Ex Parte Gunn et al

Patent Trial and Appeal Board

Apr 12, 2018

13359441 (P.T.A.B. Apr. 12, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/359,441 01/26/2012
24353 7590 04/16/2018
BOZICEVIC, FIELD & FRANCIS LLP
Bozicevic, Field & Francis
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
FIRST NAMED INVENTOR
Harold David Gunn
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.
GLHL-002CIP2CIP2CIP 2647
EXAMINER
LYONS, MARY M
ART UNIT PAPER NUMBER
1645
NOTIFICATION DATE DELIVERY MODE
04/16/2018 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):
docket@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HAROLD DAVID GUNN, SALIM DHANJI,
BRETT ANTHONY PREMACK and MICHAEL TAK HUAI CHOW
Appeal2017-003761
Application 13/359,441
Technology Center 1600
Before DONALD E. ADAMS, DEMETRA J. MILLS and FRANCISCO C.
PRATS, 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 reverse.
Appeal2017-003761
Application 13/359,441
STATEMENT OF CASE
The following claim is representative.
101. A method for treating symptoms of arthritis in a human patient
having arthritis that is symptomatic in a joint, comprising administering to
the patient a medicament comprising an effective amount of an antigenic
composition comprising antigenic determinants comprising whole killed cells
from only one bacterium, wherein the bacterium is a pathogen and is selected
on the basis that the pathogen is pathogenic in the joint, wherein the pathogen
is Staphylococcus aureus (S. aureus), wherein the arthritis is rheumatoid
arthritis, juvenile rheumatoid arthritis, or reactive arthritis, or is associated
with Crohn's disease or Lyme disease, wherein the administering is effective
in treating the symptoms of the arthritis in the joint.
Cited References
Mcintyre
Ahmad
WO 2005/049056 A2
WO 2009/013443 Al
Jun.2,2005
Jan. 29, 2009
Al-Ahaideb, Abdulaziz., "Septic arthritis in patients with rheumatoid
arthritis" Journal of Orthopaedic Surgery and Research, July 2008.
.
Grounds of Rejection
Claims 101-105, 108, 121, 124-127, 136-137 and 141 are rejected
under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mcintyre in view
of Ahmed and Al-Ahaideb.
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Application 13/359,441
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Final Action at
pages 2-19.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
"Obviousness requires a suggestion of all limitations in a claim."
CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
(citing In re Royka, 490 F .2d 981, 985 ( CCP A 197 4) ).
Obviousness Rejection
The Examiner finds that
Mcintyre et al. teach methods for treating humans having autoimmune
diseases, including rheumatoid arthritis, comprising administering an
effective amount of a whole cell, killed, pathogenic bacterial
composition which elicits a modification of the immune
system and thereby yields a therapeutic effect on the autoimmune
disease, particularly those which involve inflammation (i.e. is
effective in treating rheumatoid arthritis in a patient having
rheumatoid arthritis; e.g. pages 4, 6-7, 12; meeting limitations of
claim 101 ).
Ans. 3. The Examiner admits that Mcintyre does not teach a composition
comprises the bacteria Staphylococcus aureus. The Examiner relies on Al-
Ahaideb for teaching that
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Application 13/359,441
abnormal joint structure and pre-existing joint lesions in patients
having rheumatoid arthritis increases the susceptibility of these
patients to septic arthritis (i.e. bacterial arthritis; page 33,
"Pathogenesis" section). Al-Ahaideb teaches the association of
rheumatoid arthritis with septic arthritis has been recognized for over
50 years and chronically arthritic joints are predisposed to bacterial
infections (page 33, "Pathogenesis"). Al-Ahaideb teaches 93% of the
infections in patients with rheumatoid arthritis were caused by
Staphylococcus aureus (i.e. Staphylococcus aureus pathogen is
pathogenic in the joint; page 34, "Bacteriology"). Al- Ahaideb teaches
that in 76% of the cases in which a source of infection was found, the
most common source of the infection was the skin via rheumatoid
nodules and/or ulcerated calluses of a rheumatoid foot (i.e. requires
prior exposure to the infectious S. aureus; page 34, "Source of
Infection"; meeting limitations of instant claims 108, 136
and 137).
Ans. 4. In addition, Ahmad teaches
Ahmad et al. teach the use of an inactivated whole-cell staphylococcal
vaccine comprising whole-cell killed Staphylococcus aureus is
protective against the pathogenic bacterial species Staphylococcus
aureus (e.g. see page 1). Ahmad et al. teach inactivation of their
whole-cell bacterial vaccine compositions are achieved via heat
treatment or chemical treatment (i.e. the use of "killed" whole cell
composition; page 1 ). Ahmad et al. teach these vaccine compositions
are administered in effective amounts and are used for the prevention
of staphylococcal associated disorders, including arthritis (e.g., see
pages 5, 9-10 and 26).
Ans. 5.
The Examiner concludes that
it would have been prima facie obvious to a person of ordinary skill in
the art, at the time the invention was made, to modify a method for
treating a human patient having rheumatoid arthritis for the symptoms
of their arthritis, comprising administering an effective amount of an
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Application 13/359,441
antigenic composition comprising killed, whole cells from a bacterial
species, as taught by Mcintyre et al., by substituting the killed whole
cell bacterial formulation comprising Staphylococcus aureus, as
taught by Ahmad et al., thereby arriving at the claimed invention,
because the abnormal joint structure and pre-existing joint lesions in
patients having rheumatoid arthritis increased their susceptibility to
developing septic arthritis caused by Staphvlococcus aureus. as taught
by Al-Ahaideb and Ahmad et al., and septic arthritis could be
prevented by administering the killed, whole cell, staphylococcal
vaccine composition taught by Ahmad et al.
Ans. 8.
Appellants contend that
the combination of the cited references fails to teach or suggest using
S. aureus in a method for treating RA. Mcintyre at best suggests using
a specific type of bacteria (i.e., bacteria from the genera Rhodococcus,
Gordonia, Nocardia, Dietzia, Tsukamurella, and Nocordioides) for
treating an autoimmune disease such as RA. Importantly, Mcintyre
does not teach or even suggest that a bacterium other than the ones
from the specific genera taught in Mcintyre could be used in lieu of
these bacteria in the treatment of RA.
Similar to Mcintyre, none of the secondary references teach or suggest
that a bacteria from a different genera (i.e., not Rhodococcus,
Gordonia, Nocardia, Dietzia, Tsukamurella, and Nocordioides) could
be used to treat RA. While Al-Ahaideb supposedly teaches that RA
patients suffer from septic arthritis caused by S. aureus and Ahmad
allegedly teaches that S. aureus vaccines prevent S. aureus infection,
neither of these references teach or suggest use of S. aureus in
treatment of RA. In fact, none of these references teach or suggest
use of S. aureus in any treatment. Furthermore, there is no evidence of
record that would suggest that S. aureus is functionally equivalent to
the specific types of bacteria taught by Mcintyre. As such, there is no
teaching or suggestion by the combination of cited references to use S.
aureus in a method for treating RA.
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Application 13/359,441
Appeal Br. 6-7. Appellants further argue that, "Ahmad only teaches that a
vaccine may be used to prevent a S. aureus infection. It does not teach
or suggest that the disclosed vaccine could be used to treat symptomatic
septic arthritis in a joint, much less RA as claimed." Appeal Br. 10.
ANALYSIS
We do not find that the Examiner has provided evidence to support a
prima facie case of obviousness. In particular, we do not find that the
Examiner has provided evidence in the prior art of a method for treating
symptoms of arthritis in a human patient having arthritis that is symptomatic
in a joint. While Ahmad is a very good reference for teaching that a vaccine
may be used to prevent a S. aureus infection, we agree with Appellants that
Ahmad does not teach or suggest that the disclosed vaccine could be used to
treat symptomatic arthritis in a joint, as claimed. Appeal Br. 10.
We do not find that the Examiner has provided evidence that either Mcintyre
or Al-Ahaideb suggest treating a symptomatic arthritis in a joint, as claimed.
Furthermore, Mcintyre discloses that a whole cell of a bacterium from
any one of the actinomycete genera, Rhodococcus, Gordonia, Nocardia,
Dietzia, Tsukamurella and Nocardioides, administered to a test subject can
elicit a modification of the immune system, in particular the cellular immune
system of that test subject, such as a Thl or Th2 immune response. Spec. 1,
10. The Examiner has not established on the evidence before us that one of
ordinary skill in the art would have expected that substitution of S. aureus
for the bacteria of the actinomycete genera disclosed in Mcintyre would
elicit the same Thl or Th2 immune response, and thus would have been
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similarly useful in the treatment of rheumatoid arthritis in a symptomatic
joint.
CONCLUSION OF LAW
The cited references do not support the Examiner's obviousness
rejection, which is reversed. All pending, rejected claims fall.
REVERSED
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