Ex Parte Galdonik et al

Patent Trial and Appeal Board

May 3, 2018

13117452 (P.T.A.B. May. 3, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/117,452 05/27/2011 Jason A. Galdonik
62274 7590 05/04/2018
CHRISTENSEN, FONDER, DARDI & HERBERT PLLC
33 South Sixth Street
Suite 3950
Minneapolis, MN 55402
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.
5101.01US02 7636
EXAMINER
WEISBERG, AMY REGINA
ART UNIT PAPER NUMBER
3731
MAILDATE DELIVERY MODE
05/04/2018 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 PATENT TRIAL AND APPEAL BOARD
Ex parte JASON A. GALDONIK, EDWARD ANDERSON,
KA VITHA GANESAN, GREG BOLDENOW, JOHN KIRCHGESSNER,
and GRAZYNA WLODARSKI
Appeal2017-004458
Application 13/117,452 1
Technology Center 3700
Before DONALD E. ADAMS, ERIC B. GRIMES, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 21--40 (App.
Br. 3). Examiner entered rejections under 35 U.S.C. § 102(b) and 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Regarding the real party in interest, Appellants state that "[t]he present
application is assigned to Medtronic, Inc.," and "Mivi Neuroscience, Inc.
controls prosecution of the instant application" (App. Br. 3).
Appeal2017-004458
Application 13/117,452
STATEMENT OF THE CASE
Appellants' disclosure "relates to medical devices, such as fiber-based
vascular devices, for less invasive medical procedures, such as embolic
protection and/ or embolectomy procedures" (Spec. 1: 9-10). Claim 21 is
representative and reproduced below:
21. A method of using an aspiration catheter in a
thrombectomy procedure to treat an acute stroke condition,
wherein the aspiration catheter comprises:
a proximal portion, a connection port connected to the
proximal portion, a distal segment wherein the distal segment
comprises a single lumen, and a tube section connected
between the distal segment and the proximal portion,
wherein the distal segment consists of polymer forming a
tubular element, metal wire reinforcement embedded in the
polymer tubular element and extending around the tubular
element and optionally one or more radiopaque marker bands,
and has a constant outer diameter with a value that is from
about 25 percent to about 95 percent of the average outer
diameter of the tube section and comprises a distal opening at
the distal end of the catheter, and wherein the catheter
comprises a continuous lumen extending from the proximal
portion through the tube section and the distal segment to the
distal opening that provides fluid communication between the
proximal portion and the distal opening, and the portion of the
continuous lumen inside the distal segment has a smaller
diameter relative to the diameter of the portion of the
continuous lumen inside the tube section, the method
comprising,
tracking the aspiration catheter along a guide structure to
place the distal segment of the catheter into a small blood vessel
with the distal opening of the catheter close to thrombus
deposits within the vessel, and
applying suction through the proximal portion to effect
aspiration at the distal opening of the catheter through the
distal segment having an outer diameter with a value that is
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Application 13/117,452
from about 2 5 percent to about 9 5 percent of the average outer
diameter of the tube section to aspirate the thrombus deposits
from the vessel,
wherein the small blood vessel is an artery of the brain,
such that aspiration of the thrombus deposit treat the acute
stroke condition.
(App. Br. 28 (emphasis added).)
The claims stand rejected as follows:
Claims 21, 23, 26, 27, 30-33, 35-37, and 40 stand rejected under
35 U.S.C. § 102(b) as anticipated by von Hoffmann. 2
Claims 22 and 29 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of von Hoffmann and Boldenow. 3
Claims 25 and 28 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of von Hoffmann and Engelson. 4
Claims 24, 34, 38, and 39 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of von Hoffmann and Ha. 5
Claim Interpretation:
Appellants' claim 21, the only independent claim before this Panel for
review, is reproduced above.
Appellants' claim 21 begins by providing a description of a specific
aspiration catheter for use in Appellants' claimed method. Specifically, the
aspiration catheter comprises, inter alia, a proximal portion, a distal
2 von Hoffmann, US 7,309,334 B2, issued Dec. 18, 2007.
3 Boldenow et al., US 8,021,351 B2, issued Sept. 20, 2011.
4 Engelson et al., US 6,030,369, issued Feb. 29, 2000.
5 Ha et al., US 6,159,195, issued Dec. 12, 2000.
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Application 13/117,452
segment, and a tube section connected between the distal segment and the
proximal portion (see App. Br. 28). Appellants' claim 21 further defines the
aspiration catheter's distal segment as having a constant outer diameter with
a value that is from about 25 percent to about 95 percent of the average outer
diameter of the tube section of the aspiration catheter (see id.).
The method of Appellants' claim 21 then uses the aspiration catheter
defined in the preceding clauses of the claim, i.e., an aspiration catheter that,
inter alia, has a distal segment that has a constant outer diameter with a
value that is from about 25 percent to about 95 percent of the average outer
diameter of the tube section, to effect aspiration at the distal opening of the
catheter through the distal segment by applying suction to the proximal
portion of the aspiration catheter (see id.; see also App. Br. 14).
Therefore, we are not persuaded by Examiner's assertions that:
Appellants' claim 21 does not define the diameter of the distal segment
during aspiration, Appellants' claim 21 does not define the outer diameter of
the distal segment of the aspiration catheter during aspiration, or Appellants'
Specification fails to provide written descriptive support for a suction
diameter of the distal segment (see Final Act. 6 4; see also Ans. 6-8; cf App.
Br. 14--16 and 17-18).
To be complete, we recognize Examiner's assertion that Appellants'
Specification does not provide written descriptive "support for a constant
diameter distal segment during aspiration," but find no rejection before this
Panel or citation of a disclosure in Appellants' Specification that supports
Examiner's assertion (see Ans. 7 (emphasis removed)). Thus, Examiner's
unsupported assertion is not persuasive.
6 Office Action mailed June 24, 2016.
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Application 13/117,452
Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that von Hoffmann teaches Appellants' claimed
invention?
FACTUAL FINDINGS (FF)
FF 1. von Hoffmann discloses
a method for removing thromboembolic material from a carotid
or cerebral artery ... compris[ing] the steps of[, inter alia,]
providing a catheter having a proximal end, a distal end, an
expandable distal section having a distal port, an aspiration
lumen communicating with the port, and an axially movable
support.
( von Hoffmann 3: 4--9.)
FF 2. von Hoffmann's Figure 1 is reproduced below:
FIG. I
von Hoffmann's "FIG. 1 is a side elevational schematic view of an
intracranial aspiration catheter in accordance with [ von Hoffmann' s]
invention, with a distal segment [34] in a reduced [cross-sectional] profile
configuration" (von Hoffmann 4: 28-31 (emphasis omitted); see also id. at
5: 42 ("adjustable diameter distal section 34") (emphasis omitted)).
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Application 13/117,452
FF 3. von Hoffmann' s Figure 2 is reproduced below:
f ;>frt / J(_.,, ...,,
von Hoffmann's "FIG. 2 is a side elevational view as in FIG. 1, with the
distal segment [34] in an enlarged cross-sectional configuration" ( von
Hoffmann 4: 32-33) (emphasis omitted).
FF 4. von Hoffmann discloses that
Transluminal navigation [of its catheter] is accomplished with
the distal section of the catheter in the first, reduced cross
sectional configuration. This enables navigation of tortuous
vasculature which a larger cross section may not be able to
traverse ....
[T]he cross section of the distal segment is enlarged after the
catheter has been positioned ... [t]his allows a larger inside
diameter aspiration lumen than would otherwise have been
navigable to the treatment site.
(von Hoffmann 12: 53-63.)
ANALYSIS
Examiner incorrectly interprets Appellants' claimed invention as
comprising, inter alia, an aspiration catheter that does not comprise a "distal
segment [that] has a constant diameter during aspiration" (Ans. 7 (emphasis
removed); cf App. Br. 14--16 and 17-18). Based on this incorrect
interpretation of Appellants' claimed invention Examiner finds that von
Hoffmann, which discloses an aspiration catheter comprising a distal
segment with a variable diameter, anticipates Appellants' claimed invention
(see Ans. 7; see generally Final Act. 4; cf FF 1--4). We are not persuaded.
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Application 13/117,452
As discussed above, Examiner failed to establish that the distal segment of
the aspiration catheter set forth in the method of Appellants' claim 21 has a
variable diameter such that it would read on von Hoffmann's method (see
App. Br. 14--16 and 17-18).
CONCLUSION
The preponderance of evidence on this record fails to support
Examiner's finding that von Hoffmann teaches Appellants' claimed
invention. The rejection of claims 21, 23, 26, 2, 30-33, 35-37, and 40 under
35 U.S.C. § 102(b) as being anticipated by von Hoffmann is reversed.
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
We recognize Examiner's obviousness rejections and reliance on von
Hoffmann in combination with Boldenow, Engelson, or Ha (see Final Act.
7-10). Examiner, however, failed to establish that any of Boldenow,
Engelson, or Ha make up for the deficiency in von Hoffmann discussed
above (see App. Br. 19 ("Boldenow does not make up for [this]
deficienc[y ]"); id. at 25 ("Engelson does not make up for any deficiencies of
von Hoffmann" and "Ha does not make up for [this] deficienc[y]")).
Therefore, we reverse the obviousness rejections on this record.
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
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Application 13/117,452
The rejection of claims 22 and 29 under 35 U.S.C. § 103(a) as
unpatentable over the combination of von Hoffmann and Boldenow is
reversed.
The rejection of claims 25 and 28 under 35 U.S.C. § 103(a) as
unpatentable over the combination of von Hoffmann and Engelson is
reversed.
The rejection of claims 24, 34, 38, and 39 under 35 U.S.C. § 103(a) as
unpatentable over the combination of von Hoffmann and Ha is reversed.
REVERSED
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