internal member of the catheter body.” Appeal Br. 21; Reply Br. 13. Hence,
the Examiner’s combination would result in an “outer sheath of [Jones]
catheter body [] disposed about the entire elongate support member –
including the gap.” Appeal Br. 21; Reply Br. 13.
There is merit to Appellant’s contention because the Examiner made
clear that the recited modification was “to include” Merdan’s support
member with Jones’ catheter 48. There is no indication that after such
inclusion, Jones’ catheter would be open or arc-shaped, and especially since
Jones’ catheter is “connected to an external fluid source.” Jones 7:2–4. In
other words, the Examiner does not explain why a skilled person, seeking to
provide fluid from an external source, would desire an open arc-shaped
catheter by which to deliver such fluid to a particular location within the
patient’s body. Further, the Examiner’s attempt to explain that Appellant’s
channel 56 is not “open” because it passes through Appellant’s bore-in
mechanism 60 (Ans. 11) is unavailing because an open channel being
sheathed along its length (as in the suggested combination) is not the same
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as an open-channelled delivery tool briefly passing through a separate
element, i.e., spaced-apart helix 64. See Spec. ¶ 43 (“Helix 64 has a pitch
(P1).”); Figs. 3, 4A, C.
Accordingly, we are not persuaded the Examiner has established by a
preponderance of the evidence that the combination of Jones and Merdan
would have rendered independent claims 1 and 12 obvious. We reverse the
Examiner’s rejection of claims 1–3, 12–14, 19, and 20.
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–8, 12–14,
19, 20
102(a)(1) Assell 1–8, 12–
14, 19, 20
1 102(a)(1) Schulman 1
1, 4–8 103 Schulman, Gerber 1, 4–8
1–3, 12–14,
19, 20
103 Jones, Merdan 1–3, 12–
14, 19, 20
Overall
Outcome4
1, 4–8 2, 3, 12–
14, 19, 20
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART

4 37 C.F.R. § 41.50(a)(1) states: “The affirmance of the rejection of a claim
on any of the grounds specified constitutes a general affirmance of the
decision of the examiner on that claim.”