Ex Parte Fischer

Board of Patent Appeals and Interferences

Apr 29, 2003

08460622 (B.P.A.I. Apr. 29, 2003)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

Paper No. 40

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte GERALD W. FISCHER
__________

Appeal No. 2001-1576
Application No. 08/460,622
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ON BRIEF
__________

Before ADAMS, MILLS and GREEN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal under 35 U.S.C. § 134 from the
examiner’s final rejection of claims 17 and 23, which are all the claims pending in
the application.
Claim 17 is illustrative of the subject matter on appeal and is reproduced
below:
17. A method of preparing a Directed Human Immune Globulin having
opsonophagocytic bactericidal activity against Staphylococcus
epidermidis for the prevention or treatment of Staphylococcus
epidermidis infections comprising the steps of:

(a) immunizing plasma donors with an S. epidermis vaccine
comprising antigens in the TCA extractions of whole cell S.
epidermidis; and

(b) removing plasma from said donors for Directed Human Immune
Globulins.
Appeal No. 2001-1576 Page 2
Application No. 08/460,622

The references relied upon by the examiner are:
(Sutherland) Separation and purification of bacterial antigens in HANDBOOK OF
EXPERIMENTAL IMMUNOLOGY pp. 2.11-12 (D.M. Weir, ed., 3rd ed., Blackwell
Scientific Publications, Oxford 1978)

Ichiman et al. (Ichiman), “Protective antibodies in human sera against
encapsulated strains of Staphylococcus epidermidis,” J. Applied Bacteriology,
Vol. 63, pp. 165-69 (1987)

Fischer, “Therapeutic Uses of Intravenous Gammaglobulin for Pediatric
Infections,” New Topics in Pediatric Infectious Disease, Vol. 35, No. 3, pp. 517-
33 (1988)

Etzioni et al. (Etzioni), “Effect of an Intravenous Gammaglobulin Preparation on
the Opsonophagocytic Activity of Preterm Serum against Coagulase-Negative
Staphylococci,” Acta Paediatrica Scandinavica, Vol. 79, pp. 156-61 (1990)

GROUNDS OF REJECTION
Claim 17 and 23 stand rejected under 35 U.S.C. § 103 as obvious over
Fischer in view of Etzioni and Sutherland.
Claim 17 and 23 stand rejected under 35 U.S.C. § 103 as obvious over
Ichiman in view of Sutherland.
We reverse.
BACKGROUND
According to appellant, Directed Human Immune Globulin is different from
standard human immune globulin preparations in that it has high levels of human
anti-staphylococcal antibodies that react with surface antigens of S. epidermidis
and enhance phagocytosis and killing of S. epidermidis in vitro,
(opsonophagocytic bactericidal activity greater than 80%). Specification, page 8.
Appeal No. 2001-1576 Page 3
Application No. 08/460,622

DISCUSSION
Fischer in view of Etzioni and Sutherland:
According to the examiner (Answer, page 4), “Fischer discloses that a
directed GBS [Group B Streptococcus]-specific immunoglobulin preparation was
prepared from pooled plasma obtained from volunteers immunized with a
pentavalent GBS vaccine (Sandoglobulin, GBS-IVIG) which had consistent high
titers of antibody to each GBS serotype (p. 522).” We note that in contrast to the
claimed invention that requires immunizing plasma donors with a Staphylococcus
epidermidis vaccine (claim 1, step (a)), Sandoglobulin is a directed group B
Streptococcus specific immunoglobulin preparation. Nevertheless, the examiner
finds (Answer, page 5), with reference to Etzioni, “that Sandoglobulin contains
antibodies against two different Staphyloccus epidermidis strains (page 160,
third full paragraph).”
The examiner also finds (Answer, page 4, emphasis removed), “Fischer
further teaches the preparation and selection of specific donors necessary to
produce highly active IGIV preparations which can be analyzed for functional
activity against staphylococci (p. 529).” We, however, are unable to find such an
affirmative statement in Fischer. Instead, as we read the reference, Fischer
provides nothing more than an invitation to experiment. According to Fischer
(bridging paragraph, pages 528-529, footnotes omitted), “[d]irected
immunoglobulin preparations could be produced by selecting plasma donors with
high levels of pathogen-specific antibody or by immunizing donors prior to
plasmapheresis. … Analysis of IVIG in vitro has shown functional activity for
Appeal No. 2001-1576 Page 4
Application No. 08/460,622

staphylococci, streptococci, and E. coli, Serratia, and Pseudomonas organisms.
Ultimate success will depend on well-characterized and standardized IVIG
products.” In other words, it would have been obvious to explore this general
approach that seems to be a promising field of experimentation, where the prior
art gave only general guidance as to the particular form of the claimed invention
or how to achieve it.
Therefore, we cannot agree with the examiner’s statement (Answer, page
5) that in view of the combination of Fischer with Etzioni “one of ordinary skill in
the art at the time the invention was made would have had a reasonable
expectation of success in producing a directed human immune globulin for
treatment of S. epidermidis infections….” As discussed above, it is our opinion
that Fischer does not provide a person of ordinary skill in the art with the
guidance necessary to establish a reasonable expectation of success. Instead,
Fischer simply invites others to experiment with directed IVIG against
staphylococcus and other bacteria. Stated differently, based on the teachings of
Fischer it would have been obvious-to-try to prepare a directed human immune
globulin having opsonophagocytic bactericidal activity against Staphylococcus
epidermidis; “obvious to try,” however, is not the standard of obviousness. In re
O’Farrell, 853 F.2d 894, 903-04, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988).
Furthermore, given the emphasis the examiner placed on Etzioni, and her
statement (Answer, page 5) that a person of ordinary skill in the art would have
had a reasonable expectation of success using a commercially available product,
such as Sandoglobulin, we are unable to identify any motivation for one of
Appeal No. 2001-1576 Page 5
Application No. 08/460,622

ordinary skill in the art at the time the invention was made to prepare a different
directed human immune globulin against Staphylococcus epidermidis, having
opsonophagocytic bactericidal activity as is required by the claimed invention.
We are also unable to identify from the evidence of record, any motivation
for the use of TCA extracted antigens. As the examiner points out (Answer,
page 6), “neither reference particularly discloses a method where [sic] the S.
epidermidis antigens are obtained by TCA extraction.” While the examiner
asserts (id.), Sutherland teaches “that teichoic acids of Gram-negative bacteria
are antigenic determinants and have great immunological importance,” the
examiner failed to identify any evidence suggesting that TCA extracts of S.
epidermidis would be useful in preparing a directed human immune globulin
having opsonophagocytic bactericidal activity against Staphylococcus
epidermidis as is required by the claimed invention. Prima facie obviousness
based on a combination of references requires that the prior art provide “a
reason, suggestion, or motivation to lead an inventor to combine those
references.” Pro-Mold and Tool Co. v. Great Lakes Plastics Inc., 75 F.3d 1568,
1573, 37 USPQ2d 1626, 1629 (Fed. Cir. 1996).
[E]vidence of a suggestion, teaching, or motivation to combine may
flow from the prior art references themselves, the knowledge of one
of ordinary skill in the art, or, in some cases, from the nature of the
problem to be solved. . . . The range of sources available, however,
does not diminish the requirement for actual evidence. That is, the
showing must be clear and particular.

In re Dembiczak, 175 F.3d 994, 999, 50 USPQ2d 1614, 1617 (Fed. Cir. 1999)
(citations omitted). The suggestion to combine prior art references must come
from the cited references, not from the application’s disclosure. See In re Dow
Appeal No. 2001-1576 Page 6
Application No. 08/460,622

Chemical Co., 837 F.2d 469, 473, 5 USPQ2d 1529, 1531 (Fed. Cir. 1988).
For the forgoing reasons it is our opinion that the examiner failed to meet
her burden1 of providing the evidence necessary to establish a prima facie case
of obviousness. Accordingly we reverse the rejection of claims 17 and 23 under
35 U.S.C. § 103 as obvious over Fischer in view of Etzioni and Sutherland.
Ichiman in view of Sutherland:
According to the examiner (Answer, page 8), “Ichiman et al[.] prepare the
IVIG in a method that is essentially the same as that which is instantly claimed,
i.e., injecting S.[ ]epidermidis antigens into subjects and removing plasma for
Directed Human Immune globulin.”
In our opinion, the examiner has misapprehended the Ichiman reference.
As appellants point out (Brief, page 29);
[t]here is no suggestion in Ichiman for any method of making
Directed Human Immune Globulin by immunizing donors with an S.
epidermidis vaccine and later withdrawing plasma containing anti-
S. epidermidis antibodies. Instead, Ichiman’s study assessed
whether or not normal human sera had sufficient antibody in it to
passively protect mice against challenge by S. epidermidis.

We agree with appellants. Sutherland relied upon by the examiner to teach TCA
extraction does not make up for the deficiency of Ichiman.
Accordingly we reverse the rejection of claims 17 and 23 under 35 U.S.C.
§ 103 as obvious over Ichiman in view of Sutherland.

1 The initial burden of presenting a prima facie case of obviousness rests on the examiner. In re
Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992).
Appeal No. 2001-1576 Page 7
Application No. 08/460,622

Having determined that the examiner has not established a prima facie
case of obviousness, we find it unnecessary to discuss the Declarations and
evidence of non-obviousness, relied on by appellants to rebut any such prima
facie case.
REVERSED

)
Donald E. Adams )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Demetra J. Mills )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Lora M. Green )
Administrative Patent Judge )

Appeal No. 2001-1576 Page 8
Application No. 08/460,622

FINNEGAN HENDERSON FARABOW
GARRETT AND DUNNER
1300 I STREET NW
WASHINGTON, DC 20005-3315

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