Ex Parte Gunday et al

Patent Trials and Appeals Board

Apr 19, 2019

13736746 - (D) (P.T.A.B. Apr. 19, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
13/736,746
151971 7590
Forge IP, PLLC
1077 Bridgeport Ave
Suite 301
Shelton, CT 06484
FILING DATE FIRST NAMED INVENTOR
01/08/2013 Erhan H. Gunday
04/23/2019
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-P0038A 5882
EXAMINER
MCCROSKY, DAVID J
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
04/23/2019 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):
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 and
LA WREN CE J. GERRANS 1
Appeal2017-011499
Application 13/736,746
Technology Center 3700
Before RICHARD M. LEBOVITZ, TA WEN CHANG, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
system or method for delivery a medical instrument into a bodily cavity,
which have been rejected as obvious. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We REVERSE.
STATEMENT OF THE CASE
According to the Specification, "there is a need for systems and
methods capable of delivering therapeutic and diagnostic agents directly to
1 Appellants identify the Real Party in Interest as Sanovas, Inc. (Appeal Br.
2.)
Appeal 2017-011499
Application 13/736,746
target tissue sites inside a patient's body" and/or "introduc[ing] various
medical instruments and devices to targeted tissues to assist in performing
drug therapy or related therapeutic or diagnostic procedures." (Spec. ,r,r 4--
5.) Further according to the Specification, some of the problems with prior
art systems in the field include, e.g., the bulk and structural complexity of
the device, potential exposure of sharp portions of the device to surrounding
tissues during insertion or retraction of the device, and/or inability of the
device to be "positioned as optimally and precisely as may be desired." (Id.
,r,r 10-13.)
Claims 1-38 are on appeal. Claim 1 is illustrative and reproduced
below:
1. A system for delivering a medical instrument into
a bodily cavity, comprising:
an outer shaft having an aperture in a side wall
thereof, wherein the aperture is provided at a distal
portion of the outer shaft;
an inner shaft positioned inside the outer shaft and
having an inflatable balloon disposed at a distal portion
thereof; and
a needle member movably disposed in the outer
shaft;
wherein the balloon is in contact with and exerts a
force on the needle member when the balloon is inflated
such that the needle member extends outwardly from the
outer shaft through said aperture; and
wherein the balloon is movable longitudinally with
respect to the needle member when the balloon is in an
inflated state.
(Appeal Br. 18 (Claims App.).)
2
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Application 13/736,746
The Examiner rejects claims 1, 2, 6-8, 15-19, 26-33, and 37 under
pre-AIA 35 U.S.C. § I03(a) as being unpatentable over Takagi2 and
Ohshiro. 3 (Ans. 2.)
The Examiner rejects claims 3, 5, and 21 under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Takagi, Ohshiro, and Chow. 4 (Ans. 8.)
The Examiner rejects claims 4, 34, and 35 under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Takagi, Ohshiro, and Clair. 5 (Ans. 10.)
The Examiner rejects claims 9, 10, and 23-25 under pre-AIA
35 U.S.C. § I03(a) as being unpatentable over Takagi, Ohshiro, and
Gerrans. 6 (Ans. 11.)
The Examiner rejects claims 11-13 under pre-AIA 35 U.S.C. § I03(a)
as being unpatentable over Takagi, Ohshiro, and Samuels. 7 (Ans. 12.)
The Examiner rejects claims 14 and 22 under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Takagi, Ohshiro, and Bloom. 8 (Ans.
13.)
The Examiner rejects claim 20 under pre-AIA 35 U.S.C. § I03(a) as
being unpatentable over Takagi, Ohshiro, and Barsch. 9 (Ans. 13.)
2 Takagi et al., WO 2012/029535 Al, published Mar. 8, 2012 ("Takagi").
Citations to Takagi herein are to its English counterpart, US 2013/0178828
Al, published July 11, 2013.
3 Ohshiro, US 4,040,413, issued Aug. 9, 1977.
4 Chow et al., US 6,692,466 Bl, issued Feb. 17, 2004.
5 Clair et al., US 2013/0211379, published Aug. 15, 2013.
6 Gerrans et al., US 2011/0218494 Al, issued Sept. 8, 2011.
7 Samuels et al., US 2002/0161388 Al, published Oct. 31, 2002.
8 Bloom, US 2012/0053485 Al, published Mar. 1, 2012.
9 Barsch, US 6,234,177 B 1, issued May 22, 2001.
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Application 13/736,746
The Examiner rejects claim 38 under pre-AIA 35 U.S.C. § 103(a) as
being unpatentable over Takagi, Ohshiro, and Holman. 10 (Ans. 14.)
The Examiner rejects claim 36 under pre-AIA 35 U.S.C. § 103(a) as
being unpatentable over Takagi, Ohshiro, Clair, and Chow. (Ans. 14.)
DISCUSSION
Issue
The same issues are dispositive for all the rejections. We therefore
discuss the rejections together. Citing to Figure 2 of Takagi, the Examiner
finds that Takagi teaches almost all of the limitations of independent claims
1, 28, and 33. (Ans. 2, 5-6, 7.) Figure 2 of Takagi is reproduced below:
FIG. 2
14
13 12
7 III I 10 1
( 3
11
15 i6
6 III .J 5
(Takagi Fig. 2.) Figure 2 depicts "a partial longitudinal cross-sectional view
of a portion of [a] medical device" comprising an injection needle 16 and an
injection needle bending balloon 10 disposed within a catheter 1 having an
opening 5. (Id. ,r,r 16, 28-30.)
10 Holman et al., US 7,491,188 B2, issued Feb. 17, 2009.
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Application 13/736,746
As shown above, the needle bending balloon 10 in the medical device
depicted in Takagi's Figure 2 is disposed within a recess in the opening 5 of
catheter 1, where the recess appears to be of approximately the same length
as the needle bending balloon 10. In light of this, the Examiner concedes
that Takagi does not "explicitly teach wherein the balloon is movable
longitudinally with respect to the needle member when the balloon is in the
inflated state." (Ans. 2.) The Examiner finds, however, that Takagi
"teach[ es] an embodiment (Fig. 8) in which the opening 5 is uniform along
its longitudinal axis, i.e. there is no upper recess in the top wall of opening
5." (Id.)
Takagi's Figure 8 is reproduced below:
FIG .. 8
(Takagi Fig. 8.) Takagi's Figure 8 depicts "a partial longitudinal cross-
sectional view of a portion of the medical device according to another
embodiment," in which "the injection needle 16 ... is guided (bent) by the
inclined surface of [an] injection needle guide section 21 to project outside
the catheter 201 by way of opening 5." (Id. ,r,r 22, 68.)
The Examiner concludes that it would have been obvious to a skilled
artisan to "provide the opening 5 of the embodiment of Fig. 8 in the catheter
5
Appeal 2017-011499
Application 13/736,746
of Figs. 2-6C," i.e., to remove the upper recess in which the needle bending
balloon 10 is disposed in Takagi's Fig. 2. (Ans. 2.) The Examiner provides
in the Answer an "Annotated Fig. 2" (id. at 3), reproduced below:
6 HT ~J
(
5
(Ans. 3.) According to the Examiner, Annotated Figure 2 above depicts a
device resulting from providing the opening 5 of Figure 8 in the catheter of
Figure 2, in which the balloon 10 would be capable of longitudinal
movement with respect to the needle. (Ans. 3.) The Examiner finds that a
skilled artisan would have reason to modify the catheter of Takagi's Figure 2
as proposed in order to
allow longitudinal movement of the balloon when the balloon is
in the inflated state to provide advantages such as more
customization for the location of inflation, thereby providing the
surgeon with the ability to select the angle and location at which
the force to the needle is directed. All of the claimed elements
were known in the prior art and one skilled in the art could have
combined the elements as claimed by known methods with no
change in their respective functions and the combinations would
have yielded nothing more than predictable results to one of
ordinary skill in the art at the time of the invention.
(Ans. 3.)
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Application 13/736,746
The Examiner additionally finds that, while the proposed combination
of the embodiments in Takagi' s Figures 2 and 8 "provides the
capability/structure for longitudinal movement of the balloon, Takagi does
not explicitly teach longitudinally moving the balloon." (Id.) However, the
Examiner finds that Ohshiro teaches "longitudinally moving an inner shaft
having an inflated balloon." (Id.) The Examiner concludes that it would
have been obvious to a skilled artisan to "longitudinally move the balloon, as
taught by Ohshiro, with the device of Takagi to obtain a precise location for
inflation, thereby providing the surgeon with the ability to select the location
that provides the optimum angle of force onto the needle." (Id.) The
Examiner finds that such a combination would have been no more than the
combination of familiar elements to achieve predictable results. (Id. at 3--4.)
Appellants contend that the combination of cited prior art does not
suggest "[a] balloon ... movable longitudinally with respect to [a] needle
member [ or medical instrument] when the balloon is in an inflated state," as
required by the independent claims. (Appeal Br. 10-13; Reply Br. 2--4.)
Appellants further contend that a skilled artisan would not have had a reason
to modify Takagi to arrive at the claimed invention. (Appeal Br. 14--15;
Reply Br. 4--8.)
The issue with respect to this rejection is whether a preponderance of
evidence of record supports the Examiner's finding that a skilled artisan
would have had a reason to combine Takagi and Ohshiro to arrive at the
claimed invention.
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Application 13/736,746
Analysis
We agree with Appellants that the Examiner has not established a
prima facie case that independent claims 1, 28, and 33 are obvious over
Takagi and Ohshiro.
Each of the independent claims requires a system or method for
delivering a medical instrument into a bodily cavity "wherein [a] balloon is
movable longitudinally with respect to [a] needle member [or a medical
instrument] when the balloon is in an inflated state." (Appeal Br. 18, 21, 22
(Claims App.).) The Examiner concedes that Takagi does not explicitly
teach a device wherein the balloon in the device is movable longitudinally
with respect to a needle when the balloon is in an inflated state, because the
balloon in Takagi' s device is depicted as being disposed in a recess of
approximately the same length as the balloon. (Ans. 2, 6, 7; Takagi Figs. 2,
4A--4D, 5, and 6A---6C.)
Nevertheless, the Examiner asserts that the combination of Takagi and
Ohshiro renders the claimed system and method obvious because ( 1)
Takagi's Figure 8 discloses an embodiment where the opening in the
catheter does not include the recess present in the embodiment depicted in
Fig. 2; (2) replacing the catheter opening in the device depicted in Takagi's
Figure 2 with the catheter opening depicted in Takagi' s Figure 8 would
result in a device wherein the balloon is capable of longitudinal movement
with respect to the needle; and (3) Ohshiro teaches longitudinally moving an
inner shaft having an inflated balloon. (Ans. 2--4, 6, 7-8.)
We are not persuaded. Assuming for argument's sake that the
combination of Takagi and Ohshiro discloses each element of the claimed
invention, an invention "composed of several elements is not proved obvious
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merely by demonstrating that each of its elements was, independently,
known in the prior art. KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418
(2007). Instead, "it can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does." Id. Takagi's Figure 8
discloses an embodiment that uses a different means for bending the needle
(i.e., injection needle guide section 21) than the balloon 10 used in the
embodiment depicted in Figure 2 to bend the needle. Likewise, while
Ohshiro teaches a device comprising inner and outer sleeves that are slidable
in the longitudinal direction with respect to each other and that are provided
with balloons, the Examiner has not persuasively asserted that these balloons
are used in a manner similar to the balloon in the claimed device or in
Takagi's Figure 2 device (e.g., to exert force on a medical instrument so as
to bend and position the instrument). (Ohshiro 1:67-2:9 (describing an
endoscope comprising "an inner sleeve ... and an outer sleeve, said inner
sleeve being slidable in said outer sleeve in the longitudinal direction"
wherein "both ... sleeves are provided with balloons therearound and the
balloons of the inner ... and outer sleeve are inflated and deflated
alternately ... to facilitate the insertion of the endoscope into the body
cavity").)
Given the apparent differences between the devices in Takagi's
Figures 2 and 8 and in Ohshiro, we find that the Examiner has not provided
a persuasive explanation why a skilled artisan would have replaced the
catheter opening of the device depicted in Takagi's Figure 2 with the
opening of the device in Takagi's Figure 8, or why such an artisan would
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have combined the resulting device with Ohshiro' s longitudinally movable
balloons, to arrive at the claimed invention.
The Examiner asserts that it would have been obvious to a skilled
artisan "to longitudinally move the balloon ... to obtain a precise location
for inflation, thereby providing the surgeon with the ability to select the
location that provides the optimum angle of force onto the needle." (Ans. 2-
3; see also id. at 3 (asserting that it would have been obvious to a skilled
artisan "to longitudinally move the balloon, as taught by Ohshiro, with the
device of Takagi to obtain a precise location for inflation, thereby providing
the surgeon with the ability to select the location that provides the optimum
angle of force onto the needle").) While this statement provides a reason
why the ability to move the balloon longitudinally in the claimed device or
similar devices is advantageous, it does not provide sufficient explanation as
to why a skilled artisan would have found it obvious to have made such
modification to Figure 2 of Takagi based on Ohshiro, in which the balloons
appear to have a different function. "[R]ejections on obviousness grounds
cannot be sustained by mere conclusory statements; instead, there must be
some articulated reasoning with some rational underpinning to support the
legal conclusion of obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S.
398,418 (2007) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
Neither can rejections "resort to speculation, unfounded assumptions or
hindsight reconstruction to supply deficiencies" in the cited references. In re
Warner, 379 F.2d 1011, 1017 (CCPA 1967).
The Examiner further asserts that "[ a ]11 of the claimed elements were
known in the prior art and one skilled in the art could have combined the
elements as claimed by known methods with no change in their respective
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functions and the combination would have yielded nothing more than
predictable results." (See, e.g., Ans. 3.) While we agree that "[t]he
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results," KSR Int 'l Co.
v. Teleflex Inc., 550 U.S. 398,416 (2007), in this case the Examiner has not
provided sufficient evidence or reasoning that a longitudinally movable
balloon would have been a familiar element to a skilled artisan for
performing the function of exerting force on a medical instrument so as to
bend or position the instrument. For instance, as discussed above, the
Examiner has not persuasively asserted that the longitudinally movable
balloon in Ohshiro performs the same or a similar function as the balloon in
Takagi's device or in the claimed device.
Accordingly, we reverse the Examiner's rejection of claims 1, 28, and
33 as obvious over Takagi and Ohshiro. We also reverse the rejection of
claims 2-27, 29-32, and 34--38 for the same reasons. 11 In re Fine, 837 F.2d
1071, 1076 (Fed. Cir. 1988) ("Dependent claims are nonobvious under
section 103 if the independent claims from which they depend are
nonobvious.").
11 The Examiner cites additional references in the rejections of claims 3-5,
9-14, 20-25, 34--36, and 38. (Ans. 8-14.) However, the Examiner relies on
these references only for the disclosures of certain dependent claim
limitations. (Id.) Thus, the Examiner's citations to these references do not
cure the deficiencies discussed above with respect to the prima facie case of
obviousness as to the independent claims.
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SUMMARY
For the reasons above, we reverse the Examiner's decision rejecting
claims 1-3 8.
REVERSED
12