Ex Parte Tinkham et al

Patent Trial and Appeal Board

Feb 27, 2017

13226183 (P.T.A.B. Feb. 27, 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.
13/226,183 09/06/2011 Brian Tinkham 10121/12102 3139
(09-00077US02
30636 7590 02/27/2017
FAY KAPLUN & MARCIN, LLP
150 BROADWAY, SUITE 702
NEW YORK, NY 10038
EXAMINER
NEWTON, ALEXANDRA L
ART UNIT PAPER NUMBER
3779
MAIL DATE DELIVERY MODE
02/27/2017 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 BRIAN TINKHAM, ROBERT DEVRIES,
MICHAL WEISMAN, SHAWN RYAN, and DANIEL BACON
Appeal 2015-004172
Application 13/226,183
Technology Center 3700
Before MICHELLE R. OSINSKI, LISA M. GUIJT, and
PAUL J. KORNICZKY Administrative Patent Judges.
GUIJT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants1 seek our review under 35 U.S.C. § 134 of the Examiner’s
decision2 rejecting claims 1-5, 7—11, 13, and 14. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify the real party in interest as Boston Scientific Scimed,
Inc. Appeal Br. 2.
2 Appeal is taken from the Final Office Action dated May 6, 2014 (“Final
Act.”), as supplemented by the Advisory Action dated July 8, 2014 (“Adv.
Act.”).
Appeal 2015-004172
Application 13/226,183
CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is the sole independent claim on appeal,
with disputed limitations italicized for emphasis.
1. A handle for a medical device, comprising:
a proximal segment defining a proximal lumen3 extending
longitudinally therethrough, the proximal lumen being sized and
shaped to receive an endoscopic medical device4 therein;
a medial segment received within a distal portion of the
proximal segment, the medial segment having an outer diameter
smaller than an inner diameter of the proximal segment and
defining a medial lumen extending therethrough open to the
proximal lumen; and
a distal segment received within a distal portion of the
medial segment and defining a distal lumen extending
therethrough open to the medial lumen, the distal segment having
an outer diameter smaller than an inner diameter of the medial
segment, wherein the medial segment includes a first movement
limiting mechanism configured to limit advancement and
retraction of an endoscope attached to a distal end of the distal
segment and wherein the medial segment includes a second
movement limiting mechanism limiting movement of an
3 An ordinary definition of the claim term lumen is “the bore of a tube.”
Webster’s Third New Int’l Dictionary 1345 (1993). Thus, the
Specification’s disclosure that “the lumen 110 is rotatable relative to the
central portion 104 and the distal portion 106” or that “the lumen 110 is
slidable relative to the telescoping internal channel 138” appears to be
referring to a tubular structure or perhaps the needle (or endoscopic medical
device) rather than to a lumen. See Spec. 17.
4 See, e.g., Appeal Br. 17 (Claims App.) (claim 4: “the endoscopic medical
device is a needle.”)
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Application 13/226,183
endoscopic medical device inserted through the proximal, medial
and distal lumens along an axis of the distal lumen,
wherein the distal segment includes an attachment sized
and shaped to engage a corresponding attachment at a proximal
end of an endoscope to which the handle is to be mounted, and
wherein the proximal segment is rotatably coupled to the
distal segment and is adapted to non-rotatably couple to a needle
to be mounted therein so that rotation of the proximal segment
rotates a needle inserted therein within the distal segment and
working channel of an endoscope coupled thereto.
REJECTIONS5
I. Claim 1 stands rejected under 35 U.S.C. § 112, first paragraph,
as failing to comply with the enablement requirement.
II. Claim 1 stands rejected under 35 U.S.C. § 112, first paragraph,
as failing to comply with the written description requirement.
III. Claim 9 stands rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite.
IV. Claims 1—4, 7—10, 13, and 14 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Hiraoka (US 2009/0062830 Al; pub. Mar. 5,
2009) and Hardia (US 2004/0260199 Al; pub. Dec. 23, 2004).
V. Claims 5 and 11 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Hiraoka, Hardia, and Hardin (US 2006/0247530 Al; pub.
Nov. 2, 2006).
5 The Specification and drawings are objected to; however, these are
petitionable and not appealable matters. Final Act. 2—3.
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Application 13/226,183
ANALYSIS
Rejection I
The Examiner determines that the recitation of “a first movement
limiting mechanism configured to limit advancement and retraction of an
endoscope attached to a distal end of the distal segment,” as recited in claim
1, is not enabled by the Specification. Final Act. 4. Specifically, the
Examiner finds that there is no explanation in the Specification of “how the
first movement limiting mechanism 120, which is configured to selectively
limit a proximal-distal movement of the distal portion relative to the central
portion . . . can in turn limit movement of the entire endoscope to which the
medical device is attached.” Id. (citing Spec. 114). The Examiner reasons
that “there is nothing preventing the operator from moving the entire
endoscope at any point when the medical device is attached.” Ans. 2—3.
Appellants submit that “claim 1 states that the endoscope is attached
to the distal segment of the handle” and argue that “[t]his attachment
provides a fixed coupling between the endoscope and the distal segment
through, for example, threading such as an ‘internal threading 134 [on an
attachment 108] engaging a threaded outer wall of a proximal end of an
endoscope.’” Appeal Br. 4 (citing Spec. 113). Appellants contend that
“[t]hose skilled in the art will understand” that “[o]nce the endoscope has
been coupled to the distal segment (or distal portion 106 ...), the endoscope
will move distally and proximally only when the distal portion 106 is moved
distally and proximally,” such that “when coupled to one another, the distal
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Application 13/226,183
portion 106 and the endoscope always move together as a single unit.” Id.
Appellants further submit that “first mechanism 120 (which corresponds to
the first movement limiting mechanism of claim 1) locks the distal portion
106 relative to the medial portion 104.” Id. at 4—5 (citing Spec. 114).
Appellants conclude that “[tjhose skilled in the art will clearly understand
this structural relationship from the figures alone that support the above
description explicitly provided in the Specification.” Id. at 6; see also Reply
Br. 2-5.
The test for compliance with the enablement requirement is whether
the disclosure, as filed, is sufficiently complete to enable one of ordinary
skill in the art to make and use the claimed invention without undue
experimentation. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). Here,
we agree with Appellants that one of ordinary skill in the art would
understand, without undue experimentation, that because the endoscope is
attached via attachment portion 108 to distal segment 106, and mechanism
120 limits the proximal-distal movement (or advancement and retraction) of
distal segment 106, mechanism 120 also limits (i.e., by preventing) the
advancement and retraction of the endoscope, as required by claim 1,
regardless of whether an operator could move the entire endoscope with the
handle attached.
Accordingly, we do not sustain the Examiner’s rejection of claim 1
under 35 U.S.C. § 112, first paragraph, as failing to comply with the
enablement requirement.
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Application 13/226,183
Rejection II
The Examiner finds that the recitation of “a first movement limiting
mechanism configured to limit advancement and retraction of an endoscope
attached to a distal end of the distal segment,” as recited in claim 1, does not
comply with the written description requirement. Final Act. 4. Specifically,
the Examiner finds that there is no explanation in the Specification of “how
the first movement limiting mechanism 120, which is configured to
selectively limit a proximal-distal movement of the distal portion relative to
the central portion . . . can in turn limit movement of the entire endoscope to
which the medical device is attached.” Id. (citing Spec. 114). The
Examiner concludes that this claim recitation is “new matter.” Id.6
Appellants rely on their arguments submitted with respect to the Examiner’s
rejection of claim 1 as failing to comply with the enablement requirement, as
stated supra. Appeal Br. 6—7.
To satisfy the written description requirement, the specification must
describe the claimed invention in sufficient detail that one skilled in the art
can reasonably conclude that the inventor had possession of the claimed
invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63 (Fed. Cir.
1991). As discussed supra, the Specification describes coupling an
endoscope to the distal end of distal portion 106 in a locked manner (see
Spec. 113) and also that “first mechanism 120 .. . [is] configured to
6 This claim limitation was added by the Amendment dated January 15,
2014.
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Application 13/226,183
selectively limit proximal-distal movement of the distal portion [(or
segment)],” and more specifically, that “mechanism 120 may be formed as a
ring 124” which “is pressed tightly against the distal portion 106 locking the
positions of the distal portion 106 and the central portion 104.” Id. 110.
Thus, the Specification describes the claimed invention in sufficient detail
that one skilled in the art can reasonably conclude that Appellants had
possession of the claimed invention.
Accordingly, we do not sustain the Examiner’s rejection of claim 1
under 35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
Rejection III
The Examiner determines that claim 9 is indefinite because “it is
unclear what the applicant considers the extension member based on
contradictory drawings and no antecedent basis of the claim language in the
specification.” Final Act. 5. Appellants argue that “the component
including the reference numeral 110 in Figs. 1—3 at a distal end of the device
100 corresponds to the extension member.”7 Appeal Br. 7; see also Reply
Br. 7—8. The Examiner responds that the reference numeral 110 is defined
as the lumen, not as an extension member. Ans. 4 (citing 17).
7 Appellants note that “Appellants are amenable to amending the Drawings
and the Specification to utilize a unique reference numeral... to denote this
feature,” noting that the extension member was recited in claim 9 along with
the Specification as originally filed. Appeal Br. 7.
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Claim 9 recites “wherein the distal lumen extends through an
extension member mounted within the distal segment, the extension member
being sized and shaped for insertion into a working channel of the
endoscope to guide an endoscopic medical device inserted therethrough into
the working channel.” Appeal Br. 18 (Claims App.). Figure 3, reproduced
below, depicts a structure, identified by the arrow, which is shown as
mounted within distal segment 106 and having the distal lumen extending
therethrough, wherein the member appears (i) to extend beyond the distal
end of attachment portion 108; and (ii) to be capable of insertion into a
working channel of the endoscope to guide an endoscopic medical device,
i.e., needle, inserted in the working channel, as required by claim 9.
Figure 3 is a partial cross-sectional view of the device according to a first
embodiment of the invention, as shown in Figure 1, annotated with an arrow.
See Spec. 14.
We apply the test for indefmiteness approved by the Federal Circuit in
Packard, i.e., “a claim is indefinite when it contains words or phrases whose
meaning is unclear.” In re Packard, 751 F.3d at 1310, 1314 (Fed. Cir.
2014). Here, we do not agree with the Examiner that the claim term
“extension member” is indefinite. An ordinary meaning of the claim term
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Application 13/226,183
extension member is a member that extends. Moreover, claim 9 clearly sets
forth the structural relationship between the extension member and the distal
segment, the endoscope’s working channel, and the endoscopic medical
device (i.e., needle).
Accordingly, we do not sustain the Examiner’s rejection of claim 9
under 35U.S.C. § 112, second paragraph, as indefinite.
Rejection IV
Regarding independent claim 1, the Examiner finds, inter alia, that
Hiraoka’s slider 5 corresponds to the claimed proximal segment, Hiraoka’s
main body 4 corresponds to the claimed medial segment, and Hiraoka’s
sheath adjuster 11 corresponds to the claimed distal segment. Final Act. 5—6
(citing Hiraoka, Fig. 2A). Regarding the claim limitation requiring the
proximal segment to be rotatably coupled to the distal segment, the
Examiner determines that Hiraoka discloses that sheath adjuster 11 (the
distal segment) slides relative to main body 4 (the medial segment) and that
“sheath adjuster screw 12 does not specifically mate with any sort of groove
or hole on the outside of the sheath adjuster, but rather is able to interact
with and lock the sheath adjuster at any point along its outer surface.” Ans.
6 (citing Hiraoka 143). The Examiner concludes that “it is obvious . . . that
when the sheath adjuster screw of the main body is unscrewed, the sheath
adjuster 11 is capable of rotating in relation to both the main body [(the
medial segment)] and the slider [(the proximal segment)].” Id.
Appellants argue, inter alia, that “sheath adjuster 11 is capable of
sliding in a specific range in an axial direction of the main body 4 and is
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Application 13/226,183
fixed relative to the main body by screwing the sheath adjuster screw 12 into
the sheath adjuster.” Appeal Br. 10 (citing Hiraoka 43, 45); see also
Reply Br. 10. Appellants contend that “Hiraoka does not disclose or suggest
any rotatable feature of its components.” Reply Br. 10-11. Appellants
conclude that “as Hiraoka discloses only axial movement, the rotational
capability [as determined by the Examiner] is based on mere speculation.”
Id. at 12.
Claim 1 requires that “the proximal segment is rotatably coupled8 to
the distal segment.” Appeal Br. 17 (Claims App.). Hiraoka discloses that
“sheath adjuster 11 can be fixed at an arbitrary position relative to the main
body 4 by screwing the sheath adjuster screw 12 attached to the second end
section 4B of the main body 4 into the sheath adjuster 11.” Hiraoka 143.
We are persuaded by Appellants’ argument that the Examiner erred by
finding that because sheath adjuster 11 may rotate within main body 4 prior
to screwing sheath adjuster screw 12, the coupling between sheath adjuster
11 and main body 4 is a rotatable coupling. Rather, we agree with
Appellants that when coupled (or fastened together), Hiraoka discloses that
sheath adjuster 11 is fixed, not rotatable, with respect to main body 4, and
8 An ordinary meaning of the claim term coupled, in view of the
Specification, is “to fasten together.” Webster’s Third New Int’l
Dictionary 521 (1993); see Spec. 19 (“central portion 104 extends distally
from the proximal handle portion 102” and “although securely connected to
the proximal handle portion 102, remains rotatable relative thereto.”)
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therefore, the coupling is a fixed coupling, not a rotatable coupling, as
claimed.
Accordingly, we do not sustain the Examiner’s rejection of
independent claim 1 under 35 U.S.C. § 103(a) as unpatentable over Hiraoka
and Hardia, and claims 2-4, 7—10, 13, and 14 depending therefrom.
Rejection II
The Examiner’s reliance on Hardin for teaching endoscopic
ultrasound needles does not cure the deficiency in the Examiner’s finding
with respect to Hiraoka as applied to claim 1, and therefore, we also do not
sustain the Examiner’s rejection of claims 5 and 11. See Final Act. 8—9.
DECISION
The Examiner’s decision to reject claim 1 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement is
REVERSED.
The Examiner’s decision to reject claim 1 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement is
REVERSED.
The Examiner’s decision to reject claim 9 under 35 U.S.C. § 112,
second paragraph, as indefinite is REVERSED.
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Application 13/226,183
The Examiner’s decision to reject claims 1—5, 7
35 U.S.C. § 103(a) is REVERSED.
REVERSED
11, 13, and 14 under
12