Ex Parte Van Antwerp et al

Patent Trial and Appeal Board

Oct 3, 2017

11897106 (P.T.A.B. Oct. 3, 2017)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/897,106 08/29/2007 Nannette M. Van Antwerp G&C 130.86-US-01 4423
12813 7590 10/04/2017
Gates & Cooper LLP - Minimed
6701 Center Drive West
Suite 1050
Los Angeles, CA 90045
EXAMINER
PATEL, SHEFALI DILIP
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
10/04/2017 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 NANNETTE M. VAN ANTWERP, RAJIV SHAH,
BRADLEY J. ENEGREN, RICHARD LEMOS JR., LY PHOU,
GARRY M. STEIL, and GAYANE R. VOSKANYAN
__________

Appeal 2016-007544
Application 11/897,106
Technology Center 3700
__________

Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134(a) involving claims to a
method for inhibiting interference of an electrochemical sensor that monitors
a body characteristic of a patient. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

Statement of the Case
Background
“A variety of implantable electrochemical sensors have been
developed for detecting and/ or quantifying specific agents or compositions

1 Appellants identify the Real Party in Interest as Medtronic MiniMed, Inc.
(see App. Br. 2).
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in a patient’s blood. For instance, glucose sensors have been developed for
use in obtaining an indication of blood glucose levels in a diabetic patient”
(Spec. 2:8–11). The Specification teaches methods “to avoid interference of
an electrochemical sensor that monitors a body characteristic of a patient,
where the interference is caused by a[n] interferant present in an infusate
(e.g. a phenolic preservative)” (Spec. 3:4–6).
The Claims
Claims 16, 17, 19, and 26–30 are on appeal. Independent claim 30 is
representative and reads as follows (emphasis added to show limitation at
issue):
30. A method for inhibiting interference of an
electrochemical sensor that monitors a body characteristic of a
patient, wherein the interference is caused by an interferant
present in an infusate infused by an apparatus for supplying a
fluid to a body of the patient, the method comprising supplying
the fluid to the body of the patient using the apparatus
comprising:
a base adapted to secure the apparatus to skin of the
patient;
a first piercing member coupled to and extending from
the base, wherein the first piercing member comprises at least
one cannula for infusing the fluid to an infusion site,
a second piercing member coupled to and extending from
the base and including the electrochemical sensor having a
sensor electrode for determining the body characteristic of the
patient at a sensor placement site,
infusion set tubing adapted to connect to the at least one
cannula;
wherein:
the first and second piercing members are disposed on a
hub that can operatively engage and disengage from the base;
the first and second piercing members are coupled to the
base in an orientation such that when the first and second
piercing members are inserted into the patient, a first
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perforation channel made by the first piercing member is not in
operable contact with a second perforation channel made by the
second piercing member such that the fluid infused to the
infusion site cannot flow through the first perforation channel
or the second perforation channel to the sensor;
the first and second piercing members are coupled to the
base in the orientation such that when the first and second
piercing members are inserted into the patient, the sensor and
the at least one cannula are separated by at least seven
millimeters of tissue; and
the first and second piercing members are coupled to the
base in the orientation so that when the at least one cannula and
the sensor are disposed in the patient, the at least one cannula
and the sensor function to anchor the apparatus to skin of the
patient;
so that interference is inhibited.
The Issues

A. The Examiner rejected claim 30 under 35 U.S.C. § 103(a) as obvious
over Moberg2 and Clark3 (Final Act. 13–16).
B. The Examiner rejected claims 26 and 29 under 35 U.S.C. § 103(a) as
obvious over Moberg, Clark, and Lebel4 (Final Act. 9–12).
C. The Examiner rejected claims 27 and 28 under 35 U.S.C. § 103(a) as
obvious over Moberg, Clark, Lebel, and Gross5 (Final Act. 12–13).
D. The Examiner rejected claims 16, 17, and 19 under 35 U.S.C. § 103(a)
as obvious over Moberg, Clark, Lebel, Gross, and Mann6 (Final Act. 5–9).

2 Moberg et al., US 2006/0253086 A1, published Nov. 9, 2006 (“Moberg”).
3 Clark, Jr., US 4,680,268, issued July 14, 1987 (“Clark”).
4 Lebel et al., US 2002/0058906, published May 16, 2002 (“Lebel”).
5 Gross et al., US 5,800,420, issued Sept. 1, 1998 (“Gross”).
6 Mann et al., US 6,809,653 B1, issued Oct. 26, 2004 (“Mann”).
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A. and B. 35 U.S.C. § 103(a) over Moberg, Clark, and Lebel
Because these two rejections turn on the same issues and claims 26
and 30 share the same critical limitations, we will consider these rejections
together.
The Examiner finds that Moberg teaches the structural elements
required by claim 30 including a base, a first piercing member for fluid
infusion, a second piercing member for a glucose sensor, infusion tubing
(see Final Act. 13–14). The Examiner further finds that in Moberg’s
orientation of the piercing members “the sensor and the at least one cannula
are separated” and “function to anchor the apparatus to [the] skin of the
patient” (Final Act. 14).
The Examiner acknowledges that Moberg is silent regarding “a
method for inhibiting interference of an electrochemical sensor that monitors
a body characteristic of a patient, wherein the interference is caused by an
interferant present in an infusate” (id.). The Examiner acknowledges that
Moberg “does not teach that the first and second piercing members are
disposed on a hub that can operatively engage and disengage from the base”
(Final Act. 15). The Examiner also acknowledges that Moberg is “silent
about whether the sensor and the at least one cannula are separated by at
least seven millimeters of tissue” (id.).
The Examiner finds that Clark teaches “method for inhibiting
interference of an electrochemical sensor [5] that monitors a body
characteristic (glucose) of a patient, wherein the interference is caused by an
interferant (phenolic compounds like acetaminophen) present in an infusate”
(Final Act. 14). The Examiner finds Lebel teaches “the phenolic
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preservative to act as a preserving agent for a 2-4 month quantity of insulin”
(Final Act. 11).
The Examiner finds it obvious to combine Moberg with Clark to “to
be a method for inhibiting interference of the electrochemical sensor” in
order to “reduce the possibility of inaccurate or incorrect measurements”
(Final Act. 15). The Examiner finds it obvious as a “matter of obvious
design choice” for “the first and second piercing members being disposed on
separate hubs or on the same hub” (id.). The Examiner also finds it obvious
for the sensor and cannula “to be separated by at least seven millimeters of
tissue” as routine optimization (see Final Act. 15–16).
The issue with respect to these rejections is: Does the evidence of
record support the Examiner’s conclusion that Moberg, Clark, and Lebel
suggest first and second piercing members “separated by at least seven
millimeters of tissue” as required by claims 26 and 30?
Findings of Fact
1. Figure 28 of Moberg is reproduced below:
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FIG. 28 . . . includes a disposable base portion 20 . . . in
addition to a[n] introducer needle, the delivery device 12 in
FIG. 28 also includes a second needle 284 connected to sensor
electronics. For example, the second needle 284 may be
connected to electronics that produce an electronic signal
representative of a sensed biological state, such as, but not
limited to, blood glucose level.

(Moberg ¶ 98).
2. Moberg teaches “the needles 281 and 284 may be hollow
needles that perform the fluid communication function, once inserted into
the patient-user” (Moberg ¶ 99).
3. Figure 1 of Clark is reproduced below:
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“FIG. 1 depicts a sensor 5 connected to an enclosed container or chamber 6
. . . . Mounted on outside surface of side 6a of chamber 6 is an enzyme 7 in
contact with an anode 8” (Clark 6:20–28).
4. Clark teaches
the sensors of the present invention may include a “third”
membrane placed over anode 8 to separate enzyme 7 from
anode 8. . . . since there can be several potentially interfering
substances, such as ascorbic acid and phenolic compounds like
acetaminophen, present in the body, the employment of the
“third” membrane provides a barrier to such interfering
substances reducing the possibility of inaccurate or incorrect
measurements.

(Clark 7:2–26).
5. Lebel teaches “[t]his insulin is a highly purified, semi-synthetic
human insulin with 0.2% phenol as a preserving agent, glycerol as an
isotonic component, TRIS as a buffer, plus zinc and Genopal® as stabilizing
agents” (Lebel ¶ 208).
Principles of Law
“In In re Aller, 220 F.2d 454 . . . (1955), the court set out the rule that
the discovery of an optimum value of a variable in a known process is
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normally obvious. We have found exceptions to this rule . . . . This case, in
which the parameter optimized was not recognized to be a result-effective
variable, is another exception.” In re Antonie, 559, F.2d 618, 620 (CCPA
1977).
Analysis
The Examiner contends the separation of the sensor and cannula “by
at least seven millimeters of tissue is rendered obvious, since it has been
held that where the general conditions of a claim are disclosed in the prior
art, discovering the optimum or workable ranges involves only routine skill
in the art” (Ans. 7). The Examiner finds:
Alternatively, as a teaching reference, Gross et al shows that it
is common in the art for a sensor [22] and at least one cannula
[15] to be separated by significantly more than seven
millimeters of tissue (Figure 1 above), extrapolated from
knowing that the at least one cannula projects through a lower
surface [16] of housing [11] by a distance of 2.5 mm.

(id.).
We do not find the Examiner’s arguments persuasive. We find that
the Examiner has not provided a reason why, for claims 26 and 30, the
distance separating the sensor and cannula piercing members in Moberg
would have been recognized as a result-effective variable. None of the
references actually cited in rejections over claims 26 and 30, Moberg, Clark,
and Lebel, provide any reason to separate the sensor from the infusion
cannula by any particular distance whatsoever (FF 1–5).
In particular, the only reference suggesting a reason to avoid
interfering phenolics, Clark, uses the membrane to separate elements within
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the sensor itself (FF 3) and not to separate the sensor as a whole from a
separate delivery device.
We also find the Examiner’s reliance on Gross unpersuasive. First,
the Examiner did not rely upon Gross in the statement of the rejection for
either claims 26 or 30. If the citation of a prior art reference is necessary to
support a rejection, the reference must be included in the statement of
rejection. In re Hoch, 428 F.2d 1341, 1342 n.3 (CCPA 1970) (“Where a
reference is relied on to support a rejection whether or not in a ‘minor
capacity,’ there would appear to be no excuse for not positively including
the reference in the statement of the rejection.”)
Second, the Examiner does not clearly explicate how Gross evidences
a separation of 7 mm between a cannula and a sensor, not just the distance of
the needle from the housing (see Gross 14:66). If the Examiner is, in fact,
relying upon the figure for such a measurement, “[i]t is well established that
patent drawings do not define the precise proportions of the elements and
may not be relied on to show particular sizes if the specification is
completely silent on the issue.” Nystrom v. TREX Co., 424 F.3d 1136, 1149
(Fed. Cir. 2005). The Examiner has therefore not satisfied the burden of
providing a prima facie case of obviousness even if we considered the cited
Figure 1 of Gross.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Moberg, Clark, and Lebel suggest first and second piercing members
“separated by at least seven millimeters of tissue” as required by claims 26
and 30.

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C. 35 U.S.C. § 103(a) over Moberg, Clark, Lebel, and Gross
This rejection relies upon the underlying obviousness rejections over
Moberg and Clark with Lebel. Having reversed that rejection, even
considering Gross as discussed above, we also reverse the further
obviousness rejection that includes Gross.

D. 35 U.S.C. § 103(a) over Moberg, Clark, Lebel, Gross, and Mann
The Examiner relies upon Moberg, Clark, and Lebel as discussed
above (see Final Act. 5–7), but acknowledges they are “silent about whether
the first and second piercing members are inserted into separate in vivo
environments” (Final Act. 7). The Examiner finds Gross teaches “first and
second piercing members (needle [15] and sensor [22] having needle [23])
are inserted into separate in vivo environments (subcutaneous tissue and
bloodstream)” (id.). The Examiner finds Mann teaches “a second piercing
member (needle [14]) disposes a sensor (cannula [16] having a sensing
portion [18]) in an interstitial space” (Final Act. 8).
The Examiner finds it obvious to modify Moberg, Clark, and Lebel
because Gross evidences “it is conventional therapy in the art for insulin-
dependent diabetes mellitus to involve insulin to be administered
subcutaneously (column 1, lines 16-19) and glucose to be tested from the
blood” and because Mann teaches to “dispose the sensor in an interstitial
space” (Final Act. 7–8).
The issue with respect to this rejections is: Does the evidence of
record support the Examiner’s conclusion that Moberg, Clark, Lebel, Gross,
and Mann suggest first and second piercing members “inserted into separate
in vivo environments” as required by claim 16?
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Principles of Law
“If a person of ordinary skill can implement a predictable variation,
§ 103 likely bars its patentability.” KSR Int’l Co. v. Teleflex Inc., 550 U.S.
398, 417 (2007).
Findings of Fact
6. Gross teaches: “Conventional therapy for insulin-dependent
diabetes mellitus involves self-administered subcutaneous insulin injections”
(Gross 1:16–18).
7. Gross teaches “delivery needle 15 penetrates through the
epidermis and the dermis, thereby establishing communication between
insulin reservoir 12 and the subject’s subcutaneous tissue via the hollow
needle 15” (Gross 15:3–6).
8. Gross teaches “monitoring the patient’s blood glucose level by
means of a glucose sensor” (Gross 15:24–25).
9. Mann teaches: “Preferred embodiments of a surface mounted
sensor would utilize interstitial fluid harvested from underneath the skin”
(Mann 4:24–26).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 5–8; FF 1–9) and agree that
claim 16 is rendered obvious by Moberg, Clark, Lebel, Gross, and Mann.
We address Appellants’ arguments below.
Appellants contend “Clark teaches away from Appellant’s solution to
overcoming the problems with Apparatuses designed to both sense analyte
and also infuse substances that include sensor interfering substances (i.e. by
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overcoming the problems with interfering substances via an architectural
configuration of system elements)” (App. Br. 6).
We are not persuaded. A teaching away requires a reference to
actually criticize, discredit, or otherwise discourage the claimed solution.
See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (“The prior art’s
mere disclosure of more than one alternative does not constitute a teaching
away from any of these alternatives because such disclosure does not
criticize, discredit, or otherwise discourage the solution claimed”).
Appellants do not identify any specific teaching in either Clark that
discourages or discredits the combination found obvious by the Examiner.
Moreover, Appellants do not even identify a teaching in Clark that rebuts the
teaching of Gross that glucose sensors function by detecting blood levels
while glucose delivery is subcutaneous (FF 6–8) or Mann’s teaching to place
sensors in interstitial fluid (FF 9).
Appellants contend “neither Moberg nor Gross discuss interfering
substances, and therefore cannot teach methods for inhibiting interference,
MUCH LESS methods that do so by using an apparatus having a
constellation of elements organized to be spatially separated” (App. Br. 8).
We find this argument unpersuasive because Moberg teaches some
degree of spatial separation of the infusion needle and the sensor as shown in
figure 28 (FF 1) and Gross and Mann reasonably suggest that the infusion
needle should be in a subcutaneous environment (FF 6) while the sensor
should be in a blood vessel (FF 7) or interstitial (FF 9) environment,
satisfying the requirement of claim 16 for “separate in vivo environments”.
Claims 16 lacks any requirement for any specific amount of spatial
separation as recited in claims 26 and 30.
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We recognize, but find unpersuasive, Appellants’ hindsight argument
because the Examiner provided specific teachings and reasons to perform
the steps of claim 16, irrespective of the use recited by the preamble.
If, however, the body of the claim fully and intrinsically sets
forth the complete invention, including all of its limitations, and
the preamble offers no distinct definition of any of the claimed
invention’s limitations, but rather merely states, for example,
the purpose or intended use of the invention, then the preamble
is of no significance to claim construction because it cannot be
said to constitute or explain a claim limitation.

Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir.
1999). In this case, the method for “inhibiting interference” states the
purpose of the invention, but does not constitute a claim limitation because
in performing the method rendered obvious by Moberg, Clark, Lebel, Gross,
and Mann, each step in the body of claim 16 would have been obvious.

Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Moberg, Clark, Lebel, Gross, and Mann suggest first and second piercing
members “inserted into separate in vivo environments” as required by claim
16.
SUMMARY
In summary, we reverse the rejection of claim 30 under 35 U.S.C.
§ 103(a) as obvious over Moberg and Clark.
We reverse the rejection of claims 26 and 29 under 35 U.S.C. § 103(a)
as obvious over Moberg, Clark, and Lebel.
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We reverse the rejection of claims 27 and 28 under 35 U.S.C. § 103(a)
as obvious over Moberg, Clark, Lebel, and Gross.
We affirm the rejection of claim 16 under 35 U.S.C. § 103(a) as
obvious over Moberg, Clark, Lebel, Gross, and Mann. Claims 17 and 19 fall
with claim 16.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED-IN-PART