Ex Parte Ryan et al

Patent Trial and Appeal Board

Feb 28, 2017

12633483 (P.T.A.B. Feb. 28, 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.
10121/08702 5754
EXAMINER
DOUGHERTY, SEAN PATRICK
ART UNIT PAPER NUMBER
3736
MAIL DATE DELIVERY MODE
12/633,483 12/08/2009
30636 7590 02/28/2017
FAY KAPLUN & MARCIN, LLP
150 BROADWAY, SUITE 702
NEW YORK, NY 10038
Shawn RYAN
02/28/2017 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 SHAWN RYAN and NICK PACKET
Appeal 2015-006636
Application 12/633,483
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 appeal1 under 35 U.S.C. § 134 involving claims to a device
for storing a stylet. The Examiner rejected the claims on the ground of
obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
Appellants’ invention relates to
a device for storing a stylet comprising a stylet sized and
shaped for insertion into a lumen of a needle [and] an end cap
1 Appellants identify the Real Party in Interest as Boston Scientific Scimed,
Inc. (see App. Br. 2).
Appeal 2015-006636
Application 12/633,483
selectively coupleable to a proximal end of a needle, the end
cap being coupled to a proximal end of the stylet so that, when
the end cap is coupled to the needle, the stylet extends from
the end cap through the lumen of the needle, the end cap
including a clip mechanism for gripping a distal portion of the
stylet when the end cap is decoupled from the needle, the clip
mechanism including a space through which the distal end of
the stylet may pass substantially parallel to the proximal end
thereof.
(Spec. 12.)
The Claims
Claims 1, 2, 4—9, and 13 are on appeal.* 2 Independent claim 1
representative and reads as follows (emphasis added):
1. A device for storing a stylet comprising:
a stylet', and
an end cap selectively coupleable to a proximal end of
a needle, the end cap being coupled to a proximal end of the
sty let so that, when the end cap is coupled to the needle, the
sty let extends from the end cap through a lumen of the
needle; the end cap including a clip mechanism for gripping
a distal portion of the stylet when the end cap is decoupled
from the needle, the clip mechanism including a space
through which the distal portion of the sty let may pass
substantially parallel to the proximal end of the stylet.
2 Appellants indicate that “[cjlaims 3, 10—12 and 14—17 have been
withdrawn from consideration” (App. Br. 2).
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Application 12/633,483
The Issues
A. The Examiner rejected claims 1, 2, 4—9, and 13 under 35 U.S.C.
§ 103(a) as obvious over Anderson,3 Wada,4 and Ogawa5 (Ans. 3—6).
B. The Examiner rejected claims 1, 2, and 4—8 under 35 U.S.C. § 103(a)
as obvious over Anderson and Ogawa (Ans. 6—10).
We affirm rejection A. We vacate rejection B as cumulative to
rejection A.
35 U.S.C. § 103(a) over Anderson, Wada, and Ogawa
The Examiner finds that Anderson teaches
a device for storing a stylet comprising inter alia:
a stylet (120); and
an end cap (160) selectively coupleable to a proximal end of
a needle (32), the end cap being coupled to a proximal end of
the stylet (the proximal end of the guidewire 120 is attached
to an end cap 160, paragraph 0088) so that, when the end cap
is coupled to the needle, the stylet extends from the end cap
through a lumen of the needle, where the end cap is capable
of being decoupled from the needle (Fig. 14),
the end cap is formed integrally with the stylet (Fig. 14);
where the stylet is sized and shaped for insertion into a lumen
of a needle (note the stylet has a size and shape, therefore, it
is capable of being inserted into a lumen of a needle);
where the needle is adapted for aspiration (note the needle has
an interior space, therefore, it is adapted for aspiration via the
interior space).
(Ans. 3^4.)
3 Anderson et al., US 2008/0262430 Al, published Oct. 23, 2008.
4 Wada, WO 99/47202, published Sep. 23, 1999.
5 Ogawa et al., JP 11-76416 A, published Mar. 23, 1999.
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Application 12/633,483
The Examiner acknowledges that
Anderson discloses the claimed invention . . . except for:
where the end cap includes a clip mechanism for gripping a
distal portion of the stylet when the end cap is decoupled from
the needle, the clip mechanism including a space through
which the distal portion of the stylet may pass substantially
parallel to the proximal end of the stylet;
where the clip mechanism comprises a slot formed in the cap,
the slot sized and shaped to frictionally engage the stylet;....
(Id. at 4.)
The Examiner turns to Wada and finds that it teaches
an end cap that (54) includes a clip mechanism for gripping a
distal portion of the stylet, the clip mechanism including a
space (58) through which the distal portion of the stylet may
pass substantially parallel to the proximal end of the stylet;
where the clip mechanism comprises a slot formed in the cap
(58), the slot sized and shaped to frictionally engage the
stylet;
where the edges of the slot are flexible to permit deformation
as the stylet is inserted into the slot, where the slot is formed
between two walls extending through a thickness of the end
cap from a proximal face of the end cap to a distal face of the
end cap (Figs. 3A—3C) (Fig. 4) (Figs. 8A— 8C) (Figs. 10A—
10C) (and various other embodiments); ....
(Id. at 4—5.)
The Examiner concludes that it would have been obvious to
modify the end cap of Anderson with the clip mechanism as
Wada teaches in the abstract of the WO 99/47202 that such
configuration would be for storage of the stylet and Ogawa
further teaches in the Abstract that such configuration would
have kept the stylet held in a wound configuration.
Furthermore, a skilled artisan at the time the invention was
made would have found notoriously obvious that such clip
mechanism would have been an advantageous combination as
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Application 12/633,483
it is well known in the art that such combination would have
provided organization, control and a storage solution for the
stylet.
(Id. at 5—6.)
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Anderson, Wada, and Ogawa render
the claims prima facie obvious?
Findings of Fact
1. The Specification teaches that “[t]he end cap . . . includes a
stylet. . . formed, for example, as a flexible wire sized to slidably pass
through the lumen . . . and to seal a distal opening in the needle” (Spec. 1 6).
2. Anderson teaches
An access device places a medical article within a body space
of a patient. The device has a needle that includes a needle
body and hub. The device further includes a dilator coaxially
disposed and slideable over the needle body and a medical
article. . . . The device can further include a guide wire and
an interlock between the guidewire and the needle and/or
dilator.
(Anderson Abstract; see also Ans. 3—4.)
3. Figure 14 of Anderson is reproduced below:
54
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Application 12/633,483
Figure 14 shows “an interlock between the guidewire 120 and the needle
hub 21,” in which “[t]he proximal end of the guidewire 120 is attached to an
end cap 160,” and engages with “dilator hub 32,” and “needle body 22” (see
Anderson | 88; see also id. at Fig. 1; Ans. 3^4).
4. Figure 4 of Wada is reproduced below:
Wada teaches
A catheter connector (52), wherein the proximal end of a
guide wire, a part of or an accessory to a catheter, and storing
recesses (58) into which a part of a protection tube is
detachably fitted are formed between a plurality of flexibly
deformable flexible pieces (54) integrally formed with a hub
provided at the proximal end of the catheter to be inserted into
the human body and having holes as cast constituting the
catheter. A balloon catheter, wherein storing recesses into
which the proximal end of a monorail-type (quickly
interchangeable) guide wire exposed from a catheter opening
is detachably fitted are formed in a catheter connector
provided at the proximal end of a catheter tube.
(Wada Abstract; see also Ans. 4—5.)
FIG. 4
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Application 12/633,483
5. Figure 4 of Ogawa is reproduced below:
Ogawa teaches how “[t]o keep a medical wire in a wound ring condition by
providing a means gripping a wire part of the medical wire” (Ogawa
Abstract; see also id. at Figure 5; Ans. 5—6).
Principles of Law
“[CJlaims in an application are to be given their broadest reasonable
interpretation consistent with the specification and that claim language
should be read in light of the specification as it would be interpreted by one
of ordinary skill in the art.” In re Sneed, 710 F.2d 1544, 1548 (Fed. Cir.
1983).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 3—17; FF 1—5) and agree that claim 1
would have been obvious over Anderson, Wada, and Ogawa. We address
below Appellants’ arguments.
We begin with claim interpretation, since before a claim is properly
interpreted, its scope cannot be compared to the prior art. The limitation in
dispute is the requirement for “a stylet” as required by claim 1 (see App. Br.
4, Ans. 10-11).
Appellants contend that “the guidewire . . . does not constitute a
stylet” (App. Br. 6).
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Application 12/633,483
The Examiner contends that
[a] guidewire, especially in the medical art, is a stylet unless
otherwise stated or claimed. Both structures include long,
small and generally circular cross-sectional devices that are
navigated inside and outside the human body. Unless the
claim states otherwise, a guidewire is a stylet and vice versa.
The claim sets forth no additional structure defining the stylet.
Since both devices are so similar in the medical field, a stylet
is a guidewire.
(Ans. 10-11.)
We find that the Examiner has the better position.
The Specification does not appear to provide an explicit definition for
“a stylet.” The Specification does teach, however, that “[t]he end cap . . .
includes a stylet. . .formed, for example, as a flexible wire sized to slidably
pass through the lumen . . . and to seal a distal opening in the needle” (FF 1
(emphasis added)).
We conclude that the broadest reasonable interpretation of the term “a
stylet” in claim 1, consistent with the Specification, is a device, such as a
flexible wire, sized to slidably pass through a lumen.
We next turn to Appellants’ arguments.
Appellants contend that “Anderson does not show or suggest a stylet,
as required by the recited claim. Rather, Anderson discloses a guidewire for
guiding a needle therealong” (App. Br. 4; see also Reply Br. 3).
We are not persuaded. Because we concluded that a flexible wire is a
species of “stylet”, sized to slidably pass through a lumen, we agree with the
Examiner that “the stylet, especially as broadly claimed, reads on the
guidewire of Anderson” (Ans. 10).
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Application 12/633,483
Appellants argue that
it would not have been obvious to one of ordinary skill in the
art to have modified the end cap 160 of Anderson with the
storing recesses 58 of Wada as the end cap 160 of Anderson
and the connector 50 of Wada are used for vastly different
purposes and Wada explicitly teaches away from passing a
distal portion of a stylet through the storage recesses 58, when
the stylet is decoupled from the needle. Furthermore, neither
reference provides any motivation for the proposed
modification.
(App. Br. 5; see also Reply Br. 3.)
We are not persuaded. We find Appellants’ arguments, lacking
supporting evidence, insufficient to rebut the express teaching of Wada (FF
4 (“the proximal end of a guide wire, a part of or an accessory to a catheter,
and storing recesses (58) into which a part of a protection tube is detachably
fitted”)). See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997)
(“[Attorney argument [is] not the kind of factual evidence that is required to
rebut a prima facie case of obviousness”). Wada does not discredit, criticize,
or disparage the claimed stylet, or guidewire, but instead suggests that
“storing recesses into which the proximal end of a monorail-type (quickly
interchangeable) guide wire exposed from a catheter opening is detachably
fitted are formed in a catheter connector provided at the proximal end of a
catheter tube” (FF 4 (emphasis added)). Like our appellate reviewing court,
“[w]e will not read into a reference a teaching away from a process where no
such language exists.” DyStar Textilfarben GmbH & Co. Deutschland KG
v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006).
Appellants contend that
a stylet is understood by those of skill in the art as an element
positioned within a needle to occlude a distal opening thereof
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Application 12/633,483
to prevent non-targeted tissue from entering the lumen as the
needle is inserted through tissue to a target area. See
Specification, p. 1,1 [0001] andp. 4, | [0007]. The guidewire
120 [of Anderson] is not shown or suggested as being inserted
into the needle body 22 to keep the needle clear of debris
during insertion and, it is submitted that this function is totally
irrelevant to the device of Anderson. Indeed, the guidewire
120 is inserted through the needle body 122 after the needle
body 122 has been inserted into the body to a target l[o]cation
act as a guide for later inserted devices such as the dilator 30.
It is immaterial to the device of Anderson what tissue enters
the needle body 122 as any tissue therein is forced out as the
guidewire 120 is passed through the needle body 122 and this
tissue is of no interest in any case.
(App. Br. 5—6; see also Reply Br. 4—5).
These arguments are unpersuasive. Claim 1 does not require the stylet
to be positioned within a needle to occlude a distal opening thereof to
prevent non-targeted tissue from entering the lumen as the needle is inserted
through tissue to a target area, or that the stylet to be inserted into a needle
body to keep the needle clear of debris during insertion. “[L]imitations are
not to be read into the claims from the specification.” In re Van Geuns, 988
F.2d 1181, 1184 (Fed. Cir. 1993). See also In re Self, 671 F.2d 1344, 1348
(CCPA 1982) (“[A]ppellanf s arguments fail from the outset because ... they
are not based on limitations appearing in the claims.”). Moreover, Anderson
teaches that “[t]he device has a needle that includes a needle body and hub”
(FF 2), and that “the guidewire 120” engages with “dilator hub 32,” and
“needle body 22” (FF 3).
We recognize, but are not persuaded by, Appellants’ contention that
[e]ven if this guidewire were considered comparable to a
stylet, it is respectfully submitted that it still would not have
been obvious to have modified the end cap 160 of Anderson
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Application 12/633,483
to include a storage recesses 58 of a hub 54 of Wada, as
suggested by the Examiner. Specifically, while the end cap
160 of Anderson is used to connect a proximal end of a guide
wire to a proximal end of a needle in which the guide wire is
inserted, the connector 50 of Wada is in no way intended to
fix a balloon catheter 6, to which it is connected, within a
lumen of any other device. Rather, the connector 50 of Wada
is specifically designed only to store accessories (e.g.,
protective tube, guidewire) that maybe utilized with the
balloon catheter 6. See Wada, Abstract.
(App. Br. 6; see also Reply Br. 5—6.) As the Examiner explains,
[t]he Examiner has in no way attempted to incorporate the
balloon catheter of Wada with the device of Anderson. All
that is being modified is the end cap of Anderson with the
storage recess of Wada (and not the addition of a balloon
catheter). The storage recess of Wada, if added to the end cap
of Anderson, would have absolutely been a modification
performed by one of ordinary skill because one of skill in the
art would have found it obvious to modify the end cap of
Anderson with the storage recess of Wada as Wada teaches in
the abstract that such configuration would be for storage of
the stylet (of which the Examiner has already shown that a
stylet and a guidewire may be considered the same device
and/or be used interchangeably and/or as claimed, are the
same device). Ogawa further teaches in the Abstract that such
configuration would have kept the stylet held in a wound
configuration. Furthermore, a skilled artisan at the time the
invention was made would have found notoriously obvious
that such clip mechanism would have been an advantageous
combination as it is well known in the art that such
combination would have provided organization, control and a
storage solution for the stylet.
(Ans. 13; FF 4—5.)
We recognize, but are not persuaded by, Appellants’ contention that
Wada teaches that the recesses 58 must be formed in an
elastically deformable disk-shaped hub 54 so that the disk 54
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Application 12/633,483
may be deformed via pressure on the wing shaped ends of the
disk 54 to remove a protective tube 64 or guidewire 42 housed
within the recesses. Id. at | [0045] and 1 [0046]. It is unclear
how such an elastically deformable disk shaped member
would be incorporated in the end cap 160 of Anderson.
(App. Br. 6—7; see also Reply Br. 6.) As the Examiner explains,
it appears the Appellant is reading additional elements of the
Wada reference into the combination of Anderson and Wada.
Essentially, the Appellant[’]s arguments [are] not
commensurate in scope with the claimed invention. The
Appellant[has] only claimed an[] end cap and its various
interactions/placement with the other claimed components
and a clip mechanism. The claims lack any claim[ed
limitations] to elastic deformity and disk shapes. A skilled
artisan could have quite easily modified the end cap of
Anderson with the clip mechanism of Wada because the clip
mechanism would have been helpful in organizing and
storing the stylet. To make two pieces a unitary piece in the
art only involves routine skill in the art. Furthermore, clip
mechanism of Wada appears to be attached to a device quite
similar to the end cap of Anderson (same general shape).
(Ans. 14.) See In re Van Geuns, 988 F.2d at 1184 and In re Self, 671 F.2d at
1348.
Appellants argue that “Wada explicitly teaches away from receiving a
distal portion of a guidewire when the guidewire is decoupled from a needle,
as required by the recited claim” (App. Br. 7).
We are not persuaded for the reasons discussed above (see also Ans.
14—15).
We recognize, but are not persuaded by, Appellants’ contention that
Ogawa
does not cure the deficiency of Anderson in view of Wada. In
particular, Ogawa teaches a device for imparting torsional
force to a medical wire and does not show or suggest an end
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Application 12/633,483
cap connected to a proximal end of a sty let so that the end
cap is selectively coupleable to a proximal end of a needle
with the sty let extending through a lumen of the needle.
(App. Br. 8.) As the Examiner explains,
[i]n no way is the Examiner replying on Ogawa for teaching
an end cap connected to a proximal end of a stylet so that the
end cap is selectively coupleable to a proximal end of a needle
with the stylet extending through a lumen of the needle. It is
noted that the Examiner has relied on the Anderson reference
to disclose the argued claim limitations, therefore the
Examiner is not using the Ogawa reference to disclose such
limitations. The Examiner applied to Ogawa reference to
provide further support for a combination of Anderson and
Wada, where Ogawa teaches a wound configuration that
would keep a stylet in a configuration for storage.
(Ans. 15.) “Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references []. [The reference] must be read, not in isolation,
but for what it fairly teaches in combination with the prior art as a whole.”
In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
We thus affirm the rejection of claim 1. Because Appellants argue the
claims together, claims 2, 4—9, and 13 fall with claim 1.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over Anderson, Wada, and Ogawa. Claims 2, 4—9, and
13 fall with claim 1.
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We vacate the rejection of claims 1, 2, and 4—8 under 35 U.S.C.
§ 103(a) as obvious over Anderson and Ogawa, as cumulative to the
rejection of claims 1, 2, 4—9, and 13 under 35 U.S.C. § 103(a) as obvious
over Anderson, Wada, and Ogawa.
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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