Ex Parte Crowley

Board of Patent Appeals and Interferences

Feb 27, 2009

09879433 (B.P.A.I. Feb. 27, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ROBERT J. CROWLEY
__________

Appeal 2008-51361
Application 09/879,433
Technology Center 3700
__________

Decided:2 February 27, 2009
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL

1 The real party in interest is Boston Scientific Corporation.
2 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

Appeal 2008-5136
Application 09/879,433

This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 14-40, all the claims pending in the application. We have jurisdiction
under 35 U.S.C. § 6(b).
STATEMENT OF THE CASE
Claims 14, 27, and 28 are representative of the subject matter on
appeal:
14. A method for ablating mucosal or endothelial lining, comprising:
a) providing a light device comprising a flash lamp;
b) inserting the light device inside a body near a mucosal or
endothelial lining to be ablated, the mucosal or endothelial lining being on
top of a muscle layer;
c) energizing the flash lamp to generate a high intensity ultraviolet
light; and
d) ablating the mucosal or endothelial lining with the generated
light, and avoiding causing substantial damage to the muscle layer
underneath.

27. The method of claim 14 further comprising characterizing a targeted
portion of the mucosal or endothelial lining by transporting a dye to the
mucosal or endothelial lining to stain the targeted portion and wherein the
step of ablating the mucosal or endothelial lining comprises using light
absorbed by the stained portion.

28. The method of claim 14 further comprising introducing a drug near
the mucosal or endothelial lining and activating the drug through the light.

The Examiner relies on the following evidence:
Stanton US 3,970,394 Jul. 20, 1976
Feinbloom US 4,662,733 May 5, 1987
Spears US 4,799,479 Jan. 24, 1989
Clarke US 5,053,033 Oct. 1, 1991
Selman et al. (Selman) US 5,405,369 Apr. 11, 1995
Ohtake US 5,617,163 Apr. 1, 1997
Anderson et al. (Anderson) US 5,814,041 Sep. 29, 1998
Waksman et al. (Waksman) US 5,899,882 May 4, 1999
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The Examiner rejected the claims as follows:
I. Claims 14-18, 21, 22, 25, 27, 28, 39, and 40 under 35 U.S.C. § 103(a)
as unpatentable over Selman and Clarke.

II. Claims 20, 23, and 24 under 35 U.S.C. § 103(a) as unpatentable over
Selman, Clarke, and Waksman.

III. Claims 26, 29, and 30 under 35 U.S.C. § 103(a) as unpatentable over
Selman, Clarke, Waksman, and Spears.

IV. Claims 33 and 34 under 35 U.S.C. § 103(a) as unpatentable over
Selman, Clarke, and Feinbloom.

V. Claims 35 and 36 under 35 U.S.C. § 103(a) as unpatentable over
Selman, Clarke, Feinbloom, and Stanton.

VI. Claims 14, 19, and 37-39 under 35 U.S.C. § 103(a) as unpatentable
over Anderson and Clarke.

VII. Claims 31 and 32 under 35 U.S.C. § 103(a) as unpatentable over
Anderson, Clarke, and Ohtake.

We affirm.
OBVIOUSNESS: SELMAN AND CLARK
THE ISSUE
The principal issue common to all five of the rejections based on the
combined teachings of Selman and Clarke is whether Appellant has
established that the Examiner erred in concluding that it would have been
obvious for one skilled in the art to ablate a mucosal or endothelial lining
overlying a muscle layer, while avoiding damage to the underlying muscle
layer, by illuminating the mucosal or endothelial lining with ultraviolet light
generated by a flash lamp, rather than a laser.
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FINDINGS OF FACT
FF1 Independent claim 14 is directed to a method of ablating a
mucosal or endothelial lining overlying a muscle layer, while avoiding
substantial damage to the muscle layer, by illuminating the mucosal or
endothelial lining with a flash lamp energized to generate high intensity
ultraviolet light.
FF2 The claimed method may include staining the mucosal or
endothelial lining with a dye, and using light absorbed by the dye to ablate
the lining (dependent claim 27), or introducing a light-activated composition
near the mucosal or endothelial lining and activating the composition by
illuminating the lining (dependent claim 28).
FF3 According to the Specification,
Application of high intensity ultraviolet light ablates mucosal
linings without damaging tissue underneath the linings such as
the muscularis, because [the] ultraviolet component of the light
is greatly attenuated by tissue. Ultraviolet light is absorbed
through only a short distance before it is converted to heat.
Therefore, ultraviolet light is particularly effective in destroying
the top-most layer of cells, which is the target in ablation of
mucosal linings

(Spec. 9).
Selman
FF4 Selman describes selectively ablating a mucosal layer (e.g., in
the bladder or bowel), without damaging underlying muscle, by staining the
mucosal layer with a photosensitive compound, and then illuminating the
mucosal lining with light, including ultraviolet light, to initiate a series of
chemical reactions which preferentially damages or destroys the stained
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tissue. The underlying muscle tissue does not absorb the photosensitive
compound in sufficient amounts to cause damage, and is spared during the
illumination (Selman, col. 3, ll. 37-56; col. 6, ll. 37-41).
FF5 The only difference between Selman and the claimed invention
is that Selman does not specifically teach using a flash lamp as the source of
illumination. However, Selman teaches that illumination “can be achieved
by delivering electromagnetic radiation energy from conventional light
source” (Selman, col. 7, ll. 21-24), “such as a laser, LED device, or lamp”
(id. at col. 9, l. 18).
FF6 Selman teaches that determination of the appropriate intensity,
wavelength and duration of the illuminating energy is based at least in part
on the type and amount of photosensitive compound used (Selman, col. 9, ll.
50-53). It is evident from Selman that such a determination is within the
level of skill in the art.
Clarke
FF7 Clarke describes a method of preventing restenosis following
angioplasty. After a vessel-obstructing plaque or lesion is ablated by
ultraviolet light, or displaced by balloon angioplasty, ultraviolet light is used
to kill smooth muscle cells within the blood vessel at the angioplasty site,
“without damaging either the inner endothelium layer . . . or the outer
adventitia . . . of the blood vessel” (Clarke, col. 3, ll. 19-41; col. 5, ll. 3-5).

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FF8 Clarke’s method does not involve photosensitive compounds.
FF9 Clarke teaches that “[v]arious UV radiation sources can be
used” to kill the target muscle cells (Clarke, col. 2, l. 51), including various
lasers and “a UV flash lamp” (id. at col. 2, l. 62).
Feinbloom
FF10 The Examiner finds that “Feinbloom teaches a flash lamp
circuit that uses a transformer to step up the voltage” (Ans. 6), to “provide[ ]
a bright light” (id.). Appellant has not disputed this finding.
Stanton
FF11 The Examiner finds that “Stanton teaches the use of a foil as a
triggering electrode for a flash lamp” (Ans. 6). Appellant has not disputed
this finding.
PRINCIPLES OF LAW
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, 17-18
(1966).
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.

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KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, ___, 127 S. Ct. 1727, 1742
(2007). “The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
Id. at 1739. Moreover, “[a] person of ordinary skill is also a person of
ordinary creativity, not an automaton.” Id. at 1742. Finally, an “[e]xpress
suggestion to substitute one equivalent for another need not be present to
render such substitution obvious.” In re Fout, 675 F.2d 297, 301 (CCPA
1982).
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii)
(“[A]rguments or authorities not included in the brief or a reply brief . . .
will be refused consideration by the Board, unless good cause is shown.”).
ANALYSIS AND CONCLUSIONS OF LAW
I. Selman and Clarke
The Examiner rejected claims 14-18, 21, 22, 25, 27, 28, 39, and 40 as
unpatentable over Selman and Clarke. Claims 15-18, 21, 22, 25, 27, 28, 39,
and 40 were not separately argued, therefore, we select claim 14 as
representative for purposes of deciding the issues raised by this rejection.
See C.F.R. 41.37(c)(1)(vii).
The Examiner concluded that “[i]t would have been obvious to the
artisan of ordinary skill to employ the flash lamp of Clarke as the source [of
ultraviolet light] in the method of Selman et al, since th[e] [flash lamp] is
equivalent to the laser as taught by Clarke and since Selman et al teach that
any of a variety of light sources can be used” (Ans. 43). The Examiner’s

3 The Examiner’s Answer is not paginated - the numbers used here are
based on the assumption that the title page is the first page.
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position is essentially that “the absorption of the light in Selman et al is
controlled by the [location of the] photosensitive dye” and “the principle of
operation of Selman is preserved regardless of the ultraviolet source
employed: the dye is absorbed into the tissue to be destroyed, the dye
absorbs the light, and the tissue is destroyed” (id. at 7).
Appellant contends that Selman and Clarke “cannot reasonably be
combined” (App. Br. 11), because they take “dissimilar approaches” (id.)
and “target layers that are mutually exclusive” (id. at 11-12). Specifically,
Appellant contends that “Selman is concerned with photodynamic treatment,
which relies on tissue’s absorption of . . . [photosensitive] compositions . . .
in order to be effective” (id. at 11), while Clarke “directly radiates tissue
without the aid of any drug” (id.). Moreover, Appellant contends “[i]n
Selman, the mucosal layer is destroyed while the muscle layer is saved” but
“in Clarke, it is the smooth muscle layer that is destroyed while the mucosal
layer is saved” (id. at 12). Thus, Appellant contends, “one skilled in the art
. . . would not utilize Clarke’s flash lamp for Selman’s purpose” (id. at 12).
Appellant also contends that the “combination of Selman and Clarke
would fail to provide an enabling description of the method . . . [of] Claim
14” (App. Br. 13) because “Selman is silent on any teaching of UV radiation
outside the realm of photodynamic treatment, and Clarke teaches that UV
radiation is ineffective against the endothelial lining but effective on smooth
muscle cells” (id.).
Appellant’s arguments are not persuasive. Selman and Clarke provide
evidence that one skilled in the art of tissue ablation would have been
familiar with the destructive effect of ultraviolet light on tissue in general,
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with or without the use of a photosensitive dye (FF4, FF7). Selman teaches
that the selectivity of his method for mucosal tissue is due to preferential
absorption of the photosensitive dye by the mucosal layer (FF4). We agree
with the Examiner that one of skill would have expected Selman’s method to
be selective for mucosal tissue, regardless of the source of the light, as long
as the wavelength and intensity of the light was compatible with the
photosensitive dye - which we find would have been within the level of skill
in the art to determine (FF6).
In any case, Selman teaches that destructive illumination can be
achieved by delivering electromagnetic radiation energy from a conventional
light source, “such as a laser, LED device, or lamp” (FF5), while Clarke
teaches that an ultraviolet flash lamp is a conventional alternative to a laser
for illuminating tissue (FF9). An express suggestion to substitute one for
the other is not required to establish obviousness (In re Fout, 675 F.2d at
301).
We find that Appellant has not established that the Examiner erred in
concluding that the teachings of Selman and Clarke would have led one
skilled in the art to ablate a mucosal or endothelial lining overlying a muscle
layer, while avoiding damage to the underlying muscle layer, by
illuminating the mucosal or endothelial lining with ultraviolet light
generated by a flash lamp, rather than a laser.
II. Selman, Clarke, and Waksman
The Examiner rejected claims 20, 23, and 24 as unpatentable over
Selman, Clarke, and Waksman.
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Appellant contends that “Waksman does not provide any suggestion
as to why and how Selman and Clarke’s teachings can be combined or
modified to provide a step of ablating the mucosal or endothelial lining
using UV light generated by a flash lamp while avoiding substantial damage
to the muscle layer, as required by instant Claim 14” (App. Br. 15), and
therefore does not “remed[y] the deficiency of Selman and Clarke” (id.).
This argument is not persuasive, as Appellant has not established that
the Examiner erred in concluding that the invention of claim 14 would have
been obvious over the teachings of Selman and Clarke for the reasons
discussed above.
III. Selman, Clarke, Waksman, and Spears
The Examiner rejected claims 26, 29, and 30 as unpatentable over
Selman, Clarke, Waksman, and Spears.
Appellant contends that “Spears does not provide any suggestion as to
why and how Selman, Clarke, and Waksman’s teachings can be combined or
modified to provide a step of ablating the mucosal or endothelial lining
using UV light generated by a flash lamp while avoiding substantial damage
to the muscle layer, as required by instant Claim 14” (App. Br. 16), and
therefore does not “remed[y] the deficiency of Selman, Clarke, and
Waksman” (id. at 15).
Again, this argument is not persuasive, as Appellant has not
established that the Examiner erred in concluding that the invention of claim
14 would have been obvious over the teachings of Selman and Clarke, for
the reasons discussed above.

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IV. Selman, Clarke, and Feinbloom
The Examiner rejected claims 33 and 34 as unpatentable over Selman,
Clarke, and Feinbloom. Claim 33 depends from claim 14 and requires
“stepping up the voltage of a power supplied to the flash lamp.”
According to the Examiner, “Feinbloom teaches a flash lamp circuit
that uses a transformer to step up the voltage” and “[i]t would have been
obvious to the artisan of ordinary skill to employ a transformer to step up the
voltage [of a flash lamp], since this provides a bright light” (Ans. 6).
Appellant contends that “Feinbloom does not concern medical
treatment . . . [and] does not provide any suggestion as to why and how
Selman and Clarke’s teachings can be combined or modified to provide the
steps recited in instant Claim 14” (App. Br. 17), and moreover, “is silent as
to why the power supply’s voltage should be stepped up in an in vivo tissue
ablation method” (id.).
This argument is not persuasive. As discussed above, Appellant has
not established that the Examiner erred in concluding that it would have
been obvious to use a UV flash lamp to ablate mucosal tissue based on the
teachings of Selman and Clarke. The Examiner cited Feinbloom merely as
evidence that transformers are conventionally used to step up the voltage to
flash lamps to produce a bright light (FF10), and Appellant has not disputed
this finding.
V. Selman, Clarke, Feinbloom, and Stanton
The Examiner rejected claims 35 and 36 as unpatentable over Selman,
Clarke, Feinbloom, and Stanton. Claim 35 depends from claim 33, and
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ultimately from 14 and requires “stepping up the voltage . . . using a separate
lead connected to a foil disposed adjacent the flash lamp.”
According to the Examiner, “Stanton teaches the use of a foil as a
triggering electrode for a flash lamp” and “[i]t would have been obvious to
the artisan of ordinary skill to employ the triggering electrode . . . since this
would help provide a more evenly distributed flash” (Ans. 6).
Appellant contends that
Stanton does not concern medical treatment . . . [or] provide
reasons why the power supply’s voltage should be stepped up
in an in vivo tissue ablation method. Therefore, Stanton does
not provide any suggestion as to why and how the teachings of
Selman, Clarke, and Feinbloom can be combined or modified to
provide the steps recited in instant Claim 33.

(App. Br. 17-18.)
This argument is not persuasive. As discussed above, Appellant has
not established that the Examiner erred in concluding that it would have
been obvious to use a UV flash lamp to ablate mucosal tissue based on the
teachings of Selman and Clarke. The Examiner cited Feinbloom merely as
evidence that transformers are conventionally used to step up the voltage to
flash lamps to produce a bright light (FF10), and Stanton as evidence that
triggering electrodes are likewise conventional (FF11) , and Appellant has
not disputed these findings.
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OBVIOUSNESS: ANDERSON AND CLARKE
The principal issue common to both of the rejections based on the
combined teachings of Anderson and Clarke is whether Appellant has
established that the Examiner erred in concluding that it would have been
obvious for one skilled in the art to ablate a mucosal or endothelial lining
overlying a muscle layer, while avoiding damage to the underlying muscle
layer, by illuminating the mucosal or endothelial lining with ultraviolet light
generated by a flash lamp, rather than a laser.
FINDINGS OF FACT
Anderson
FF12 Anderson discloses selective ablation of endometrial tissue (the
mucosal lining of the uterus), without damaging the myometrium (the
smooth muscle layer underlying the endometrium), by staining the lining
with a photosensitive compound, and illuminating the lining with laser light,
including ultraviolet light (Anderson, col. 1, ll. 46-52; col. 2, ll. 29-34 and
61-64; col. 3, ll. 7-8).
FF13 Anderson uses an optical radiator with regions of different,
complementary transmissivities and reflectivities to illuminate the target
area uniformly (Anderson, col. 1, ll. 55-65).
FF14 Anderson teaches that the method can also be used to illuminate
and ablate tissue in the mouth, esophagus, bladder, bronchus, skin, or blood
vessels (Anderson, col. 4, ll. 40-43).
FF15 The Examiner finds that Anderson teaches that the light source
in photodynamic treatment of photosensitized tissue “is ‘usually a laser
fiber’ . . . [an] indication that other sources can be used” (Ans. 8).
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Ohtake
FF16 The Examiner finds that Ohtake describes “the use of a
lenticular surface which take[s] the form of a Fresnel lens . . . with a flash
lamp” (Ans. 6) that “provide[s] a more even distribution of light” (id.).
ANALYSIS AND CONCLUSIONS OF LAW
VI. Anderson and Clarke
The Examiner concluded that “[i]t would have been obvious to the
artisan of ordinary skill to employ a flash lamp as the light source in the
method of Anderson” (Ans. 5), because Anderson teaches “tissue ablation
by photodynamic therapy by illuminating a photosensitizer” (id. at 8),
“wherein the light source is ‘usually a laser fiber’” (id.), and “wherein the
device can employ ultraviolet light” (id.), while Clarke “teaches the
equivalence of flash lamps and lasers as sources of ultraviolet light” (id.).
Appellant contends Anderson “teaches that the endometrium can be
ablated if treated with a photosensitive composition that renders it
vulnerable to ablation . . . impl[ying] that under natural conditions, the
endometrium is not responsive to light ablation, which is consistent with
Clarke’s description that UV radiation is ineffective against endothelial
lining” (App. Br. 14). Appellant contends that Anderson, “like Selman, . . .
describes a method that targets a tissue layer excluded by Clarke, namely,
the mucous membrane. Accordingly, the skilled artisan would also be
dissuaded from combining the disclosure of Anderson and Clarke as the two
references target mutually exclusive tissue layers” (id.).
Appellant’s arguments are not persuasive. Anderson and Clarke
provide evidence that one skilled in the art of tissue ablation would have
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been familiar with the destructive effect of ultraviolet light on tissue in
general, with or without the use of a photosensitive dye (FF7, 12, 14).
Anderson teaches that endometrial tissue can be selectively ablated without
damaging the myometrium, by staining the lining with a photosensitive
compound, and illuminating the lining (FF12). We agree with the Examiner
that one of skill would have expected Anderson’s method to be selective for
mucosal tissue, regardless of the source of the light, as long as the
wavelength and intensity of the light was compatible with the photosensitive
dye - which we find would have been within the level of skill in the art to
determine (FF6).
In any case, Clarke teaches that an ultraviolet flash lamp is a
conventional alternative to a laser for illuminating tissue (FF9). An express
suggestion to substitute one for the other is not required to establish
obviousness (In re Fout, 675 F.2d at 301).
We find that Appellant has not established that the Examiner erred in
concluding that the teachings of Selman and Clarke would have led one
skilled in the art to ablate a mucosal or endothelial lining overlying a muscle
layer, while avoiding damage to the underlying muscle layer, by
illuminating the mucosal or endothelial lining with ultraviolet light
generated by a flash lamp, rather than a laser.
VII. Anderson, Clarke, and Ohtake
The Examiner rejected claims 31 and 32 as unpatentable over
Anderson, Clarke, and Ohtake.
The Examiner concluded that “[i]t would have been obvious to the
artisan of ordinary skill to employ a lenticular surface [in the form of a
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Fresnel lens] in the method of Anderson et al in combination with Clarke,
since this would provide a more even distribution of light” (Ans. 6).
Appellant contends that
Ohtake does not teach or suggest medical use of light, [and]
therefore, does not suggest why one should combine aspects of
Clarke’s UV therapy with Anderson’s photodynamic treatment.
Accordingly, Ohtake does not provide any suggestion as to why
and how Anderson and Clarke’s teachings can be combined or
modified to . . . ablat[e] the mucosal or endothelial lining using
UV light generated by a flash lamp while avoiding substantial
damage to the muscle layer, as required by instant Claim 14.

(App. Br. 16.) Appellant further contends that “Ohtake is silent as to why
[a] Fresnel lens should be used in an in vivo tissue ablation method” (id.).
Appellant’s argument is not persuasive. As discussed above,
Appellant has not established that the Examiner erred in concluding that it
would have been obvious to use a UV flash lamp to ablate mucosal tissue
based on the teachings of Anderson and Clarke. Moreover, Anderson
teaches that even illumination of the target area is important (FF13), and the
Examiner cited Ohtake as evidence that Fresnel lenses are conventionally
used with flash lamps to provide an even distribution of light (FF16), and
Appellant has not disputed this finding.
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SUMMARY
Appellant has not established that the Examiner erred in concluding
that it would have been obvious for one skilled in the art to ablate a mucosal
or endothelial lining overlying a muscle layer, while avoiding damage to the
underlying muscle layer, by illuminating the mucosal or endothelial lining
with ultraviolet light generated by a flash lamp, rather than a laser.
Accordingly:
I. The rejection of claims 14-18, 21, 22, 25, 27, 28, 39, and 40 under 35
U.S.C. § 103(a) as unpatentable over Selman and Clarke is affirmed.

II. The rejection of claims 20, 23, and 24 under 35 U.S.C. § 103(a) as
unpatentable over Selman, Clarke, and Waksman is affirmed.

III. The rejection of claims 26, 29, and 30 under 35 U.S.C. § 103(a) as
unpatentable over Selman, Clarke, Waksman, and Spears is affirmed.

IV. The rejection of claims 33 and 34 under 35 U.S.C. § 103(a) as
unpatentable over Selman, Clarke, and Feinbloom is affirmed.

V. The rejection of claims 35 and 36 under 35 U.S.C. § 103(a) as
unpatentable over Selman, Clarke, Feinbloom, and Stanton is
affirmed.

VI. The rejection of claims 14, 19, and 37-39 under 35 U.S.C. § 103(a) as
unpatentable over Anderson and Clarke is affirmed.

VII. The rejection of claims 31 and 32 under 35 U.S.C. § 103(a) as
unpatentable over Anderson, Clarke, and Ohtake is affirmed.

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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)(1)(iv)(2006).

AFFIRMED

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