Ex Parte Rao et al

Patent Trial and Appeal Board

Feb 7, 2019

12966852 (P.T.A.B. Feb. 7, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/966,852 12/13/2010 K.T. Venkateswara Rao
128926 7590 02/11/2019
Foley & Lardner LLP
3000 K Street N.W.
Suite 600
Washington, DC 20007-5109
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.
109167-0287 9567
EXAMINER
TON, MARTIN TRUYEN
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
02/11/2019 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte K.T. VENKATESWARA RAO, RAJP. GANPATH,
AMY LEE, andANUPAMAKARWA
Appeal2017-007203
Application 12/966,852
Technology Center 3700
Before ULRIKE W. JENKS, JOHN G. NEW, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants 1 appeals from Examiner's
decision to reject claims as obvious and for containing new matter. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the real party in interest as Endologix, Inc. Br. 3.
In addition to the Final Office Action dated Dec. 10, 2015 ("Final Act."), we
herein refer to the Appeal Brief, filed Oct. 21, 2016 ("Br."); and Examiner's
Answer, mailed Dec. 9, 2016 ("Ans."). No Reply Brief has been filed.
Appeal2017-007203
Application 12/966,852
STATEMENT OF THE CASE
Claims 1-10, 19, 22, 23, and 26-39 are on appeal, and can be found in
the Claims Appendix of the Appeal Brief. Claim 1 is representative of the
claims on appeal, and reads as follows:
1. A system for treating an aneurysm in a patient, the system
compnsmg:
a double-walled filling structure having an outer wall and
an inner wall, wherein the filling structure is adapted to be filled
with a hardenable fluid filling medium such that when the filling
structure is positioned across the aneurysm and filled with the
hardenable fluid filling medium, the outer wall expands to
conform to an inside surface of the aneurysm and the inner wall
forms a tubular lumen to permit blood flow therethrough; and
a reinforcing tube surrounding the inner wall, wherein the
inner wall is separate from the reinforcing tube and prevents the
inner wall from expanding outward beyond the radial dimensions
of the reinforcing tube, wherein the reinforcing tube is of a
continuous material.
Br. 19 (Claims Appendix)
Appellants seek review2 of the following rejections made by
Examiner:
I. Claim 29 under pre-AIA 35 U.S.C. § 112, first paragraph as failing to
provide sufficient written description for the elements claimed (new
matter). Final Act. 5.
2 In the Final Office Action, Examiner also rejected claim 31 under 35
U.S.C. § 112(d) or pre-AIA 35 U.S.C. § 112, fourth paragraph as failing to
further limit the subject matter of claim 1 upon which it depends. Final Act.
6. Appellants do not provide arguments with respect to this rejection,
accordingly, we summarily affirm this rejection for the reasons set out by
Examiner.
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Application 12/966,852
II. Claims 1-8, 10, 19, 22, 23, 26, 27, 29, 31-33, 35, 36, and 38 under
pre-AIA 35 U.S.C. § I03(a) as unpatentable over Evans3 in view of
Whalen. 4 Id. at 6-12.
III. Claims 9 and 34 under pre-AIA 35 U.S.C. § I03(a) as unpatentable
over Evans in view of Whalen and further in view ofLee. 5 Id. at 12-
13.
IV. Claims 6, 28, 30, 37, and 39 under pre-AIA 35 U.S.C. § I03(a) as
unpatentable over Evans in view of Whalen and further in view of
Kubo. 6 Id. at 13-14.
I. New Matter
Examiner finds that claim 3 9:
[R ]ecites the limitation "wherein the reinforcing tube is not a
coil, spring, stent or scaffold." However, the specification merely
states that "The reinforcing tube may be of a continuous material,
or it may be a mesh attached to the inner lumen" but it does not
at all exclude the device from being a coil spring, stent, or
scaffold.
Final Act. 5. Examiner directs us to guidance in the MPEP that explains any
negative limitation still requires a basis in the original disclosure. Id. ( citing
MPEP 2I 73.05(i)).
Appellants contend that positively recited elements may be excluded
from the claims. Br. 10 (citing In re Johnson, 558 F.2d 1008, 1019 (CCPA
1977)). Appellants contend that the Specification teaches expanded
3 Michael A. Evans et al., US 2006/0025853 Al, published Feb. 2, 2006
("Evans").
4 Robert L. Whalen, US 4,130,904, issued Dec. 26, 1978 ("Whalen").
5 Amy Lee et al., US 2007/0276477 Al, published Nov. 29, 2007 ("Lee").
6 Yoshihiko Kubo et al., US 5,236,447, issued Aug. 17, 1993 ("Kubo").
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Application 12/966,852
polytetrafluoroethylene ( ePTFE) as a reinforcing material, and the
"reinforcing tube or sleeve can reasonably be formed from
ePTFE,[however,] it is unreasonable to argue that a coil spring, stent or
scaffold can be formed of ePTFE." Id.
"To satisfy [the written description] requirement, the specification
must describe the invention in sufficient detail so 'that one skilled in the art
can clearly conclude that the inventor invented the claimed invention as of
the filing date sought."' In re Alonzo, 545 F.3d, 1015, 1019 (Fed. Cir. 2008),
citingLockwoodv. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed.Cir.1997).
It is not necessary that specification provide ipsis verbis support for
the claimed subgenus so long as its disclosure reasonably conveys to persons
skilled in the art that inventors invented the subgenus claimed, i.e., by
adequately directing one skilled in the art to that subgenus. In re Edwards,
568 F.2d 1349, 1351-52 (CCPA 1978). When we consider the disclosure as
a whole, in view of the record before us, we are not persuaded by
Appellants' contention that the specification's recitation of ePTFE as a
material that may form the reinforcing tube or sleeve provides a sufficient
description of the subgenus Appellants now seek to exclude from the scope
of the claims. As Examiner explains, "[ t ]here is nothing inherent to the
structures of a stent, coil spring, or scaffold that would suggest that it cannot
be formed of ePTFE." Ans. 2.
Citing Johnson, 558 F.2d at 1019, Appellants argue that if an element
is positively recited it may be explicitly excluded from the claims. Br. 10.
Here, Appellants are adding an embodiment, i.e., "the reinforcing tube is not
a coil spring, stent or scaffold." In Johnson the applicant was removing
species within a described genus. Further, in Johnson, the Court noted that
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Application 12/966,852
the specification contained extensive examples that fully supported the
subgenus claimed. See Johnson, 558 F.2d at 1018 (noting that "appellants'
grandparent application contains a broad and complete generic disclosure,
coupled with extensive examples fully supportive of the limited genus now
claimed."). Appellants contend that the Specification teaches "reinforcement
of the inner wall is provided by metal rings or compressible and readily
expandable rings, each ring forming an undulating or zigzag pattern
(Paragraph [0013]), which clearly encompass springs, stents or scaffolds."
Br. 10. We are not persuaded that the description of a ring, even an
undulating ring, necessarily describes a subgenus comprising a coil spring,
stent or scaffold even if they share a common circular shape.
We agree with Examiner that the Specification does not recite a coil
spring, stent or scaffold. See Final Act. 5. We are not persuaded by
Appellants' contention that disclosure of expandable rings including those
with zig-zag patterns would necessarily describe coil springs, stent, or
scaffolds. See Br. 10. A "description need not recite the claimed invention in
haec verba but must do more than merely disclose that which would render
the claimed invention obvious." ICU Medical, Inc. v. Alaris Medical
Systems, Inc. 558 F.3d 1368, 1377 (Fed. Cir. 2009). In the present situation
we find that Examiner has the better position. Here, Appellants disclosure as
filed does not provide sufficient examples to describe a genus in order to
support the subgenus Appellants now seek to exclude from the claims.
Accordingly, we affirm the new matter rejection of claim 39.
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II. Obviousness over Evans and Whalen
The issue is: Does the preponderance of evidence of record support
Examiner's conclusion that the addition of a support structure into the
system described in Evans is obvious?
Findings of Fact
FF 1. Evans teaches a double-walled prosthesis system comprising a filling
structure mounted over a delivery catheter for treating an aneurism.
Evans Abstract, see also ,r 30. Figure 1, reproduced below, depicts
such a prosthesis system.
Figure 1 shows system 10 comprising a delivery catheter 14 having an
expandable element 16 for delivery of a double-walled filling
structure 12 to an aneurysm. Id. ,r 37. The structure contains:
a filling tube 20 for delivering a filling medium or material
to an internal space 22 of the double-walled filling
structure 12. The internal space 22 is defined between an
outer wall 24 and inner wall 26 of the filling structure.
Upon inflation with the filling material or medium, the
outer wall will expand radially outwardly, as shown in
broken line, as will the inner wall 26, also shown in broken
line. Expansion of the inner wall 26 defines an internal
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Application 12/966,852
lumen 28. The expandable balloon or other structure 16
will be expandable to support an inner surface of the
lumen 28.
Id. "After the double-walled filling structure 12 is properly positioned,
a hardenable inflation medium is introduced into the internal space 22
filling of the inner space 22 expands the outer wall 24 of the structure
outwardly so that it conforms to the inner surface (S) of the
aneurismal space." Id. ,r 44.
FF2. Evans teaches that the wall of the double-walled filling structure may
be more complex. Figure 3, reproduced below, shows several wall
complexes.
FIG. 3A
24
tizzz5'
FIG.3C
48
~l 2z ~z 2z zl{
FIG. 3B
FIG. 3A shows a multi-layered wall comprising layers 42,
43 and 44 . ... FIG. 3B, a single wall or multiple wall
structure can be reinforced by braid, coils, or other metal
or non-polymeric reinforcement layers or structures ....
FIG. 3C, the external surface 24 of the wall may be
covered with drugs, fibers, protrusions, holes, active
agents or other substances for a variety of purposes.
Id. ,I4I.
FF3. Evans teaches:
The walls of the filling structures may consist of a
single layer or may comprise multiple layers which are
laminated or otherwise formed together. Different layers
may comprise different materials, including both
compliant and/or non-compliant materials. The structure
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Application 12/966,852
walls may also be reinforced in various ways, including
braid reinforcement layers, filament reinforcement layers,
and the like. In some instances, it would be possible to
include self-expanding scaffolds within the filling
structures so that the structures could be initially delivered
and be allowed to self-expand at the treatment site, thus
obviating the need for an expansion delivery catheter as
described as the preferred embodiment below.
Id. ,I 16.
FF4. Evans teaches using the system to treat the complex geometry of a
transmural abdominal aortic aneurysm (AAA). Id. ,r 43. Figure 5C,
reproduced below, shows a tubular lumen flared to different opening
sizes across the aneurism.
Figure 5C shows the use of "a balloon 16 or other expansible structure
which will be shaped to preferentially open the lower proximal end 50
of the tubular lumen to a larger diameter than the upper or distal end
52." Id. ,I 45.
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FF5. Whalen teaches prosthetic blood conduit made of two polyester fabric
tubes and a coil spring enclosed therebetween. Figure 1, reproduced
below, shows such a conduit.
Figure 1, shows the blood conduit 10 includes a flexible fabric tube 14
forming an inner surface 12. Id. 1 :48--49. An outer tube 24, encloses
both the inner tube 14 and the spring 18. Id. 2: 10-11.
A helical reinforcing spring 18 closely surrounds
the inner tube 14. Radial strength afforded by the wall
structure of the inner tube 14 maintains a close fit between
said tube and the spring 18. The spring 18, responsible for
most of the radial strength, must be sufficiently flexible to
avoid substantial resistance to bending in vivo so the
conduit will not interfere with natural organs. One
biologically compatible material used for the spring 18 is
No. 316 stainless steel. The spring may be entirely of
stainless steel or coated therewith. Obviously other
biologically compatible spring materials may be used.
Id. 1:66-2:9.
"The reinforcing spnng 18 is also described as being
helical." Id. 2:56-57. "With the spring 18 holding the inner tube
14 in a close fit the sides of the tube 14 cannot expand outwardly
and the small but significant radial strength of the tube 14
prevents collapse." Id. 3:19--22.
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Analysis
Examiner finds that Evans teaches a double-walled filling structure
for use in a system to treat an aneurysm. Final Act. 6. The double-walled
structure has an outer wall and an inner wall. "[T]he outer wall expands to
conform to an inside surface of the aneurysm and the inner wall forms a
generally tubular lumen to permit bloodflow therethrough." Id. at 7. (citing
Evans ,r 39, Figs 1 and 5C); see FFl, FF4. Examiner finds that Evans
teaches that the walls of the filling structure may be reinforced. Final Act. 7
( citing Evans ,r 16); see FF2-FF3. Examiner acknowledges that Evans "does
not specifically teach a reinforcing tube surrounding the inner wall, wherein
said inner wall is separate from said reinforcing tube and prevents said inner
wall from expanding outward beyond the radial dimension of said
reinforcing tube." Final Act. 7. Examiner relies on the teaching of Whalen to
incorporate "a reinforcing tube surrounding said wall that prevents the wall
from expanding outward beyond the radial dimensions of the tube ... ,
wherein the tube is made of a stainless steel strand of material formed into a
coil spring." Final Act. 7 (citing Whalen 1 :6-2:9); see FF2-FF3. Examiner
concludes that
it would have been obvious to a person having ordinary skill in
the art at the time of invention to utilize the reinforcement tube
of the Whalen reference as a means for reinforcing the inner wall
of the Evans reference since it is a simple substitution of one
known element for reinforcement of a tubular lumen of a
prosthesis for another known reinforcement structure.
Final Act. 7-8.
Appellants contend that "[ t ]he alleged separate reinforcing tube in
Whalen is actually a spring 18 that contacts both the inner and outer walls"
(Br. 12); that Evans does not suggest a separate reinforcing tube that
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surrounds the inner wall (id. at 14); that there is "no apparent reason why
one would remove a supporting scaffold, stent or coil spring from an
integrated stent-graft and include it as a separate element inside of a filings
structure between flexible inner and outer walls" (id. at 15); that interpreting
a coil spring to read on a separate reinforcing tube that is made of a
continuous material is unreasonable (id. at 13-14 ).
We are not persuaded by Appellants contention that Whalen's spring
contacting both inner and outer wall of the conduit cannot be incorporated
into Evans' s structure. Appellants' arguments attacking the Whalen and
Evans references individually (see, e.g., Br. 12), when the rejection is based
on their combination, is improper. In re Keller, 642 F.2d 413, 426 (CCPA
1981 ). "[I]t is not necessary that the inventions of the references be
physically combinable to render obvious the invention under review." In re
Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983). Here, Whalen explains that
having the spring 18 in close fit with the sides of the tube 14 ensures that
tube 14 "cannot expand outwardly and the small but significant radial
strength of the tube 14 prevents collapse." FF5. Thus, the role of the spring
in Whalen is to provide support for the walls of the inner tube. Furthermore,
describing something as being in close fit does not mean that the structures
are physically linked together and thereby cannot be separated.
Evans teaches that there are numerous ways to reinforce the filling
structure. FF2-FF3. Specifically, "including braid reinforcement layers,
filament reinforcement layers, and the like."" FF3; see also Ans. 4 ("In fact,
using the terms 'reinforced in various ways' and 'and the like' suggests that
there are many different ways that can be used to reinforce the walls of the
structure, including a reinforcement element as the one taught in Whalen.").
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In addition, Evans teaches that the filling space can also incorporate self-
expanding scaffolds. FF3. The inclusion of self-expanding scaffold within
the filling structure of Evans suggests that the system is flexible in how the
components may be arranged, and that such a component would function in
the delivery of the system to the intended site of the aneurysm, and also
provide some structural reinforcement for the system. Accordingly, we are
not persuaded by Appellants contention that Evans does not suggest a
reinforcing component.
"[W]hen a patent claims a structure already known in the prior art that
is altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result." KSR
Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007), citing United States v.
Adams, 383 U.S. 39, 50-51 (1966). Here, Examiner is relying on substitution
of one reinforcement structure for another to reach the conclusion that the
combination of references renders the claims obvious. Evans teaches the
inclusion of reinforcement structures into the system and also teaches
incorporating self-expanding structures, such as a stent, into the filling space
of the device. FF3. It is reasonable to interpret that such a self-expanding
scaffold not only assists in the placement of the system at the treatment site
but that it can simultaneously provide structural support. More importantly,
the teaching that a scaffold can be incorporated into filling space reasonably
suggests that the inclusion of additional structures within Evans's filling
space does not render the system inoperable. We find no error with
Examiner's reliance on the combination of Evans and Whalen.
We are not persuaded by Appellants' contention that there is no
reason to remove a supporting scaffold stent or coil spring from an
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integrated stent-graft and use it as a separate structure. See Br. 15. As
discussed above, Evans discloses multiple ways to reinforce the system.
Evans teaches that the walls may be constructed of single or multiple layers.
See FF2-FF3. The walls in Evans can also incorporate braids coils or other
metal or non-polymeric reinforcement layers. FF2. We agree with
Examiner's interpretation that describing that the system may be "reinforced
in various ways" and "and the like" implies that other known structural
reinforcements are also acceptable. See Ans. 4. This interpretation is further
supported by Evans' s suggestion of incorporating a self-expanding scaffold
within the filling space of the endovascular aneurysm treatment system. FF3.
As discussed above, such a self-expanding scaffold would reasonably
function to provide support for the structure. Accordingly we are not
persuaded by Appellants' contention that the teachings in Evans would
require rearrangement of the reinforcement structure.
We are also not persuaded by Appellants' contention that a coil
cannot be interpreted to meet the limitations of a tube that is made out of a
continuous material. Br. 13-14. As noted by Examiner, "the definition of a
tube as referenced in the Appeal Brief is 'a hollow cylindrical structure' or
'a pipe-like structure.' The overall shape formed by the coils of the spring
forms a hollow cylindrical structure that is pipe-like in shape and structure,
therein fitting with the definition discussed in the Appeal Brief." Ans. 3; see
also Br. 13 ("a 'tube', which is understood as a hollow cylindrical body").
We also agree with Examiner position that because "the coil spring is made
of a single continuous wire" it reasonably meets the requirement of a
contiguous material. Ans. 3.
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We conclude that the evidence cited by Examiner supports a prima
facie case of obviousness with respect to claim 1, and Appellants have not
provided sufficient rebuttal evidence that outweighs the evidence supporting
Examiner's conclusion of obviousness. As Appellants do not argue the
claims separately, claims 2-8, 10, 19, 22, 23, 26, 27, 29, 31-33, 35, 36, and
38 fall with claim 1. 37 C.F.R. § 41.37 (c)(l)(iv).
III. Obviousness over Evans, Whalen, and Lee
Examiner has rejected claims 9 and 34 as obvious based Evans,
Whalen, and Lee. Final Act. 12-13. Appellants' only argument with respect
to this rejection is that "Lee fails to cure the deficiencies noted in the cited
combination of Evans and Whalen." Br. 17. This argument is not persuasive
because, as discussed above, we conclude that Evans and Whalen would
have made obvious the system recited in claim 1. We affirm the rejection of
claims 9 and 34 for the reasons given by Examiner in the Final Office
Action and Answer.
IV. Obviousness over Evans, Whalen, and Kubo
Examiner has rejected claims 6, 28, 30, 37, and 39 as obvious based
Evans, Whalen, and Kubo. Final Act. 13-14. Appellants only argument with
respect to this rejection is that "Kubo fails to cure the deficiencies noted in
the cited combination of Evans and Whalen." Br. 1 7. This argument is not
persuasive because, as discussed above, we conclude that Evans and Whalen
would have made obvious the system recited in claim 1. We affirm the
rejection of claims 6, 28, 30, 37, and 39 for the reasons given by Examiner
in the Final Office Action and Answer.
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SUMMARY
We affirm the new matter rejection of claim 29.
We affirm the rejection of claims 1-8, 10, 19, 22, 23, 26, 27, 29, 31-
33, 35, 36, and 38 under pre-AIA 35 U.S.C. § 103(a) over Evans and
Whalen.
We affirm the rejection of claims 9 and 34 under pre-AIA 35 U.S.C.
§ 103(a) over Evans, Whalen, and Lee.
We affirm the rejection of claims 6, 28, 30, 37, and 39 under pre-AIA
35 U.S.C. § 103(a) over Evans, Whalen, and Kubo.
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
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