Ex Parte Nickel et al

Patent Trial and Appeal Board

Nov 17, 2014

11155985 (P.T.A.B. Nov. 17, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JANICE H. NICKEL,
PETER G. HARTWELL, and
SEAN ZHANG
__________

Appeal 2012-006810
Application 11/155,985
Technology Center 3700
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Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
ROBERT A. POLLOCK, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a smart
drug delivery system. 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 Hewlett-Packard
Development Company (see App. Br. 3).
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Statement of the Case
The Claims
Claims 1, 2, 4–10, 14–18, 27, and 28 are on appeal. Independent
claim 1 is representative and reads as follows:
1. A smart drug delivery system comprising:
a sensor component;
an analytical component coupled to the sensor
component;
a drug delivery component coupled to the analytical
component for delivering a drug to a host; and
an energy harvesting component coupled to the sensor
component, the analytical component and the drug delivery
component, the energy harvesting component being an
inertial device other than a piezoelectric crystal device that
can be internally located on a muscle or diaphragm of the
host and that generates and stores energy based on
movement of the host.

The issues
A. The Examiner rejected claims 1, 2, 4–10, and 15–18 under 35 U.S.C.
§ 103(a) as being obvious over Aceti2 and Estevez3 (Ans. 5–6).
B. The Examiner rejected claims 1, 2, 4–10, and 14–18 under 35 U.S.C.
§ 103(a) as being obvious over Sun4 and Estevez (Ans. 6–8).
C. The Examiner rejected claim 27 under 35 U.S.C. § 103(a) as being
obvious over Aceti or Sun, Estevez, and Allen5 (Ans. 8).

2 Aceti et al., US 2003/0153900 A1, published Aug. 14, 2003.
3 Estevez, L.W., US 6,822,343 B2, issued Nov. 23, 2004.
4 Sun et al., US 5,995,860, issued Nov. 30, 1999.
5 Allen et al., US 6,334,856 B1, issued Jan. 1, 2002.
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D. The Examiner rejected claim 28 under 35 U.S.C. § 103(a) as being
obvious over Aceti or Sun, Estevez, and Casscells III6 (Ans. 8–9).
A. and B. 35 U.S.C. § 103(a) over Aceti or Sun and Estevez
Because both of these rejections turn on the same issues, we will
consider them together. The Examiner relies upon either Aceti or Sun to
teach drug delivery systems with sensor, analytical, and drug delivery
components designed for delivery drugs to a host (Ans. 5–7). The Examiner
finds that “Estevez discloses a device which generates electricity to power
an electronic device connected to the device wherein the device generates
the electricity by harnessing energy from the cardio-pulmonary activity of a
user” (Ans. 6).
The Examiner finds it obvious to “modify the device of Aceti with the
teachings of Estevez in order to make a medical device that did not require
battery replacement” (Ans. 6; cf. Ans. 8 referring to Sun).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Estevez, in combination with either
Aceti or Sun, renders the claims obvious?
Findings of Fact
1. Aceti teaches “a pharmaceutical agent delivery device operable
to deliver a pharmaceutical agent to a subject. The device has a first
plurality of microneedles and a plurality of pharmaceutical agent delivery
microchannels. . . . The device also has a controller operable to initiate
delivery of the pharmaceutical agent” (Aceti 2 ¶ 22).

6 Casscells III et al., US 6,821,249 B2, issued Nov. 23, 2004.
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2. Aceti teaches that “processor 30 controls the operation of the
device and is in data communication with the actuator, motor 32, sensor 34
and interface 38” (Aceti 4 ¶ 73).
3. Aceti teaches that the “microchannels may be filled with drug
and used to deliver drugs used in small doses (high potency). The capability
to deliver drug and or monitor blood analytes in an automated fashion using
a portable device” (Aceti 11 ¶ 144).
4. Aceti teaches that “both the monitoring and pharmaceutical
agent delivery system within one unit (preferably a disposable unit). For
example, military personnel may be unknowingly exposed to a toxin. The
device can periodically extract blood and assay for predetermined toxins. If
a toxin is detected, the device can deliver antidote” (Aceti 11 ¶ 145).
5. Aceti teaches that “at least one pharmaceutical agent delivery
microchannel is sealed with a polymer” (Aceti 2 ¶ 25).
6. Sun teaches
[A]device for both measuring and controlling the level of a
blood constituent in a mammal, and comprises an
implantable infrared source and sensor module for directing
infrared radiation through vascular tissue and for sensing the
infrared radiation after it has passed through the tissue and
generating an output signal representative of the sensed
infrared radiation, a processor module responsive to the
output signal from the infrared source and sensor module for
performing spectral analysis of the output signal and
deriving therefrom a control signal representative of the
level of the blood constituent, and an insulin pump for
dispensing doses of insulin in response to the control signal.

(Sun, col. 4, ll. 33–45.)
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7. Sun teaches that “system 10 comprises a sensor assembly 14
connected to a processor/pump module 16 . . . processor/pump module
dispenses insulin via a non-thrombogenic multilumen catheter including a
one-way valve” (Sun, col. 5, ll. 43–51).
8. Estevez teaches that “generator 16 may include a direct current
(DC) generator with a turbine that, in response to movement of fluid 18
through generator 16 as user 12 breathes, rotates a wire coil around an axis
and through a magnetic field created by permanent magnets to induce an
electric current in the wire coil” (Estevez, col. 2, ll. 66 to col. 3, l. 4).
9. Estevez teaches that
[D]evice 10 may be analogously used to generate electric
power in response to any appropriate cyclical movements of
user 12. For example, device 10 may include[] a cuff or
other structure (e.g., integral to sleeve 30) that can be
secured about the upper arm or leg of user 12 to generate
electric power in response to repeated flexion and extension
of muscles of the upper arm or leg, respectively. Such
cyclical movements may occur naturally during exercise or
other activities or may be undertaken for the express purpose
of generating electric power, for example, in an emergency
situation.

(Estevez, col. 5, ll. 14–23.)
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10. Figure 1 of Estevez is reproduced below:

Figure 1 describes that as “user 12 breathes in the chest
cavity of user 12 expands (as indicated by arrow 36),
causing at least some fluid 18 in inner fluid-containing
portion 20 to move through generator 16 to outer fluid-
containing portion 24 (as indicated by arrows 38) and fluid
interface 32 to move in a first direction (as indicated by
arrow 40). Wall 26 of outer fluid-containing portion 24 may
expand as a result. Conversely, as user 12 breathes out the
chest cavity of user 12 contracts (as indicated by arrow 42),
causing at least some fluid 18 in outer fluid-containing
portion 24 to move through generator 16 to inner fluid-
containing portion 20 (as indicated by arrows 44) and fluid
interface 32 to shift in a second direction opposite the first
direction (as indicated by arrow 46). . . . Movement of fluid
18 through generator 16 from inner fluid-containing portion
20 to outer fluid-containing portion 24 as user 12 breathes
in, from outer fluid-containing portion 24 to inner fluid-
containing portion 20 as user 12 breathes out, or both may
result in the generation of electric power.

(Estevez, col. 3, l. 49 to col. 4, l. 2.)
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11. The Specification teaches that “[o]ne example of such a system
would be an inertial device or a piezoelectric crystal device internally
located on a person’s muscle or diaphragm. The energy conversion device
converts mechanical motion into electrical energy that can be stored in an
inert storage device within the system” (Spec. 14, ll. 23–28).
12. The Specification teaches “a micro-fluidic delivery system that
is configured to operate in conjunction with Micro Electro-Mechanical
System (MEMS) based valves, reservoirs and/or pumps” (Spec. 11, ll. 19–
21).
Principles of Law
“An examiner bears the initial burden of presenting a prima facie case
of obviousness.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
2011).
“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
Claim 1
We begin with claim interpretation, since before a claim is properly
interpreted, its scope cannot be compared to the prior art. The limitation at
issue is an “energy harvesting component being an inertial device other than
a piezoelectric crystal device that can be internally located on a muscle or
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diaphragm of the host and that generates and stores energy based on
movement of the host” as required by claim 1.
During prosecution, claim terms are given their broadest reasonable
interpretation as they would be understood by persons of ordinary skill in the
art in the light of the Specification. See In re Sneed, 710 F.2d 1544, 1548
(Fed. Cir. 1983). We therefore first turn to the Specification, which refers to
an “inertial device” once, stating that “[o]ne example of such a system
would be an inertial device or a piezoelectric crystal device internally
located on a person’s muscle or diaphragm. The energy conversion device
converts mechanical motion into electrical energy that can be stored in an
inert storage device within the system” (Spec. 14, ll. 23–28; FF 11; emphasis
added).
The Specification therefore imposes no specific structural
requirements on the claimed “inertial device,” nor have Appellants provided
any evidence which demonstrates that the skilled artisan would have
interpreted “inertial device” to refer to a particular apparatus.
Consequently, in interpreting the phrase “inertial device” in light of
the Specification and claim 1, we broadly interpret this element functionally
as an apparatus, not comprising a piezoelectric crystal, which “generates and
stores energy based on movement of the host.”
Appellants contend that “Estevez does not teach or suggest such an
inertial device” (App. Br. 11). Appellants contend that “Estevez’s energy
conversion device does not rely upon the physical movement of the host, but
rather relies upon the movement of fluid associated with activity of a
biological system of the host” (Reply Br. 6).
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We are not persuaded. While Estevez does teach an embodiment
relying upon blood flow (see Estevez, col. 6, ll. 1–17), Estevez also teaches
an embodiment shown in Figure 1 which can “generate electric power in
response to repeated flexion and extension of muscles of the upper arm or
leg” (Estevez, col. 5, ll. 14–23; FF 9). The Figure 1 embodiment of Estevez
teaches a device located on a muscle which generates energy based on the
movement of the host, specifically teaching that as the person breathes out,
expansion of the person’s chest cavity moves fluid through a generator to
generate power and then as the person breathes in, contraction of the chest
cavity again moves fluid generating power (FF 9–10).
Claim 17
Appellants contend that “Sun does not teach any alternatives for the
conventional insulin pump, and thus never teaches or even suggests a
MEMS pump” (App. Br. 13).
We are not persuaded. While claim 17 requires “micro electro-
mechanical system based pumps,” no other specific structure is required (see
Spec. 11, ll. 19–21; FF 12). Without any specific structural requirements
identified by the Specification or claim, and where Appellants provide no
evidence of a specific meaning of the phrase to the skilled artisan, we
interpret these “pumps” broadly. Sun teaches a pump for dispensing insulin,
which is reasonably interpreted as mechanically based and which is placed
within the patient, and is therefore micro-sized relative to many other
industrial pumps (FF 7).
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Claim 18
Appellants contend that “Aceti never teaches or even suggests that
this polymer seal is a very small mechanical device that is driven by
electricity (i.e., a MEMS device)” (App. Br. 12). Appellants contend that
“Sun never teaches or even suggests that this one-way valve is a very small
mechanical device that is driven by electricity (i.e., a MEMS device)” (App.
Br. 13).
We are not persuaded. While claim 18 requires “micro electro-
mechanical system based valves,” no other specific structure is required (see
Spec. 11, ll. 19–21; FF 12). Without any specific structural requirements
identified by the Specification or claim, and where Appellants provide no
evidence of a specific meaning of the phrase to the skilled artisan, we
interpret these “valves” broadly. Aceti teaches a microchannel seal, which
functions as a one-time micro-valve for release of drug (FF 5). Sun teaches
a valve for use in dispensing insulin, which is reasonably interpreted as
mechanically based and which is placed within the patient, and is therefore
micro-sized relative to many other industrial valves (FF 7).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Estevez, in combination with either Aceti or Sun, renders claims 1, 17, and
18 obvious.
C. 35 U.S.C. § 103(a) over Aceti or Sun, Estevez, and Allen
Appellants contend that “it appears that Aceti has excluded
electrochemical assays and sensors by omitting them from his examples. In
light of this, one skilled in the art would not be led to replace Aceti’s electro-
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optical or electrical sensors with Allen’s potentiometric sensor” (App. Br.
14). Appellants contend that “[g]iven the drawbacks notes by Sun when
electro-chemical sensors are utilized, one skilled in the art would not be led
to replace the optical radiation and detection system of Sun with the
potentiometric sensor (which is an electro-chemical sensor) of Allen” (App.
Br. 14).
The Examiner finds that “just because electrochemical sensors are not
the preferred embodiment does not mean that electrochemical sensors are
excluded from consideration” (Ans. 12). The Examiner finds that “the
references are analogous in that Sun and Allen both disclose sensors for the
measurement of blood glucose and the [sic] therefore the combination is still
deemed to be proper” (Ans. 12).
We find that the Examiner has the better position. Disclosed
examples and preferred embodiments do not constitute a teaching away from
a broader disclosure or non-preferred embodiments. In re Susi, 440 F.2d
442, 446 n.3 (CCPA 1971). Further, a teaching away requires a reference to
actually criticize, discredit, or otherwise discourage the claimed solution.
See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (“The prior art’s
mere disclosure of more than one alternative does not constitute a teaching
away from any of these alternatives because such disclosure does not
criticize, discredit, or otherwise discourage the solution claimed”).
Appellants do not identify any teaching in Aceti which criticizes,
discourages, or discredits the use of a potentiometric sensor.
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D. 35 U.S.C. § 103(a) over Aceti or Sun, Estevez, and Casscells III
Appellants contend that “Aceti and Sun focus on the testing of blood,
for example, for glucose levels . . . [n]either a heart rate monitor nor a breath
rate monitor would be suitable for these purposes” (App. Br. 15–16).
Appellants “submit that the Office has not provided the required rational
underpinning to combine Casscells with Aceti and/or Sun and thus has failed
to set forth a prima facie case of obviousness” (App. Br. 16).
The Examiner responds that the rejection is “not suggesting the
substitution of the sensors of Aceti and Sun for the sensor of Casscells but is
suggesting including the sensor of Casscells in addition to the sensors of
Aceti and Sun. The motivation to do so would be if the patient treated by
the Aceti or Sun device also suffered from congestive heart failure” (Ans.
12).
We find that the Examiner has the better position. The Examiner has
provided a specific reason to incorporate Casscells III heart rate sensor into
the sensor devices of either Aceti or Sun, which is to combine two medical
devices into a single device for treatment of suitable patients requiring both
interventions. Such a combination is merely a “predictable use of prior art
elements according to their established functions.” KSR, 550 U.S. at 417.

SUMMARY
In summary, we claims 1, 17, and 18 under 35 U.S.C. § 103(a) as
being obvious over Aceti and Estevez. Pursuant to 37 C.F.R. § 41.37(c),
claims 2, 4–10, 15, and 16 fall with claim 1, as these claims were not argued
separately.
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We affirm the rejection of claims 1, 2, 4–10, and 14–18 under
35 U.S.C. § 103(a) as being obvious over Sun and Estevez. Pursuant to
37 C.F.R. § 41.37(c), claims 2, 4–10, and 14–16 fall with claim 1, as these
claims were not argued separately.
We affirm the rejection of claim 27 under 35 U.S.C. § 103(a) as being
obvious over Aceti or Sun, Estevez, and Allen.
We affirm the rejection of claim 28 under 35 U.S.C. § 103(a) as being
obvious over Aceti or Sun, Estevez, and Casscells III.

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

cdc