Ex Parte Nazareth et al

Patent Trial and Appeal Board

Aug 30, 2018

14521958 (P.T.A.B. Aug. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/521,958 10/23/2014
27581 7590 09/04/2018
Medtronic, Inc. (CVG)
8200 Coral Sea Street NE.
MS:MVC22
MINNEAPOLIS, MN 55432-9924
FIRST NAMED INVENTOR
Vishal R. Nazareth
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
C0006495.USU2 8871
EXAMINER
MANUEL, GEORGE C
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
09/04/2018 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):
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte VISHAL R. NAZARETH, GREGORY A. BOSER,
AND LORRAINE R. GAUNT 1
Appeal2017-008169
Application 14/521,958
Technology Center 3700
Before RICHARD M. LEBOVITZ, RICHARD J. SMITH, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to implantable electrode lead for
electrical stimulation of a body. The Examiner rejected the claims as
anticipated under 35 U.S.C. § 102 and as failing to comply with the
enablement requirement under 35 U.S.C. § 112. Appellants appeal the
rejection pursuant to 35 U.S.C. § 134. We have jurisdiction under 35 U.S.C.
§ 6(b ). We affirm-in-part.
1 The Appeal Brief ("Appeal Br.") 2 lists Medtronic, Inc. of Minneapolis,
Minnesota, the assignee of record, and Medtronic plc of Dublin, Ireland, the
ultimate parent entity of Medtronic, Inc. as the real parties in interest.
Appeal2017-008169
Application 14/521,958
STATEMENT OF THE CASE
The claims stand rejected by the Examiner as follows:
Claims 6-15 and 24--31 under 35 U.S.C. § 112(a) for lack of
enablement. Ans. 2.
Claims 1-15 and 21-31 under 35 U.S.C. § 102(a)(l) based upon a
public use or sale or other public availability of the invention.
ENABLEMENT REJECTION
Claims 6-15 and 24--31 stand rejected by the Examiner under 3 5
U.S.C. § 112(a). The Examiner found that Specification, while being
enabling for a platinum-iridium cladding, does not reasonably provide
enablement for employing Anomet, Inc. or for cladding in the 1-3 micron
range. 2 Ans. 2.
Claims 6 and 11 are independent claims. Claim 6 is illustrative of the
rejected claims and reads as follows:
6. A system of producing an implantable electrode lead for
electrical stimulation of a body of the type comprising an
elongated insulative lead body, a conductor within the lead
body and an electrode coupled to the conductor, comprising:
employing Anomet, Inc to apply a platinum-iridium
cladding to a tantalum core to produce an electrode wire in
which the cladding forms an exposed surface of the electrode
having a maximum thickness of less than three microns; and
means for coiling the wire to form the electrode.
Independent claim 11 is also a method claim and comprises the same
step of "employing Anomet, Inc" as recited in claim 1.
2 Claim 1 also has the limitation of a cladding "having a maximum thickness
of less than three microns," but was not rejected for lack of enablement.
Claim 1 does not recite the step of "employing Anomet Inc."
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Appeal2017-008169
Application 14/521,958
According to the Specification, "Anomet, Inc" is a company located
in Shrewsbury, Massachusetts. Spec. 3:24--25. The Specification states:
The invention is practiced employing a cladding technique
provided by Anomet, Inc. Shrewsbury, MA
(www.anometproducts.com) to fabricate the wires used to form
these electrodes. Unlike the current traditional DPT approach,
the inventors understand that Anomet wraps a foil around a core
to form the cladding, extruding the clad core within in a
nickel/stainless steel outer layer and then etching off the outer
layer and drawing the cladded core to finished size. This process
as applied to a melt quality tantalum core wire is particularly
beneficial in the context of a coiled wire defibrillation electrode
as in the present invention. The resultant clad wires can be
obtained from Anomet, Inc.
Spec. 3 :24--Spec. 4:2.
The rejected claims require Anomet, Inc to be "employed" to produce
the electrode wire. As we understand the claims, the term "employed"
means that Anomet is used to make the electrode wire and that therefore the
wire is obtained from Anomet, Inc. The Examiner found that the
Specification does not describe or provide guidance on how the wire is
produced, but relies entirely on Anomet, Inc. for its production. Ans. 2-3.
Appellants do not dispute the Examiner's finding, but rather assert that
"Because this component is commercially available, it is sufficient under
Section 112 to identify the component and indicate where it may be
purchased, i.e., from Anomet, Inc." Appeal Br. 4. Appellants contend that
You don't have to know how to apply the coating to practice the
claimed inventions. You just need to know about Anomet.
Employing Anomet to coat the wire is simple. You ask
them to do so and pay them to do it. In other words, you buy it
from Anomet. One of skill in the art is presumed to know how to
buy components from vendors.
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Appeal2017-008169
Application 14/521,958
Appeal Br. 4.
The step of "employing Anomet" means using the company.
Anomet is a company, not a process. The company uses the
process. The person practicing the invention as claimed doesn't
need to know how the coating is applied any more than an
electrical engineer needs to know how to make a transistor in
order to use one in a circuit.
Reply Br. 5.
Appellants' argument does not persuade us that the Examiner erred in
rejecting the claims for lack of enablement. It is undisputed that the rejected
claims require one of ordinary skill in the art to obtain electrode wire from
Anomet in order to practice the claimed method. For a Specification to be
enabling under 35 U.S.C. § 112, a material necessary to practice the claim
must be available to the public for the pendency of the patent. In re Lundak,
773 F.2d 1216 (Fed. Circ. 1985); In reArgoudelis, 434 F.2d 1390 (CCPA
1970), John E. Schneider, Microorganisms and the Patent Office: To
Deposit or Not to Deposit, That is the Question. 52 Fordham L. Rev. 592,
595-596 (1984). Thus, in Lundak, where the invention was found to depend
on the use of a microorganism, and the microorganism was not known or
readily available, a deposit of the microorganism in a publically accessible
depository was considered necessary to meet the enablement requirement to
ensure that the claims were enabled for the life of the patent.
In this case, where the electrode wire provided by Anomet is
necessary to carry out the claimed method, the availability of the wire must
be ensured for the patent's pendency to meet the enablement requirement
under 35 U.S.C. § 112.
Because the claim explicitly names Anomet, Inc. in the claim as the
wire's sole source, and the Specification lacks a description of how the wire
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Appeal2017-008169
Application 14/521,958
is made, the Examiner had a reasonable basis to question the enablement of
the rejected claims. In re Wright, 999 F.2d 1557, 1562 (Fed. Cir. 1993). In
response, Appellants assert that the wire is commercially available from
Anomet, Inc., but do not provide any assurances that Anomet, Inc., which is
explicitly recited in the claim as the source of the electrode wire, will make
the claimed electrode commercially for the patent's pendency, should a
patent on the claims issue. Thus, even if the disclosure is initially enabling,
there is no assurance that it will be enabled for the patent's pendency. See In
re Metcalfe, 410 F.2d 1378, 1382 (CCPA 1969). Consequently, we affirm
the enablement rejection of claims 6 and 11, and dependent claims 7-10 and
24--31.
ANTICIPATION REJECTION
Independent claim 1 is directed to an implantable electrode
comprising: 1) an elongated insulative body; 2) a conductor in the body; and
3) an electrode coupled to the conductor comprising a coiled wire
comprising "a platinum-iridium cladding directly overlaying an un-
smoothed melt quality tantalum core." Independent claim 5 is directed to a
method of making an implantable electrode with the same three elements of
the implantable electrode of claim 1. Independent claims 5, 6, and 11 are
directed to methods of producing the electrode lead having the same
limitations.
The Examiner rejected that the claims based on the "public
availability of the invention" because the Specification "disclose[ s] the
invention is practiced employing a cladding technique provided by Anomet,
Inc. to fabricate the wires used to form the electrodes. The coiled wire
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Application 14/521,958
defibrillation electrode of the present invention is stated on page 4 of the
specification to be obtained from Anomet, Inc." Ans. 3.
The Specification discloses that Anomet makes the electrode wire.
Spec. 3. The Specification also discloses that the wire "is particularly
beneficial in the context of a coiled wire defibrillation electrode as in the
present invention. The resultant clad wires can be obtained from Anomet,
Inc." Id. at 3 :30-4:2. The Specification states that "the resultant composite
wire displays improved rotary bend fatigue performance" and describes
aspects of the coiling process, indicating that Anomet, Inc. does not provide
the coiled wire itself (id. at 4: 16-27), despite the Examiner's conclusion to
the contrary (Ans. 3).
However, even if Anomet, Inc. sells the coiled wire of element (3) of
claims 1, 5, 6, and 11, the Examiner did not identify disclosure in the
Specification that Anomet, Inc. provides (1) the elongated insulative body or
(2) the conductor within in the lead body as required by all of the rejected
claims. A claim is anticipated under 35 U.S.C. § 102 when a publication
"disclose[ s] all elements of the claim within the four comers of the
document" and "arranged as in the claim." Net MoneyIN, Inc. v. VeriSign,
Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). In this case, the Examiner did
not provide evidence that Anomet provides all the elements of claims 1, 5, 6,
and 11, particularly 1) an elongated insulative body; and 2) a conductor in
the lead body. Consequently, the anticipation rejection of claims 1, 5, 6, and
11, and of dependent claims 2--4, 7-10, 12-15, and 21-31, is reversed.
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Application 14/521,958
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED-IN-PART
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