Ex Parte Fulton et al

Patent Trial and Appeal Board

Aug 21, 2017

10943433 (P.T.A.B. Aug. 21, 2017)

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.
10/943,433 09/16/2004 Richard E. Fulton 032001.00268 2824
145309 7590 08/23/2017
Arent Fox LLP and Leica Biosystems GmbH
1717 K Street, NW
WASHINGTON, DC 20006-5344
EXAMINER
HOEKSTRA, JEFFREY GERBEN
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
08/23/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
patentdocket @ arentfox. com
patents @ fbtlaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RICHARD E. FULTON and WILLIAM RICHARD DUBRUL
Appeal 2016-000765
Application 10/943,433
Technology Center 3700
Before DEMETRA J. MILLS, LORA M. GREEN, and RICHARD M.
LEBOVITZ, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for anticipation and obviousness. We have jurisdiction under 35
U.S.C. § 6(b).
We affirm-in-part.
Appeal 2016-000765
Application 10/943,433
STATEMENT OF CASE
The Specification, page 3, states that
The present invention is directed 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. This eliminates the need to use of metallic clips during
biopsies and often eliminates the need for a return to the radiologist for
preoperative needle localization.
Claims 17-21 and 26-33 are on appeal, and the following claims are
representative.
17. A biopsy method comprising:
positioning a sheath and a biopsy needle with respect to a
target site in tissue to be biopsied;
extending the biopsy needle at least partially through the
sheath;
removing at least one tissue biopsy sample from the
target site through the biopsy needle;
removing the biopsy needle from the sheath while
leaving the sheath positioned in the tissue at the target site;
after the step of removing the biopsy needle, inserting a
delivery device into the sheath, wherein the delivery device
comprises at least one dehydrated bioabsorbable element
including starch; and
delivering the bioabsorbable element from the delivery
device to the target site from which the tissue biopsy sample
was removed.
26. A breast biopsy localization method comprising:
positioning a sheath having a distal end with respect to a
target site in breast tissue to be biopsied;
taking a tissue sample from the target site within a patient
by a needle biopsy device passing through and extending from
the distal end of the sheath so as to create a biopsy site;
removing the biopsy needle from the sheath while
leaving the sheath in the breast tissue;
2
Appeal 2016-000765
Application 10/943,433
without removing the sheath from the breast tissue, and
after removing the biopsy needle from the sheath, inserting a
bioabsorbable element delivery device into the sheath, wherein
the bioabsorbable element delivery device contains at least one
detectable bioabsorbable element;
deploying the at least one detectable bioabsorbable
element through the bioabsorbable element delivery device to
mark the biopsy site from which the tissue sample was taken.
30. The method of claim 26, wherein the detectable
bioabsorbable element comprises a material selected from the group
consisting of collagen, proteins, gelatins, starches, polysaccharides,
ceramics, polyamino acids and hydrogels.
33. A breast biopsy localization method comprising:
positioning a sheath having a distal end with respect to a target
site in breast tissue to be biopsied;
taking a tissue sample from the target site within a patient by a
needle biopsy device passing through and extending from the distal
end of the sheath so as to create a biopsy site;
removing the tissue sample from the sheath while leaving the
sheath in the breast tissue;
without removing the sheath from the breast tissue, and after
removing the tissue sample from the sheath, inserting a bioabsorbable
element delivery device through the sheath, wherein the bioabsorbable
element delivery device contains at least one detectable bioabsorbable
element;
deploying the at least one detectable bioabsorbable element
through the bioabsorbable element delivery device to mark the biopsy
site from which the tissue sample was taken.
Cited References
Sieger
Foerster
US 2,899,362
US 6,228,055 B1
US 6,376,742 B1
Aug. 11, 1959
May 8, 2001
Apr. 23, 2002Zdrahala
3
Appeal 2016-000765
Application 10/943,433
Bleyer US 7,713,552 B2 May 11,2010
Lindgren RE 34,056 Sept. 8, 1992
Grounds of Rejection
1. Claims 26-29 and 33 are rejected under 35 U.S.C. § 102(e) as
being anticipated by Foerster.
2. Claims 17-21 are rejected under pre-AIA 35 U.S.C. § 103(a) as
being unpatentable over Foerster in view of Zdrahala.
3. Claims 17-21 are rejected under pre-AIA 35 U.S.C. § 103(a) as
being unpatentable over Foerster in view of Sieger.
4. Claims 30-32 are rejected under pre-AIA 35 U.S.C. § 103(a) as
being unpatentable over Foerster in view of Bleyer.
FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Final Action at
pages 4-9. The following facts are highlighted.
1. Figures 3-5 of the Specification are reproduced below.
4
Appeal 2016-000765
Application 10/943,433
FIG. 3 is a simplified view illustrating a biopsy needle
assembly obtaining a tissue sample of an abnormality at a target
site;
FIG. 4 illustrates the main housing and sheath of the needle
biopsy assembly left in place after the tissue sample has been
removed leaving a biopsied open region at the target site;
FIG. 5 illustrates the barrel of the delivery device of FIG. 4
inserted into the main housing of the biopsy needle assembly and
the plunger depressed injecting the bioabsorbable element into the
biopsied open region, thus effectively filling the biopsied open
region at the target site.
Spec. 7-8 18-20, emphasis added.
2. Figure 2 of Foerster is reproduced below.
Fig. 2 shows biopsy instrument 26, outer hollow piercing needle
38, and cannular inner cutter 44 movably positioned coaxially
within the hollow outer piercing needle 38 and housing 26. Col. 7,
11. 24-40.
3. Fig. 3 of Foerster is reproduced below.
A/7'7 X
■» \ x. yy ., \ V(, n .......... .............................
v ^ g c-ooyp' ^ y - 4f.< v..
FIG. 3
Figure 3 shows a vacuum source attached to vacuum
5
Appeal 2016-000765
Application 10/943,433
line 46 is actuated, thereby generating a region of low
pressure at the vacuum ports 50 to facilitate the prolapse of
tissue 51a immediately adjacent to the tissue receiving port
42 into the hollow interior of hollow outer piercing needle 38. Col.
8,11. 4-9.
4. Figs. 4 and 4A of Foerster are reproduced below.
Foerster Figure 4 shows a tissue marking device tube 54,
illustrating the device in a first position in preparation for
delivering a marker 12 (4A) to tissue targeted for marking. Col
6,11. 34-38.
5. Foerster states:
A cannular inner cutter 44 is movably positioned coaxially
within the hollow outer piercing needle 38 and housing 28. A
vacuum line 46 supplies vacuum to ports 50 in the bottom of
the receiving bowl 42. Col. 7,11. 35-40.
6. Foerster states that
In operation, the tube 54 of the marking instrument is
inserted into the patient's body in the direction of the arrow
58, as shown in FIG. 4, until the distal end 20 of the center wire
8 approaches the desired location, adjacent to or in the
abnormal tissue or lesion. Because direct visual access to the
targeted tissue is impossible, an aided visualization device, such
as the stereotactic guidance system described above, is used to
guide the distal portion of the marking instrument to the
targeted tissue. Then, if the biopsy instrument ... is utilized to
deploy the markers, the targeted tissue 51a (FIG. 5) is
6
Appeal 2016-000765
Application 10/943,433
vacuumed into the tissue receiving port 42. Referring
particularly to FIG. 5, once the distal end 20 of the center wire
reaches the targeted, vacuumed tissue, the ring 24 is pulled
away from the tissue in the direction of the arrow 60. This
action deploys the marker attachment members 14 and 16 as
they are forced into a die formed in the tip 62 of the tube.
Col. 8,11. 17-22.
7. According to Foerster,
Other ... marker materials may include adhesives and
epoxies which would be injected at the biopsy site. Biodegradable
polymers and other plastics could also be used, as
long as they are biocompatible, implantable, and visible
using an imaging system.
Col. 13,11. 32-37.
8. Figure 1 of Foerster is reproduced below.
Figure 1 shows, “distal end point 40 of the hollow outer piercing
needle 38 in position to pierce a target tissue 51. The initial
position of the point 40 with respect to the 45 tissue area being
marked is determined by the overall position of the biopsy
instrument with respect to the patient.” Col. 7,11. 43-47.
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
x
FIG, 1
PRINCIPLES OF LAW
7
Appeal 2016-000765
Application 10/943,433
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
In order for a prior art reference to serve as an anticipatory reference,
it must disclose every limitation of the claimed invention, either explicitly or
inherently. See In re Schreiber, 128 F.3d 1473 (Fed. Cir. 1997).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Anticipation Rejection - Foerster
Claims 26, 33
The Examiner argues that Foerster teaches each element claimed in
claims 26 and 33. Ans. 4-5.
Appellants contend that Foerster,
As . . . Col. 9, lines 5-20, reveals, this section relates to
possible mechanisms for deployment of marker element 12, but
fails to address how a tissue sample is taken. Appellant finds no
disclosure in Col. 9, lines 5-20, teaching positioning a sheath
having a distal end with respect to a target site in breast tissue
to be biopsied and taking a tissue sample from the target site
within a patient by a needle biopsy device passing through and
extending from the distal end of the sheath so as to create a
biopsy site.
App. Br. 11. Appellants further argue that
The Examiner admits that Foerster (when considered alone)
fails to disclose the claimed biopsy device and consequently
relies upon the discussion of U.S. Patent No. Re. 34,056 (“Re.
34,056”) found within the disclosure of Foerster. While the
disclosure of Foerster does suggest that any instrument capable
of delivering a marker element percutaneously may be utilized,
such as the hand-held biopsy gun described in Re. 34,056, this
8
Appeal 2016-000765
Application 10/943,433
disclosure does not explain or teach “positioning a sheath
having a distal end with respect to a target site in breast tissue
to be biopsied” or “taking a tissue sample from the target site
within a patient by a needle biopsy device passing through and
extending from the distal end of the sheath so as to create a
biopsy site” or “removing the biopsy needle from the sheath
while leaving the sheath in the breast tissue” as required by the
pending claims.
App. Br. 11-12.
ANALYSIS
Appellants provide separate arguments for claims 26 and 33 in the
Brief. We address these claims separately, and select claims 26 and 33 as
representative claims for deciding Rejection 1.
Claim 33
We find that the Examiner has provided evidence to support a prima
facie case of anticipation for claim 33. In order for a prior art reference to
serve as an anticipatory reference, it must disclose every limitation of the
claimed invention, either explicitly or inherently. See In re Schreiber, 128
F.3d 1473 (Fed. Cir. 1997).
Figure 4 of Foerster shows the claim 33 steps of “positioning a sheath
having a distal end with respect to a target site in breast tissue to be
biopsied.” FF2; cols. 7-8. The sheath is feature 38 of Figure 3. A tissue
sample 51 from the target site within a patient is removed by a needle biopsy
device passing through and extending from the distal end of the sheath so as
to create a biopsy site. FF3; cols. 7-8. Biopsy tissue is vacuumed through
vacuum ports 50 of the receiving bowl of the hollow needle (sheath). FF3.
The tissue sample is removed from the receiving bowl 42 of the hollow
9
Appeal 2016-000765
Application 10/943,433
needle 38 (sheath) while leaving the sheath in the breast tissue” as required
by the pending claims. FF3; Foerester, Fig 3. As summarized in the
findings, Foerster discloses that the claimed steps of “without removing the
sheath from the breast tissue, and after removing the tissue sample from the
sheath, inserting a bioabsorbable element delivery device through the sheath,
wherein the bioabsorbable element delivery device contains at least one
detectable bioabsorbable element; deploying the at least one detectable
bioabsorbable element through the bioabsorbable element delivery device to
mark the biopsy site from which the tissue sample was taken,” as required
by the pending claims. Fig. 4, FF4, 6, 7.
Subsequent to removing the tissue from the hollow outer piecing
needle (sheath), the biopsy instrument may be utilized to deploy the markers.
Col. 8,11. 4-36. In Foerster, once the distal end 20 of the center wire of the
marking instrument reaches the targeted, vacuumed tissue, the ring 24 is
pulled away from the tissue in the direction of the arrow 60. This action
deploys the marker attachment members 14 and 16 as they are forced into a
die formed in the tip 62 of the tube. Col. 8,11. 17-22; Fig. 5; FF4. These
steps correspond to the last step of claim 33 involving deployment of the
bioabsorbable element. According to Foerster, other marker materials may
be injected at the biopsy site. Biodegradable polymers and other plastics
could also be used, as long as they are biocompatible, implantable, and
visible using an imaging system. FF5. Note Fig. 4 above shows that the
marker deployment is through hollow piercing needle or sheath. Appellants
have failed to specifically indicate which feature of claim 33 is not disclosed
in Foerster.
The anticipation rejection of claim 33 is affirmed.
10
Appeal 2016-000765
Application 10/943,433
Claim 26
With respect to claim 26, Appellants contend that Foerster does not
disclose the claimed step of “removing the biopsy needle from the sheath
while leaving the sheath in the breast tissue.” App. Br. 10. (This claim
feature is not present in claim 33, above.)
We do not find that the Examiner has provided a prima facie case of
anticipation for claim 26. Claim 26 requires a step of “removing the biopsy
needle from the sheath while leaving the sheath in the breast tissue.” We do
not find that the Examiner has provided evidence that Foerster teaches this
claim element. In particular, Fig. 1 of Foerster shows hollow outer piercing
needle 38 (sheath) with needle point 40, and cannular inner cutter 44. Col.
7,11. 24-40; FF8. While the inner cutter 44 is movable within the hollow
piercing needle (sheath), the needle point 40 and tissue receiving port 42 of
Foerster appear to be stationary, at the end of the hollow piercing needle.
Thus, Foerster does not appear to reasonably depict or describe a step of
“removing the biopsy needle from the sheath while leaving the sheath in the
breast tissue.” In other words, both the needle and the sheath remain in the
breast tissue during the subsequent tissue marking procedure in Foerster.
In the “Response to Arguments” section of the Final Action dated
Aug. 13, 2014, the Examiner newly refers to Lindgren, RE 34,056,
mentioned in Foerster at Col. 9, lines 5-20, as support for the claim
limitation, “removing the biopsy needle from the sheath while leaving the
sheath in the breast tissue.” Final Act. 8. However, Appellants are correct in
that Col. 9, lines 5-20, of Foerster itself does not explain or teach a step of
11
Appeal 2016-000765
Application 10/943,433
“removing the biopsy needle from the sheath while leaving the sheath in the
breast tissue” as required by claim 26. App. Br. 11-12.1
The anticipation rejection of claim 26 is reversed.
Obviousness Rejections 2-4
We reverse obviousness rejections 2-4. Each of rejections 2—4 is
based on Foerster in combination with a reference that teaches a collagen or
starch bioabsorbable marker.
Claim 17, in a manner similar to claim 26, includes the claim
limitation, “removing the biopsy needle from the sheath while leaving the
sheath positioned in the tissue at the target site.” For the reasons indicated
with respect to claim 26, Foerster does not appear to reasonably depict or
describe a step of “removing the biopsy needle from the sheath while
leaving the sheath in the tissue at the target site.” In other words, both the
needle and the sheath remain in the breast tissue during the subsequent tissue
marking procedure in Foerster. The Examiner has failed to provide evidence
in the cited references of record, of this claimed feature. The cited
secondary references for rejections 2-4 do not overcome the deficiencies of
Foerster.
Claim 30 is dependent upon claimed 26 and is reversed for similar
reasons presented with respect to claim 26.
Obviousness rejections 2—4 are reversed.
1 Upon return of the Application to the Examiner, if the Examiner intends to
rely on further disclosure from Findgren, RE 34,056, the Examiner should
properly make this reference of record.
12
Appeal 2016-000765
Application 10/943,433
CONCLUSION OF LAW
The anticipation rejection of claim 33 is affirmed. The anticipation
rejection of claims 26-29 is reversed. Obviousness rejections 2-4 (Claims
17-29, and 30-32) are reversed.
AFFIRMED-IN-PART
13