Ex Parte Hood et al

Patent Trials and Appeals Board

May 1, 2013

11335786 - (D) (P.T.A.B. May. 1, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte LEROY E. HOOD, MURIEL Y. ISHIKAWA,
EDWARD K.Y. JUNG, ROBERT LANGER,
CLARENCE T. TEGREENE, LOWELL L. WOOD JR.,
and VICTORY Y.H. WOOD
__________

Appeal 2012-001955
Application 11/335,786
Technology Center 3700
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a delivery
system and method of delivery. The Examiner rejected the claims as
indefinite, as anticipated and as obvious. We have jurisdiction under 35
U.S.C. § 6(b). We affirm-in-part.

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Statement of the Case
Background
“[T]he present application relates to remotely controlled delivery
devices in which the concentration of a material in a fluid to be delivered
may be varied” (Spec. 6).
The Claims
Claims 1-3, 20, 23-25, 37, 42, 45-47, 57-63, and 66-70 are on appeal.
Claim 1 is representative and reads as follows:
1. A delivery system, comprising:
a delivery device including:
a fluid-containing structure having at least one
outlet through which fluid may exit the fluid-
containing structure;
a delivery fluid contained within the fluid-
containing structure;
a primary material contained within the fluid-
containing structure and having a controllable
effective concentration in the delivery fluid; and
at least one electromagnetically responsive
control element responsive to an incident
electromagnetic control signal by one or more of
heating, cooling, vibrating, expanding, stretching,
unfolding, contracting, deforming, softening, or
folding to modify the distribution of the primary
material between a first active form carried in the
delivery fluid and a second form within the fluid-
containing structure in response to the incident
electromagnetic control signal to modify the effective
concentration of the primary material in the delivery
fluid, the effective concentration being the
concentration of the first active form in the delivery
fluid; and

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a remote controller including:
an electromagnetic signal generator capable of
producing the electromagnetic control signal
sufficient to activate the electromagnetically
responsive control element of the delivery device
located in an environment to change the effective
concentration of the primary material in the delivery
fluid within the fluid-containing structure of the
delivery device; and
an electromagnetic signal transmitter capable of
wirelessly transmitting the electromagnetic control
signal to the electromagnetically responsive control
element of the delivery device in the environment.

The issues
A. The Examiner rejected claim 60 under 35 U.S.C. § 112, second
paragraph as indefinite (Ans. 5).
B. The Examiner rejected claims 1, 2, 20, 23, 25, 37, 45-47, 57-63, and
66-70 under 35 U.S.C. § 102(e) as anticipated by Coppeta1 (Ans. 6-9).
C. The Examiner rejected claim 24 under 35 U.S.C. § 103(a) as obvious
over Coppeta (Ans. 11).
D. The Examiner rejected claim 3 under 35 U.S.C. § 103(a) as obvious
over Coppeta and Lurvey2 (Ans. 11-12).
E. The Examiner rejected claim 42 under 35 U.S.C. § 103(a) as obvious
over Coppeta and Falk3 (Ans. 12).

1 Coppeta et al., US 2005/0055014 A1, published Mar. 10, 2005.
2 Lurvey et al., US 2006/0224128 A1, published Oct. 5, 2006.
3 Falk et al., US 2005/0191194 A1, published Sep. 1, 2005.
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A. 35 U.S.C. § 112, second paragraph
The Examiner finds that “Claim 60 discloses a remote controller
which is ‘configured to produce a rotating electromagnetic signal.’ The
examiner is unable to determine the meets and bounds of the claim with
regards to this limitation” (Ans. 5). The Examiner finds that while the
Specification “describes electromagnetic control signals can have particular
signal characteristics (frequency, phase, amplitude, etc.) to control
electromagnetically responsive control elements, the specification does not
clearly link these particular signal characteristics as associated with ‘a
rotating electromagnetic signal’” (Ans. 5).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that claim 60 is indefinite?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
1. The Specification teaches that:
Selective activation or control of electromagnetically
responsive control elements may be achieved by configuring
electromagnetically responsive control elements to be
activated by electromagnetic control signals having
particular signal characteristics, which may include, for
example, particular frequency, phase, amplitude, temporal
profile, polarization, and/or directional characteristics, and
spatial variations thereof. For example, different control
elements may be responsive to different frequency
components of a control signal, thereby allowing selective
activation of the different control elements.

(Spec. 48).
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2. The Specification teaches that the “remote controller may be
configured to produce a rotating electromagnetic signal, the rotating
electromagnetic signal capable of activating the two or more delivery
devices independently as a function of the orientation of the rotating
electromagnetic signal” (Spec. 48).
Principles of Law
The fact that a claim is broad does not mean that it is indefinite, and
even undue breadth is not indefiniteness. In re Johnson, 558 F.2d 1008,
1016 n.17 (CCPA 1977).
Analysis
The Examiner “is unable to determine the meets and bounds of the
claim with regards to this limitation” (Ans. 5). It is clear that the Examiner
actually finds that it is the breadth of the claim, rather than the literal
meaning of the claim, indefinite. While a variety of different components of
an electromagnetic signal may vary in a “rotating electromagnetic signal”,
the Examiner does not contend that the term “rotating electromagnetic
signal” itself is incomprehensible, or is open to two inconsistent
interpretations, but rather that claim 60 broadly encompasses a variety of
possible characteristics. Therefore, the phrase “rotating electromagnetic
signal” is not indefinite, but is simply broad and “breadth is not to be
equated with indefiniteness.” In re Miller, 441 F.2d 689, 693 (CCPA 1971).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that claim 60 is indefinite.

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B. 35 U.S.C. § 102(e) over Coppeta
The Examiner finds that Coppeta teaches
a delivery device (figure 10, item 120) including: a body
structure . . . a fluid-containing structure (figure 10, item 14)
having at least one outlet through which fluid may exit the
fluid-containing structure (figure 10, item 18); a delivery
fluid contained within the fluid-containing structure (figure
10, item 122); a primary material contained within the fluid-
containing structure and having a controllable effective
concentration in the delivery fluid. . . . and a plurality of
electromagnetically responsive control elements (micron-
sized magnetic particles . . . a magnetic flux causes the gel to
expand, thereby causing the ejection of reservoir contents
for patient treatment

(Ans. 6-7).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Coppeta anticipates the claims?
Findings of Fact
3. Coppeta teaches that “devices have been developed to
accelerate the release of reservoir contents, particularly a drug formulation,
out of a reservoir device, such as an implantable drug delivery device”
(Coppeta 2 ¶ 0029).
4. Coppeta teaches that:
Device 120 includes a substrate 12 having a plurality of
reservoirs 14 loaded with a drug formulation 122 which
includes a gel interdispersed with micron-sized magnetic
particles. Two reservoirs are shown: The one on the right is
sealed, with the release opening covered by reservoir cap 18,
and the one on the left has been opened.

(Coppeta 6 ¶ 0083).
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5. Figure 10 of Coppeta is reproduced below:

“FIG. 10 is a cross-sectional view of one embodiment of a device for
accelerating release using a magnetic field to drive a drug formulation
containing magnetic particles” (Coppeta 2 ¶ 0028).
6. Coppeta teaches that in “operation, a magnetic flux is applied to
cause the gel to expand, forcing the drug formulation 122 out of the
reservoir” (Coppeta 6 ¶ 0083)
7. Coppeta teaches that the “molecules of interest may be mixed
with other materials to control or enhance the rate and/or time of release
from an opened reservoir. . . . In other embodiments, the molecules are in
liquid-comprising forms, such as solutions, emulsions, colloidal
suspensions, slurries, or gel mixtures such as hydrogels” (Coppeta 8 ¶ 0105).
8. Coppeta teaches that:
Rupturing of the reservoir cap can occur due to the force
created by the magnetically induced expansion of the gel
pushing against/through the reservoir cap, or alternatively,
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the reservoir cap can be disintegrated or ruptured by an
independent mechanism with subsequent, coordinated
magnetic actuation used to discharge the drug through the
opening created by the other mechanism.

(Coppeta 7 ¶ 0085).
9. Coppeta teaches that “[d]evices may be controlled by local
microprocessors or remote control” (Coppeta 10 ¶ 0119).
10. Coppeta teaches that:
an implantable medical device includes reservoirs
comprising sensor, sealed as described herein, and a signal
from the sensor is transmitted (by any number of means,
including hardwire or telemetry) to a separate drug delivery
device, which could be a wearable (i.e., external) or internal
pump, the signal being used in the control of the dosing of
the drug.

(Coppeta 10 ¶ 0121).
11. Coppeta teaches that “[a]pplication of a non-uniform magnetic
field will impart a force on the magnetic particles creating a convective flow
to drag the drug out of the reservoir” (Coppeta 7 ¶ 0086).
12. Coppeta teaches that:
the biosensor may measure intrinsic electrical signals (EKG,
EEG, or other neural signals), pressure, temperature, pH, or
mechanical loads on tissue structures at various in vivo
locations. The electrical signal from the biosensor can then
be measured, for example by a microprocessor/controller,
which then can transmit the information to a remote
controller . . . For example, the system can be used to relay
or record information on the patient’s vital signs or the
implant environment, such as drug concentration.

(Coppeta 10 ¶ 0122).
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Principles of Law
“A single prior art reference that discloses, either expressly or
inherently, each limitation of a claim invalidates that claim by anticipation.”
Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir.
2005).
Analysis
Claims 1 and 70
Coppeta teaches a delivery device with a fluid containing reservoir
(FF 3-5) which contains delivery solution containign a primary drug material
(FF 7). Coppeta teaches a reservoir with a “electromagnetically responsive
control element”, here a reservoir cap, which is responsive to a magnetic
field where activation of the magnetic field will modify the distribution of
the drug material (FF 6, 8). Coppeta teaches the use of a remote control (FF
9) which activates and releases the dosing of the drug (FF 10), specifically
the wireless application of a magnetic field (FF 11).
Appellants contend that the Examiner “failed to provide any evidence
that the magnetic particles or reservoir caps of Coppeta are ‘responsive to an
incident electromagnetic control signal by one or more of heating, cooling,
vibrating, expanding, stretching, unfolding, contracting, deforming,
softening, or folding to modify the distribution of the primary material . . .,"
as recited in claims 1 and 70” (App. Br. 42).
We are not persuaded. Coppeta expressly teaches that in “operation, a
magnetic flux is applied to cause the gel to expand, forcing the drug
formulation 122 out of the reservoir” (Coppeta 6 ¶ 0083; FF 6). This is an
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express teaching of “expanding”, one of the responses listed in claims 1 and
70.
Appellants contend that the “Examiner failed to demonstrate, using
objectively-verifiable evidence, where the Examiner-cited portion of
Coppeta discloses an equivalent to ‘a delivery fluid contained within the
fluid-containing structure’ (emphasis added), as recited in claim 1” (App. Br.
43).
We are not persuaded. The Specification teaches that the “term
‘delivery fluid’ as used herein, is intended to cover materials having any
form that exhibits fluid or fluid-like behavior, including liquids, gases,
powders or other solid particles in a liquid or gas carrier. The delivery fluid
may be a solution, suspension, or emulsion” (Spec. 17). Coppeta teaches
that the “molecules of interest may be mixed with other materials to control
or enhance the rate and/or time of release from an opened reservoir. . . . In
other embodiments, the molecules are in liquid-comprising forms, such as
solutions, emulsions, colloidal suspensions, slurries, or gel mixtures such as
hydrogels” (Coppeta 8 ¶ 0105; FF 7). Coppeta’s teaching of solutions,
suspensions and emulsions are precise teachings of a “delivery fluid”
consistent with the express definition in the Specification.
Appellants contend that “the Examiner’s assertion that magnetic
particles are equivalent to an ‘electromagnetically responsive control
element’ is legally insufficient to support a prima facie case of anticipation
of Appellant’s claims” (App. Br. 48).
We are not persuaded. The Specification teaches that “the
electromagnetically responsive control element may be an expanding
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element” (Spec. 12). The Specification teaches that “the electromagnetically
responsive control element may include a hydrogel” (Spec. 13). Thus,
consistent with the Specification, the phrase “electromagnetically responsive
control element” reasonably encompasses hydrogels which expand in
response to an electromagnetic signal.
Coppeta teaches that in “operation, a magnetic flux is applied to cause
the gel to expand, forcing the drug formulation 122 out of the reservoir”
(Coppeta 6 ¶ 0083; FF 6). This is an express teaching of a gel which
expands in response to an electromagnetic signal, reasonably satisfying the
requirement for an “electromagnetically responsive control element” (FF 6).
Appellants contend that “[n]owhere has the Examiner demonstrated
evidence of a modification to the ‘effective concentration of the primary
material in the delivery fluid’ (emphasis added), as recited in claim 1” (App.
Br. 50).
We are not persuaded. Claim 1 does not require that the second form
is “inactive”, only that there is a modification of distribution so that upon the
expansion of the electromagnetically responsive control element, an active
form is released. Coppeta teaches that:
Rupturing of the reservoir cap can occur due to the force
created by the magnetically induced expansion of the gel
pushing against/through the reservoir cap, or alternatively,
the reservoir cap can be disintegrated or ruptured by an
independent mechanism with subsequent, coordinated
magnetic actuation used to discharge the drug through the
opening created by the other mechanism.

(Coppeta 7 ¶ 0085; FF 8). The discharge of the drug into the body
environment, caused by the expansion of the gel, necessarily results in a
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modification of the effective concentration of the drug, increasing the
concentration in the body and decreasing the concentration in the reservoir,
where only the concentration in the body will function as a pharmaceutical
agent.
Appellants contend that the “Examiner failed to establish where the
Examiner-cited portion of Coppeta discloses each and every recitation of
claim 1 as arranged in claim 1” (App. Br. 51).
While we agree that an anticipatory reference must disclose the
invention as arranged in the claim, we find that Example 10 of Coppeta, with
the further teachings throughout the Specification which explain the
examples, including Example 10, reasonably teach the limitations of claim 1
as discussed above (FF 3-10).
Claim 23
Appellants contend that “failed to demonstrate where the Examiner-
cited portion of Coppeta discloses generating ‘local magnetic fields to
selectively open individual reservoirs’ (emphasis added), as asserted by the
Examiner” (App. Br. 53).
We are not persuaded. Claim 23 does not require the ability to
“selectively open individual reservoirs” as argued by Appellants. Instead,
claim 23 requires a remote controller with a signal that is “selectively
receivable by the at least one electromagnetically responsive control
element. Coppeta teaches that:
an implantable medical device includes reservoirs
comprising sensor, sealed as described herein, and a signal
from the sensor is transmitted (by any number of means,
including hardwire or telemetry) to a separate drug delivery
device, which could be a wearable (i.e., external) or internal
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pump, the signal being used in the control of the dosing of
the drug.

(Coppeta 10 ¶ 0121; FF 10). This is an express teaching of a signal which
is transmitted to the device which is receivable for drug release (FF 10).
Claim 59
Appellants contend that “the assertion by the Examiner that paragraph
[0086] of Coppeta teaches ‘magnetic fields to control the release and flow of
reservoir contents’ is legally insufficient to support a prima facie case of
anticipation” (App. Br. 55).
We are not persuaded. Claim 59 requires a remote controller which
can generate a “static or quasi-static magnetic field control signal”. As
discussed above, Coppeta teaches remote control (FF 9-10). Coppeta also
teaches that “[a]pplication of a non-uniform magnetic field will impart a
force on the magnetic particles creating a convective flow to drag the drug
out of the reservoir” (Coppeta 7 ¶ 0086; FF 11). As we already discussed,
the release of the drug inherently controls the concentration of the drug in
the delivery fluid.
Claim 60
Appellants contend that “[t]here is no teaching, and the Examiner
failed to point to any, in the Examiner-cited portion of Coppeta that the
voice coil is capable of activating multiple delivery devices” (App. Br. 56).
The Examiner finds that “Coppeta discloses a plurality of delivery
devices (paragraph [0006]), wherein a plurality of remote controllers (voice
coil/current carrying conductors; producing multiple control signals) is
configured to produce a rotating electromagnetic signal” (Ans. 9).
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We find that Appellants have the better position. Claim 60 requires
activation of at least two different delivery devices independently based
upon the electromagnetic signal. While Coppeta teaches the use of multiple
reservoirs, we agree with Appellants that Coppeta does not teach the use of
multiple delivery devices with a “rotating electromagnetic signal capable of
activating two or more of the plurality of delivery devices independently as a
function of the orientation of the rotating electromagnetic signal” (Claim
60).
Claims 25 and 37
Appellants contend that “the Examiner has not met his burden under
35 U.S.C § 102(e) by demonstrating that Coppeta discloses each and every
recitation of Appellant’s independent claim 25, arranged in the same way as
in Appellant’s claim 25” (App. Br. 59). Appellants similarly argue for claim
37 that “the Examiner has not met his burden under 35 U.S.C § 102(e) by
demonstrating that Coppeta discloses each and every recitation of
Appellant’s independent claim 37” (App. Br. 66).
We are not persuaded. Appellants rely upon arguments raised to
overcome the rejection of claim 1, which we affirmed above. We find
claims 25 and 37 anticipated for the same reasons as given above.
Claims 45-47, 62 and 63
Appellants contend that the “Examiner failed to demonstrate objective
evidence of where the Examiner-cited portion of Coppeta discloses a
‘constant pumping rate’” (App. Br. 60).
The Examiner finds that “Coppeta also discloses the rate at which
materials are pumped out of the reservoirs may be varied” (Ans. 8).
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We find that Appellants have the better position. Claim 45 requires
“modifying the rate of pumping . . . responsive to receipt of a second
electromagnetic signal”. Claim 62 is a method claim which requires a
“constant pumping rate”. Claim 63 requires a “time-varying pumping rate”.
The Examiner does not identify, and we do not find, a teaching in Coppeta
to use two different magnetic signals for control of drug release. We also do
not find any teaching in Coppeta that the release rates using the magnetic
beads are expressly or inherently either constant or time-varying, or any
other teaching of any specifics relating to rate of pumping or release. While
we recognize that the rate must either be constant or varying, these rejected
method claims require a specific teaching in order for Coppeta to properly
anticipate, because the issue before us is not obviousness.
Claim 66
Appellants contend that “the Examiner provided no objectively-
verifiable evidence that the gel of Coppeta ‘has a different stability,
immunogenicity, reactivity, or activity’ in the unexpanded form than in the
expanded form” (App. Br. 68).
The Examiner does not specifically address claim 66 in the rejection,
nor provide specific identification of a teaching in Coppeta which anticipates
this claim. We are therefore constrained to reverse the rejection of claim 66.
Claim 67
Appellants contend that “the Examiner failed to provide any evidence
of an equivalent to ‘wherein the first effective concentration is different than
the second effective concentration’” (App. Br. 69).
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The Examiner finds that Coppeta teaches “to modify the effective
concentration of the primary material in the delivery fluid (second effective
concentration occurs when the gel (primary material) expands and is
released from the reservoir)” (Ans. 7).
We find that the Examiner has the better position. Coppeta teaches
that in “operation, a magnetic flux is applied to cause the gel to expand,
forcing the drug formulation 122 out of the reservoir” (Coppeta 6 ¶ 0083; FF
6). We agree with the Examiner that when the concentrated drug material is
released into the body from Coppeta’s implant, the concentration will
inherently and necessarily change from the concentrated form found in the
reservoir to a less concentrated form in the body (FF 6).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Coppeta anticipates claims 1, 2, 20, 23, 25, 37, 57-59, 61, and 67-70.
The evidence of record does not support the Examiner’s conclusion
that Coppeta anticipates claims 45-47, 60, 62, 63, and 66.
C. 35 U.S.C. § 103(a) over Coppeta
The Examiner relies upon Coppeta for the device (Ans. 11). The
Examiner finds that “Coppeta does not specifically disclose the remote
controller utilizes encrypted signals” (Ans. 11). The Examiner finds it
obvious to “utilize encrypted signals in order to protect and ensure patient
privacy and safety” (Ans. 11).
Appellants contend that “the Examiner failed to demonstrate where
the Examiner-cited portion of Coppeta . . . discloses or suggests the
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biosensors collecting and transmitting ‘patient sensitive information,’ as
asserted by the Examiner” (App. Br. 74).
We find that the Examiner has the better position. As the Examiner
notes (Ans. 18), Coppeta teaches that “the system can be used to relay or
record information on the patient’s vital signs or the implant environment,
such as drug concentration” (Coppeta 10 ¶ 0122; FF 12). This information
is reasonably interpreted as being information that is both private to a
patient, and relevant to a patient’s safety, supporting the Examiner’s
conclusion that an ordinary artisan would have been motivated to encrypt the
signal in order to protect privacy and safety. “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).
D. 35 U.S.C. § 103(a) over Coppeta and Lurvey
The Examiner finds that “Coppeta teaches the limitations of claim
1 . . . Coppeta does not specifically disclose the delivery device includes an
RFID or a remote controller including an RF interrogation signal generator”
(Ans. 11). The Examiner finds that “Lurvey discloses an infusion delivery
system which comprises an RF interrogation signal generator capable of
generating an RF interrogation signal tuned to an RFID on the delivery
device” (Ans. 12). The Examiner finds it obvious to “modify the structure
taught by Coppeta, with the RFID incorporated delivery system taught by
Lurvey, in order to provide increased control and security of the remotely
activated fluid delivery system, as well as to protect and ensure patient
privacy and safety” (Ans. 12).
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The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s finding that Coppeta and Lurvey renders claim 3
obvious?
Findings of Fact
13. Lurvey teaches “an infusion delivery system 10 for delivering
an infusate to a patient is shown. Infusion delivery system 10 includes an
infusion set 12, an infusion device 14, a detection device 16 which generates
a signal 18 and a controller 20” (Lurvey 4 ¶ 0055).
14. Lurvey teaches that:
As a passive device, an RFID tag transmits a signal only
upon reception of an RF interrogation signal utilizing
operating power generated from the RF interrogator. As an
active device, an RFID tag is configured with its own power
supply and thereby capable of transmitting a signal
independently. As passive RFID tags are smaller and lighter
than active RFID tags, it is preferred that RFID tag 96 is a
passive RFID device.

(Lurvey 9 ¶ 0101).
Principles of Law
As noted by the Court in KSR, “[a] person of ordinary skill is also a
person of ordinary creativity, not an automaton.” Id. at 421. “The
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results.” Id. at 416.
Analysis
Appellants contend that “alleging ‘increasing control and security’
and ‘protecting and ensuring patient privacy and safety’ without any factual
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basis is insufficient to satisfy the requirements set forth in KSR.” (App. Br.
77).
We are not persuaded. In DyStar, the Court recognized that
an implicit motivation to combine exists not only when a
suggestion may be gleaned from the prior art as a whole, but
when the “improvement” is technology-independent and the
combination of references results in a product or process that
is more desirable, for example because it is stronger,
cheaper, cleaner, faster, lighter, smaller, more durable, or
more efficient.

DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464
F.3d 1356, 1368 (Fed. Cir. 2006). This “technology-independent”
motivation is precisely what the Examiner is relying upon in the instant case,
where increased control and security in the delivery of medicines to a
patient, along with improved privacy, are technology-independent reasons to
improve an apparatus such as the implantable devices of Coppeta with the
RFID devices of Lurvey.
Conclusion of Law
The evidence of record supports the Examiner’s finding that Coppeta
and Lurvey renders claim 3 obvious.
E. 35 U.S.C. § 103(a) over Coppeta and Falk
Appellants contend that “the Examiner failed to demonstrate where
Coppeta or Falk, alone or in combination, discloses or suggests ‘filtering the
second form of the primary material from the delivery fluid prior to pumping
the delivery fluid containing the primary material at the second effective
concentration’” (App. Br. 80).
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The Examiner finds that “it would be advantageous to remove these
magnetic particles prior to patient delivery. As another delivery system, one
of ordinary skill in the art would look to Falk, which teaches an
electromagnetic pump usable within medical device applications which
includes filtering flow at the inlet side of the pump” (Ans. 21).
We find that Appellants have the better position. While we agree that
filtering to remove the magnetic material would be desirable, the magnetic
material is identified by the Examiner in the anticipation rejection as the
“plurality of electromagnetically responsive control elements” (see Ans. 6),
an interpretation with which we agree. Thus, the magnetic material cannot
be both the electromagnetically responsive control element in claim 37 and
the primary material in claim 37. Therefore, if the Examiner interprets the
magnetic material as a component of the primary material for purposes of
claim 42, this interpretation conflicts with the interpretation of this material
in anticipating claim 37. We therefore find the interpretation inconsistent,
and the Examiner has failed to identify a “second form” that would be
desirably removed in either Coppeta or Falk.
SUMMARY
In summary, we reverse the rejection of claim 60 under 35 U.S.C.
§ 112, second paragraph as indefinite.
We affirm the rejection of claims 1, 2, 20, 23, 25, 37, 57-59, 61, and
67-70 under 35 U.S.C. § 102(e) as anticipated by Coppeta.
We reverse the rejection of claims 45-47, 60, 62, 63, and 66 under 35
U.S.C. § 102(e) as anticipated by Coppeta.

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We affirm the rejection of claim 24 under 35 U.S.C. § 103(a) as
obvious over Coppeta.
We affirm the rejection of claim 3 under 35 U.S.C. § 103(a) as
obvious over Coppeta and Lurvey.
We reverse the rejection of claim 42 under 35 U.S.C. § 103(a) as
obvious over Coppeta and Falk.

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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