Ex Parte Brady et al

Patent Trial and Appeal Board

Feb 5, 2013

10753979 (P.T.A.B. Feb. 5, 2013)

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.
10/753,979 01/08/2004 Martin Brady SCHWP0211USA 6449
46140 7590 02/05/2013
DON W. BULSON (BRAI)
RENNER, OTTO, BOISSELLE & SKLAR, LLP
1621 EUCLID AVENUE - 19TH FLOOR
CLEVELAND, OH 44115
EXAMINER
SCHELL, LAURA C
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
02/05/2013 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MARTIN BRADY and CHRISTOPH PEDAIN
____________

Appeal 2010-006420
Application 10/753,979
Technology Center 3700
____________

Before MICHAEL L. HOELTER, RICHARD E. RICE and
CARL M. DeFRANCO, Administrative Patent Judges.

RICE, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Martin Brady, et al. (Appellants) seek our review under 35 U.S.C.
§ 134 of the Examiner’s rejection of claims 1-4, 6-8 and 11-25. Claims 5, 9
and 10 are canceled. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.

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The Claimed Subject Matter
The claimed subject matter “relates generally to catheters, and
particularly, but not by way of limitation, to a device for use in inserting a
catheter into tissue.” Spec. 1. Claim 1, reproduced below, is representative
of the subject matter on appeal:
1. A system comprising a flexible
tubular infusion catheter; a hollow rigid tube
including a proximal end and a distal end and a
lumen extending therebetween, wherein the hollow
tube is shaped and sized to permit insertion into a
lumen of the infusion catheter, and wherein the
hollow tube is stiffer than the infusion catheter
such that the hollow tube acts as a stylet for
guiding the catheter through tissue to a target
location in a patient's body; a positioning system
that can be coupled to an image-guided surgical
workstation; and a remotely detectable locator on
the hollow rigid tube trackable by the positioning
system as the hollow rigid tube is tunneled through
tissue in the patient’s body toward the target
location whereby the progress of the locator can be
tracked and thus the position of the hollow rigid
tube can be positionally tracked by the positioning
system for proper positioning of the infusion
catheter in relation to the patient's body into which
the hollow rigid tube and catheter have been
inserted and displayed on a monitor of the image-
guided surgical workstation.
The Rejections
The Examiner makes the following obviousness rejections under 35
U.S.C. § 103(a):
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(1) claims 1-4, 6, 8, 11, 12 and 16-25 over Elsberry (US 5,603,703,
iss. Feb. 18, 1997), Thomas (US 5,342,383, iss. Aug. 30, 1994) and
Rosenman (US 2006/0084943 A1, pub. Apr. 20, 2006);
(2) claims 7 and 15 over Elsberry, Thomas, Rosenman and
Maginot (US 6,743,218 B2, iss. Jun. 1, 2004); and
(3) claims 13 and 14 over Elsberry, Thomas, Rosenman and Hogan
(US 5,137,515, iss. Apr. 11, 1992).

OPINION
Rejection (1) − Claims 1-4, 6, 8, 11, 12 and 16-25
Appellants separately argue claims 1, 2, 11, 16 and 18. App. Br. 13-
18. We select claims 3, 4, 6, 12, 24 and 25 to stand or fall with claim 1;
claim 17 to stand or fall with claim 16; and claims 19-23 to stand or fall with
claim 18. See 37 C.F.R. § 41.37(c)(1)(vii) (2011).
Claim 1
The Examiner finds that Elsberry discloses substantially all of the
limitations of claim 1, but “does not disclose that the hollow rigid tube
(stylet) has a remotely detectable locator positioned on the tube allowing the
stylet to be tracked by a positioning system for proper positioning of the
catheter within the patient’s body.” Ans. 6. The Examiner finds that
Thomas discloses a stylet (obturator) for use with a catheter having a
radiopaque material at its tip that can be tracked radiographically when
positioned within the patient’s body. Id. (citing Thomas, abstract; col. 3,
ll. 10-18). The Examiner finds that Rosenman discloses the use of
fluoroscopy to track radiographically a similar medical device (Ans. 6-7
(citing Rosenman, para. [0042])) and further that “[i]t is well known to one
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of ordinary skill in the art [that] fluoroscopy involves imaging the patient
and the device within the patient and displaying the resulting images on the
monitor of a surgical guided work station” (Ans. 7). The Examiner
concludes that “it would have been obvious to one of ordinary skill in the art
at the time of the invention to have modified Elsberry with the remotely
detectable radiopaque locator, as taught by Thomas and further supported by
Rosenman, . . . in order to provide a guiding and positioning system to
properly and accurately position the catheter and stylet for treatment.” Id.
Appellants contest the Examiner’s rejection of claim 1 on two
grounds. First, Appellants argue that the Examiner’s reason for combining
Elsberry, Thomas and Rosenman is improper. App. Br. 13-15; Reply Br. 2.
Appellants contend that the teachings of neither Elsberry nor Thomas
suggest the combination. App. Br. 13-15. In particular, Appellants argue
that the skilled person would not have looked to Thomas for improvements
in the device of Elsberry because Thomas’ obturator extends beyond the
lumen into which it is inserted and Elsberry’s stylet does not. Id. at 15.
Second, Appellants argue that claim 1 recites features relating to “real-time,
or online, tracking,” such that “the position of the remotely detectable
locator is tracked as the rigid tube is tunneled through the tissue in the
patient’s body,” and that “[n]either Elsberry nor Thomas offer any
suggestion of this real time tracking.” Id. at 15-16. Appellants assert that
tracking based on radiography, as disclosed in Thomas, is “offline or static”
in contrast with Appellants’ image-guided surgery, in which the surgeon
“uses indirect visualization to operate, i.e. by employing imaging
instruments in real time.” Id. at 15; Reply Br. 3-4 (referencing a definition
of “image-guided surgery” in Wikipedia). Appellants contend that
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fluoroscopy does not employ continuous or uninterrupted (real-time)
tracking as claim 1 requires. Reply Br. 4.
In response to Appellants’ second argument, the Examiner contends
that Appellants have “not claimed ‘real time tracking’ within the claim
language” and, further, that the Specification “does not define the ‘image-
guided surgical workstation’ as needing to provide real time tracking.” Ans.
9. The Examiner further contends that
. . . even if Appellant[s] had support for real time tracking, the
tracking of Thomas’ radiopaque marker via fluoroscopy (as
Rosenman discloses) could be considered real time tracking.
Fluoroscopy involves taking a radiographic image of the
marked device in the patient, and then viewing the image on a
screen to ensure that the device is in the correct position. The
device can then be moved/adjusted further within the patient
and another image can be taken to ensure correct placement,
and then the device can be moved further, another image taken,
and so on. This may be a bit slower of a process, but it can be
considered to be done in real time.
Id. at 9-10.
On this record, Appellants have not persuaded us of error in the
Examiner’s rejection of claim 1. An express teaching, suggestion or
motivation to combine references is not required to support a conclusion of
obviousness based on the combination of the references. KSR Int’l Co. v.
Teleflex, Inc., 550 U.S. 398, 418 (2007). Thus, Elsberry need not expressly
teach that its stylet could be improved by incorporating a radiopaque marker
at its tip. See App. Br. 13-14. Nor is it fatal to the combination that
Thomas’ obturator extends beyond the lumen into which it is inserted and
Elsberry’s stylet does not (see id. at 15), because the proper legal standard is
not whether Thomas’ device can be bodily incorporated into Elsberry’s
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device. See In re Young, 927 F.2d 588, 591 (Fed. Cir. 1991) (The test for
obviousness is not whether the features of a secondary reference may be
bodily incorporated into the structure of the primary reference, nor is it that
the claimed invention must be expressly suggested in any one or all of the
references.). We determine that the Examiner’s conclusion of obviousness
is supported by adequate articulated reasoning with rational underpinning.
Further, we agree with the Examiner that Appellants have not claimed
“real-time” tracking, either expressly or implicitly. See Ans. 9. Appellants
rely on the language of claim 1 reciting “a positioning system that can be
coupled to an image-guided surgical workstation” and
a remotely detectable locator . . . trackable by the positioning
system as the hollow rigid tube is tunneled through tissue in the
patient’s body . . . whereby the progress of the locator can be
tracked and thus the position . . . can be positionally tracked . . .
for proper positioning of the infusion catheter in relation to the
patient's body into which the hollow rigid tube and catheter
have been inserted and displayed on a monitor of the image-
guided surgical workstation (emphasis added).
See App. Br. 15-16; Reply Br. 2-3. However, the only portion of this claim
language that speaks to time is the phrase “as the hollow rigid tube is
tunneled through tissue in the patient’s body.” In this context, the broadest
reasonable construction of “as” is “while.”1 This claim construction is

1 E.g., WEBSTER’S THIRD NEW INTERNATIONAL DICTIONARY OF THE ENGLISH
LANGUAGE UNABRIDGED (1971) at 125. During examination, the PTO gives
claims “their broadest reasonable construction consistent with the
specification.” In re Suitco Surface, Inc., 603 F.3d 1255, 1259 (Fed. Cir.
2010) (quoting In re ICON Health & Fitness, Inc., 496 F.3d 1374, 1379
(Fed. Cir. 2007)).
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consistent with the Specification.2 Thus, claim 1 is not limited to continuous
or uninterrupted (real-time) trackability as Appellants contend (see Reply
Br. 4), but rather more broadly encompasses a detectable locator that is
trackable utilizing periodic images taken while the hollow tube is tunneled
through tissue in the patient’s body. See Ans. 9-10. In view of this claim
construction, Appellants have not persuaded us that the Examiner erred in
finding that Thomas and Rosenman, in combination with Elsberry, disclose
the claimed tracking.3
Accordingly, we sustain the rejection of claims 1, 3, 4, 6, 12, 24 and
25.
Claim 2
Claim 2 calls for the proximal end of the hollow tube to be configured
to be closed to retain fluid within the lumen of the hollow tube. Appellants
contend that backfill opening 24 precludes valve 12 of Elsberry’s stylet
(hollow tube) from being closed to retain fluid. App. Br. 16-17; Reply Br. 5.
The Examiner responds, and we agree, that valve 12 can be closed to retain
fluid within the hollow tube. See Ans. 10; see Elsberry, col. 4, ll. 24-28,

2 Spec. 7 (“As the hollow-tube stylet 110 and the catheter 140 are tunneled
through tissue toward a desired target, the locator’s progress is tracked and
displayed on a monitor of the ICS workstation.”) (bold omitted).
3 Appellants do not dispute that fluoroscopy, as disclosed in Rosenman, can
be used to take periodic images of a radiopaque marker while a hollow tube
is tunneled through tissue in a patient’s body and to display the images on
the monitor of an image-guided surgical work station. See Ans. 6-7 and 9-
10; Reply Br. 4 (“The Examiner correctly observes that fluoroscopy involves
taking a radiographic image and that such an image can be used to determine
if a device is in the correct position. In order to take such an image, the
surgical procedure must be interrupted to allow the image to be taken.”).
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l. 56 – col. 5, l. 3. Appellants do not address Elsberry’s express disclosure
that valve 12 may be closed in order to retain fluid within the stylet.4
Accordingly, we sustain the rejection of claim 2.
Claim 11
Dependent claim 11 recites “[t]he system of claim 1, including the
image-guided surgical workstation coupled to the positioning system.”
Appellant argues that “[f]or the reasons discussed above regarding real time
tracking, the feature of claim 11 further distances the system from the prior
art.” App. Br. 17. For the reasons discussed supra with respect to claim 1
and real-time tracking, we sustain the rejection of claim 11.
Claim 16
Claim 16 is independent and pertinently recites “at least a portion of
an inner diameter of the flexible infusion catheter snugly seals to an outer
diameter of the hollow tube to prevent air from passing therebetween as the
hollow tube is withdrawn from the flexible infusion catheter.” Claim 16 also
pertinently recites “a positioning system that can be coupled to an image-
guided surgical workstation; and a remotely detectable locator on the hollow
rigid tube trackable by the positioning system as the hollow rigid tube is
tunneled through tissue in the patient’s body,” similar to claim 1.

4 “The backfill opening 24 allows fluid to flow from within the stylet to fill
the annular space between the catheter and the stylet. Such flow is
necessary in creating an air-free fluid column within the catheter/stylet
assembly.” Col. 4, ll. 24-28. “Once catheter 18 and lower stylet body
portion 16 are filled with fluid, valve assembly 12 is closed to prevent any
fluid communication between the upper and lower stylet body portion 14,
16. At this point, the catheter/stylet assembly may be inserted to a desired
location within the patient's body in a conventional manner.” Col. 4, l. 65 –
col. 5, l. 3.
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Appellants make the same arguments for claim 16 as for claim 1.
App. Br. 17. We are not persuaded by these arguments as discussed supra
with respect to claim 1.
Appellants additionally argue that the backfill opening 24 of
Elsberry’s stylet (hollow tube) allows air to pass between the catheter and
the hollow tube as the hollow tube is withdrawn from the catheter. Id. at 17;
Reply Br. 6. However, the Examiner responds, and we agree, that
. . . Elsberry provides element 22 (sealing means) which
allows a portion of the inner tube to seal snugly against the
inner surface of the catheter. . . . Elsberry discloses that [] when
the device is filled with fluid prior to insertion in the patient, the
device is filled such that it is an air-free column of fluid (col. 4,
lines 60-65). Therefore there is no air present within the
assembly. Once the assembly is tunneled into the patient, the
inner tube is withdrawn from the catheter and the vacuum
created between the catheter and the inner tube pulls the fluid
from the inner tube so that it empties into the catheter. Since
the assembly was filled such that it was “air-free”, no air would
pass between the two tubes despite the presence of hole 24.
Ans. 11. We are not persuaded by Appellants’ conclusory argument in reply
that “once the seal (22) is broken, air can pass into the inner tube as is
intended by Elsberry.” Reply Br. 6. Appellants do not explain why seal 22
would necessarily be broken as the stylet (inner tube) is withdrawn or where
Elsberry discloses the intention to pass air into the inner tube.
Accordingly, we sustain the rejection of claims 16 and 17.
Claim 18
Appellants make the same arguments for claim 18 as for claim 1.
App. Br. 17-18. For the reasons discussed supra with respect to claim 1, we
sustain the rejection of claims 18-23.
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Rejection (2) – Claims 7 and 15
Claim 7
Claim 7 recites “[t]he system of claim 6, in which the proximal end of
the tubular catheter includes a clamp that closes around the hollow tube.”
The Examiner’s position is that Maginot discloses a clamp to be used at the
proximal end of a catheter to prevent any fluid flow through the catheter
system and that Maginot’s clamp would have been used by the skilled
person in the combination of Elsberry, Thomas, Rosenman and Maginot “to
provide another mechanism in which [to] stop the flow of fluid through the
hollow tube.” Ans. 7-8. However, the Examiner’s reasoning does not
adequately explain where Maginot discloses or suggests a clamp at the
proximal end of the catheter that closes around the hollow tube, as claimed,
or why the person of ordinary skill in the art would want to stop the flow of
fluid through the hollow tube at the proximal end of the catheter. As recited
in claim 6, from which claim 7 depends, the proximal end of the catheter
“sealingly engages around the hollow tube.” See App. Br. 18-19; Reply Br.
7; Spec. 5, fig. 1 (encircling clamp 165).
Accordingly, we do not sustain the rejection of claim 7.
Claim 15
Dependent claim 15 calls for “a clamp sized and shaped to pinch off a
portion of the hollow tube.” The Examiner’s reasoning for the rejection of
claim 15 is the same as for claim 7. Ans. 7-8, 12. Here, however,
Appellants have not persuaded us that the Examiner erred in finding that it
would have been obvious to one skilled in the art to employ Maginot’s
clamp “in order to provide another mechanism in which [to] stop the flow of
fluid through the hollow tube.” Id. at 7-8; see also App. Br. 18-19 and
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Reply Br. 7; Spec. 6 (“the proximal end of the hollow stylet 110 can be
temporarily sealed using a cap or clamp”).
Accordingly, we sustain the rejection of claim 15.
Rejection (3) – Claims 13 and 14
The Examiner’s position is that Hogan discloses a cap/plug for the
end of a hollow tube and that Maginot’s clamp/plug would have been used
by the skilled person in the combination of Elsberry, Thomas, Rosenman
and Hogan “to provide mechanisms to seal the end of the hollow tube.”
Ans. 8. We are not persuaded by Appellants’ argument (App. Br. 20) that
Hogan does not teach the use of the disclosed cap/plug in “a system like that
shown in Elsberry.” See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 127
(2007) (stating that “if a technique has been used to improve one device, and
a person of ordinary skill in the art would recognize that it would improve
similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”).
Accordingly, we sustain the rejection of claims 13 and 14.

DECISION
We affirm the rejections under 35 U.S.C. § 103(a) of claims 1-4, 6, 8
and 11-25.
We reverse the rejection under 35 U.S.C. § 103(a) of claim 7.

AFFIRMED-IN-PART

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