Ex Parte Quick et al

Patent Trial and Appeal Board

Sep 4, 2018

13749241 (P.T.A.B. Sep. 4, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/749,241 01/24/2013
96000 7590 09/06/2018
C. R. Bard, Inc./BBS
Intellectual Property Department
1415 W. 3rd St.
Tempe, AZ 85281
FIRST NAMED INVENTOR
Richard L. Quick
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.
297-PDD-10-181 US CON 3887
EXAMINER
ABOUELELA, MAY A
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
09/06/2018 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):
raust@austiplaw.com
BBSIP.Docket@crbard.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RICHARD L. QUICK,
FRANK R. LOUW, PAUL LUBOCK, and MARTIN V. SHABAZ
Appeal2017-008293 1
Application 13/749,241
Technology Center 3700
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to tissue biopsy
devices and methods for using them. The Examiner rejected the claims as
anticipated and for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b)(l).
We affirm.
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 52-55, 59, 74, 77, and 78, under 35 U.S.C. § 102(b) as
1 The real party in interest is SenoRx, Inc. Appeal Br. 3.
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Application 13/749,241
anticipated by Burbank2 (Final Act. 2-7);
(2) Claims 56, 57, 75, and 76, under 35 U.S.C. § 103(a) as obvious
over Burbank (id. at 7-8), and
(3) Claims 58 and 79, under 35 U.S.C. § 103(a) as obvious over
Burbank and Ryan3 (id. at 8-10). 4
Claim 52 is illustrative, and reads as follows:
52. A tissue biopsy device for accessing and severing a
tissue specimen from supporting tissue at a target site within a
patient, comprising:
a. an elongated probe member which has a
longitudinal axis, an inner lumen extending
therein, a tissue penetrating distal tip, and a tissue
receiving aperture proximal to the tissue
penetrating distal tip and defined at least in part by
a longitudinally oriented tissue cutting edge; and
b. an elongated tissue cutting member disposed
within the inner lumen of the elongated probe
member and configured for cutting movements
therein, which has a distal tip with a distal tissue
cutting edge having an arcuate shape that is at least
in part diagonally oriented at an acute cutting angle
with respect to the longitudinally oriented tissue
cutting edge defining in part the tissue receiving
aperture of the elongated probe member, and
which is configured to be connected to at least one
drive unit configured to rotationally oscillate the
elongated tissue cutting member side-to-side such
that with the rotational oscillation of the elongated
tissue cutting member a point of intersection of the
distal tissue cutting edge of the elongated tissue
2 US 5,526,822 (issued June 18, 1996).
3 US 5,285,795 (issued Feb. 15, 1994).
4 The Examiner withdrew the rejection of claims 71-73 over Burbank and
Ryan. Ans. 2.
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Appeal Br. 42--43.
cutting member is longitudinally advanced with
respect to the longitudinally oriented tissue cutting
edge at the tissue receiving aperture of the
elongated probe member when the elongated tissue
cutting member is rotated in a first direction, and
the point of intersection of the distal tissue cutting
edge of the elongated tissue cutting member is
longitudinally retreated with respect to the
longitudinally oriented tissue cutting edge at the
tissue receiving aperture of the elongated probe
member when the elongated tissue cutting member
is rotated in a second direction opposite the first
direction.
ANTICIPATION-CLAIM 52
The Examiner's Prima Facie Case
In determining that Burbank describes a device anticipating
Appellants' claim 52, the Examiner cited Burbank's Figure 4 as showing an
element corresponding to the outer elongated probe member of Appellants'
claimed device, that is, element "a" of claim 52. Final Act. 2-3.
As to the inner elongated tissue cutting member, element "b" of claim
52, disposed within the lumen of element "a," the Examiner cited Figure 6A
of Burbank as describing the arcuate shape and diagonal orientation of the
distal tip of the claimed cutting member, and cited Figures 13A and 13C,
and related disclosures in column 18 of Burbank as meeting claim 52's
configurational limitations relating to rotational motion and cutting edge
position. Id. at 3.
Analysis
As stated inJn re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
primafacie case ofunpatentability ....
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After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In the present case, having carefully considered all of the arguments
and evidence advanced by Appellants and the Examiner, Appellants do not
persuade us that the preponderance of the evidence fails to support the
Examiner's determination Burbank describes a device having all of the
features required by Appellants' claim 52. In particular, Appellants do not
persuade us (see Appeal Br. 20-27; Reply Br. 5-11) that the inner cutting
member of Burbank's device fails to include a distal tip with a diagonally
oriented, arcuate shaped, cutting edge that is configured to rotationally
oscillate, as claim 52 requires.
As Appellants explain (Appeal Br. 19-20), Appellants' Figures 19
and 20, reproduced below, illustrate the device recited in Appellants' claim
52:
FIG. 20
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Figure 20 shows, as to element "a" of claim 52, elongated probe
member 86, which has a longitudinal axis 94, an inner lumen extending
therein, a tissue penetrating distal tip (pointed structure adjacent to reference
number 94), and a tissue receiving aperture 92 proximal to the tissue
penetrating distal tip, defined at least in part by longitudinally oriented tissue
cuttings edge 90, 91.
Figure 20 also shows the distal tip 83 of inner tissue cutting member,
element "b" of claim 52, disposed within the inner lumen of elongated probe
86.
Figure 20 also includes arrows showing the oscillating rotational
motion of the inner tissue cutting member within the outer probe member,
which results the advance and retreat of the intersection point between the
cutting edge 84 of the inner member and the longitudinal cutting edge 90, 91
of the outer member.
Figure 19 shows, as to element "b" of claim 52, the "distal cutting
section 82 has a beveled, needle-like distal tip 83 with a sharpened opposed
edges 84 and 85 which facilitate cutting of the tissue specimen when the
cutting member 80 is moved within the outer tubular member or cannula
86." Spec. ,r 44.
Burbank's Figure 6A, is reproduced below:
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Burbank's Figure 6A shows "hollow outer piercing needle 44 in
position to pierce a tissue sample 132 which is to be sampled" (Burbank
14:3-5), as well as hollow inner cutting member 68 disposed therein, having
a diagonally oriented distal tip, identified by the Examiner as corresponding
to element "b" of Appellants' claim 52.
Burbank's Figure 13A is reproduced below:
FIG~13A
\
68
Burbank's Figure 13A shows
an alternate cutting action for the cutting mechanism
previously described in connection with FIGS. lK--6. The
cutting action described in FIGS. lK--6 was a linear slicing of
the tissue which had prolapsed into the tissue receiving port 46
by the coaxial linear motion of the cannular inner cutter 68
through the hollow outer piercing needle 44. FIGS. 13A and
13B illustrate the same structure comprising the cannular inner
cutter 68 and the hollow outer piercing needle 44. However,
the cutting action is modified. As shown by arrows 410 and
412, the cannular inner cutter 68 is capable of rotational motion
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within the hollow piercing needle 44 as well as translational
motion along their common longitudinal axis. The cannular
inner cutter 68 rotational motion is controlled by cutter drive
motor 80 and the linear motion along the longitudinal axis is
controlled by the linear driver 88. A combination of these two
actions provides the cutting action necessary to sever a tissue
sample which has prolapsed into the tissue receiving port 46.
The rotational motion may be continuous or oscillatory, as
shown in FIG. 13C.
Burbank 18:9-27.
We acknowledge, as Appellants contend (Appeal Br. 21-22), that
Figure 13A of Burbank depicts the inner cutting member 68 as having a
blunt circle-shaped distal end, rather than the beveled configuration that
provides the diagonally oriented, arcuate shaped, cutting edges 84 and 85,
shown in Appellants' Figure 19 and recited in Appellants' claim 52. As
seen above, however, and as the Examiner found, Figure 6A of Burbank
shows the inner cutting member 68 as having the same beveled
configuration shown in Appellants' Figure 19.
Burbank does not include a perspective view of the device shown in
Figure 6A comparable to the perspective view of Appellants' Figure 19.
Nonetheless, Burbank consistently depicts the distal end of the inner cutting
member 68 as having the same beveled configuration that provides the
diagonally oriented, arcuate shaped, pair of cutting edges 84 and 85, shown
in Appellants' Figure 19. See Burbank Figs. 6A---6H; see also Spec. ,r 44
( explaining as to Appellants' Figure 19 that the "distal cutting section 82 has
a beveled, needle-like distal tip 83 with a sharpened opposed edges 84 and
85"). Appellants, therefore, do not persuade us (see Appeal Br. 25) that the
Examiner erred in finding that the diagonally oriented distal end of inner
cutting member 68 of the device shown in Burbank's Figure 6A includes the
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diagonally oriented, arcuate shaped, cutting edge required by Appellants'
claim 52.
We acknowledge, as Appellants contend (see id.), that Appellants'
Figure 19 includes a notation of the cutting angle theta between the inner
diagonal cutting edge and outer longitudinal edge. Appellants' claim 52,
however, does not recite any specific limitation as to the cutting angle of the
inner element, other than the diagonally oriented acute cutting angle, which
as discussed above, is shown in Figure 6A of Burbank. Appellants,
moreover, fail to explain with any particularity how or why the Examiner
erred in finding that Burbank's device has the arcuate shaped, cutting edge
required by Appellants' claim 52, given that Burbank's device has the same
beveled end shown in Appellants' own disclosure at Figure 19 as providing
those elements.
As noted above, moreover, Burbank discloses that the oscillating
rotational motion of the inner member 68 described in column 18 in relation
to Figure 13A (Burbank 18:26-36) is "an alternate cutting action/or the
cutting mechanism previously described in connection with FIGS JK-6."
Id. at 18:9-11 (emphasis added). Accordingly, contrary to Appellants'
contention that Burbank's disclosures regarding the oscillating rotational
motion of its inner cutting member 68 relate only to the embodiment shown
in Figure 13A (Appeal Br. 23-24, 26; Reply Br. 8-11), Burbank states
expressly that the oscillating rotational cutting action described in column 18
is "for the cutting mechanism previously described in connection with FIGS
lK---6." Id. at 18:10-11.
In sum, as discussed above, Burbank states expressly that the
oscillating rotational cutting action described in column 18 is for the cutting
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mechanism described in connection with its Figure 6, and Figure 6A of
Burbank depicts the distal end of the inner cutting member 68 as having the
same beveled configuration that provides a diagonally oriented, arcuate
shaped, pair of cutting edges shown in Appellants' Figure 19. Accordingly,
Appellants do not persuade us (see Appeal Br. 23-24) that the Examiner
erred in finding that the oscillating rotational motion described in Burbank
would result in the scissoring action recited in claim 52, in which the
intersection point of the inner cutting member and outer longitudinal cutting
member advances and retreats.
The preponderance of the evidence, thus, supports the Examiner's
determination that Burbank describes a device having an inner cutting
member with a distal tip that includes a diagonally oriented, arcuate shaped,
cutting edge that is configured to rotationally oscillate, in the manner
required by Appellants' claim 52. Because Appellants do not persuade us,
therefore, that the Examiner erred in determining that Burbank describes a
device having all of the features required by claim 52, we affirm the
Examiner's rejection of claim 52 as anticipated by Burbank.
ANTICIPATION-CLAIMS 53 AND 54
In contending that the Examiner erred in determining (see Final Act.
4) that Burbank anticipates claims 53 and 54, Appellants rely entirely on
their arguments as to claim 52, discussed above. See Appeal Br. 27. As
discussed above, however, we find those arguments unpersuasive.
Accordingly, because Appellants do not identify, nor do we discern,
error in the Examiner's determination that Burbank anticipates claims 53
and 54, we affirm the Examiner's rejection of claims 53 and 54 over
Burbank.
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ANTICIPATION-CLAIM 55
In contending that the Examiner erred in determining (see Final Act.
4) that Burbank anticipates claim 55, Appellants contend that the inner
cutting cannula shown in Figure 13A of Burbank fails to include the first and
second distal cutting edges required by claim 55. Appeal Br. 27-28.
In particular, Appellants contend, the distal end of the inner cutting
cannula shown in Figure 13A of Burbank is circular, "which by plain
definition has only one side." Id. at 28.
As the Examiner contends, however (Ans. 5-6), and as discussed
above, Figure 6A of Burbank depicts the distal end of the inner cutting
member 68 as having the same beveled configuration that provides the
diagonally oriented, arcuate shaped, pair of first and second cutting edges 84
and 85, shown in Appellants' Figure 19. See Burbank Fig. 6A; see also
Spec. ,r 44 (explaining as to Appellants' Figure 19 that the "distal cutting
section 82 has a beveled, needle-like distal tip 83 with a sharpened opposed
edges 84 and 85"); Appeal Br. 8-9 (identifying cutting edges 84 and 85 as
corresponding to first and second cutting edges of claim 55).
Accordingly, because Appellants do not explain specifically why the
Examiner erred in finding that the cutting device shown in Figure 6A of
Burbank includes the first and second cutting edges required by Appellants'
claim 55, we affirm the Examiner's rejection of claim 55 as anticipated by
Burbank.
ANTICIPATION-CLAIM 59
In contending that the Examiner erred in determining (see Final Act.
4--5) that Burbank anticipates claim 59, Appellants rely entirely on their
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arguments as to claim 55, discussed above. See Appeal Br. 29. As
discussed above, however, we find those arguments unpersuasive.
Accordingly, because Appellants do not identify, nor do we discern,
error in the Examiner's determination that Burbank anticipates claim 59, we
affirm the Examiner's rejection of claim 59 over Burbank.
ANTICIPATION-CLAIM 74
In contending that the Examiner erred in determining (see Final Act.
5---6) that Burbank anticipates claim 7 4, Appellants contend, similar to their
contention in relation to claim 55 discussed above, that the inner cutting
cannula shown in Figure 13A of Burbank fails to include the first and second
distal cutting edges required by claim 74. Appeal Br. 30.
In particular, Appellants contend, the distal end of the inner cutting
cannula shown in Figure 13A of Burbank is circular, "which by definition
has only one side." Id.
As the Examiner contends, however (Ans. 5---6), and as discussed
above, Figure 6A of Burbank depicts the distal end of the inner cutting
member 68 as having the same beveled configuration that provides the
diagonally oriented, arcuate shaped, pair of first and second cutting edges 84
and 85, shown in Appellants' Figure 19. See Burbank Fig. 6A; see also
Spec. ,r 44 ( explaining as to Appellants' Figure 19 that the "distal cutting
section 82 has a beveled, needle-like distal tip 83 with a sharpened opposed
edges 84 and 85"); Appeal Br. 13 (identifying cutting edges 84 and 85 as
corresponding to first and second cutting edges of claim 74).
In sum, because Appellants do not explain specifically why the
Examiner erred in finding that the cutting device shown in Figure 6A of
Burbank includes the first and second cutting edges required by Appellants'
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claim 74, we affirm the Examiner's rejection of claim 74 as anticipated by
Burbank.
ANTICIPATION-CLAIM 77
In contending that the Examiner erred in determining (see Final Act.
6) that Burbank anticipates claim 77, Appellants rely entirely on their
arguments as to claim 52, discussed above. See Appeal Br. 31. As
discussed above, however, we find those arguments unpersuasive.
Accordingly, because Appellants do not identify, nor do we discern,
error in the Examiner's determination that Burbank anticipates claim 77, we
affirm the Examiner's rejection of claim 77 over Burbank.
ANTICIPATION-CLAIM 78
In contending that the Examiner erred in determining (see Final Act.
6-7) that Burbank anticipates claim 78, Appellants contend, similar to their
contention in relation to claim 52 discussed above, that the distal end of the
inner cutting cannula shown in Figure 13A of Burbank is blunt and circular,
and therefore would not provide the scissoring action recited in claim 78, in
which the intersection point of the inner cutting member and outer
longitudinal cutting member advances and retreats. Appeal Br. 31-33.
As discussed above in relation to claim 52, however, Burbank states
expressly that the oscillating rotational cutting action described in column 18
is for the cutting mechanism described in connection with its Figure 6
(Burbank 18:9-11), and Figure 6A of Burbank depicts the distal end of the
inner cutting member 68 as having a same beveled configuration that
provides a diagonally oriented, arcuate shaped, pair of cutting edges shown
in Appellants' Figure 19.
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Because Burbank thus describes applying the same oscillating
rotational motion to components having the same shape and relative
orientations as claimed by Appellants, Appellants do not persuade us that the
Examiner erred in finding that the oscillating rotational motion described in
Burbank would result in the scissoring action recited in claim 78, in which
the intersection point of the inner cutting member and outer longitudinal
cutting member advances and retreats. We, therefore, affirm the Examiner's
rejection of claim 78 as anticipated by Burbank.
OBVIOUSNESS-CLAIMS 56, 57, 75, AND 76
In rejecting claims 56, 57, 75, and 76 for obviousness over Burbank,
the Examiner determined that it would have been obvious to configure the
distal cutting edge of Burbank's device to have a cutting angle within the
ranges recited in claims 56, 57, 75, and 76. Final Act. 8.
In contending that the Examiner erred in determining that claims 56,
57, 75, and 76 would have been obvious over Burbank, Appellants rely
entirely on their arguments as to claim 52, discussed above. See Appeal Br.
34--35. As discussed above, however, we find those arguments
unpersuasive.
Accordingly, because Appellants do not identify, nor do we discern,
error in the Examiner's determination that Burbank renders obvious the
devices recited in claims 56, 57, 75, and 76, we affirm the Examiner's
obviousness rejection of claims 56, 57, 75, and 76 over Burbank.
OBVIOUSNESS-CLAIMS 58 AND 79
In rejecting claims 58 and 79 for obviousness over Burbank and Ryan,
the Examiner determined that it would have been obvious in view of Ryan to
configure the distal cutting edge of Burbank's device to have an outward
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flare as recited in claims 58 and 79, and to also have the beveled tip and
distal slot recited in claim 79. Final Act. 9-10.
In contending that the Examiner erred in determining that claims 58
and 79 would have been obvious over Burbank and Ryan, Appellants rely
entirely on their arguments as to claims 52, 54, and 7 4, discussed above. See
Appeal Br. 36, 40. As discussed above, however, we find those arguments
unpersuasive.
Accordingly, because Appellants do not identify, nor do we discern,
error in the Examiner's determination that the combination of Burbank and
Ryan renders obvious the device recited in claim 58, and the process recited
in claim 79, we affirm the Examiner's obviousness rejection of claims 58
and 79 over Burbank and Ryan.
SUMMARY
For the reason discussed, we affirm each of the Examiner's rejections.
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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