Ex Parte 6699205 et al

Board of Patent Appeals and Interferences

Oct 25, 2010

90008995 (B.P.A.I. Oct. 25, 2010)

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.
90/008,995 01/17/2008 6699205 077574-00005 3743
27805 7590 10/25/2010
THOMPSON HINE L.L.P.
Intellectual Property Group
P.O. BOX 8801
DAYTON, OH 45401-8801
EXAMINER
CLARK, JEANNE MARIE
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
10/25/2010 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 ARTEMIS MEDICAL, INC.,
Appellant and Patent Owner
____________

Appeal 2010-009683
Reexamination Control 90/008,995
Patent 6,699,205 C2
Technology Center 3900
____________

Before ROMULO H. DELMENDO, RICHARD M. LEBOVITZ, and
JEFFREY B. ROBERTSON, Administrative Patent Judges.

DELMENDO, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
shown on the PTOL-90A cover letter attached to this decision.
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Patent 6,699,205 C2

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Artemis Medical, Inc., the record owner of United States Patent
6,699,205 B2 (hereinafter the “‘205 Patent”), appeals from a final rejection
of claims 1-7, 9-17, 19-26, and 28-312 (Corrected Appeal Brief filed
February 11, 2010, hereinafter “App. Br.,” at 3, 5; Final Office Action
mailed March 9, 2009). Claims 30 and 31 were added during the
reexamination proceeding. We have jurisdiction under 35 U.S.C. §§ 134(b)
and 306.
We AFFIRM.

STATEMENT OF THE CASE
The current reexamination proceeding arose from a third-party request
for ex parte reexamination filed by Douglas R. Hanscom of Jones, Tullar &
Copper, P.C., Arlington, Virginia (Request for Ex Parte Reexamination filed
January 17, 2008). A written transcript of the October 6, 2010 oral
arguments presented for this appeal together with those of two related
appeals – namely Appeal 2010-009098 (Control No. 90/008,824) and
Appeal 2010-009099 (Control 90/009,167) – will be entered into the record
in due course.
The ‘205 Patent states that the invention relates to a “biopsy
localization method and device which uses a locatable bioabsorbable
element left at the biopsy site so that if testing of the biopsy sample indicates
a need to do so, the biopsy site can be relocated by finding the bioabsorbable
element” (col. 2, ll. 12-17). According to the ‘205 Patent, the “swellable

2 Claims 8, 18, and 27 have not been reexamined in this proceeding.
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bioresorbable body” recited in the claims “swell[s] on contact with an
aqueous liquid within [a] biopsied open region” (col. 5, ll. 11-13).
Claims 1, 5, 7, and 30 read as follows:
1. A method for marking a biopsy site, comprising the
steps of:
providing a swellable bioresorbable body having a
radiopaque marker carried by the bioresorbable body;
removing a biopsy specimen from the breast of a patient,
thereby creating a biopsy site;
inserting the bioresorbable body into the biopsy site to
mark the location of the biopsy site, wherein the bioresorbable
body swells upon contact with body fluid; and
testing the biopsy specimen.

5. The method of claim 1, wherein the bioresorbable
body is polylactic acid/polyglycolic acid.

7. The method of claim 1, wherein the radiopaque
marker is contained within the bioresorbable body.

30. The method of claim 1, wherein the bioresorbable
body swells at least about 50% in size upon contact with the
body fluid.
(Claims App’x, App. Br. 17, 19.)

In the statement of rejection, the Examiner relied upon the following
prior art references as evidence of unpatentability (Examiner’s Answer
mailed June 18, 2010, hereinafter “Ans.,” 5):
Anderson 4,832,686 May 23, 1989
Nabai 5,388,588 Feb. 14, 1995
Foerster 6,228,055 B1 May 8, 2001
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The Examiner also relied on, inter alia, the following extrinsic
evidence to show a state of fact:
Julina Ongkasuwan, Hemostatic Agents (October 20, 2005),
http://www.bcm.edu/oto/grand/10_20_05.htm (hereinafter “Ongkasuwan”).

The Examiner rejected claims 1-7, 9-17, 19-26, and 28-31 under 35
U.S.C. § 103(a) as unpatentable over Foerster in view of Nabai and
Anderson (Ans. 5-10).

ISSUES
In its opening brief, the Patent Owner argued several groups of
dependent claims – namely (i) claims 5, 15, and 24, (ii) claims 7, 17, and 26,
and (iii) claims 30 and 31 – separately from the other claims (i.e., claims 1-
4, 6, 9-14, 16, 19-23, 25, 28, and 29) (App. Br. 9-15). Accordingly, we
confine our discussion to claims 1, 5, 7, and 30, which we select as
representative of each of the Patent Owner’s claim groupings. See 37 C.F.R.
§ 41.37(c)(1)(vii).
The Examiner found that Foerster describes every limitation of claim
1 except for the requirement of a “swellable bioresorbable body” (i.e., that
the “bioresorbable body swells upon contact with body fluid”) (Ans. 6). The
Examiner then resolved this difference by relying on the disclosures of
Nabai and Anderson, which were found to teach that: (i) a swellable
bioresorbable body may be used to terminate the flow of blood in a skin
biopsy site; and (ii) a bioresorbable body, which may function as a
hemostatic agent, may further contain a radiopaque marker, respectively
(Ans. 6-7). According to the Examiner, it would have been obvious to a
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person of ordinary skill in the art to use a swellable bioresorbable body with
a radiopaque marker in Foerster in view of the collective teachings of Nabai
and Anderson ( Ans. 7).
The Patent Owner contends that the “combination of disparate
references to produce the claimed breast biopsy method is unrealistic and
improper – nor would the combination actually yield the claimed breast
biopsy method” (App. Br. 9). Specifically, the Patent Owner argues that
unlike a breast biopsy, which requires sampling an internal gland, “Nabai
only pertains to skin biopsy sites, which are readily locatable due to redness,
scabbing and swelling . . .” and that “there is absolutely no reason or need to
mark the skin biopsy site created in accordance with the disclosure of Nabai
with a radiopaque material . . .” (App. Br. 11). The Patent Owner further
asserts that Nabai discloses GELFOAM® sponge, which “has never been
suggested or approved for use as a biopsy marker” and that it is not
“swellable per se” (App. Br. 11-12). Regarding Anderson, the Patent Owner
asserts that Anderson teaches the administration of interleukin-2 (IL-2),
which requires delivery systems “designed to liquefy and/or erode or resorb
readily,” and therefore “Anderson is directed to a completely different field
of endeavor than Foerster and Nabai” (App. Br. 12-13). The Patent Owner
further argues that Anderson teaches away from swellable implants (App.
Br. 14).
With respect to claim 5, the Examiner construed the limitation
“polylactic acid/polyglycolic acid” to read on polylactic acid or polyglycolic
acid in the alternative, which is described in Anderson as a suitable
biocompatible material (Ans. 23). The Patent Owner argues that “Anderson
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only discloses polymers of glycolide, lactic acid and lactide and copolymers
of lactic acid, and does not specifically disclose a body of polylactic
acid/polyglycolic acid” (App. Br. 14).
With respect to claim 7, the Examiner found that Anderson teaches
the incorporation of a radiopaque marker in the biocompatible polymer
(Ans. 24). The Patent Owner disputes that finding (App. Br. 15).
With respect to claim 30, the Examiner found that GELFOAM®, when
used, would “swell[] to at least 50% or 100% because of its known ability to
swell up to 200%,” as evidenced by Ongkasuwan (Ans. 25). The Patent
Owner argues that “the Examiner failed to articulate reasons why the
specific percentages claimed are obvious in view of Foerster, Nabai and
Anderson” (App. Br. 15).
Thus, the dispositive issues are:
(1) Did the Examiner err in concluding that the collective teachings
of Nabai and Anderson would have provided a reason for a person of
ordinary skill in the art to use a “swellable bioresorbable body” with a
radiopaque marker in Foerster, as required by claim 1?
(2) Did the Examiner err in construing the recitation “polylactic
acid/polyglycolic acid” in claim 5 as reciting polylactic acid or polyglycolic
acid in the alternative?
(3) Did the Examiner err in finding that Anderson teaches the
incorporation of a radiopaque marker in a biocompatible polymer, as
required by claim 7?
(4) Did the Examiner fail to articulate a reason why the combined
teachings of the applied prior art references would have resulted in the use of
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a bioresorbable body that “swells at least about 50% in size upon contact
with the body fluid,” as recited in claim 30?

FINDINGS OF FACT (“FF”)
1. The ‘205 Patent Specification states: “[T]he bioabsorbable
element can include, for example, one or more of the following
materials[:] polyactic [sic, polylactic] and polyglycolic acids,
polyorthoesters, resorbable silicones and urethanes, lipids,
polysaccharides, starches, ceramics, polyamino acids, proteins,
hydrogels and other gels, gelatins, polymers, cellulose, elastin,
and the like” (col. 6, ll. 59-65).
2. Foerster’s disclosure “relates to methods and devices for
marking and defining particular locations in human tissue,” in
particular “in a human breast” (col. 1, ll. 8-13).
3. Foerster teaches that “[i]t is desirable and often necessary to
perform procedures for detecting, sampling, and testing lesions
and other abnormalities in the tissue of humans and other
animals, particularly in the diagnosis and treatment of patients
with cancerous tumors, pre-malignant conditions and other
diseases or disorders” (col. 1, ll. 14-18).
4. Foerster explains that its invention fulfills a need in the art by
“providing an implantable device which is particularly adapted
to mark the location of a biopsy or surgery for the purpose of
identification” and “to provide evidence of the location of the
lesion after the [tissue removal or sampling] procedure is
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completed for reference during future examinations” (col. 4, ll.
8-11 and 16-19).
5. Foerster states that while a marker fabricated of stainless steel is
preferred, “many other biocompatible, radiopaque, implantable
materials may be used . . . including, for example, titanium,
tantalum, or nickel-titanium alloys” (emphasis added; col. 8, l.
65 to col. 9, l. 2).
6. With regard to the marker material, Foerster further discloses
that “[b]iodegradable polymers and other plastics could also be
used, as long as they are biocompatible, implantable, and
visible during an imaging system” (col. 13, ll. 33-36).
7. Foerster does not state that the radiopaque markers made of
biodegradable polymers are “swellable.”
8. Nabai discloses “a biopsy wound closure apparatus and method
for controlling bleeding and repair of the biopsy site during a
routine skin biopsy procedure” (col. 1, ll. 6-9).
9. Specifically, Nabai teaches the use of “a pre-cut sterile sponge
and applicator for hemostasis and repair of a biopsy site during
a routine biopsy procedure” (col. 1, ll. 50-53).
10. Nabai explains that the “sponge . . . is a water-insoluble, porous
item which is absorbed completely, with little tissue reaction”
and that it “is implanted into the bleeding site, the sponge . . .
absorbs blood, swells and terminates the flow of blood in the
bleeding site and by filling up the biopsy site defect promotes
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healing without the necessity of approximation of the defect
sides by suturing” (col. 3, ll. 43-49).
11. According to Nabai, “[o]ne material which has been evaluated
and found to be acceptable [as the sponge] . . . is an absorbable
gelatin sponge manufactured by the Upjohn Company under the
registered trademark ‘GELFOAM’” (col. 3, ll. 57-60).
12. Ongkasuwan states that GELFOAM®, when used as a
hemostatic agent, “absorb[s] approximately 45 times its weight
in blood and can expand to approximately 200% of its initial
volume” (2nd page, 2nd full paragraph).
13. Anderson describes a method comprising removing malignant
tissue and then implanting a controlled-release bioerodible
polymer matrix including IL-2 into the site from which the
malignant tissue was removed; the “material may be injected
into any desired site, e.g., the brain, the prostate, the breast, the
liver, or the pancreas” (col. 3, ll. 61-68; col. 7, ll. 27-29 (italics
added)).
14. Anderson states that other materials such as hemostatic agents
and radiopaque markers may also be incorporated into the
polymer matrix in addition to the bioerodible polymer and IL-2
(col. 6, l. 61 to col. 7, l. 6).
15. Anderson describes a prophetic surgical procedure as follows
(col. 7, ll. 30-49 (italics added)):
The preferred surgical procedure for
intracranial use of the composite material of the
present invention involves a traditional craniotomy
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procedure, followed by tumor removal and
implantation of the controlled-release composite
material. Under a general anesthetic, routine
preparation and craniotomy skin flap development
is performed in a customary fashion. Burr holes
are created or utilized as necessary in order to
remove the bone plate. The dura matter is opened
to provide access to the tumor field. Cortical
incision is then performed to provide mechanical
access to the central tumor core. Tumor core
localization is confirmed by tissue biopsy. The
tumor is gutted and debrided under direct vision in
order to provide a central tumor cavity and access
to adjacent, viable, residual tumor bed.
After the gross visible tumor resection has
been completed, the tumor cavity is irrigated free
of debris and hemostasis is accomplished. The
composite biodegradable, controlled release PLA
[polylactic acid]/IL-2 material is then placed in
the tumor cavity.
16. Anderson’s prophetic Example 10 teaches that the composite
material (i.e., the matrix material comprising PLA and IL-2) has
a “significant hemostatic effect” and “gradually erodes,
providing sustained IL-2 release in the tumor field for a period
of several months” after being applied to the tumor cavity of a
resected brain tumor (col. 9, l. 44 to col. 10, l. 2).

PRINCIPLES OF LAW
“During reexamination, as with original examination, the PTO must
give claims their broadest reasonable construction consistent with the
specification . . . . Therefore, we look to the specification to see if it provides
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a definition for claim terms, but otherwise apply a broad interpretation.” In
re ICON Health and Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007).
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 390 (2007), the Supreme
Court “expanded the sources of information for a properly flexible
obviousness inquiry to include market forces; design incentives; the
‘interrelated teachings of multiple patents’; ‘any need or problem known in
the field of endeavor at the time of invention and addressed by the patent’;
and the background knowledge, creativity, and common sense of the person
of ordinary skill.” PerfectWeb Tech., Inc., 587 F.3d 1324, 1329 (Fed. Cir.
2009) (internal citation omitted).

ANALYSIS
Claim 1:
Having considered each of the Patent Owner’s arguments, we discern
no error in the Examiner’s factually supported conclusion that a person of
ordinary skill in the art would have found the claimed subject matter obvious
in view of the collective teachings of Foerster, Nabai, and Anderson.
It is undisputed that Foerster discloses every limitation of claim 1
except for the “swellable” limitation (App. Br. 9; FF 2-6). That is, while
Foerster discloses the use of radiopaque biocompatible polymer as the
marker, it does not state that the biocompatible polymer is swellable (FF 7).
Anderson and Nabai, however, fill the gap between the claimed
invention and Foerster. In particular, Anderson discloses the use of a
biodegradable polymer having IL-2 and other materials such as radiopaque
markers and hemostatic agents following removal of internal cancer tissue
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removed from any desired site (e.g., the brain, the prostate, the breast, the
liver, or the pancreas) (FF 13-16). While directed to a method for
controlling bleeding and promoting healing following a skin biopsy, Nabai
discloses that GELFOAM® is biocompatible and that, when implanted, it
“absorbs blood, swell, and terminates the flow of blood in the bleeding site
and filling up the biopsy defect promotes healing without the necessity of
approximation of the defect sides by suturing” (FF 8-11).
Given Anderson’s disclosure that hemostatic agents may be used
following removal or sampling of internal tissue (FF 14), we conclude that a
person of ordinary skill in the art would have been prompted to use Nabai’s
swellable GELFOAM® material as (or in addition to) the radiopaque
biocompatible polymeric marker in Foerster with the reasonable expectation
of successfully controlling internal bleeding and promoting healing (FF 10).
“[F]amiliar items may have obvious uses beyond their primary purposes, and
in many cases a person of ordinary skill will be able to fit the teachings of
multiple patents together like pieces of a puzzle.” KSR, 550 U.S. at 420.
We find no persuasive force in the Patent Owner’s argument that
Nabai’s GELFOAM® sponge has not been suggested or approved for use as
a biopsy marker (App. Br. 11), because that argument overlooks Foerster’s
disclosure that “[b]iodegradable polymers and other plastics could also be
used, as long as they are biocompatible, implantable, and visible using an
imaging system” (FF 6). Thus, Foerster indicates to one of ordinary skill in
the art that a wide variety of biocompatible, implantable, and visible
polymers may be used. Nabai’s GELFOAM® appears to be precisely such a
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polymer, as the Patent Owner has not offered any persuasive evidence to the
contrary.
The Patent Owner’s allegation that GELFOAM® is not “swellable” is
similarly unavailing. Although it is not prior art, Ongkasuwan confirms
Nabai’s disclosure that GELFOAM® is in fact “swellable” and that evidence
has not been rebutted (FF 10, 12). “[E]xtrinsic evidence may be considered
when it is used to explain, but not expand, the meaning of a reference.” In
re Baxter Travenol Lab., 952 F.2d 388, 390 (Fed. Cir. 1991).
Also, while the Patent Owner points out “Anderson discloses that
‘[s]welling or scarring of the brain is to be avoided . . .’” (App. Br. 14;
quoting Anderson col. 2, ll. 3-9), that argument fails to appreciate that the
Examiner’s rejection is based on the collective teachings of the prior art
references. The Examiner is not proposing that a swellable polymer should
be used in Anderson’s method as it relates to the treatment of brain cancer.
Rather, the Examiner’s rejection makes it clear that the collective teachings
of the references would have suggested the use of a swellable polymer as a
hemostatic agent in Foerster’s breast biopsy method (Ans. 7).
For these reasons, we uphold the Examiner’s rejection as to claim 1
(and other claims falling therewith).

Claim 5:
We are in complete agreement with the Examiner’s claim construction
of the cryptic recitation “polylactic acid/polyglycolic acid” in claim 5. In
this case, the Examiner properly took into account the description in the ‘205
Patent, which discloses that the “bioabsorbable element” may contain “one
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or more” of various polymers including polylactic acid or polyglycolic acid
(Ans. 23; FF 1). Given the lack of any meaningful enlightenment for the
cryptic recitation “polylactic acid/polyglycolic acid,” we detect no error in
the Examiner’s conclusion that when the term is given its broadest
reasonable interpretation consistent with the specification, it reads on
polylactic acid or polyglycolic acid in the alternative.

Claim 7:
We find no error in the Examiner’s factual finding that Anderson
teaches the incorporation of a radiopaque marker in a biocompatible
polymer (FF 14). Moreover, Foerster (the principal prior art reference)
teaches that “biocompatible, radiopaque, implantable materials may be used
for the marker element . . .” (FF 5).

Claim 30:
Ongkasuwan provides unrebutted evidence that Nabai’s GELFOAM®
would swell to the degree recited in claim 30 (FF 12). Thus, we find no
error in the Examiner’s rejection.

CONCLUSION
On this record, we conclude that:
(1) the Examiner did not err in concluding that the collective
teachings of Nabai and Anderson would have provided a reason for a person
of ordinary skill in the art to use a “swellable bioresorbable body” with a
radiopaque marker in Foerster, as required by claim 1;
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(2) the Examiner did not err in construing the recitation “polylactic
acid/polyglycolic acid” in claim 5 as reciting polylactic acid or polyglycolic
acid in the alternative;
(3) the Examiner did not err in finding that Anderson teaches the
incorporation of a radiopaque marker in a biocompatible polymer, as
required by claim 7; and
(4) the Examiner articulated a sufficient reason why the combined
teachings of the applied prior art references would have resulted in the use of
a bioresorbable body that “swells at least about 50% in size upon contact
with the body fluid,” as recited in claim 30.

DECISION
The Examiner’s decision to reject claims 1-7, 9-17, 19-26, and 28-31
is affirmed.
Requests for extensions of time in this ex parte reexamination
proceeding are governed by 37 C.F.R. § 1.550(c). See 37 C.F.R. § 41.50(f).

AFFIRMED

ack
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FOR PATENT OWNER:
THOMPSON HINE, L.L.P.
INTELLECTUAL PROPERTY GROUP
P.O. BOX 8801
DAYTON, OH 45401-8801

FOR THIRD-PARTY REQUESTER:
DOUGLAS R. HANSCOM
JONES, TULLAR & COOPER, P.C.
P.O. BOX 2266 EADS STATION
ARLINGTON, VA 22202