Ex Parte Carroll

Board of Patent Appeals and Interferences

Oct 30, 2002

08304602 (B.P.A.I. Oct. 30, 2002)

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for publication and is not binding precedent of the Board.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. 35

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte SEAN B. CARROLL
__________

Appeal No. 2001-1298
Application No. 08/304,602
__________

ON BRIEF
__________

Before WINTERS, ADAMS 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 1-3, 5-29 and 31-34, which are all the claims
pending in the application.
Claim 1 is illustrative of the subject matter on appeal and is reproduced
below:
1. An antibiotic-antibody conjugate, comprising surface-active
antibiotic covalently bound via a non-carbodiimide cross-linker to
non-specific immunoglobulin having an Fc region wherein said
conjugate binds to bacteria via said antibiotic.
The references relied upon by the examiner are:

Hawiger et al. (Hawiger) 4,703,039 Oct. 27, 1987

Jawetz et al. (Jawetz), “Antimicrobioal Chemotherapy,” Review of Medical
Microbiology, pp. 122-135 and 142 (1984)
Appeal No. 2001-1298 Page 2
Application No. 08/304,602

Drabick et al. (Drabick), “Covalent Polymyxin B-starch and polymyxin B-
immunoglobulin conjugates as novel anti-endotoxin reagents,” Clinical Research,
Vol. 40, No. 2, p. 287 (1992)
GROUNDS OF REJECTION

Claims 1-3, 5-6, 8-21, 28, 29, 31 and 32 stand rejected under 35 U.S.C.
§ 103 as being unpatentable over Drabick in view of admitted prior art at pages
14-15, 26-28, 29 and 30 of appellant’s specification.
Claims 7, 23-27 and 34 stand rejected under 35 U.S.C. § 103 as being
unpatentable over Drabick in view of admitted prior art at pages 16-18 of
appellant’s specification, further in view of Jawetz and the admitted prior art on
page 24 (Table 2) of appellant’s specification.
Claims 22 and 33 stand rejected under 35 U.S.C. § 103 as being
unpatentable over Drabick in view of admitted prior art at page 16 of appellant’s
specification, further in view of Jawetz and the admitted prior art on page 24 of
appellant’s specification and further in view of Hawiger.
We reverse
DISCUSSION
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,
Appeal No. 2001-1298 Page 3
Application No. 08/304,602

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
Chemical Co., 837 F.2d 469, 473, 5 USPQ2d 1529, 1531 (Fed. Cir. 1988).
On this record, there are three separate rejections; each, however, relies
on the same primary reference (Drabick), therefore we will discuss the rejections
together.
According to the examiner (Answer, page 3), Drabick “teach a conjugate
comprising the surface active antibiotic Polymyxin B (PMB) covalently linked to
IgG which specifically binds Paeruginosa and has antiendotoxin activity.” The
examiner, however, recognizes (Answer, page 4) that Drabick “do not teach that
PMB and IgG are linked via a cross-linker….” To make up for this deficiency in
Drabick, the examiner finds (id.) that appellant’s specification admits that “cross-
linking agents for cross-linking biological molecules were known and available in
the art at the time [the] claimed invention was made.”
Therefore, the examiner concludes (id.), “[i]t would have been prima facie
obvious to one of ordinary skill in the art at the time the claimed invention was
made to cross[-]link IgG and PMB using any of the numerous cross-linking
agents known to those of ordinary skill in the art.”
In response, appellant argues (Brief, bridging paragraph, pages 9-10):
[I]n the present patent application, the claims all recite that
the binding of the components of the conjugate is via a
cross-linker. The Drabick abstract does not mention this
Appeal No. 2001-1298 Page 4
Application No. 08/304,602

limitation, thus giving no instruction of it or of the particular
cross[-]linking conditions necessary to provide the claimed
conjugates to one of ordinary skill in the art.
Because of the absence of any of this information
from Drabick, as well as absence of even a suggestion of
using crosslinking chemistry, it is improper to combine
Drabick with any other art. Since the reference cannot be
properly combined, there is no prima facie showing of
obviousness.

We agree with appellant.

As set forth in In re Kotzab, 217 F.3d 1365, 1369-70, 55 USPQ2d
1313, 1316 (Fed. Cir. 2000):
A critical step in analyzing the patentability of claims pursuant to
section 103(a) is casting the mind back to the time of invention, to
consider the thinking of one of ordinary skill in the art, guided only
by the prior art references and the then-accepted wisdom in the
field. … Close adherence to this methodology is especially
important in cases where the very ease with which the invention
can be understood may prompt one “to fall victim to the insidious
effect of a hindsight syndrome wherein that which only the
invention taught is used against its teacher.”
…
Most if not all inventions arise from a combination of old elements.
… Thus, every element of a claimed invention may often be found
in the prior art. … However, identification in the prior art of each
individual part claimed is insufficient to defeat patentability of the
whole claimed invention. … Rather, to establish obviousness based
on a combination of the elements disclosed in the prior art, there
must be some motivation, suggestion or teaching of the desirability
of making the specific combination that was made by the applicant.
[citations omitted]

In other words, “there still must be evidence that ‘a skilled artisan, ... with
no knowledge of the claimed invention, would select the elements from the cited
prior art references for combination in the manner claimed.’” Ecolochem Inc. v.
Appeal No. 2001-1298 Page 5
Application No. 08/304,602

Southern California Edison, 227 F.3d 1361, 1375, 56 USPQ2d 1065, 1075-76
(Fed. Cir. 2000). At best, the statement of the rejection establishes that
individual parts of the claimed invention were known in the prior art. The
statement of the rejection, however, does not establish the requisite suggestion
in the art to combine that knowledge. In this regard, we remind the examiner
that “a rejection cannot be predicated on the mere identification … of individual
components of claimed limitations. Rather particular findings must be made as
to the reason the skilled artisan, with no knowledge of the claimed invention,
would have selected these components for combination in the manner claimed.”
Ecolochem, 227, F.3d at 1375, 56 USPQ2d at 1076, quoting Kotzab, 217 F.3d at
1371, 55 USPQ2d at 1317.
The examiner relies (Answer, page 5) on Jawetz to “teach that the use of
antimicrobial drugs to treat Gram-positive microbial infections was known as was
the use of antimicrobial drugs in combination.” In addition, the examiner relies
(Answer, page 6) on Hawiger to teach the “conjugation of small peptides to
molecules such as immunoglobulin to increase their biological half-life.”
However, in our opinion, neither of these references make up for the deficiencies
found in the primary reference.

Accordingly, we reverse each of the three rejections under 35 U.S.C.
§ 103.
Appeal No. 2001-1298 Page 6
Application No. 08/304,602

REVERSED

Sherman D. Winters )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Donald E. Adams )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Lora M. Green )
Administrative Patent Judge )

DA/dym

Peter G Carroll
Medlen and Carroll
220 Montgomery Street ST 2200
San Francisco, CA 94104