Ex Parte Kim et al

Patent Trial and Appeal Board

Nov 10, 2016

13143960 (P.T.A.B. Nov. 10, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/143,960 07 /11/2011
23413 7590
CANTOR COLBURN LLP
20 Church Street
22nd Floor
Hartford, CT 06103
11/15/2016
FIRST NAMED INVENTOR
Sun Ill Kim
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
JKP0003US 1099
EXAMINER
AGAHI,PUYA
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
11/15/2016 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):
usptopatentmail@cantorcolbum.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SUN ILL KIM, SEON JEONG KIM,
and JANG HYUN YOUN 1
Appeal2015-003144
Application 13/143,960
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
biosensor for analyzing concentration of an analyte which have been
rejected as obvious.2 We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as INDUSTRY-
UNIVERSITY COOPERATION FOUNDATION HANY ANG
UNIVERSITY. (Br. 3.)
2 The obviousness-type double patenting rejection (see Final Act. 5-7) is
moot in view of abandonment of US 13/144,324 (see Notice of
Abandonment issued Nov. 5, 2014).
Appeal2015-003144
Application 13/143,960
STATEMENT OF THE CASE
Appellants' invention "relates to a biosensor to which an electroactive
polymer layer is attached, and more specifically, to a biosensor including an
electroactive polymer layer attached to the surface of a bioreceptor and
electrodes connected to the electroactive polymer layer." (Spec. 1:7-10.)
The biosensor "allows reversible deformation of the electroactive polymer
layer when an electrical stimulation is applied to the electrode and can
thereby analyze the concentration of an analyte when the surface of the
bioreceptor is exposed to the analyte." (Id. at 1:10-13.)
Claims 1 and 3---6 are on appeal. Claim 1 is illustrative:
1. A biosensor for analyzing concentration of an analyte,
compnsmg:
a bioreceptor capable of detecting an analyte to be
analyzed;
a signal transducer converting concentration information
of the analyte detected by the bioreceptor into an analyzable
signal;
at least two electroactive polymer layers attached on a
surface of the bioreceptor to close the bioreceptor, the at least
two electroactive polymer layers contracting in response to an
electrical stimulation to thereby expose the surface of the
bioreceptor to the analyte and allowing the bioreceptor to detect
the analyte, and restoring to close the bioreceptor when the
electrical stimulation is removed after detecting the analyte; and
an electrode connected to the at least two electroactive
polymer layers to apply the electrical stimulation to the
electroactive polymer layers.
(Br. 15 (Claims App'x) (emphasis added).)
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Application 13/143,960
Claims 1and3---6 are rejected under 35 U.S.C. § 103(a) over Shah3
and Low.4
Appellants argue the patentability of the claims together. We select
claim 1 as representative.
The Examiner finds that
Shah teaches a biosensor for analyzing concentration of an
analyte (abstract), comprising: a bioreceptor capable of detecting
an analyte to be analyzed; a signal transducer converting
concentration information of the analyte detected by the
bioreceptor into an analyzable signal (par.[]0025). Shah also
teaches [that] the invention provides [a] sensor array of analyte
sensing elements, optionally within reservoirs/wells and sealed
with controllable membranes and which is useful for long term
analyte sensing ... the analyte sensing element can be coated
with an expanding hydrogel within the well, such that the
voltage-induced dissolution of a portion of the gold membrane
induces expansion of the hydrogel, thus mechanically assisting
the removal of the membrane from the well' s surface
(par.[]0032).
(Final Act. 3.) The Examiner finds that
Shah does not teach at least two electroactive polymer layers
contracting in response to an electrical stimulation to thereby
expose the surface of the bioreceptor to the analyte and allowing
the bioreceptor to detect the analyte, and restoring to close the
bioreceptor when the electrical stimulation is removed after
detecting the analyte; and an electrode connected to the at least
two electroactive polymer layers to apply the electrical
stimulation to the electroactive polymer layers.
(Id. at 3--4.)
The Examiner, however, turns to Low and finds it teaches
3 Shah et al., US 2006/0004272 Al, published Jan. 5, 2006.
4 Low et al., Microactuators toward microvalves for responsive controlled
drug delivery, B 67 SENSORS AND ACTUATORS 149-160 (2000).
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Application 13/143,960
a blend of conducting polymer and a hydrogel that contracts and
relaxes. In the development of a reversible polymeric valve or
artificial muscle, a blend of a conducting polymer and a hydro gel
was synthesized and its peculiar property of swelling and
shrinking was employed to demonstrate the opening and closing
of the passages in a drug reservoir. The conducting polymer in
the blend forms the "electronic backbone" of the artificial muscle
and is sensitive to pH, applied electrical potential, and chemical
potential in its microenvironment. The hydro gel forms the "ionic
body" of the muscle and exhibits dramatic effects of swelling and
shrinking upon changes in pH, solvent, temperature, electric
field, or ambient light conditions. (see Low page 154 section 3 .2
"Polymeric valves: artificial muscle (reversible valves)"; Fig.4).
(Id. at 4.) The Examiner concludes that it would have been obvious to
"modify Shah's degrading reservoirs/wells with Law's reversible valves
because doing so would allow for more focused sensor readings, while
isolating spent sensor elements from obscuring the newly exposed sensor
signal (Shah par.[]0032)," and that "one of ordinary skill in the art at the
time of invention would have had predictable success incorporating
controllable membranes that open/close in analyte sensing since doing [so]
would allow for long term analyte sensing." (Id.)
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Shah and Low would have
rendered claim 1 obvious?
Findings of Fact (FF)
1. Shah teaches
A long term analyte sensor for measuring at least one analyte in
the body of a user and which includes a housing, a plurality of
analyte contacting sensor elements and at least one structure for
relaying information away from the sensor. This plurality of
analyte contacting sensor elements are typically disposed in an
array. The analyte sensor further includes at least one sensor
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Application 13/143,960
protection membrane that is controllable in a manner such that
sensor elements may be activated (e.g. exposed to the external
environment) at different times so as to extend the useful life of
the sensor. In illustrative analyte sensors, the analyte is glucose.
(Shah Abstract; see also Final Act. 3.)
2. Shah teaches that "[t]he analyte sensing protection membranes
can take a variety of structural forms (e.g. a film, a layer, a cap etc.) as long
as they function to reversibly protect the analyte sensing element of the
analyte sensing device from the environment into which the analyte sensing
device is placed." (Shah i-f 28; see also Ans. 3.)
3. Shah teaches that
[t]he glucose oxidase can be covered by a material such as a
Glucose Limiting Membrane (GLM) within the well or on top of
the membrane. In a specific example, the well can be
hermetically sealed with a gold membrane until programmed
voltage-induced dissolution of the membrane. Alternatively, the
analyte sensing element can be coated with an expanding
hydrogel within the well, such that the voltage-induced
dissolution of a portion of the gold membrane induces expansion
of the hydrogel, thus mechanically assisting the removal of the
membrane from the well' s surface.
(Shah i-f 32; see also Final Act. 3.)
4. Shah teaches that "the analyte sensor membrane can be a
material that is permeabilizable in response to an applied signal such as an
electric field or current, magnetic field, change in pH, or by thermal,
chemical, electrochemical, or mechanical signal." (Shah i-f 34; see also Ans.
3.)
5. Shah teaches
barrier membranes that reversibly cover both analyte sensing
elements as well [as] reservoirs containing compounds that can
be controllably released into the environment, include those
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Application 13/143,960
where the compounds in the reservoirs are designed to enhance
the function of the analyte sensing device by, for example,
reshaping and/or adapting the in vivo tissue environment into
which the sensing device is placed.
(Shah i-f 87; see also Ans. 4.)
6. Shah's Figure 2 is reproduced below:
108
104 ---·-·--"~·--r---102 ·1
l __________________________________ -------------------------------------------·------------------------------------------!
FIG. 2
Figure 2 shows a "sensor 100" having: (a) a "base layer 102," (b) a
"conductive layer 104 [that] comprises one or more electrodes," (c) "an
analyte sensing layer 110," (d) a "protein layer 116," (e) "an adhesion
promoter layer 114," (f) an "analyte modulating layer 112," (g) "an
electrically insulating cover layer 106," and (h) "one or more exposed
regions or apertures 108." (Shah i-fi-1 47-50, 53; see also Ans. 4.)
7. Low teaches
In the development of a reversible polymeric valve or artificial
muscle, a blend of a conducting polymer and a hydrogel was
synthesized and its peculiar property of swelling and shrinking
was employed to demonstrate the opening and closing of the
passages in a drug reservoir. The conducting polymer in the
blend forms the "electronic backbone'" of the artificial muscle
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Application 13/143,960
and is sensitive to pH, applied electrical potential, and chemical
potential in its microenvironment. The hydrogel forms the "ionic
body" of the muscle and exhibits dramatic effects of swelling and
shrinking upon changes in pH, solvent, temperature, electric
field, or ambient light conditions.
(Low 154, second col.; see also Final Act. 4.)
8. Low's Figure 4c is reproduced below:
(c)
Figure 4c shows "[ s ]chematic of alternative designs for opening and closing
holes in a drug reservoir using the artificial muscle concept." (Low 154,
first col., Fig. 4c; see also Final Act. 4.)
DISCUSSION
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 3-5; Ans. 2--4; FF 1-8) and
agree that claim 1 would have been obvious over Shah and Low. We
address below Appellants' arguments.
Appellants contend that "their intended purposes and functions in the
claimed invention and Low are different from each other, and thus there is
no reason, motivation and expectation for a person, having ordinary skill and
not knowing the claimed invention, to combine Low into other prior art to
reach the claimed invention." (Br. 10.) Appellants argue that "there is no
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Application 13/143,960
need and reason for Shah to combine any additional opening/closing element
thereinto." (Id. at 13.)
These arguments are unpersuasive.
Shah teaches that "[t]he analyte sensor further includes at least one
sensor protection membrane that is controllable in a manner such that sensor
elements may be activated (e.g. exposed to the external environment) at
different times so as to extend the useful life of the sensor." (FF 1; see also
FF 2--4, 6.) Shah teaches "barrier membranes that reversibly cover both
analyte sensing elements as well [as] reservoirs containing compounds that
can be controllably released into the environment" (FF 5 (emphasis added);
see also FF 2.) Low teaches "[i]n the development of a reversible polymeric
valve or artificial muscle, a blend of a conducting polymer and a hydrogel
was synthesized and its peculiar property of swelling and shrinking was
employed to demonstrate the opening and closing of the passages in a drug
reservoir." (FF 7 (emphasis added); see also FF 8.)
As the Examiner explains, "one of ordinary skill in the art would have
had predictable success modifying Shah so as to replace [its] protective
membrane 106 with Low's two electroactive polymer layers since this
would be a simple substitution." (Ans. 4.) "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'! 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. Moreover, an
"[ e ]xpress suggestion to substitute one equivalent for another need not be
present to render such substitution obvious." In re Fout, 675 F.2d 297, 301
(CCP A 1982).
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Application 13/143,960
We thus agree with Examiner that "since both [Shah and Low] are
directed towards implantable devices with membranes that function to
open/close a reservoir, one of ordinary skill would have had[] reason to
combine the two teachings." (Ans. 2.)
Referring to the Examiner's conclusion concerning combining the
teachings of Low and Shah, Appellants contend that
"placing Low's artificial muscle/reversible valves in Shah's one
or more exposed regions or aperture 108" cannot reach the
claimed structures. As clearly recited in Claim 1, the claimed
electroactive polymer layers are attached on a surface of the
bioreceptor, and configured to expose the surface of the
bioreceptor, not simply "placing one or more exposed regions or
aperture 108" as in the Examiner's proposed combination.
(Br. 12.)
This argument is also unpersuasive.
As the Examiner explains,
nothing in claim 1 requires the two electroactive polymer layers
to be directly attached to the bioreceptor. That is to say, the fact
that Shah teaches intermediate layers (116, 114, and 112 in
Fig.[]2) between sensing layer 110 (i.e. the bioreceptor) and
protective membrane 106 (i.e. modified with Low) is not relevant
as it is understood that the protective membrane is attached to the
surface of sensing layer 110 via the intermediate layers.
(Ans. 4.) During prosecution, we give claim terms the broadest reasonable
interpretation as understood by a person of ordinary skill in the art in light of
the specification. In re Morris, 127 F.3d at 1054 (Fed. Cir. 1997); In re Am.
Acad. Of Sci. Tech. Ctr., 367 F.1359, 1364 (Fed. Cir. 2004) ("Construing
claims broadly during prosecution is not unfair to the applicant ... because
the applicant has the opportunity to amend the claims to obtain more precise
claim coverage.")
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Application 13/143,960
Appellants contend that
The Examiner's proposed combination of Low and Shah can lead
to mal-operation of Shah and degradation of the Shah's sensing
element, due to unnecessary closing/ opening of their other
structures from the environment. For example, when the Shah's
sensing element 110 and other functional structures are closed,
the analyte permeated in the analyte modulating layer 112
remains in contact with the sensing layer 110 at a closed state.
Then, this situation can result in mal-sensing of the sensing layer
110 for the next sensing operation where the Low's artificial
muscle/reversible valves is opened again, and further lead to
degradation in the sensibility of the sensing layer 110.
(Br. 13.)
We are not persuaded by Appellants' contention that modifying
Shah's device in the manner suggested by the Examiner would have
prevented Shah's device from functioning as intended, including some
degradation sensitivity of the sensing layer. (Id.) Even if sensitivity was
reduced somewhat to gain the benefit of providing opening and closing of
passages as in Low (FF 7), that would not mean claim 1 is nonobvious. See
In re Urbanski, 809 F.3d 1237, 1243 (Fed. Cir. 2016) (holding that a
combination of references may be obvious even if the combination is at the
expense of a benefit of one of the references). Appellants also provide no
persuasive factual evidence to show that Shah's device, as modified by the
Examiner, would "lead to mal-operation" as Appellants contend. See In re
Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) ("[A]ttomey argument [is] not
the kind of factual evidence that is required to rebut a prima facie case of
obviousness").
Appellants argue that "the Examiner's proposed combination cannot
reach the claimed invention in the same way that the new claimed invention
does, without significant re-design or change in the prior art structures, and
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without losing their original intended purposes and associated operation
principles." (Br. 13.)
We are also not persuaded that the skilled artisan, desiring the benefit
of Low's two artificial muscles (i.e., to open and close passages) in a known
analyte sensor, such as that of Shah, would have been unable to design a
modified device that maintained a sufficient sensitivity. "[A] person of
ordinary skill is also a person of ordinary creativity, not an automaton."
KSR, 550 U.S. at 421. The obviousness analysis "take[s] account of the
inferences and creative steps that a person of ordinary skill in the art would
employ." Id. at 418. "[I]f a technique has been used to improve one device,
and a person of ordinary skill in the art would recognize that it would
improve similar devices in the same way, using the technique is obvious
unless its actual application is beyond his or her skill." Id. at 417.
Appellants have provided no persuasive argument or evidence showing that
Examiner's proposed combination of known prior art elements according to
their known functions would involve more than routine engineering efforts
or that the device, as modified by the Examiner, would not work.
For the above reasons, the preponderance of the evidence supports the
Examiner's conclusion that claim 1 would have been obvious.
CONCLUSION OF LAW
We affirm the rejection of claims 1and3---6 under 35 U.S.C. § 103(a)
over Shah and Low.
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TIME PERIOD FOR RESPONSE
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
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