Ex Parte D et al

Patent Trial and Appeal Board

Oct 21, 2016

13015779 (P.T.A.B. Oct. 21, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/015,779 01/28/2011 Adrian D'Lima
30636 7590 10/24/2016
FAY KAPLUN & MARCIN, LLP
150 BROADWAY, SUITE 702
NEW YORK, NY 10038
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.
10121110702 3265
EXAMINER
BOSWORTH, KAMI A
ART UNIT PAPER NUMBER
3763
MAILDATE DELIVERY MODE
10/24/2016 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 ADRIAN D'LIMA and DANIEL VUICH1
Appeal2014-005231
Application 13/015,779
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
device for facilitating fluid transfer between an internal structure of a living
body and an exterior thereof. The claims are rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the Real Party in Interest is Boston Scientific
Scimed, Inc. (App. Br. 2).
Appeal2014-005231
Application 13/015,779
STATEMENT OF THE CASE
The Specification describes "a device for facilitating fluid
communication with an internal body structure comprising a hub including
first and second ports configured to couple to external medical devices"
(Spec. i-f 3). Claims 1-11 are on appeal. Claim 1 is illustrative and reads as
follows (emphasis added):
1. A device facilitating fluid transfer between an internal
structure of a living body and an exterior thereof, comprising:
a hub including first and second ports configured to
couple to external medical devices, the first port including a
first lumen extending therethrough along a first axis between a
proximal opening at the first port and a distal opening at a distal
end of the hub, the second port including a second lumen
extending therethrough along a second axis non-parallel to the
first axis from a proximal end to a distal end, the second axis
intersecting the first axis at the distal end of the second lumen,
the distal end of the second lumen being open to the first
lumen;
an inner sleeve defining a third lumen therethrough from
a proximal opening at a proximal end thereof to a distal opening
at a distal end thereof; and
a first connector securing the proximal end of the inner
sleeve to the hub at a desired position in the first lumen
proximal of the distal end of the second lumen, the first
connector being shaped to force an outer surface of the inner
sleeve into frictional engagement with an inner surface of the
first lumen.
2
Appeal2014-005231
Application 13/015,779
The claims stand rejected as follows:
I. Claims 1--4, 6, 10, and 11 stand rejected under 35 U.S.C.
§ 103(a) as being obvious based on Knapp2 and Landskron.3
II. Claims 7 and 8 stand rejected under 35 U.S.C. § 103(a) as being
obvious based on Knapp, Landskron, and Parks.4
III. Claims 5 and 9 stand rejected under 35 U.S.C. § 103(a) as being
obvious based on Knapp, Landskron, and Gailey. 5
I.
The Examiner has rejected claims 1--4, 6, 10, and 11 under 35 U.S.C.
§ 103(a) as being obvious based on Knapp and Landskron. We focus our
discussion on independent claim 1, which is representative.
Findings of Fact
FF 1. Knapp discloses "an access sheath [that] includes a sheath
assembly including sheath tubing, the sheath tubing having a main lumen
and a secondary lumen that extends along the length of the main lumen, the
main lumen being large enough to receive an endoscope" (Knapp Abstract;
see also Ans. 3--4).
FF 2. Knapp depicts in Figure 29 a ureteral access sheath having a
hub and sheath tubing (Knapp i-f 55). Figure 29 is reproduced below.
2 Knapp, US 2004/0267213 Al, published Dec. 30, 2004.
3 Landskron et al., US 4,838,873, issued June 13, 1989.
4 Parks et al., US 5,399,173, issued Mar. 21, 1995.
5 Gailey et al., US 6, 113,572, issued Sept. 5, 2000.
3
Appeal2014-005231
Application 13/015,779
Fig. 29
(Id. at Fig. 29.) Figure 29 shows "a sheath assembly 12' that comprises a
sheath tubing 16', a hub 18', and two leader tubes 22A, 22B. Each of the
two leader tubes 22A, 22B is in fluid communication with a separate one of
the two secondary lumens lO[O]A, lOOB" (id. i-f 108; see also Ans. 3--4).
FF 3. Landskron depicts in Figure 2 an apparatus having a sleeve-
type catheter hub (Landskron 3:54--56). Figure 2 is reproduced below.
FIG.2
(Id. at Fig. 2.) Figure 2 shows that "[t]he cylindrical sleeve 35 projects
through the thick head portion 31 to extend over some distance inside the
catheter capillary 30" (id. at 5:6-8; see also Ans. 4).
4
Appeal2014-005231
Application 13/015,779
FF 4. Landskron discloses:
With its shoulder 32a passing over into sleeve 35 via a
concave round-off portion 32b, the cylindrical plastic bushing
32 presses against the end face of the thicker head portion 31 to
axially compress it with a resultant radial enlargement of said
head portion which is pressed against the wall of the
intermediate section llc. Additionally, in the range of the
longitudinal channel section llb, the head portion 31 as well as
part 30a of the catheter capillary 30 are pressed to the outside
thus improving the retention effect for the catheter capillary 30.
In this embodiment, the retaining force for the catheter capillary
30 is excellent due to the plastic bushing 32 contributing to the
improved clamping retention effect by the radial enlargement of
the thick head portion 31 as a result of axial pressure, and due
to the sleeve 35 contributing to such improvement by the radial
expansion. At the same time, the thin wall of the catheter
capillary 30 cannot be damaged because at the transition 36
from the longitudinal channel section 1 lb to the orifice section
lla, the end of sleeve 35 does not exert any contact pressure on
the catheter capillary 30. There is only a tensionless guiding of
the orifice section lla of a smaller diameter to section llb of a
larger diameter. The retention force is exerted predominantly in
the range of the thick head portion 31, while the thin wall of the
catheter capillary 30 is kept free of detrimental forces.
(Landskron 5:21--47; see also Ans. 4.)
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 3-12; FF 1--4), and agree that the
claims are obvious over Knapp and Landskron. We address Appellants'
arguments below.
Appellants contend that it would not have been obvious to modify the
ureteral access sheath disclosed by Knapp to include the shaped connector of
Landskron because the device taught by Knapp includes an elastomeric
5
Appeal2014-005231
Application 13/015,779
cover that holds the sheath tubing in place within the hub, and thus, there is
no teaching, suggestion, or motivation to modify the device of Knapp (App.
Br. 5---6; Reply Br. 3). Appellants also assert that Knapp teaches away from
the inclusion of a shaped connector such as that taught by Landskron
because "Knapp explicitly teaches a method for assembling the sheath
tubing 16 and hub 18, which would preclude the use of a connector" (Reply
Br. 3; see also id. at 4--5). Lastly, Appellants take the position, for the first
time in the Reply Brief, that the Examiner erred in rejecting claim 2 (Reply
Br. 5---6).
We recognize, but are not persuaded by, Appellants' arguments.
Knapp teaches a ureteral access sheath assembly including a sheath tubing
and having a main lumen, a secondary lumen, a hub, and two leader tubes
(FF 1-2; Ans. 3--4). Landskron discloses a sleeve-type catheter hub having
a cylindrical sleeve that projects through a thick head portion inside a
catheter capillary, and a cylindrical plastic bushing having a shoulder that
passes into the sleeve (FF 3; Ans. 4 ). Landskron further teaches that
the retaining force for the catheter capillary 30 is excellent due
to the plastic bushing 32 contributing to the improved clamping
retention effect by the radial enlargement of the thick head
portion 31 as a result of axial pressure, and due to the sleeve 35
contributing to such improvement by the radial expansion.
(FF 4; Ans. 4.)
In view of these disclosures, we agree with the Examiner that an
ordinarily skilled artisan would have had reason, with a reasonable
expectation of success, to combine the shaped connector of Landskron with
the sheath assembly of Knapp, irrespective of whether the elastomeric cover
of Knapp holds the sheath tubing in place, because "the addition of
connector 32 ofLandskron into the device of Knapp would provide an added
6
Appeal2014-005231
Application 13/015,779
benefit of improved retention" (Ans. 11). See KSR Int'! Co. v. Teleflex Inc.,
550 U.S. 398, 417 (2007) ("[I]f a technique has been used to improve one
device, and a person of ordinary skill in the art would recognize that it would
improve similar devices in the same way, using the technique is obvious
unless its actual application is beyond his or her skill.").
With regard to Appellants' position that an ordinarily skilled artisan
would have been dissuaded from modifying the device of Knapp because the
disclosed elastomeric cover adequately secured the sheath tubing within the
hub, we note that in determining whether the prior art supplies a reason for
practicing the claimed subject matter, the analysis "need not seek out precise
teachings directed to the specific subject matter of the challenged claim, for
a court can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ." KSR, 550 U.S. at 418; see also id. at
421 ("A person of ordinary skill is ... a person of ordinary creativity, not an
automaton."). Here, we agree with the Examiner that an ordinarily skilled
artisan would have been motivated to incorporate the shaped connector of
Landskron into the sheath assembly of Knapp for improved retention.
We also find unpersuasive Appellants' assertion that Knapp teaches
away from the proposed combination because Knapp discloses a method for
assembling the sheath tubing and hub that precludes the use of a connector
(Reply Br. 4--5). We observe that Knapp does not discredit, criticize, or
disparage using a connector as claimed (FF 1-2). Like our appellate
reviewing court, "[ w ]e will not read into a reference a teaching away from a
process where no such language exists." DyStar Textilfarben GmbH & Co.
Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006).
7
Appeal2014-005231
Application 13/015,779
Moreover, Appellants' unsupported contention that "including a
connector would require the sheathing tube 16 and the hub 18 to be coupled
to one another prior to positioning a cover over any portion thereof' (Reply
Br. 4) is not persuasive. Appellants do not explain why the assembly
method disclosed by Knapp is incompatible with the proposed combination,
but rather, describe the assembly method outlined by Knapp, and conclude,
without explanation, that it is incompatible with the proposed combination.
See In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir. 1997) (argument by
counsel cannot take the place of evidence).
Turning to Appellants' assertion that the combination of Knapp and
Landskron does not suggest a first connector including a flared distal end as
recited in claim 2 (Reply Br. 5---6), we observe that this argument was
presented for the first time in the Reply Brief, and that Appellants relied
solely on the above-described arguments pertaining to claim 1 to support
reversal of the rejection of claim 2 in the Appeal Brief. (See App. Br. 6
("Because claims 2--4, 6, 10 and 11 depend from and include all of the
limitations of claim 1, it is respectfully submitted that these claims are also
allowable.").)
Any argument raised in the reply brief which was not raised in
the appeal brief, or is not responsive to an argument raised in
the examiner's answer, including any designated new ground of
rejection, will not be considered by the Board for purposes of
the present appeal, unless good cause is shown.
(37 C.F.R. § 41.41(b)(2).) We note that the Examiner's rejection of claim 2
(Ans. 5---6) is the same as in the Final Action (Final Act. 4--5), and therefore,
no new grounds of rejection were presented. Because Appellants'
arguments in regard to this claim are not responsive to arguments raised by
the Examiner's Answer, and no good cause has been shown, they will not be
8
Appeal2014-005231
Application 13/015,779
considered. See Ex parte Borden, 93 USPQ2d 1473, 1477 (RPAI 2010)
(informative) ("Properly interpreted, the Rules do not require the Board to
take up a belated argument that has not been addressed by the Examiner,
absent a showing of good cause.").
Therefore, we affirm the rejection of claim 1. Because they were not
argued separately, claims 2--4, 6, 10, and 11 fall with claim 1.
II.
The Examiner has rejected claims 7 and 8 under 35 U.S.C. § 103(a) as
being obvious based on Knapp, Landskron, and Parks. Appellants present
no additional argument based on the teachings of Parks, and rely on the
same arguments addressed above with regard to Knapp and Landskron (see
App. Br. 7; Reply Br. 7). Therefore, we affirm the rejection of claims 7 and
8.
III.
The Examiner has rejected claims 5 and 9 under 35 U.S.C. § 103(a) as
being obvious based on Knapp, Landskron, and Gailey. Appellants present
no additional argument based on the teachings of Gailey, and rely on the
same arguments addressed above with regard to Knapp and Landskron (see
App. Br. 7; Reply Br. 7-8). Therefore, we affirm the rejection of claims 5
and 9.
9
Appeal2014-005231
Application 13/015,779
SUMMARY
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) based on
Knapp and Landskron. Claims 2--4, 6, 10, and 11 fall with claim 1.
We affirm the rejection of claims 7 and 8 under 35 U.S.C. § 103(a)
based on Knapp, Landskron, and Parks.
We affirm the rejection of claims 5 and 9 under 35 U.S.C. § 103(a)
based on Knapp, Landskron, and Gailey.
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).
AFFIRMED
10