Ex Parte Bufe et al

Patent Trial and Appeal Board

Nov 8, 2017

12041553 (P.T.A.B. Nov. 8, 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.
12/041,553 03/03/2008 Albrecht Bufe WERK39.001AUS 1619
20995 7590 11/13/2017
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
EXAMINER
MARX, IRENE
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
11/13/2017 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):
jayna.cartee@knobbe.com
efiling @ knobbe. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALBRECHT BUFE, OTTO HOLST, HARALD RENZ,
ERIKA VON MUTIUS, JOHANN BAUER, NICOLE BLUMER,
JENNIFER DEBARRY, MARKUS EGE, SUSANNE FRIEDRICH,
HOLGER GARN SOREN GATERMANN, ANNA HANUSZKIEWICZ,
HOLGER HEINE, and MICHAEL WEGMANN
Appeal 2017-0037491
Application 12/041,553
Technology Center 1600
Before RICHARD M. LEBOVITZ, RYAN H. FLAX, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a method for reduction of the
likelihood of occurrence in a human subject of an allergic or chronic
1 The Appeal Brief (“Br.”) identifies FORSCHUNGSZENTRUM
BORSTEL, and PROTECTIMMUN GMBH as the real-parties-in-interest.
Br. 3.
Appeal 2017-003749
Application 12/041,553
inflammatory disorder comprising administering a Lactococcus bacteria
strain. The Examiner rejected the claims under 35 U.S.C. § 103 as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). The rejection is reversed.
STATEMENT OF THE CASE
Claims 12, 13, 15, 16, 18 and 19, the only pending claims in this
appeal, stand rejected under pre-AIA 35 U.S.C. § 103(a) as obvious in view
of Kilkkinen (Diabetologia, 2006, 49: 66—70), Kimoto (Microbial.
Immunol., 2004, 48(2): 75—82), Norton (FEMS Microbiology Letters, 1994,
120(3): 249-256), and Repa (Vaccine, 2003, 22: 87-95).2 Ans. 2.
Claim 12, the only independent on appeal, reads as follows:
12. A method for reduction of the likelihood of occurrence in a
human subject of an allergic or chronic inflammatory disorder
selected from the group consisting of IgE-dependent type I
allergies to at least one antigen, type IV allergies to at least one
antigen, chronic inflammatory cutaneous disorders resulting
from an allergy to at least one antigen and autoimmune diseases
directed against at least one antigen comprising:
administering intranasally to the human subject in the
first two years of life before symptoms of said allergic or
chronic inflammatory disorder occur, an effective amount of a
pharmaceutical composition consisting essentially of a naturally
occurring, non-transgenic, isolated Lactococcus bacteria strain
known to have no adverse effect on physical wellness or on
health from 1 to 21 times a week.
2 Three rejections under 35 U.S.C. § 112, first and second paragraphs, were
withdrawn by the Examiner. Ans. 2.
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Application 12/041,553
CLAIM INTERPRETATION
Claim 12 is a method “for reduction of the likelihood of occurrence in
a human subject of an allergic or chronic inflammatory disorder” where the
disorder is selected from a list of specific disorders. The method
“comprises” intranasal administration to a human within the first two years
of life before the symptoms of the disorder occur of “an effective amount of
a pharmaceutical composition.” The composition is defined as “consisting
essentially of a naturally occurring, non-transgenic, isolated Lactococcus
bacteria strain.”
“Consisting essentially of’ is a transition phrase
commonly used to signal a partially open claim in a patent.
Typically, “consisting essentially of’ precedes a list of
ingredients in a composition claim or a series of steps in a
process claim. By using the term “consisting essentially of,”
the drafter signals that the invention necessarily includes the
listed ingredients and is open to unlisted ingredients that do not
materially affect the basic and novel properties of the invention.
PPG Indus, v. Guardian Indus. Corp., 156 F.3d 1351, 1354 (Fed. Cir. 1998).
In this case, it is understood from the claim preamble that the
composition consisting essentially of the Lactococcus bacteria is delivered in
an effective amount to reduce the likelihood of occurrence in a human
subject of an allergic or chronic inflammatory disorder. The Specification
also teaches that the composition containing Lactococcus is for preventing
and treating allergic and inflammatory disorders. Spec. Tflf 12, 13. Based on
the claim language and the teaching in the Specification, we conclude that
“the basic and novel propert[y] of the invention” is the use of Lactococcus to
reduce the likelihood of occurrence in a human subject of an allergic or
chronic inflammatory disorder. Accordingly, we interpret “consisting
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Application 12/041,553
essentially of’ to exclude any ingredient that would affect the activity of the
composition in reducing the likelihood of the listed inflammatory disorders.
REJECTION
The Examiner found that Kimoto “disclose[s] the administration of
L[actococcus] lactis for the purpose of reducing the likelihood of occurrence
of allergic or chronic inflammatory disorders, such as Type I allergies” as
required by the claim. Non-Final Rejection (“Rej.”) 7. The Examiner
further cited Kimoto as evidence that Lactococcus “shows immune
modulation in vivo and that oral administration of the strain enhances the
Thl-type immune response.” Id. Based on their data, Kimoto concludes that
the “Strain G50 [Lactococcus] is a potential probiotic strain for the
suppression of hyper-sensitive reactions.” Kimoto 81. The Examiner also
cited Norton as disclosing that “the administration of L. lactis [Lactococcus]
to animals including baby mice, . . . stimulate[s] the immune system as a
whole.” Rej. 7. The Examiner acknowledged that Kimoto and Norton do
not disclose intranasal administration. Id. However, the Examiner found
that Repa “teach[es] the intranasal administration of L. lactis to reduce the
likelihood of acquiring hay fever.” Id. Based on these teachings, the
Examiner concluded that it would have been obvious to one of ordinary skill
in the art to modify the teachings in Kimoto and Norton
... by providing the L. lactis bacteria intranasally as suggested
by the teachings of Repa et al. to babies and children or other
humans for the expected benefit of stimulating the immune
system including mucosal immune system and more effectively
prevent the occurrence of unpleasant and debilitating allergic or
chronic inflammatory disorders, such as Type I allergies, Type
IV hypersensitivity and hay fever.
Id. 8.
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Application 12/041,553
Appellants contend that Repa teaches away from using Lactococcus
alone because:
Repa explicitly disclosed that an antigen must be administered
along with the Lactococcus bacteria in order to achieve the
allergy-relieving effects. Specifically, Repa teaches that “the
combined application of allergen and bacteria is needed for a
specific anti-allergic effect” (see page 93, second paragraph,
last sentence). In contrast, the method according to the claims
requires administering an effective amount of a pharmaceutical
composition consisting essentially of Lactococcus bacteria.
Appeal Br. 20 (emphasis in the original).
FINDINGS OF FACT (“FF”)
Repa teaches:
FF1.
In the present study, we tested the capacity of two LAB strains,
Lactococcus lactis MG 1363 (L. lactis, a dairy strain) and
Lactobacillus plantarum NCIMB8826 (L. plantarum, a human
isolate), to prevent or modulate allergic immune responses. At
first, we analyzed the cytokine profile induced by each LAB
strain in murine spleen cell cultures. Subsequent intranasal
application of these bacteria co-applied with the major birch
pollen allergen Bet v I-prior or after sensitization with the
allergen-indicates that such LAB strains are promising
candidates for mucosal vaccination against type I allergies.
Repa 88.
FF2.
Intranasal pre-treatment of BALB/c mice with L. lactis or L.
plantarum mixed with rBet v 1, followed by intraperitoneal
sensitization with rBet v l/Al(OH)3, induced high and
significant levels of allergen-specific IgG2a antibodies. . . .
Mice pre-treated with the LAB strains without rBet v 1, or
sham pre-treated with NaCl, produced very low (L. plantarum)
to undetectable (L. lactis, NaCl) levels of this isotype.
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Id. 91.
FF3.
The allergenic antibody activity of the sera of mice intranasally
pre-treated with LAB with or without Bet v 1 was determined
in three dilutions (1:10, 1:30 and 1:100) and compared to the
sham pre-treated sensitized control group. Sera from groups
intranasally pre-treated with L. lactis and Bet v 1 as well as L.
plantarum and Bet v 1 showed a significantly reduced capacity
to induce P-hexosaminidase release from rat basophils in
comparison to sera from sensitized control mice. In contrast,
pre-treatment with L. lactis or L. plantarum alone did not
reduce the allergen-induced basophil degranulation.
Id.
FF4.
Comparing mice treated with LAB or the mixture of LAB and
rBet v 1 subsequent to sensitization, a specific increase (3—4-
fold) in IgG2a levels was only seen in the groups treated with
LAB and rBet v 1 (Table 2).
Id. 92.
FF5.
The fact that pre-treatment with the bacteria alone did not result
in significant allergen-specific immunomodulation (i.e.
induction of IgG2a, enhanced IFN-y levels and reduced
basophil degranulation), indicates that the combined application
of allergen and bacteria is needed for a specific anti-allergic
effect.
Similarly as in the prophylactic approach, only the combined
treatment with LAB and the recombinant allergen subsequent to
sensitization-resulted in a substantial increase of allergen-
specific IgG2a.
Id. 93-94.
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DISCUSSION
The reason provided by the Examiner to utilize intranasal
administration of Lactococcus bacteria as required by all the claims in this
appeal is based on the teaching in Repa that such a route is effective to
reduce the likelihood of allergy. Rej. 7. Appellants argue that Repa also
requires the presence of an allergen, which is excluded by the claim because
of the recitation of “consisting essentially of’ with respect to the
composition having the Lactococcus. Appeal Br. 20—21. The Examiner
rejected this argument, construing the term “consisting essentially of’ to be
open-ended and the same as “comprising.” Ans. 4; Rej. 9. Thus, the
Examiner construed the claim to permit the inclusion of an allergen, either
before administration of the composition or within it. Ans. 4.
The Examiner’s broad interpretation of the claim is not reasonable.
As discussed above, based on the claim language and Specification, the
skilled worker would have found that any ingredient that materially affects
the properties of Lactococcus bacteria in reducing the likelihood of
occurrence in a human subject of an allergic or chronic inflammatory
disorder is excluded by the claim. The allergens utilized in Repa are said to
be useful for mucosal vaccination against allergy and act in combination
with the Lactococcus. FF1; Repa, Abstract. Moreover, Repa teaches that
the combination Lactococcus and allergen is necessary to achieve its anti­
allergic efficacy. FF5. Thus, the allergen materially affects the novel
properties of the claimed invention. Consequently, we agree with
Appellants that allergens are excluded from the claimed composition.
The Examiner’s rationale for not adopting this claim interpretation
appears to have been based on an enablement argument, i.e., that only one
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Application 12/041,553
Lactococcus strain was shown to work. Rej. 9-10. This argument is not
persuasive because whether the claims are enabled for their full scope (and
apparently the enablement rejection was withdrawn) is a separate question
from what falls within the scope of the claim in considering obviousness.
The principal issue in this appeal is, therefore, whether one of
ordinary skill in the art would have had reason to administer a composition
of Lactococcus bacteria alone to a human subject in the first two years of life
to achieve the claimed reduction of the likelihood of occurrence in of an
allergic or chronic inflammatory disorder. As indicated by Appellants, Repa
expressly teaches that Lactococcus, alone, when administered intranasally
and without allergen (“rBet v 1”) produced “undetectable” levels of antibody
(FF2) and did not reduce allergen-induced basophil degranulation (FF3).
Based on these results, Repa concluded “that the combined application of
allergen and bacteria is needed for a specific anti-allergic effect.” FF5.
Thus, because Repa expressly teaches that the allergen is needed to
achieve the anti-allergic effect, one of ordinary skill would have been led
away from administering the Lactococcus alone as a composition. “A
reference may be said to teach away when a person of ordinary skill, upon
reading the reference, would be discouraged from following the path set out
in the reference, or would be led in a direction divergent from the path that
was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir.
1994). Thus, we agree with Appellants’ contention that Repa teaches away
because its disclosure that only a combination of both Lactococcus and
allergen worked when applied intranasally would have discouraged the
skilled worker from administering Lactococcus alone.
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Application 12/041,553
In reaching this determination, we recognize that the claim, itself, is
open-ended “method . . . comprising”) and does not exclude a separate step
or separate pharmaceutical composition of administering an allergen.
However, the Examiner did not provide a reason to have administered the
allergen separately or sequentially from the Lactococcus, particularly when
Repa expressly describes a “combined” approach as needed (FF5) and
achieved it by mixing Lactococcus with antigen (FF2, FF4).
The obviousness rejection of independent claims 12 and dependent
claims 13, 15, 16, 18 and 19 is reversed.
REVERSED
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