Ex Parte Gerber

Patent Trial and Appeal Board

Oct 29, 2012

11591447 (P.T.A.B. Oct. 29, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte MARTIN T. GERBER
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Appeal 2011-008920
Application 11/591,447
Technology Center 3700
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Before LORA M. GREEN, FRANCISCO C. PRATS, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
implantable elongated member comprising a balloon fixation element
composed at lease in part of a biocompatible degradable material, a system
comprising the elongated member, and a method of inserting the elongated
member into a patient. The Patent Examiner rejected the claims as
anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse and enter a New Ground of rejection, pursuant to 37 C.F.R.
§ 41.50(b).

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Application 11/591,447

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STATEMENT OF THE CASE
Claims 1-28 are on appeal. Independent claims 1, 14, and 21 are
representative and read as follows:
1. An implantable elongated member comprising:
an elongated body configured to be coupled to a medical device to
deliver a therapy from the medical device to a target therapy delivery site in
a patient;
an inflation lumen; and
a balloon fixation element coupled to the elongated body and
composed at least in part of a biocompatible degradable material, the balloon
fixation element being configured to receive a fluid via the inflation lumen
to expand from a first state to a second state.

14. A system comprising:
a medical device; and
an elongated member comprising:
an implantable elongated body configured to be coupled to a
medical device to deliver a therapy from the medical device to a target
therapy delivery site in a patient;
an inflation lumen; and
a balloon fixation element coupled to the elongated body and
composed at least in part of a biocompatible degradable material, the
balloon fixation element being configured to receive a fluid via the
inflation lumen to expand from a first state to a second state.

21. A method comprising:
inserting an elongated member into the patient, wherein the elongated
member includes a balloon fixation element mounted to the elongated
member and composed at least in part of a biocompatible degradable
material;
advancing the elongated member to a target therapy delivery site to
deploy the balloon fixation element into tissue of the patient proximate to
the target therapy delivery site; and
delivering a fluid to the balloon fixation element via an inflation
lumen to inflate the balloon fixation element from a first state to a second
state, wherein in the second state, the balloon fixation element engages with
tissue at the target therapy delivery site.
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The Examiner rejected the claims as follows:
• claims 1-5, 10-12, 14-16, 18, 19, 21-23, 26-28 under 35 U.S.C.
§102(b) as anticipated by Karicherla;1
• claims 6, 7, 9, 17, 24, and 25 under 35 U.S.C. § 103(a) as
unpatentable over Karicherla;
• claims 8, 13, and 20 under 35 U.S.C. § 103(a) as unpatentable over
Karicherla and Kucharczyk.2

ANTICIPATION/OBVIOUSNESS
For both the anticipation and obviousness rejections, the Examiner’s
position is that Karicherla disclosed an intracardiac lead system with an
implantable elongated member comprising a balloon attachment structure or
fixation element composed of a biocompatible degradable material. (See,
e.g., Ans. 3-4.)
Appellant contends that “Karicherla does not disclose or even suggest
constructing the balloons 2002, 2004 from a biodegradable material. (App.
Br. 9.) Appellant asserts that Karicherla’s disclosure that an attachment
structure may be constructed of a biodegradable material that degrades over
time referred to an embodiment other than one with balloon-like structures.
(Id.) According to Appellant, Karicherla “failed to make any connection
between the biodegradable material and the balloons 2002, 2004.” (Id.)

1 Patent No. US 7,448,999 B1 issued to Erica Franklin et al., Nov. 11, 2008.
2 Patent No. US 6,463,317 B1 issued to John Kucharczyk et al., Oct. 8,
2002.

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Further, Appellant asserts that a skilled artisan would have recognized that it
was “undesirable to form balloons from a biodegradable material when the
balloons are filled with a fluid and implanted within the patient’s heart
because … use of such a material could lead to the release of the fluid into
the heart or the patient’s bloodstream upon the breakdown of the degradable
material.” (Id. at 9.) Moreover, Appellant assert that such a fluid release
would render the lead 2000 inoperable for its intended purpose, as the fluid
used to inflate the balloons is “essential to the lead function.” (Id.)
Issue
Did Karicherla explicitly or inherently disclose that its balloon-like
structures may be composed at least in part of a biocompatible degradable
material?
Principles of Law
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). A rejection under
35 U.S.C. § 102 is proper only when the claimed subject matter is identically
disclosed or described in the prior art, without any need for picking,
choosing and combining various disclosures. In re Arkley, 455 F.2d 586,
587 (CCPA 1972).
Findings of Fact
1. Karicherla disclosed an intra-cardiac lead system comprising a lead
that is coupled to a medical device capable of providing pacing therapy to
the heart chamber, wherein the lead includes an attachment structure that
secures the lead to one or both of the septal walls of a patient’s heart.
(Karicherla Abstract; col. 2, ll. 10-11; col. 6, ll. 25-67.)
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2. Karicherla disclosed that “a variety of different attachment structures
may be used in accordance with the teachings herein.” (Id. at col. 17, ll. 61-
62.)
3. Karicherla disclosed that “[a]n attachment structure may be
constructed of a variety of materials including, for example, biocompatible
materials such as silicone and polyurethane.” (Id. at col. 18, ll. 3-5.)
4. Karicherla disclosed that “[i]n some embodiments the attachment
structure may be constructed of a biodegradable material that degrades over
time. This type of material may be used, for example, in a case where it may
be necessarily to remove the lead sometime in the future.” (Id. at col. 18, ll.
6-10.)
5. Karicherla disclosed that “[i]n some embodiments the attachment
structure includes one or more inflatable membranes that expand outwardly
from the lead. For example, the lead may include a pair of balloon-like
structures,” which Karicherla “referred to as ‘balloons’ for convenience….”
(Id. at col. 2, ll. 40-43; col. 25, ll. 26-29.)
6. Karicherla disclosed that “the balloons may be formed in various
shapes and constructed of various materials. For example, the balloons may
be constructed using biocompatible material such as silicone rubber or
polyurethane.” (Id. at col. 28, ll. 2-6.)
Analysis
When describing its attachment structures in general, Karicherla
distinguishes material that is biocompatible and material that is more
specifically biodegradable. (Compare FF-3 with FF-4.) Subsequently, when
expressly describing the construction of balloon attachment structures,
Karicherla only disclosed the material as being biocompatible and not
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specifically as biodegradable also. (FF-6.) Thus, we agree with Appellant
that Karicherla did not expressly teach that the balloons were composed at
least in part of a biocompatible degradable material. Moreover, we agree
with Appellant that Karicherla did not disclose that its balloons are
necessarily composed of a biodegradable material. Rather, the Examiner’s
anticipation rejection involved picking, choosing and combining various
disclosures to satisfy this element. See Arkley, 455 F.2d at 587.
Accordingly, we reverse the anticipation rejection. Because the
anticipation rejection includes the only independent claims on appeal, claims
1, 14, and 21, the obviousness rejections of dependent claims 6-9, 13, 17, 20,
and 24-25 must also be reversed for the same reasons.

NEW GROUND OF REJECTION
Independent claims 1, 14, and 21 are newly rejected under 35 U.S.C.
§ 103(a) as unpatentable over Karicherla. (37 C.F.R. § 41.50(b)).
Principle of Law
Picking, choosing and combining various disclosures not directly
related to each other by the teachings of the prior art may be entirely proper
in the making of a §103 rejection. Arkley, 455 F.2d at 587.
Additional Finding of Fact
7. The Specification states that “[a]t least a portion of the balloon
fixation element is composed of a biocompatible degradable material, such
that once the elongated member is implanted in a patient, at least the portion
of the balloon fixation element may degrade in vivo over time.” (Spec.
[0007].)
Analysis
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Karicherla taught an intra-cardiac lead system having an implantable
elongated member and a method of using the elongate member in a patient
to deliver therapy to a target site. (FF-1.) Karicherla taught that the
elongated member comprised an elongated body configured to be coupled to
a medical device, i.e., electrical stimulator, to deliver a therapy from the
medical device to a target delivery site in a patient (FF- 1); an inflation
lumen (FF-5); and a balloon fixation element coupled to the elongated body
and configured to receive a fluid via the inflation lumen to expand from a
first state to a second state (FF-5,6 ). Karicherla disclosed that the balloon
fixation element may be composed of a biocompatible material. (FF-6.)
Karicherla did not expressly disclose that the balloon may be
composed of a biodegradable material. However, Karicherla generally
disclosed that “[i]n some embodiments the attachment structure may be
constructed of a biodegradable material that degrades over time. This type of
material may be used, for example, in a case where it may be necessary to
remove the lead sometime in the future.” (FF-4.) Karicherla also
specifically described the balloon as an attachment structure. (FF-5.) Thus,
we find that Karicherla would have reasonably suggested to a person of
ordinary skill in the art at the time the invention was made to have
constructed its balloons using, at least in part, a biocompatible material that
was also biodegradable. To the extent that this suggestion is the result of
picking, choosing and combining various disclosures not directly related to
each other by the teachings of the prior art, such is proper in the making of
an obviousness rejection. See Arkley, 455 F.2d at 587. Moreover, we note
that Karicherla described a biodegradable material in a similar manner as the
instant Specification, i.e., material that “degrades over time.” (See FF-4, 7.)
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The amount or duration of time over which the material degrades is not
specified, or otherwise limited in either Karicherla or the instant
Specification. Thus, a skilled artisan may select a biodegradable material
that requires a degradation time that would extend beyond the length of time
that the balloon fixation element would be used in and removed from a
patient, such that any potential harmful effects of the degradation in vivo
may be avoided.
Accordingly, we conclude that the inventions of independent claims 1,
14, and 21 would have been obvious to a person of ordinary skill in the art at
the time the invention was made over Karicherla.
We leave the analysis of whether the pending dependent claims are
subject to this rejection based on Karicherla alone or in combination with
Kucharczyk, or other available prior art, to the Examiner.

SUMMARY
We reverse the Examiner’s anticipation and obviousness rejections.
A new ground of rejection under 35 U.S.C. § 103(a) as unpatentable
over Karicherla is ENTERED for independent claims 1, 14, and 21.

37 C.F.R. § 41.50(b)
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37
CFR § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.”
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37 C.F.R. § 41.50(b) also provides that the Appellant, 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
proceeding 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.…

REVERSED; 37 C.F.R. § 41.50(b)

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