Ex Parte Kushner

Patent Trial and Appeal Board

Aug 24, 2017

12108547 (P.T.A.B. Aug. 24, 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.
12/108,547 04/24/2008 David M. Kushner 1512.250 1840
72088 7590 08/28/2017
WISCONSIN ALUMNI RESEARCH FOUNDATION
C/O BOYLE FREDRICKSON S.C
840 North Plankinton Avenue
Milwaukee, WI53203
EXAMINER
OSINSKI, BRADLEY JAMES
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
08/28/2017 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):
docketing @boylefred.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID M. KUSHNER
Appeal 2015-005668
Application 12/108,547
Technology Center 3700
Before MICHAEL L. HOELTER, ANNETTE R. REIMERS, and
BRANDON J. WARNER, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from a rejection of claims
1, 3—14, and 21—23. App. Br. 1,3. Claim 2 has been canceled, and claims
15—20 have been withdrawn. App. Br. 17, 20 (Claims Appendix). We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
Appeal 2015-005668
Application 12/108,547
THE CLAIMED SUBJECT MATTER
The disclosed subject matter “relates to sonohysterography and in
particular to a steerable sonohysterographic injection catheter for cancer
sentinel lymph node mapping.” Spec. 1 3. Apparatus claims 1 and 21 are
independent. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. A steerable sonohysterographic injection catheter comprising:
a tubular sheath having an outer sheath an inner sheath that is
selectively extendable from the outer sheath, the tubular sheath
extending along an axis and having a proximal end and a distal end;
a needle slidably receivable in the tubular sheath and extendible
therefrom to move with respect to the tubular sheath, the needle sized
for intrauterine insertion to deliver a tracking fluid to a location in a
patient’s uterus;
a channel formed along a wall of the inner sheath to deliver an
expansion fluid to separate the patient’s uterine walls; and
a sealing device attached to the outer sheath and disposed at a
fixed location between ends of the catheter and configured for
placement at an opening of patient’s cervix, the sealing device being
selectively inflatable so that the sealing device is sized and shaped to
fit within the cervix to prevent the tracking fluid and the expansion
fluid from leaking out of the patient’s uterus through the patient’s
cervix;
wherein a distal end of the needle is selectively controllably
curved with respect to the axis within the uterus so as to allow the
distal end of the needle to be positioned at different locations about
the location; and wherein at least a portion of the tubular sheath is
selectively slidable relative to the sealing device when the sealing
device is inflated.
REFERENCES
Middleman
Greff
Callister
US 5,345,937
US 2005/0090714 A1
US 2005/0288551 A1
Sept. 13, 1994
Apr. 28, 2005
Dec. 29, 2005
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Application 12/108,547
REJECTIONS
Claims 1, 3, 5—7, and 21 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Callister and Greff.
Claims 4, 8—14, 22, and 23 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Callister, Greff, and Middleman.
ANALYSIS
The rejection of claims 1, 3, 5—7, and 21
as unpatentable over Callister and Greff
Appellant argues all these claims together. App. Br. 7—15. We select
independent claim 1 for review with the remaining claims standing or falling
therewith. See 37 C.F.R. § 41.37(c)(l)(iv). In arguing claim 1, Appellant
presents four separate arguments that we address in turn. App. Br. 7.
“A. The Examiner improperly combines Callister with Greff
Based on Knowledge from Applicant’s disclosure.” See App. Br. 7—9.
Appellant contends, “[t]he present inventor first recognized the
problem of providing sentinel lymph node mapping in uterine cancer
patients without substantial distention of the uterus with fluid that could spill
out and spread the disease.” App. Br. 7. Appellant contends, “[t]he
Examiner improperly uses this teaching to reject the claims” by modifying
“an embodiment of Callister . . . with Greff.” App. Br. 7—8. In other words,
Appellant asserts, “there is no independent reason” one skilled in the art
“would have in fact modified Callister with Greff without the benefit of the
present inventor’s teaching.” App. Br. 8.
As stated in the record, the Examiner primarily relies on Callister for
disclosing the limitations of claim 1 including the teaching of a channel for
the delivery of an expansion fluid to a uterus, an inserted needle, and a
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Application 12/108,547
sealing device to prevent inserted fluid from leaking out of the uterus. Final
Act. 2—3 (referencing Callister Figs. 1—4 and 145). However, the Examiner
relies on Greff for teaching “a needle slidably receivable in the tubular
sheath and extendible therefrom” and that the needle is “sized for
intrauterine insertion to deliver a fluid to a location in a patient’s uterus.”
Final Act. 3 (referencing Greff Fig. 1 and 175). The Examiner concludes
that it would have been obvious “to modify the device of Callister by
providing a needle ... as taught by Greff to deliver fluid to the wall of the
uterus (which will allow a variety of procedures, such as gynecologic
embolotherapy).” Final Act. 3.
Hence, the Examiner states that the motivation to combine Callister
and Greff is to encompass additional procedures, “such as gynecological
embolotherapy.” Regarding “gynecologic embolotherapy,” paragraph 47 of
Greff states, “[e]mbolization of tumors may be performed preoperatively . . .
to aid in visualization of the tumor.” Paragraph 29 of Greff states,
“[visualization is particularly necessary when using catheter delivery
techniques” and discusses the use of “contrast agents” “to visualize the
embolized mass.”1 In view of such teachings (and Callister’s teaching of
distending the uterus with fluid and sealing same to prevent leakage
therefrom), Appellant does not explain how the Examiner’s reliance on
Callister and Greff fails to teach or suggest “mapping in uterine cancer
patients” as asserted. App. Br. 7. More specifically, Appellant fails to
1 Additionally, paragraph 44 of Callister teaches a series of optical fibers
(33, 34, 35) embedded in the wall of working channel 32 with “optical fiber
35 for transmitting images from the distal end to an eye-piece 36 (or a
camera or other device).” Hence, Callister also teaches the visualization of
the treatment site.
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Application 12/108,547
explain how the “Examiner improperly uses [Appellant’s] teaching to reject
the claims” in view of the above teachings of Callister and Greff.2 App. Br.
7.
Accordingly, and based on the record presented, Appellant’s argument
is not persuasive of Examiner error.
“B. The Examiner Modifies Callister in a Contradictory Manner,
Against the Teaching of Callister.” See App. Br. 9—11.
Here, Appellant focuses on the limitations of a “needle sized for
intrauterine insertion to deliver a tracking fluid to a location in a patient’s
uterus” and “a channel formed ... to deliver an expansion fluid to separate
the patient’s uterine walls.” App. Br. 9. Appellant contends that upon
selection of a working channel, the Examiner “then attempts to modify the
‘working channel’ to provide two simultaneous mutually exclusive
purposes” of this channel (i.e., the two above limitations). App. Br. 9; see
also Reply Br. 1. As support that Callister does not teach these two
“simultaneous mutually exclusive purposes,” Appellant identifies where
Callister teaches “[t]hus if the working channel 42 is not being used for an
instrument or medical device such as a delivery catheter 42, it may be
supplied with an irrigation fluid or fluid may be drained from the uterus.”
App. Br. 10 (quoting Callister | 51 but also referencing Callister || 50, 52
and Figs. 5, 6); see also Reply Br. 1. Thus, per Appellant, “Callister fails to
prove any enabling teaching for how to simultaneously use the working
channel 42 for two purposes without interference between the needle and
2 Appellant also argues, “Callister does not suggest ‘gynecologic
embolotherapy’ at all” (App. Br. 8); however, the Examiner relies on Greff
for such teachings, not Callister (Final Act. 3).
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flow of liquid and the needle and sealing pressurized liquid flow.” App. Br.
11; see also Reply Br. 1.
The fallacy in Appellant’s argument is the lack of any recitation in
claim 1 (or any other claim on appeal) to the effect that both operations are
to occur simultaneously. The claims on appeal are apparatus claims, not
method claims. See also Ans. 9 (“these are device claims”). The limitations
in question recite the intended function of the recited structure, and Callister
clearly teaches a “working channel” that can have dual purposes (i.e., deliver
fluid as in Figs. 1—3 or deliver a catheter as in Figs. 5—6).3 See supra.
Appellant contends, “the Examiner is in effect double counting the same
structure” and further, the Examiner is double counting the structure “in a
manner contradictory to the teaching of Callister.” Reply Br. 1—2.
However, the Examiner is simply acknowledging what is expressly taught
by Callister; further, it is not understood how the disclosed working
channel’s ability to do both operations is “contradictory to the teaching of
Callister” since Callister itself teaches that such double-duty is possible. See
Callister | 51.
Regarding Appellant’s contention that “[a] proposed modification
cannot change the principle of operation of a reference” (App. Br. 11), the
Examiner states, “the catheter is still capable of being used as originally
disclosed only in Callister.” Ans. 9.
Appellant also disputes the Examiner’s reliance on Greff “to be
‘slidably receivable in the tubular sheath and extendible therefrom to move
3 The Examiner states, “there is nothing saying the device of Greff may not
be considered the instrument or medical device” referred to in paragraph 51
of Callister. Ans. 9.
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Application 12/108,547
with respect to the tubular sheath.’” Reply Br. 2. Appellant contends that
this “imports additional features which are not supported by the stated
motivation to combine.” Reply Br. 2. However, as stated above, Callister
teaches the ability of the working channel to be “used for an instrument or
medical device” (Callister 151) and Callister further teaches a “driving
device” that “facilitates longitudinal movement of an elongated [] delivery
catheter [i.e., Greffs device] within the working channel 42.” Callister 149.
Accordingly, and based on the record presented, Appellant’s argument
is not persuasive of Examiner error.
“C. The Examiner Ignores Aspects of Canister which Lead Away
from the Claimed Invention.” App. Br. 12—13.
Appellant’s contention that Callister’s teachings “lead away from the
claimed invention” is based on the presumption that “if one of ordinary skill
were to provide a catheter in Callister, one would look to the embodiments
of Figs. 5 and 6,” or other Callister embodiments, and not Greff. App. Br.
12. In effect, Appellant is seeking to limit any such variation of Callister to
only the variations Callister itself discloses. As above, Callister teaches that
the working channel can be “used for an instrument or medical device”
(Callister 151) and Appellant does not explain how the Examiner is wrong,
based on such instructions, to consider Greff as disclosing “the instrument or
medical device” that can be used (Ans. 9).
Appellant further fails to identify any criticism or the like that might
cause one skilled in the art to be “lead away” from modifying Callister with
Greffs teachings. App. Br. 12; see also Ans. 10.
Accordingly, and based on the record presented, Appellant’s argument
is not persuasive of Examiner error.
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“D. The References do not Disclose that a ‘Needle is Selectively
Controllably Curved.’” App. Br. 13—15.
Appellant addresses Greff on this point (replicating certain figures and
text from Greff) stating that Greff does not disclose this limitation. App. Br.
13—14. In summary, however, Appellant states, “neither Callister nor Greff
disclose” this limitation. App. Br. 14. The Examiner relies on Callister for
this teaching, not Greff, and specifically identifies “lever 38” of Callister as
providing such control. Final Act. 3; see also Ans. 10. Paragraph 44 of
Callister states, “[deflecting lever 38 allows the operator to move the lever
(arrows at lever) to deflect the distal end 39 of the endoscope (arrows at
tip).” See also Callister || 9 and 12, each discussing tip deflection.
Accordingly, and based on the record presented, Appellant’s argument
regarding Greff (and lack of any argument regarding Callister) is not
persuasive of Examiner error.
In summation, we sustain the Examiner’s rejection of claims 1,3, 5—7,
and 21 as unpatentable over Callister and Greff.
The rejection of claims 4, 8—14, 22, and 23
as unpatentable over Callister, Greff, and Middleman
Appellant argues all these claims together. App. Br. 15. We select
dependent claim 4 for review with the remaining claims standing or falling
therewith. The Examiner relies on the additional teachings of Middleman
for disclosing the additional limitation recited in claim 4 directed to a
“filament.” Final Act. 6. Appellant does not dispute Middleman’s
disclosure of this limitation, only that “Middleman fails to cure the
deficiencies of the combination of Callister and Greff’ because “Middleman
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does not disclose ‘a distal end of the needle is selectively controllably
curved’” as recited. App. Br. 15.
Appellant’s argument is not persuasive that the Examiner erred in
relying on Middleman for the reasons stated. See Ans. 10. We sustain the
Examiner’s rejection of claims 4, 8—14, 22, and 23 as being unpatentable
over Callister, Greff, and Middleman.
DECISION
The Examiner’s rejections of claims 1, 3—14, and 21—23 are affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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