Ex Parte Chen et al

Patent Trial and Appeal Board

Sep 26, 2016

13078745 (P.T.A.B. Sep. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/078,745 04/01/2011
121974 7590 09/28/2016
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
Hancun Chen
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.
7313982001 8226
EXAMINER
YABUT,DIANED
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
09/28/2016 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):
kddocketing@cpaglobal.com
Docketing@kdbfirm.com
bbonneville@kdbfirm.com
PTOL-90A (Rev. 04/07)
L11'-~ITED ST ATES PATENT AND TRADE~'v1ARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HAN CUN CHEN and RICHARD MURPHY
Appeal2015-000802
Application 13/078,745 1
Technology Center 3700
Before LYNNE H. BROWNE, LISA M. GUIJT, and MARK A. GEIER,
Administrative Patent Judges.
GUIJT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134 of the Examiner's
decision,2 rejecting claims 1-5 and 20-22 under 35 U.S.C. § 103(a) as
unpatentable over Shireman (US 7,316,656 B2; iss. Jan. 8, 2008), Bosley (US
1 Appellants identify Boston Scientific Scimed, Inc. as the real party in interest.
App. Br. 3.
2 Appeal is taken from the Final Office Action dated March 21, 2014 ("Final
Act.").
Appeal2015-000802
Application 13/078,745
5,514,176; iss. May 7, 1996), and Jayaraman (US 2007/0239199 Al; pub. Oct. 11,
2007). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM and designate our affirmance as containing NEW GROUNDS
OF REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b).
CLAIMED SUBJECT MATTER
Claim 1 is the sole independent claim on appeal. Claim 1 is reproduced
below as illustrative of the claims on appeal.
1. An occlusive device, comprising:
a coil having a proximal end and a distal end, the coil comprising
a helically wound elongated member having a core and an outer layer,
the outer layer being made from a metal or alloy, and having a stiffness3
that is different from a stiffness of the core, the coil having a primary
structure characterized by a constant diameter and a first stiffness at the
proximal end, a second stiffness at the distal end, and a third stiffness
at a point between the proximal and distal ends, wherein
(a) the first stiffness is less than the second stiffens; and
(b) the third stiffens is greater than the first stiffness and less
than the second stiffness.
ANALYSIS
Regarding independent claim 1, the Examiner finds, inter alia, that
Shireman discloses "a vaso-occlusive device" comprising coil 590 having proximal
and distal ends, and a primary structure characterized by a constant diameter, and
comprised of a helically wound elongated member having a core 510 and an outer
layer 511 made from a metal or alloy. Final Act. 2-3 (citing Shireman 16:21-25,
37-39, Fig. 14). The Examiner determines that although Shireman does not
3 An ordinary meaning of the claim term "stiffness," in view of the Specification,
is "rigidity" (WEBSTER'S THIRD NEW INT'L DICTIONARY 2242 (1993)), wherein
"rigid" means "very firm rather than pliant in composition or structure: lacking or
devoid of flexibility." Id. at 1957.
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Application 13/078,745
"expressly disclose" outer layer 511 having a different stiffness than core 590, as
required by claim 1, Shireman discloses that outer layer 511 and core 510 may be
made from different materials, and more specifically, that the outer layer may be
made of tungsten and the core of nitinol, which has a lower elastic modulus
relative to tungsten, such that Shireman's device "appears" to meet the claim
limitation that the outer layer has a stiffness that is different from a stiffness of the
core. Id. at 3, 4 (citing Shireman 16:8-39). The Examiner further finds that
Shireman discloses that a pitch of coil 590 at the coil' s distal end may be different
than the pitch at the coil's proximal end. Id. at 3 (citing Shireman 16:56-64).4
The Examiner also determines that although Shireman does not "expressly
disclose" the coil having a first stiffness at the proximal end that is less than a
second stiffness at the distal end, and a third stiffness at a point between the
proximal and distal ends that is greater than the first and less than the second
stiffnesses, Jayaraman teaches a vascular coil having the claimed stiffnesses due to
different pitches along the length of the coil. Id. at 4--5 (referencing the
Examiner's Annotated Jayaraman Fig. 3). The Examiner reasons that it would
have been obvious to modify Shireman's coil, as taught by Jayaraman, because
Shireman "acknowledge[ s] that the pitch may 'vary, depending upon the desired
characteristics, for example, flexibility' ... and [in] order for the stiffer regions to
facilitate steering and the more flexible regions to facilitate bending through
tortuous vasculature." Id.
First, Appellants argue that "Shireman is devoid of any teaching or
suggestion of the use of a coil as a vaso-occlusive device." App. Br. 7; see also
4 The Examiner additionally relies on Bosley for an express disclosure that the
core is stiffer than the outer layer of the coil, and also for expressly disclosing
limitations recited in the dependent claims. See Final Act.
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Application 13/078,745
Reply Br. 3---6. The Examiner responds that Shireman discloses that Shireman's
device "'may be applicable to a variety of medical devices', including ... 'embolic
protection devices."' Ans. 2 (citing Shireman 3: 12-21 ). Appellants reply that
"[ v Jaso-occlusive devices ... block the flow of blood through a vessel ... via the
formation of an embolus," as compared to Shireman's embolic protection devices
that "avoid formation of an embolus." Reply Br. 5; see also Spec. i-f 3. Appellants
submit that, regarding the claimed occlusive device, "a stiffer distal region allows
the occlusive device to better anchor against the wall of a vessel or aneurysm,
whereas softer proximal sections are provided to improve packing inside the vessel
or aneurysm because the proximal sections may be bent more easily" (Reply Br. 9
(citing Spec. ,-r 24)), and that "such advantages would have no significance vis-a-
vis the distal end of a guidewire or other medical device that [] is adapted to be
advanced into the anatomy of a patient" (id.).
Although Shireman discloses that "Figure 14 [depicts an] example coil 590
that can be used in medical devices, such as guidewires," Appellants are con-ect in
that Shirernan does not explicitly disclose "[a]n occlusive device~ comprising[] a
coil;" as recited in claim 1. I-iowever, Shireman discloses a coil disposed about a
portion of guidewires sections 14/ 16 of Shireman' s medical device (Shireman
15:5----7\ and teaches that the device may be applicable to a variety of medical
devices (Ans. 2 (citing Shireman 12----21). l\lloreover, J ayaraman discloses that
vasooclusive devices are known to have coil portions and further that Jayaraman's
device may be used as a filler. Jayaraman i-fi-1 80, 119. Therefore, one skilled in the
art would understand that the coil in Shireman's guidewire device may be
modified, as proposed by the Examiner, for use as an occlusive device, as claimed.
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Application 13/078,745
J\1oreover, notwithstanding such lack of explicit disclosure in Shireman, the
term "occlusive device" appears only in the preamble of the appealed claims and
provides only an intended use for the claimed coil; therefore, as discussed il1j1·a, we
decHne to give the prearnbie tenn "occlusive device" any patentable weight "In
general, a preamble limits the invention if it recites essential structure or steps, or if
it is 'necessary to give life, meaning, and vitality' to the claim." Catalina Mktg.
Int'!., Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (citing
Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999))
(emphasis added). "Conversely, a preamble is not limiting 'where a patentee
defines a structurally complete invention in the claim body and uses the preamble
only to state a purpose or intended use for the invention."' Id. (citing Rowe v.
Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). The court in Catalina noted that
although no litmus test exists for determining whether to treat a preamble as a
limitation, several "guideposts" have emerged from the case lmv in this area. id.
In paiiicular, guideposts tending to show that the preamble is a claim limitation
include: Jepson claiming, dependence on a particular disputed prearnble phrase for
antecedent basis, when the preamble is essential to understand limitations or terms
in the claim body, and when the preamble recites additional structure or steps
underscored as important by the specification. ld. On the other hand, guideposts
tending to show that the preamble is not a claim limitation include: when the claim
body describes a structurally complete invention such that deletion of the preamble
phrase does not affect the stmcture or steps of the claimed invention, and when the
preamble describes the use of an invention. Id. at 809.
Neither the Appellants nor the Examiner directly address the issue of
whether the term "occlusive device" in the preamble should be given patentable
weight. In the claims before us, the occlusive device itself is not paii of the
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Application 13/078,745
claimed invention; rather, the claims are limited to a coil fi..)r use in an occlusive
device and the limitations in the body of the claim define a stn1cturally complete
invention. \Ne understand that an occlusive device, by definition, is intended to
obstruct, however, this definition provides no further constraints cm the specifics of
the coH itself, other than that 1t must be a stn1cture capable of obstructing. Further,
we detennine that Appellants' contention that the variable stiffness of the coil
provides advantages when the coil is used as an occlusive device that are not
realized when the coil is used in other medical devices (such as a guidewire
device) does not require the term "occlusive device" to be given patentable weight,
because the structural variability of the stiffness of the coil is wholly recited in the
body of the claim, and the advantages pertain solely to the intended use rather than
the structure of the coil. Finally, deletion of the term "occlusive device" from the
claim does not affect the structure of the claimed invention. Because we ascribe no
patentable weight to the term "occlusive device" in the preamble of claim 1, the
Examiner's erroneous finding that Shireman discloses the use of Shireman's coil in
or as an occlusive device has no relevance as to whether the claimed invention is
unpatentable over the Examiner's proposed combination. 5• 6
Second, Appellants state that "Shireman does not appear to discuss changes
in stiffness along a length of coil as being pertinent to any characteristic, much less
5 Use of the transitional phrase "comprising" does not exclude the claimed coil
from being one of many structures comprising the occlusive device; in other
words, Shireman's coil may meet the limitations of claim 1 even though
Shireman' s coil is described as one structure of an elongated medical device rather
than as the device itself.
6 For the same reasons, we are not persuaded by Appellants' arguments that
neither Bosley nor Jayaraman disclose "a vaso-occlusive coil," or an occlusive
device, or even "an occlusive device comprising a coil." See App. Br. 8, 9; see
also Reply Br. 6, 9.
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having to do with tradeoff between coil flexibility and coil stiffness with regard to
pushability and torqueability." App. Br. 8; see also Reply Br. 5---6, 8. We
disagree. Shireman discloses that, with respect to the coil, "the pitch can be
constant throughout the length of the coil[], or can vary, depending upon the
desired characteristics, for example flexibility" (or stiffness) (Shireman 16: 56-58
(emphasis added)), and also that
[b ]ecause the anatomy of a patient may be very tortuous, it is desirable
to combine a number of performance features in [elongated medical
devices]. For example, it is sometimes desirable that the device have
relatively high level of pushability and torqueability, particularly near
its proximal end. It is also sometimes desirable that a device be
relatively flexible, particularly near its distal end.
Shireman 1: 18-24 (emphasis added). Thus, Shireman supports the Examiner's
findings, because Shireman discloses that changes in the pitch along the length of
coil effects the resulting flexibility (or stiffness) of the coil, and also that the
flexibility (or stiffness), which is effected by the coil' s pitch, may be chosen
according to desired performance features, such as pushability and torqueability.
Third, Appellants argue that
Shireman and Bosley are not "in the same field of endeavor," nor would
there be any reason absent impermissible hindsight, to employ a
structure from a coil whose adjacent loops can be pulled apart for
removing a stent from the body lumen as taught by Bosley, in order to
provide a coil that has enough stiffness in order to facilitate pushability
of a guidewire through a tortuous body lumen.
App. Br. 8-9.
We determine that a preponderance of the evidence supports the Examiner's
finding that Shireman inherently discloses "an outer layer ... having a stiffness
that is different from a stiffness of the core," as required by claim 1. As disclosed
in the Specification,
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Application 13/078,745
core 30 may be made from a metal, such as pure platinum, and the outer
layer 32 may be made form an alloy, such as platinum-tungsten alloy ..
. . The mechanical strength of pure platinum is about 1/3 of the
platinum-tungsten alloy. Thus, the softer platinum core 30 may provide
a softer coil (e.g., for a given cross sectional dimension of the elongated
member 14) and may provide memory property for shape retention.
Spec. i-f 15. Shireman discloses that "coil 590 includes an inner portion, layer or
wire 510 [(or core)] that includes or is made of a first material, and an outer
portion, layer or wire 511 that includes or is made of a second material." Shireman
16:32-35, Fig. 14. Shireman more specifically discloses that "inner portion 510
could be a wire or ribbon as discussed above," referring to the disclosure that "coil
80 may be made of a variety of materials including made of metals, metal alloys,
polymers, and the like," and "outer portion 511 could be a coating, cladding,
plating, or extrusion of radiopaque material or an MRI compatible imaging
material," which are described as "gold, platinum, tungsten, or the like, or
combinations or alloys thereof, or polymer materials." Id. 16:8-12, 32--49, Fig. 14.
Further, Shireman generally discloses that "[sections] formed of different materials
(i.e., materials having different moduli of elasticity) result[] in a different in
flexibility." Id. at 8:6-9. Thus, Shireman discloses that one possible combination
for the construction of coil 590 is a pure metal coated with a platinum alloy outer
layer, such that the outer layer would inherently have a stiffness that is different
from a stiffness of the core. The Examiner's additional reliance on Bosley for an
express disclosure of this claim limitation is unnecessary.
Fourth, Appellants argue that "the problems encountered[] and addressed
[by Jayaraman's] filter coils are not pertinent to those encountered with a coiled
portion of a device such as a guidewire," as disclosed in Shireman, and that "one of
ordinary skill in the art would not look to ... Jayaraman to modify the coiled
device of Shireman." App. Br. 10-11. The Examiner responds that Jayamaran
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Application 13/078,745
"acknowledges providing the necessary combination of flexibility and stiffness
(rigidity) in a coil which enhances its ability to retain its shape and to navigate
through tortuous regions," and thus, both Shireman and Jayamaran are concerned
with "imparting the combination of flexibility and stiffness to a coil that is
advanced through tortuous body lumens." Ans. 4 (citing Jayaraman i-f 123).
We are not persuaded by Appellants' argument, because we know of no
requirement that the prior art references must be pertinent to the same problems to
be combinable by the Examiner. The relevant inquiry is whether the Examiner has
set forth "some articulated reasoning with some rational underpinning to support
the legal conclusion of obviousness." In re Kahn, 441F.3d977, 988 (Fed. Cir.
2006) (cited with approval in KSR Int'! v. Teleflex Inc., 550 U.S ...... at 418).
Shireman discloses a coil having a first stiffness at the proximal end and a
second stiffness at the distal end, as recited in claim 1. Shireman 16:63-64 ("a
larger pitch can be achieved on the distal portion of the coil 80"). Moreover,
Shireman discloses that "[t]he diameter of the coil 80 can be constant or tapered."
Shireman 17:6-7. Also, as noted supra, Shireman discloses that "[t]he pitch ...
throughout the length of the coil ... can vary[] depending upon the desired
characteristics, for example flexibility." Id. at 16:56-58 (emphasis added). In
other words, Shireman discloses to one skilled in the art that the pitch of the coil
may be varied along the length of the coil depending upon the desired flexibility
along the length of the coil in accordance with performance requirements (i.e., use
of the coil). Similar to Shireman's disclosure of a tapered coil (Shireman 17:6-7),
the Examiner relies on Jayaraman for depicting a coil that has a pitch that
gradually increases along the length of the coil, such that Jayaraman expressly
discloses pitches that result in the first, second, and third stiffnesses as recited in
claim 1. See Final Act. 4; Jayaraman, e.g., Fig. 3; see also Jayaraman i-f 9 ("the
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Application 13/078,745
loops can form a substantially conical coil having a variable pitch"). Jayaraman
further discloses that "the coils may be right-handed or left-handed spirals," such
that either the proximal or distal ends (or opposing ends) may have the greatest or
least stiffness (or flexibility). Jayaraman i-f 85. The Examiner reasons that it would
have been obvious to provide Shireman' s coil with the gradually increasing pitch
taught by Jayaraman "to facilitate steering ... and bending through tortuous
vasculature." See, e.g., Shireman 1:15-30, 16:56-58. Appellants' argument does
not apprise us of errors in the Examiner's findings, which supports the Examiner's
reasoning, or explain why the Examiner's rationale does not support the conclusion
of obviousness, in that the combination of features of the claimed coil would be
obvious in view of the teachings of Shireman and J ayaraman. Although J ayaraman
refers to the material properties of a multilayered wire as effecting flexibility,
rather than referring to pitch along the coil' s length as in Shireman, contrary to
Appellants' contention, Jayaraman is concerned with the same problem as
Shireman: "facility[ ating] the navigation of the device through tortuous
anatomical regions," as correctly noted by the Examiner. See Jayaraman i-f 123.
Fifth, Appellants argue that "the coil in Jayaraman [is] conic whereas the
coil in Shireman is cylindrical, and Jayaraman says nothing about varying the
stiffness of the coil along the length of the coil or that the stiffness may be varied
by varying the pitch of the conic." App. Br. 11. Appellants further argue that
"even assuming ... one of ordinary skill in the art were to modify the device of
Shireman to include features of the conical coil of Jayaraman, the result would not
be in accordance with the claimed invention, which requires an occlusive device
having a helically wound coil of constant diameter." App. Br. 11-12. The
Examiner correctly responds that "Jayaraman is not relied upon to teach a coil of
constant diameter, but rather ... Shireman discloses a coil 590 ... of constant
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Application 13/078,745
diameter along it length" (Ans. 5; see Shireman 17:6-7), and as discussed supra,
Shireman also discloses that varying the pitch effects the flexibility or stiffness of
the coil and may be selected according to use. As also explained supra, the claim
term "occlusive device" in the preamble is not given patentable weight. Thus, we
are not apprised of error in the Examiner's findings or reasoning.
Sixth, Appellants argue that the Examiner relied on impermissible hindsight
"to modify the cylindrical guidewire coil of Shireman based on the conical coil
disclosed in Jayaraman." App. Br. 11. However, Appellants do not identify any
knowledge that the Examiner relied upon that was gleaned only from Appellants'
disclosure and that was not otherwise within the level of ordinary skill at the time
of the invention. See In re McLaughlin, 443 F.2d 1392 (CCPA 1971).
For the first time in the Reply Brief, Appellants argue that "the change in
pitch discussed in Shireman involves the creation of a larger pitch (and thus a
lower stiffness) at the distal portion of the coil,[] whereas [claim 1 requires] the
stiffness of the coil is lowest at the proximal end and highest at the distal end."
Reply Br. 9. Appellants submit that
[ w] ith regard to an occlusive device as claimed, a stiffer distal region
allows the occlusive device to better anchor against the wall of a vessel
or aneurysm, whereas softer proximal sections are provided to improve
packing inside the vessel or aneurysm because the proximal section
may be bent more easily .... However, such advantages would have no
significance vis-a-vis the distal end of a guidewire or other medical
device that [] is adapted to be advanced into the anatomy of a patient.
Id. Although Appellants have not shown good cause as to why this argument was
not presented in the Appeal Brief (see 37 C.F.R. § 41.41(b )(2)), we determine that
the ends of the coil disclosed in Shireman may be characterized as either proximal
or distal, because claim 1 does not exclude such a characterization by establishing
that the proximal end is situated nearer to any structure than the distal end.
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Application 13/078,745
Moreover, we determine that it would be within the knowledge of one of ordinary
skill in the art to modify a coil as disclosed by Shireman to gradually increase the
pitch, as taught by J ayaraman, along the length of the coil from the proximal end to
the distal end, or alternatively, from the distal end to the proximal end, depending
upon the desired flexibility of the coil. As stated supra, Jayaraman discloses right
and left-handed conical coils.
Accordingly, we sustain the Examiner's rejection of independent claim 1.
Because our affirmance relies on determining that "occlusive device" is a term in
the preamble that is not entitled to patentable weight, we designate our affirmance
as a NEW GROUND OF REJECTION, to afford Appellants an opportunity to
address the rejection as articulated in this Decision. Appellants chose not to
present separate arguments for the patentability of dependent claims 2-5 and 20-
22. App. Br. 12. Therefore, we also sustain the Examiner's rejection of dependent
claims 2-5 and 20-22.
DECISION
The Examiner's rejection of claims 1-5 and 20-22 under 35 U.S.C. § 103(a)
is affirmed, and we designate the affirmance as containing NEW GROUNDS OF
REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b). 37 C.F.R. §
41.50 provides "[a] new ground of rejection pursuant to this paragraph shall not be
considered final for judicial review". 3 7 C.F .R. § 41. 50(b) also provides that
Appellants, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION,
must exercise on of the following two options with respect to the new grounds of
rejection to avoid termination of the appeal as to the rejected claims:
( 1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected, or
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both, and have the matter reconsidered by the Examiner, in which event
the proceeding will be remanded to the Examiner.
(2) Request rehearing. Request that the proceeding be reheard under§
41.52 by the Board upon the same record ....
No time period for taking any subsequent action in connection with this
appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED; 37 C.F.R. § 41.50(b)
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