Ex Parte Krishnan et al

Board of Patent Appeals and Interferences

Feb 3, 2012

10731421 (B.P.A.I. Feb. 3, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MOHAN KRISHNAN,
ERIC HAMMILL, and REBECCA ARON
__________

Appeal 2010-009092
Application 10/731,421
Technology Center 3700
__________

Before LORA M. GREEN, JEFFREY N. FREDMAN, and
ERICA A. FRANKLIN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1, 5, 7, and 9-18.1 We have jurisdiction
under 35 U.S.C. § 6(b).

1 Claims 2-4, 8, 19, and 20 are also pending, but stand withdrawn from
consideration (App. Br. 4).
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Application 10/731,421

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STATEMENT OF THE CASE
Claim 1 is representative of the claims on appeal, and reads as
follows:
1. A lead comprising:
a lead body extending from a proximal end to a distal end; and
a ring electrode coupled to the lead body;
wherein the lead body and the ring electrode each have an outer surface
adapted to passively prevent formation of clots on the outer surfaces,
wherein the outer surface of the lead body is adapted such that a layer of
blood cells is formed on the outer surface when exposed to a bloodstream,
and wherein the outer surface of the ring electrode includes a textured
coating including titanium microspheres.

The following grounds of rejection are before us for review:
I. Claims 1, 5, 7, and 9-18 stand rejected under 35 U.S.C. § 103(a) as
being rendered obvious by the combination of Thorén2 and
Helland3 (Ans. 3).
II. Claims 1, 5, 7, and 9-18 stand rejected under 35 U.S.C. § 103(a) as
being rendered obvious by the combination of Thorén, Helland,
and MacGregor4 (Ans. 6).
We vacate Rejection I and affirm Rejection II. But as our reasoning
differs from that of the Examiner, we designate our affirmance as a new
ground of rejection.

2 Thorén, US 4,149,542, issued Apr. 17, 1979.
3 Helland et al., US 5,318,572, issued Jun. 7, 1994.
4 MacGregor, US 4,101,984, issued Jul. 25, 1978.
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ISSUE
Does the preponderance of evidence of record support the Examiner’s
conclusion that the combination of Thorén, Helland, and MacGregor renders
obvious the claimed lead?

FINDINGS OF FACT
FF1. The Specification teaches that the invention “relates to the field of
implantable leads, and more specifically to an endocardial lead” (Spec. 1).
FF2. According to the Specification:
Medical leads, such as cardiac leads, have a distal end
having one or more electrodes and a proximal end having a
terminal which is coupled to a pulse generator. Electrical
therapy is delivered from the pulse generator to the heart via the
electrode in order to manage cardiac rhythms. One type of
therapy includes cardiac resynchronization therapy. This is
typically done with the lead placed in the coronary veins.
However, it can be difficult to implant leads in the coronary
veins. Further, the therapy may work better with the electrical
energy delivered directly to the lateral free wall of the heart.
However, the concern with placing a lead in the left atrium or
left ventricle is that the left atrium and ventricle pump blood
directly to the brain and there is a risk of emboli and therefore
stroke from an implanted device in the left chamber of the
heart.

(Id.)
FF3. The Examiner’s finds that Thorén teaches “an endocardial lead with a
lead body extending from proximal to a distal end” (Ans. 6).
FF4. The Examiner finds further that “Thoren discloses a titanium ring
electrode (e.g. side component 5) that is textured with pores to allow for
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tissue ingrowth and a distal tip electrode that is inert and thereby prevents
clotting (e.g. Col. 2, line 24- Col. 3, line 52)” (id.).
FF5. Thorén teaches that the “art is aware of endocardial electrodes
comprised of an elongated electrical conductor encased or enveloped within
an electrical insulator and having an electrode head or tip on the distal end of
such conductor for transmitting stimulating impulses to the heart pursuant to
the controlled application of an electrical current to the conductor” (Thorén,
col. 1, ll. 11-17).
FF6. The Examiner notes that “Thoren fails to . . . teach the use of titanium
microspheres for texturing the ring electrode” (Ans. 5).
FF7. The Examiner finds that “Helland teaches that it is known to use
titanium microspheres between 75-100um to form a layer of blood cells
around the lead body electrode as set forth in e.g., column 5, lines 62 -66;
column 10, lines 19-20, Col. 6, line 16; for providing the predictable results
of immobilizing and stabilizing the electrode and lead body upon
implantation” (id.).
FF8. The Examiner concludes:
It would have been obvious to one having ordinary skill in the
art at the time the invention was made to modify the system as
taught by Thoren with use of a textured coating of titanium
microspheres between 75-100um to form a layer of blood cells
around the ring electrode and lead body for providing the
predictable results of immobilizing and stabilizing the ring
electrode and lead body upon implantation.

(Ans. 5.)
FF9. The Examiner finds that “MacGregor teaches that it is known to select
the particle size and orientation of sphere particles on an electrode surface to
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provide the predictable results of promoting tissue ingrowth while at the
same time preventing clot formation through formation of flattened
endothelial-like cells which confer thromboresistance (e.g. Col. 2, line 59-
Col. 3, line 22)” (id. at 6).
FF10. Specifically, MacGregor teaches:
It is well known that the introduction of foreign bodies
into the blood stream, for example, the polished metal surfaces
of artificial heart valves, tends to cause the formation of blood
clots which may break loose and embolize to various parts of
the body. Such thromboembolic problems have led to the
administration of anticoagulants to patients with artificial heart
valves. The effects of these anticoagulants on the blood
clotting mechanism cause difficulties in stopping the flow of
blood through even a minor flesh wound. In addition, flexible
plastic conduits are used for vascular graft purposes and such
surfaces also are thrombogenic.

(MacGregor, col. 1, ll. 10-21.)
FF11. MacGregor thus teaches:
The present invention provides a heart valve which
overcomes the prior art defects by providing the blood-
engaging metallic parts in the form of a solid substrate having
an adherent porous metallic surface coating which has a
network of interconnected pores therein. It has been found that
the rigid nature of the metal coating, the strength of the
substrate-coating interface and the strength of the particle-
particle bond in the coating provide excellent strength and wear
resistance characteristics while nucleated cells circulating in the
blood stream colonize onto the blood-engaging surface of the
porous coating and subsequently differentiate into other cell
types to form a thin, smooth, generally uniformly-thick, firmly
attached tissue covering on the surface. The tissue covering is
formed rapidly over about a one month period, does not appear
to increase significantly in thickness thereafter, and includes
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flattened endothelial-like cells at the surface thereof. The tissue
formation is not accompanied by thrombosis or embolish owing
to its blood-compatible nature, and once the maximum
thickness has been attained, the tissue covering is self-
regenerating.

(Id. at col. 1, ll. 43-64.)
FF12. MacGregor also teaches that the “invention is not restricted to heart
valves but is applicable to a wide variety of cardiovascular prosthetic
devices or implants having blood engaging surfaces. In accordance with the
invention, the blood engaging surface is porous in nature and has an
interconnected network of pores in the subsurface thereof” (id. at col. 3, ll,
21-26).

ANALYSIS
Appellants argue that the combination as set forth by the Examiner
does not teach or suggest that “the outer surface of the lead body is adapted
such that a layer of blood cells is formed on the outer surface when exposed
to a bloodstream” (App. Br. 10).
We disagree. We conclude that it would have been obvious to the
ordinary artisan to adapt an outer surface of the lead body such that a layer
of blood cells is formed on the outer surface when exposed to a bloodstream,
such as by using an adherent porous metallic surface coating which has a
network of interconnected pores therein as taught by MacGregor. Thus, we
agree with the Examiner that the combination of Thorén, Helland, and
MacGregor renders obvious the subject matter of independent claims 1, 11,
and 17. But as our reasoning differs from that of the Examiner, and in order
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to give Appellants an opportunity to respond, we designate our affirmance as
a new ground of rejection.

CONCLUSION OF LAW
We conclude that the preponderance of evidence of record supports
the Examiner’s conclusion that the combination of Thorén, Helland, and
MacGregor renders obvious the claimed lead. We thus affirm the rejection
of claims 1, 11, and 17 as being rendered obvious by the combination of
Thorén, Helland, and MacGregor. As Appellants did not argue dependent
claims 5, 7, 9, 10, 12-16, and 18 separately, we affirm the rejection as to
those claims as well. 37 C.F.R. § 41.37(c)(1)(vii).

TIME PERIOD FOR RESPONSE
This decision contains new grounds 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.”
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 grounds 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….
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(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). See 37 C.F.R.
§1.136(a)(1)(iv)(2007).

AFFIRMED; 37 C.F.R. § 41.50(b)

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