Ex Parte Rooney et al

Patent Trial and Appeal Board

Sep 21, 2012

11450127 (P.T.A.B. Sep. 21, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ETHAN A. ROONEY, CARL D. WAHLSTRAND,
GARY W. KING, THOMAS E. CROSS JR., and RICHARD T. STONE
__________

Appeal 2011-012629
Application 11/450,127
Technology Center 3700
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to an implantable medical device and a method of making
the device. The Patent Examiner rejected the claims for anticipation and
obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-
part.
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STATEMENT OF THE CASE
Claims 1-5, 7-18, and 25-29 are on appeal. Claims 1 and 25 are
representative and read as follows:
1. An implantable medical device comprising:
a housing that includes a first major surface and a second major
surface;
a plurality of electrodes, wherein a first set of the electrodes is located
on the first major surface of the housing, and a second set of the electrodes is
located on the second major surface of the housing; and
a stimulation generator within the housing configured to deliver
electrical stimulation to a patient via the first and second sets of the
electrodes.

25. A method comprising:
forming a housing for an implantable medical device, the housing
including a first major surface and a second major surface;
forming a first set of one or more electrodes on the first major surface
of the housing;
forming a second set of one or more electrodes on the second major
surface of the housing; and
coupling a stimulation generator to the first and second sets of
electrodes.

The Examiner rejected the claims as follows:
 claims 1-5, 7, 8, 10, 12-14, 17, 18, and 25-29 under 35 U.S.C.
§ 102(b) as anticipated by, or in the alternative under 35 U.S.C.
§ 103(a) as obvious over Whitehurst;1
 claims 9 and 11 under 35 U.S.C. § 103(a) as unpatentable over
Whitehurst; and
 claims 15 and 16 under 35 U.S.C. § 103(a) as unpatentable over
Whitehurst and Bardy.2

1 Todd K. Whitehurst et al., US 2004/0015204 A1, published Jan. 22, 2004.
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ANTICIPATION
The Issue
The Examiner found that Whitehurst disclosed an implantable medical
device for delivering peripheral nerve field stimulation, and a method of
making the device. (Ans. 4.) The Examiner found that Whitehurst’s device
included:
a housing that includes first and second opposing, parallel, major
surfaces (e.g. two end of micro stimulator 100 as shown in Figure 2E);
a plurality of electrodes, wherein a first set of electrodes is located on
the first surface of the housing and a second set of the electrodes is
located on a second surface of the housing (e.g. electrodes 110 of
Figure 2E, wherein at least two electrodes are located on the surface
of each end of the micro stimulator); and a stimulation generator
within the housing configured to deliver electrical stimulation to a
patient via the electrode sets (e.g. electrical circuitry 104).

(Id.) Claim 1 recites that the housing includes first and second major
surfaces, and the Examiner explained that Whitehurst’s device had first and
second major surfaces:
The ends of micro stimulator 100 are considered “major”
surfaces of the device because their surface areas are roughly the same
order of magnitude as the surface area of the cylindrical surface, and
thus they are “relatively large” compared to the other cylindrical
surface of the micro stimulator. The claims as currently filed do not
require that a “major” surface have a larger surface area than any of
the other surfaces, but rather only require that the surface be
“relatively large” compared to the other surfaces. Absent a specific
definition of “relatively large,” the broadest reasonable interpretation
of the term has been taken to be roughly the same order of magnitude
of surface areas.

2 Gust H. Bardy et al., US 7,120,495 B2, filed Nov. 5, 2001.
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(Id.)
Appellants contend the rejections should be reversed because they
violate the “all-elements rule.” (App. Br. 6.) According to Appellants,
“[t]he Examiner’s construction of ‘major surface’ contradicts the plain
meaning of this term, particularly as the term would be interpreted by one of
ordinary skill in the art in light of the specification.” (Id. at 8.) Based on the
Specification’s definition that “[a] ‘major’surface of a housing has a
relatively large surface area when compared to other surfaces,” Appellants
argue that “in order to have a ‘relatively large surface area when compared
to other surfaces,’ a major surface necessarily must be larger, that is have a
larger surface area, than the other surfaces. If it were not so, the surface area
of the major surface would not be ‘relatively large’ when it is ‘compared to
[the] other surfaces.” (Id. at 7-8.) Appellants further argue: “Dictionary
definitions of ‘major’ note that something that is ‘major’ is larger than other,
similar objects. ‘Major’ is often used in conjunction with the term ‘minor,’
which generally denotes being smaller than the ‘major’ item.” (Id. at 10,
citations omittted.) Based on calculations of cylinder surface, Appellants
contend “it is impossible for the cylindrical microstimulator disclosed in
Whitehurst to have end surfaces that are ‘major surfaces,’ e.g., that are
relatively large compared to the cylindrical surface.” (Id. at 12.)
The issue with respect to the anticipation rejection is whether the term
“major” is reasonably applied to the end surfaces of Whitehurst’s stimulator.

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Findings of Fact
1. We adopt the Examiner’s findings concerning the scope and content
of the prior art.
2. The Specification states: “A ‘major’ surface of a housing has a
relatively large surface area when compared to other surfaces.” (Spec.
14, ¶ [0061].)
3. The Specification states: “As illustrated in FIG. 2B, top and bottom
housing surfaces 22A and 22B (collectively ‘housing surfaces 22’)
may be substantially parallel, opposing, major surfaces of housing
21.” (Id.)
4. Specification Figure 2B is reproduced here:

Figure 2B is a schematic diagram illustrating a side view of the
implantable medical device with electrodes located on a top surface
and a bottom surface of the implantable medical device housing. (Id.
at 9, ¶ [0032].)

5. An ordinary dictionary definition of “major” includes:
1: greater in dignity, rank, importance, or interest
2: greater in number, quantity, or extent
3: having attained majority
4a : notable or conspicuous in effect or scope : CONSIDERABLE
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b : prominent or significant in size, amount, or degree
5: involving grave risk : SERIOUS

(Merriam-Webster, accessed at merriam-
webster.com/dictionary/major, Aug. 24, 2012.)

6. Whitehurst’s Figure 2E is reproduced here:

“FIG. 2E is an isometric view of an exemplary microstimulator of the
present invention, including a plurality of partitioned electrodes.”
(Whitehurst 2, ¶ [0031].)

7. Whitehurst disclosed:
The configuration of microstimulator 100 may be determined
by the structure of the desired target, the surrounding area, and the
method of implantation. The size and the shape of the microstimulator
may be varied in order to deliver more effective treatment. A thin,
elongated cylinder with electrodes at the ends and/or along the
cylindrical case are possible configurations, but other shapes, such as
disks, spheres, helical structures, and others are possible. Additional
alterations in configuration, such as the number, orientation, and
shape of electrodes (which may be programmably configurable), may
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be varied in order to deliver more effective treatment. For instance,
the electrodes may be rectangular, semi-spherical, arcs, bands/rings,
or any other useful shape, and may be distributed along and/or around
the surface of the microstimulator.

(Id. at 6, ¶ [0070].)

Principles of Law
[T]he PTO applies to the verbiage of the proposed claims the
broadest reasonable meaning of the words in their ordinary
usage as they would be understood by one of ordinary skill in
the art, taking into account whatever enlightenment by way of
definitions or otherwise that may be afforded by the written
description contained in the applicant’s specification.

In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).

Absent an express definition in their specification, the fact that
appellants can point to definitions or usages that conform to their
interpretation does not make the PTO's definition unreasonable when
the PTO can point to other sources that support its interpretation.

Morris, 127 F.3d at 1056. “Absent claim language carrying a narrow
meaning, the PTO should only limit the claim based on the specification or
prosecution history when those sources expressly disclaim the broader
definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004).
“[P]atent drawings are not ordinarily considered to be working
drawings drawn to scale.” In re Heinrich, 268 F.2d 753, 755 (CCPA 1959)
(emphasis in original). “Absent any written description in the specification
of quantitative values, arguments based on measurement of a drawing are of
little value.” In re Wright, 569 F.2d 1124, 1127 (CCPA 1977) (“We
disagree with the Solicitor's conclusion, reached by a comparison of the
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relative dimensions of appellant’s and Bauer’s drawing figures, that Bauer
‘clearly points to the use of a chime length of roughly 1/2 to 1 inch for a
whiskey barrel.’ This ignores the fact that Bauer does not disclose that his
drawings are to scale”) (emphasis in original). See also, In re Chitayat,
408 F.2d 475, 478 (CCPA 1969) (“In view of the absence in Frank’s
specification of any written description of the quantitative value of the image
displacement relative to fiber diameter, the arguments based on mere
measurement of the drawings appear to us of little value.”).
[U]nless a prior art reference discloses within the four corners of the
document not only all of the limitations claimed but also all of the
limitations arranged or combined in the same way as recited in the
claim, it cannot be said to prove prior invention of the thing claimed
and, thus, cannot anticipate under 35 U.S.C. § 102. . . . Thus, it is not
enough that the prior art reference . . . includes multiple, distinct
teachings that the artisan might somehow combine to achieve the
claimed invention.

Net MoneyIN, Inc. v. Verisign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).

Analysis
Claim 1
When the inventors described their invention, they chose to define
“major” as “relatively large,” not “relatively larger.” (FF 2.) By choosing
the broader “large,” rather than the narrower comparative “larger,” they
retained broader meanings of “major” rather than limiting major to a strictly
comparative sense. Broad meanings of major include “notable,”
“conspicuous in … scope,” “considerable,” and “prominent or significant in
size.” (FF 5.) Based on the Specification’s choice to define “major” as
“relatively large,” not “relatively larger,” we find Appellants’ semantic
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arguments unpersuasive. Appellants’ arguments by analogy to the major
and minor axes of an ellipse are also not persuasive, as claim 1 does not
limit the device to an object having only a major axis and a minor axis, or to
an elliptical object like a prolate or oblate solid. The Examiner’s position is
reasonable in light of the Specification and consistent with ordinary
meanings of “major.” See Morris, 127 F.3d at 1056.
Further, although Appellants stress the appearance of Whitehurst’s
Figure 2E, there is no evidence that a person of ordinary skill in the art
would have perceived Figure 2E to be a scale drawing. Ordinarily, a patent
drawing is not considered a working drawing drawn to scale. E.g., Heinrich,
268 F.2d at 755. As the Examiner noted, Whitehurst gave a broad
description of shapes and configurations. (FF 7.) Given Whitehurst’s broad
description, we decline to read scale into Figure 2E. See Wright, 569 F.2d at
1127; Chitayat, 408 F.2d at 478.
Accordingly, we find the anticipation rejection of claim 1 did not
violate the all-elements rule and we affirm it.
Claim 2
Claim 2 recites: “The device of claim 1, wherein the first and second
major surfaces of the housing are opposing surfaces of the housing.”
Appellants contend that “Whitehurst fails to disclose or suggest the
implantable medical device recited in claim 2 having electrodes located on a
first major surface and an opposing second major surface. Rather,
Whitehurst discloses essentially the opposite configuration, with electrodes
located on opposing minor surfaces.” (App. Br. 15-16.) This argument is
unpersuasive for the reason explained with regard to claim 1: Whitehurst’s
end surfaces are properly considered “major” in the sense of “notable,”
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“conspicuous in … scope,” “considerable,” and “prominent or significant in
size.”
Claim 3
Claim 3 recites “The device of claim 1, wherein the first and second
major surfaces are substantially parallel surfaces.” Appellants’ argument for
claim 3 (App. Br. 16-17) is the same as that for claim 2, and is likewise
unpersuasive.
Claims 4, 5, 7, 8, 10, 12, and 17
For each of these claims, Appellants recite a limitation of the claim,
and argue that the claim is “patentable over Whitehurst for at least the same
reasons as described above with respect to claim 1.” (App. Br. 17-18, 20.)
“A statement which merely points out what a claim recites will not be
considered an argument for separate patentability of a claim.” 37 C.F.R.
§ 41.37(c)(1)(vii). These claims have not been argued separately and
therefore fall with claim 1.
Claim 13
Claim 13 recites: “The device of claim 1, wherein the housing defines
an angle between a first section of the housing and a second section of the
housing.” Appellants contend that “Whitehurst fails to disclose a housing
that defines an angle between a first section of the housing and a second
section of the housing.” (App. Br. 18.) Notwithstanding that argument,
Appellants note that Whitehurst’s Figure 2E disclosed a cylindrically shaped
housing. (Id. at 20.) A cylinder necessarily comprises an angle between an
end section and the side section. We find no reasonable way to agree with
Appellants.

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Claim 14
Appellants recite a limitation of claim 14, and contend that claim 14 is
patentable for the reasons claims 1 and 13 were said to be patentable. (App.
Br. 20.) This argument is unpersuasive for the reasons the arguments about
claims 1 and 13 were unpersuasive.
Claim 18
Claim 18 recites: “The device of claim 1, wherein the stimulation
generator is configured to deliver peripheral nerve field stimulation to the
patient via the electrodes.” The Examiner found that Whitehurst disclosed
“the claimed apparatus for delivering peripheral nerve field stimulation.”
(Ans. 4.) Appellants argue Whitehurst did not disclose a stimulator
configured as claimed and that “[i]n contrast to the PNFS [peripheral nerve
field stimulation] described in Appellant’s disclosure, the micro stimulators
100 disclosed in Whitehurst are designed to provide for unidirectional
propagation of action potentials (UPAPs) along a specific nerve or bundle of
nerve fibers.” (App. Br. 21-22.)
The Examiner responds:
The device of Whitehurst is capable of providing the peripheral nerve
field stimulation as described by Applicant, because although some
embodiments describe targeting specific nerves, the microstimulator
of Whitehurst can be ‘implanted in any location that is likely to be
therapeutic, and the stimulation parameters may be adjusted to any set
of parameters that prove efficacious.’ (Page 5, paragraph 68). Thus
Whitehurst is capable of being configured to deliver peripheral nerve
field stimulation.

(Ans. 10.)
The Examiner’s response indicates that the Whitehurst device could
be configured, if desired, to deliver peripheral nerve field stimulation. In
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other words, Whitehurst did not disclose the device so configured, although
the device was capable of re-configuration to the configuration defined in
claim 18. We agree with Appellants that on these facts, Whitehurst did not
disclose a device configured to deliver peripheral nerve field stimulation.
See Net MoneyIN, 545 F.3d at 1371. The anticipation rejection of claim 18
is reversed.
Claims 25-29
Appellants separately address each of claims 25-29, but the arguments
parallel those for claims 1-3 and others. (App. Br. 22-24.) The arguments
are again unpersuasive of error.

OBVIOUSNESS
A. Obviousness over Whitehurst
In the alternative obviousness rejection over Whitehurst alone, the
Examiner concluded it would have been obvious to modify Whitehurst’s
device to include electrodes on surfaces larger than other surfaces, “since it
appears to be an arbitrary design consideration that does not provide any
unexpected results.” (Ans. 4-5.)
Appellants contend (i) “there is no rule of patent law that Appellant
must disclose some advantage or purpose in order to make a particular
feature of Appellant’s claim nonobvious” (App. Br. 13); (ii) “the Examiner
failed to explain why one of ordinary skill in the art would have modified
the Whitehurst device to have two major surfaces, rather than the single
large cylindrical surface disclosed, or to move the electrodes so that a first
subset of electrodes was on a first of the major surfaces and a second subset
was on a second of the major surfaces;” (id. at 14-15); and (iii) “Whitehurst
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discloses a cylindrical miniature implantable stimulator 100 including one
major cylindrical surface and two minor circular surfaces” (id. at 15.)
The Examiner responds that support for modifying the Whitehurst
device with electrodes on surfaces larger than other surfaces “comes from
another Whitehurst Figure 2A, wherein the cylindrical surfaces are roughly
the same size, if not smaller than those of the end surfaces.” (Ans. 9.)
Appellants reply that “[t]he Examiner's asserted modification to the
Whitehurst would have been recognized by a person of ordinary skill in the
art as conflicting with this goal of Whitehurst, as the larger surface would
interfere with the ability to steer the electrical field radially around the
microstimulator. Thus, such a person would have consciously avoided,
rather than found obvious, the modification to Whitehurst proposed by the
Examiner.” (Reply Br. 9.)
We conclude that the Examiner has the better position. Whitehurst
did disclose electrodes on two major surfaces, and did disclose that a variety
of device configurations, sizes, and shapes would be effective. (FF 7.)
There is no evidence that anything other than ordinary skill in the art would
have been needed to follow Whitehurst’s disclosure. Appellants list the
claims separately argued for the anticipation rejection (claims 2-5, 7, 8, 10,
12, 13, 14, 17, and 25-29), but we find those arguments again unpersuasive.
Claim 18
Appellants again argue that “[i]n contrast to the PNFS described in
Appellant's disclosure, the micro stimulators 100 disclosed in Whitehurst are
designed to provide for unidirectional propagation of action potentials
(UPAPs) along a specific nerve or bundle of nerve fibers.” (App. Br. 21-
22.)
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The Examiner responds that Whitehurst’s device “is capable of being
configured to deliver peripheral nerve field stimulation” (Ans. 10), but the
rejection did not allege, and the response does not show, that a person of
ordinary skill in the art would have had a reason to do so and would have
considered it obvious to do so. We agree with Appellants that on these facts,
there is insufficient evidence that Whitehurst rendered obvious a device
configured to deliver peripheral nerve field stimulation. The obviousness
rejection of claim 18 is reversed.

B. Claims 9 and 11
Claims 9 and 11 each recite a specific inter electrode distance. For
claim 9, the rejection took the position that
the insulating material 120 found between electrodes 110 of
Whitehurst is necessarily within the range from approximately 0.lmm
to approximately 5.0mm. In the alternative, it would have been
obvious to one having ordinary skill in the art to include an
interelectrode distance of the range as cited above in the device of
Whitehurst, since “it is not inventive to discover the optimum or
workable ranges by routine experimentation.”

(Ans. 6-7, quoting In re Aller, 220 F.2d 454, 456 (CCPA 1955). For claim
11, the rejection stated:
While Whitehurst does not disclose a housing with a width within the
range of approx. 10-25mm, Whitehurst does disclose that the
stimulator could be larger or shaped differently (e.g. Page 6,
Paragraph 71). It would have been obvious to one having ordinary
skill in the art at the time the invention was made to include a slightly
larger width of 10mm instead of a width of only 8mm as taught by
Whitehurst, since such a modification would provide the system with
the predictable results of a more effective stimulation device capable
of being placed closer to the intended stimulation target.

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(Ans. 7.)
Appellants contend that “the Examiner has failed to establish that a
person of ordinary skill in the art would have had an apparent reason to
modify the Whitehurst disclosure to arrive at the implantable medical device
recited in claim 9 [or claim 11].” (App. Br. 25.) This argument is
unpersuasive because it shows no error in the Examiner’s findings and
reasoning.

C. Obviousness of claims 15 and 16 over Whitehurst and Bardy
The Examiner found that Whitehurst did not disclose a housing with a
10-45 degree angle, but that Bardy disclosed that “it was known in the
art to form a housing with an angle of two sections between 10-45 degrees
and include flexible bellows between the two sections (e.g. pleats 352;
Figure 29B).” (Ans. 7.) The Examiner concluded that it would have been
obvious “to include the angle and flexible bellows of Bardy in the device of
Whitehurst, since such a modification would provide the system of
Whitehurst with the ability to more completely conform to the location of
implantation for providing the predictable results of complete stimulation of
the desired location.” (Id. at 7.)
Appellants contend “the Examiner has failed to establish that a person
of ordinary skill in the art would have had an apparent reason to modify
Whitehurst in view of Bardy to arrive at the implantable medical device
recited in claim 15 [and claim 16].” (App. Br. 26.) This argument is
unpersuasive because it shows no error in the Examiner’s finding and
reasoning that conforming the device to the implantation site would provide
complete stimulation.
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SUMMARY
We affirm the rejection of claims 1-5, 7, 8, 10, 12-14, 17, and 25-29
under 35 U.S.C. § 102(b) as anticipated by, or in the alternative under
35 U.S.C. § 103(a) as obvious over, Whitehurst.
We reverse the rejection of claim 18 under 35 U.S.C. § 102(b) as
anticipated by, or in the alternative under 35 U.S.C. § 103(a) as obvious
over, Whitehurst.
We affirm the rejection of claims 9 and 11 under 35 U.S.C. § 103(a)
as unpatentable over Whitehurst.
We affirm the rejection of claims 15 and 16 under 35 U.S.C. § 103(a)
as unpatentable over Whitehurst and Bardy.

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-IN-PART

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