Ex Parte Sirimanne et al

Board of Patent Appeals and Interferences

Jun 1, 2009

10961491 (B.P.A.I. Jun. 1, 2009)

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 2009-004712
Application 10/961,491
Technology Center 3700
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Decided:1 June 1, 2009
__________

Before LORA M. GREEN, RICHARD M. LEBOVITZ, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a biopsy
site marker. The Patent Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).
Appeal 2009-004712
Application 10/961,491

STATEMENT OF THE CASE
The invention relates to a subcutaneous cavity marking device. (Spec.
1:11.) The Specification explains that after a biopsy sample is removed
from the body, there is a need to determine the location, orientation, and
periphery of the subcutaneous cavity from which the lesion was removed.
(Id. at 2:2-4.) “[T]he inventive device is a biopsy cavity-marking body
made of a resilient, preferably bioabsorbable material having at least one
preferably radiopaque or echogenic marker.” (Id. at 4:15-16.) Claim 1 is
representative and reads as follows:
1. A biopsy site marker comprising:

a body of gelatin, and

an X-ray detectable metallic element of specific predetermined
non-biological configuration embedded in said body of gelatin.

Claims 1 and 3-5, which are all the pending claims, are on appeal.
The Examiner rejected the claims under 35 U.S.C. § 103(a) as unpatentable
over the combined teachings of Krag2 and Stinson.3 The claims have not
been argued separately (App. Br. 5), and therefore stand or fall together.
37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS
The Issue
The Examiner’s position is that Krag disclosed a biopsy site marker
comprising a body of gelatin and an X-ray detectable body embedded in the

2 U.S. Patent No. 6,363,940 B1, issued to David N. Krag, Apr. 2, 2002.
3 U.S. Patent No. 7,083,641 B2, issued to Stinson et al., Aug. 1, 2006.
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Application 10/961,491

gelatin body. (Ans. 3.) The Examiner found that Krag did not explicitly
teach a metallic element embedded in the gelatin. (Id.) The Examiner found
that Stinson taught a medical marker system comprising metal, steel, gold,
platinum or metal oxides. (Id.) The Examiner concluded it would have been
obvious to apply Stinson’s teachings to Krag’s marker “for the purpose of
enhancing detectability and efficiency.” (Id.)
Appellants contend that there would have been no need to look
beyond Krag for biocompatible materials because Krag’s dye was already
biocompatible. (App. Br. 8-9.) Appellants argue that Krag’s device and
Stinson’s device have very different functions, and Krag’s flowable dye
serves a very specific purpose crucial to the use of Krag’s device. (Id. at 9.)
Thus, if modified as suggested, Krag’s devices could no longer “accomplish
their intended function of providing an indicator as to when the boundary of
a tissue volume has been encountered.” (Id.) Appellants argue that
combining the reference teachings in the way the Examiner did was
improper. (Id.) Appellants also contend that Krag did not teach a marker
material embedded in gelatin, but rather taught a gelatin capsule containing
colored dye. (Id. at 10.)
The issue is whether Appellants demonstrated that the Examiner’s
combination of the reference teachings was improper.

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Findings of Fact
Krag
1. Krag described a method of removing tissue that used markers to
define the boundary of tissue to be removed, i.e., a biopsy method.
(Col. 3, ll. 35-44.)
2. Krag’s markers were biopsy site markers because they defined a
boundary of tissue volume for removal.
3. Krag described a “surgical marker that includes a quantity of colored
dye and a capsule encasing the quantity of colored dye. One or both
of the dye and capsule are readily imagable by at least one of
ultrasonic, magnetic resonance and X-ray energy.” (Col. 3, ll. 1-5.)
4. Krag’s marker 30g comprised “a capsule . . . filled with a colored dye
78, e.g., a vital dye”. (Col. 8, ll. 30-32.)
5. Krag taught that “[t]he capsule is made from gelatin or other suitable
material . . . relatively easily cut by the cutting tool used to remove the
tissue volume.” (Col. 8, ll. 36-41.)
6. Krag taught that “[m]arker 30g provides a visual guide as to its
location by releasing colored dye 78 when severed by a surgical
cutting tool.” (Col. 8, ll. 41-43.)

Stinson
7. Stinson described a radiopaque marker for use on an implantable
endoprosthesis. (Col. 1, ll. 9-11.)
8. According to Stinson, there was “a need for an improved radiopaque
marker for use in medical devices, particularly in temporary medical
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devices having low radiopacity,” and the need was “particularly
important for surgery . . . performed under fluoroscopy.” (Col. 1, ll.
56-63.)
9. Stinson’s markers could include “an oxide or salt material,” “barium
sulfate, bismuth trioxide, iodine, iodide, titanium oxide, zirconium
oxide, gold, platinum, silver, tantalum, niobium, stainless steel, or
combinations thereof.” (Col. 4, ll. 50-54.)
10. In one Stinson embodiment, a “retrievable radiopaque marker 14 may
be loosely incorporated into the implantable endoprosthesis 16.”
(Col. 13, ll. 17-19.)
11. Marker 14 could have a radiopaque core 13 within a hollow portion.
(Col. 14, ll. 23-26.)
12. “[R]adiopaque core 13 may be solid or include a casing surrounding a
solid, gel, powder, or combination thereof and be held in place with a
relatively weak bioabsorbable adhesive gelatin . . . .” (Col. 14, ll. 32-
35.)

Principles of Law
A rejection for obviousness must include “articulated reasoning with
some rational underpinning to support the legal conclusion.” KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 418 (2007), quoting In re Kahn, 441 F.3d 977,
988 (Fed. Cir. 2006).
The proper question to ask is whether a person of ordinary skill in the
art would have seen a benefit to combining the prior art teachings. KSR,
550 U.S. at 424; see also In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004)
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(the desirability of the combination may arise from the nature of the
problem, teachings of references, or the ordinary knowledge of those skilled
in the art). “[A] combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results. . . . [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.” KSR, 550 U.S. at 401.
“‘A reference is reasonably pertinent if, even though it may be in a
different field from that of the inventor’s endeavor, it is one which, because
of the matter with which it deals, logically would have commended itself to
an inventor’s attention in considering his problem.’ In re Clay, 966 F.2d
656, 659 (Fed. Cir. 1992). In other words, ‘familiar items may have obvious
uses beyond their primary purposes.’ KSR Int’l Co. v. Teleflex, Inc.,
550 U.S. 398, [420], 127 S.Ct. 1727, 1742 (2007).” In re Icon Health and
Fitness, Inc., 496 F.3d 1374, 1379-80 (Fed. Cir. 2007) (a reference
describing a folding bed found analogous to an Appellant’s folding
treadmill).
References need not be capable of physical combination in order to
show obviousness. In re Etter, 756 F.2d 852, 859, 225 USPQ 1, 6 (Fed. Cir.
1985) (in banc); see also, In re Nievelt, 482 F.2d 965, 968, 179 USPQ 224,
226 (CCPA 1976) (“Combining the teachings of references does not involve
an ability to combine their specific structures”) (emphasis in original).

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Analysis
We agree with the Examiner’s finding that Krag disclosed a biopsy
site marker. (FF2.) The Examiner also found that Krag’s marker was an
“X-ray detectable body embedded in said body of gelatin,” citing col. 5, ll.
37-53. (Ans. 3.) We do not agree that the cited passage made that
disclosure. Krag disclosed a body of gelatin, i.e. a gelatin capsule,
containing a vital dye. (FF4 and FF5.) However, the Examiner did not
allege, nor produce evidence, that a vital dye is X-ray detectable.
We agree with the Examiner’s finding that Krag did not teach a
metallic element embedded in the body of gelatin. (Ans. 3.) We agree with
the Examiner’s finding that Krag and Stinson are in the same art, detectable
medical implants, and therefore pertinent to each other and to Appellants’
claimed subject matter. See Icon Health, 496 F.3d at 1379-80. We agree
with the Examiner’s finding that Stinson disclosed a marker system
comprising metal, steel, metal oxides, titanium oxide, gold, platinum and
other such materials. (FF9.) Based on the findings made, the Examiner
concluded: “[i]t would therefore have been obvious to one of ordinary skill
in the art to use the teaching by Stinson to modify the teaching by Krag for
the purpose of enhancing detectability and efficiency (col. 1 lines 56-65, col.
15 lines 39-43).” (Ans. 3.) The particular modification(s) the Examiner had
in mind was not stated.4
The explanation did not identify the modification(s) that would have

4 See MANUAL OF PATENT EXAMINING PROCEDURE § 706.02(j) (“the
[E]xaminer should set forth in the Office Action: . . . (C) the proposed
modification of the applied reference(s) necessary to arrive at the claimed
subject matter . . . .”).
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been obvious, nor did it explain why one of ordinary skill in the art would
have thought a particular modification(s) desirable. “Under the correct
analysis, any need or problem known in the field of endeavor at the time of
invention and addressed by the patent can provide a reason for combining
the elements in the manner claimed.” KSR, 550 U.S. at 421. The rejection
did not indicate a reason. We find that the statements explaining the
rejection do not meet the KSR standard of “articulated reasoning with some
rational underpinning to support the legal conclusion.” KSR, 550 U.S. at
418.
We note that the section of the Examiner’s Answer headed “(10)
Response to Argument,” references Stinson, col. 14, ll. 10-39, as supporting
a finding that Stinson taught a “gelatin core.” (Ans. 4.) We do not agree.
Stinson taught using “adhesive gelatin” to adhere a radiopaque core in a
cavity of a marker. (FF12.) The Examiner’s reliance on that disclosure is
unclear. To the extent the Examiner may be implying that the Stinson
embodiment disclosed at col. 14 reads on a body of gelatin and an X-ray
detectable metallic element, Appellants have not been given notice of a
clearly stated finding in that regard.

CONCLUSIONS OF LAW
The explanation of the obviousness rejection did not include
“articulated reasoning with some rational underpinning to support the legal
conclusion” and therefore failed to state a prima facie case of obviousness.

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SUMMARY
We reverse the rejection of claims 1 and 3-5 under 35 U.S.C. § 103(a)
as unpatentable over the combined teachings of Krag and Stinson.

REVERSED

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