Ex Parte Simpson et al

Patent Trials and Appeals Board

Feb 22, 2019

13780808 - (D) (P.T.A.B. Feb. 22, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/780,808 02/28/2013
68851 7590 02/26/2019
KNOBBE, MARTENS, OLSON & BEAR, LLP
DEXCOM, INC.
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
FIRST NAMED INVENTOR
Peter C. Simpson
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.
DEXCOM.238A 2685
EXAMINER
WEARE, MEREDITH H
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
02/26/2019 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):
j ayna.cartee@knobbe.com
efiling@knobbe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PETER C. SIMPSON, JENNIFER BLACKWELL,
and SEBASTIAN BOHM
Appeal 2018-003038 1
Application 13/780,808
Technology Center 3700
Before JENNIFERD. BAHR, LEE L. STEPINA, and
ARTHUR M. PESLAK, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134 from the Examiner's
decision rejecting claims 1, 18, 20-23, and 26-28. 2 We have jurisdiction
under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellant (DexCom, Inc.) is listed in the Appeal Brief as the real party in
interest. Appeal Br. 2.
2 Claims 2-17, 19, 24, 25, and 29-32 have been cancelled. Appeal Br. 17-
18 ( Claims App.).
Appeal 2018-003038
Application 13/780,808
CLAIMED SUBJECT MATTER
The claims are directed to a sensor for continuous analyte monitoring.
Claim 1, reproduced below with emphasis added, is illustrative of the
claimed subject matter:
1. A sensor device for measuring an analyte concentration in
a host, comprising:
a sensor unit comprising a sensor body, at least one
electrode comprising an electroactive surface, and a membrane
covering at least a portion of the at least one electrode, wherein
the sensor body comprises a distal end, wherein the distal end is
blunt, wherein the membrane comprises an enzyme configured
to react with the analyte, wherein the sensor unit lacks a column
strength necessary to be inserted alone through the host's skin
without substantial buckling;
a coating layer covering at least a portion of the
membrane, wherein the coating layer is configured to prevent the
membrane from peeling back when the sensor unit is advanced
through tissue during sensor insertion, wherein the coating layer
is configured to provide a column strength that allows the sensor
body to be inserted through the host's skin without substantial
buckling, wherein the coating layer comprises a coating material,
wherein the coating material is a dissolvable or biodegradable
material, wherein the coating layer forms a sensor tip; and
a base spaced from the sensor body distal end and
configured to support the sensor device on an exterior surface of
the host's skin.
Appeal Br. 17 (Claims App.).
REFERENCES RELIED ON BY THE EXAMINER
Hague
Harris
Kastanos
Simpson
US 2002/0072720 Al
US 2006/0030833 Al
US 2011/0073475 Al
US 2011/0077490 Al
2
June 13, 2002
Feb.9,2006
Mar. 31, 2011
Mar. 31, 2011
Appeal 2018-003038
Application 13/780,808
THE REJECTIONS ON APPEAL 3
I. Claims 1, 18, 20-23, 26, and 27 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Simpson, Hague, and Kastanos.
II. Claim 28 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Simpson, Hague, Kastanos, and Harris.
III. Claim 1 is provisionally rejected on the ground of nonstatutory
double-patenting over claim 25 of Application No. 14/962,972, Simpson,
and Kastanos.
IV. Claim 1 is provisionally rejected on the ground of nonstatutory
double-patenting over claim 23 of Application No. 14/963,065,4 Simpson,
and Kastanos.
OPINION
Rejection I
Appellant argues the claims subject to the first ground of rejection,
i.e., claims 1, 18, 20-23, 26, and 27, as a group. See Appeal Br. 9. We
select claim 1 as representative of the group, and claims 18, 20-23, 26, and
27 stand or fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
The Summary of the Claimed Subject Matter in the Appeal Brief
refers to Figure 9 as depicting some of the elements recited in claim 1.
Appeal Br. 6-7. We reproduce Appellant's Figure 9 below.
3 As claims 29--32 have been cancelled, the rejections of these claims under
35 U.S.C. § 112, first and second paragraphs (Final Act. 2--4), have been
withdrawn. Advisory Act. 2.
4 This Application was indicated as abandoned on October 11, 2017.
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Application 13/780,808
906\
908
910
Appellant's Figure 9 depicts (as a cross-section) a host's skin
penetrated by a sensor body 904 partially covered by a membrane 902 that is
coated with hardening agent 900. Spec. ,r,r 91, 149
The Examiner finds that Simpson discloses many of the elements
required by claim 1, but relies on Kastanos to teach a sensor device with a
sensor body that lacks the column strength necessary to enable the sensor
device to be inserted alone, without buckling, through a host's skin. See
Final Act. 5-8 (citing Simpson ,r,r 156, 167, 185, Fig. 1; Kastanos ,r,r 6, 8,
44). 5 The Examiner also relies on Kastanos to teach a coating layer that is
configured to provide enough column strength to allow the sensor body to be
inserted through the host's skin without substantial buckling. See id. at 8
(citing Kastanos ,r,r 78, 83). The Examiner reasons that it would have been
5 The Examiner relies on Hague to teach elements of claim 1 that are not
pertinent to Appellant's arguments. See Final Act. 6-7.
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Application 13/780,808
obvious to modify the sensor device of Simpson such that the sensor unit
would, by itself, lack column strength to avoid substantial buckling during
insertion through a host's skin and to also add a coating layer that provides
the column strength necessary to insert the sensor body without substantial
buckling "in order to provide sufficient structural support for direct,
unassisted insertion of the sensor ... while improving comfort for the user
and reducing damage to the surrounding tissue of the insertion site." Id.
(citing Kastanos ,r,r 2, 42). We reproduce Figure 1 of Simpson below.
170
(
'
FIG. 1
'--- ... ----!JO
---~120
-//6
-/80
Figure 1 of Simpson is a schematic cross-section of skin 180 pierced
by sensor body 120 having a support member 130 covered by membrane
140. Simpson ,r,r 121, 156.
Appellant attacks the Examiner's rationale for modifying the device
of Simpson, but does not traverse Examiner's determination that the
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Application 13/780,808
combination of the teachings of Simpson, Hague, and Kastanos, if made as
proposed, would include all of the elements recited in claim 1. Specifically,
Appellant asserts (i) Simpson teaches away from the Examiner's proposed
modification, (ii) the proposed modification renders Simpson's device
inoperable for its intended purpose, (iii) the proposed modification changes
the principle of operation of Simpson's device, and (iv) the rationale for the
proposed modification relies on improper hindsight by violating the express
teachings in Simpson. See Appeal Br. 9--15.
(i) Teaching Away
Appellant contends that Simpson teaches away from any modification
that would remove the column strength necessary for its sensor body to be
inserted, alone, through the host's skin without substantial buckling. See
Appeal Br. 11. In support of this argument, Appellant quotes the portion of
Simpson's Abstract reproduced below.
The in vivo portion may comprise a tissue piercing element 110
configured for piercing the skin 180 of the host and a sensor body
120 comprising a material or support member 130 that provides
sufficient column strength to allow the sensor body to be
pushable in a host tissue without substantial buckling.
Appeal Br. 11-12 (quoting Simpson, Abstract). Based on this portion of
Simpson's Abstract, Appellant states, "[a]s shown, Simpson expressly
teaches away from a modification that would render the sensor body without
the column strength necessary to be inserted alone through the host's skin
without substantial buckling." Appeal Br. 12.
In response, the Examiner refers to paragraphs 98 and 167 of
Simpson, which teach that the sensor body may be embedded in a
biodegradable coating that functions as a tissue piercing element (namely, a
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Application 13/780,808
needle) and that a tissue piercing element can be configured with column
strength sufficient to avoid buckling. Ans. 3.
In reply, Appellant reiterates that Simpson teaches away from
reducing the column strength of the sensor body. Reply Br. 2-5. As for
Simpson's discussion of a needle, Appellant contends that the needle
described by Simpson does not qualify as a tissue piercing element. Id. at 5
("Simpson never discloses that the sensor body is encapsulated or embedded
within the tissue piercing element. This feature actually relates to the needle
in Simpson"). Appellant further argues "the purpose of the needle is not to
provide column strength, but rather 'to provide protection of the membrane
during insertion of the sensor device."' Id. (quoting Simpson ,r 167).
We disagree with Appellant's argument because the Examiner's
proposed modification to Simpson provides a device with sufficient column
strength to be insertable through a host's skin without substantial buckling,
despite the fact that a subcomponent of the device, i.e., the sensor unit
without its coating, lacks the column strength to perform this function. See
Final Act. 8. In other words, we understand Simpson to teach that the ability
to insert the sensor device through the skin is the characteristic that is most
important, not that any particular portion of the sensor device provide this
ability. See Simpson ,r 156 ("In the particular embodiment illustrated in
FIG. 1, the sensor device 100 comprises an in vivo portion 160 (also referred
to as a sensor unit) configured for insertion under the skin of the host and an
ex vivo portion 170 configured to remain above the host's skin surface after
sensor insertion."). Thus, we agree with the Examiner (Ans. 3) that Simpson
does not criticize, discredit, or otherwise discourage the claimed solution.
Indeed, the Examiner's proposed modification to add a coating appears to be
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Application 13/780,808
in accordance with at least one express teaching in Simpson. See Simpson
,r 167 ( discussing encapsulation in a biodegradable material).
(ii) Inoperability
Appellant next argues that the Examiner's proposed modification
would cause the sensor body taught by Simpson to buckle, i.e., fail, when
subjected to the resistance associated with penetrating tissue and skin. See
Appeal Br. 12-13, Reply Br. 5---6. This argument is, in essence, a
paraphrasing of Appellant's "teaching away" argument discussed above,
and, for the same reasons, is unavailing. Specifically, the Examiner's
proposed modification to the device in Simpson results in a sensor that can
be inserted without substantial buckling.
In support of the assertion that the proposed modification would
render Simpson's device inoperable, Appellant states, "the bending
characteristics of the planar substrate sensor of Kastanos are substantially
different than the bending characteristics of the wire sensor of Simpson[, and
s ]uch differences highlight that the proposed modification of such different
types of sensors would render Simpson inoperable for its intended purpose."
Appeal Br. 13.
Aside from pointing out that the devices disclosed by Simpson and
Kastanos have different shapes with allegedly different bending
characteristics, Appellant provides no explanation as to why the teachings of
Kastanos, as applied by the Examiner in the proposed modification, would
render Simpson's device inoperable for its intended purpose. Accordingly,
this argument does not apprise us of Examiner error.
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(iii) Changing the Principle of Operation
Appellant next contends that the proposed modification to Simpson's
device changes its principle of operation, "namely that the sensor body of
Simpson does not substantially buckle when inserted alone through the
host's skin." Appeal Br. 14; see also Reply Br. 6-7.
The Examiner disagrees, stating "[ t ]he intended purpose or principle
of operation of Simpson is providing a sensor unit that is directly insertable
without the use of a separate device, such as an applicator or introducer."
Ans. 5 ( citing Simpson ,r 155).
The Examiner has the better position on this point. We agree that the
proposed modification does not change the principle of operation of the
sensor device disclosed by Simpson because the modified sensor still
functions as it did before the modification, even with respect to being
inserted through a host's skin. The fact that a portion of any resistance
encountered during insertion is being born by the coating the Examiner
proposes to add does not change this principle.
(iv) Impermissible Hindsight
Appellant next contends that the Examiner applies impermissible
hindsight reasoning in rejecting claim 1 because "the proposed modification
... violates the express teachings of Simpson by changing Simpson's sensor
body, which has sufficient column strength to avoid substantial buckling, to
a sensor body that lacks such column strength." Appeal Br. 15.
Appellant's argument does not apprise us of Examiner error. As
discussed above, the Examiner's proposed modification to the device
disclosed by Simpson does not undermine teachings of Simpson. Further,
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Application 13/780,808
the Examiner's reasoning for modifying Simpson based on the teachings of
Kastanos is supported by the express disclosure in Kastanos. See Kastanos
We have considered all of Appellant's arguments contesting Rejection
I, but find them unavailing. Accordingly, we sustain the rejection of claims
1, 18, 20-23, 26, and 27 as unpatentable over Simpson, Hague, and
Kastanos.
Rejection II
Appellant makes no additional arguments in support of the
patentability of claim 28. See Appeal Br. 16. Accordingly, we sustain
Rejection II for the same reasons discussed above regarding Rejection I.
Rejections III and IV
The scope of claim 25 of Application No. 14/962,972 has changed
since the notification date of the Final Office Action. Application No.
14/963,065 has been abandoned. Accordingly, we leave it to the Examiner
to determine the propriety of Rejections III and IV.
DECISION
The Examiner's decision to reject claims 1, 18, 20-23, 26-28 is
affirmed.
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Application 13/780,808
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
11