Ex Parte Rahn

Patent Trial and Appeal Board

Jun 26, 2013

11515306 (P.T.A.B. Jun. 26, 2013)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/515,306 08/31/2006 Norbert Rahn 2005P10438US 7156
22116 7590 06/26/2013
SIEMENS CORPORATION
INTELLECTUAL PROPERTY DEPARTMENT
170 WOOD AVENUE SOUTH
ISELIN, NJ 08830
EXAMINER
GOOD, SAMANTHA M
ART UNIT PAPER NUMBER
3739
MAIL DATE DELIVERY MODE
06/26/2013 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte NORBERT RAHN
__________

Appeal 2012-003739
Application 11/515,306
Technology Center 1600
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN and SHERIDAN
K. SNEDDEN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for lack of written description and obviousness. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
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STATEMENT OF CASE
Claims 16-18, 30, 31, and 35 are on appeal. The claims have not been
argued separately and therefore stand or fall together with independent claim
16. 37 C.F.R. § 41.37(c)(1)(vii). Claim 16 reads as follows:
16. An ablation catheter for setting a linear lesion of a tissue to be
ablated of a patient in a medical procedure, comprising:
a catheter sleeve;
an ablation element that is enclosed in the catheter sleeve and has a
front end;
a looped section that is arranged on the front end of the ablation
element and self expanded into an imposed pre-specified shape
corresponding to an actual shape of an area of the tissue when the ablation
catheter is inserted into the area and the ablation element is slid out of the
catheter sleeve such that the pre-specified shape of the self-expanded looped
section is sized to precisely fit against the area of the tissue to set the linear
lesion along the area of tissue; and
a control device configured to supply high-frequency energy to the
ablation element to produce the linear lesion along the area of tissue;
wherein the pre-specified shape of the self-expanded looped section is
matched to the actual shape of the area prior to said insertion of said ablation
catheter into the area;
and wherein the looped section includes a plurality of electrodes
electrically coupled to the control device by a signal lead enclosed in the
catheter sleeve; upon the looped section being matched to the actual shape of
the area, said electrodes are configured to generate an electrical signal along
the signal lead, to verify a wall contact between the looped section and the
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area of the tissue and to initiate the control device to supply the high-
frequency energy along the ablation element and to the looped section.

Cited References

Kordis et al. US 5,549,661 Aug. 27, 1996
Wittkampf US 6,063,078 May 16, 2000

Grounds of Rejection
Claims 16-18, 30-31 and 35 are rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
Claims 16-18, 30-31, and 35 are rejected under 35 U.S.C. §103(a) as
being unpatentable over Kordis in view of Wittkampf.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 4-
9. The following facts are highlighted.
1. The Specification discloses that the electrodes 12 generate
electrophysiological signals along the signal lead 13, but not upon the
looped section being matched to the actual shape of the (tissue) area.
(Spec. [0015]). (Br. 5.) The Specification discloses that, “The
looped section’s necessary wall contact can also be checked via these
immediately prior to ablation, meaning, therefore, that correct
positioning can also be checked electrophysiologically.” (Published
Application page 2, col. 1, para [0015].)
2. The Specification discloses: (1) a looped section 4 with electrodes 12
to derive electrophysiological signals via. a signal lead, (2) that
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adequate wall contact of the looped section 4 is checked by the
electrodes 12, (3) High Frequency energy is not applied until adequate
wall contact is established, and (4) if the looped section 4 is correctly
positioned, the electrodes 12 will also be correctly positioned against
the tissue wall so that correct wall contact is established and registered
via. the signal (page 9, lines 15-26). (Br. 5.)

PRINCIPLES OF LAW
Written Description
“In the context of the written description requirement, an adequate
prima facie case must . . . sufficiently explain to the applicant what, in the
examiner’s view, is missing from the written description.” See Hyatt v.
Dudas, 492 F.3d 1365, 1370 (Fed. Cir. 2007).
As stated in Ariad Pharms., Inc. v. Eli Lilly and Co.,
[T]he test for sufficiency is whether the disclosure of the
application relied upon reasonably conveys to those skilled in
the art that the inventor had possession of the claimed subject
matter as of the filing date.… The term “possession,” however,
has never been very enlightening. It implies that as long as one
can produce records documenting a written description of a
claimed invention, one can show possession. But the hallmark
of written description is disclosure. Thus, “possession as
shown in the disclosure” is a more complete formulation. Yet
whatever the specific articulation, the test requires an objective
inquiry into the four corners of the specification from the
perspective of a person of ordinary skill in the art. Based on
that inquiry, the specification must describe an invention
understandable to that skilled artisan and show that the inventor
actually invented the invention claimed.

598 F. 3d 1336, 1351 (Fed. Cir. 2010) (en banc).
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Thus, “[i]t is not necessary that the application describe the claim
limitations exactly, but only so clearly that persons of ordinary skill in the
art will recognize from the disclosure that appellants invented processes
including those limitations.” In re Wertheim, 541 F.2d 257, 262 (CCPA
1976) (citation omitted); see also Purdue Pharma L.P. v. Faulding, Inc., 230
F.3d 1320, 1323 (Fed. Cir. 2000) (“In order to satisfy the written description
requirement, the disclosure as originally filed does not have to provide in
haec verba support for the claimed subject matter at issue.”).

Obviousness
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).

Discussion Written Description
ISSUE
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The Examiner concludes that
There is no disclosure of an ablation catheter that upon
the looped section being matched to the actual shape of the
area, said electrodes are configured to generate an electrical
signal along the signal lead, to verify a wall contact between the
looped electrodes and the area of the tissue and to initiate the
control device to supply the high frequency energy along the
ablation element and to the looped section. …
[Specification] Paragraphs 0015 and 0032 do not provide any
details with regard to how wall contact is determined or
verified, how the control device knows when to switch on the
HF energy (ex- does a measured value have to reach a certain
threshold?), how the signal are processed to perform the desired
results, what types of signals are being used, along with other
critical features. Therefore, there is no specific description that
explains the manner in which the wall contact is verified in
order to initiate the control device to supply the high-frequency
energy.

(Ans. 4-5.)

Appellant argues the Specification inherently supports the claim
language of claim 16, since one of ordinary skill in the art would recognize
that those details (whether a threshold is used, how the signals are
processed) are necessarily present in the Specification. (Br. 4.) More
particularly, Appellant argues that the Examiner
conceded that the specification discloses that the electrodes 12
generate electrophysiological signals along the signal lead 13,
but not “upon the looped section being matched to the actual
shape of the (tissue) area” (Advisory Action, p. 2). However, in
addition to the three numbered items discussed above, the
Specification discloses: (1) a looped section 4 with electrodes
12 to derive electrophysiological signals via. a signal lead, (2)
that adequate wall contact of the looped section 4 is checked by
the electrodes 12, (3) High Frequency energy is not applied
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until adequate wall contact is established, and (4) if the looped
section 4 is correctly positioned, the electrodes 12 will also be
correctly positioned against the tissue wall so that correct wall
contact is established and registered via the signal (page 9, lines
15-26). Thus, at a minimum, the Specification inherently
supports the claim language of claim 16, since one of ordinary
skill in the art would recognize that those details (that upon
matching the loop section 4 to the shape of the tissue area –
using the wall contact technique described - the electrodes 12
generate signals along the signal lead 13) are necessarily
present in the Specification. (Br. 5.)

The issue is: Does the written description support the invention as
claimed?
ANALYSIS
Upon review of the arguments of record we find that the Appellant
has the better position. Appellant argues that the Specification discloses that
“The looped section’s necessary wall contact can also be checked via these
immediately prior to ablation, meaning, therefore, that correct positioning
can also be checked electrophysiologically.” (Published Application page 2,
col. 1, para [0015]. (FF1.) Appellant argues that one of ordinary skill in the
art would understand what is entailed by checking correct positioning
electrophysiologically. Appellant argues that the Examiner, “did not fulfil[l]
the initial burden under 35 USC [§] 112, first paragraph, since the Appellee
did not provide evidence why someone skilled in the art would not recognize
in the Specification a description of the claimed invention.” (App. Br. 4.)
We agree. The Examiner must support a prima facie case of lack of written
description by explaining what is missing from the written description and
why one of ordinary skill in the art would have understood that the
Specification was incomplete. Even if a prima facie case had been
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established, “[w]hen prima facie case…is established and evidence is
submitted in rebuttal, the decision-maker must start over.” In re Rinehart,
531 F.2d 1048, 1052 (CCPA 1976); In re Hedges, 783 F.2d 1038, 1039
(Fed. Cir. 1986) (“If a prima facie case is made in the first instance, and if
the applicant comes forward with reasonable rebuttal, whether buttressed by
experiment, prior art references, or argument, the entire merits of the matter
are to be reweighed”).
The Examiner failed to provide argument or evidence as to why one
of ordinary skill in the art would not have understood or recognized what is
meant by the description in the specification of “by checking correct
positioning electrophysiologically.”
Because the Examiner has not met this burden, the written description
rejection is reversed.

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Obviousness
Claims 16-18, 30-31, and 35 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Kordis in view of Wittkampf.
ISSUE
The Examiner concludes that Kordis teaches each element claimed
except that
Kordis et al fails to expressly teach that the electrodes are
configured to generate an electrical signal along the signal lead,
to verify a wall contact between the looped section and the area
of the tissue and to initiate the control device to supply the
high-frequency energy. Wittkampf teaches an analogous
ablation catheter (14) wherein the electrode (128) is configured
to generate an electrical signal along the signal lead, to verify a
wall contact between the looped section and the area of the
tissue and to initiate the control device (12/500) to supply the
high-frequency energy to the electrode (Col. 3, line 48 through
Col. 4, line 63; Col. 5, line 61 through Col. 6, line 21; Figures
1- 7). It would have been obvious to one of ordinary skill in the
art at the time that the invention was made to modify the
electrodes of the looped section, as taught by Kordis et al. to be
configured to verify a wall contact, as taught by Wittkampf, in
order to properly locate the electrode in the specific area in
which the ablative procedure is to be performed (Col. 6, lines
18-21).

(Ans. 8.)

The Examiner argues that

Applicant has failed to provide an explicit definition for the
term [linear] in the specification and therefore the word has
been given its customary meaning. The examiner does not find
the cited passage of page 1, lines 15-17 (paragraph 0003 of the
Published Patent Application), as found on page 8 of the
submitted appeal brief, to be sufficiently clear and does not
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specify the term with reasonable clarity, deliberateness and/or
precision. Additionally, the cited passage in paragraph 0003 of
the Published Patent Application only discusses the difference
between circular lesions and linear lesions, but does not give a
clear definition as to what the appellant is defining as a linear
lesion. If the appellant intend for their definition of a linear
lesion to be any lesion that is not circular, then the examiner
notes that a curvilinear lesion is not a circular lesion. (Ans. 10-
11.)

Appellant argues that

As disclosed in the Specification: “the pulmonary veins leading
into the left atrium are nowadays no longer isolated by means
of circular lesions in the area of the ends of said veins as that
would entail a relatively high risk of producing stenoses of the
pulmonary veins; ablation is instead performed so as to produce
a linear lesion” (page 1 lines 15- 17). Indeed, the Appellant
chose to differentiate between a linear lesion and a curvilinear
lesion, and thus the [Examiner’s] cited dictionary definition is
not applicable…

Accordingly, Kordis et al. fails to disclose a control device
configured to supply high-frequency energy to the ablation
element to produce a linear lesion along the area of tissue, as
recited in independent claim 16.

(Br. 8.)

Appellant further argues that
Wittkampf expressly teaches that the reflected heat 302 (FIG. 4)
increases when the electrode 128 is in contact with the tissue.
Thus, unlike the claimed invention, which matches the looped
section to shape of the tissue area, verifies wall contact and
subsequently supplies high-frequency energy to the looped
element, Wittkampf initially supplies RF energy to the
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electrode and subsequently determines whether sufficient
contact has been made with the tissue. Thus, neither of the
Kordis et al. or Wittkampf references, alone or in combination,
disclose that upon the looped section being matched to the
actual shape of the area, the electrodes are configured to
generate an electrical signal along the signal lead, to verify a
wall contact between the looped section and the area of the
tissue and to initiate the control device to supply the high-
frequency energy along the ablation element and to the looped
section.

(Br. 9.)

The Issue is: Does the combination of references support the
Examiner’s conclusion that the claimed subject matter is obvious?

FINDINGS OF FACT

3. The Specification Figures 5 and 6 are reproduced below.

Figure 5 shows the ablation catheter including the electrodes located
on the ablation element.
Figure 6 of the Specification is reproduced below.
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Fig. 6 shows a … variant of an ablation catheter 21
comprising a catheter sleeve 22 having, arranged slidably
therein, a wire ablation element 23 which likewise has a looped
section 24 that can be folded and retracted into the catheter
sleeve 22 and slide out of it assuming a pre-specified, three-
dimensional, shape matched tissue surface shape. Here, too, the
resilient section 24 itself serves to convey the coupled HF
energy, which is to say to set the linear lesion. Departing from
the embodiment variant according to FIG. 1, the looped section
24 is here assembled from a multiplicity of individual wire
segments 25a to 25f. These are mutually isolated and can be
supplied separately with HF energy over the wire feeder,
formed via the wire part of the ablation element 23 ducted in
the catheter sleeve 22, for which purpose corresponding line
connections are provided. This means that the wire section
inside the catheter sleeve can consist of a plurality of individual
strands each leading to in each case one wire segment 25a to
25f.

Published Appl. Page 4, [0036].

4. Kordis Figs 5A and 5B are reproduced below.
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Kordis Figs 5A, B show

the ablating elements 42 make intimate contact against the atrial
wall to create an array of adjoining curvilinear lesions L all at
once. (Col. 8, l. 27-29.) …
the splines 102 include regions 104 that are electrically conductive
(called the "conductive regions"). The splines 102 also include
regions 106 that are electrically not conductive (called the
"nonconductive regions"). (Col. 11, l. 50-55.)

5. Kordis, Figs. 27 and 28 are reproduced below.

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Kordis, Figs. 27 and 28 show

the ablating elements 42 make intimate contact against the atrial
wall to create discrete elongated, curvilinear lesions L, one at a
time. The physician individually deploys these ablating
elements 42 in succession to form the desired maze pattern.
(Col. 8, l. 39-43.) …
the regions 192 can comprise metallic rings of conductive
material, like platinum. In this embodiment, the rings are
pressure fitted about the body 190, which is made from a
nonconductive flexible plastic material, like polyurethane or
polyethylene. The portions of the body 190 between the rings
comprise the nonconductive regions 194.
The conductive regions 192 of the body 190 are attached
to signal wires (not shown) to conduct ablating energy to one or
more of the conductive regions 192. (Col. 24, l. 20-29.)

ANALYSIS
Appellant does not provide separate arguments for individual claims
in the Brief or Reply Brief. We therefore select claim 16 as representative.
We find that the Examiner has presented sufficient evidence to support a
prima facie case of obviousness which has not been rebutted by a
preponderance of the evidence by Appellant.
Appellant argues that their Specification page 1 differentiates between
a linear lesion and a curvilinear lesion. We are not persuaded. Appellant
argues that there is a difference between the curvilinear ablation of Kordis
and the linear ablation claimed. However, Fig. 6 of the Specification shows
“the resilient section 24 itself serves to convey the coupled HF energy,
which is to say to set the linear lesion.” Figure 6 indicates ablation section
24 is linear however it appears to have a curvilinear appearance. (FF3.)
Similarly Kordis, Fig 5A shows ablation section 104 having a substantially
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linear appearance, with Fig. 5B ablation section 104 having a curvilinear
appearance similar to that of Fig. 6 of the specification, ablation section 24.
Furthermore, Kordis indicates that the curvilinear lesions may be made
either all at once or one at a time. (FF5.) Thus, if a single lesion is made by
section 104 of Fig. 5B of Kordis it will produce a substantially linear lesion,
as claimed. Therefore, we agree with the Examiner that the specification
does not provide a definition for “linear” in a “sufficiently clear” way with
“reasonable clarity, deliberateness and precision,” and that when claim 16 is
interpreted in view of Appellant’s specification, including Fig. 6, that,
Appellant has failed to differentiate between a linear lesion and a curvilinear
lesion. (Ans. 11.) See In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989)
(“[D]uring patent prosecution when claims can be amended, ambiguities
should be recognized, scope and breadth of language explored, and
clarification imposed.”)
Moreover, while the Specification page 1 differentiates between full
circular lesions, which lead to stenosis and linear lesions, the lesions of
Kordis (5B, section 104) are not full circular lesions, but partial linear or
curvilinear lesions (FF5).
Appellant further argues that Wittkampf initially supplies RF energy
to the electrode and subsequently determines whether sufficient contact has
been made with the tissue, thus Wittkampf teaches away from the claimed
invention which matches the looped section to shape of the tissue area,
verifies wall contact and subsequently supplies high-frequency energy to the
looped element. Again we are not persuaded.
Wittkampf discloses that
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Thermistor assembly is used to sense the temperature of the
electrode, although other types of temperature sensors may also
be used, such as a thermocouple for example. As discussed in
more detail below, the degree to which the electrode contacts
the heart tissue (e.g. no contact, moderate contact, good contact
or excellent contact) may be determined by sensing the
temperature of the electrode while also sensing the amount of
energy which is non damaging to the cellular structures of the
body tissue (or "non-ablative") is delivered to the electrode.

(Col. 3, ll. 57-67.)

Thus, Wittkampf does not supply ablative, high frequency energy
when temperature sensing and verifying the structure wall, but supplies non-
damaging energy. In other words, Wittkampf’s non-damaging electrical
signal is reasonably interpreted as an electrical signal within the scope of
claim 16. Wittkampf matches the predetermined shape of the area to be
treated with the electrodes which produce a desired lesion.
Appellant’s other arguments are addressed fully in the Answer. The
obviousness rejection is affirmed for the reasons of record.

CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejection.
The written description rejection 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).

AFFIRMED
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