Ex Parte Selman

Board of Patent Appeals and Interferences

May 13, 2008

10201164 (B.P.A.I. May. 13, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte STEVEN H. SELMAN
__________

Appeal 2008-0967
Application 10/201,164
Technology Center 3700
__________

Decided: May 13, 2008
__________

Before, DONALD E. ADAMS, DEMETRA J. MILLS, and
LORA M. GREEN, 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 obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
Representative claims follow.
16. A method for relieving the symptoms of a patient suffering with a
prostatic disorder comprising:

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Application 10/201,164

(a) administering to the patient an effective amount of a
photosensitive composition delivered by direct injection to the patient’s
prostate tissue such that the effective amount of photosensitive composition
accumulates in the prostatic tissue at a point in time prior to irradiation of
the prostatic tissue with an apparatus for diagnosing or treating prostatic
tissue comprising a catheter for insertion through the patient's prostatic
urethral lumen when the patient's prostatic contains no effective amount of
the photosensitive composition, the catheter having a proximal end and a
distal end, the catheter comprising at least one axially extending opening
therethrough for receiving a light delivery means;

(b) inserting the catheter through the patient's urethra;

(c) inserting the light delivery means through the catheter;

(d) determining the position of the light delivery means relative to the
prostatic tissue and surrounding tissue of the patient to ensure that the distal
end of the light delivery means is adjacent the prostatic tissue;

(e) irradiating the prostatic tissue by delivering light energy through
the distal end of the light delivery means to the prostatic tissue; the light
energy being delivered for a predetermined time and at a predetermined
wavelength sufficient to effectively treat the prostatic tissue, the light
delivery means distributing the light energy substantially evenly, whereby
the light energy is transmitted to the patient's prostate; and

(f) removing the catheter and the light delivery means from the
urethra of the patient.

18. The method of claim 16, wherein a first balloon is operatively
connected to the distal end of the catheter, which method further comprises
delivering a suitable quantity of fluid material into the first balloon prior to
insertion of the light delivery means into the catheter.

19. The method of claim 16, wherein a coaxially extending
transparent or second translucent balloon is placed adjacent the distal end of
the catheter for receiving a transparent or translucent material; which
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method further comprises delivering a suitable quantity of the transparent or
translucent material into the second balloon prior to irradiating the prostatic
tissue.

20. The method of claim 16, wherein the distal end of the catheter
further comprises a stop means; which method further comprises positioning
the stop means adjacent the patient’s bladder and sphincter muscle to ensure
placement of the catheter with the urethra at a point spaced apart from the
sphincter muscle and bladder of the patient.

Cited References
Hascoet et al. US 5,234,004 Aug. 10, 1993
Makower et al. WO 93/15664 Aug. 19, 1993

Windahl et al., The Lancet, “Photodynamic therapy of localized prostatic
cancer”, vol. 336, p. 1139 (Nov. 3, 1990).

Grounds of Rejection
1. Claims 16, 17, 25 and 26 stand rejected under 35 U.S.C. § 103(a)
as obvious over Windahl in view of Makower.
2. Claims 18-20 stand rejected under 35 U.S.C. § 103 as obvious over
Windhal in view of Makower and Hascoet.

DISCUSSION
Background
“This invention relates generally to the medical field and, more
particularly, to the use of photodynamic therapy to treat prostatic tissues, and
to the use of transurethral photodynamic therapy to treat malignant
transformation of the prostate tissue, such as obstructive carcinoma of the
prostate and inflammatory conditions of the prostate. The present invention
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involves treatment of a patient with prostatic disorders using a
photosensitive composition which accumulates in the prostatic tissue.”
(Spec. 1.)
In addition,
[v]arious types of prostatic tissue become hypertrophied or
increased in size, which increase does not necessarily involve
malignant transformation. While the causes of such hypertrophy of
the tissue are numerous, until the present invention, the treatments
of such hypertrophied tissue have various limitations. In particular,
benign prostatic hypertrophy (BPH) causes enlargement of the
prostate gland and/or constriction of the urethra. Benign prostatic
hypertrophy is a relatively common disorder in older males. Another
type of prostate disorder is cancer of the prostate, such as
obstructive carcinoma of the prostate. Still another type of prostate
disorder is prostatitis. Prostatitis is an inflammatory condition due to
an infective pathogen, such as a bacterium or other microbe. Often
prostatitis does not respond well to antibiotic treatment. In chronic
or severe cases of prostatitis, abscesses can form and destroy
prostatic tissue.

(Spec. 1.)

1. Claims 16, 17, 25 and 26 stand rejected under 35 U.S.C. § 103(a)
as obvious over Windahl in view of Makower. We select claim 16 as
representative of the rejection before us since Appellants have not separately
argued the claims. 37 C.F.R. 41.37(c)(1)(vii).
The Examiner finds that
Windahl et a1 teach a method as claimed except the particular
administration route of the photosensitive substance; the
balloon; and treatment of non-cancerous tissue … Makower et
a1 teach a method such as claimed … for placing the treatment
device in the prostatic urethra; … for insertion of the laser fiber
and determining the position thereof; … for irradiating the
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tissue; … for application of the photodynamic compound to the
treatment area directly; … for removal of the cannula with the
optical fiber after the treatment is completed; …for the use of
balloons on the shaft; … for the use of a balloon on the tip (tip
is extended as in figure 11); …for treatment of benign prostatic
hypertrophy) except for the explicit requirement that the light
delivery means distribute the light substantially evenly.

(Ans. 3.)

The Examiner concludes that
[i]t would have been obvious to the artisan of ordinary
skill to employ the administration route of Makower et al in the
method of Windahl et al, since this would photosensitize less
peripheral tissue and to a lesser degree; to employ the treatment
on benign prostate hypertrophy, since PDT is an appropriate
treatment modality for this disorder, as taught by Makower et
a1 or to employ the spherical radiator of Windahl et a1 in the
method of Makower et al, since this would provide uniform
irradiation and thus prevent over treatment of some areas and
under treatment of others, thus producing a method such as
claimed.

(Id. 3-4.)

Appellant, on the other hand, contends that “the Examiner has failed
to advance any factual basis to support the conclusion that it would have
been obvious to one of ordinary skill in the art to administer to the patient an
effective amount of photosensitive composition delivered by direct injection
to the patient's prostate tissue.” (Br. 4.) The Appellant further argues the
Examiner has not “advanced any factual basis to support the conclusion that
the administering is such that the effective amount of photosensitive
composition accumulates in the prostatic tissue.” (Id. at 4-5) Appellant
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argues that this is because Windahl indicates that the prostatic tissue has
been resected or removed and that Windahl does not directly inject prostatic
tissue. (Br. 8.)
We are not persuaded by this argument. To the contrary we find the
Examiner has presented evidence of direct injection into prostatic tissue of a
photosensitive composition. Windahl describes photodynamic therapy of
localized prostate cancer by injecting a photosensitive composition into the
treatment area (prostatic cavity) and irradiating the cavity tissue with a laser.
(Windhal, col. 1, 2nd ¶.) Makower also describes a photodynamic therapy
may be applied to the prostate using a compound which is specifically
targeted to particular cells and sensitive to selected light frequencies.
(Makower 20: 1-10.) In view of this one of ordinary skill in the art would
have understood that either the prostatic cavity or prostatic tissue could be
injected with a photosensitive composition and subjected to photodynamic
therapy.
In addition, Appellant argues that Makower fails to disclose that the
light delivery means distributes the light substantially evenly to the prostrate.
(Br. 5.) The Examiner responds, arguing that Makower describes irradiating
a spherical treatment area and that one of ordinary skill in the art would
reasonably understand that this would administer the light substantially
evenly to the patient's prostate. (Ans. 5; Makower 10:13-17.) We find no
error in the Examiner’s prima facie case of obviousness and no rebuttal
argument put forth by Appellant to the Examiner’s position.
In view of the above, the obviousness rejection is affirmed.

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2. Claims 18-20 are rejected under 35 U.S.C. 103(a) as being
unpatentable over Windahl in view of Makower and Hascoet. Each of
claims 18-20 have been argued separately by Appellant and therefore
we address each claim individually.
With respect to claims 18 and 20 the Examiner finds that
Hascoet “teach the use of balloons as well as material opaque to the
applied radiation.” (Ans. 4.) The Examiner concludes that
[i]t would have been obvious to the artisan of ordinary
skill to employ balloons and a stop means as taught by Hascoet
et a1 since this would secure the catheter (column 4, line 12-20)
and protect the bladder (see column 11, lines 5-13 and column
14, line 13-26) and sphincter (see column 17, lines 27 to 30), as
taught by Hascoet et al, thus producing a device such as
claimed.

(Ans. 4.)

Appellant contends that Hascoet fails to teach the use of
photosensitive compositions to treat prostatic tissue. (Br. 12.) However, the
Examiner relies additionally on the disclosures of Windahl and Makower to
meet this limitation discussed herein. Non-obviousness cannot be
established by attacking references individually where the rejection is based
upon the teachings of a combination of references. In re Merck & Co., Inc.,
800 F.2d 1091, 1097 (Fed. Cir. 1986). The test of obviousness is “whether
the teachings of the prior art, taken as a whole, would have made obvious
the claimed invention.” In re Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991).
Thus, we are not persuaded by Appellant’s argument.

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Appellant further argues that “Hascoet et al. does not teach the use of
a balloon to more evenly deliver light into the affected area of the prostate”
(Br. 11.)
The Examiner responds, arguing that it is the combination of
references that is being relied on to meet this limitation. The Examiner
contends that
Makower . . . teach the use of multiple balloons, both on
the shaft (see page 12, lines 1 to 20, note especially lines 14 to
20), describing the locking function of the balloon and noting
that the balloon can also serve a cooling function) and at the
distal end thereof (see page 17, lines 21 to 26). Hascoet et al.
teach the use of a cooling medium, which may be water, along
the shaft of the catheter, (see column 14, lines 26 to 39) and the
balloon connected to the distal end (element 22) can also be
filled with a liquid medium through which the radiation cannot
pass.

(Ans. 6.)

We initially note that claim 18 does not recite the intended use of the
balloon as argued by appellant, “to more evenly deliver light into the
affected area of the prostate.” (Ans. 9.) The issue then becomes, whether
the combination of references teaches a first balloon connected to the distal
end of a catheter which is fluid filled, as recited in claim 18. We agree with
the Examiner that the evidence of record supports that one of ordinary skill
in the art upon review of Windhal, Makower and Hascoet would have found
it obvious to place a balloon adjacent the distal end of the catheter for
receiving a transparent or translucent material and irradiating the tissue with
a laser. The rejection of claim 18 is affirmed.
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Appellant further argues that the cited references do not teach the
limitations of claim 19. (Br. 11.) With respect to claim 19, we find the
Examiner has presented evidence of a second balloon adjacent to the distal
of end of the catheter. For example, Makower describes a tip balloon
(located adjacent to the end of the catheter). (Makower 17, ll. 14-26.)
Hascoet describes a “rectal inflatable element 92 forming ballooned [sic]
fixed around [a] rectal probe” which is adjacent to the distal end of the
catheter. (Hascoet, col. 16, l. 67 to col 17, l. 8; Fig. 1.)
Appellant provides no further rebuttal argument to the evidence
presented by the Examiner. In view of the above, the rejection of claim 19
is affirmed.
Appellant further argues that the cited references do not teach the stop
means of claim 20. (Br. 11.) We find the Examiner has presented evidence
of stop means, as claimed. Hascoet discloses that balloon means (stop
means) lock the front end of the urethral probe in the bladder neck to
“protect from the heat the sensitive tissues other than the tissues to be
treated, such as the bladder and sphincter” (Hascoet, col. 11, ll. 5-13).
(Hascoet, col. 4, ll. 12-20; col 14, ll. 13-25.) Hascoet further discloses a
radioreflecting screen 22 (stop means) to protect tissues of the prostate.
(Hascoet, col. 17, ll. 48-50; 55-62.)
Appellant provides no further rebuttal argument to the evidence
presented by the Examiner. In view of the above, the rejection of claim 20
is affirmed.

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SUMMARY
The obviousness rejections are affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 CFR 1.136(a).
AFFIRMED
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