Ex Parte Sirimanne et al

Board of Patent Appeals and Interferences

Sep 4, 2012

10114712 (B.P.A.I. Sep. 4, 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.
10/114,712 04/01/2002 D. Laksen Sirimanne DEV-5247USCNT2 9897
21884 7590 09/04/2012
WELSH FLAXMAN & GITLER LLC
2000 DUKE STREET, SUITE 100
ALEXANDRIA, VA 22314
EXAMINER
CHENG, JACQUELINE
ART UNIT PAPER NUMBER
3777
MAIL DATE DELIVERY MODE
09/04/2012 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

Ex Parte D. LAKSEN SIRIMANNE, DOUGLAS S. SUTTON,
NATALIE V. FAWZI, and GAIL LEBOVIC

Appeal 2010-008289
Application 10/114,712
Technology Center 3700

Before JENNIFER D. BAHR, BENJAMIN D.M. WOOD
and REMY J. VANOPHEM, Administrative Patent Judges

VANOPHEM, Administrative Patent Judge

DECISION ON APPEAL
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STATEMENT OF THE CASE

Appellants appeal under 35 U.S.C. § 134(a) from a final rejection of
claims 77-85, 87-92, 94, 96, 98-105 and 107-110. We have jurisdiction
under 35 U.S.C. § 6.

CLAIMED SUBJECT MATTER
Claim 77 is illustrative of the subject matter on appeal.
77. A subcutaneous cavity marking device
comprising:
(a) at least one resilient filler body having an
interior and a surface, the interior filled with a
solid or gelatinous material, and
(b) at least one detectable marker attached to
the interior or on the surface of said filler body
wherein the marker has a configuration selected
from the group consisting of a sphere, a ring, a
band, and a hollow configuration.

REJECTIONS
1. Claims 77-79, 84, 85, 87, 89, 90, 96, 100-102, 107 and 109 are
rejected under 35 U.S.C. § 102(e) as being anticipated by the disclosure of
Crittenden, (U.S. Pat. 6,197,324 B1; iss. March 6, 2001).
2. Claims 81, 91, 92, 94, and 108 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over the teachings of Crittenden in view of
the teachings of Burney (U.S. Pat. 6,056,700; iss. May 2, 2000).
3. Claim 88 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over the teachings of Crittenden in view of the teachings of
Arias (U.S. Pat. 5,281,197; iss. Jan. 25, 1994).
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4. Claim 98 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over the teachings of Crittenden in view of the teachings of
Cragg (U.S. Pat. 6,071,301; iss. June 6, 2000).
5. Claims 77, 79, 87, 88, 92, 96, 102, 104, 105, 109 and 110 are
rejected under 35 U.S.C. § 103(a) as being unpatentable over the teachings
of Corbitt, Jr. (U.S. Pat. 6,214,045 B1; iss. April 10, 2001) in view of the
teachings of Reimels (U.S. Pat. 3,736,935; iss. June 6, 1973).
6. Claims 80, 82, and 83 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over the teachings of Corbitt, Jr. in view of Reimels and
further in view of the teachings of Fulton, III, (U.S. Pat. 6,270,464 B1; iss.
Aug. 7, 2001).
7. Claims 99 and 103 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over the teachings of Corbitt, Jr. in view of the teachings
of Reimels and further in view of the teachings of Cragg.

PRINCIPLES OF LAW
It is well settled that “[a] claim is anticipated only if each and every
element as set forth in the claim is found, either expressly or inherently, in a
single prior art reference.” Verdegaal Bros. v. Union Oil Co. of Calif., 814
F.2d 628, 631 (Fed. Cir. 1987).
The question of obviousness is resolved on the basis of underlying
factual determinations including (1) the scope and content of the prior art,
(2) any differences between the claimed subject matter and the prior art, and
(3) the level of skill in the art. Graham v. John Deere Co. of Kansas City,
383 U.S. 1, 17-18 (1966). Further, the Federal Circuit has stated that
“rejections on obvious grounds cannot be sustained by mere conclusory
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statements; instead, there must be some articulated reasoning with some
rational underpinning to support the legal conclusion of obviousness.” In re
Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited with approval in KSR Int’l
Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007).

ANALYSIS
Rejection of claims 77-79, 84, 85, 87, 89, 90, 96, 100-102, 107 and 109
under 35 U.S.C. § 102(e).

In contesting this rejection, Appellants argue these claims as a group.
We select claim 77 as representative, with the remainder of the claims
standing or falling with claim 77. See 37 C.F.R. 41.37 (c)(1)(vii) (2011).
Independent claim 77 recites a subcutaneous cavity marking device
comprising at least one resilient filler body having an interior and a surface,
the interior filled with a solid or gelatinous material and at least one
detachable marker attached to the interior or on the surface of said filler
body wherein the marker has a configuration selected from the group
consisting of a sphere, a ring, a band, and a hollow configuration.
The Examiner found that Crittenden discloses an implantable pellet 70
(FIG. 4a) comprising a solid filler body 72 (FIG. 4a) composed of a
synthetic polymer material such as polylactic acid (a resilient material) (col.
9, ll. 56-57), which is seeded with a desired therapeutic agent such as
anesthetic (pain killing) agents (col. 3, ll. 30-33). To aid in visualizing the
implant by fluoroscopy, a sphere of precious metal 74 (FIG. 4a) such as gold
or platinum can be placed at the center of the pellet (col. 4, ll. 45-48). The
implantable pellet can be of any shape such as a sphere, cylinder, disc
shaped pills, or helical (col. 10, ll. 25-30, col. 10, line 64). Ans. 3.
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Appellants argue that Appellants’ claims are all directed to a
subcutaneous cavity marking device requiring a resilient filler body and that
there is no disclosure in Crittenden that the implantable pellet or the polymer
coating used in Crittenden is resilient. App. Br. 7-8. Further, Appellants
assert the metal core disclosed in Crittenden aids in visualizing the delivery
of the drug pellet to the desired tissue site, thereby making sure the proper
tissue is treated. Appellants argue that this is not the same as marking a
subcutaneous cavity. App. Br. 8. Neither of these arguments is convincing,
for the reasons that follow.
The Examiner reasoned that because Crittenden discloses polylactic
acid for the body material, and Appellants disclose that polylactic acid is a
suitable material for the resilient body (Spec., para. [0057]), it is inherent
that the filler body of Crittenden is also resilient. Ans. 7.
“It is well settled that a prior art reference may anticipate when the
claim limitations not expressly found in that reference are nonetheless
inherent in it. Under the principles of inherency, if the prior art necessarily
functions in accordance with, or includes, the claimed limitations, it
anticipates.” In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir.
2002) (citations and internal quotation marks omitted). “Inherency,
however, may not be established by probabilities or possibilities. The mere
fact that a certain thing may result from a given set of circumstances is not
sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citations
and internal quotation marks omitted). When relying on the theory of
inherency, the examiner has the initial burden of providing a basis in fact
and/or technical reasoning to reasonably support the determination that the
allegedly inherent characteristic reasonably flows from the teachings of the
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applied prior art. See In re King, 801 F.2d 1324, 1327 (Fed. Cir. 1986).
Once the PTO establishes a prima facie case of anticipation based on
inherency, the burden shifts to the applicant to prove that the prior art does
not possess the characteristic at issue. See id.
In this case, the Examiner found that Crittenden discloses forming the
pellets of a polymer such as polylactic acid. Ans. 3; Crittenden, col. 9, l. 57.
Appellants disclose that the body of the inventive device is “resilient”
(Spec., para. [0014]), and further disclose that polylactic acid (without
further qualification) is a suitable polymer for the body of the device (Spec.,
para. [0057]). This is sufficient to reasonably support the Examiner’s
determination that Crittenden’s polylactic acid pellet body is resilient,
thereby shifting the burden to Appellants to show that this is not the case. In
response, Appellants state that “[p]olylactic acid polymers can be rigid or
resilient. Resiliency is a characteristic of a polymer, but is not an inherent
property of a polymer.” Reply Br. 2. Appellants’ response amounts to
unsupported attorney argument, and therefore we give it little weight. In re
Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
We agree with and adopt the Examiner’s findings and reasoning in
responding to Appellants’ argument that Crittenden fails to disclose a device
for marking a subcutaneous cavity. Ans. 7. Appellants’ articulation of the
argument and accompanying characterization of the perceived deficiencies
in Crittenden manifest the fact that Appellants’ argument is directed to the
intended use of the device. App. Br. 8 (stating “the purpose of Crittenden is
to . . . and Crittenden fails to disclose a device for marking a subcutaneous
cavity”).
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For the above reasons, Appellants’ arguments do not apprise us of
error in the Examiner’s rejection of claim 77 as anticipated by Crittenden.
We sustain the rejection of claims 77-79, 84, 85, 87, 89, 90, 96, 100-102,
107, and 109 as anticipated by Crittenden.

Claims 81, 91, 92, 94, and 108 as obvious over the teachings of Crittenden
in view of the teachings of Burney.

All of these dependent claims depend directly or indirectly from
independent claim 77. The Examiner relies on Burney to teach radiopaque
markers that have a form of a band and a wire and that these markers can be
bio absorbable, markers that are made of any shape and size, so it would be
obvious to have a hollow sphere marker. Ans. 4. In contesting this
rejection, Appellants merely rely on their arguments asserted against the
rejection of claim 77. App. Br. 8. Having found these arguments
unpersuasive for the reasons discussed above, we will therefore sustain the
Examiner’s rejection of claims 81, 91, 92, 94, and 108.

Claim 88 as obvious over teachings of Crittenden in view of the teachings of
Arias.

Claim 88 depends from independent claim 77 and recites the device of
claim 77 comprising a hemostatic substance. The Examiner relies on Arias
to teach a therapeutic agent which has therapeutic affects such as the
hemostatic agent taught by Arias. Ans. 5. In contesting this rejection,
Appellants merely rely on their arguments asserted against the rejection of
claim 77. App. Br. 9. Having found these arguments unpersuasive for the
reasons discussed above, we will sustain the rejection of claim 88.
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Claim 98 as obvious over the teachings of Crittenden in view of the
teachings of Cragg.

Claim 98 depends from independent claim 77 and recites the device of
claim 77 wherein the marker is radioactive. The Examiner relies on Cragg
to teach the use of drug-filled polymer such as a radioactive tracer disclosed
by Cragg. Ans. 5. In contesting this rejection, Appellants merely rely on
their arguments asserted against the rejection of claim 77. App. Br. 9.
Having found these arguments unpersuasive for the reasons discussed above,
we will sustain the Examiner’s rejection of claim 98.

Claims 77, 79, 87, 88, 92, 96, 102, 104, 105, 109, 110 under 35 U.S.C.
§ 103(a) as unpatentable over the teachings of Corbitt, Jr. in view of the
teachings of Reimels.

Appellants argue that claims 77, 79, 87, 88, 92, 96, 102, 104, 105, 109
and 110 as a group. See App.Br. 9. We select claim 77 as representative.
See 37 C.F.R. 41.37 (c)(1)(vii) (2011). Claims 79, 87, 88, 92, 96, 102, 104,
105, 109 and 110 are not separately argued and therefore will stand or fall
with claim 77.
The Examiner contends that Corbitt, Jr. teaches a breast implant
comprising a resilient filler body such as a sponge. The implant has a
porous structure which provides a framework for the in-growth of tissue
material and can comprise a radiographic marker for identification of the
area (Abstract, col. 3, ll. 15-21; col. 3, ll. 38-39; col. 4, ll. 31-41; col. 5, ll. 5-
8). According to the Examiner it would be obvious to use any radiographic
makers well known in the art such as disclosed by Reimels. The Examiner
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States that Reimels discloses applying two bands of radiopaque material to a
sponge for the same purpose as Corbitt, Jr. to identify where the sponge is
located (Abstract, col. 2, ll. 49-56). Ans. 6.
Appellants argue that Corbitt, Jr. teaches an implantable sponge which
may be instilled with a metallic material so the area of implantation can be
identified. However, the Examiner acknowledges that Corbitt, Jr. does not
disclose markers as required by independent claim 77. The Examiner
attempts to remedy the deficiency of Corbitt, Jr. by citing Reimels as
teaching the obviousness of providing markers in the form of bands.
Appellants respond that
Reimels teaches a surgical sponge used during a surgery to
absorb body fluids. Reimels’ sponge is not implantable. In
fact, the sponge of Reimels includes strips 14 and 15 of
radiopaque material for the purpose of locating and retrieving
the sponge in event the retrieval thread 12 fails. Basically, the
sponge of Reimels serves a purpose which is exactly opposite
of the sponge of Corbitt, that is, one is implantable and the
other is not implantable.App.Br. 11

Therefore, Appellants contend that there is no reason why one of ordinary
skill in the art would look to Reimels for reasons to modify Corbitt, Jr. to
include marker elements as claimed. App. Br. 10-11.
Appellants’ argument is not persuasive because the Examiner’s reason
for adding Reimels’ radiographic markers to Corbitt, Jr.(i.e., as a mere
replacement of one radiographic marker with another known in the field) is
supported by a rational underpinning. Appellants have not persuaded us of
error in the Examiner’s findings or conclusions of obviousness. For
example, Appellants have not persuaded us that the addition of the type of
radiographic markers of Reimels to the implant of Corbitt, Jr. is
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incompatible when Corbitt, Jr. specifically discloses the use of radiographic
markers at col. 5, ll. 5-8 and the Examiner has determined that it would have
been obvious to use Reimels’ known markers with the implant of Corbitt,
Jr.. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“when a
patent claims a structure already known in the prior art that is altered by the
mere substitution of one element for another known in the field, the
combination must do more than yield a predictable result”). To the extent
that Appellants argue that a specific teaching, suggestion, or motivation in
the art must be shown to establish obviousness (App. Br. 9-10), the Supreme
Court has rejected the rigid requirement of a teaching, suggestion, or
motivation to combine known elements to show obviousness. KSR Int'l, 550
U.S. at 418-19.

Claims 80, 82, and 83 as obvious over the teachings of Corbitt, Jr. in view of
the teachings of Reimels and Fulton, III.

In contesting this rejection, Appellants merely rely on their arguments
asserted against the rejection of claim 77 based on Corbett, Jr. and Reimels.
App. Br. 12. Having found these arguments unpersuasive for the reasons
discussed above, we will sustain the Examiner’s rejections of claims 80, 82,
and 83.

Claims 99 and 103 as obvious over the teachings of Corbitt, Jr. in view of
the teachings of Reimels and further in view of the teachings of Cragg.

All of these dependent claims depend from independent claim 77. In
contesting this rejection, Appellants merely rely on their arguments asserted
against the rejection of claim 77 based on Corbett, Jr. and Reimels. App. Br.
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12. Having found these arguments unpersuasive for the reasons discussed
above, we will sustain the rejection of claims 99 and 103.

DECISION

1. The rejection of claims 77-79, 84, 85, 87, 89, 90, 96, 100-102,
107 and 109 under 35 U.S.C. § 102(e) as being anticipated by the disclosure
of Crittenden is sustained.
2. The rejection of claims 81, 91, 92, 94, and 108 under 35 U.S.C.
§ 103(a) as being unpatentable over the teachings of Crittenden in view of
the teachings of Burney is sustained.
3. The rejection of claim 88 under 35 U.S.C. § 103(a) as being
unpatentable over the teachings of Crittenden in view of the teachings of
Arias is sustained.
4. The rejection of claim 98 under 35 U.S.C. § 103(a) as being
unpatentable over the teachings of Crittenden in view of the teachings of
Cragg is sustained.
5. The rejection of claims 77, 79, 87, 88, 92, 96, 102, 104, 105,
109 and 110 under 35 U.S.C. § 103(a) as being unpatentable over the
teachings of Corbitt, Jr., in view of the teachings of Reimels is sustained.
6. The rejection of claims 80, 82, and 83 under 35 U.S.C. § 103(a)
as being unpatentable over the teachings of Corbitt, Jr. in view of the
teachings of Reimels and Fulton, III is sustained.
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7. The rejection of claims 99 and 103 under 35 U.S.C. § 103(a) as
being unpatentable over the teachings of Corbitt, Jr. in view of the teachings
of Reimels and further in view of the teachings of Cragg is sustained.

AFFIRMED

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