Ex Parte Dubrul et al

Patent Trial and Appeal Board

Nov 8, 2016

10943121 (P.T.A.B. Nov. 8, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
10/943,121 09/15/2004 William Richard Dubrul
4372 7590 11/10/2016
ARENT FOX LLP
1717 K Street, NW
WASHINGTON, DC 20006-5344
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
032001.00272 1813
EXAMINER
OU, JING RU!
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
11/10/2016 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
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILLIAM RICHARD DUBRUL and RICHARD E. FULTON
Appeal2014-008621
Application 10/943,121
Technology Center 3700
Before DEMETRA J. MILLS, ERIC B. GRIMES, and ERICA A.
FRANKLIN, 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 obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
WE AFFIRM.
STATEMENT OF CASE
The Specification discloses that
[T]he instant invention relates to an improved device for the
removal of tissue or foreign bodies from the body. One particular use
of this improved device is removal of obstructions from the tubular
channels of the body. These obstructions are usually blood clots
(thrombi) or other byproducts of occlusive vascular disease (e.g.,
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Application 10/943,121
plaque) or even instruments/implants lost by the physician during an
intervention including but not limited to wires, stents, staples,
components, embolic coils, etc. Further, the removal of matter from
non-vascular channels is disclosed.
Spec. 1.
The following claims are representative.
1. A method for separating a soft tissue section from a
body comprising:
inserting an elongate shaft into tissue adjacent a target
tissue section having surrounding tissue, the elongate shaft
having a lumen that carries a tubular braid, wherein the tubular
braid has a radially compressed state and a radially expanded
state;
advancing the tubular braid from the shaft to sever and
separate the target tissue section from the surrounding tissue
creating a separated target tissue section;
expanding the tubular braid to a radially expanded state
as it advances beyond a distal end of the elongate shaft as a
result of shortening of the tubular braid caused by longitudinal
compression wherein a helix angle of filaments from which the
tubular braid is composed increases as the tubular braid
expands;
contracting the tubular braid from its radially expanded
state to a radially compressed state to enclose the separated
target tissue section; and
removing the separated target tissue section from the
body while the tubular braid is in its radially compressed state.
3. The method of claim 1, wherein the step of creating a
separated target tissue section is accomplished by inserting
expandable blades into the tissue adjacent a target tissue
section.
4. The method of claim 3, wherein the expandable blades
separate the target tissue section mechanically.
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10. The method of claim 2, wherein the cutting device is
a sharp distal end of the tubular braid, and wherein the target
tissue section is separated by rotating the tubular braid.
18. The method of claim 1, further comprising the step of
contracting the tubular braid by lengthening the tubular braid as
the tubular braid is put into a tensile mode.
19. The method of claim 18, wherein the step of
contracting the tubular braid causes further severing of the
target tissue section.
Henrie
Nakao et al.
Kieturakis
McGuckin, Jr.
Grounds of Rejection1
Cited References
us 4,729,763
us 5,486, 182
us 5,643,282
US 2002/0019640 Al
Mar. 8, 1988
Jan.23, 1996
July. 1, 1997
Feb. 14,2002
1. Claims 1-9 and 11-18 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over McGuckin in view of Kieturakis.
2. Claim 10 is rejected under 35 U.S.C. §103(a) as being
unpatentable over McGuckin in view of Kieturakis and Henrie.
3. Claims 19, 21, 23, and 24 are rejected under 35 U.S.C. § 103(a)
as being unpatentable over McGuckin in view of Kieturakis and
Nakao.
1 Other rejections set forth in the Final Action dated Dec. 31, 2013, have
been withdrawn by the Examiner. Ans. 2.
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Application 10/943,121
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Final Action at
pages 3-11. The following facts are highlighted.
1. An embodiment of Appellants' invention is reproduced below in
Figs. 9B and 9C.
FIG. 98.
F/G.. 9C:
Fig. 9B shows the expandable channel, PYTHON, of the
instant invention, as it is being deployed and beginning to
engulf the obstruction. FIG. 9C shows the PYTHON
expandable channel of the instant invention in its deployed
state with the obstruction engulfed within the
expanded/ deployed channel. Spec. 11.
2. McGuckin, JR discloses a method for separating a soft tissue
section from a body comprising: inserting an elongate shaft (202)
into tissue adjacent a target tissue section (228) having surrounding
tissue (tissue surrounding the tissue section 228), the elongate shaft
having a lumen that carrie[]s a tubular member (216), wherein the
tubular member has a compressed state (Fig. 13) and an expanded
state (Fig. 14 ); advancing the tubular member from the shaft to
sever and separate the target tissue section from the surrounding
tissue creating a separat[ ed] tissue section (Figs. 28-30, Figs. 10
and 11, and Paras. [0081], [0082], and [0091][)], the tubular
member 216 is advanced with cutting elements 214 of the cutting
device 206, 214 to the target tissue as shown in Figures 28-30.
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Application 10/943,121
Then, the cutting elements 214 of the cutting device 206, 214 on
the distal end of the tubular braid separates the target tissue section
from the surrounding tissue creating a separat[ ed] tissue section as
explained in Paras. [0081 ]-[0086]); expanding the tubular member
to a[] radially expanded state as it advances beyond a distal end of
the elongate shaft separating the target tissue section (Figs. lB and
2A); contracting the tubular member from its radially expanded
state to a radially compressed state to enclose the separated target
tissue section (Para. [0086]); and removing the separat[ ed] target
tissue from the body while the tubular braid is in its compress[ ed]
state (Para. [0086]); wherein the step of separating the target tissue
section is accomplished by activating a cutting device
(combination of 206 and 214) associated with distal end of the
tubular member (Figs. 28-30 and Figs. 10 and 11 [)], members 206
of the cutting device initially cuts into the body tissue.
Final Act. 7-8.
3. Then, in McGuckin,
the wires 214 which attached to the distal end of the tubular
member are advanced to the target tissue as shown in Figures 28-
30. The separating of the target tissue section is completed by
activating the wires 214 as shown in Fig 11 and explained in Para.
[0081 ]); wherein the step of separating the target tissue section is
accomplished [by] inserting expandable blades (206 and 214) into
the tissue adjacent a target tissue section (Figs. 30 and 11 ); wherein
the step of separating the target tissue is accomplished
mechanically or using electrosurgery, laser energy, and electrical
energy (claims 4 7-51 ); removing the target tissue section from the
body (Para. 0087]).
Final Act. 8.
4. McGuckin does not disclose "a tubular braid having a radially
expanded state and a radially compressed state; wherein a helix
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angle of filaments from which the tubular braid is composed
increases as the tubular braid expands." Final Act. 8.
5. Kieturakis teaches a method of removing tissue from the body
using a tubular braid (distal portion of sleeve 245, Fig. 15) that has
a radially expanded state and a radially compressed state (Figs. 15-
16B); wherein the tubular braid expands to a radially expanded
state as it advances beyond a distal end of an elongate shaft as a
result of a shortening of the tubular braid caused by longitudinal
compression (Fig. 15) and contracts the tubular braid by
lengthening the tubular braid as the tubular braid is put into a
tensile mode (Fig. 16B); wherein a helix angle of filaments from
which the tubular braid is composed increases as the tubular braid
expands (Figs. 13-15).
Final Act. 8.
6. Figure 10 of McGuckin is reproduced below.
Figure 10 shows a side view of a preferred embodiment of
the apparatus of McGuckin, "showing advancement of the
cutting wire [214] along a strut [206] margin." i-fi-129; 78.
7. Figures 15, 16A, and 16B ofKieturakis are reproduced below.
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:?~~'. ~·\:.-. :;:y:: ~~;:::~
\..... \ ,.... . '.•::. ·, :?··:~:· Vi~.
·.··,, x:: :::.·e;:~~~~~;,;~~;;~?:~i~~~c:::~:::::;;:::::::::::::::::::::::::::::::·.:L~~~~] ,~~=?: :o:::r:::::::a~~~~
L.._ .. --i
Figures 15, 16A, and 16B show sectional views of a patient's
abdominal wall illustrating the manner in which a method in
accordance with the surgical instrument may be practiced
utilizing the tissue-recovery sleeve of Fig. 15. Col. 3, 11. 15-
18. The distal portion of the sleeve (245, not shown) is
capable of both expanding and contracting in transverse
sectional dimension as spiral lead 253a changes. Col. 7, 11.
10-24.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F .2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
"In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant." In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted).
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"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
"[I]t is the language itself of the claims which must particularly point
out and distinctly claim the subject matter which the applicant regards as his
invention, without limitations imported from the specification ....
Limitations in the specification not included in the claims may not be relied
upon to impart patentability to an otherwise unpatentable claim." In re
Lundberg, 244 F.2d 543, 548(CCPA1957).
Rejection 1
We agree with the Examiner's fact finding, statement of the rejection
and responses to Appellants' arguments as set forth in the Final Action and
Answer. We find that the Examiner has provided evidence to support a
prima facie case of obviousness. \Ve provide the follov,ring additional
comment to the Examiner's rejection and argument set forth in the Final
Action and Answer. Appellants separately argue the claims 1, 3, 4 and 18.
Other claims that are not argued, fall with claim 1. 2
Appellants contend that
As to the rejections based upon McGuckin in view of
Kierturakis [sic], the claims require advancing the tubular braid
from the shaft to sever and separate the target tissue. McGuckin
is not capable of performing this step. While the cutting wires
214 and bag 216 (not a "tubular member") of McGuckin may
2 In our previous Decision addressing the instant application (Appeal 2011-
003282, decided March 25, 2013) we affirmed the rejection of a different set
of claims over the same prior art.
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be attached, this fact does not change the operation of the
cutting wires. The wires do not cut as they are advanced from
support catheters 212 along support members 206.
Appeal Br. 13. We are not persuaded by Appellants' argument. Figure 10
of McGuckin shows a side view of an embodiment of the apparatus of
McGuckin, "showing advancement of the cutting wire [214] along a strut
[206] margin." i-fi-129; 78. FF 6. The cutting wire is advanced "for cutting
circumferential swath ... in order to separate the target tissue mass from
surrounding tissue for excision thereof through the incision." (i.e., severs
and separates a tissue mass). i-f 12. Appellants provide no evidence that the
cutting wire of McGuckin does not cut when it advances along the strut
mar gm.
Appellants argue that "the support arms of McGuckin are not a
tubular braid advanced to sever tissue as required by the claims." Appeal
Br. 14. \Ve are not persuaded. To begin, claim l does not require that the
tubular braid perform the cutting. Ans. 3. Moreover, this reading of claim 1
is consistent with Appellants' Specification, page 19, which states:
This entrapment [of tissue by the PYTHON expandable channel 22]
may be aided by adding energies including, but not limited to
thermal, electrical, radio frequency, etc. or with the aid of a cutting
edge on the most distal end 32 of the PYTHON expandable channel.
Further, although not illustrated here, the distal end of the PYTHON
expandable channel 32 [sic] may have a mechanism that will close the
expanded channel prior to removal. This mechanism may include a
mechanism for severing the tissue that is not severed during the
pushing forward of the PYTHON as well.
Emphasis added. Thus, in Appellants' invention, it would appear to be a
cutting aid, not necessarily the braid, which performs the cutting. The
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Application 10/943,121
Examiner relies on Kieturakis not McGuckin for the disclosure of a tubular
braid (distal portion of sleeve 245, Fig. 15) that has a radially expanded state
and a radially compressed state. FF 5.
Appellants argue that "attempting to replace the bag of McGuckin
with the recovery sleeve of Kierturakis [sic] would effectively destroy the
operation of McGuckin as McGuckin requires a bag in order to operate as
intended." Appeal Br. 15. We are not persuaded. Appellants have not
shown why replacing the bag of McGuckin with the recovery sleeve of
Kieturakis would effectively destroy the operation of McGuckin. Both
devices capture/bag the tissue mass to be removed, and therefore, function
similarly. See McGuckin i-f 12; Kieturakis, col. 7, 11. 45--48.
Claims 3, 4, and 18
With regard to claim 3, Appellants argue that, "Mc Guckin fails to
sho\~1 inserting expandable blades into the tissue adjacent a target tissue
section and Kierturakis [sic] does not remedy this shortcoming. Wires 214
and support arms 206 are not blades as defined by Appellants." Appeal Br.
18. Similarly, Appellants argue that claim 4 "requires the expandable blades
separate the target tissue section mechanically. McGuckin fails to show this
feature and Kierturakis [sic] does not remedy this shortcoming. Wires 214
and support arms 206 are not blades as defined by Appellants." Id.
We are not persuaded by Appellants' argument. Ribs or blades are
described in Appellants' Specification, pages 16-17, and depicted in Figures
7 A and 7B. The Specification only uses the terms "ribs or blades" with no
further description other than that "they could be one or more in number."
Id. at 17. We decline to read limitations from the Specification or drawings
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into the claims, a practice that the Court of Appeals for the Federal Circuit,
our reviewing court, cautions against. See SuperGuideCorp. v. DirecTV
Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) ("Though
understanding the claim language may be aided by explanations contained in
the written description, it is important not to import into the claim limitations
that are not part of the claim. For example, a particular embodiment in the
written description may not be read into a claim when the claim language is
broader than the embodiment.").
We agree with the Examiner that McGuckin's "pair of cutting
wireloops 214" (McGuckin i-f 78) meet the broadest reasonable interpretation
of "blades," as recited in claims 3 and 4. See also id. at i-fi-174--83; Final Act.
8.
With regard to claim 18, Appellants argue that the claim, "requires the
step of contracting the tubular braid by lengthening the tubular braid as the
tubular braid is put into a tensile mode. l\1cGuckin fails to sho\~1 this feature
and Kierturakis [sic] does not remedy this shortcoming." Appeal Br. 18.
The Examiner finds that McGuckin discloses "contracting the tubular
member from its radially expanded state to a radially compressed state to
enclose the separated target tissue section (Para. [0086]); and removing the
separating target tissue from the body while the tubular braid is in its
compress[ed] state (Para. [0086])." Final Act. 7.
McGuckin states that
The radially inward force provided on tissue containment
bag 216 and target tissue mass 228 contained therein by
expandable sheath 230, as tissue containment bag 216 is
pulled to the left in FIG. 19, compresses tissue mass 228
into a smaller volume and essentially squashes tissue mass
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228 into a longitudinally elongated form for passage through
support conduit 202. Application of the radial force to tissue
mass 228 reduces the transverse cross-sectional dimension
of tissue mass 228 to at least the diameter of support conduit
202 as tissue containment bag 216 is drawn through the
funnel-shaped expandable portion 231 of sheath 230 and
into the interior of support conduit 202.
i-f 86. Kieturakis teaches
a method of removing tissue from the body using a tubular braid
(distal portion of sleeve 245, Fig. 15) that has a radially expanded
state and a radially compressed state (Figs. 15-16B); wherein the
tubular braid expands to a radially expanded state as it advances
beyond a distal end of an elongate shaft as a result of a shortening of
the tubular braid ... and contracts the tubular braid by lengthening the
tubular braid as the tubular braid is put in tensile mode.
Final Act. 8. We agree with the Examiner that McGuckin in combination
with Kieturakis discloses, "contracting the tubular braid by lengthening the
tubular braid as the tubular braid is put into a tensile mode."
Rejection 1 is affirmed for the reasons of record.
Rejections 2 and 3
Appellants do not argue Rejections 2 and 3 on the merits, but instead
rely only on their arguments for Rejection 1. Appeal Br. 18 and 19.
Having found no deficiency in Rejection 1, Rejections 2 and 3 are
affirmed for the reasons of record.
CONCLUSION OF LAW
The cited references support the Examiner's obviousness rejections,
which are affirmed for the reasons of record. All pending, rejected claims
fall.
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TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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