Ex Parte Zhang et al

Board of Patent Appeals and Interferences

Sep 29, 2010

10895747 (B.P.A.I. Sep. 29, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte YONGXING ZHANG
and CHRISTOPHER P. KNAPP
____________

Appeal 2009-013431
Application 10/895,747
Technology Center 3700
____________

Before STEVEN D.A. McCARTHY, KEN B. BARRETT and
FRED A. SILVERBERG, Administrative Patent Judges.

McCARTHY, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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STATEMENT OF THE CASE 1
The Appellants appeal under 35 U.S.C. § 134 of the Examiner’s final 2
decision rejecting: 3
claims 1, 7-14, 16-18, 20-37, 41-45, 47 and 48 under 35 4
U.S.C. § 102(b) as being anticipated by Blake (US 3,995,623, 5
issued Dec. 7, 1976); 6
claims 1-6, 14 and 15 under § 102(b) as being anticipated 7
by Bornzin (US 5,643,338, issued Jul. 1, 1997); 8
claims 14, 19, 20 and 26-28 under § 102(b) as being 9
anticipated by Obino (US 5,800,498, issued Sep. 1, 1998); 10
claims 14, 24 and 25 under 35 U.S.C. § 103(a) as being 11
by unpatentable over Bornzin; 12
claim 38 under § 103(a) as being unpatentable over Blake 13
and Ideker (US 6,122,553, issued Sep. 19, 2000); 14
claims 39 and 40 under § 103(a) as being unpatentable 15
over Blake, Obino, or Bornzin; and; 16
claim 46 under § 103(a) as being unpatentable over Blake 17
and Bornzin. 18
The Appellants do not appear to have responded to the rejections of 19
claims 39 and 40 under § 103(a) as being unpatentable over Obino or 20
Bornzin. We summarily sustain those grounds of rejection. 21
We sustain the final rejections of claims 1, 7-18, 20-28, and 36-48. 22
We do not sustain the final rejections of claims 2-6, 19 and 29-35. 23
In the Office Action mailed December 19, 2007, the Examiner 24
provisionally rejects claims 1-4 and 29 for non-statutory obviousness-type 25
double patenting over claims 1, 10-14 and 20 of Application 10/895,748; 26
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claim 29 for non-statutory obviousness-type double patenting over claim 27 1
of Application 10/325,659; and claims 29 and 36 for non-statutory 2
obviousness-type double patenting over claims 47 and 58 of Application 3
10/325,659. Since the Appellants do not appeal these provisional rejections 4
(App. Br. 4), we summarily sustain the provisional rejections. 5
Claims 1, 14, 20, 29, 36 and 38 are independent claims. Claim 1 is 6
illustrative of the claims on appeal: 7
1. A lead comprising: 8
a lead body extending from a proximal end 9
to a distal end and having an intermediate portion; 10
and 11
a first electrode disposed along the 12
intermediate portion of the lead body; 13
wherein the distal end of the lead body 14
integrally includes a pre-formed, biased shape, the 15
pre-formed biased shape being dimensioned such 16
that at least two surfaces of the lead body contact 17
opposing walls of a pulmonary artery when the 18
distal end of the lead is located in the pulmonary 19
artery, such that the pre-formed biased shape is 20
adapted to passively fixate the distal end of the 21
lead body within the pulmonary artery with the 22
first electrode positioned against the ventricular 23
septum or ventricular outflow tract; 24
the lead body having a curved portion and a 25
second electrode disposed along the curved 26
portion, wherein the second electrode is positioned 27
a distance from the first electrode such that the 28
second electrode is within a right atrium when the 29
first electrode is positioned against the ventricular 30
septum or ventricular outflow tract. 31
32
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ISSUES 1
This appeal turns on the following issues: 2
First, with respect to independent claims 1, 14, 20, 29, 36 and 3
38, does Blake disclose a lead body where the distal end of the lead 4
integrally includes a pre-formed biased shape? (App. Br. 12-15 and 5
18; Reply Br. 2). 6
Second, with respect to claim 29, does Blake disclose a lead 7
body having a second electrode on a pre-formed curved portion 8
disposed in the right atrium? (App. Br. 14). 9
Third, with respect to claim 1, does Bornzin disclose a lead 10
body wherein the distal end of the lead body is in the pulmonary 11
artery and the first electrode is positioned against the ventricular 12
septum or ventricular outflow tract? (App. Br. 15, Reply Br. 3). 13
Fourth, with respect to claim 14, does Bornzin disclose two 14
electrodes proximate a ventricular septum or ventricular outflow tract 15
when the distal end of the lead body is in the pulmonary artery? 16
(App. Br. 17, Reply Br. 4). 17
Fifth, with respect to claim 14, does Bornzin disclose a lead 18
body adapted to be passively fixated within the pulmonary artery such 19
that at least two surfaces of the lead body contact opposing walls of 20
the pulmonary artery? (App. Br. 16-17, Reply Br. 4). 21
Sixth, with respect to claims 14 and 20, does Obino disclose 22
two surfaces of the lead body in contact with opposing walls of the 23
pulmonary artery? (App. Br. 16-17). 24
The Appeal Brief includes statements separately addressing dependent 25
claims 2-13, 15-19, 21-28, 30-35, 37 and 39-48. (See App. Br. 12-18). 26
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These statements rely on the arguments provided for independent claims 1, 1
14, 20, 29, 36 and 38. (Id.) In view of the manner in which the Appellants 2
frame their arguments regarding the patentability of the independent claims, 3
the arguments raise no issue independent of the issues raised with respect to 4
the dependent claims. 5
6
FINDINGS OF FACTS 7
The record supports the following findings of fact (“FF”) by a 8
preponderance of the evidence. 9
1. We adopt and incorporate by reference the Examiner’s findings at 10
page 4, lines 6-18 of the Examiner’s Answer, beginning “Blake discloses 11
. . .” through the remainder of the paragraph. 12
2. Blake describes electrodes 43, 44 and 45 on a catheter 25 which 13
are disposed in the right atrium. (Blake, col. 4, ll. 61-65). 14
3. Bornzin describes a lead 30 having a right ventricular outflow tract 15
(RVOT) electrode 50 at the distal tip of lead 30. (Bornzin, col. 6, ll. 12-13.) 16
4. Bornzin describes an electrode 56 placed in the right atrium of the 17
heart. (Bornzin, col. 6, ll. 19-20 and fig. 2). 18
5. Bornzin describes in Figures 7A and 7B that lead 30 has a loop 123 19
to direct the electrode to different positions along the medial wall so as to 20
accommodate different medical conditions. (Bornzin, col. 8, ll. 47-63). 21
6. Obino describes a catheter 14 having tines 102 at the distal end of 22
the catheter 14 that project radially away from the elongated body 32 of the 23
catheter 14. (Obino, col. 5, ll. 51-58). 24
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PRINCIPLES OF LAW 1
During examination of a patent application, pending claims are given 2
their broadest reasonable construction consistent with the specification. In 3
re Prater, 415 F.2d 1393, 1404-05 (CCPA 1969); In re Am. Acad. of Sci. 4
Tech Ctr., 367 F.3d 1359, 1369, (Fed. Cir. 2004). 5
6
ANALYSIS 7
First Issue 8
The Appellants argue that: 9
claim 1 does not recite that the lead per se includes 10
a pre-formed biased shape. Instead, claim 1 recites 11
that: the lead body integrally includes a pre-12
formed, biased shape. Balloon 27 is not an 13
integral part of the lead body 25. The balloon 27 14
of Blake is a discrete, separate member from 15
catheter tube 25, and cannot be construed as being 16
an integral part of a lead body. Again referring 17
Figure 3 of Blake, it is seen that balloon 27 is a 18
discrete, attached member of the lead and is not 19
integral with lead body/catheter tube 25. 20
(Reply Br. 2). 21
The Examiner is correct in finding that Blake’s balloon 27 and lead 22
body 25 are integral in the sense that they function as a unit. The Appellant 23
does not appear to contest that the balloon 27 is attached to the lead body 25. 24
In addition, the Examiner is correct in finding (see Ans. 12-13) that the 25
balloon 27 and the lead body 25 advance as a unit to the correct position 26
within the patient. Fixation of the balloon 27 within the pulmonary artery 27
fixes both the balloon 27 and the lead body 25 in place in the artery. Since 28
the balloon 27 has a pre-formed, biased shape, that is, a pre-formed inflated 29
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shape toward which the balloon 27 is biased by the inflating medium, Blake 1
does disclose a lead body where the distal end of the lead integrally includes 2
a pre-formed biased shape. 3
4
Second Issue 5
The Appellants contend that “Blake does not include a pre-formed 6
curved portion and a second electrode disposed along the pre-formed curved 7
portion, as claimed” in claim 29. (App. Br. 14). 8
The Examiner finds that Blake’s balloon 27 is a pre-formed curved 9
portion and that one or more of the electrodes 43, 44 and 45, which are 10
disposed in the right atrium after implantation, are a second electrode as 11
recited in claim 29. (see Ans. 15; see also FF 1 and 2). Nevertheless, the 12
Examiner does not make a finding that electrodes 43, 44 and 45 are disposed 13
along on a pre-formed curved portion of the lead body 25. (See, e.g., Ans. 6 14
and 15). The Appellants correctly point out that: 15
even if the balloon is considered a pre-formed 16
curved portion, the balloon does not have an 17
electrode disposed along the pre-formed curved 18
portion, as recited in claim 29. Moreover, the 19
balloon of Blake is not configured in any manner 20
to be implanted in the right atrium, where the "pre-21
formed curved portion" and "second electrode" are 22
positioned, as recited in claim 29.” 23
(App. Br. 14). Blake fails to disclose a lead body having a second electrode 24
on a pre-formed curved portion disposed in the right atrium. 25
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Third Issue 1
In regards to claim 1, the Examiner finds Bornzin’s lead 30 is adapted 2
to be placed in the pulmonary artery and includes a RVOT electrode 50. 3
(Ans. 16-17; see also FF 3). The Examiner reasons that lead 30 is “capable 4
of being placed within a pulmonary artery . . . [and] nothing prevents 5
Bornzin’s lead from being placed within a pulmonary artery.” (Ans. 16). 6
The Appellants contend that, 7
even if the Bornzin lead were advanced into the 8
pulmonary artery there would be no electrode 9
positioned against the ventricular septum or 10
ventricular outflow tract, as recited in claim 1. In 11
this case, the tip electrode 50 of Bornzin would be 12
in the pulmonary artery and would not be 13
positioned against the ventricular septum or 14
ventricular outflow tract. 15
16
(Reply Br. 3). More specifically, the electrode 50 is at the tip of the lead 30 17
(FF 4). If the lead 30 is placed in the pulmonary artery, electrode 50 18
logically would be in the pulmonary artery as well. (See FF 3). Thus 19
Bornzin does not disclose a lead body wherein the distal end of the lead 20
body is in the pulmonary artery and the first electrode is positioned against 21
the ventricular septum or ventricular outflow tract. 22
23
Fourth Issue 24
In regards to claim 14, the Appellants contend that “even if the 25
Bornzin lead were advanced into the pulmonary artery there would . . . not 26
be at least two electrodes proximate a ventricular septum or ventricular 27
outflow tract.” (App. Br. 16 and 17; Reply Br. 4). On the other hand, the 28
Examiner reasons that any endocardial electrode constitutes “an electrode 29
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that is proximate a ventricular septum or ventricular outflow tract.” (Ans. 1
18). 2
Bornzin’s lead includes two endocardial electrodes, 50 and 56. (FF 3-3
4). As such, the Examiner reasons that Bornzin’s lead, if advanced into the 4
pulmonary artery, would provide at least two electrodes proximate a 5
ventricular septum or ventricular outflow tract. (Ans. 18). This reasoning is 6
correct. The Appellants do not formally define the term “proximate” in the 7
Specification or persuasively explain how the Specification disclaims a 8
meaning for the term broader than its ordinary meaning. The ordinary 9
meaning of the word “proximate” includes “very near : CLOSE.” 10
MERRIAM-WEBSTER’S COLLEGIATE DICTIONARY (10th ed. 1999). The 11
pulmonary artery itself is proximate, that is, very near, the ventricular 12
septum and the ventricular outflow tract. Once the electrode 50 advances 13
with the distal end of Bornzin’s lead into the pulmonary artery, the electrode 14
is proximate the ventricular septum or the ventricular outflow tract. 15
Meanwhile, as the distal end of Bornzin’s lead advances into the pulmonary 16
artery, the electrode 56 must advance into the ventricle into a position 17
proximate the ventricular outflow tract. 18
19
Fifth Issue 20
In regards to claim 14, the Examiner concludes that the language 21
defining the pre-formed, biased shape of the distal end of the lead body to be 22
“adapted to be passively fixated within a pulmonary artery such that at least 23
two surfaces of the lead body contact opposing walls of the pulmonary 24
artery” is satisfied by a showing that the distal end of the lead is susceptible 25
of passive fixation in the manner recited. (See Ans. 7 and 16). The 26
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Appellants do not appear to contest this interpretation, arguing instead that 1
only the tip of the lead would contact the artery if the distal end of the lead 2
was advanced into the pulmonary artery. (Reply Br. 3). The Appellants 3
further argue that “it is not apparent that the distal end of the Bornzin lead 4
would have ‘at least two surfaces of the lead body contact opposing walls of 5
a pulmonary artery when the distal end of the lead is located in the 6
pulmonary artery[.]’” (Id.) 7
The Examiner finds multiple shaped curves at the distal end of the 8
lead body, including a loop 123 in lead 30. (Ans. 7 and 9; FF 5). These 9
multiple curved shapes, as depicted in Figure 7 of Bornzin, would have 10
adapted the pre-formed, biased shape of the distal end of the lead body to be 11
passively fixated within a pulmonary artery such that at least two surfaces of 12
the lead body contact opposing walls of the pulmonary artery. In addition, 13
as the Examiner correctly reasons: 14
[I]n each of the lead shape configurations of 15
Bornzin, the distal end of the lead would naturally 16
have at least two surfaces of the lead body 17
contacting opposing walls of the pulmonary artery 18
when the distal end of the lead is located in the 19
pulmonary artery. The lead is sized and shaped 20
such that, if placed in the pulmonary artery, the 21
passive fixation explicitly disclosed in the 22
paragraphs cited above by Bornzin would dictate 23
that at least two surfaces of the distal lead end 24
would touch the pulmonary artery. There is 25
nothing in the structure of Bornzin that would 26
prevent use or render the lead unusable if the 27
intended use of the claim were performed. 28
(Ans. 17). 29
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Sixth Issue 1
In regards to claims 14 and 20, the Appellants contend that if Obino’s 2
lead was “advanced to the pulmonary artery [the lead] would not contact 3
opposing sides of the pulmonary artery.” (App. Br. 16). 4
The Examiner reasons that “tines 102, shown in Figure 2 of Obino, 5
. . . touch at least two surfaces of the heart. A lead such as Obino’s, passed 6
through the pulmonary artery, would contact opposing sides of the 7
pulmonary artery.” (Ans. 18). On the other hand, the Appellants point out 8
that “[t]he distal end of the Obino lead is generally straight and it appears the 9
lead would just lie in the pulmonary artery without contacting opposing 10
sides.” (App. Br. 17). If the distal end of catheter 14 were to be placed in 11
the pulmonary artery, it is clear that tines 102 would contact two surfaces of 12
the pulmonary artery. (See Obino, col. 5, ll. 51-58). Nevertheless, the 13
Examiner has not provided reasoning which persuasively explains how the 14
tines 102 could contact opposing sides of the pulmonary artery as required 15
by the language of claims 14 and 20. 16
17
CONCLUSIONS 18
First, with respect to claims 1, 14, 20, 29, 36 and 38, Blake discloses a 19
lead body where the distal end of the lead integrally includes a pre-formed 20
biased shape. We sustain the rejections of claims 1, 7-14, 16-18, 20-28, 36, 21
37, 41-45, 47 and 48 under 35 U.S.C. § 102(b) as being anticipated by 22
Blake; the rejection of claim 38 under § 103(a) as being unpatentable over 23
Blake and Ideker; the rejections of claims 39 and 40 under § 103(a) as being 24
unpatentable over Blake; and the rejection of claim 46 under § 103(a) as 25
being unpatentable over Blake and Bornzin. 26
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Second, with respect to claim 29, Blake does not disclose a lead body 1
having a second electrode on a pre-formed curved portion disposed in the 2
right atrium. We do not sustain the rejections of claims 29-35 under 35 3
U.S.C. § 102(b) as being anticipated by Blake. 4
Third, with respect to claim 1, Bornzin does not disclose a lead body 5
wherein the distal end of the lead body is in the pulmonary artery and the 6
first electrode is positioned against the ventricular septum or ventricular 7
outflow tract. We do not sustain the rejections of claims 1-6 under § 102(b) 8
as being anticipated by Bornzin. 9
Fourth, with respect to claim 14, Bornzin discloses two electrodes 10
proximate a ventricular septum or ventricular outflow tract when the distal 11
end of the lead body is in the pulmonary artery. 12
Fifth, with respect to claim 14, Bornzin discloses a lead body adapted 13
to be passively fixated within the pulmonary artery such that at least two 14
surfaces of the lead body contact opposing walls of the pulmonary artery. 15
We sustain the rejection of claims 14 and 15 under § 102(b) as being 16
anticipated by Bornzin; and of claims 14, 24 and 25 under 35 U.S.C. 17
§ 103(a) as being unpatentable over Bornzin. 18
Sixth, with respect to claims 14 and 20, Obino does not disclose two 19
surfaces of the lead body in contact with opposing walls of the pulmonary 20
artery. We do not sustain the rejection of claims 14, 19, 20 and 26-28 under 21
§ 102(b) as being anticipated by Obino. 22
23
DECISION 24
We AFFIRM the Examiner’s decision finally rejecting claims 1, 7-18, 25
20-28, and 36-48; and provisionally rejecting claims 2-4, 6 and 29. 26
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We REVERSE the Examiner’s decision rejecting claims 5, 19 and 30-1
35. 2
No time period for taking any subsequent action in connection with 3
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. 4
§ 1.136(a)(1) (2009). 5
6
AFFIRMED-IN-PART 7
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Klh 10
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