Ex Parte Bierman

Board of Patent Appeals and Interferences

Jun 18, 2012

11355048 (B.P.A.I. Jun. 18, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte STEVEN F. BIERMAN
__________

Appeal 2010-007800
Application 11/355,048
Technology Center 3700
__________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to
an anchoring system for securing a medical article, such as a catheter. The
Examiner has rejected the claims as obvious and on the ground of non-
statutory obviousness-type double patenting. We have jurisdiction under 35
U.S.C. § 6(b). An oral hearing was held June 6, 2012. We affirm.

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STATEMENT OF THE CASE
The Specification describes an anchoring system for securing a
medical device, such as a Foley catheter, to the body of a patient. (Spec.
[0045].) As shown in Figure 2 of the Specification, the system comprises an
anchor pad 12 with a lower surface 16 having an adhesive layer and an
upper surface 14, where a retainer 20 is mounted onto the upper surface of
the anchor pad and receives a portion of the medical article. (Id. at [0011].)
As shown in Figure 4, the retainer comprises a base 22 with a lower groove
30 and a cover 22 with an upper groove 36, where the cover is releasably
coupled to the base and moveable from a closed position. (Id.) When the
cover is closed, the two grooves define a channel that is configured to
support a portion of the medical article received by the retainer. (Id. at
[0012].)
The system also comprises a retaining structure, which protrudes into
the channel and inhibits axial movement of the medical article. (Id. at
[0084].) As shown in Figures 4, 5A, 6B, and 6C of the Specification, for
example, a retaining structure 73 forms upon joining a base post 74 and a
cover post 78, and can be located within the channel or outside the distal end
of the channel. (Id. at [0086].)
Claims 27-28, 31-41, 43-48, 50-52 and 55 are on appeal.
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Claims 27, 36, 46, and 55 are independent, and claim 27 is
representative (emphasis added):
27. An anchoring system for securing a medical article having a y-
site to a patient, comprising:
a base having a groove with a tapering cross-sectional shape
and a retaining structure, the retaining structure being disposed to lie
within the y-site of the medical article and extend in a generally
transverse direction; and
a cover releasably coupled to the base and movable from a
closed position so as to expose the groove in the base, the cover
including a groove having a tapering cross-sectional shape
corresponding in position to the groove in the base to define a channel
when the cover lies in the closed position, the defined channel having
a tapering cross-sectional shape with a cross-sectional area of the
channel varying along the length of the channel, the channel securing
a portion of the medical article.
Independent claim 36 recites a similar anchoring system that in
addition has a retainer comprising “a second portion coupled to the first
portion and moveable between an open position and a closed position,” as
well as a “passage being configured to support a portion of the medical
article on at least diametrically opposed sides thereof.” Independent claim
46 recites “a second portion being movable relative to the first portion,” as
well as “at least one post … being configured to engage the medical article
so as to inhibit longitudinal movement.” Independent claim 55 recites “a
second portion coupled to the first portion and moveable between an open
position and a closed position,” as well as a “channel being sized to
generally match the tapering shape of the medical article.”

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The claims stand rejected as follows:
• Claims 27, 28, 32-40, 44-47, 50-52, and 55 under 35 U.S.C.
§ 103(a) as obvious over Cianci (U.S. Pat. No. 4,149,539, Apr. 17, 1979) in
view of Alexander (U.S. Pat. No. 5,334,186, Aug. 2, 1994).
1

• Claims 27, 28, 31-41, 43-48, 50-52, and 55 on the ground of
nonstatutory obviousness-type double patenting over:
2

o claims 1-9 of U.S. Patent No. 6,413,240;
o claims 1-14 of U.S. Pat. No. 6,663,600;
o claims 1-19 of U.S. Pat. No. 7,018,362;
o claims 1-5 of U.S. Pat. No. 7,563,251 (corresponding to claims
1-20 of U.S. Pat. Appl. Publ. No. 2006/0129103);
3

o claims 1-15 of U.S. Pat. No. 7,762,991 (corresponding to
claims 1-21 of U.S. Pat. Appl. Publ. No. 2005/0192539);
4

o claims 1-19 of U.S. Pat. No. 8,025,643 (corresponding to
claims 1-20 of U.S. Pat. Appl. Publ. No. 2007/0276335);
5
and
on the ground of provisional nonstatutory obviousness-type double patenting
over claims 27-40 of U.S. Pat. Appl. Publ. No. 2007/0142782.

1
The Examiner has withdrawn the obviousness rejection of claims 31, 43
and 48 (Ans. 2).
2
Appellant submitted, and the USPTO approved on Sept. 3, 2008, a
Terminal Disclaimer regarding U.S Pat. Nos. 6,951,550, 6,283,945 and
6,361,523. Thus, rejections based on these patent references are not on
appeal here. (Ans. 10.)
3
U.S. Pat. Appl. Publ. No. 2006/0129103 issued as U.S. Pat. No. 7,563,251
on July 21, 2009, with claims 1-5.
4
U.S. Pat. Appl. Publ. No. 2005/0192539 issued as U.S. Pat. No. 7,762,991
on July 27, 2010, with claims 1-15.
5
U.S. Pat. Appl. Publ. No. 2007/0276335 issued as U.S. Pat. No. 8,025,643
on Sept. 27, 2011, with claims 1-19.
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I.
Issue
In relation to the obviousness rejection, would a skilled artisan have
modified the device of Cianci to include the tube holder of Alexander, i.e., a
cover releasably coupled to a base, where the cover is movable from a
closed position so as to expose a groove in the base, as recited in claim 27?
Principles of Law
The Examiner bears the initial burden, on review of the prior art or on
any other ground, of presenting a prima facie case of unpatentability. In re
Oetiker, 977 F.2d 1443, 1445 (1992). If the Examiner meets that initial
burden, the burden of coming forward with evidence or argument shifts to
the applicant. In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993). After the
applicant submits such evidence or argument, the PTO then determines
patentability “on the totality of the record, by a preponderance of evidence
with due consideration to persuasiveness of argument.” Oetiker, 977 F.2d at
1445.
Analysis
Both references cited by the Examiner, Cianci and Alexander,
describe devices that hold in place medical tubes or catheters proximate to a
patient. (Cianci, col. 2, ll. 9-27; Alexander, abstract.) The Examiner
concludes that Cianci discloses all elements recited in claim 27, except that
it discloses a one-piece retainer, rather than a retainer having a cover that is
releasable and movable from a closed to open position so as to expose the
groove in the base. (Ans. 3-4, App. Br. 7.) The Examiner relies on
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Alexander to provide the two-piece retainer element. (Ans. 4; see also
Alexander, col. 3, ll. 32-53.) The Examiner concludes that, at the time of
Appellant‟s claimed invention, it would have been prima facie obvious to a
person of ordinary skill in this art to modify Cianci‟s device to include a
cover releasably coupled to a base to secure the tubes (see Ans. 4.)
We adopt the Examiner‟s factual findings as our own. (Ans. 3-5.)
Along these lines, we agree with the Examiner that Alexander discloses a
relevant device that includes tube holder 50 (a retainer) comprising an upper
member 52 (a cover) releasably coupled to a lower member 54 (a base),
where the upper member is movable from a closed position to expose at least
one cavity 70 (a groove) in the lower member. Appellant does not dispute
this finding. Rather, Appellant argues that one would not have modified the
retainer in Cianci to have a base and moveable cover (lower and upper
members) as described in Alexander because to do so would “conflict with
the intended purpose of Cianci.” (App. Br. 7.)
Specifically, Appellant asserts that Cianci discloses a hemostatic
device (i.e., one used to stop bleeding inside a body cavity). (Id. at 8.)
According to Appellant, “the portion of the catheter secured within the
device of Cianci is allowed to move or stretch with respect to the device,”
and “[b]y stretching the catheter and maintaining the tension created using
the traction member 18, the device performs its hemostatic function.” (Id.)
Appellant then argues that “[c]hanging the one-piece design of the traction
member 18 to a two-piece design would frustrate Cianci‟s hemostatic
function” because (1) it “would result in the loss of the inherent rigidity
provided by a one-piece design” in Cianci (2) it “may prevent the resulting
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traction member 18 from withstanding tension equivalent to a 12 lb force,”
(3) it “would necessarily require the use of a latch mechanism such as the
hook and loop type fasteners 52a, 54a disclosed in Figure 3 of Alexander,”
and (4) “[t]he tube holder 50 [of Alexander] is not designed to withstand the
direction and magnitude of forces … applied to the device in Cianci by the
y-shaped catheter … when the catheter is in tension and performing its
hemostatic function,” and such “forces would likely defeat the hook and
loop type fasteners 52a, 54a” of Alexander. (Id. at 8-9; see also Reply Br.
3.)
Upon review of the record before us, we find that the Examiner
established a prima facie case of obviousness with regard to claim 27. We
agree with the Examiner‟s conclusion that a skilled artisan would have been
motivated to modify the traction member 18 (retainer) in Cianci‟s device to
have two pieces including a movable cover, as taught in Alexander, because
it would have been quicker and easier to place the catheter inside the
retainer. (Ans. 8.)
Appellant has pointed to nothing in Cianci or Alexander, or elsewhere
in the record, indicating that any amount of applied tension, 12 lbs or
otherwise, would cause the tube holder (retainer with a base and
releasable/movable cover) of Alexander to malfunction, open when it should
not, or otherwise prevent/frustrate a device of Cianci from working as
intended. Without more, Appellant‟s position constitutes attorney argument,
which fails to convince us of non-obviousness based on the totality of the
record here. Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 595 (Fed. Cir.
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1997) (stating that attorney argument cannot take the place of evidence
lacking in the record).
Conclusion of Law
The record before us supports the conclusion that a person of ordinary
skill in this art would have had reason to modify the device of Cianci to
include the tube holder of Alexander, i.e., a cover releasably coupled to a
base, where the cover is movable from a closed position so as to expose a
groove in the base, as recited in claim 27. The preponderance of the
evidence on this record supports Examiner‟s conclusion that claim 27 is
obvious over Cianci in view of Alexander. Appellant does not argue claims
28 and 32-35 separately, and therefore these claims fall with independent
claim 27. 37 C.F.R. § 41.37(c)(1)(vii).

II.
Issue
Does a preponderance of the evidence support the Examiner‟s
conclusion that claims 36, 46, and 55 are obvious over Cianci in view of
Alexander?
Analysis
In relation to the obviousness rejection of independent claims 36, 46,
and 55, Appellant asserts that the Examiner incorrectly identifies elements in
the claims “(e.g., „the passage being configured to support a portion of the
medical article‟; „to inhibit longitudinal movement of the medical article‟;
and „the channel being sized to generally match the tapering shape of the
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medical article‟)” as being functional limitations, and therefore
inappropriately accords the elements no patentable weight. (App. Br. 11.)
In the Final Office Action, the Examiner states that “a recitation with
respect to the manner in which an apparatus is intended to be employed …
do[es] not impose any structural limitation upon the claimed apparatus
which differentiates it from a prior art reference disclosing the structural
limitations of the claim.” (Final Office Action, 4.) In the Answer, the
Examiner further explains:
If the prior art structure is capable of performing the intended
use, then it meets the claim. In this case, the retainer of Cianci
is capable of performing the claimed structures. For example:
In Fig. 8, Cianci clearly shows that the passage 42, 44 being
configured to support a portion (20 and 34) of the medical
article on at least diametrically opposed sides thereof along the
entire length of the received portion of the medical article. In
Figs. 6, 8 and 10, Cianci shows that the upright structure 46
extending in a direction away from the anchor and sized to fit
between the branches of the y-sites of the medical article to
inhibit longitudinal movement of the medical article.
Furthermore, the passage/channel 42, 44 being sized to
generally match the tapering shape of the medical article, see
Figs. 8 and 10.
(Ans. 9-10.) In other words, the Examiner delineates how Cianci discloses
each of the recited elements referenced by Appellant with regard to claims
36, 46, and 55.
In their Appeal Brief, Appellant does not indicate how Cianci fails to
disclose the mentioned elements. Moreover, in their Reply Brief, Appellant
does not respond to the further explanation provided by the Examiner.
Instead, Appellant again argues that “modifying Cianci as taught by
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Alexander would frustrate the purpose of Cianci” for the same reasons
asserted in the Appeal Brief (Reply Br. 2-3), which we address above.
We agree with the Examiner‟s factual findings quoted above (Ans. 9-
10), and Appellant does not convince us that Cianci fails to disclose the
elements at issue.
Conclusion of Law
A preponderance of the evidence supports the Examiner‟s conclusion
that claims 36, 46, and 55 are obvious over Cianci in view of Alexander.
Appellant does not argue claims 37-41, 44-45, 47, and 50-52 separately, and
therefore these claims fall with independent claims 36, 46, and 55. 37
C.F.R. § 41.37(c)(1)(vii).
III.
Issue
Does a preponderance of the evidence support the Examiner‟s
conclusion that claim 27 is unpatentable on the ground of nonstatutory
obviousness-type double patenting?
Analysis
The Examiner also rejects pending claims on the ground of
nonstatutory obviousness-type double patenting in view of claims recited in
a number of cited patents, as well as one pending patent application. (See
page 4 and footnotes 3-5 herein.) Appellant responds that claims in the cited
patents recite “an adhesive spot,” which is not recited in claims pending in
this appeal. (App. Br. 13.)
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Pending claims here used the transitional phrase “comprising,” which
means the recited anchoring system may include additional elements not
recited in the claims. Thus, as inferred by Appellant, claims in the cited
patents recite a species of a genus claimed in pending claims. The cited
claims therefore anticipate pending claims. Double patenting exists if a
claim of a second patent, or a claim under examination, is obvious over, or
anticipated by, a claim of a first patent. See Pfizer, Inc. v. Teva
Pharmaceuticals USA, Inc., 518 F.3d 1353, 1363 (Fed. Cir. 2008); see also
In re Berg, 140 F. 3d 1428, 1437 (Fed. Cir. 1998) (obviousness-type double
patenting rejection affirmed where generic claims were anticipated by
patented claims directed to a species within the genus).
At this time, only one cited patent application has not issued as a
patent. Because Appellant does not address this pending application or any
patents that have issued from other cited published patent applications, we
affirm the Examiner‟s rejection based on claims in those patent documents
as well.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner‟s conclusion that claim 27 is unpatentable on the ground of
nonstatutory obviousness-type double patenting. Claims 28, 31-41, 43-48,
50-52, and 55 are not separately argued and therefore fall together with
claim 27. 37 C.F.R. § 41.37(c)(1)(vii).

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SUMMARY
We affirm the rejection of claims 27, 28, 31-40, 43-48, 50-52, and 55
under 35 U.S.C. § 103(a) as obvious over Cianci in view of Alexander. We
also affirm the rejection of claims 27, 28, 31-41, 43-48, 50-52, and 55 on the
ground of nonstatutory obviousness-type double patenting over claims
recited in patents and a patent application cited by the Examiner.

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

AFFIRMED

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