Medtronic, Inc.

Patent Trials and Appeals Board

Mar 25, 2020

14620410 - (D) (P.T.A.B. Mar. 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.
14/620,410 02/12/2015 Andrea J. ASLESON C0010053.USU1/
LG10126.L33
5780
27581 7590 03/25/2020
Medtronic, Inc. (CVG)
8200 Coral Sea Street NE.
MS: MVC22
MINNEAPOLIS, MN 55112
EXAMINER
TEMPLETON, CHRISTOPHER L
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
03/25/2020 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 ANDREA J. ASLESON, RONALD A. DRAKE,
MARK T. MARSHALL, and KELLY M. WIEN
____________

Appeal 2019-005148
Application 14/620,410
Technology Center 3700
____________

Before CHARLES N. GREENHUT, WILLIAM A. CAPP, and
JEREMY M. PLENZLER, Administrative Patent Judges.

CAPP, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final
rejection of claims 1–3, 5–8, 10–14, 16, 17, and 22. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM IN PART.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies Medtronic, Inc. as the Applicant and
real party in interest. Appeal Br. 3.
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Application 14/620,410
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THE INVENTION
Appellant’s invention relates to surgical tools that provide access to
implant medical leads. Spec. 1. Claim 1, reproduced below, is illustrative
of the subject matter on appeal.
1. A medical access tool comprising:
a needle member including a proximal end, a piercing distal
tip, and a lumen, the needle member extending along a
longitudinal axis of the medical access tool between the
proximal end thereof and the piercing distal tip thereof, the
lumen extending from a proximal opening thereof at the
proximal end to a distal opening thereof at the distal tip;
a coiled wire extending around the longitudinal axis of the
medical access tool with a pitch, the coiled wire including a
proximal segment, a distal segment, and a tissue-engaging tip,
the coiled wire having an inner surface, the inner surface being
spaced radially apart from an outer surface of the needle
member along a length of the proximal segment, the distal
segment extending distally from the proximal segment to the
tissue-engaging tip, the distal tip of the needle member being
recessed proximally from the tissue-engaging tip by a fixed
distance equal to a length of the distal segment, and the coiled
wire having a stiffness that prevents significant deformation of
the pitch thereof during operation of the medical access tool,
wherein the coiled wire is configured to proximally pull tissue
up the coiled wire by rotating without advancing until the distal
tip passively pierces the tissue without advancing; and
a junction connecting the coiled wire to the medical access
tool, the junction being configured to prevent movement of the
coiled wire along the longitudinal axis of the medical access
tool relative to the needle member.

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Application 14/620,410
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THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
NAME REFERENCE DATE
Altman US 6,416,510 B1 July 9, 2002
Ryan US 2004/0002699 A1 Jan. 1, 2004
Rioux US 2008/0108950 A1 May 8, 2008
Kauphusman US 2009/0163862 A1 June 25, 2009
Gillies US 2012/0123461 A1 May 17, 2012
Smith US 2013/0178845 A1 July 11, 2013
Nita US 8,690,819 B2 Apr. 8, 2014
The following rejections are before us for review:2
1. Claims 1–3, 10–12, 16, and 17 are rejected under 35 U.S.C. § 103
as being unpatentable over Altman and Gillies.
2. Claims 7, 13, and 22 are rejected under 35 U.S.C. § 103 as being
unpatentable over Altman, Gillies, and Rioux.
3. Claim 5 is rejected under 35 U.S.C. § 103 as being unpatentable
over Altman, Gillies, and Nita.
4. Claims 1, 8, 12, and 14 are rejected under 35 U.S.C. § 103 as being
unpatentable over Ryan, Smith, and Gillies.
5. Claims 2 and 6 are rejected under 35 U.S.C. § 103 as being
unpatentable over Ryan, Smith, Gillies, and Kauphusman.
6. Claim 5 is rejected under 35 U.S.C. § 103 as being unpatentable
over Ryan, Smith, Gillies, Kauphusman, and Nita.

2 Rejections of claims 1–8, 10, and 11 under 35 U.S.C. § 112(b) and of
claim 4 under 35 U.S.C. § 103 have been withdrawn by the Examiner.
Ans. 11.
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7. Claims 11 and 17 are rejected under 35 U.S.C. § 103 as being
unpatentable over Ryan, Smith, Gillies, and Nita.
OPINION
Unpatentability of Claims 1–3, 5, 7, 10–13, 16, 17, and 22
over Combinations Based on Altman
We limit our discussion to the following claim language which is
where the dispute between the Examiner and Appellant centers:
wherein the coiled wire is configured to proximally pull tissue
up the coiled wire by rotating without advancing until the distal
tip passively pierces the tissue without advancing.
Claims App.
The Examiner concludes that claims 1–3, 5, 7, 10–13, 16, 17, and 22
are unpatentable as obvious over various combinations based on the Altman
reference. Final Act. 3–7. The Examiner’s rejections are predicated on a
factual finding that Altman’s needle is coiled “just like” Appellant’s needle
and, therefore, “is capable of pulling tissue up the coiled wire.” Id. at 4.
Appellant argues that Altman is designed and configured to penetrate
tissue by advancing by means of rotation. Appeal Br. 11. “Through such
rotation, the structure may be ‘screwed into the heart’ to travel to a target
site.” Id.
In response, the Examiner reiterates that Altman’s needle is coiled just
like Appellant’s needle and, therefore, is capable of pulling tissue up the
coiled wire. Ans. 11. The Examiner finds that Altman’s coiled wire can be
rotated without advancing by rotating element 102 with element 106 while
the coiled wire is advanced from 106. Id. at 12. Alternatively, the Examiner
finds that Altman’s coiled wire can be rotated without advancing by rotating
element 102 while proximally pulling element 106. Id.
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Altman is directed to a drug delivery catheter for cardiac procedures.
Altman, Abstract. Altman’s catheter includes a distal helical coil that
engages and penetrates the myocardium. Id. Altman’s helical coil 114 is
screwed into the heart by turning coil 102 inside outer catheter body 106.
Id. at col. 10, ll. 47–54. Fixed structure 130, on the inner wall of catheter
body 106, forces helical coil 114 to advance from the distal end of the
catheter when coil 102 and drug delivery tube 104 are rotated. Id.
The Examiner’s explanation as to how Altman is allegedly configured
to be capable of pulling tissue up the coiled wire is not supported by
evidence or sound technical reasoning. Ans. 14. The Examiner’s position
that coil 102 and body 106 could be rotated simultaneously is not well taken.
Altman is specifically configured so that coil 102 turns “inside of” body 106.
Altman, col. 10, ll. 47–49. Thus, coil 102 rotates in relation to body 106
such that the two elements are not configured to rotate in unison.
We find similarly unpersuasive the Examiner’s position that Altman’s
coil 114 could pull tissue without advancing by rotating element 102 and
simultaneously pulling on body 106 at the same pace that the coiled wire is
extended from 106. Ans. 14. As previously explained, Altman’s coil turns
relative to body 106. Altman, col. 10, ll. 47–49. Such turning causes the
intended result of tip 132 advancing with respect to the distal end of
body 106, thereby advancing into and penetrating a patient’s tissue. Id.
Essentially, the Examiner considers that a user could thwart such intended
and designed advance into body tissue by pulling body 106 away from the
body tissue at the same rate of motion that tip 132 is advancing distally from
body 106 as coil 102 is rotated. Whether such a non-intended use is feasible
for a skilled medical practitioner is a matter of pure speculation on the
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Examiner’s part. Here, the Examiner is proposing to operate Altman in a
manner that runs counter to the manner in which it is “configured to”
operate. Thus, it cannot be said to be “configured to” operate in the manner
proposed by the Examiner.
The Examiner’s finding that Altman is configured to pull tissue up by
rotating without advancing or is at least capable of doing so is not supported
by a preponderance of the evidence and, therefore, constitutes reversible
error. 3
The Examiner’s error infects independent claims 1 and 12, as well as
all claims that depend therefrom that are rejected over combinations based
on Altman. Consequently, we do not sustain the Examiner’s unpatentability
rejections of claims 1–3, 5, 7, 10–13, 16, 17, and 22 over combinations
based on Altman.
Unpatentability of Claims 1, 8, 12, and 14
over Ryan, Smith, and Gillies
Claims 1 and 8
Appellant argues claims 1 and 8 as a group. Appeal Br. 30. We select
claim 1 as representative. See 37 C.F.R. § 41.37(c)(1)(iv).
The Examiner finds that Ryan discloses the invention substantially as
claimed except for a lumen, for which the Examiner relies on Smith. Final
Act. 7–8. The Examiner further finds that Ryan is capable of pulling tissue
as claimed and that Gillies specifically teaches that it was known to

3 In the Answer, the Examiner, for the first time, alleges that claims 1–3, 10–
12, 16, and 17 are anticipated by Altman under 35 U.S.C. § 102(a)(1).
Ans. 3. We do not sustain the Examiner’s alternative Section 102 rejection
for essentially the same reasons discussed herein regarding erroneous
findings of fact with respect to whether Altman is configured to pull tissue
as claimed.
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configure and use a coiled wire to proximally pull tissue by rotating the wire
without advancing until distal tip (106) passively pierces the tissue. Id. at 8.
The Examiner concludes that it would have been obvious to a person of
ordinary skill in the art at the time of the invention to combine the teachings
of Ryan, Smith, and Gillies to achieve the claimed invention. Id. at 9.
According to the Examiner, a person of ordinary skill in the art would have
done this to access anatomical spaces. Id.
Appellant argues that the prior art fails to disclose a coiled wire that is
configured to proximally pull tissue up the coiled wire by rotating without
advancing until the distal tip passively pierces the tissue without advancing
as recited in claim 1. Appeal Br. 31. Appellant argues that the intended
purpose of Ryan is screwing a probe into a resistant tissue mass using a
helical needle. Id. at 32. Appellant argues that using Ryan in a manner as
taught by Gillies to pull tissue up a helical tine would frustrate the intended
purpose of Ryan. Id. at 33.
In response, the Examiner notes that Appellant fails to disclose any
structure other than the coiled shape that can pull tissue up the coiled wire.
Ans. 16. The Examiner infers that Ryan is configured to proximally pull
tissue up the coiled wire by rotating without advancing since it has a coiled
shape similar to that of Appellant. Id.
The coiled wire of Ryan is coiled just like Appellant’s, and thus
is capable of pulling tissue up the coiled wire. Appellant has
not disclosed any structure other than the coiled shape that can
pull tissue up the coiled wire; thus the coiled wire of Ryan is
configured to proximally pull tissue up the coiled wire by
rotating without advancing since it has a coiled shape.
Id. at 17.
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In reply, Appellant directs our attention to the “junction” recited in
claim 1 as structure that enables the coiled wire to pull tissue without
advancing as claimed. Reply Br. 11.
Ryan is directed to a helical needle that is attached to a surgical probe
to aid in the insertion of the probe into a tissue mass. Ryan, Abstract. Ryan
features probe 10 that includes needle like element 14 with a distal end 16
that is surrounded by helical needle 12. Id. ¶ 26, Fig. 1. Distal end 16 of
needle-like element 14 is terminated by a sharp tip 24 for entering a tissue
mass 28. Id. The proximal end 20 of needle-like element 14 includes a
handle member 32 having a pair of opposing turning tabs 34a, 34b attached
to the exterior wall surface 22 for rotating helical needle 12 and probe 10.
Id. Tip 46 of helical needle 12 is spaced longitudinally and distally from
tip 24 of needle-like element 14. Id.
The proximal end of Ryan’s helical needle 12 is attached to needle-
like element 14 at attachment section 48. Id. ¶ 27, Fig. 1. Attachment
section 48 of helical needle 12 is affixed to the elongated shaft section 18 of
element 14 such that helical needle 12 and needle-like element 14 cannot be
moved in a rotational or axial direction independently of each other. Id.
¶ 28, Fig 1.
The above referenced disclosure from paragraph 28 of Ryan
effectively refutes Appellant’s argument that the “junction” recited in
Appellant’s claim 1 structurally differentiates Ryan from the claimed
invention. Attachment section 48 of Ryan corresponds to Appellant’s
claimed juncture. See Appellant’s Fig. 3A.
We agree with the Examiner’s position that Ryan is capable of pulling
tissue as claimed. Although Ryan’s primary purpose is to advance into
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tissue mass in a screw-like manner, such does not negate the fact that it is
capable of being used for other purposes. “A reference may be read for all
that it teaches, including uses beyond its primary purpose.” In re
Mouttet, 686 F.3d 1322, 1331 (Fed. Cir. 2012), citing KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418–421 (2007). “It is well settled that the
recitation of a new intended use for an old product does not make a claim to
that old product patentable.” In re Schreiber, 128 F.3d 1473, 1477 (Fed.
Cir. 1997).
In view of the foregoing discussion, we determine the Examiner’s
findings of fact are supported by a preponderance of the evidence and that
the Examiner’s legal conclusion of unpatentability is well-founded. We
sustain the Examiner’s unpatentability rejection of claims 1 and 8 over
Ryan, Smith, and Gillies.
Claims 12 and 14
Appellant argues independent claim 12 and claim 14 that depends
therefrom as a group. Appeal Br. 35–39. We select claim 12 as
representative. 37 C.F.R. § 41.37(c)(1)(iv).
In traversing the rejection, Appellant raises the same argument about
the helical coil pulling tissue that we considered and found unpersuasive
with respect to claim 1 and find equally unpersuasive here. Appeal Br. 36.
Appellant next argues that the prior art fails to disclose or suggest a
proximal end of the needle lumen being configured to engage with a
connector of a syringe assembly as claimed. Id. In response, the Examiner
directs our attention to elements 40, 42, and 44 of Smith as allegedly
corresponding to Appellant’s needle element. Ans. 19. In reply, Appellant
argues that the proximal end of element 42 is always encased with actuator
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element 44 and, therefore, would not be configured to engage with a
connector of a syringe assembly. Reply Br. 14.
Smith discloses an integrated catheter assembly. Smith, Abstract.
Smith’s tool 40 includes needle 42 that allows injections of fluids, drugs,
and further can apply suction. Id. ¶¶ 24–25. Actuator 44 has a Luer-type
fitting that allows passage of fluids for injection. Id.
Having considered the competing positions of Appellant and the
Examiner, we find the Examiner’s position more persuasive. Smith’s
disclosure of a Luer-type fitting that allows passage fluids for injection
satisfies the disputed claim language regarding a lumen in fluid
communication with an interior of a barrel of a syringe assembly. We
sustain the Examiner’s unpatentability rejection of claims 12 and 14 over
Ryan, Smith, and Gillies.
Unpatentability of Claims 2, 5, 6, 11, and 17
Over Combinations Based on Ryan, Smith, and Gillies
In traversing these grounds of rejection, Appellant relies solely on
arguments that we previously considered and found unpersuasive with
respect to either claim 1 and/or claim 12 and find equally unpersuasive here.
Appeal Br. 40–42. We sustain the Examiner’s unpatentability rejections of
claims 2, 5, 6, 11, and 17 over combinations based on Ryan, Smith, and
Gillies.

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11
CONCLUSION
Claims
Rejected
§ References Aff’d Rev’d
1-3, 10-12,
16, 17 103 Altman, Gillies
1-3, 10-12,
16, 17
7, 13, 22 103 Altman, Gillies, Riox 7, 13, 22
5 103 Altman, Gillies, Nita 5
1, 8, 12, 14 103 Ryan, Smith, Gillies 1, 8, 12, 14
2, 6 103 Ryan, Smith, Gillies, Kauphusman 2, 6

5 103 Ryan, Smith, Gillies, Kauphusman, Nita 5

11, 17 Ryan, Smith, Gillies, Nita 11, 17

Overall
Outcome
1, 2, 5, 6,
8, 11, 12,
14, 17
3, 7, 10, 13,
16, 22

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).
AFFIRMED IN PART