Ex Parte Malhi

Patent Trial and Appeal Board

Sep 28, 2017

13630475 (P.T.A.B. Sep. 28, 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.
13/630,475 09/28/2012 Arnaz S. Malhi H-KN-02424US/1216-009US01 9836
77218 7590 10/02/2017
MeHtrnnio Vasionlar - APV Division
EXAMINER
c/o IP Legal Department
3576 Unocal Place
ULSH, GEORGE J
Santa Rosa, CA 95403 ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
10/02/2017 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):
rs. docketingap v @ medtronic .com
medtronic_apv_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ARNAZ S. MALHI
Appeal 2016-008053
Application 13/630,4751
Technology Center 3700
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to an occlusion
treatment device. The Examiner entered final rejections for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.
1 Appellant identifies the Real Party in Interest as “Medtronic pic of Dublin,
Ireland, which is the ultimate parent entity of the assignee of record,
Covidien LP, a Delaware limited partnership, having a place of business in
Mansfield, MA.” App. Br. 3.
Appeal 2016-008053
Application 13/630,475
STATEMENT OF THE CASE
Background
Known thrombectomy catheters treat occlusions in the
immediate vicinity of their cutting tips. However, the transverse
(radial) position of the cutting tips of these known
thrombectomy catheters is not amenable to alteration. For
example, transverse (radial) movement of the cutting tip in situ
can result in contact between the cutting tip and an inner wall of
the body lumen.
Spec. 13. “The present disclosure relates to treatment of an occluded body
lumen, specifically adjustable treatment of a body lumen.” Spec. 11.
The Claims
Claims 1—4 and 22—28 are on appeal. App. Br. 3. Sole independent
claim 1 is illustrative and reads as follows:
1. An occlusion treatment device comprising:
an outer catheter positionable within a body lumen, the
outer catheter including a proximal end portion and a distal end
portion, the outer catheter defining a passageway extending
longitudinally therethrough;
a first expandable member and a second expandable
member, each expandable member secured to an outer surface
of the outer catheter; and
an inner catheter having a body portion including a
proximal end portion and a distal end portion, and the inner
catheter including a cutting tip adjacent the distal end portion of
the body portion, the inner catheter axially movable along the
passageway between a retracted position, in which the inner
catheter is stressed within the passageway in a substantially
linear orientation, and an advanced position, in which at least a
portion of the cutting tip is exposed from the outer catheter, and
the inner catheter assumes a nonlinear orientation as the inner
catheter is advanced out of the passageway of the outer
catheter, wherein advancement and retraction of the inner
2
Appeal 2016-008053
Application 13/630,475
catheter relative to the outer catheter transversely moves the
cutting tip of the inner catheter relative to the outer catheter.
App. Br. 14 (Claims Appendix).
The following rejections are before us to review:
Claims 1—4, 22—24, and 26—28 are rejected under pre-AIA § 103(a) as
unpatentable over Bonnette2 in view of Bertolero.3 Ans. 2.
Claim 25 is rejected under pre-AIA § 103(a) as unpatentable over
Bonnette, Bertolero, and in further view of Pageard.4 Id.
I
The Examiner has rejected claims 1—4, 22—24, and 26—28 as obvious
based on Bonnette and Bertolero. In making the rejection, the Examiner
finds that Bonnette discloses an occlusion treatment device comprising all of
the elements of claim 1, except that it does not disclose “a first expandable
member and a second expandable member, each expandable member
secured to an outer surface of the outer catheter” as recited in the claim.
Ans. 3. The Examiner finds that Bertolero discloses a medical device
having a first and second expandable member each “secured to an outer
surface of the outer catheter.” Ans. 3^4.
The Examiner concludes that it would have been obvious “to have
modified Bonnette to incorporate the expandable members taught by
Bertolero ... to provide advantages in steering the catheter as well as
positioning the cutting element.” Ans. 4.
2 U.S. 2008/0319386 Al, published December 25, 2008 (“Bonnette”).
3 U.S. 2005/0159645 Al, published July 21, 2005 (“Bertolero”).
4 U.S. 2011/0184400 Al, published July 28, 2011 (“Pageard”).
3
Appeal 2016-008053
Application 13/630,475
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s rejection of the claimed subject matter
over Bonnette and Bertolero. We select claim 1 as representative of the
claims subject to this ground of rejection. 37 C.F.R. § 41.37(c)(l)(iv).
Findings of Fact (FF)
FF1. Bonnette discloses:
a forwardly directable fluid jet crossing catheter used for the
purpose of crossing a Chronic Total Occlusion (CTO), whereby
a moderate speed and safe velocity fluid jet is used to wear
away arterial lesions forming a CTO and advancing
therethrough. . . . This invention is intended to help a guidewire
penetrate the chronic total occlusion by directing a moderate
speed fluid jet at the occlusion.
Bonnette 13.
FF2. Bonnette’s Figures 9a, 9b, and 9c are reproduced below:
NON
exreasiON
posmoN
,.-SS f~ 34
r ^ .............. m AfJSiE
FIG. 9a
EisfT&NStOM
POSITION
FIG. 9b
34-r‘ 40 —’ / f
aSEDSUM ANGLE
Z'l
LAftGE
EXTSNSK3N
POSiTiGN
too- jf
34"“
FIG, 9c
........f
i
LARGE ANGLE
46 •
102 —
>/
4
Appeal 2016-008053
Application 13/630,475
Figures “9a, 9b and 9c illustrate the longitudinal positional and slideable
relationships of the tip, the bend and a distal portion of the nitinol tube of the
jet body to the distal end of the sheath.” Bonnette 132.
FF3 The Examiner finds Bonnette’s Figures 9a—c show
an occlusion treatment device comprising “an outer catheter
(22) positionable within a body lumen, the outer catheter (22)
including a proximal end portion and a distal end portion, the
outer catheter (22) defining a passageway (100) extending
longitudinally there through; and an inner catheter (26) having a
body portion including a proximal end portion and a distal end
portion, and the inner catheter (26) including a cutting tip (34)
adjacent the distal end portion of the body portion, the inner
catheter (26) axially movable along the passageway between a
retracted position, in which the inner catheter (26) is stressed
within the passageway in a substantially linear orientation, and
an advanced position, in which at least a portion of the cutting
tip (34) is exposed from the outer catheter (22), and the inner
catheter (26) assumes a nonlinear orientation as the inner
catheter (26) is advanced out of the passageway of the outer
catheter (26), wherein advancement and retraction of the inner
catheter (22) relative to the outer catheter (26) transversely
moves the cutting tip (34) of the inner catheter (22) relative to
the outer catheter (26).”
Ans. 3—4, citing Bonnette Figures 9a-c and H 3, 7—22, 38, and 45 49.
FF4. Bonnette discloses:
The distal portion of the nitinol tube 26 includes a tip 34 which
is annealed and atraumatic being distal to a super-elastic shaped
bend 36. The tip 34 is soft, flexible and shapeable. The portion
of the nitinol tube 26 proximal to the bend 6 is super-elastic, as
is the bend 36, and each are soft and bendable and predisposed
to return to an original memory shape.
Bonnette 138.
FF5. Bonnette discloses Figure 11, reproduced below:
5
Appeal 2016-008053
Application 13/630,475
FIG. 11
Figure 11 “shows the distal end of the sheath and the tip of the forwardly
directable fluid jet crossing catheter aligned in a vessel having a chronic
total occlusion.” Id. 134.
FF6. Bertolero discloses “disposable jackets or sheaths for use with many
kinds of surgical devices, but is particularly beneficial for use on catheters,
endoscopes, and the like ... to add functionality to the devices on which
they are used.” Id. 1 5.
FF7. Bertolero discloses Figure 3A, reproduced below:
40'
Figure 3A “shows an embodiment with separately inflatable balloon
chambers [40 and 40’].” Id. 116.
FF8. Bertolero discloses:
The balloons of the invention may have more than one
compartment, which may be inflated individually, or all
compartments may be inflated at once. For example, FIG. 3 A
shows an embodiment of the sheath 38 with separately
inflatable balloon chambers 40, 40’. Differential inflation of the
6
Appeal 2016-008053
Application 13/630,475
balloons 40, 40’ may provide advantages including but not
limited to assisting in steering the catheter 100.
Id. 127.
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417. The KSR Court noted that a combination of old
elements has been held to be obvious when “[t]he two [elements] in
combination did no more than they would in separate, sequential operation.”
Id. (citing Anderson’s-BlackRock, Inc. v. Pavement Salvage Co., 396 U.S.
57 (1969)).
Analysis
We adopt the Examiner’s findings regarding the scope and content of
the prior art (Ans. 3^4; FF 1—8) and agree that the claimed device would
have been obvious over the teachings of Bonnette and Bertolero. Only those
arguments made by Appellant in the Briefs have been considered in this
Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R.
§ 41.37(c)(l)(iv) (2015). We address Appellant’s arguments below.
Appellant argues Bonnette teaches away from any modification that
would include a first and second expandable member with each expandable
member secured to an outer surface of the outer catheter because the
modification proposed by the Examiner “would have frustrated the purpose
of the Bonnette disclosure.” App. Br. 6. According to Appellant, Bonnette
emphasizes that the catheter tip should have a “small crossing profile” to
increase the chance “to successfully navigating across the lesion.” Id.
7
Appeal 2016-008053
Application 13/630,475
Appellant further argues that the skilled artisan would not have modified the
catheter of Bonnette to add an expandable member as taught by Bertolero
“because such a modification would have increased the crossing profile of
the Bonnette device” and frustrated the intended use of a small profiled
catheter. Id. at 6—7. Appellant argues that “other structures would also have
been required to allow the expandable member to expand, which would have
further increased the crossing profile of the modified Bonnette device” such
as the inflation lumen taught in Bolero, along with the balloons themselves.
Id. Appellant further argues that the Examiner has not provided any
disclosure indicating “that steering the catheter or positioning the fluid jet
was an issue that needed to be improved.” Id. at 9. Appellant argues the
proposed combination therefore lacks a rational underpinning. Id.
In response, the Examiner cites paragraphs 38 and Figures 1 and 2 as
evidence that the entire device of Bonnette could not be used to navigate the
lesion because part of the unit is the “manually grasped handle.” Ans. 6.
Furthermore, the Examiner argues that Bonnette discloses “‘a wide expanse
of directed fluid jet stream (102) for crossing a chronic total occlusion, and
where the fluid jet stream (102) is distally directed toward the chronic total
occlusion (CTO 108) in order to provide a path through the chronic total
occlusion (CTO 108) thereby perfecting a crossing therethrough.’” Id. at 7—
8 (emphasis removed). The Examiner finds, therefore, that “the fluid jet is
the only thing that crosses the occlusion.” Id. at 8. The Examiner provides
annotated Figures 11 and 9a—c (see Ans. 8) showing that the addition of the
expandable members of Bertolero would not interfere with the action of the
fluid jet. Id.
8
Appeal 2016-008053
Application 13/630,475
The Examiner further responds that because “Bonnette’s device
comprises mostly a catheter with no imaging or marker component, and
steering is done bluntly via threading the device through the vasculature[,
the] addition of the expandable members provides a much needed boost in
steering capability and positioning.” Id. at 8—9. For instance, the Examiner
posits, “if the target vasculature occurs just past a vessel branch or arch the
two expandable members would prevent the distal end of the catheter from
penetrating/bumping into the interior of the vessel while traversing the
branch or arch.” Id. at 9.
In reply, Appellant argues that the Examiner mischaracterizes the
argument and that “when Bonnette describes that ‘the device of this
invention is used to cross chronic total occlusions,’ Bonnette is describing
the portions of the fluid jet crossing catheter that are actually inserted within
the patient, such as the sheath 22 and the nitinol tube 26.” Reply Br. 4.
Appellant further argues that the skilled artisan would understand Bonnette’s
disclosure to refer to “portions of the device, such as the sheath 22, when
describing the need for a smaller crossing profile” and that the Examiner’s
contention that the fluid jet of Bonnette is the only thing crossing the
occlusion is erroneous. Id. at 4—5.
Appellant further argues the Examiner has not provided evidence that
the steering system of Bonnette’s device was “blunt” or needed
improvement. Id. at 5. Appellant further argues that because “the Examiner
has not shown that the two expandable members would be deployed while
traversing any portion of the vasculature, the skilled artisan would not have
understood this to be a reason for modifying Bonnette with the balloons of
Bertolero.” Id. Appellant further argues that the Examiner’s proposed
9
Appeal 2016-008053
Application 13/630,475
combination “do not address the alleged problems with the Bonnette
device,” which are that the device “comprises mostly a catheter with no
imaging or marker component.” Id. at 5—6. For this reason, Appellant
argues, the proposed combination lacks a reason to modify the Bonnette
device as proposed. Id. at 6.
We are not persuaded that the Examiner erred in finding that Bonnette
and Bertolero render the claimed device obvious.
Bonnette discloses a forwardly directable fluid jet crossing catheter
for use in crossing occlusions and advancing through them. FF1. The
device contains the recited elements of claim 1, which Appellant does not
contest. Control of the catheter is provided by easing the tension or stress
placed on the catheter through the bend 36 as the catheter exits the distal end
of the sheath. FF2. The nitinol tube 26 provides strength but also elasticity
due to its ability to “return to an original memory shape.” FF3. The catheter
is navigable in a complete arc (see Bonnette Figure 10) and the forward end
of the tip issues a fluid jet directed at the occlusion (102). FF4, FF5.
We agree with Appellant that the sheath portion of the Bonnette
device would traverse the occlusion in addition to the tip, as supported by
Figure 11. However, as shown in the Examiner’s annotated version of
Figure 11 (Ans. 8), reproduced below, the addition of the balloon sheaths
taught by Bertolero would not alter the size of the portion of the catheter that
would traverse the occlusion:
10
Appeal 2016-008053
Application 13/630,475
u
j ^ A ' 1 ' N N
.-..... 'AN
Va*l s* "V* ■‘•'V4
■"* «• ** s N N *
veW- ■'•>’
wv \ N V‘s‘ A*V *
.vvy^^*»W:;.
Annotated Figure 11 “shows the distal end of the sheath and the tip of the
forwardly directable fluid jet crossing catheter aligned in a vessel having a
chronic total occlusion.” Id. 134 (as modified by Examiner at Ans. 8).
Appellant has not sufficiently explained why the balloons of Bertolero
or the inclusion of an inflation lumen would negatively impact the ability of
the directable tip and catheter to cross an occlusion because the balloons can
be placed distal to the advancing tip (shown in the annotated figure as the
structures between numerals 26 and 100). In other words, the crossing
profile is not increased by the addition of the balloon members. Without
evidence, Appellant’s argument to the contrary is unpersuasive. In re
Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997) (citing In re Antonie, 559
F.2d 618, 620 (CCPA 1977)). “Furthermore, it is well settled that
unexpected results must be established by factual evidence. ‘Mere argument
or conclusory statements in the specification does not suffice.’” Id. (citing
In re De Blauwe, 736 F.2d 699, 705 (Fed.Cir.1994)).
Moreover, we do not agree that Bonnette teaches away from the
proposed modification. “Under the proper legal standard, a reference will
teach away when it suggests that the developments flowing from its
disclosures are unlikely to produce the objective of the applicant’s invention.
A statement that a particular combination is not a preferred embodiment
does not teach away absent clear discouragement of that combination.”
11
Appeal 2016-008053
Application 13/630,475
Syntex (U.S.A.) LLCv. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005)
(citations omitted). Appellant has not directed us to any teaching in
Bonnette that would discourage the modification as suggested by the
Examiner.
We are persuaded that the proposed modification provides the
advantages of assisting in steering the catheter, including by inflating the
balloons at separate times to traverse a bend, as proposed by the Examiner.
FF6—8. We are not persuaded that the Examiner has failed to show that the
expandable members would be deployed while traversing the occlusion as
the Examiner has cited to portions in Bertolero that suggest general use with
a catheter, without restriction. See Bertolero 127 (“Differential inflation of
the balloons 40, 40’ may provide advantages including but not limited to
assisting in steering the catheter 100.”) Nor do we agree that the Examiner’s
characterization of the Bonnette device as “mostly a catheter with no
imaging or marker component” need guide or constrain the proposed
modifications; the Examiner has proposed a reason for modifying Bonnette
to include the balloon sheaths of Bertolero regardless of other characteristics
the device may have.
We are not persuaded that the Examiner was required to produce
evidence that the steering system of Bonnette was blunt in order to justify
the proposed combination as “interrelated teachings of multiple patents; the
effects of demands known to the design community or present in the
marketplace; and the background knowledge possessed by a person having
ordinary skill in the art, all [can provide] an apparent reason to combine the
known elements in the fashion claimed.” KSR 550 U.S. at 418. In addition,
where “two [elements] in combination did no more than they would in
12
Appeal 2016-008053
Application 13/630,475
separate, sequential operation,” the combination of elements is obvious. Id.
at 417.
Here, Bonnette shows a catheter with the ability to traverse occlusions
and Bertolero shows a sheath that can be added to the catheter to enhance
the user’s ability to control the catheter. “If a person of ordinary skill can
implement a predictable variation [of a known work], § 103 likely bars its
patentability.” Id. at 417. Appellant has not persuasively shown why the
skilled artisan could not have combined these two elements, and we are not
persuaded by Appellant’s proposed reasons not to do so. Accordingly, we
affirm the rejection of claim 1.
Conclusion of Law
The rejection of claim 1 is affirmed. Claims 2-4, 22—24, and 26—28
have not been argued separately and therefore fall with claim 1. 37 C.F.R.
§ 41.37(c)(l)(iv).
II
Issue
The Examiner has rejected claim 25 as obvious over Bonnette,
Bertolero, and in further view of Pageard. The Examiner finds that Bonnette
and Bertolero do not disclose the elements of claim 25 “wherein the first
expandable member and the second expandable member are formed from
different materials, the material of the first expandable member having a
coefficient of elasticity differing from a coefficient of elasticity of the
material of the second expandable member.” Ans. 5. The Examiner finds
that Pageard discloses “a similar device wherein the first expandable
member (150) and the second expandable member (152) are formed from
different materials, the material of the first expandable member (150) having
13
Appeal 2016-008053
Application 13/630,475
a coefficient of elasticity differing from a coefficient of elasticity of the
material of the second expandable member (152). Id.
The Examiner concludes that it would have been obvious to have
incorporated the teachings of Pageard into the modified Bonnette/Bertolero
combination because the “sufficiently-compliant interface with the
contacting tissue [would allow] the second balloon to conform to the uneven
surface topography of the occluded vessel, resulting in an enhanced, more
effective [treatment of an] occlusion.” Ans. 6.
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s rejection of the claimed subject matter
over Bonnette, Bertolero and Pageard.
Findings of Fact (FF)
FF9. Pageard discloses:
A cryogenic device is also provided, including a first
substantially non-compliant balloon; a second substantially
compliant balloon positioned distal to the first balloon; and a
third substantially compliant balloon surrounding the first and
second balloons. The first balloon may be constructed from
PET, nylon or similar polymeric materials or composites, and
the second balloon may be constructed from polyurethane,
latex, or similar polymeric materials or composites. The first
balloon may have an elastic modulus between approximately
2700 MPa and approximately 4250 MPa, while the second
balloon may have an elastic modulus between approximately 50
MPa and approximately 600 MPa. The first and second
balloons may be expandable independently of one another, and
may not be in fluid communication with each other. The device
may also include a cryogenic fluid supply in fluid
communication with the first balloon, and a non-cryogenic fluid
in fluid communication with the second balloon. Further, an
interstitial region may be defined between the third balloon and
at least one of the first and second balloons; and a vacuum
14
Appeal 2016-008053
Application 13/630,475
source can be placed in fluid communication with the
interstitial region.
Pageard 115.
FF10. Pageard discloses:
FIG. 17a provides an additional illustration of a triple-balloon
configuration of the catheter 34 for the medical system. In
particular, a first balloon 150 may be disposed on the elongate
body of the catheter 34. The first balloon 150 may be
substantially non-compliant when in an inflated state. For
example, the first balloon 150 may be constructed from
polyethylene terephthalate (“PET”), nylon or similar polymeric
materials or composites. Located distally of the first balloon
150 on the catheter 34 may be a substantially compliant, second
balloon 152. The second balloon 152 may be constructed from
polyurethane, latex, or similar polymeric materials or
composites. The substantially increased elasticity or
compliance of the second balloon 152 as compared to the first
balloon 150 may result in the second balloon 152 being more
readily deformable than the first balloon 150 when inflated
and/or in contact with a targeted tissue area. To facilitate the
desired conformity or lack thereof, the first balloon may have
an elastic modulus approximately five to fifty times that of the
second balloon. For example, the first balloon may define an
elastic modulus between approximately 2700 MPa and
approximately 4250 MPa, while the second balloon may have
an elastic modulus between approximately 50 MPa and
approximately 600 MPa.
Id. 1 56.
FF11. Pageard recites claims 1—4 and 5 as follows:
1. A cryogenic device, comprising:
a first substantially non-compliant balloon;
a second substantially compliant balloon positioned distal to the
first balloon; and
a third substantially compliant balloon surrounding the first and
second balloons.
15
Appeal 2016-008053
Application 13/630,475
2. The cryogenic device of claim 1, wherein the first balloon is
constructed from at least one of polyethylene terephthalate or
nylon.
3. The cryogenic device of claim 2, wherein the second balloon
is constructed from at least one of polyurethane and latex.
4. The cryogenic device of claim 1, wherein the first and second
balloons are expandable independently of one another.
9. A medical system, comprising:
a flexible catheter body;
a first balloon disposed on the catheter body;
a second balloon disposed distally of the first balloon, wherein
the second balloon is more readily deformable than the first
balloon; and
a third balloon substantially enclosing the first and second
balloons to [] define an interstitial region therebetween.
Analysis
We adopt the Examiner’s findings regarding the scope and content of
the prior art (Ans. 5—6; FF9—11) and agree that the claimed device would
have been obvious over the teachings of Bonnette, Bertolero, and Pageard.
We address Appellant’s arguments below.
Appellant incorporates arguments raised with respect to the rejection
based on Bonnette and Bertolero in the response to this rejection. App. Br.
10. As discussed above, those arguments are unpersuasive.
Appellant argues that the Examiner has not shown that the skilled
artisan “would have had any reason to modify the device of Bonnette, alone
or in combination with Bertolero, with the disclosure of Pageard.” Id.
Appellant argues that inclusion of the ablative balloon as disclosed by
Pageard would frustrate the purpose of Bonnette and would have been
avoided. Id.
16
Appeal 2016-008053
Application 13/630,475
Appellant further argues that the Examiner’s proposed modification
does not explain the specificity required of the claim with respect to use of
different materials with different coefficients of elasticity. Id. According to
Appellant, the Examiner has not explained why “allowing the second
balloon to conform to the uneven surface topography of the occluded vessel,
resulting in an enhanced, more effective [treatment of]5 occlusion” would
improve the treatment, and is speculative or hindsight reasoning. Id. at 12.
The Examiner responds that Pageard is relied upon not for its
structure or ablation features, but for “using [the] expandable members[’]
chemical composition and inherent physical properties.” Ans. 9. The
Examiner further explains the basis for the reason for modification as:
[t]he human vasculature is not a perfect cylinder, smaller
deposit of debris (clots, cholesterol, previously embedded
medical devices, and etc.) and anatomical features (one way
venous valves, tissue abnormalities, etc.) having an expandable
member that is sufficiently compliant to occlude the vessel
without damaging or dislodging debris or anatomical features is
obvious to one of ordinary skill in the art.
Id.
In reply, Appellant argues that regardless of what portion of Pageard
the Examiner relied upon, Pageard must be considered as a whole, including
for any portions leading away from the claimed invention. Reply Br. 7.
Appellant reiterates that Pageard teaches ablation and that Pageard’s reason
for using expandable members having materials of differing coefficients of
elasticity, if disclosed, is done so because “Pageard’s balloon 150 exchanges
5 Given the Examiner’s rejection as a whole, we find that “treatment of’ or a
similar phrase was inadvertently omitted by the Examiner, and we read the
rejection with this understanding.
17
Appeal 2016-008053
Application 13/630,475
thermal energy and the other balloon 152 occludes the targeted vessel.” Id.
at 7—8. According to Appellant, the skilled artisan would only use this
teaching of Pageard “to modify Bonnette’s device to cryogenically ablate
areas of tissue,” which, because it would have been avoided in this scenario,
means the Examiner was using hindsight reasoning in constructing the
rejection. Id. at 8.
We are not persuaded that the Examiner erred in finding that
Bonnette, Bertolero, and Pageard render claim 25 obvious. Pageard teaches
a system for ablating tissue that uses deformable balloons and/or flexible
elements that can be controlled to regulate pressure within the balloons or
elements. Pageard Abstract. Pageard teaches that the balloons have
different “compliance,” in that one is more flexible than the other due to its
construction from a more rigid materials. FF9, FF10. Pageard teaches that
“[t]he substantially increased elasticity or compliance of the second balloon
152 as compared to the first balloon 150 may result in the second balloon
152 being more readily deformable than the first balloon 150 when inflated
and/or in contact with a targeted tissue area.” FF10. Pageard claim 9
recites use of the system with a flexible catheter:
9. A medical system, comprising:
a flexible catheter body;
a first balloon disposed on the catheter body;
a second balloon disposed distally of the first balloon, wherein
the second balloon is more readily deformable than the first
balloon; and
a third balloon substantially enclosing the first and second
balloons to [] define an interstitial region therebetween.
18
Appeal 2016-008053
Application 13/630,475
FF11. We are persuaded by the Examiner’s reasoning (Ans. 9) that in
performing an occlusion treatment, the skilled artisan may need to adapt to
the varying anatomy of the human body, and that using balloons with
varying compliance would permit better contact with the targeted tissue area.
FF9. “A person of ordinary skill is also a person of ordinary creativity, not
an automaton.” KSR, 550 U.S. at 421. Thus, one of ordinary skill in the art,
as found by the Examiner, would have recognized that the properties of the
materials would be useful in the context of assisting in steering the catheter
of Bonnete. Because Pageard both discloses and claims use of such balloons
in general medical systems employing a flexible catheter, we are not
persuaded by Appellant’s argument (App. Br. 10-11) that they are useful
only for arterial ablation procedures. The rejection is affirmed.
SUMMARY
We affirm the rejection of claims 1—4, 22—24, and 26—28 under pre-
AIA § 103(a) as obvious over Bonnette and Bertolero.
We affirm the rejection of claim 25 under pre-AIA § 103(a) as
obvious over Bonnette, Bertolero, and Pageard.
TIME PERIOD FOR RESPONSE
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
19