Ex Parte Stiefel

Patent Trial and Appeal Board

Nov 30, 2016

13207864 (P.T.A.B. Nov. 30, 2016)

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.
13/207,864 08/11/2011 Thomas STIEFEL 708766 6869
23460 7590 12/02/2016
LEYDIG VOIT & MAYER, LTD
TWO PRUDENTIAL PLAZA, SUITE 4900
180 NORTH STETSON AVENUE
CHICAGO, IL 60601-6731
EXAMINER
FISHER, ABIGAIL L
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
12/02/2016 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):
Chgpatent @ ley dig. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THOMAS STIEFEL1
Appeal 2015-001022
Application 13/207,864
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and
TAWEN CHANG, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a method of treating sepsis, systemic inflammatory response syndrome,
and/or septic shock in a patient. The Examiner rejects the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellant, the real party in interest is Biosyn Arzneimittel
GmbH. (App. Br. 2.)
Appeal 2015-001022
Application 13/207,864
STATEMENT OF THE CASE
Claims 1-20 are on appeal, and can be found in the Claims Appendix
of the Appeal Brief. Claim 1 is representative of the claims on appeal, and
reads as follows:
1. A method of treating sepsis, systemic inflammatory response
syndrome (SIRS), and/or septic shock in a patient, which
method comprises administering to the patient (a) a
pharmaceutical composition comprising a selenium containing
active substance comprising 100-2035 pg of selenium, (b) a
pharmaceutical composition comprising a corticoid-containing
active substance, and (c) a pharmaceutical composition
comprising insulin, whereby the patient is treated for sepsis,
SIRS, and/or septic shock.
Appellant requests review of the Examiner rejection of claims 1-20
under 35 U.S. C. § 103(a) as unpatentable over Van den Berghe,2 Briegel,3
and Forceville.4
Issue
Does the preponderance of the evidence of record support the
Examiner’s conclusion that the combination of references renders the
method of treating sepsis obvious? And if so, has Appellant provided
sufficient rebuttal evidence or evidence of unexpected results to overcome
the prima facie showing of obviousness?
2 Van den Berghe et al., Intensive Insulin Therapy in Critically III Patients,
345 New England J. Med. 1359-1367 (2001) (“Van den Berghe”).
3 Briegel et al., Low dose hydrocortisone infusion attenuates the systemic
inflammatory response syndrome, 72 Clin. Investig. 782-787 (1994)
(“Briegel”).
4 Forceville, WO 00/12101, published Mar. 9, 2000 (“Forceville”).
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Appeal 2015-001022
Application 13/207,864
Findings of Fact
We adopt the Examiner’s findings concerning the scope and content
of the prior art (Ans. 2-6), and provide the following findings for reference
convenience.
FF1. Van den Berghe teaches that “[gjlycemic control is a preventive
approach that is more broadly applicable to critically ill patients and
that reduced mortality during intensive care by more than 40 percent”
(Van den Berghe 1364). The goal of “intensive insulin therapy [is] to
maintain blood glucose at a level that did not exceed 110 mg per
deciliter” in critically ill patients {id. at 1363; see also 1360 (“Study
Design”)). Teaching that insulin therapy reduced “deaths from
multiple organ failure with sepsis regardless of whether there was a
history of diabetes or hypoglycemia” {id. at 1364).
FF2. Briegel teaches that “low-dose hydrocortisone infusion in patients
with septic shock decreased the febrile response and heart rate, and
increased the mean arterial pressure” (Briegel 785). “Infusion was
started with a loading dose of (100 mg in 30 min) and continued with
a constant infusion of 10 mg per hour” {id. at 783). “The infusion of
hydrocortisone at a dose of 10 mg/hr corresponds to the maximum
secretory rate achieved in corticotropin simulated healthy humans”
{id. at 786, see 784-785).
FF3. Forceville teaches the application of “2 to 40 mg, even 80 mg of
atomic selenium equivalent” for treating severe systemic
inflammatory response syndrome (Forceville, Abstract; see col. 2 165
to col. 3,1. 4).
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Appeal 2015-001022
Application 13/207,864
Principle of Law
It is prima facie obvious to combine two compositions each of
which is taught by the prior art to be useful for the same
purpose, in order to form a third composition which is to be
used for the very same purpose. . . . [T]he idea of combining
them flows logically from their having been individually taught
in the prior art.
In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980)(citations omitted).
Analysis
Based on the combination of Van den Berghe, Briegel, and Forceville,
the Examiner concludes that, at the time Appellant’s inventions was made, it
would have been prima facie obvious to combine “selenium, insulin and
hydrocortisone to treat sepsis. One of ordinary skill in the art would have
been motivated to utilize these three components together as they are all
individually taught as being effective for the treatment of sepsis” (Ans. 4, 9;
FF1-FF3).
Appellant contends that the experimental data shown in the
Specification “demonstrates synergistic effects for patients treated with
2035 pg of selenium on day 1 and 1035 pg of selenium per day after day 1,
which tested dosages span[ning] a significant portion of the claimed range of
100-2035 pg of selenium” (App. Br. 10; Reply Br. 35). Relying on]|8 of
Dr. Stiefel’s Declaration6, Appellant contends that the claimed combination
therapy achieves substantially superior results than with selenium alone,
5 We note that the Reply Brief makes a correction to the table shown on page
10 of the Appeal Brief, specifically indicating that the control group A is
treated with insulin to control blood sugar. (Reply Br. 3).
6 Declaration under 35 U.S.C. § 1.132 by Dr. Stiefel signed May 24, 2013.
4
Appeal 2015-001022
Application 13/207,864
further citing Angstwurm7 in support (App. Br. 11). In particular, Appellant
notes that “Angstwurm reports a reduction in mortality of only 14.3% with
selenium alone, whereas the claimed combination therapy results in a
reduction in mortality of 80%, such that the claimed combination therapy is
substantially superior to a selenium-only therapy” {id.).
We are not persuaded by Appellant’s contention. We note that the
reliance on Angstwurm in Dr. Stiefel’s Declaration ignores the contribution
made by insulin therapy and corticosteroid therapy in similarly situated
patients, each of which would be expected to contribute a beneficial effect
when applied as a combination therapy. We agree with the Examiner that
the data shown in the Specification and represented in table form in both the
Appeal Brief and Reply Brief show an improved mortality rate for the
combination; however, this is not sufficient to overcome prima facie
showing of obviousness {see App. Br. 10 and Reply Br. 3; see Ans. 10).
Specifically, the Examiner explains that the improved mortality rate is
shown for a single data point presented, but there is insufficient evidence in
the Specification or the Stiefel Declaration to establish an expectation that
this improvement in mortality rate would translate to the entire claimed
range {see App. Br. 10; Reply Br. 3; see also Ans. 10 (stating that
“appellants have only presented data at the highest data point claimed; they
have not established that the surprising unexpected results occur over the
entire claimed range”)). We agree with the Examiner’s position that each of
7 Angstwurm et al., Selenium in Intensive Care (SIC): Results of a
prospective randomized, placebo-controlled, multiple-center study in
patients with severe systemic inflammatory response syndrome, sepsis, and
septic shock, 35 Crit. Car. Med. 118-126 (2007), submitted with Form 1049
on July 18, 2013.
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Appeal 2015-001022
Application 13/207,864
the cited references individually shows that each claimed component results
in a reduction in mortality; therefore, the combination would be expected to
achieve at least an additive effect (see FF1-FF3). Because the data
presented in the Specification is at the upper limit of the claimed range for
each of the components there is insufficient evidence in the record to
establish that lower concentration in any one of the components would
produce the same effect, i.e., improvement in the mortality rate for septic
patients. Accordingly, we agree with the Examiner that disclosure of “one
data point [] is not commensurate in scope with the claimed invention.
While the declaration may argue one of skill in the art could reasonably
conclude [that the synergistic effects of combination therapy extend beyond
the particular dosage used in the study described in the Specification], there
is no evidence to support such a statement” (Ans. 10; see Stiefel Decl. ^ 9).
The preponderance of the evidence of record supports the Examiner’s
conclusion of obviousness and Appellant has not sufficiently rebutted the
Examiner’s prima facie case. We affirm the rejection of claim 1 based on
the combination of Van den Berghe, Briegel, and Forceville references.
Claims 2-20 were not separately argued and fall with claim 1.
SUMMARY
We affirm the rejection of all claims.
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
6