Ex Parte Iaizzo et al

Board of Patent Appeals and Interferences

Feb 22, 2012

10876301 (B.P.A.I. Feb. 22, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PAUL A. IAIZZO and TIMOTHY G. LASKE
__________

Appeal 2010-010530
Application 10/876,301
Technology Center 3700
__________

Before DONALD E. ADAMS, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a system
for positioning a cardiac lead. The Examiner has rejected the claims as
anticipated and/or obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
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STATEMENT OF THE CASE
Claims 1-17 and 25-27 are on appeal (App. Br. 2).
1
We will focus on
independent claims 1, 14, and 25, which read as follows:
1. A system for positioning a cardiac lead coupleable with an
implantable medical device (IMD) implantable within a living body, the
system comprising:
an elongated body having a lead delivery lumen through which the
lead may be deployed and the elongated body withdrawn over the deployed
lead;
a flow-directed member coupled to the elongated body; and
a pressure measuring device coupled to the elongated body to obtain
pressure measurements so that a location of one or more portions of the
elongated body is determinable based upon the pressure measurements and
the lead is deployable at the location through the elongated body.
14. A sheath for use in implanting a cardiac lead within a living body,
comprising:
an elongated body having a proximal end and a distal end, and an
inner lumen to receive the cardiac lead;
a flow-directed member coupled to the distal end;
a pressure measuring device coupled to the elongated body to measure
pressure at one or more predetermined points adjacent the elongated body
when the elongated body is located within the living body; and
a pressure monitor coupled to the pressure measuring device to
estimate a position of at least a portion of the elongated body relative to the
living body.
25. A system for positioning a cardiac lead coupleable with an
implantable medical device (IMD) implantable within a living body, the
system comprising:
a lead delivery means for delivering a cardiac lead to a desired
delivery position and for being withdrawn after the cardiac lead is delivered;

1
Claims 18-24 are also pending but have been withdrawn from
consideration (App. Br. 2).
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a flow-directed means coupled to the lead delivery means for directing
the lead delivery means to the desired delivery position utilizing a flow of
blood within the living body; and
a pressure measuring means coupled to the lead delivery means for
obtaining pressure measurements such that a location of the lead delivery
means is determinable based upon the pressure measurements,
wherein the lead delivery means is further configured for delivering
the cardiac lead at the desired delivery position based on a corresponding
pressure measurement obtained by the pressure measuring means.
Claims 1-4, 7-9, 13, and 14 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Eggers et al. (US 5,928,155, Jul. 27, 1999) (Ans. 3).
Claims 1, 4, 6, 9, 13, and 25 stand rejected under 35 U.S.C. § 102(b)
as anticipated by Millar (US 4,901,731, Feb. 20, 1990) (Ans. 4).
Claims 1, 3, 4, 6, 9, 13, and 25 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Orth (US 5,423,323, Jun. 13, 1995) (Ans. 5).
Claims 5 and 17 stand rejected under 35 U.S.C. § 103(a) as obvious
over Eggers in view of Lesh et al. (US 6,650,923 B1, Nov. 18, 2003)
(Ans. 5).
Claims 5 and 17 stand rejected under 35 U.S.C. § 103(a) as obvious
over Orth in view of Lesh (Ans. 5).
Claim 6 stands rejected under 35 U.S.C. § 103(a) as obvious over
Eggers in view of Nassi et al. (US 5,078,148, Jan. 7, 1992) (Ans. 6).
Claim 6 stands rejected under 35 U.S.C. § 103(a) as obvious over
Orth in view of Nassi (Ans. 6).
Claims 10-12 stand rejected under 35 U.S.C. § 103(a) as obvious over
Eggers in view of Shimazu et al. (US 5,961,467, Oct. 5, 1999) (Ans. 6).
Claims 15, 16, and 27 stand rejected under 35 U.S.C. § 103(a) as
obvious over Millar in view of Burns (US 5,919,162, Jul. 6, 1999) (Ans. 7).
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Claim 26 stands rejected under 35 U.S.C. § 103(a) as obvious over
Orth in view of Nassi (Ans. 7).
PRINCIPLES OF LAW
“[I]t is elementary that the mere recitation of a newly
discovered function or property, inherently possessed by things
in the prior art, does not cause a claim drawn to those things to
distinguish over the prior art. Additionally, where the Patent
Office has reason to believe that a functional limitation asserted
to be critical for establishing novelty in the claimed subject
matter may, in fact, be an inherent characteristic of the prior art,
it possesses the authority to require the applicant to prove that
the subject matter shown to be in the prior art does not possess
the characteristic relied on.”
In re Best, 562 F.2d 1252, 1254-55 (CCPA 1977) (quoting In re Swinehart,
439 F.2d 210, 212-13 (CCPA 1971)). “Whether the rejection is based on
„inherency‟ under 35 U.S.C. § 102, on „prima facie obviousness‟ under 35
U.S.C. § 103, jointly or alternatively, the burden of proof is the same.” Id. at
1255.
EGGERS
The Examiner finds:
Eggers shows a catheter 60 having an elongated body, a flow
directing member, balloon 64, and a distal pressure port, which
is a pressure measuring device that is able to determine the
location of the catheter based on pressure measurements. The
catheter has open lumen 222 extending therethrough. This
lumen is a “lead delivery” lumen, in that a lead can be inserted
through the lumen and then the catheter retracted to leave the
lead in place. The examiner notes that the lead is not part of the
claim, so the reference need only have a lumen capable of
delivering a lead.
(Ans. 3-4.)
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Findings of Fact
1. Eggers discloses an apparatus “for determining the cardiac
output (CO) of the cardiovascular system of the body of a patient” (Eggers,
col. 5, ll. 44-46).
2. In particular, Eggers discloses device 60, which is “„flow-
directed‟, movement into position being achieved as a consequence of blood
flow by virtue of the partially inflated balloon 64” (id. at col. 11, ll. 11-14).
3. Eggers also discloses that “the proper positioning of the tip and
measurement region 62 is confirmed, for example, by the pulmonary blood
pressure waveforms developed by utilization of an open-ended fluid filled
channel or lumen extending through catheter 60” (id. at col. 11, ll. 14-18).
4. In addition, Eggers discloses that “channel or lumen 222
extends through the catheter 60 and carries a saline solution for purposes of
transmitting blood pressure witnessed at the tip 66” (id. at col. 20, ll. 4-6).
Analysis
The Examiner relies on channel or lumen 222 for being both the
lumen and the pressure measuring device of claims 1 and 14, stating that,
using the lumen, “the lead could be implanted and pressure measurement
briefly interrupted” (Ans. 3 & 9). However, we interpret claims 1 and 14 to
require both a lumen and a pressure measuring device. Because the
Examiner has not shown that Eggers teaches a system having both of these
elements, we reverse the anticipation rejection over Eggers of claims 1 and
14 and of claims 2-4, 7-9, and 13, which depend from claim 1.
In addition, the Examiner has not explained how Lesh, Nassi, or
Shimazu overcomes this deficiency. Therefore, we also reverse the
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obviousness rejections of claims 5 and 17 over Eggers in view of Lesh, of
claim 6 over Eggers in view of Nassi, and of claims 10-12 over Eggers in
view of Shimazu.
MILLAR
The Examiner finds:
Millar shows a catheter having a pressure sensor 46, connected
to a monitor with processing electronics, a flow directed
member, inflatable balloon 52, and a lumen through which a
guidewire is inserted 62. The examiner notes that the guidewire
passage is capable of having a pressure lead passing
therethrough to be deployed and have the catheter withdrawn,
leaving the lead in place.
(Ans. 4.)
“With respect to claim 25, the examiner notes that a means plus
function clause is based on equivalent structure. While not designed for the
same purpose, it is the examiner‟s position that the structure of Millar is at
least equivalent and therefore meets the means plus function clause.” (Id.)
Findings of Fact
5. The Specification discloses that the “flow-directed member
may be an inflatable member such as a balloon” (Spec. ¶ [0012]).
6. The Specification also discloses that the flow-directed member
“is deployed after the IMD distal portion is introduced into the right atrium
of a heart. The flow of blood may be allowed to carry the distal portion
through the tricuspid valve, into the ventricle, and even further through the
pulmonary valve and into the pulmonary artery if desired.” (Id. at ¶ [0013].)
7. Millar discloses “an apparatus 10 for sensing the fluid pressure
differential between spaced locations” (Millar, col. 4, ll. 14-16).
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8. In particular, Millar discloses “a coronary angioplasty type of
catheter [that] includes an elongated catheter body 12 receivable in a fluid-
filled biological vessel, . . . and sensor mechanism 16 and dilation
mechanism 18 coupled to the distal end of the catheter body 12” (id. at
col. 4, ll. 16-22).
9. Millar discloses that the sensor mechanism 16 includes a
transducer 34, which includes a semiconductor member 40, which includes a
weakened area that acts as a diaphragm 46 (id. at col. 4, ll. 27-48).
10. Millar also discloses that the dilation mechanism 18 includes
dilation balloon 52 (id. at col. 4, ll. 64-66).
11. In addition, Millar discloses that “an elongated tubular structure
defines passage 62 extending the length of the catheter of the apparatus 10
for shiftably receiving a steerable guidewire” (id. at col. 5, ll. 14-17).
12. Millar also discloses that apparatus 10 “allows for continuous
monitoring of pressure differential, helping safe cannulation of coronary
arteries and prompt recognition of ischemia precipitated by the introduction
of the contrast media or drugs, or inappropriate location of the nose 22” (id.
at col. 6, ll. 42-47).
Analysis
Millar discloses an apparatus having an elongated body having a
lumen 62, a balloon 52, and a pressure measuring device 16 comprising a
diaphragm 46 (Findings of Fact (FF) 7-11). We conclude that the Examiner
has set forth a prima facie case that this apparatus can achieve the functional
recitations of claims 1 and 25.
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Appellants argue, however, that Millar‟s balloon 52 “is not a flow-
directed member that is carried by the flow of blood” (App. Br. 13). We are
not persuaded.
While the Examiner has not pointed to any teaching in Millar
indicating that its balloon can be used as a flow-directed member,
Appellants‟ attorney argument does not persuade us that it could not be used
in this way. Although it may be true that Millar‟s balloon would not be
carried by the flow of blood if inflated at the region of a lesion, as described
in Millar, Appellants have not explained why this balloon could not act as a
flow-directed member if inflated at a different location, such as at the
location indicated in the Specification (FF 6).
Appellants also argue that, “[b]ecause the pressure gradient
measurement of diaphragm 46 varies with the degree of stenosis, not
location, it can produce different readings at the same location or similar
readings at different locations. Thus, location is not determinable based on
the pressure gradient measurements of diaphragm 46 of Millar.” (App.
Br. 11-12.) We are not persuaded.
Claim 1 recites a pressure measuring device “to obtain pressure
measurements so that a location of one or more portions of the elongated
body is determinable based upon the pressure measurements.” Similarly,
claim 25 recites a pressure measuring means “for obtaining pressure
measurements such that a location of the lead delivery means is
determinable based upon the pressure measurements.” However, Millar
discloses that its apparatus “allows for continuous monitoring of pressure
differential, helping safe cannulation of coronary arteries and prompt
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recognition of . . . inappropriate location of the nose” (FF 12). Thus, we
agree with the Examiner that the “differential between the two pressure
locations can be used to determine the location of the distal port, as when the
gradient changes, the user knows that the location has changed” (Ans. 10).
Appellants have not adequately explained why the language of claims 1 and
25 requires a greater degree of precision.
In addition, Appellants argue that “there is no corresponding structure
disclosed within Millar „731 that performs the function of „delivering the
cardiac lead at the desired delivery position based on a corresponding
pressure measurement obtained by the pressure measuring means‟” (App.
Br. 12 (emphasis omitted)). We are not persuaded.
The Examiner relies on lumen 62 for being the lead delivery means
(Ans. 4). Appellants have not explained why its configuration cannot be
used for delivering a cardiac lead at a desired delivery position based on a
pressure measurement obtained by the pressure measuring means. In
particular, Appellants have not pointed to any additional structural feature
beyond a lumen required to achieve this function (see Supp. App. Br.
2
4).
We conclude that the Examiner has set forth a prima facie case that
Millar anticipates claims 1 and 25, which Appellants have not rebutted. We
therefore affirm the anticipation rejection over Millar of claims 1 and 25.
Claims 4, 6, 9, and 13 have not been argued separately and therefore fall
with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

2
Response to Notification of Non-Compliant Appeal Brief & Revised
Summary of the Claimed Subject Matter filed November 5, 2009.
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With regard to claims 15, 16, and 27, the Examiner additionally relies
on Burns for teaching “that it is known to provide an inflation means to
compress a guidewire lumen and grip the guidewire” (Ans. 7). Appellants
traverse the rejection of these claims based on the dependency of claims 15
and 16 on claim 14 and the dependency of claim 27 on claim 25 (App.
Br. 22).
With regard to claim 27, we are not persuaded by Appellants‟
argument that Millar does not anticipate claim 25 for the reasons discussed
above. For the same reasons, we are not persuaded by Appellants‟ argument
the Millar and Burns do not suggest the system of claim 27. We therefore
affirm the obviousness rejection of claim 27 over Millar in view of Burns.
However, the Examiner has withdrawn the rejection of claim 14 as
anticipated by Millar (Ans. 11). In addition, the Examiner has not explained
how Burns overcomes the deficiencies in Millar with respect to claim 14.
Thus, we conclude that the Examiner has not set forth a prima facie case that
Millar and Burns suggest claims 15 and 16. We therefore reverse the
obviousness rejection of claims 15 and 16 over Millar in view of Burns.
ORTH
The Examiner finds: “Orth shows a catheter including lead delivery
means, i.e. lumen 22[,] . . . a flow-directed means, balloon 20 or 30, a
pressure measuring means, lumen 44, opening 18, and sensor 56, wherein
the lead delivery means, i.e. the lumen can deliver the lead to the desired
location, based on the pressure measurement” (Ans. 5).
“The examiner notes that a means plus function clause is based on
equivalent structure. While not designed for the same purpose, it is the
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examiner‟s position that the structure of Orth is at least equivalent and
therefore meets the means plus function clause.” (Id.)
Findings of Fact
13. The Specification discloses:
Periodically throughout the procedure, pressure measurements
may be obtained by transducer 32 or another pressure
measuring device. The measured pressure signals may be used
by pressure monitor 30 to estimate a location of a portion of the
catheter within the patient‟s body. This is possible because
intravascular pressure varies by location within the heart as well
as within the associated vascular system.
(Spec. ¶ [0049].)
14. Orth discloses that “[c]atheter set 10 includes a catheter 14
having a distal orifice 18 and a flotation balloon 20, used to drag catheter 14
to the desired location, for example, the pulmonary artery” (Orth, col. 6,
ll. 35-38).
15. Orth also discloses:
[C]atheter set 10 may include more components than are
necessary for the invention (including components not shown in
FIG. 1), but which may be convenient or desirable for some
other purpose. For example, an additional lumen 22 may be
desirable for monitoring the central venous pressure, injecting
drugs, or performing other procedures through an optional
proximal orifice 28 which are not part of the present invention.
(Id. at col. 6, ll. 43-51.)
16. In addition, Orth discloses that “[b]lood pressure may be
measured by standard techniques, such as, for example, a pressure
transducer 56, which is connected to distal orifice 18 through tube 44 and a
distal lumen or connector 46” (id. at col. 7, ll. 20-24).
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Analysis
Orth discloses an apparatus having an elongated body having a
lumen 22, a flotation balloon 20, and a pressure transducer 56 (FF 14-16).
We conclude that the Examiner has set forth a prima facie case that this
apparatus can achieve the functional recitations of claims 1 and 25.
Appellants argue, however, that “[t]here is no teaching or suggestion
in Orth „323 to use pressure measurements taken by its pressure transducer
sensor 56 to identify a precise location of a catheter” (App. Br. 15). We are
not persuaded.
Orth‟s device determines blood pressure (FF 16). As noted in the
Specification, “intravascular pressure varies by location within the heart as
well as within the associated vascular system” (FF 13). As a result, the
“measured pressure signals may be used . . . to estimate a location of a
portion of the catheter within the patient‟s body” (id.). Thus, regardless of
whether Orth teaches or suggests using its pressure measurements to identify
a precise location of a catheter, we conclude that the evidence supports the
Examiner‟s conclusion that Orth discloses a pressure measuring device that
obtains pressure measurements that are capable of being used to determine
the location of one or more portions of the elongated body.
Appellants also argue that Orth “fails to discloses the function of
delivering a cardiac lead to a desired position that corresponds to a pressure
measurement” (App. Br. 15). We are not persuaded.
First, we agree with the Examiner that the language of each of
claims 1 and 25 does not require a cardiac lead and is instead directed to a
system that is capable of positioning a cardiac lead (Ans. 3-4 & 10). In
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addition, Appellants have not adequately explained why Orth‟s lumen 22 is
not capable of deploying a cardiac lead at a location determined by the
pressure measuring device.
We conclude that the Examiner has set forth a prima facie case that
Orth anticipates claims 1 and 25, which Appellants have not rebutted. We
therefore affirm the anticipation rejection over Orth of claims 1 and 25.
Claims 3, 4, 6, 9, and 13 have not been argued separately and therefore fall
with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
With regard to claims 5 and 17, the Examiner additionally relies on
Lesh for disclosing “a cardiac catheter that uses a pull wire to position the
distal tip” (Ans. 5). Claims 5 and 17 depend from claims 2 and 14,
respectively. The Examiner has withdrawn the rejection of claims 2 and 14
as anticipated by Orth (Ans. 12). In addition, the Examiner has not
explained how Lesh overcomes the deficiencies in Orth with respect to
claims 2 and 14. Thus, we conclude that the Examiner has not set forth a
prima facie case that Orth and Lesh suggest claims 5 and 17. We therefore
reverse the obviousness rejection of claims 5 and 17 over Orth in view of
Lesh.
With regard to claims 6 and 26, the Examiner additionally relies on
Nassi for disclosing “a catheter for making similar measurements as [Orth],
which includes a stiffening member to facilitate introduction of the device
into the body” (Ans. 6 & 7). Appellants traverse these rejections based on
the dependency of claims 6 and 26 on claims 1 and 25, respectively (App.
Br. 21-22 & Reply Br. 14-15). However, we are not persuaded by
Appellants‟ arguments that Orth does not anticipate claims 1 and 25 for the
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reasons discussed above. For the same reasons, we are not persuaded by
Appellants‟ arguments that Orth and Nassi do not suggest the systems of
claims 6 and 26. We therefore affirm the rejections of claims 6 and 26 over
Orth in view of Nassi.
SUMMARY
We affirm the anticipation rejection of claims 1, 4, 6, 9, 13, and 25
over Millar; the anticipation rejection of claims 1, 3, 4, 6, 9, 13, and 25 over
Orth; the obviousness rejections of claims 6 and 26 over Orth in view of
Nassi; and the obviousness rejection of claim 27 over Millar in view of
Burns. However, we reverse the anticipation rejection of claims 1-4, 7-9,
13, and 14 over Eggers; the obviousness rejections of claims 5 and 17 over
Eggers in view of Lesh and over Orth in view of Lesh; the obviousness
rejection of claim 6 over Eggers in view of Nassi; the obviousness rejection
of claims 10-12 over Eggers in view of Shimazu; and the obviousness
rejection of claims 15 and 16 over Millar in view of Burns. Thus, claims 2,
5, 7, 8, 10-12, and 14-17 are no longer subject to a rejection.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED-IN-PART

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