Ex Parte Van Antwerp et al

Patent Trial and Appeal Board

Feb 21, 2013

11897106 (P.T.A.B. Feb. 21, 2013)

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 02/22/2013
Gates & Cooper LLP - Minimed
6701 Center Drive West
Los Angeles, CA 90045
EXAMINER
PATEL, SHEFALI DILIP
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
02/22/2013 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 2011-002719
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 appeal under 35 U.S.C. § 134 involving claims to a device
for fluid dispensing and patient monitoring. The Examiner rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

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Statement of the Case
Background
The Specification teaches that the “apparatus design described herein
allows the sensor and infusion catheter to be built into a single set, which
greatly improves comfort and convenience for the patient” (Spec. 15, ll. 29-
31). The Specification teaches “a combination glucose sensor/insulin
infusion reduces both the amount of hardware the patient has to wear on
their body and the number of needle sticks required” (Spec. 15, ll. 31-33).
The Claims
Claims 1-3, 5-7, 9-13, and 15-19 are on appeal. Independent claim 1
is representative and reads as follows:
1. An apparatus for supplying a fluid to a body of a patient and for
monitoring a body characteristic of the patient, the apparatus
comprising:
a base adapted to secure the apparatus to the skin of a patient;
a first piercing member coupled to and extending from the base,
wherein the first piercing member is operatively coupled to at least
one cannula for infusing a fluid to an infusion site;
a second piercing member coupled to and extending from the
base and operatively coupled to an electrochemical sensor having a
sensor electrode for determining at least one body characteristic of the
patient at a sensor placement site;
infusion set tubing adapted to connect to the cannula;
wherein:
the first and second piercing members are disposed on a hub
that can operatively engage and disengage from the base; and
the first and second piercing members are coupled to the base in
an orientation such that when the first and second piercing members
are operatively coupled to the base and inserted into a patient, a first
perforation channel made by the first piercing member is not in
operable contact with a second perforation channel made by the
second piercing member.
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The issues
A. The Examiner rejected claims 1-3, 5, 6, and 9-13 under 35 U.S.C.
§ 103(a) as obvious over Moberg1 (Ans. 4-7).
B. The Examiner rejected claim 7 under 35 U.S.C. § 103(a) as obvious
over Moberg and Douglas2 (Ans. 7).
C. The Examiner rejected claim 15 under 35 U.S.C. § 103(a) as obvious
over Moberg and Gross3 (Ans. 7-8).
D. The Examiner rejected claims 16-18 under 35 U.S.C. § 103(a) as
obvious over Moberg and Clark4 (Ans. 8-10).
E. The Examiner rejected claim 19 under 35 U.S.C. § 103(a) as obvious
over Moberg, Clark, and Gross (Ans. 10).
F. The Examiner rejected claims 1-3, 5, 6, 9-13, and 15 under 35 U.S.C.
§ 103(a) as obvious over Gross, Fangrow,5 and Mann6 (Ans. 11-15).
G. The Examiner rejected claim 7 under 35 U.S.C. § 103(a) as obvious
over Gross, Fangrow, Mann, and Douglas (Ans. 15).
H. The Examiner rejected claims 16-19 under 35 U.S.C. § 103(a) as
obvious over Gross, Fangrow, and Clark (Ans. 15-19).

1 Moberg et al., US 2006/0253086 A1, published Nov. 9, 2006.
2 Douglas, J., US 2005/0131346 A1, published Jun. 16, 2005.
3 Gross et al., US 5,800,420, issued Sep. 1, 1998.
4 Clark, Jr., L., US 4,680,268, issued Jul. 14, 1987.
5 Fangrow, Jr., T., US 2005/0107743 A1, published May 19, 2005.
6 Mann et al., US 6,809,653 B1, issued Oct. 26, 2004.
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A. 35 U.S.C. § 103(a) over Moberg
The Examiner finds that the device of the rejected claims differs from
Moberg’s device in that Moberg “teaches that the first and second piercing
members [281][284] are disposed on separate hubs (‘introducer needle
hubs’) that can operatively engage and disengage from the base [20];
however, Moberg et al does not teach that the first and second piercing
members are disposed on the same one hub” (Ans. 5).
The Examiner finds it obvious to “modify the two separate hubs of the
first and second piercing members to be one integral hub, since it has been
held that forming in one piece an article which has formerly been formed in
two pieces and put together involves only routine skill in the art” (Ans. 5).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Moberg renders claim 1
obvious?
Findings of Fact
1. Moberg teaches that “when used in conjunction with glucose
sensors or monitors, insulin pumps may be automatically controlled to
provide appropriate doses of infusion medium at appropriate times of need,
based on sensed or monitored levels of blood glucose” (Moberg 1 ¶ 0006).
2. Moberg teaches that the
delivery device 12 in FIG. 28 also includes a disposable
base portion 20 on which a reservoir canister 24 may be
supported, as described above. An introducer needle 281 has
a handle portion 282 and is positioned to allow the needle to
be passed through the septum 27 of the reservoir 24, when
the reservoir 24 is supported on the base portion 20.

(Moberg 11 ¶ 0098).
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3. Figure 28 of Moberg is reproduced below

Figure 28 shows “a generalized perspective view of needle insertion portions
of delivery devices” (Moberg 1 ¶ 0015).
4. Moberg teaches that 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 11 ¶ 0098).
5. Moberg teaches that “reservoir 24 has a port and may be
supported by the base portion 20 in a position at which a connector 26 may
engage or otherwise come into fluid flow communication with the reservoir
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port, when the connector 26 is connected to the port 23 on the base portion
20” (Moberg 4 ¶ 0037).
6. Moberg teaches that “a needle hub comprises a needle 220 for
piercing a septum of a reservoir canister 24” (Moberg 9 ¶ 0087).
7. The Examiner finds that “Moberg et al teaches that the first and
second piercing members [281][284] are disposed on separate hubs
(‘introducer needle hubs’) that can operatively engage and disengage from
the base [20]” (Ans. 5).
8. Figure 2 is reproduced below:

“FIG. 2 is a perspective view of a delivery device and related components”
(Moberg 1 ¶ 0011).
9. Moberg teaches that the “base portion 20 may include a suitable
opening or port 23 for connecting a hollow tube 25 to the reservoir, to
convey infusion media from the reservoir” (Moberg 2-3 ¶ 0028).
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10. Moberg teaches that the “other end of the tube 25 may
connected to a hollow needle 21 for piercing the patient’s skin and
conveying infusion media into the patient” (Moberg 3 ¶ 0029).
11. Moberg teaches that in “other embodiments, as described
below, a hollow needle and insertion mechanism may be included within the
delivery device 12, so as to avoid the need for a port 23, tube 25 and
connector 26” (Moberg 3 ¶ 0029).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
Analysis
Moberg teaches an apparatus that “when used in conjunction with
glucose sensors or monitors, insulin pumps may be automatically controlled
to provide appropriate doses of infusion medium at appropriate times of
need, based on sensed or monitored levels of blood glucose” (Moberg 1 ¶
0006; FF 1). Moberg teaches a base (FF 2) with a first piercing member for
infusing a fluid (FF 2-3) and a second piercing member for sensing a body
characteristic, specifically glucose levels (FF 4). Moberg suggests the use of
infusion tubing connecting the reservoir to the needle (FF 8-9). Moberg
teaches that the piercing members are on a hub which can engage and
disengage from the base and which are operatively coupled to the base but
which do not come into contact after piercing the patient (FF 3, 6, 7).
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Applying the KSR standard of obviousness to the findings of fact, we
conclude that the person of ordinary skill would have reasonably
incorporated the infusion tubing of Moberg into the apparatus of figure 28
where the tubing was necessary to connect the needle to the reservoir or to
refill the internal reservoir from an external reservoir. We also agree with
the Examiner that forming the hub of the two needles into a single piece
would have been reasonably obvious for the reasons given by the Examiner.
Such a combination is merely a “predictable use of prior art elements
according to their established functions.” KSR, 550 U.S. at 417.
Appellants contend that the “port in the delivery needle that allows a
fluid medication to flow from the fluid medication reservoir to the site of
infusion eliminates the need for infusion set tubing adapted to connect to a
cannula” (App. Br. 5).
We are not persuaded. Moberg teaches an alternative embodiment in
figure 2 (FF 8) where the “base portion 20 may include a suitable opening or
port 23 for connecting a hollow tube 25 to the reservoir, to convey infusion
media from the reservoir” (Moberg 2-3 ¶ 0028; FF 9). Moberg teaches that
the “other end of the tube 25 may connected to a hollow needle 21 for
piercing the patient’s skin and conveying infusion media into the patient”
(Moberg 3 ¶ 0029; FF 10). We conclude that it would have been an obvious
alternative to either refill the reservoir 24 in Figure 28 or directly infuse
through the needle in figure 28 by using a tube such as that shown in figure
2 and discussed by Moberg (FF 8-10). Moberg specifically teaches that
these are known alternatives or equivalents, stating that in “other
embodiments, as described below, a hollow needle and insertion mechanism
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may be included within the delivery device 12, so as to avoid the need for a
port 23, tube 25 and connector 26” (Moberg 3 ¶ 0029; FF 11).
Appellants contend that “the addition of infusion set tubing will
contribute no benefit (or any function whatsoever) to this apparatus. In fact,
the addition of infusion set tubing to Moberg’s apparatuses . . . will in fact
compromise the operability of these devices” (App. Br. 6).
We are not persuaded. Moberg teaches embodiments in which
infusion tubing is used (FF 8-10). There is no evidence that using tubing
would, in any way, prevent the system of Moberg from operating. See In re
Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a
brief cannot take the place of evidence.”). That Moberg teaches devices,
some of which use infusion tubing and some of which do not use infusion
tubing, does not teach away from the use of infusion tubing. Disclosed
examples and preferred embodiments do not constitute a teaching away from
a broader disclosure or non-preferred embodiments. See In re Susi, 440 F.2d
442, 446 n.3 (CCPA 1971).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Moberg renders claim 1 obvious.
B.-E. 35 U.S.C. § 103(a)
Appellants do not separately argue the claims in these obviousness
rejections. Having affirmed the obviousness rejection of Claim 1 over
Moberg, we also find the further combinations with Douglas, Gross, Clark,
renders claims 7 and 15-19, obvious for the reasons given by the Examiner
(see Ans. 7-10).
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F. 35 U.S.C. § 103(a) over Gross, Fangrow, and Mann
The Examiner finds that Gross’s device differs from the claimed
device in that
Gross et al does not teach a first piercing member
operatively coupled to the at least one cannula [15], since
the cannula itself is a needle, thus not requiring a further
piercing member for insertion of the cannula into the body.
Fangrow teaches an apparatus (Figures 1-14) wherein a first
piercing member (introducer needle [66]) is coupled to and
extends from a base (base member [60]), wherein the first
piercing member is operatively coupled to at least one
cannula (soft cannula [52]) for infusing a fluid to an infusion
site.

(Ans. 11). The Examiner finds that “Fangrow teaches that the first piercing
member [66] is disposed on a hub (introducer cap [64]) that can operatively
engage and disengage from the base [60]” (Ans. 12). The Examiner finds
that Mann teaches “an apparatus (Figures 1-14), wherein a second piercing
member (needle [14]), which is disposed on a hub (full round cross-sectional
shape of the needle [14] that is disposed above the mounting base [30]), is
operatively coupled to a sensor (cannula [16] with sensing portion [18])”
(Ans. 13).
The Examiner finds it obvious to “substitute the cannula (‘delivery
needle’), of the apparatus of Gross et al, with a first piercing member and
soft cannula, as taught by Fangrow, as a soft cannula with a removable
piercing member is more comfortable to a patient” (Ans. 11-12). The
Examiner further finds it obvious “to modify the second piercing member, of
the modified apparatus of Gross et al and Fangrow, to be disposed on a hub
and operatively engageable and disengageable from the base, as taught by
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Mann et al, as the withdrawal of the second piercing member from the
sensor after the sensor has been placed into the body of the patient will
provide more comfort to the patient as an unnecessary piercing member will
not be present in the body of the patient during the sensing procedure” (Ans.
13).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Gross, Fangrow, and Mann
render claim 1 obvious?
Findings of Fact
12. Figure 1 of Gross is reproduced below:

“FIG. 1 is a cross-section through a liquid delivery device” (Gross, col. 14, l.
9).
13. Gross teaches that “device 10 comprises a housing 11
containing an insulin reservoir 12 for storing insulin” (Gross, col. 14, ll. 58-
59).
14. Gross teaches that “delivery needle 15 penetrates through the
epidermis and the dermis, thereby establishing communication between
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insulin reservoir 12 and the subject's subcutaneous tissue via the hollow
needle 15” (Gross, col. 15, ll. 3-6).
15. Gross teaches that “[m]icroprocessor 21 controls . . . the rate of
insulin delivery, by monitoring the patient’s blood glucose level by means of
a glucose sensor, indicated generally at 22. Sensor 22 comprises a platinum-
iridium sensor needle 23” (Gross, col. 15, ll. 22-26).
16. Fangrow teaches that
Once the needle 66 and soft cannula 52 have been inserted
to the desired depth, the introducer cap 64 can be removed
from the base member 60 and from the patient . . . Once the
introducer cap 64 is disengaged from the base member 60,
the cap is pulled outward and away from the patient, and the
needle 66 is withdrawn from the soft cannula 52. The soft
cannula remains within the patient, extending to a desired
depth within the patient’s sub-dermal tissue and held in
place by the base member 60 and the adhesive layer 50.

(Fangrow 6 ¶¶ 0069-0070).
17. Fangrow teaches that “an infusion system may comprise
additional tubes, connectors, or other components between the soft cannula
and a fluid source” (Fangrow 7 ¶ 0079).
18. Fangrow teaches that in “alternative embodiments, the base
member 60 shown and described herein can be employed to deliver
medicants or other therapeutic fluids to a patient without the use of the other
members of the infusion set described herein” (Fangrow 7 ¶0080).
19. Mann teaches that the
insertion needle 14 is adapted for slide-fit reception 30
through a needle port 42 formed in the upper base layer 36
and further through the lower bore 40 in the lower base layer
38. As shown, the insertion needle 14 has a sharpened tip 44
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and an open slot 46 which extends longitudinally from the
tip 44 at the underside of the needle 14 to a position at least
within the bore 40 in the lower base layer 36. Above the
mounting base 30, the insertion needle 14 may have a full
round cross-sectional shape

(Mann, col. 7, ll. 30-38).
20. Mann teaches that “[a]fter insertion, the insertion needle 14 is
withdrawn to leave the cannula 16 with the sensing portion 18 and the sensor
electrodes 20 in place at the selected insertion site” (Mann, col. 6, ll. 29-32).
Analysis
Gross teaches a device which comprises a base (FF 13), a first needle
to infuse a fluid (FF 14) and a second needle operatively connected to a
sensor (FF 15) where the perforation channels of the two needles are not in
operable contact (FF 12). Fangrow teaches the use of a needle for delivery
of a cannula (FF 16) as well as infusion tubing to connect the cannula to a
reservoir (FF 17). Mann teaches a sensor connected to a hub where the
cannula may be withdrawn, leaving the sensor in place (FF 19-20).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that the person of ordinary skill would have reasonably
incorporated the soft cannula and introduction system of Fangrow and the
sensor hub of Mann into the apparatus of Gross since the Examiner finds
that “a soft cannula with a removable piercing member is more comfortable
to a patient, in an infusion procedure” (Ans. 12). In addition, we agree with
the Examiner that infusion tubing provides “an efficient means for
connecting and disconnecting the cannula with a pump or fluid source that is
external to the base of the apparatus” (Ans. 12). Such a combination is
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merely a “predictable use of prior art elements according to their established
functions.” KSR, 550 U.S. at 417.
Appellants contend that the “compact arrangement of elements in the
Gross apparatus therefore eliminates the need for an infusion tubing set (i.e.
to form a fluid conduit between an external fluid source and the infusion
site)” (App. Br. 8).
We are not persuaded. While Gross prefers the use of an internal
reservoir, Fangrow teaches that in “alternative embodiments, the base
member 60 shown and described herein can be employed to deliver
medicants or other therapeutic fluids to a patient without the use of the other
members of the infusion set described herein” (Fangrow 7 ¶0080; FF 18).
That is, the prior art as represented by Fangrow recognizes that the infusion
system may comprise tubes (FF 17) but may also use a direct delivery
method. Disclosed examples and preferred embodiments do not constitute a
teaching away from a broader disclosure or non-preferred embodiments. See
In re Susi, 440 F.2d 442, 446 n.3 (CCPA 1971).
Appellants contend that “because infusion set tubing is made from
materials that are not designed to be electrically conductive, a modification
to Gross’s patch pump that added ‘infusion set tubing adapted to connect to
the cannula’ would further render this apparatus unsatisfactory for its
intended purpose by introducing an electrically non-conductive material
barrier” (App. Br. 9).
We are not persuaded. We agree with the Examiner that
whether or not the infusion set tubing is made from
electrically conductive materials is a design choice for the
material of the tubing. Electrically conductive tubing is well-
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known in the art, thus an electrically non-conductive
material barrier would not be introduced into the resultant
apparatus of Gross and Fangrow that would disrupt the flow
of electrical current within the sensor potentiostat circuit.

(Ans. 23).
Appellants also contend that “[o]ne of skill in the art would further
disagree with Patent Office’s assertion that a motivation to combine the
disclosure in Fangrow and Gross is present because infusion set tubing
would provide the benefit of allowing the apparatus to be coupled to an
external fluid source. Instead, the skilled artisan would note that the Gross
device is already coupled to a fluid source, internal reservoir 12” (App. Br.
10).
We do not find this argument persuasive since the ordinary artisan
would recognize that external and internal reservoirs are both known
elements in the prior art, where the choice depends upon whether portability
or volume is in greater demand for the device. Where there is a need to
introduce large amounts of volume which would not fit within a compact
device, the ordinary artisan would reasonably be motivated to select an
external reservoir, as the Examiner notes that “[s]uch will be useful in the
case that the reservoir [12] of Gross is depleted, thus requiring a means for
providing additional fluid into the apparatus from a secondary external fluid
source” (Ans. 24).
G.-H. 35 U.S.C. § 103(a)
Appellants do not separately argue the claims in these obviousness
rejections. Having affirmed the obviousness rejection of Claim 1 over
Gross, Fangrow, and Mann, we also find the further combinations with
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Douglas, and Clark, render claims 7 and 16-19, obvious for the reasons
given by the Examiner (see Ans. 15-19).
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over Moberg. Pursuant to 37 C.F.R. § 41.37(c)(1), we
also affirm the rejection of claims 2, 3, 5, 6, and 9-13 as these claims were
not argued separately.
We affirm the rejection of claim 7 under 35 U.S.C. § 103(a) as
obvious over Moberg and Douglas.
We affirm the rejection of claim 15 under 35 U.S.C. § 103(a) as
obvious over Moberg and Gross.
We affirm the rejection of claims 16-18 under 35 U.S.C. § 103(a) as
obvious over Moberg and Clark.
We affirm the rejection of claim 19 under 35 U.S.C. § 103(a) as
obvious over Moberg, Clark, and Gross.
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as
obvious over Gross, Fangrow, and Mann. Pursuant to 37 C.F.R.
§ 41.37(c)(1), we also affirm the rejection of claims 2, 3, 5, 6, 9-13, and 15
as these claims were not argued separately.
We affirm the rejection of claim 7 under 35 U.S.C. § 103(a) as
obvious over Gross, Fangrow, Mann, and Douglas.
We affirm the rejection of claims 16-19 under 35 U.S.C. § 103(a) as
obvious over Gross, Fangrow, and Clark.

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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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