Ex Parte 6447485 et al

Board of Patent Appeals and Interferences

Jul 18, 2012

95000271 (B.P.A.I. Jul. 18, 2012)

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.
95/000,271 06/25/2007 6447485 VINTL.26FCPDIRX 2227
20995 7590 07/18/2012
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
EXAMINER
FLANAGAN, BEVERLY MEINDL
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
07/18/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

NEXUS MEDICAL LLC
Requester1

v.

Patent of VENETEC INTERNATIONAL, INC.
(a subsidiary of C.R. BARD, INC.)
Patent Owner and Appellant
____________

Appeal 2012-005323
Reexamination Control 95/000,271
Patent 6,447,485 B2
Technology Center 3900
____________

Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON, and
RAE LYNN P. GUEST, Administrative Patent Judges.

ROBERTSON, Administrative Patent Judge.

DECISION ON APPEAL

1 Nexus Medical did not participate in this appeal.
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Patent Owner Venetec International Inc. (a subsidiary of C.R. Bard,
Inc.) (“Patent Owner”) appeals under 35 U.S.C. §§ 134(b) and 315(a) the
Examiner’s decision to reject claims 1-33.2 We have jurisdiction under 35
U.S.C. §§ 134(b) and 315(a).
We heard oral arguments from Patent Owner on June 6, 2012, a
written transcript of which will be entered into the electronic record in due
course.
We affirm-in-part and enter a new ground of rejection pursuant to our
authority under 37 C.F.R. § 41.77(b).

STATEMENT OF THE CASE
United States Patent 6,447,485 B2 (hereinafter the “‘485 Patent”),
which is the subject of the current inter partes reexamination, issued to
Steven F. Bierman on September 10, 2002. The ‘485 patent is one of three
related patents that were the subject of a civil case captioned Venetec
International, Inc. v. Nexus Medical LLC, Civil Action 1:07-cv-0057-MPT
(D. Del.), which Patent Owner informs us has been settled. (App. Br. 1.)
We previously affirmed the Examiner’s rejections of the claims subject to
reexamination in the two other related patents, namely 6,213,979 B1
(reexamination control. No. 90/010,167, 2010-007376, from which the ‘485
Patent claims divisional status), and 7,247,150 B2 (reexamination control.

2 See Patent Owner’s Appeal Brief 1 (filed April 4, 2011) (hereinafter “PO
App. Br.”) Examiner’s Answer (mailed September 27, 2011) (hereinafter
“Ans.”); Right of Appeal Notice (mailed April 13, 2010) (hereinafter
“RAN.”).
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No. 90/010,211, 2010-007390, which is a continuation of the ‘485 Patent via
United States Patent 6,213,979 B1.) As previously mentioned, Third-Party
Requester Nexus Medical, LLC3 (hereinafter “Requester”) did not file a
Respondent Brief in this appeal.
The ‘975 Patent relates to anchoring systems for anchoring medical
lines to patients. (Col. 1, ll. 10-11.) Claims 1, 12, and 22, which are
illustrative of the appealed subject matter, read as follows (with underlining
showing added text relative to the original patent claims):
1. A method of securing a medical device to the body of
a patient, the method comprising the steps of:
providing a retainer including a base that defines a
receiving area for receiving a portion of the medical device, a
cover permanently coupled to the base, the cover being
movable between a closed position, in which at least a portion
of the cover extends over at least a portion of the receiving area,
and an open position, in which the receiving area is at least
partially open, a latching mechanism operating between the
base and the cover to releasably latch the cover to the base with
the cover in the closed position, and interacting structure which
is adapted to engage the medical device in a non-occlusive
manner and to limit longitudinal movement of the medical
device through the retainer when the medical device is placed
within the receiving area;
positioning the retainer on the body of the patient;
attaching the retainer to the body of the patient with an adhesive
layer; securing a portion of the medical device in the receiving
area of the base; moving the cover over the base so that the
cover is located over at least a portion of the interacting
structure; and
securing the cover in position upon the base using the
latching mechanism.

3 See Request for Inter Partes Reexamination filed June 25, 2007.
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12. A method of securing a medical line to the body of a
patient, the medical line having an irregularly shaped portion,
the method comprising the steps of:
providing a retainer attachable to a medical line,
including a base, a cover permanently coupled to the base, a
latching mechanism, a channel, and an adhesive layer attached
to the retainer, the cover being movable between an open
position and a closed position, the latching mechanism
releasably latching the cover to the base in the closed position,
the channel being disposed between the base and the cover
when the cover is in the closed position, the channel having an
irregular shape along its length that substantially corresponds in
shape to the irregularly shaped portion of the medical line
[being shaped] to retain the irregularly shaped portion of the
medical line between the cover and the base with the cover in
the closed position in order to inhibit movement of the
irregularly shaped portion of the medical line in a direction
generally parallel to the medical line's longitudinal axis;
positioning the retainer on the body of the patient;
attaching the adhesive layer to the body of the patient; placing a
portion of the medical line into the channel; moving the cover
over the base so that the medical line is retained within the
channel; and
securing the cover in position upon the base using the
latching mechanism.

22. A method of securing a medical line to the body of a
patient, the method comprising the steps of:
providing a retainer, the retainer including a base that
defines a receiving area for receiving a portion of the medical
line and a cover coupled to the base, means for releasably
latching the cover to the base, and means for limiting
longitudinal movement of the medical line relative to the
retainer;
positioning the retainer on the body of the patient;
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attaching the adhesive layer to the body of the patient;
placing a portion of the medical line into the receiving
area;
moving the cover over the base so that the cover lies at
least partially over the movement limiting means; and
securing the cover in position upon the base using the
latching mechanism.

(PO App. Br. 34-37 Claims App’x.)

Patent Owner contests the Examiner’s decision to reject the claims as
follows (presented in a different order than in the Appeal Brief as noted in
the parentheses):
I. Claim 12 under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement (Rejection 8,
Ans. 17-18);
II. Claims 1-3, 5-8, 11-13, 15-18, 21, and 22 under 35 U.S.C. §
102(b) as anticipated by Sorbonne4 (Rejection 1, Ans. 5-6);
III. Claims 12, 22, and 29 under 35 U.S.C. § 102(b) as anticipated
by Gordon ‘647 (Rejection 5, Ans. 13-14); 5
IV. Claims 22 and 30-33 under 35 U.S.C. § 102(b) as anticipated
by Bierman ‘4356 (Rejection 6, Ans. 14-16);
V. Claims 1, 12, and 23-29 under 35 U.S.C. § 103(a) as obvious
over Bierman ‘435 in view of Sorbonne (Rejection 2, Ans. 7-8);

4 United States Patent No. 4,517,971, issued May 21, 1985.
5 United States Patent 4,397,647, issued August 9, 1983.
6 WO 96/10435, published April 11, 1996.
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VI. Claims 2, 6, 16, and 22 under 35 U.S.C. § 103(a) as obvious
over Sorbonne in view of Bierman ‘435 (Rejection 3, Ans. 9-
11);
VII. Claims 1, 23, and 24 under 35 U.S.C. § 103(a) as obvious over
Gordon ‘647 in view of Gordon ‘8807 (Rejection 4, Ans. 11-
13); and
VIII. Claims 22, 30, and 33 under 35 U.S.C. § 103(a) as obvious over
Gordon ‘647 in view of Bierman ‘435 (Rejection 7, Ans. 16-
17).

The Patent Owner relies on the following rebuttal evidence:
Amended Declaration of Paul Frankhauser executed December 21,
2007 (Ex. II, App. Br.; hereinafter “First Frankhauser Decl.”).
Supplemental Declaration of Paul Frankhauser executed December
21, 2007 (Ex. III, App. Br.; hereinafter “Second Frankhauser Decl.”).
Amended Declaration of Steven F. Bierman executed December 21,
2007 (Ex. V, App. Br.; hereinafter “First Bierman Decl.”).
Supplemental Declaration of Steven F. Bierman executed December
21, 2007 (Ex. VI, App. Br.; hereinafter “Second Bierman Decl.”).
Patent Owner also relies on evidence of secondary considerations
presented in Exhibits VIII-XIII of the Appeal Brief.

7 United States Patent 4,250,880, issued February 17, 1981.
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35 U.S.C. § 112 1st PARAGRAPH REJECTION
Rejection I
Discussion
Regarding claim 12, the Examiner found that there was no written
description support for the added limitations of a “medical line having an
irregularly shaped portion” and a “channel having an irregular shape along
its length.” (Ans. 18.) The Examiner found that Patent Owner’s reliance on
mounting structure and channels as depicted in the figures are of a regular
hour glass shape and not an irregular shape. (Ans. 18.)
Patent Owner contends that Figures 10A-12 provide examples of a
non-uniform channel and a medical line (with adaptor body 170) having a
non-uniform, truncated shape, such that there is support for the term
“irregularly shaped” as recited in the claims. (App. Br. 14.)
We previously addressed the term “irregularly shaped” in our
Decision in Appeal No. 2010-007390 (ex parte reexamination control No.
90/010,211 of U.S. Patent No. 7,247,150 B2) (“the ‘390 Decision” pages 19-
22). In the ‘390 Decision, we interpreted “irregularly shaped” as not being
limited to the shapes disclosed in Figures 10A-12, and concluded that the
term, which is not defined in the Specification, should be interpreted
broadly. (The ‘390 Decision, pages 21-22.)
Here, we agree with Patent Owner that Figures 10A-12, in depicting
an adaptor body 170 and channels formed from box-like extensions 141 with
inner faces 142 (see the ‘485 Patent, col. 17, ll. 48-66) provide support for
the limitations “irregularly shaped” as related to the recited channel and
portion of the medical line. Specifically, neither the channel created by the
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box-like extensions nor the adaptor body is uniform or regular in shape.
However, consistent with the ‘390 Decision, we do not impart any specific
structure from Figures 10A-12 as being required for the claimed channel or
portion of the medical line to be “irregularly shaped.” See Crown Packaging
Tech., Inc. v. Ball Metal Beverage Container Corp., 635 F.3d 1373, 1381
(Fed. Cir. April 1, 2011) (citing Lampi Corp. v. Am. Power Prods., 228 F.3d
1365, 1378 (Fed. Cir. 2000) (concluding that the embodiment drawings did
not compel a conclusion that the written description is so narrowly tailored
to be limited to the embodiments depicted in the drawings).
Accordingly, we reverse the Examiner’s rejection of claim 12 as
failing to comply with 35 U.S.C. § 112, first paragraph.

ANTICIPATION REJECTIONS
Rejection II
Issue
The issue with respect to Rejection II is:
Did the Examiner err in finding that Sorbonne discloses the
interacting structure recited in claim 1, the medical line and channel
configuration recited in claim 12, or the means for limiting longitudinal
movement in claim 22 in view of the evidence of record?

Findings of Fact
Sorbonne discloses a catheter and intravenous tubing retainer (Col. 1,
ll. 9-10.) Sorbonne discloses that the device disclosed therein is constructed
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of a semi-soft flexible and clear synthetic resinous material that retains its
shape. (Col. 2, ll. 7-9.)
Figure 4 of Sorbonne is reproduced below:

Figure 4 is a plan view of a venipuncture guard retainer in the
installed position, with a portion of the lid broken away. (Col. 3, ll. 22-25.)
Sorbonne discloses that the device 10 (ref. no. not shown) includes posts 42
and 44, where tubing 102 of a medical device is threaded around the post
“while preventing crimping or occlusion of the tubing 102” to prevent
catheter displacement. (Col. 6, ll. 10-26.)

Analysis
Claim 1
The Examiner found that Sorbonne discloses an interacting structure
in the form of cylindrical posts secured to a base, where the tubing is
threaded around the posts to prevent crimping or occlusion of the tubing
inhibiting movement in the longitudinal direction. (Ans. 5-6.)
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Patent Owner contends that Sorbonne fails to disclose an “interacting
structure which is adapted to engage the medical device” as recited in the
claims because there is no additional structure in Sorbonne besides the
medical line and spools around which the medical line is threaded. (App.
Br. 6.) Patent Owner also argues that the evidence of record demonstrates
that the device of Sorbonne is not effective without substantially occluding
flow. (App. Br. 7.) Specifically, Patent Owner contends that the contact
between the medical line and spools necessarily results in some crimping,
which would occlude flow. (App. Br. 8.)
Initially, we are not persuaded by Patent Owner’s argument that the
interacting structure recited in the claims requires “some additional
structure” beyond the spools 42, 44 disclosed in Sorbonne in light of the
embodiments disclosed in the Specification of the ‘485 Patent. (App. Br. 6-
7.) The claims do not recite any such structure. (See Ans. 19-20. )8
Sorbonne discloses that the medical line is threaded around (interacts with)
the spools 42, 44 in order to prevent catheter displacement (longitudinal
movement). (Sorbonne, col. 6, ll. 10-26.) Accordingly, Sorbonne discloses
an interacting structure as recited in the claims.
We are also not persuaded by Patent Owner’s argument that the
evidence of record, namely the first and second Frankhauser Declarations,
demonstrates that Sorbonne does not engage the medical device in a non-
occlusive manner as recited in the claims. As the Examiner stated, Sorbonne
expressly discloses that the medical lines are not occluded. (Ans. 22-23;

8 In the Answer, the Examiner specifically agreed with Requester’s
comments submitted in the responses filed December 21, 2007 and January
22, 2008 and which are reproduced in the Answer, pages 18-55.
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Sorbonne, col. 6, ll. 10-26.) We do not find the statements made in the First
and Second Frankhauser Declarations to be sufficient to outweigh the
express statements made in Sorbonne that the interaction between the
medical line and the posts does not occlude the medical line.
Specifically, the First Frankhauser declaration states that the device
disclosed in Sorbonne would not retain catheters without occlusion of the
tubing or without slippage of the tubing. (First Frankhauser Dec., para. 12.)
However, the First Frankhauser Declaration does not direct our attention to
sufficient supporting evidence to support the statements made therein. In
addition, the First Frankhauser Declaration states that the diameter and
material of the tubing “may” prevent the device disclosed in Sorbonne from
retaining the tubing in a non-tension state, and that in the tension state, if the
tubing had sufficient integrity to avoid occlusion against the spools, the
tubing “would most likely” slip through the spools. (First Frankhauser Dec.
para. 12.) Such unsupported qualified statements are insufficient to
overcome the express disclosure in Sorbonne that the tubing would not be
occluded.
To the extent Patent Owner argues that the Second Frankhauser
Declaration provides supporting evidence for the First Frankhauser
Declaration, we are also not persuaded. In the Second Frankhauser
Declaration, Mr. Frankhauser constructed a device that is said to have been a
mock-up of the device described in Figures 3-9 of Sorbonne, in which two
wooden dowels were used for spools. (Second Frankhauser Dec., para. 4
and 11.) Mr. Frankhauser acknowledged that the coefficient of friction
would likely be different between tubing and other materials. Mr.
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Frankhauser declared that due to the use of different sized spools, employing
a material with a higher coefficient of friction would not change his analysis.
(Second Frankhauser Dec. para. 11.) Mr. Frankhauser declared that when
the tubing was held in the devices in a tension state, the tubing deformed
causing occlusion. (Second Frankhauser Dec., para. 9.)
We do not find the tests conducted to be sufficient to show that the
device disclosed in Sorbonne would result in occlusion of the medical lines
when subjected to longitudinal force. Sorbonne discloses that the device is
constructed of a semi-soft flexible and clear synthetic resinous material that
retains its shape (col. 2, ll. 7-9), whereas the tests described in Patent
Owner’s evidence of record employ wooden dowels for the spools disclosed
in Sorbonne. The materials are therefore not the same. Because the tested
device does not replicate the Sorbonne device, the weight accorded to the
statements regarding the amount of occlusion of the tube is diminished. In
addition, we are not persuaded by the Declarant’s position that the larger
spools of the test device provide a sufficient comparison with a material
having a higher coefficient of friction. Sorbonne discloses that the material
is “semi-soft and flexible” (col. 2, ll. 7-9), the effect of which on the
occlusion of the tubing is not discussed in either the First or Second
Frankhauser Declaration. Accordingly, the evidence presented by Patent
Owner is not sufficient to outweigh the express statements made in
Sorbonne that the device retains the medical line without crimping or
occluding when subjected to external stress. As a result, we affirm the
Examiner’s rejection of claim 1 as anticipated by Sorbonne.

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Claim 12
Patent Owner contends that Sorbonne does not disclose an irregularly
shaped channel that corresponds to a medical line having an irregularly
shaped portion as recited in claim 12. (App. Br. 15.)
We agree with Patent Owner that Sorbonne fails to anticipate claim
12. Claim 12 requires not only that the channel has an irregular shape along
its length, but also that the medical line has an irregularly shaped portion
that corresponds in shape to the irregularly shaped channel. Sorbonne
discloses that the medical line is threaded around the two spools, but
Sorbonne does not disclose an arrangement between the channel and the
medical line where the interaction of an irregularly shaped portion of the
medical line and the irregular shape of the channel inhibits movement in a
direction generally parallel to the longitudinal axis of the medical line as
recited in claim 12. (Col. 6, ll. 10-26; Fig. 4.) The Examiner does not
appear to address this deficiency in formulating the rejection or in the
response to arguments. (Ans. 6, 19-24.) Therefore, we reverse the
Examiner’s rejection of claim 12 as anticipated by Sorbonne.

Claim 22
In rejecting claim 22, the Examiner reiterated that the spools in
Sorbonne are configured to engage the catheter tube in a non-occlusive
manner, which satisfies the “means for limiting the longitudinal movement”
limitation recited in claim 22. (Ans. 24.)
Patent Owner contends that Sorbonne does not disclose any of the
structures corresponding to the “means” recited in the claim as expressed in
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the ‘485 Patent. (App. Br. 17.) Specifically, Patent Owner argues that the
structure corresponding to the “means for limiting longitudinal movement of
the medical line relative to the retainer” is either posts interacting with holes
on a fitting of a medical line or walls defined by mounting structures that are
shaped and arranged relative to each other to generally correspond or
interact with a fitting on a medical line. (App. Br. 17.)
We addressed similar arguments made by Patent Owner in our
Decision in the ex parte reexamination of 6,213,979 B1 (reexamination
control 90/010,167, Appeal 2010-007376, “the ‘376 Decision”), and which
we hereby incorporate by reference. (See the ‘376 Decision, pages 5, 12-
13.) In the ‘376 Decision, we concluded that in light of the Specification of
the ‘979 Patent, which is the same as the Specification of the ‘485 Patent,
the unrestrictive broadening language of the Specification did not limit the
“means” recited in the claims to the two structures identified by Patent
Owner, but rather included equivalent structures that rely on the use of
compressive or downward force forces directly on the medical line,
including those with tolerable degrees of crimping or compression. (The
‘376 Decision, pages 12-13.)
In view of this claim construction, which we adopt herein, we agree
with Patent Owner that Sorbonne fails to disclose a means for limiting
longitudinal movement as disclosed in the Specification of the ‘485 Patent or
an equivalent thereof. That is, the means for retaining the medical line in
place in Sorbonne does not rely on a compressive or downward force on the
medical line. Rather the medical line is prevented from moving
longitudinally by threading the medical line around spools to prevent
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crimping or occlusion. (Sorbonne, col. 6, ll. 10-26.) Accordingly, the
“means” disclosed in Sorbonne is not an equivalent of the means disclosed
in the ‘485 Patent, as it does not perform the claimed function in
substantially the same way as the structure described in the ‘485 Patent
Specification. Therefore, we do not sustain the Examiner’s rejection of
claim 22 as anticipated by Sorbonne.

Rejection III
The Rejection
In rejecting claims 12, 22, and 29, the Examiner found that Gordon
‘647 discloses an interacting structure comprising ribs 21 and 28 positioned
within a cradle, which hold a catheter within the cradle upon closing of a
cover, such that the vertical spacing or height of the ribs provides a firm grip
against longitudinal displacement of the tubing within the stabilizer. (Ans.
13-14.) The Examiner stated that the channel in Gordon ‘647 includes side
walls 19, 20, rear walls 17, 18, bottom wall 22, and ribs 21. (Ans. 42.) As a
result the Examiner found that the width of the channel varies due to the
presence of the ribs, and is irregularly shaped. (Ans. 42.) The Examiner
also found that Gordon ‘647 discloses a means for preventing longitudinal
movement as recited in claim 22 in the form of projection 55, which engages
the medical line in one embodiment of Gordon ‘647 or the channel with ribs
21 as in another embodiment of Gordon ‘647. (Ans. 46-47.)
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Issues
The issues with respect to Rejection III are:
Did the Examiner err in finding that Gordon ‘647 discloses the
medical line and channel configuration recited in claim 12?
Did the Examiner err in finding that Gordon ‘647 discloses the means
for limiting longitudinal movement recited in claim 22?

Findings of Fact
Gordon ’647 discloses a device for positionally stabilizing a catheter
on the body of a patient. (Col. 1, ll. 23-24.)
Figures 3 and 7 of Gordon ‘647 are reproduced below:

Figures 3 and 7 are perspective views of catheter stabilizing devices
according to Gordon ‘647. (Col. 3, ll. 16-30.)
The device in Figure 3 includes a base member 11, a support member
14, a cradle 16 including a front wall 17, a rear wall 18 (not shown), side
walls 19 and 20, bottom wall 22, gripping members (ribs) 21, and cover 25
with downward extending ribs 28. (Col. 3, l. 41 through col. 4, l. 39.) In
use, the stabilizer depicted in Figure 3 is secured to the catheter tube, where
the ribs 21 and 28 engage the catheter tube, and by virtue of a slight
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crimping of the tube, provides firm engagement of the tube preventing
longitudinal displacement of the tube. (Col. 4, l. 63 – col. 5, l. 25.)
Figure 7 depicts a stabilizer 40 including base member 41, base
portion 43, a pair of side walls 44 and 45 terminating in recesses 47 and 48
(not shown) which receive catheter tube 50. (Col. 6, ll. 15-51.) The
stabilizer depicted in Figure 7 also includes a snap-over cover 46 that
includes a gripping projection 55 to engage and slightly crimp the catheter
tube 50 forcing the catheter tube 50 slightly downward into central opening
49. (Col. 7, ll. 32-49.)

Analysis
Claim 12
Patent Owner contends that the channel in Gordon ‘647 is defined by
ribs 21 and 28, which are shaped to hold a medical tube with constant
diameter. (App. Br. 16.) We agree with Patent Owner that Gordon ‘647
fails to anticipate claim 12. Specifically, the Examiner fails to identify
where Gordon ‘647 discloses a “medical line having an irregularly shaped
portion” as recited in claim 12. While Gordon ‘647 discloses a device for
stabilizing a catheter containing an irregularly shaped channel (Fig. 3),
Gordon ‘647 does not disclose a medical line having an irregularly shaped
portion. Gordon ‘647 discloses catheter tubing, but does not disclose any
particular shape that would include an “irregularly shaped portion” even
when the term is accorded its broadest reasonable interpretation as discussed
supra. Accordingly, we reverse the Examiner’s rejection of claim 12 and
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claim 29, which depends indirectly from claim 12, as being anticipated by
Gordon’647.

Claim 22
Regarding claim 22, Patent Owner argues that Gordon ‘647 relies on
compression or crimping to prevent longitudinal movement, which is not
equivalent structure to the means recited in the claims as disclosed in the
‘485 Patent. (App. Br. 19.) However, as discussed supra with respect to
Sorbonne, the “means for limiting longitudinal movement” recited in claim
22 does allow for tolerable amounts of compression or crimping. Gordon
‘647 discloses devices that prevent longitudinal displacement of the catheter
tube via compressive or downward force, via the ribs 21 and 28 in the device
depicted in Figure 3 or projection 55 in the device depicted in Figure 7.
Thus, Gordon ‘647 discloses a “means for limiting longitudinal movement”
as recited in claim 22. Accordingly, Patent Owner’s argument is
unpersuasive. Therefore, we affirm the Examiner’s rejection of claim 22 as
anticipated by Gordon ‘647.

NEW GROUND OF REJECTION
Claim 12 is Anticipated by Gordon ‘880
In the course of responding to Patent Owner’s arguments, the
Examiner incorporated comments from the Requester’s response during
prosecution, which advanced the position to the Examiner that in light of the
amendments to claim 12, that claim 12 is anticipated by Gordon ‘880. (Ans.
41, 43-44.) Although the Examiner did not appear to adopt this rejection in
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the subsequent Action Closing Prosecution (mailed November 9, 2009), we
agree with the Requester’s position in Requester’s Comments to the Patent
Owner’s Response to the Office Action Dated September 21, 2007, dated
December 21, 2007, Pages 31-33) and incorporated by reference in the
Examiner’s Answer. Thus, claim 12 is rejected under 35 U.S.C. § 102(b) as
anticipated by Gordon ‘880 for the reasons expressed therein. This rejection
is designated as a new ground of rejection pursuant to our authority under 37
C.F.R. § 41.77(b).

Rejection IV
Issue
The dispositive issue in this rejection is whether Bierman ‘435
discloses a “cover coupled to the base” as recited in claim 22.
The Examiner’s position is that Bierman ‘435 discloses that box
clamp 14 is coupled to the retainer upon securement of the medical line to
the retainer, where the box clamp constitutes the claimed cover and where
the retainer constitutes the claimed base. (Ans. 51-52.)
Patent Owner argues that Bierman ‘435 does not disclose a cover
coupled to a base because box clamp 14 is not coupled to the retainer in the
open position, and the claim requires the cover to be coupled both before
and after the medical article is placed within the retainer. (App. Br. 23.)

Findings of Fact
Bierman ‘435 discloses an anchoring system for catheters. (Page 1, ll.
4-5.)
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Figure 2 of Bierman ‘435 is reproduced below:

Figure 2 depicts an exploded view of a central line catheter anchoring
system. (Page 3, ll. 30-33.) The anchoring system 10 includes a retainer 20,
box clamp 14, and wing clamp 18. (Page 4, ll. 22-35.) In use, the wing
clamp 18 is stretched over the catheter 12, and the downwardly extending
posts 17 of box clamp 14 are inserted through the holes 36, to form a
combination wing clamp/box clamp. Posts 17 are further aligned with the
slotted openings 42 in the top surface of the retainer 42 to engage the
openings 42 and moved laterally to retain the box clamp 14 in place. (Page
7, ll. 4-20.)

Analysis
We cannot agree with the Examiner’s position that the cover recited in
claim 22 need not be coupled prior to securement of the medical line to the
retainer. Claim 22 recites “providing a retainer including a base . . . and a
cover coupled to the base.” Thus, claim 22 plainly requires that the cover is
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coupled to the base at the time the retainer is provided. Bierman ‘435, on
the other hand, discloses that the box clamp 14 is not attached to the base
until after the device is completely assembled. (Page 7, ll. 4-20; Fig. 2.)
The Examiner did not dispute this fact, but rather argued that coupling
occurred “upon securement” of the medical line (Answer 51-52.) As this
interpretation is improper, we conclude that Bierman ‘435 does not disclose
a cover coupled to the base as recited in claim 22.
The Examiner relies on the position that the claims do not disclose the
method in any particular order. (Ans. 53-54.) However, the order of method
steps as it relates to placing a portion of the medical line into the receiving
area and moving the cover over the base does not change the structural
requirements of the retainer at the time of providing the retainer. Thus,
because Bierman ‘435 does not disclose a cover coupled to the base at the
time of providing the retainer, we reverse the Examiner’s rejection of claim
22 and 30-33 as being anticipated by Bierman ‘435.

OBVIOUSNESS REJECTIONS
Rejection V
The Rejection
The Examiner found that Bierman ‘435 discloses a device for
engaging and securing a catheter in place through the combination of a box
clamp having posts, a wing clamp which surrounds and engages a catheter,
and a retainer. (Ans. 8.) The Examiner relied on Sorbonne for disclosing
that a cover which overlies a device for securing a medical line is well-
known, concluding that it would have been obvious to provide the device of
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Bierman ‘435 with a cover as disclosed in Sorbonne. (Ans. 7.) The
Examiner’s position is that Bierman ‘435 discloses the identical interacting
structure that was disclosed in the ‘485 Patent, which does not occlude the
catheter tube and limits the longitudinal movement of the medical device.
(Ans. 25-28.) The Examiner also stated that modifying the cover of
Sorbonne so that it would function in conjunction with the device in
Bierman ‘435 would have been an obvious modification within the level of
ordinary skill in the art. (Ans. 28-29.)

Issues
The issues for this rejection are:
Does Bierman ‘435 disclose that the interacting structure limits
longitudinal movement as recited in claim 1?
Would it have been obvious to one of ordinary skill in the art to have
added a cover to the device of Bierman ‘435 in view of Sorbonne?
Does Bierman ‘435 disclose the medical line and channel
configuration recited in claim 12?

Findings of Fact
Sorbonne discloses that the cover of the venipuncture site guard is
adapted to conceal and enclose the venipuncture and retainer section to
protect against inadvertent catheter displacement and contact. (Col. 5, ll. 7-
11, col. 6, ll. 18-25.) Sorbonne discloses and depicts covers that are attached
via a hinge at the longitudinal axis of the base or at the side edge of the base.
(Col. 3, ll. 56-57, col. 4, ll. 38-55, Fig. 5; col. 6, ll. 56-60; Fig. 9.)
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Bierman ‘435 discloses a box clamp 14 that overlies the wing clamp
18 and conveniently and painlessly anchors a catheter to the patient’s skin.
(Bierman ‘435, page 4, ll. 22-28.)

Principles of Law
In KSR, the Supreme Court explained, “[w]hen a work is available in
one field of endeavor, design incentives and other market forces can prompt
variations of it, either in the same field or a different one. 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). “A
person of ordinary skill is also a person of ordinary creativity, not an
automaton.” Id. at 421. “[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.

Analysis
Claim 1
We are unpersuaded by Patent Owner’s argument that (1) Bierman
‘435 discloses a friction fit between the wing clamp and the groove of the
box clamp, and not between the wing clamp and the catheter and (2)
Bierman ‘435 does not specifically describe “inhibiting longitudinal
movement.” (App. Br. 9.) We addressed similar arguments made by Patent
Owner in the ‘376 Decision. (See ‘376 Decision, pages 14-15, 18-20.) In
the ‘376 Decision, we stated that Bierman ‘435 contained either the same or
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substantially the same structures as disclosed in the ‘979 Patent, and thus
would reasonably appear to limit the longitudinal movement of the catheter
relative to the retainer. (Decision, p. 19.) We see no reason to disturb that
analysis here where the disclosures of the ‘979 Patent and the ‘485 Patent
are the same and no additional persuasive rebuttal evidence or arguments
have been put forth. Therefore, we agree with the Examiner that there is
sufficient evidence that Bierman ‘435 discloses limiting longitudinal
movement as recited in claim 1.
Additionally, we are not persuaded by Patent Owner’s arguments that
one of ordinary skill in the art would not have combined Bierman ‘435 and
Sorbonne to arrive at the cover arrangement recited in the claims.
Specifically, Sorbonne discloses that the cover is adapted to conceal and
enclose the venipuncture and retainer section to protect against inadvertent
catheter displacement and contact. (Col. 5, ll. 7-11, col. 6, ll. 18-25.)
Similarly, Bierman ‘435 discloses a box clamp 14, which the Examiner
found corresponded to a cover (Ans. 8), that overlies the wing clamp 18 and
conveniently and painlessly anchors the catheter to the patient’s skin.
(Bierman ‘435, page 4, ll. 22-28.) Thus, both references disclose similar
reasons for employing covers in catheter retaining devices.
Patent Owner argues that combining Sorbonne with Bierman ‘435
would frustrate the purpose of Bierman ‘435 because the cover could not
engage properly and the base and hinge structure of the cover would prevent
the box clamp from moving in a lateral direction to slide posts through the
holes as required for operation of the device in Bierman ‘435 by not
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allowing for lateral movement of the box clamp. (App. Br. 10.) Patent
Owner’s arguments are unavailing.
Patent Owner focuses on the bodily incorporation of one embodiment
disclosed in Sorbonne rather than what Sorbonne as a whole would convey
to one of ordinary skill in the art. Sorbonne discloses that the covers are
attached via a hinge either on the longitudinal axis of the base, or at the side
edge of the base. (Col. 3, ll. 56-57, col. 4, ll. 38-55, Fig. 5; col. 6, ll. 56-60;
Fig. 9.) Thus, Patent Owner’s arguments fail to take into account the full
scope of Sorbonne as well as the knowledge of one of ordinary skill in the
art. We agree with the Examiner, that as a result of the general disclosure in
Sorbonne that retaining devices include covers that are attached to the base
of the device, an obvious modification of Bierman’435 would have been to
attach box clamp 14 to the retainer 20 via a hinge in a manner that would
preserve the ability of the box clamp 14 to move laterally as required in the
locking system of Bierman ‘435. (See Ans. 28.) Whether the modification
would have been to use a hinge that allows for small lateral movement, or by
attaching the box clamp at the side edge of the base, Patent Owner has not
provided sufficient evidence that such modifications would have been
beyond the capabilities of one of ordinary skill in the art. Therefore, the
Examiner properly rejected claim 1 as obvious over Bierman ‘435 in view of
Sorbonne.

Claim 12
We agree with Patent Owner that Bierman ‘435 in view of Sorbonne
fails to teach a channel having an irregular shape along its length that
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substantially corresponds in shape to an irregularly shaped portion of the
medical line as required in claim 12. (App. Br. 15-16.) That is, the channel
in Bierman ‘435 is a straight, cylindrical channel, and thus is not of an
irregular shape as required in claim 12. (Figure 2; see numeral 40.) As
discussed above, Sorbonne also fails to disclose the required relationship
between the channel and the medical line recited in claim 12. The Examiner
does not account for this deficiency in formulating the rejection. (Ans. 7-8.)
Therefore, we reverse the Examiner’s rejection of claim 12 as obvious over
Bierman ‘435 in view of Sorbonne.

Rejection VI
Issue
The Examiner concluded that it would have been obvious to provide
the device of Sorbonne with the channel disclosed by Bierman ‘435 as a
means to secure the medical device of Sorbonne in position. (Ans. 10-11.)
Patent Owner contends that Bierman ‘435 does not disclose a means
for limiting longitudinal movement as recited in claim 22. (App. Br. 18.)
Patent Owner additionally contends that Sorbonne teaches away from
clamping to the medical line as disclosed in Bierman ‘435 such that one of
ordinary skill in the art would not have been led to incorporate the clamp
disclosed in Bierman ‘435 into the Sorbonne device. (App. Br. 18.)
Therefore, the dispositive issue is whether the Examiner erred in
concluding it would have been obvious to have incorporated the clamp of
Bierman ‘435 into the device of Sorbonne?

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Discussion
As to Patent Owner’s first argument, we are not persuaded that
Bierman ‘435 fails to disclose a “means for limiting longitudinal movement”
for similar reasons as discussed supra.
Additionally, we do not agree with Patent Owner that Sorbonne
teaches away from applying the clamp of Bierman ‘435 to the device of
Sorbonne. Patent Owner relies on the statement in Sorbonne that prior art
devices have failed to provide a venipuncture site guard that allows the
cannula at the venipuncture site to move independently of the site guard
while protecting the site as a teaching away from applying a clamp as
disclosed in Bierman ‘435. (App. Br. 18; Sorbonne, col. 1, ll. 44-49.)
However, as pointed out by the Examiner, Sorbonne itself is directed to
secure engagement of the medical line, where unless the anchoring system
as a whole moves, the medical line will also not move. (Ans. 22; see
Sorbonne, col. 6, ll. 10-26, Fig. 4.) Thus, the securing system disclosed in
Bierman ‘435 is an alternative to that disclosed in Sorbonne, such that the
substitution of one for another would have been a predictable use of prior art
elements. Therefore, we are not persuaded by Patent Owner’s arguments.

Rejection VII
The Rejection
The Examiner found that Gordon ‘647 discloses a catheter stabilizer
having a cradle that acts as a receiving area for the catheter tube. (Ans. 11.)
The Examiner found that Gordon ‘880 discloses a similar cradle with
longitudinal ridges 28 and hub boss 36a which limits the longitudinal
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movement of the catheter by providing a surface that cannot move past ribs
60. (Ans. 12.) The Examiner concluded that it would have been obvious to
provide the device of Gordon ‘647 with longitudinal ridges 28 to limit the
longitudinal movement of the catheter. (Ans. 12.)
Issue
The dispositive issue with respect to this rejection is: Did the
Examiner err in concluding that it would have been obvious to have
incorporated the longitudinal ridges and hub boss configuration disclosed in
Gordon ‘880 as a means for limiting longitudinal movement in the device
disclosed in Gordon ‘647?
Findings of Fact
Gordon ‘880 discloses a fitting for securing an intravenous catheter in
as stabilized manner to a patient’s skin. (Col. 1, ll. 11-13.) Figures 16 and
17 of Gordon ‘880 are reproduced below:
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Figure 16 is a perspective view of a stabilizing fitting and Figure 17 is
a perspective view of a stabilizing fitting showing a catheter hub in place.
(Col. 2, ll. 54-57.) The stabilizing fitting includes a catheter boss 36a that is
longitudinally located between a pair of ribs 60 in order to maintain the
catheter hub 36 in position. (Col. 4, ll. 30-64.)

Analysis
Patent Owner’s first argument, that Gordon ‘647 does not disclose
limiting longitudinal movement in a non-occlusive manner (App. Br. 11), is
unpersuasive, as it fails to address the Examiner’s rejection, which does not
rely on Gordon’647 for the manner of limiting longitudinal movement, but
rather relies on Gordon ‘880 for that limitation. (See Ans. 37.)
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We do not agree with Patent Owner that Gordon ‘880 fails to disclose
the interacting structure of claim 1. (App. Br. 13.) Patent Owner does not
substantively address the Examiner’s rejection or response to Patent
Owner’s arguments, which address how Gordon ‘880 discloses the
interacting structure of claim 1. (Ans. 11-12, 37.)
We are also unpersuaded by Patent Owner’s argument that Gordon
‘647 and Gordon ‘880 teach away from the Examiner’s proposed
combination. In this regard, Patent Owner contends that Gordon ‘880
discloses a device for releasably engaging a fitting, where the boss 36a is
located outside the cover 66 (Fig. 17 supra), and Gordon ‘647 discloses a
device for securing medical tubing, where the stabilizer disclosed in Gordon
‘647 is not capable of receiving the medical device in Gordon ‘880. (App.
Br. 12.) Patent Owner argues that the ribs 60 and boss 36a of Gordon ‘880
would change the principle of operation in Gordon ‘647, where the positive
engagement of the boss and ribs would defeat the purpose of achieving
frictional engagement, prevent closure of the cover, and that the gripping
members would have no purpose in the modified device of Gordon ‘647.
(App. Br. 12-13; See Ans. 38-39.)
We do not subscribe to Patent Owner’s view that one of ordinary skill
in the art would not have incorporated the securing system of Gordon ‘880
into the device of Gordon ‘647 because Gordon ‘647 relies on frictional
engagement of the ribs with the medical line. Rather, Gordon ‘880 provides
an alternative mechanism for limiting longitudinal movement using the
combination of ribs 60 and hub boss 36a. (Col. 1, ll. 11-13, col. 4, ll. 30-64;
Fig. 16, 17.) Thus, we agree with the Examiner that rather than changing the
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principle of operation, the proposed modification would contain additional
features in order to retain the catheter in place. (See Ans. 40.) In addition,
that Gordon ‘880 discloses a device for engaging a catheter fitting and
Gordon ‘647 discloses a device for securing medical tubing, does not mean
that one of ordinary skill in the art would not have considered each reference
to be relevant to one another. Both are concerned with limiting movement
of a catheter, and, as a result, one of ordinary skill in the art would have
considered each together for that purpose.
Moreover, Patent Owner has not provided sufficient evidence that one
of ordinary skill in the art would have been incapable of modifying the cover
in Gordon ‘647 to accommodate the rib and hub boss elements incorporated
therein. As both patents establish that persons of ordinary skill in the art
were familiar with the design and production of devices for securing and
holding catheters and tubing in place, we agree with the Examiner that it
would have been within the knowledge of one of ordinary skill in the art to
extend the cover disclosed in Gordon ‘880 over the ribs 60 and to size the
cover to accommodate the hub boss 36a of the catheter hub. (Ans. 38.)
Therefore, we agree with the Examiner that Gordon ‘647 in view of
Gordon ‘880 would have rendered claim 1 obvious to one of ordinary skill in
the art.

Rejection VIII
Discussion
The Examiner’s position is that Gordon ‘647 device in Figures 6-9
could receive the soft, pliable and flexible wing clamp disclosed in Bierman
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‘435. The Examiner’s position is also that Gordon ‘647 and Bierman ‘435
could have been combined because Gordon ‘647 expressly states that the
securement device is for an intravenous catheter, which is the type disclosed
in Bierman ‘435. (Ans. 55.) The Examiner also adopted the position that it
would have been obvious to secure a catheter fitting as disclosed in Bierman
‘435 because the catheter fitting (wing clamp) is made of a soft, pliable
flexible material that could easily be fit within the securement device
disclosed in Gordon ‘647. (Ans. 55.)
Patent Owner contends that neither Gordon ‘647 nor Bierman ‘435
discloses a means for limiting longitudinal movement that falls within the
scope of claim 22, and further that there would be no reason to combine
Gordon ‘647, which discloses a device for securing medical tubing directly,
with Bierman ‘435, which discloses a device for securing a fitting attached
to a medical line. (App. Br. 24.)
Patent Owner’s first argument that Bierman ‘435 fails to disclose a
means for limiting longitudinal movement as recited in claim 22 is not
persuasive for the reasons discussed above. We are also not persuaded by
Patent Owner’s argument that there would be no reason to combine Gordon
‘647, which discloses a device for securing medical tubing directly, with
Bierman ‘435, which discloses securing a fitting attached to a medical line
for similar reasons discussed supra with respect to the rejection of Gordon
‘647 in view of Gordon ‘880.

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Secondary Considerations
In light of the evidence of secondary considerations submitted by
Patent Owner, it is necessary to re-weigh the evidence of obviousness in the
rejections discussed above against Patent Owner’s evidence in order to
determine whether, in light of the totality of evidence, the rejected claims
would have been obvious.
Patent Owner contends that the Examiner has not properly considered
Appellants’ evidence of non-obviousness. (App. Br. 24-25.) Specifically,
Patent Owner contends that there is sufficient evidence of commercial
success, in the form of an increase in market share from 30% to 50% in five
years for an embodiment, Statlock PICC Plus that falls within the scope of
claims 1 and 22. (App. Br. 25-26.) Patent Owner further contends that
packaging the securement device as part of a kit does not amount to forced
consumption of the claimed articles. (App. Br. 26.) Patent Owner also
contends that the reason for the commercial success was due to the claimed
features, which resulted in a reduced amount of time to secure the PICC and
eliminated the risk of needle stick injuries. (App. Br. 27.) Patent Owner
argues that marketing efforts did not drive sales, as evidenced by the high
sales account retention.
Patent Owner contends that there is evidence of industry praise and
initial skepticism as evidenced by several studies which suggested the use of
the Statlock PICC Plus and CV Plus products. (Ans. 28-29.) In addition,
Patent Owner argues that the Examiner’s position that medical professionals
were typically reluctant to adopt new technology supports Patent Owner’s
position that the devices were met with initial skepticism. (App. Br. 30-31.)
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Patent Owner also argues that there was a long felt need for improved
securement devices that reduce the risk of needle stick injury and infection,
and that the health care industry has recognized the shortcomings of tape and
sutures as securing methods. (App. Br. 31-32.)
The Examiner also adopted the Requester’s comments regarding
secondary considerations made in the response filed December 21, 2007.
(Ans. 55.)

Principles of Law
Once a prima facie case of obviousness has been established,
objective evidence of secondary considerations must be considered in
making an obviousness decision. See Stratoflex, Inc. v. Aeroquip Corp., 713
F.2d 1530, 1538-39 (Fed. Cir. 1983). Any initial obviousness determination
is reconsidered anew in view of the proffered evidence of nonobviousness.
See In re Rinehart, 531 F.2d 1048, 1052 (CCPA 1976); In re Eli Lilly & Co.,
902 F.2d 943, 945 (Fed. Cir. 1990)

Discussion
Considering the totality of the evidence, we are of the opinion that
Patent Owner’s evidence of secondary considerations is insufficient to
outweigh the evidence of obviousness of record for the reasons discussed
infra.

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Commercial Success
While we acknowledge that the market share, units sold, and revenue
data submitted by Patent Owner by way of the Supplemental Declaration of
Steven F. Bierman are not insignificant (Third Bierman Dec. paras. 4-7), we
nevertheless do not agree that the data constitutes sufficient evidence to
provide a nexus between the alleged commercial success and the features of
the claims. Specifically, there is insufficient evidence that the data for the
product StatLock® PICC plus demonstrates that the alleged success is
related to claimed features not already found in the prior art. See Tokai
Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 (Fed. Cir. 2011) (“If
commercial success is due to an element in the prior art, no nexus exists.”);
Ormco Corp. v. Align Technology, Inc., 463 F.3d 1299, 1312 (Fed. Cir.
2006) (“[I]f the feature that creates the commercial success was known in
the prior art, the success is not pertinent.”).
In this regard, Patent Owner points to evidence that the success of the
PICC Plus products was “due to their design” where the “inner structure . . .
helps retain the catheter in the lateral and longitudinal directions [and] does
not occlude the lumen of the catheter or tubing.” (First Frankhauser Dec.
para. 5.) The evidence indicated that the attached cover has the advantage of
“minimizing potential contamination during insertion, and reducing the
likelihood of the cover being misplaced.” (Id.) The evidence also indicated
that the advantages “included reduced application time, increased catheter
securement without occluding the catheter, even when the catheter or
attached medical tube was tugged or pulled, and the elimination of needle-
stick injuries.” (First Bierman Dec., para. 10.) However, as discussed
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above, the prior art already contained inner structures as recited in claims 1
and 22 for limiting longitudinal movement, for example in Bierman ‘435. In
addition, the prior art also contained attached covers, as disclosed in
Sorbonne, Gordon ‘647, and Gordon ‘880. Therefore, Patent Owner’s
evidence of commercial success is not entitled to significant weight.

Skepticism/Praise/Long Felt Need
Patent Owner’s evidence of initial skepticism, industry praise, and
long felt need are likewise unpersuasive. The studies pointed to by Patent
Owner, only appear to consider the use of tape or sutures as alternative
means of securing a medical line, and not the devices disclosed in the prior
art applied to the claims. (First Bierman Decl., paras. 10, 11; First
Frankhauser Decl. paras. 7-10; App. Br. Ex. IX-XIII.) Patent Owner’s
statements only relate to the Sorbonne and Gordon references, and do not
discuss the device disclosed in Bierman ‘435. (App. Br. 32.) Asyst Techs.,
Inc. v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008) ("While the
evidence shows that the overall system drew praise as a solution to a felt
need, there was no evidence that the success of the commercial embodiment
. . . was attributable to the . . . only material difference between [the prior
art] and the patented invention.") (citation omitted, emphasis added); In re
Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) ("Where the offered secondary
consideration actually results from something other than what is both
claimed and novel in the claim, there is no nexus to the merits of the claimed
invention").
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Thus, we have not been directed to sufficient evidence of industry
praise, initial skepticism, and long felt need to outweigh the evidence
supporting a conclusion of obviousness.

Summary of Secondary Consideration Evidence
After evaluating the evidence of obviousness as well as the evidence
of secondary considerations, commercial success, industry praise, initial
skepticism, and long felt need, we conclude that the evidence as a whole
weighs in favor of obviousness in light of the strong evidence of
obviousness discussed above, and the deficiencies in the secondary
consideration evidence as discussed supra. Accordingly, we sustain the
Examiner’s rejections of the claims as obviousness with the exception of
those expressly reversed as discussed above.

DECISION
In sum, we affirm the Examiner’s decision to reject:
Claims 1-3, 5-8, and 11 under 35 U.S.C. § 102(b) as anticipated
by Sorbonne;
Claim 22 under 35 U.S.C. § 102(b) as anticipated by Gordon
‘647;
Claims 1 and 23-27 under 35 U.S.C. § 103(a) as obvious over
Bierman ‘435 in view of Sorbonne;
Claims 2, 6, and 22 under 35 U.S.C. § 103(a) as obvious over
Sorbonne in view of Bierman ‘435;
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Claims 1, 23, and 24 under 35 U.S.C. § 103(a) as obvious over
Gordon ‘647 in view of Gordon ‘880, and
Claims 22, 30, and 33 under 35 U.S.C. § 103(a) as obvious over
Gordon ‘647 in view of Bierman ‘435.

We reverse the following rejections:
Claim 12 under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement;
Claims 12, 13, 15-18, and 21 under 35 U.S.C. § 102(b) as
anticipated by Sorbonne;
Claims 12 and 29 under 35 U.S.C. § 102(b) as anticipated by
Gordon ‘647;
Claims 22 and 30-33 under 35 U.S.C. § 102(b) as anticipated
by Bierman ‘435;
Claims 12, 28, and 29 under 35 U.S.C. § 103(a) as obvious over
Bierman ‘435 in view of Sorbonne; and
Claim 16 under U.S.C. § 103(a) as obvious over Sorbonne in
view of Bierman ‘435.
We enter the following new ground of rejection:
Claim 12 is rejected under 35 U.S.C. § 102(b) as anticipated by
Gordon ‘880.

NEW GROUND OF REJECTION
37 C.F.R. § 41.77(b) states:
(b) Should the Board reverse the examiner’s determination not
to make a rejection proposed by a requester, the Board shall set
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forth in the opinion in support of its decision a new ground of
rejection; or should the Board have knowledge of any grounds
not raised in the appeal for rejecting any pending claim, it may
include in its opinion a statement to that effect with its reasons
for so holding, which statement shall constitute a new ground of
rejection of the claim. Any decision which includes a new
ground of rejection pursuant to this paragraph shall not be
considered final for judicial review. When the Board makes a
new ground of rejection, the owner, within one month from the
date of the decision, must exercise one of the following two
options with respect to the new ground of rejection to avoid
termination of the appeal proceeding as to the rejected claim:

(1) Reopen prosecution. The owner may file a response
requesting reopening of prosecution before the examiner. Such
a response must be either an amendment of the claims so
rejected or new evidence relating to the claims so rejected, or
both.

(2) Request rehearing. The owner may request that the
proceeding be reheard under § 41.79 by the Board upon the
same record. The request for rehearing must address any new
ground of rejection and state with particularity the points
believed to have been misapprehended or overlooked in
entering the new ground of rejection and also state all other
grounds upon which rehearing is sought.

Requests for extensions of time in this inter partes reexamination
proceeding are governed by 37 C.F.R. § 1.956. See 37 C.F.R. § 41.79.

AFFIRMED-IN-PART; NEW GROUND OF REJECTION

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ack

PATENT OWNER:
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614

THIRD-PARTY REQUESTER:

HOVEY WILLIAMS, LLP
2405 GRAND BLVD.
SUITE 400
KANSAS CITY, MO 64108