Ex Parte Spencer et al

Patent Trial and Appeal Board

Apr 5, 2017

13571552 (P.T.A.B. Apr. 5, 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.
13/571,552 08/10/2012 Steven Spencer 1001.2694101 3954
11050 7590 04/07/2017
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
ALEMAN, SARAH WEBB
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
04/07/2017 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):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEVEN SPENCER and RICHARD GUNDERSON
Appeal 2015-0041131
Application 13/5 71,5 522
Technology Center 3700
Before HUBERT C. LORIN, KENNETH G. SCHOPFER, and
AMEE A. SHAH, Administrative Patent Judges.
SCHOPFER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the Examiner’s Final
rejection of claims 1—12 and 14—20. We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM-IN-PART.
1 Our decision references Appellants’ Appeal Brief (“Appeal Br.,” filed
Aug. 15, 2014) and Reply Brief (“Reply Br.,” filed Feb. 20, 2015), and the
Examiner’s Answer (“Ans.,” mailed Dec. 22, 2014) and Final Office Action
(“Final Act.,” mailed Mar. 21, 2014).
2 According to Appellants, the real party in interest is Boston Scientific
SciMed, Inc. Appeal Br. 4.
Appeal 2015-004113
Application 13/571,552
BACKGROUND
According to Appellants, “the disclosure is directed to self-expanding
scaffolds with cutting elements mounted thereto and balloon catheters
insertable within the scaffold to radially expand the cutting elements against
a stenotic lesion.” Spec. 1,11. 10-12.
CLAIMS
Claims 1—12 and 14—20 are on appeal. Claim 1 is illustrative of the
appealed claims and recites:
1. A medical device assembly for incising a stenosis in a
blood vessel, the medical device assembly comprising:
a self-expanding scaffold configured to be expandable
from a first contracted configuration to a second expanded
configuration, the self-expanding scaffold being biased toward
the second expanded configuration;
a cutting element secured to the self-expanding scaffold
and extending radially outward therefrom;
a sheath having a lumen therein, the self-expanding
scaffold positionable in the lumen of the sheath in the first
contracted configuration;
an elongate member extending proximally from the self-
expanding scaffold through the lumen of the sheath;
an inflatable balloon mounted on a catheter slidably
disposed within the lumen of the sheath; and
a guidewire disposed within the lumen of the sheath;
wherein the self-expanding scaffold is constrained by the
sheath to maintain the self-expanding scaffold in the first
contracted configuration in the lumen of the sheath, and deployed
out of the lumen of the sheath to permit the self-expanding
scaffold to expand to the second expanded configuration.
Appeal Br. 32.
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Application 13/571,552
REJECTIONS
1. The Examiner rejects claims 1—3, 12, 14, and 17—19 under 35
U.S.C. § 103(a) as unpatentable over Sciver3 in view of Appling.4
2. The Examiner rejects claims 4—6, 15, and 20 under 35 U.S.C.
§ 103(a) as unpatentable over Sciver in view of Appling and
Uflacker.5
3. The Examiner rejects claims 8 and 9 under 35 U.S.C. § 103(a) as
unpatentable over Sciver in view of Appling and Lukic.6
4. The Examiner rejects claims 10 and 11 under 35 U.S.C. § 103(a)
as unpatentable over Sciver in view of Appling, Lukic, and
Stinson.7
5. The Examiner rejects claims 7 and 16 under 35 U.S.C. § 103(a) as
unpatentable over Sciver in view of Appling and Nott.8
DISCUSSION
Obviousness over Sciver and Appling
With respect to claim 1, the Examiner finds that Sciver teaches a
device for incising a stenosis including a self-expanding scaffold, a cutting
element, a sheath, an elongate member, and a guide wire as claimed. Final
Act. 2 (citing Sciver Figs. 2B, 3A, 3B; col. 3,11. 1—13; col. 4,11. 8—16). The
Examiner acknowledges that Sciver does not disclose an inflatable balloon
as claimed, but the Examiner finds that “Sciver does disclose that other
3 Sciver, US 6,036,708, iss. Mar. 14, 2000.
4 Appling et al., US 7,131,981 B2, iss. Nov. 7, 2006.
5 Uflacker et al., US 2006/0173487 Al, pub. Aug. 3, 2006.
6 Lukic et al., US 5,709,703, iss. Jan. 20, 1998.
7 Stinson, US 7,127,789 B2, iss. Oct. 31, 2006.
8 Nott et al., US 6,013,093, iss. Jan. 11, 2000.
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instruments ... are slidably disposed within the sheath and scaffold to aid in
removal of stenosed tissue.” Final Act. 2 (citing Sciver col. 3,11. 13—22; col.
5,11. 36—60). The Examiner further finds that Appling discloses an assembly
for incising stenosis including an expandable scaffold, cutting elements, a
tubular sheath, and an inflatable balloon. Final Act. 2—3 (citing Appling
Figs. 2A, 2B, 3A, 12; col. 8,11. 1—13; col. 11,11. 1—19). Also, the Examiner
finds and concludes:
Appling further teaches that the balloon may aid in properly
positioning cutting elements in certain situations wherein the
lumen of the lesion is too tight or small to allow space for the
wires to deploy (column 11, lines 40-50). As known in the art,
lesions exist in a wide range of sizes and shapes due to variances
in patient anatomy, health, and the particular medical condition.
In light of Appling’s teachings, one of ordinary skill in the art
would have found it obvious to combine a balloon catheter with
the Sciver assembly so that it is slidably disposed within the
sheath lumen, in order to enhance the ability of the cutting
elements to be properly deployed within a variety of lesions so
that its performance is optimized for different patient needs.
Final Act. 3.
We agree with and adopt the Examiner’s findings and conclusion
regarding Sciver and Appling with respect to claim 1. As discussed below,
we are not persuaded of reversible error by Appellants’ arguments.
Appellants first argue that there is no reason to add a balloon to
Sciver’s device because it would not aid in the removal of stenosed tissue.
Appeal Br. 11. In support, Appellants assert that outward radial expansion
in Sciver is limited to contacting a permanent stent and adding a balloon
would not allow for ease of expansion of the vessel because that purpose
cannot be achieved with the permanent stent. Id. We disagree and find that
the Examiner has provided sufficient reasoning to support the conclusion of
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obviousness. In particular, the Examiner not only finds that Appling teaches
the use of a balloon to ease expansion of a vessel but also that Appling
teaches the balloon aiding in positioning of cutting elements, which would
enhance the ability of cutting implements to be deployed. We are not
persuaded that Sciver’s teaching of a permanent stent would nullity the
proposed reasoning for the combination. In short, the Examiner has
identified certain advantages that may be obtained, as taught by Appling,
and we are not persuaded of any incompatibility between the relied-upon
teachings of Appling and the fact that Sciver discloses the use of a device
within a permanent stent. Finally, we agree with the Examiner’s response
that “[expanding a balloon to aid in expanding the scaffold (40) of Sciver
would aid in penetrating a stenosis (14) (Figure 3B of Sciver) that is resistant
or has a geometry preventing proper deployment of the scaffold.” Ans. 9.
Next, Appellants argue that adding a balloon to Sciver or substituting
a balloon for the other instruments in Sciver would render Sciver’s device
unsuitable for its intended purpose. Appeal Br. 12—13. In support,
Appellants first assert that pushing the scar tissue outward through the
permanent stent would not leave any tissue to be cut and removed. Id.
However, we agree with the Examiner’s response to this point. In particular,
“[o]ne of ordinary skill in the art would recognize the benefit of combining
the balloon taught by Appling with the Sciver scaffold to aid in expanding
the scaffold outwardly to fracture and/or cut a resistant stenosis, therefore
allowing the wires of the scaffold to penetrate into the thickness of the lesion
so that the step of removing the lesion with the screw (36) may be
performed.” Ans. 10. As such, the addition of the balloon as proposed by
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Application 13/571,552
the Examiner would aid in using Sciver’s device to remove tissue and would
not render it inoperable for that purpose.
Appellants also assert with respect to this argument that the addition
of the balloon would interfere with the other instruments provided in
Sciver’s device, e.g. the screw, coil, or ring. Appeal Br. 12. Along the same
lines, Appellants assert that the Examiner erroneously found that Sciver’s
instruments are separate from the scaffold and inserted into the vessel
separately. Id. 13. We also agree with the Examiner’s response to these
points. Specifically, one of ordinary skill in the art would have found it
obvious to deploy the balloon as needed in a separate step so as not to
interfere with the other instruments, and we consider any required
modification to Sciver’s device to implement the balloon as proposed to be
well within capabilities of a person of ordinary skill in the art. As the
Examiner states, “[bjalloon catheters exist in a wide variety of shapes and
sizes for various types of procedures and combinations with a wide range of
instruments, so one of ordinary skill in the art would have been capable of
configuring a balloon catheter for insertion within the sheath lumen.” Ans.
11.
Next, Appellants argue that Appling “fail[s] to teach a balloon
catheter disposed within the lumen of a sheath, where the sheath meets the
limitations of the pending claim(s)” and that Sciver also fails to teach this
configuration. Appeal Br. 13. One cannot show nonobviousness by
attacking references individually where the rejections are based on
combinations of references. See In re Keller, 642 F.2d 413, 426 (CCPA
1981); In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Here,
Appellants’ argument is unpersuasive because the Examiner does not rely on
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either Appling or Sciver individually to disclose the claimed balloon
disposed within the lumen of the sheath. Rather, the rejection relies on the
proposed combination for this element.
Finally, Appellants argue that “[tjhere has been no persuasive
evidence presented to show that the stent 40 of Sciver is in some way
inadequate for its stated purpose,” and thus, “there is no reason to make the
proposed modification, which appears to merely solve a problem that does
not exist, except for the teachings of Appellants’ own disclosure, reliance
upon which is clearly improper.” Appeal Br. 14. However, we agree with
the Examiner that “Sciver is not required to describe deficiencies of his own
device, as Appling is relied upon for providing motivation for the
combination by describing various benefits for expanding a cutting scaffold
with a balloon.” Ans. 12. Further, to the extent Appellants are arguing that
the rejection is based on hindsight, we see no indication that the rejection is
based on knowledge gleaned only from Appellants’ disclosure. See In re
McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971).
For these reasons, we are not persuaded of reversible error, and thus,
we sustain the rejection of claim 1.
Claim 2
With respect to claim 2, the Examiner maintains that “both Sciver and
Appling disclose [that] the scaffold defines a proximal opening providing
passage of a balloon catheter.” Final Act. 3. Appellants argue that “Sciver
fails to teach a balloon in conjunction with the disclosed cutting stent.”
Appeal Br. 14. However, we do not read the Examiner’s statement as a
finding that Sciver teaches a balloon as the rejection of independent claim 1
clearly acknowledges that Sciver does not disclose a balloon and relies on
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Appling for the balloon. Thus, we are not persuaded of error with respect to
claim 2 for this reason and the reasons discussed above with respect to claim
1.
Claim 3
With respect to claim 3, the Examiner finds that “the distal end of the
scaffold (40) of Sciver meet[s] the requirements of a distal tip, since it is
capable of allowing passage of a guidewire (30) and is coaxial with the
remainder of the scaffold (40).” Final Act. 3. Appellants argue:
One of ordinary skill in the art, having possession of the instant
application, would not recognize the distal end of the stent 40 of
Sciver as corresponding to the claimed distal tip. When properly
considered in view of the instant specification, Sciver fails to
teach the claimed distal tip. Similarly, Appling et al. fail to teach
an expandable scaffold includes a distal tip having a guidewire
lumen therethrough.
Appeal Br. 15. We are not persuaded because this argument fails to provide
any specific explanation as to why one of ordinary skill in the art would not
recognize that Sciver includes a distal tip as claimed. Accordingly, we
sustain the rejection of claim 3.
Claim 12
Appellants’ arguments with respect to independent claim 12 are
substantially the same as the arguments presented with respect to claim 1.
See Appeal Br. 15—19. We find those arguments equally unpersuasive with
respect to claim 12, and thus, we sustain the rejection of claim 12 for the
same reasons.
Claim 14
Appellants’ argument with respect to claim 14 is substantially the
same as the argument presented with respect to claim 3. See Appeal Br. 20.
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We are unpersuaded for the same reasons discussed above, and thus, we
sustain the rejection of claim 14.
Claims 17—19
With respect to independent claim 17, Appellants first present
arguments that are substantially the same as the arguments presented with
respect to claims 1 and 12. See Appeal Br. 20-24. We find those arguments
equally unpersuasive with respect to claim 17.
Additionally, Appellants argue that the Examiner erred in finding that
Appling discloses withdrawing the sheath to deploy the self-expanding
scaffold because Appling discloses only advancing the sheath distally
relative to the cutting elements to deploy them. Appeal Br. 24—25. We are
not persuaded of reversible error by this argument because the Examiner
also finds, and we agree, that “Sciver discloses the steps of advancing the
scaffold and withdrawing the sheath 38 so that it automatically expands.”
Final Act. 3 (citing Sciver Figs. 3A—B; col. 3,11. 1—12). Thus, we find that
the proposed combination of art renders the claimed withdrawing step
obvious, regardless of whether Appling individually teaches such a step.
Accordingly, we sustain the rejection of claim 17. We also sustain the
rejection of claims 18 and 19, for which Appellants do not provide separate
arguments. See Appeal Br. 25.
Obviousness over Sciver, Appling, and Uflacker
Claim 4 depends from claim 3 and further requires “wherein the
catheter includes a distal tip configured to contact the distal tip of the self­
expanding scaffold when the inflatable balloon is properly positioned within
the interior of the self-expanding scaffold.”
With respect to claim 4, the Examiner states:
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Appling teaches the concept of configuring the scaffold
(5) to define a distal tip that is contacted by the distal tip of the
balloon catheter (24) (see Figure 11). Uflacker discloses another
stenosis incising scaffold (12) configured to be positioned above
an expandable balloon (16) (see Figure 1 and 2). Uflacker
teaches a configuration wherein the balloon catheter (14) defines
a distal tip (21) that contacts a distal tip (20) of the scaffold when
the balloon is properly positioned within the scaffold (para 32).
It would have been obvious to one of ordinary skill in the art at
the time the invention was made to configure the scaffold of the
modified Sciver device to have a distal tip that is contacted by
the distal tip of the balloon catheter, as taught by Uflacker, as this
modification merely involves a combination of known cutting
scaffolds according to known methods to obtain a predictable
result of an expandable stenosis incising instrument.
Final Act. 4—5.
We are persuaded of error by Appellants’ argument that “Uflacker et
al. fails to provide the teachings set forth by the Examiner.” Appeal Br. 26.
In particular, the rejection relies on a finding that the distal tip of Uflacker’s
balloon catheter contacts the distal tip of the scaffold. However, we agree
with Appellants that Uflacker shows a balloon catheter 14 that extends
distally past the balloon 16 such that the distal tip of the catheter is not
configured to contact the distal tip of Uflacker’s scaffold 12. See Uflacker
Figs. 1, 2. Because the rejection relies on a mischaracterization of
Uflacker’s disclosure, we are persuaded of reversible error and we do not
sustain the rejection of claim 4. For the same reasons, we do not sustain the
rejection of claims 5, 6, 15, and 20, the rejection of which rely on the same
erroneous findings with respect to Uflacker. See Final Act. 4—5.
Remaining Obviousness Rejections
With respect to the rejections of claims 7—11 and 16, Appellants argue
only that the additional art relied upon by the Examiner does not remedy the
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deficiencies in the rejection of the independent claims. See Appeal Br. 29—
31. Having found no deficiencies in the rejection of the independent claims,
we are also not persuaded of error in the rejections of these claims.
Accordingly, we sustain the rejections of claims 7—11 and 16.
CONCLUSION
For the reasons set forth above, we conclude as follows.
We AFFIRM the rejection of claims 1—3, 12, 14, and 17—19 under 35
U.S.C. § 103(a) as unpatentable over Sciver in view of Appling.
We REVERSE the rejection of claims 4—6, 15, and 20 under 35
U.S.C. § 103(a) as unpatentable over Sciver in view of Appling and
Uflacker.
We AFFIRM the rejection of claims 8 and 9 under 35 U.S.C. § 103(a)
as unpatentable over Sciver in view of Appling and Lukic.
We AFFIRM the rejection of claims 10 and 11 under 35 U.S.C.
§ 103(a) as unpatentable over Sciver in view of Appling, Lukic, and Stinson.
We AFFIRM the rejection of claims 7 and 16 under 35 U.S.C.
§ 103(a) as unpatentable over Sciver in view of Appling and Nott.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED-IN-PART
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