Ex Parte Forbes et al

Patent Trials and Appeals Board

Mar 14, 2019

14282888 - (D) (P.T.A.B. Mar. 14, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/282,888 05/20/2014
120260 7590
Bass, Berry & Sims PLC
P.O. Box 14532
Washington, DC 20044
03/18/2019
FIRST NAMED INVENTOR
William Forbes
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
123958.0002.NPUSOO 9882
EXAMINER
BROWN-PETTIGREW, ANGELA C
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
03/18/2019 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):
BassBerryPatentDocket@bassberry.com
jwaack@bassberry.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILLIAM FORBES, ENOCH BORTEY,
CRAIG PATERSON, and PAM GOLDEN
(APPLICANT: SALIX PHARMACEUTICALS, INC.)
Appeal 2018-003 954
Application 14/282,888 1
Technology Center 1600
Before DONALD E. ADAMS, RYAN H. FLAX, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1 and 3-70
(Final Act. 2 1). Examiner entered rejections under 35 U.S.C. § 103(a). We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellants identify "Dr. Falk Pharma GmbH" as the real party in interest
(Appeal Brief (App. Br.) 2).
2 Examiner's February 7, 2017 Final Office Action.
Appeal2018-003954
Application 14/282,888
STATEMENT OF THE CASE
Appellants' disclosure relates to "methods of treating ulcerative colitis
in a subject" (Spec. 3 ,r 7). Claims 1 and 42 are representative and
reproduced below:
1. A method of treating ulcerative colitis (UC) in a subject with
hepatic impairment, comprising rectally administering a foam
composition comprising budesonide to the subject with hepatic
impairment at a dosing regimen of 2 mg budesonide BID for
two weeks followed by 2 mg budesonide QD for four weeks.
(App. Br. i.)
42. The method of claim 1, wherein the foam composition is
administered with a device comprising a canister and a
metering valve.
(Id. at vi.)
Grounds of rejection before this Panel for review:
I. Claims 1, 3--41, and 47-70 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Clinica1Trials4 and Budenofalk. 5
3 Appellants' May 20, 2014 Specification.
4 Clinical Trials.gov, A service of the U.S. National Institutes of Health,
http://web.archive.org/web/20111023143506/http://clinicaltrials.gov/ct2/sho
w/NCT01008423, last accessed Jan. 13, 2015.
5 BUDENOFALK FOAM EMEMA-Enema, Product Information 1-11,
available at http://www. aspenpharma. com. au/product_info/pi/Budenofalk_
foam_enema_PI_12Jun12.pdf) (June 12, 2012).
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Application 14/282,888
II. Claims 42--46 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Clinical Trials, Budenofalk, Salix, 6 and
Budenofalk Leaflet. 7
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. ClinicalTrials discloses a
study [] to establish the efficacy profile of rectally administered
budesonide foam administered as 2mg/25ml BID for 2 weeks
followed by 2mg/25ml OD for 4 weeks, as compared to an
equivalent volume of rectally administered placebo foam over
the same dosing schedule, in subjects who present with a
diagnosis of active, mild to moderate, ulcerative proctitis (UP)
or ulcerative proctosigmoiditis (UPS).
(ClinicalTrials, Purpose; see Ans. 4--5.)
FF 2. Examiner acknowledges that ClinicalTrials "does not teach [a]
patient having hepatic impairment" (Ans. 5).
FF 3. Budenofalk discloses:
[I]n patients with liver disease without hepatic cirrhosis oral
budesonide in daily doses of 3 mg TID was safe and well
tolerated. There is no evidence that a specific dose
recommendation for patients with non-cirrhotic liver diseases or
only slightly impaired liver function is necessary. As the
plasma levels of budesonide appear to be generally slightly
6 SALIX PHARMACEUTICALS, LTD., FORM 8-K, available at
http://google.brand.edgar-online.com/EFX_dll/EDGARpro.dll?
FetchFilingHTMLl ?ID=58 ... , last accessed Aug. 29, 2014.
7 Budenofalk 2mg/dose Rectal Foam, PACKAGE LEAFLET:
INFORMATION FOR THE USER, 1-8 (Mar. 2014).
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Application 14/282,888
higher with rectal budesonide, Budenofalk Foam Enema should
be used only with caution in patients with hepatic impairment.
(Budenofalk 4--5 ( emphasis added); see Ans. 5; see also Golden Dec. 8 ,r 9
("Those in the field understand the pharmacokinetics of budesonide to be
typically very sensitive to changes in hepatic function and expect to observe
an effect of hepatic function on budesonide pharmacokinetics regardless of
the route of administration selected"); Budenofalk 2: ("Compromised
hepatic function has an influence on the pharmacokinetics ofbudesonide
with a reduced elimination rate and increased oral systemic availability").)
FF 4. Examiner finds that the combination of Clinical Trials and
Budenofalk is "silent on how [] budesonide foam is administered" and relies
on Salix and Budenofalk leaflet to make up for this deficiency in the
combination of Clinical Trials and Budenofalk (Ans. 7-8).
ANALYSIS
Rejection I:
Based on the combination of Clinical Trials and Budenofalk, Examiner
concludes that, at the time Appellants' invention was made, it would have
been prima facie obvious to treat "UC in patients also having hepatic
impairment [because] budesonide is already used to treat patient[ s] suffering
from UC and is safe to use in hepatic impairment patients" (Ans. 5). We
find no error in Examiner's prima facie case of obviousness.
Appellants acknowledge Examiner's finding that ClinicalTrials "does
not teach [a] patient having hepatic impairment" (FF 2; see App. Br. 18).
Recognizing Examiner's reliance on Budenofalk to disclose administration
of budesonide to a subject with hepatic impairment, Appellants' direct
8 Declaration of Pamela L. Golden, signed Apr. 8, 2015.
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Application 14/282,888
attention to Budenofalk's disclosure that "Budenofalk Foam Enema should
be used only with caution in patients with hepatic impairment," because
"plasma levels ofbudesonide appear to be generally slightly higher with
rectal budesonide" (see FF 3; see App. Br. 18-19). Appellants contend that
Budenofalk's "cautionary language ... is with regard to a dosing regimen of
2 mg of budesonide daily; whereas, the claimed dosing regimen of the
instant application is twice that" (App. Br. 19 (emphasis original)). In this
regard, Appellants contend that notwithstanding Examiner's assertion to the
contrary, Budenofalk
simply does not teach that twice as much budesonide
administered rectally can be used safely in patients with hepatic
impairment - the strong, cautionary language teaches away
from delivery of the higher dosage to such patients because they
are vulnerable to potentially higher systemic levels of
budesonide due to their compromised liver function.
(Id. at 19-20.) We are not persuaded.
For a reference to teach away, it must state more than a general
preference for an alternative invention. It must "'criticize, discredit, or
otherwise discourage"' investigation into the invention claimed. DePuy
Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed.
Cir. 2009), quoting In re Fulton, 391 F.3d 1195, 1201 (Fed.Cir.2004). On
this record, Budenofalk simply directs a patient with hepatic impairment to
exercise caution when following a rectally administrable budesonide dosage
regimen (FF 3). Appellants fail to establish an evidentiary basis on this
record to support a conclusion that a disclosure that suggests the exercise of
caution teaches away from its combination with the rectally administrable
budesonide dosage regimen disclosed by ClinicalTrials. Stated differently,
we find nothing in Budenofalk that discredits, criticizes, or otherwise
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Application 14/282,888
discourages the rectal administration of budesonide according to
ClinicalTrials (see Final Act. 15 (Although "Budenofalk ... teaches caution
should be used when using the enema in patients with hepatic impairment, it
does not teach that [] the foam cannot be used with this particular patient
population")). Therefore, we are not persuaded by Appellants' contention
that ClinicalTrials in combination with Budenofalk teaches away from
Appellants' claimed invention (App. Br. 19-20).
As discussed above, ClinicalTrials discloses the dosage regimen
required by Appellants' claimed invention (FF 1 ). Budenofalk discloses the
administration of budesonide to patients with hepatic impairment (FF 3).
Although Budenofalk encourages the exercise of caution when rectally
administering budesonide to patients with hepatic impairment, we do not
find and Appellants do not identify a disclosure in Budenofalk that excludes
rectally administering the dosage regimen disclosed by ClinicalTrials to
patients with hepatic impairment. Even if, as Appellants' contend,
ClinicalTrials is a study plan (see App. Br. 21-22), we find no error in
Examiner's reliance on ClinicalTrials to suggest a rectally administered
budesonide dosage regimen.
Therefore, we find no error in Examiner's conclusion that it would
have been prima facie obvious to administer, with caution, the rectal dosage
of budesonide disclosed by Clinical Trials to subjects with hepatic
impairment as suggested by the combination of Clinical Trials and
Budenofalk (see Ans. 5; FF 1-3). We disagree with Appellants' assertion
that it would have been unexpected to follow the direction of the prior art
(see App. Br. 20 (citing Golden Dec. ,r 10)). Therefore, we are not
persuaded by Appellants' assertion of unexpected results. See, e.g., Senju
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Application 14/282,888
Pharmaceutical Co. v. Lupin Ltd., 780 F.3d 1337, 1353 (Fed. Cir. 2015)
("the district court properly considered evidence of unexpected results ...
and did no err in finding [the results] ... not unexpected").
To be complete, we note that the foregoing analysis does not rely
upon inherency; therefore, we are not persuaded by Appellants' contentions
regarding inherency (see App. Br. 21-23).
Rejection II:
Appellants' claim 42 depends from and further limits Appellants'
claim 1 to require that the foam composition is administered with a device
comprising a canister and a metering valve.
Based on the combination of Clinical Trials, Budenofalk, Salix, and
Budenofalk Leaflet, Examiner concludes that, at the time Appellants'
invention was made, it would have been prima facie obvious to use a device
comprising a canister and a metering valve to rectally administer a foam
composition comprising budesonide to a subject with hepatic impairment at
a dosing regimen of 2 mg budesonide BID for two weeks followed by 2 mg
budesonide QD for four weeks (see Ans. 7-8; cf App. Br. i and vi).
Having found no deficiency in the rejection of Appellants' claim 1
over ClinicalTrials and Budenofalk, we are not persuaded by Appellants'
contention that Salix and Budenofalk Leaflet fail to make up for Appellants'
asserted deficiencies in the combination of Clinical Trials and Budenofalk
(see App. Br. 23-24; cf Ans. 12-13).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
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Application 14/282,888
The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Clinical Trials and Budenofalk is affirmed. Claims
3--41 and 47-70 are not separately argued and fall with claim 1.
The rejection of claim 42 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Clinical Trials, Budenofalk, Salix, and Budenofalk
Leaflet is affirmed. Claims 43--46 are not separately argued and fall with
claim 42.
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).
AFFIRMED
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