Ex Parte Iaizzo et al

Patent Trial and Appeal Board

Aug 9, 2017

10876301 (P.T.A.B. Aug. 9, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/876,301 06/24/2004 Paul A. Iaizzo P0008837.02/LG10126 1955
27581 7590
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
EXAMINER
BERHANU, ETSUB D
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
08/11/2017 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):
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PAUL A. IAIZZO and TIMOTHY G. LASKE
Appeal 2016-0007571
Application 10/876,3012
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims 1, 3—14, 16, 17,
28, and 31—36 (Advisory Act. 1). Examiner entered rejections under 35
U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE and enter new grounds of rejection.
1 This Appeal is related to Appeal 2010-010530, Application 10/876,301,
Decision affirming-in-part entered February 24, 2012.
2 Appellants identify the real party in interest as “Medtronic, Inc.” (App. Br.
2).
Appeal 2016-000757
Application 10/876,301
STATEMENT OF THE CASE
Appellants’ disclosure “relates generally to a system and method for
placing implantable medical devices within a body . . (Spec. 12).
Independent claims 1, 14, 28, and 34—36 are representative and reproduced
below:
1. A system, comprising:
a cardiac lead coupleable with an implantable medical
device (IMO) implantable within a living body;
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withdrawn over the deployed lead;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;
a pressure measuring device coupled to the elongated body
to obtain pressure measurements; and
a pressure monitor coupled to the pressure measuring device
to utilize the pressure measurements to estimate the location of
the one or more portions of the elongated body relative to the
living body.
(App. Br. 15 (emphasis added).)
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; and
further including an inflatable member coupled to the
elongated body adapted to compress the inner lumen and grip
the cardiac lead positioned within the lumen.
{Id. at 16—17 (emphasis added).)
2
Appeal 2016-000757
Application 10/876,301
28. A system for positioning a cardiac lead coupleable with an
implantable medical device (IMO) 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;
a pressure measuring device coupled to the elongated body
to obtain pressure measurements; and
a pressure monitor coupled to the pressure measuring
device;
wherein the flow-directed member is an inflatable device
and wherein the inflatable member is adapted to compress the
lead within the lumen to grip the cardiac lead.
{Id. at 17 (emphasis added).)
34. 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
an inflatable member coupled to the elongated body adapted
to compress the inner lumen and grip the cardiac lead
positioned within the lumen.
{Id. at 18 (emphasis added).)
35. A system for positioning a cardiac lead coupleable with an
implantable medical device (IMO) 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;
a pressure measuring device coupled to the elongated body
to obtain pressure measurements; and
3
Appeal 2016-000757
Application 10/876,301
wherein the flow-directed member is inflatable and wherein
the inflatable member is adapted to compress the lead within
the lumen to grip the cardiac lead.
(Id. at 18 (emphasis added).)
36. A system, comprising:
a cardiac lead coupleable with an implantable medical
device (IMO) implantable within a living body;
an elongated body having a lead delivery lumen through
which the lead may be deployed and the elongated body
withdrawn over the deployed lead; and
a flow-directed member coupled to the elongated body;
wherein the flow-directed member is inflatable and
wherein the inflatable member is adapted to compress the lead
within the lumen to grip the cardiac lead.
(Id. at 18—19 (emphasis added).)
The claims stand rejected as follows:
Claims 1,3,4, 6, 9, and 13 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Orth,3 Haynor,4 Miyata,5 and
Brenner.6
Claims 14 and 16 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Orth, Haynor, Miyata, and Kajiwara.7
Claims 28, 32, 35, and 36 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Orth, Bonner,8 Brooks,9 and Brenner.
3 Orth, US 5,423,323, issued June 13, 1995.
4 Haynor et al., US 5,879,297, issued Mar. 9, 1999.
5 Miyata et al., US 5,356,427, issued Oct. 18, 1994.
6 Brenner, US 6,497,681 Bl, issued Dec. 24, 2002.
7 Kajiwara et al., US 5,379,765, issued Jan. 10, 1995.
8 Bonner et al., US 5,902,331, issued May 11, 1999.
9 Brooks et al., US 5,749,370, issued May 12, 1998.
4
Appeal 2016-000757
Application 10/876,301
Claim 34 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth and Kajiwara.
Claim 5 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Orth, Haynor, Miyata, Brenner, and Lesh.10
Claim 7 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Orth, Haynor, Miyata, Brenner, and Glaser.* 11
Claim 8 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Orth, Haynor, Miyata, Brenner, and Zarychta.12
Claims 10-12 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Haynor, Miyata, Brenner, and Shimazu.13
Claim 17 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Haynor, Miyata, Kajiwara, and Lesh.
Claims 28, 32, 35, and 36 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Orth, Kajiwara, and Brenner.
Claim 31 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Kajiwara, Brenner, and Lesh.
Claim 33 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Kajiwara, Brenner, and Glaser.
Claims 14 and 16 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Orth, Haynor, Miyata, Bonner, and
Brooks.
Claim 17 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Haynor, Miyata, Bonner, Brooks, and Lesh.
10 Lesh et al., US 6,650,923 Bl, issued Nov. 18, 2003.
11 Glaser, US 5,353,643, issued Oct. 11, 1994.
12 Zarychta et al., US 6,259,938 Bl, issued July 10, 2001.
13 Shimazu et al., US 5,961,467, issued Oct. 5, 1999.
5
Appeal 2016-000757
Application 10/876,301
Claim 31 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Bonner, Brooks, Brenner, and Lesh.
Claim 33 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Bonner, Brooks, Brenner, and Glaser.
Claim 34 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Bonner, and Brooks.
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion that Orth implicitly discloses a delivery lumen capable of
delivering a pacing or ECG sensing lead?
FACTUAL FINDINGS (FF)
We adopt Examiner’s findings concerning the scope and content of
the prior art (Ans. 2—16), and emphasize the following factual findings:
FF 1. Orth’s Figure 1 is reproduced below:
%. t
6
Appeal 2016-000757
Application 10/876,301
Orth’s
FIG. 1 shows a preferred embodiment of a catheter set 10,
which is preferably disposable. Catheter 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. Catheter 14 may be a standard flow directed
thermal dilution catheter, although the present invention does
not involve using a thermistor or heating band that may or may
not be on the catheter or rapidly injecting cooled or warm
fluids. In this respect, catheter 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. Catheter set 10 may include
the ability to measure wedge pressure, even though measuring
wedge pressure might not be used in the present invention.
Catheter set 14 could include pacing or ECG sensing leads,
fiber optic pulse oximetry channels or additional infusion
lumens.
(Orth 6:34—56; see Ans. 2.)
FF 2. Brenner
relates generally to medical devices, and more particularly to
devices and methods of use for removing an introducer sheath
or other elongated tubular member which has been used to
place a cardiac pacemaker (pacing) lead or other elongated
intravascular instrument at a desired position within the body of
a patient and without disturbing that pacing lead or instrument.
(Brenner 1:10—16; see Ans. 4.)
FF 3. Brenner discloses that “[i]n current electrophysiology practice, the
physician typically uses both hands to grasp and peel or split an introducer
sheath to remove it from a cardiac pacing lead that has been positioned
7
Appeal 2016-000757
Application 10/876,301
through the sheath to a desired location within the patient’s body” (Brenner
1:30-34 (emphasis added); see Ans. 4).
ANALYSIS
Each of Appellants’ independent claims requires, inter alia, an
elongated body having a: (1) lead delivery lumen through which the lead
may be deployed and the elongated body withdrawn over the deployed lead
(see App. Br. 15, 17, and 18—19) or (2) proximal end and a distal end, and an
inner lumen to receive the cardiac lead (see id. at 16—17 and 18).
Each rejection presented by Examiner relies on Orth to disclose “a
lead delivery lumen 22/44 through which [pacing or ECG sensing] lead[s]
may be deployed” (see Ans. 2; see generally FF 1). In this regard, Examiner
finds that Orth’s “Figure 1 clearly shows lumen 22 through which a pacing
lead can be delivered” (Ans. 16) and, thus, “[a] delivery lumen 22 capable of
delivering a pacing lead is implicitly disclosed in Orth” (id. at 18).
It is clear that Examiner’s rationale accounted for the common sense
or knowledge of a person of ordinary skill in this art to reach a conclusion
that Orth “implicitly disclosed” a “delivery lumen 22 capable of delivering a
pacing lead” (id.). Stated differently, Examiner relied on common sense or
knowledge to infer that a structural limitation required by Appellants’
claimed invention was necessarily present in Orth (Ans. 16 and 18). Our
reviewing court has held
that while an analysis of obviousness always depends on
evidence that supports the required Graham factual findings, it
also may include recourse to logic, judgment, and common
sense available to the person of ordinary skill that do not
necessarily require explication in any reference or expert
opinion.
8
Appeal 2016-000757
Application 10/876,301
Perfect Web Technologies, Inc., vlnfoUSA, Inc., 587 F.3d 1324, 1329 (Fed.
Cir. 2009).
Appellants, however, contest Examiner’s inference. Specifically,
Appellants correctly contend that Orth does not expressly disclose that
pacing or ECG sensing leads, which may be included with Orth’s catheter
set, are deployed through a lumen of Orth’s catheter set (see App. Br. 8). In
this regard, Appellants contend that “[tjhere is no reason to believe that” a
person of ordinary skill in this art would have understood Orth to disclose or
suggest placing a lead for pacing in the lumen of one of Orth’s catheters (id.;
see also id. at 9—10).
Although this
Board has subject matter expertise, [] the Board cannot accept
general conclusions about what is “basic knowledge” or
“common sense” as a replacement for documentary evidence
for core factual findings in a determination of patentability. . . .
To hold otherwise would be to embark down a slippery slope
which would permit the examining process to deviate from the
well-established and time-honored requirement that rejections
be supported by evidence. It would also ultimately “render the
process of appellate review for substantial evidence on the
record a meaningless exercise.”
K/S Himpp v. Hear-Wear Technologies LLC, 751 F.3d 1362, 1366 (Fed. Cir.
2014) (quoting In re Zurko, 258 F.3d 1385—86 (Fed. Cir. 2001)); see
generally, Manual of Patent Examining Procedure § 2144.03(C) (“If
applicant adequately traverses the examiner’s assertion of official notice, the
examiner must provide documentary evidence in the next Office action if the
rejection is to be maintained”).
In response to Appellants’ contentions, Examiner directed attention to
column 1, lines 10—16 and 30—34 of Brenner to disclose the delivery of
9
Appeal 2016-000757
Application 10/876,301
pacing leads through the lumen of a catheter to a desired location within the
body (see Ans. 19; FF 2—3). Examiner makes clear, however, that Brenner
is not relied upon as evidence to support a finding that a person of ordinary
skill in this art would have found Orth’s catheter set to include a lumen for
the deployment of pacing or ECG sensing leads (see Ans. 20; see also Reply
Br. 3 (“there is no question [] that Brenner is not presently being used to
imply that Orth discloses a lumen through which a lead can be delivered or
that Brenner somehow teaches [the addition of] such a lumen to Orth”)).
“Where a reference is relied on to support a rejection, whether or not
in a ‘minor capacity,’ there would appear to be no excuse for not positively
including the reference in the statement of the rejection.” In re Hoch, 428
F.2d 1341, 1342 n.3 (CCPA 1970). Appellants contend, in both their Brief
and Reply Brief, that, absent Brenner’s disclosure of a lumen through which
pacing leads may be passed, Examiner failed to establish an evidentiary
basis on this record to support a conclusion that a person of ordinary skill in
this art would have understood that pacing or ECG sensing leads could have
been delivered through the lumen of a catheter within the scope of Orth’s
catheter set (see generally App. Br. 10—11; Reply Br. 3—5).
Thus, when this record is viewed as a whole, we find that the
rejections presented by Examiner for our review fail to support a conclusion
that Orth implicitly discloses a delivery lumen capable of delivering a pacing
or ECG sensing lead.
NEW GROUNDS OF REJECTION
To resolve the evidentiary deficiency and controversy on this record,
we reverse the rejections of record and restate each of Examiner’s rejections
10
Appeal 2016-000757
Application 10/876,301
as new grounds of rejection in order to add and/or additionally rely upon
Brenner, as an evidentiary disclosure, to support Examiner’s finding that a
person of ordinary skill in this art would have understood Orth to disclose “a
lead delivery lumen 22/44 through which [pacing or ECG sensing] lead[s]
may be deployed” (see Ans. 2; FF 1—3). Brenner clearly demonstrates that it
was known in the art to position pacing leads through a lumen of a sheath, or
catheter, to a desired location within the patient’s body (FF 3). Therefore,
we find no error in Examiner’s rationale that, at the time of Appellants’
claimed invention, a person of ordinary skill in this art would have found it
prima facie obvious to place the pacing or ECG sensing leads of Orth’s
catheter set through lumen 22 of Orth’s catheter set as evidenced by
Brenner. Thus, absent evidence to the contrary and notwithstanding
Appellants’ contention to the contrary, as Examiner explained, Orth
necessarily discloses a “delivery lumen 22 capable of delivering a pacing
lead” (see Ans. 16 and 18).
But for the foregoing modification to Examiner’s rejections, we find
no error in, and incorporate by reference, the factual findings, reasoning, and
conclusion of obviousness presented in Examiner’s Answer, which are
otherwise not contested by Appellants (see id. at 2—16). See In re Pearson,
494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot
take the place of evidence.”). Arguments not made are waived.
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion that Orth implicitly discloses a delivery lumen capable
11
Appeal 2016-000757
Application 10/876,301
of delivering a pacing or ECG sensing lead. Therefore, we reverse the
rejections of record.
12
Appeal 2016-000757
Application 10/876,301
For the reasons set forth above, we enter the following new grounds
of rejection:
Claims 1, 3, 4, 6, 9, and 13 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Orth, Haynor, Miyata, and Brenner.
Claims 14 and 16 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Orth, Haynor, Miyata, Kajiwara, and
Brenner.
Claims 28, 32, 35, and 36 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Orth, Bonner, Brooks, and Brenner.
Claim 34 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Kajiwara, and Brenner.
Claim 5 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Orth, Haynor, Miyata, Brenner, and Lesh.
Claim 7 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Orth, Haynor, Miyata, Brenner, and Glaser.
Claim 8 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Orth, Haynor, Miyata, Brenner, and Zarychta.
Claims 10-12 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Haynor, Miyata, Brenner, and Shimazu.
Claim 17 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Haynor, Miyata, Kajiwara, Lesh, and Brenner.
Claims 28, 32, 35, and 36 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Orth, Kajiwara, and Brenner.
Claim 31 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Kajiwara, Brenner, and Lesh.
13
Appeal 2016-000757
Application 10/876,301
Claim 33 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Kajiwara, Brenner, and Glaser.
Claims 14 and 16 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Orth, Haynor, Miyata, Bonner,
Brooks, and Brenner.
Claim 17 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Haynor, Miyata, Bonner, Brooks, Lesh, and
Brenner.
Claim 31 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Bonner, Brooks, Brenner, and Lesh.
Claim 33 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Bonner, Brooks, Brenner, and Glaser.
Claim 34 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Orth, Bonner, Brooks, and Brenner.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.”
14
Appeal 2016-000757
Application 10/876,301
37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new ground of rejection
to avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. . . .
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
REVERSED: 37 C.F.R, $ 41.50(b)
15