Ex Parte Wang et al

Patent Trial and Appeal Board

Jun 8, 2016

12650956 (P.T.A.B. Jun. 8, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/650,956 12/31/2009
55962 7590
Wiley Rein LLP
Patent Administration
1776 K Street, NW
Washington, DC 20006
06/10/2016
FIRST NAMED INVENTOR
Huisun Wang
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.
OB-140000US/82410-0373 8223
EXAMINER
GOOD, SAMANTHA M
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
06/10/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
ptodocket@wileyrein.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HUISUN WANG, DALEE. JUST, and HARRY A. PURYEAR
Appeal2014-005254
Application 12/650,956
Technology Center 3700
Before JENNIFER D. BAHR, GEORGE R. HOSKINS, and
LEE L. STEPINA, Administrative Patent Judges.
HOSKINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Huisun Wang et al. ("Appellants") 1 appeal under 35 U.S.C. § 134
from the Examiner's final decision rejecting claims 1-17 in this application.
The Board has jurisdiction over the appeal under 35 U.S.C. § 6(b).
We REVERSE.
1 The Appeal Brief identifies St. Jude Medical, Atrial Fibrillation Division,
Inc., as the real party in interest. Appeal Br. 2.
Appeal2014-005254
Application 12/650,956
CLAIMED SUBJECT MATTER
Claims 1 and 11 are independent. Claim 1 illustrates the subject
matter on appeal, and it recites:
1. An irrigated catheter system, comprising:
a catheter body having at least one proximal irrigation
passageway and at least one distal irrigation passageway;
a first fluid delivery tube extending through the catheter
body and defining a first irrigation lumen, wherein the first
irrigation lumen is in fluid communication with the at least one
proximal irrigation passageway and fluidly isolated from the at
least one distal irrigation passageway; and
a second fluid delivery tube extending through the catheter
body and defining a second irrigation lumen, wherein the second
irrigation lumen is in fluid communication with the at least one
distal irrigation passageway and fluidly isolated from the at least
one proximal irrigation passageway.
Appeal Br. 15 (Claims App.).
Claims 11-17 stand rejected under 35 U.S.C. § 112, second
paragraph, as indefinite.
Claims 1-5 and 7 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Don Michael (US 2003/0109915 Al, pub. June 12, 2003).
Claims 1-7, 11-13, 15, and 17 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Edwards (US 6,569,159 Bl, iss. May 27, 2003).
Claims 8, 9, and 14 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Edwards and Coen (US 2005/0177151 Al, pub. Aug. 11,
2005).
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Application 12/650,956
Claim 10 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Edwards, Coen, and Wang (US 2007/0270791 Al, pub. Nov. 22,
2007).
Claim 16 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Edwards.
ANALYSIS
A. Indefiniteness-Claims 11-17
The Examiner determines independent claim 11 is indefinite in
reciting first, second, third, and fourth subsets of a "plurality" of irrigation
passageways. Final Act. 2. The Examiner determines the recited plurality
"only requires at least two irrigation passageways, therefore the recitations
of 'first, second, third and fourth subsets' are vague and indefinite." Id. The
Examiner reads claim 11 as reciting "four separate subsets" of passageways.
Id. at 11-12 (emphasis added). According to the Examiner, the claimed
plurality "could be only two,'' in which case "it is not clear how there could
be four subsets since only three subsets are possible." Ans. 2.
Appellants agree with the Examiner that the recited plurality means
"at least two," but assert there is no indefiniteness. Appeal Br. 8. According
to Appellants, the Examiner's claim interpretation "reads the term 'unique'
into the claim," and the Examiner erroneously concludes "the claimed
subsets cannot overlap." Id. at 8-9; Reply Br. 4. Appellants assert: "Two
irrigation passageways can form any number of subsets (including four),
provided there is no prohibition on identical subsets." Reply Br. 4.
Appellants further point to dependent claim 12, reciting the first subset "is
co-extensive with" the fourth subset, and the second subset "is co-extensive
with" the third subset. Appeal Br. 9.
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Application 12/650,956
We conclude claim 11 clearly defines each of the four subsets of
passageways. That is, the first subset is in fluid communication with the
first delivery lumen, the second subset is fluidly isolated from the first
delivery lumen, the third subset is in fluid communication with the second
delivery lumen, and the fourth subset is fluidly isolated from the second
delivery lumen. Br. 17 (Claims App.). Moreover, we agree with Appellants
that the Examiner errs in construing claim 11 as requiring four separate
subsets of passageways. That construction is inconsistent with dependent
claim 12, which indicates the first and fourth subsets may be "co-extensive,"
and the second and third subsets may be "co-extensive." Id. In this way,
claim 12 encompasses Appellants' Figure 5, for example.
Thus, we do not sustain the Examiner's rejection of claim 11 as
indefinite. The indefiniteness rejection of dependent claims 12-17 is
premised solely on the indefiniteness of their common parent claim 11, 2 so
we likewise do not sustain the indefiniteness rejection of those claims.
B. Anticipation by Don Michael-Claims 1-5 and 7
In rejecting claim 1 as anticipated by Don Michael, the Examiner
finds the claimed first and second irrigation lumens correspond, respectively,
to Don Michael's proximal balloon inflation lumen 26 and distal balloon
inflation lumen 28. Final Act. 3.
Appellants argue the Examiner errs in construing the claimed
"irrigation passageways" to encompass balloon inflation lumens. Appeal
Br. 9-11. According to Appellants, their Specification "makes clear that the
2 The indefiniteness rejection directed to the subject matter added by
claims 14 and 15 has been withdrawn. Adv. Act. (July 12, 2013) Item #5.
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Application 12/650,956
claimed 'irrigation passageway' is an orifice that permits the flow of irrigant
out of the catheter and into the [patient's] body." Id. at 10 (citing Spec. i-fi-13,
4, 52). In Appellants' view, the Examiner's finding that Don Michael meets
the above-recited limitation is incorrect, because Don Michael's balloon
inflation lumens 26 and 28 "preclude outflow of an irrigant." Id.
Appellants assert "fluid cannot escape through the distal-most portions of
lumens 26 and 28," and "if fluid could so escape, balloons 40 and 42 would
not inflate." Id.
The Examiner responds: "[T]he features upon which applicant relies
(i.e., an orifice that permits the flow of irrigant out of the catheter and into
the body) are not recited in the rejected claim(s)." Final Act. 12. The
Examiner further "disagrees that it is inherent in the definition of irrigation
passageway that the orifice leads out of the catheter and into the body."
Ans. 2. The Examiner states "[d]ictionary.com defines 'irrigation' as 'the
flushing or washing out of anything with water or other liquid'," and finds
Don Michael's passageways 26 and 28 "can be used to flush or wash out an
internal portion of the medical device without leading out of the body." Id.
at 2-3.
We determine the Examiner errs in finding Don Michael's balloon
inflation lumens 26 and 28 are "irrigation passageways" as claimed.
Lumens 26 and 28 are fluid passageways, but a preponderance of the
evidence does not support the Examiner's finding that a person of ordinary
skill in the art would understand them to be irrigation passageways. Don
Michael discloses the fluid carried by passageways 26 and 28 inflates,
respectively, balloons 40 and 42. Don Michaels, Fig. 1, i-fi-f 10, 17-18. A
person of ordinary skill in the art would not understand balloon inflation to
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Application 12/650,956
be irrigation of the balloons, or of anything else. Further, the tluidic
connection between passageways 26 and 28 and balloons 40 and 42 that
allows for inflation of the balloons would interfere with the fluid being used
for irrigation.
Thus, we do not sustain the Examiner's rejection of claim 1, and of
claims 2-5 and 7 depending therefrom, as anticipated by Don Michael.
C. Anticipation by Edwards-Claims 1-7, 11-13, 15, and 17
Claims 1-7
In rejecting claim 1 as anticipated by Edwards, the Examiner appears
to find the claimed "catheter body" corresponds to the entirety of Edwards' s
ablation apparatus 10. Final Act. 4--5, 13; Ans. 3--4; Edwards, 6:61-7:3.
However, there is at least one more specific reference to Edwards's delivery
catheter 12 as corresponding to the claimed catheter body. Final Act. 13.
The Examiner finds the alleged catheter body 10 or 12 has "proximal
irrigation passageway (proximal 26 of one of 2or and "distal irrigation
passageway (distal 26 of one of 20)." Id. at 4. That is, according to the
Examiner, Edwards's alleged catheter body 10 or 12 is disclosed as "having"
(claim 1) the fluid delivery passageways formed within electrodes 20, and
leading to fluid distribution ports 26 at the distal ends of electrodes 20. Id. at
13; see Edwards, 9:43-51, Figs. 8 and 14. Further according to the
Examiner: "The catheter body ( 10) of Edwards is the entire structure of the
instrument which therefore meets the claim recitation that the fluidly
isolated irrigation passageways are part of the same body since they are all
contained within catheter body 10." Ans. 3.
Appellants argue claim 1 requires "the fluidly isolated irrigation
passageways are part of the same [catheter/ body." Appeal Br. 11.
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According to Appellants, the Examiner errs in finding Edwards discloses
such a body. Id. at 11-12; Reply Br. 4--5. Appellants assert the Examiner's
finding that Edwards' s entire ablation apparatus 10 is a "body" as recited in
claim 1 exceeds the bounds of reasonableness. Reply Br. 5.
We are persuaded of Examiner error in finding Edwards' s entire
ablation apparatus 10 is a "catheter body." In particular, apparatus 10
includes many different structures, performing different functions within
apparatus 10. These components include delivery catheter 12 for delivering
electrodes 20 to a tissue for ablation, and electrodes 20 which are deployed
out of distal end 16 of catheter 12 to ablate the tissue. Edwards, 6:62-7:20,
Fig. 1. The components of apparatus 10 further include removable
handle 18 for manipulating catheter 12, and electrical components for
operating electrodes 20. Id. at 6:66----67, 11:28-30, Fig. 1 (showing wires for
connecting to electrode control equipment).
The Examiner's finding that these disparate structures together form a
"catheter body" as recited in claim 1 is based on an unreasonably broad
claim interpretation in light of Appellants' Specification. The Specification
illustratively describes catheter body 12 having irrigation passageways 36
and 38. Spec. i-fi-146 and 50, Figs. 4--5. This disclosure does not support the
Examiner's construction of "body" to include an entire assembly of
components including a delivery catheter, electrodes and associated
electrical components, and a removable handle. Therefore, to the extent the
anticipation rejection rests upon the finding that the entire ablation
assembly 10 of Edwards is a "body," the Examiner errs.
As already noted, the Examiner at least once specifically refers to
Edwards's delivery catheter 12 as the claimed catheter body. Final Act. 13.
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Application 12/650,956
Catheter 12 houses electrodes 20 within its hollow interior, so that
electrodes 20 may be deployed out of distal end 16 of catheter 12 to ablate
tissue. Edwards, 6:62-7:20, Figs. 1 and 14. However, catheter 12 is not
thereby "having" the irrigation passageways formed within electrodes 20, as
claimed. Our reviewing court admonishes us that:
[U]nder the broadest reasonable interpretation, the Board's
construction "cannot be divorced from the specification and the
record evidence," In re NTP, Inc., 654 F.3d 1279, 1288 (Fed. Cir.
2011 ), and "must be consistent with the one that those skilled in
the art would reach," In re Cortright, 165 F.3d 1353, 1358 (Fed.
Cir. 1999). A construction that is "unreasonably broad" and
which does not "reasonably reflect the plain language and
disclosure" will not pass muster.
Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015)
(quoting In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010)).
Appellants' Specification indicates a catheter body is "having" irrigation
passageways when the body itself forms the irrigation passageways. Spec.
i-fi-1 46 and 50, Figs. 4--5. Edwards' s irrigation passageways are formed by
electrodes 20, not by catheter 12. Edwards, 9:43-51, Figs. 8 and 14.
Therefore, the Examiner errs in finding catheter 12 is "having" irrigation
passageways, as claimed.
Thus, we do not sustain the Examiner's rejection of claim 1, and of
claims 2-7 depending therefrom, as anticipated by Edwards.
Claims 11-13, 15, and 17
In rejecting claim 11 as anticipated by Edwards, the Examiner finds
the claimed "catheter shaft ... including a plurality of irrigation
passageways" corresponds to the entirety of Edwards' s ablation
apparatus 10. Final Act. 6. Similarly to claim 1, discussed above, the
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Application 12/650,956
Examiner finds the irrigation passageways of claim 11 correspond to the
passageways in Edwards's electrodes 20. Id.
For similar reasons as discussed above, we determine the Examiner
errs in finding the entire assembly 10 of components in Edwards is a
"catheter shaft" as recited in claim 11. Further, we interpret a catheter shaft
"including" irrigation passageways in claim 11, similar to a catheter body
"having" irrigation passageways in claim 1, as requiring the catheter shaft to
form the irrigation passageways. Therefore, while Edwards' s delivery
catheter 12 may be a catheter shaft, it does not "includ[e]" irrigation
passageways as required by claim 11. Thus, for the same reasons discussed
in connection with claim 1, we do not sustain the Examiner's rejection of
claim 11, and of claims 12, 13, 15, and 17 depending therefrom, as
anticipated by Edwards.
D. Obviousness based at least partly on Edwards-
Claims 8-10, 14, and 16
The Examiner's rejections of claims 8, 9, and 14 as unpatentable over
Edwards and Coen, of claim 10 as unpatentable over Edwards, Coen, and
Wang, and of claim 16 as unpatentable over Edwards, do not cure the
deficiencies of the Edwards disclosure noted above in connection with
claims 1 and 11. See Final Act. 9-11. Thus, we do not sustain these
rejections.
DECISION
The Examiner's decision rejecting claims 1-17 is reversed.
REVERSED
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