Ex Parte 6730042 et al

Board of Patent Appeals and Interferences

Oct 15, 2010

90009167 (B.P.A.I. Oct. 15, 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.
90/009,167 06/03/2008 6730042 077574-00006 4968
27805 7590 10/15/2010
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
10/15/2010 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
____________

Appeal 2010-009099
Reexamination Control 90/009,167
Patent 6,730,042 B2
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.
Appeal 2010-009099
Reexamination Control 90/009,167
Patent 6,730,042 B2

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Artemis Medical, Inc., the record owner of United States Patent
6,730,042 B2 (hereinafter the “‘042 Patent”), appeals from a final rejection
of claims 24-27, 30-35, 38, and 39 (Corrected Appeal Brief filed February 9,
2010, hereinafter “App. Br.,” at 3, 5; Final Office Action mailed March 10,
2009). We have jurisdiction under 35 U.S.C. §§ 134(b) and 306.
We REVERSE.

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 &
Cooper, P.C., Arlington, Virginia (Request for Ex Parte Reexamination filed
June 3, 2008). A written transcript of the October 6, 2010 oral arguments
presented for this appeal together with those of two other appeals argued at
the same time – namely Appeal 2010-009098 (Control No. 90/008,824) and
Appeal 2010-009683 (Control 90/008,995) – will be entered into the record
in due course.
The ‘042 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).
Claims 24 and 30, the only independent claims on appeal, read as
follows:
24. A target tissue localization device comprising:
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an elongate tubular member having a proximal end, a
distal end, and a lumen therebetween;
a bioresorbable body contained within the elongate
tubular member, the bioresorbable body comprising polylactic
acid and polyglycolic acid; and
a radiopaque marker carried by the bioresorbable body.

30. A method for marking a biopsy cavity comprising
the steps of:
providing a bioresorbable body having a radiopaque
marker carried by the bioresorbable body, said bioresorbable
body comprising polylactic acid and polyglycolic acid;
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; and
testing the biopsy specimen.
(Claims App’x, App. Br. 17.)

The Examiner relied upon the following as evidence of
unpatentability (Examiner’s Answer mailed May 3, 2010, hereinafter
“Ans.,” 5):
Casey 4,438,253 Mar. 20, 1984
Anderson 4,832,686 May 23, 1989
Nabai 5,388,588 Feb. 14, 1995
Foerster 6,228,055 B1 May 8, 2001
Jeffrey A. Sosman & James W. Mier, Biological drug duo delivers
one-two tumor punch, 9 NATURE MEDICINE 649-50, No. 6 (2003).
The Examiner rejected claims 24-27, 30-35, 38, and 39 under 35
U.S.C. § 103(a) as follows:
I. Claims 24-27 as unpatentable over Anderson (Ans. 5-6);
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II. Claims 24-27 and 30-35 as unpatentable over Foerster in
view of Anderson (Ans. 7-10); and
III. Claims 38 and 39 as unpatentable over Foerster in view
of Anderson and Nabai (Ans. 10-11).

ISSUES
The Examiner asserts that, in view of the description in the ‘042
Specification, one skilled in the relevant art would have construed the
limitation “bioresorbable body comprising polylactic acid and polyglycolic
acid” (in independent claims 24 and 30) to require only one of the two
recited polymers (Ans. 19-20). The Examiner further asserts that even if the
limitation requires both polymers, “Anderson’s disclosure clearly teaches
materials that one of ordinary skill in the art would readily and predictably
recognize as equivalent materials to that disclosed in the ‘042 [P]atent.” (Id.
at 20).
The Patent Owner contends, inter alia, that “Anderson does not
specifically teach a body of PLA [polylactic acid] and PGA [polyglycolic
acid] together” and that “neither Anderson nor Foerster teaches a
bioresorbable body comprising PLA and PGA that carries a radiopaque
marker” (App. Br. 13-14; italics added).
Thus, the dispositive issues common to all three rejections are:
(1) Did the Examiner err in construing the claim limitation
“bioresorbable body comprising polylactic acid and polyglycolic acid” to
require only one of the two recited polymers?
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(2) If so, did the Examiner otherwise account for this claim
limitation by articulating a sufficient reason as to why a person of ordinary
skill in the art would have been prompted to use both polylactic acid and
polyglycolic acid in view of the teachings of the applied prior art references?

FINDINGS OF FACT (“FF”)
1. The ‘042 Patent Specification states: “[T]he bioabsorbable
element can include, for example, one or more of the following
materials[:] polyactic [sic] 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. 57-62).
2. Anderson teaches a biodegradable polymer useful for
administering interleukin-2 dispersed therein to a brain cancer
patient at the site where the cancer has been removed, the
biodegradable polymer preferably being “a polymer or
copolymer of one or more of lactic acid, lactide, glycolide, and
glutamic acid,” with “[p]olylactic acid and copolymers of lactic
acid (or lactide)” being “particularly preferred” (col. 2, ll. 38-
46; col. 3, ll. 61-68).
3. Anderson’s Prophetic Example 2 describes the preparation of a
copolymer obtained by polymerizing lactic acid and glycolide
monomers (col. 8, ll. 29-33).
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4. Foerster discloses “procedures for detecting, sampling, and
testing lesions and other abnormalities in the tissue of humans
and other animals [sic], particularly in the diagnosis and
treatment of patients with cancerous tumors, pre-malignant
conditions and other diseases or disorders” (col. 1, ll. 14-18).
5. Foerster further discloses the use of a radiopaque marker
element (e.g., stainless steel) “to provide evidence of the
location of the lesion after the procedure is completed, for
reference during future examinations or procedures” (col. 4, ll.
14-19; col. 8, l. 60 to col. 9, l. 4).

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
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).
Nevertheless, “this interpretation must be consistent with the one that those
skilled in the art would reach.” In re Cortright, 165 F.3d 1353, 1358 (Fed.
Cir. 1999). See also In re Baker Hughes, Inc., 215 F.3d 1297, 1303 (Fed.
Cir. 2000) (explaining that interpretation of claim language must be
“reasonable in light of the totality of the written description.”).
The Supreme Court of the United States explained that “a patent
composed of several elements is not proved obvious merely by
demonstrating that each of its elements was, independently, known in the
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prior art.” KSR Int’l v. Teleflex, Inc., 550 U.S. 398, 418 (2007). “Although
common sense directs one to look with care at a patent application that
claims . . . the combination of two known devices according to their
established functions, it can be important to identify a reason that would
have prompted a person of ordinary skill . . . to combine the elements in the
way the claimed new invention does.” Id. While the Supreme Court
warned against “[r]igid preventative rules that deny factfinders recourse to
common sense,” it stated that the “factfinder should be aware . . . of the
distortion caused by hindsight bias and must be cautious of arguments reliant
upon ex post reasoning.” Id. at 421.

ANALYSIS
We cannot sustain the Examiner’s rejections.
Claims 24 and 30, the only independent claims on appeal, plainly
recite a “bioresorbable body comprising polylactic acid and polyglycolic
acid” (emphasis added). Thus, the claims unequivocally recite the presence
of both polylactic acid and polyglycolic acid, which are enumerated in the
‘042 Patent Specification as distinct materials (FF 1).
Contrary to the Examiner’s belief (Ans. 19-20), the description in the
‘042 Patent Specification (FF 1) does not logically lead to a different
conclusion. While the Examiner is correct that the ‘042 Patent discloses
“one or more” of the enumerated materials, that does not necessarily mean
that the scope of the claimed invention is controlled by the scope of the
Specification disclosure, for inventors may choose to submit claims of much
narrower scope.
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Accordingly, we conclude that the Examiner erred in construing the
disputed claim limitation to require only one of the two recited polymers.
Next, we review the Examiner’s alternate theory in support of
obviousness. While conceding that neither Anderson nor Foerster describes
the disputed claim limitation (Ans. 5-6, 8; FF 4, 5), the Examiner urges that
Anderson “clearly teach[es] the use of polylactic and glycolide and generally
teaches use of a physiologically acceptable biodegradable polymer” (Ans.
20; FF2). But that disclosure in Anderson merely discloses “a polymer or
copolymer of one or more of lactic acid, lactide, glycolide, and glutamic
acid” (FF 2; see also FF 3), not both polylactic acid and polyglycolic acid, as
recited in the claims. Finally, while the Examiner states that “Anderson’s
disclosure clearly teaches materials that one of ordinary skill in the art would
readily and predictably recognize as equivalent materials to that disclosed in
the ‘042 [P]atent” (Ans. 6), that statement falls short of articulating a
sufficient reason why a person of ordinary skill in the art would have
employed both polylactic acid and polyglycolic acid.
Accordingly, we conclude that the Examiner failed to establish a
prima facie case of obviousness.
We need not discuss any of the other cited references as they have not
been applied to cure the above-noted deficiencies in the Examiner’s
rejections.

CONCLUSION
On this record, we conclude that:
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(1) the Examiner erred in construing the claim limitation
“bioresorbable body comprising polylactic acid and polyglycolic acid” to
require only one of the two recited polymers; and
(2) the Examiner failed to otherwise account for this claim
limitation in the manner required under 35 U.S.C. § 103(a).

DECISION
The Examiner’s decision to reject claims 24-27, 30-35, 38, and 39 is
reversed.
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).

REVERSED
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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