Ex Parte Coppeta et al

Board of Patent Appeals and Interferences

Feb 5, 2009

10668573 (B.P.A.I. Feb. 5, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JONATHAN R. COPPETA, JOHN T. SANTINI, JR., and
SCOTT A. UHLAND
__________

Appeal 2008-4898
Application 10/668,573
Technology Center 3700
__________

Decided:1 February 5, 2009
__________

Before ERIC GRIMES, RICHARD M. LEBOVITZ, and FRANCISCO C.
PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

Appeal 2008-4898
Application 10/668,573

This is an appeal under 35 U.S.C. § 134 involving claims to a device
for the controlled release of chemical molecules. The Examiner has rejected
the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
Claims 14-29, 35, 36, and 39-47 stand finally rejected and are on
appeal (App. Br. 2). Claims 14 and 19 are representative and read as
follows:
14. A device for the controlled release of chemical molecules
comprising:
an array of discrete microtubes constructed of a metal or
an alloy, each microtube comprising a reservoir defined therein;
a release formulation which comprises the chemical
molecules, the release formulation being wholly contained in
each reservoir;
a rupturable covering which closes an opening at a first
end of each reservoir; and
a means for rupturing the rupturable covering and
positively displacing the release formulation through the
opening at the first end, to release the chemical molecules.

19. A device for the controlled release of chemical molecules
comprising:
an array of discrete microtubes, each microtube
comprising a reservoir defined therein;
a release formulation which comprises the chemical
molecules, the release formulation being disposed in each
reservoir;
a rupturable covering enclosing a first end of each
reservoir; and
a means for rupturing the rupturable covering and
positively displacing the release formulation through an
opening at the first end, to release the chemical molecules,
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wherein the means for rupturing comprises a layer of an
expanding material which can be activated to expand upon
application of heat and a resistive heating element or resistive
coating for heating the end of the microtube distal the
rupturable covering upon application of an electric current
through the resistive heating element or resistive coating, the
release formulation being disposed between the layer of
expanding material and the rupturable covering.

The Examiner cites the following documents as evidence of
unpatentability:
Theeuwes US 4,111,202 Sep. 5, 1978
Santini, Jr. et al. US 5,797,898 Aug. 25, 1998
Eppstein et al. US 6,692,456 B1 Feb. 17, 2004
Krulevitch et al. US 7,025,323 B2 Apr. 11, 2006

The following rejections are before us for review:
Claims 14-18, 20-29, 35, 36, and 39 stand rejected under 35 U.S.C. §
102(e) as being anticipated by Eppstein (Ans. 3-4).
Claims 19 and 42-47 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Krulevitch and Santini (Ans. 4-5).
Claims 40 and 41 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Eppstein and Theeuwes (Ans. 5).
ANTICIPATION -- EPPSTEIN
ISSUE
The Examiner finds that Eppstein teaches an array of microtubes as
recited in claim 14, each microtube having a reservoir and release
formulation contained therein, each microtube also having a rupturable
covering (Ans. 3). The Examiner further finds that Eppstein’s device has
“means for rupturing the covering/barrier material (e, thermal poration
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element) and positively displacing the release formulation (pressure
modulation activation linkages, Fig 23a and 23b, activated by a small pump,
Col 29 lines 45-55)” (id.).
Appellants contend that Eppstein’s device does not have a single
means that accomplishes both the rupturing of the rupturable covering, and
the positive displacement of the release formulation, as required by claim 14
(App. Br. 5-6). Moreover, Appellants argue, the Examiner has not made a
prima facie case that the structures disclosed in Eppstein are equivalent to
the means disclosed in the Specification as accomplishing the claimed
functions (id. at 6-8).
The Examiner responds that the means-plus-function language in
claim 14 is “open-ended because the specification gives no explicit
definition of what the ‘means’ or their equivalents are” (Ans. 6). Rather, the
Examiner urges, the Specification “uses terms like ‘such as’ or ‘for example’
when describing the means and therefore any structure which performs the
same function is an equivalent” (id.). The Examiner concludes that it is
reasonable to interpret the means recited in claim 14 as encompassing “two
separate means, not a single means . . . . The applicant has not claimed or
limited the means-plus-function language to be a single means for
performing two functions” (id.).
Appellants reply that the Examiner erred in interpreting claim 14 as
encompassing two separate means, given the Specification’s disclosure of
embodiments “in which the rupturing and displacement functions are
inextricably linked together” (Reply Br. 3).
In view of the positions advanced by Appellants and the Examiner,
the critical issue with respect to this rejection is whether the Examiner erred
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in finding that Eppstein meets the limitation in claim 14 requiring the device
to have “a means for rupturing the rupturable covering and positively
displacing the release formulation through the opening at the first end.”
FINDINGS OF FACT (“FF”)
1. Claim 14 recites a device for the controlled release of chemical
molecules. The device has an array of microtubes, each microtube having a
reservoir that contains a release formulation, the chemical molecules being
contained in the release formulation. Each microtube’s reservoir has a
rupturable covering at one end.
The device of claim 14 also has “a means for rupturing the rupturable
covering and positively displacing the release formulation through the
opening at the first end, to release the chemical molecules.”
2. The Specification discloses a number of mechanisms that both rupture
the covering at the end of the microtubes and positively displace the release
formulation from the tubes.
Appellants’ Figure 1A is reproduced below:
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Figure 1A shows device 10, which includes “reservoir 12 [which]
contains a drug formulation 16 for release. The drug formulation is adjacent
the release opening 22. A piston 18 is also provided in the reservoir. The
piston 18 separates the drug formulation 16 from an osmotic pressure
generating agent 20” (Spec. 8).
The Specification discloses that “swelling of osmotic pressure
generating agent 20 occurs when fluid enters through semi-permeable
membrane 26,” and that, “[a]s the osmotic pressure generating agent 20
swells, pressure is generated to drive the piston 18 against the drug
formulation 16. Consequently, the drug formulation 16 is pushed out of the
reservoir 12” through release opening 22 (id.).
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The Specification discloses that “[t]he pressure of the drug
formulation 16 on the rupturable covering 28 covering the release opening
22 causes the rupturable covering 28 to rupture, allowing the drug
formulation to be move from the reservoir and into surrounding
environment” (id.).
3. Appellants’ Figure 7 is reproduced below:

Figure 7 shows “microtube 220 [which] includes tubular structure 222
(which are the walls defining the reservoir), rupturable covering 232, and
barrier material 228, interposed between drug formulation 230 and
expansion material 226” (Spec. 16).
The Specification discloses that “[t]he expansion material 226
preferably is one that can be thermally activated” (id. at 17). The
Specification further discloses that the rupturable covering 232 “ruptures to
initiate release of the drug formulation from the reservoir. In one
embodiment, the rupturable covering comprises or consists of a metal foil.
The metal foil may be provided with one or more defects to facilitate rupture
due to expansion of the expansion material” (id.).
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4. The Specification discloses that “[i]n another embodiment, release of
reservoir contents from the microtube is controlled by changing the shape of
the microtube, rather than expanding a material inside the reservoir of the
microtube. For example, the shape change can contract the reservoir,
thereby forcing the contents of the reservoir out” (Spec. 19).
The Specification discloses that heat can be used to cause the
reservoir to contract, and that, “[u]pon heating . . ., the . . . microtube
undergoes a contraction that causes a hydrostatic pressure that ruptures the
rupturable covering to release the drug formulation” (id. at 20).
5. Eppstein discloses “devices and method for the creation of small holes
or perforations or micropores in biological membranes, such as the outer
layers of the skin or the mucosal linings, [and] the delivery of drugs or other
permeants through the micropores” (Eppstein, col. 1, ll. 15-19). One
embodiment disclosed by Eppstein is a TFTI, or Thin Film Tissue Interface
device, that “efficiently create[s] a pattern or array of micropores on the
surface of a biological membrane” (id. at col. 10, ll. 10-12).
6. Figures 23a and 23b of Eppstein are reproduced below:

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Figures 23a and 23b “show a cross-sectional schematic of a multi-
chamber, micro-cell array that also incorporates a thermal poration
element(s) at the skin contact point for each micro-cell. The multi-chamber,
micro-cell array could operate by the method and principle illustrated in
FIGS. 22(a-d)” (Eppstein, col. 31, ll. 13-18).
7. As seen in Figures 23a and 23b, Eppstein’s device includes a thin film
backing for its poration elements, such that when the drug solution is to be
delivered from the reservoirs, the thermal stress from the heat used to
activate the porating element causes a hole to open in the backing.
8. The device shown in Figures 23a and 23b functions by placing the
drug-containing reservoir adjacent to the skin of the recipient, applying
pressure to the center of the reservoir to force the interstitial fluid adjacent to
the reservoir away from the reservoir by “blanching” the underlying tissue,
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and then pulling the reservoir away from the skin, thereby allowing the drug
solution to be sucked into the skin (see Eppstein, Figure 22). That is, “the
decompressed state of the recently blanched skin cell tissue matrix directly
beneath the micropore would induce fluid from the drug reservoir to flow
through the pore into these skin tissues beneath the porated surface” (id. at
col. 28, ll. 36-40).
9. Eppstein discloses that, to coordinate its device’s actions, a pre-
programmed controller can be used to generate the signals needed to cycle
the system through the steps required for drug delivery (Eppstein, col. 29, ll.
44-47). Eppstein states that the “controller may contain a microprocessor
which would generate the appropriate sequence of control signals to enable
the different functions of the system in the desired sequence. A small
pump(s), such as a small diaphragm or peristaltic pump could be engaged
when needed to develop a suction or pressure” (id. at col. 29, ll. 47-52).
10. Regarding control of its devices, Eppstein further discloses:
Alternatively, a small pressure reservoir such as a metal or
plastic cylinder or bladder of compressed gas, or a pressure
produced via the electrolysis of a liquid in a closed chamber,
producing gas, could be used to supply pressure. Optionally,
control over all aspects of the movement of the system could
easily be achieved with a simple valving mechanism(s) to
provide the microprocessor coordinated control of reservoir
pressure/suction and the action of a controllable actuator to
provide the requisite movement of the central reservoir relative
to the outer portions of the structure during the
compression/decompression cycles. With suitable additional
valves and seals, one could utilize the suction and pressure
sources to provide the depression/withdrawal, action of the
central portion from the skin surface. In this manner, a single
peristaltic pump mechanism, with one or more circuits, could
be engaged in either the forward or reverse direction, generating
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either pressure or suction as required, with the proper design of
the swept area of the different pump circuits, and optionally,
appropriately sized pressure bleed ports and one way valves, the
required, coordinated, sequence of suction, pressure and
mechanical translation could all be performed by a system with
a single peristaltic pump based moving part. As peristaltic
pumps are by nature, a positive displacement mechanism, they
are very efficient. Alternatively, these motive forces could
easily be provided by a small motor(s) or actuator(s) under
microprocessor control with appropriate linkage to coordinate
movements to the device cycle.

(Eppstein, col. 29, l. 52, through col. 30, l. 13 (emphasis added).)
PRINCIPLES OF LAW
Paragraph Six of 35 U.S.C. § 112 states:
An element in a claim for a combination may be
expressed as a means or step for performing a specified
function without the recital of structure, material, or acts in
support thereof, and such claim shall be construed to cover the
corresponding structure, material, or acts described in the
specification and equivalents thereof.

Thus, “one construing means-plus-function language in a claim must
look to the specification and interpret that language in light of the
corresponding structure, material, or acts described therein, and equivalents
thereof, to the extent that the specification provides such disclosure.” In re
Donaldson Co., Inc., 16 F.3d 1189, 1193 (Fed. Cir. 1994).
In order to meet a means-plus-function limitation, a “structure must
either be the same as the disclosed structure or be a section 112, paragraph 6
‘equivalent,’ i.e., (1) perform the identical function and (2) be otherwise
insubstantially different with respect to structure.” Kemco Sales, Inc. v.
Control Papers Co., Inc., 208 F.3d 1352, 1364 (Fed. Cir. 2000). Thus, “two
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structures may be ‘equivalent’ for purposes of section 112, paragraph 6 if
they perform the identical function, in substantially the same way, with
substantially the same result.” Id.
ANALYSIS
We agree with Appellants that the Examiner erred in finding that
Eppstein meets the limitation in claim 14 requiring the claimed device to
have “a means for rupturing the rupturable covering and positively
displacing the release formulation through the opening at the first end.”
Claim 14 uses the phrase “means for,” followed by a recitation of the
functions that the means must accomplish, without reciting the structures or
materials used to accomplish the functions (FF 1). Therefore, 35 U.S.C. §
112, sixth paragraph, requires the limitation at issue to be interpreted as
covering the structure, material, or acts that the Specification describes as
corresponding to the means, or equivalents thereof. See Donaldson, 16 F.3d
at 1193.
In the instant case, the Specification discloses several mechanisms
that both rupture a rupturable covering at the end of a microtube’s reservoir
and positively displace the release formulation through the opening at the
end of the tube. Specifically, the Specification discloses that the rupturing
and positive displacement can be performed by an osmotic pressure
generating agent located in the reservoir behind or beneath the release
formulation (FF 2). The osmotic pressure generating agent takes in fluid and
swells, thereby generating sufficient pressure in the reservoir to rupture the
covering at the end of the reservoir and push the release formulation through
the resultant opening at the end of the reservoir (id.).
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The Specification also discloses that a thermally activated expansion
material can be used in a similar manner to create sufficient pressure to
rupture the covering and positively displace the release formulation from the
reservoir (FF 3). The Specification further discloses that by contracting the
microtube, enough pressure can be generated in the reservoir to rupture the
covering and push the release formulation from the reservoir (FF 4).
Thus, when claim 14 is viewed consistently with the Specification, it
requires the device to have a single means capable of accomplishing both the
rupturing of the cover and the positive displacement of the release
formulation. The mechanisms disclosed in the Specification for
accomplishing those functions include osmotically- or thermally-driven
expansion materials that push a piston against the release formulation to
create sufficient pressure in the reservoir to rupture the covering and drive
the formulation out of the tube, and a thermally-driven mechanism that
contracts the reservoir to create the rupturing and driving pressure (FF 2-4).
In contrast, Eppstein’s device uses at least two separate means to
accomplish the recited functions. Specifically, Eppstein uses a thermally
activated poration device to rupture the thin film backing at the end of the
microtubes (see FF 6-7). Separate from the thermal tearing of the covering,
Eppstein uses a pushing and pulling action on its device to cause the tissue
adjacent to the device to draw the fluid out of the tube (FF 8), and also
discloses that “[a] small pump(s), such as a small diaphragm or peristaltic
pump [which] could be engaged when needed to develop a suction or
pressure” (Eppstein, col. 29, ll. 47-52 (FF 9)).
Because Eppstein uses a combination of heat-induced tearing in the
tubes’ film backing, along with suction to remove the drug formulation, we
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agree with Appellants that the reference does not use the same structure as
the expansion- or contraction-driven mechanisms described in Appellants’
Specification as corresponding to the means-plus-function limitation at
issue.
We also agree with Appellants that Eppstein’s combination of
elements is not equivalent to the structures disclosed in Appellants’
Specification as corresponding to the means at issue. Specifically, to rupture
the covering on its microtubes, Eppstein’s device uses heat in its poration
element to create thermal stress in the film backing (FF 6-7).
In contrast, Appellants’ Specification discloses that the claimed
rupturing and positive displacement are accomplished using mechanisms
that apply pressure within the reservoir sufficient to cause the rupturable seal
to burst (FF 2-4). Because we agree with Appellants that using heat to
rupture the covering is substantially different than using internal pressure,
we also agree with Appellants that the Examiner has not shown that the
structures encompassed by claim 14 are equivalent to Eppstein’s.
We note, as the Examiner points out, that Eppstein discloses that a
peristaltic pump is useful in its devices (FF 9, 10). We also note that
Eppstein describes a peristaltic pump as a “positive displacement
mechanism” (Eppstein, col. 30, l. 9 (FF 10)).
However, even assuming for argument’s sake that the peristaltic pump
is used as part of the mechanism to drive the drug formulation from the
microtubes, rather than to accomplish the pushing and pulling action
described in Eppstein’s Figure 22 (FF 8), Eppstein nonetheless discloses that
its device uses a thermally-activated poration element to rupture the tubes’
coverings (FF 6, 7), which is not an equivalent to the pressure-driven
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structures described in Appellants’ Specification. We are therefore not
persuaded that Eppstein’s device meets the means-plus-function limitation at
issue.
In sum, we do not agree with the Examiner that Eppstein meets the
limitation in claim 14 requiring the claimed device to have “a means for
rupturing the rupturable covering and positively displacing the release
formulation through the opening at the first end.” We therefore reverse the
Examiner’s rejection of claim 14, and its dependent claims 15-18, 20-29, 35,
36, and 39 as anticipated by Eppstein.
OBVIOUSNESS -- KRULEVITCH AND SANTINI
ISSUE
Claims 19 and 42-47 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Krulevitch and Santini (Ans. 4-5).
The Examiner cites Krulevitch as teaching an “array of discrete
microtubes (97) defining a reservoir (86-90), a release formulation (103),
and means for dispensing the release formulation (81-85) by positive
displacement of a barrier material (98-102) by an expanding material (81-
85) by application of heat from a resistive heating element (81'-85')” (id. at 4
(citing Krulevitch, Figures 7A and 7B)). The Examiner concedes that
Krulevitch “does not disclose the material of the microneedles being made
of a metal, or a rupturable metal foil covering over the distal end of the
microneedles” (id.).
To meet the missing limitation, the Examiner cites Santini as
disclosing “a microreservoir array which is covered by a metal foil where
the array is made of a biocompatible material (copper or gold, for example)”
(id.). The Examiner concludes, based on the references’ teachings, that one
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of ordinary skill in the art would have considered it obvious “to place a
metallic cover over the microneedles in order to prevent leakage of the
reservoirs or contamination of the reservoir contents” (id. at 4-5).
Appellants contend that the Examiner has failed to make a prima facie
case of obviousness (App. Br. 8-12). Specifically, Appellants argue, “[t]he
Examiner has not set forth the required showing that all elements of
Applicants’ claim 19 are included in the prior art or would be combined in
the fashion claimed” (id. at 10). Moreover, Appellants urge, “the Examiner
has not set forth a showing as to why one of ordinary skill in the art would
combine Krulevitch and Santini to derive Applicants’ particularly claimed
device” (id. at 11).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the Examiner has made a
prima facie case that Krulevitch and Santini would have rendered a device
having all of the elements recited in claim 19, in the configuration recited in
the claim, obvious to a person of ordinary skill in the art.
FINDINGS OF FACT
11. Claim 19 recites a device similar to that of claim 14. The device has
an array of microtubes, each microtube having a reservoir that contains a
release formulation, the chemical molecules being contained in the release
formulation. Each microtube’s reservoir has a rupturable covering at one
end.
Like the device of claim 14, the device of claim 19 has “a means for
rupturing the rupturable covering and positively displacing the release
formulation through an opening at the first end, to release the chemical
molecules.”
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Claim 19 recites that the rupturing means has a layer of material
which can be activated to expand upon application of heat by a resistive
heating element or resistive coating. The expanding material is distal to the
rupturable covering, and the release formulation is positioned between the
expanding material and rupturable covering.
12. Krulevitch discloses methods of providing “integrated, low power
pumps and valves for manipulating fluids in micro-devices” (Krulevitch, col.
1, ll. 47-49). Figures 7A and 7B, reproduced below, “illustrate[] top and
side views of a microsyringe array application, such as transdermal drug
delivery via microneedle” (id. at col. 2, ll. 65-67):

Figures 7A and 7B show:
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A . . . substrate 80 [which] is provided with a plurality of
thermopneumatic chambers which may include resistive heaters
81'-85' and indicates at 81, 82, 83, 84 and 85 each chamber
connected to a respective channel 86, 87, 88, 89 and 90 formed
in the substrate 80. Each chamber 81-85 is connected to a
programmable chip or microchip controller 91 via leads 92, 93,
94, 95 and 96. Channels 86-90 are each provided at an outer
end with a plurality of microneedles 97 (see FIGS. 7B) and
each channel 86-90 contains a piston 98, 99, 100, 101 and 102
and is provided with a desired reagent 103 intermediate pistons
98-102 and microneedles 97. The reagent 103 in each of the
channels 86-90 may be the same or different, depending on the
desired application. Each channel 86-90 contains a driving or
actuation fluid 104 located intermediate pistons 98-102 and
thermopneumatic chamber 81-85.

(Krulevitch, col. 8, ll. 14-30.)
13. Krulevitch describes the operation of the device shown in Figures 7A
and 7B as follows:
In operation, one or more resistive heaters 81'-85' heat
fluid in thermopneumatic chambers 81-85 which cause the
expansion of the driving fluid 104 and movement of one or
more pistons 98-102 along channels 86-90 forcing the desired
reagent 103 toward microneedles 97 for delivery of the reagent
to a patient or other point of use.

(Krulevitch, col. 8, ll. 31-36.)
14. Santini discloses “[m]icrochip devices . . . which can accurately
deliver drugs and other molecules at defined rates and times according to the
needs of the patient or other experimental system” (Santini, col. 3, ll. 9-12).
15. Santini discloses that each microchip device “consists of a substrate,
reservoirs, and a release system containing or enclosing the molecules to be
delivered. Devices which control the release time of the molecules may
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include reservoir caps. Active devices may include control circuitry and a
power source” (Santini, col. 3, ll. 44-48).
16. Santini discloses that “[i]n the passive timed release drug delivery
devices, the reservoir caps are formed from a material that degrades over
time, or does not degrade but is permeable to the molecules to be delivered.
These materials are preferably polymeric materials” (Santini, col. 5, ll. 30-
34).
17. Santini discloses:
In the active timed release devices, the reservoir caps
consist of thin films of conductive material patterned in the
shape of anodes surrounded by cathodes. Any conductive
material that can oxidize and dissolve in solution upon
application of an electric potential can be used for the
fabrication of the anodes and cathodes. Examples of such
materials include metals such as copper, gold, silver, and zinc,
and some polymers . . . . The anode is defined as the electrode
where oxidation occurs. The portion of the anode directly
above the reservoir oxidizes and dissolves into solution upon
the application of a potential between the cathode and anode.
This exposes the release system to the surrounding fluids and
results in the release of the molecules.

(Santini, col. 5, l. 64, through col. 6, l. 14.)
PRINCIPLES OF LAW
In proceedings before the Patent and Trademark Office,
the Examiner bears the burden of establishing a prima facie
case of obviousness based upon the prior art. “[The Examiner]
can satisfy this burden only by showing some objective
teaching in the prior art or that knowledge generally available to
one of ordinary skill in the art would lead that individual to
combine the relevant teachings of the references.”

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In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992) (citations omitted,
bracketed material in original).
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, ___, 127 S. Ct. 1727
(2007), the Supreme Court reaffirmed that it is obvious to choose from
among known solutions to a problem recognized in the art:
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that is was obvious under § 103.

Id. at 1742.
The Supreme Court also noted that the analysis under 35 U.S.C. § 103
“need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” Id. at
1741. The Court further advised that “[a] person of ordinary skill is . . . a
person of ordinary creativity, not an automaton.” Id. at 1742.
Emphasizing the flexibility required in obviousness analyses, the
Court further noted that “[a] factfinder should be aware, of course, of the
distortion caused by hindsight bias and must be cautious of arguments reliant
upon ex post reasoning. Rigid preventative rules that deny factfinders
recourse to common sense, however, are neither necessary under our case
law nor consistent with it.” Id. at 1742-1743 (citations omitted).
While it focused on the flexibility of the analysis, the Court
nonetheless did not dispense with the premise that a conclusion of
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obviousness requires some explicit rationale for practicing the claimed
subject matter:
[I]t can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention
does . . . because inventions in most, if not all, instances rely
upon building blocks long since uncovered, and claimed
discoveries almost of necessity will be combinations of what, in
some sense, is already known.

Id. at 1741 (emphasis added); see also 1740-41 (requiring a determination of
“whether there was an apparent reason to combine the known elements in
the fashion claimed by the patent at issue”) (emphasis added).
Accordingly, as our reviewing court has stated, “obviousness requires
a suggestion of all limitations in a claim.” CFMT, Inc. v. Yieldup Int’l
Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) (citing In re Royka, 490 F.2d
981, 985 (CCPA 1974)).
ANALYSIS
We agree with Appellants that the Examiner has not made a prima
facie case that Krulevitch and Santini would have rendered a device having
all of the elements recited in claim 19, in the configuration recited in the
claim, obvious to a person of ordinary skill in the art.
Like claim 14, claim 19 recites that its device has “a means for
rupturing the rupturable covering and positively displacing the release
formulation through the opening at the first end, to release the chemical
molecules” (FF 11). As discussed above, when that means-plus-function
limitation is viewed consistently with the Specification, it requires the device
to have a single means capable of accomplishing both the rupturing of the
cover and the positive displacement of the release formulation.
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By its terms, claim 19 limits the rupturing means to a thermally-driven
expansion material (FF 11). As the Examiner points out, Krulevitch uses a
thermally-activated expanding fluid to drive the medicament out of the
reservoirs in its device, through the attached microsyringes (FF 12-13).
However, even assuming for argument’s sake that an ordinary artisan
would have been prompted, as posited by the Examiner, to cover
Krulevitch’s microneedles with Santini’s metallic covers to prevent leakage
and/or contamination, Santini discloses that its metallic reservoir covers are
provided as electrodes that rupture when an electric potential is applied to
them (FF 17). Thus, following Santini’s teachings and applying metallic
covers to Krulevitch’s microneedles would result in a device having separate
means for rupturing the rupturable covering, and positively displacing the
release formulation from the reservoirs. The combination of Krulevitch and
Santini posited by the Examiner would therefore not result in the device
recited in claim 19, which requires a single means that both ruptures the
cover, and positively displaces the release formulation.
In sum, we do not agree with the Examiner that Krulevitch and
Santini would have rendered a device having all of the elements recited in
claim 19, in the configuration recited in the claim, obvious to a person of
ordinary skill in the art. We therefore reverse the Examiner’s rejection of
claim 19, and its dependent claims 42-47, as obvious over Krulevitch and
Santini.
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OBVIOUSNESS -- EPPSTEIN AND THEEUWES
Claims 40 and 41 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Eppstein and Theeuwes (Ans. 5). The Examiner finds that
Eppstein differs from claims 40 and 41 in that Eppstein “do[es] not teach the
use of a semi permeable membrane which allows water or another liquid to
diffuse into the expanding material in order to displace and expel the drug
formulation” (id.).
The Examiner cites Theeuwes to meet that limitation, and concludes
that a person of ordinary skill in the art would have considered it obvious “to
combine the osmotic delivery system of Theeuwes as an alternate ‘small
pump’ with the micro needle array of Eppstein in order to facilitate
expansion of the expandable member without electronics” (id.).
Claims 40 and 41 both depend, ultimately, from claim 14, and require
all of the limitations of claim 14. As discussed above, Eppstein does not
meet the limitation in claim 14 requiring the device to have a “means for
rupturing the rupturable covering and positively displacing the release
formulation through the opening at the first end.”
Having reviewed the Theeuwes reference, we do not see, and the
Examiner does not point to, any teaching in Theeuwes’ disclosure of
osmotic dosage devices that remedies Eppstein’s failure to meet the means-
plus-function limitation discussed above. Thus, the combined disclosures of
the references do not disclose or suggest all of the limitations recited in
claims 40 and 41. We therefore reverse the Examiner’s rejection of claims
40 and 41 as being obvious over Eppstein and Theeuwes.
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SUMMARY
We reverse the Examiner’s rejection of claims 14-18, 20-29, 35, 36,
and 39 under 35 U.S.C. § 102(e) as being anticipated by Eppstein.
We reverse the Examiner’s rejection of claims 19 and 42-47 under 35
U.S.C. § 103(a) as being unpatentable over Krulevitch and Santini.
We reverse the Examiner’s rejection of claims 40 and 41 under 35
U.S.C. § 103(a) as being unpatentable over Eppstein and Theeuwes.

REVERSED

cdc

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