Ex Parte AMOS

Patent Trial and Appeal Board

Aug 8, 2018

13559229 (P.T.A.B. Aug. 8, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/559,229 07/26/2012
121974 7590 08/10/2018
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
Raymond G. AMOS JR.
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.
8150BSC0025C2 4973
EXAMINER
IWAMAYE, ANDREW MICHAEL
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
08/10/2018 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):
bbonneville@kdbfirm.com
docketing@kdbfirm.com
ehysesani@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAYMOND G. AMOS, JR. 1
Appeal2017-008093
Application 13/559,229
Technology Center 3700
Before DONALD E. ADAMS, ERIC B. GRIMES, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a ureteral
stent, which have been rejected as obvious. We have jurisdiction under 35
U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
"Known ureteral stents are typically placed within a urinary tract of a
patient such that one end portion of the ureteral stent is located in a kidney
of the patient and another end portion of the ureteral stent is located in either
a bladder or a ureter of the patient." Spec. ,r 3. "Some known ureteral stents
1 Appellant identifies the Real Party in Interest as Boston Scientific Scimed,
Inc. Appeal Br. 2.
Appeal2017-008093
Application 13/559,229
include a retention member at a kidney end portion of the ureteral stent and a
retention member at a bladder end portion of the ureteral stent" to prevent
migration of the stent in either direction. Id. ,r 4. "Known ureteral stents
often cause pain and discomfort to the patient once the ureteral stents are
positioned within the body. In particular, the retention member of the
bladder end portion can irritate sensitive regions in the bladder." Id. ,r 5.
The Specification discloses a ureteral stent comprising retention
members at each end, where the retention member at the proximal (bladder)
end portion "includes a dissolving portion configured to dissolve in response
to being exposed to a bodily fluid for a period of time" and the retention
member at the distal (kidney) end portion "is substantially stable in the
bodily fluid of the urinary tract of the patient." Id. ,r,r 6-8. As a result,
irritation of sensitive regions in the bladder can be minimized. Id. ,r 25.
Claims 1, 2, 4, 7, 9--11, 19-24, 28, and 30 are on appeal. Claims 1
and 19 are the independent claims and read as follows:
1. A ureteral stent, comprising:
a distal end portion configured to be disposed within at least one of a
kidney and a ureter of a patient, the distal end portion including a retention
member configured to help retain a portion of the ureteral stent within the
kidney of the patient, the retention member of the distal end portion being
formed entirely of a non-dissolving material, the non-dissolving material
being stable in a bodily fluid of a urinary tract of the patient;
a medial portion including a non-dissolving material;
a proximal end portion configured to be disposed within at least one
of the ureter and a bladder of the patient, the proximal end portion including
a curved retention member configured to help retain a portion of the ureteral
stent within the bladder of the patient, the curved retention member of the
proximal end portion being formed entirely of a dissolving material, the
dissolving material being configured to dissolve in response to being
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Application 13/559,229
exposed to the bodily fluid for a period of time, the proximal end portion
defining a lumen; and
a tether extending through an entire length of the lumen of the
proximal end portion, the tether being attached to the medial portion and
configured to help remove the distal end portion from the body of the
patient, the tether not extending through the retention member of the distal
portion.
19. A ureteral stent, comprising:
a distal end portion configured to be disposed within at least one of a
kidney and a ureter of a patient, the distal end portion having a retention
member configured to help retain at least a portion of the ureteral stent
within the kidney of the patient, the retention member of the distal end
portion being formed entirely of a non-dissolving material, the non-
dissolving material being stable in a bodily fluid of a urinary tract of the
patient;
a medial portion including a non-dissolving polymer-based material;
a proximal end portion configured to be disposed within at least one
of a ureter and a bladder of the patient, the proximal end portion defining a
lumen and having a curved retention member configured to help retain a
portion of the ureteral stent within the bladder of the patient, the lumen and
the curved retention member being formed entirely of a dissolving polymer-
based material configured to dissolve in response to being exposed to the
bodily fluid for a period of time; and
a tether attached to the medial portion and configured to help remove
the distal end portion from the body of the patient, at least a portion of the
tether being disposed within the lumen defined by the medial portion.
The claims stand rejected as follows:
Claims 1, 2, 4, 7, 9-11, 19-24, and 28 under 35 U.S.C. § I03(a) based
on Segura2 and Li '033 3 (Final Action4 7); and
2 US 2003/0171708 Al, published Sept. 11, 2003.
3 US 2003/0224033 Al, published Dec. 4, 2003.
4 Office Action mailed April 21, 2016.
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Application 13/559,229
Claim 30 under 35 U.S.C. § I03(a) based on Segura, Li '033, and Li
'8245 (Final Action 11);
Claims 19--24 under 35 U.S.C. § I03(a) based on Li '033 and
Wetterman6 (Final Action 2).
I
The Examiner has rejected claims 1, 2, 4, 7, 9--11, 19-24, and 28 as
obvious based on Segura and Li '033. The Examiner finds that Segura
discloses a ureteral stent comprising a distal portion, a medial portion, a
proximal portion, and a tether. Final Action 7-9. The Examiner finds that
"Segura fails to teach non-dissolving and dissolving materials disposed as
claimed." Id. at 9.
The Examiner finds that "Li ['033] teaches a ureteral stent wherein
one half of the stent is made from a non-dissolving material and another half
is made from a dissolving material." Id. at 10. The Examiner concludes that
it would have been obvious "to modify the stent of Segura by making one
half of the stent from a non-dissolving material and the other half from a
dissolving material, as taught by Li ['033], in order to deliver drug from the
stent and tailor drug delivery rates from different areas of the stent." Id.,
citing ,r,r 69, 70, 72 of Li '033.
We agree with the Examiner that the ureteral stent of claim 1 would
have been obvious based on the cited references. Segura discloses a ureteral
stent. Segura ,r 5. Segura states that "[r]eferring to FIGS. 1 and 2A, a stent
200 according to the invention includes an elongated portion 205 that spans
5 US 2004/0022824 Al, published Feb. 5, 2004.
6 US 4,931,037, issued June 5, 1990.
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Application 13/559,229
between ... first and a second end portions 220, 230. The elongated portion
205 has a sufficient length to extend substantially the entire ureter 110 from
the kidney 105 to the bladder 120." Id. ,r 42. Segura's Figure 1 shows that
first ( curled) end portion 220 is at the kidney end of the stent; second
(flared) end portion 230 is at the bladder end of the stent; and elongated
portion 205 extends between the two end portions. Id. Thus, Segura's "first
end portion" corresponds to the "distal end portion" of claim 1; Segura's
"second end portion" corresponds to the "proximal end portion" of claim 1;
and Segura's "elongated portion" corresponds to the "medial portion" of
claim 1.
Segura also discloses that "the ureteral stent 200 may further include
one or more tails 265 extending from an inner surface 270 of the second
[proximal] end portion 230. The tails 265, as shown in FIG. 7D, transport
liquid by capillary action through the second end portion 230 to the bladder
120." Id. ,r 53. Because Segura's tails function to transport liquid to the
bladder, they are reasonably interpreted as extending into the bladder.
Segura also states that "[ t ]he tails 265 may be attached near the proximal end
225 of the elongated [medial] portion 205." Id. Segura thus describes the
tails of its device as being attached to the medial portion of the device and
extending the length of the proximal end portion to the bladder. Segura's
tails thus meet the limitations of the tether recited in claim 1.
Li '033 discloses "implantable or insertable medical devices," such as
stents, including ureteral stents. Li '033 ,r,r 7, 34, 36. "The stents may
comprise a hollow tubular structure, which is particularly useful in providing
flow or drainage through ureteral or biliary lumens." Id. ,r 36.
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Application 13/559,229
Li '033 states that, "[i]n many embodiments of the invention, a
therapeutic agent of interest is released from a polymeric matrix. The term
'polymeric matrix' refers to a region that comprises a biocompatible
polymer and at least one additive, for example, one or more therapeutic
agents." Id. ,r 38. "The polymeric regions used in the implantable or
insertable medical device of the present invention may comprise any
biocompatible polymer suitable for use in implantable or insertable medical
devices. The biocompatible polymer may be substantially non-
biodegradable or biodegradable." Id. ,r 60. Li '033 provides numerous
examples of suitable non-biodegradable and biodegradable polymers. Id.
,r,r 61---64.
Li '033 states that "a medical device in accordance with the present
invention may comprise a structure comprising (a) a first region comprising
a first therapeutic agent and a first biocompatible polymer, and (b) a second
region comprising a second therapeutic agent and a second biocompatible
polymer." Id. ,r 69. "A simplified schematic representation of a device of
this type is depicted in FIG. 4." Id. Li '033 states that "myriad possibilities
exist regarding the regions that can comprise the medical devices of the
present invention." Id. ,r 70. "As specific examples, ... different polymers
can be provided in different regions of the device (e.g., ... different
polymers in different sections along the length of the stent)." Id.
Li '033 states that "[p ]olymer matrices of different compositions
typically exhibit different release characteristic [ s]. In this connection,
release characteristics may be changed by changing, for example, (1) the
amount and type of biocompatible polymer. ... " Id. ,r 72. Based on these
teachings, it would have been obvious "to modify the stent of Segura by
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Application 13/559,229
making one half of the stent from a non-dissolving material and the other
half from a dissolving material, as taught by Li ['033], in order to deliver
drug from the stent and tailor drug delivery rates from different areas of the
stent." Final Action 10.
Appellant argues that "a medial portion is not mentioned anywhere in
Segura, but exists only as a result of the arbitrary sectioning in the
Examiner's annotation." Appeal Br. 14.
Segura, however, expressly describes an "elongated portion" that
extends between two (distal and proximal) end portions. Thus, Segura's
elongated portion corresponds to the "medial portion" recited in claim 1.
Appellant also argues that "it is misplaced to characterize the fluid
tranporting [sic] tails 265 ... of Segura as a tether of any sort, let alone a
tether configured to remove the distal portion of the ureteral stent from the
body." Appeal Br. 13.
This argument is not persuasive. The tails of Segura's device extend
the entire length of the proximal end portion to help transport liquid to the
bladder. Appellant has not pointed to any structural difference between the
"tether" of claim 1 and the "tails" of Segura's device, or provided evidence
or sound technical reasoning to support the position that Segura' s tails could
not "help remove the distal end portion from the body," as recited in claim 1.
Therefore, despite the difference in terminology, the evidence supports the
Examiner's conclusion that Segura's tails meet the "tether" limitation of
claim 1.
Appellant also argues that "even if it were practical to characterize the
fluid transporting tails 265 as a tether, ... the fluid transporting tails 265 are
attached near the proximal end 225, or attached near the first end portion
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Application 13/559,229
220 [which] is contrary to the proposition by the Examiner that such tails
265 are attached to a medial portion of the ureteral stent." Appeal Br. 14.
This argument is also unpersuasive. As Appellant notes, Segura
discloses that "[ t ]he tails 265 may be attached near the proximal end 225 of
the elongated portion 205." Segura ,r 53. As discussed above, the elongated
portion of Segura's device corresponds to the medial portion of the device of
claim 1. Segura thus expressly suggests attaching the tails of its device near
the proximal end of the medial portion of its ureteral stent, which includes
attaching them to the medial portion near its proximal end.
We therefore affirm the rejection of claim 1 as obvious based on
Segura and Li '033. Claims 2, 4, 7, 9--11, 19--24, and 28 have not been
argued separately and therefore fall with claim 1. 37 C.F.R.
§ 4I.37(c)(l)(iv).
Regarding the rejection of claim 30 as obvious based on Segura, Li
'033, and Li '824, Appellant has waived arguments based on Li '824.
Appeal Br. 14--15. We therefore affirm the rejection of claim 30 for the
reasons of record and as discussed above. See 37 C.F.R. § 4I.37(c)(l)(iv)
(The Appeal Brief must include "[ t ]he arguments of appellant with respect to
each ground of rejection, and the basis therefor, with citations of the statutes,
regulations, authorities, and parts of the Record relied on."); see also In re
Huai-Hung Kao, 639 F.3d 1057, 1065 (Fed. Cir. 2011) (Statements in a brief
that "merely mention [a] claim ... and lack any type of separate, substantive
argument concerning the claim" are not sufficient to constitute separate
argument regarding that claim under 37 C.F.R. § 4I.37(c)(l)(iv).).
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II
The Examiner has rejected claims 19-24 as obvious based on Li '033
and Wetterman. The Examiner finds that Li '033 discloses a ureteral stent
having distal, medial, and proximal end portions, and discloses that different
parts of the stent can be made from different materials, including either
dissolving or non-dissolving materials. Final Action 2-3.
The Examiner finds that Li '033 does not disclose retention members
at each end of the stent, and does not disclose a tether. Id. at 4. The
Examiner finds, however, that W etterman discloses the retention members
recited in claim 19. Id. The Examiner also finds that W etterman
teaches a tether 32 ( e.g. the guidewire) attached to the medial
portion ( e.g. Merriam-Webster defines "attached" as
"connected or joined to something"; the tether 32 of Wetterman
is clearly connected or joined to the medial portion as the tether
is inserted within the lumen of the medial portion and therefore
is attached to the medial portion) and configured to help
remove the distal end portion from the body of the patient
( e.g. the stent is able to be removed from the body by being
guided along the guidewire ), at least a portion of the tether 32
being disposed within the lumen defined by the medial
portion and distal end portion during insertion of the stent in
the body.
Id. at 4--5.
The Examiner concludes that it would have been obvious to modify
the stent taught by Li '033 to include the retention members taught by
Wetterman, and "to modify the stent of Li ['033] by further incorporating a
tether ( e.g. a guidewire ), as taught by Wetterman, in order to facilitate
delivery of the stent." Id. at 5.
Appellant argues, among other things, that the Examiner erred in
finding that it would have been obvious to combine Li '033 and Wetterman
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Application 13/559,229
because the Examiner's "motivation actually emphasizes the distinction
between a tether (e.g., used for removal) and a guidewire (e.g., used for
delivery)." Appeal Br. 11. Appellant also argues that "it makes little sense
to argue that a removable guidewire is attached to any portion of the medical
device within which it is disposed, let alone the medial portion as presently
recited in independent claim 19." Id.
We agree with Appellant that the Examiner's interpretation of
"attached" is unreasonably broad. The Examiner reasons that, in
W etterman, the guidewire is "attached" to the medial portion of the stent
because the guidewire is inserted into the medial portion of the stent.
However, Wetterman describes the use of its ureteral stent as follows: "The
guide wire is first introduced into the ureter and guided therealong until the
proximal end rests in the renal pelvis. Thereafter, the proximal end of the
stent 10 is placed upon the exposed end of the guide wire 32 and the stent is
slid therealong." Wetterman 4:60-64. Wetterman states that:
Using the push catheter 34, the stent 10 is advanced along the
guide wire 32 until the distal end of the stent 10 is at the
uretero-vesical junction. Then, while holding the stent 10 in
place with the push catheter 34, the guide wire 32 is pulled out
by an assistant. When the guide wire 32 is removed, the curled
section 16 at the proximal end of the stent 10 will form its curl
12 in the renal pelvis.
Id. at 5: 1-8.
Thus, W etterman states that the stent is slid along the guidewire until
the stent is in the desired position, after which the guide wire is pulled out so
that the stent can form its desired curl (i.e., retention member). We agree
with Appellant that W etterman does not describe attaching the guidewire to
the stent - if the two were attached, the stent could not be slid along the
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guide wire to its desired position, and the guide wire could not be removed
in order to allow the distal end of the stent to form its desired shape. We
therefore reverse the rejection of claims 19--24 as obvious based on Li '033
and W etterman.
SUMMARY
We affirm the rejection of claims 1, 2, 4, 7, 9-11, 19--24, and 28 under
35 U.S.C. § 103(a) based Segura and Li '033.
We affirm the rejection of claim 30 under 35 U.S.C. § 103(a) based on
Segura, Li '033, and Li '824.
We reverse the rejection of claims 19-24 under 35 U.S.C. § 103(a)
based on Li '033 and Wetterman. However, these claims still stand rejected
under 35 U.S.C. § 103(a) based on Segura and Li '033.
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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