Ex Parte Folk et al

Patent Trial and Appeal Board

Nov 30, 2017

13567125 (P.T.A.B. Nov. 30, 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.
13/567,125 08/06/2012 Christopher Folk H-KN-02374US/1213-006US01 1042
137834 7590 12/04/2017
MDT_RTGNV/Shumaker & Sieffert P.A.
Attn: IP Legal Department
826 Coal Creek Circle
Louisville, CO 80027
EXAMINER
SCHMIDT, EMILY LOUISE
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
12/04/2017 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):
pairdocketing @ ssiplaw.com
Medtronic_rtg-nv_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHRISTOPHER FOLK and DAVID FRANCO
Appeal 2016-006392
Application 13/567,125
Technology Center 3700
Before JENNIFER D. BAHR, FREDERICK C. LANEY, and
ANTHONY KNIGHT, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants1 appeal under 35 U.S.C. § 134(a) from the Examiner’s
decision, set forth in the Final Action (June 23, 2015; hereinafter “Final
Act.”), rejecting claims 1—8 and 12—16.2 We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 The Appeal Brief (Dec. 28, 2015; hereinafter “Appeal Br.”), identifies
Medtronic pic, parent company of assignee of record Covidien LP, as the
real party in interest. Appeal Br. 3.
2 Claims 9—11 and 17—20 were withdrawn pursuant to the Restriction and
Election of Species Requirements dated October 27, 2014. Appeal Br. 3.
Appeal 2016-006392
Application 13/567,125
THE CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is illustrative of the claimed subject
matter.
1. A microcatheter for delivery of embolic fluids, which
comprises:
an outer member dimensioned for insertion within a blood
vessel adjacent an embolization site, the outer member defining
a first longitudinal lumen;
an inner member selectively positionable within the first
longitudinal lumen of the outer member, the inner member
defining a second longitudinal lumen and having a delivery port
in fluid communication with the second longitudinal lumen for
passage and delivery of embolic fluids toward the embolization
site; and
a valve disposed within the outer member, the valve
dimensioned to establish a substantial seal about the inner
member, to minimize entry of the embolic fluids within the first
longitudinal lumen of the outer member subsequent to delivery
thereof toward the embolization site.
REJECTION
Claims 1—8 and 12—16 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Jones (US 6,306,124 Bl, issued Oct. 23, 2001) and
Sepetka et al. (US 5,882,334, issued Mar. 16, 1999).
DISCUSSION
Claim Groupings
In contesting the rejection, Appellants group claims 1, 5—8, 12, and
14—16 together. Appeal Br. 5—10; see id. at 11—12 (relying on the arguments
presented for claim 1 in contesting the rejection of claims 12 and 14—16).
We decide the appeal of the rejection as to the claims in this group on the
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Application 13/567,125
basis of claim 1. See 37 C.F.R. § 41.37(c)(l)(iv) (permitting the Board to
select a single claim to decide the appeal as to a single ground of rejection of
a group of claims argued together). Appellants present separate arguments
for claims 2-4 and for claim 13 (Appeal Br. 10—11, 12—13), which we
address separately below.
Group 1 (Claims 1, 5—8, 12, and 14—16)
The Examiner finds that Jones discloses a system substantially as
recited in independent claim 1, including “a microcatheter for delivery of
embolic fluids, which comprises: an outer member dimensioned for
insertion within a blood vessel adjacent an embolization site, the outer
member defining a first longitudinal lumen.” Final Act. 2 (citing Jones, Fig.
14). The Examiner further finds that Jones discloses “an inner member
selectively positionable within the first longitudinal lumen of the outer
member.” Id. (citing Jones 4:21—25). The Examiner further finds that Jones
discloses a “valve disposed within the outer member, the valve dimensioned
to establish a substantial seal about the inner member, to minimize entry of
the embolic fluids within the first longitudinal lumen of the outer member
subsequent to delivery thereof toward the embolization site.” Id. (citing
Jones, Fig. 8, 12:1—38). Finally, the Examiner finds that Jones discloses that
the first lumen can be used to deliver a variety of medications. Id. (citing
Jones 8:1—11).
The Examiner finds that Jones does not explicitly teach an inner
member having a port with a lumen for delivering fluids. However, the
Examiner finds that Sepetka discloses:
delivering vaso-occlusive drugs through an inner catheter which is
positioned within an outer catheter having a balloon, the inner catheter
is delivered over a guidewire and can be inserted through a valving
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Application 13/567,125
member associated with the outer catheter, this minimizes catheter
recoil and allows the balloon and delivery port to be positioned
relative to one another.
Id. at 2-3 (citing Sepetka 1:6-8, 3:1-7, 5:27-6:29, 7:39-A0, Fig. 9B). The
Examiner determines that it would have been obvious to use Sepetka’s inner
delivery catheter through the balloon catheter of Jones because “Jones
teaches other tools can be used and Sepetka et al. teach this is effective for
delivery as it prevents recoil and allows adjustment between the position of
the delivery port and the balloon.” Id. at 3. In the Answer (Apr. 20, 2016,
hereinafter “Ans.”), the Examiner explains further that providing an inner
member inserted through Jones’s balloon catheter “is beneficial in that it
allows a balloon to be used ... for proper placement/anchoring or flow
isolation while delivery is achieved to the desired location” and “it allows
for both balloon use and drug delivery as opposed to one or the other and
allows for adjustment.” Ans. 2 (citing Sepetka 5:28—54, 6:25—30).
Appellants argue that the Examiner “has failed to establish a reason,
with rational underpinning, for the proposed modification of Jones’s balloon
catheter” to add the inner delivery lumen taught in Sepetka. Appeal Br. 6.
Specifically, Appellants argue that the Examiner has not shown that Jones’s
balloon catheter is used for the delivery of drugs or other material. Id.
Accordingly, Appellants argue that a person having ordinary skill in the art,
at the time of Appellants’ invention, would not have recognized any benefit
to modifying Jones’s balloon microcatheter to allow adjustment between the
positions of the delivery port and the balloon because this “would have
served no apparent purposes with Jones’[s] balloon microcatheter 108.” Id.
at 7. In other words, according to Appellants, because Jones’s balloon
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Application 13/567,125
catheter does not deliver drugs, a modification allowing adjustment between
the position of a drug delivery port and balloon would serve no apparent
purpose. Id.
We are not persuaded by Appellants’ argument and agree with the
Examiner that “[tjhough Jones may not disclose delivery in the embodiment
in Figure 14, it does not mean the device would not benefit from being able
to use both the balloon and delivery in Sepetka.” Ans. 2. Appellants’
argument essentially attacks Jones individually, rather than in combination
with Sepetka as set forth in the rejection. “Non-obviousness cannot be
established by attacking references individually where the rejection is based
upon the teachings of a combination of references.” In re Merck & Co., 800
F.2d 1091, 1097 (Fed. Cir. 1986) (citing In re Keller, 642 F.2d 413, 425
(CCPA 1981). Sepetka evidences that the combination of an inner member
selectively positionable within an outer lumen of a balloon catheter for
delivering vaso-occlusive agents was well known in the art at the time of
Appellants’ invention. Sepetka 5:28—54, 6:25—30.
The Examiner has articulated reasoning for combining Jones’s balloon
catheter with the inner delivery member of Sepetka as offering the advantage
of “allowing] adjustment between the position of the delivery port and the
balloon.” Final Act. 2—3; see Ans. 2 (citing Sepetka 5:28—54, 6:25—30). The
ability to adjust the position of Jones’s balloon catheter and the added inner
delivery lumen of Sepetka would allow for simultaneous balloon inflation
and drug delivery for specific vaso-occlusion procedures. See Sepetka 6:25—
30. Therefore, in light of the above, the Examiner provided sufficient
articulated reasoning with rational underpinning to establish why an artisan
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would have been prompted to combine the references as set forth in the
rejection. Final Act. 2-3; Ans. 2.
For these reasons, Appellants’ arguments do not apprise us of error in
the rejection of independent claim 1. Accordingly, we sustain the rejection
of independent claim 1, as well as claims 5—8, 12, and 14—16, which fall
with claim 1.
Group 2 (Claims 2-4)
Claim 2 depends from independent claim 1 and further recites
“wherein the outer member includes an expandable member disposed on an
exterior wall surface thereof adjacent the delivery port, the expandable
member dimensioned to expand and engage an interior wall portion of the
blood vessel to at least partially isolate the embolization site.”
Appeal Br. 15 (Claims App.). In addressing these limitations, the Examiner
points to inflatable balloon 112 of Jones’s Figure 14. Final Act. 3. The
Examiner then explains: “Jones teaches expandable member 112, further
Sepetka et al. teach an expandable member 323. As combined this member
would necessarily be adjacent the delivery port as they would be near each
other and [Appellant] has not recited any specific distance dimension.”
Ans. 3.
Appellants argue that “Jones, alone or in any proper combination with
Sepetka, has not been shown to disclose or suggest that the balloon 112 is
disposed on an exterior wall surface of the tubular member 110 adjacent a
delivery port.” Appeal Br. 10. Specifically, Appellants argue that the
Examiner has not properly explained how the combined teachings of Jones
and Sepetka disclose a balloon member disposed adjacent to a delivery port
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Application 13/567,125
because the Examiner has merely relied upon Figure 14 of Jones depicting a
balloon catheter with no disclosure of a delivery port. Id. at 10, 11.
Appellants’ argument is persuasive. The Examiner relies on Figure
14 of Jones, which discloses a balloon catheter, but does not depict a
delivery port and, thus, is unavailing as to the relative proximity of the
balloon member to a delivery port. The Examiner further directs us to
Sepetka’s balloon member 323, which is depicted in Figures 9A and 9B.
Ans. 3. However, although the catheter depicted in Sepetka’s Figures 9A
and 9B contains a balloon member, Figure 9B does not depict a delivery
port, much less give any indication as to proximity of the balloon member to
a delivery port. Figure 9A depicts balloon member 323 at a substantial
distance from the distal end of delivery shaft 311. The Examiner directs us
to several passages in Sepetka as teaching delivering vaso-occlusive agents
while a site is isolated, including, in particular, one passage teaching
“[k]nown delivery techniques . . . through balloon/delivery catheters having
delivery ports adjacent to expandable balloons” and the desirability of
isolating target delivery sites (Sepetka 5:42—54), and another passage
teaching varying “[t]he desired spatial arrangement of an occlusive balloon
and a delivery port” and “allow[ing] for adjustable positioning of an
occlusive balloon relative to a delivery port of a delivery catheter” (Sepetka
6:25—30). Ans. 3 (citing Sepetka 5:28—54, 6:25—30, 7:43^45). However, the
Examiner does not provide any cogent explanation as to why, in the
combination of Jones and Sepetka, the expandable member would
necessarily be adjacent the delivery port as posited by the Examiner. See id.
The Examiner points out that Appellants have “not recited any
specific distance dimension.” Ans. 3. To the extent that the Examiner is
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Application 13/567,125
treating the absence of a particular numerical dimension limitation from the
claim as license to simply ignore the “adjacent” limitation of the claim, such
claim construction is improper. See Stumbo v. Eastman Outdoors, Inc., 508
F.3d 1358, 1362 (Fed. Cir. 2007) (denouncing claim constructions which
render phrases in claims superfluous). The Examiner cannot read a claim
limitation so unreasonably broadly as to effectively ignore the limitation in
determining whether to reject a claim under § 103(a). This is true even if the
Examiner believes the limitation to be unclear or insufficiently supported by
the Specification. See In re Wilson, 424 F.2d 1382, 1385 (CCPA 1970).
For these reasons, we are persuaded of error in the rejection of claim
2, as well as claims 3 and 4, which depend from claim 2. Accordingly, we
reverse the rejection of claims 2—A.
Group 3 (Claim 13)
Claim 13 depends from claim 12 and further recites “a balloon
member mounted about the outer member and being adapted for expansion
to engage an interior wall of the blood vessel to at least partially isolate the
embolization site to assist in containing the embolic composition within the
embolization site.” Appeal Br. 17 (Claims App.).3 In addressing these
limitations, the Examiner points to inflatable balloon 112 of Jones’s Figure
14, without further explanation. Final Act. 4.
Appellants argue:
Jones, alone or in any proper combination with Sepetka, has not
been shown to disclose or suggest that balloon 112 is “adapted
for expansion to engage an interior wall of the blood vessel to at
least partially isolate [an] embolization site, to assist in
3 Unlike claim 2, claim 13 does not require that the expandable member (i.e.,
balloon member) be adjacent the delivery port. See id.
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Application 13/567,125
containing an embolic composition within an embolization site,”
as recited in claim 13.
Appeal Br. 13 (footnote omitted).
The Examiner responds by pointing to Jones’s expandable member
112 and Sepetka’s expandable member 323. Ans. 3. The Examiner adds
that Jones’s balloon “is capable of the function recited in the claim” and
points out that Sepetka additionally teaches “delivering vaso-occlusive
agents while a site is isolated.” Id. (citing Sepetka 5:28—54).
Jones discloses an inflatable, and expandable, balloon 112, and further
teaches that the inflated diameter of the balloon “can be varied widely
depending upon the intended clinical use.” Jones 13:4—6. With respect to
the structure, capabilities and function of Appellants’ balloon 154,
Appellants’ Specification discloses that “balloon 154 is dimensioned to
expand and engage an interior wall portion of a blood vessel to at least
partially isolate an embolization site.” Spec. 132. Given the uses
contemplated by Jones and Sepetka (i.e., balloon dilation and isolation of
target delivery sites for delivery of vaso-occlusive agents), it is not apparent,
and Appellants do not adequately explain, why the inflatable balloon of
Jones, in combination with Sepetka, would have been other than
dimensioned to expand and engage an interior wall portion of a blood vessel,
nor why it would have lacked the capability to thereby at least partially
isolate the embolization site to assist in containing the embolic composition
within the embolization site, as called for in claim 13. See Jones 1:20—24,
13:66—14:1; Sepetka 5:27—6:29, 8:6—32. In particular, the balloon, when
inflated so as to engage an interior wall portion of a blood vessel, would
isolate the embolization site from flow into or from vasculature on the side
of the balloon opposite the delivery site.
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For the above reasons, Appellants do not apprise us of error in the
rejection of claim 13, which we thus sustain.
DECISION
The Examiner’s decision rejecting claims 1, 5—8, and 12—16 is
AFFIRMED.
The Examiner’s decision rejecting claims 2—A is REVERSED.
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-IN-PART
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