Ex Parte Ganz et al

Board of Patent Appeals and Interferences

Mar 25, 2008

10370645 (B.P.A.I. Mar. 25, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte
ROBERT A. GANZ, BRIAN D. ZELICKSON, and ROGER A. STERN
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Appeal 2008-0010
Application 10/370,645
Technology Center 3700
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Decided: March 25, 2008
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Before DONALD E. ADAMS, LORA M. GREEN,
and RICHARD M. LEBOVITZ, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 80-101 and 103-131. We have
jurisdiction under 35 U.S.C. § 6(b). Claims 80, 100, and 116 are the
independent claims on appeal, and read as follows:
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Application 10/370,645

80. A method of ablating mucosal tissue in an esophagus, comprising:
providing an energy delivery device:
positioning at least a portion of the energy delivery device at a
mucosal tissue surface of the esophagus;
delivering sufficient energy from the energy delivery device to the
mucosal tissue surface to create a lesion in the mucosal tissue, while
controlling a depth of the lesion.

100. A method of treating a tissue site in an esophagus, comprising:
providing a dilation and ablation catheter having a balloon member;
providing an energy delivery device having a plurality of RF
electrodes positioned on an outside surface of the balloon member;
positioning at least a portion of the energy delivery device at a
mucosal surface of the tissue site in the esophagus;
expanding the balloon member in the esophagus;
delivering sufficient energy from the energy device to create a lesion
with a controlled depth in the mucosal tissue.

116. A method for treating a tissue site in the esophagus, comprising:
providing an energy delivery device that includes a plurality of RF
electrodes, a width of each RF electrode and a spacing between adjacent RF
electrodes being selected to control a depth of ablation in mucosal layer of
the esophagus;
positioning at least a portion of the energy device at the tissue site in
the esophagus;
delivering sufficient energy from the energy delivery device to create
a desired ablation depth in the mucosal layer.

The Examiner relies on the following references:
Kelleher US 6,112,123 Aug. 29, 2000
Edwards US 6,405,732 B1 Jun. 18, 2002
Hovda US 6,053,172 Apr. 25, 2000

We reverse.

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DISCUSSION
Claims 80-95, 97, 99, 100-105, 107, 110, 111, 113, 116-121, 123,
126, 127, and 129 stand rejected under 35 U.S.C. § 103(a) as being obvious
over the combination of Edwards and Kelleher.
Edwards is cited for teaching treating a tissue site in the esophagus,
but, according to the Examiner, “neglects to expressly disclose targeting
esophageal mucosal layers.” (Ans.1 3.) According to the Examiner,
however, Edwards “repeatedly mentions targeting the sphincter wall,” which
includes the mucosal layer (id.).
Kelleher, according to the Examiner, discloses “an example of
targeted ablation of the esophageal mucosal layer using a device analogous
to that in Edwards.” (Id.) Thus, the Examiner concludes, “this makes
obvious the Applicant’s claimed methods.” (Id.)
The burden is on the Examiner to set forth a prima facie case of
obviousness. In re Fine, 837 F.2d 1071, 1074 (Fed. Cir. 1988). The
question of obviousness is resolved on the basis of underlying factual
determinations including: (1) the scope and content of the prior art; (2) the
level of ordinary skill in the art; (3) the differences between the claimed
invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
The Supreme Court has recently emphasized that “the [obviousness] analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and

1 All references to the Answer are to the Examiner’s Answer mailed January
30, 2007.
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creative steps that a person of ordinary skill in the art would employ.” KSR
Int’l v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007). However, in order to
facilitate review of the obviousness determination, the “analysis should be
made explicit.” Id. at 1741.
Appellants argue the Examiner has not addressed the limitation that at
least a portion of the energy delivery device be positioned at the mucosal
surface of the esophagus (Br. 8). In the treatment method of Edwards,
Appellants assert, the lesion is not made on the mucosal surface of the
esophagus, but is made to the muscle tissue 1-5 mm beneath the mucosal
surface, which is created by injecting a needle electrode into the esophageal
tissue or uses nerve pathways to create lesions within the muscle tissue (id.
at 6). According to Appellants, “Edwards specifically avoids damage or
destruction of mucosal tissue.” (Id.) Kelleher, Appellants assert, cites
significant problems associated with ablation of tissue in the lower
esophagus, such as obtaining uniform ablation over the entire tissue surface
(id. at 7). Kelleher, however, uses electrolyte assisted ablation, and the
electrode is spaced away from the tissue surface (id.). Thus, Appellants
assert, “the Examiner has not presented evidence that one having ordinary
skill in the art would have been led to combine the relevant teachings of
Edwards and Kelleher to arrive at the claimed invention nor how such a
combination might work.” (Id. at 8.)
The Examiner responds that Appellants are very narrowly construing
the Edwards patent (Ans. 10). According to the Examiner, “just because
Edwards mentions preventing damage to the mucosa in a small two-line
excerpt . . . [with] at least 10 object/embodiments does not mean that the
excerpt applies universally.” (Id.) As to the positioning of the energy
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device at the mucosal surface, the Examiner points to Figure 2a of Edwards,
stating that the Figure does not differentiate between the anatomically
adjacent mucosal and submucosal surfaces, asserting that the lesion could be
easily construed as being within the mucosal layer (id. at 11).
We conclude that Appellants have the better argument. Claim 80 (as
do claims 100 and 116, the other independent claims), requires 1)
“positioning at least a portion of the energy delivery device at a mucosal
tissue surface of the esophagus; and 2) delivering sufficient energy from the
energy delivery device to the mucosal tissue surface to create a lesion in the
mucosal tissue, while controlling a depth of the lesion. Thus, claim 80
requires that a portion of the energy delivering device be positioned at the
tissue surface of the mucosa, and also requires that the device positioned at
the surface of the mucosa deliver energy to the mucosa to create a lesion in
the mucosal tissue.
Although Edwards has multiple embodiments, they are all directed to
ablating tissue below the mucosal surface, and are performed such that the
mucosal surface is not damaged (see, e.g., Edwards, col. 12, ll. 40-41; col.
14, ll. 29-32; col. 16, ll. 31-39; col. 17, ll. 1-8). Thus, while the Examiner
argues that Figure 2a can be construed as having the lesion within the
mucosal layer, Edwards states that the Figure is drawn to producing lesions
in a sphincter (Edwards, col. 7, ll. 41-48). Edwards teaches further as to
Figures 12 and 13, drawn to treatment of the sphincter, that the needle
electrode is introduced into the smooth muscle tissue of the sphincter wall
(Edwards, col. 13, ll. 16-46). Thus the ordinary artisan when reading that
teaching, coupled with the other portions of Edwards that teach that the
mucosal surface is not damaged, would not construe Figure 2a as the energy
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delivery device being positioned at the mucosal tissue surface of the
esophagus, and then using the delivery device at the surface of the mucosal
tissue to produce a lesion in the mucosal tissue. Moreover, while the
Examiner asserts that Edwards mentions preventing damage to the mucosa
in only one embodiment while disclosing at least ten objects/embodiments,
the Examiner does not point to any portion of the disclosure of Edwards that
introduces lesions at the mucosal surface through the use of a energy
delivery device, where at least a portion of the device used to deliver energy
is positioned at the mucosal tissue surface of the esophagus.
Finally, the Examiner has not explained how Kelleher remedies the
deficiencies of Edwards, because, as explained by Appellants (Br. 7),
Kelleher discloses an electrolyte assisted ablation, wherein the energy
delivering electrode is spaced away from the tissue surface in the conducting
medium (Kelleher, abstract, see also, col. 3, ll. 34-51). Therefore, the
Examiner has failed to set forth a prima facie case of obviousness as to
independent claims 80, 100, and 116, and we are compelled to reverse the
rejection.
Claims 95, 96, 98, 106, 108, 109, 112, 114, 115, 122, 124, 125, 128,
130, and 131 stand rejected under 35 U.S.C. § 103(a) as being obvious over
the combination of Edwards and Kelleher as further combined with Hovda.
The combination of Edwards and Kelleher is relied upon as set forth
above (Ans. 8). Hovda is cited for addressing the limitation of using the
device to perform esophageal tumor surgery (id.). Thus, as Hovda fails to
remedy the deficiencies of the combination of Edwards and Kelleher, we are
compelled to reverse this rejection as well.

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CONCLUSION
In summary, as we conclude that the Examiner has failed to set forth a
prima facie case of obviousness, the rejection of claims 80-95, 97, 99, 100-
105, 107, 110, 111, 113, 116-121, 123, 126, 127, and 129 under 35 U.S.C. §
103(a) over the combination of Edwards and Kelleher, and the rejection of
claims 95, 96, 98, 106, 108, 109, 112, 114, 115, 122, 124, 125, 128, 130, and
131 under 35 U.S.C. § 103(a) over the combination of Edwards and Kelleher
as further combined with Hovda, are reversed.

REVERSED

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