Ex Parte GROFF et al

Patent Trials and Appeals Board

Apr 29, 2019

14155028 - (D) (P.T.A.B. Apr. 29, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/155,028 01/14/2014
121974 7590 05/01/2019
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
JOEL N. GROFF
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.
8150BSC0181 6791
EXAMINER
HUPCZEY, JR, RONALD JAMES
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
05/01/2019 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):
bbonneville@kdbfirm.com
docketing@kdbfirm.com
ehysesani@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOEL N. GROFF, MARK L. JENSON, MARTIN R. WILLARD,
JASON P. HILL, and GARY L. HENDRICKSON
Appeal2017-008494
Application 14/155,028
Technology Center 3700
Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants1 submit this appeal under 35 U.S.C. § 134 involving
claims to a device for ablating nerves. The Examiner rejected the claims as
anticipated. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
According to the Specification, "[t]he present disclosure pertains to
medical devices, and methods for manufacturing medical devices. More
1 Appellants identify the Real Party in Interest as Boston Scientific Scimed,
Inc. App. Br. 3.
Appeal2017-008494
Application 14/155,028
particularly, the present disclosure pertains to ablating and/or modulating
renal nerves." Spec. 1 :9-11.
In summarizing the subject matter, the Specification states that "[ a ]n
example medical device may include an expandable frame slidably disposed
within a catheter shaft." Id. at 1 :24-25. Moreover, "[t]he expandable frame
may be configured to shift between a collapsed configuration and an
expanded configuration," and"[ o ]ne or more electrodes may be disposed on
a surface of the expandable frame." Id. at 1:25-27.
An embodiment of the disclosed medical device is depicted in the
Specification's Fig. 4, which is reproduced below.
FIG. 4
Spec., Fig. 4. Figure 4 is a side view of an expandable member or basket
(400), "whose form may be provided by one or more struts or ribbons 402."
Id. at 11: 15-16. As shown in Fig. 4, the expandable member is in an
expanded state, and is disposed within the lumen of a blood vessel (200). Id.
at 6: 17-18. As further shown above, ribbons ( 402) comprise wall-contact
2
Appeal2017-008494
Application 14/155,028
segments (410), electrode segments (412), and bend segments (414). Id. at
11:29-30. A "control wire" (408) may be used to collapse and expand the
basket (400). Id. at 12:6-7. More specifically, moving the control wire
distally (to the left in Fig. 4) will push the basket into a collapsed state. Id.
at 12:7-8. Conversely, pulling the control wire proximally (to the right in
Fig. 4) urges the basket into an expanded state. Id. at 12:8-10.
Claims 8-12 and 16-19 are on appeal. 2 Independent claim 8 is
illustrative and reads:
8. A medical device for ablating nerves perivascularly,
the medical device comprising:
an expandable frame slidably disposed within a
catheter, the expandable frame being configured to shift
between a collapsed configuration and an expanded
configuration; and
one or more electrodes disposed on a surface of the
expandable frame,
wherein the one or more electrodes are disposed
radially inward relative to the greatest radial extent of the
expandable frame when the expandable frame is in the
expanded configuration, and
wherein the expandable frame includes a basket
comprising one or more partially insulated conductive
ribbons comprising one or more uninsulated portions that
correspond to the one or more of the electrodes.
App. Br. 11 (Claims App.) ( emphases added).
2 The Examiner entered an after-final amendment, cancelling claims 1-7,
13-15, and 20, and amending the language of independent claims 8 and 16.
Adv. Act. (Feb. 6, 2017), 2 (hereafter "Adv. Act.").
3
Appeal2017-008494
Application 14/155,028
The claims stand rejected under 35 U.S.C. § 102(b) as anticipated by
Kunis. 3 Adv. Act. 2; Ans. 2-6.4
DISCUSSION
Claim 8
The Examiner, relying primarily on the structures of the medical
device as shown in Kunis' s Figs. 1 and 2, finds that the medical device of
claim 8 is anticipated. Adv. Act. 2, Ans. 3-5.
Figure 2(B) of Kunis is reproduced below for reference.
94
FIG. 2{B)
3 Kunis et al., US 7,850,685 B2, issued Dec. 14, 2010.
4 In the Answer, the Examiner notes that the § 102 rejection of claims 1-7,
13-15, and 20 have been withdrawn in view of amendment canceling those
claims. Ans. 2. Further, the Examiner's Answer characterizes the rejection
of claims 9-12 and 17-19 as being "a new ground of rejection," offering
Appellants the option of reopening prosecution or maintaining the appeal.
Id. at 6. Appellants took the latter option by filing their May 22, 2017
Reply. 37 C.F.R. § 41.39(b)(2).
4
Appeal2017-008494
Application 14/155,028
Kunis, Fig. 2(B). Figure 2(B) depicts a distal portion of an ablation catheter
(50) including, among other features, proximal carrier arms (86) and distal
carrier arms (88), which carrier arms are in an expanded state, and ablation
elements (92) mounted to the carrier arms. Id. at 10:6-30, 45-52. Kunis
defines a "carrier arm" as referring to "a wire-like shaft capable of
interfacing with electrodes and a control shaft," and as "not limited to any
size or measurement." Id. at 8:37-39. Kunis further describes examples of
carrier arms as "includ[ing], but ... not limited to: stainless steel shafts;
Nitinol shafts; titanium shafts; polyurethane shafts; nylon shafts; and steel
shafts. Carrier arms can be entirely flexible, or may include flexible and
rigid segments." Id. at 8:40-43. Kunis also discloses that "'ablation
element' refers to an energy delivery element, such as an electrode for
delivering electrical energy such as RF energy." Id. at 7:53-55.
The Examiner finds that Kunis describes a medical device with all the
elements recited in claim 8. Adv. Act. 2; Ans. 3-5. The disputed issue on
appeal is whether Kunis describes a medical device with the features recited
in claim 8's final wherein clause: "wherein the expandable frame includes a
basket comprising one or more partially insulated conductive ribbons
comprising one or more uninsulated portions that correspond to the one or
more of the electrodes."
On that question, the Examiner finds, inter alia, that "the basket with
conductive ribbons formed by each of [carrier] arms 86 [ of Kunis] to be
partially insulated via the disposing of an insulative material thereon and
further with the elements 92 forming the uninsulated [electrode] portions."
Ans. 3. According to the Examiner, Kunis discloses that the carrier arms
5
Appeal2017-008494
Application 14/155,028
may be formed from non-conductive, insulating materials like polyurethane,
and the "arms would necessarily require some manner of conductive
material to provide for a connection between the energy source and the
element 92." Id. at 4. Further to that point, the Examiner cites to Kunis's
teaching that, to provide the electrodes with a source of energy, conductive
wire may be located on or within the carrier arms. Id. ( quoting Kunis,
18:31-48 ("wires may be located on the external surface of carrier arms 186,
or travel within a lumen of carrier arm 186" in reference to Fig. 12a)); see
also id. ("These uninsulated portions of the ribbons [ wires interfacing with
ablation elements 92 of Fig. 2(B)] would indeed correspond to the one or
more electrodes as they provide the electrical connection for the electrodes
to the source of energy of the device.").
Appellants argue that Kunis' s "carrier arms 86 are not partially
insulated conductive ribbons as claimed, and ablation elements 92 are not
uninsulated portions of the partially insulated conductive ribbons that
correspond to one or more electrodes as claimed." App. Br. 8. According to
Appellants, Kunis's arms "do not form electrodes at all, but rather function
as carriers for ablation elements 92." Id. Appellants argue the "carrier arms
need not be conductive at all as they may be formed from non-conductive
materials such as polyurethane and nylon." Id. Attaching wires to the
electrodes, Appellants argue, "is remote from the presently claimed
invention." Id. at 8-9; Reply 8 (Kunis's wires "are distinctfrom the arms
and thus do not transform the non-conductive arms into partially insulated
conductive structures ... [and] while the wires are conductive, they are
surrounded by insulation and are not partially insulated."). Appellants argue
6
Appeal2017-008494
Application 14/155,028
Kunis discloses "electrodes attached to the arms/ribbons," which allegedly
is not encompassed claim 8's recitation of uninsulated portions of the
ribbons that "correspond to" the electrodes. Reply 9. ( emphasis added).
The preponderance of the evidence on this record supports the
Examiner's rejection. As noted, Kunis teaches that the carrier arms may be
formed from an insulating material ( e.g., polyurethane) with, for example,
conductive wire running through the arms to power ablation elements 92.
Ans. 4-5. Appellants' arguments do not persuade us that such an
arrangement of non-conductive and conductive materials in Kunis is
excluded from the broadest reasonable interpretation of the phrase "insulated
conductive ribbons" in claim 8. Appellants cite no disclosure in the
Specification that would support such an interpretation of the claims and
thereby exclude such an arrangement. And, portions of the Specification
appear to support the Examiner's interpretation. See, e.g., 15: 19-28
( disclosing that the ribbons may be formed from the same materials as
Kunis's arms, including polyurethane and nylon, as well as metallic
materials like nitinol, and disclosing broad methods for insulating the
ribbons (e.g., dip or spray coating, providing tubing over other elements)).
We are also unpersuaded that the interface between conductive wires
and ablation elements/electrodes on Kunis's carrier arms would not meet
claim 8' s requirement for an "uninsulated portions that correspond to the one
or more of the electrodes." One of ordinary skill in the art would understand
from reading Kunis that the wire and electrode must be uninsulated at that
portion of Kunis's arms to enable energy transfer and ablation of tissue.
Other portions are insulated as discussed above and, thus, the arms are
7
Appeal2017-008494
Application 14/155,028
"partially" insulated as well. Appellants seek to distinguish Kunis' s
arrangement from claim 8 because the ablation elements are carried by or
attached to the arms, but that is a distinction without a difference for the
pending claims. The Specification discloses that "[t]he electrodes ... may
be external members that may attach to the surface of the expandable
member." Spec. 9:17-18 (emphasis added). Thus, the Specification
contemplates embodiments wherein the electrodes are carried by or attached
to the expandable frame/ribbons-like the electrodes in Kunis. And we are
unpersuaded the broadest reasonable interpretation of claim 8 excludes such
embodiments.
While the Specification discloses that the electrodes "may be formed
integral of the expandable member," pending claim 8 is not so specific. See
Spec. 9: 17-18 ( emphasis added). Appellants appear to read claim 8 as
requiring such an integral formation of the electrodes and expandable
frame/ribbons. App. Br. 8; Reply Br. 8-9. Yet the term "integral" is not
used in the claim. Claim 8 requires only that the "uninsulated portions ...
correspond to the one or more of the electrodes." (emphasis added). And,
given the otherwise broad disclosure of the Specification as discussed above,
we are unwilling to read the phrase "correspond to"5 as more narrowly
requiring that the electrodes be integral to the expandable frame or ribbons.
Appellants make the same arguments for independent claim 16, which
are unpersuasive for that claim as well. App. Br. 7-9. Appellants do not
5 The Specification never uses the phrase "correspond to" in describing any
relationship between the electrodes and the uninsulated portions of the
expandable member/ribbons.
8
Appeal2017-008494
Application 14/155,028
argue dependent claims 9-12 and 17-19 separately, so those claims fall with
claims 8 and 16. 37 C.F.R. § 41.37(c)(l)(iv).
Conclusion
For the reasons explained above, we conclude that the preponderance
of the evidence on this record supports the Examiner's finding that the
claims are anticipated by Kunis.
SUMMARY
We affirm the rejection for anticipation on appeal.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a).
AFFIRMED
9