Ex Parte Khan et al

Board of Patent Appeals and Interferences

Jul 26, 2012

10812380 (B.P.A.I. Jul. 26, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/812,380 03/29/2004 Iftikhar Khan 1800-000001 2606
7590 07/27/2012
Nazir A Khan MD
150 Glenmora Drive
Burr Ridge, IL 60527
EXAMINER
DEAK, LESLIE R
ART UNIT PAPER NUMBER
3761
MAIL DATE DELIVERY MODE
07/27/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
________________

Ex parte IFTIKHAR KHAN and NAZIR KHAN
________________

Appeal 2012-006569
Application 10/812,380
Technology Center 3700
________________

Before STEVEN D.A. McCARTHY, PHILLIP J. KAUFFMAN
and GAY ANN SPAHN, Administrative Patent Judges.

McCARTHY, Administrative Patent Judge.

DECISION ON APPEAL

The Appellants1 appeal under 35 U.S.C. § 134 from the Examiner’s 1
final decision rejecting claims 1-20. The Examiner rejects under 35 U.S.C. 2
§ 103(a) claims 1-5, 7-10, 12-14, 17 and 18 as being unpatentable over 3
Squitieri (US 6,102,884, issued Aug. 15, 2000); Twardowski (US 5,509,897, 4
issued Apr. 23, 1996); and Parks (US 5,399,173, issued Mar. 21, 1995); and5

1 The Appellants are the real party in interest.
Appeal No. 2012-006569
Application No. 10/812,380

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claims 6, 11, 15, 16, 19 and 20 as being unpatentable over Squitieri, 1
Twardowski, Parks and Trerotola (US 5,591,226, issued Jan. 7, 1997). An 2
oral argument was held on June 5, 2012. We have jurisdiction under 35 3
U.S.C. § 6(b). 4
We REVERSE.2 5
Claims 1-20 as entered by the Examiner on November 30, 2011 are at 6
issue in this appeal. Claims 1, 13 and 17 are independent. Claim 17 is 7
illustrative of the claimed subject matter:3 8
17. A method of performing hemodialysis on a 9
patient comprising: 10
a. Surgically inserting an arteriovenous shunt 11
into a patient, wherein said arterio venous 12
shunt comprises: 13
i. An arterial graft comprising a 14
body, a lead end and a terminal 15
end, said lead end being 16
configured for subcutaneous 17
connection to an artery by 18
anastomosis, wherein said 19
arterial graft has a first diameter 20
of about 2-8 mm; and 21
22

2 We also recommend that the Appellants consider whether they
intended method claims 18-20 to depend from system claim 16 or method
claim 17.

3 The version of claim 17 reproduced in this opinion is taken from an
amendment which was filed November 3, 2011 and entered November 30,
2011. Strikeouts and underlining are omitted.
Appeal No. 2012-006569
Application No. 10/812,380

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ii. A single lumen venous outflow 1
catheter comprising an intake 2
end and depositing end, said 3
depositing end being 4
configured for insertion 5
through a vein into the right 6
atrium of the heart, wherein 7
said venous outflow catheter 8
has a second diameter of about 9
1-7mm different from said first 10
diameter; and 11
iii. A cylindrical cuff operable to 12
direct passage of blood from 13
said arterial graft to said venous 14
outflow catheter, said cuff 15
comprising an inlet in blood 16
communication with an outlet: 17
I. Said inlet being 18
disposed about and 19
connected to said 20
terminal end of 21
said arterial graft; 22
and 23
II. Said outlet being 24
disposed about and 25
connected to said 26
intake end of said 27
venous outflow 28
catheter, wherein 29
said cuff provides 30
a secure fit for said 31
arterial graft first 32
diameter and said 33
venous outflow 34
catheter second 35
diameter; 36
Appeal No. 2012-006569
Application No. 10/812,380

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b. connecting said arterial graft to a 1
hemodialysis apparatus; 2
c. collecting blood from the patient through 3
said arterial graft with a dialysis catheter; 4
d. passing said blood through the hemodialysis 5
apparatus; 6
e. collecting purified blood from hemodialysis 7
apparatus with a dialysis cannula to the 8
graft; and 9
f. Transmitting said purified blood through 10
said cuff into said venous outflow catheter 11
which is located in the right atrium and the 12
blood is directly deposited into the right 13
atrium. 14
Claims 1 and 13 each recite an arterio venous shunt including an 15
arterial graft, a single lumen venous outflow catheter and a cylindrical cuff. 16
Claim 17 recites a method including the step of surgically inserting an 17
arteriovenous shunt into a patient. The arteriovenous shunt inserted into the 18
patient includes an arterial graft, a single lumen venous outflow catheter and 19
a cylindrical cuff. The shunts of claims 1, 13, and 17 each have an inlet of 20
the cylindrical cuff disposed about and connected to a terminal end of the 21
arterial graft. Likewise, an outlet of the cuff is disposed about and 22
connected to an intake end of the venous outflow catheter. 23
In a Final Decision mailed August 24, 2010 in Appeal 2010-003194 24
(“Prior Decision”), a panel of this Board sustained the rejection of claim 17 25
under § 103(a) as being unpatentable over Squitieri, Parks and Twardowski. 26
The panel did not sustain rejections of claims 1-5, 7-10, 12-14, 17 and 18 as 27
being unpatentable over Squitieri and Parks; claims 6, 11, 15, 16, 19 and 20 28
under § 103(a) as being unpatentable over Squitieri, Parks and Trerotola; 29
Appeal No. 2012-006569
Application No. 10/812,380

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and claim 10 under § 103(a) as being unpatentable over Squitieri and 1
Trerotola. The dispositions of these rejections were based on the language 2
of the claims at issue and the arguments presented by the Appellants in that 3
appeal. 4
As in FF 1 of the Prior Decision, we adopt the Examiner’s finding 5
that: 6
Squitieri discloses an arteriovenous shunt system 7
comprising an arterial graft 53 with a lead end 62 8
anastomosed to an artery and [a] terminal end 9
connected to needle access site [20], which acts as 10
a connector that corresponds to applicant’s cuff. 11
. . . The access site [20], corresponding to 12
applicant’s cuff, directs passage of blood from the 13
arterial catheter to the venous catheter, and is in 14
communication with the terminal end of the 15
arterial graft and the inlet end of the venous 16
catheter (see FIGS 6-9, column 5, lines 19-60). 17
(Ans. 5). Squitieri further discloses that the access site 20 includes an in line 18
aperture 16 conducting a blood stream accessible by needles 15. (Squitieri, 19
col. 4, ll. 15-18). Squitieri teaches that the access sites 20 “are designed in 20
such a way to preserve laminar flow as far as possible (i.e. not a reservoir 21
arrangement).” (Squitieri, col. 4, ll. 32-35). 22
Figure 11 of Squitieri depicts a connection between the arterial graft 23
53 and a port 46 of an access site 20. (Squitieri, col. 5, ll. 66-67; fig. 11). In 24
this depiction, the port 46 itself is not disposed around the terminal end of 25
the graft 53. Instead, the port 46 fits within the terminal end of the graft 53. 26
Figure 12 of Squitieri depicts an access site having inlet and outlet couplings 27
73, 74 which fit within tubing (e.g., 88) to which the access site is to be 28
connected. (See Squitieri, col. 6, ll. 14-20). 29
Appeal No. 2012-006569
Application No. 10/812,380

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In their briefs, the Appellants seek to identify structural differences 1
between the claimed subject matter and the prior art. For example, the 2
Appellants state that: 3
In Claimed Invention, the cuff connects the graft 4
and the venous outflow catheter. The cuff is made 5
of biocompatible material. It encircles the inlet 6
end of the venous out flow catheter and it is 7
sutured to the outlet end of the graft by an 8
anastomosis (see specification and abstract of the 9
published patent application, US 2005/0215938 10
A1). . . . In Squitieri’s art, the cuff consists of two 11
reservoirs which connect the graft and the venous 12
outflow catheter (see fig 9, US Patent US 13
6.582,409, B1, Sheets 5 of 8). The reservoirs are 14
metallic chambers with a silicone membrane. 15
(App. Br. 8 (italics added)). The Examiner has not provided reasoning with 16
some rational underpinning sufficient to show that one of ordinary skill in 17
the art would have had reason to modify Squitieri’s catheter to include a cuff 18
having an outlet end disposed about and connected to an intake end of the 19
venous outflow catheter 20
In particular, Parks discloses an enteral feeding device including a 21
ferrule. (Parks, col. 3, ll. 67-68; see Prior Decision at 7 (FF 11)). Parks 22
describes embodiments in which tubing connects to the ferrule by means of 23
a taper lock. (See, e.g., Parks, col. 6, ll. 60-63; col. 7, ll. 50-54; and figs. 7, 9 24
and 13). In each case, the upstream end of the ferrule engages the tubing by 25
being disposed about and connected to ends of the tubing. Parks does not 26
appear to disclose any embodiment in which the downstream end of the 27
ferrule engages tubing by being disposed about and connected to ends of the 28
tubing. (See, e.g., figs. 8 and 10). 29
Appeal No. 2012-006569
Application No. 10/812,380

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This conclusion is not inconsistent with the Prior Decision. Although 1
the Prior Decision addressed the recited cuff in general terms, the Prior 2
Decision did not specifically address the manner in which the outlet end of 3
the cuff connects to the inlet end of the venous outflow catheter. (See, e.g., 4
Prior Decision at 12, l. 9 -13, l. 22). Since neither Squitieri, nor 5
Twardowski, nor Parks discloses at least one limitation recited in each of 6
independent claims 1, 13 and 17; and since the Examiner articulates no 7
persuasive reason for modifying Squitieri’s shunt system to include this 8
limitation, we do not sustain the rejection of claims 1-5, 7-10, 12-14, 17 and 9
18 under § 103(a) as being unpatentable over Squitieri; Twardowski; and 10
Parks. Furthermore, since the Examiner does not cite Trerotola for any 11
teaching which might remedy the deficiencies in the combined teachings of 12
Squitieri, Twardowski and Parks (see Ans. 9; Prior Decision at 8-9 (FF 18)), 13
we do not sustain the rejection of claims 6, 11, 15, 16, 19 and 20 under 14
§ 103(a) as being unpatentable over Squitieri, Twardowski, Parks and 15
Trerotola. 16
17
DECISION 18
We REVERSE the Examiner’s decision rejecting claims 1-20. 19
20
REVERSED 21
22
Klh 23