Ex Parte Delaney et al

Patent Trial and Appeal Board

Oct 26, 2018

14329123 (P.T.A.B. Oct. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/329,123 07/11/2014 Joseph T. Delaney JR.
42074 7590 10/30/2018
Faegre Baker Daniels LLP
PATENT DOCKETING - INTELLECTUAL PROPERTY (32469)
2200 WELLS FARGO CENTER
90 SOUTH SEVENTH STREET
MINNEAPOLIS, MN 55402-3901
UNITED ST A TES OF AMERICA
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.
432469.000866 1822
EXAMINER
GETZOW, SCOTT M
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
10/30/2018 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):
PatentDocketing@FaegreBD.com
e-OfficeActionBSC@FaegreBD.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOSEPH T. DELANEY JR.,
JEANNETTE C. POLKINGHORNE, ADEGBOLA 0. ADENUSI,
DAVID R. WULFMAN, and KASY AP SEETHAMRAm
Appeal2017-009170
Application 14/329,123
Technology Center 3700
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to a
medical electrical lead. The Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as Cardiac Pacemakers, Inc. a
wholly owned subsidiary of Boston Scientific Corporation (see Br. 3).
2 We have considered and herein refer to the Specification of July 11, 2014
("Spec."); Final Office Action of July 15, 2016 ("Final Act."); Appeal Brief
of Oct. 20, 2016 ("Br."); and Examiner's Answer of Dec. 30, 2016 ("Ans.").
Appeal2017-009170
Application 14/329,123
Statement of the Case
Background
"Cardiac pacing leads are well known and widely employed for
carrying pulse stimulation signals to the heart from a battery operated
pacemaker ... as well as for monitoring electrical activity of the heart"
(Spec. ,r 3). "Some factors that affect electrode performance include
polarization at the electrode/tissue interface, electrode capacitance, sensing
impedance, and voltage threshold" (id.). "A recognized performance
challenge of materials conventionally used as electrodes includes the
difficulty of controlling tissue in-growth while optimizing the lead
performance characteristics at the electrode/tissue interface" (id. ,r 4).
The Claims
Claims 1-11 and 21 are on appeal. Claim 1 is representative and
reads as follows:
1. A medical electrical lead comprising:
an insulative lead body extending from a distal region to
a proximal region;
a conductor disposed within the insulative lead body and
extending from the proximal region to the distal region;
an electrode disposed on the insulative lead body and in
electrical contact with the conductor; and
a cross-linked hydrophilic polymer coating disposed over
at least a portion of the electrode, the cross-linked hydrophilic
polymer coating comprising:
a fibrous matrix comprising a plurality of discrete fibers
and pores formed between at least a portion of the fibers,
wherein the fibers range from about 200 nanometers to 1,000
nanometers in diameter; and
a hydrophilic polyethylene glycol-containing hydrogel
network disposed within the pores of the fibrous matrix,
wherein the hydrogel network is biostable.
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Application 14/329,123
The Re} ections
A. The Examiner rejected claims 1, 2, 5-11 and 21 under 35 U.S.C.
§ I03(a) as obvious over Polkinghome3 and Vachon4 (Final Act. 2).
B. The Examiner rejected claims 3 and 4 under 35 U.S.C. § I03(a) as
obvious over Polkinghome, Vachon, and Arps5 (Final Act. 2).
Because these rejections substantially rely upon the same prior art and
depend upon the same issues, and Appellants do not separately argue any of
the dependent claims (see Br. 10), we will consider these rejections together.
The issue with respect to these rejections is: Does the preponderance
of the evidence of record support the Examiner's conclusion that the prior
art renders the claims obvious?
Findings of Fact
1. Polkinghome teaches
Leads represent the electrical link between an implantable
medical device (referred to as "IMD"), such as a pacer or
defibrillator, and a subject's cardiac or other bodily tissue,
which is to be sensed or stimulated. A lead generally includes a
lead body that contains one or more electrical conductors
extending from a proximal end portion of the lead to an
intermediate or distal end portion of the lead. The lead body
includes insulating material for covering and electrically
insulating the electrical conductors.
(Polkinghome ,r 2).
3 Polkinghome et al., US 2007 /0255378 Al, published Nov. 1, 2007.
4 Vachon, US 5,861,023, issued Jan. 19, 1999.
5 Arps et al., US 2011/0021899 Al, published Jan. 27, 2011.
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Application 14/329,123
2. Figure 4 of Polkinghome is reproduced below:
Figure 4 depicts a lead body 202 where the "lead body 202 may comprise
one or more lumens 404 and may be surrounded by an optional modified
surface layer 402 and a fibrous matrix coating 310. The optional modified
surface layer 402 may comprise a surface of the lead 104 or a separate layer"
(Polkinghome ,r 28).
3. Polkinghome teaches a "fibrous matrix coating 310 may cover
all or portions of the lead 104, including the one or more electrodes"
(Polkinghome ,r 26).
4. Polkinghome teaches "[ e ]xamples of materials used to make a
fibrous matrix coating 310 include natural and synthetic polymers. More
specific examples include fibrin, elastin, fibronectin, Teflon®, carbon
nanofibers, polypyrrole, polyethylenedioxythiophene, Nation®, PEDOT, or
combinations thereof' (Polkinghome ,r 31 ).
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Application 14/329,123
5. Polkinghome teaches "a thin polymeric web 712 may be
formed with nanofibers having controllable diameters in the range of about
10-3000 nm, for example. The fiber diameter size may be about ... 100-
1000 nm" (Polkinghome ,r 29).
6. Vachon teaches "a transvenous combined pacing and
defibrillation lead 10 designed for intravenous insertion and contact with
either tissue or blood" (Vachon 3:34--37).
7. Vachon teaches
because shocking coils present a large, convoluted
surface area to tissue or blood, tissue ingrowth can be promoted
between adjacent shocking coil windings making subsequent
removal of the lead difficult. ...
To address these problems, the outer surface 32 of the
shocking coil 30 is provided with an encapsulating coating or
tubular sleeve 34 preferably comprising a biocompatible,
biostable, non-water soluble hydrogel-like material.
(Vachon 4:6-17).
8. Vachon teaches: "It is known to coat or otherwise cover a
helically wound transvenous defibrillator electrode with an electrically
conductive polymeric material for inhibiting tissue ingrowth, thus reducing
the risk to the patient in the event removal of the lead becomes necessary"
(Vachon 1 :54--58).
9. Vachon teaches "hydrogel-like materials can be processed into
lacquers allowing them to be readily applied as coatings. When these
coatings have absorbed water (that is, hydrated to 50-200%), they remain
tough unlike conventional hydrogels which have a tendency to rip, peel and
tear" (Vachon 4:25-29).
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Application 14/329,123
10. Vachon teaches "hydrogel-like materials such as ... PEG
(polyethylene glycol) acrylates ... may be used for the overlay" (Vachon
4:31-34).
11. Vachon teaches "[a]s an alternative to an overlay 40 in the form
of a tube or tube-like structure, a tubular substrate such as woven
polyethylene terephthalate (PET/Dacron), impregnated with any of the
described hydrogel materials, may be used" (Vachon 4:62-65).
12. Vachon teaches "[w]hen the distal end 14 of the lead 10 is
placed in contact with physiologic fluids (blood), the hydrogel-like material
absorbs fluid and swells thereby occupying the interstices between adjacent
windings of the coil 30" (Vachon 4:53-57).
Principles of Law
The Examiner has the initial burden of establishing a prima facie case
obviousness under 35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992). "The combination of familiar elements according to
known methods is likely to be obvious when it does no more than yield
predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416
(2007).
Analysis
Both Polkinghome and Vachon teach medical electrical leads with
insulative lead bodies (FF 1, 6). Polkinghome teaches a conductor within a
lead body and an electrode disposed on the lead body, along with a fibrous
matrix coating covering the electrode (FF 2--4 ). Polkinghome teaches an
overlapping diameter for the matrix fibers of 100 nanometers to 1,000
nanometers (FF 5) relative to the 200 nanometers to 1,000 nanometers range
recited in claim 1.
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Application 14/329,123
Polkinghome does not teach inclusion of a hydrogel material onto the
leads. Vachon teaches that after leads are implanted, tissue ingrowth may
prevent lead removal where necessary and that hydrogels can be used on the
leads to prevent such tissue ingrowth (FF 7-8). Vachon teaches the use of
PEG hydro gel (FF 10) to impregnante a woven matrix (FF 11 ). Vachon
explains that the PEG hydro gel will penetrate "the interstices" of the
components of the lead body (FF 12).
The Examiner found that it would have been obvious to use the
hydro gel of Vachon to coat the leads of Polkinghome in order to prevent
undesired tissue ingrowth as taught by Vachon (FF 7-8) that would
inherently result in PEG hydro gel "disposed within the pores of the fibrous
matrix" of Polkinghome as required by claim 1. We address Appellants
arguments below.
Appellants contend the "Examiner acknowledges that Polkinghorne
does not disclose a hydrophilic polyethylene glycol-containing hydrogel
network disposed within the pores of the fibrous matrix, wherein the
hydrogel network is biostable, and relies on Vachon for this disclosure" ( Br.
8). Appellants contend "Vachon discloses nothing about applying a PEG or
PEG acrylate, and then crosslinking the PEG in situ to form the
hydrogel. It is only by cross-linking the PEG in situ that a hydrophilic
polyethylene glycol-containing hydrogel network can be disposed within
the pores of the fibrous matrix" (id. at 9).
The Examiner responds "[ A ]ppellant[ s] ha[ ve] submitted no
persuasive evidence that only cross-linking the PEG in situ permits the PEG
to be disposed within the pores of the fibrous matrix of Polkinghome" (Ans.
2).
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Application 14/329,123
The Examiner's position is supported by a preponderance of the
evidence. Vachon teaches that a woven material is "impregnated with any
of the described hydro gel materials" (FF 11 ). One of ordinary skill in the art
would have understood the word "impregnated" in the context of Vachon's
disclosure to mean "[t]o diffuse, saturate, or permeate with another
substance."6 Thus, the ordinary artisan would have reasonably understood a
matrix "impregnated" with hydro gel to have hydro gel within the pores of the
matrix. This meaning is further supported by Vachon' s teaching that "the
hydrogel-like material absorbs fluid and swells thereby occupying the
interstices" (FF 12), indicating that the hydrogel penetrates small intervening
spaces which would include pores.
As noted in Best, "[ w ]here, as here, the claimed and prior art products
are identical or substantially identical, or are produced by identical or
substantially identical processes, the PTO can require an applicant to prove
that the prior art products do not necessarily or inherently possess the
characteristics of his claimed product." In re Best, 562 F.2d 1252, 1255
(CCPA 1977). Even where, as here, the rejection is based on "'prima facie
obviousness' under 35 U.S.C. § 103 ... the burden of proof is the same and
its fairness is evidenced by the PTO' s inability to manufacture products or to
obtain and compare prior art products." (Id.) As applied to the instant facts,
Vachon provides evidence suggesting that a hydrogel coating impregnated
on a porous matrix on a lead would inherently result in that hydrogel
6 See Impregnate. (1992). In C. G. Morris (Ed.), Academic Press Dictionary
of Science and Technology ( 4th ed.). Oxford, UK: Elsevier Science &
Technology. Retrieved from https :// search. credoreference.com/ content/
entry/ apdst/impregnate/O?institutionid=7 4 3
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Application 14/329,123
network "disposed within the pores of the fibrous matrix" as required by
claim 1 based both on the plain meaning of the word "impreganted" and
based on Vachon's teaching that the hydrgel swells to "occupy[] the
insterstices" of the substrate on which it is coated (FF 11-12).
In response, Appellants provide no evidence rebutting the Examiner's
reasoning, such as evidence showing that a hydro gel of Vachon coated on a
lead body of Polkinghome would not necessarily result in a network
"disposed within the pores of the fibrous matrix" as required by claim 1.
Instead there is only attorney argument that cross-linking in situ would have
been required to create a network within pores. However, "[a]ttomey's
argument in a brief cannot take the place of evidence." In re Pearson, 494
F.2d 1399, 1405 (CCPA 1974).
Conclusion of Law
The evidence of record supports the Examiner's conclusion that the
prior art renders the claims obvious.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over Polkinghome and Vachon. Claims 2, 5-11 and 21
fall with claim 1.
We affirm the rejection of claims 3 and 4 under 35 U.S.C. § 103(a) as
obvious over Polkinghome, Vachon, and Arps.
No timeperiod for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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