Ex Parte Zappia et al

Patent Trial and Appeal Board

Aug 9, 2017

13599929 (P.T.A.B. Aug. 9, 2017)

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.
13/599,929 08/30/2012 Thomas Zappia 09423.0145-00000 7629
109610 7590
Bookoff McAndrews, PLLC
2401 Pennsylvania Avenue, NW, Suite 450
Washington, DC 20037
EXAMINER
TORRES DIAZ, ARNALDO
ART UNIT PAPER NUMBER
3779
NOTIFICATION DATE DELIVERY MODE
08/11/2017 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):
usptomail @bookoffmcandrews.com
Kross @ bookoffmcandrews.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THOMAS ZAPPIA and BRIAN MACLEAN1
Appeal 2016-002795
Application 13/599,929
Technology Center 3700
Before ERIC B. GRIMES, TAWEN CHANG, and RYAN H. FLAX,
Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
system and method for determining the position of a medical device, which
have been rejected as anticipated. We have jurisdiction under 35 U.S.C.
§ 6(b).
We REVERSE.
1 Appellants identify the real party in interest as Boston Scientific Scimed,
Inc. (Br. 1.)
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Application 13/599,929
STATEMENT OF THE CASE
According to the Specification,
[embodiments of the present disclosure are directed to systems and
methods for preventing medical devices, such as, e.g., laser fibers,
lithotripters, cauterizing end-effectors, or other energized devices,
from actuating while their distal tips are still within an endoscopic
access device. To this end, embodiments of the present disclosure
introduce a detection system that determines the position of a medical
device with respect to the endoscopic device. Based on the position,
the detection system may automatically actuate or prevent actuation of
the medical device, or use an indicator to inform the operator whether
it is safe to actuate the device or not.
(Spec. 124.)
Claims 1, 2, 4—10, 12—15, 19, and 20 are on appeal. Claims 1, 10, and
15 are the independent claims and reproduced below:
1. A system for preventing inadvertent actuation of a medical
device, the system comprising:
a medical device comprising a laser and configured to transition
between an actuated state and an inactive state;
an elongate tube having a proximal end, a distal end, and a
lumen extending from the proximal end to the distal end, the lumen
configured to receive the medical device; and
a detection system configured to determine a position of a distal
end of the medical device relative to the distal end of the elongate
tube, wherein the detection system includes a transmitting element
disposed on a distal portion of the elongate tube and a receiving
element disposed on a distal portion of the medical device.
10. A system for determining the position of a medical device, the
system comprising:
a medical device comprising a laser;
an elongate tube having a proximal end, a distal end, and a
lumen extending therebetween, wherein the lumen is defined by an
internal wall of the elongate tube, the medical device is slidably
positioned within the lumen, and the elongate tube includes an
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Application 13/599,929
illumination element disposed between the internal wall and an
external wall of the elongate tube;
a geometric feature disposed at a first location of the internal
wall, wherein the geometric feature is configured to deflect a portion
of light energy from the illumination element to a sensor disposed on
the medical device, wherein the medical device is configured to move
between a first position and a second position, wherein, when in the
first position, a distal end of the medical device is disposed proximally
of the first location, and, when in the second position, the distal end of
the medical device is disposed distally of the first location.
15. A method of determining a position of a laser medical device
within a lumen of an endoscopic access device, the endoscopic access
device including a light source, the method comprising:
sensing an intensity of light reflected from the light source;
comparing the sensed intensity to a predetermined threshold
intensity; and
if the sensed intensity is below the predetermined threshold
intensity, generating a first signal indicative of a first position of the
medical device;
wherein the step of sensing is accomplished by a sensor located
on the laser medical device.
(Br. 15, 16—17 (Claims App.).)
The Examiner rejects claims 1, 2, 4—10, 12—15, 19, and 20 under 35
U.S.C. § 102(b) as being anticipated by Brown.2 (Final Act. 3.)
DISCUSSION
The Examiner finds that Brown discloses each element of claims 1,
10, and 15. With respect to claim 1, the Examiner finds that Brown
discloses a medical device comprising a laser and an elongated tube (an
introducer or endoscope) having a lumen configured to receive the laser, and
a detection system configured to determine the position of the distal end of
2 Brown, US 2009/0177191 Al, published Jul. 9, 2009.
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Application 13/599,929
the laser relative to the distal end of the introducer or catheter, where the
detection includes a transmitting element (the laser delivery fiber) and a
receiving element (the external sense fiber or detector). (Final Act. 3.) With
respect to claim 10, the Examiner additionally finds that the laser light and
the “bend” in optical fiber disclosed in Brown meets, respectively, the
limitations of “an illumination element disposed between the internal and an
external wall of the elongate tube” and “a geometric feature . . . configured
to deflect a portion of light energy from the illumination element.” {Id. at 5—
6.) With respect to claim 15, the Examiner notes that “the method claim
encompass[es] the apparatus of claims 1 and 10.” {Id. at 6.)
Appellants contend that “any alleged transmitter of Brown would, at
best, correspond to the coded fiber rather than an element disposed on a
distal portion of an elongate tube or an illumination element disclosed
between inner and outer walls of an elongate tube,” as required by claims 1
and 10, respectively. (Br. 11.) Appellants also argue that the “bend” in the
fiber disclosed in Brown does not read on the limitation of “‘a geometric
feature disclosed at a first location of the internal wall,’ as required by claim
10.” {Id.)
We find Appellants to have the better argument. Claim 1 requires a
detection system having a transmitting element “disposed on a distal portion
of the elongate tube.” {Id. at 15 (Claims App.).) The Examiner points to the
introducer or the catheter as the “elongate tube.” (Final Act. 3; Ans. 6.) The
Examiner points to the laser delivery fiber 28 as the transmitting element of
the detection system. (Final Act. 3; Ans. 7.) However, the Examiner does
not explain how the laser fiber may be considered to be “disposed on a distal
portion of the introducer or catheter” as required by claim 1, given that the
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laser fiber is located and movable within the lumen of the introducer or
catheter. (Brown 124 (explaining that, “during laser surgery, surgeons can
accidentally pull a laser fiber back into a delivery catheter such as an
endoscope’s working channel or a vein introducer”).)
We also agree with Appellants that the Examiner has not made out a
prima facie case with respect to claim 10. Claim 10 requires an “elongate
tube including] an illumination element disposed between [a]n internal wall
and an external wall of the elongate tube” and further requires “a geometric
feature disposed at a first location of the internal wall, wherein the geometric
feature is configured to deflect a portion of the light energy from the
illumination element to a sensor disposed on the medical device.” (Br. 16—
17 (Claims App.).)
The Examiner points to “laser light, fig. 3” or laser delivery fiber 28
as meeting the limitation of the illumination element. (Final Act. 5; Ans.
11.) The Examiner also points out that Brown describes the working
channel of an endoscope as “a Teflon tube surrounded by image and
illumination bundles” and that a skilled artisan would further recognize that
a catheter or introducer would inherently have an internal wall forming the
working channel and an external wall that forms the lumen portion that
“protects . . . structures [such as] image and illumination bundles . . . from
unintentional perforations or laser energy release from the delivery fiber.”
(Ans. 10.) The Examiner points to a bend in the laser delivery fiber as the
recited “geometric feature.” (Final Act. 5; Ans. 10—11.)
To the extent the Examiner is relying on the laser delivery fiber 28 to
meet the limitation of the “illuminating element,” the Examiner has not
explained how the laser delivery fiber 28 is disposed “between the internal
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wall and an external wall of the elongate tube.” In particular, Brown
describes the laser fiber as located within an endoscope’s working channel.
(Brown 124.) Thus, the “illuminating element” the Examiner points to in
Brown appears to be located in a lumen formed by the internal wall of the
endoscope (Ans. 10), not between the internal and external wall of the
elongate tube. To the extent the Examiner is relying on the illumination
bundles of an endoscope as the “illuminating element” of claim 10, the
Examiner has not provided sufficient evidence that the illumination bundles
are inherently (i.e., necessarily) between the internal and external wall of the
endoscope and also does not explain how the bend in the fiber disclosed in
Brown, i.e., the “geometric feature,” is configured to deflect a portion of the
light energy from the illumination bundles. In particular, Brown discloses
the function of the bend in the fiber as follows:
Each of the embodiments [of feedback arrangements arranged
to monitor temperature in a treatment area at a distal end of a laser
delivery fiber 28] depends on detection of radiation in the fiber core.
. . . [According to an especially advantageous embodiment of the
invention, the property that light emitted from the distal end of the
fiber creates a lot of weakly guided high order propagation modes is
utilized to eliminate the need for splicing or other modifications of the
fiber. In particular, a slight bend will readily leak out the thermal
runaway light with minimal loss from the primary laser source and
therefore ... the light can be detected simply by placing a photo
detector 32 and the bend 34 in the fiber and connecting the photo
detector 32 to controller 10 by a wire or fiber 38.
(Brown || 39, 46.) In short, while the bend in the laser fiber appears to
permit leakage of thermal runaway light, nothing in Brown suggests the
bend in the fiber is configured to deflect a portion of the light energy from
endoscopic illumination bundles.
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Application 13/599,929
Likewise, regardless of what structure is considered the “illumination
element” in Brown, the Examiner does not explain how a bend in the fiber,
which as discussed above is located within a lumen of the elongate tube
(e.g., the working channel of the endoscope), is “disposed at a first location
of the internal wall.” Given that the bend is located on the fiber itself, the
Examiner also has not satisfactorily explained how the laser (i.e., the
“medical device”) in Brown is configured to move between a first position
where the distal end of the laser is disposed proximally of the geometric
feature and a second location where the distal end of the laser is disposed
distally of the geometric feature.
Appellants do not separately address claim 15, arguing merely that,
while of different scope, claim 15 “recites features similar to those of claims
1 and 10” and that “Brown fails to disclose or suggest at least these
features.” We do not agree that claim 15 is so similar to claims 1 and 10 that
the reasoning showing Brown does not anticipate claims 1 and 10 is equally
applicable to claim 15. Nevertheless, as discussed below, we find that the
Examiner also has not established a prima facie case of anticipation with
respect to this claim.
Claim 15 recites a method of determining a position of a laser within
the lumen of an endoscope having a light source, where the method
comprises the steps of (1) a sensor located on the laser sensing the light
intensity from the endoscopic light source, (2) comparing the sensed
intensity to a predetermined threshold, and (3) generating a signal indicative
of the position of the laser if the sensed intensity is below the threshold. (Br.
18 (Claims App.).) In support of the finding that Brown discloses such a
method and claimed methods depending therefrom, the Examiner cites to
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paragraphs 45—46, 51, and 55—56 and further appears to rely on the
argument that claim 15 “encompass[es] the apparatus of claims 1 and 10.”
(Final Act. 6.)
Brown discloses a method of detecting a laser fiber position relative to
the working channel of a catheter or introducer. (Brown Abstract, || 10,
29.) Brown also discloses endoscopes including a light source. {Id. 124
(describing illumination bundles in endoscopes).) However, the Examiner
has not pointed to any disclosure in Brown, and we have not located any,
where the laser fiber’s position is determined via sensing the light intensity
of the endoscopic light source (e.g., the illumination bundles). Rather,
Brown suggests providing fiber position feedback by using the endoscope’s
image detection system, or by encoding the fiber buffer with readable
markings and using the output from a sensor on an introducer or catheter to
provide a signal relating to the fiber’s position.3 (Brown H 35, 54—56.)
3 The paragraphs in Brown cited by the Examiner do not disclose
determining the laser fiber’s position by sensing the light intensity of the
endoscopic light source. Paragraphs 45, 46, and 51 relate to methods for
detecting thermal runaway and/or notifying an operator that the fiber is clean
enough of debris. (Brown || 45 46, 51.) While paragraphs 55 and 56
disclose a method of detecting fiber position, the disclosed method
comprises encoding the fiber buffer “by optical, mechanical, or electrical
means” and positioning a reader to “detect the encoding and therefore the
fiber position,” as discussed above. {Id. Tflf 55—56.) To the extent the
Examiner contends that optical encoding of the fiber buffer reads on the
light source recited in claim 15, the Examiner has not provided any
arguments or evidence supporting such a construction. Neither has the
Examiner pointed to any disclosures in Brown where light intensity is
compared to a predetermined threshold intensity to indicate laser position
rather than, e.g., thermal runaway. {Id. 1 51 (disclosing “detector . . .
arranged to detect thermal runaway at some predetermined intensity
threshold”).) In reArkley, 455 F.2d 586, 587-588 (CCPA 1972) (In an
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“[Ujnless a prior art reference discloses within the four comers 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 Money IN, Inc. v. VeriSign, Inc.,
545 F.3d 1359, 1371 (Fed. Cir. 2008). Accordingly, we agree with
Appellants that the Examiner has not made out a prima facie case that
Brown anticipates independent claims 1,10, and 15. The Examiner also has
not shown that Brown anticipates claims 2, 4—9, 12—14, 19, and 20, which
depend from claims 1, 10, or 15, for at least the same reasons.
SUMMARY
For the reasons above, we reverse the Examiner’s decision rejecting
claims 1, 2, 4—10, 12—15, 19, and 20.
REVERSED
anticipation rejection “the . . . reference must clearly and unequivocally
disclose the claimed [invention] or direct those skilled in the art to the
[invention] without any need for picking, choosing, and combining various
disclosures not directly related to each other by the teachings of the cited
reference. Such picking and choosing may be entirely proper in the making
of a 103, obviousness rejection, where the applicant must be afforded an
opportunity to rebut with objective evidence any inference of obviousness
. . . but it has no place in the making of a 102, anticipation rejection.”).
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