Ex Parte Yang et al

Patent Trial and Appeal Board

Oct 21, 2016

12572087 (P.T.A.B. Oct. 21, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/572,087 10/01/2009 Qingling Yang
12813 7590 10/21/2016
Gates & Cooper LLP - Minimed
6701 Center Drive West
Suite 1050
Los Angeles, CA 90045
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.
130.97-US-Ol 3212
EXAMINER
JANG, CHRISTIAN YONGKYUN
ART UNIT PAPER NUMBER
3735
MAILDATE DELIVERY MODE
10/21/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte QINGLING YANG, RAJIV SHAH, MEGAN E.
LITTLE, and CHIA-HUNG CHIU 1
Appeal2014-005250
Application 12/572,087
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
PERCURIAM
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
analyte sensor having an interference rejection membrane. The claims are
rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 According to Appellants, the Real Party in Interest is Medtronic
MiniMed, Inc. (App. Br. 2).
Appeal2014-005250
Application 12/572,087
STATEMENT OF THE CASE
The Specification describes an amperometric analyte sensor having an
interference rejection membrane that purports to inhibit diffusion of
compounds that confound the accuracy of analyte measurements
(Spec. 2:24--3:14). Claims 1, 6-11, 28-33, and 44 are on appeal. Claim 1 is
illustrative and reads as follows (emphasis added):
1. An amperometric analyte sensor apparatus comprising:
a base layer;
a conductive layer disposed on the base layer and
comprising a working electrode;
an interference rejection membrane disposed on an
electroactive surface of the working electrode, wherein:
the interference rejection membrane comprises
Poly(2-hydroxyethyl methacrylate) polymers having an
average molecular weight between 100 and
1000 kilodaltons cross linked by a hydrophilic
crosslinking agent; and
the interference rejection membrane is between
0.1 µm and 1.0 µm thick; and
an analyte sensing layer.
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Application 12/572,087
The claims stand rejected as follows:
I. Claims 1, 8, 11, 28, 29, 31, and 32 stand rejected under
35 U.S.C. § 103(a) as being obvious based on Boock, 2 Laitenberger, 3 and
Hutter. 4
II. Claims 7 and 44 stand rejected under 35 U.S.C. § 103(a) as
being obvious based on Boock, Laitenberger, and Hutter, and evidenced by
Petisce. 5
III. Claim 9 stands rejected under 35 U.S.C. § 103(a) as being
obvious based on Boock, Laitenberger, Hutter, and Gross. 6
IV. Claim 30 stands rejected under 35 U.S.C. § 103(a) as being
obvious based on Boock, Laitenberger, Hutter, and Shah. 7
V. Claim 33 stands rejected under 35 U.S.C. § 103(a) as being
obvious based on Boock, Laitenberger, Hutter, and Brister. 8
I.
We have considered Appellants' arguments, but are not persuaded that
the Examiner erred in rejecting claims 1, 8, 11, 28, 29, 31, and 32 under
35 U.S.C. § 103(a) as being unpatentable over Boock, Laitenberger, and
Hutter. Because the claims are not separately argued, we focus our
discussion on independent claim 1, which is representative.
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 2---6; Ans. 3--4; FF 1-9), and
2 Boock et al., US 2007 /0244379 Al, published Oct. 18, 2007.
3 Laitenberger et al., US 2010/0163431 Al, published July 1, 2010.
4 Hutter et al., US 2002/0127376 Al, published Sept. 12, 2002.
5 Petisce et al., US 2010/0121169 Al, published May 13, 2010.
6 Gross et al., US 6,275,717 Bl, issued Aug. 14, 2001.
7 Shah et al., US 2005/0272989 Al, published Dec. 8, 2005.
8 Brister et al., US 2007/0027384 Al, published Feb. 1, 2007.
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Application 12/572,087
agree that the claims are obvious over Hoock, Laitenberger, and Hutter. We
address Appellants' arguments below.
Findings of Fact
FF 1. Boock discloses:
Membrane systems incorporating silicone polymers are
described for use in implantable analyte sensors. Some layers
of the membrane system may comprise a blend of a silicone
polymer with a hydrophilic polymer, for example, a triblock
poly( ethylene oxide )[]-poly(propylene oxide )-poly( ethylene
oxide) polymer. Such polymeric blends provide for both high
oxygen solubility and aqueous analyte solubility.
(Boock Abstract; see also Final Act. 2.)
FF 2. Boock depicts in Figure 4 "a schematic illustration of a
membrane system" (Boock i-f 15; see also Final Act. 2). Figure 4 is
reproduced below.
lP---s-----
FIG, 4
(Boock Fig. 4.) Referring to Figure 4, Boock discloses that
the membrane system 18 includes a cell disruptive layer 40
most distal of all domains from the electrochemically reactive
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surfaces, a bioprotective layer 42 less distal from the
electrochemically reactive surfaces than the cell disruptive
layer, a diffusion resistance layer 44 less distal from the
electrochemically reactive surfaces than the bioprotective layer,
an enzyme layer 46 less distal from the electrochemically
reactive surfaces than the diffusion resistance layer, an
interference layer 48 less distal from the electrochemically
reactive surfaces than the enzyme layer, and an electrode layer
50 adjacent to the electrochemically reactive surfaces.
(Id. at i-f 68; see also Final Act. 2.)
FF 3. Boock discloses that "the ratio of silicone polymer to
hydrophilic polymer as well as the polymeric compositions are selected such
that a layer constructed from the material has interference characteristics that
inhibit transport of one or more interfering species through the layer"
(Boock i-f 73), that "[t]he hydrophilic polymer for use in the blend may be
any suitable hydrophilic polymer, including but not limited to components
such as polyvinylpyrrolidone (PVP), polyhydroxyethyl methacrylate, ... "
(id. at 77); and that "[i]n one embodiment; the interference layer[] is formed
from silicone polymer/hydrophilic polymer blends" (id. at 112).
FF 4. Boock discloses that "[i]n one embodiment, bioprotective layer
[] is formed from high oxygen soluble materials such as polymers formed
from ... hydyoxyethyl methacrylate (HEMA)" (id. at 90; see also Ans. 4).
FF 5. Boock discloses that
In one alternative embodiment, the interference layer[] is
formed from cellulose acetate. Cellulose acetate with a
molecular weight of about 30,000 daltons or less to about
100,000 daltons or more, preferably from about 35,000, 40,000,
or 45,000 daltons to about 55,000, 60,000, 65,000, 70,000,
75,000, 80,000, 85,000, 90,000, or 95,000 daltons, and more
preferably about 50,000 daltons is preferred.
(Boock i-f 116; see also Final Act. 3, Ans. 3.)
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FF 6. Hoock discloses that "the thick,.ness of the interference domain
is from about 0.05 microns or less to about 20 microns or more" (Boock
i-f 121; see also Final Act. 3, Ans. 3).
FF 7. Boock discloses that "[i]n various embodiments, any of the
layers discussed above can be omitted, altered, substituted for, and/or
incorporated together" (Boock i-f 126).
FF 8. Laitenberger discloses
a sensor for detecting an analyte in the presence of at least one
interferent in a fluid sample. The sensor comprises a substrate,
a channel disposed on the substrate, at least one transducer
disposed in the channel, and a filter for selectively absorbing
the analyte in preference to the at least one interferent.
(Laitenberger Abstract; see also Final Act. 2.)
FF 9. Laitenberger discloses that "[t]he amperometric sensor may
also be functionalized through the deposition of enzymes ... , membranes
(for example, comprising silicone, HEMA, ... ) in order to detect
preferentially the analyte of interest and remove the effects of interforents"
(Laitenberger i-f 46; see also Final Act. 2, Ans. 4).
Analysis
Appellants contend that the Examiner failed to identify a sufficient
motivation to combine the cited prior art references to produce a sensor
having the claimed interference rejection membrane (App. Br. 6). In
particular, Appellants assert that the Examiner's reasoning reduces to
generic boilerplate that is "globally applicable to ALL inventions formed
from combinations of know/old elements" (App. Br. 6 (emphasis omitted)).
We are not persuaded. As an initial matter, we note that it is well-
established that "[ t ]he combination of familiar elements according to known
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methods is likely to be obvious when it does no more than yield predictable
results." KSR Int'! 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. 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 (CCPA 1982).
Further, with regard to the instant appeal, we agree with the Examiner
that "it would have been obvious to modify the teachings of Boock with that
of Laitenberger and Hutter to utilize another material (pHEMA) that is
known to be useful to block interferents as a substitut[ e for] the cellulosic
derivative taught by Boock to obtain similar, and thus equivalent, results"
(Final Act. 3).
Boock teaches that "the membrane system [] includes ... an
interference layer[]" (FF 2), and that "[i]n various embodiments, any of the
layers discussed above can be omitted, altered, substituted for, and/or
incorporated together" (FF 7; see also Final Act. 3).
Laitenberger teaches that "[ t ]he amperometric sensor may also be
functionalized through the deposition of enzymes ... , membranes (for
example, comprising silicone, HEMA, ... ) in order to detect preferentially
the analyte of interest and remove the effects of interferents" (FF 9; see also
Final Act. 2).
The combined teachings of Boock and Laitenberger regarding using
HEMA as a membrane layer would yield predictable results of blocking
interferents (see Final Act. 3). We therefore, agree with the Examiner that it
would have been obvious to substitute the known equivalent of an
interference layer of Boock for the HEMA membrane of Laitenberger. Such
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a combination is merely a "predictable use of prior art elements according to
their established functions." KSR Int'! Co. v. Teleflex Inc., 550 U.S. at 417.
"[W]hen a patent claims a structure already known in the prior art that is
altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result." Id. at
416, citing United States v. Adams, 383 U.S. 39, 50-51 (1966); see also In re
Fout, 675 F.2d at 301.
Appellants argue that the claims require pHEMA having specific
properties including molecular weights and membrane thickness, that
Boock's cellulose derivatives are not the same material as Poly(2-
hydroxyelthyl methacrylate ), and that the properties of cellulose derivatives
cannot be used to predict the properties of Poly(2-hydroxyelthyl
methacrylate) (App. Br. 7).
We are not persuaded. In light of Laitenberger' s express teaching of
using HEMA membranes to remove the effects of interferents, we find
Appellants' arguments, unsupported by evidence, insufficient to rebut the
express teaching of Laitenberger. 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"). "Non-
obviousness cannot be established by attacking references individually
where the rejection is based upon the teachings of a combination of
references []. [The reference] must be read, not in isolation, but for what it
fairly teaches in combination with the prior art as a whole." In re Merck &
Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Moreover, regarding ranges of molecular weights and membrane
thickness, as the Examiner explains "it is noted that one of ordinary skill in
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the art would be capable of finding an effective optimization of ranges
within the prior art conditions or through routine experimentation" (Final
Act. 3). See In re Aller, 220 F .2d 454, 456 (CCP A 1955) ("where the
general conditions of a claim are disclosed in the prior art, it is not inventive
to discover the optimum or workable ranges by routine experimentation").
"[T]he discovery of an optimum value of a variable in a known process is
usually obvious." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir.
2007). The rationale for determining the optimal parameters for prior art
result effective variables "flows from the 'normal desire of scientists or
artisans to improve upon what is already generally known.'" Id. (quoting In
re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).
Appellants contend that Boock and Laitenberger screen for
interferents in different ways using different mechanisms (Reply Br. 3--4).
More particularly, Appellants argue that one skilled in the art would not be
motivate to mix and match the elements of Boock's and Laitenberger's
sensors because it is that absence of the analyte that is detected by
Laitenberger in which the signal from the second transducer is subtracted is
subtracted from the signal from the first transducer (id. at 4). Appellants
contend that, in contrast, Appellants' sensor detects the signal generated by
the reaction of the analyte and enzyme without detecting the signal from the
interferent, which is a different principle of operation that that employed by
Laitenberger (id.).
As an initial matter, we note that the Examiner has not introduced new
grounds of rejection and Appellants' arguments above are not responsive to
arguments raised by the Examiner's Answer. Without good cause, they need
not be considered.
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Application 12/572,087
Any argument raised in the reply brief which was not raised in
the appeal brief, or is not responsive to an argument raised in
the examiner's answer, including any designated new ground of
rejection, will not be considered by the Board for purposes of
the present appeal, unless good cause is shown.
(37 C.F.R. § 41.4l(b)(2).) See also Ex Parte Borden, 93 USPQ2d 1473,
1473-74 (BPAI 2010) (informative opinion) (absent a showing of good
cause, the Board is not required to address an argument newly presented in
the reply brief that could have been presented in the principal brief on
appeal).
For completeness, however, we observe that even had these
arguments been timely raised, they are nevertheless unpersuasive. In light of
Laitenberger' s express teaching of using HEMA membranes to remove the
effects of interferents, we find that these arguments lack supporting
evidence, and are insufficient to rebut the express teaching of Laitenberger.
See In re Geisler, 116 F.3d at 1470. Moreover, Appellants contentions
concerning the purported differences in the principle of operation for
Appellants' sensor and Laitenberger' s sensor have no bearing on whether an
ordinarily skilled artisan would have been motivated to combine the sensors
disclosed by Boock and Laitenberger. Accordingly, Appellants' arguments
do not demonstrate that the proposed modification would render Boock' s
invention unsatisfactory for its intended purpose.
Further, even crediting, arguendo, Appellants' argument that
Laitenberger uses signal subtraction, we are not persuaded that the cited
references invoke different principles of operation because Boock also uses
signal subtraction (see Boock i-f 47 ("baseline subtracting electrode")),
discloses "a sensor signal from a sensor including a silicon/hydrophilic-
hydrophobic polymer blend membrane" (id. i-f 19), and teaches the
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transmission of signals between components (id. i-f 24) while taking into
consideration signal artifacts and noise (id. i-fi-133-35, 39). Therefore, we
conclude that it is reasonable to substitute the HEMA material of
Laitenberger for another interference membrane material of Boock.
Appellants contend that Boock teaches away from the claimed
combination because of the conspicuous absence of pHEMA in the
interference rejection layer (App. Br. 5).
We are not persuaded because Boock teaches that compositions
having a hydrophilic polymer such as polyhydroxyethyl methacrylate can be
selected to "inhibit transport of one or more interfering species through the
layer" (FF 3). Moreover, Boock does not discredit, criticize, or disparage
using pHEMA as claimed (FF 1-7). Like our appellate reviewing court,
"[ w ]e will not read into a reference a teaching away from a process where no
such language exists." DyStar Textilfarben GmbH & Co. Deutsch/and KG
v. CH Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006).
Therefore, we affirm the rejection of claim 1. Because they are not
separately argued, claims 8, 11, 28, 29, 31, and 32 fall with claim 1.
II.
The Examiner has rejected claims 7 and 44 under 35 U.S.C. § 103(a)
as being obvious based on Boock, Laitenberger, and Hutter, as evidenced by
Petisce (Ans. 4). Appellants present no additional argument based on
Petisce, and rely on the same arguments addressed above with regard to
Boock, Laitenberger, and Hutter (see App. Br. 7). Therefore, we affirm the
rejection of claims 7 and 44.
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III.
The Examiner has rejected claim 9 under 35 U.S.C. § 103(a) as being
obvious based on Boock, Laitenberger, Hutter, and Gross. Appellants
present no additional argument based on the teachings of Gross, and rely on
the same arguments addressed above with regard to Boock, Laitenberger,
and Hutter (see id.). Therefore, we affirm the rejection of claim 9.
IV.
The Examiner has rejected claim 30 under 35 U.S.C. § 103(a) as
being obvious based on Boock, Laitenberger, Hutter, and Shah. Appellants
present no additional argument based on the teachings of Shah, and rely on
the same arguments addressed above with regard to Boock, Laitenberger,
and Hutter (see id.). Therefore, we affirm the rejection of claim 30.
v.
The Examiner has rejected claim 33 under 35 U.S.C. § 103(a) as
being obvious based on Boock, Laitenberger, Hutter, and Brister.
Appellants present no additional argument based on the teachings of Brister,
and rely on the same arguments addressed above with regard to Boock,
Laitenberger, and Hutter (see id.). Therefore, we affirm the rejection of
claim 33.
SUMMARY
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) based on
Boock, Laitenberger, and Hutter. Claims 8, 11, 28, 29, 31, and 32 fall with
claim 1.
We affirm the rejection of claims 7 and 44 under 35 U.S.C. § 103(a)
based on Boock, Laitenberger, and Hutter, and evidenced by Petisce.
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We affirm the rejection of claim 9 under 35 U.S.C. § 103(a) based on
Boock, Laitenberger, Hutter, and Gross.
We affirm the rejection of claim 30 under 35 U.S.C. § 103(a) based on
Boock, Laitenberger, Hutter, and Shah.
We affirm the rejection of claim 33 under 35 U.S.C. § 103(a) based on
Boock, Laitenberger, Hutter, and Brister.
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)(l )(iv).
AFFIRMED
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