Ex Parte Gunday et al

Patent Trial and Appeal Board

Jul 16, 2018

13837970 (P.T.A.B. Jul. 16, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
13/837,970
151971 7590
Forge IP, PLLC
1077 Bridgeport Ave
Suite 301
Shelton, CT 06484
FILING DATE FIRST NAMED INVENTOR
03/15/2013 Erhan H. Gunday
07/18/2018
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.
04530-P0053A 6030
EXAMINER
NEAL, TIMOTHY JAY
ART UNIT PAPER NUMBER
3779
NOTIFICATION DATE DELIVERY MODE
07/18/2018 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):
patent@forge-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ERHAN H. GUNDA Y, LAWRENCE J. GERRANS,
ALEX HSIA, DEVIN J. S. SCHEIFELE, and JESSIE TUNG
Appeal2017-007255
Application 13/837,970 1
Technology Center 3700
Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims that recite
catheter assemblies. The Examiner entered rejections for anticipation and
for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm-in-part.
STATEMENT OF THE CASE
The following rejections are before us for review:
1 Appellants state that the "real party in interest for the present application is
Sanovas, Inc., the assignee of the patent application." Appeal Br. 2.
Appeal2017-007255
Application 13/837,970
(1) Claims 1, 3-5, and 12, under 35 U.S.C. § I02(b) as being
anticipated by Perkins2 (Ans. 2--4);
(2) Claims 2, 6, 7, 10, 16, 17, 22, 23, and 25, under 35 U.S.C. § I03(a)
as being unpatentable over Perkins and Gunday3 (Ans. 4--7);
(3) Claims 13-15, 21, and 26-28, under 35 U.S.C. § I03(a) as being
unpatentable over Perkins and Rosenbluth4 (Ans. 7-1 O);
(4) Claims 8, 9, and 11, under 35 U.S.C. § I03(a) as being
unpatentable over Perkins, Gunday, and Powell5 (Ans. 10-11);
(5) Claim 18, under 35 U.S.C. § I03(a) as being unpatentable over
Perkins and Frye 6 (Ans. 12);
(6) Claims 19 and 20, under 35 U.S.C. § I03(a) as being unpatentable
over Perkins and Grice 7 (Ans. 12-13);
(7) Claim 24, under 35 U.S.C. § I03(a) as being unpatentable over
Perkins and Eidenschink8 (Ans. 13);
(8) Claim 24, under 35 U.S.C. § I03(a) as being unpatentable over
Perkins and Lafontaine9 (Ans. 14); and
(9) Claims 26-28, under 35 U.S.C. § I03(a) as being unpatentable
over Perkins and Bales 10 (Ans. 14--15).
2 US 2002/0077593 Al (published June 20, 2002).
3 US 2010/0121270 Al (published May 13, 2010).
4 US 5,007,898 (issued Apr. 16, 1991).
5 US 2009/0264866 Al (published Oct. 22, 2009).
6 US 2005/0004504 Al (published Jan. 6, 2005).
7 US 2006/0293559 Al (published Dec. 28, 2006).
8 US 2008/0077085 Al (published Mar. 27, 2008).
9 US 2008/0161890 Al (published July 3, 2008).
10 US 4,726,374 (issued Feb. 23, 1988).
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Claim 1 is representative and reads as follows:
1. A catheter assembly, comprising:
a hub having a proximal end and a distal end;
a catheter with a proximal portion and a distal portion,
wherein the proximal portion of said catheter is located at the
distal end of said hub; and
at least one balloon at the distal portion of said catheter,
said balloon at least partially enclosing an inflation chamber
and having a resecting surface for resecting biological material;
wherein said catheter has a first lumen in fluid
communication with the inflation chamber of said balloon, and
a second lumen; and
wherein said hub has an inflation port in fluid
communication with said first lumen for supplying fluid to
inflate said balloon, a delivery port in fluid communication with
said second lumen for delivering an agent to the distal portion
of said catheter, and an aperture for inserting a device into said
second lumen.
Appeal Br. 1 7.
ANTICIPATION-PERKINS
The Examiner's Position
In rejecting claims 1, 3-5, and 12 as anticipated by Perkins, the
Examiner finds that the reference discloses a catheter assembly having all of
the features recited in the rejected claims. Ans. 2-3. In particular, the
Examiner finds that, as required by Appellants' claim 1, the balloon of
Perkins' s catheter has "a resecting surface for resecting biological material
(the outer surface of the balloon can resect biological material)." Id. at 3.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
primafacie case ofunpatentability ....
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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 the present appeal, Appellants persuade us that the preponderance
of the evidence does not support the Examiner's finding that Perkins
describes a catheter assembly having all of the features required by the
rejected claims. In particular, we are not persuaded that the Examiner has
shown sufficiently that the balloon of Perkins' s catheter has a resecting
surface encompassed by claim 1.
The language at issue in claim 1 requires the claimed catheter to
include "at least one balloon ... having a resecting surface for resecting
biological material." Appeal Br. 17. Although we do not import limitations
from the Specification into the claims, Appellants' Specification discloses
that examples of resecting surfaces are surfaces textured with a mesh
material, or bumps, or other surface protrusions that resect biological
materials. Spec. ,r,r 45--46.
The Examiner contends that "resecting biological material" as recited
in claim 1 encompasses removal of "material such as blood, saliva, mucous,
and soft-tissue such as fascia or even individual cells." Ans. 15. The
Examiner, however, cites to no evidence of record suggesting that the
posited interpretation is reasonable.
Appellants, in contrast, point to a dictionary definition to support their
position that "[t]he term 'resecting' has a particular meaning in the art,
namely something that is specifically designed to perform a resection or 'the
surgical removal of part of an organ or structure."' Appeal Br. 7 ( citing
http://www.merriam-webster.com/dictionary/resection).
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We find that Appellants' argument is supported by persuasive
evidence. We acknowledge, as the Examiner contends, that claim 1 recites
"resecting biological material." Ans. 15. (emphasis added). As noted
above, however, the term "resecting" undisputedly has a dictionary
definition that requires surgical removal of part of an organ or structure.
Accordingly, the Examiner does not persuade us that, reading the
claim as a whole, a skilled artisan would have considered it reasonable to
interpret claim 1 as encompassing a balloon with a surface capable only of
removing fluid materials like blood or mucus. See In re Cortright, 165 F .3d
1353, 1358 (Fed. Cir. 1999) ("Although the PTO must give claims their
broadest reasonable interpretation, this interpretation must be consistent with
the one that those skilled in the art would reach."). Thus, that the surface of
Perkins's balloon might remove mucus or blood does not demonstrate that
Perkins' s balloon has a resecting surface encompassed by claim 1.
Alternatively, the Examiner contends as follows:
[E]ven if the balloon [of Perkins] is only intended to be used to
isolate regions of the lung, the balloon can be used in other
ways. The balloon can be moved back and forth within any
number of hollow structures ( esophagus, large intestine, blood
vessels, etc.) creating friction to remove material from the
surface of the structure.
The claim does not, as the Examiner previously
indicated, include any particular structure related to the
resecting surface. The surface is referenced solely by what it
does, namely, resect biological material. Perkins discloses a
balloon with a surface that can perform this function.
Ans. 16.
We are not persuaded. We agree with the Examiner that claim 1 is
not limited to any particular structure constituting the resecting material.
That fact, however, does not relieve the Examiner of providing evidentiary
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support for the assertion that the surface of Perkins' s balloon is capable of
performing the claimed function of resecting biological material.
In the present case, the Examiner does not identify any specific
disclosure in Perkins that discusses the structure of the surface of its balloon.
Nor does the Examiner identify any evidence of record, in Perkins or
elsewhere, demonstrating that Perkins' s balloon necessarily has a surface
structure capable of resecting biological material.
In the absence of such an evidentiary basis for finding that Perkins' s
balloon necessarily has a resecting surface encompassed by Appellants'
claim 1, we must reverse the Examiner's rejection of that claim, and its
dependent claims 3-5, and 12, as anticipated by Perkins. See In re Oelrich,
666 F.2d 578, 581 (CCPA 1981) ("Inherency ... may not be established by
probabilities or possibilities. The mere fact that a certain thing may result
from a given set of circumstances is not sufficient.").
OBVIOUSNESS-PERKINS AND GUNDA Y
The Examiner's Position
In rejecting Appellants' claims 2, 6, 7, 10, 16, 17, 22, 23, and 25 for
obviousness over Perkins and Gunday, the Examiner cited Perkins for the
teachings discussed above, but acknowledged that Perkins differs from the
rejected claims in that, contrary to the requirements of claims 2 and 25,
Perkins does not disclose its catheter as "necessarily hav[ing] any imaging
capabilities (the possibility is not foreclosed; see Paragraph 0021 )." Ans. 4,
7.
To address that deficiency, the Examiner cited Gunday as describing
"an imaging device disposed in the aperture of said hub and the second
lumen of said catheter (Paragraph O 101 ). " Id. The Examiner asserted,
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moreover, that "[p ]lacing an inner imaging device through an outer sheath-
like device for internal visualization of the body is old and well-known in
the art." Id.
Based on the references' combined teachings, the Examiner
concluded that it would have been obvious to "include an inner catheter with
imaging capabilities in Perkins' assembly. Such a modification permits the
internal area of a surgical site to be viewed by the surgeon." Id.
The Examiner also acknowledged that, contrary to the requirements of
claims 16 and 17, Perkins "does not explicitly disclose wherein the resecting
surface comprises a mesh affixed to the outer surface of the balloon and
wherein the mesh comprises elastane." Id. at 5.
To address that deficiency, the Examiner cited Gunday as describing a
catheter having a balloon with a resecting surface, "wherein the resecting
surface comprises an elastane mesh affixed to the outer surface of the
balloon (34, Fig. 2B; Paragraphs 0078, 0081, 0083) for resecting." Id.
Therefore, the Examiner concluded, it would have been obvious to
"modify Perkins' balloon to include Gunday's resecting surface. Such a
modification helps the balloon resect tissue." Id.
In response to Appellants' arguments, the Examiner further reasoned
that including Gunday's mesh on the surface of Perkins's balloon would
have been obvious "in that it will help Perkins' balloon stay in place.
Increasing the friction between Perkins' balloon and an anatomical wall is an
improvement over Perkins' device in that the balloon is more likely to stay
in place and keep the region of the lung isolated." Id. at 16-17.
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Analysis
In this instance, Appellants do not persuade us that the preponderance
of the evidence fails to support the Examiner's conclusion of obviousness.
In particular, Appellants do not persuade us that the Examiner erred in
concluding that the combination of Perkins and Gunday suggests a catheter
having the mesh resecting surface required by Appellants' claims 16 and 1 7.
Nor are we persuaded that the Examiner erred in concluding that the
combination of Perkins and Gunday also suggests an imaging device
disposed within the catheter as required by Appellants' claim 25. 11
We tum first to Appellants' claims 16 and 17. Claim 16 recites "[ t ]he
catheter assembly of claim 1, wherein the resecting surface comprises a
mesh affixed to the outer surface of the balloon." Appeal Br. 19.
Claim 1 7 recites "[ t ]he catheter assembly of 16, wherein the mesh
comprises elastane." Id.
Appellants do not assert error in the Examiner's finding (Ans. 5
(citing Gunday Fig. 2B and ,r,r 78, 81, and 83)) that Gunday discloses a
catheter having a balloon with a resecting surface encompassed by claims 16
and 17. See Appeal Br. 9--10; Reply Br. 5---6. Rather, Appellants contend
that it would not have been obvious to modify the balloon of Perkins' s
11 Technically, to present separate argument regarding claims, "[u]nder each
heading identifying the ground of rejection being contested, any claim(s)
argued separately or as a subgroup shall be argued under a separate
subheading that identifies the claim(s) by number." 37 C.F.R.
§ 4I.37(c)(l)(iv). Although Appellants direct argument to the rejections of
claims 16, 17, and claim 25 (see Appeal Br. 9--12), Appellants have not
presented separate argument as to any claims by providing a separate
subheading, as required.
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catheter to have the resecting surface of Gunday's balloon. See id. For the
reasons below, we are not persuaded.
Perkins describes an "apparatus for isolating sub-bronchial regions of
the lung and delivering or retrieving substances from such isolated regions."
Perkins ,r 3.
As required by claims 16 and 1 7, through their dependence on claim
1, Perkins' s catheter includes a balloon 18 at its distal end. See, e.g., Fig. 5.
As Appellants contend (Appeal Br. 9), Perkins discloses that balloon
18 is deployed to a desired location within the lung, and then inflated,
thereby isolating the region of the lung distal to the inflated balloon. Perkins
,r 57; see also id. at Fig. 12B (showing inflated balloon 18 and target region
of lung "TR" distal to balloon 18).
As Appellants contend, Perkins discloses that the region of the lung
isolated by the balloon may be treated without treating other portions of the
lung, for example by delivering a drug, or delivering a washing fluid for
lavage purposes. Id. ,r 58.
We, thus, acknowledge that Perkins is directed to using its balloon to
allow targeted drug delivery or lavage to an isolated portion of the lung.
Appellants do not persuade us, however, that it would have been
"undesirable" (Appeal Br. 9; Reply Br. 5) for Perkins's balloon to have a
resecting surface encompassed by claims 16 and 1 7.
Specifically, as background to the disclosure of the inventive resecting
surface of its balloon catheter, Gunday explains that removal from the lungs
of undesired or obstructive cancerous materials was known to be desirable.
See Gunday ,r,r 2-7. Thus, even if it were true that Perkins viewed alone
would not have suggested that a balloon with a resecting surface would be a
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desirable feature of a lung-treating catheter, Gunday teaches that, in certain
instances, a balloon with a resecting surface is in fact a highly useful feature
of a lung-treating catheter, contrary to Appellants' arguments.
As to Appellants' contention that modifying Perkins' s catheter to
include a balloon with Gunday' s resecting surface would render Perkins' s
catheter unsuitable for its intended purpose (Appeal Br. 9--10; Reply Br. 5-
6), we note that Gunday discloses multiple-balloon embodiments in which
two outer balloons hold the catheter in place, and an inner balloon performs
the resection. See Gunday ,r 91 ( disclosing that "proximal and distal balloon
segments (72, 76) ... hold the catheter (24) steady where the tissue to be
removed is located while the center balloon (74) is cyclically inflated and
deflated to resect the unwanted biological material"); see also id. ("[B]y
inflating the proximal and distal balloons (72, 76), one can prevent the
resected material from escaping into the bodily cavity, and instead, can
capture the loose tissue for easy removal.").
Thus, contrary to Appellants' contention that adding Gunday's
resecting surface to Perkins' s balloon would render Perkins' s balloon
unsuitable for its intended purpose, Gunday discloses that balloons with its
resecting surface are not only useful for holding a catheter in place, as the
Examiner found (Ans. 16-17), but are also useful for maintaining the
isolation of the occluded portion of the lungs, one of Perkins's primary
objectives. Consequently, the Examiner's rationale for modifying Perkins
based on Gunday's teaching is supported by objective, factual evidence.
Accordingly, for the reasons discussed, Appellants do not persuade us
that the preponderance of the evidence fails to support the Examiner's
conclusion of obviousness as to Appellants' claims 16 and 1 7. We,
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therefore, affirm the Examiner's rejection of claims 16 and 17 over Perkins
and Gunday.
We next tum to Appellants' claim 25. We acknowledge, as
Appellants contend (Appeal Br. 11) that claim 25 requires the catheter to be
configured such that delivery of an agent may be accomplished through the
same lumen in which the imaging device is disposed. See id. at 21 ( claim 25
reciting a "second lumen for delivering an agent to the distal portion of said
catheter ... and [an] imaging device is disposed in said second lumen of the
catheter").
We acknowledge, as Appellants contend (Appeal Br. 10-11; Reply
Br. 6-7), that the outer "isolation catheter" 10 of Perkins' s device includes
lumens for the imaging devices ( optical fiber 24 and illuminating fiber 26)
that are separate from the main lumen 32. See Perkins ,r,r 47--48; see also id.
at Fig. IA (showing lumens 24 and 26 distinct from main lumen 32).
Perkins explains, however, that inner catheter 80, which includes the
occluding balloon discussed above, is deployed through main lumen 32. See
id. ,r 52 ("As illustrated in FIGS. 4 and 5, the inner catheter 80 is sized and
adapted to fit within the main lumen 32 of the isolation catheter 10.").
Perkins discloses further that "the inner catheter may in some
instances incorporate optical and illumination fibers .... " Id. ,r 21.
Thus, despite Perkins's disclosure its inner catheter "will usually not
have such imaging capabilities" (id.), and despite Perkins's disclosure that
imaging devices are generally deployed through lumens that are distinct
from the main lumen (id. ,r 47), Perkins nonetheless also expressly discloses
that its inner catheter, which is deployed through the main lumen of the
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outer isolation catheter, "may in some instances incorporate optical and
illumination fibers." Id. ,r 21.
In addition to this disclosure that optical and illumination fibers may
be delivered through the main lumen 32 of its outer isolation catheter via the
inner catheter, Perkins also discloses that, as required by Appellants' claim
25, agents may be delivered through the main lumen. See id. ,r 52
( disclosing that "materials can be withdrawn or introduced through the
isolation catheter 10 as well as through the lumen of the inner catheter 80")
( emphasis added).
Thus, given Perkins' s disclosure that, in certain instances, optical and
illumination fibers may be delivered through the main lumen 32 of its outer
isolation catheter via the inner catheter, and given Perkins's disclosure that
therapeutic material may also be delivered through the main lumen of the
outer isolation catheter, Appellants do not persuade us that Perkins fails to
suggest a catheter in which an imaging device and agents are deployed
through the same lumen, as Appellants' claim 25 requires.
Accordingly, for the reasons discussed, Appellants do not persuade us
that the preponderance of the evidence fails to support the Examiner's
conclusion of obviousness as to Appellants' claim 25. We, therefore, affirm
the Examiner's rejection of claim 25 over Perkins and Gunday. Claims 2, 6,
7, 10, 22, and 23 fall with claim 25. See 37 C.F.R. § 4I.37(c)(l)(iv).
OBVIOUSNESS-PERKINS AND ROSENBLUTH
In rejecting Appellants' claims 13-15, 21, and 26-28 over Perkins and
Rosenbluth, the Examiner relied on Perkins for the teachings discussed
above, including the disclosure of a resecting surface, and cited Rosenbluth
as evidence that certain additional elements recited in claims 13-15, 21, and
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26-28, such as a silicone plug, would have been obvious features of
Perkins's catheter. Ans. 7-10.
Each of claims 13-15 and 21 depends directly or ultimately from
claim 1, which includes a balloon with a resecting surface, as discussed
above. See Appeal Br. 19-20. Independent claim 26, like claim 1, includes
"at least one balloon ... having a resecting surface for resecting biological
material." Id. at 21. Claims 27 and 28 depend from claim 26. Id. at 22.
As discussed above, the Examiner does not persuade us that Perkins
describes a catheter having a balloon with a resecting surface. Because the
Examiner does not identify, nor do we discern, any teaching in Rosenbluth
that remedies that deficiency as to claims 13-15, 21, and 26-28, we reverse
the Examiner's rejection of claims 13-15, 21, and 26-28 over Perkins and
Rosenbluth.
OBVIOUSNESS-
PERKINS, GUNDA Y, AND POWELL
In rejecting claims 8, 9, and 11 over Perkins, Gunday, and Powell, the
Examiner relied on the teachings in Perkins and Gunday discussed above,
and cited Powell as evidence that the elements recited in claims 8, 9, and 11
would have been obvious features of the device suggested by Perkins and
Gunday. Ans. 10-11.
Each of claims 8, 9, and 11 depends ultimately from claim 1. See
Appeal Br. 18. Appellants argue only that "[t]he purported combinations of
these references suffer from the same deficiencies discussed above with
respect to claim 1 and also regarding Gunday et al. with respect to claim
25." Id. at 14.
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We are not persuaded. As discussed above, we agree with the
Examiner that it would have been obvious to include Gunday's resecting
surface on Perkins' s balloon. Because Appellants therefore do not persuade
us that the combination of Perkins, Gunday, and Powell suggests a catheter
assembly having all of the features required by claims 8, 9, and 11, we
affirm the Examiner's rejection of claims 8, 9, and 11 over Perkins, Gunday,
and Powell.
OBVIOUSNESS-
REMAINING REJECTIONS
In the remaining rejections, the Examiner rejected claims 18-20, 24,
and 26-28 over Perkins combined with either Frye, Grice, Eidenschink,
Lafontaine, or Bales. Ans. 12-15.
In making those rejections, the Examiner relied on Perkins for the
teachings discussed above, including the disclosure of a resecting surface,
and cited the additional references evidence that the elements recited in
claims 18-20, 24, and 26-28 would have been obvious features of Perkins's
catheter. See id.
Claims 18-20 and 24 depend directly or ultimately from claim 1, and
thus include the resecting surface feature recited in claim 1. See Appeal Br.
19-20. As noted above, moreover, claims 26-28 also include the resecting
surface feature.
As discussed above, the Examiner does not persuade us that Perkins
describes a catheter having a balloon with a resecting surface. Because the
Examiner does not identify, nor do we discern, any teachings in Frye, Grice,
Eidenschink, Lafontaine, or Bales that remedy that deficiency as to claims
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18-20, 24, and 26-28, we reverse the Examiner's rejections of claims 18-
20, 24, and 26-28.
SUMMARY
For the reasons discussed, we reverse the Examiner's rejection of
claims 1, 3-5, and 12, under 35 U.S.C. § 102(b) as being anticipated by
Perkins;
For the reasons discussed, however, we affirm the Examiner's
rejection of claims 2, 6, 7, 10, 16, 17, 22, 23, and 25, under 35 U.S.C.
§ 103(a) for obviousness over Perkins and Gunday;
For the reasons discussed, we reverse the Examiner's rejection of
claims 13-15, 21, and 26-28, under 35 U.S.C. § 103(a) for obviousness over
Perkins and Rosenbluth;
For the reasons discussed, however, we affirm the Examiner's
rejection of claims 8, 9, and 11, under 35 U.S.C. § 103(a) for obviousness
over Perkins, Gunday, and Powell;
For the reasons discussed, we reverse the Examiner's rejection of
claim 18, under 35 U.S.C. § 103(a) for obviousness over Perkins and Frye;
For the reasons discussed, we reverse the Examiner's rejection of
claims 19 and 20, under 35 U.S.C. § 103(a) for obviousness over Perkins
and Grice;
For the reasons discussed, we reverse the Examiner's rejection of
claim 24, under 35 U.S.C. § 103(a) for obviousness over Perkins and
Eidenschink;
For the reasons discussed, we reverse the Examiner's rejection of
claim 24, under 35 U.S.C. § 103(a) for obviousness over Perkins and
Lafontaine; and
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For the reasons discussed, we reverse the Examiner's rejection of
claims 26-28, under 35 U.S.C. § 103(a) for obviousness over Perkins and
Bales.
TIME PERIOD
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-IN-PART
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