Ex Parte Honeck et al

Patent Trial and Appeal Board

Sep 25, 2013

11764886 (P.T.A.B. Sep. 25, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JORDON D. HONECK, ANDREW J. RIES,
and KAREL F.A.A. SMITS
__________

Appeal 2011-010512
Application 11/764,886
Technology Center 3700
__________

Before TONI R. SCHEINER, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 from the final rejection of
claims directed to an implantable medical device system. The claims have
been rejected on the grounds of indefiniteness, anticipation and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).

1 Appellants identify the Real Party-In-Interest as Medtronic, Inc. (App.
Br. 2.)
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BACKGROUND
ICDs deliver relatively high-energy cardioversion and/or
defibrillation shocks to a patient's heart when a malignant
tachyarrhythmia . . . is detected. ICDs typically operate in
conjunction with one or more leads carrying a coil electrode(s)
for delivering high-voltage shocking pulses. In addition to a
coil electrode, the lead may carry pace/sense electrodes for
sensing intracardiac electrogram signals (EGM) or
subcutaneous ECG signals and for delivering low-voltage
pacing pulses.
Numerous ICD systems are commercially available and
may be used in conjunction with a variety of lead systems.
Industry standards have been developed to prevent the insertion
and electrical coupling of a high voltage lead terminal to a low
voltage ICD connector module terminal and vice versa.
Improper connection of electrical leads to the ICD may cause
device damage, inappropriate or failed operation of the ICD,
and undue risk to the patient.
(Spec. ¶¶ 2, 3.)
The Specification discloses an implantable medical device system
designed to prevent improper connection of a high voltage lead terminal to a
low voltage ICD connector module. The system comprises, in relevant part,
an electrical lead “with a single, in-line bipolar connector assembly having a
high-voltage connector coupled to [a] high-voltage coil electrode . . . and a
low-voltage connector coupled to [a] low-voltage pace/sense electrode” (id.
at ¶ 21) configured to correspond to “a connector module having a bipolar
in-line connector bore including a high-voltage contact adapted to be
electrically coupled to the lead assembly high-voltage connector and a low-
voltage contact adapted to be electrically coupled to the lead assembly low-
voltage connector” (id.).
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STATEMENT OF THE CASE
Claims 1-24 are pending. Appellants indicate that an amendment
filed October 27, 2010 “attempted to cancel rejected claims 6-11 . . . but [the
amendment] was refused entry” (App. Br. 2). Accordingly, Appellants
indicate that “the rejections of claims 1-5, 12-15, 23 and 24 are hereby
appealed” (id.), while claims 6-11 “are not appealed” (id.).2
Claims 1 and 24 are representative of the subject matter on appeal and
are reproduced below:
1. An implantable medical device system, comprising:
a medical electrical lead having a lead body extending from a
proximal end to a distal end, the proximal end having an in-line connector
assembly, the in-line connector assembly comprising
a connector pin having an outer diameter corresponding to a
DF-1 standard,
a first sealing member proximate and distal to the connector pin
and having an outer diameter corresponding to an IS-1 standard,
a connector ring proximate and distal to the first sealing
member and having an outer diameter corresponding to the IS-1
standard, and
a second sealing member proximate and distal to the connector
ring and having an outer diameter corresponding to the DF-1 standard;
a device comprising a housing and a connector module coupled to the
housing, the connector module comprising an in-line connector bore
configured for receiving the in-line connector assembly, the in-line
connector bore comprising
a lead pin receptacle sized to receive the connector pin, and
a first bore portion sized to form a fluid-resistant interface with
the second sealing ring.

24. An implantable medical device lead, comprising:
a lead body extending from a proximal end to a distal end, and

2 We note that no rejection of claims 6-11 has been carried forward from the
Final Rejection.
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an in-line connector assembly extending from the lead body proximal
end comprising
a distal portion having a distal sealing member having a first
outer diameter;
an intermediate portion having a second sealing member having
a second outer diameter smaller than the first outer diameter, and
a connector pin extending from the intermediate portion, the
connector pin having an outer diameter corresponding to a DF-1
standard.
The Examiner relies on the following evidence:
Williams et al. US 6,038,472 Mar. 14, 2000
Thompson et al. US 6,675,049 B2 Jan. 6, 2004
Ries et al. US 2004/0064164 A1 Apr. 1, 2004
International Organization for Standardization (ISO) publication ISO
11318:2002(E).
The claims stand rejected as follows:
Claims 1-5, 12-15, 23, and 24 under 35 U.S.C. § 112, second
paragraph, as indefinite (Ans. 3-4).
Claim 24 under 35 U.S.C. § 102(b) as anticipated by ISO
11318:2002(E) (Ans. 4-5).
Claims 1, 3, 23, and 24 under 35 U.S.C. § 103(a) as unpatentable over
Williams and Ries (Ans. 6-9).
Claims 2, 4, 5, and 12-15 under 35 U.S.C. § 103(a) as unpatentable
over Williams, Ries, and Thompson (Ans. 10-13).
We affirm the anticipation rejection, and reverse the obviousness and
indefiniteness rejections.
FINDINGS OF FACT
The following findings of fact are supported by a preponderance of
the evidence of record:
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1. Standard ISO 11318:1993(E) of the International Organization
for Standards specifies the dimensions and performance requirements for a
unipolar connector assembly, DF-1, used in connecting implantable
defibrillator leads to defibrillator generators. Specifically, the standard
specifies the dimensions of the various components of the connector
assembly, e.g., the connector pin, sealing rings, and sealing zone (Spec. ¶¶
30, 31, 35).
2. Standard ISO 11318:2002(E) of the International Organization
for Standards also specifies the dimensions for components of the unipolar
connector assembly, DF-1.
3. Figure 1 of ISO 11318:2002(E) is reproduced below:

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Figure 1 of ISO 11318:2002(E) specifies the dimensions of the DF-1
lead connector, including the outer diameters of the sealing mechanism zone
1, the seal zone 2, and the connector pin. According to the key, the seal
zone 2 is “[f]or optional seal mechanism in connector cavity.” That is, for
interaction with sealing mechanisms in the cavity or receptacle the DF-1
connector is seated in.
4. Standard ISO 5841-3:1992(E) of the International Organization
for Standards specifies the dimensions and performance requirements for a
connector assembly, IS-1, used in connecting implantable pacemaker leads
to implantable pacemaker generators (Spec. ¶¶ 32, 33).
5. According to the Specification, in order of arrangement from
the proximal end of the lead toward the distal end, the connector pin having
an outer diameter corresponding to a DF-1 standard has an outer diameter of
0.049 inches (Spec. ¶ 31); the first set of sealing rings having an outer
diameter corresponding to an IS-1 standard have an outer diameter of 0.125
inches (id. at ¶ 32); the connector ring having an outer diameter
corresponding to an IS-1 standard has an outer diameter of 0.105 inches (id.
at ¶ 33); and the second set of sealing rings having an outer diameter
corresponding to the DF-1 standard has an outer diameter of 0.150 inches
(id. at ¶ 35).
6. The Specification refers to sealing rings, rather than sealing
members, the term used in the claims.
7. The claimed connector assembly incorporates components with
outer diameters from connector assemblies for two different types of leads;
the connector pin and second sealing member (one type of sealing member
disclosed in the Specification is sealing rings) correspond to components of
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the DF-1 connector assembly for a high-voltage defibrillation lead, while the
first sealing member (cf. sealing rings) and the connector ring correspond to
components of the IS-1 connector for a low-voltage pacemaker lead.
8. Williams discloses a cardioversion/defibrillation and pace/sense
lead. Figure 27 of Williams is reproduced below:

Figure 27 illustrates a side, plan view of a defibrillation lead, with “a
connector assembly 500 at its proximal end provided with a connector ring
502 and a connector pin 504. Sealing rings 506 and 508 are provided to seal
the lead within the connector block of the associated implantable
defibrillator” (Williams, col. 18, ll. 35-40). No dimensions are specified for
connector pin 504, connector ring 502, or sealing rings 506, and 508.
“A defibrillation coil electrode 512 is visible located along the distal
portion of the lead, and a [pace/sense] helical electrode 514 is shown located
at the distal most extremity of the lead” (id. at col. 18, ll. 44-47; see also col.
6, ll. 56-60). “Electrode 514 is coupled to connector pin 504” and “[c]oil
electrode 512 is . . . coupled to connector ring 502” (id. at col. 18, ll. 47-53).
In other words, the low-voltage helical electrode 514 is connected to the
connector pin 504, and the high-voltage coil electrode 512 is connected to
the connector ring 502.
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9. Ries discloses “quadrapolar connector ports in . . . ICDs, and
configuring the ports so that quadrapolar leads of differing conductor
configurations will properly function therein” (Ries ¶ 1).
10. Ries teaches that:
Leads may be unipolar, in which case they are
constructed with a single conductor wire, typically coiled
around a central axis and encased in a sleeve of insulation. In
addition, leads may have multiple conductors, where each
conductor is separately insulated from each other . . . Examples
of such include bipolar, tripolar, and quadrapolar leads. . . . IS-1
and DF-1 connectors generally have two and one conductor
wires, respectively.
(Ries ¶ 6.)
In addition, Ries teaches:
By definition, leads are considered to be high voltage (HV) if
they contain any high voltage electrodes, otherwise, they are
considered to be low voltage (LV). . . . While HV electrodes are
designed to fight fibrillation and organized tachycardia
episodes, LV electrodes are designed to pace or sense
arrhythmias. A DF-1 connector is configured for high voltage,
whereas a IS-1 connector is configured for low voltage. Thus,
these two connector types, even though they may have some
similarities in electrode layout, are not interchangeable. One
would obviously not want to place high voltage on a conductor
designed for low voltage. Such an event may cause an unsafe
environment for the patient. Thus, there are safeguards in place
that guard against this scenario from happening. For instance, if
one attempts to insert an IS-1 connector (LV) into a DF-1
connector port on an ICD header, the IS-1 connector (LV),
because of the size of its lead connector, would be physically
locked out of the DF-1 connector port and thus, not insert to full
depth, thereby, not allowing the IS-1 lead to function.
(Id. at ¶ 7.)

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INDEFINITENESS
The Examiner finds that claims 1-5, 12-15, 23, and 24 are indefinite
because “the terms ‘IS-1’ and ‘DF-1’ in the claims . . . appear[] to refer to
International Organization for Standardization documents that are
continuously updated” (Ans. 4). According to the Examiner, “ISO
11318:2002 revises ISO 11318:1993 for DF-1 standards” (id.), thus, “[i]t is
unclear if the scope of the claim is directed to an IS-1 or DF-1 standard
document of the past, present or future” (id.).
Appellants contend, among other things, that “ISO 11318:2002
republishes the DF-1 standard previously published in publication ISO
11318:1993” (App. Br. 8). Appellants contend “[a] lead connector assembly
connector meeting ISO 11318:1993 will meet ISO 11318:2002” (id.), and
“[t]his is necessary to insure backward compatibility” (id. at 8-9). According
to Appellants, “[t]ypically, when substantive changes to a standard are made,
the changed standard is designated as a new standard, e.g. DF-4 or IS-4” (id.
at 9), and “[a]s new standards are added, they are given new designations,
because they are different standards” (id.). Appellants argue “[w]hile it is
theoretically possible that someday the ISO will issue a DF-1 standard that
differs substantially from the present standard without changing the name
(e.g., DF-2 or the like), such a possibility does not render references to IS-1,
DF-1 or other standards as vague under Section 112” (id.).
Appellants’ argument is persuasive. The Examiner has not
established that the dimensions specified in the claims as corresponding to
the standard for a DF-1 lead connector, or the dimensions corresponding to
an IS-1 lead connector have changed, or are likely to change. Nor has the
Examiner established that a person of ordinary skill in the art, aware of the
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filing date of this application, and thus, the standard in place at that time,
would be uncertain of the meaning of these terms. The rejection of the
claims as indefinite is reversed.
ANTICIPATION
Claim 24 stands rejected as anticipated by the DF-1 connector of
Standard ISO 11318:2002(E).
The Examiner finds, in relevant part, that ISO 11318:2002(E)
discloses a medical electrical lead with “a distal portion having a first outer
diameter and a distal sealing member, an intermediate portion having a
second sealing member with an outer diameter smaller than the first outer
diameter and a connector pin extending from the intermediate portion having
an outer diameter corresponding to a DF-1 standard” (Ans. 4-5).
Specifically, the Examiner finds that sealing mechanism zone 1 and seal
zone 2 (designated Section A and Section B, respectively, by the Examiner)
satisfy the claim’s requirement for “the second sealing member having an
outer diameter smaller than the outer diameter of the first sealing member”
(id. at 5).
Appellants contend that “[t]he sealing members of the illustrated DF-1
connector all have the same outer diameter” (App. Br. 15), and seal zone 2,
designated Section B by the Examiner, “is not a sealing member and
according to the publication cited by the Examiner does not function as a
sealing member” (id. at 16). Appellants contend that according to the key
below the illustration, the seal zone “may optionally engage along its length
with a sealing member in the connector receptacle, but such sealing member
is not part of the lead connector assembly” (id.).
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While we agree with Appellants that Figure 1 of ISO 11318:2002(E)
depicts different structures in the sealing mechanism zone and the seal zone
of the DF-1 connector assembly, the reference indicates that both structures
are involved in sealing. Claim 24 requires “a distal sealing member having a
first outer diameter” and “a second sealing member having a second outer
diameter smaller than the first outer diameter,” but nothing in the
Specification limits the “sealing member” to a specific structure, e.g., a
sealing ring. In fact, the term “sealing member” does not appear in the
Specification at all (FF6). That being the case, the Examiner’s finding that
the term “sealing member” is broad enough to encompass various structures
involved in sealing is reasonable (Ans. 15), and we agree with the Examiner
that the term reads on the structures depicted in the sealing mechanism zone
and the seal zone of the DF-1 connector.3
Accordingly, the rejection of claim 24 as anticipated by Standard ISO
11318:2002(E) is affirmed.
OBVIOUSNESS
There are two obviousness rejections, but both are premised, in whole
or in part, on the teachings of Williams alone, or on Williams and Ries, so
we will discuss them together.

3 During examination, the USPTO must interpret terms in a claim using “the
broadest reasonable meaning of the words in their ordinary usage as they
would be understood by one of ordinary skill in the art, taking into account
whatever enlightenment by way of definitions or otherwise that may be
afforded by the written description contained in the applicant’s
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).

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The Examiner finds that Williams discloses an implantable medical
device system comprising a connector assembly that corresponds to the
connector assembly of claims 1, 3, 23, and 24 in all respects, except that
Williams does not specify the “connector pin having an outer diameter
corresponding to a DF-1 standard, the first sealing member having an outer
diameter corresponding to an IS-1 standard, the connector ring having an
outer diameter corresponding to the IS-1 standard, and the second sealing
member having an outer diameter corresponding to the DF-1 standard” (Ans.
6-7).
However, the Examiner concludes that:
It would have been an obvious matter of design choice to
modify the pin connector to have a diameter of 0.049 inches
and the ring connector to have a diameter of 0.105 inches, since
this modification is a mere change in size of a component,
which is generally recognized as being within the level of
ordinary skill in the art. . . . Similarly, it would have been
obvious that the sealing members could also be sized so that
[the] first sealing member would have a diameter of 0.125
inches and the second sealing member would have a diameter
of 0.150 inches.
(Id. at 7.)
In addition, the Examiner notes that Appellants have indicated “that
not all connector assemblies conform to an IS-1 or DF-1 standard” (id.),
which, the Examiner reasons, “suggests this type of modification is not
unknown in the art of lead design” (id.).
Appellants contend that “[n]o reason is given by the Examiner for
changing the dimension of the Williams connector pin” (App. Br. 22). In
addition, Appellants contend that “[e]ven if [it] is assumed that all other
dimensions of the connector assembly of Williams are set equal to the IS-1
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standard, setting the connector pin diameter to a DF-1 size would be
counter-indicated” because “[t]he resultant connector of the modified
Williams lead could be inserted into a standard DF-1 receptacle with the
connector pin coupled to the high voltage output of the associated pulse
generator” (id.).
Appellants’ arguments are persuasive. We cannot agree with the
Examiner that combining components associated with high voltage leads and
components associated with low voltage lead in the same connector is
merely “an obvious matter of design choice” (Ans. 7), given the functional
consequences of such a change. Moreover, a rejection on the ground of
obviousness must include “articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.” In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006). “[T]his analysis should be made
explicit” and it “can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does.” KSR Int’l Co., v.
Teleflex Inc., 550 U.S. 398, 418 (2007). Here, the Examiner has not
adequately explained why one of ordinary skill in the art would have had
reason to select these particular components, and arrange them in the
particular manner required by the claims.
Alternatively, the Examiner concludes that “it would have been
obvious to switch the positions” of Williams’ pace/sensing helical electrode
514 and defibrillation coil electrode 512 “such that the defibrillation coil
electrode 512 is coupled to the connector pin 504 and the helical electrode
514 is coupled to the connector ring 502” (Ans. 8), because “lacking any
criticality,” “mere reversal of parts . . . is an obvious expedient” (id.). The
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Examiner further concludes that it would have been obvious “to modify the
connector pin 504 to have an outer diameter corresponding to a DF-1
standard, . . . the connector ring 502 to have an outer diameter corresponding
to a IS-1 standard” (id. at 9), and “the first sealing member 506 [to] have an
outer diameter corresponding to the IS-1 standard similar to that of the
connector ring 502” (id.), in part, because Ries “teaches that defibrillation
electrodes are considered high voltage electrodes and that pacing or sensing
electrodes are considered low voltage, and that a DF-1 connector is
configured for high voltage and a IS-1 connector is configured for low
voltage” (id. at 8).
Nevertheless, we agree with Appellants that this alternative aspect of
the Examiner’s rejection is without merit, and would not, in any case, result
in the claimed structure, for the reasons set forth on pages 17-20 of the
Appeal Brief.
Accordingly, both rejections of the claims on the ground of
obviousness are reversed.
SUMMARY
The rejection of claims 1-5, 12-15, 23, and 24 as indefinite is
reversed.
The rejection of claim 24 as anticipated by ISO 11318:2002(E) is
affirmed.
The rejection of claims 1, 3, 23, and 24 as unpatentable over Williams
and Ries is reversed.
The rejection of claims 2, 4, 5, and 12-15 as unpatentable over
Williams, Ries, and Thompson is reversed.
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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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