Ex Parte Krolik et al

Patent Trial and Appeal Board

May 3, 2018

11466439 (P.T.A.B. May. 3, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111466,439 08/22/2006 Jeffrey A. Kralik
23410 7590 05/04/2018
Vista IP Law Group LLP
100 Spectrum Center Drive
Suite 900
IRVINE, CA 92618
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
NCPT-007 2001
EXAMINER
EASTWOOD, DAVID C
ART UNIT PAPER NUMBER
3731
MAILDATE DELIVERY MODE
05/04/2018 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 JEFFREY A. KROLIK, ELIOT KIM, and
JAMES HOW ARD DREHER
Appeal2017-002806
Application 11/466,439
Technology Center 3700
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and
JOHN G. NEW, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant 1 appeals from the
Examiner's decision to reject the claims as obvious and as lacking written
descriptive support for a claim element. We have jurisdiction under
35 U.S.C. § 6(b ).
We REVERSE.
STATEMENT OF THE CASE
The Specification describes stent placement at the branch point of
vessels. Spec. Abstract.
1 Appellant is the Applicant, Incept LLC, which, according to the Brief, is
the real party in interest. Appeal Br. 2.
Appeal2017-002806
Application 11/466,439
Claims 1, 4--6, 29--42, 49-50, 53, and 55-60 are on appeal, and can be
found in the Claims Appendix of the Appeal Brief. Claims 1 and 30 read in
pertinent part as follows:
1. An apparatus for locating an ostium of a body lumen,
compnsmg:
an elongate member ... ;
a first expandable member on the distal end of the
elongate member, the first expandable member being
expandable from a contracted condition to an enlarged
condition, the first expandable member formed from material
shaped to expand such that a proximal portion of the first
expandable member has a predetermined substantially
spherical shape when expanded to the enlarged condition and a
distal portion extends distally from the proximal portion and
has a substantially cylindrical shape, the proximal portion
comprising a distal surface, a proximal surface, and an
intermediate region between the proximal and distal surfaces in
the enlarged condition;
a prosthesis comprising first and second ... ;
a stop on the distal end of the elongated member ... ; and
a second expandable member ... , the second expandable
member expands at least the second portion of the prosthesis.
Appeal Br. 30-31 (Claims Appendix)(formatting and emphasis added).
The other independent claims similarly recite an expandable member
having simultaneously a spherical and elongated shape. Specifically,
claim 6 recites an expandable member that has a "predetermined
substantially spherical shape when expanded to the enlarged condition and a
distal portion extends distally from the proximal portion over at least a
portion of the second expandable member and has a substantially cylindrical
shape." Id. at 32. Claim 30 recites an elongated member having a
"predetermined substantially spherical shape when expanded to the enlarged
condition and a distal portion extends distally from the proximal portion and
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Application 11/466,439
has a substantially cylindrical shape." Id. at. 33-34. Claim 53 recited an
elongated member having "a predetermined shape in which the proximal
portion has a substantially spherical shape when expanded from a contracted
condition to an enlarged condition that includes a tapered distal surface
extending transversely outwardly and proximally from the distal portion and
the distal portion has a substantially cylindrical shape." Id. at 38-39.
Appellant requests review of the following grounds of rejection made
by the Examiner:
I. Claims 53 and 55 under pre-AIA 35 U.S.C. § 112, first paragraph
as failing to comply with the written description requirement.
II. Claims 1, 4--6, 29, 34--42, 49, 50, 53, and 55-58 under pre-AIA
35 U.S.C. § 103(a) as obvious over Boatman2 in view of
Svensson. 3
III. Claims 30-33, 59, 60 under pre-AIA 35 U.S.C. § 103(a) as
obvious over Boatman in view of Fischell. 4
I. Written Description
The Examiner finds that there is no written descriptive support for the
claim 53 limitation of "'the first expandable member formed from material
to [achieve] a predetermined shape."' Final Act. 10; see Ans. 3. The
Examiner recognizes that the Specification describes the expandable
member, i.e. a balloon, to take on a particular shape when inflated. See Final
Act. 10 ("At best the instant specification provides support for the first
2 Boatman et al., US 2005/0171597 Al, publ. Aug. 4, 2005 ("Boatman").
3 Svensson, US 6,620,191 Bl, issued Sept. 16, 2003.
4 Fischell et al., US 2005/0049680 Al, publ. Mar. 3, 2005 ("Fischell").
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Application 11/466,439
expandable member formed from material which is shaped to expand to a
substantially spherical shape"). The contention lies with what does it mean
to be "predetermined" based on material.
In rebuttal, Appellant points to passages in the Specification that
explain that the balloon "is shaped to expand to a substantially spherical
shape in the enlarged condition ... [and] may be shaped to expand to a
substantially cylindrical shape in the enlarged condition." Appeal Br. 14
(citing Spec. 29:9-17)(emphasis removed). "One of ordinary skill in the art
would immediately understand that a balloon being 'shaped' to expand to a
particular enlarged shape" is a predetermined shape. Id. at 15; see also
Reply Br. 3 ("predetermined shape which will expand to the desired
enlarged shape, such as a substantially spherical shape or a substantially
cylindrical shape).
We find that Appellant has provided adequate evidence that the
disputed claim limitation is supported by the written description of the
Specification. The Specification teaches that the balloons may be formed
from either a "substantially compliant or semi-compliant material, ... [or]
substantially non-compliant material." Spec. 28: 1--4; see also Spec. 69:3-8
(The balloons 622 may be formed from substantially
inelastic material, e.g., PET, nylon, or PEBAX, such that each
balloon 622 expands to a predetermined size in its enlarged
condition once sufficient fluid is introduced into the interior of
the balloon 622. Alternatively, the balloon 622 may be formed
from substantially elastic material, e.g., silicone, polyurethane,
or polyethylene, such that the balloon 622 may be expanded to
a variety of sizes depending upon the volume and/or pressure of
fluid within the interior).
We find that this disclosure in the Specification sufficiently describes that
the materials the balloon is made from determines the balloon's final shape.
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Application 11/466,439
When inelastic materials are used, the above-reproduced disclosure teaches
that the final size of the balloon is determined by the material, i.e., the size
(and shape) is predetermined. On the other hand the balloon size is not
predetermined when elastic materials are used because they can be
"expanded to a variety of sizes." Thus, describing the balloon as having a
predetermined shape indicates that the balloon is made of inelastic material
and can only assume one expanded shape and not a variety of shapes as with
an elastic material. Accordingly, we reverse the rejections of claim 53 and
55 as not complying with the written description.
II. and III. Obviousness over Boatman
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that Boatman teaches a balloon catheter with an
expandable balloon member having two different shapes when expanded?
Findings of Fact
FF 1. Boatman teaches a delivery system for a branched vessel prosthesis.
The delivery system may include a balloon expansion catheter having
a multi-layer balloon. Boatman i-fi-f 141, 146. Examples of a multi-
layer balloon in the collapsed and expanded state are shown below:
FIG. 27G
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Application 11/466,439
FIG. 27 H '\.,014
812 . ~ .. ~ · ...... --... 1111
910
806
Fig. 27 G and Hare shown above both depict a multi-layer balloon.
The inner and outer layers 810, 812 may be of different
compliancy. The inner layer 810 may be less compliant
than the outer layer 812. For example, the inner layer
810 may be constructed of a semi-compliant or
noncompliant material, and the outer layer 812 may be
constructed of a compliant material. To expand and flare
the branch vessel prosthesis 11 with this embodiment, the
inner layer may be inflated to expand the branch vessel
prosthesis 11. Subsequently or simultaneously, the outer
layer 812 may be inflated to expand or flare the flaring
portion 814, which is not constrained by the branch
vessel 5, of the branch vessel stent graft 814.
Boatman i-f 146; see Ans. 4--7 (citing figure 27H); see Final Act. 11-
23 (citing figures 27G and 27H).
Principle of Law
"An examiner bears the initial burden of presenting a prima facie case
of obviousness." In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
2011).
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Analysis
Since both of the obviousness rejections rely upon the teaching of
Boatman regarding a "first expandable member ha[ ving] a predetermined
substantially spherical shape when expanded to the enlarged condition and a
distal portion [that] extends distally from the proximal portion and has a
substantially cylindrical shape," the same issue is dispositive for both of
these rejections, so we will consider the rejections together.
The Examiner finds that Boatman teaches a first and second
expandable member, with the "first expandable member being expandable
from a contracted condition to an enlarged condition (note figures 27G and
H)." Final Act. 12, see id. 24. The "second expandable member being
expandable from a contracted condition to an enlarged condition
independent of the first expandable member." Final Act. 14.
The Examiner finds that Boatman meets all the claimed elements but
fails to explicitly disclose a stop on the distal end of the
elongate member adjacent the second portion of the prosthesis,
the stop comprising a substantially blunt annular proximal edge
at a proximal most end of the stop that extends
circumferentially around the distal portion of the first
expandable member distal to and abutting a distal end of the
second portion of the prosthesis to prevent distal migration of
the prosthesis when the first expandable member is expanded.
Ans. 14. The Examiner finds that "Boatman [also] fails to explicitly
disclose the first flaring portion further comprising the second set of cells
disposed adjacent the first set of cells and the first axial length being
substantially shorter than the second axial length." Ans. 24. The Examiner
looks to either Svensson or Fishman for teaching these missing limitations.
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Appellant contends that "the claimed first expandable member
[disclosed in Boatman] is not formed from a material shaped to expand such
that a proximal portion of the balloon 812 has substantially spherical shape
in an unconstrained condition." Appeal Br. 19. Appellant cites to the Yang
Declaration5 as providing support for the position that "the resulting shape
[of Boatman] is not due to any shape formed (e.g., molded) in the material of
the outer layer 812 but [is] merely due to the lack of any constraint from the
branch vessel." Id. at 20; see also Yang Dec. 3 ("that the outer layer 812,
given its compliant construction, would simply conform substantially to
surrounding anatomy when expanded within a patient's body").
We agree with Appellant that the limitation of an "expandable
member has a predetermined substantially spherical shape when expanded to
the enlarged condition and a distal portion extends distally from the
proximal portion and has a substantially cylindrical shape" as recited in
claim 1 reasonably describes a balloon that in the expanded state attains a
particular form.
To begin, we interpret the claim to require that the "substantially
spherical shape" and "substantially cylindrical shape 6" are "predetermined."
As discussed above, we interpret "predetermined" to mean that there is one
final shape which is determined based on how the balloon is formed and the
material from which it is made. As explained in the Specification, balloons
5 Supplemental declaration by Yi Yang signed May 18, 2015 ("Yang
Dec.").
6 The Specification provides that a cylindrical shape is "predetermined"
shape because it made of "semi-compliant or substantially non-compliant"
material, in other words, material that is constrained. Spec. 28:3--4; see id.
at 69:3-8.
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Application 11/466,439
made of inelastic materials form one size when expanded. See Spec. 28:1--4;
see id. at 69:3-8. A "predetermined spherical shape" as recited in the claim,
and as reasonably understood in light of the Specification, is the final shape
of the balloon (a sphere) that is made of inelastic material (or non-compliant
material), so that the size does not vary. See id. at 28: 1--4; see id. at 69:3-8.
The claim further requires that the balloon, when filled with air or
liquid, has a shape that comprises both a sphere and a cylinder. This
interpretation is consistent with the Specification that describes the balloon
having a spherical shape with a diameter of 10-20 millimeters, and the same
balloon having a cylindrical shape with a diameter of 2-8 millimeters ( 10-20
mm) and a length of at least 8-30 millimeters. See Spec. 29-30 (citing
Fig. 8).
We agree with Appellant that the Examiner's interpretation that
adapting a balloon made of compliant material to conform to the shape of
the surrounding vessel as meeting the claim element of having
"predetermined" shape that is both spherical and cylindrical is not a
reasonable interpretation of the claim. See Appeal Br. 18-20, see Final
Act. 13 ("inflation of the balloon within the intended target area expands the
balloon to the substantially spherical shape as reasonably shown in figure
27h [of Boatman] and as described in paragraph 141 and 146-14 7) and a
distal portion (distal portion distal flared region of stent 11) extends distally
from the proximal portion and has a substantially cylindrical shape").
Boatman's expandable member identified by the Examiner as meeting
the claimed elements is Fig. 27 Hand 27 Gare not made of semi-compliant
or non-compliant materials, and do not expand to a pre-determined shape as
we have interpreted the claim. FF 1. The Examiner finds that the balloon of
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Application 11/466,439
Boatman has the requisite shape because "the outer layer 812 may be
inflated to expand or flare the flaring portion 814, which is not constrained
by the branch vessel 5, of the branch vessel stent graft 814." FFI. 7 The
reason the balloon in Fig 27H appears to have a spherical shape is the
compliant material of layer 812 and the lack of constraint by the branch
vessel. See FF 1; see Yang Dec. 3. We agree with Appellant that the
evidence of record does not support the Examiner's position that the balloon
disclosed in figures 27G and 27H of Boatman meets the structural
requirements of having an expandable member that has a predetermined
shape/size that is both spherical and cylindrical when expanded.
We conclude that the preponderance of the evidence of record does
not support the Examiner's conclusion that the combination of Boatman
with either Svensson or Fischell discloses an apparatus having the requisite
expandable member. The Examiner has not articulated any other rationale
for arriving at the claimed expandable member. Because the combination
does not disclose all limitations of independent claims 1, 6, 30, and 33, we
reverse the rejections under pre-AIA 35 U.S.C. § 103(a) that rely on the
teachings of Boatman with Svensson or Boatman with Fischell.
7 We note that Figures 27C and 27D (not shown) of Boatman, shows an
alternate embodiment of a single balloon (i.e. expandable member) "having
the inflated diameter D1 of the first portion 803 may be smaller than the
inflated diameter D2 of the second portion 805." Boatman i-f 144. This
figure, however, is not relied on by the Examiner in formulating the
rejection.
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SUMMARY
We reverse claims 53 and 55 under pre-AIA 35 U.S.C. § 112, first
paragraph as failing to comply with the written description requirement.
We reverse the rejection of claims 1, 4---6, 29, 34--42, 49, 50, 53, and
55-58 under pre-AIA 35 U.S.C. § 103(a) over Boatman and Svensson.
We reverse the rejection of claims 30-33, 59, 60 under pre-AIA 35
U.S.C. § 103(a) Boatman and Fischell.
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)(l)(iv).
REVERSED
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