Richard T. Stone et al.

Patent Trials and Appeals Board

Jan 16, 2020

13982159 - (D) (P.T.A.B. Jan. 16, 2020)

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.
13/982,159 07/26/2013 Richard T. Stone 1123-012US01/
P0035838.USN
5116
71996 7590 01/16/2020
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
KREMER, MATTHEW
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
01/16/2020 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):
pairdocketing@ssiplaw.com
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 RICHARD T. STONE and XUAN WEI

Appeal 2017-010175
Application 13/982,159
Technology Center 3700
____________

Before MICHELLE R. OSINSKI, SUSAN L. C. MITCHELL, and
GEORGE R. HOSKINS, Administrative Patent Judges.

MITCHELL, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
The Appellant1 seeks our review under 35 U.S.C. § 134(a) of the
Examiner’s rejections of claims 13–41 as set forth in a Final Office Action.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real parties in interest as
Medtronic, Inc. and Medtronic plc, the ultimate parent entity of Medtronic,
Inc. Appeal Brief (March 13, 2017) (“Appeal Br.”) 3.
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Final Office Action (October 13, 2016) (“Final Act.”); 37 C.F.R.
§ 41.31(a)(1). We have jurisdiction under 35 U.S.C. § 6(b).
The Examiner rejected the claims as unpatentable for failure to
comply with the written description requirement, indefiniteness, and
obviousness. Appellant argues that the claims, as properly interpreted, have
adequate written description support and are not indefinite. Appellant also
argues that the prior art does not disclose all the elements of the claims on
appeal.
For the reasons explained below, we sustain the indefiniteness
rejection concerning claims 28 and 29 and do not sustain the remaining
rejections. Thus, we affirm in part.
CLAIMED SUBJECT MATTER
The claimed subject matter relates to an implantable medical device
(“IMD”) that produces and detects pressure waves with a portion of the IMD
housing to detect a physiological state of a patient. Spec. Abst., ¶ 5. Claims
13, 24, and 36 are independent. Claim 13 is illustrative and reads as follows
with particular emphasis on the claim language that is the focus of our
analysis.
13. A method comprising:
producing a pressure wave within a patient with a
portion of a device housing of an implantable medical device
using an actuator element configured to contact the portion of
the device housing, wherein the device housing encloses a
processor and the actuator element, and wherein the
implantable medical device is configured to couple to an
implantable medical lead;
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detecting at least one reflected pressure wave with the
portion of the device housing; and
determining, by the processor and based on the at least
one reflected pressure wave, a physiological condition of the
patient.
Appeal Br. 34.
Independent claim 24, an apparatus claim, has similar language
requiring “an actuator element configured to contact a portion of the device
housing to produce a pressure wave within a patient with the portion of the
device housing.” Id. at 37. Similarly, independent claim 36, also an
apparatus claim, has similar language requiring a “means for producing a
pressure wave within a patient with a portion of a device housing of an
implantable medical device.” Id. at 41.
EVIDENCE
The prior art on which the Examiner relies in rejecting the claims on
appeal is:
Name Reference Date
Gerber US 2007/0027494 A1 Feb. 1, 2007
Penner et al. US 2004/0204744 A1 Oct. 14, 2004
Von Arx et al. US 2006/0009818 A1 Jan. 12, 2006
Tepper et al. US 5,524,624 June 11, 1996
Rondoni et al. US 2007/0255176 A1 Nov. 1, 2007
Guly et al. WO 86/06606 Nov. 20, 1986
Freudenrich How Ultrasound Works, printed in
http://www.physics.utoronto.ca
Feb. 1, 2001
Chua The Principles of Medical Ultrasound,
printed in http://www.mrcophth.com/
commonultrasoundcases
Feb. 1, 2001
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Name Reference Date
Simmons Medical Physics - Ultrasound, printed
in http://www.genesis.net.au
Aug. 2, 2003
Dynamic
Ultrasound
Group
Fundamentals of Ultrasound Imaging,
printed in http://dynamicultrasound.org
March 11, 2007

REJECTIONS
The Final Office Action includes the following rejections:
1. Claim 39 is rejected under 35 U.S.C. § 112, first paragraph,
as failing to comply with the written description requirement;
2. Claims 24–35, 40, and 41 are rejected under 35 U.S.C. § 112,
second paragraph, as being indefinite;
3. Claims 13–16, 19–27, and 30–41 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Gerber and at least one
of Penner, Von Arx, or Tepper; and
4. Claims 17 and 28 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Gerber and at least one of Penner,
Von Arx, or Tepper, and one or more of Freudenrich, Chua,
Simmons, and Dynamic Ultrasound Group;
5. Claims 13–16, 19–27, and 30–41 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Rondoni, Guly, Gerber,
and at least one of Penner, Von Arx, or Tepper;
6. Claims 17, 18, 28, and 29 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Rondoni, Guly, Gerber,
and at least one of Penner, Von Arx, or Tepper, and one or
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more of Freudenrich, Chua, Simmons, and Dynamic
Ultrasound Group.
ANALYSIS
Written Description Rejection
The Examiner determines that the limitation in claim 39 reciting
“means for controlling, based on the physiological condition, the electrical
stimulation therapy,” is a means-plus-function limitation under 35 U.S.C.
§ 112 with processor 56 and processor 82 as corresponding structure
described in the Specification. Final Act. 4. The Examiner further
determines that there is no written description support for this limitation
“because the specification fails to provide the algorithm (e.g., the necessary
steps and/or flowcharts) that performs the claimed function of controlling,
based on the physiological condition, the electrical stimulation therapy.” Id.
at 6.
Appellant responds that the Specification does provide such an
algorithm. Appeal Br. 22–26. Appellant specifically points to paragraphs
38, 61, 71, and 110 as providing “example algorithms for ‘controlling, based
on [a] physiological condition, [] electrical stimulation therapy,” such that
sufficient detail is provided for one of skill in the art to reasonably conclude
that Appellant had possession of the claimed invention. Id. at 23.
To satisfy the written description requirement, “the [original]
specification must describe an invention understandable to that skilled
artisan and show that the inventor actually invented the invention claimed.”
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
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(en banc). “[T]he test for sufficiency is whether the disclosure of the
application relied upon reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date.”
Id. “[T]he level of detail required to satisfy the written description
requirement varies depending on the nature and scope of the claims and on
the complexity and predictability of the relevant technology.” Id. at 1351
(citing Capon v. Eshhar, 418 F.3d 1349, 1357–58 (Fed. Cir. 2005)).
When construing a means-plus-function limitation under 35 U.S.C.
§ 112, ¶ 6, the corresponding structure of a computer-implemented, means-
plus-function limitation that performs a particular function, in this case
processors 56 or 82, must be more than simply a general-purpose computer
or microprocessor to avoid impermissible functional claiming. Aristocrat
Techs. Austl. Pty Ltd. v. Int’l Game Tech., 521 F.3d 1328, 1333 (Fed. Cir.
2008); see In re Katz Interactive Call Proc. Patent Litig., 639 F.3d 1303,
1316 (Fed. Cir. 2011). That is, the specification must disclose “enough of an
algorithm to provide the necessary structure under § 112” or a disclosure
that can be expressed in any understandable terms, e.g., a mathematical
formula, in prose, or as a flowchart. Finisar Corp. v. The DirectTV Grp.,
Inc., 523 F.3d 1323, 1340 (Fed. Cir. 2008). Simply reciting a claimed
function in the specification, and saying nothing about how the computer or
processor ensures that such a function is performed, is not a sufficient
disclosure for an algorithm which, by definition, must contain a sequence of
steps. Blackboard, Inc. v. Desire2Learn, Inc., 574 F.3d 1371, 1384 (Fed.
Cir. 2009).
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We agree with Appellant that sufficient detail, including the necessary
steps and flowcharts, is provided for one of skill in the art to reasonably
understand that Appellant had possession of the claimed subject matter
including a “means for controlling, based on the physiological condition, the
electrical stimulation therapy.” For instance, the Specification states that the
IMD controls delivery of a second electrical stimulation therapy to a patient
based on a physiological condition such as bladder fullness determined by
reflected pressure waves detected by a portion of the IMD housing. Spec.
¶ 38. The Specification also states that processor 56 controls therapy
delivery module 64, which may be done by selectively accessing and
loading stimulation therapy programs 60 to therapy delivery module 64. Id.
¶¶ 61, 71.
The Specification also states that the therapy program “may define a
set of therapy parameters that define the electrical stimulation, e.g., pulse
rate, pulse width, voltage or current amplitude, and pulse frequency,” see
Spec. ¶ 29, and describes that “the stimulation parameters for stimulation
therapy programs 60 may be selected to relax bladder 12 (FIG. 1) or close or
maintain internal urinary sphincter closure or urethral tone.” Spec. ¶ 65.
Example ranges of stimulation parameters for a first stimulation therapy
program that may be applied to the sacral or pudendal nerves include
frequency, amplitude, and pulse width. Id. ¶ 65. The Specification also
describes second stimulation therapy programs “to maximize the closure of
one or more of internal urinary sphincter, external urinary sphincter, and
periurethral muscles . . . [and] may also be selected to minimize muscle
fatigue.” Id. ¶ 66. Example ranges of stimulation parameters for a second
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stimulation therapy program are also described. Id. ¶ 67. The Specification
also provides a specific example of a stimulation therapy program that
delivers more than one set of stimulation parameters to activate fast-twitch
and then slow-twitch muscle fibers. Id. ¶¶ 68–69.
Figure 6, set forth below, depicts a flow diagram of an example
technique for determining a bladder fullness state with pressure waves
generated and detected by the housing of IMD 20.

In describing Figure 6 set forth above, the Specification states:
In response to determining the determined bladder
fullness state is above the fullness threshold (“YES” branch of
block 122), processor 56 controls therapy delivery module 64 to
deliver stimulation therapy to patient 14, where the electrical
stimulation is configured to compensate for the determined
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bladder fullness state (124), e.g., to help prevent an
incontinence event. Stimulation control may be in the form of
adjusting a single stimulation parameter, e.g., increasing a
voltage amplitude value or frequency (e.g., according to therapy
adjustment instructions associated with the detected bladder
fullness state in memory 58), or delivering stimulation
according to a different or additional therapy program (e.g., a
stimulation therapy program 60 associated with the detected
bladder fullness state in memory 58), or delivering a second
stimulation therapy, e.g., a “boost” to the first stimulation
therapy already delivered to patient 14.
Spec. ¶ 110.
From these exemplary descriptions, we find that Appellant has
provided a sufficiently fulsome description of steps in prose and the
flowchart set forth in Figure 6 for one of skill in the art to reasonably
understand that Appellant had possession of the claimed subject matter
including a “means for controlling, based on the physiological condition, the
electrical stimulation therapy.”
Therefore, we do not sustain the Examiner’s rejection of claim 39 as
failing to comply with the written description requirement.
Indefiniteness Rejection
The Examiner rejected several claims as indefinite for failing to
particularly point out and distinctly claim the subject matter of the invention.
Final Act. 6–9.
We determine that a claim is indefinite “when it contains words or
phrases whose meaning is unclear.” Ex parte McAward, Case No. 2015-
006416, slip op. at 11 (PTAB Aug. 25, 2017) (citing In re Packard, 751 F.3d
1307, 1313 (Fed. Cir. 2014) (per curiam)). In other words, “claims are
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required to be cast in clear—as opposed to ambiguous, vague, indefinite—
terms.” Id. This requirement, however, does not demand unreasonable
precision in drafting. Id. We apply this standard to the claims that the
Examiner rejected as indefinite.
A. Claim 24
The Examiner rejects claims 24–35, 40, and 41 as indefinite for
failing to particularly point out and distinctly claim the subject matter of the
invention because the recitation of an actuator element or a detector element
as detecting at least one reflected pressure wave with a portion of the device
housing renders claim 24 unclear as to whether a detector is required. Final
Act. 6–7. The Examiner determines that claims 25 through 35 and claims 40
and 41, all of which depend on claim 24, suffer from the same defect. Id.
at 7.
As to claim 24 and those claims which depend from claim 24,
Appellant asserts that the alternative between whether an actuator or a
detector element detects at least one pressure wave with a portion of the
device housing is acceptable because it is clear from the Specification that
an actuator element and a detector element may be a single element such that
a separate detector element is absent. Appeal Br. 27 (citing Spec. ¶ 75);
Reply Br. 18 (stating “claim 24 merely recites two alternatives for what
element is configured to detect at least one reflected pressure wave with a
portion of the device housing”).
Although the detector element is not listed separately as a limitation
of claim 24, it is clear from the language used by the Appellant that a
detector element is not part of the apparatus as claimed in claim 24 if the
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actuator element is used to detect the pressure wave as opposed to the
detector element. This interpretation is supported by the Specification as
pointed out by Appellant. The Specification provides:
In other examples, actuator element 72 and detector element 74
may be a single element. Actuator element 72 and detector
element 74 may be, for example, a single piezoelectric element
that transforms energy between mechanical and electrical states.
Accordingly, in some examples, actuator circuit 68 and detector
circuit 70 may be a single electrical circuit that both produces
and detects pressure waves with housing 52 of IMD 20.
Spec. ¶ 75. As Appellant has stated, “there is no question as to scope or
clarity, but instead there is a clear binary pair of options.” Reply Br. 18.
Therefore, we do not sustain the rejection of claims 24–35, 40, and 41
as indefinite as being unclear as to whether a detector is required.
B. Claims 28 and 29
The Examiner also finds that claims 28 and 29 have the additional
problem of a recitation of “one or more circuits” where it is not clear if those
circuits are part of the processor of claim 24 or a separate and distinct set of
circuits. Final Act. 7–8. Appellant responds that the claims clearly state that
the acoustic module comprises the claimed one or more circuits, and if the
processor is a circuit, “one of ordinary skill in the art would have understood
that the acoustic module may have separate circuits to perform this feature
or include the processor as part of the acoustic module.” Appeal Br. 28
(citing Spec. ¶¶ 71, 73).
The Examiner maintains that the processor of claim 24 and the
acoustic module of claims 28 and 29 are separate and distinct elements as
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evidenced by the transitional phrase “further comprising” of claims 28 and
29. Ans. 35. Specifically, the Examiner states:
On their face, claims 28 and 29 present one or more circuits
(being part of the acoustic module) as being an additive element
to all the previously cited elements due to the use of the
transitional phrase “further comprising”. However, the
specification and the Appellant’s remarks indicate this is not
always the case. Thus, there is a contradiction to the
presentation of the claim elements and what these claim
elements are intended to encompass.
Id. at 36.
Appellant replies:
To the extent that the one or more circuits may include the
processor recited in claim 24, all claim 28 recites is that the
acoustic module now includes the processor. Dependent claim
28 thus would narrow the recited features as including an
additional relationship between the acoustic module and the
processor.
Reply Br. 20.
We agree with the Examiner that the recitation of “one or more
circuits” in claims 28 and 29 is unclear. Both claims 28 and 29 depend
directly from claim 24 that recites a system comprising at least an actuator
element and a processor that is configured to determine a physiological
condition of the patient based on a reflected pressure wave. Appeal Br. 37–
38. Both dependent claims 28 and 29 recite the system of claim 24 “further
comprising an acoustic module comprising at least one of the actuator
element or the detector element and one or more circuits” configured to
determine various data concerning the reflected pressure wave. Id. at 38.
It is unclear from the further recitation of claims 28 and 29 whether
the “one or more circuits” are part of the processor of claim 24, or a separate
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circuit. Appellant admits that the acoustic module may now include the
processor, but that is not made clear from the language used in dependent
claims 28 and 29 that just recite “one or more circuits” without defining the
circuit(s)’ relationship to the processor recited in claim 24.
Therefore, we sustain the rejection of claims 28 and 29 as indefinite.
C. Claim 36
The Examiner rejects claim 36 as indefinite because it is not clear
from the Specification what structure, whether the processor or acoustic
module, is intended to perform the “means for determining.” Final Act. 8–9.
Appellant responds that the “means for determining” could include “any
structures described by the specification,” such as the processor. Appeal
Br. 32. The Examiner responds that this blurring of the lines between what
functions are performed by the acoustic module and those performed by the
processor renders the claim indefinite. Ans. 37–38.
We agree with Appellant that the fact that the Specification describes
two structures that can perform the function of the “means for determining”
does not render the claimed means-plus-function limitation unclear. That
two structures may perform the function renders the claim broader than if
the structure performing the function of the means limitation were specified
in the claim, but not unclear.
Therefore, we do not sustain the rejection of claim 36 as indefinite.
D. Claim 39
Finally, the Examiner rejects claim 39 for failing to disclose a
corresponding algorithm that performs the function of controlling, based on
the physiological condition, the electrical stimulation therapy, the same
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rationale as for the written description rejection discussed above. Final
Act. 9.
For the same reasons set forth above with regard to the written
description rejection of claim 39, we do not sustain the rejection of claim 39
as indefinite.
Rejection of claims 13–16, 19–27, and 30–41 over Gerber and at least one
of Penner, Von Arx, or Tepper
The Examiner relies primarily on Gerber to teach the majority of the
claim limitations in each independent claim. See Final Act. 10–12, 14–15,
18–19. Specifically, concerning the requirement of each claim of producing
“a pressure wave within a patient with a portion of a device housing” of an
implantable medical device, the Examiner recognizes that Gerber alone does
not teach this limitation. See, e.g., id. at 10–12; Ans. 38–39.
The Examiner states the following:
Gerber teaches the use of implantable ultrasound sensors
(entire disclosure including paragraph 0058; FIGS. 3 and 4C;
transceiver(s) 46 detects the reflected waves). It is known in the
art to seal the components, including the acoustic/ultrasound
sensors/transducers, in a titanium casing so as to protect the
sensors/transducers and internal components from the
environment (paragraphs 0035 and 0055 of Penner; paragraphs
0044-0051 and FIGS. 4-9 of Von Arx) and/or to use a titanium
device housing as part of the sensor-transducer as an alternative
construction of the sensor/transducer (FIG. 8 and cols. 5-6 and
12 of Tepper). It would have been obvious to one of ordinary
skill in the art at the time of the invention to seal the components,
including the ultrasound sensors of the combination, in a titanium
or stainless steel casing so as to protect the sensors/transducers
and internal components from the environment and/or to use a
titanium device housing as part of the sensor/transducer since it
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is a simple substitution of one known element for another to
obtain predictable results.
Final Act. 10–11.
With reference to the requirement of independent claims 13, 24, and
36 of producing “a pressure wave within a patient with a portion of a device
housing,” the Examiner cites to “the transceiver or the actuating unit of the
transceiver produces ultrasonic waves in a housing constituted by the
housing 31 of Gerber, the lead 24C of Gerber, and the titanium or stainless
steel casing of the combination” and references the analysis set forth
immediately above. Id. at 11, 14–15, 18, respectively.
Appellant asserts that the combination proposed by the Examiner is in
error because “there would have been no apparent reason that would have
caused one of ordinary skill in the art to modify the applied references to
arrive at the claimed features.” See Appeal Br. 7–8. For instance, Appellant
states that the Examiner has not alleged that Gerber teaches producing a
pressure wave within a patient with a portion of a device housing, much less
shown how combining Gerber’s system with a “titanium or stainless steel
casing” as disclosed in Penner, Von Arx, or Tepper would arrive at a method
that includes producing a pressure wave within a patient with a portion of a
device housing, “wherein the device housing encloses a processor and the
actuator element,” as required by claim 13. Appeal Br. 8–9.2

2 Independent claim 24 has a similar requirement that “the device housing
encloses the processor and the actuator element.” Appeal Br. 37.
Independent claim 36 also requires that “the housing encloses a processor
and at least a portion of the means for producing the pressure wave with the
portion of the device housing.” Id. at 41.
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The Examiner responds that Appellant is improperly attacking the
references individually because the Examiner is relying on the housing 31 of
Gerber, the lead 24C of Gerber, and the titanium or stainless steel casing of
the combination to teach the claimed “device housing.” Ans. 38–39. The
Examiner explains that:
The housing of the combination encloses the processor
because a housing part constituted by the housing part 31 of
Gerber encloses the processor 32 of Gerber. This housing
part 31 of Gerber is also part of the housing along with the
titanium casing portion covering the sensor/transducers. There
is no requirement in the claim language that the housing be a
contiguous piece of material. In other words, there is nothing in
the claim language to preclude the housing from being made of
multiple parts. In the case of the combination, the housing has
multiple parts: housing part 31 of Gerber, the lead 24C of
Gerber, and the titanium or stainless steel casing portion of the
combination.
Id. at 39–40.
Appellant responds that the Examiner has not provided reasoning as to
why one of ordinary skill in the art would locate the transceiver that is on the
distal end of sensing lead 24 of Gerber within the structure that is also
described as the housing of Gerber. Reply Br. 3–4. Appellant further argues
that “even if it were obvious to seal an ultrasound transceiver of Gerber with
a titanium or stainless steel casing, the Examiner has not explained how the
suggested combination teaches producing a pressure wave within a patient
with a portion of a device housing of an implantable medical device,
wherein the housing encloses the processor.” Id. at 5. Appellant points to
the references that are used by the Examiner in the rejection to show that the
definition of “housing” as used by the Examiner is just too broad. Id. at 5–8.
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Appellant concludes that:
Appellant did not and is not making the argument that one of
ordinary skill in the art [would] “simply not” cover the
ultrasound sensor with a titanium or stainless steel casing.
Rather, Appellant is asserting that there is no definition of a
housing of an implantable medical device as would be
understood by one skilled in the art that would include both
housing 31 of Gerber and lead 24 of Gerber. Thus, whether or
not the transceiver was independently encased in a stainless
steel casing that could be defined as a housing, such a potential
housing could not be the same housing as housing 31 that
contains processing electronics.
Id. at 8.
We agree with Appellant that the asserted combination does not teach
producing a pressure wave within a patient with a portion of a device
housing of an implantable medical device or such a device wherein the
housing encloses the processor. A review of the claimed subject matter and
what Gerber teaches is instructive.
With regard to the claimed subject matter at issue here, the IMD
detects a physiological state of a patient as follows.
The portion of the IMD housing may be a free wall that is
configured to move (e.g., oscillate) to generate pressure waves
that are transmitted into adjacent fluids or tissue within a body
of a patient and detect the pressure waves that were transmitted
through tissue or fluid within the body. An actuator element
contacts the free wall to generate pressure waves, and a detector
may contact the free wall to detect wall motion. Based on the
relative position of anatomical structures and bodily fluids to
the IMD housing, the IMD may determine a physiological
condition of a patient.
Spec. ¶ 5.
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Figure 5 set forth below is a conceptual cross-sectional diagram
illustrating such an IMD.

As shown in Figure 5 above, IMD 20 has outer housing 52, battery 98,
operational circuitry 100, acoustic module 66, actuator element 72, detector
element 74, and connector ribbons 92 and 94. Id. ¶ 99. Operational
circuitry 100 may include processor 56. Id. Outer housing 52 has free wall
54, a portion of housing 52 that is designed to move (e.g., vibrate or
oscillate) relative to other portions of housing 52, as well as relative to
battery 98 and operational circuity 100. Id. ¶ 100. Housing 52 may be made
of a single material such as biocompatible materials like metal alloys (e.g.,
stainless steel or titanium alloys), or any combination of materials such as a
ceramic composite for free wall 54, while the balance of housing 52 is a
titanium alloy. Id. ¶ 105. Housing 52 may also be “any variety of shapes
and sizes configured to implant IMD 20 at specific locations within patient
14.” Id.
The operation of free wall 54 of housing 52 is further described as
follows.
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Few, if any (e.g., sometimes none), rigid components are
attached or mounted to free wall 54, thereby permitting free
wall 54 freedom of motion to vibrate. Free space 96 is the
volume of space within housing 52 adjacent to free wall 54 that
allows free wall 54 to move in relation to the rest of housing 52.
Free space 96 may be a vacuum or filled with air, filled with a
gas mixture, or filled with an inert single gas. Although free
space 96 may be of any volume, the distance between the inside
surface of free wall 54 and other components is at least large
enough to allow free wall 54 to move enough to produce the
pressure waves of the desired frequency or to receive the
reflected pressure waves. In the example shown in FIG. 5, the
curved side walls of housing 52 provide a relatively stiff
support structure for free wall 54.
Actuator element 72 and detector element 74 contact free
wall 54 either directly or indirectly (e.g., via an intervening
adhesive or other intervening component). Acoustic module 66
is electrically coupled to actuator element 72 via conductive
ribbon 92 and detector element 74 via conductive ribbon 94
passing through free space 96. . . . [A]ctuator element 72 is
configured to produce pressure waves by causing motion of free
wall 54 (e.g., oscillations of free wall 54). The produced
pressure waves are transmitted away from free wall 54 and
IMD 20. At least some of the transmitted pressure waves that
reflect off of anatomical structures or other changes in medium
density traverse back through patient 14 to contact free wall 54.
The contact made by the reflected pressure waves causes
vibration or motion in free wall 54. Detector element 74
contacting free wall 54 is configured to detect these vibrations
or motions and converts them to electrical signals with which
acoustic module 66 may determine a bladder fullness state of
patient 14.
Id. ¶¶ 100–101.
Gerber, on the other hand, describes a device that provides
transmembrane sensing of internal bladder conditions by implanting a
sensing device outside the bladder, but using a sensor deployed within the
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bladder on the end of a lead extending from the sensing device that
penetrates the bladder wall. Gerber ¶¶ 5, 20–21. Gerber’s Figure 3, shown
below, depicts such a device.

As shown in FIG. 3 [above], sensing device 16 includes a
device housing 31 and sensing lead 24 that extends from the
housing through bladder wall 38 and into bladder 14. The
distal end of sensing lead 24 carries sensor 26. Device
housing 31 includes a circuit board 32 carrying sensing
circuitry which is electronically coupled to sensor 26, as well as
a power source 34.
Id. ¶ 24.
The Examiner determines that one of skill in the art would view
Gerber as teaching the claimed device housing from Gerber’s housing 31
and lead 24 that penetrates the bladder wall with sensor 26 mounted on the
distal end of lead 24. The Examiner then combines Gerber’s alleged device
Appeal 2017-010175
Application 13/982,159

21
housing teaching with Penner and Von Arx’s teachings of encasing
vulnerable components in a titanium casing to protect them from the
environment and the teaching of Tepper that such a casing may be used as
the sensor-transducer. We agree with Appellant that one of skill in the art
would not make these leaps from these teachings to arrive at the claimed
invention.
We do not agree that one of skill in the art would view housing 31 and
lead 24 of Gerber as the claimed device housing. In reviewing the claimed
subject matter in light of the Specification, it is clear that the device housing
of the claimed IMD would not be considered as including a lead that extends
from the device with a sensor on the proximal end of that lead. The sensing
of the physiological conditions of the bladder are performed by the claimed
subject matter by producing pressure waves from the housing itself as shown
by example in Appellant’s Figure 5, as set forth and described above, and
not by a sensor mounted on the distal end of a lead that extends from the
housing. Although we acknowledge that the Specification states that the
housing may be a variety of shapes, we agree with Appellant that one of skill
in the art in reviewing Gerber would not include lead 24 as part of the
claimed device housing. To read the device housing of the claimed subject
matter as including such a lead would strain the meaning of “device
housing” as used in the claimed subject matter and also as shown in Gerber,
Penner, Von Arx, and Tepper that all use “device housing” in a consistent
manner as the Specification of the claimed subject matter at issue here.
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Application 13/982,159

22
Therefore, we do not sustain the Examiner’s rejection of claims 13–
16, 19–27, and 30–41 over Gerber and at least one of Penner, Von Arx, and
Tepper.
Remaining Obviousness Rejections of claims 13–41
In the remaining obviousness rejections, the Examiner relies on the
same finding that the claimed “housing” for “producing a pressure wave
within a patient with a portion of a device housing” is taught by housing 31
of Gerber, the lead 24C of Gerber, and the titanium or stainless steel casing
of the combination of Penner, Von Arx, or Tepper with Gerber. See Final
Act. 20–23; Pre-appeal Conference Dec. 6–9; Ans. 45–47.
For the same reasons discussed above, we do not sustain the
remaining rejections under 35 U.S.C. § 103(a) of claims 13–41.
DECISION
The decision of the Examiner rejecting claims 28 and 29 as indefinite
is affirmed. The remaining rejections are reversed.
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).
Appeal 2017-010175
Application 13/982,159

23
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
39 112, first
paragraph
(pre-AIA)
Written Description 39
24–35, 40,
41
112, second
paragraph
(pre-AIA)
Indefiniteness 28, 29 24–27, 30–
35, 40, 41
13–16, 19–
27, 30–41
103

Gerber, Penner, Von
Arx, Tepper
13–16, 19–
27, 30–41
17, 28 103

Gerber, Penner, Von
Arx, Tepper,
Freudenrich, Chua,
Simmons, Dynamic
Ultrasound Group
17, 28
13–16, 19–
27, 30–41
103

Rondoni, Guly,
Gerber, Penner, Von
Arx, Tepper
13–16, 19–
27, 30–41
17, 18, 28,
29
103

Rondoni, Guly,
Gerber, Penner, Von
Arx, Tepper,
Freudenrich, Chua,
Simmons, Dynamic
Ultrasound Group
17, 18, 28,
29
Overall
Outcome
28, 29 13–27, 30–
41

AFFIRMED IN PART