Ex Parte van de Winkel

Board of Patent Appeals and Interferences

Sep 28, 2005

09820099 (B.P.A.I. Sep. 28, 2005)

1This decision supercedes the one mailed on September 21, 2005.
The opinion in support of the decision being entered today was not written for publication
and is not binding precedent of the Board
UNITED STATES PATENT AND TRADEMARK OFFICE
______________________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
______________________
Ex parte JAN G. J. van de WINKEL
______________________
Appeal No. 2005-1504
Application No. 09/820,099
______________________
ON BRIEF
_____________________
ELLIS, MILLS and GRIMES, Administrative Patent Judges.
ELLIS, Administrative Patent Judge.
DECISION ON APPEAL1
This is an appeal pursuant to 35 U.S.C. § 134 from the examiner’s final rejection
of claims 1 and 6-12. Claims 2-5 and 13-25 have been cancelled.
Claim 1 is representative of the subject matter on appeal and reads as follows:
1. A method for eliminating a target cell or antigen from the circulatory system of
a subject comprising administering to the subject a complex comprising
monomeric IgA or a portion thereof that binds to Fc"RI, linked to a second
portion which specifically binds the target cell or antigen.
Appeal No. 2005-1504
Application No. 09/820,099
2 We point out that the author’s last name in the publication which both the
examiner and the appellant refer to as “Shen” is “Li.” That is, the first author’s name is
Shen Li. Nevertheless, for purposes of consistency, we have also referred to the
publication as “Shen.”
2
The references relied upon by the examiner are:
Shen et al. (Shen) WO 98/23646 Jun. 4, 1998
Monteiro et al., “Cellular Distribution, Regulation, and Biochemical Nature of An Fc"
Receptor in Humans,” J. Exp. Med, vol. 171, pp. 597-613 (March 1990).
Claims 1 and 6-12 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Shen,2 Monteiro and the teachings of the specification.
Background
Antibodies are part of a class of proteins known as immunoglobulins.
Immunoglobulins are produced by the immune system in response to antigens; i.e.,
substances which are recognized as foreign by the body. Consequently, they are one
of the body’s most important defenses against disease.
There are five immunoglobulin isotypes- IgG, IgA, IgD, IgM and IgE. IgG is the
predominant isotype in human serum, but most of the immunoglobulin-producing cells in
the various mucosal and exocrine sites and along the intestinal tract make IgA
antibodies. IgA occurs in different molecular forms (monomeric, polymeric and
secretory) and subclasses (IgA1 and IgA2). Prior to the present invention, secretory IgA
(dimeric IgA) was known to interfere with microbial adherence to epithelial cells in the
intestines by forming a coat around the microorganism. According to the specification,
“the present invention is based on the discovery that monomeric (serum) IgA plays a
Appeal No. 2005-1504
Application No. 09/820,099
3
previously unknown important role in systemic immunity by virtue of its interaction with
Fc"R [IgA Fc receptor] expressed on Kupffer cells and other Fc"R-expressing cells
(e.g., neutrophils) present at the interface of the mucosal and systemic immune systems
(e.g., the sinusoidal lining of the liver).” Specification, p. 2, lines
20-24.
With respect to the Fc"R, the specification discloses that “[a] single class of IgA
receptor, Fc"RI or CD89, which binds to monomeric IgA” had “been identified and
characterized” by prior investigators. Id., p. 1, lines 6-7. It was also known in the art
that (I) “Fc"RI is constitutively expressed primarily of cytotoxic immune effector cells
including monocytes, macrophages, neutrophils, and eosinophils” and that they are
“capable of promoting effector cell function” (id., lines 8-10 and 28-29); (ii) “[b]inding of
ligand to Fc"R triggers phagocytosis and antibody mediated cell cytotoxicity in
leukocytes and Fc"R-bearing cell lines” (lines 29-30); (iii) “Fc"RI binds both antigen-
complexed and monomeric (serum) IgAI and IgA2”; and (iv) “[c]ross-linking Fc"RI on
myeloid effector cells, by polymeric IgA, IgA immune complexes, or mAb specific for
epitopes within or outside the ligand binding domain, stimulates degranulation,
superoxide release, secretion of inflammatory cytokines, endocytosis and phagocytosis”
(line 35 - p. 2, line 4).
Appeal No. 2005-1504
Application No. 09/820,099
3 We find that the examiner relies on Monteiro for its disclosure of the presence
of the Fc"R on Kupffer cells. A method of administering the complex described in claim
1 in Kupffer cells is limited to claim 9. Thus, given our disposition of this case, we need
not reach the teachings of this publication.
4
As indicated by claim 1, above, the present invention is said to be directed to a
method of administering a complex which comprises monomeric IgA, or a portion
thereof which binds to the IgA Fc receptor, Fc"RI, and a second “portion” which is
capable of binding to a target cell or antigen.
Discussion
The examiner argues that Shen discloses (I) “binding agents specific for the
Fc"R and [that] the binding agents triggers [sic, trigger] an Fc mediated effector cell
activity such as phagocytosis”; (ii)”bifunctional binding agents comprising an agent that
binds Fc"RI and a bacteria . . . or cancer cell or antigen . . . thereof”; (iii) a method of
administering the bifunctional agent to a subject intravenously; and (iv) “the binding
agents bind the Fc"R with the same affinity as a type of IgA which can be monomeric
IgA.” Answer, p. 3. With respect Monteiro,3 the examiner argues that the publication
evinces that “there is only a single class of IgA Fc receptor, Fc"RI, therefore since the
agent binds to Fc"RI, it would be obvious that the agent would bind to the Fc"RI
expressed on Kupffer cells. Id., pp. 3-4. The examiner concludes that
It would have been prima facie obvious to one of ordinary skill in the art at
the time the claimed invention was made to have used the complex comprising
monomeric IgA linked to a second antibody (bispecific agent) for the elimination
of a target cell or antigen.
Appeal No. 2005-1504
Application No. 09/820,099
5
One of ordinary skill in the art would have been motivated to and had a
reasonable expectation of success to have used the complex comprising
monomeric IgA linked to a second antibody (a bispecific agent or multispecific)
for the elimination of a target cell or antigen because Shen et al[.] teach Fc"Rs
are capable of interacting with IgA in the form of monomers and binding induces
phagocytosis . . . and Shen et al[.] teach that the binding agent binds with the
same affinity as monomeric IgA and that the binding agent does not inhibit the
binding of IgA [Answer, p. 4].
It is well established that the examiner has the initial burden under 35 U.S.C.
§ 103 to establish a prima facie case. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d
1443, 1444 (Fed. Cir. 1992); In re Piasecki, 745 F.2d 1468, 1471-72, 223 USPQ 785,
787-88 (Fed. Cir. 1984). To that end, it is the examiner’s responsibility to show that
some objective teaching or suggestion in the applied prior art, or knowledge generally
available in the art, would have led one of ordinary skill in the art to combine the
references to arrive at the claimed invention. Pro-Mold & Tool Co. v. Great Lakes
Plastics, Inc., 745 F.3d 1568, 1573, 37 USPQ2d 1626, 1629 (Fed. Cir. 1996).
Here, we find that the examiner has not provided any reason based on the
applied prior art as to why the claimed invention would have been obvious to one of
ordinary skill in the art. That is, if we look only at the subject matter recited in claim 1,
we find that it is directed to a method of administering a complex comprising (1)
monomeric IgA or a portion thereof which binds to Fc"RI; and (2) a portion which
specifically binds to a target cell or antigen. We agree with the examiner that Shen
teaches a bispecific complex having the second portion; i.e., a complex having a portion
which specifically binds to a target cell or antigen (page 1, lines 29-32); however, we do
not find that Shen teaches or suggests that the complex comprise monomeric IgA, or a
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portion thereof. To the contrary, although Shen recognizes that the receptor for IgA,
Fc"R, is capable of binding monomeric IgA (p. 3, lines 28-29) and that “[b]inding of IgA
to cells bearing these receptors induces a variety of effector functions, such as
phagocytosis, antibody dependent cellular cytotoxicity (ADCC), inflammatory mediator
release, lysozyme production, and superoxide anion production” (id., lines 29-32);
however, Shen teaches using other binding agents whose binding is not blocked by IgA.
For example, Shen discloses that “a preferred binding agent binds to a site on an IgA
receptor which is different from the binding site for IgA. . . . [such as] monoclonal
antibodies specific for different portions of the receptor” [emphases added]. Shen, p. 4,
lines 29-33; see also, p. 5, lines 10-12, lines 21-23 and lines 29-34. Shen further
discloses that the “preferred binding agents of the invention bind to the Fc"R with a
higher affinity than a type of IgA” [emphasis added]. Id., p. 6, lines 4-5. Thus, given
these and similar teachings found throughout the publication, we agree with the
appellant that Shen “teaches away” from using monomeric IgA.
Accordingly, it reasonably follows that we do not find that Shen would have
suggested to one of ordinary skill in the art a complex comprising monomeric IgA and a
compound which binds to a target cell or antigen. Rather, on this record, the only
suggestion we find to administer such a complex is in the appellant’s disclosure. Thus,
we find that the examiner has engaged in impermissible hindsight to arrive at the
conclusion that the claimed invention would have been obvious over Shen and
Monteiro. In re Fritch, 972 F.2d 1260, 1266, 23 USPQ2d 1780, 1784 (Fed. Cir. 1992);
Appeal No. 2005-1504
Application No. 09/820,099
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Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1138, 227 USPQ 543, 547 (Fed.
Cir. 1985); W.L. Gore & Assocs. v. Garlock, Inc., 721 F.2d 1540, 1553, 220 USPQ 303,
312-313 (Fed. Cir. 1983) cert. denied 469 U.S. 851 (1984)(“To imbue one of ordinary
skill in the art with knowledge of the invention in suit, when no prior art reference or
references of record convey or suggest that knowledge, is to fall victim to the insidious
effect of a hindsight syndrome wherein that which only the inventor taught is used
against its teacher”).
In view of the foregoing, the decision of the examiner is reversed.
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Application No. 09/820,099
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Another Issue
Upon return of the application to the corps, the examiner may wish to consider
whether the complex recited in claim 1 “reads on” monomeric IgA itself. If so, the
examiner should determine whether there is any prior art which teaches a method of
administering monomeric IgA to a subject.
REVERSED
JOAN ELLIS )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
DEMETRA J. MILLS ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
ERIC GRIMES )
Administrative Patent Judge )
JE/ki
Appeal No. 2005-1504
Application No. 09/820,099
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