Ex Parte Coulter

Patent Trial and Appeal Board

Jan 4, 2017

13441780 (P.T.A.B. Jan. 4, 2017)

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.
13/441,780 04/06/2012 Ivan Coulter 8365-83989-02 2041
24197 7590 01/06/2017
KLARQUIST SPARKMAN, LLP
121 SW SALMON STREET
SUITE 1600
PORTLAND, OR 97204
EXAMINER
MAEWALL, SNIGDHA
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
01/06/2017 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):
tanya.harding@klarquist.com
docketing @klarquist.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IVAN COULTER
Appeal 2015-004451
Application 13/441,780
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a method
for treating celiac disease. The Examiner rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
Statement of the Case
Background
“The invention provides an oral composition comprising minicapsules
wherein the minicapsules comprise one or more therapeutic or prophylactic
substances in a liquid, semi-solid, or solid core, the minicapsules having
release profiles to release the substance in an active form at one or more
sites along the gastrointestinal tract” (Spec. 11:22—26).
1 Appellant identifies the Real Party in Interest as Sigmoid Pharma Limited
(see App. Br. 1).
Appeal 2015-004451
Application 13/441,780
The Claims
Claims 1—32 are on appeal. Claim 1 is representative and reads as
follows:
1. A method for treating [cjeliac disease, wherein the
method is selected from A or B:
A. a method comprising administering to a patient in
need thereof a composition comprising minicapsules, wherein
the minicapsules comprise a steroid in a liquid, semi-solid or
solid core, the minicapsules having release profiles to release
the steroid in an active form at one or more sites along the
gastrointestinal tract, the one or more sites comprising the
proximal small intestine beginning at the duodenum and ending
at the ileum; and
B. a method comprising administering budesonide to a
patient in need thereof in a solubilised drug delivery format.
The Issue
The Examiner rejected claims 1—32 under 35 U.S.C. § 103(a) as
obvious over Severin,2 Moodley,3 Patel,4 and Sandbom5 (Ans. 2—6).
The Examiner finds Severin teaches “therapy with budesonide (a
steroid) in patients with refractory sprue and with celiac disease” and that
“[ijnadvertent but also deliberate gluten intake is clearly the commonest
cause of apparent unresponsiveness to GFD [gluten free diet] in celiac
disease patients” (Ans. 3).
2 Severin Daum et al., Therapy with Budesonide in Patients with Refractory
Sprue, 73 Digestion 60—68 (2006) (“Severin”).
3 Moodley et al., US 2006/0018965 Al, published Jan. 26, 2006
(“Moodley”).
4 Patel et al., US 2003/0180352 Al, published Sept. 25, 2003 (“Patel”).
5 Sandbom et al., US 6,166,044, issued Dec. 26, 2000 (“Sandbom”).
2
Appeal 2015-004451
Application 13/441,780
The Examiner acknowledges that Severin “does not disclose use of
minicapsules as claimed for delivery of budesonide [for] treating celiac
disease” and does “not teach use of steroid in liquid, semi-solid or solid core
of minicapsules as claimed in claim 1” (Ans. 3).
The Examiner finds Moodley suggests use of a “microcapsule to
deliver the drugs such as steroids for the gastrointestinal treatment of
disease” (Ans. 3). The Examiner finds Moodley teaches the “dosage form
can be further coated to release the microcapsules at predetermined rates
and/or site of gastrointestinal sites” (Ans. 4).
The Examiner finds Patel teaches “targeted delivery of active
ingredients to duodenum, ileum and colon” (Ans. 5). The Examiner finds
Sandbom teaches “ileum delivery of nicotine and budesonide wherein the
active ingredient is coated with Eudragit L30D” (Ans. 5).
The Examiner concludes that it would have been obvious to
have utilized the microcapsule of Moodley et al. and administer
such microcapsule comprising budesonide to patients with
celiac disease with refractory sprue. One of ordinary skill
would have been motivated to do so because Moodley teaches .
. . the microcapsules can be coated to release the
pharmaceutically active ingredient at specific gastrointestinal
sites and for pre-determined rates and suggests use of steroids
in such microcapsules to be used in delivering the agent to [a]
predetermined site in gastrointestinal region.
(Ans. 4—5).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the prior art renders claim 1
obvious?
3
Appeal 2015-004451
Application 13/441,780
Findings of Fact
1. Severin teaches:
Refractory sprue (RS) is a malabsorption syndrome defined by
persisting villous atrophy, usually with an increase in
intraepithdial lymphocytes (IELs) in the small bowel in spite of
a strict gluten-free diet (GFD)[.] Persisting vinous atrophy has
been found in 5—8% of patients with celiac disease (CD),
including patients with persistent gluten intake.
(Severin 60, col. 2; citations omitted).
2. Severin teaches “[ljocally acting budesonide could replace
systemic corticosteroid therapy and reduce toxicity in patients with RS”
(Severin, abstract).
3. Severin teaches a “clinical long-term response (>12 months)
was documented in 7 patients (4 of 6 with underlying CD, 3 of 3 without
CD) for 21 months (range 14—60) under 6 mg of budesonide” (Severin 62,
col. 2).
4. Table 1 of Severin is reproduced, in part, below (Severin 63):
Chai^dariftks of paSctiR
* , S Kd j ? P< til' Po n't
AIE RSI R$ 3 .RSI RS s’ ES l\ RS li CD4 * R S11
rfCL
c. 9 3
P mS-ok >a j