Tom Steinke et al.

Patent Trials and Appeals Board

Jul 8, 2021

2020006451 (P.T.A.B. Jul. 8, 2021)

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.
13/403,920 02/23/2012 Tom A. Steinke 8150BSC0251C1 2576
121974 7590 07/08/2021
Kacvinsky Daisak Bluni PLLC (8150)
2601 Weston Parkway, Suite 103
Cary, NC 27513
EXAMINER
PEFFLEY, MICHAEL F
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
07/08/2021 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):
docketing@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD

Ex parte TOM A. STEINKE, CORBETT W. STONE,
STEPHEN O. ROSS, BRIAN S. KELLEHER,
RAPHAEL M. MICHEL, and DONALD H. KOENIG

Appeal 2020-0064511
Application 13/403,920
Technology Center 3700
Before FRANCISCO C. PRATS, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the
Examiner’s decision to reject claims 1–4, 9, 11, 14, 15, 17–21, and 29–32.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 This application has been before us previously in Appeal 2017-000578,
decision entered Feb. 2, 2018).
2 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as Boston Scientific
Scimed, Inc. Appeal Br. 3.
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Application 13/403,920

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CLAIMED SUBJECT MATTER
Appellant’s invention is directed to catheters that are deployed in
blood vessels having atherosclerotic lesions, and which use energized
electrodes to remodel the atherosclerotic material. Spec. ¶ 14.
Appellant’s claim 1, the only independent claim on appeal, is
representative of the appealed subject matter and reads as follows:
1. A system for remodeling of tissue about a blood vessel of
a patient, the system comprising:
an elongate catheter body having a proximal end and a
distal end with an axis therebetween for delivery into the blood
vessel;
a radially expandable structure near the distal end of the
catheter body that comprises a plurality of flexible struts having
openings therebetween;
a plurality of electrodes supported by the expandable
structure so as to be urged radially outward and engage a
luminal wall of the blood vessel when the expandable structure
expands therein, each of the plurality of electrodes comprising a
metallic body affixed to one of the struts of the radially
expandable structure, the struts being cut from a tube of
material;
a plurality of temperature sensors configured to provide
temperature measurement for use in control of energy delivery
from the electrodes;
a power source electrically coupled to the electrodes, the
power source configured for energizing the electrodes so as to
remodel the tissue; and
a controller coupling the power source to the electrodes,
the controller configured to selectively energize individual
electrodes, and to direct energy eccentrically without rotating
the electrodes about the axis by selectively energizing a subset
of the electrodes;
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wherein the controller controls energy delivery to the
electrodes using temperature feedback and wherein the
controller controls the power source to deliver RF energy to the
electrodes so as to heat the tissue material to a temperature in a
range from about 40 to about 63° C.
Appeal Br. 11 (emphasis added to claim limitation at issue).
REJECTION(S)
The following rejections are before us for review:
(1) Claims 1–4, 9, 11, 14, 15, 17, 18, 20, 21, and 29–32 under 35
U.S.C. § 103(a) as being unpatentable over Collins,3 Imran,4 and Swanson,5
(Final Act. 2–5 (entered July 10, 2019)); and
(2) Claim 19 under 35 U.S.C. § 103(a) as being unpatentable over
Collins, Imran, Swanson, and Eggers6 (Final Act. 5–6).
DISCUSSION
In rejecting Appellant’s representative claim 1, the Examiner cited
Collins and Imran as evidence that a device having the strut/electrode
configuration required by claim 1 would have been obvious to a skilled
artisan. See Final Act. 3–4 (determining that providing Collins’s device
“with electrodes comprising a metallic body affixed to the struts for
contacting tissue would have been an obvious alternative design
consideration for one of ordinary skill in the art since Imran fairly teaches
this is a known technique for providing electrodes on an analogous
expandable structure”).

3 US 6,837,886 B2 (issued Jan.4, 2005).
4 US 5,156,151 (issued Oct. 20, 1992).
5 US 6,640,120 B1 (issued Oct. 28, 2003).
6 US 5,419,767 (issued May 30, 1995).
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The Examiner cited Swanson as evidence that it would have been
obvious to configure the device suggested by Collins and Imran to control
tissue heating to a temperature within the range required by Appellant’s
representative claim 1. See Final Act. 4 (determining providing the device
with a controller that “maintains tissue temperature below about 63 degrees
Celsius to avoid damaging non-targeted tissue would have been an obvious
consideration for one of ordinary skill in the art in view of the teaching of
Swanson et al who specifically disclose a similar temperature range in an
analogous treatment device/method”).
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant in
response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992); see also In re Jung, 637
F.3d 1356, 1365 (Fed. Cir. 2011) (holding that requiring an applicant to
identify “reversible error” in an examiner’s rejection is consistent with long
standing Board practice).
In the present case, having carefully considered all of the evidence
and argument presented by Appellant and the Examiner, we are not
persuaded that Appellant has shown reversible error in the Examiner’s
conclusion of obviousness as to Appellant’s representative claim 1.
In asserting error in the Examiner’s conclusion of obviousness,
Appellant contends only that the Examiner erred in determining that Imran
describes a device in which the struts are cut from a tube of material, as
recited in Appellant’s claim 1. See Appeal. Br. 7–8. In particular, Appellant
contends that Imran describes first cutting the struts from a sheet of material,
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and then rolling the material into the shape of a tube, contrary to the
language recited in Appellant’s claim 1:
[T]he process of rolling a sheet into a tube would require the
ends of the sheet to be attached in order to form a tube which
would result in a change in physical characteristics where the
ends of the sheet are fixed together (e.g., a mechanical
interlock, a weld/solder line, an adhesive, etc.).
Appeal Br. 8.
In asserting that Imran’s struts are structurally distinct from the struts
of the device of Appellant’s claim 1, Appellant argues as follows:
In the specific case of Imran, the following is described at col.
5, lines 37-42: “The sheet 51 is wrapped into a cylinder with the
ears 52 overlapping the ears 53 by inserting the ears 52 through
T-shaped slots 99 formed in the ears 53 and having pairs of
spaced-apart slits 101 mating with the slots 99 s [sic] that the
outer side margins of the sheet 51 are brought together to form
another slit 56 between the two adjacent arms 47.” Clearly this
is distinct from the presently claimed invention wherein struts
are cut from a tube.
Appeal Br. 8.
The Examiner responds that “the limitation ‘the struts being cut from
a tube of material’ is directed to a product-by-process claim” and that “the
final product of the Imran device is substantially analogous to that which is
recited in the above noted limitation from claim 1. That is, the Imran device
is a tubular (or cylindrical) member having struts which are cut from the
tubular member.” Ans. 3–4. Moreover, the Examiner contends, “the
securing tabs of Imran present no functional or structurally significant
difference over the tube of material disclosed in [A]ppellant’s
[S]pecification.” Ans. 4.
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We find that the preponderance of the evidence supports the
Examiner’s position.
As our reviewing court has explained, it is “well settled that the
presence of process limitations in product claims, which product does not
otherwise patentably distinguish over the prior art, cannot impart
patentability to that product.” SmithKline Beecham Corp. v. Apotex Corp.,
439 F.3d 1312, 1318 (Fed. Cir. 2006) (quoting In re Stephens, 345 F.2d
1020, 1023 (CCPA 1965).
As explained further in In re Thorpe, 777 F.2d 695, 697 (Fed. Cir.
1985) (citations omitted, emphasis added):
[E]ven though product-by-process claims are limited by and
defined by the process, determination of patentability is based
on the product itself. The patentability of a product does not
depend on its method of production. If the product in the
product-by-process claim is the same as or obvious from a
product of the prior art, the claim is unpatentable even though
the prior product was made by a different process.

In the present case, as required by Appellant’s claim 1, Imran
discloses that its device is in the form of a tube (cylinder), with struts 47 cut
into the tube. See Imran Fig. 6; see also id. at 5:37 (disclosing that the sheet
that forms the tube is “wrapped into a cylinder”).
We acknowledge that, rather than being cut from material in the shape
of a tube, Imran’s struts are first cut into the sheet of material that forms the
tube, and the sheet is subsequently rolled into the tube shape. See Imran Fig.
2; see also id. at 3:60–64 (“[T]he sheet 51 is slitted with a knife or die (not
shown) to provide parallel spaced apart slits 56 extending longitudinally
between the ears 52 and 53 to form the plurality of circumferentially spaced
longitudinally extending arms 47.”).
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We are not persuaded, however, that Appellant has identified any
structural differences between Imran’s tube, and a tube in which the struts
are cut into material already in the form of a tube. To the contrary, the sole
structural elements asserted by Appellant as differentiating the device of
representative claim 1 from Imran’s device, the ears used for attaching the
two edges of the material to form the tube/cylinder (see Imran 5:37–45), are
simply not excluded by representative claim 1, which recites the claimed
device using the open transitional phrase “comprising” (see Appeal Br. 11).
Accordingly, for the reasons discussed, Appellant does not persuade
us of reversible error in the Examiner’s determination that the cited
references suggest a device having all of the features required by Appellant’s
representative claim 1. We therefore affirm the Examiner’s rejection of
claim 1 for obviousness over the cited references. Claims 2–4, 9, 11, 14, 15,
17, 18, 20, 21, and 29–32 fall with claim 1 because they were not argued
separately. 37 C.F.R. 41.37(c)(1)(iv).
In rejecting claim 19 for obviousness, the Examiner cited Collins,
Imran, and Swanson for the teachings discussed above, and cited Eggers as
evidence that the additional elements recited in claim 19 would have obvious
features of the device suggested by the other references. See Final Act. 5–6.
In traversing the Examiner’s rejection of claim 19, Appellant relies entirely
on its arguments, discussed above, in relation to claim 1. See Appeal Br. 9.
For the reasons discussed above, we do not find those arguments persuasive.
We therefore also affirm the Examiner’s rejection of claim 19 for
obviousness.

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Application 13/403,920

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DECISION SUMMARY
In summary:
Claim(s)
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
1–4, 9,
11, 14,
15, 17,
18, 20,
21, 29–
32
103(a) Collins, Imran,
Swanson
1–4, 9, 11,
14, 15, 17,
18, 20, 21,
29–32

19 103(a) Collins, Imran,
Swanson
19
Overall
Outcome
1–4, 9, 11,
14, 15, 17–
21, 29–32

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. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED