Ex Parte Schneider et al

Patent Trial and Appeal Board

Oct 16, 2012

11646744 (P.T.A.B. Oct. 16, 2012)

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.
11/646,744 12/27/2006 Clint Schneider 0B-047303US 9606
55714 7590 10/16/2012
ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION
Kite & Key, LLC
P.O. Box 315
Hamel, MN 55340-0315
EXAMINER
SHUMATE, VICTORIA PEARL
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
10/16/2012 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 CLINT SCHNEIDER, JOSHUA L. DUDNEY,
RICHARD E. STEHR, TROY TEGG, MICHAEL C. BEDNAREK,
GUY P. VANNEY, JAMES JENSEN, and
MICHAEL STINE
__________

Appeal 2011-011275
Application 11/646,744
Technology Center 3700
__________

Before ERIC GRIMES, MELANIE L. McCOLLUM, and SHERIDAN K.
SNEDDEN, Administrative Patent Judges.

SNEDDEN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to control
handles for catheters and other elongate medical devices. The Examiner has
rejected the claims as anticipated and obvious. We have jurisdiction under
35 U.S.C. § 6(b). We reverse.

Appeal 2011-011275
Application 11/646,744

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STATEMENT OF THE CASE
According to Appellants, the invention relates to control handles, for
catheters and other elongate medical devices, that include “an actuator and
an autolocking mechanism that holds the actuator in a displaced position
without additional user input (e.g., without requiring the user to hold the
actuator in the displaced position), which in turn holds the distal end of the
medical device in a deflected position.” (App. Br. 6.) The structure of the
autolocking mechanism, or force-generating mechanism, is illustrated in
Figure 2, reproduced below.

Figure 2 is described in the Specification as follows:
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Application 11/646,744

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In another embodiment, as illustrated in FIG. 2, an auto-
locking mechanism 54 pivotally couples the first actuator 20 to
the lower grip portion 24b and can include one or more washers
56, a bushing 58 and a screw 60, e.g., a hex-head screw, for
attaching the auto-locking mechanism 54 as an integral unit to a
pivot base 62 on the lower grip portion 24b. As shown in FIG.
2, each washer 56 can be the same or different.

(Specification, ¶ 0092.)
Claims 1-8, 12-18, 21, 22, and 24 are on appeal. Claims 1, 12, 22 and
24 are independent. Claims 1, 22 and 24 are representative and read as
follows:

1. A catheter handle for use with a catheter, the handle
comprising
a grip portion;
an actuator that is bi-directionally displaceable via
operator input from a neutral position laterally relative to the
grip portion; and
an auto-locking mechanism having a single operational
state in which it generates a force sufficient to hold the actuator
in a displaced position.

22. A system comprising
a catheter having a catheter shaft with a proximal portion
and a distal portion;
a handle attached to the proximal portion, the handle
comprising a user-operated actuation means and means for
generating a force sufficient to retain the actuation means into a
position set by an operator, wherein the force-generating means
maintains a substantially constant force on the actuation means.

24. A catheter comprising
a catheter shaft with a proximal portion and a distal
portion;
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Application 11/646,744

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a handle attached to the proximal portion, the handle
comprising a user-operated actuator and a means, having a
single mode of operation, for automatically generating a
substantially constant force sufficient to retain the actuator in a
position set by an operator.

The claims stand rejected as follows:
I. Claims 1, 2, 12, 13, 21, 22, and 24 under 35 U.S.C. 102(b) as being
anticipated by Muller (USPGPub 2003/0149422 A1, August 7, 2003).
II. Claims 3-5 and 14-16 under 35 U.S.C. 103(a) as being unpatentable
over Muller in view of Wilson (US 4,196,730, April 8, 1980).
III. Claims 1, 6, 12, and 17 under 35 U.S.C. 102(b) as being anticipated
by Rosenman et al. (USPGPub 2002/0082584 A1, June 27, 2002).
IV. Claims 7, 8, and 18 under 35 U.S.C. 103(a) as being unpatentable
over Rosenman et al in view of the Standard Handbook of Machine
Design 6.40-6.49 (The McGraw-Hill Companies, 3th ed., 2004).

I.
Issue
The Examiner has rejected claims 1, 2, 12, 13, 21, 22, and 24 under 35
U.S.C. 102(b) as anticipated by Muller. The Examiner finds that Muller
discloses a steering catheter having all elements of the claims, including a
single operational state where the terms “single operational state” or “single
mode of operation” are interpreted to include a plurality of single operational
states or modes of operation selectable for use by a physician. (Ans. 4-5 and
9.)
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Application 11/646,744

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Appellants contend that Muller “requires a second operational state - a
non-ratcheted state - where the alleged auto-locking mechanism is not
engaged - for smooth actuation of its catheter” and that Appellants’ claimed
device requires no such second state. (Reply. Br. 4, citing Muller at
¶ [0038].)
The issue with respect to this rejection is: Whether the Examiner erred
by rejecting the claims as being anticipated by Muller based on finding that
Muller’s steering catheter has a “single operational state” or “single mode of
operation.”
Findings of Fact
FF1. Muller discloses a steerable catheter that is “operable in a first
mode for smooth steering movement of a tip of an elongated tube and a
second mode for ratcheted steering movement of the tip of the elongated
tube.” (Muller 1, ¶ 0007.)
FF2. Figures 2 and 4 of Muller are reproduced below:
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Application 11/646,744

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Figures 2 and 4 illustrate the steerable catheter of Muller that includes
a locking mechanism and are summarized in the following passage:
[T]he locking tab 58 includes a planar portion 70 and a
generally cylindrical post 72 which extends from the planar
portion 70. The generally cylindrical post 72 extends through
an aperture 74 in the guide wheel 40 as shown in FIG. 4. To
prevent rotation of the locking tab 58 relative to the guide
wheel 40, the planar portion 70 is positioned between a pair of
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flange elements 76 on the back surface of the guide wheel 40.
The planar portion 70 is spaced from a rear surface of the guide
wheel 40 by a pair of stand-off segments 78. …[T]he stand-off
segments 78 normally provide a space between the pluralities of
teeth 66 and 68. In a manner to be discussed below, the planar
portion 70 can be biased such that the pluralities of teeth 66 and
68 engage.
…
In the first mode, the actuation member 62 is translated in the
direction of arrow A (see FIG. 2) and the planar portion 70 of
the locking tab 58 is adjacent the lower segment 88. In this
position, the standoff segments 78 of the locking tab 58
normally maintain a space between the pluralities of locking
teeth 66 and 68 and smooth movement of the guide wheel 40 is
permitted for steering the distal end of the tip 32. In a second
mode of operation, the actuation member 62 is translated in the
direction of arrow B (see FIG. 2) and the planar portion 70 of
the locking tab 58 is adjacent the upper segment 90 of the
actuation member 62. In this position, the actuation member 62
forces the pluralities of teeth 66 and 68 into engagement and
movement of the guide wheel 40 relative to the housing 12 is
ratcheted.
(Muller, ¶¶ 0037 and 0038; emphasis added.)
FF3. The Examiner finds that “the device of Muller has a ratcheted
state, which in itself is a single operational state, regardless of the presence
of additional modes of operation (which, would each themselves be a ‘single
operational state’).” (Ans. 9.) That is, the “single operational state or single
mode of operation is selected from a plurality of single operational states or
modes of operation for use by a physician.” (id.)
FF4. Regarding claim 22, the Examiner finds that “the force of the
teeth of the ratchet mechanism pressing against one another … is the force-
generating means relied on in the rejection with regard to the Muller
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reference, and no argument toward an adjustable force-generating means
was made.” (Ans. 10.)
Principles of Law
“[U]nless a prior art reference discloses within the four corners of the
document not only all of the limitations claimed but also all of the
limitations arranged or combined in the same way as recited in the claim, it
cannot be said to prove prior invention of the thing claimed and, thus, cannot
anticipate under 35 U.S.C. § 102. ” Net MoneyIN, Inc. v. VeriSign, Inc.,
545 F.3d 1359, 1371 (Fed. Cir. 2008).
“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000). However, a claim element cannot be
interpreted so broadly so as to read the limitation out of the claim. See Texas
Instr. Inc. v. United States Int’l Trade Comm’n, 988 F.2d 1165, 1171 (Fed.
Cir. 1993) (Claim language cannot be mere surplusage. An express
limitation cannot be read out of the claim).

Analysis
Muller expressly discloses a locking mechanism that permits the
smooth movement of the guide wheel, which is described by Muller as a
first mode of operation. (FF1, FF2.) Muller also discloses a second mode of
operation where the movement of the guide wheel is ratcheted. (id.) Claim
1, however, requires “an auto-locking mechanism having a single
operational state in which it generates a force sufficient to hold the actuator
in a displaced position.” Similarly, claim 24 requires “a means, having a
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Application 11/646,744

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single mode of operation, for automatically generating a substantially
constant force sufficient to retain the actuator in a position set by an
operator.”
We agree with Appellants that the claim limitations requiring a
“single operational state” or a “single mode of operation” mean that “the
auto-locking mechanism cannot be disabled and will always retain the
actuator when the user displaces it from neutral.” (App. Br. 7.) That is,
“there is no ‘locked’ and ‘unlocked’ state.” (Reply Br. 4.) Consistent with
this interpretation of the claims, the Specification distinguishes the claimed
invention from the prior art as follows: “In prior art devices this pressure
must be counteracted by the operator, either by holding the actuator(s) in
place, or by manually setting a locking mechanism before or during the
procedure. In the present invention, the auto-locking mechanism
automatically retains the distal end in the deflected state set by the operator
with no input from the operator.” (Spec. 8, ¶ 50.)
The Examiner’s interpretation that a “single operational state” or
“single mode of operation” reads on each of the two disclosed modes of
operation effectively reads the term “single” out of the claim, which is
improper. We thus agree with Appellants that Muller fails to disclose a
catheter handle having an auto-locking mechanism with a “single
operational state” or “single mode of operation” as recited in claims 1 and
24, respectively.
Regarding claim 22, Appellants argue that the Examiner’s findings
“ignores the plain language of the claims, which are directed to only certain
of the embodiments disclosed in the specification specifically, those where
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Application 11/646,744

10
the force-generating means generates a ‘substantially constant force on the
actuation means.’” (App. Br. 11.) The Examiner points to paragraph 6 and
elements 66 and 68 in Muller’s specification and figures, respectively, as
addressing this feature of claim 22 (Ans. 5) but does not explain how
Muller’s disclosure meets the claim limitation. It therefore appears that the
Examiner’s findings that Muller teaches a “force-generating means that
maintains a substantially constant force on the actuation means” lacks
evidentiary support in the record. As stated in In re Warner, 379 F.2d 1011,
1017 (CCPA 1967), “[w]here the legal conclusion is not supported by facts
it cannot stand.”
Conclusion of Law
For the reasons above, we reverse the rejection of claims 1, 2, 12, 13,
21, 22, and 24 under 35 U.S.C. 102(b) as anticipated by Muller.

II.
Claims 3-5 and 14-16 are rejected under 35 U.S.C. 103(a) as being
unpatentable over Muller in view of Wilson. Claims 3-5 depend from claim
1 and claims 14-16 depend from claim 12. We have reversed the
anticipation rejection over Muller and find that this obviousness rejection
over Muller does not remedy the deficiencies of the anticipation rejection.
We therefore reverse this obviousness rejection for the reasons given above.
Appeal 2011-011275
Application 11/646,744

11
III.
Issue
The Examiner has rejected claims 1, 6, 12, and 17 under 35 U.S.C.
§ 102(b) as anticipated by Rosenman. Claim 1 is representative.
The issue with respect to this rejection is: Did the Examiner’s stated
rejection over Rosenman satisfy the Examiner’s initial burden of presenting
evidence to establish a prima facie case of unpatentability so as to shift the
burden to the Appellants?
Principles of Law
[T]he examiner bears initial burden, on review of the prior art
or on any other ground, of presenting a prima facie case of
unpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant.

After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).

Additional Findings of Fact
FF5. Figure 5 of Rosenman is reproduced below:
App
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Appeal 2011-011275
Application 11/646,744

13
in a displaced position, wherein “each discrete increment of tension is a
‘single’ operational state.” (Ans. 6.)
FF7. The Examiner finds that the Specification discloses an auto-
locking mechanism having “a near infinite number of modes of operation”
through the ability to alter the tension “T” on the device. (Final Office
Action, mailed Oct. 13, 2010, at 7 (citing Spec. ¶ 95).)
FF8. The Examiner finds that Rosenman discloses “a ‘single
operational state’ or a ‘single mode of operation’ in the same manner as the
instant invention.” (Ans. 9.)
Analysis
Appellants argue that the Examiner’s application of Rosenman is
flawed because “[i]n arguing that Rosenman teaches an auto-locking
mechanism with a single operational state, ‘the examiner notes that each
discrete increment of tension is a “single” operational state.’ Examiner’s
Answer, p. 6. In other words, the Examiner argues that each of Rosenman's
multiple operational states, is a single operational state.” (Reply Br. 4.)
We agree with Appellants that Rosenman’s description of its locking
mechanism as adjustable “from loose to locked” (FF5) is not consistent with
the broadest reasonable interpretation of the claims consistent with the
Specification, for the reasons discussed above with regard to Muller. The
Examiner found that the Specification discloses an auto-locking mechanism
having “a near infinite number of modes of operation” through the ability to
alter the tension “T” on the device. (FF7.) The Examiner reasoned that
Rosenman’s mechanism operates in the “same manner as the instant
invention.” (FF8.). The passage in the Specification that the Examiner relies
Appeal 2011-011275
Application 11/646,744

14
on, however, states that the tension is set “during manufacturing” to be
appropriate for a given application (Spec. 19, ¶ 95). Thus, the Examiner has
not shown that the claim language is reasonably interpreted to encompass
the adjustable mechanism disclosed by Rosenman. Accordingly, we reverse
the Examiner’s anticipation rejection that relies on Rosenman.
Conclusion of Law
We conclude that the Examiner’s stated rejection over Rosenman
failed to satisfy the Examiner’s initial burden of presenting evidence to
establish a prima facie case of unpatentability. We thus reverse the rejection
of claims 1, 6, 12, and 17 under 35 U.S.C. § 102(b) as anticipated by
Rosenman.

IV.
Claims 7, 8, and 18 are rejected under 35 U.S.C. 103(a) as being
unpatentable over Rosenman in view of the Standard Handbook of Machine
Design, 3th ed. Claims 7 and 8 depend from claim 1 and claim 18 depends
from claim 12. We have reversed the anticipation rejection of independent
claims 1 and 12. We therefore also reverse the Examiner’s obviousness
rejection in view of Rosenman.

SUMMARY
We reverse the rejection of claims 1, 2, 12, 13, 21, 22, and 24 under
35 U.S.C. 102(b) as being anticipated by Muller.
Appeal 2011-011275
Application 11/646,744

15
We reverse the rejection of claims 3-5 and 14-16 under 35 U.S.C.
103(a) as being unpatentable over Muller in view of Wilson.
We reverse the rejection of claims 1, 6, 12, and 17 under 35 U.S.C.
102(b) as being anticipated by Rosenman.
We reverse the rejection of claims 7, 8, and 18 under 35 U.S.C. 103(a)
as being unpatentable over Rosenman in view of the Standard Handbook of
Machine Design, 3rd Edition.

REVERSED

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