Ex Parte 6530876 et al

Patent Trial and Appeal Board

Apr 30, 2014

95001858 (P.T.A.B. Apr. 30, 2014)

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.
95/001,858 12/19/2011 6530876 HEWI-002/00US
313341-2004
9905
58249 7590 05/01/2014
COOLEY LLP
ATTN: Patent Group
1299 Pennsylvania Avenue, NW
Suite 700
Washington, DC 20004
EXAMINER
FLANAGAN, BEVERLY MEINDL
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
05/01/2014 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
________________

CIRCULITE, INC.
1

Respondent, Cross-Appellant, Requester
v.
HEARTWARE, INC.
Appellant, Cross-Respondent, Patent Owner
________________

Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1
2

Technology Center 3900
________________

Before JOHN C. KERINS, STEVEN D.A. McCARTHY and
RAE LYNN P. GUEST, Administrative Patent Judges.

McCARTHY, Administrative Patent Judge.

1
As presently advised, the Patent Owner, HeartWare, Inc., purchased
Circulite, Inc. on or about December 1, 2013. (See Press Release,
HeartWare® International Announces Acquisition of Circulite®, Inc.,
reproduced at http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-
newsArticle&ID=1880820&highlight (last visited March 24, 2013).

2
Issued March 11, 2003, to Paul A. Spence (the “′876 patent”) and is
said to be assigned to HeartWare, Inc. The ′876 patent issued from Appl.
No. 09/557,562, filed April 25, 2000.
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

2
DECISION ON APPEAL

STATEMENT OF THE CASE 1
The Appellant/Cross-Respondent/Patent Owner (“PO”) appeals from 2
a final rejection of claims 1, 2, 4, 5, 8, 13, 14, 16, 21-32, 39-52, and 55-64. 3
(“Corrected Patent Owner’s Appellant’s Brief in Inter Partes Reexamination 4
Under 37 C.F.R.§ 41.67” dated May 8, 2013 (“Patent Owner’s Appeal 5
Brief” or “App. Br. PO”) at 1 and 2). The Respondent/Cross-6
Appellant/Third Party Requester (“Requester”) cross-appeals the Examiner’s 7
decision not to adopt Requester’s proposed rejections against claims 33-38, 8
53, and 54. (“Appeal Brief Under 37 C.F.R. § 41.67” dated April 19, 2013 9
(“Requester’s Appeal Brief” or “App. Br. Req’r”) at 1). Claims 3, 6, 7, 9-10
12, 15 and 17-20 are not subject to reexamination. (See Right of Appeal 11
Notice mailed January 18, 2013 (“RAN”) at 25-26). 12
Claims 1, 2, 4, 5, 8, 13, 14 and 16 were in the ′867 patent prior to the 13
commencement of this proceeding. The claims have not been amended in 14
this proceeding. (App. Br. PO 1). Claims 21-64 were added during the 15
course of reexamination. (App. Br. PO 2). Counsel for the Patent Owner 16
participated in an oral hearing held on March 19, 2014.
3
We have 17
jurisdiction under 35 U.S.C. § 134(b) (2011) and 35 U.S.C. § 315(a) (2011). 18
On the Patent Owner’s appeal, we sustain the rejection of claims 1, 2, 19
4, 5, 8, 13, 14, 16, 39 and 40. We do not sustain the rejection of claims 21-20
32, 41-52, and 55-64. On the Requester’s cross-appeal, we sustain the 21

3
Requester did not participate in the oral hearing.
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

3
Examiner’s determination not to adopt rejections proposed by the Requester 1
against claims 33-38, 53, and 54. 2
The decision of the Examiner is set forth in the RAN.
4
The Patent 3
Owner relies on the Patent Owner’s Appeal Brief, a “Patent Owner’s 4
Respondent’s Brief in Inter Partes Reexamination Under 37 C.F.R. § 41.68” 5
dated May 20, 2013 (“Patent Owner’s Respondent Brief” or “Resp. Br. 6
PO”), and a “Patent Owner’s Rebuttal Brief Under 37 C.F.R. § 41.71” dated 7
July 18, 2013 (“Reb. Br. PO”). The Patent Owner additionally relies on a 8
Declaration of Paul A. Spence, executed June 11, 2012; and two 9
“Declarations of Dr. Mark S. Slaughter under 37 C.F.R. § 1.132,” executed 10
on June 11, 2012 (“First Slaughter Declaration” or “First Slaughter Decl.”), 11
and September 29, 2012 (“Second Slaughter Decl.”), respectively. 12
The Requester relies on Requester’s Appeal Brief, a “Respondent, 13
Third Party Requestor’s, Brief Under 37 CFR § 41.68 in Response to Patent 14
Owner’s Appellant Brief Under 37 CFR § 41.67 in Reexamination of US 15
Patent 6,530,876” dated on June 10, 2013 (“Requester’s Respondent Brief” 16
or “Resp. Br. Req’r”), and a “Third Party Requestor’s, Rebuttal Brief Under 17
37 CFR § 41.71 in Response to Examiner’s Answer and Patent Owner’s 18
Respondent Brief in Reexamination of US Patent 6,530,876” dated July 18, 19
2013 (“Requester’s Rebuttal Brief” or “Reb. Br. Req’r”). Our review is 20
limited to issues and findings of fact raised in these sources. See 37 C.F.R. 21
§ 41.67(c)(1)(vii) (2011); In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011); 22
Ex parte Frye, 94 USPQ2d 1072, 1075-76 (BPAI 2010). 23

4
The Examiner’s Answer mailed June 18, 2013, merely incorporates
the RAN by reference.
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

4
Neither the Patent Owner nor the Requester has identified any prior 1
litigation or post-grant proceeding involving the ′876 patent. 2
3
THE ′876 PATENT 4
The claims on appeal relate to a method for assisting heart function by 5
employing devices that supplement the natural blood pumping ability of a 6
patient’s heart. (′876 patent, col. 1, ll. 6-10). As depicted in Figure 1, one 7
such method includes implanting a pump 16 in a small pocket made 8
subcutaneously in the patient’s chest. (Id., col. 4, ll. 5-8). The pump 16 is 9
coupled to an electric power supply 18, which may be implanted partially, 10
such as in the lower abdominal region of the patient, or wholly external to 11
the patient. (Id., col. 4, ll. 9-11, 15-18 and 29-33). In order to facilitate the 12
blood flow, the pump 16 is coupled to an inflow catheter/conduit which 13
extends through the heart 12 and into the left atrium 22. (Id., col. 4, ll. 22-14
25). Blood is then withdrawn from the left atrium 22 by the pump 16 and 15
discharged into an outflow catheter/conduit 24. (Id., col. 4, ll. 25-28). The 16
outflow conduit 24 is in fluid communication with the axillary artery 26, 17
which is located in the shoulder region. (Id.) 18
Claims 1 and 13 are independent. Claim 1 recites: 19
1. A method of supplementing the blood flow 20
from the heart of a patient using a pump assist 21
system, the method comprising: 22
directing a first conduit into the left 23
side of the heart, 24
coupling a second conduit in fluid 25
communication with a superficial artery of 26
the patient, 27
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

5
connecting a pump between the first 1
and second conduits, 2
implanting the pump in a superficial, 3
subcutaneous area of the patient, 4
connecting an electrical power supply 5
to the pump, 6
suctioning blood from the left side of 7
the heart through the first conduit and into 8
the pump, and 9
expelling the blood from the pump 10
into the second conduit and the superficial 11
artery. 12
(App. Br. PO 31 (Claims App’x); see also ′876 patent, col. 6, ll. 21-35). 13
14
I. 15
APPEAL OF THE PATENT OWNER 16
17
ISSUES 18
The Examiner adopts the Requester’s proposed rejection of claims 1, 19
4, 5, 8, 13, 16, 39, and 40 under 35 U.S.C. § 103(a) (2011) as being 20
unpatentable over DeBakey (The Artificial Heart, K. Mattox, ed., THE 21
HISTORY OF SURGERY IN HOUSTON, 346-458 (Eakin Press, Austin 1998) 22
(“DeBakey”)) and either Bolling (US 6,299,575 B1, issued Oct. 9, 2001) 23
(RAN 5 (Ground 1)
5
) or Buck (US 5,701,919, issued Dec. 30, 1997) (RAN 8 24

5
The numbers in parentheses reflect the numbering of the rejections in
the RAN.

Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

6
(Ground 3)). This opinion will address as representative the rejection of 1
claim 1 as being unpatentable over DeBakey and Bolling. 2
A first issue in this appeal is: 3
Would one of ordinary skill in the art have had reason to 4
modify DeBakey’s technique for installing the left ventricular 5
assist device (“LVAD”) depicted in Figure 6 of DeBakey in 6
light of the teachings of Bolling to include the steps of 7
“implanting the pump in a superficial, subcutaneous area of the 8
patient” and “connecting an electrical power supply to the 9
pump?” 10
The Examiner also adopts the proposed rejection under § 103(a) of 11
claims 2 and 14, which depend from claims 1 and 13, respectively, as being 12
unpatentable over DeBakey; any one of Bolling or Buck; and Kyo 13
(Percutaneous Introduction of Left Atrial Cannula for Left Heart Bypass: 14
Utility of Biplane Transesophageal Echocardiographic Guidance for 15
Transseptal Puncture, 16 ARTIFICIAL ORGANS, 386-91 (1992) (“Kyo”)) 16
(Grounds 2, 4, 10 and 12). (RAN 8, 10, 13 and 15).

Each of claims 2 and 17
14 recites the additional limitation “wherein the step of directing a first 18
conduit into the left side of the heart further comprises: directing the first 19
conduit into a superficial vein and transeptally [sic] through the heart.” 20
(′876 patent, col. 6, ll. 36-39 and col. 8, ll. 11-15). This opinion will address 21
as representative the rejection of claim 2 under § 103(a) as being 22
unpatentable over DeBakey, Bolling and Kyo. 23
A second issue in this appeal is: 24
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

7
Would one of ordinary skill in the art have had reason to 1
modify DeBakey’s technique for installing the left ventricular 2
assist device (“LVAD”) depicted in Figure 6 of DeBakey in 3
view of the teachings of Bolling and Kyo such that “the step of 4
directing a first conduit into the left side of the heart further 5
comprises: directing the first conduit into a superficial vein and 6
transseptally through the heart?” 7
The Examiner adopts the rejection of claims 1, 4, 5, 8, 13, 16, 39, and 8
40 under 35 U.S.C. § 103(a) (2011) as being unpatentable over DeBakey and 9
either Nishimura (Results of Chronic Animal Experiments With a New 10
Version of a Magnetically Suspended Centrifugal Pump, 44 ASAIO J. 11
M725-27 (1998) (“Nishimura”)) (RAN 11 (Ground 9)) or Macha (Survival 12
for Up to Six Months in Calves Supported With an Implantable Axial Flow 13
Ventricular Assist Device, 43 ASAIO J. 311-15 (1997) (“Macha”)) (RAN 13 14
(Ground 11)). The Examiner additionally adopts the proposed rejection 15
under § 103(a) of claims 2 and 14 as being unpatentable over DeBakey; 16
either Nishimura or Macha; and Kyo. Finally, the Examiner rejects claims 17
21-32, 41-52, and 55-64 under § 103(a) as being unpatentable over DeBakey 18
and either Nishimura or Macha as applied to claim 1 or claim 13, and further 19
in view of Rueter. The rejections of claim 1 as being unpatentable over 20
DeBakey and either Nishimura or Macha are representative. 21
A third issue in this appeal is: 22
Would one of ordinary skill in the art have had reason to 23
modify DeBakey’s technique for installing the left ventricular 24
assist device (“LVAD”) depicted in Figure 6 of DeBakey in 25
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

8
view of the teachings of Nishimura or Macha and Rueter to 1
include the steps of “implanting the pump in a superficial, 2
subcutaneous area of the patient” and “connecting an electrical 3
power supply to the pump?” 4
5
FINDINGS OF FACT 6
The record supports the following findings of fact (“FF”) by a 7
preponderance of the evidence. 8
9
DeBakey 10
1. DeBakey reports a case study in which a left ventricular assist 11
device (“LVAD”) was used to treat a human patient recovering from aortic 12
and mitral valve replacement. As depicted in Figure 6 of DeBakey, the 13
LVAD included an inlet tube or conduit attached to an opening in the left 14
atrium of the heart by end-to-side anastomosis; an outlet tube attached to the 15
right axillary artery by end-to-side anastomosis; and a positive displacement 16
pump connected between the inlet and outlet tubes. (DeBakey 353 and fig. 17
6). The pump was driven by an electric motor. (DeBakey 351). 18
2. DeBakey describes the LVAD as having been “energized to 19
provide a flow rate of 1,200 ml/min.” (DeBakey 353). In other words, 20
electrical power was supplied to the pump (or at least to the electric motor 21
driving the pump). The pump suctioned oxygen-rich blood from the left 22
atrium of the heart through the inlet tube and into the pump. The pump then 23
expelled blood from the pump into the outlet tube and the right axillary 24
artery so as to induce a flow of oxygen-rich blood from the left side of the 25
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

9
heart to the artery. (See DeBakey 351 and 352 (figs. 4a and 4b)(depicting 1
the direction of blood flow through the pump)). 2
3. The LVAD described in DeBakey was used to treat the patient 3
as a temporary measure after those treating the patient were unable to 4
remove the patient from a heart-lung machine. (DeBakey 353). The LVAD 5
was removed after ten or eleven days. (DeBakey 355). Perhaps as a result 6
of the size of the pump (which was approximately the size of a baseball) and 7
the expected duration of the treatment, the pump was not implanted into the 8
patient. (See DeBakey, fig. 7; see also First Slaughter Decl., paras. 13 and 9
20). Instead, the inlet and outlet tubes were brought out of the chest through 10
stab wounds and connected to the pump externally of the patient’s body. 11
(See DeBakey 353). 12
4. Figure 17 of DeBakey is a schematic view depicting a projected 13
clinical application of an LVAD including a magnetically-driven, miniature 14
axial flow pump. (See DeBakey 363 and 364). In Figure 17, the pump is 15
depicted implanted within the thoracic cavity close to the heart. (See First 16
Slaughter Decl., para. 17). In preliminary experiments performed in calves, 17
the inflow to the pump was connected to the calves’ left ventricles and the 18
outflow was connected to the calves’ descending thoracic aortas. (DeBakey 19
363-64). The application as depicted in Figure 17 includes a partially 20
implanted internal battery connected to the pump. (DeBakey 361-63). 21
5. DeBakey teaches that the proposed LVAD depicted in Figure 22
17 23
will be useful not only for temporary use for 24
transient but recoverable cardiac failure resulting 25
from myocardial infarction, cardiac operation, and 26
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

10
bridge-to-transplant, but also in a larger number of 1
patients with chronic irreversible heart failure 2
(Figure 17). Because of its small size (about the 3
size of a AA battery) and its efficacy (requiring 4
about 6 or 7 watts of power), it can easily be 5
implanted with all components inside the body 6
including the transdermal rechargeable battery. 7
(DeBakey 365). This passage would have suggested the desirability of 8
implanting an LVAD for longer-term use in a patient having chronic 9
irreversible heart failure. 10
11
Bolling 12
6. Bolling discloses a heart assist system including a pump 32 13
actuated by an electric motor 40. (Bolling, col. 8, ll. 14-17). Bolling teaches 14
that the pump 32 “should be sufficiently small to be implanted 15
subcutaneously and preferably extrathoracically, for example in the groin 16
area of the patient, without the need for major invasive surgery.” (Bolling, 17
col. 7, ll. 12-15). That said, Bolling also teaches that the pump 32 may be 18
either continuous-flow or pulsatile. (Bolling, col. 7, ll. 35-40). 19
7. Bolling’s pump 32 is connected to the left axillary artery 24 via 20
an out-flow conduit 52 and the left femoral artery 26 via an in-flow conduit 21
50. (Bolling, col. 8, ll. 55-58; col. 9, ll. 8-13 and 19-24; and fig. 2). As 22
depicted in Figure 2 of Bolling, the left side of the heart pumps oxygen-rich 23
blood through the aorta to the femoral arteries. Bolling’s system pumps 24
blood from the femoral artery 26 to the left axillary artery 24. Bolling 25
teaches that the “connection of the inflow and outflow conduits [of the 26
pump] is performed subcutaneously; not so deep as to involve major 27
invasive surgery.” (Bolling, col. 5, ll. 16-19). 28
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

11
8. Bolling recognizes that the left atrium is a significant source of 1
oxygen-rich blood for distribution to the patient’s organs. (See, e.g., 2
Bolling, col. 2, ll. 7-11). Nevertheless, Bolling teaches that the heart assist 3
system 4
comprises an extracardiac pumping system for 5
supplementing the circulation of blood through the 6
patient without any component thereof being 7
connected to the patient’s heart or primary vessel 8
[e.g., aorta]. Thus, it is extracardiac in nature. 9
With the ability to be applied within a minimally 10
invasive procedure, [Bolling’s system] 11
significantly improves the condition of a patient 12
suffering from CHF [that is, congestive heart 13
failure, a chronic condition], resulting in the 14
patient feeling much better, even where CHF 15
continues. 16
(Bolling, col. 4, ll. 46-56). Bolling teaches that the preferred embodiment 17
described in Bolling “provides a heart assist system that is extracardiac in 18
nature. In other words, the [system] supplements blood perfusion, without 19
the need to interface directly with the heart and aorta. Thus, no major 20
invasive surgery is necessary to use the [system].” (Bolling, col. 6, ll. 58-21
61). Bolling specifically teaches that a preferred location for implanting the 22
pump is the groin area (Bolling, col. 7, ll. 12-15), through which the femoral 23
veins pass. 24
25
Kyo 26
9. Kyo teaches performing a transseptal puncture within the heart, 27
that is, puncturing the septum dividing the left atrium from the right atrium 28
of the heart. The puncture is used to introduce a percutaneous cannula from 29
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

12
the venous system, through the right atrium of the heart, to the left atrium of 1
the heart. (See Kyo 387, second col. (describing the introduction of 2
“percutaneous LA cannulas” into the left atria of patients after performing 3
transseptal punctures); see also First Slaughter Decl., para. 67).
6
In 4
particular, Kyo describes a case study in which a left atrial cannula was 5
introduced into the patient through the femoral vein. (See Kyo 389, first 6
col.). This disclosure supports the Examiner’s finding that Kyo “teaches 7
cannulating through the femoral artery [sic: femoral vein].” (RAN 25). 8
10. The Patent Owner does not appear to contest the Examiner’s 9
finding that Kyo describes a technique involving the direction of a cannula 10
into a superficial vein and transseptally through the heart. (See RAN 8; see 11
also First Slaughter Decl., paras. 67 and 68). 12
11. Kyo discloses that: 13
In 1962 Dennis and associates (16, 17) developed 14
the percutaneous left atrial-femoral artery bypass 15
(AAB) system using a rigid metal cannula through 16
the internal jugular vein with subsequent puncture 17
of the interatrial septum. 18
(Kyo 386, second col.). Even assuming for the sake of this appeal that this 19
passage teaches directing a cannula into a superficial vein and transseptally 20
through the heart, Kyo states that “these techniques have precluded 21

6
More specifically, Kyo describes a study “to investigate the clinical
feasibility of B-TEE [biplane transesophageal echocardiography, an
ultrasonic imaging technique] guidance for safe and efficient introduction of
an LA [left atrial] cannula by Brockenbrough transseptal puncture for AAB
[percutaneous left atrial-femoral artery bypass, a left heart bypass technique
in which blood is pumped from the left atrium of a patient’s heart into a
femoral artery] support.” (See Kyo 387, first col.).
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

13
widespread clinical application because of their technical difficulty and the 1
complication of arrhythmia.” (Kyo 387, first col.). 2
3
Nishimura 4
12. Nishimura describes an animal experiment to test the 5
effectiveness of a centrifugal pump including an impeller supported by 6
magnetic bearings. (Nishimura M725, first col. (describing pump) and 7
second col. (describing experiment)). LVADs including the centrifugal 8
pump were implanted in three sheep. In each of the sheep, an outflow 9
cannula was connected to the descending aorta and an inflow catheter was 10
inserted into the left atrium. (Nishimura M725, second col. – M726, first 11
col.). In one of the sheep, the pump was implanted in a superficial, 12
subcutaneous area, namely, in a pocket inside the skin on the chest wall. 13
(Nishimura M276, first col.). 14
15
Macha 16
13. Macha describes an animal experiment to test the effectiveness 17
of an axial flow blood pump. LVADs including the axial pump were 18
implanted in six calves. (Macha 311, first col.). In each of the six calves, an 19
outflow cannula was connected to the descending thoracic aorta and an 20
inflow catheter was connected to the apex of the left ventricle. (Macha 312, 21
first col.). The inflow and outflow cannulae were passed outwardly through 22
the ribs and connected to a pump implanted in a superficial, subcutaneous 23
pocket below the diaphragm. (Macha 312, col. 1 – col. 2). 24
25
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

14
Rueter 1
14. Rueter describes: 2
a conventional lateral transvenous implantation of 3
a pacemaker system within the body of a patient 4
26. Hematic enclosure 12 is disposed within a 5
small subcutaneous pocket inferior to the patient’s 6
clavicle. Lead 14 extends transvenously from 7
enclosure 12 such that its distal end is disposed 8
within the heart 28 of patient 26. 9
(Rueter, col. 3, ll. 5-10; see also id., fig. 2). Figure 2 illustrates the lead 14 10
extending through the venous system (for example, through an axillary or 11
subclavian vein) into the right atrium of the heart. Rueter does not teach that 12
it is desirable to implant a pump for an LVAD in a superficial, subcutaneous 13
area, much less that it is desirable to implant the pump in a subclavicular 14
pocket. 15
16
ANALYSIS 17
First Issue 18
The Examiner adopts the rejection of representative claim 1 under 19
§ 103(a), relying on teachings associated with Figures 6 and 17 of DeBakey 20
in view of the teachings of Bolling. The Examiner correctly finds that the 21
installation of the LVAD depicted in Figure 6 of DeBakey necessarily would 22
have satisfied each and every step of the method of claim 1 except 23
“implanting the pump in a superficial, subcutaneous area of the patient” and 24
“connecting an electrical power supply to the pump.” (See RAN 5; see also 25
FF 1). Although the Patent Owner does not appear to contest this finding, 26
the Patent Owner argues that the LVADs depicted in Figures 6 and 17 of 27
DeBakey “are not properly combinable.” (App. Br. PO 9-13). 28
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

15
An electric motor drove the pump in the LVAD depicted in Figure 6 1
of DeBakey. (FF 1). While Figure 6 of DeBakey itself did not depict a 2
power supply for the electric motor, Figure 17 of DeBakey depicted an 3
implantable LVAD including an electrical power supply in the form of an 4
internal battery connected to its pump. (FF 4). The Examiner correctly 5
concludes that it would have been obvious from the teachings of DeBakey to 6
connect an electric power supply such as a battery to the pump of the LVAD 7
depicted in Figure 6. (See RAN 5 (“DeBakey also teaches connecting an 8
electrical power supply to the pump (see Fig. 17 and page 364).”)). Indeed, 9
common sense would have recognized that an electrically-driven pump had 10
to be connected to an electrical power supply to operate. Even without the 11
teachings of Figure 17 of DeBakey, it would have been obvious to connect 12
an electric power supply to a pump driven by an electric motor. 13
As to the step of “implanting the pump in a superficial, subcutaneous 14
area of the patient,” the Examiner finds that “DeBakey does not specifically 15
show implanting the pump in a superficial, subcutaneous area of the patient, 16
but suggests that such implantations are desirable (see page 365 and Fig. 17
17).” (See RAN 5-6; see also App. Br. Req’r 8-9). The finding that 18
DeBakey suggests the implantation (although not necessarily the 19
subcutaneous, superficial implantation) of an LVAD designed for chronic 20
use is supported by DeBakey’s teachings. (See FF 5). 21
The Examiner relies on Bolling “for the proposition that cardiac assist 22
devices are known to include pumps that are implanted in superficial, 23
subcutaneous areas of the patients, as clearly shown in Fig. 2 of Bolling.” 24
(RAN 6-7). The Patent Owner argues that one of ordinary skill in the art 25
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

16
familiar with the teachings of Bolling would not have had reason to implant 1
the particular LVAD depicted in Figure 6 of DeBakey subcutaneously and 2
superficially as recited in claim 1. (App. Br. PO 13-15). 3
The Board does not endorse the Examiner’s suggestion (see RAN 7) 4
that the teachings of references may be combined merely because they are in 5
the same field of endeavor. Neither does the Board adopt the Requester’s 6
assertion (see Reb. Br. Req’r 9-10) that the Patent Owner must show that the 7
subject matter of the claims on appeal is patentable. Nevertheless, the 8
LVAD depicted in Figure 6 of DeBakey and the heart assist device 9
described by Bolling are similar devices in that both use pumps to drive 10
oxygen-rich blood into one of the axillary arteries. (Compare FF 1 and 2 11
with FF 7). The Examiner correctly concludes that it would have been 12
obvious to improve DeBakey’s LVAD to provide longer-term treatment for 13
a patient having chronic heart failure by modifying DeBakey’s LVAD to 14
include a suitably-sized pump and then subcutaneously and superficially 15
implanting the pump in the patient. (See RAN 6 (“It would have been 16
obvious . . . to utilize the pump placement in Bolling in the method of 17
DeBakey to avoid the use of bulky pumps and avoid major surgery in 18
placement of the pump.”)).
7
19
The Patent Owner argues that one of ordinary skill in the art familiar 20
with the teachings of Bolling would not have had reason to direct a first (that 21

7
As to claim 5, the proposed LVAD depicted in Figure 17 of DeBakey
includes a partially embedded power supply. (FF 4). Despite Patent
Owner’s argument to the contrary (see App. Br. PO 28-29), the Examiner
correctly concludes that it was known to partially implant a power supply for
a LVAD for treatment of a patient with chronic heart failure. (See RAN 7).
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

17
is, inlet) conduit of the pump of an LVAD into the left side of the heart as 1
opposed to the femoral artery. (App. Br. PO 13-15). More specifically, 2
Bolling teaches drawing oxygen-rich blood from an artery outside the 3
thoracic cavity rather than directly from the heart or from the aorta so as not 4
to involve invasive surgery. (See FF 6 and 8). 5
That said, the left atrium of the heart was known to be a significant 6
source of oxygen-rich blood. (FF 8). The LVAD depicted in Figure 6 of 7
DeBakey drew oxygen-rich blood from the left atrium for distribution to the 8
left axillary artery. (FF 1 and 2). One of ordinary skill in the art would have 9
balanced the risk required to connect the inflow to the pump to the left side 10
of the heart with the advantage of drawing oxygen-rich blood from the left 11
side of the heart rather than downstream in the femoral artery, and chosen 12
the former over the latter. See Medichem, S.A. v. Rolabo, S.L., 437 F.3d 13
1157, 1165 (Fed. Cir. 2006) (“[A] given course of action often has 14
simultaneous advantages and disadvantages, and this does not necessarily 15
obviate motivation to combine.”). Having made this choice, one of ordinary 16
skill in the art would have chosen to implant the pump outside the thoracic 17
cavity as taught by Bolling, and to pump the oxygen-rich blood into an 18
axillary artery as described by both DeBakey and Bolling, to avoid the use 19
of bulky pumps and avoid major surgery in placement of the pump. 20
At pages 12 through 13 of the Patent Owner’s Appeal Brief, the 21
Patent Owner argues that DeBakey teaches away from subcutaneous, 22
superficial implantation of the pump of an LVAD because: 23
one of ordinary skill in the art would have considered a pulsatile pump 24
better suited than a continuous-flow pump such as that depicted in Figure 17 25
of DeBakey for driving blood through a superficial artery into the aorta 26
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

18
against natural arterial pressure (citing First Slaughter Decl., paras. 12 and 1
19; see also id., para. 16); 2
one of ordinary skill in the art would have considered an inflow cannula of 3
the length required to connect a superficially implanted pump to the left side 4
of the heart undesirable because of the risk that neointimal tissue might 5
gradually form on the inner surface of the inflow cannula (citing First 6
Slaughter Decl., para. 18 and 20); and 7
one of ordinary skill in the art would have understood the goal of DeBakey’s 8
research team to have been the development of an LVAD system including a 9
deeply-implanted pump rather than a subcutaneously and superficially 10
implanted pump for chronic applications (citing First Slaughter Decl., para. 11
31). 12
See In re Gurley, 27 F.3d 551 (Fed. Cir. 1994)(“A reference may be said to 13
teach away when a person of ordinary skill, upon reading the reference, 14
[would have been] discouraged from following the path set out in the 15
reference, or would [have been] led in a direction divergent from the path 16
that was taken by the applicant.”). 17
The Patent Owner’s assertion that one of ordinary skill in the art 18
would have considered a pulsatile pump better suited than a continuous-flow 19
pump such as that depicted in Figure 17 of DeBakey for driving blood 20
through a superficial artery into the aorta against natural arterial pressure is 21
not persuasive. Bolling teaches that the pump for driving blood into an 22
axillary artery for distribution to the patient’s organs may be either 23
continuous-flow or pulsatile, without reference to any resistance from 24
natural arterial pressure. (Bolling, col. 7, l. 7  col. 8, l. 31). 25
Furthermore, one of ordinary skill in the art may be presumed to 26
possess some level of skill to adapt the teachings of the prior art. See ICON 27
Health & Fitness, Inc., 496 F.3d 1374, 1382 (Fed. Cir. 2007)(“[W]e do not 28
ignore the modifications that of one skilled in the art would make to a device 29
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

19
borrowed from the prior art.”). Figure 6 of DeBakey depicts an LVAD 1
using a pump approximately the size of a baseball. (See FF 3). 2
Nevertheless, one of ordinary skill, who may be presumed to have been 3
familiar with different types of pumps, would not have felt bound to implant 4
a baseball-sized pump in a patient with chronic heart failure merely because 5
DeBakey described using a pump of that size when treating an acute or 6
transient heart failure. The Examiner’s reasoning contemplates that one of 7
ordinary skill in the art would have chosen to substitute a less bulky pump 8
for that depicted in Figure 6 of DeBakey, such as that described in Bolling. 9
(See RAN 6). 10
As to the risk that neointimal tissue might gradually form on the inner 11
surface of an inflow cannula sufficiently long to connect a superficially 12
implanted pump to the left side of the heart, one of ordinary skill in the art 13
would have been entitled to balance risks and advantages in choosing where 14
to implant the pump of an LVAD. See Medichem. Bolling itself points out 15
the risk posed by invasive surgery (see FF 6 and 8) and implanting the pump 16
outside the thoracic cavity might have limited the surgical risk required to 17
implant the LVAD as a whole. One of ordinary skill in the art familiar with 18
the teachings of DeBakey and Bolling could have chosen to connect the left 19
side of the heart to a pump implanted outside the thoracic cavity, despite the 20
increased risk of tissue forming on the interior of a longer inflow cannula, to 21
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

20
reduce the risk inherent in implanting the pump itself in the thoracic cavity.
8
1
Finally, the Patent Owner points out that Figure 17 of DeBakey 2
depicts an LVAD implanted deeply near the patient’s heart. (See App. Br. 3
PO 13 (Citing First Slaughter Decl., para. 18). Meanwhile, DeBakey is 4
silent as to costs or benefits of subcutaneous, superficial implantation. As 5
the Requester points out at page 5 of Requester’s Rebuttal Brief, the mere 6
fact that one of ordinary skill in the art might have understood the goal of 7
DeBakey’s research team to have been the development of an LVAD system 8
including a deeply-implanted pump does not imply that DeBakey would 9
have discouraged one of ordinary skill in the art from pursuing 10
subcutaneous, superficial implantation. See In re Fulton, 391 F.3d 1195, 11
1201 (Fed. Cir. 2004)(“The prior art’s mere disclosure of more than one 12
alternative does not constitute a teaching away from any of these alternatives 13
because such disclosure does not criticize, discredit, or otherwise discourage 14
the solution claimed.”). 15
The Examiner and the Requester have shown that the subject matter 16
of representative claim 1 would have been obvious from the teachings of 17
DeBakey and Bolling. The Patent Owner’s argument that DeBakey teaches 18
away from the combination is not persuasive. Therefore, we sustain the 19
rejection of claims 1, 4, 5, 8, 13, 16, 39, and 40 under § 103(a) as 20

8
In fact, concerns regarding the length of the inflow and outflow
cannulae might have provided one of ordinary skill in the art additional
reason to draw oxygen-rich blood from the left side of the heart for deposit
into an axillary artery in order to shorten the overall lengths of the cannulae.
While our conclusion that the subject matter of claim 1 would have been
obvious does not rely on this reasoning, the reasoning does suggest the
correctness of the conclusion.
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

21
unpatentable over DeBakey and Bolling. Since this holding stands as a 1
general affirmance of the Examiner’s decision to reject these claims, see 37 2
C.F.R. § 41.77(a) (2011), we do not separately address the rejection of 3
claims 1, 4, 5, 8, 13, 16, 39, and 40 under § 103(a) as being unpatentable 4
over DeBakey and Buck. 5
6
Second Issue 7
The Examiner correctly concludes that it would have been obvious to 8
modify DeBakey’s LVAD to include a suitably-sized pump subcutaneously 9
and superficially implanted in the patient. With regard to representative 10
claim 2, Kyo describes a technique involving the direction a cannula into a 11
superficial vein and transseptally through the heart. (FF 11). 12
The Patent Owner points out that “Kyo’s approach to delivery of a 13
cannula to the left atrium involves inserting the cannula percutaneously into 14
the right femoral vein, to the right atrium, and through the septum into the 15
left atrium.” (App. Br. PO 20; see also FF 11). The Patent Owner argues 16
that: 17
This approach is incompatible with the use of a 18
deeply implanted pump, because the approach 19
would entail routing the inflow cannula from the 20
deeply implanted pump, out of the body, to the leg, 21
into the femoral vein, into the right atrium, and 22
through the septum to the left atrium. A deeply 23
implanted pump is already close to the heart and 24
can be coupled directly to the left side of the heart 25
(atrium or ventricle). 26
(App. Br. PO 20, citing First Slaughter Decl., para. 70; see also First 27
Slaughter Decl. para. 69). This argument is premised on a deep implantation 28
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

22
of the pump in the thoracic cavity of the patient. As noted earlier, the Patent 1
Owner has not identified error in the Examiner’s conclusion that it would 2
have been obvious to implant the pump subcutaneously and superficially. 3
Since the Patent Owner does not allege any incompatibility between 4
directing a cannula percutaneously to the right atrium and transseptally into 5
the left atrium for the ease and rapidity of accessing the left atrium, as taught 6
by Kyo (see Resp. Br. Req’r 15-16), and the use of a subcutaneously and 7
superficially implanted pump, the argument is not persuasive. We sustain 8
the rejection of claims 2 and 14 under § 103(a) as unpatentable over 9
DeBakey, Bolling, and Kyo. Since this holding stands as a general 10
affirmance of the Examiner’s decision to reject these claims, see 37 C.F.R. § 11
41.77(a) (2011), we do not separately address the rejection of claims 2 and 12
14 under § 103(a) as being unpatentable over DeBakey, Buck and Kyo. 13
14
Third Issue 15
Turning to the rejection of claim 1 as being unpatentable over 16
DeBakey and Nishimura, the Examiner reasons that: 17
As DeBakey suggests the advantages of implanting 18
the pump in a superficial, subcutaneous area and 19
Nishimura specifically discusses placing the pump 20
in a superficial, subcutaneous area of the patient, it 21
would have been obvious for one of ordinary skill 22
in the art at the time the invention was made to 23
utilize the pump placement in Nishimura in the 24
method of DeBakey. 25
(RAN 12; see also “Statement and Explanation Under 37 CFR 1.915 in 26
Support of Request for Inter Partes Reexamination of US Patent 6,530,876” 27
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

23
dated December 19, 2011 (“Request”) 59). The Examiner also reasons, in 1
almost the same words, that: 2
As DeBakey suggests the advantages of implanting 3
the pump in a superficial, subcutaneous area and 4
Macha specifically discusses placing the pump in a 5
superficial, subcutaneous area of the patient, it 6
would have been obvious for one of ordinary skill 7
in the art at the time the invention was made to 8
utilize the pump placement in Macha in the 9
method of DeBakey. 10
(RAN 14; see also Request 63). 11
DeBakey would have suggested the desirability of implanting an 12
LVAD for longer-term use in a patient having chronic irreversible heart 13
failure. (FF 5). DeBakey does not mention, much less disclose any 14
advantages of, implanting the pump of an LVAD in a superficial, 15
subcutaneous area, however. While the Examiner correctly finds that both 16
Nishimura and Macha described animal experiments in which pumps of 17
LVADs were implanted in superficial, subcutaneous areas of test animals 18
(FF 12 and 13), “a patent composed of several elements is not proved 19
obvious merely by demonstrating that each of its elements was, 20
independently, known in the prior art.” KSR Int’l Co. v. Teleflex, Inc., 550 21
U.S. 398, 418 (2007). The Examiner articulates no persuasive reason why it 22
might have been obvious to implant the pump of an LVAD such as that 23
depicted in Figure 6 of DeBakey in a superficial, subcutaneous area based on 24
the teachings either Nishimura or Macha, other than the Examiner’s 25
erroneous finding that DeBakey suggests the advantages of implanting the 26
pump in a superficial, subcutaneous area. Neither the Requester’s argument 27
on pages 14-15 of the Requester’s Respondent Brief, nor the argument at 28
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

24
page 13 of the Requester’s Rebuttal Brief, is persuasive that one of ordinary 1
skill in the art might have had reason to combine the teachings of DeBakey 2
and either Nishimura or Macha in the fashion claimed in claim 1 or claim 3
13. 4
The teachings of Rueter (see FF 14) as applied in the rejection of 5
claims do not remedy the deficiencies in the combined teachings of 6
DeBakey and Nishimura or DeBakey and Macha as applied to independent 7
claims 1 and 13. We do not sustain the rejection of claims 21-32, 41-52, and 8
55-64 under § 103(a) as being unpatentable over DeBakey; either Nishimura 9
or Macha; and Rueter. 10
11
DECISION 12
We AFFIRM the Examiner’s decision rejecting claims 1, 2, 4, 5, 8, 13
13, 14 and 16. 14
We REVERSE the Examiner’s decision rejecting claims 21-32, 41-52, 15
and 55-64. 16
17
II. 18
CROSS-APPEAL OF THE REQUESTER 19
20
ISSUE 21
The Examiner determined not to adopt the Requester’s proposed 22
rejection of claims 33, 34, 37 and 38 under § 103(a) as being unpatentable 23
over DeBakey, Bolling, and Kyo. In addition, the Examiner determined not 24
to adopt the Requester’s proposed rejections of claims 35, 36, 53 and 54 25
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

25
under § 103(a) as being unpatentable over DeBakey; any one of Buck, 1
alleged Applicants’ Admitted Prior Art (“AAPA”), Nishimura or Macha; 2
and Kyo. (See RAN 25). 3
Claim 33 depends from claim 1 and recites the additional limitation 4
“wherein the directing the first conduit includes cannulating a vein in one of 5
a shoulder area or a neck area of a patient and directing an end portion of the 6
first conduit through the right atrium and the septum and into the left 7
atrium.” Claims 34-38 depend ultimately from independent claims 1 and 13. 8
Although claims 34-38 directly depend from different claims, they recite 9
additional limitations identical to the additional limitation of claim 33. 10
Claims 53 and 54 depend from claims 2 and 14, respectively, and 11
additionally recite “wherein the directing the first conduit into the superficial 12
vein includes cannulating a vein at a cannulation point in one of a shoulder 13
area or a neck area of a patient.” 14
Both the Patent Owner and the Requester make similar arguments 15
with regard to the patentability of claims 33-38, 53 and 54. The rejection of 16
claim 33 under § 103(a) as being unpatentable over DeBakey, Bolling and 17
Kyo is representative. 18
A fourth issue in this appeal is: 19
Would one of ordinary skill in the art have had reason to 20
modify DeBakey’s technique for installing the left ventricular 21
assist device (“LVAD”) depicted in Figure 6 of DeBakey in 22
view of the teachings of Bolling and Kyo “wherein the 23
directing the first conduit into the superficial vein includes 24
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

26
cannulating a vein at a cannulation point in one of a shoulder 1
area or a neck area of a patient?” 2
Fourth Issue 3
The Examiner correctly finds that Kyo “teaches cannulating through 4
the femoral artery.” (RAN 25; see also FF 9; App. Br. PO 28). This finding 5
implies that Kyo does not teach cannulating a superficial vein in either a 6
shoulder area or a neck area. 7
The Requester correctly points out that Kyo includes one sentence 8
describing the development of an AAB system using a rigid metal cannula 9
through the internal jugular vein with subsequent puncture of the interatrial 10
septum. (See App. Br. Req’r 9-10; see also FF 11). Even assuming for 11
purposes of this appeal that this sentence describes cannulating a superficial 12
vein in a shoulder or neck and directing an end portion of the first conduit 13
through the right atrium and the septum and into the left atrium, Kyo also 14
teaches that “these techniques have precluded widespread clinical 15
application because of their technical difficulty and the complication of 16
arrhythmia.” (Kyo 387, first col.; see also FF 11). 17
The Requester argues that the described method was a “well known 18
and commonly used technique” and that Kyo describes “the ease and 19
rapidity” of performing the procedure. (App. Br. Req’r 12). While these 20
advantages may have been acknowledged in Kyo for percutaneous 21
introduction via the femoral artery, the reasoning is contradicted by the 22
statement in Kyo of a lack of widespread clinical application and technical 23
difficulty of the procedure via the jugular vein. (FF 11). Notwithstanding 24
this unpersuasive argument, the Requester has not shown that one of 25
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

27
ordinary skill in the art might have had reason to modify the installation of 1
an LVAD of DeBakey to include the step of cannulating the superficial vein 2
in one of a shoulder area or a neck area and directing an end portion of the 3
first conduit through the right atrium and the septum and into the left atrium. 4
We sustain the Examiner’s refusal to adopt the Requester’s proposed 5
rejection of claims 33, 34, 37 and 38 under § 103(a) as being unpatentable 6
over Debakey, Bolling, and Kyo. 7
Requester has put forth the same arguments applying Kyo as 8
discussed above in the rejections of 35, 36, 53 and 54, which include 9
substantially similar language to that of claim 33. For the same reasons 10
discussed above with respect to claim 33, we also sustain Examiner’s refusal 11
to adopt the Requester proposed the rejection of claims 35, 36, 53 and 54 12
under § 103(a) as being unpatentable over DeBakey; any one of Buck, 13
AAPA, Nishimura, or Macha; and Kyo. 14
15
DECISION 16
We AFFIRM the Examiner’s decision to not adopt the proposed 17
rejections of claims 33-38, 53, and 54. 18
In view of our affirming the Examiner’s rejections of claims 1, 2, 4, 5, 19
8, 13, 14 and 16, we decline to address the Examiner’s non-adoption of 20
alternative rejections of the same claims. 21
Requests for extensions of time in this inter partes reexamination 22
proceeding are governed by 37 C.F.R. § 1.956 (2010). 23
In the event neither party files a request for rehearing within the time 24
provided in 37 C.F.R. § 41.79 (2010), and this decision becomes final and 25
Appeal 2014-000136
Reexamination Control 95/001,858
Patent No. US 6,530,876 B1

28
appealable under 37 C.F.R. § 41.81 (2010), a party seeking judicial review 1
must timely serve notice on the Director of the United States Patent and 2
Trademark Office. See 37 C.F.R. § 1.983 (2010) and 37 C.F.R. §§ 90.1 3
(2010). 4
5
AFFIRMED-IN-PART 6
7
8
9
10
ack 11
Patent Owner: 12
COOLEY LLP 13
ATTN: PATENT GROUP 14
1299 PENNSYLVANIA AVENUE, NW 15
SUITE 700 16
WASHINGTON DC, 20004 17
18
Third Party Requester: 19
SNR DENTON US LLP 20
P.O. BOX. 061080 21
CHICAGO, IL 60606-1080 22