Ex Parte Shabaz et al

Patent Trial and Appeal Board

Feb 25, 2019

14700574 (P.T.A.B. Feb. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
14/700,574
96000 7590
AUST IP LAW
Ronald K. Aust
FILING DATE
04/30/2015
02/27/2019
12029 E. WASHINGTON STREET
INDIANAPOLIS, IN 46229
FIRST NAMED INVENTOR
Martin V. Shabaz
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.
297-PDD-10-158
USDIV2CON
CONFIRMATION NO.
5703
EXAMINER
KREMER, MATTHEW
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
02/27/2019 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
tshort@austiplaw.com
ip.docket@bd.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARTIN V. SHABAZ, RICHARD L. QUICK,
FRANK R. LOUW, PAUL LUBOCK, and JASON H. SAP ABASH
Appeal2017-009735 1
Application 14/700,574
Technology Center 3700
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
RYAN H. FLAX, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to methods of
collecting tissue specimens from patients. The Examiner finally rejected the
claims as failing to comply with the enablement requirement.
We have jurisdiction under 35 U.S.C. § 6(b )(1 ).
We reverse.
1 Appellants state that the real party in interest is SenoRx, Inc. Appeal Br. 3.
Appeal2017-009735
Application 14/700,574
STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner's rejection of
claims 57 and 61---66 under 35 U.S.C. § 112, first paragraph, as failing to
comply with the enablement requirement. Ans. 2---6.
Claim 57 is illustrative of the rejected claims, and depends from
independent claim 37. Appeal Br. 55.
Claims 37 and 57 read as follows:
37. A method for collecting one or more tissue
specimens from a target site within a patient, comprising:
a. providing a biopsy device having:
i. a disposable elongated probe component
compnsmg:
an elongated tubular section which has a
longitudinal axis, which has an inner
lumen extending therein, which has a
penetrating distal tip and which has a
tissue receiving aperture proximal to
the penetrating distal tip configured to
receive tissue from the target site,
a first driven gear coupled to the elongated
tubular section and configured to
rotate, to in tum rotate the elongated
tubular section around the
longitudinal axis,
an elongated tissue cutting member which is
disposed within the elongated tubular
section, which has a distal end having
at least one tissue cutting edge and
which has an inner lumen extending
therein, the elongated tissue cutting
member having a proximal end
opposite the distal end, and
a second driven gear coupled to the
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Application 14/700,574
elongated tissue cutting member and
configured to rotate to longitudinally
move the elongated tissue cutting
member relative to the elongated
tubular section along the longitudinal
axis,
the first driven gear and the second driven
gear being arranged coaxially and
adjacent each other on the
longitudinal axis;
ii. a driver component configured to receive a
proximal portion of the disposable elongated
probe component in an operational relationship,
the driver component having:
a first driver unit configured to rotate the
elongated tubular section of the
disposable elongated probe
component to orient the tissue
receiving aperture of the elongated
tubular section, the first driver unit
having a first drive gear, and
a second driver unit configured to drive the
elongated tissue cutting member
longitudinally within the elongated
tubular section to cut a tissue
specimen from the tissue received in
the tissue receiving aperture of the
elongated tubular section, the second
driver unit having a second drive gear
positioned adjacent the first drive
gear,
the first drive gear and the second drive gear
of the driver component configured to
respectively drivably engage the first
driven gear and the second driven
gear that are arranged coaxially and
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Application 14/700,574
adjacent to each other on the
longitudinal axis; and
iii. a tissue collection device located at the
proximal end of the elongated tissue cutting
member, a portion of the elongated tissue cutting
member being positioned inside the tissue
collection device;
b. advancing the disposable elongated probe component
at least partially into or adjacent to tissue at the target
site;
c. rotating the elongated tubular section about the
longitudinal axis by the first driver unit to a
predetermined aperture orientation of the tissue
receiving aperture;
d. applying a vacuum within the elongated tubular
section to draw the tissue at the tissue site through the
tissue receiving aperture of the elongated tubular section
into an interior thereof;
e. advancing the elongated tissue cutting member
longitudinally within the elongated tubular section by
the second driver unit to cut the tissue specimen from the
tissue extending into the elongated tubular section; and
f. applying a vacuum to the proximal end of the
elongated tissue cutting member for transporting the cut
tissue specimen through the inner lumen of the
elongated tissue cutting member to discharge the cut
tissue specimen directly from the proximal end of the
elongated tissue cutting member into the tissue
collection device.
57. The method of claim 37, comprising:
providing the disposable elongated probe component
with a third driven gear coupled to the elongated tissue cutting
member, the third driven gear being arranged on the
longitudinal axis such that the third driven gear is coaxial with
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Application 14/700,574
the first driven gear and the second driven gear on the
longitudinal axis;
providing the driver component with a third driver unit
having a third drive gear configured to drivably engage the third
driven gear, the third drive gear positioned adjacent the second
drive gear; and
driving the third driven gear with the third drive gear
simultaneously with driving the second driven gear with the
second drive gear, such that the act of advancing the
elongated tissue cutting member longitudinally is achieved by
driving the second driven gear and the act of advancing the
elongated tissue cutting member longitudinally is
accompanied by a rotational or oscillation motion of the
elongated tissue cutting member about the longitudinal axis
by driving the third driven gear.
Appeal Br. 53-56 (emphasis added to show claim language at issue).
DISCUSSION
The Examiner's Prima Facie Case
In rejecting claims 57 and 61---66 for failure to comply with the
enablement requirement, the Examiner determined, as to claim 57, that the
driving operation of the third driven gear with the third drive
gear so as to cause rotational or oscillation motion of the
elongated tissue cutting member is not described in the
specification in such a way as to make it clear how the
rotational or oscillation motion is caused by the driving
operation.
Ans. 3 (citing Spec. ,r 36 and Fig. 4B).
Therefore, the Examiner concluded, a skilled artisan "would not have
enough information to be able to make and use the invention. Thus, the
claimed driving operation of the third driven gear with the third drive gear so
as to cause rotational or oscillation motion of the elongated tissue cutting
member is not enabled by the specification." Id. at 4.
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Application 14/700,574
The Examiner concluded that the methods recited in claims 61 and 62
also lacked enablement, based on a similar language in those claims reciting
a third driven gear causing rotation or oscillation of the biopsy device's
cutting member. Id. at 4---6.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability ....
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.
Having carefully considered the arguments and evidence advanced by
Appellants and the Examiner, Appellants persuade us that the preponderance
of the evidence does not support the Examiner's conclusion of non-
enab lement.
We understand the Examiner's position to be that Appellants'
disclosure does not provide sufficiently specific detail as to how the third
driven gear provides a rotational oscillation motion to the cutting element
while the second driven gear provides a longitudinal motion at the same
time, stated by the Examiner as follows:
[P]aragraphs 0036 and 0039 of the specification ... merely
disclose the effect to be achieved, but does not explain how it
can be done. That is, it is not clear from paragraphs 0036 and
0039 how the oscillation shaft 42 causes the oscillation or
rotation of the tissue cutting member 20 since the shaft 42 is
symmetrical about the tissue cutting member 20 and is not
disclosed to be attached to the tissue cutting member 20 in such
a way as to be able to have the tissue cutting member 20 be
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Application 14/700,574
slidable within the shaft 42 yet also permit rotation relative to
the shaft 42.
Ans. 11; see also id. at 13 ("[T]hese passages do not fully describe the
working example so as to make clear how the oscillation or rotational
movement of the tissue cutting member 20 is created as a result of the
operation of the third driving gear 40 and the cutter oscillation shaft 42.");
id. at 18 ("[H]ow is the oscillation back and forth in the longitudinal
direction made manifest if there is free longitudinal motion between the
cutter shuttle 36 and the oscillation shaft 42? The Appellant[s'] unsupported
explanation, the written description, and FIGS. 4A-4B does not address this
issue.").
It is well settled, however, that "it is unnecessary to spell out every
detail of the invention in the specification; only enough must be included to
convince a person of skill in the art that the inventor possessed the invention
and to enable such a person to make and use the invention without undue
experimentation." Palko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1366
(Fed. Cir. 2006) (internal citations omitted); see also In re Gay, 309 F.2d
769, 774 (CCPA 1962) ("Not every last detail is to be described, else patent
specifications would tum into production specifications, which they were
never intended to be.").
As explained in Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314
F.3d 1313, 1334 (Fed. Cir. 2003):
The enablement requirement is often more indulgent than
the written description requirement. The specification need not
explicitly teach those in the art to make and use the invention;
the requirement is satisfied if, given what they already know, the
specification teaches those in the art enough that they can make
and use the invention without "undue experimentation."
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In the present case, as to the level of skill in this art, the Examiner
concedes that "[ o ]ne of ordinary skill in the art would be a biomechanical
engineer that would be able to construct such a device given the descriptions
of the various interactions between the components so as to achieve the three
different kinds of movement for the cutting member." Ans. 12.
Thus, despite the alleged lack of detail in Appellants' disclosure, the
Examiner concedes that a skilled artisan would have been able to construct a
device having the functionality required by Appellants' claims. We are not
persuaded, therefore, that the Examiner has adequately explained why
Appellants' disclosure fails to enable a skilled artisan to make and use the
claimed invention.
We agree with Appellants, moreover, that Figure 4A (showing the
cutting element in a withdrawn position (Spec. ,r 20)), and Figure 4B
(showing the cutting element in an extended forward position (id. ,r 21)), and
the supporting disclosures, sufficiently explain the functionality at issue. As
explained in the Specification, probe gear 31 (second driven gear of
Appellants' claims) is attached to cutter traverse nut 32 by adhesive, and
rotation of probe gear 31, therefore, causes cutter traverse nut 32 to rotate.
Id. ,I 35.
Due to the threaded connection between the outer surface of cutter
screw 33 and inner surface of cutter traverse nut 32, rotation of cutter
traverse nut 32 results in longitudinal motion of the cutting element from the
retracted position in Figure 4A to the extended position shown in Figure 4B.
See id. ("The driving gear 30 engages probe gear 31 which drives cutter
traverse nut 32 and cutter screw 33 threadably connected to the cutter
traverse nut.").
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As explained in the Specification, the rotational motion recited in
Appellants' claims is caused by elements independent of the threaded
connection that drives the longitudinal motion of the cutter screw 33.
Specifically, "third driving gear 40 engages probe gear 41 which is secured
to cutter oscillation shaft 42 by adhesive 43," such that probe gear 41 "may
be oscillated back and forth about the longitudinal axis 28 or rotated
continuously in a single direction about the longitudinal axis, or both
depending upon the desired rotational movement of the tissue cutter." Id.
Given these disclosures, the Examiner does not persuade us that the
Specification fails to explain sufficiently to the skilled artisan how the
longitudinal and rotational motions recited in the rejected claims are
accomplished. We are not persuaded, therefore, that the Examiner has
shown sufficiently that the disclosures in Appellants' Specification and
Figures fail to enable a skilled artisan to perform the process recited in
claims 57 and 61-66, including the longitudinal and rotational motions
recited in those claims. We, therefore, reverse the Examiner's rejection of
claims 57 and 61-66, for lack of enablement.
REVERSED
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