Ex Parte Colvin et al

Patent Trial and Appeal Board

Dec 2, 2014

12767056 (P.T.A.B. Dec. 2, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/767,056 04/26/2010 Michael Steven Colvin 1362009-2020.1 2887
50638 7590 12/02/2014
Boston Scientific Neuromodulation Corp.
c/o Lowe Graham Jones
701 Fifth Avenue
Suite 4800
Seattle, WA 98104
EXAMINER
HELLER, TAMMIE K
ART UNIT PAPER NUMBER
3766
MAIL DATE DELIVERY MODE
12/02/2014 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MICHAEL STEVEN COLVIN,
TOM XIAOHAI HE, and
MATT ISAAC HALLER
__________

Appeal 2012-007215
Application 12/767,056
Technology Center 3700
__________

Before DONALD E. ADAMS, ERIC B. GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to an
implantable microstimulator. 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 Boston Scientific
Neuromodulation Corporation (see App. Br. 3).
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Statement of the Case
Background
The Specification teaches that “implantable microstimulators can be
used in neurological therapy by stimulating nerves or muscles, for urinary
urge incontinence by stimulating nerve fibers proximal to the pudendal
nerves of the pelvic floor, for erectile and other sexual dysfunctions” (Spec.
1, ll. 16–19). The Specification teaches that “[i]mplantable microstimulators
. . . have exposed electrodes . . . . It is preferable that the electronic circuitry
and power source be held within the housing in a hermetically-sealed
environment for the protection of the user and the protection of the circuitry
and power source” (Spec. 1, ll. 24–26).
The Claims
Claims 1–15, 17, and 19–22 are on appeal. Independent claim 1 is
representative and reads as follows:
1. An implantable microstimulator comprising:
an elongate plastic housing having a first end and a second end,
wherein the first end includes a first plastic threaded region and an
interior of the housing, wherein the plastic housing and the first plastic
threaded region are comprised of hydrophobic plastic;
an electronic subassembly disposed within the interior of the
housing;
a first end cap disposed at the first end of the plastic housing,
the first end cap comprising a second plastic threaded region and a
first electrode, wherein the first electrode is in electrical
communication with the electronic subassembly, wherein the first and
second plastic threaded regions are coupled together to form a seal
therebetween, the seal blocking the access to the interior of the
housing; and
a second electrode disposed at the second end of the plastic
housing and in electrical communication with the electronic
subassembly.
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The issues
A. The Examiner rejected claims 1–10, 12–14, 19, 21, and 22 under
35 U.S.C. § 103(a) as being obvious over Schulman2 and Richter3 (Ans. 4–
10).
B. The Examiner rejected claim 11 under 35 U.S.C. § 103(a) as being
obvious over Schulman, Richter, and Loeb4 (Ans. 10).
C. The Examiner rejected claims 15 and 17 under 35 U.S.C. § 103(a) as
being obvious over Schulman, Richter, and Rini5 (Ans. 11).
D. The Examiner rejected claim 20 under 35 U.S.C. § 103(a) as being
obvious over Schulman, Richter, and Meadows6 (Ans. 11–12).
A. 35 U.S.C. § 103(a) over Schulman and Richter
The Examiner finds that “Schulman discloses an implantable
microstimulator 2 comprising an elongate housing 4 . . . made of an
electrically insulating material that is capable of being hermetically sealed
and is biocompatible, such as plastic” (Ans. 4–5). The Examiner further
finds that Schulman teaches an internal electronic subassembly in electrical
contact with an electrode, and a threaded end cap (see Ans. 5). The
Examiner finds that “Schulman discloses that when the first and second
threaded regions are coupled together, a seal is formed therebetween” (Ans.
5).

2 Schulman et al., US 2002/0193859 A1, published Dec. 19, 2002.
3 Richter et al., US 4,281,668, issued Aug. 4, 1981.
4 Loeb et al., US 6,214,032 B1, issued Apr. 10, 2001.
5 Rini et al., US 2003/0181794 A1, published Sept. 25, 2003.
6 Meadows et al., US 2003/0191504 A1, published Oct. 9, 2003.
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The Examiner acknowledges that Schulman’s “conductive electrode 8
and end cap 10, and the threaded regions of each, are not made from plastic,
but rather are made from metallic materials” (Ans. 5).
The Examiner finds that “Richter teaches an implantable stimulation
electrode that comprises a carbon electrode with a smooth coating of
hydrophilic ion conducting plastic that includes hydrophobic monomers”
(Ans. 5).
The Examiner finds it obvious to use Richter’s plastic-coated
electrodes in the place of Schulman’s electrodes “to obtain the predictable
results of preventing the degradation of tissue surrounding the electrode after
implantation, improving the biocompatibility of the electrode, and
preventing thrombus formation” (Ans. 6).
The issues with respect to this rejection are:
(i) Does the evidence of record support the Examiner’s conclusion
that Schulman and Richter render obvious an implantable microstimulator
with a plastic threaded region “comprised of hydrophobic plastic” as
required by claim 1?
(ii) Does the evidence of record support the Examiner’s conclusion
that Richter’s gold plated carbon electrode comprises “a metal or an alloy”
as required by claim 21?
Findings of Fact
1. The Specification teaches that:
The plastic housing 102 can be formed of a plastic
material that resists the transport of moisture into the interior
of the housing and is sufficiently sturdy to protect the
components on the interior of the housing from damage
under expected implantation and usage conditions.
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Preferably, the material of the plastic housing is a
hydrophobic polymer material. The plastic material of the
housing can be a homopolymer, a copolymer formed using
two or more different monomeric units, or a mixture of
polymers or other materials. Examples of suitable polymer
materials include polyolefins, polypropylene homopolymers
and copolymers, teflon, and polyetheretherketone (PEEK).

(Spec. 4, ll. 3–10.)
2. Figure 1 of Schulman is reproduced below:

“An implantable miniature stimulator 2 is illustrated in FIG. 1. . . .
Electrically conductive electrodes 8 are shown threaded in FIG. 1”
(Schulman 3 ¶ 70).
3. Schulman teaches that:
Insulating case 4 contains the electronics, which may
include a battery or other energy storage device and signal
generating or receiving circuitry and is made of an
electrically insulating material that is capable of being
hermetically sealed and that is also biocompatible, such as
plastic or ceramic. The plastic may be epoxy, polycarbonate,
or plexiglass.

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(Schulman 3 ¶ 71).
4. Schulman teaches that the “electrically conductive case end 6 is
preferably a biocompatible, non-corrosive material, such as titanium or a
titanium alloy, although other metals . . . may be used” (Schulman 3 ¶ 72).
5. Richter teaches that the
[E]lectrode surface has a smooth coating of hydrophilic, ion-
conducting plastic, and that at least the surface of the plastic
coating consists of body- and/or blood-compatible material.
The coating of hydrophilic, ion-conducting plastic
according to the invention results in the coverage and
equalization of the microporous surface of the implantable
electrode. The coating of a smooth, water-containing plastic
layer improves the compatibility, reduces friction with the
muscle tissue, and at the same time prevents thrombus
formation.

(Richter, col. 2, ll. 29–39.)
6. Richter teaches that “all hydrophilic, ionizable monomers are
suitable for polymerization; they can be used also in mixture with one
another and with hydrophobic monomers” (Richter, col. 2, l. 66 to col. 3, l.
1).
7. Richter teaches that:
A carbon fiber bundle of a diameter of about 2 mm is
gold-plated at one end over a length of 0.5 cm, surrounded
with an Elgiloy coil, and spot welded therewith. Then the
fiber bundle is cut off 1 cm behind the gold-plated point and
immersed in concentrated sulfuric acid heated to about 330º
C. for 2 minutes for activation at the free end. The adhering
sulfuric acid is washed out thoroughly with distilled water,
and the electrode is then immersed in a phosphate buffer
solution of a pH value of 7.4 for neutralization. The Elgiloy
coil and the carbon fiber bundle are thereafter coated with a
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fitting silicone hose to the extent that 2.5 mm of the fiber
bundle protrude.

(Richter, col. 5, ll. 18–30; Example 5.)
Principles of Law
“In proceedings before the Patent and Trademark Office, the
Examiner bears the burden of establishing a prima facie case of obviousness
based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (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’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 4–12; FF 1–6) and agree that claims
1 and 21 are obvious over Schulman and Richter. We address Appellants’
arguments below.
Claim 1
Appellants contend that “[n]either Schulman nor Richter, alone or in
combination, teaches or suggests a plastic housing or a first plastic threaded
region comprised of hydrophobic plastic” (App. Br. 10). Appellants contend
that “[i]nclusion of one or more hydrophobic monomers in a hydrophilic
material does not make the hydrophilic material into a hydrophobic coating,
as asserted in the Office Action. The coating of Richter remains a
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hydrophobic [sic] material despite the presence of some hydrophobic
monomeric units” (App. Br. 11).
We do not find this argument persuasive. We begin with claim
interpretation. Claim 1 requires an “implantable microstimulator comprising
. . . an elongate plastic housing . . . comprised of hydrophobic plastic.” We
first review the Specification to interpret the phrase “comprised of
hydrophobic plastic.” The Specification teaches that the “plastic material of
the housing can be a homopolymer, a copolymer formed using two or more
different monomeric units, or a mixture of polymers or other materials”
(Spec. 4, ll. 6–8; FF 1). Appellants’ claim 1 does not exclude the use of
hydrophilic polymers, nor does the claim exclude the use of any other types
of polymer, where the “plastic housing” and “plastic threaded region” in
claim 1 solely uses the open transitional phrase “comprising” when referring
to the “hydrophobic plastic.” See Georgia-Pacific Corp. v. U.S. Gypsum
Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999) (The transitional term
“comprising” is “inclusive or open-ended and does not exclude additional,
unrecited elements or method steps.”) We therefore agree with the
Examiner (Final Rej. 11; Ans. 13–14) and interpret “comprised of
hydrophobic plastic” as encompassing polymer mixtures where at least one
polymer must be hydrophobic, but the polymer mixtures may comprise other
polymers which are not hydrophobic, including hydrophilic polymers (see
FF 1).
Appellants contend that “[o]ne of skill in the art would not consider
the hydrophilic plastic of Richter . . . which has a mixture that includes both
hydrophilic and hydrophobic monomers to be a hydrophobic plastic” (App.
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Br. 11). Appellants contend that “if the plastic electrode coating of Richter
were to be modified to be hydrophobic, then the electrode of Richter would
be unable to propagate stimulation energy through the electrode coating”
(App. Br. 11). Appellants contend that “modifying the hydrophilic plastic
coating of Richter to be hydrophilic would render the electrode of Richter
unsatisfactory for its intended purpose” (App. Br. 12).
We do not find these arguments persuasive. These are both factual
allegations for which Appellants provide no supporting evidence, only
attorney argument. Appellants’ own Specification recognizes that the plastic
may be composed of polymer mixtures (FF 1) and Richter expressly teaches
that the plastics may be mixtures of hydrophilic and hydrophobic plastics
(FF 6). See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (“[A]ttorney
argument [is] not the kind of factual evidence that is required to rebut a
prima facie case of obviousness”).
Appellants’ argument regarding the inability of a hydrophobic coating
to propagate energy is also unpersuasive, because Richter expressly teaches
that the plastic may comprise hydrophobic polymers (FF 6). In addition to
being solely attorney argument, without evidence, we note separately that
Richter is presumed enabled in the absence of evidence to the contrary. See
In re Antor Media Corp., 689 F.3d 1282, 1289 (Fed. Cir. 2012) (“[D]uring
patent prosecution, an examiner is entitled to reject claims . . . by a prior art
publication or patent without conducting an inquiry into whether or not that
prior art reference is enabling. As long as an examiner makes a proper
prima facie case . . . by giving adequate notice under § 132, the burden shifts
to the applicant to submit rebuttal evidence of nonenablement.)
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Claim 21
Appellants contend that the “electrodes of Richter cannot be
substituted for the electrodes of Schulman because the electrodes of Richter
do not include at least one of a metal or an alloy, as recited in claim 21.
There is no explicit teaching in Richter that the first electrode includes any
metal” (App. Br. 13). Appellants contend that “[t]here is, likewise, no
inherent teaching in Richter that any of the metal used during preparation of
the first electrode remains on the electrodes after the electrodes are
prepared” (App. Br. 13).
The Examiner finds that:
[C]laim 21 includes the open-ended transitional term
“comprises.” As such, claim 21 requires that the first
electrode comprises, or includes, at least one of a metal or an
alloy. Richter, beginning at column 5, line 18, describes a
procedure by which a carbon electrode is produced, that
includes gold-plating the carbon bundle electrode. The
procedures that are performed subsequent to the gold-plating
would not be expected to remove the gold plating from the
electrode and, thus, the gold-plating would remain on the
electrode.

(Ans. 15.)
We find that the Examiner has the better position. Richter discloses,
in Example 5, an electrode which is comprised of gold, a metal, where
Richter does not teach that the gold is removed from the electrode during the
synthesis process (FF 7).
Where, 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
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not necessarily or inherently possess the characteristics of
his claimed product. . . . Whether the rejection is based on
“inherency” under 35 U.S.C. § 102, on “prima facie
obviousness” under 35 U.S.C. § 103, jointly or alternatively,
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.

In re Best, 562 F.2d 1252, 1255 (CCPA 1977). The Examiner reasonably
relies upon Richter’s teaching of a carbon electrode comprising gold to
render claim 21 obvious under the inherency doctrine. This shifts the burden
of production to Appellants, to demonstrate that Richter’s process would
remove the gold plating. Appellants provide no evidence to satisfy this
burden.
Conclusions of Law
(i) The evidence of record supports the Examiner’s conclusion that
Schulman and Richter render obvious an implantable microstimulator with a
plastic threaded region “comprised of hydrophobic plastic” as required by
claim 1.
(ii) The evidence of record supports the Examiner’s conclusion that
Richter’s gold plated carbon electrode comprises “a metal or an alloy” as
required by claim 21.
B–D. 35 U.S.C. § 103(a)
Appellants do not argue separately the claims in these obviousness
rejections (see App. Br. 12). Having affirmed the obviousness rejection of
claims 1 and 21 over Schulman and Richter for the reasons given above, we
also find that the further combinations render the remaining claims obvious
for the reasons given by the Examiner (see Ans. 10–12).
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SUMMARY
In summary, we affirm the rejection of claims 1 and 21 under
35 U.S.C. § 103(a) as being obvious over Schulman and Richter. Pursuant
to 37 C.F.R. § 41.37(c)(1), we also affirm the rejection of claims 2–10, 12–
14, 19, and 22, as these claims were not argued separately.
We affirm the rejection of claim 11 under 35 U.S.C. § 103(a) as being
obvious over Schulman, Richter, and Loeb.
We affirm the rejection of claims 15 and 17 under 35 U.S.C. § 103(a)
as being obvious over Schulman, Richter, and Rini.
We affirm the rejection of claim 20 under 35 U.S.C. § 103(a) as being
obvious over Schulman, Richter, and Meadows.

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

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