Ex Parte Grigoryants et al

Patent Trial and Appeal Board

Oct 31, 2016

13660626 (P.T.A.B. Oct. 31, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/660,626 10/25/2012
104919 7590 11/02/2016
Fay Kaplun & Marcin, LLP -- BSC
150 Broadway, suite 702
New York, NY 10038
FIRST NAMED INVENTOR
Sergey S. Grigoryants
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.
10121112907 (03-058US4) 6865
EXAMINER
STOUT, MICHAEL C
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
11/02/2016 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):
okaplun@fkmiplaw.com
fkmiplaw@yahoo.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SERGEY S. GRIGORY ANTS and LUIS J. MASEDA1
Appeal2014-008715
Application 13/660,626
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a tissue
sampling device which have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as Boston Scientific Scimed,
Inc. (App. Br. 2.)
Appeal2014-008715
Application 13/660,626
STATEMENT OF THE CASE
Appellants' "invention relates generally to tissue sampling devices
and relates more particularly to transbronchial needle aspiration devices."
(Spec. 1:7-8.)
Claims 10, 12-21, and 23-29 are on appeal. Claim 10 is illustrative:
10. A tissue sampling device, comprising:
a flexible catheter extending longitudinally from a
proximal end to a distal end and including a channel extending
therethrough;
a sampling needle slidably received within the channel of
the catheter and including a distal tip;
a wire extending through the channel and including a distal
end connected to the proximal end of the sampling needle to
move the sampling needle between a retracted position in which
the distal end thereof is disposed within the channel of the
catheter to an extended position in which the distal end thereof
extends distally beyond the distal end of the catheter;
a handle coupled to the proximal end of the catheter; and
a sliding lock coupled to a proximal end of the wire
mounted within the handle to move the sampling needle between
the retracted and extended position, the sliding lock including a
releasable locking mechanism to lock the sampling needle in the
retracted position, wherein the locking mechanism includes a
proximal notch extending through a proximal portion of the
handle and a pawl extending laterally from the sliding lock, the
pawl being biased radially outward to engage the proximal notch
in the retracted position and movable radially inward to
disengage the proximal notch.
(App. Br. 13 (Claims App'x).)
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Application 13/660,626
The claims stand rejected as follows:
I. Claims 10, 12-17, 19, 21, 23-27, and 29 are rejected under
35 U.S.C. § 103(a) over Wang2 and Haber.3
II. Claims 18 and 28 are rejected under 35 U.S.C. § 103(a) over
Wang, Haber, and Smith.4
III. Claim 20 is rejected under 35 U.S.C. § 103(a) over Wang,
Haber, and Savage. 5
REJECTION!
Appellants argue the patentability of the claims together. We select
claim 10 as representative. Claim 10 requires, among other things,
a sliding lock coupled to a proximal end of the wire mounted
within the handle to move the sampling needle between the
retracted and extended position, the sliding lock including a
releasable locking mechanism to lock the sampling needle in the
retracted position, wherein the locking mechanism includes a
proximal notch extending through a proximal portion of the
handle and a pawl extending laterally from the sliding lock, the
pawl being biased radially outward to engage the proximal notch
in the retracted position and movable radially inward to
disengage the proximal notch.
(App. Br. 13 (Claims App'x).)
The Examiner finds that "Wang teaches a sampling device for
collecting tissue wherein a needle is reciprocated [from] a retracted
2 Wang, US 4,791,937, issued Dec. 20, 1988.
3 Haber et al., US 4,813,426, issued Mar. 21, 1989.
4 Smith et al., US 6,743,206 Bl, issued June 1, 2004.
5 Savage et al., US 5,830,209, issued Nov. 3, 1998.
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Application 13/660,626
position[], the needle being attached to the distal end of a wire 22, to an
extended position to sample tissue." (Ans. 3.) The Examiner finds that
Wang is silent regarding the mechanism to extend and retract the
needle member, specifically a mechanism including a sliding
lock coupled to a proximal end of the wire mounted within the
handle to move the sampling needle between the retracted and
extended position, the sliding lock including a releasable locking
mechanism to lock the sampling needle in the retracted position.
(Id. at 4.)
The Examiner, however, turns to Haber and finds it teaches
a device for collecting a tissue sample comprising a needle ... ,
wherein the needle is moved in a reciprocal manner wherein the
hub assembly is fit[ted] within a housing, best shown in Figures
3 and 5, the device comprising a sliding lock coupled to a
proximal end of the shaft (a button 20 attached to the carrier 14,
see Figure 1) mounted within the handle to move the sampling
needle between the retracted and extended position (retracted
position be[st] shown in Figure 5, extended position shown in
Figure 3), the sliding lock including a releasable locking
mechanism to lock the sampling needle in the retracted position
... , wherein the locking mechanism includes a proximal notch
extending through a proximal portion of the handle and a pawl
extending laterally from the sliding lock ....
(Id. at 4--5.) The Examiner concludes that it would have been obvious to
"modify the device taught by Wang to include a slide locking mechanism
in a reciprocating actuator as taught by Haber in order to secure the needle in
a retracted position to prevent accidental contact with a potentially
contaminated needle." (Id. at 5.)
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Wang and Haber would have
rendered claim 10 obvious?
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Application 13/660,626
Findings of Fact (FF)
1. Wang teaches
A biopsy needle assembly comprised of an outer flexible catheter
and a reciprocating interior structure on which the needle is
mounted. In one embodiment, the needle is directly connected
to an internal guide wire. In another, the needle is directly
connected to an inner flexible catheter and the guide wire can
either extend through the needle or be stopped within the needle.
(Wang Abstract; see also Ans. 2-3.)
2. Wang teaches that "[i]n obtaining the tissue sample within the
needle it is necessary to apply some negative pressure or suction to the
needle once the needle is inserted into the tissue to help assure tissue
collection." (Wang 1 :56-59; see also Reply Br. 6.)
3. Wang teaches that
suction will be applied to the cavity defined between the interior
of the outer catheter and the exterior of the inner catheter which
will lead directly to the tip of the hollow needle through the
lateral opening in the needle and allow negative pressure to be
applied directly to the tissue being sampled. Because the guide
wire is designed to fit tightly within the inner catheter the guide
wire will provide a seal therein so that negative pressure or
suction will only be applied via the chamber between the two
catheters and through the hollow needle. Sufficient diagnostic
tissue or material can be obtained and it will be easier to interpret
the results from the tissue being sampled because there will be a
lack of contamination by otherwise unwanted tissue or cells and
it will be possible as well to obtain a relatively large quantity of
the diagnostic material or tissue since the continued presence of
the guide wire continues to provide rigidity to the catheter
assembly.
(Wang 4: 18-37; see also Ans. 15.)
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Application 13/660,626
4. Wang's Figure lb is reproduced below:
Figure 1 b shows that
guide wire 20 is bent or kinked, as indicated at 66, so that the
distal e[ n ]d of the hollow tubular member 56 will act as a stop
member and prevent further retraction of guide wire 20 . ... It is
preferred to limit travel of needle 22 so that the tip will not be
retracted beyond the interior of tip 14 whereby the distal tip of
needle 22 will not be retracted to a position beyond sealing
means 30 as to do so would destroy that seal.
(Wang Fig. lb, 7:46-57; see also Fig. la, Ans. 2-3.)
5. Wang teaches that "[t]uming now to the next embodiment, as
shown in FIGS. 3a-5b, the outer hollow catheter and its distal and proximal
ends are formed as described above with respect to the first embodiment."
(Wang Fig., 8:13-16; see also Ans. 2-3, 10.)
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6. Wang's Figure 3b is reproduced below:
Figure 3b shows "three portions[:] housing 42, end cap 112 and an
intermediate member 116," in which "intermediate member 116 includes a
central tubular hub portion 128 in which the proximal end of a tubular
mounting sleeve 130 is secured, as for example by use of an adhesive or
friction fit." (Wang Fig. 3b, 8:42--44, 53-59; see also Fig. 3a, Ans. 2-3, 11.)
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Application 13/660,626
7. Haber's Figure 3 is reproduced below:
Figure 3 shows
A shielded safety syringe compnsmg a cylindrical, outer
protective sleeve, an inner needle carrier movable axially
through the sleeve, and a double-ended hypodermic needle
supported by the needle carrier and aligned coaxially with
respect to the outer sleeve and needle carrier. . . . A position
control button is connected to the needle carrier and slidable
through an axial guide channel formed in the outer sleeve for
moving the needle carrier between proximal and distal positions
within the sleeve. . . . Locking detents are formed at opposite
ends of the guide channel to receive the position control button,
so that the needle maybe reliably retained in either the axially
extended or retracted position.
(Haber Fig. 3, Abstract; see also Ans. 4--5, 13-14.)
DISCUSSION
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 2-16; FF 1-7) and agree that claim
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Application 13/660,626
10 would have been obvious over Wang and Haber. We address below
Appellants' arguments.
Appellants contend that "it would not have been obvious to one of
ordinary skill in the art have modified the device of Wang to include a
sliding lock mechanism." (App. Br. 6.) More particularly, Appellants argue
that, in regard to Wang,
a cap 60 coupled to a proximal end of a guide wire is an essential
feature of the assembly 10 as it includes a plug member for
sealing a first passage of the housing so that, when the cap is
coupled to the housing, a needle is both locked in an extended
configuration and so that it is sealed to permit a vacuum force to
be applied through the needle via a second passage. Thus,
modifying the assembly 10 of Wang to include a sliding lock
mechanism in the housing would prevent the assembly 10 of
Wang from functioning as intended.
(App. Br. 7; see also Reply Br. 4.)
Appellants further argue that
The needle carrier 14 [of Haber] is configured to be
longitudinally slidable within an outer sleeve 2 such that a seal
cannot be established therebetween. Haber does not teach, show
or suggest that the needle carrier 14 is in any way capable of
establishing a seal with the outer sleeve 2.
(Reply Br. 6.)
These arguments are unpersuasive.
Wang teaches that "[i]n obtaining the tissue sample within the needle
it is necessary to apply some negative pressure or suction to the needle once
the needle is inserted into the tissue to help assure tissue collection." (FF 2
(emphasis added); see also Reply Br. 6.) Wang further teaches that
"[b ]ecause the guide wire is designed to fit tightly within the inner catheter
the guide wire will provide a seal therein so that negative pressure or suction
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will only be applied via the chamber between the two catheters and through
the hollow needle. Sufficient diagnostic tissue or material can be obtained."
(FF 3; see also Ans. 15.) Wang also teaches that
guide wire 20 is bent or kinked, as indicated at 66, so that the
distal e[ n ]d of the hollow tubular member 56 will act as a stop
member and prevent further retraction of guide wire 20. . . . It
is preferred to limit travel of needle 22 so that the tip will not be
retracted beyond the interior of tip 14 whereby the distal tip of
needle 22 will not be retracted to a position beyond sealing
means 30 as to do so would destroy that seal.
(FF 4.) Wang further teaches that "intermediate member 116 includes a
central tubular hub portion 128 in which the proximal end of a tubular
mounting sleeve 130 is secured, as for example by use of an adhesive or
friction fit." (FF 6.)
We are not persuaded by Appellants' contention that modifying
Wang's device in the manner suggested by the Examiner would have
prevented Wang's device from functioning as intended, including preventing
any seal or vacuum (see also Ans. 9 ("A modified[] cap is still capable of
providing a seal")). Even if suction was reduced somewhat to gain the
benefit of a sliding lock as in Haber, that would not mean claim 10 is
nonobvious. See In re Urbanski, 809 F.3d 1237, 1243 (Fed. Cir. 2016)
(holding that a combination of references may be obvious even if the
combination is at the expense of a benefit of one of the references).
Appellants provide no persuasive factual evidence to show that Wang's
device, as modified by the Examiner, would be inoperable. See In re
Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) ("[A]ttomey argument [is] not
the kind of factual evidence that is required to rebut a prima facie case of
obviousness").
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We are also not persuaded the skilled artisan, desiring the benefit of
Haber's slidable/lockable control button (i.e., to keep a needle in an
extended or retracted position) in a known transbronchial needle aspiration
device, such as Wang, would have been unable to design a modified device
that maintained a sufficient seal and level of suction. As the Supreme Court
has emphasized, "[a] person of ordinary skill is also a person of ordinary
creativity, not an automaton." KSR Int 'l v. Teleflex Inc., 550 U.S. 398, 421
(2007). The obviousness analysis thus can and should "take account of the
inferences and creative steps that a person of ordinary skill in the art would
employ." Id. at 418. "[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." Id. at 417. Nothing
in the record here suggests the Examiner's proposed combination of known
prior art elements according to their known functions would involve more
than routine engineering efforts. Accordingly, the preponderance of the
evidence supports the Examiner's conclusion that claim 10 would have been
obvious.
Appellants also contend that "[t]he embodiment of Pigs. 3a-5b [of
Wang], does not show a sampling needle movable between a retracted and
extended position via a guide wire coupled to a proximal end thereof, as
required by the recited claim." (App. Br. 8; see also Reply Br. 5---6.)
This argument is unpersuasive.
Wang teaches that "[t]uming now to the next embodiment, as shown
in FIGS. 3a-5b, the outer hollow catheter and its distal and proximal ends
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are formed as described above with respect to the first embodiment." (FF 5;
see also Ans. 10.)
We recognize, but are not persuaded by Appellants' contention that
Although column 8 does include description for the embodiment
of Figs. 3a-5b, it is respectfully noted that all of the references
to column 8 the Examiner refers to have been with respect to
columns 6-8 and Figs. 1 a-2b. See 8127113 Office Action, pp. 3-
4 and 7. In the Final Office Action, the Examiner never
references any portions of the needle assembly of Figs. 3a-5b or
any of the corresponding description in columns 8-10.
(Reply Br. 5.)
This argument is unpersuasive as well. As Appellants point out, the
Examiner did refer to column 8 of Wang (see also Ans. 10). Moreover, see
Merck & Co. Inc. v. Biocraft Labs. Inc., 874 F.2d 804, 807 (Fed. Cir. 1989)
("'the fact that a specific [embodiment] is taught to be preferred is not
controlling, since all disclosures of the prior art, including unpreferred
embodiments, must be considered."') (quoting In re Lamberti, 545 F .2d 7 4 7,
750 (CCPA 1976)).
REJECTION II
Appellants contend that "Smith does not cure the deficiency of Wang
in view of Haber." (App. Br. 11.) Having affirmed the rejection of the
parent claim for the reasons given above, we thus affirm the rejection of
claims 18 and 28.
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REJECTION III
Appellants contend that "Savage does not cure the deficiency of Wang
in view of Haber." (Id.) Having affirmed the rejection of the parent claim
for the reasons given above, we thus affirm the rejection of claim 20.
CONCLUSION OF LAW
We affirm the rejection of claims 10, 12-17, 19, 21, 23-27, and 29
under 35 U.S.C. § 103(a) over Wang and Haber.
We affirm the rejection of claims 18 and 28 under 35 U.S.C. § 103(a)
over Wang, Haber, and Smith.
We affirm the rejection of claim 20 under 35 U.S.C. § 103(a) over
Wang, Haber, and Savage.
TIME PERIOD FOR RESPONSE
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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