Dadas, Christopher A. et al.

Patent Trials and Appeals Board

Jan 28, 2020

14722473 - (R) (P.T.A.B. Jan. 28, 2020)

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.
14/722,473 05/27/2015 Christopher A. Dadas 19420 (BOT) 8225
51957 7590 01/28/2020
ALLERGAN, INC.
2525 DUPONT DRIVE, T2-7H
IRVINE, CA 92612-1599
EXAMINER
BARRON, SEAN C
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
01/28/2020 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):
blake.morgan@allergan.com
pair_allergan@firsttofile.com
patents_ip@allergan.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte CHRISTOPHER A. DADAS and
TAMER ABOUSHWAREB
____________________

Appeal 2019-003280
Application 14/722,473
Technology Center 1600
____________________

Before DONALD E. ADAMS, ERIC B. GRIMES, and TAWEN CHANG,
Administrative Patent Judges.

CHANG, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
Appellant1 requests rehearing of the decision entered 18, 2019
(“Decision”), which entered a new ground of rejection of claim 1 as obvious
over Veeratterapillay and Schmidt.
We deny the requested relief.

DISCUSSION
Appellant contends that “Schmidt does not contemplate stones, much
less bladder calculi formation associated with bladder augmentation surgery,

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42.
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as one of the symptoms of urinary retention that can be treated by local
administration of botulinum toxin.” Req. Reh’g 2.
We are not persuaded. “Non-obviousness cannot be established by
attacking references individually where the rejection is based upon the
teachings of a combination of references. . . . [The reference] must be read,
not in isolation, but for what it fairly teaches in combination with the prior
art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
In this case, while Schmidt does not specifically mention bladder calculi
(i.e., stone) formation caused by bladder augmentation surgery,
Veeratterapillay teaches that bladder stones in augmentation cystoplasty are
thought to arise as a result of urinary stasis (i.e., retention), while Schmidt
similarly teaches that stones may be a symptom of urinary retention and
further teaches that administering a therapeutic amount of botulinum toxin
into the bladder wall of a patient with urinary retention can relieve said
urinary retention and/or a symptom thereof. Veeratterapillay 325; Schmidt
2:30–32; 5:61–66; 6:31–35; 7:42–47.
Appellant cites to other portions of Schmidt as teaching that
“botulinum can be used to treat urinary retention caused by a hypertrophied
bladder neck and/or symptoms of it,” that “[s]ymptoms of urinary retention
include recurrent bladder infection, incontinence, and urge incontinence,”
and that “preferred symptom[s] to relieve by methods of the present
invention include increased incidents of UTIs . . . or recurrent infection . . .
[,] urge incontinence and incontinence.” Req. Reh’g 2. These passages do
not render irrelevant Schmidt’s general teaching that bladder stones may be
a symptom of urinary retention and that botulinum toxin is useful for
treating symptoms of urinary retention: “It is well settled that a prior art
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reference is relevant for all that it teaches to those of ordinary skill in the
art,” not merely its preferred embodiments. In re Fritch, 972 F.2d 1260,
1264 (Fed. Cir. 1992). In short, the additional passages in Schmidt
Appellant cites do not support Appellant’s contention that “[n]owhere does
Schmidt consider stones as a symptom of urinary retention that is treatable
by botulinum toxin.” Id.
Appellant concedes that “Schmidt discloses that ‘[s]tones may also
form in the urinary tract of individuals with urinary retention caused by the
stoppage of urine flow and/or infection.’” Req. Reh’g 2. Appellant argues,
however, that Schmidt teaches that “urinary retention caused by a
hypertrophied bladder neck . . . can be treated by botulinum toxin” and “the
Board has not established that urinary retention caused by the stoppage of
urine flow and/or infection equates to urinary retention caused by a
hypertrophied bladder neck.” Id. Req. Reh’g 2 (emphasis added).
Appellant contends that Veeratterapillay adds nothing to Schmidt’s
disclosure on this point.
We are not persuaded. As discussed above, and contrary to
Appellant’s argument, Schmidt’s teaching is not limited to treatment of
urinary retention caused by a hypertrophied bladder neck. Rather, Schmidt
generally teaches that botulinum toxin may be used to treat urinary retention
and/or its symptoms. See, e.g., Schmidt Abstract (invention relates to
methods for treating urinary retention by administering botulinum toxin into
lower urinary tract of patient); 5:61–66 (generally teaching method for
relieving urinary retention and/or symptoms thereof by administering
botulinum toxin); 7:42–60 (teaching method of treating urinary retention
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where urinary retention is due to causes other than hypertrophied bladder
neck, including where urinary retention is due to idiopathic causes).
Appellant contends that, assuming Schmidt teaches that “stones are
symptoms of urinary retention caused by a hypertrophied bladder neck, the
fact that Schmidt is aware of stones but fails to list stones as a symptom
treatable by botulinum toxin does not support the Board’s position that
bladder calculi formation associated with bladder augmentation surgery is a
symptom of urinary retention treatable by botulinum toxin.” Req. Reh’g 2.
We are not persuaded for reasons similar to those already discussed
above. Schmidt teaches that stones may be a symptom of urinary retention
and that botulinum toxin can relieve urinary retention and/or a symptom
thereof. Schmidt 2:30–32; 5:61–66; 6:31–35; 7:42–47. The fact that
Schmidt does not list stones as a symptom of urinary retention treated by
botulinum toxin in its preferred embodiment does not render treatment of
stones by botulinum toxin non-obvious. In re Fritch, 972 F.2d at 1264.
Appellant contends that “the Board’s unspoken theory that a therapy
for any given disease (such as urinary retention) would necessarily treat
every condition/complication/symptom (such as the alleged stones) resulting
from the disease is baseless and lacks scientific support.” Req. Reh’g 3.
We are not persuaded. The obviousness rejection of claim 1 over
Veeratterapillay and Schmidt was not based on an “unspoken theory that a
therapy for any given disease . . . would necessarily treat every
condition/complication/symptom . . . resulting from the disease.” Rather, as
discussed above and in the Decision, the rejection is based on the teaching in
Veeratterapillay and Schmidt that bladder stones, including stones in
augmentation cystoplasty, may be a symptom of urinary retention, and
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Schmidt’s teaching that administration of botulinum toxin can relieve
urinary retention and/or its symptoms.
Finally, Appellant contends that, “under an analysis analogous to the
Board’s causative reasoning, evidence on the record, including Linsenmeyer
and Veeratterapially [sic], together actually teaches against using botulinum
toxin to treat bladder stone associated with bladder augmentation,” because
Veeratterapillay teaches that bladder stones are thought to arise as a result of
urinary retention, while Linsenmeyer teaches that one of botulinum toxin’s
side effects is urinary retention. Id. at 3–4.
We are not persuaded. Linsenmeyer does teach that urinary retention
is a potential adverse reaction following injection of botulinum neurotoxin A
for treatment of neurogenic detrusor overactivity. Linsenmeyer Abstract;
414, right column; 415, left column; Table 2. However, “[w]here the prior
art contains ‘apparently conflicting’ teachings (i.e., where some references
teach the combination and others teach away from it) each reference must be
considered ‘for its power to suggest solutions to an artisan of ordinary
skill. . . . consider[ing] the degree to which one reference might accurately
discredit another.’” Medichem S.A. v. Rolabo S.L., 437 F.3d 1157, 1165
(Fed. Cir. 2006) (quoting In re Young, 927 F2d 588, 591 (Fed. Cir. 1991)).
In this case, Linsenmeyer notes that, in one study at least, incidents of
urinary retention primarily occurred in patients with multiple sclerosis and
was also more frequent at higher dosages (e.g., 300 U). Linsenmeyer 415,
left column. Given this relatively limited teaching and especially given
Schmidt’s explicit teaching that botulinum toxin can relieve urinary
retention and its symptoms, we find that a skilled artisan would find the
method of claim 1 to be obvious in light of the combination of references
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despite Linsenmeyer’s teaching of urinary retention as a potential adverse
reaction following injection of botulinum neurotoxin A.

CONCLUSION
We have carefully reviewed the original decision in light of
Appellant’s request, but we find no point of law or fact which we
overlooked or misapprehended in arriving at our decision. Therefore,
Appellant’s request is denied with respect to making any modifications to
the Decision.

Outcome of Decision on Rehearing:

Claims 35 U.S.C § Reference(s)/Basis Denied Granted
1 103 Veeratterapillay,
Schmidt
1

Final Outcome of Appeal after Rehearing:

Claims 35 U.S.C.
§
Reference(s) /
Basis
Affirmed Reversed New
Ground
1–4, 7–9,
11, 13
103 Linsenmeyer,
Veeratterapillay
1–4, 7–9,
11, 13

1, 5–8,
10, 12
103 Linsenmeyer,
Veeratterapillay,
Brin
1, 5–8,
10, 12

14 103 Linsenmeyer,
Veeratterapillay,
Brin, Schmidt
14
1 103 Veeratterapillay,
Schmidt
1
Overall
Outcome
1–14 1

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Application 14/722,473

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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). See 37 C.F.R.
§ 1.136(a)(1)(iv).

REHEARING DENIED